Document and Entity Information
Document and Entity Information | 9 Months Ended |
Sep. 30, 2021 | |
Document and Entity Information [Abstract] | |
Document Type | POS AM |
Entity Registrant Name | Humacyte, Inc. |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | true |
Entity Ex Transition Period | false |
Entity Central Index Key | 0001818382 |
Amendment Flag | true |
Amendment Description | Humacyte, Inc., a Delaware corporation, filed with the Securities and Exchange Commission (the "SEC") a Registration Statement on Form S-1 on September 17, 2021, as amended on October 22, 2021 by Pre-Effective Amendment No. 1 to the Registration Statement on Form S-1, which was declared effective by the SEC on October 25, 2021 (as amended, the "Registration Statement"). This Post-Effective Amendment No. 1 to the Registration Statement is being filed in order to update disclosures in the registration statement reflecting the filing by Humacyte, Inc. of its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021, and to make certain other updates. Unless otherwise noted, all common and preferred share and related price information has been retroactively adjusted to give effect to the Exchange Ratio established in the Business Combination Agreement (each as defined in this prospectus). |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
Current assets | ||||
Cash and cash equivalents | $ 240,449 | $ 39,929 | $ 93,713 | |
Accounts receivable | 240 | 113 | 601 | |
Prepaid expenses | 3,490 | 1,407 | 640 | |
Total current assets | 244,179 | 41,449 | 94,954 | |
Finance lease right-of-use assets, net | 21,947 | 23,492 | 25,552 | |
Operating lease right-of-use assets, net | 738 | 769 | 897 | |
Property and equipment, net | 36,499 | 40,978 | 47,288 | |
Total assets | 303,363 | 106,688 | 168,691 | |
Current liabilities | ||||
Accounts payable | 5,830 | 2,274 | 3,272 | |
Accrued expenses | 9,422 | 4,592 | 6,000 | $ 7,049 |
PPP loan payable, current portion | 2,451 | |||
Deferred payroll tax, current portion | 145 | 145 | ||
Finance lease obligation, current portion | 1,915 | 1,729 | 1,500 | |
Operating lease obligation, current portion | 44 | 42 | 70 | |
SVB loan payable, current portion | 3,889 | |||
Total current liabilities | 21,245 | 11,233 | 10,842 | |
PPP loan payable, net of current portion | 822 | |||
Deferred payroll tax, net of current portion | 144 | 144 | ||
Finance lease obligation, net of current portion | 21,627 | 23,090 | 24,819 | |
Operating lease obligation, net of current portion | 693 | 727 | 829 | |
Contingent earnout liability | 169,200 | |||
SVB loan payable, net of current portion | 14,038 | |||
Common stock warrant liabilities | 555 | |||
Total liabilities | 227,502 | 36,016 | 36,490 | |
Commitments and contingencies (Note 11) | ||||
Redeemable convertible preferred stock (Series A, B, C and D) $0.001 par value, 0 and 69,613,565 shares authorized as of September 30, 2021 and December 31, 2020, respectively; 0 and 69,613,562 shares outstanding as of September 30, 2021 and December 31, 2020, respectively; liquidation preference of $0 and $435,579 as of September 30, 2021 and December 31, 2020, respectively. | 420,989 | 420,989 | ||
Stockholders' equity (deficit) | ||||
Preferred stock, $0.0001 par value; 20,000,000 and 0 shares designated as of September 30, 2021 and December 31, 2020; 0 shares issued and outstanding as of September 30, 2021 and December 31, 2020 | ||||
Common stock, $0.0001 and $0.0001 par value as of September 30, 2021 and December 31, 2020, respectively; 250,000,000 and 340,216,780 shares authorized as of September 30, 2021 and December 31, 2020, respectively; 103,003,384 and 5,822,396 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively. | 10 | 1 | 1 | |
Additional paid-in capital | 533,009 | 37,778 | 32,783 | |
Accumulated deficit | (457,158) | (388,096) | (321,572) | $ (234,289) |
Total stockholders' equity (deficit) | 75,861 | (350,317) | (288,788) | |
Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | $ 303,363 | $ 106,688 | $ 168,691 |
Balance sheet (Parenthetical)
Balance sheet (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2021 | Aug. 26, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Balance Sheets | ||||
Redeemable convertible preferred stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | |
Redeemable convertible preferred stock, shares authorized | 0 | 69,613,565 | 69,613,565 | |
Redeemable convertible preferred stock, shares outstanding | 0 | 69,613,562 | 69,613,562 | |
Redeemable convertible preferred stock, liquidation preference | $ 0 | $ 435,579 | $ 435,579 | |
Preferred stock, par value | $ 0.0001 | $ 0.0001 | ||
Preferred stock, shares designated | 20,000,000 | 0 | ||
Preferred stock, shares issued | 0 | 0 | ||
Preferred stock, shares outstanding | 0 | 0 | ||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 250,000,000 | 340,216,780 | 340,216,780 | |
Common stock, shares issued | 103,003,384 | 5,822,396 | 5,627,157 | |
Common stock, shares outstanding | 103,003,384 | 103,003,384 | 5,822,396 | 5,627,157 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||
Grant Revenue | $ 241 | $ 914 | $ 1,086 | $ 1,367 | $ 1,491 | $ 6,187 |
Operating expenses: | ||||||
Research and development (includes related party expenses of $2 and $149 for the three months ended September 30, 2021 and 2020 and $168 and $462 for the nine months ended September 30, 2021 and 2020) | 15,386 | 14,692 | 45,091 | 40,879 | 54,078 | 75,603 |
General and administrative | 5,398 | 3,435 | 15,576 | 9,416 | 12,013 | 16,275 |
Total operating expenses | 20,784 | 18,127 | 60,667 | 50,295 | 66,091 | 91,878 |
Loss from operations | (20,543) | (17,213) | (59,581) | (48,928) | (64,600) | (85,691) |
Other expenses, net: | ||||||
Interest income | 3 | 2 | 6 | 277 | 278 | 2,567 |
Change in fair value of contingent earnout liability | (9,768) | (9,768) | ||||
Interest expense | (1,204) | (549) | (2,952) | (1,661) | (2,202) | (2,298) |
Transaction costs expensed | (49) | (49) | ||||
Change in fair value of common stock warrant liabilities | (2) | (2) | ||||
Gain on PPP loan forgiveness | 3,284 | |||||
Total other expenses, net | (11,020) | (547) | (9,481) | (1,384) | (1,924) | 269 |
Net loss and comprehensive loss | $ (31,563) | $ (17,760) | $ (69,062) | $ (50,312) | $ (66,524) | $ (85,422) |
Net loss per share attributable to common stockholders, basic | $ (0.72) | $ (3.07) | $ (3.69) | $ (8.74) | ||
Net loss per share attributable to common stockholders, diluted | $ (0.72) | $ (3.07) | $ (3.69) | $ (8.74) | ||
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic | 43,950,856 | 5,788,130 | 18,728,471 | 5,755,418 | ||
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, diluted | 43,950,856 | 5,788,130 | 18,728,471 | 5,755,418 | ||
Net loss per share attributable to common stockholders, basic and diluted | $ (11.54) | $ (16.17) | ||||
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted | 5,765,688 | 5,283,628 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations and Comprehensive Loss (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||
Related party expenses | $ 2 | $ 149 | $ 168 | $ 462 | $ 620 | $ 571 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Redeemable Convertible Preferred Stock. | Common Stock | Additional Paid-in Capital | Accumulated DeficitCumulative Effect Adjustment | Accumulated Deficit | Cumulative Effect Adjustment | Total |
Balance at the beginning at Dec. 31, 2018 | $ 420,989 | ||||||
Balance at the beginning (in shares) at Dec. 31, 2018 | 69,613,562 | ||||||
Balance at the end at Dec. 31, 2019 | $ 420,989 | $ 420,989 | |||||
Balance at the end (in shares) at Dec. 31, 2019 | 69,613,562 | 69,613,562 | |||||
Balance at the beginning at Dec. 31, 2018 | $ 1 | $ 27,108 | $ (234,289) | $ (207,180) | |||
Balance at the beginning (in shares) at Dec. 31, 2018 | 5,006,326 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options | 1,218 | $ 1,218 | |||||
Proceeds from the exercise of stock options (in shares) | 620,831 | 620,831 | |||||
Net loss | (85,422) | $ (85,422) | |||||
Stock-based compensation | 4,457 | 4,457 | |||||
Balance at the end (ASU 2016-02) at Dec. 31, 2019 | $ (1,861) | $ (1,861) | |||||
Balance at the end at Dec. 31, 2019 | $ 1 | 32,783 | (321,572) | (288,788) | |||
Balance at the end (in shares) at Dec. 31, 2019 | 5,627,157 | ||||||
Balance at the end at Mar. 31, 2020 | $ 420,989 | ||||||
Balance at the end (in shares) at Mar. 31, 2020 | 69,613,562 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options | 175 | 175 | |||||
Proceeds from the exercise of stock options (in shares) | 148,159 | ||||||
Net loss | (17,674) | (17,674) | |||||
Stock-based compensation | 1,182 | 1,182 | |||||
Balance at the end at Mar. 31, 2020 | $ 1 | 34,140 | (339,246) | (305,105) | |||
Balance at the end (in shares) at Mar. 31, 2020 | 5,775,316 | ||||||
Balance at the beginning at Dec. 31, 2019 | $ 420,989 | $ 420,989 | |||||
Balance at the beginning (in shares) at Dec. 31, 2019 | 69,613,562 | 69,613,562 | |||||
Balance at the end at Sep. 30, 2020 | $ 420,989 | ||||||
Balance at the end (in shares) at Sep. 30, 2020 | 69,613,562 | ||||||
Balance at the beginning (ASU 2016-02) at Dec. 31, 2019 | (1,861) | (1,861) | |||||
Balance at the beginning at Dec. 31, 2019 | $ 1 | 32,783 | (321,572) | $ (288,788) | |||
Balance at the beginning (in shares) at Dec. 31, 2019 | 5,627,157 | ||||||
Equity | |||||||
Net loss | (50,312) | ||||||
Balance at the end at Sep. 30, 2020 | $ 1 | 36,484 | (371,884) | (335,399) | |||
Balance at the end (in shares) at Sep. 30, 2020 | 5,788,877 | ||||||
Balance at the beginning at Dec. 31, 2019 | $ 420,989 | $ 420,989 | |||||
Balance at the beginning (in shares) at Dec. 31, 2019 | 69,613,562 | 69,613,562 | |||||
Balance at the end at Dec. 31, 2020 | $ 420,989 | $ 420,989 | |||||
Balance at the end (in shares) at Dec. 31, 2020 | 69,613,562 | 69,613,562 | |||||
Balance at the beginning (ASU 2016-02) at Dec. 31, 2019 | $ (1,861) | $ (1,861) | |||||
Balance at the beginning at Dec. 31, 2019 | $ 1 | 32,783 | (321,572) | $ (288,788) | |||
Balance at the beginning (in shares) at Dec. 31, 2019 | 5,627,157 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options | 301 | $ 301 | |||||
Proceeds from the exercise of stock options (in shares) | 195,239 | 195,239 | |||||
Net loss | (66,524) | $ (66,524) | |||||
Stock-based compensation | 4,694 | 4,694 | |||||
Balance at the end at Dec. 31, 2020 | $ 1 | 37,778 | (388,096) | (350,317) | |||
Balance at the end (in shares) at Dec. 31, 2020 | 5,822,396 | ||||||
Balance at the beginning at Mar. 31, 2020 | $ 420,989 | ||||||
Balance at the beginning (in shares) at Mar. 31, 2020 | 69,613,562 | ||||||
Balance at the end at Jun. 30, 2020 | $ 420,989 | ||||||
Balance at the end (in shares) at Jun. 30, 2020 | 69,613,562 | ||||||
Balance at the beginning at Mar. 31, 2020 | $ 1 | 34,140 | (339,246) | (305,105) | |||
Balance at the beginning (in shares) at Mar. 31, 2020 | 5,775,316 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options | 48 | 48 | |||||
Proceeds from the exercise of stock options (in shares) | 11,761 | ||||||
Net loss | (14,878) | (14,878) | |||||
Stock-based compensation | 1,114 | 1,114 | |||||
Balance at the end at Jun. 30, 2020 | $ 1 | 35,302 | (354,124) | (318,821) | |||
Balance at the end (in shares) at Jun. 30, 2020 | 5,787,077 | ||||||
Balance at the end at Sep. 30, 2020 | $ 420,989 | ||||||
Balance at the end (in shares) at Sep. 30, 2020 | 69,613,562 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options | 12 | 12 | |||||
Proceeds from the exercise of stock options (in shares) | 1,800 | ||||||
Net loss | (17,760) | (17,760) | |||||
Stock-based compensation | 1,170 | 1,170 | |||||
Balance at the end at Sep. 30, 2020 | $ 1 | 36,484 | (371,884) | (335,399) | |||
Balance at the end (in shares) at Sep. 30, 2020 | 5,788,877 | ||||||
Balance at the beginning at Dec. 31, 2020 | $ 420,989 | $ 420,989 | |||||
Balance at the beginning (in shares) at Dec. 31, 2020 | 69,613,562 | 69,613,562 | |||||
Balance at the end at Mar. 31, 2021 | $ 420,989 | ||||||
Balance at the end (in shares) at Mar. 31, 2021 | 69,613,562 | ||||||
Balance at the beginning at Dec. 31, 2020 | $ 1 | 37,778 | (388,096) | $ (350,317) | |||
Balance at the beginning (in shares) at Dec. 31, 2020 | 5,822,396 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options | 206 | 206 | |||||
Proceeds from the exercise of stock options (in shares) | 116,149 | ||||||
Net loss | (20,301) | (20,301) | |||||
Stock-based compensation | 2,528 | 2,528 | |||||
Issuance of warrants in conjunction with debt | 2,360 | 2,360 | |||||
Balance at the end at Mar. 31, 2021 | $ 1 | 42,872 | (408,397) | (365,524) | |||
Balance at the end (in shares) at Mar. 31, 2021 | 5,938,545 | ||||||
Balance at the beginning at Dec. 31, 2020 | $ 420,989 | $ 420,989 | |||||
Balance at the beginning (in shares) at Dec. 31, 2020 | 69,613,562 | 69,613,562 | |||||
Balance at the end (in shares) at Sep. 30, 2021 | 0 | ||||||
Balance at the beginning at Dec. 31, 2020 | $ 1 | 37,778 | (388,096) | $ (350,317) | |||
Balance at the beginning (in shares) at Dec. 31, 2020 | 5,822,396 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options (in shares) | 188,006 | ||||||
Net loss | $ (69,062) | ||||||
Balance at the end at Sep. 30, 2021 | $ 10 | 533,009 | (457,158) | 75,861 | |||
Balance at the end (in shares) at Sep. 30, 2021 | 103,003,384 | ||||||
Balance at the beginning at Mar. 31, 2021 | $ 420,989 | ||||||
Balance at the beginning (in shares) at Mar. 31, 2021 | 69,613,562 | ||||||
Balance at the end at Jun. 30, 2021 | $ 420,989 | ||||||
Balance at the end (in shares) at Jun. 30, 2021 | 69,613,562 | ||||||
Balance at the beginning at Mar. 31, 2021 | $ 1 | 42,872 | (408,397) | (365,524) | |||
Balance at the beginning (in shares) at Mar. 31, 2021 | 5,938,545 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options | 30 | 30 | |||||
Proceeds from the exercise of stock options (in shares) | 5,204 | ||||||
Net loss | (17,198) | (17,198) | |||||
Stock-based compensation | 2,930 | 2,930 | |||||
Balance at the end at Jun. 30, 2021 | $ 1 | 45,832 | (425,595) | $ (379,762) | |||
Balance at the end (in shares) at Jun. 30, 2021 | 5,943,749 | ||||||
Redeemable convertible preferred Stock | |||||||
Conversion of redeemable convertible preferred stock into common stock in connection with the Merger and related PIPE financing | $ (420,989) | ||||||
Conversion of redeemable convertible preferred stock into common stock in connection with the Merger and related PIPE financing (in shares) | (69,613,562) | ||||||
Balance at the end (in shares) at Sep. 30, 2021 | 0 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options | 360 | $ 360 | |||||
Proceeds from the exercise of stock options (in shares) | 99,624 | ||||||
Conversion of redeemable convertible preferred stock into common stock in connection with the Merger and related PIPE financing | $ 7 | 420,982 | 420,989 | ||||
Conversion of redeemable convertible preferred stock into common stock in connection with the Merger and related PIPE financing (in shares) | 69,613,562 | ||||||
The merger and related PIPE financing, net of transaction costs and acquired liabilities | $ 2 | 209,478 | 209,480 | ||||
Public warrants assumed upon the merger, net of transaction costs | 13,912 | 13,912 | |||||
Issuance of common stock upon the Merger and related PIPE Financing, net of issuance costs (in shares) | 27,346,449 | ||||||
Net loss | (31,563) | (31,563) | |||||
Stock-based compensation | 1,877 | 1,877 | |||||
Contingent consideration liability recognized upon closing of the reverse recapitalization | 159,432 | 159,432 | |||||
Balance at the end at Sep. 30, 2021 | $ 10 | $ 533,009 | $ (457,158) | $ 75,861 | |||
Balance at the end (in shares) at Sep. 30, 2021 | 103,003,384 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities | ||
Net loss | $ (66,524) | $ (85,422) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 6,291 | 4,689 |
Stock-based compensation expense | 4,694 | 4,457 |
Loss on disposal of property and equipment | 177 | 69 |
Amortization expense | 2,060 | 2,060 |
Non-cash operating lease costs | 81 | 62 |
Accrued interest on PPP loan obligation | 22 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | 488 | (185) |
Prepaid expenses | (767) | 216 |
Other assets | 112 | |
Accounts payable | (889) | 2,434 |
Accrued expenses | (1,408) | 372 |
Operating lease obligation | (82) | (62) |
Deferred payroll taxes | 289 | |
Deferred revenue | (589) | |
Net cash used in operating activities | (55,568) | (71,787) |
Cash flows from investing activities | ||
Purchase of property and equipment | (318) | (8,125) |
Proceeds from sale of property and equipment | 50 | |
Net cash used in investing activities | (268) | (8,125) |
Cash flows from financing activities | ||
Proceeds from the exercise of stock options | 301 | 1,218 |
Proceeds from PPP loan | 3,251 | |
Payment of finance lease principal | (1,500) | (1,292) |
Net cash provided by financing activities | 2,052 | (74) |
Net increase (decrease) in cash and cash equivalents | (53,784) | (79,986) |
Cash and cash equivalents at the beginning of the period | 93,713 | 173,699 |
Cash and cash equivalents at the end of the period | 39,929 | 93,713 |
Supplemental disclosure of noncash activities: | ||
Operating lease right-of-use assets obtained in exchange for lease obligations | 36 | 36 |
Accrued property and equipment | $ 4 | $ 113 |
Organization and Description of
Organization and Description of Business | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Organization and Description of Business | ||
Organization and Description of Business | 1. Organization and Description of Business Organization Humacyte, Inc.and subsidiary, or the Company, is pioneering the development and manufacture of off-the-shelf, universally implantable, bioengineered human tissues designed to improve the lives of patients and transform the practice of medicine. The Company is leveraging its technology platform to develop proprietary, bioengineered, acellular human tissues for use in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. On August 26, 2021 (the “ ” “ ” “ ” “ ” “ ” “ ” “ ” Refer to Note 3 — Liquidity and Going Concern Since its inception in 2004, the Company has generated no product revenue and has incurred net losses and negative cash flows from operations in each year. To date, the Company has financed its operations primarily through the sale of equity securities and convertible debt and, to a lesser extent, through governmental and other grants. At December 31, 2020 and September 30, 2021, the Company had an accumulated deficit of $388.1 million and $457.2 million, respectively. The Company ’ ’ ’ ’ As of September 30, 2021, the Company had cash and cash equivalents of $240.4 million. Based on the cash and cash equivalents on hand, the Company believes its combined cash and cash equivalents will be sufficient to fund operations, including clinical trial expenses and capital expenditure requirements, for at least 12 months from the issuance date of these interim financial statements. Impact of COVID-19 The COVID-19 pandemic, which began in December ’ ’ ’ ’ ’ To date, the COVID-19 pandemic has not resulted in material financial impacts or impairment losses in the carrying values of the Company ’ ’ | 1. Organization and Description of Business Organization Humacyte, Inc., or the Company, is pioneering the development and manufacture of off-the-shelf, universally implantable, bioengineered human tissues to improve the lives of patients and transform the practice of medicine. The Company is leveraging its technology platform to develop proprietary, bioengineered, acellular human tissues for use in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. Liquidity and Going Concern Since its inception in 2004, the Company has generated no product revenue and has incurred net losses and negative cash flows from operations in each year. To date, the Company has financed its operations primarily through the sale of equity securities and convertible debt and, to a lesser extent, through governmental and other grants. At December 31, 2019 and December 31, 2020, the Company had an accumulated deficit of $321.6 million and $388.1 million, respectively. The Company ’ ’ ’ ’ The Company does not believe its existing cash and cash equivalents will be sufficient to fund its anticipated operating expenses, including clinical trial expenses, and capital expenditure requirements for at least twelve months following the date these financial statements were issued. Until such time, if ever, as the Company is able to successfully develop and commercialize one or more of its product candidates, it expects to fund its operations through the sale of equity, debt, borrowing under credit facilities or through potential collaborations with other companies, other strategic transactions or government contracts and grants. The Company ’ ’ substantial doubt about its ability to continue as a going concern within one year The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty. Accordingly, the financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business. Impact of COVID-19 The COVID-19 pandemic, which began in December ’ ’ ’ ’ ’ 1. Organization and Description of Business (continued) To date, the COVID-19 pandemic has not resulted in material financial impacts or impairment losses in the carrying values of the Company ’ ’ |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Summary of Significant Accounting Policies | ||
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The Company has prepared the accompanying financial statements in conformity with accounting principles generally accepted in the United ’ Unless otherwise noted, the Company has retroactively adjusted all common and preferred share and related price information to give effect to the Exchange Ratio established in the Merger Agreement. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates in the financial statements include stock-based compensation costs, right-of-use, or ROU, assets, accruals for research and development activities, contingent earnout liability, fair value of common stock warrants, redeemable convertible preferred stock and income taxes. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. Unaudited Interim Condensed Consolidated Financial Statements The accompanying interim condensed consolidated financial statements and the related footnote disclosures are unaudited. These unaudited interim financial statements have been prepared on the same basis as the audited financial statements, and in management ’ ’ Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2020 and the related notes included elsewhere in this prospectus, which provides a more complete discussion of the Company’s accounting policies and certain other information. Other than the policies noted below, there have been no significant changes to the significant accounting policies disclosed in Note 2 of the audited consolidated financial statements as of and for the years ended December 31, 2019 and 2020 included elsewhere in this prospectus. Common Stock Warrants The Company assumed 5,000,000 publicly-traded warrants ( “ ” “ ” ’ “ ” “ ” ’ “ ” The Company evaluated the Common Stock Warrants to determine the appropriate financial statement classification upon the consummation of the Merger. The Common Stock Warrants are not mandatorily redeemable and are considered to be freestanding instruments as they are separately exercisable into common shares. As such, the Common Stock Warrants were not classified as liabilities under FASB ASC Topic 480, Distinguishing Liabilities from Equity Derivatives and Hedging The agreement governing the Common Stock Warrants includes a provision ( “ ” ’ “ ’ ” ’ The Public Warrants are considered to be “indexed to the Company’s own stock”. The agreement provides that in the event of a tender or exchange offer made to and accepted by holders of more than 50% of the outstanding shares of the Company ’ ’ ’ Contingent Earnout Liability In connection with the Reverse Recapitalization and pursuant to the Business Combination Agreement dated as of February 17, 2021 by and among Legacy Humacyte, Merger Sub, and AHAC (the “ ” ’ “ ” The estimated fair value of the Contingent Earnout Shares was determined using a Monte Carlo simulation using a distribution of potential outcomes on a monthly basis over a ten-year period prioritizing the most reliable information available. The assumptions utilized in the calculation were based on the achievement of certain stock price milestones, including the current Company common stock price, expected volatility, risk-free rate, expected term and expected dividend yield. The Contingent Earnout Shares are categorized as a Level Segments The Company operates and manages its business as one reportable and operating segment. The Company is developing proprietary, bioengineered, acellular human tissues that are designed to be used in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. The Company ’ Revenue Recognition The Company ’ Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services and is recognized in an amount that reflects the consideration that an entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) In addition, ASC 606 requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. For contracts where the period between when the Company transfers a promised good or service to the customer and when the customer pays is one year or less, the Company has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing component. Grant Revenue The Company generates revenue primarily from government and other awarded grants that reimburse the Company for certain allowable costs related to research and development efforts. These grants include the following terms: The Department of Defense grants are for an award of $4.0 million, all of which was recognized as revenue before the program ended, for work on bioengineered blood vessels for vascular trauma, which was awarded to the Company in September 2017 and ended in February 2020, and an award of $7.1 million for work to support human tissue engineered blood vessels for vascular reconstruction in the injured warfighter, which was awarded to the Company in August 2017 and is ongoing. The Company has recognized revenue of $0.6 million and $1.0 million during the three and nine months ended September 30, 2020,respectively, and $0.2 million and $1.1 million during the three and nine months ended September 30, 2021, respectively, for reimbursement of certain allowable costs related to these grants. The National Institutes of Health grant is for $1.6 million for work to support bioengineered grafts for peripheral vascular disease, which was awarded to the Company in November 2013. The Company recognized $1.6 million for the reimbursement of certain allowable costs related to the grant before this program ended in 2020. The Company recognized $0.3 million during the three and nine months ended September 30, 2020, and no revenue during the three and nine months ended September 30, 2021, for reimbursement of certain allowable costs related to these grants. The Company has determined that the grants are not within the scope of ASC 606 as they do not meet the definition of a contract with a customer. The Company has concluded that the grants meet the definition of a contribution and are nonexchange transactions and has applied the contribution accounting model in Subtopic 958-605, Not-for-Profit-Entities-Revenue Recognition by analogy. The Company recognizes funding received from grants as revenue, rather than as a reduction of research and development expenses, because the Company is the principal in conducting the research and development activities and these grants are central to the Company ’ ’ Revenue from grants not within the scope of ASC 606 was $0.9 million and $1.4 million for the three and nine months ended September 30, 2020, respectively, and $0.2 million and $1.1 million for the three and nine months ended September 30, 2021, respectively. Concentration of Credit Risk Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. Total cash balances exceeded insured balances by the Federal Deposit Insurance Corporation as of December 31, 2020 and September 30, 2021. Cash equivalents are invested in highly rated money market funds invested only in obligations of the U.S. government and its agencies. The majority of the Company ’ ’ ’ Revenue Accounts Receivable Three Months Nine Months December 31, September 30, 2020 2021 2020 2021 2020 2021 Grant A — — — — — — Grant B 0 — % 11 — % — — Grant C 68 % 100 % 65 % 100 % 100 % 100 % Grant D 30 — % 20 — % — — Total 98 % 100 % 96 % 100 % 100 % 100 % All of the Company ’ Other Risks and Uncertainties The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, successful discovery and development of its product candidates, the success of clinical trials and other studies for its product candidates, including for its ongoing V005 Phase II/III clinical trial and V007 Phase III clinical trial, the regulatory approval and commercialization of its HAVs and other product candidates, ’ ’ ’ Product candidates currently under development will require extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company ’ ’ Net Loss per Share Attributable to Common Stockholders The Company follows the two-class method to compute basic and diluted net loss per share attributable to common stockholders when shares met the definition of participating securities. The two-class method determines net loss per common share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to share in the earnings as if all income for the period had been distributed. During periods of loss, there is no allocation required under the two-class method since the redeemable convertible preferred stock did not have a contractual obligation to share in the Company ’ Basic net loss per share attributable to common stockholders is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period without consideration of potentially dilutive common stock. Diluted net loss per share attributable to common stockholders reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the Company unless inclusion of such shares would be anti-dilutive. As the Company has only incurred losses, basic and diluted net loss per share is the same. The potential shares of common stock that were excluded from the computation of diluted net loss per share for each period because including them would have had an antidilutive effect were as follows: September 30, 2020 2021 Shares issuable upon conversion of Series A redeemable convertible preferred stock 18,421,897 — Shares issuable upon conversion of Series B redeemable convertible preferred stock 24,137,647 — Shares issuable upon conversion of Series C redeemable convertible preferred stock 11,241,283 — Shares issuable upon conversion of Series D redeemable convertible preferred stock 15,812,735 — Exercise of options under stock plan 4,516,907 6,399,888 Warrants to purchase common stock 32,961 5,465,204 The 15,000,000 Contingent Earnout shares are excluded from the anti-dilutive table for all the periods presented as such shares are contingently issuable until the share price of the Company exceeds specified thresholds that have not yet been achieved, or upon the occurrence of a change in control. Impairment of Long-Lived Assets The Company reviews the carrying value of property and equipment for indicators of possible impairment whenever events and circumstances indicate that the carrying value of an asset or asset group may not be recoverable from the estimated future net undiscounted cash flows expected to result from its use and eventual disposition. In cases where estimated future net undiscounted cash flows are less than the carrying value, an impairment loss is recognized equal to an amount by which the carrying value exceeds the fair value of the asset or asset group. The factors considered by management in performing this assessment include current operating results, trends and prospects, the manner in which the property is used, and the effects of obsolescence, demand, competition, and other economic factors. Based on this assessment, during the nine months ended September 30, 2020 and 2021, respectively, the Company concluded there were no such events or changes in circumstances requiring review of the carrying amount of the Company ’ Recently Adopted Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, “ ’ ’ ” “ ” ’ Recently Issued Accounting Pronouncements In May 2021, the FASB issued “ ’ ” “ ” ’ | 2. Summary of Significant Accounting Policies Basis of Presentation The Company has prepared the accompanying financial statements in conformity with accounting principles generally accepted in the United Reverse Recapitalization On August 26, 2021 (the “ ” “ ” “ ” “ ” “ ” “ ” “ ” “ ” Unless otherwise noted, the Company has retroactively adjusted all common and preferred share and related price information to give effect to the Exchange Ratio of approximately 0.26260 established in the Merger Agreement. Segments The Company operates and manages its business as one reportable and operating ’ Comprehensive loss Comprehensive loss includes net loss as well as other changes in stockholders ’ Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates in the financial statements include stock-based compensation costs, right-of-use, or ROU assets, accruals for research and development activities, fair value of common stock, useful lives of property and equipment, redeemable convertible preferred stock and income taxes. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. 2. Summary of Significant Accounting Policies (continued) Cash and Cash Equivalents The Company considers all short-term, highly liquid investments purchased with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash deposits are held with financial institutions with investment-grade ratings in the United Redeemable Convertible Preferred Stock The Company analyzes all issued equity instruments to determine the appropriate accounting and classification. The Company evaluates its equity instruments under Accounting Standards Codification, or ASC 480, Distinguishing liabilities from equity The Company records equity instruments that are classified as temporary equity at fair value upon issuance, net of issuance costs. The Company accretes the carrying value of its redeemable convertible preferred stock to the redemption or liquidation amount once the Company has determined that it is probable that it will become redeemable or be liquidated. The accretion will be recorded as charges against additional paid-in capital until the additional paid-in capital balance is reduced to zero. At that time, additional accretion adjustments will be recorded as additions to accumulated deficit. The Company also analyzes instances where the equity instrument has a conversion feature pursuant to ASC 815, Derivatives and hedging Revenue Recognition The Company ’ In 2014, the Financial Accounting Standards Board, or FASB issued Accounting Standards Update No. Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services and is recognized in an amount that reflects the consideration that an entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) In addition, ASC 606 requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. 2. Summary of Significant Accounting Policies (continued) For contracts where the period between when the Company transfers a promised good or service to the customer and when the customer pays is one year or less, the Company has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing component. Grant Revenue We generate revenue primarily from government and other awarded grants that reimburse us for certain allowable costs related to research and development efforts. The Company has determined that the grants are not within the scope of ASC 606 as they do not meet the definition of a contract with a customer. The Company has concluded that the grants meet the definition of a contribution and are nonexchange transactions and has applied the contribution accounting model in Subtopic 958-605, Not-for-Profit-Entities-Revenue Recognition by analogy. The Company recognizes funding received from grants as revenue, rather than as a reduction of research and development expenses, because the Company is the principal in conducting the research and development activities and these grants are central to the Company ’ Revenue from grants not within the scope of ASC 606 was $6.2 million and $1.5 million for the years ending December 31, 2019 and 2020, respectively. Concentration of Credit Risk Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. Total cash balances exceeded insured balances by the Federal Depository Insurance Corporation as of December 31, 2019 and 2020. Cash equivalents are invested in highly rated money market funds invested only in obligations of the US government and its agencies. The majority of the Company ’ ’ ’ 2019 2020 Accounts Accounts Revenue Receivable Revenue Receivable Grant A 28 % — — — Grant B 38 % 67 % 10 % — Grant C 34 % 33 % 67 % 100 % Grant D — — 18 % — Total 100 % 100 % 95 % 100 % All of the Company ’ 2. Summary of Significant Accounting Policies (continued) Other Risks and Uncertainties The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, successful discovery and development of its product candidates, the success of clinical trials and other studies for its product candidates, including for its ongoing V005 Phase II/III clinical trial and V007 Phase III clinical trial, the regulatory approval and commercialization of its HAVs and other product candidates, ’ ’ ’ Product candidates currently under development will require extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company ’ ’ Net Loss per Share Attributable to Common Stockholders The Company applies the two-class method to compute basic and diluted net loss per share attributable to common stockholders when shares meet the definition of participating securities. The two-class method determines net loss per share for each class of common and redeemable convertible preferred stock according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income (loss) available to common stockholders for the period to be allocated between common and redeemable convertible preferred stock based upon their respective rights to share in the earnings as if all income (loss) for the period had been distributed. During periods of loss, there is no allocation required under the two-class method since the redeemable convertible preferred stock does not have a contractual obligation to share in the Company ’ 2. Summary of Significant Accounting Policies (continued) Basic net loss per share attributable to common stockholders is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period without consideration of potentially dilutive common stock. Diluted net loss per share attributable to common stockholders reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the Company unless inclusion of such shares would be anti-dilutive. Since the Company has only incurred losses, basic and diluted net loss per share is the same. Securities that could potentially dilute net loss per share in the future that were not included in the computation of diluted net loss per share are as follows: December 31, 2019 2020 Shares issuable upon conversion of Series A redeemable convertible preferred stock 18,421,897 18,421,897 Shares issuable upon conversion of Series B redeemable convertible preferred stock 24,137,647 24,137,647 Shares issuable upon conversion of Series C redeemable convertible preferred stock 11,241,283 11,241,283 Shares issuable upon conversion of Series D redeemable convertible preferred stock 15,812,735 15,812,735 Options to purchase common stock 5,220,236 4,813,262 Warrant to purchase common stock 32,961 32,961 Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants at the measurement date. ASC 820, Fair Value Measurement and Disclosures ● Level 1 — Observable inputs that reflect unadjusted quoted prices for identical assets or liabilities in active markets. ● Level 2 — Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. ● Level 3 — Unobservable inputs in which little or no market data exists, therefore requiring the Company to develop its own assumptions. The Company evaluates assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them for each reporting period, utilizing valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The determination requires significant judgments to be made by the Company. The Company ’ 2. Summary of Significant Accounting Policies (continued) Property and Equipment, Net Property and equipment, net are recorded at cost less accumulated depreciation. Expenditures for major additions and improvements are capitalized and minor replacements, maintenance, and repairs are charged to expense as incurred. When property and equipment are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet accounts and any resulting gain or loss is included in the results of operations for the respective period. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets. The estimated useful lives for significant asset categories are as follows: Estimated Useful Property and equipment Lives (Years) Scientific equipment 5 – 7 Computer equipment 5 Software 3 Furniture and fixtures 5 – 7 Leasehold improvements Lesser of useful life or life of lease Construction in progress N/A Impairment of Long-Lived Assets The Company reviews the carrying value of property and equipment for indicators of possible impairment whenever events and circumstances indicate that the carrying value of an asset or asset group may not be recoverable from the estimated future net undiscounted cash flows expected to result from its use and eventual disposition. In cases where estimated future net undiscounted cash flows are less than the carrying value, an impairment loss is recognized equal to an amount by which the carrying value exceeds the fair value of the asset or asset group. The factors considered by management in performing this assessment include current operating results, trends and prospects, the manner in which the property is used, and the effects of obsolescence, demand, competition, and other economic factors. Based on this assessment, there was no impairment at December 31, 2019 and 2020. Income Taxes Income taxes are computed using the asset and liability approach that requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company ’ 2. Summary of Significant Accounting Policies (continued) The Company recognizes the benefit of an income tax position only if it is more likely than not (greater than 50%) that the tax position will be sustained upon tax examination, based solely on the technical merits of the tax position. Otherwise, no benefit can be recognized. Assessing an uncertain tax position begins with the initial determination of the sustainability of the position and is measured at the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed. Additionally, the Company must accrue interest and related penalties, if applicable, on all tax exposures for which reserves have been established consistent with jurisdictional tax laws. The Company has analyzed its filing positions in all significant Federal and state jurisdictions where it is required to file income tax returns, as well as open tax years in these jurisdictions. As of December 31, 2019 and 2020, the Company has determined that no uncertain tax positions would have a material impact on the financials statements of the Company. The Company is no longer subject to Federal, state, and local tax examinations by tax authorities for years before 2017 although carry-forward attributes that were generated prior to 2017 may still be adjusted upon examination by the taxing authorities if they either have been or will be used in a future period. No income tax returns are currently under examination by taxing authorities. As of December 31, 2019 and 2020, the Company had not recorded any amounts for unrecognized tax benefits. The Company ’ ’ Intellectual Property The Company seeks to protect its intellectual property by filing patent applications in the United ’ Research and Development The Company expenses research and development costs as operating expenses as incurred. Research and development expenses consist primarily of: ● salaries and related overhead expenses for personnel in research and development functions, including stock-based compensation and benefits; ● fees paid to consultants and CROs, including in connection with clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work and statistical compilation and analysis; ● allocation of facility lease and maintenance costs; ● depreciation of leasehold improvements, laboratory equipment and computers; ● costs related to purchasing raw materials for and producing product candidates for clinical trials; ● costs related to compliance with regulatory requirements; ● costs related to the manufacturing scale-out initiative; and ● license fees related to in-licensed technologies. 2. Summary of Significant Accounting Policies (continued) Accrued Research and Development The Company has entered into various agreements with CROs and a CMO, which conduct preclinical studies and clinical trials and contract manufacturing activities. The Company ’ Stock-Based Compensation The Company accounts for stock-based compensation for employees and non-employees measured at grant date, based on the fair value of the award. The Company measures the fair value of awards granted using the Black-Scholes option pricing model and recognizes the expense over the requisite service period using the straight-line method. Option valuation models, including the Black-Scholes option-pricing model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility, the expected term of the award, and the fair value of the underlying common stock on the date of grant. Forfeitures are accounted for as they occur. Leases Effective January 1, 2019, the Company accounts for its leases under ASC 842, Leases ’ “ ” “ ” “ ” ’ “ ” “ ” “ ” Under this guidance, arrangements meeting the definition of a lease are classified as operating or finance leases, and are recorded on the balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company ’ 2. Summary of Significant Accounting Policies (continued) Lease expenses for minimum lease payments for operating leases are recognized on a straight-line basis over the lease term. Amortization expense of the right-of-use asset for finance leases is recognized on a straight-line basis over the lease term and interest expense for finance leases is recognized based on the incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right of use asset is amortized over the lease term. In calculating the right-of-use assets and lease liabilities, the Company has elected to combine lease and non-lease components for all asset classes. The Company excludes short-term leases, if any, having initial terms of 12 months or less from the new guidance as an accounting policy election, and recognizes rent expense on a straight-line basis over the lease term. Prior to the adoption of ASC 842 on January 1, 2019 the Company was deemed to be the accounting owner of leased space during the construction of its headquarters in a build-to-suit arrangement. Upon substantial completion of construction in June ’ ’ each The cumulative effect of initially applying the new lease guidance on January 1, 2019 is as follows: January 1, 2019 Cumulative Beginning Beginning Effect Balance, ($ in thousands) Balance Adjustment As Adjusted Assets Building asset $ 25,091 $ (25,091) $ — Finance lease right-of-use assets, net $ — $ 27,612 $ 27,612 Operating lease right-of-use assets, net $ — $ 923 $ 923 Liabilities and stockholders’ deficit Accrued expenses $ 7,049 $ (1) $ 7,048 Facility financing obligation, current portion $ 276 $ (276) $ — Finance lease obligation, current portion $ — $ 1,292 $ 1,292 Operating lease obligation, current portion $ — $ 55 $ 55 Facility financing obligation, net of current portion $ 22,955 $ (22,955) $ — Finance lease obligation, net of current portion $ — $ 26,319 $ 26,319 Operating lease obligation, net of current portion $ — $ 870 $ 870 Accumulated deficit $ (234,289) $ (1,861) $ (236,150) 2. Summary of Significant Accounting Policies (continued) Recently Adopted Accounting Pronouncements In August — Recently Issued Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, “ – ’ – ’ “ ” |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Property and Equipment, Net | ||
Property and Equipment, Net | 5. Property and Equipment, Net Property and equipment, net consist of the following: December 31, September 30, ($ in thousands) 2020 2021 Scientific equipment $ 27,412 $ 27,578 Computer equipment 149 154 Software 335 335 Furniture and fixtures 988 988 Leasehold improvements 26,355 26,355 55,239 55,410 Accumulated depreciation (14,261) (18,911) Property and equipment, net $ 40,978 $ 36,499 Depreciation expense totaled $1.6 million and $4.7 million for the three and nine months ended September 30, 2020, respectively, and $1.5 million and $4.7 million for the three and nine months ended September 30, 2021, respectively. All long-lived assets are maintained in the United | 3. Property and Equipment, Net Property and equipment, net consist of the following: As of December 31, ($ in thousands) 2019 2020 Scientific equipment $ 27,822 $ 27,412 Computer equipment 218 149 Software 340 335 Furniture and fixtures 988 988 Leasehold improvements 26,337 26,355 55,705 55,239 Accumulated depreciation (8,417) (14,261) Property and equipment, net $ 47,288 $ 40,978 Depreciation expense totaled $4.7 million and $6.3 million for the years ended December 31, 2019 and 2020, respectively. All long-lived assets are maintained in the United |
Accrued Expenses
Accrued Expenses | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Accrued Expenses | ||
Accrued Expenses | 6. Accrued Expenses Accrued expenses consisted of the following: December 31, September 30, ($ in thousands) 2020 2021 Accrued external research, development and manufacturing costs $ 2,615 $ 2,685 Accrued employee compensation and benefits 1,009 4,025 Accrued professional fees 968 2,712 Total $ 4,592 $ 9,422 | 4. Accrued Expenses Accrued expenses consisted of the following: As of December 31, ($ in thousands) 2019 2020 Accrued external research, development and manufacturing costs $ 3,872 $ 2,615 Accrued employee compensation and benefits 1,260 1,009 Accrued professional fees 868 968 Total $ 6,000 $ 4,592 |
Debt
Debt | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Debt | ||
Debt | 7. Debt On April 30, 2020, the Company received loan proceeds in the amount of approximately $3.3 million under the Paycheck Protection Program ( “ ” In March 2021, the Company entered into a term loan agreement with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P., which provides a term loan facility of up to $50.0 million with a maturity date of March 1, 2025, or the Loan Agreement. The Company ’ The Loan Agreement provides that the term loans will be distributed in tranches. The initial term loan tranche of $20.0 million was drawn in March 2021 and is accounted for net of issuance costs which are being accreted to interest expense over the term of the loan using the effective interest method. As of September 30, 2021, three subsequent $10.0 million term loan tranches were eligible to be disbursed at the request of the Company during specified draw periods between now and 2023 if certain business development milestones and other specified requirements are met by the dates specified in the Loan Agreement. Borrowings bear interest at the greater of 7.5% or the Wall Street Journal Prime Rate plus 4.25% (7.5% as of September 30, 2021). Interest only payments on the principal amount outstanding are due monthly beginning in the first month after the loan is dispersed. Repayment of principal may begin as soon as April 1, 2022 under the level of borrowing outstanding at September 30, 2021, and no later than April 1, 2024. The term loans may only be prepaid in full, and such prepayment requires 30 days ’ On October 13, 2021, the Company borrowed an additional $10.0 million under the Loan Agreement. As a result of the additional borrowing, the commencement of repayment of principal was deferred to no earlier than July 2023. In connection with the Loan Agreement, the Company granted warrants to the lenders to purchase shares of common stock at an exercise price of $10.28 per share, of which 287,704 warrants were immediately exercisable. The warrants are classified within stockholders ’ ’ ’ At issuance, the Company initially determined that the funding of an additional tranche was not probable, and therefore no value was ascribed to the remaining 123,302 warrants that were only exercisable upon the funding of the additional tranche. As a result of the Company ’ ’ SVB loan payable and net discount or premium balances are as follows: September 30, ($ in thousands) 2021 Principal amount of SVB loan payable $ 20,000 Final payment amount of SVB loan payable 1,000 Net premium associated with accretion of final payment and other debt issuance costs (3,073) SVB loan payable, current and noncurrent 17,927 Less SVB loan payable, current portion (3,889) SVB loan payable, noncurrent portion $ 14,038 Future minimum payments of principal on the Company ’ Year ending December 31: ($ in thousands) 2021 (remainder) $ — 2022 5,555 2023 6,667 2024 6,667 2025 1,111 Total future payments 20,000 | 5. Debt On April 30, 2020, the Company received loan proceeds in the amount of approximately $3.3 million under the Paycheck Protection Program ( “ ” “ ” In September 2020, the Company applied for forgiveness of the outstanding amount under its PPP loan. The Company used the proceeds for purposes it believes were consistent with the requirements of the PPP. The Company determined that loan forgiveness would become probable upon approval by the Small Business Administration of the Company ’ |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases | |
Leases | 6. Leases The Company ’ ’ At December 31, 2019 and 2020, the Company had finance lease liabilities of $26.3 million and $24.8 million, respectively, and right-of-use assets of $25.6 million and $23.5 million, respectively, and operating lease liabilities of $0.9 million and $0.8 million, respectively, and right-of-use assets of $0.9 million and $0.8 million, respectively, all of which were included in the balance sheet. The Company ’ ’ renewal options have been included in the calculation of the lease liabilities and right of use assets as the Company is reasonably certain to exercise the options due to the specialized nature of the leased building. Variable expenses generally represent the Company ’ ’ The following summarizes quantitative information about the Company ’ Year Ended December 31, ($in thousands) 2019 2020 Finance lease cost Amortization of right-of-use assets $ 2,060 $ 2,060 Interest on lease liabilities 2,298 2,180 Total finance lease cost 4,358 4,240 Operating lease cost 137 152 Total lease cost $ 4,495 $ 4,392 Year Ended Year Ended December 31, 2019 December 31, 2020 Finance Operating Finance Operating ($ in thousands) Leases Leases Leases Leases Operating cash flows from leases $ (2,298) $ (137) $ (2,180) $ (182) Financing cash flows from leases $ (1,292) $ — $ (1,500) $ — Weighted-average remaining lease term 6.02 6.38 5.52 6.24 Weighted-average discount rate 8.50 % 8.50 % 8.50 % 8.50 % As of December 31, 2020, the maturities of the Company ’ ($ in thousands) Finance Operating Year Ended December 31, 2021 $ 3,773 $ 105 Year Ended December 31, 2022 3,868 105 Year Ended December 31, 2023 3,965 105 Year Ended December 31, 2024 4,065 106 Year Ended December 31, 2025 4,167 106 Thereafter 16,937 678 Total 36,775 1,205 Less: present value discount (11,956) (436) Lease liabilities $ 24,819 $ 769 |
Redeemable Convertible Preferre
Redeemable Convertible Preferred Stock | 12 Months Ended |
Dec. 31, 2020 | |
Redeemable Convertible Preferred Stock | |
Redeemable Convertible Preferred Stock | 7. Redeemable Convertible Preferred Stock Redeemable Convertible Preferred Stock and Preferred Stock Terms The Company has outstanding series A redeemable convertible preferred stock, series B redeemable convertible preferred stock, series C redeemable convertible preferred stock and series D redeemable convertible preferred stock, which are collectively referred to as “ ” “ ” As of December 31, 2019 and December 31, 2020, redeemable convertible preferred stock consisted of the following (in thousands, except share amounts): Redeemable Redeemable Convertible Convertible Preferred Preferred Stock Stock Issued and Carrying Liquidation Issuance Authorized Outstanding Value Preference Price Series A redeemable convertible preferred stock 18,421,897 18,421,897 $ 74,079 $ 74,079 $ 4.0212 Series B redeemable convertible preferred stock 24,137,647 24,137,647 127,358 136,500 $ 5.6550 Series C redeemable convertible preferred stock 11,241,286 11,241,283 70,704 75,000 $ 6.6717 Series D redeemable convertible preferred stock 15,812,735 15,812,735 148,848 150,000 $ 9.4859 69,613,565 69,613,562 $ 420,989 $ 435,579 In connection with the series D redeemable convertible preferred stock financing, the Company granted Fresenius Medical Care the right to purchase up to an aggregate of $30.0 million of its common stock in a private placement effected concurrently with its initial public offering at a price per share equal to the initial public offering price. See Note 13: Related Party Transactions for further discussion of the Company ’ Election of Directors The holders of the series A redeemable convertible preferred stock and the series B redeemable convertible preferred stock may designate one individual and two individuals, respectively, to the Board of Directors. The holders of the series C redeemable convertible preferred stock may designate one individual to the Board of Directors and Fresenius Medical Care may designate one representative to attend, in a non-voting observer capacity, all meetings of the Company ’ Conversion to Common Stock Each share of redeemable convertible preferred stock is convertible, at the option of the holder thereof, into that number of the fully paid and nonassessable shares of common stock determined by dividing the original issue price for the relevant shares by the conversion price. Each share of redeemable convertible preferred stock will automatically be converted into that number of fully-paid, nonassessable shares of common stock at the then effective conversion rate for such shares (i) 7. Redeemable Convertible Preferred Stock (continued) The following are the conversion prices for each series of the redeemable convertible preferred stock as of December 31, 2020: Series Conversion Series A redeemable convertible preferred stock $ 4.0212 Series B redeemable convertible preferred stock $ 5.6550 Series C redeemable convertible preferred stock $ 6.6717 Series D redeemable convertible preferred stock $ 9.4859 These conversion prices are subject to adjustment from time to time including for certain share issuances made without consideration or for consideration less than the then applicable conversion price of a series of redeemable convertible preferred stock, dividends, stock splits, and combinations. As of December 31, 2020, each series of redeemable convertible preferred stock is convertible on a one-for-one basis. The series A, series B, series C and series D redeemable convertible preferred stock includes an anti-dilution feature that adjusts the conversion price, in certain scenarios, if the Company sells shares at a price below the stated conversion price. The anti-dilution provision is considered a contingent beneficial conversion feature. Due to the inability of the Company to determine the price of the shares sold, the Company is unable to determine the number of shares that the holder would receive if the contingency occurs. Therefore, the beneficial conversion feature is not recognized until the contingent event occurs. Dividends Any dividends on the redeemable convertible preferred stock are not cumulative. The holders of the redeemable convertible preferred stock are entitled to receive dividends pro rata with the holders of common stock on an as-converted basis, when and if declared and paid by the Board of Directors, out of any assets at the time legally available. Any declared and unpaid dividends on the redeemable convertible preferred stock are payable upon certain voluntary or involuntary acquisition or sale transactions or the liquidation, dissolution or winding up of the Company as described below under “ ” 7. Redeemable Convertible Preferred Stock (continued) Liquidation In the event of certain voluntary or involuntary acquisition or sale transactions or upon the liquidation, dissolution or winding up of the Company, each, a Reorganization, in which the holders of the series D redeemable convertible preferred stock receive less than $9.4859 per share plus any declared but unpaid dividends, referred to as the Series D Liquidation Preference, or such lesser amount approved in writing by the holders of a majority of the then outstanding series D redeemable convertible preferred stock, the series D stockholders will receive the series D liquidation preference before the holders of the series C, series B, series A redeemable convertible preferred stock or common stockholders would receive any proceeds relating to such Reorganization, and the entire assets of the Company available for distribution would be distributed pro rata among holders of the series D redeemable convertible preferred stock. In the event that, after the payment to the holders of the series D redeemable convertible preferred stock, the holders of the series C redeemable convertible preferred stock would receive less than $6.6717 per share plus any declared but unpaid dividends or such lesser amount approved by the holders of at least 80% of the then outstanding series C redeemable convertible preferred stock, the entire remaining assets of the Company available for distribution would be distributed pro rata among holders of the series C redeemable convertible preferred stock. In the event that, after the payment to the holders of the series D redeemable convertible preferred stock and series C redeemable convertible preferred stock, the holders of the series B redeemable convertible preferred stock would receive less than $5.6550 per share plus any declared but unpaid dividends or such lesser amount approved by the holders of a majority of the then outstanding series B redeemable convertible preferred stock, the entire remaining assets of the Company available for distribution would be distributed pro rata among holders of the series B redeemable convertible preferred stock. However, in the event of any Reorganization, if the holders of the series D redeemable convertible preferred stock, series C redeemable convertible preferred stock or series B redeemable convertible preferred stock would receive less than 1.25 times their respective liquidation preference per share, the holders of each such series will be entitled to receive, in preference to any distribution of assets to the holders of any junior series, an amount per share equal to 1.25 times such liquidation preference. In the event that, after the payment to the holders of the series D redeemable convertible preferred stock, series Voting Except as provided in the Company ’ ’ 7. Redeemable Convertible Preferred Stock (continued) Redemption and Balance Sheet Classification In accordance with the Company ’ |
Stockholders, Equity (Deficit)
Stockholders, Equity (Deficit) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Stockholders' Equity (Deficit) | ||
Stockholders' Equity (Deficit) | 8. Stockholders ’ Equity (Deficit) Redeemable Convertible Preferred Stock As of December 31, 2020 and immediately prior to the Merger, Legacy Humacyte had outstanding series A redeemable convertible preferred stock, series B redeemable convertible preferred stock, series C redeemable convertible preferred stock and series D redeemable convertible preferred stock, which are collectively referred to as “ ” In connection with the Merger, all previously issued and outstanding redeemable convertible preferred stock was converted into an equivalent number of shares of common stock of the Company on a one-to-one basis, then multiplied by the Exchange Ratio pursuant to the Merger Agreement. Common Stock On August 26, 2021, the Merger and related PIPE Financing was consummated and the Company issued 27,346,449 shares of common stock for proceeds of $242.4 million. The Company incurred $3.9 million of transaction costs, consisting of banking, legal, and other professional fees. Legacy Humacyte assumed $15.2 million of liabilities, including PIPE Financing fees and legal fees, and $0.1 million of assets from AHAC. Immediately following the Merger, there were 103,003,384 shares of common stock outstanding with a par value of $0.0001. As of September 30, 2021, the Company ’ The holders of common stock are entitled to receive dividends from time to time as may be declared by the Company ’ The holders of common stock are entitled to one vote for each share held with respect to all matters voted on by the common stockholders of the Company. In the event of a reorganization of the Company, after payment to the preferred stockholders of their liquidation preferences, holders of common stock are entitled to share ratably in all remaining assets of the Company. As of September 30, 2021, the Company had reserved common stock for future issuances as follows: September 30, 2021 Common stock reserved for Contingent Consideration Shares 15,000,000 Exercise of options under stock plans 6,399,888 Issuance of options under stock plans 7,730,503 Shares available for grant under ESPP 1,030,033 Warrants to purchase common stock 5,465,204 35,625,628 On August 26, 2021, upon the Closing, all of the outstanding redeemable convertible preferred stock was converted to Common Stock pursuant to the conversion rate effective immediately prior to the Merger and the Exchange Ratio and the remaining amount was reclassified to additional paid-in capital. Preferred Stock The Company ’ ’ Warrants Activity of warrants for the nine months ended September 30, 2021 is set forth below: Legacy Humacyte Common Stock Private Placement Total Common Warrants Warrants Public Warrants Stock Warrants Outstanding as of December 31, 2020 32,961 — — 32,961 Common Stock Warrants issued to SVB 287,704 — — 287,704 Common Stock Warrants as Part of the Merger — 177,500 5,000,000 5,177,500 Warrants Exercised (32,961) — — (32,961) Oustanding as of September 30, 2021 287,704 177,500 5,000,000 5,465,204 In conjunction with a long-term debt agreement entered into on March 15, 2006 and paid in full during 2011, the Company issued a warrant that gave the holder the right to purchase 32,961 shares of the Company ’ See Note 7 — ’ Private Placement Warrants The Private Placement Warrants were initially recognized as a liability on the Closing Date, at a fair value of $0.6 million, and the Private Placement Warrant liability was remeasured to fair value as of September 30, 2021, resulting in a loss of less than $0.1 million for the three and nine months ended September 30, 2021, classified within change in fair value of common stock warrant liabilities in the condensed consolidated statements of operations and comprehensive loss. The Private Placement Warrants were valued using the following assumptions under the Monte Carlo simulation value model: August 26, September 30, 2021 2021 Market price of public stock $ 10.96 $ 11.61 Exercise price $ 11.50 $ 11.50 Expected term (years) 5.00 4.91 Expected share price volatility 32.5 % 28.5 % Risk-free interest rate 0.68 % 0.96 % Estimated dividend yield 0 % 0 % Public Warrants The Public Warrants may only be exercised for a whole number of shares and will expire five years after the completion of the Merger. The Public Warrants became exercisable 30 days after the completion of the Merger. The Public Warrants were initially recognized as equity on the Closing Date at a fair value of $2.80 per share. There were no exercises of the Public Warrants during the three months ended September 30, 2021. Contingent Earnout Liability Following the Closing, former holders of Legacy Humacyte common and preferred shares may receive up to 15,000,000 additional shares of the Company ’ “ ” stock quoted on the Nasdaq (or the exchange on which the shares of common stock are then listed) is greater or equal to $15.00 and $20.00, respectively, over any twenty trading days within any thirty-day trading period. Upon the Closing, the contingent obligation to issue Contingent Earnout Shares was accounted for as a liability because the triggering events that determine the number of Contingent Earnout Shares required to be issued include events that are not solely indexed to the common stock of Humacyte. The estimated fair value of the total Contingent Earnout Shares at the Closing on August 26, 2021, was $159.4 million based on a Monte Carlo simulation valuation model using a distribution of potential outcomes on a monthly basis over a ten-year period using the most reliable information available. The Contingent Earnout Liability was remeasured to fair value as of September 30, 2021, resulting in the recording of a non-cash loss of $9.8 million for the three and nine months ended September 30, 2021, classified within change in fair value of contingent earnout liability in the condensed consolidated statements of operations and comprehensive loss. Assumptions used in the valuations are described below: August 26, September 30, 2021 2021 Current stock price $ 10.96 $ 11.61 Expected share price volatility 79.6 % 78.9 % Risk-free interest rate 1.34 % 1.55 % Estimated dividend yield 0 % 0.0 % Expected term (years) 10.00 10.00 | 8. Stockholders ’ Deficit Common Stock As of December 31, 2019 and 2020, the Company ’ ’ The holders of common stock are entitled to receive dividends from time to time as may be declared by the Board of Directors. No cash dividend may be declared or paid to common stockholders until paid on each series of outstanding redeemable convertible preferred stock in accordance with its terms. Through December 31, 2020, no The holders of common stock are entitled to one vote for each share held with respect to all matters voted on by the common stockholders of the Company. Preferred stockholders generally vote together with the holders of common stock as a single class ’ In the event of a Reorganization of the Company, after payment to the preferred stockholders of their liquidation preferences, holders of common stock are entitled, together with holders of redeemable convertible preferred stock, to share ratably in all remaining assets of the Company. 8. Stockholders ’ Deficit (continued) At December 31, 2019 and 2020, the Company had reserved common stock for future issuances as follows: December 31, 2019 2020 Conversion of Series A redeemable convertible preferred stock 18,421,897 18,421,897 Conversion of Series B redeemable convertible preferred stock 24,137,647 24,137,647 Conversion of Series C redeemable convertible preferred stock 11,241,286 11,241,286 Conversion of Series D redeemable convertible preferred stock 15,812,735 15,812,735 Exercise of options under stock plan 5,220,236 4,813,262 Issuance of options under stock plan 2,736,954 2,948,598 Warrant to purchase common stock 32,961 32,961 77,603,716 77,408,386 Warrant In conjunction with a long-term debt agreement entered into on March 15, 2006 and paid in full during 2011, the Company issued a warrant that gave the holder the right to purchase 32,961 shares of the Company ’ |
Stock-based Compensation
Stock-based Compensation | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Stock-based Compensation | ||
Stock-based Compensation | 9. Stock-based Compensation At Closing, the 2021 Long-Term Incentive Plan, or the 2021 Plan, and the 2021 Employee Stock Purchase Plan, or the ESPP, became effective. As of September 30, 2021, 7,730,503 and 1,030,033 shares of common stock were available under the 2021 Plan and ESPP, respectively. On January 1 of each year commencing January 1, 2022, the 2021 Plan and the ESPP reserve will automatically increase in an amount equal to the lesser of (a) 5% and 1%, respectively, of the number of shares of the Company ’ ’ Under the 2021 Plan, the Company can grant non-statutory stock options, or NSOs, incentive stock options, or ISOs, stock appreciation rights, restricted stock, restricted stock units, unrestricted stock, performance awards and other forms of awards. Under the ESPP, eligible employees are permitted to purchase shares of the Company ’ ’ Prior to the Closing, Legacy Humacyte had two equity incentive plans, the 2015 Omnibus Incentive Plan, as amended, or the 2015 Plan, and the 2005 Stock Option Plan, or the 2005 Plan. As a result of the Merger, no further awards may be granted under either the 2015 plan or the 2005 Plan. All awards previously granted and outstanding as of the effective date of the Merger, which total The Company ’ ’ ’ The Company has granted options that include either a service-based or performance-based vesting conditions, or both, and a 10-year contractual term. The service-based vesting condition for the plans is generally satisfied over 36 Company recognizes stock-based compensation expense based on the grant date fair value of the awards measured using the Black-Scholes option pricing model. Compensation expense related to awards with service-based vesting conditions is recognized on a straight-line basis over the requisite service period. Option valuation models, including the Black-Scholes option-pricing model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility, the expected term of the award, and the fair value of the underlying common stock on the date of grant. Forfeitures are accounted for as they occur. Compensation expense related to awards with performance-based vesting conditions is recognized over the requisite service period using the accelerated attribution method to the extent achievement of the performance-based condition is probable. The Company does not recognize compensation expense related to awards with performance-based vesting conditions until it is probable that the performance-based vesting condition will be achieved. Forfeitures are accounted for as they occur. Option awards under the Company ’ ’ ’ Under the terms of her employment agreement, the Company awarded the Company ’ ’ three The Company estimated the fair value of the stock options on the date of grant using the following assumptions in the Black-Scholes option-pricing model: Three Months Ended Nine Months Ended September 30, 2020 2021 (1) 2020 2021 Estimated dividend yield 0 % — 0 % 0 % Expected share price volatility (weighted average and range, if applicable) 91.6 % — 91.4% (89.4% to 91.6%) 91.4% (91.0% to 92.1%) Risk-free interest rate (weighted average and range, if applicable) 0.34 % — 0.40% (0.34% to 0.75%) 0.68% (0.62% to 1.02%) Expected term of options (in years) 6.0 — 6.0 6.0 (1) The Company did not grant any stock options during the three months ended September 30, 2021. ● Fair Value of Common Stock. As the Company ’ s common stock was not publicly traded prior to the Merger, the fair value of the shares of its common stock underlying the options has historically been determined by the Company ’ s board of directors with input from management, after considering independent third-party valuation reports. ● Expected Term. The expected term represents the period that stock options are expected to be outstanding. The Company calculated the expected term using the simplified method for options, which is available where there is insufficient historical data about exercise patterns and post-vesting employment termination behavior. The simplified method is based on the vesting period and the contractual term for each grant, or for each vesting-tranche for awards with graded vesting. The mid-point between the vesting date and the maximum contractual expiration date is used as the expected term under this method. For awards with multiple vesting-tranches, the times from grant until the mid-points for each of the tranches may be averaged to provide an overall expected term. ● Expected Volatility. The expected volatility was based on the historical share volatility of several publicly traded peer companies over a period of time equal to the expected term of the options, as the Company does not have any trading history to use the volatility of its common stock. For purposes of identifying these peer companies, the Company considered the industry, stage of development, size and financial leverage of potential comparable companies. ● Risk-Free Interest Rate. The risk-free interest rate was based on the yields of U.S. Treasury zero-coupon securities with maturities similar in duration to the expected term of the options. ● Expected Dividend Yield. The Company has not paid dividends on its common stock nor does it expect to pay dividends in the foreseeable future. Accordingly, the Company has estimated the dividend yield to be zero. At September 30, 2021, there were 7,730,503 options remaining available for grant under the 2021 Plan. The Company has sufficient authorized and unissued shares to make all issuances currently available under the 2021 Plan. The following tables show a summary of stock-based compensation expense included in the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2021, and the three and nine months ended September 30, 2020, and remaining unrecognized cost as of September 30, 2021 and 2020: Three Months Ended Nine Months Ended ($ in thousands) 2020 2021 2020 2021 Research and development $ 308 $ 486 $ 781 $ 1,837 General and administrative 862 1,391 2,685 5,498 Total $ 1,170 $ 1,877 $ 3,466 $ 7,335 December 31, September 30, ($ in thousands) 2020 2021 Unrecognized share-based compensation cost $ 5,789 $ 12,480 Expected weighted average period compensation costs to be recognized (years) 1.7 2.1 A summary of option activity under the Company ’ Weighted Average Weighted Remaining Aggregate Average Exercise Contractual Term Intrinsic Value Number of Shares Price Per Share (years) (in thousands) Options outstanding at December 31, 2020 4,813,262 $ 6.04 6.6 $ 20,422 Granted 1,838,029 $ 10.28 Exercised (188,006) $ 2.97 Forfeited (63,397) $ 7.87 Options outstanding at September 30, 2021 6,399,888 $ 7.33 6.6 $ 26,705 Vested and exercisable, September 30, 2021 4,092,342 $ 5.74 5.1 $ 23,345 Vested and expected to vest, September 30, 2021 6,399,888 $ 7.33 6.6 $ 26,705 The Company did not grant any stock options during the three months ended September 30, 2021. | 9. Stock-based Compensation The Company has adopted the 2015 Omnibus Incentive Plan, as amended, or the 2015 Plan, which allows for the grant of nonstatutory stock options, or NSOs, and incentive stock options, or ISOs, stock appreciation rights, restricted stock, restricted stock units and unrestricted stock awards to employees, officers, directors, and consultants in the service of the Company. The Company believes that such awards aid in aligning the interests of these persons with those of its stockholders. The Board of Directors determines the specific terms of equity incentive grants, including the exercise price per share and vesting period for option awards. Option awards are granted with an exercise price equal to the fair market value of the Company ’ The Company has granted options that include either a service-based or performance-based vesting condition and a 10-year contractual term. The service-based vesting condition is generally satisfied over 36 months from the date of grant. The performance-based vesting conditions are satisfied upon the attainment of certain product development milestones. The Company recognizes stock-based compensation expense based on the grant date fair value of the awards. Compensation expense related to awards with service-based vesting conditions is recognized on a straight-line basis over the requisite service period. Compensation expense related to awards with performance-based vesting conditions is recognized over the requisite service period using the accelerated attribution method to the extent achievement of the performance-based condition is probable. The Company does not recognize compensation expense related to awards with performance-based vesting conditions until it is probable that the performance-based vesting condition will be achieved. Forfeitures are accounted for as they occur. Option awards under the 2015 Plan generally provide for accelerated vesting of the unvested portions of any option award in the event of an involuntary termination, as such term is defined in the relevant stock option agreement, of a grantee ’ ’ 9. Stock-based Compensation (continued) The Company used the following assumptions on the date of grant to estimate the fair value of the stock options in the Black-Scholes option-pricing model as follows: Year Ended 2019 2020 Estimated dividend yield 0 % 0 % Expected share price volatility 70.1%-87.7 % 89.4% - 91.6 % Risk-free interest rate 1.76% - 2.46 % 0.34% - 0.75 % Expected term of options (in years) 6.00 6.00 ● Fair Value of Common Stock. As the Company ’ s common stock has not historically been publicly traded, the fair value of the shares of its common stock underlying the options has historically been determined by the Company ’ s board of directors with input from management, after considering independent third-party valuation reports. ● Expected Term. The expected term represents the period that stock options are expected to be outstanding. The Company calculated the expected term using the simplified method for options, which is available where there is insufficient historical data about exercise patterns and post-vesting employment termination behavior. The simplified method is based on the vesting period and the contractual term for each grant, or for each vesting-tranche for awards with graded vesting. The mid-point between the vesting date and the maximum contractual expiration date is used as the expected term under this method. For awards with multiple vesting-tranches, the times from grant until the mid-points for each of the tranches may be averaged to provide an overall expected term. ● Expected Volatility. The expected volatility was based on the historical share volatility of several publicly traded peer companies over a period of time equal to the expected term of the options, as the Company does not have any trading history to use the volatility of its common stock. For purposes of identifying these peer companies, the Company considered the industry, stage of development, size and financial leverage of potential comparable companies. ● Risk-Free Interest Rate. The risk-free interest rate was based on the yields of US Treasury zero-coupon securities with maturities similar in duration to the expected term of the options. ● Expected Dividend Yield. The Company has not paid dividends on its common stock nor does it expect to pay dividends in the foreseeable future. Accordingly, the Company has estimated the dividend yield to be zero. At December 31, 2020, there were 2,948,598 options remaining available for grant under the 2015 Plan. The Company has sufficient authorized and unissued shares to make all issuances currently contemplated under the 2015 Plan. 9. Stock-based Compensation (continued) The following tables show a summary of stock-based compensation expense included in the statements of operations and comprehensive loss for the years ended December 31, 2019 and 2020, and remaining unrecognized cost as of December 31, 2019 and 2020: Year Ended ($ in thousands) 2019 2020 Research and development $ 914 $ 1,135 General and administrative 3,543 3,559 Total $ 4,457 $ 4,694 As of December 31, ($ in thousands) 2019 2020 Unrecognized share-based compensation cost $ 7,919 $ 5,789 Expected weighted average period compensation costs to be recognized (years) 1.8 1.7 A summary of option activity under the 2015 Plan during the years ended December 31, 2019 and 2020 is presented below: Weighted Average Weighted Remaining Aggregate Number of Average Exercise Contractual Term Intrinsic Value Shares Price Per Share (years) (in thousands) Options outstanding at December 31, 2018 5,638,773 $ 4.69 7.4 $ 21,354 Granted 621,031 8.49 Exercised (620,831) 1.97 Forfeited (418,737) 7.62 Options outstanding at December 31, 2019 5,220,236 $ 5.22 6.5 $ 17,044 Granted 480,856 9.79 Exercised (195,239) 1.55 Forfeited (692,591) 3.76 Options outstanding at December 31, 2020 4,813,262 $ 6.04 6.6 $ 20,422 Vested and exercisable, December 31, 2020 3,392,302 $ 4.99 5.9 $ 17,925 Vested and expected to vest, December 31, 2020 4,813,262 $ 6.04 6.6 $ 20,422 The total intrinsic value of options exercised during the years ended December 31, 2019 and 2020 was $4.0 million and $1.4 million, respectively. The weighted-average grant-date fair value per share of options granted during the years ended December 31, 2019 and 2020 was $5.84 and $7.26, respectively. |
Income Taxes
Income Taxes | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Income Taxes | ||
Income Taxes | 10. Income Taxes The Company ’ ’ The Company did not record any income tax expense or benefit during the three and nine months ended September 30, 2020 and 2021. The Company has a net operating loss and has provided a valuation allowance against net deferred tax assets due to uncertainties regarding the Company ’ On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security ( “ ” ’ | 10. Income Taxes The Company did not record any income tax expense or benefit during the years ended December 31, 2019 and 2020. The Company has a net operating loss and has provided a valuation allowance against net deferred tax assets due to uncertainties regarding the Company ’ Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company ’ As of December 31, ($ in thousands) 2019 2020 Deferred tax assets: Net operating loss $ 50,616 $ 53,515 Capitalized research and development 19,660 32,337 Research credits 10,658 15,056 Share-based compensation 1,669 2,519 Right of use lease liability 207 177 Accrued expenses 71 57 Other 1 1 Total deferred tax asset 82,882 103,662 Less: valuation allowance (82,193) (101,757) Total net deferred tax asset 689 1,905 Deferred tax liabilities: Basis difference in fixed assets (482) (1,728) Right of use lease assets (207) (177) Total deferred tax liability (689) (1,905) Total net deferred tax asset/(liability) $ — $ — A valuation allowance is provided for deferred tax assets where the recoverability of the assets is uncertain. The determination to provide a valuation allowance is dependent upon the assessment of whether it is more likely than not that sufficient future taxable income will be generated to utilize the deferred tax assets. Based on the weight of the available evidence, which includes the Company ’ 10. Income Taxes (continued) The reasons for the difference between the actual income tax benefit for the years ended December 31, 2019 and 2020, and the amount computed by applying the statutory Federal income tax rate to losses before income taxes are as follows: December 31, 2019 2020 ($ in thousands) Amount Rate Amount Rate Income tax benefit at statutory rate $ (17,939) 21.0 % $ (13,970) 21.0 % State income taxes, net of federal benefit (1,739) 2.0 % (1,338) 2.0 % Tax credits (1,821) 2.1 % (2,625) 3.9 % Other nondeductible expenses 54 0.0 % 90 (0.1) % Deferred rate changes 16 0.0 % 16 0.0 % Other 449 (0.5) % (1,736) 2.6 % Change in valuation allowance 20,980 (24.6) % 19,563 (29.4) % Provision for income taxes $ — 0.0 % $ — 0.0 % As of December 31, 2020 the Company had approximately $232.7 million and $232.6 million of Federal and state net operating losses, respectively. Of this amount, $71.5 million of Federal net operating losses are carried over indefinitely, while the remaining amount begins to expire in 2025. The Company ’ As of December 31, 2019 and December 31, 2020 the Company had Federal and state research tax credit carryforwards of $10.7 million and $15.1 million, respectively. These credit carryforwards begin to expire in 2021. Net operating loss carryforwards and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service, or IRS, and may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders or groups over a three-year period in excess of 50% as defined under Sections The Company applies the accounting guidance for uncertainties in income taxes, which prescribes a recognition threshold and measurement process for recording uncertain tax positions taken, or expected to be taken, in a tax return in the financial statements. Additionally, the guidance also prescribes the treatment for derecognition, classification, accounting in interim periods and disclosure requirements for uncertain tax positions. The Company accrues for the estimated amount of taxes for uncertain tax positions if it is more likely than not that the Company would be required to pay such additional taxes. On March 27, 2020, the CARES Act was passed by the U.S. Congress and signed into United ’ |
Retirement Plan
Retirement Plan | 12 Months Ended |
Dec. 31, 2020 | |
Retirement Plan | |
Retirement Plan | 11. Retirement Plan The Company maintains two defined contribution employee retirement plans, or 401(k) plans, for all employees upon their date of hire. The 401(k) plans are intended to qualify as tax-qualified plans under Section ’ ’ |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Commitments and Contingencies | ||
Commitments and Contingencies | 11. Commitments and Contingencies Patent License Agreements Duke University In March In connection with the Company ’ ’ ● a low single-digit percentage royalty on eligible sales of licensed products and licensed services, plus a low double-digit percentage of any sublicensing revenue; ● an annual minimum royalty beginning in 2012, which increases in the calendar year immediately following the first commercial sale of licensed products or licensed services (whichever occurs first); and ● an additional amount in license fees, as certain milestones are met. The license agreement remains effective until the last of the patent rights expires or four years after the Company ’ ’ Yale University In February – ’ fee, increasing between the first and fourth anniversaries of the agreement up to a maximum of less than $0.1 million per year for this license. In August ’ In August ’ The Company has agreed to use reasonable commercial efforts to develop and commercialize the licensed patents and any licensed products and methods, and to use reasonable efforts to make the licensed products available to patients in low and low-middle income countries. The Company is also obligated to provide Yale periodically an updated and revised copy of its plan for each license, which must indicate progress of its development and commercialization. The Company may also sublicense the Company ’ ’ In connection with its entry into the license agreement, the Company paid Yale upfront cash fees. The Company has also agreed to pay Yale: ● annual maintenance fees, increasing between the first anniversary of the agreement until the fifth anniversary for the coating and BVP licenses and until the fourth anniversary for the tubular prostheses license up to a maximum of less than $0.1 million per year; ● milestone payments upon achievement of certain regulatory and commercial milestones of $0.2 million and $0.6 million; ● a low single-digit percentage royalty on worldwide net sales, subject to reductions for third-party license fees; and ● a low double-digit percentage of sublicensing income. If the Company or any of its future sublicensees bring a patent challenge against Yale or assists another party in bringing a patent challenge against Yale, the license fees described above will be subject to certain increases and penalties. The agreements expire on a country-by-country basis on the date on which the last of the patents in such country expires, lapses or is declared invalid. Yale may terminate the agreements if the Company fails to (i) ’ ’ ’ ’ respect to the licensed patents. The Company has agreed to indemnify Yale against certain third-party claims. Payments to Yale under the license agreement were immaterial during the periods presented. Legal Matters The Company currently is not aware of any legal proceedings or claims that management believes will have, individually or in the aggregate, a material adverse effect on the Company ’ Indemnification To the extent permitted under Delaware law, the Company has agreed to indemnify its directors and officers for certain events or occurrences while the director or officer is, or was serving, at the Company ’ ’ ’ | 12. Commitments and Contingencies Patent License Agreements Duke University In March In connection with the Company ’ ’ ● a low single-digit percentage royalty on eligible sales of licensed products and licensed services, plus a low double-digit percentage of any sublicensing revenue; ● an annual minimum royalty beginning in 2012, which increases in the calendar year immediately following the first commercial sale of licensed products or licensed services (whichever occurs first); and ● an additional amount in license fees, as certain milestones are met. The license agreement remains effective until the last of the patent rights expires or four years after our first commercial sale, unless earlier terminated. Either party may terminate the agreement for fraud, willful misconduct or illegal conduct, or uncured material breach. Duke may terminate the agreement if the Company becomes insolvent. Duke may also terminate the license, convert the license into a non-exclusive license or seek assignment of any sublicense if the Company fails to reach diligence milestones within the applicable time period. If the Company abandons any claim, patent or patent application, its rights under the license with respect to such patent rights will be terminated in the territory in which the Company abandons such rights. The Company may terminate the license agreement unilaterally upon three months ’ 12. Commitments and Contingencies (continued) Yale University In February – ’ In August ’ In August ’ The Company has agreed to use reasonable commercial efforts to develop and commercialize the licensed patents and any licensed products and methods, and to use reasonable efforts to make the licensed products available to patients in low and low-middle income countries. The Company is also obligated to provide Yale periodically an updated and revised copy of its plan for each license, which must indicate progress of its development and commercialization. The Company may also sublicense the Company ’ ’ In connection with its entry into the license agreement, the Company paid Yale upfront cash fees. The Company has also agreed to pay Yale: ● annual maintenance fees, increasing between the first anniversary of the agreement until the fifth anniversary for the coating and BVP licenses and until the fourth anniversary for the tubular prostheses license; ● milestone payments upon achievement of certain regulatory and commercial milestones; ● a low single-digit percentage royalty on worldwide net sales, subject to reductions for third-party license fees; and ● a low double-digit percentage of sublicensing income. If the Company or any of its future sublicensees bring a patent challenge against Yale or assists another party in bringing a patent challenge against Yale, the license fees described above will be subject to certain increases and penalties. 12. Commitments and Contingencies (continued) The agreements expire on a country-by-country basis on the date on which the last of the patents in such country expires, lapses or is declared invalid. Yale may terminate the agreements if the Company fails to (i) ’ ’ ’ ’ Legal Matters The Company currently is not aware of any legal proceedings or claims that management believes will have, individually or in the aggregate, a material adverse effect on the Company ’ Indemnification To the extent permitted under Delaware law, the Company has agreed to indemnify its directors and officers for certain events or occurrences while the director or officer is, or was serving, at the Company ’ ’ ’ |
Related Party Transactions
Related Party Transactions | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Related Party Transactions | ||
Related Party Transactions | 12. Related Party Transactions Fresenius Medical Care investments and distribution agreement In June 2018, the Company completed a $150 million financing transaction pursuant to which Fresenius Medical Care purchased shares of series D redeemable convertible preferred stock that at the Closing of the Merger converted into 15,812,735 shares of the Company ’ ’ In addition, the Company entered into a distribution agreement with Fresenius Medical Care in June 2018 which, as amended as of February 16, 2021, granted Fresenius Medical Care and its affiliates exclusive rights to develop outside the United States and EU and commercialize outside of the United States the Company ’ The Company is responsible for developing and seeking regulatory approval for the distribution product in the field in the United States. For countries outside the United States, the parties agreed to use commercially reasonable efforts to satisfy certain agreed minimum market entry criteria for the distribution product in the field in such country. For the EU, once such criteria have been satisfied for the applicable country, or if the parties otherwise mutually agree to obtain regulatory approval for the distribution product in the field in the applicable country, the Company agreed to use commercially reasonable efforts to obtain such regulatory approval (other than pricing approval), and Fresenius Medical Care agreed to use commercially reasonable efforts to obtain the corresponding pricing approval. For the rest of the world (i.e., outside the United States and the EU), once such criteria have been satisfied for the applicable country, or if the parties otherwise mutually agree to obtain regulatory and pricing approval for the distribution product in the field in the applicable country, Fresenius Medical Care agreed to use commercially reasonable efforts to obtain such approvals, and the Company agreed to use commercially reasonable efforts to support Fresenius Medical Care in its efforts. Under the distribution agreement, the Company grants an exclusive, sublicensable license to Fresenius Medical Care under the patents, know-how and regulatory materials controlled by the Company during the term to commercialize the distribution product in the field outside the United States, subject to the Company ’ and regulatory materials controlled by the Company during the term to develop the distribution product in accordance with the terms of the distribution agreement. In addition, the Company grants to Fresenius Medical Care, among other things, a perpetual, irrevocable, non-exclusive sublicensable license under the patents and know-how that primarily relate to the distribution product or its manufacture and that were created, conceived or developed solely or jointly by or on behalf of Fresenius Medical Care in the performance of its activities under the distribution agreement. The distribution agreement provides that the Company will own all know-how and patents that primarily relate to the distribution product or its manufacture that are created, conceived or developed by or on behalf of either party in the performance of activities under the distribution agreement. Ownership of all other know-how, patents, materials and other intellectual property created, conceived or developed during the performance of activities under the distribution agreement will be determined in accordance with U.S. patent laws for determining inventorship. The Company is obligated to make payments to Fresenius Medical Care based on a share of aggregate net sales by or on behalf of the Company of the distribution product in the United States in the field. Such revenue-share payments will be a percentage of net sales in the low double digits, without regard to the calendar year in which such net sales are attributable, until such time that the Company has paid to Fresenius Medical Care a certain total amount, at which time the revenue-share will decrease to a percentage of net sales in the mid-single digits. The amounts that Fresenius Medical Care will be obligated to pay the Company under the distribution agreement for sales of the distribution product in the field outside of the United States will vary. Fresenius Medical Care agreed to pay the Company initially, on a country-by-country basis for sales outside of the United States, the amount equal to the average cost of manufacturing the Company ’ The distribution agreement will generally continue on a country-by-country basis until the later of (a) the tenth anniversary of the launch date of the distribution product in the relevant country or (b) the expiration of the last-to-expire valid claim of specified patents in such country. Each party is permitted to terminate the distribution agreement for insolvency of, or, under certain circumstances, including various cure periods, material breach by the other party. Subject to a cure period, Fresenius Medical Care may also terminate the distribution agreement in its entirety or on a country-by-country basis (i) for certain withdrawals of regulatory approval or (ii) for termination or expiration of any of our in-licenses that is necessary for the exercise of Fresenius Medical Care ’ ’ Arrangements with Dr. Niklason and Yale University In September The MOU provided for the Company to make a payment each year through 2023 to the academic institution with which Dr. ’ ’ The following table shows a summary of related party expenses included in the statements of operations and comprehensive loss for the three and nine months ended September 30, 2020 and 2021: Three Months Nine Months ($ in thousands) 2020 2021 2020 2021 Expenses under MOU 125 — 375 — License expenses 20 — 70 85 Other 4 2 17 83 Total 149 2 462 168 As of December 31, 2020 and September 30, 2021, the Company was a party to license agreements with Yale University, as described in Note 11 — | 13. Related Party Transactions Fresenius Medical Care distribution agreement In addition to Fresenius Medical Care ’ ’ The Company is responsible for developing and seeking regulatory approval for the distribution product in the field in the United States. For countries outside the United States, the parties agreed to use commercially reasonable efforts to satisfy certain agreed minimum market entry criteria for the distribution product in the field in such country. For the EU, once such criteria have been satisfied for the applicable country, or if the parties otherwise mutually agree to obtain regulatory approval for the distribution product in the field in the applicable country, the Company agreed to use commercially reasonable efforts to obtain such regulatory approval (other than pricing approval), and Fresenius Medical Care agreed to use commercially reasonable efforts to obtain the corresponding pricing approval. For the rest of the world (i.e., outside the United States and the EU), once such criteria have been satisfied for the applicable country, or if the parties otherwise mutually agree to obtain regulatory and pricing approval for the distribution product in the field in the applicable country, Fresenius Medical Care agreed to use commercially reasonable efforts to obtain such approvals, and the Company agreed to use commercially reasonable efforts to support Fresenius Medical Care in its efforts. Under the distribution agreement, the Company grants an exclusive, sublicensable license to Fresenius Medical Care under the patents, know-how and regulatory materials controlled by the Company during the term to commercialize the distribution product in the field outside the United States, subject to the Company ’ The distribution agreement provides that the Company will own all know-how and patents that primarily relate to the distribution product or its manufacture that are created, conceived or developed by or on behalf of either party in the performance of activities under the distribution agreement. Ownership of all other know-how, patents, materials and other intellectual property created, conceived or developed during the performance of activities under the distribution agreement will be determined in accordance with U.S. patent laws for determining inventorship. 13. Related Party Transactions (continued) The Company is obligated to make payments to Fresenius Medical Care based on a share of aggregate net sales by or on behalf of the Company of the distribution product in the United States in the field. Such revenue-share payments will be a percentage of net sales in the low double digits, without regard to the calendar year in which such net sales are attributable, until such time that the Company has paid to Fresenius Medical Care a certain total amount, at which time the revenue-share will decrease to a percentage of net sales in the mid-single digits. The amounts that Fresenius Medical Care will be obligated to pay the Company under the distribution agreement for sales of the distribution product in the field outside of the United States will vary. Fresenius Medical Care agreed to pay the Company initially, on a country-by-country basis for sales outside of the United States, the amount equal to the average cost of manufacturing the Company ’ The distribution agreement will generally continue on a country-by-country basis until the later of (a) the tenth anniversary of the launch date of the distribution product in the relevant country or (b) the expiration of the last-to-expire valid claim of specified patents in such country. Each party is permitted to terminate the distribution agreement for insolvency of, or, under certain circumstances, including various cure periods, material breach by the other party. Subject to a cure period, Fresenius Medical Care may also terminate the distribution agreement in its entirety or on a country-by-country basis (i) for certain withdrawals of regulatory approval or (ii) for termination or expiration of any of our in-licenses that is necessary for the exercise of Fresenius Medical Care ’ ’ Arrangements with Dr. Niklason and Yale University In September The MOU provided for the Company to make a payment each year through 2023 to the academic institution with which Dr. ’ ’ The following table shows a summary of related party expenses included in the statements of operations and comprehensive loss for the years ended December 31, 2019 and 2020: Year Ended December 31, ($ in thousands) 2019 2020 Expenses under MOU $ 422 $ 500 License expenses 110 92 Other 39 28 Total $ 571 $ 620 As of December 31, 2019 and December 31, 2020, the Company was a party to license agreements with Yale University, as described in Note 12 — |
Subsequent Events
Subsequent Events | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Subsequent Events [Abstract] | ||
Subsequent Events | 13. Subsequent Events In preparing the condensed consolidated financial statements as of September 30, 2021 and for the three and nine months ended September 30, 2021, the Company evaluated the effect subsequent events would have on the financial statements through the date the financial statements were issued. On October 13, 2021, the Company borrowed an additional $10.0 million under the Loan Agreement, and the warrants to purchase an additional 123,302 shares of the Company ’ — — ’ | 14. Subsequent Events The Company evaluated the effect subsequent events would have on the financial statements through March 22, 2021, which is the date the financial statements were issued. Under the terms of her employment agreement, the Company awarded Dr. Niklason an additional stock option award in January 2021 entitling her to purchase 1,312,984 shares of the Company ’ none three Under the terms of his consulting agreement, the Company awarded Mr. Sander an additional stock option award in January 2021 entitling him to purchase 183,817 shares of the Company ’ three On February 17, 2021, the Company entered into a business combination agreement with AHAC and Merger Sub, a wholly owned subsidiary of AHAC, pursuant to which Merger Sub will merge with the Company, with the Company surviving the Merger as a wholly owned subsidiary of AHAC. As a result of the Merger, AHAC will immediately be renamed New Humacyte. Immediately prior to the consummation of the Merger, the Company ’ ’ ’ ’ ’ No |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Summary of Significant Accounting Policies | ||
Basis of Presentation | Basis of Presentation The Company has prepared the accompanying financial statements in conformity with accounting principles generally accepted in the United ’ Unless otherwise noted, the Company has retroactively adjusted all common and preferred share and related price information to give effect to the Exchange Ratio established in the Merger Agreement. | Basis of Presentation The Company has prepared the accompanying financial statements in conformity with accounting principles generally accepted in the United Reverse Recapitalization |
Unaudited Interim Condensed Consolidated Financial Statements | Unaudited Interim Condensed Consolidated Financial Statements The accompanying interim condensed consolidated financial statements and the related footnote disclosures are unaudited. These unaudited interim financial statements have been prepared on the same basis as the audited financial statements, and in management ’ ’ Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2020 and the related notes included elsewhere in this prospectus, which provides a more complete discussion of the Company’s accounting policies and certain other information. Other than the policies noted below, there have been no significant changes to the significant accounting policies disclosed in Note 2 of the audited consolidated financial statements as of and for the years ended December 31, 2019 and 2020 included elsewhere in this prospectus. | On August 26, 2021 (the “ ” “ ” “ ” “ ” “ ” “ ” “ ” “ ” Unless otherwise noted, the Company has retroactively adjusted all common and preferred share and related price information to give effect to the Exchange Ratio of approximately 0.26260 established in the Merger Agreement. |
Common Stock Warrants | Common Stock Warrants The Company assumed 5,000,000 publicly-traded warrants ( “ ” “ ” ’ “ ” “ ” ’ “ ” The Company evaluated the Common Stock Warrants to determine the appropriate financial statement classification upon the consummation of the Merger. The Common Stock Warrants are not mandatorily redeemable and are considered to be freestanding instruments as they are separately exercisable into common shares. As such, the Common Stock Warrants were not classified as liabilities under FASB ASC Topic 480, Distinguishing Liabilities from Equity Derivatives and Hedging The agreement governing the Common Stock Warrants includes a provision ( “ ” ’ “ ’ ” ’ The Public Warrants are considered to be “indexed to the Company’s own stock”. The agreement provides that in the event of a tender or exchange offer made to and accepted by holders of more than 50% of the outstanding shares of the Company ’ ’ ’ | |
Contingent Earnout Liability | Contingent Earnout Liability In connection with the Reverse Recapitalization and pursuant to the Business Combination Agreement dated as of February 17, 2021 by and among Legacy Humacyte, Merger Sub, and AHAC (the “ ” ’ “ ” The estimated fair value of the Contingent Earnout Shares was determined using a Monte Carlo simulation using a distribution of potential outcomes on a monthly basis over a ten-year period prioritizing the most reliable information available. The assumptions utilized in the calculation were based on the achievement of certain stock price milestones, including the current Company common stock price, expected volatility, risk-free rate, expected term and expected dividend yield. The Contingent Earnout Shares are categorized as a Level | |
Segments | Segments The Company operates and manages its business as one reportable and operating segment. The Company is developing proprietary, bioengineered, acellular human tissues that are designed to be used in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. The Company ’ | Segments The Company operates and manages its business as one reportable and operating ’ |
Comprehensive loss | Comprehensive loss Comprehensive loss includes net loss as well as other changes in stockholders ’ | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates in the financial statements include stock-based compensation costs, right-of-use, or ROU, assets, accruals for research and development activities, contingent earnout liability, fair value of common stock warrants, redeemable convertible preferred stock and income taxes. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates in the financial statements include stock-based compensation costs, right-of-use, or ROU assets, accruals for research and development activities, fair value of common stock, useful lives of property and equipment, redeemable convertible preferred stock and income taxes. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. 2. Summary of Significant Accounting Policies (continued) |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all short-term, highly liquid investments purchased with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash deposits are held with financial institutions with investment-grade ratings in the United | |
Redeemable Convertible Preferred Stock | Redeemable Convertible Preferred Stock The Company analyzes all issued equity instruments to determine the appropriate accounting and classification. The Company evaluates its equity instruments under Accounting Standards Codification, or ASC 480, Distinguishing liabilities from equity The Company records equity instruments that are classified as temporary equity at fair value upon issuance, net of issuance costs. The Company accretes the carrying value of its redeemable convertible preferred stock to the redemption or liquidation amount once the Company has determined that it is probable that it will become redeemable or be liquidated. The accretion will be recorded as charges against additional paid-in capital until the additional paid-in capital balance is reduced to zero. At that time, additional accretion adjustments will be recorded as additions to accumulated deficit. The Company also analyzes instances where the equity instrument has a conversion feature pursuant to ASC 815, Derivatives and hedging | |
Revenue Recognition | Revenue Recognition The Company ’ Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services and is recognized in an amount that reflects the consideration that an entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) In addition, ASC 606 requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. For contracts where the period between when the Company transfers a promised good or service to the customer and when the customer pays is one year or less, the Company has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing component. | Revenue Recognition The Company ’ In 2014, the Financial Accounting Standards Board, or FASB issued Accounting Standards Update No. Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services and is recognized in an amount that reflects the consideration that an entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) In addition, ASC 606 requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. 2. Summary of Significant Accounting Policies (continued) For contracts where the period between when the Company transfers a promised good or service to the customer and when the customer pays is one year or less, the Company has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing component. |
Grant Revenue | Grant Revenue The Company generates revenue primarily from government and other awarded grants that reimburse the Company for certain allowable costs related to research and development efforts. These grants include the following terms: The Department of Defense grants are for an award of $4.0 million, all of which was recognized as revenue before the program ended, for work on bioengineered blood vessels for vascular trauma, which was awarded to the Company in September 2017 and ended in February 2020, and an award of $7.1 million for work to support human tissue engineered blood vessels for vascular reconstruction in the injured warfighter, which was awarded to the Company in August 2017 and is ongoing. The Company has recognized revenue of $0.6 million and $1.0 million during the three and nine months ended September 30, 2020,respectively, and $0.2 million and $1.1 million during the three and nine months ended September 30, 2021, respectively, for reimbursement of certain allowable costs related to these grants. The National Institutes of Health grant is for $1.6 million for work to support bioengineered grafts for peripheral vascular disease, which was awarded to the Company in November 2013. The Company recognized $1.6 million for the reimbursement of certain allowable costs related to the grant before this program ended in 2020. The Company recognized $0.3 million during the three and nine months ended September 30, 2020, and no revenue during the three and nine months ended September 30, 2021, for reimbursement of certain allowable costs related to these grants. The Company has determined that the grants are not within the scope of ASC 606 as they do not meet the definition of a contract with a customer. The Company has concluded that the grants meet the definition of a contribution and are nonexchange transactions and has applied the contribution accounting model in Subtopic 958-605, Not-for-Profit-Entities-Revenue Recognition by analogy. The Company recognizes funding received from grants as revenue, rather than as a reduction of research and development expenses, because the Company is the principal in conducting the research and development activities and these grants are central to the Company ’ ’ Revenue from grants not within the scope of ASC 606 was $0.9 million and $1.4 million for the three and nine months ended September 30, 2020, respectively, and $0.2 million and $1.1 million for the three and nine months ended September 30, 2021, respectively. | Grant Revenue We generate revenue primarily from government and other awarded grants that reimburse us for certain allowable costs related to research and development efforts. The Company has determined that the grants are not within the scope of ASC 606 as they do not meet the definition of a contract with a customer. The Company has concluded that the grants meet the definition of a contribution and are nonexchange transactions and has applied the contribution accounting model in Subtopic 958-605, Not-for-Profit-Entities-Revenue Recognition by analogy. The Company recognizes funding received from grants as revenue, rather than as a reduction of research and development expenses, because the Company is the principal in conducting the research and development activities and these grants are central to the Company ’ Revenue from grants not within the scope of ASC 606 was $6.2 million and $1.5 million for the years ending December 31, 2019 and 2020, respectively. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. Total cash balances exceeded insured balances by the Federal Deposit Insurance Corporation as of December 31, 2020 and September 30, 2021. Cash equivalents are invested in highly rated money market funds invested only in obligations of the U.S. government and its agencies. The majority of the Company ’ ’ ’ Revenue Accounts Receivable Three Months Nine Months December 31, September 30, 2020 2021 2020 2021 2020 2021 Grant A — — — — — — Grant B 0 — % 11 — % — — Grant C 68 % 100 % 65 % 100 % 100 % 100 % Grant D 30 — % 20 — % — — Total 98 % 100 % 96 % 100 % 100 % 100 % All of the Company ’ | Concentration of Credit Risk Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. Total cash balances exceeded insured balances by the Federal Depository Insurance Corporation as of December 31, 2019 and 2020. Cash equivalents are invested in highly rated money market funds invested only in obligations of the US government and its agencies. The majority of the Company ’ ’ ’ 2019 2020 Accounts Accounts Revenue Receivable Revenue Receivable Grant A 28 % — — — Grant B 38 % 67 % 10 % — Grant C 34 % 33 % 67 % 100 % Grant D — — 18 % — Total 100 % 100 % 95 % 100 % All of the Company ’ |
Other Risks and Uncertainties | Other Risks and Uncertainties The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, successful discovery and development of its product candidates, the success of clinical trials and other studies for its product candidates, including for its ongoing V005 Phase II/III clinical trial and V007 Phase III clinical trial, the regulatory approval and commercialization of its HAVs and other product candidates, ’ ’ ’ Product candidates currently under development will require extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company ’ ’ | 2. Summary of Significant Accounting Policies (continued) Other Risks and Uncertainties The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, successful discovery and development of its product candidates, the success of clinical trials and other studies for its product candidates, including for its ongoing V005 Phase II/III clinical trial and V007 Phase III clinical trial, the regulatory approval and commercialization of its HAVs and other product candidates, ’ ’ ’ Product candidates currently under development will require extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company ’ ’ |
Net Loss per Share Attributable to Common Stockholders | Net Loss per Share Attributable to Common Stockholders The Company follows the two-class method to compute basic and diluted net loss per share attributable to common stockholders when shares met the definition of participating securities. The two-class method determines net loss per common share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to share in the earnings as if all income for the period had been distributed. During periods of loss, there is no allocation required under the two-class method since the redeemable convertible preferred stock did not have a contractual obligation to share in the Company ’ Basic net loss per share attributable to common stockholders is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period without consideration of potentially dilutive common stock. Diluted net loss per share attributable to common stockholders reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the Company unless inclusion of such shares would be anti-dilutive. As the Company has only incurred losses, basic and diluted net loss per share is the same. The potential shares of common stock that were excluded from the computation of diluted net loss per share for each period because including them would have had an antidilutive effect were as follows: September 30, 2020 2021 Shares issuable upon conversion of Series A redeemable convertible preferred stock 18,421,897 — Shares issuable upon conversion of Series B redeemable convertible preferred stock 24,137,647 — Shares issuable upon conversion of Series C redeemable convertible preferred stock 11,241,283 — Shares issuable upon conversion of Series D redeemable convertible preferred stock 15,812,735 — Exercise of options under stock plan 4,516,907 6,399,888 Warrants to purchase common stock 32,961 5,465,204 The 15,000,000 Contingent Earnout shares are excluded from the anti-dilutive table for all the periods presented as such shares are contingently issuable until the share price of the Company exceeds specified thresholds that have not yet been achieved, or upon the occurrence of a change in control. | Net Loss per Share Attributable to Common Stockholders The Company applies the two-class method to compute basic and diluted net loss per share attributable to common stockholders when shares meet the definition of participating securities. The two-class method determines net loss per share for each class of common and redeemable convertible preferred stock according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income (loss) available to common stockholders for the period to be allocated between common and redeemable convertible preferred stock based upon their respective rights to share in the earnings as if all income (loss) for the period had been distributed. During periods of loss, there is no allocation required under the two-class method since the redeemable convertible preferred stock does not have a contractual obligation to share in the Company ’ 2. Summary of Significant Accounting Policies (continued) Basic net loss per share attributable to common stockholders is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period without consideration of potentially dilutive common stock. Diluted net loss per share attributable to common stockholders reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the Company unless inclusion of such shares would be anti-dilutive. Since the Company has only incurred losses, basic and diluted net loss per share is the same. Securities that could potentially dilute net loss per share in the future that were not included in the computation of diluted net loss per share are as follows: December 31, 2019 2020 Shares issuable upon conversion of Series A redeemable convertible preferred stock 18,421,897 18,421,897 Shares issuable upon conversion of Series B redeemable convertible preferred stock 24,137,647 24,137,647 Shares issuable upon conversion of Series C redeemable convertible preferred stock 11,241,283 11,241,283 Shares issuable upon conversion of Series D redeemable convertible preferred stock 15,812,735 15,812,735 Options to purchase common stock 5,220,236 4,813,262 Warrant to purchase common stock 32,961 32,961 Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants at the measurement date. ASC 820, Fair Value Measurement and Disclosures ● Level 1 — Observable inputs that reflect unadjusted quoted prices for identical assets or liabilities in active markets. ● Level 2 — Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. ● Level 3 — Unobservable inputs in which little or no market data exists, therefore requiring the Company to develop its own assumptions. The Company evaluates assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them for each reporting period, utilizing valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The determination requires significant judgments to be made by the Company. The Company ’ 2. Summary of Significant Accounting Policies (continued) |
Fair Value of Financial Instruments | December 31, 2019 2020 Shares issuable upon conversion of Series A redeemable convertible preferred stock 18,421,897 18,421,897 Shares issuable upon conversion of Series B redeemable convertible preferred stock 24,137,647 24,137,647 Shares issuable upon conversion of Series C redeemable convertible preferred stock 11,241,283 11,241,283 Shares issuable upon conversion of Series D redeemable convertible preferred stock 15,812,735 15,812,735 Options to purchase common stock 5,220,236 4,813,262 Warrant to purchase common stock 32,961 32,961 | |
Property and Equipment, Net | Property and Equipment, Net Property and equipment, net are recorded at cost less accumulated depreciation. Expenditures for major additions and improvements are capitalized and minor replacements, maintenance, and repairs are charged to expense as incurred. When property and equipment are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet accounts and any resulting gain or loss is included in the results of operations for the respective period. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets. The estimated useful lives for significant asset categories are as follows: Estimated Useful Property and equipment Lives (Years) Scientific equipment 5 – 7 Computer equipment 5 Software 3 Furniture and fixtures 5 – 7 Leasehold improvements Lesser of useful life or life of lease Construction in progress N/A | |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews the carrying value of property and equipment for indicators of possible impairment whenever events and circumstances indicate that the carrying value of an asset or asset group may not be recoverable from the estimated future net undiscounted cash flows expected to result from its use and eventual disposition. In cases where estimated future net undiscounted cash flows are less than the carrying value, an impairment loss is recognized equal to an amount by which the carrying value exceeds the fair value of the asset or asset group. The factors considered by management in performing this assessment include current operating results, trends and prospects, the manner in which the property is used, and the effects of obsolescence, demand, competition, and other economic factors. Based on this assessment, during the nine months ended September 30, 2020 and 2021, respectively, the Company concluded there were no such events or changes in circumstances requiring review of the carrying amount of the Company ’ | Estimated Useful Property and equipment Lives (Years) Scientific equipment 5 – 7 Computer equipment 5 Software 3 Furniture and fixtures 5 – 7 Leasehold improvements Lesser of useful life or life of lease Construction in progress N/A |
Income Taxes | Income Taxes Income taxes are computed using the asset and liability approach that requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company ’ 2. Summary of Significant Accounting Policies (continued) The Company recognizes the benefit of an income tax position only if it is more likely than not (greater than 50%) that the tax position will be sustained upon tax examination, based solely on the technical merits of the tax position. Otherwise, no benefit can be recognized. Assessing an uncertain tax position begins with the initial determination of the sustainability of the position and is measured at the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed. Additionally, the Company must accrue interest and related penalties, if applicable, on all tax exposures for which reserves have been established consistent with jurisdictional tax laws. The Company has analyzed its filing positions in all significant Federal and state jurisdictions where it is required to file income tax returns, as well as open tax years in these jurisdictions. As of December 31, 2019 and 2020, the Company has determined that no uncertain tax positions would have a material impact on the financials statements of the Company. The Company is no longer subject to Federal, state, and local tax examinations by tax authorities for years before 2017 although carry-forward attributes that were generated prior to 2017 may still be adjusted upon examination by the taxing authorities if they either have been or will be used in a future period. No income tax returns are currently under examination by taxing authorities. As of December 31, 2019 and 2020, the Company had not recorded any amounts for unrecognized tax benefits. The Company ’ ’ | |
Intellectual Property | Intellectual Property The Company seeks to protect its intellectual property by filing patent applications in the United ’ | |
Research and Development | Research and Development The Company expenses research and development costs as operating expenses as incurred. Research and development expenses consist primarily of: ● salaries and related overhead expenses for personnel in research and development functions, including stock-based compensation and benefits; ● fees paid to consultants and CROs, including in connection with clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work and statistical compilation and analysis; ● allocation of facility lease and maintenance costs; ● depreciation of leasehold improvements, laboratory equipment and computers; ● costs related to purchasing raw materials for and producing product candidates for clinical trials; ● costs related to compliance with regulatory requirements; ● costs related to the manufacturing scale-out initiative; and ● license fees related to in-licensed technologies. | |
Accrued Research and Development | Accrued Research and Development The Company has entered into various agreements with CROs and a CMO, which conduct preclinical studies and clinical trials and contract manufacturing activities. The Company ’ | |
Leases | Leases Effective January 1, 2019, the Company accounts for its leases under ASC 842, Leases ’ “ ” “ ” “ ” ’ “ ” “ ” “ ” Under this guidance, arrangements meeting the definition of a lease are classified as operating or finance leases, and are recorded on the balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company ’ 2. Summary of Significant Accounting Policies (continued) Lease expenses for minimum lease payments for operating leases are recognized on a straight-line basis over the lease term. Amortization expense of the right-of-use asset for finance leases is recognized on a straight-line basis over the lease term and interest expense for finance leases is recognized based on the incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right of use asset is amortized over the lease term. In calculating the right-of-use assets and lease liabilities, the Company has elected to combine lease and non-lease components for all asset classes. The Company excludes short-term leases, if any, having initial terms of 12 months or less from the new guidance as an accounting policy election, and recognizes rent expense on a straight-line basis over the lease term. Prior to the adoption of ASC 842 on January 1, 2019 the Company was deemed to be the accounting owner of leased space during the construction of its headquarters in a build-to-suit arrangement. Upon substantial completion of construction in June ’ ’ each The cumulative effect of initially applying the new lease guidance on January 1, 2019 is as follows: January 1, 2019 Cumulative Beginning Beginning Effect Balance, ($ in thousands) Balance Adjustment As Adjusted Assets Building asset $ 25,091 $ (25,091) $ — Finance lease right-of-use assets, net $ — $ 27,612 $ 27,612 Operating lease right-of-use assets, net $ — $ 923 $ 923 Liabilities and stockholders’ deficit Accrued expenses $ 7,049 $ (1) $ 7,048 Facility financing obligation, current portion $ 276 $ (276) $ — Finance lease obligation, current portion $ — $ 1,292 $ 1,292 Operating lease obligation, current portion $ — $ 55 $ 55 Facility financing obligation, net of current portion $ 22,955 $ (22,955) $ — Finance lease obligation, net of current portion $ — $ 26,319 $ 26,319 Operating lease obligation, net of current portion $ — $ 870 $ 870 Accumulated deficit $ (234,289) $ (1,861) $ (236,150) | |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, “ ’ ’ ” “ ” ’ | Recently Adopted Accounting Pronouncements In August — |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In May 2021, the FASB issued “ ’ ” “ ” ’ | Recently Issued Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, “ – ’ – ’ “ ” |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Summary of Significant Accounting Policies | ||
Summary of 10% or more of the Company's total revenue or accounts receivable balance | Revenue Accounts Receivable Three Months Nine Months December 31, September 30, 2020 2021 2020 2021 2020 2021 Grant A — — — — — — Grant B 0 — % 11 — % — — Grant C 68 % 100 % 65 % 100 % 100 % 100 % Grant D 30 — % 20 — % — — Total 98 % 100 % 96 % 100 % 100 % 100 % | 2019 2020 Accounts Accounts Revenue Receivable Revenue Receivable Grant A 28 % — — — Grant B 38 % 67 % 10 % — Grant C 34 % 33 % 67 % 100 % Grant D — — 18 % — Total 100 % 100 % 95 % 100 % |
Summary of securities that could potentially dilute net loss per share in the future that were not included in the computation of diluted net loss per share | September 30, 2020 2021 Shares issuable upon conversion of Series A redeemable convertible preferred stock 18,421,897 — Shares issuable upon conversion of Series B redeemable convertible preferred stock 24,137,647 — Shares issuable upon conversion of Series C redeemable convertible preferred stock 11,241,283 — Shares issuable upon conversion of Series D redeemable convertible preferred stock 15,812,735 — Exercise of options under stock plan 4,516,907 6,399,888 Warrants to purchase common stock 32,961 5,465,204 | December 31, 2019 2020 Shares issuable upon conversion of Series A redeemable convertible preferred stock 18,421,897 18,421,897 Shares issuable upon conversion of Series B redeemable convertible preferred stock 24,137,647 24,137,647 Shares issuable upon conversion of Series C redeemable convertible preferred stock 11,241,283 11,241,283 Shares issuable upon conversion of Series D redeemable convertible preferred stock 15,812,735 15,812,735 Options to purchase common stock 5,220,236 4,813,262 Warrant to purchase common stock 32,961 32,961 |
Summary of estimated useful lives for significant asset | Estimated Useful Property and equipment Lives (Years) Scientific equipment 5 – 7 Computer equipment 5 Software 3 Furniture and fixtures 5 – 7 Leasehold improvements Lesser of useful life or life of lease Construction in progress N/A | |
Summary of cumulative effect of initially applying the new lease guidance | January 1, 2019 Cumulative Beginning Beginning Effect Balance, ($ in thousands) Balance Adjustment As Adjusted Assets Building asset $ 25,091 $ (25,091) $ — Finance lease right-of-use assets, net $ — $ 27,612 $ 27,612 Operating lease right-of-use assets, net $ — $ 923 $ 923 Liabilities and stockholders’ deficit Accrued expenses $ 7,049 $ (1) $ 7,048 Facility financing obligation, current portion $ 276 $ (276) $ — Finance lease obligation, current portion $ — $ 1,292 $ 1,292 Operating lease obligation, current portion $ — $ 55 $ 55 Facility financing obligation, net of current portion $ 22,955 $ (22,955) $ — Finance lease obligation, net of current portion $ — $ 26,319 $ 26,319 Operating lease obligation, net of current portion $ — $ 870 $ 870 Accumulated deficit $ (234,289) $ (1,861) $ (236,150) |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Property and Equipment, Net | ||
Schedule of Property and equipment | December 31, September 30, ($ in thousands) 2020 2021 Scientific equipment $ 27,412 $ 27,578 Computer equipment 149 154 Software 335 335 Furniture and fixtures 988 988 Leasehold improvements 26,355 26,355 55,239 55,410 Accumulated depreciation (14,261) (18,911) Property and equipment, net $ 40,978 $ 36,499 | As of December 31, ($ in thousands) 2019 2020 Scientific equipment $ 27,822 $ 27,412 Computer equipment 218 149 Software 340 335 Furniture and fixtures 988 988 Leasehold improvements 26,337 26,355 55,705 55,239 Accumulated depreciation (8,417) (14,261) Property and equipment, net $ 47,288 $ 40,978 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Accrued Expenses | ||
Schedule of Accrued Expenses | December 31, September 30, ($ in thousands) 2020 2021 Accrued external research, development and manufacturing costs $ 2,615 $ 2,685 Accrued employee compensation and benefits 1,009 4,025 Accrued professional fees 968 2,712 Total $ 4,592 $ 9,422 | As of December 31, ($ in thousands) 2019 2020 Accrued external research, development and manufacturing costs $ 3,872 $ 2,615 Accrued employee compensation and benefits 1,260 1,009 Accrued professional fees 868 968 Total $ 6,000 $ 4,592 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Debt | |
Summary of SVB loan payable and net discount or premium balances | September 30, ($ in thousands) 2021 Principal amount of SVB loan payable $ 20,000 Final payment amount of SVB loan payable 1,000 Net premium associated with accretion of final payment and other debt issuance costs (3,073) SVB loan payable, current and noncurrent 17,927 Less SVB loan payable, current portion (3,889) SVB loan payable, noncurrent portion $ 14,038 |
Summary of future minimum payments of principal and estimated payments of interest | Year ending December 31: ($ in thousands) 2021 (remainder) $ — 2022 5,555 2023 6,667 2024 6,667 2025 1,111 Total future payments 20,000 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases | |
Summary of quantitative information about the leases | Year Ended December 31, ($in thousands) 2019 2020 Finance lease cost Amortization of right-of-use assets $ 2,060 $ 2,060 Interest on lease liabilities 2,298 2,180 Total finance lease cost 4,358 4,240 Operating lease cost 137 152 Total lease cost $ 4,495 $ 4,392 Year Ended Year Ended December 31, 2019 December 31, 2020 Finance Operating Finance Operating ($ in thousands) Leases Leases Leases Leases Operating cash flows from leases $ (2,298) $ (137) $ (2,180) $ (182) Financing cash flows from leases $ (1,292) $ — $ (1,500) $ — Weighted-average remaining lease term 6.02 6.38 5.52 6.24 Weighted-average discount rate 8.50 % 8.50 % 8.50 % 8.50 % |
Schedule of maturities of lease liabilities | ($ in thousands) Finance Operating Year Ended December 31, 2021 $ 3,773 $ 105 Year Ended December 31, 2022 3,868 105 Year Ended December 31, 2023 3,965 105 Year Ended December 31, 2024 4,065 106 Year Ended December 31, 2025 4,167 106 Thereafter 16,937 678 Total 36,775 1,205 Less: present value discount (11,956) (436) Lease liabilities $ 24,819 $ 769 |
Redeemable Convertible Prefer_2
Redeemable Convertible Preferred Stock (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Redeemable Convertible Preferred Stock | |
Summary of redeemable convertible preferred stock | As of December 31, 2019 and December 31, 2020, redeemable convertible preferred stock consisted of the following (in thousands, except share amounts): Redeemable Redeemable Convertible Convertible Preferred Preferred Stock Stock Issued and Carrying Liquidation Issuance Authorized Outstanding Value Preference Price Series A redeemable convertible preferred stock 18,421,897 18,421,897 $ 74,079 $ 74,079 $ 4.0212 Series B redeemable convertible preferred stock 24,137,647 24,137,647 127,358 136,500 $ 5.6550 Series C redeemable convertible preferred stock 11,241,286 11,241,283 70,704 75,000 $ 6.6717 Series D redeemable convertible preferred stock 15,812,735 15,812,735 148,848 150,000 $ 9.4859 69,613,565 69,613,562 $ 420,989 $ 435,579 |
Summary of conversion prices for each series of the redeemable convertible preferred stock | Series Conversion Series A redeemable convertible preferred stock $ 4.0212 Series B redeemable convertible preferred stock $ 5.6550 Series C redeemable convertible preferred stock $ 6.6717 Series D redeemable convertible preferred stock $ 9.4859 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Schedule of activity of warrants | Legacy Humacyte Common Stock Private Placement Total Common Warrants Warrants Public Warrants Stock Warrants Outstanding as of December 31, 2020 32,961 — — 32,961 Common Stock Warrants issued to SVB 287,704 — — 287,704 Common Stock Warrants as Part of the Merger — 177,500 5,000,000 5,177,500 Warrants Exercised (32,961) — — (32,961) Oustanding as of September 30, 2021 287,704 177,500 5,000,000 5,465,204 | |
Summary of common stock reserved for future issuances | September 30, 2021 Common stock reserved for Contingent Consideration Shares 15,000,000 Exercise of options under stock plans 6,399,888 Issuance of options under stock plans 7,730,503 Shares available for grant under ESPP 1,030,033 Warrants to purchase common stock 5,465,204 35,625,628 | December 31, 2019 2020 Conversion of Series A redeemable convertible preferred stock 18,421,897 18,421,897 Conversion of Series B redeemable convertible preferred stock 24,137,647 24,137,647 Conversion of Series C redeemable convertible preferred stock 11,241,286 11,241,286 Conversion of Series D redeemable convertible preferred stock 15,812,735 15,812,735 Exercise of options under stock plan 5,220,236 4,813,262 Issuance of options under stock plan 2,736,954 2,948,598 Warrant to purchase common stock 32,961 32,961 77,603,716 77,408,386 |
Private Placement Warrants | ||
Schedule of assumptions used in the valuations | August 26, September 30, 2021 2021 Market price of public stock $ 10.96 $ 11.61 Exercise price $ 11.50 $ 11.50 Expected term (years) 5.00 4.91 Expected share price volatility 32.5 % 28.5 % Risk-free interest rate 0.68 % 0.96 % Estimated dividend yield 0 % 0 % | |
Contingent earnout liability | ||
Schedule of assumptions used in the valuations | August 26, September 30, 2021 2021 Current stock price $ 10.96 $ 11.61 Expected share price volatility 79.6 % 78.9 % Risk-free interest rate 1.34 % 1.55 % Estimated dividend yield 0 % 0.0 % Expected term (years) 10.00 10.00 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Stock-based Compensation | ||
Summary of assumptions on the date of grant to estimate the fair value of the stock options in the Black-Scholes option-pricing model | Three Months Ended Nine Months Ended September 30, 2020 2021 (1) 2020 2021 Estimated dividend yield 0 % — 0 % 0 % Expected share price volatility (weighted average and range, if applicable) 91.6 % — 91.4% (89.4% to 91.6%) 91.4% (91.0% to 92.1%) Risk-free interest rate (weighted average and range, if applicable) 0.34 % — 0.40% (0.34% to 0.75%) 0.68% (0.62% to 1.02%) Expected term of options (in years) 6.0 — 6.0 6.0 | Year Ended 2019 2020 Estimated dividend yield 0 % 0 % Expected share price volatility 70.1%-87.7 % 89.4% - 91.6 % Risk-free interest rate 1.76% - 2.46 % 0.34% - 0.75 % Expected term of options (in years) 6.00 6.00 |
Summary of stock-based compensation expense included in the statements of operations and comprehensive loss | Three Months Ended Nine Months Ended ($ in thousands) 2020 2021 2020 2021 Research and development $ 308 $ 486 $ 781 $ 1,837 General and administrative 862 1,391 2,685 5,498 Total $ 1,170 $ 1,877 $ 3,466 $ 7,335 December 31, September 30, ($ in thousands) 2020 2021 Unrecognized share-based compensation cost $ 5,789 $ 12,480 Expected weighted average period compensation costs to be recognized (years) 1.7 2.1 | Year Ended ($ in thousands) 2019 2020 Research and development $ 914 $ 1,135 General and administrative 3,543 3,559 Total $ 4,457 $ 4,694 As of December 31, ($ in thousands) 2019 2020 Unrecognized share-based compensation cost $ 7,919 $ 5,789 Expected weighted average period compensation costs to be recognized (years) 1.8 1.7 |
Summary of option activity | Weighted Average Weighted Remaining Aggregate Average Exercise Contractual Term Intrinsic Value Number of Shares Price Per Share (years) (in thousands) Options outstanding at December 31, 2020 4,813,262 $ 6.04 6.6 $ 20,422 Granted 1,838,029 $ 10.28 Exercised (188,006) $ 2.97 Forfeited (63,397) $ 7.87 Options outstanding at September 30, 2021 6,399,888 $ 7.33 6.6 $ 26,705 Vested and exercisable, September 30, 2021 4,092,342 $ 5.74 5.1 $ 23,345 Vested and expected to vest, September 30, 2021 6,399,888 $ 7.33 6.6 $ 26,705 | Weighted Average Weighted Remaining Aggregate Number of Average Exercise Contractual Term Intrinsic Value Shares Price Per Share (years) (in thousands) Options outstanding at December 31, 2018 5,638,773 $ 4.69 7.4 $ 21,354 Granted 621,031 8.49 Exercised (620,831) 1.97 Forfeited (418,737) 7.62 Options outstanding at December 31, 2019 5,220,236 $ 5.22 6.5 $ 17,044 Granted 480,856 9.79 Exercised (195,239) 1.55 Forfeited (692,591) 3.76 Options outstanding at December 31, 2020 4,813,262 $ 6.04 6.6 $ 20,422 Vested and exercisable, December 31, 2020 3,392,302 $ 4.99 5.9 $ 17,925 Vested and expected to vest, December 31, 2020 4,813,262 $ 6.04 6.6 $ 20,422 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
Schedule of components of Company's deferred tax assets and deferred tax liabilities | As of December 31, ($ in thousands) 2019 2020 Deferred tax assets: Net operating loss $ 50,616 $ 53,515 Capitalized research and development 19,660 32,337 Research credits 10,658 15,056 Share-based compensation 1,669 2,519 Right of use lease liability 207 177 Accrued expenses 71 57 Other 1 1 Total deferred tax asset 82,882 103,662 Less: valuation allowance (82,193) (101,757) Total net deferred tax asset 689 1,905 Deferred tax liabilities: Basis difference in fixed assets (482) (1,728) Right of use lease assets (207) (177) Total deferred tax liability (689) (1,905) Total net deferred tax asset/(liability) $ — $ — |
Schedule of difference between the actual income tax benefit and amount computed by applying the statutory Federal income tax rate to losses before income taxes | December 31, 2019 2020 ($ in thousands) Amount Rate Amount Rate Income tax benefit at statutory rate $ (17,939) 21.0 % $ (13,970) 21.0 % State income taxes, net of federal benefit (1,739) 2.0 % (1,338) 2.0 % Tax credits (1,821) 2.1 % (2,625) 3.9 % Other nondeductible expenses 54 0.0 % 90 (0.1) % Deferred rate changes 16 0.0 % 16 0.0 % Other 449 (0.5) % (1,736) 2.6 % Change in valuation allowance 20,980 (24.6) % 19,563 (29.4) % Provision for income taxes $ — 0.0 % $ — 0.0 % |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Related Party Transactions | ||
Summary of related party expenses included in statements of operations and comprehensive loss | Three Months Nine Months ($ in thousands) 2020 2021 2020 2021 Expenses under MOU 125 — 375 — License expenses 20 — 70 85 Other 4 2 17 83 Total 149 2 462 168 | Year Ended December 31, ($ in thousands) 2019 2020 Expenses under MOU $ 422 $ 500 License expenses 110 92 Other 39 28 Total $ 571 $ 620 |
Organization and Description _2
Organization and Description of Business (Details) - USD ($) $ in Thousands | Aug. 26, 2021 | Mar. 22, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
Organization and Description of Business | |||||||||||||
Proceeds from merger | $ 242,400 | $ 242,400 | |||||||||||
Accumulated deficit | $ 457,158 | 457,158 | $ 388,096 | $ 321,572 | $ 234,289 | ||||||||
Net loss | 31,563 | $ 17,198 | $ 20,301 | $ 17,760 | $ 14,878 | $ 17,674 | 69,062 | $ 50,312 | 66,524 | 85,422 | |||
Cash and cash equivalents | $ 240,449 | $ 240,449 | $ 39,929 | $ 93,713 | |||||||||
Substantial Doubt about Going Concern, within One Year [true false] | true |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Basis of Presentation (Details) - shares | Aug. 26, 2021 | Dec. 31, 2020 |
Summary of Significant Accounting Policies | ||
Exchange ratio | 0.2626% | |
Public warrants assumed | 5,000,000 | |
Private placement warrants assumed | 177,500 | |
Share accepting a tender offer entitles warrants to receive cash (as a percent) | 50.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Segment (Details) - segment | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Segments | ||||||
Number of reportable segment | 1 | 1 | 1 | 1 | 1 | 1 |
Number of operating segment | 1 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Grant Revenue (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | 86 Months Ended | |||||
Sep. 30, 2017 | Aug. 31, 2017 | Nov. 30, 2013 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2020 | |
Disaggregation of Revenue [Line Items] | ||||||||||
Revenue from grants not within the scope of ASC 606 | $ 200 | $ 900 | $ 1,100 | $ 1,400 | $ 1,500 | $ 6,200 | $ 1,600 | |||
Department of Defense grants | Work on bioengineered blood vessels for vascular trauma | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Grants | $ 4,000 | |||||||||
Department of Defense grants | Work to support human tissue engineered blood vessels for vascular reconstruction | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Grants | $ 7,100 | |||||||||
Department of Defense grants | Reimbursement of certain allowable costs related to grants | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Recognized revenue | 200 | 600 | 1,100 | 1,000 | ||||||
National Institutes of Health grant | Reimbursement of certain allowable costs related to grants | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Recognized revenue | $ 0 | $ 300 | $ 0 | $ 300 | ||||||
National Institutes of Health grant | Work to support bioengineered grafts for peripheral vascular disease | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Grants | $ 1,600 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies -Concentration of Credit Risk (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue | Customer concentration | ||||||
Concentration Risk [Line Items] | ||||||
Concentration of Credit Risk | 100.00% | 98.00% | 100.00% | 96.00% | 95.00% | 100.00% |
Revenue | Customer concentration | Grant A | ||||||
Concentration Risk [Line Items] | ||||||
Concentration of Credit Risk | 28.00% | |||||
Revenue | Customer concentration | Grant B | ||||||
Concentration Risk [Line Items] | ||||||
Concentration of Credit Risk | 0.00% | 11.00% | 10.00% | 38.00% | ||
Revenue | Customer concentration | Grant C | ||||||
Concentration Risk [Line Items] | ||||||
Concentration of Credit Risk | 100.00% | 68.00% | 100.00% | 65.00% | 67.00% | 34.00% |
Revenue | Customer concentration | Grant D | ||||||
Concentration Risk [Line Items] | ||||||
Concentration of Credit Risk | 30.00% | 20.00% | 18.00% | |||
Accounts Receivable | Credit concentration | ||||||
Concentration Risk [Line Items] | ||||||
Concentration of Credit Risk | 100.00% | 100.00% | 100.00% | |||
Accounts Receivable | Credit concentration | Grant B | ||||||
Concentration Risk [Line Items] | ||||||
Concentration of Credit Risk | 67.00% | |||||
Accounts Receivable | Credit concentration | Grant C | ||||||
Concentration Risk [Line Items] | ||||||
Concentration of Credit Risk | 100.00% | 100.00% | 33.00% |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Net Loss per Share Attributable to Common Stockholders (Details) - shares | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Contingent consideration (in shares) | 15,000,000 | |||
Series A redeemable convertible preferred stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Securities that were not included in the computation of diluted net loss per share | 18,421,897 | 18,421,897 | 18,421,897 | |
Series B redeemable convertible preferred stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Securities that were not included in the computation of diluted net loss per share | 24,137,647 | 24,137,647 | 24,137,647 | |
Series C redeemable convertible preferred stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Securities that were not included in the computation of diluted net loss per share | 11,241,283 | 11,241,283 | 11,241,283 | |
Series D redeemable convertible preferred stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Securities that were not included in the computation of diluted net loss per share | 15,812,735 | 15,812,735 | 15,812,735 | |
Exercise of options under stock plan | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Securities that were not included in the computation of diluted net loss per share | 6,399,888 | 4,516,907 | 4,813,262 | 5,220,236 |
Warrants to purchase common stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Securities that were not included in the computation of diluted net loss per share | 5,465,204 | 32,961 | 32,961 | 32,961 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Property and Equipment, Net (Details) | 12 Months Ended |
Dec. 31, 2020 | |
Scientific equipment. | Minimum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 5 years |
Scientific equipment. | Maximum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 7 years |
Computer equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 5 years |
Software | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 3 years |
Furniture and fixtures | Minimum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 5 years |
Furniture and fixtures | Maximum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 7 years |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Impairment of Long-Lived Assets and Income Taxes (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | 24 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2020 | |
Impairment of Long-Lived Assets | ||||
Impairment of long-lived assets | $ 0 | $ 0 | $ 0 | |
Income Taxes | ||||
Uncertain tax positions | 0 | $ 0 | ||
Accrued interest or penalties related to uncertain tax positions | $ 0 | 0 | ||
interest or penalties related to uncertain tax positions expensed | $ 0 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Leases (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Accumulated deficit | $ (457,158) | $ (388,096) | $ (321,572) | $ (234,289) |
Lease liabilities, Finance leases | 24,819 | 26,300 | ||
Finance lease right-of-use assets | 21,947 | 23,492 | 25,552 | |
Operating right-of-use assets | $ 738 | 769 | 897 | |
Lease liabilities, Operating leases | $ 769 | $ 900 | ||
Cumulative Effect Adjustment | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Accumulated deficit | (1,861) | |||
Lease liabilities, Finance leases | 27,600 | |||
Finance lease right-of-use assets | 27,612 | |||
Operating right-of-use assets | 923 | |||
Lease liabilities, Operating leases | 900 | |||
ASU 2016-02 | Cumulative Effect Adjustment | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Accumulated deficit | $ 1,900 |
Summary of Significant Accou_12
Summary of Significant Accounting Policies - New lease guidance on January 1, 2019 (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
Assets | ||||
Building asset | $ 25,091 | |||
Finance lease right-of-use assets, net | $ 21,947 | $ 23,492 | $ 25,552 | |
Operating lease right-of-use assets, net | 738 | 769 | 897 | |
Liabilities and stockholders' deficit | ||||
Accrued expenses | 9,422 | 4,592 | 6,000 | 7,049 |
Facility financing obligation, current portion | 276 | |||
Finance lease obligation, current portion | 1,915 | 1,729 | 1,500 | |
Operating lease obligation, current portion | 44 | 42 | 70 | |
Facility financing obligation, net of current portion | 22,955 | |||
Finance lease obligation, net of current portion | 21,627 | 23,090 | 24,819 | |
Operating lease obligation, net of current portion | 693 | 727 | 829 | |
Accumulated deficit | $ (457,158) | $ (388,096) | $ (321,572) | (234,289) |
Cumulative Effect Adjustment | ||||
Assets | ||||
Building asset | (25,091) | |||
Finance lease right-of-use assets, net | 27,612 | |||
Operating lease right-of-use assets, net | 923 | |||
Liabilities and stockholders' deficit | ||||
Accrued expenses | (1) | |||
Facility financing obligation, current portion | (276) | |||
Finance lease obligation, current portion | 1,292 | |||
Operating lease obligation, current portion | 55 | |||
Facility financing obligation, net of current portion | (22,955) | |||
Finance lease obligation, net of current portion | 26,319 | |||
Operating lease obligation, net of current portion | 870 | |||
Accumulated deficit | (1,861) | |||
Beginning Balance, As Adjusted | ||||
Assets | ||||
Finance lease right-of-use assets, net | 27,612 | |||
Operating lease right-of-use assets, net | 923 | |||
Liabilities and stockholders' deficit | ||||
Accrued expenses | 7,048 | |||
Finance lease obligation, current portion | 1,292 | |||
Operating lease obligation, current portion | 55 | |||
Finance lease obligation, net of current portion | 26,319 | |||
Operating lease obligation, net of current portion | 870 | |||
Accumulated deficit | (236,150) | |||
ASU 2016-02 | Cumulative Effect Adjustment | ||||
Liabilities and stockholders' deficit | ||||
Accumulated deficit | $ 1,900 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | ||||||
Property and equipment, gross | $ 55,410 | $ 55,410 | $ 55,239 | $ 55,705 | ||
Accumulated depreciation | (18,911) | (18,911) | (14,261) | (8,417) | ||
Property and equipment, net | 36,499 | 36,499 | 40,978 | 47,288 | ||
Depreciation expense | 1,500 | $ 1,600 | 4,650 | $ 4,729 | 6,291 | 4,689 |
Scientific equipment | ||||||
Property, Plant and Equipment [Line Items] | ||||||
Property and equipment, gross | 27,578 | 27,578 | 27,412 | 27,822 | ||
Computer equipment | ||||||
Property, Plant and Equipment [Line Items] | ||||||
Property and equipment, gross | 154 | 154 | 149 | 218 | ||
Software | ||||||
Property, Plant and Equipment [Line Items] | ||||||
Property and equipment, gross | 335 | 335 | 335 | 340 | ||
Furniture and fixtures | ||||||
Property, Plant and Equipment [Line Items] | ||||||
Property and equipment, gross | 988 | 988 | 988 | 988 | ||
Leasehold improvements | ||||||
Property, Plant and Equipment [Line Items] | ||||||
Property and equipment, gross | $ 26,355 | $ 26,355 | $ 26,355 | $ 26,337 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
Accrued Expenses | ||||
Accrued external research, development and manufacturing costs | $ 2,685 | $ 2,615 | $ 3,872 | |
Accrued employee compensation and benefits | 4,025 | 1,009 | 1,260 | |
Accrued professional fees | 2,712 | 968 | 868 | |
Total | $ 9,422 | $ 4,592 | $ 6,000 | $ 7,049 |
Debt - PPP (Details)
Debt - PPP (Details) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | 12 Months Ended | |
Apr. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Debt Instrument [Line Items] | ||||
Proceeds from debt instruments | $ 3,251 | $ 3,251 | ||
Gain on PPP loan forgiveness | $ 3,284 | |||
Paycheck Protection Program | ||||
Debt Instrument [Line Items] | ||||
Proceeds from debt instruments | $ 3,300 | |||
Gain on PPP loan forgiveness | $ 3,284 |
Leases - Paragraphs (Details)
Leases - Paragraphs (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Operating Lease, Liability | $ 769 | $ 900 | ||
Finance Lease, Liability | 24,819 | 26,300 | ||
Operating Lease, Right-of-Use Asset | $ 738 | 769 | 897 | |
Finance lease right-of-use assets, net | $ 21,947 | $ 23,492 | $ 25,552 | |
Maximum | ||||
Gain (Loss) on Termination of Lease | $ 100 |
Leases - Costs (Details)
Leases - Costs (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Finance lease cost | ||||
Amortization of right-of-use assets | $ 2,060 | $ 2,060 | ||
Interest on lease liabilities | 2,180 | 2,298 | ||
Total finance lease cost | 4,240 | 4,358 | ||
Operating lease cost | $ 31 | $ 71 | 152 | 137 |
Total lease cost | $ 4,392 | $ 4,495 |
Leases - Cash flows (Details)
Leases - Cash flows (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Leases | ||||
Operating cash flows from leases, Operating Leases | $ (182) | $ (137) | ||
Operating cash flows from leases, Finance Leases | (2,180) | (2,298) | ||
Financing cash flows from leases | $ (1,277) | $ (1,107) | $ (1,500) | $ (1,292) |
Weighted-average remaining lease term, Operating Leases | 6 years 2 months 26 days | 6 years 4 months 17 days | ||
Weighted-average remaining lease term, Finance Leases | 5 years 6 months 7 days | 6 years 7 days | ||
Weighted-average discount rate, Operating Leases | 8.50% | 8.50% | ||
Weighted-average discount rate, Finance Leases | 8.50% | 8.50% |
Leases - Maturities (Details)
Leases - Maturities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Operating leases | ||
2021 | $ 105 | |
2022 | 105 | |
2023 | 105 | |
2024 | 106 | |
2025 | 106 | |
Thereafter | 678 | |
Total, Operating leases | 1,205 | |
Less: present value discount, Operating leases | 436 | |
Lease liabilities, Operating leases | 769 | $ 900 |
Finance leases | ||
2021 | 3,773 | |
2022 | 3,868 | |
2023 | 3,965 | |
2024 | 4,065 | |
2025 | 4,167 | |
Thereafter | 16,937 | |
Total, Finance leases | 36,775 | |
Less: present value discount, Finance leases | 11,956 | |
Lease liabilities, Finance leases | $ 24,819 | $ 26,300 |
Redeemable Convertible Prefer_3
Redeemable Convertible Preferred Stock - Preferred Stock Terms (Details) - USD ($) $ / shares in Units, $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Temporary Equity [Line Items] | |||
Redeemable Convertible Preferred Stock, Authorized | 0 | 69,613,565 | 69,613,565 |
Redeemable Convertible Preferred Stock, Issued and Outstanding | 0 | 69,613,562 | 69,613,562 |
Redeemable Convertible Preferred Stock, Carrying Value | $ 420,989 | $ 420,989 | |
Redeemable Convertible Preferred Stock, Liquidation Preference | $ 0 | $ 435,579 | $ 435,579 |
Series A redeemable convertible preferred stock | |||
Temporary Equity [Line Items] | |||
Redeemable Convertible Preferred Stock, Authorized | 18,421,897 | ||
Redeemable Convertible Preferred Stock, Issued and Outstanding | 18,421,897 | ||
Redeemable Convertible Preferred Stock, Carrying Value | $ 74,079 | ||
Redeemable Convertible Preferred Stock, Liquidation Preference | $ 74,079 | ||
Redeemable Convertible Preferred Stock, Issuance Price | $ 4.0212 | ||
Series B redeemable convertible preferred stock | |||
Temporary Equity [Line Items] | |||
Redeemable Convertible Preferred Stock, Authorized | 24,137,647 | ||
Redeemable Convertible Preferred Stock, Issued and Outstanding | 24,137,647 | ||
Redeemable Convertible Preferred Stock, Carrying Value | $ 127,358 | ||
Redeemable Convertible Preferred Stock, Liquidation Preference | $ 136,500 | ||
Redeemable Convertible Preferred Stock, Issuance Price | $ 5.6550 | ||
Series C redeemable convertible preferred stock | |||
Temporary Equity [Line Items] | |||
Redeemable Convertible Preferred Stock, Authorized | 11,241,286 | ||
Redeemable Convertible Preferred Stock, Issued and Outstanding | 11,241,283 | ||
Redeemable Convertible Preferred Stock, Carrying Value | $ 70,704 | ||
Redeemable Convertible Preferred Stock, Liquidation Preference | $ 75,000 | ||
Redeemable Convertible Preferred Stock, Issuance Price | $ 6.6717 | ||
Series D redeemable convertible preferred stock | |||
Temporary Equity [Line Items] | |||
Redeemable Convertible Preferred Stock, Authorized | 15,812,735 | ||
Redeemable Convertible Preferred Stock, Issued and Outstanding | 15,812,735 | ||
Redeemable Convertible Preferred Stock, Carrying Value | $ 148,848 | ||
Redeemable Convertible Preferred Stock, Liquidation Preference | $ 150,000 | ||
Redeemable Convertible Preferred Stock, Issuance Price | $ 9.4859 |
Redeemable Convertible Prefer_4
Redeemable Convertible Preferred Stock (Details) | Dec. 31, 2020USD ($) |
Fresenius Medical Care | Private placement | |
Class of Stock [Line Items] | |
Right to purchase common stock granted | $ 30 |
Redeemable Convertible Prefer_5
Redeemable Convertible Preferred Stock - Election of Directors (Details) | 12 Months Ended |
Dec. 31, 2020individual | |
Fresenius Medical Care | |
Temporary Equity [Line Items] | |
Number of representative to attend, in a non-voting observer capacity designated by related party | 1 |
Series A redeemable convertible preferred stock | |
Temporary Equity [Line Items] | |
Number of individual designated for board of director by holder of stock | 1 |
Series B redeemable convertible preferred stock | |
Temporary Equity [Line Items] | |
Number of individual designated for board of director by holder of stock | 2 |
Series C redeemable convertible preferred stock | |
Temporary Equity [Line Items] | |
Number of individual designated for board of director by holder of stock | 1 |
Redeemable Convertible Prefer_6
Redeemable Convertible Preferred Stock - Conversion to Common Stock (Details) $ / shares in Units, $ in Millions | 12 Months Ended |
Dec. 31, 2020USD ($)$ / shares | |
Redeemable Convertible Preferred Stock | |
Minimum offering price required for automatic conversion | $ / shares | $ 2.7401 |
Minimum aggregate gross proceeds required for automatic conversion | $ | $ 100 |
Percentage of written request of holder required for automatic conversion | 60.00% |
Redeemable Convertible Prefer_7
Redeemable Convertible Preferred Stock- Conversion prices (Details) | Dec. 31, 2020$ / shares |
Temporary Equity [Line Items] | |
Conversion ratio | 1 |
Series A redeemable convertible preferred stock | |
Temporary Equity [Line Items] | |
Conversion Price | $ 4.0212 |
Series B redeemable convertible preferred stock | |
Temporary Equity [Line Items] | |
Conversion Price | 5.6550 |
Series C redeemable convertible preferred stock | |
Temporary Equity [Line Items] | |
Conversion Price | 6.6717 |
Series D redeemable convertible preferred stock | |
Temporary Equity [Line Items] | |
Conversion Price | $ 9.4859 |
Redeemable Convertible Prefer_8
Redeemable Convertible Preferred Stock - Liquidation (Details) | 12 Months Ended |
Dec. 31, 2020$ / shares | |
Temporary Equity [Line Items] | |
Number of times of liquidation preference per share holder is entitled to receive | 1.25 |
Series A redeemable convertible preferred stock | |
Temporary Equity [Line Items] | |
Liquidation preference per share | $ 4.0212 |
Series B redeemable convertible preferred stock | |
Temporary Equity [Line Items] | |
Liquidation preference per share | 5.6550 |
Series C redeemable convertible preferred stock | |
Temporary Equity [Line Items] | |
Liquidation preference per share | $ 6.6717 |
Percentage of holders required for approval of liquidation preference | 80.00% |
Series D redeemable convertible preferred stock | |
Temporary Equity [Line Items] | |
Liquidation preference per share | $ 9.4859 |
Stockholders' Equity (Deficit_2
Stockholders' Equity (Deficit) - Common Stock (Details) $ / shares in Units, $ in Thousands | Aug. 26, 2021USD ($)$ / sharesshares | Sep. 30, 2021$ / sharesshares | Sep. 30, 2021USD ($)Vote$ / sharesshares | Dec. 31, 2020Vote$ / sharesshares | Dec. 31, 2019$ / sharesshares |
Proceeds from merger | $ 242,400 | $ 242,400 | |||
Assets | $ 100 | ||||
Common stock, shares outstanding | shares | 103,003,384 | 103,003,384 | 103,003,384 | 5,822,396 | 5,627,157 |
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Dividends declared | $ / shares | $ 0 | $ 0 | |||
Number of vote per common share held | Vote | 1 | ||||
Common stock, authorized | shares | 250,000,000 | 250,000,000 | 340,216,780 | 340,216,780 | |
Common Stock | |||||
Issuance of common stock upon the Merger and related PIPE Financing, net of issuance costs | shares | 27,346,449 | 27,346,449 | |||
Proceeds from merger | $ 242,400 | ||||
Transaction costs | $ 3,900 | ||||
Common stock, shares outstanding | shares | 103,003,384 | ||||
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||
Number of vote per common share held | Vote | 1 | ||||
Common stock, authorized | shares | 250,000,000 | 250,000,000 | |||
Alpha Healthcare Acquisition Corp. and Hunter Merger Sub, Inc. | Common Stock | |||||
Contingent consideration liability | $ 15,200 | ||||
Assets | $ 100 |
Stockholders' Equity (Deficit_3
Stockholders' Equity (Deficit) - Common stock for future issuances (Details) - shares | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 35,625,628 | 77,408,386 | 77,603,716 |
Series A redeemable convertible preferred stock | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 18,421,897 | 18,421,897 | |
Series B redeemable convertible preferred stock | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 24,137,647 | 24,137,647 | |
Series C redeemable convertible preferred stock | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 11,241,286 | 11,241,286 | |
Series D redeemable convertible preferred stock | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 15,812,735 | 15,812,735 | |
Common stock reserved for Contingent Consideration Shares | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 15,000,000 | ||
Exercise of options under stock plan | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 6,399,888 | 4,813,262 | 5,220,236 |
Issuance of options under stock plan | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 7,730,503 | 2,948,598 | 2,736,954 |
Shares available for grant under ESPP | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 1,030,033 | ||
Warrants to purchase common stock | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 5,465,204 | 32,961 | 32,961 |
Stock-based Compensation (Detai
Stock-based Compensation (Details) - $ / shares | 1 Months Ended | 9 Months Ended | 12 Months Ended | ||
Jan. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Number of options remaining available for grant | 7,730,503 | 2,948,598 | |||
Outstanding awards | 6,399,888 | 4,813,262 | 5,220,236 | 5,638,773 | |
Contractual term | 10 years | 10 years | |||
Vesting period | 3 years | 36 months | |||
Commencement of involuntary termination term prior to effective date of corporate transaction | 30 days | 30 days | |||
End of involuntary termination term after effective date of corporate transaction | 12 months | 12 months | |||
Granted | 1,838,029 | 480,856 | 621,031 | ||
Exercise price | $ 10.28 | $ 9.79 | $ 8.49 | ||
Minimum | |||||
Vesting period | 36 months | ||||
Maximum | |||||
Vesting period | 48 months | ||||
Chief Executive Officer [Member] | |||||
Vesting period | 3 years | ||||
Granted | 1,312,984 | ||||
Exercise price | $ 10.28 |
Stock-based Compensation - Fair
Stock-based Compensation - Fair value of the stock options (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Assumptions on the date of grant to estimate the fair value of the stock options | ||||||
Estimated dividend yield | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | |
Expected price volatility | 91.60% | 91.40% | 91.40% | |||
Expected share price volatility, minimum | 91.00% | 89.40% | 89.40% | 70.10% | ||
Expected share price volatility, maximum | 92.10% | 91.60% | 91.60% | 87.70% | ||
Risk-free interest rate | 0.34% | 0.68% | 0.40% | |||
Risk-free interest rate, minimum | 0.62% | 0.34% | 0.34% | 1.76% | ||
Risk-free interest rate, maximum | 1.02% | 0.75% | 0.75% | 2.46% | ||
Expected term of options (in years) | 6 years | 6 years | 6 years | 6 years | 6 years |
Stock-based Compensation - Avai
Stock-based Compensation - Available options (Details) - shares | Sep. 30, 2021 | Dec. 31, 2020 |
Stock-based Compensation | ||
Number of options remaining available for grant | 7,730,503 | 2,948,598 |
Stock-based Compensation - Expe
Stock-based Compensation - Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||
Stock-based compensation expense | $ 1,877 | $ 1,170 | $ 7,335 | $ 3,466 | $ 4,694 | $ 4,457 |
Research and development | ||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||
Stock-based compensation expense | 486 | 308 | 1,837 | 781 | 1,135 | 914 |
General and administrative | ||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||
Stock-based compensation expense | $ 1,391 | $ 862 | $ 5,498 | $ 2,685 | $ 3,559 | $ 3,543 |
Stock-based Compensation - Unre
Stock-based Compensation - Unrecognized cost (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Stock-based Compensation | |||
Unrecognized share-based compensation cost | $ 12,480 | $ 5,789 | $ 7,919 |
Expected weighted average period compensation costs to be recognized (years) | 2 years 1 month 6 days | 1 year 8 months 12 days | 1 year 9 months 18 days |
Stock-based Compensation - Opti
Stock-based Compensation - Option activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Number of Shares | ||||
Options outstanding at the beginning | 4,813,262 | 5,220,236 | 5,638,773 | |
Granted | 1,838,029 | 480,856 | 621,031 | |
Exercised | (188,006) | (195,239) | (620,831) | |
Forfeited | (63,397) | (692,591) | (418,737) | |
Options outstanding at the end | 6,399,888 | 4,813,262 | 5,220,236 | 5,638,773 |
Vested and exercisable at the end of period | 4,092,342 | 3,392,302 | ||
Vested and expected to vest at the end | 6,399,888 | 4,813,262 | ||
Weighted Average Exercise Price Per Share | ||||
Options outstanding at the beginning (in dollars per share) | $ 6.04 | $ 5.22 | $ 4.69 | |
Granted (in dollars per share) | 10.28 | 9.79 | 8.49 | |
Exercised (in dollars per share) | 2.97 | 1.55 | 1.97 | |
Forfeited (in dollars per share) | 7.87 | 3.76 | 7.62 | |
Options outstanding at the end (in dollars per share) | 7.33 | 6.04 | $ 5.22 | $ 4.69 |
Vested and exercisable at the end of period (in dollars per share) | 5.74 | 4.99 | ||
Vested and expected to vest at the end (in dollars per share) | $ 7.33 | $ 6.04 | ||
Weighted Average Remaining Contractual Term and Aggregate Intrinsic Value | ||||
Options outstanding (in years) | 6 years 7 months 6 days | 6 years 7 months 6 days | 6 years 6 months | 7 years 4 months 24 days |
Vested and exercisable at the end of period (in years) | 5 years 1 month 6 days | 5 years 10 months 24 days | ||
Vested and expected to vest at the end (in years) | 6 years 7 months 6 days | 6 years 7 months 6 days | ||
Options outstanding at the beginning (in dollars) | $ 20,422 | $ 17,044 | $ 21,354 | |
Options outstanding at the end (in dollars) | 26,705 | 20,422 | $ 17,044 | $ 21,354 |
Vested and exercisable at the end of period (in years) | 23,345 | 17,925 | ||
Vested and expected to vest at the end (in dollars) | $ 26,705 | $ 20,422 |
Stock-based Compensation - Othe
Stock-based Compensation - Other information (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Stock-based Compensation | ||
Total intrinsic value of options exercised | $ 1.4 | $ 4 |
Weighted-average grant-date fair value per share of options granted | $ 7.26 | $ 5.84 |
Income Taxes - Deferred tax ass
Income Taxes - Deferred tax assets and deferred tax liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
Net operating loss | $ 53,515 | $ 50,616 |
Intangible assets | 32,337 | 19,660 |
Research credits | 15,056 | 10,658 |
Share-based compensation | 2,519 | 1,669 |
Right of use lease liability | 177 | 207 |
Accrued expenses | 57 | 71 |
Other | 1 | 1 |
Total deferred tax asset | 103,662 | 82,882 |
Less: valuation allowance | (101,757) | (82,193) |
Total net deferred tax asset | 1,905 | 689 |
Deferred tax liabilities: | ||
Basis difference in fixed assets | (1,728) | (482) |
Right of Use Lease Assets | (177) | (207) |
Total deferred tax liability | $ (1,905) | $ (689) |
Income Taxes - Tax reconciliati
Income Taxes - Tax reconciliation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes | ||||||
Income tax benefit at statutory rate, Amount | $ (13,970) | $ (17,939) | ||||
State income taxes, net of federal benefit, Amount | (1,338) | (1,739) | ||||
Tax credits, Amount | (2,625) | (1,821) | ||||
Other nondeductible expenses, Amount | 90 | 54 | ||||
Deferred rate changes, Amount | 16 | 16 | ||||
Other, Amount | (1,736) | 449 | ||||
Change in valuation allowance, Amount | $ 19,563 | $ 20,980 | ||||
Income tax benefit at statutory rate, Rate | 21.00% | 21.00% | ||||
State income taxes, net of federal benefit, Rate | 2.00% | 2.00% | ||||
Tax credits, Rate | 3.90% | 2.10% | ||||
Other nondeductible expenses, Rate | (0.10%) | 0.00% | ||||
Deferred rate changes, Rate | 0.00% | 0.00% | ||||
Other, Rate | 2.60% | (0.50%) | ||||
Change in valuation allowance, Rate | (29.40%) | (24.60%) | ||||
Effective tax rate | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
Income Taxes - Additional infor
Income Taxes - Additional information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Operating Loss Carryforwards [Line Items] | ||
Percent of limitation on taxable income | 80.00% | |
Effective federal tax rate | $ (13,970) | $ (17,939) |
Effective federal tax rate | 21.00% | 21.00% |
Foreign | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss | $ 232,700 | |
Operating loss | 71,500 | |
Tax credit carryforwards | $ 10,700 | |
State | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss | 232,600 | |
Tax credit carryforwards | $ 15,100 |
Retirement Plan (Details)
Retirement Plan (Details) $ in Millions | 12 Months Ended | |
Dec. 31, 2020USD ($)plan | Dec. 31, 2019USD ($) | |
Defined Contribution Plan Disclosure [Line Items] | ||
Number of plans | plan | 2,000 | |
Qualified Plan | ||
Defined Contribution Plan Disclosure [Line Items] | ||
Employer's contribution for retirement plan | $ | $ 0.6 | $ 0.6 |
Plan 401 (K) | ||
Defined Contribution Plan Disclosure [Line Items] | ||
Employer's contribution Percentage for retirement plan | 4.00% |
Commitments and Contingencies -
Commitments and Contingencies - Duke University (Details) - Duke university - License agreement - shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Agreement expiration term after first commercial sale | 4 years | 4 years |
Threshold notice period required to terminate the agreement | 3 months | 3 months |
Collaborative Arrangement, Shares Issued In Connection With License Agreement | 52,693 | 52,693 |
Commitments and Contingencies_2
Commitments and Contingencies - Yale University (Details) - Yale university - USD ($) $ in Millions | 1 Months Ended | 9 Months Ended | 12 Months Ended | |
Aug. 31, 2019 | Feb. 28, 2014 | Sep. 30, 2021 | Dec. 31, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Milestone payments upon achievement of certain regulatory milestones | $ 0.2 | |||
Milestone payments upon achievement of certain commercial milestones | $ 0.6 | |||
License agreement | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Threshold notice period required to terminate the agreement | 90 days | 90 days | ||
License agreement related to coatings for small diameter vessels to inhibit clotting | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Collaborative Arrangement, Maximum Annual Maintenance Fee | $ 0.1 | $ 0.1 | ||
License agreement related to bioartificial vascular pancreas | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Collaborative Arrangement, Maximum Annual Maintenance Fee | $ 0.1 | |||
License agreement related to tubular prostheses | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Collaborative Arrangement, Maximum Annual Maintenance Fee | $ 0.1 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) $ in Millions | Aug. 26, 2021 | Aug. 31, 2021 | Jun. 30, 2018 | Sep. 30, 2020 | Sep. 30, 2020 | Dec. 31, 2023 | Dec. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2021 |
Related Party Transaction [Line Items] | |||||||||
Proceeds from PIPE | $ 175 | ||||||||
Common stock, shares issued | 5,822,396 | 5,627,157 | 103,003,384 | ||||||
Fresenius Medical Care | |||||||||
Related Party Transaction [Line Items] | |||||||||
Financing amount | $ 150 | ||||||||
Shares issued for conversion of preferred shares | 15,812,735 | ||||||||
Proceeds from PIPE | $ 25 | ||||||||
Common stock, shares issued | 2,500,000 | ||||||||
Dr. Niklason, President, CEO and member of board of directors | |||||||||
Related Party Transaction [Line Items] | |||||||||
Aggregate amount | $ 2.5 | ||||||||
Payments made | $ 0.1 | $ 0.4 | $ 0.5 | $ 0.4 |
Related Party Transactions - Ex
Related Party Transactions - Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Related Party Transaction [Line Items] | ||||||
Total | $ 2 | $ 149 | $ 168 | $ 462 | $ 620 | $ 571 |
Expenses under MOU | ||||||
Related Party Transaction [Line Items] | ||||||
Total | 125 | 375 | 500 | 422 | ||
License expenses | ||||||
Related Party Transaction [Line Items] | ||||||
Total | 20 | 85 | 70 | 92 | 110 | |
Other | ||||||
Related Party Transaction [Line Items] | ||||||
Total | $ 2 | $ 4 | $ 83 | $ 17 | $ 28 | $ 39 |
Subsequent Events - Stock optio
Subsequent Events - Stock option grants (Details) - $ / shares | 1 Months Ended | 9 Months Ended | 12 Months Ended | ||
Jan. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Mar. 22, 2021 | |
Subsequent Event [Line Items] | |||||
Option to purchase shares of common stock | 1,838,029 | 480,856 | 621,031 | ||
Exercise price | $ 10.28 | $ 9.79 | $ 8.49 | ||
Number of shares vested as of the issuance date | 6,399,888 | 4,813,262 | |||
Vesting period | 3 years | 36 months | |||
Dr. Niklason | |||||
Subsequent Event [Line Items] | |||||
Option to purchase shares of common stock | 1,312,984 | ||||
Exercise price | $ 10.28 | ||||
Vesting period | 3 years | ||||
Subsequent event | Dr. Niklason | |||||
Subsequent Event [Line Items] | |||||
Option to purchase shares of common stock | 1,312,984 | ||||
Exercise price | $ 10.28 | ||||
Number of shares vested as of the issuance date | 0 | ||||
Vesting period | 3 years | ||||
Subsequent event | Mr. Sander | |||||
Subsequent Event [Line Items] | |||||
Option to purchase shares of common stock | 183,817 | ||||
Exercise price | $ 10.28 | ||||
Number of shares vested as of the issuance date | 0 |
Subsequent Events - Merger (Det
Subsequent Events - Merger (Details) - Subsequent event | Feb. 17, 2021USD ($) |
Subsequent Event [Line Items] | |
Amount of common stock investors have agreed to purchase | $ 175,000,000 |
Intangible Assets, Net (Including Goodwill) | $ 0 |
Balance Sheets_2
Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
Current assets | ||||
Cash and cash equivalents | $ 240,449 | $ 39,929 | $ 93,713 | |
Accounts receivable | 240 | 113 | 601 | |
Prepaid expenses | 3,490 | 1,407 | 640 | |
Total current assets | 244,179 | 41,449 | 94,954 | |
Finance lease right-of-use assets, net | 21,947 | 23,492 | 25,552 | |
Operating lease right-of-use assets, net | 738 | 769 | 897 | |
Property and equipment, net | 36,499 | 40,978 | 47,288 | |
Total assets | 303,363 | 106,688 | 168,691 | |
Current liabilities | ||||
Accounts payable | 5,830 | 2,274 | 3,272 | |
Accrued expenses | 9,422 | 4,592 | 6,000 | $ 7,049 |
SVB loan payable, current portion | 3,889 | |||
Finance lease obligation, current portion | 1,915 | 1,729 | 1,500 | |
Deferred payroll tax, current portion | 145 | 145 | ||
Operating lease obligation, current portion | 44 | 42 | 70 | |
PPP loan payable, current portion | 2,451 | |||
Total current liabilities | 21,245 | 11,233 | 10,842 | |
Contingent earnout liability | 169,200 | |||
Finance lease obligation, net of current portion | 21,627 | 23,090 | 24,819 | |
SVB loan payable, net of current portion | 14,038 | |||
Operating lease obligation, net of current portion | 693 | 727 | 829 | |
Common stock warrant liabilities | 555 | |||
Deferred payroll tax, net of current portion | 144 | 144 | ||
PPP loan payable, net of current portion | 822 | |||
Total liabilities | 227,502 | 36,016 | 36,490 | |
Commitments and contingencies (Note 11) | ||||
Redeemable convertible preferred stock (Series A, B, C and D) $0.001 par value, 0 and 69,613,565 shares authorized as of September 30, 2021 and December 31, 2020, respectively; 0 and 69,613,562 shares outstanding as of September 30, 2021 and December 31, 2020, respectively; liquidation preference of $0 and $435,579 as of September 30, 2021 and December 31, 2020, respectively. | 420,989 | 420,989 | ||
Stockholders' equity (deficit) | ||||
Preferred stock, $0.0001 par value; 20,000,000 and 0 shares designated as of September 30, 2021 and December 31, 2020; 0 shares issued and outstanding as of September 30, 2021 and December 31, 2020 | ||||
Common stock, $0.0001 and $0.0001 par value as of September 30, 2021 and December 31, 2020, respectively; 250,000,000 and 340,216,780 shares authorized as of September 30, 2021 and December 31, 2020, respectively; 103,003,384 and 5,822,396 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively. | 10 | 1 | 1 | |
Additional paid-in capital | 533,009 | 37,778 | 32,783 | |
Accumulated deficit | (457,158) | (388,096) | (321,572) | $ (234,289) |
Total stockholders' equity (deficit) | 75,861 | (350,317) | (288,788) | |
Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | $ 303,363 | $ 106,688 | $ 168,691 |
Balance sheet (Parenthetical)_2
Balance sheet (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2021 | Aug. 26, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Balance Sheets | ||||
Redeemable convertible preferred stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | |
Redeemable convertible preferred stock, shares authorized | 0 | 69,613,565 | 69,613,565 | |
Redeemable convertible preferred stock, shares outstanding | 0 | 69,613,562 | 69,613,562 | |
Redeemable convertible preferred stock, liquidation preference | $ 0 | $ 435,579 | $ 435,579 | |
Preferred stock, par value | $ 0.0001 | $ 0.0001 | ||
Preferred stock, shares designated | 20,000,000 | 0 | ||
Preferred stock, shares issued | 0 | 0 | ||
Preferred stock, shares outstanding | 0 | 0 | ||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 250,000,000 | 340,216,780 | 340,216,780 | |
Common stock, shares issued | 103,003,384 | 5,822,396 | 5,627,157 | |
Common stock, shares outstanding | 103,003,384 | 103,003,384 | 5,822,396 | 5,627,157 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||
Grant Revenue | $ 241 | $ 914 | $ 1,086 | $ 1,367 | $ 1,491 | $ 6,187 |
Operating expenses: | ||||||
Research and development (includes related party expenses of $2 and $149 for the three months ended September 30, 2021 and 2020 and $168 and $462 for the nine months ended September 30, 2021 and 2020) | 15,386 | 14,692 | 45,091 | 40,879 | 54,078 | 75,603 |
General and administrative | 5,398 | 3,435 | 15,576 | 9,416 | 12,013 | 16,275 |
Total operating expenses | 20,784 | 18,127 | 60,667 | 50,295 | 66,091 | 91,878 |
Loss from operations | (20,543) | (17,213) | (59,581) | (48,928) | (64,600) | (85,691) |
Other expenses, net: | ||||||
Interest income | 3 | 2 | 6 | 277 | 278 | 2,567 |
Change in fair value of contingent earnout liability | (9,768) | (9,768) | ||||
Interest expense | (1,204) | (549) | (2,952) | (1,661) | (2,202) | (2,298) |
Transaction costs expensed | (49) | (49) | ||||
Change in fair value of common stock warrant liabilities | (2) | (2) | ||||
Gain on PPP loan forgiveness | 3,284 | |||||
Total other expenses, net | (11,020) | (547) | (9,481) | (1,384) | (1,924) | 269 |
Net loss and comprehensive loss | $ (31,563) | $ (17,760) | $ (69,062) | $ (50,312) | $ (66,524) | $ (85,422) |
Net loss per share attributable to common stockholders, basic | $ (0.72) | $ (3.07) | $ (3.69) | $ (8.74) | ||
Net loss per share attributable to common stockholders, diluted | $ (0.72) | $ (3.07) | $ (3.69) | $ (8.74) | ||
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic | 43,950,856 | 5,788,130 | 18,728,471 | 5,755,418 | ||
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, diluted | 43,950,856 | 5,788,130 | 18,728,471 | 5,755,418 | ||
Net loss per share attributable to common stockholders, basic and diluted | $ (11.54) | $ (16.17) | ||||
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted | 5,765,688 | 5,283,628 |
Condensed Consolidated Statem_6
Condensed Consolidated Statements of Operations and Comprehensive Loss (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||
Related party expenses | $ 2 | $ 149 | $ 168 | $ 462 | $ 620 | $ 571 |
Condensed Consolidated Statem_7
Condensed Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Redeemable Convertible Preferred Stock. | Common Stock | Additional Paid-in Capital | Accumulated DeficitCumulative Effect Adjustment | Accumulated Deficit | Cumulative Effect Adjustment | Total |
Balance at the beginning at Dec. 31, 2018 | $ 420,989 | ||||||
Balance at the beginning (in shares) at Dec. 31, 2018 | 69,613,562 | ||||||
Balance at the end at Dec. 31, 2019 | $ 420,989 | $ 420,989 | |||||
Balance at the end (in shares) at Dec. 31, 2019 | 69,613,562 | 69,613,562 | |||||
Balance at the beginning at Dec. 31, 2018 | $ 1 | $ 27,108 | $ (234,289) | $ (207,180) | |||
Balance at the beginning (in shares) at Dec. 31, 2018 | 5,006,326 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options | 1,218 | $ 1,218 | |||||
Proceeds from the exercise of stock options (in shares) | 620,831 | 620,831 | |||||
Net loss | (85,422) | $ (85,422) | |||||
Stock-based compensation | 4,457 | 4,457 | |||||
Balance at the end (ASU 2016-02) at Dec. 31, 2019 | $ (1,861) | $ (1,861) | |||||
Balance at the end at Dec. 31, 2019 | $ 1 | 32,783 | (321,572) | (288,788) | |||
Balance at the end (in shares) at Dec. 31, 2019 | 5,627,157 | ||||||
Balance at the end at Mar. 31, 2020 | $ 420,989 | ||||||
Balance at the end (in shares) at Mar. 31, 2020 | 69,613,562 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options | 175 | 175 | |||||
Proceeds from the exercise of stock options (in shares) | 148,159 | ||||||
Net loss | (17,674) | (17,674) | |||||
Stock-based compensation | 1,182 | 1,182 | |||||
Balance at the end at Mar. 31, 2020 | $ 1 | 34,140 | (339,246) | (305,105) | |||
Balance at the end (in shares) at Mar. 31, 2020 | 5,775,316 | ||||||
Balance at the beginning at Dec. 31, 2019 | $ 420,989 | $ 420,989 | |||||
Balance at the beginning (in shares) at Dec. 31, 2019 | 69,613,562 | 69,613,562 | |||||
Balance at the end at Sep. 30, 2020 | $ 420,989 | ||||||
Balance at the end (in shares) at Sep. 30, 2020 | 69,613,562 | ||||||
Balance at the beginning (ASU 2016-02) at Dec. 31, 2019 | (1,861) | (1,861) | |||||
Balance at the beginning at Dec. 31, 2019 | $ 1 | 32,783 | (321,572) | $ (288,788) | |||
Balance at the beginning (in shares) at Dec. 31, 2019 | 5,627,157 | ||||||
Equity | |||||||
Net loss | (50,312) | ||||||
Balance at the end at Sep. 30, 2020 | $ 1 | 36,484 | (371,884) | (335,399) | |||
Balance at the end (in shares) at Sep. 30, 2020 | 5,788,877 | ||||||
Balance at the beginning at Dec. 31, 2019 | $ 420,989 | $ 420,989 | |||||
Balance at the beginning (in shares) at Dec. 31, 2019 | 69,613,562 | 69,613,562 | |||||
Balance at the end at Dec. 31, 2020 | $ 420,989 | $ 420,989 | |||||
Balance at the end (in shares) at Dec. 31, 2020 | 69,613,562 | 69,613,562 | |||||
Balance at the beginning (ASU 2016-02) at Dec. 31, 2019 | $ (1,861) | $ (1,861) | |||||
Balance at the beginning at Dec. 31, 2019 | $ 1 | 32,783 | (321,572) | $ (288,788) | |||
Balance at the beginning (in shares) at Dec. 31, 2019 | 5,627,157 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options | 301 | $ 301 | |||||
Proceeds from the exercise of stock options (in shares) | 195,239 | 195,239 | |||||
Net loss | (66,524) | $ (66,524) | |||||
Stock-based compensation | 4,694 | 4,694 | |||||
Balance at the end at Dec. 31, 2020 | $ 1 | 37,778 | (388,096) | (350,317) | |||
Balance at the end (in shares) at Dec. 31, 2020 | 5,822,396 | ||||||
Balance at the beginning at Mar. 31, 2020 | $ 420,989 | ||||||
Balance at the beginning (in shares) at Mar. 31, 2020 | 69,613,562 | ||||||
Balance at the end at Jun. 30, 2020 | $ 420,989 | ||||||
Balance at the end (in shares) at Jun. 30, 2020 | 69,613,562 | ||||||
Balance at the beginning at Mar. 31, 2020 | $ 1 | 34,140 | (339,246) | (305,105) | |||
Balance at the beginning (in shares) at Mar. 31, 2020 | 5,775,316 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options | 48 | 48 | |||||
Proceeds from the exercise of stock options (in shares) | 11,761 | ||||||
Net loss | (14,878) | (14,878) | |||||
Stock-based compensation | 1,114 | 1,114 | |||||
Balance at the end at Jun. 30, 2020 | $ 1 | 35,302 | (354,124) | (318,821) | |||
Balance at the end (in shares) at Jun. 30, 2020 | 5,787,077 | ||||||
Balance at the end at Sep. 30, 2020 | $ 420,989 | ||||||
Balance at the end (in shares) at Sep. 30, 2020 | 69,613,562 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options | 12 | 12 | |||||
Proceeds from the exercise of stock options (in shares) | 1,800 | ||||||
Net loss | (17,760) | (17,760) | |||||
Stock-based compensation | 1,170 | 1,170 | |||||
Balance at the end at Sep. 30, 2020 | $ 1 | 36,484 | (371,884) | (335,399) | |||
Balance at the end (in shares) at Sep. 30, 2020 | 5,788,877 | ||||||
Balance at the beginning at Dec. 31, 2020 | $ 420,989 | $ 420,989 | |||||
Balance at the beginning (in shares) at Dec. 31, 2020 | 69,613,562 | 69,613,562 | |||||
Balance at the end at Mar. 31, 2021 | $ 420,989 | ||||||
Balance at the end (in shares) at Mar. 31, 2021 | 69,613,562 | ||||||
Balance at the beginning at Dec. 31, 2020 | $ 1 | 37,778 | (388,096) | $ (350,317) | |||
Balance at the beginning (in shares) at Dec. 31, 2020 | 5,822,396 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options | 206 | 206 | |||||
Proceeds from the exercise of stock options (in shares) | 116,149 | ||||||
Net loss | (20,301) | (20,301) | |||||
Stock-based compensation | 2,528 | 2,528 | |||||
Issuance of warrants in conjunction with debt | 2,360 | 2,360 | |||||
Balance at the end at Mar. 31, 2021 | $ 1 | 42,872 | (408,397) | (365,524) | |||
Balance at the end (in shares) at Mar. 31, 2021 | 5,938,545 | ||||||
Balance at the beginning at Dec. 31, 2020 | $ 420,989 | $ 420,989 | |||||
Balance at the beginning (in shares) at Dec. 31, 2020 | 69,613,562 | 69,613,562 | |||||
Balance at the end (in shares) at Sep. 30, 2021 | 0 | ||||||
Balance at the beginning at Dec. 31, 2020 | $ 1 | 37,778 | (388,096) | $ (350,317) | |||
Balance at the beginning (in shares) at Dec. 31, 2020 | 5,822,396 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options (in shares) | 188,006 | ||||||
Net loss | $ (69,062) | ||||||
Balance at the end at Sep. 30, 2021 | $ 10 | 533,009 | (457,158) | 75,861 | |||
Balance at the end (in shares) at Sep. 30, 2021 | 103,003,384 | ||||||
Balance at the beginning at Mar. 31, 2021 | $ 420,989 | ||||||
Balance at the beginning (in shares) at Mar. 31, 2021 | 69,613,562 | ||||||
Balance at the end at Jun. 30, 2021 | $ 420,989 | ||||||
Balance at the end (in shares) at Jun. 30, 2021 | 69,613,562 | ||||||
Balance at the beginning at Mar. 31, 2021 | $ 1 | 42,872 | (408,397) | (365,524) | |||
Balance at the beginning (in shares) at Mar. 31, 2021 | 5,938,545 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options | 30 | 30 | |||||
Proceeds from the exercise of stock options (in shares) | 5,204 | ||||||
Net loss | (17,198) | (17,198) | |||||
Stock-based compensation | 2,930 | 2,930 | |||||
Balance at the end at Jun. 30, 2021 | $ 1 | 45,832 | (425,595) | $ (379,762) | |||
Balance at the end (in shares) at Jun. 30, 2021 | 5,943,749 | ||||||
Redeemable convertible preferred Stock | |||||||
Conversion of redeemable convertible preferred stock into common stock in connection with the Merger and related PIPE financing | $ (420,989) | ||||||
Conversion of redeemable convertible preferred stock into common stock in connection with the Merger and related PIPE financing (in shares) | (69,613,562) | ||||||
Balance at the end (in shares) at Sep. 30, 2021 | 0 | ||||||
Equity | |||||||
Proceeds from the exercise of stock options | 360 | $ 360 | |||||
Proceeds from the exercise of stock options (in shares) | 99,624 | ||||||
Conversion of redeemable convertible preferred stock into common stock in connection with the Merger and related PIPE financing | $ 7 | 420,982 | 420,989 | ||||
Conversion of redeemable convertible preferred stock into common stock in connection with the Merger and related PIPE financing (in shares) | 69,613,562 | ||||||
The merger and related PIPE financing, net of transaction costs and acquired liabilities | $ 2 | 209,478 | 209,480 | ||||
Public warrants assumed upon the merger, net of transaction costs | 13,912 | 13,912 | |||||
Issuance of common stock upon the Merger and related PIPE Financing, net of issuance costs (in shares) | 27,346,449 | ||||||
Net loss | (31,563) | (31,563) | |||||
Stock-based compensation | 1,877 | 1,877 | |||||
Contingent consideration liability recognized upon closing of the reverse recapitalization | 159,432 | 159,432 | |||||
Balance at the end at Sep. 30, 2021 | $ 10 | $ 533,009 | $ (457,158) | $ 75,861 | |||
Balance at the end (in shares) at Sep. 30, 2021 | 103,003,384 |
Condensed Consolidated Statem_8
Condensed Consolidated Statements of Cash Flows $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Cash flows from operating activities | |
Net loss | $ (69,062) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
Depreciation expense | 4,650 |
Stock-based compensation expense | 7,335 |
Change in fair value of contingent earnout liability | 9,768 |
Change in fair value of common stock warrant liabilities | 2 |
Amortization expense | 1,545 |
Non-cash operating lease costs | 31 |
Amortization of SVB debt discount | 628 |
Accrued interest on PPP loan obligation | 11 |
Gain on PPP loan forgiveness | (3,284) |
Payment of liabilities acquired in Merger | (12,363) |
Changes in operating assets and liabilities: | |
Accounts receivable | (127) |
Prepaid expenses | (2,002) |
Accounts payable | 757 |
Accrued expenses | 2,401 |
Operating lease obligation | (32) |
Net cash used in operating activities | (59,742) |
Cash flows from investing activities | |
Purchase of property and equipment | (175) |
Net cash used in investing activities | (175) |
Cash flows from financing activities | |
Proceeds from merger | 242,400 |
Payment of transaction costs related to Merger | (941) |
Proceeds from the exercise of stock options | 596 |
Proceeds from SVB loan | 19,659 |
Payment of finance lease principal | (1,277) |
Net cash provided by financing activities | 260,437 |
Net increase (decrease) in cash and cash equivalents | 200,520 |
Cash and cash equivalents at the beginning of the period | 39,929 |
Cash and cash equivalents at the end of the period | 240,449 |
Supplemental disclosure | |
Cash paid for interest on SVB loan | 642 |
Supplemental disclosure of noncash activities: | |
Issuance of warrants in conjunction with debt | 2,360 |
Unpaid liabilities assumed in connection with Merger | 2,228 |
Unpaid transaction costs in connection with Merger | 3,004 |
Conversion of redeemable convertible preferred stock into common stock in connection with the reverse capitalization | 420,989 |
Contingent Consideration Liability recognized upon the closing of the reverse recapitalization | $ 159,432 |
Organization and Description _3
Organization and Description of Business | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Organization and Description of Business | ||
Organization and Description of Business | 1. Organization and Description of Business Organization Humacyte, Inc.and subsidiary, or the Company, is pioneering the development and manufacture of off-the-shelf, universally implantable, bioengineered human tissues designed to improve the lives of patients and transform the practice of medicine. The Company is leveraging its technology platform to develop proprietary, bioengineered, acellular human tissues for use in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. On August 26, 2021 (the “ ” “ ” “ ” “ ” “ ” “ ” “ ” Refer to Note 3 — Liquidity and Going Concern Since its inception in 2004, the Company has generated no product revenue and has incurred net losses and negative cash flows from operations in each year. To date, the Company has financed its operations primarily through the sale of equity securities and convertible debt and, to a lesser extent, through governmental and other grants. At December 31, 2020 and September 30, 2021, the Company had an accumulated deficit of $388.1 million and $457.2 million, respectively. The Company ’ ’ ’ ’ As of September 30, 2021, the Company had cash and cash equivalents of $240.4 million. Based on the cash and cash equivalents on hand, the Company believes its combined cash and cash equivalents will be sufficient to fund operations, including clinical trial expenses and capital expenditure requirements, for at least 12 months from the issuance date of these interim financial statements. Impact of COVID-19 The COVID-19 pandemic, which began in December ’ ’ ’ ’ ’ To date, the COVID-19 pandemic has not resulted in material financial impacts or impairment losses in the carrying values of the Company ’ ’ | 1. Organization and Description of Business Organization Humacyte, Inc., or the Company, is pioneering the development and manufacture of off-the-shelf, universally implantable, bioengineered human tissues to improve the lives of patients and transform the practice of medicine. The Company is leveraging its technology platform to develop proprietary, bioengineered, acellular human tissues for use in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. Liquidity and Going Concern Since its inception in 2004, the Company has generated no product revenue and has incurred net losses and negative cash flows from operations in each year. To date, the Company has financed its operations primarily through the sale of equity securities and convertible debt and, to a lesser extent, through governmental and other grants. At December 31, 2019 and December 31, 2020, the Company had an accumulated deficit of $321.6 million and $388.1 million, respectively. The Company ’ ’ ’ ’ The Company does not believe its existing cash and cash equivalents will be sufficient to fund its anticipated operating expenses, including clinical trial expenses, and capital expenditure requirements for at least twelve months following the date these financial statements were issued. Until such time, if ever, as the Company is able to successfully develop and commercialize one or more of its product candidates, it expects to fund its operations through the sale of equity, debt, borrowing under credit facilities or through potential collaborations with other companies, other strategic transactions or government contracts and grants. The Company ’ ’ substantial doubt about its ability to continue as a going concern within one year The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty. Accordingly, the financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business. Impact of COVID-19 The COVID-19 pandemic, which began in December ’ ’ ’ ’ ’ 1. Organization and Description of Business (continued) To date, the COVID-19 pandemic has not resulted in material financial impacts or impairment losses in the carrying values of the Company ’ ’ |
Summary of Significant Accou_13
Summary of Significant Accounting Policies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Summary of Significant Accounting Policies | ||
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The Company has prepared the accompanying financial statements in conformity with accounting principles generally accepted in the United ’ Unless otherwise noted, the Company has retroactively adjusted all common and preferred share and related price information to give effect to the Exchange Ratio established in the Merger Agreement. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates in the financial statements include stock-based compensation costs, right-of-use, or ROU, assets, accruals for research and development activities, contingent earnout liability, fair value of common stock warrants, redeemable convertible preferred stock and income taxes. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. Unaudited Interim Condensed Consolidated Financial Statements The accompanying interim condensed consolidated financial statements and the related footnote disclosures are unaudited. These unaudited interim financial statements have been prepared on the same basis as the audited financial statements, and in management ’ ’ Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2020 and the related notes included elsewhere in this prospectus, which provides a more complete discussion of the Company’s accounting policies and certain other information. Other than the policies noted below, there have been no significant changes to the significant accounting policies disclosed in Note 2 of the audited consolidated financial statements as of and for the years ended December 31, 2019 and 2020 included elsewhere in this prospectus. Common Stock Warrants The Company assumed 5,000,000 publicly-traded warrants ( “ ” “ ” ’ “ ” “ ” ’ “ ” The Company evaluated the Common Stock Warrants to determine the appropriate financial statement classification upon the consummation of the Merger. The Common Stock Warrants are not mandatorily redeemable and are considered to be freestanding instruments as they are separately exercisable into common shares. As such, the Common Stock Warrants were not classified as liabilities under FASB ASC Topic 480, Distinguishing Liabilities from Equity Derivatives and Hedging The agreement governing the Common Stock Warrants includes a provision ( “ ” ’ “ ’ ” ’ The Public Warrants are considered to be “indexed to the Company’s own stock”. The agreement provides that in the event of a tender or exchange offer made to and accepted by holders of more than 50% of the outstanding shares of the Company ’ ’ ’ Contingent Earnout Liability In connection with the Reverse Recapitalization and pursuant to the Business Combination Agreement dated as of February 17, 2021 by and among Legacy Humacyte, Merger Sub, and AHAC (the “ ” ’ “ ” The estimated fair value of the Contingent Earnout Shares was determined using a Monte Carlo simulation using a distribution of potential outcomes on a monthly basis over a ten-year period prioritizing the most reliable information available. The assumptions utilized in the calculation were based on the achievement of certain stock price milestones, including the current Company common stock price, expected volatility, risk-free rate, expected term and expected dividend yield. The Contingent Earnout Shares are categorized as a Level Segments The Company operates and manages its business as one reportable and operating segment. The Company is developing proprietary, bioengineered, acellular human tissues that are designed to be used in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. The Company ’ Revenue Recognition The Company ’ Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services and is recognized in an amount that reflects the consideration that an entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) In addition, ASC 606 requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. For contracts where the period between when the Company transfers a promised good or service to the customer and when the customer pays is one year or less, the Company has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing component. Grant Revenue The Company generates revenue primarily from government and other awarded grants that reimburse the Company for certain allowable costs related to research and development efforts. These grants include the following terms: The Department of Defense grants are for an award of $4.0 million, all of which was recognized as revenue before the program ended, for work on bioengineered blood vessels for vascular trauma, which was awarded to the Company in September 2017 and ended in February 2020, and an award of $7.1 million for work to support human tissue engineered blood vessels for vascular reconstruction in the injured warfighter, which was awarded to the Company in August 2017 and is ongoing. The Company has recognized revenue of $0.6 million and $1.0 million during the three and nine months ended September 30, 2020,respectively, and $0.2 million and $1.1 million during the three and nine months ended September 30, 2021, respectively, for reimbursement of certain allowable costs related to these grants. The National Institutes of Health grant is for $1.6 million for work to support bioengineered grafts for peripheral vascular disease, which was awarded to the Company in November 2013. The Company recognized $1.6 million for the reimbursement of certain allowable costs related to the grant before this program ended in 2020. The Company recognized $0.3 million during the three and nine months ended September 30, 2020, and no revenue during the three and nine months ended September 30, 2021, for reimbursement of certain allowable costs related to these grants. The Company has determined that the grants are not within the scope of ASC 606 as they do not meet the definition of a contract with a customer. The Company has concluded that the grants meet the definition of a contribution and are nonexchange transactions and has applied the contribution accounting model in Subtopic 958-605, Not-for-Profit-Entities-Revenue Recognition by analogy. The Company recognizes funding received from grants as revenue, rather than as a reduction of research and development expenses, because the Company is the principal in conducting the research and development activities and these grants are central to the Company ’ ’ Revenue from grants not within the scope of ASC 606 was $0.9 million and $1.4 million for the three and nine months ended September 30, 2020, respectively, and $0.2 million and $1.1 million for the three and nine months ended September 30, 2021, respectively. Concentration of Credit Risk Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. Total cash balances exceeded insured balances by the Federal Deposit Insurance Corporation as of December 31, 2020 and September 30, 2021. Cash equivalents are invested in highly rated money market funds invested only in obligations of the U.S. government and its agencies. The majority of the Company ’ ’ ’ Revenue Accounts Receivable Three Months Nine Months December 31, September 30, 2020 2021 2020 2021 2020 2021 Grant A — — — — — — Grant B 0 — % 11 — % — — Grant C 68 % 100 % 65 % 100 % 100 % 100 % Grant D 30 — % 20 — % — — Total 98 % 100 % 96 % 100 % 100 % 100 % All of the Company ’ Other Risks and Uncertainties The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, successful discovery and development of its product candidates, the success of clinical trials and other studies for its product candidates, including for its ongoing V005 Phase II/III clinical trial and V007 Phase III clinical trial, the regulatory approval and commercialization of its HAVs and other product candidates, ’ ’ ’ Product candidates currently under development will require extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company ’ ’ Net Loss per Share Attributable to Common Stockholders The Company follows the two-class method to compute basic and diluted net loss per share attributable to common stockholders when shares met the definition of participating securities. The two-class method determines net loss per common share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to share in the earnings as if all income for the period had been distributed. During periods of loss, there is no allocation required under the two-class method since the redeemable convertible preferred stock did not have a contractual obligation to share in the Company ’ Basic net loss per share attributable to common stockholders is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period without consideration of potentially dilutive common stock. Diluted net loss per share attributable to common stockholders reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the Company unless inclusion of such shares would be anti-dilutive. As the Company has only incurred losses, basic and diluted net loss per share is the same. The potential shares of common stock that were excluded from the computation of diluted net loss per share for each period because including them would have had an antidilutive effect were as follows: September 30, 2020 2021 Shares issuable upon conversion of Series A redeemable convertible preferred stock 18,421,897 — Shares issuable upon conversion of Series B redeemable convertible preferred stock 24,137,647 — Shares issuable upon conversion of Series C redeemable convertible preferred stock 11,241,283 — Shares issuable upon conversion of Series D redeemable convertible preferred stock 15,812,735 — Exercise of options under stock plan 4,516,907 6,399,888 Warrants to purchase common stock 32,961 5,465,204 The 15,000,000 Contingent Earnout shares are excluded from the anti-dilutive table for all the periods presented as such shares are contingently issuable until the share price of the Company exceeds specified thresholds that have not yet been achieved, or upon the occurrence of a change in control. Impairment of Long-Lived Assets The Company reviews the carrying value of property and equipment for indicators of possible impairment whenever events and circumstances indicate that the carrying value of an asset or asset group may not be recoverable from the estimated future net undiscounted cash flows expected to result from its use and eventual disposition. In cases where estimated future net undiscounted cash flows are less than the carrying value, an impairment loss is recognized equal to an amount by which the carrying value exceeds the fair value of the asset or asset group. The factors considered by management in performing this assessment include current operating results, trends and prospects, the manner in which the property is used, and the effects of obsolescence, demand, competition, and other economic factors. Based on this assessment, during the nine months ended September 30, 2020 and 2021, respectively, the Company concluded there were no such events or changes in circumstances requiring review of the carrying amount of the Company ’ Recently Adopted Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, “ ’ ’ ” “ ” ’ Recently Issued Accounting Pronouncements In May 2021, the FASB issued “ ’ ” “ ” ’ | 2. Summary of Significant Accounting Policies Basis of Presentation The Company has prepared the accompanying financial statements in conformity with accounting principles generally accepted in the United Reverse Recapitalization On August 26, 2021 (the “ ” “ ” “ ” “ ” “ ” “ ” “ ” “ ” Unless otherwise noted, the Company has retroactively adjusted all common and preferred share and related price information to give effect to the Exchange Ratio of approximately 0.26260 established in the Merger Agreement. Segments The Company operates and manages its business as one reportable and operating ’ Comprehensive loss Comprehensive loss includes net loss as well as other changes in stockholders ’ Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates in the financial statements include stock-based compensation costs, right-of-use, or ROU assets, accruals for research and development activities, fair value of common stock, useful lives of property and equipment, redeemable convertible preferred stock and income taxes. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. 2. Summary of Significant Accounting Policies (continued) Cash and Cash Equivalents The Company considers all short-term, highly liquid investments purchased with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash deposits are held with financial institutions with investment-grade ratings in the United Redeemable Convertible Preferred Stock The Company analyzes all issued equity instruments to determine the appropriate accounting and classification. The Company evaluates its equity instruments under Accounting Standards Codification, or ASC 480, Distinguishing liabilities from equity The Company records equity instruments that are classified as temporary equity at fair value upon issuance, net of issuance costs. The Company accretes the carrying value of its redeemable convertible preferred stock to the redemption or liquidation amount once the Company has determined that it is probable that it will become redeemable or be liquidated. The accretion will be recorded as charges against additional paid-in capital until the additional paid-in capital balance is reduced to zero. At that time, additional accretion adjustments will be recorded as additions to accumulated deficit. The Company also analyzes instances where the equity instrument has a conversion feature pursuant to ASC 815, Derivatives and hedging Revenue Recognition The Company ’ In 2014, the Financial Accounting Standards Board, or FASB issued Accounting Standards Update No. Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services and is recognized in an amount that reflects the consideration that an entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) In addition, ASC 606 requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. 2. Summary of Significant Accounting Policies (continued) For contracts where the period between when the Company transfers a promised good or service to the customer and when the customer pays is one year or less, the Company has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing component. Grant Revenue We generate revenue primarily from government and other awarded grants that reimburse us for certain allowable costs related to research and development efforts. The Company has determined that the grants are not within the scope of ASC 606 as they do not meet the definition of a contract with a customer. The Company has concluded that the grants meet the definition of a contribution and are nonexchange transactions and has applied the contribution accounting model in Subtopic 958-605, Not-for-Profit-Entities-Revenue Recognition by analogy. The Company recognizes funding received from grants as revenue, rather than as a reduction of research and development expenses, because the Company is the principal in conducting the research and development activities and these grants are central to the Company ’ Revenue from grants not within the scope of ASC 606 was $6.2 million and $1.5 million for the years ending December 31, 2019 and 2020, respectively. Concentration of Credit Risk Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. Total cash balances exceeded insured balances by the Federal Depository Insurance Corporation as of December 31, 2019 and 2020. Cash equivalents are invested in highly rated money market funds invested only in obligations of the US government and its agencies. The majority of the Company ’ ’ ’ 2019 2020 Accounts Accounts Revenue Receivable Revenue Receivable Grant A 28 % — — — Grant B 38 % 67 % 10 % — Grant C 34 % 33 % 67 % 100 % Grant D — — 18 % — Total 100 % 100 % 95 % 100 % All of the Company ’ 2. Summary of Significant Accounting Policies (continued) Other Risks and Uncertainties The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, successful discovery and development of its product candidates, the success of clinical trials and other studies for its product candidates, including for its ongoing V005 Phase II/III clinical trial and V007 Phase III clinical trial, the regulatory approval and commercialization of its HAVs and other product candidates, ’ ’ ’ Product candidates currently under development will require extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company ’ ’ Net Loss per Share Attributable to Common Stockholders The Company applies the two-class method to compute basic and diluted net loss per share attributable to common stockholders when shares meet the definition of participating securities. The two-class method determines net loss per share for each class of common and redeemable convertible preferred stock according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income (loss) available to common stockholders for the period to be allocated between common and redeemable convertible preferred stock based upon their respective rights to share in the earnings as if all income (loss) for the period had been distributed. During periods of loss, there is no allocation required under the two-class method since the redeemable convertible preferred stock does not have a contractual obligation to share in the Company ’ 2. Summary of Significant Accounting Policies (continued) Basic net loss per share attributable to common stockholders is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period without consideration of potentially dilutive common stock. Diluted net loss per share attributable to common stockholders reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the Company unless inclusion of such shares would be anti-dilutive. Since the Company has only incurred losses, basic and diluted net loss per share is the same. Securities that could potentially dilute net loss per share in the future that were not included in the computation of diluted net loss per share are as follows: December 31, 2019 2020 Shares issuable upon conversion of Series A redeemable convertible preferred stock 18,421,897 18,421,897 Shares issuable upon conversion of Series B redeemable convertible preferred stock 24,137,647 24,137,647 Shares issuable upon conversion of Series C redeemable convertible preferred stock 11,241,283 11,241,283 Shares issuable upon conversion of Series D redeemable convertible preferred stock 15,812,735 15,812,735 Options to purchase common stock 5,220,236 4,813,262 Warrant to purchase common stock 32,961 32,961 Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants at the measurement date. ASC 820, Fair Value Measurement and Disclosures ● Level 1 — Observable inputs that reflect unadjusted quoted prices for identical assets or liabilities in active markets. ● Level 2 — Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. ● Level 3 — Unobservable inputs in which little or no market data exists, therefore requiring the Company to develop its own assumptions. The Company evaluates assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them for each reporting period, utilizing valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The determination requires significant judgments to be made by the Company. The Company ’ 2. Summary of Significant Accounting Policies (continued) Property and Equipment, Net Property and equipment, net are recorded at cost less accumulated depreciation. Expenditures for major additions and improvements are capitalized and minor replacements, maintenance, and repairs are charged to expense as incurred. When property and equipment are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet accounts and any resulting gain or loss is included in the results of operations for the respective period. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets. The estimated useful lives for significant asset categories are as follows: Estimated Useful Property and equipment Lives (Years) Scientific equipment 5 – 7 Computer equipment 5 Software 3 Furniture and fixtures 5 – 7 Leasehold improvements Lesser of useful life or life of lease Construction in progress N/A Impairment of Long-Lived Assets The Company reviews the carrying value of property and equipment for indicators of possible impairment whenever events and circumstances indicate that the carrying value of an asset or asset group may not be recoverable from the estimated future net undiscounted cash flows expected to result from its use and eventual disposition. In cases where estimated future net undiscounted cash flows are less than the carrying value, an impairment loss is recognized equal to an amount by which the carrying value exceeds the fair value of the asset or asset group. The factors considered by management in performing this assessment include current operating results, trends and prospects, the manner in which the property is used, and the effects of obsolescence, demand, competition, and other economic factors. Based on this assessment, there was no impairment at December 31, 2019 and 2020. Income Taxes Income taxes are computed using the asset and liability approach that requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company ’ 2. Summary of Significant Accounting Policies (continued) The Company recognizes the benefit of an income tax position only if it is more likely than not (greater than 50%) that the tax position will be sustained upon tax examination, based solely on the technical merits of the tax position. Otherwise, no benefit can be recognized. Assessing an uncertain tax position begins with the initial determination of the sustainability of the position and is measured at the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed. Additionally, the Company must accrue interest and related penalties, if applicable, on all tax exposures for which reserves have been established consistent with jurisdictional tax laws. The Company has analyzed its filing positions in all significant Federal and state jurisdictions where it is required to file income tax returns, as well as open tax years in these jurisdictions. As of December 31, 2019 and 2020, the Company has determined that no uncertain tax positions would have a material impact on the financials statements of the Company. The Company is no longer subject to Federal, state, and local tax examinations by tax authorities for years before 2017 although carry-forward attributes that were generated prior to 2017 may still be adjusted upon examination by the taxing authorities if they either have been or will be used in a future period. No income tax returns are currently under examination by taxing authorities. As of December 31, 2019 and 2020, the Company had not recorded any amounts for unrecognized tax benefits. The Company ’ ’ Intellectual Property The Company seeks to protect its intellectual property by filing patent applications in the United ’ Research and Development The Company expenses research and development costs as operating expenses as incurred. Research and development expenses consist primarily of: ● salaries and related overhead expenses for personnel in research and development functions, including stock-based compensation and benefits; ● fees paid to consultants and CROs, including in connection with clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work and statistical compilation and analysis; ● allocation of facility lease and maintenance costs; ● depreciation of leasehold improvements, laboratory equipment and computers; ● costs related to purchasing raw materials for and producing product candidates for clinical trials; ● costs related to compliance with regulatory requirements; ● costs related to the manufacturing scale-out initiative; and ● license fees related to in-licensed technologies. 2. Summary of Significant Accounting Policies (continued) Accrued Research and Development The Company has entered into various agreements with CROs and a CMO, which conduct preclinical studies and clinical trials and contract manufacturing activities. The Company ’ Stock-Based Compensation The Company accounts for stock-based compensation for employees and non-employees measured at grant date, based on the fair value of the award. The Company measures the fair value of awards granted using the Black-Scholes option pricing model and recognizes the expense over the requisite service period using the straight-line method. Option valuation models, including the Black-Scholes option-pricing model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility, the expected term of the award, and the fair value of the underlying common stock on the date of grant. Forfeitures are accounted for as they occur. Leases Effective January 1, 2019, the Company accounts for its leases under ASC 842, Leases ’ “ ” “ ” “ ” ’ “ ” “ ” “ ” Under this guidance, arrangements meeting the definition of a lease are classified as operating or finance leases, and are recorded on the balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company ’ 2. Summary of Significant Accounting Policies (continued) Lease expenses for minimum lease payments for operating leases are recognized on a straight-line basis over the lease term. Amortization expense of the right-of-use asset for finance leases is recognized on a straight-line basis over the lease term and interest expense for finance leases is recognized based on the incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right of use asset is amortized over the lease term. In calculating the right-of-use assets and lease liabilities, the Company has elected to combine lease and non-lease components for all asset classes. The Company excludes short-term leases, if any, having initial terms of 12 months or less from the new guidance as an accounting policy election, and recognizes rent expense on a straight-line basis over the lease term. Prior to the adoption of ASC 842 on January 1, 2019 the Company was deemed to be the accounting owner of leased space during the construction of its headquarters in a build-to-suit arrangement. Upon substantial completion of construction in June ’ ’ each The cumulative effect of initially applying the new lease guidance on January 1, 2019 is as follows: January 1, 2019 Cumulative Beginning Beginning Effect Balance, ($ in thousands) Balance Adjustment As Adjusted Assets Building asset $ 25,091 $ (25,091) $ — Finance lease right-of-use assets, net $ — $ 27,612 $ 27,612 Operating lease right-of-use assets, net $ — $ 923 $ 923 Liabilities and stockholders’ deficit Accrued expenses $ 7,049 $ (1) $ 7,048 Facility financing obligation, current portion $ 276 $ (276) $ — Finance lease obligation, current portion $ — $ 1,292 $ 1,292 Operating lease obligation, current portion $ — $ 55 $ 55 Facility financing obligation, net of current portion $ 22,955 $ (22,955) $ — Finance lease obligation, net of current portion $ — $ 26,319 $ 26,319 Operating lease obligation, net of current portion $ — $ 870 $ 870 Accumulated deficit $ (234,289) $ (1,861) $ (236,150) 2. Summary of Significant Accounting Policies (continued) Recently Adopted Accounting Pronouncements In August — Recently Issued Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, “ – ’ – ’ “ ” |
Reverse Recapitalization
Reverse Recapitalization | 9 Months Ended |
Sep. 30, 2021 | |
Reverse Recapitalization | |
Reverse Recapitalization | 3. Reverse Recapitalization On August 26, 2021, Merger Sub, a wholly-owned subsidiary of AHAC, merged with Legacy Humacyte, with Legacy Humacyte surviving as a wholly-owned subsidiary of AHAC. At the effective time of the Merger: ● each outstanding share of Legacy Humacyte common stock was converted into approximately 0.26260 shares of the Company’s common stock; ● each outstanding share of preferred stock of Legacy Humacyte was cancelled and converted into the aggregate number of shares of New Humacyte’s common stock that would be issued upon conversion of the shares of Legacy Humacyte preferred stock based on the applicable conversion ratio immediately prior to the effective time, multiplied by approximately 0.26260 ; and ● each outstanding option or warrant to purchase Legacy Humacyte common stock was converted into an option or warrant, as applicable, to purchase a number of shares of the Company’s common stock equal to the number of shares of Legacy Humacyte common stock subject to such option or warrant multiplied by approximately 0.26260 , at an exercise price per share equal to the current exercise price per share for such option or warrant divided by approximately 0.26260 ; in each case, rounded down to the nearest whole share. In addition, upon the closing of the merger (the “Closing”), 2,500,000 Class B shares of AHAC (Founder Shares) automatically converted into shares of the Company’s common stock, on a one-for-one Former holders of the Legacy Humacyte common stock and Legacy Humacyte preferred stock are eligible to receive up to an aggregate of 15 million additional shares of the Company’s common stock (the “Contingent Earnout Shares”) in the aggregate in two equal tranches of 7.5 million shares if the volume-weighted average closing sale price of the common stock is greater than or equal to $15.00 and $20.00, respectively, for any 20 trading days within any 30 consecutive trading day period. At the Closing on August 26, 2021, the Company recorded a liability (“Contingent Earnout Liability”) of $159.4 million, based on the estimated fair value of the 15 million Contingent Earnout Shares with a corresponding reduction of additional paid-in capital in the equity section of the Company’s condensed consolidated balance sheet. Concurrently with the execution of the Business Combination Agreement, AHAC entered into subscription agreements (the “Subscription Agreements”) with certain investors (the “PIPE Investors”). Pursuant to the Subscription Agreements, the PIPE Investors purchased an aggregate of 17,500,000 shares of the Company’s common stock (the “PIPE Shares”) in a private placement at a price of $10.00 per share for an aggregate purchase price of $175 million (the “PIPE Financing”). The PIPE Financing was consummated in connection with the Closing. The number of shares of the Company’s common stock outstanding immediately following the consummation of the Merger was: Shares Common stock of AHAC, outstanding prior to Merger 10,355,000 Less redemption of AHAC shares (3,008,551) Common stock of AHAC 7,346,449 AHAC Founder Shares 2,500,000 New Humacyte shares issued to PIPE Investors 17,500,000 Issuance of common stock upon reverse recapitalization and PIPE Financing 27,346,449 New Humacyte shares issued in Merger to Legacy Humacyte stockholders 75,656,935 (1) Total shares of common stock immediately after Merger 103,003,384 (1) Includes 69,613,562 shares of common stock issued upon conversion of Legacy Humacyte ’ The Merger is accounted for as a reverse recapitalization in accordance with U.S. GAAP. Under this method of accounting, AHAC is treated as the acquired company for financial reporting purposes and Legacy Humacyte is treated as the acquiror. This determination is primarily based on the fact that subsequent to the Merger, the Legacy Humacyte stockholders hold a majority of the voting rights of the combined company, Legacy Humacyte comprises all of the ongoing operations of the combined company, Legacy Humacyte comprises a majority of the carryover governing body of the combined company, and Legacy Humacyte’s senior management comprises all of the senior management of the combined company. Accordingly, for accounting purposes, the Merger was treated as the equivalent of Legacy Humacyte issuing shares for the net assets of AHAC, accompanied by a recapitalization. The net assets of AHAC were stated at historical costs. No goodwill or other intangible assets were recorded. Operations prior to the Merger are those of Legacy Humacyte. In connection with the Merger, the Company received $242.4 million in proceeds from the Merger and related PIPE Financing. The Company incurred $3.9 million of transaction costs, consisting of banking, legal, and other professional fees, of which $3.9 million was recorded as a reduction of proceeds to additional paid-in capital, and less than $0.1 million related to the Private Placement Warrants, which are classified as liabilities in the condensed consolidated balance sheets, was expensed in the condensed consolidated statements of operations and comprehensive loss. Legacy Humacyte assumed $15.2 million of liabilities, including PIPE Financing fees and legal fees, and $0.1 million of assets from AHAC. Of the $15.2 million of liabilities assumed from AHAC, as of September 30, 2021, $2.2 million was included in accounts payable and accrued expenses. In addition, there were $3.0 million of unpaid transaction costs included in accounts payable and accrued expenses as of September 30, 2021. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Measurements | |
Fair Value Measurements | 4. Fair Value Measurements Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants at the measurement date. ASC 820, Fair Value Measurement and Disclosures ● Level 1 — Observable inputs that reflect unadjusted quoted prices for identical assets or liabilities in active markets. ● Level 2 — Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. ● Level 3 — Unobservable inputs in which little or no market data exists, therefore requiring the Company to develop its own assumptions. The Company evaluates assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them for each reporting period, utilizing valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The determination requires significant judgments to be made by the Company. The Company’s assets and liabilities that were measured at fair value on a recurring basis were as follows: Fair Value Measured as of December 31, 2020 ($in thousands) Level 1 Level 2 Level 3 Total Assets: Money market funds $ 35,623 $ — $ — $ 35,623 Total financial assets $ 35,623 $ — $ — $ 35,623 Fair Value Measured as of September 30, 2021 ($in thousands) Level 1 Level 2 Level 3 Total Assets: Money market funds $ 238,375 $ — $ — $ 238,375 Total financial assets $ 238,375 $ — $ — $ 238,375 Liabilities: Contingent earnout liability $ — $ — $ 169,200 $ 169,200 Common stock warrant liabilities (Private Placement Warrants) — — 555 555 Total financial liabilities $ — $ — $ 169,755 $ 169,755 The following table presents a summary of the changes in the fair value of the Company’s Level 3 financial instruments: Contingent Private Placement ($in thousands) Earnout Liability Warrants Fair value as of December 31, 2020 $ — $ — Private placement warrant liability acquired as part of the merger — (553) Contingent earount liability recognized upon the closing of the reverse recapitalization (159,432) — Change in fair value included in other (expense) income (9,768) (2) Fair value as of September 30, 2021 $ (169,200) $ (555) The fair value of the Contingent Earnout Liability and Private Placement Warrants liability are based on significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. In determining the fair value of the Contingent Earnout Liability, the Company used the Monte Carlo simulation value model using a distribution of potential outcomes on a monthly basis over a ten-year period prioritizing the most reliable information available. The assumptions utilized in the calculation were based on the achievement of certain stock price milestones, including the current Company common stock price, expected volatility, risk-free rate, expected term and expected dividend yield (see Note 8). In determining the fair value of the Private Placement Warrants liability, the Company used the Monte Carlo simulation valuation model to estimate the fair value utilizing assumption including the current Company stock price, expected volatility, risk-free rate, expected term and expected dividend yield (see Note 8). The Company’s cash equivalents are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices. The carrying values of other receivables, accounts payable and accrued expenses as of December 31, 2020 and September 30, 2021 approximated their fair values due to the short-term nature of these items. |
Property and Equipment, Net_2
Property and Equipment, Net | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Property and Equipment, Net | ||
Property and Equipment, Net | 5. Property and Equipment, Net Property and equipment, net consist of the following: December 31, September 30, ($ in thousands) 2020 2021 Scientific equipment $ 27,412 $ 27,578 Computer equipment 149 154 Software 335 335 Furniture and fixtures 988 988 Leasehold improvements 26,355 26,355 55,239 55,410 Accumulated depreciation (14,261) (18,911) Property and equipment, net $ 40,978 $ 36,499 Depreciation expense totaled $1.6 million and $4.7 million for the three and nine months ended September 30, 2020, respectively, and $1.5 million and $4.7 million for the three and nine months ended September 30, 2021, respectively. All long-lived assets are maintained in the United | 3. Property and Equipment, Net Property and equipment, net consist of the following: As of December 31, ($ in thousands) 2019 2020 Scientific equipment $ 27,822 $ 27,412 Computer equipment 218 149 Software 340 335 Furniture and fixtures 988 988 Leasehold improvements 26,337 26,355 55,705 55,239 Accumulated depreciation (8,417) (14,261) Property and equipment, net $ 47,288 $ 40,978 Depreciation expense totaled $4.7 million and $6.3 million for the years ended December 31, 2019 and 2020, respectively. All long-lived assets are maintained in the United |
Accrued Expenses_2
Accrued Expenses | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Accrued Expenses | ||
Accrued Expenses | 6. Accrued Expenses Accrued expenses consisted of the following: December 31, September 30, ($ in thousands) 2020 2021 Accrued external research, development and manufacturing costs $ 2,615 $ 2,685 Accrued employee compensation and benefits 1,009 4,025 Accrued professional fees 968 2,712 Total $ 4,592 $ 9,422 | 4. Accrued Expenses Accrued expenses consisted of the following: As of December 31, ($ in thousands) 2019 2020 Accrued external research, development and manufacturing costs $ 3,872 $ 2,615 Accrued employee compensation and benefits 1,260 1,009 Accrued professional fees 868 968 Total $ 6,000 $ 4,592 |
Debt_2
Debt | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Debt | ||
Debt | 7. Debt On April 30, 2020, the Company received loan proceeds in the amount of approximately $3.3 million under the Paycheck Protection Program ( “ ” In March 2021, the Company entered into a term loan agreement with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P., which provides a term loan facility of up to $50.0 million with a maturity date of March 1, 2025, or the Loan Agreement. The Company ’ The Loan Agreement provides that the term loans will be distributed in tranches. The initial term loan tranche of $20.0 million was drawn in March 2021 and is accounted for net of issuance costs which are being accreted to interest expense over the term of the loan using the effective interest method. As of September 30, 2021, three subsequent $10.0 million term loan tranches were eligible to be disbursed at the request of the Company during specified draw periods between now and 2023 if certain business development milestones and other specified requirements are met by the dates specified in the Loan Agreement. Borrowings bear interest at the greater of 7.5% or the Wall Street Journal Prime Rate plus 4.25% (7.5% as of September 30, 2021). Interest only payments on the principal amount outstanding are due monthly beginning in the first month after the loan is dispersed. Repayment of principal may begin as soon as April 1, 2022 under the level of borrowing outstanding at September 30, 2021, and no later than April 1, 2024. The term loans may only be prepaid in full, and such prepayment requires 30 days ’ On October 13, 2021, the Company borrowed an additional $10.0 million under the Loan Agreement. As a result of the additional borrowing, the commencement of repayment of principal was deferred to no earlier than July 2023. In connection with the Loan Agreement, the Company granted warrants to the lenders to purchase shares of common stock at an exercise price of $10.28 per share, of which 287,704 warrants were immediately exercisable. The warrants are classified within stockholders ’ ’ ’ At issuance, the Company initially determined that the funding of an additional tranche was not probable, and therefore no value was ascribed to the remaining 123,302 warrants that were only exercisable upon the funding of the additional tranche. As a result of the Company ’ ’ SVB loan payable and net discount or premium balances are as follows: September 30, ($ in thousands) 2021 Principal amount of SVB loan payable $ 20,000 Final payment amount of SVB loan payable 1,000 Net premium associated with accretion of final payment and other debt issuance costs (3,073) SVB loan payable, current and noncurrent 17,927 Less SVB loan payable, current portion (3,889) SVB loan payable, noncurrent portion $ 14,038 Future minimum payments of principal on the Company ’ Year ending December 31: ($ in thousands) 2021 (remainder) $ — 2022 5,555 2023 6,667 2024 6,667 2025 1,111 Total future payments 20,000 | 5. Debt On April 30, 2020, the Company received loan proceeds in the amount of approximately $3.3 million under the Paycheck Protection Program ( “ ” “ ” In September 2020, the Company applied for forgiveness of the outstanding amount under its PPP loan. The Company used the proceeds for purposes it believes were consistent with the requirements of the PPP. The Company determined that loan forgiveness would become probable upon approval by the Small Business Administration of the Company ’ |
Stockholders, Equity (Deficit_2
Stockholders, Equity (Deficit) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Stockholders' Equity (Deficit) | ||
Stockholders' Equity (Deficit) | 8. Stockholders ’ Equity (Deficit) Redeemable Convertible Preferred Stock As of December 31, 2020 and immediately prior to the Merger, Legacy Humacyte had outstanding series A redeemable convertible preferred stock, series B redeemable convertible preferred stock, series C redeemable convertible preferred stock and series D redeemable convertible preferred stock, which are collectively referred to as “ ” In connection with the Merger, all previously issued and outstanding redeemable convertible preferred stock was converted into an equivalent number of shares of common stock of the Company on a one-to-one basis, then multiplied by the Exchange Ratio pursuant to the Merger Agreement. Common Stock On August 26, 2021, the Merger and related PIPE Financing was consummated and the Company issued 27,346,449 shares of common stock for proceeds of $242.4 million. The Company incurred $3.9 million of transaction costs, consisting of banking, legal, and other professional fees. Legacy Humacyte assumed $15.2 million of liabilities, including PIPE Financing fees and legal fees, and $0.1 million of assets from AHAC. Immediately following the Merger, there were 103,003,384 shares of common stock outstanding with a par value of $0.0001. As of September 30, 2021, the Company ’ The holders of common stock are entitled to receive dividends from time to time as may be declared by the Company ’ The holders of common stock are entitled to one vote for each share held with respect to all matters voted on by the common stockholders of the Company. In the event of a reorganization of the Company, after payment to the preferred stockholders of their liquidation preferences, holders of common stock are entitled to share ratably in all remaining assets of the Company. As of September 30, 2021, the Company had reserved common stock for future issuances as follows: September 30, 2021 Common stock reserved for Contingent Consideration Shares 15,000,000 Exercise of options under stock plans 6,399,888 Issuance of options under stock plans 7,730,503 Shares available for grant under ESPP 1,030,033 Warrants to purchase common stock 5,465,204 35,625,628 On August 26, 2021, upon the Closing, all of the outstanding redeemable convertible preferred stock was converted to Common Stock pursuant to the conversion rate effective immediately prior to the Merger and the Exchange Ratio and the remaining amount was reclassified to additional paid-in capital. Preferred Stock The Company ’ ’ Warrants Activity of warrants for the nine months ended September 30, 2021 is set forth below: Legacy Humacyte Common Stock Private Placement Total Common Warrants Warrants Public Warrants Stock Warrants Outstanding as of December 31, 2020 32,961 — — 32,961 Common Stock Warrants issued to SVB 287,704 — — 287,704 Common Stock Warrants as Part of the Merger — 177,500 5,000,000 5,177,500 Warrants Exercised (32,961) — — (32,961) Oustanding as of September 30, 2021 287,704 177,500 5,000,000 5,465,204 In conjunction with a long-term debt agreement entered into on March 15, 2006 and paid in full during 2011, the Company issued a warrant that gave the holder the right to purchase 32,961 shares of the Company ’ See Note 7 — ’ Private Placement Warrants The Private Placement Warrants were initially recognized as a liability on the Closing Date, at a fair value of $0.6 million, and the Private Placement Warrant liability was remeasured to fair value as of September 30, 2021, resulting in a loss of less than $0.1 million for the three and nine months ended September 30, 2021, classified within change in fair value of common stock warrant liabilities in the condensed consolidated statements of operations and comprehensive loss. The Private Placement Warrants were valued using the following assumptions under the Monte Carlo simulation value model: August 26, September 30, 2021 2021 Market price of public stock $ 10.96 $ 11.61 Exercise price $ 11.50 $ 11.50 Expected term (years) 5.00 4.91 Expected share price volatility 32.5 % 28.5 % Risk-free interest rate 0.68 % 0.96 % Estimated dividend yield 0 % 0 % Public Warrants The Public Warrants may only be exercised for a whole number of shares and will expire five years after the completion of the Merger. The Public Warrants became exercisable 30 days after the completion of the Merger. The Public Warrants were initially recognized as equity on the Closing Date at a fair value of $2.80 per share. There were no exercises of the Public Warrants during the three months ended September 30, 2021. Contingent Earnout Liability Following the Closing, former holders of Legacy Humacyte common and preferred shares may receive up to 15,000,000 additional shares of the Company ’ “ ” stock quoted on the Nasdaq (or the exchange on which the shares of common stock are then listed) is greater or equal to $15.00 and $20.00, respectively, over any twenty trading days within any thirty-day trading period. Upon the Closing, the contingent obligation to issue Contingent Earnout Shares was accounted for as a liability because the triggering events that determine the number of Contingent Earnout Shares required to be issued include events that are not solely indexed to the common stock of Humacyte. The estimated fair value of the total Contingent Earnout Shares at the Closing on August 26, 2021, was $159.4 million based on a Monte Carlo simulation valuation model using a distribution of potential outcomes on a monthly basis over a ten-year period using the most reliable information available. The Contingent Earnout Liability was remeasured to fair value as of September 30, 2021, resulting in the recording of a non-cash loss of $9.8 million for the three and nine months ended September 30, 2021, classified within change in fair value of contingent earnout liability in the condensed consolidated statements of operations and comprehensive loss. Assumptions used in the valuations are described below: August 26, September 30, 2021 2021 Current stock price $ 10.96 $ 11.61 Expected share price volatility 79.6 % 78.9 % Risk-free interest rate 1.34 % 1.55 % Estimated dividend yield 0 % 0.0 % Expected term (years) 10.00 10.00 | 8. Stockholders ’ Deficit Common Stock As of December 31, 2019 and 2020, the Company ’ ’ The holders of common stock are entitled to receive dividends from time to time as may be declared by the Board of Directors. No cash dividend may be declared or paid to common stockholders until paid on each series of outstanding redeemable convertible preferred stock in accordance with its terms. Through December 31, 2020, no The holders of common stock are entitled to one vote for each share held with respect to all matters voted on by the common stockholders of the Company. Preferred stockholders generally vote together with the holders of common stock as a single class ’ In the event of a Reorganization of the Company, after payment to the preferred stockholders of their liquidation preferences, holders of common stock are entitled, together with holders of redeemable convertible preferred stock, to share ratably in all remaining assets of the Company. 8. Stockholders ’ Deficit (continued) At December 31, 2019 and 2020, the Company had reserved common stock for future issuances as follows: December 31, 2019 2020 Conversion of Series A redeemable convertible preferred stock 18,421,897 18,421,897 Conversion of Series B redeemable convertible preferred stock 24,137,647 24,137,647 Conversion of Series C redeemable convertible preferred stock 11,241,286 11,241,286 Conversion of Series D redeemable convertible preferred stock 15,812,735 15,812,735 Exercise of options under stock plan 5,220,236 4,813,262 Issuance of options under stock plan 2,736,954 2,948,598 Warrant to purchase common stock 32,961 32,961 77,603,716 77,408,386 Warrant In conjunction with a long-term debt agreement entered into on March 15, 2006 and paid in full during 2011, the Company issued a warrant that gave the holder the right to purchase 32,961 shares of the Company ’ |
Stock-based Compensation_2
Stock-based Compensation | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Stock-based Compensation | ||
Stock-based Compensation | 9. Stock-based Compensation At Closing, the 2021 Long-Term Incentive Plan, or the 2021 Plan, and the 2021 Employee Stock Purchase Plan, or the ESPP, became effective. As of September 30, 2021, 7,730,503 and 1,030,033 shares of common stock were available under the 2021 Plan and ESPP, respectively. On January 1 of each year commencing January 1, 2022, the 2021 Plan and the ESPP reserve will automatically increase in an amount equal to the lesser of (a) 5% and 1%, respectively, of the number of shares of the Company ’ ’ Under the 2021 Plan, the Company can grant non-statutory stock options, or NSOs, incentive stock options, or ISOs, stock appreciation rights, restricted stock, restricted stock units, unrestricted stock, performance awards and other forms of awards. Under the ESPP, eligible employees are permitted to purchase shares of the Company ’ ’ Prior to the Closing, Legacy Humacyte had two equity incentive plans, the 2015 Omnibus Incentive Plan, as amended, or the 2015 Plan, and the 2005 Stock Option Plan, or the 2005 Plan. As a result of the Merger, no further awards may be granted under either the 2015 plan or the 2005 Plan. All awards previously granted and outstanding as of the effective date of the Merger, which total The Company ’ ’ ’ The Company has granted options that include either a service-based or performance-based vesting conditions, or both, and a 10-year contractual term. The service-based vesting condition for the plans is generally satisfied over 36 Company recognizes stock-based compensation expense based on the grant date fair value of the awards measured using the Black-Scholes option pricing model. Compensation expense related to awards with service-based vesting conditions is recognized on a straight-line basis over the requisite service period. Option valuation models, including the Black-Scholes option-pricing model, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility, the expected term of the award, and the fair value of the underlying common stock on the date of grant. Forfeitures are accounted for as they occur. Compensation expense related to awards with performance-based vesting conditions is recognized over the requisite service period using the accelerated attribution method to the extent achievement of the performance-based condition is probable. The Company does not recognize compensation expense related to awards with performance-based vesting conditions until it is probable that the performance-based vesting condition will be achieved. Forfeitures are accounted for as they occur. Option awards under the Company ’ ’ ’ Under the terms of her employment agreement, the Company awarded the Company ’ ’ three The Company estimated the fair value of the stock options on the date of grant using the following assumptions in the Black-Scholes option-pricing model: Three Months Ended Nine Months Ended September 30, 2020 2021 (1) 2020 2021 Estimated dividend yield 0 % — 0 % 0 % Expected share price volatility (weighted average and range, if applicable) 91.6 % — 91.4% (89.4% to 91.6%) 91.4% (91.0% to 92.1%) Risk-free interest rate (weighted average and range, if applicable) 0.34 % — 0.40% (0.34% to 0.75%) 0.68% (0.62% to 1.02%) Expected term of options (in years) 6.0 — 6.0 6.0 (1) The Company did not grant any stock options during the three months ended September 30, 2021. ● Fair Value of Common Stock. As the Company ’ s common stock was not publicly traded prior to the Merger, the fair value of the shares of its common stock underlying the options has historically been determined by the Company ’ s board of directors with input from management, after considering independent third-party valuation reports. ● Expected Term. The expected term represents the period that stock options are expected to be outstanding. The Company calculated the expected term using the simplified method for options, which is available where there is insufficient historical data about exercise patterns and post-vesting employment termination behavior. The simplified method is based on the vesting period and the contractual term for each grant, or for each vesting-tranche for awards with graded vesting. The mid-point between the vesting date and the maximum contractual expiration date is used as the expected term under this method. For awards with multiple vesting-tranches, the times from grant until the mid-points for each of the tranches may be averaged to provide an overall expected term. ● Expected Volatility. The expected volatility was based on the historical share volatility of several publicly traded peer companies over a period of time equal to the expected term of the options, as the Company does not have any trading history to use the volatility of its common stock. For purposes of identifying these peer companies, the Company considered the industry, stage of development, size and financial leverage of potential comparable companies. ● Risk-Free Interest Rate. The risk-free interest rate was based on the yields of U.S. Treasury zero-coupon securities with maturities similar in duration to the expected term of the options. ● Expected Dividend Yield. The Company has not paid dividends on its common stock nor does it expect to pay dividends in the foreseeable future. Accordingly, the Company has estimated the dividend yield to be zero. At September 30, 2021, there were 7,730,503 options remaining available for grant under the 2021 Plan. The Company has sufficient authorized and unissued shares to make all issuances currently available under the 2021 Plan. The following tables show a summary of stock-based compensation expense included in the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2021, and the three and nine months ended September 30, 2020, and remaining unrecognized cost as of September 30, 2021 and 2020: Three Months Ended Nine Months Ended ($ in thousands) 2020 2021 2020 2021 Research and development $ 308 $ 486 $ 781 $ 1,837 General and administrative 862 1,391 2,685 5,498 Total $ 1,170 $ 1,877 $ 3,466 $ 7,335 December 31, September 30, ($ in thousands) 2020 2021 Unrecognized share-based compensation cost $ 5,789 $ 12,480 Expected weighted average period compensation costs to be recognized (years) 1.7 2.1 A summary of option activity under the Company ’ Weighted Average Weighted Remaining Aggregate Average Exercise Contractual Term Intrinsic Value Number of Shares Price Per Share (years) (in thousands) Options outstanding at December 31, 2020 4,813,262 $ 6.04 6.6 $ 20,422 Granted 1,838,029 $ 10.28 Exercised (188,006) $ 2.97 Forfeited (63,397) $ 7.87 Options outstanding at September 30, 2021 6,399,888 $ 7.33 6.6 $ 26,705 Vested and exercisable, September 30, 2021 4,092,342 $ 5.74 5.1 $ 23,345 Vested and expected to vest, September 30, 2021 6,399,888 $ 7.33 6.6 $ 26,705 The Company did not grant any stock options during the three months ended September 30, 2021. | 9. Stock-based Compensation The Company has adopted the 2015 Omnibus Incentive Plan, as amended, or the 2015 Plan, which allows for the grant of nonstatutory stock options, or NSOs, and incentive stock options, or ISOs, stock appreciation rights, restricted stock, restricted stock units and unrestricted stock awards to employees, officers, directors, and consultants in the service of the Company. The Company believes that such awards aid in aligning the interests of these persons with those of its stockholders. The Board of Directors determines the specific terms of equity incentive grants, including the exercise price per share and vesting period for option awards. Option awards are granted with an exercise price equal to the fair market value of the Company ’ The Company has granted options that include either a service-based or performance-based vesting condition and a 10-year contractual term. The service-based vesting condition is generally satisfied over 36 months from the date of grant. The performance-based vesting conditions are satisfied upon the attainment of certain product development milestones. The Company recognizes stock-based compensation expense based on the grant date fair value of the awards. Compensation expense related to awards with service-based vesting conditions is recognized on a straight-line basis over the requisite service period. Compensation expense related to awards with performance-based vesting conditions is recognized over the requisite service period using the accelerated attribution method to the extent achievement of the performance-based condition is probable. The Company does not recognize compensation expense related to awards with performance-based vesting conditions until it is probable that the performance-based vesting condition will be achieved. Forfeitures are accounted for as they occur. Option awards under the 2015 Plan generally provide for accelerated vesting of the unvested portions of any option award in the event of an involuntary termination, as such term is defined in the relevant stock option agreement, of a grantee ’ ’ 9. Stock-based Compensation (continued) The Company used the following assumptions on the date of grant to estimate the fair value of the stock options in the Black-Scholes option-pricing model as follows: Year Ended 2019 2020 Estimated dividend yield 0 % 0 % Expected share price volatility 70.1%-87.7 % 89.4% - 91.6 % Risk-free interest rate 1.76% - 2.46 % 0.34% - 0.75 % Expected term of options (in years) 6.00 6.00 ● Fair Value of Common Stock. As the Company ’ s common stock has not historically been publicly traded, the fair value of the shares of its common stock underlying the options has historically been determined by the Company ’ s board of directors with input from management, after considering independent third-party valuation reports. ● Expected Term. The expected term represents the period that stock options are expected to be outstanding. The Company calculated the expected term using the simplified method for options, which is available where there is insufficient historical data about exercise patterns and post-vesting employment termination behavior. The simplified method is based on the vesting period and the contractual term for each grant, or for each vesting-tranche for awards with graded vesting. The mid-point between the vesting date and the maximum contractual expiration date is used as the expected term under this method. For awards with multiple vesting-tranches, the times from grant until the mid-points for each of the tranches may be averaged to provide an overall expected term. ● Expected Volatility. The expected volatility was based on the historical share volatility of several publicly traded peer companies over a period of time equal to the expected term of the options, as the Company does not have any trading history to use the volatility of its common stock. For purposes of identifying these peer companies, the Company considered the industry, stage of development, size and financial leverage of potential comparable companies. ● Risk-Free Interest Rate. The risk-free interest rate was based on the yields of US Treasury zero-coupon securities with maturities similar in duration to the expected term of the options. ● Expected Dividend Yield. The Company has not paid dividends on its common stock nor does it expect to pay dividends in the foreseeable future. Accordingly, the Company has estimated the dividend yield to be zero. At December 31, 2020, there were 2,948,598 options remaining available for grant under the 2015 Plan. The Company has sufficient authorized and unissued shares to make all issuances currently contemplated under the 2015 Plan. 9. Stock-based Compensation (continued) The following tables show a summary of stock-based compensation expense included in the statements of operations and comprehensive loss for the years ended December 31, 2019 and 2020, and remaining unrecognized cost as of December 31, 2019 and 2020: Year Ended ($ in thousands) 2019 2020 Research and development $ 914 $ 1,135 General and administrative 3,543 3,559 Total $ 4,457 $ 4,694 As of December 31, ($ in thousands) 2019 2020 Unrecognized share-based compensation cost $ 7,919 $ 5,789 Expected weighted average period compensation costs to be recognized (years) 1.8 1.7 A summary of option activity under the 2015 Plan during the years ended December 31, 2019 and 2020 is presented below: Weighted Average Weighted Remaining Aggregate Number of Average Exercise Contractual Term Intrinsic Value Shares Price Per Share (years) (in thousands) Options outstanding at December 31, 2018 5,638,773 $ 4.69 7.4 $ 21,354 Granted 621,031 8.49 Exercised (620,831) 1.97 Forfeited (418,737) 7.62 Options outstanding at December 31, 2019 5,220,236 $ 5.22 6.5 $ 17,044 Granted 480,856 9.79 Exercised (195,239) 1.55 Forfeited (692,591) 3.76 Options outstanding at December 31, 2020 4,813,262 $ 6.04 6.6 $ 20,422 Vested and exercisable, December 31, 2020 3,392,302 $ 4.99 5.9 $ 17,925 Vested and expected to vest, December 31, 2020 4,813,262 $ 6.04 6.6 $ 20,422 The total intrinsic value of options exercised during the years ended December 31, 2019 and 2020 was $4.0 million and $1.4 million, respectively. The weighted-average grant-date fair value per share of options granted during the years ended December 31, 2019 and 2020 was $5.84 and $7.26, respectively. |
Income Taxes_2
Income Taxes | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Income Taxes | ||
Income Taxes | 10. Income Taxes The Company ’ ’ The Company did not record any income tax expense or benefit during the three and nine months ended September 30, 2020 and 2021. The Company has a net operating loss and has provided a valuation allowance against net deferred tax assets due to uncertainties regarding the Company ’ On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security ( “ ” ’ | 10. Income Taxes The Company did not record any income tax expense or benefit during the years ended December 31, 2019 and 2020. The Company has a net operating loss and has provided a valuation allowance against net deferred tax assets due to uncertainties regarding the Company ’ Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company ’ As of December 31, ($ in thousands) 2019 2020 Deferred tax assets: Net operating loss $ 50,616 $ 53,515 Capitalized research and development 19,660 32,337 Research credits 10,658 15,056 Share-based compensation 1,669 2,519 Right of use lease liability 207 177 Accrued expenses 71 57 Other 1 1 Total deferred tax asset 82,882 103,662 Less: valuation allowance (82,193) (101,757) Total net deferred tax asset 689 1,905 Deferred tax liabilities: Basis difference in fixed assets (482) (1,728) Right of use lease assets (207) (177) Total deferred tax liability (689) (1,905) Total net deferred tax asset/(liability) $ — $ — A valuation allowance is provided for deferred tax assets where the recoverability of the assets is uncertain. The determination to provide a valuation allowance is dependent upon the assessment of whether it is more likely than not that sufficient future taxable income will be generated to utilize the deferred tax assets. Based on the weight of the available evidence, which includes the Company ’ 10. Income Taxes (continued) The reasons for the difference between the actual income tax benefit for the years ended December 31, 2019 and 2020, and the amount computed by applying the statutory Federal income tax rate to losses before income taxes are as follows: December 31, 2019 2020 ($ in thousands) Amount Rate Amount Rate Income tax benefit at statutory rate $ (17,939) 21.0 % $ (13,970) 21.0 % State income taxes, net of federal benefit (1,739) 2.0 % (1,338) 2.0 % Tax credits (1,821) 2.1 % (2,625) 3.9 % Other nondeductible expenses 54 0.0 % 90 (0.1) % Deferred rate changes 16 0.0 % 16 0.0 % Other 449 (0.5) % (1,736) 2.6 % Change in valuation allowance 20,980 (24.6) % 19,563 (29.4) % Provision for income taxes $ — 0.0 % $ — 0.0 % As of December 31, 2020 the Company had approximately $232.7 million and $232.6 million of Federal and state net operating losses, respectively. Of this amount, $71.5 million of Federal net operating losses are carried over indefinitely, while the remaining amount begins to expire in 2025. The Company ’ As of December 31, 2019 and December 31, 2020 the Company had Federal and state research tax credit carryforwards of $10.7 million and $15.1 million, respectively. These credit carryforwards begin to expire in 2021. Net operating loss carryforwards and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service, or IRS, and may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders or groups over a three-year period in excess of 50% as defined under Sections The Company applies the accounting guidance for uncertainties in income taxes, which prescribes a recognition threshold and measurement process for recording uncertain tax positions taken, or expected to be taken, in a tax return in the financial statements. Additionally, the guidance also prescribes the treatment for derecognition, classification, accounting in interim periods and disclosure requirements for uncertain tax positions. The Company accrues for the estimated amount of taxes for uncertain tax positions if it is more likely than not that the Company would be required to pay such additional taxes. On March 27, 2020, the CARES Act was passed by the U.S. Congress and signed into United ’ |
Commitments and Contingencies_3
Commitments and Contingencies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Commitments and Contingencies | ||
Commitments and Contingencies | 11. Commitments and Contingencies Patent License Agreements Duke University In March In connection with the Company ’ ’ ● a low single-digit percentage royalty on eligible sales of licensed products and licensed services, plus a low double-digit percentage of any sublicensing revenue; ● an annual minimum royalty beginning in 2012, which increases in the calendar year immediately following the first commercial sale of licensed products or licensed services (whichever occurs first); and ● an additional amount in license fees, as certain milestones are met. The license agreement remains effective until the last of the patent rights expires or four years after the Company ’ ’ Yale University In February – ’ fee, increasing between the first and fourth anniversaries of the agreement up to a maximum of less than $0.1 million per year for this license. In August ’ In August ’ The Company has agreed to use reasonable commercial efforts to develop and commercialize the licensed patents and any licensed products and methods, and to use reasonable efforts to make the licensed products available to patients in low and low-middle income countries. The Company is also obligated to provide Yale periodically an updated and revised copy of its plan for each license, which must indicate progress of its development and commercialization. The Company may also sublicense the Company ’ ’ In connection with its entry into the license agreement, the Company paid Yale upfront cash fees. The Company has also agreed to pay Yale: ● annual maintenance fees, increasing between the first anniversary of the agreement until the fifth anniversary for the coating and BVP licenses and until the fourth anniversary for the tubular prostheses license up to a maximum of less than $0.1 million per year; ● milestone payments upon achievement of certain regulatory and commercial milestones of $0.2 million and $0.6 million; ● a low single-digit percentage royalty on worldwide net sales, subject to reductions for third-party license fees; and ● a low double-digit percentage of sublicensing income. If the Company or any of its future sublicensees bring a patent challenge against Yale or assists another party in bringing a patent challenge against Yale, the license fees described above will be subject to certain increases and penalties. The agreements expire on a country-by-country basis on the date on which the last of the patents in such country expires, lapses or is declared invalid. Yale may terminate the agreements if the Company fails to (i) ’ ’ ’ ’ respect to the licensed patents. The Company has agreed to indemnify Yale against certain third-party claims. Payments to Yale under the license agreement were immaterial during the periods presented. Legal Matters The Company currently is not aware of any legal proceedings or claims that management believes will have, individually or in the aggregate, a material adverse effect on the Company ’ Indemnification To the extent permitted under Delaware law, the Company has agreed to indemnify its directors and officers for certain events or occurrences while the director or officer is, or was serving, at the Company ’ ’ ’ | 12. Commitments and Contingencies Patent License Agreements Duke University In March In connection with the Company ’ ’ ● a low single-digit percentage royalty on eligible sales of licensed products and licensed services, plus a low double-digit percentage of any sublicensing revenue; ● an annual minimum royalty beginning in 2012, which increases in the calendar year immediately following the first commercial sale of licensed products or licensed services (whichever occurs first); and ● an additional amount in license fees, as certain milestones are met. The license agreement remains effective until the last of the patent rights expires or four years after our first commercial sale, unless earlier terminated. Either party may terminate the agreement for fraud, willful misconduct or illegal conduct, or uncured material breach. Duke may terminate the agreement if the Company becomes insolvent. Duke may also terminate the license, convert the license into a non-exclusive license or seek assignment of any sublicense if the Company fails to reach diligence milestones within the applicable time period. If the Company abandons any claim, patent or patent application, its rights under the license with respect to such patent rights will be terminated in the territory in which the Company abandons such rights. The Company may terminate the license agreement unilaterally upon three months ’ 12. Commitments and Contingencies (continued) Yale University In February – ’ In August ’ In August ’ The Company has agreed to use reasonable commercial efforts to develop and commercialize the licensed patents and any licensed products and methods, and to use reasonable efforts to make the licensed products available to patients in low and low-middle income countries. The Company is also obligated to provide Yale periodically an updated and revised copy of its plan for each license, which must indicate progress of its development and commercialization. The Company may also sublicense the Company ’ ’ In connection with its entry into the license agreement, the Company paid Yale upfront cash fees. The Company has also agreed to pay Yale: ● annual maintenance fees, increasing between the first anniversary of the agreement until the fifth anniversary for the coating and BVP licenses and until the fourth anniversary for the tubular prostheses license; ● milestone payments upon achievement of certain regulatory and commercial milestones; ● a low single-digit percentage royalty on worldwide net sales, subject to reductions for third-party license fees; and ● a low double-digit percentage of sublicensing income. If the Company or any of its future sublicensees bring a patent challenge against Yale or assists another party in bringing a patent challenge against Yale, the license fees described above will be subject to certain increases and penalties. 12. Commitments and Contingencies (continued) The agreements expire on a country-by-country basis on the date on which the last of the patents in such country expires, lapses or is declared invalid. Yale may terminate the agreements if the Company fails to (i) ’ ’ ’ ’ Legal Matters The Company currently is not aware of any legal proceedings or claims that management believes will have, individually or in the aggregate, a material adverse effect on the Company ’ Indemnification To the extent permitted under Delaware law, the Company has agreed to indemnify its directors and officers for certain events or occurrences while the director or officer is, or was serving, at the Company ’ ’ ’ |
Related Party Transactions_2
Related Party Transactions | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Related Party Transactions | ||
Related Party Transactions | 12. Related Party Transactions Fresenius Medical Care investments and distribution agreement In June 2018, the Company completed a $150 million financing transaction pursuant to which Fresenius Medical Care purchased shares of series D redeemable convertible preferred stock that at the Closing of the Merger converted into 15,812,735 shares of the Company ’ ’ In addition, the Company entered into a distribution agreement with Fresenius Medical Care in June 2018 which, as amended as of February 16, 2021, granted Fresenius Medical Care and its affiliates exclusive rights to develop outside the United States and EU and commercialize outside of the United States the Company ’ The Company is responsible for developing and seeking regulatory approval for the distribution product in the field in the United States. For countries outside the United States, the parties agreed to use commercially reasonable efforts to satisfy certain agreed minimum market entry criteria for the distribution product in the field in such country. For the EU, once such criteria have been satisfied for the applicable country, or if the parties otherwise mutually agree to obtain regulatory approval for the distribution product in the field in the applicable country, the Company agreed to use commercially reasonable efforts to obtain such regulatory approval (other than pricing approval), and Fresenius Medical Care agreed to use commercially reasonable efforts to obtain the corresponding pricing approval. For the rest of the world (i.e., outside the United States and the EU), once such criteria have been satisfied for the applicable country, or if the parties otherwise mutually agree to obtain regulatory and pricing approval for the distribution product in the field in the applicable country, Fresenius Medical Care agreed to use commercially reasonable efforts to obtain such approvals, and the Company agreed to use commercially reasonable efforts to support Fresenius Medical Care in its efforts. Under the distribution agreement, the Company grants an exclusive, sublicensable license to Fresenius Medical Care under the patents, know-how and regulatory materials controlled by the Company during the term to commercialize the distribution product in the field outside the United States, subject to the Company ’ and regulatory materials controlled by the Company during the term to develop the distribution product in accordance with the terms of the distribution agreement. In addition, the Company grants to Fresenius Medical Care, among other things, a perpetual, irrevocable, non-exclusive sublicensable license under the patents and know-how that primarily relate to the distribution product or its manufacture and that were created, conceived or developed solely or jointly by or on behalf of Fresenius Medical Care in the performance of its activities under the distribution agreement. The distribution agreement provides that the Company will own all know-how and patents that primarily relate to the distribution product or its manufacture that are created, conceived or developed by or on behalf of either party in the performance of activities under the distribution agreement. Ownership of all other know-how, patents, materials and other intellectual property created, conceived or developed during the performance of activities under the distribution agreement will be determined in accordance with U.S. patent laws for determining inventorship. The Company is obligated to make payments to Fresenius Medical Care based on a share of aggregate net sales by or on behalf of the Company of the distribution product in the United States in the field. Such revenue-share payments will be a percentage of net sales in the low double digits, without regard to the calendar year in which such net sales are attributable, until such time that the Company has paid to Fresenius Medical Care a certain total amount, at which time the revenue-share will decrease to a percentage of net sales in the mid-single digits. The amounts that Fresenius Medical Care will be obligated to pay the Company under the distribution agreement for sales of the distribution product in the field outside of the United States will vary. Fresenius Medical Care agreed to pay the Company initially, on a country-by-country basis for sales outside of the United States, the amount equal to the average cost of manufacturing the Company ’ The distribution agreement will generally continue on a country-by-country basis until the later of (a) the tenth anniversary of the launch date of the distribution product in the relevant country or (b) the expiration of the last-to-expire valid claim of specified patents in such country. Each party is permitted to terminate the distribution agreement for insolvency of, or, under certain circumstances, including various cure periods, material breach by the other party. Subject to a cure period, Fresenius Medical Care may also terminate the distribution agreement in its entirety or on a country-by-country basis (i) for certain withdrawals of regulatory approval or (ii) for termination or expiration of any of our in-licenses that is necessary for the exercise of Fresenius Medical Care ’ ’ Arrangements with Dr. Niklason and Yale University In September The MOU provided for the Company to make a payment each year through 2023 to the academic institution with which Dr. ’ ’ The following table shows a summary of related party expenses included in the statements of operations and comprehensive loss for the three and nine months ended September 30, 2020 and 2021: Three Months Nine Months ($ in thousands) 2020 2021 2020 2021 Expenses under MOU 125 — 375 — License expenses 20 — 70 85 Other 4 2 17 83 Total 149 2 462 168 As of December 31, 2020 and September 30, 2021, the Company was a party to license agreements with Yale University, as described in Note 11 — | 13. Related Party Transactions Fresenius Medical Care distribution agreement In addition to Fresenius Medical Care ’ ’ The Company is responsible for developing and seeking regulatory approval for the distribution product in the field in the United States. For countries outside the United States, the parties agreed to use commercially reasonable efforts to satisfy certain agreed minimum market entry criteria for the distribution product in the field in such country. For the EU, once such criteria have been satisfied for the applicable country, or if the parties otherwise mutually agree to obtain regulatory approval for the distribution product in the field in the applicable country, the Company agreed to use commercially reasonable efforts to obtain such regulatory approval (other than pricing approval), and Fresenius Medical Care agreed to use commercially reasonable efforts to obtain the corresponding pricing approval. For the rest of the world (i.e., outside the United States and the EU), once such criteria have been satisfied for the applicable country, or if the parties otherwise mutually agree to obtain regulatory and pricing approval for the distribution product in the field in the applicable country, Fresenius Medical Care agreed to use commercially reasonable efforts to obtain such approvals, and the Company agreed to use commercially reasonable efforts to support Fresenius Medical Care in its efforts. Under the distribution agreement, the Company grants an exclusive, sublicensable license to Fresenius Medical Care under the patents, know-how and regulatory materials controlled by the Company during the term to commercialize the distribution product in the field outside the United States, subject to the Company ’ The distribution agreement provides that the Company will own all know-how and patents that primarily relate to the distribution product or its manufacture that are created, conceived or developed by or on behalf of either party in the performance of activities under the distribution agreement. Ownership of all other know-how, patents, materials and other intellectual property created, conceived or developed during the performance of activities under the distribution agreement will be determined in accordance with U.S. patent laws for determining inventorship. 13. Related Party Transactions (continued) The Company is obligated to make payments to Fresenius Medical Care based on a share of aggregate net sales by or on behalf of the Company of the distribution product in the United States in the field. Such revenue-share payments will be a percentage of net sales in the low double digits, without regard to the calendar year in which such net sales are attributable, until such time that the Company has paid to Fresenius Medical Care a certain total amount, at which time the revenue-share will decrease to a percentage of net sales in the mid-single digits. The amounts that Fresenius Medical Care will be obligated to pay the Company under the distribution agreement for sales of the distribution product in the field outside of the United States will vary. Fresenius Medical Care agreed to pay the Company initially, on a country-by-country basis for sales outside of the United States, the amount equal to the average cost of manufacturing the Company ’ The distribution agreement will generally continue on a country-by-country basis until the later of (a) the tenth anniversary of the launch date of the distribution product in the relevant country or (b) the expiration of the last-to-expire valid claim of specified patents in such country. Each party is permitted to terminate the distribution agreement for insolvency of, or, under certain circumstances, including various cure periods, material breach by the other party. Subject to a cure period, Fresenius Medical Care may also terminate the distribution agreement in its entirety or on a country-by-country basis (i) for certain withdrawals of regulatory approval or (ii) for termination or expiration of any of our in-licenses that is necessary for the exercise of Fresenius Medical Care ’ ’ Arrangements with Dr. Niklason and Yale University In September The MOU provided for the Company to make a payment each year through 2023 to the academic institution with which Dr. ’ ’ The following table shows a summary of related party expenses included in the statements of operations and comprehensive loss for the years ended December 31, 2019 and 2020: Year Ended December 31, ($ in thousands) 2019 2020 Expenses under MOU $ 422 $ 500 License expenses 110 92 Other 39 28 Total $ 571 $ 620 As of December 31, 2019 and December 31, 2020, the Company was a party to license agreements with Yale University, as described in Note 12 — |
Subsequent Events_2
Subsequent Events | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Subsequent Events [Abstract] | ||
Subsequent Events | 13. Subsequent Events In preparing the condensed consolidated financial statements as of September 30, 2021 and for the three and nine months ended September 30, 2021, the Company evaluated the effect subsequent events would have on the financial statements through the date the financial statements were issued. On October 13, 2021, the Company borrowed an additional $10.0 million under the Loan Agreement, and the warrants to purchase an additional 123,302 shares of the Company ’ — — ’ | 14. Subsequent Events The Company evaluated the effect subsequent events would have on the financial statements through March 22, 2021, which is the date the financial statements were issued. Under the terms of her employment agreement, the Company awarded Dr. Niklason an additional stock option award in January 2021 entitling her to purchase 1,312,984 shares of the Company ’ none three Under the terms of his consulting agreement, the Company awarded Mr. Sander an additional stock option award in January 2021 entitling him to purchase 183,817 shares of the Company ’ three On February 17, 2021, the Company entered into a business combination agreement with AHAC and Merger Sub, a wholly owned subsidiary of AHAC, pursuant to which Merger Sub will merge with the Company, with the Company surviving the Merger as a wholly owned subsidiary of AHAC. As a result of the Merger, AHAC will immediately be renamed New Humacyte. Immediately prior to the consummation of the Merger, the Company ’ ’ ’ ’ ’ No |
Summary of Significant Accou_14
Summary of Significant Accounting Policies (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Summary of Significant Accounting Policies | ||
Basis of Presentation | Basis of Presentation The Company has prepared the accompanying financial statements in conformity with accounting principles generally accepted in the United ’ Unless otherwise noted, the Company has retroactively adjusted all common and preferred share and related price information to give effect to the Exchange Ratio established in the Merger Agreement. | Basis of Presentation The Company has prepared the accompanying financial statements in conformity with accounting principles generally accepted in the United Reverse Recapitalization |
Unaudited Interim Condensed Consolidated Financial Statements | Unaudited Interim Condensed Consolidated Financial Statements The accompanying interim condensed consolidated financial statements and the related footnote disclosures are unaudited. These unaudited interim financial statements have been prepared on the same basis as the audited financial statements, and in management ’ ’ Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2020 and the related notes included elsewhere in this prospectus, which provides a more complete discussion of the Company’s accounting policies and certain other information. Other than the policies noted below, there have been no significant changes to the significant accounting policies disclosed in Note 2 of the audited consolidated financial statements as of and for the years ended December 31, 2019 and 2020 included elsewhere in this prospectus. | On August 26, 2021 (the “ ” “ ” “ ” “ ” “ ” “ ” “ ” “ ” Unless otherwise noted, the Company has retroactively adjusted all common and preferred share and related price information to give effect to the Exchange Ratio of approximately 0.26260 established in the Merger Agreement. |
Common Stock Warrants | Common Stock Warrants The Company assumed 5,000,000 publicly-traded warrants ( “ ” “ ” ’ “ ” “ ” ’ “ ” The Company evaluated the Common Stock Warrants to determine the appropriate financial statement classification upon the consummation of the Merger. The Common Stock Warrants are not mandatorily redeemable and are considered to be freestanding instruments as they are separately exercisable into common shares. As such, the Common Stock Warrants were not classified as liabilities under FASB ASC Topic 480, Distinguishing Liabilities from Equity Derivatives and Hedging The agreement governing the Common Stock Warrants includes a provision ( “ ” ’ “ ’ ” ’ The Public Warrants are considered to be “indexed to the Company’s own stock”. The agreement provides that in the event of a tender or exchange offer made to and accepted by holders of more than 50% of the outstanding shares of the Company ’ ’ ’ | |
Contingent Earnout Liability | Contingent Earnout Liability In connection with the Reverse Recapitalization and pursuant to the Business Combination Agreement dated as of February 17, 2021 by and among Legacy Humacyte, Merger Sub, and AHAC (the “ ” ’ “ ” The estimated fair value of the Contingent Earnout Shares was determined using a Monte Carlo simulation using a distribution of potential outcomes on a monthly basis over a ten-year period prioritizing the most reliable information available. The assumptions utilized in the calculation were based on the achievement of certain stock price milestones, including the current Company common stock price, expected volatility, risk-free rate, expected term and expected dividend yield. The Contingent Earnout Shares are categorized as a Level | |
Segments | Segments The Company operates and manages its business as one reportable and operating segment. The Company is developing proprietary, bioengineered, acellular human tissues that are designed to be used in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. The Company ’ | Segments The Company operates and manages its business as one reportable and operating ’ |
Comprehensive loss | Comprehensive loss Comprehensive loss includes net loss as well as other changes in stockholders ’ | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates in the financial statements include stock-based compensation costs, right-of-use, or ROU, assets, accruals for research and development activities, contingent earnout liability, fair value of common stock warrants, redeemable convertible preferred stock and income taxes. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates in the financial statements include stock-based compensation costs, right-of-use, or ROU assets, accruals for research and development activities, fair value of common stock, useful lives of property and equipment, redeemable convertible preferred stock and income taxes. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could differ from those estimates. 2. Summary of Significant Accounting Policies (continued) |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all short-term, highly liquid investments purchased with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash deposits are held with financial institutions with investment-grade ratings in the United | |
Redeemable Convertible Preferred Stock | Redeemable Convertible Preferred Stock The Company analyzes all issued equity instruments to determine the appropriate accounting and classification. The Company evaluates its equity instruments under Accounting Standards Codification, or ASC 480, Distinguishing liabilities from equity The Company records equity instruments that are classified as temporary equity at fair value upon issuance, net of issuance costs. The Company accretes the carrying value of its redeemable convertible preferred stock to the redemption or liquidation amount once the Company has determined that it is probable that it will become redeemable or be liquidated. The accretion will be recorded as charges against additional paid-in capital until the additional paid-in capital balance is reduced to zero. At that time, additional accretion adjustments will be recorded as additions to accumulated deficit. The Company also analyzes instances where the equity instrument has a conversion feature pursuant to ASC 815, Derivatives and hedging | |
Revenue Recognition | Revenue Recognition The Company ’ Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services and is recognized in an amount that reflects the consideration that an entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) In addition, ASC 606 requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. For contracts where the period between when the Company transfers a promised good or service to the customer and when the customer pays is one year or less, the Company has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing component. | Revenue Recognition The Company ’ In 2014, the Financial Accounting Standards Board, or FASB issued Accounting Standards Update No. Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services and is recognized in an amount that reflects the consideration that an entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) In addition, ASC 606 requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. 2. Summary of Significant Accounting Policies (continued) For contracts where the period between when the Company transfers a promised good or service to the customer and when the customer pays is one year or less, the Company has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing component. |
Grant Revenue | Grant Revenue The Company generates revenue primarily from government and other awarded grants that reimburse the Company for certain allowable costs related to research and development efforts. These grants include the following terms: The Department of Defense grants are for an award of $4.0 million, all of which was recognized as revenue before the program ended, for work on bioengineered blood vessels for vascular trauma, which was awarded to the Company in September 2017 and ended in February 2020, and an award of $7.1 million for work to support human tissue engineered blood vessels for vascular reconstruction in the injured warfighter, which was awarded to the Company in August 2017 and is ongoing. The Company has recognized revenue of $0.6 million and $1.0 million during the three and nine months ended September 30, 2020,respectively, and $0.2 million and $1.1 million during the three and nine months ended September 30, 2021, respectively, for reimbursement of certain allowable costs related to these grants. The National Institutes of Health grant is for $1.6 million for work to support bioengineered grafts for peripheral vascular disease, which was awarded to the Company in November 2013. The Company recognized $1.6 million for the reimbursement of certain allowable costs related to the grant before this program ended in 2020. The Company recognized $0.3 million during the three and nine months ended September 30, 2020, and no revenue during the three and nine months ended September 30, 2021, for reimbursement of certain allowable costs related to these grants. The Company has determined that the grants are not within the scope of ASC 606 as they do not meet the definition of a contract with a customer. The Company has concluded that the grants meet the definition of a contribution and are nonexchange transactions and has applied the contribution accounting model in Subtopic 958-605, Not-for-Profit-Entities-Revenue Recognition by analogy. The Company recognizes funding received from grants as revenue, rather than as a reduction of research and development expenses, because the Company is the principal in conducting the research and development activities and these grants are central to the Company ’ ’ Revenue from grants not within the scope of ASC 606 was $0.9 million and $1.4 million for the three and nine months ended September 30, 2020, respectively, and $0.2 million and $1.1 million for the three and nine months ended September 30, 2021, respectively. | Grant Revenue We generate revenue primarily from government and other awarded grants that reimburse us for certain allowable costs related to research and development efforts. The Company has determined that the grants are not within the scope of ASC 606 as they do not meet the definition of a contract with a customer. The Company has concluded that the grants meet the definition of a contribution and are nonexchange transactions and has applied the contribution accounting model in Subtopic 958-605, Not-for-Profit-Entities-Revenue Recognition by analogy. The Company recognizes funding received from grants as revenue, rather than as a reduction of research and development expenses, because the Company is the principal in conducting the research and development activities and these grants are central to the Company ’ Revenue from grants not within the scope of ASC 606 was $6.2 million and $1.5 million for the years ending December 31, 2019 and 2020, respectively. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. Total cash balances exceeded insured balances by the Federal Deposit Insurance Corporation as of December 31, 2020 and September 30, 2021. Cash equivalents are invested in highly rated money market funds invested only in obligations of the U.S. government and its agencies. The majority of the Company ’ ’ ’ Revenue Accounts Receivable Three Months Nine Months December 31, September 30, 2020 2021 2020 2021 2020 2021 Grant A — — — — — — Grant B 0 — % 11 — % — — Grant C 68 % 100 % 65 % 100 % 100 % 100 % Grant D 30 — % 20 — % — — Total 98 % 100 % 96 % 100 % 100 % 100 % All of the Company ’ | Concentration of Credit Risk Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. Total cash balances exceeded insured balances by the Federal Depository Insurance Corporation as of December 31, 2019 and 2020. Cash equivalents are invested in highly rated money market funds invested only in obligations of the US government and its agencies. The majority of the Company ’ ’ ’ 2019 2020 Accounts Accounts Revenue Receivable Revenue Receivable Grant A 28 % — — — Grant B 38 % 67 % 10 % — Grant C 34 % 33 % 67 % 100 % Grant D — — 18 % — Total 100 % 100 % 95 % 100 % All of the Company ’ |
Other Risks and Uncertainties | Other Risks and Uncertainties The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, successful discovery and development of its product candidates, the success of clinical trials and other studies for its product candidates, including for its ongoing V005 Phase II/III clinical trial and V007 Phase III clinical trial, the regulatory approval and commercialization of its HAVs and other product candidates, ’ ’ ’ Product candidates currently under development will require extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company ’ ’ | 2. Summary of Significant Accounting Policies (continued) Other Risks and Uncertainties The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, successful discovery and development of its product candidates, the success of clinical trials and other studies for its product candidates, including for its ongoing V005 Phase II/III clinical trial and V007 Phase III clinical trial, the regulatory approval and commercialization of its HAVs and other product candidates, ’ ’ ’ Product candidates currently under development will require extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company ’ ’ |
Net Loss per Share Attributable to Common Stockholders | Net Loss per Share Attributable to Common Stockholders The Company follows the two-class method to compute basic and diluted net loss per share attributable to common stockholders when shares met the definition of participating securities. The two-class method determines net loss per common share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to share in the earnings as if all income for the period had been distributed. During periods of loss, there is no allocation required under the two-class method since the redeemable convertible preferred stock did not have a contractual obligation to share in the Company ’ Basic net loss per share attributable to common stockholders is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period without consideration of potentially dilutive common stock. Diluted net loss per share attributable to common stockholders reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the Company unless inclusion of such shares would be anti-dilutive. As the Company has only incurred losses, basic and diluted net loss per share is the same. The potential shares of common stock that were excluded from the computation of diluted net loss per share for each period because including them would have had an antidilutive effect were as follows: September 30, 2020 2021 Shares issuable upon conversion of Series A redeemable convertible preferred stock 18,421,897 — Shares issuable upon conversion of Series B redeemable convertible preferred stock 24,137,647 — Shares issuable upon conversion of Series C redeemable convertible preferred stock 11,241,283 — Shares issuable upon conversion of Series D redeemable convertible preferred stock 15,812,735 — Exercise of options under stock plan 4,516,907 6,399,888 Warrants to purchase common stock 32,961 5,465,204 The 15,000,000 Contingent Earnout shares are excluded from the anti-dilutive table for all the periods presented as such shares are contingently issuable until the share price of the Company exceeds specified thresholds that have not yet been achieved, or upon the occurrence of a change in control. | Net Loss per Share Attributable to Common Stockholders The Company applies the two-class method to compute basic and diluted net loss per share attributable to common stockholders when shares meet the definition of participating securities. The two-class method determines net loss per share for each class of common and redeemable convertible preferred stock according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income (loss) available to common stockholders for the period to be allocated between common and redeemable convertible preferred stock based upon their respective rights to share in the earnings as if all income (loss) for the period had been distributed. During periods of loss, there is no allocation required under the two-class method since the redeemable convertible preferred stock does not have a contractual obligation to share in the Company ’ 2. Summary of Significant Accounting Policies (continued) Basic net loss per share attributable to common stockholders is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period without consideration of potentially dilutive common stock. Diluted net loss per share attributable to common stockholders reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the Company unless inclusion of such shares would be anti-dilutive. Since the Company has only incurred losses, basic and diluted net loss per share is the same. Securities that could potentially dilute net loss per share in the future that were not included in the computation of diluted net loss per share are as follows: December 31, 2019 2020 Shares issuable upon conversion of Series A redeemable convertible preferred stock 18,421,897 18,421,897 Shares issuable upon conversion of Series B redeemable convertible preferred stock 24,137,647 24,137,647 Shares issuable upon conversion of Series C redeemable convertible preferred stock 11,241,283 11,241,283 Shares issuable upon conversion of Series D redeemable convertible preferred stock 15,812,735 15,812,735 Options to purchase common stock 5,220,236 4,813,262 Warrant to purchase common stock 32,961 32,961 Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants at the measurement date. ASC 820, Fair Value Measurement and Disclosures ● Level 1 — Observable inputs that reflect unadjusted quoted prices for identical assets or liabilities in active markets. ● Level 2 — Inputs other than quoted prices included in Level 1 that are observable for the asset or liability, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. ● Level 3 — Unobservable inputs in which little or no market data exists, therefore requiring the Company to develop its own assumptions. The Company evaluates assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them for each reporting period, utilizing valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The determination requires significant judgments to be made by the Company. The Company ’ 2. Summary of Significant Accounting Policies (continued) |
Fair Value of Financial Instruments | December 31, 2019 2020 Shares issuable upon conversion of Series A redeemable convertible preferred stock 18,421,897 18,421,897 Shares issuable upon conversion of Series B redeemable convertible preferred stock 24,137,647 24,137,647 Shares issuable upon conversion of Series C redeemable convertible preferred stock 11,241,283 11,241,283 Shares issuable upon conversion of Series D redeemable convertible preferred stock 15,812,735 15,812,735 Options to purchase common stock 5,220,236 4,813,262 Warrant to purchase common stock 32,961 32,961 | |
Property and Equipment, Net | Property and Equipment, Net Property and equipment, net are recorded at cost less accumulated depreciation. Expenditures for major additions and improvements are capitalized and minor replacements, maintenance, and repairs are charged to expense as incurred. When property and equipment are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet accounts and any resulting gain or loss is included in the results of operations for the respective period. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets. The estimated useful lives for significant asset categories are as follows: Estimated Useful Property and equipment Lives (Years) Scientific equipment 5 – 7 Computer equipment 5 Software 3 Furniture and fixtures 5 – 7 Leasehold improvements Lesser of useful life or life of lease Construction in progress N/A | |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews the carrying value of property and equipment for indicators of possible impairment whenever events and circumstances indicate that the carrying value of an asset or asset group may not be recoverable from the estimated future net undiscounted cash flows expected to result from its use and eventual disposition. In cases where estimated future net undiscounted cash flows are less than the carrying value, an impairment loss is recognized equal to an amount by which the carrying value exceeds the fair value of the asset or asset group. The factors considered by management in performing this assessment include current operating results, trends and prospects, the manner in which the property is used, and the effects of obsolescence, demand, competition, and other economic factors. Based on this assessment, during the nine months ended September 30, 2020 and 2021, respectively, the Company concluded there were no such events or changes in circumstances requiring review of the carrying amount of the Company ’ | Estimated Useful Property and equipment Lives (Years) Scientific equipment 5 – 7 Computer equipment 5 Software 3 Furniture and fixtures 5 – 7 Leasehold improvements Lesser of useful life or life of lease Construction in progress N/A |
Income Taxes | Income Taxes Income taxes are computed using the asset and liability approach that requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company ’ 2. Summary of Significant Accounting Policies (continued) The Company recognizes the benefit of an income tax position only if it is more likely than not (greater than 50%) that the tax position will be sustained upon tax examination, based solely on the technical merits of the tax position. Otherwise, no benefit can be recognized. Assessing an uncertain tax position begins with the initial determination of the sustainability of the position and is measured at the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed. Additionally, the Company must accrue interest and related penalties, if applicable, on all tax exposures for which reserves have been established consistent with jurisdictional tax laws. The Company has analyzed its filing positions in all significant Federal and state jurisdictions where it is required to file income tax returns, as well as open tax years in these jurisdictions. As of December 31, 2019 and 2020, the Company has determined that no uncertain tax positions would have a material impact on the financials statements of the Company. The Company is no longer subject to Federal, state, and local tax examinations by tax authorities for years before 2017 although carry-forward attributes that were generated prior to 2017 may still be adjusted upon examination by the taxing authorities if they either have been or will be used in a future period. No income tax returns are currently under examination by taxing authorities. As of December 31, 2019 and 2020, the Company had not recorded any amounts for unrecognized tax benefits. The Company ’ ’ | |
Intellectual Property | Intellectual Property The Company seeks to protect its intellectual property by filing patent applications in the United ’ | |
Research and Development | Research and Development The Company expenses research and development costs as operating expenses as incurred. Research and development expenses consist primarily of: ● salaries and related overhead expenses for personnel in research and development functions, including stock-based compensation and benefits; ● fees paid to consultants and CROs, including in connection with clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work and statistical compilation and analysis; ● allocation of facility lease and maintenance costs; ● depreciation of leasehold improvements, laboratory equipment and computers; ● costs related to purchasing raw materials for and producing product candidates for clinical trials; ● costs related to compliance with regulatory requirements; ● costs related to the manufacturing scale-out initiative; and ● license fees related to in-licensed technologies. | |
Accrued Research and Development | Accrued Research and Development The Company has entered into various agreements with CROs and a CMO, which conduct preclinical studies and clinical trials and contract manufacturing activities. The Company ’ | |
Leases | Leases Effective January 1, 2019, the Company accounts for its leases under ASC 842, Leases ’ “ ” “ ” “ ” ’ “ ” “ ” “ ” Under this guidance, arrangements meeting the definition of a lease are classified as operating or finance leases, and are recorded on the balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company ’ 2. Summary of Significant Accounting Policies (continued) Lease expenses for minimum lease payments for operating leases are recognized on a straight-line basis over the lease term. Amortization expense of the right-of-use asset for finance leases is recognized on a straight-line basis over the lease term and interest expense for finance leases is recognized based on the incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right of use asset is amortized over the lease term. In calculating the right-of-use assets and lease liabilities, the Company has elected to combine lease and non-lease components for all asset classes. The Company excludes short-term leases, if any, having initial terms of 12 months or less from the new guidance as an accounting policy election, and recognizes rent expense on a straight-line basis over the lease term. Prior to the adoption of ASC 842 on January 1, 2019 the Company was deemed to be the accounting owner of leased space during the construction of its headquarters in a build-to-suit arrangement. Upon substantial completion of construction in June ’ ’ each The cumulative effect of initially applying the new lease guidance on January 1, 2019 is as follows: January 1, 2019 Cumulative Beginning Beginning Effect Balance, ($ in thousands) Balance Adjustment As Adjusted Assets Building asset $ 25,091 $ (25,091) $ — Finance lease right-of-use assets, net $ — $ 27,612 $ 27,612 Operating lease right-of-use assets, net $ — $ 923 $ 923 Liabilities and stockholders’ deficit Accrued expenses $ 7,049 $ (1) $ 7,048 Facility financing obligation, current portion $ 276 $ (276) $ — Finance lease obligation, current portion $ — $ 1,292 $ 1,292 Operating lease obligation, current portion $ — $ 55 $ 55 Facility financing obligation, net of current portion $ 22,955 $ (22,955) $ — Finance lease obligation, net of current portion $ — $ 26,319 $ 26,319 Operating lease obligation, net of current portion $ — $ 870 $ 870 Accumulated deficit $ (234,289) $ (1,861) $ (236,150) | |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, “ ’ ’ ” “ ” ’ | Recently Adopted Accounting Pronouncements In August — |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In May 2021, the FASB issued “ ’ ” “ ” ’ | Recently Issued Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, “ – ’ – ’ “ ” |
Summary of Significant Accou_15
Summary of Significant Accounting Policies (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Summary of Significant Accounting Policies | ||
Summary of 10% or more of the Company's total revenue or accounts receivable balance | Revenue Accounts Receivable Three Months Nine Months December 31, September 30, 2020 2021 2020 2021 2020 2021 Grant A — — — — — — Grant B 0 — % 11 — % — — Grant C 68 % 100 % 65 % 100 % 100 % 100 % Grant D 30 — % 20 — % — — Total 98 % 100 % 96 % 100 % 100 % 100 % | 2019 2020 Accounts Accounts Revenue Receivable Revenue Receivable Grant A 28 % — — — Grant B 38 % 67 % 10 % — Grant C 34 % 33 % 67 % 100 % Grant D — — 18 % — Total 100 % 100 % 95 % 100 % |
Summary of securities that could potentially dilute net loss per share in the future that were not included in the computation of diluted net loss per share | September 30, 2020 2021 Shares issuable upon conversion of Series A redeemable convertible preferred stock 18,421,897 — Shares issuable upon conversion of Series B redeemable convertible preferred stock 24,137,647 — Shares issuable upon conversion of Series C redeemable convertible preferred stock 11,241,283 — Shares issuable upon conversion of Series D redeemable convertible preferred stock 15,812,735 — Exercise of options under stock plan 4,516,907 6,399,888 Warrants to purchase common stock 32,961 5,465,204 | December 31, 2019 2020 Shares issuable upon conversion of Series A redeemable convertible preferred stock 18,421,897 18,421,897 Shares issuable upon conversion of Series B redeemable convertible preferred stock 24,137,647 24,137,647 Shares issuable upon conversion of Series C redeemable convertible preferred stock 11,241,283 11,241,283 Shares issuable upon conversion of Series D redeemable convertible preferred stock 15,812,735 15,812,735 Options to purchase common stock 5,220,236 4,813,262 Warrant to purchase common stock 32,961 32,961 |
Summary of estimated useful lives for significant asset | Estimated Useful Property and equipment Lives (Years) Scientific equipment 5 – 7 Computer equipment 5 Software 3 Furniture and fixtures 5 – 7 Leasehold improvements Lesser of useful life or life of lease Construction in progress N/A | |
Summary of cumulative effect of initially applying the new lease guidance | January 1, 2019 Cumulative Beginning Beginning Effect Balance, ($ in thousands) Balance Adjustment As Adjusted Assets Building asset $ 25,091 $ (25,091) $ — Finance lease right-of-use assets, net $ — $ 27,612 $ 27,612 Operating lease right-of-use assets, net $ — $ 923 $ 923 Liabilities and stockholders’ deficit Accrued expenses $ 7,049 $ (1) $ 7,048 Facility financing obligation, current portion $ 276 $ (276) $ — Finance lease obligation, current portion $ — $ 1,292 $ 1,292 Operating lease obligation, current portion $ — $ 55 $ 55 Facility financing obligation, net of current portion $ 22,955 $ (22,955) $ — Finance lease obligation, net of current portion $ — $ 26,319 $ 26,319 Operating lease obligation, net of current portion $ — $ 870 $ 870 Accumulated deficit $ (234,289) $ (1,861) $ (236,150) |
Reverse Recapitalization (Table
Reverse Recapitalization (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Reverse Recapitalization | |
Schedule of common stock outstanding immediately following the consummation of the Merger | Shares Common stock of AHAC, outstanding prior to Merger 10,355,000 Less redemption of AHAC shares (3,008,551) Common stock of AHAC 7,346,449 AHAC Founder Shares 2,500,000 New Humacyte shares issued to PIPE Investors 17,500,000 Issuance of common stock upon reverse recapitalization and PIPE Financing 27,346,449 New Humacyte shares issued in Merger to Legacy Humacyte stockholders 75,656,935 (1) Total shares of common stock immediately after Merger 103,003,384 (1) Includes 69,613,562 shares of common stock issued upon conversion of Legacy Humacyte ’ |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Measurements | |
Schedule of assets and liabilities that were measured at fair value on a recurring basis | Fair Value Measured as of September 30, 2021 ($in thousands) Level 1 Level 2 Level 3 Total Assets: Money market funds $ 238,375 $ — $ — $ 238,375 Total financial assets $ 238,375 $ — $ — $ 238,375 Liabilities: Contingent earnout liability $ — $ — $ 169,200 $ 169,200 Common stock warrant liabilities (Private Placement Warrants) — — 555 555 Total financial liabilities $ — $ — $ 169,755 $ 169,755 |
Summary of the changes in the fair value of the Company's Level 3 financial instruments | Contingent Private Placement ($in thousands) Earnout Liability Warrants Fair value as of December 31, 2020 $ — $ — Private placement warrant liability acquired as part of the merger — (553) Contingent earount liability recognized upon the closing of the reverse recapitalization (159,432) — Change in fair value included in other (expense) income (9,768) (2) Fair value as of September 30, 2021 $ (169,200) $ (555) |
Property and Equipment, Net (_2
Property and Equipment, Net (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Property and Equipment, Net | ||
Schedule of Property and equipment | December 31, September 30, ($ in thousands) 2020 2021 Scientific equipment $ 27,412 $ 27,578 Computer equipment 149 154 Software 335 335 Furniture and fixtures 988 988 Leasehold improvements 26,355 26,355 55,239 55,410 Accumulated depreciation (14,261) (18,911) Property and equipment, net $ 40,978 $ 36,499 | As of December 31, ($ in thousands) 2019 2020 Scientific equipment $ 27,822 $ 27,412 Computer equipment 218 149 Software 340 335 Furniture and fixtures 988 988 Leasehold improvements 26,337 26,355 55,705 55,239 Accumulated depreciation (8,417) (14,261) Property and equipment, net $ 47,288 $ 40,978 |
Accrued Expenses (Tables)_2
Accrued Expenses (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Accrued Expenses | ||
Schedule of Accrued Expenses | December 31, September 30, ($ in thousands) 2020 2021 Accrued external research, development and manufacturing costs $ 2,615 $ 2,685 Accrued employee compensation and benefits 1,009 4,025 Accrued professional fees 968 2,712 Total $ 4,592 $ 9,422 | As of December 31, ($ in thousands) 2019 2020 Accrued external research, development and manufacturing costs $ 3,872 $ 2,615 Accrued employee compensation and benefits 1,260 1,009 Accrued professional fees 868 968 Total $ 6,000 $ 4,592 |
Debt (Tables)_2
Debt (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Debt | |
Summary of SVB loan payable and net discount or premium balances | September 30, ($ in thousands) 2021 Principal amount of SVB loan payable $ 20,000 Final payment amount of SVB loan payable 1,000 Net premium associated with accretion of final payment and other debt issuance costs (3,073) SVB loan payable, current and noncurrent 17,927 Less SVB loan payable, current portion (3,889) SVB loan payable, noncurrent portion $ 14,038 |
Summary of future minimum payments of principal and estimated payments of interest | Year ending December 31: ($ in thousands) 2021 (remainder) $ — 2022 5,555 2023 6,667 2024 6,667 2025 1,111 Total future payments 20,000 |
Stockholders' Equity (Deficit_4
Stockholders' Equity (Deficit) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Schedule of activity of warrants | Legacy Humacyte Common Stock Private Placement Total Common Warrants Warrants Public Warrants Stock Warrants Outstanding as of December 31, 2020 32,961 — — 32,961 Common Stock Warrants issued to SVB 287,704 — — 287,704 Common Stock Warrants as Part of the Merger — 177,500 5,000,000 5,177,500 Warrants Exercised (32,961) — — (32,961) Oustanding as of September 30, 2021 287,704 177,500 5,000,000 5,465,204 | |
Summary of common stock reserved for future issuances | September 30, 2021 Common stock reserved for Contingent Consideration Shares 15,000,000 Exercise of options under stock plans 6,399,888 Issuance of options under stock plans 7,730,503 Shares available for grant under ESPP 1,030,033 Warrants to purchase common stock 5,465,204 35,625,628 | December 31, 2019 2020 Conversion of Series A redeemable convertible preferred stock 18,421,897 18,421,897 Conversion of Series B redeemable convertible preferred stock 24,137,647 24,137,647 Conversion of Series C redeemable convertible preferred stock 11,241,286 11,241,286 Conversion of Series D redeemable convertible preferred stock 15,812,735 15,812,735 Exercise of options under stock plan 5,220,236 4,813,262 Issuance of options under stock plan 2,736,954 2,948,598 Warrant to purchase common stock 32,961 32,961 77,603,716 77,408,386 |
Private Placement Warrants | ||
Schedule of assumptions used in the valuations | August 26, September 30, 2021 2021 Market price of public stock $ 10.96 $ 11.61 Exercise price $ 11.50 $ 11.50 Expected term (years) 5.00 4.91 Expected share price volatility 32.5 % 28.5 % Risk-free interest rate 0.68 % 0.96 % Estimated dividend yield 0 % 0 % | |
Contingent earnout liability | ||
Schedule of assumptions used in the valuations | August 26, September 30, 2021 2021 Current stock price $ 10.96 $ 11.61 Expected share price volatility 79.6 % 78.9 % Risk-free interest rate 1.34 % 1.55 % Estimated dividend yield 0 % 0.0 % Expected term (years) 10.00 10.00 |
Stock-based Compensation (Tab_2
Stock-based Compensation (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Stock-based Compensation | ||
Summary of assumptions on the date of grant to estimate the fair value of the stock options in the Black-Scholes option-pricing model | Three Months Ended Nine Months Ended September 30, 2020 2021 (1) 2020 2021 Estimated dividend yield 0 % — 0 % 0 % Expected share price volatility (weighted average and range, if applicable) 91.6 % — 91.4% (89.4% to 91.6%) 91.4% (91.0% to 92.1%) Risk-free interest rate (weighted average and range, if applicable) 0.34 % — 0.40% (0.34% to 0.75%) 0.68% (0.62% to 1.02%) Expected term of options (in years) 6.0 — 6.0 6.0 | Year Ended 2019 2020 Estimated dividend yield 0 % 0 % Expected share price volatility 70.1%-87.7 % 89.4% - 91.6 % Risk-free interest rate 1.76% - 2.46 % 0.34% - 0.75 % Expected term of options (in years) 6.00 6.00 |
Summary of stock-based compensation expense included in the statements of operations and comprehensive loss | Three Months Ended Nine Months Ended ($ in thousands) 2020 2021 2020 2021 Research and development $ 308 $ 486 $ 781 $ 1,837 General and administrative 862 1,391 2,685 5,498 Total $ 1,170 $ 1,877 $ 3,466 $ 7,335 December 31, September 30, ($ in thousands) 2020 2021 Unrecognized share-based compensation cost $ 5,789 $ 12,480 Expected weighted average period compensation costs to be recognized (years) 1.7 2.1 | Year Ended ($ in thousands) 2019 2020 Research and development $ 914 $ 1,135 General and administrative 3,543 3,559 Total $ 4,457 $ 4,694 As of December 31, ($ in thousands) 2019 2020 Unrecognized share-based compensation cost $ 7,919 $ 5,789 Expected weighted average period compensation costs to be recognized (years) 1.8 1.7 |
Summary of option activity | Weighted Average Weighted Remaining Aggregate Average Exercise Contractual Term Intrinsic Value Number of Shares Price Per Share (years) (in thousands) Options outstanding at December 31, 2020 4,813,262 $ 6.04 6.6 $ 20,422 Granted 1,838,029 $ 10.28 Exercised (188,006) $ 2.97 Forfeited (63,397) $ 7.87 Options outstanding at September 30, 2021 6,399,888 $ 7.33 6.6 $ 26,705 Vested and exercisable, September 30, 2021 4,092,342 $ 5.74 5.1 $ 23,345 Vested and expected to vest, September 30, 2021 6,399,888 $ 7.33 6.6 $ 26,705 | Weighted Average Weighted Remaining Aggregate Number of Average Exercise Contractual Term Intrinsic Value Shares Price Per Share (years) (in thousands) Options outstanding at December 31, 2018 5,638,773 $ 4.69 7.4 $ 21,354 Granted 621,031 8.49 Exercised (620,831) 1.97 Forfeited (418,737) 7.62 Options outstanding at December 31, 2019 5,220,236 $ 5.22 6.5 $ 17,044 Granted 480,856 9.79 Exercised (195,239) 1.55 Forfeited (692,591) 3.76 Options outstanding at December 31, 2020 4,813,262 $ 6.04 6.6 $ 20,422 Vested and exercisable, December 31, 2020 3,392,302 $ 4.99 5.9 $ 17,925 Vested and expected to vest, December 31, 2020 4,813,262 $ 6.04 6.6 $ 20,422 |
Income Taxes (Tables)_2
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
Schedule of components of Company's deferred tax assets and deferred tax liabilities | As of December 31, ($ in thousands) 2019 2020 Deferred tax assets: Net operating loss $ 50,616 $ 53,515 Capitalized research and development 19,660 32,337 Research credits 10,658 15,056 Share-based compensation 1,669 2,519 Right of use lease liability 207 177 Accrued expenses 71 57 Other 1 1 Total deferred tax asset 82,882 103,662 Less: valuation allowance (82,193) (101,757) Total net deferred tax asset 689 1,905 Deferred tax liabilities: Basis difference in fixed assets (482) (1,728) Right of use lease assets (207) (177) Total deferred tax liability (689) (1,905) Total net deferred tax asset/(liability) $ — $ — |
Schedule of difference between the actual income tax benefit and amount computed by applying the statutory Federal income tax rate to losses before income taxes | December 31, 2019 2020 ($ in thousands) Amount Rate Amount Rate Income tax benefit at statutory rate $ (17,939) 21.0 % $ (13,970) 21.0 % State income taxes, net of federal benefit (1,739) 2.0 % (1,338) 2.0 % Tax credits (1,821) 2.1 % (2,625) 3.9 % Other nondeductible expenses 54 0.0 % 90 (0.1) % Deferred rate changes 16 0.0 % 16 0.0 % Other 449 (0.5) % (1,736) 2.6 % Change in valuation allowance 20,980 (24.6) % 19,563 (29.4) % Provision for income taxes $ — 0.0 % $ — 0.0 % |
Related Party Transactions (T_2
Related Party Transactions (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Related Party Transactions | ||
Summary of related party expenses included in statements of operations and comprehensive loss | Three Months Nine Months ($ in thousands) 2020 2021 2020 2021 Expenses under MOU 125 — 375 — License expenses 20 — 70 85 Other 4 2 17 83 Total 149 2 462 168 | Year Ended December 31, ($ in thousands) 2019 2020 Expenses under MOU $ 422 $ 500 License expenses 110 92 Other 39 28 Total $ 571 $ 620 |
Organization and Description _4
Organization and Description of Business (Details) - USD ($) $ in Thousands | Aug. 26, 2021 | Mar. 22, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
Organization and Description of Business | |||||||||||||
Proceeds from merger | $ 242,400 | $ 242,400 | |||||||||||
Accumulated deficit | $ 457,158 | 457,158 | $ 388,096 | $ 321,572 | $ 234,289 | ||||||||
Net loss | 31,563 | $ 17,198 | $ 20,301 | $ 17,760 | $ 14,878 | $ 17,674 | 69,062 | $ 50,312 | 66,524 | 85,422 | |||
Cash and cash equivalents | $ 240,449 | $ 240,449 | $ 39,929 | $ 93,713 | |||||||||
Substantial Doubt about Going Concern, within One Year [true false] | true |
Summary of Significant Accou_16
Summary of Significant Accounting Policies - Common Stock Warrants (Details) - $ / shares | Aug. 26, 2021 | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Mar. 15, 2006 |
Summary of Significant Accounting Policies | |||||
Public warrants assumed | 5,000,000 | ||||
Private placement warrants assumed | 177,500 | ||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Warrants, exercise price | $ 11.50 | $ 1.14 | |||
Share accepting a tender offer entitles warrants to receive cash (as a percent) | 50.00% |
Summary of Significant Accou_17
Summary of Significant Accounting Policies - Contingent Earnout Liability (Details) | Sep. 30, 2021 | Aug. 26, 2021trancheshares | Feb. 17, 2021trancheshares |
Summary of Significant Accounting Policies | |||
Maximum contingent earnout shares | 15,000,000 | 15,000,000 | |
Number of tranches of contingent earnout shares | tranche | 2 | 2 | |
Number of contingent earnout shares per tranche | 7,500,000 | 7,500,000 | |
Warrants term | 10 years |
Summary of Significant Accou_18
Summary of Significant Accounting Policies (Details) - segment | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Segments | ||||||
Exchange ratio | 0.2626% | |||||
Number of reportable segment | 1 | 1 | 1 | 1 | 1 | 1 |
Number of operating segment | 1 |
Summary of Significant Accou_19
Summary of Significant Accounting Policies - Grant Revenue (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | 86 Months Ended | |||||
Sep. 30, 2017 | Aug. 31, 2017 | Nov. 30, 2013 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2020 | |
Disaggregation of Revenue [Line Items] | ||||||||||
Revenue from grants not within the scope of ASC 606 | $ 200 | $ 900 | $ 1,100 | $ 1,400 | $ 1,500 | $ 6,200 | $ 1,600 | |||
Department of Defense grants | Work on bioengineered blood vessels for vascular trauma | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Grants | $ 4,000 | |||||||||
Department of Defense grants | Work to support human tissue engineered blood vessels for vascular reconstruction | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Grants | $ 7,100 | |||||||||
Department of Defense grants | Reimbursement of certain allowable costs related to grants | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Recognized revenue | 200 | 600 | 1,100 | 1,000 | ||||||
National Institutes of Health grant | Reimbursement of certain allowable costs related to grants | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Recognized revenue | $ 0 | $ 300 | $ 0 | $ 300 | ||||||
National Institutes of Health grant | Work to support bioengineered grafts for peripheral vascular disease | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Grants | $ 1,600 |
Summary of Significant Accou_20
Summary of Significant Accounting Policies -Concentration of Credit Risk (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue | Customer concentration | ||||||
Concentration Risk [Line Items] | ||||||
Concentration of Credit Risk | 100.00% | 98.00% | 100.00% | 96.00% | 95.00% | 100.00% |
Revenue | Customer concentration | Grant A | ||||||
Concentration Risk [Line Items] | ||||||
Concentration of Credit Risk | 28.00% | |||||
Revenue | Customer concentration | Grant B | ||||||
Concentration Risk [Line Items] | ||||||
Concentration of Credit Risk | 0.00% | 11.00% | 10.00% | 38.00% | ||
Revenue | Customer concentration | Grant C | ||||||
Concentration Risk [Line Items] | ||||||
Concentration of Credit Risk | 100.00% | 68.00% | 100.00% | 65.00% | 67.00% | 34.00% |
Revenue | Customer concentration | Grant D | ||||||
Concentration Risk [Line Items] | ||||||
Concentration of Credit Risk | 30.00% | 20.00% | 18.00% | |||
Accounts Receivable | Credit concentration | ||||||
Concentration Risk [Line Items] | ||||||
Concentration of Credit Risk | 100.00% | 100.00% | 100.00% | |||
Accounts Receivable | Credit concentration | Grant B | ||||||
Concentration Risk [Line Items] | ||||||
Concentration of Credit Risk | 67.00% | |||||
Accounts Receivable | Credit concentration | Grant C | ||||||
Concentration Risk [Line Items] | ||||||
Concentration of Credit Risk | 100.00% | 100.00% | 33.00% |
Summary of Significant Accou_21
Summary of Significant Accounting Policies - Net Loss per Share Attributable to Common Stockholders (Details) - shares | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Contingent consideration (in shares) | 15,000,000 | |||
Series A redeemable convertible preferred stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Securities that were not included in the computation of diluted net loss per share | 18,421,897 | 18,421,897 | 18,421,897 | |
Series B redeemable convertible preferred stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Securities that were not included in the computation of diluted net loss per share | 24,137,647 | 24,137,647 | 24,137,647 | |
Series C redeemable convertible preferred stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Securities that were not included in the computation of diluted net loss per share | 11,241,283 | 11,241,283 | 11,241,283 | |
Series D redeemable convertible preferred stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Securities that were not included in the computation of diluted net loss per share | 15,812,735 | 15,812,735 | 15,812,735 | |
Exercise of options under stock plan | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Securities that were not included in the computation of diluted net loss per share | 6,399,888 | 4,516,907 | 4,813,262 | 5,220,236 |
Warrants to purchase common stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Securities that were not included in the computation of diluted net loss per share | 5,465,204 | 32,961 | 32,961 | 32,961 |
Summary of Significant Accou_22
Summary of Significant Accounting Policies - Property and Equipment, Net (Details) | 12 Months Ended |
Dec. 31, 2020 | |
Scientific equipment. | Minimum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 5 years |
Scientific equipment. | Maximum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 7 years |
Computer equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 5 years |
Software | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 3 years |
Furniture and fixtures | Minimum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 5 years |
Furniture and fixtures | Maximum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 7 years |
Summary of Significant Accou_23
Summary of Significant Accounting Policies - Impairment of Long-Lived Assets and Income Taxes (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | 24 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2020 | |
Impairment of Long-Lived Assets | ||||
Impairment of long-lived assets | $ 0 | $ 0 | $ 0 | |
Income Taxes | ||||
Uncertain tax positions | 0 | $ 0 | ||
Accrued interest or penalties related to uncertain tax positions | $ 0 | 0 | ||
interest or penalties related to uncertain tax positions expensed | $ 0 |
Reverse Recapitalization (Detai
Reverse Recapitalization (Details) | Aug. 26, 2021USD ($)$ / sharestrancheshares | Sep. 30, 2021USD ($) | Sep. 30, 2021USD ($) | Feb. 17, 2021trancheshares |
Business Acquisition [Line Items] | ||||
Legacy Humacyte common stock conversion ratio to common stock | 0.26260 | |||
Founder shares converted to commons stock | shares | 2,500,000 | |||
Founder shares conversion ratio | 1 | |||
Maximum contingent earnout shares | shares | 15,000,000 | 15,000,000 | ||
Number of tranches of contingent earnout shares | tranche | 2 | 2 | ||
Number of contingent earnout shares per tranche | shares | 7,500,000 | 7,500,000 | ||
Closing stock price to trigger first trance of contingent earnout shares (USD per share) | $ / shares | $ 15 | |||
Closing stock price to trigger second trance of contingent earnout shares (USD per share) | $ / shares | $ 20 | |||
Number of days within 30 day period of stock price at $15 or $20 to trigger earnout shares | $ / shares | 20 | |||
Period of over which 20 days stock price at $15 or $20 to trigger earnout shares | 30 days | |||
Contingent Consideration Liability recognized upon the closing of the reverse recapitalization | $ 159,400,000 | $ 159,432,000 | ||
Proceeds from PIPE | $ 175,000,000 | |||
Share Price | $ / shares | $ 10 | |||
Proceeds from merger | $ 242,400,000 | 242,400,000 | ||
Transaction costs recorded in APIC | 3,900,000 | |||
Public warrants assumed upon the merger, net of transaction costs | 100,000 | $ 13,912,000 | ||
Liabilities assumed | 15,200,000 | |||
Assets | $ 100,000 | |||
Accounts Payable and Accrued Liabilities [Member] | ||||
Business Acquisition [Line Items] | ||||
Unpaid assumed liabilities | 2,200,000 | 2,200,000 | ||
Unpaid transaction costs | $ 3,000,000 | $ 3,000,000 |
Reverse Recapitalization - Shar
Reverse Recapitalization - Share After Merger (Details) - shares | Aug. 26, 2021 | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Reverse Recapitalization | ||||
Common stock of AHAC, outstanding prior to Merger | 10,355,000 | |||
Less redemption of AHAC shares | (3,008,551) | |||
Common stock of AHAC | 7,346,449 | |||
AHAC Founder Shares | 2,500,000 | |||
New Humacyte shares issued to PIPE Investors | 17,500,000 | |||
Issuance of common stock upon reverse recapitalization and PIPE Financing | 27,346,449 | |||
New Humacyte shares issued in Merger to Legacy Humacyte stockholders | 75,656,935 | |||
Total shares of common stock immediately after Merger | 103,003,384 | 103,003,384 | 5,822,396 | 5,627,157 |
Common stock issued upon conversion of Legacy Humacyte's redeemable convertible preferred stock | 69,613,562 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Assets: | ||
Financial assets | $ 238,375 | $ 35,623 |
Liabilities: | ||
Financial liabilities | 169,755 | |
Contingent earnout liability | ||
Liabilities: | ||
Financial liabilities | 169,200 | |
Private Placement Warrants | ||
Liabilities: | ||
Financial liabilities | 555 | |
Money market funds | ||
Assets: | ||
Financial assets | 238,375 | 35,623 |
Level 1 | ||
Assets: | ||
Financial assets | 238,375 | 35,623 |
Level 1 | Money market funds | ||
Assets: | ||
Financial assets | 238,375 | $ 35,623 |
Level 3 | ||
Liabilities: | ||
Financial liabilities | 169,755 | |
Level 3 | Contingent earnout liability | ||
Liabilities: | ||
Financial liabilities | 169,200 | |
Level 3 | Private Placement Warrants | ||
Liabilities: | ||
Financial liabilities | $ 555 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in the fair value (Details) | 9 Months Ended | |
Sep. 30, 2021USD ($)Y | Aug. 26, 2021USD ($) | |
Contingent earnout liability | Expected term | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Measurement input | 10 | 10 |
Level 3 | Contingent earnout liability | ||
Changes in the fair value of the Level 3 financial instruments | ||
Fair value of liability recognized | $ (159,432,000) | |
Change in fair value included in other (expense) income | (9,768,000) | |
Ending balance | (169,200,000) | |
Level 3 | Private Placement Warrants | ||
Changes in the fair value of the Level 3 financial instruments | ||
Fair value of liability recognized | (553,000) | |
Change in fair value included in other (expense) income | (2,000) | |
Ending balance | $ (555,000) |
Property and Equipment, Net (_3
Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | ||||||
Property and equipment, gross | $ 55,410 | $ 55,410 | $ 55,239 | $ 55,705 | ||
Accumulated depreciation | (18,911) | (18,911) | (14,261) | (8,417) | ||
Property and equipment, net | 36,499 | 36,499 | 40,978 | 47,288 | ||
Depreciation expense | 1,500 | $ 1,600 | 4,650 | $ 4,729 | 6,291 | 4,689 |
Scientific equipment | ||||||
Property, Plant and Equipment [Line Items] | ||||||
Property and equipment, gross | 27,578 | 27,578 | 27,412 | 27,822 | ||
Computer equipment | ||||||
Property, Plant and Equipment [Line Items] | ||||||
Property and equipment, gross | 154 | 154 | 149 | 218 | ||
Software | ||||||
Property, Plant and Equipment [Line Items] | ||||||
Property and equipment, gross | 335 | 335 | 335 | 340 | ||
Furniture and fixtures | ||||||
Property, Plant and Equipment [Line Items] | ||||||
Property and equipment, gross | 988 | 988 | 988 | 988 | ||
Leasehold improvements | ||||||
Property, Plant and Equipment [Line Items] | ||||||
Property and equipment, gross | $ 26,355 | $ 26,355 | $ 26,355 | $ 26,337 |
Accrued Expenses (Details)_2
Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
Accrued Expenses | ||||
Accrued external research, development and manufacturing costs | $ 2,685 | $ 2,615 | $ 3,872 | |
Accrued employee compensation and benefits | 4,025 | 1,009 | 1,260 | |
Accrued professional fees | 2,712 | 968 | 868 | |
Total | $ 9,422 | $ 4,592 | $ 6,000 | $ 7,049 |
Debt - PPP (Details)_2
Debt - PPP (Details) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | 12 Months Ended | |
Apr. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Debt Instrument [Line Items] | ||||
Proceeds from debt instruments | $ 3,251 | $ 3,251 | ||
Gain on PPP loan forgiveness | $ 3,284 | |||
Paycheck Protection Program | ||||
Debt Instrument [Line Items] | ||||
Proceeds from debt instruments | $ 3,300 | |||
Gain on PPP loan forgiveness | $ 3,284 |
Debt - Term Loan (Details)
Debt - Term Loan (Details) $ / shares in Units, $ in Millions | Oct. 13, 2021USD ($)$ / sharesshares | Mar. 31, 2021USD ($)shares | Sep. 30, 2021USD ($)tranche$ / sharesshares | Aug. 26, 2021$ / shares | Mar. 15, 2006$ / shares |
Line of Credit Facility [Line Items] | |||||
Warrants, exercise price | $ / shares | $ 11.50 | $ 1.14 | |||
Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P., | |||||
Line of Credit Facility [Line Items] | |||||
Percent of outstanding principal and interest collateralized | 50.00% | ||||
Term loan agreement | |||||
Line of Credit Facility [Line Items] | |||||
Number of tanches | tranche | 3 | ||||
Amount of loan drawn | $ 10 | $ 20 | |||
Amount that are eligible to disburse | $ 10 | ||||
Borrowings bearing interest rate | 7.50% | ||||
Advance notice period | 30 days | ||||
Prepayment fee | 3.00% | ||||
Prepayment fee after March 30, 2022 | 2.00% | ||||
Prepayment fee after March 30, 2023 | 1.00% | ||||
Warrants, exercise price | $ / shares | $ 10.28 | ||||
Warrants immediately exercisable | shares | 287,704 | ||||
Fair value of warrants | $ 2.4 | ||||
Final payment fee (as a percent) | 5.00% | ||||
Final payment fee | $ 1 | ||||
Debt issuance costs | $ 0.3 | ||||
Number of warrants with no probable funding that becomes exercisable | shares | 123,302 | ||||
Number of warrants that becomes exercisable for no probable funding | shares | 123,302 | ||||
Exercise price of warrants that became exercisable for no probable funding (USD per share) | $ / shares | $ 10.28 | ||||
Term loan agreement | Prime Rate | |||||
Line of Credit Facility [Line Items] | |||||
Borrowings bearing interest rate | 7.50% | ||||
Basis spread on variable rate | 4.25% | ||||
Term loan agreement | Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P., | |||||
Line of Credit Facility [Line Items] | |||||
Maximum loan facility amount | $ 50 |
Debt - SVB loan payable and net
Debt - SVB loan payable and net discount (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Debt Instrument [Line Items] | |
SVB loan payable, current and noncurrent | $ 20,000 |
SVB Loan payable | |
Debt Instrument [Line Items] | |
Principal amount of SVB loan payable | 20,000 |
Final payment amount of SVB loan payable | 1,000 |
Net premium associated with accretion of final payment and other debt issuance costs | (3,073) |
SVB loan payable, current and noncurrent | 17,927 |
Less SVB loan payable, current portion | (3,889) |
SVB loan payable, noncurrent portion | $ 14,038 |
Debt - Future minimum payments
Debt - Future minimum payments (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Future minimum payments of principal and estimated payments of interest | |
2022 | $ 5,555 |
2023 | 6,667 |
2024 | 6,667 |
2025 | 1,111 |
Total future payments | 20,000 |
SVB Loan payable | |
Future minimum payments of principal and estimated payments of interest | |
Total future payments | 17,927 |
Less final payment | (1,000) |
Total principal amount of SVB loan payments | $ 20,000 |
Stockholders' Equity (Deficit_5
Stockholders' Equity (Deficit) - Common Stock (Details) $ / shares in Units, $ in Thousands | Aug. 26, 2021USD ($)$ / sharesshares | Sep. 30, 2021$ / sharesshares | Sep. 30, 2021USD ($)Vote$ / sharesshares | Dec. 31, 2020Vote$ / sharesshares | Dec. 31, 2019$ / sharesshares |
Proceeds from merger | $ 242,400 | $ 242,400 | |||
Assets | $ 100 | ||||
Common stock, shares outstanding | shares | 103,003,384 | 103,003,384 | 103,003,384 | 5,822,396 | 5,627,157 |
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Dividends declared | $ / shares | $ 0 | $ 0 | |||
Number of vote per common share held | Vote | 1 | ||||
Common stock, authorized | shares | 250,000,000 | 250,000,000 | 340,216,780 | 340,216,780 | |
Common Stock | |||||
Issuance of common stock upon the Merger and related PIPE Financing, net of issuance costs | shares | 27,346,449 | 27,346,449 | |||
Proceeds from merger | $ 242,400 | ||||
Transaction costs | $ 3,900 | ||||
Common stock, shares outstanding | shares | 103,003,384 | ||||
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||
Number of vote per common share held | Vote | 1 | ||||
Common stock, authorized | shares | 250,000,000 | 250,000,000 | |||
Alpha Healthcare Acquisition Corp. and Hunter Merger Sub, Inc. | Common Stock | |||||
Contingent consideration liability | $ 15,200 | ||||
Assets | $ 100 |
Stockholders' Equity (Deficit_6
Stockholders' Equity (Deficit) - Common stock for future issuances (Details) - shares | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 35,625,628 | 77,408,386 | 77,603,716 |
Series A redeemable convertible preferred stock | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 18,421,897 | 18,421,897 | |
Series B redeemable convertible preferred stock | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 24,137,647 | 24,137,647 | |
Series C redeemable convertible preferred stock | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 11,241,286 | 11,241,286 | |
Series D redeemable convertible preferred stock | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 15,812,735 | 15,812,735 | |
Common stock reserved for Contingent Consideration Shares | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 15,000,000 | ||
Exercise of options under stock plan | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 6,399,888 | 4,813,262 | 5,220,236 |
Issuance of options under stock plan | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 7,730,503 | 2,948,598 | 2,736,954 |
Shares available for grant under ESPP | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 1,030,033 | ||
Warrants to purchase common stock | |||
Class of Stock [Line Items] | |||
Reserved common stock for future issuances | 5,465,204 | 32,961 | 32,961 |
Stockholders' Equity (Deficit_7
Stockholders' Equity (Deficit) - Preferred Stock (Details) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred Stock, Shares Authorized | 20,000,000 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Preferred Stock | ||
Preferred stock, par value | $ 0.0001 | |
Preferred Stock, Shares Authorized | 20,000,000 | |
Preferred stock, shares outstanding | 0 |
Stockholders' Equity (Deficit_8
Stockholders' Equity (Deficit) - Warrants (Details) - $ / shares | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2021 | Aug. 26, 2021 | Dec. 31, 2020 | Mar. 15, 2006 | |
Warrants to purchase shares of common stock | 32,961 | ||||
Warrants, exercise price | $ 11.50 | $ 1.14 | |||
Warrants to purchase common stock | |||||
Balance, beginning of period | 32,961 | ||||
Common Stock Warrants issued to SVB | 287,704 | ||||
Common Stock Warrants as Part of the Merger | 5,177,500 | ||||
Warrants Exercised | (32,961) | ||||
Ending balance | 5,465,204 | 5,465,204 | |||
Warrants to purchase shares of common stock | 32,961 | ||||
Warrants, exercise price | $ 1.14 | ||||
Private Placement Warrants | |||||
Common Stock Warrants as Part of the Merger | 177,500 | ||||
Ending balance | 177,500 | 177,500 | |||
Public Warrants | |||||
Common Stock Warrants as Part of the Merger | 5,000,000 | ||||
Warrants Exercised | 0 | ||||
Ending balance | 5,000,000 | 5,000,000 | |||
Humacyte, Inc. | |||||
Balance, beginning of period | 32,961 | ||||
Common Stock Warrants issued to SVB | 287,704 | ||||
Warrants Exercised | (32,961) | ||||
Ending balance | 287,704 | 287,704 |
Stockholders' Equity (Deficit_9
Stockholders' Equity (Deficit) - Private Placement Warrants (Details) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2021USD ($) | Sep. 30, 2021USD ($) | |
Change in fair value of common stock warrant liabilities | $ 2 | $ 2 |
Private Placement Warrants | ||
Fair value of warrant liability | 600 | 600 |
Change in fair value of common stock warrant liabilities | $ 100 | $ 100 |
Private Placement Warrants | Estimated dividend yield | ||
Measurement input | 0 | 0 |
Stockholders' Equity (Defici_10
Stockholders' Equity (Deficit) - Public Warrants (Details) - $ / shares | Aug. 26, 2021 | Sep. 30, 2021 | Sep. 30, 2021 |
Warrants term | 10 years | 10 years | |
Warrants to purchase common stock | |||
Warrants Exercised | (32,961) | ||
Public Warrants | |||
Warrants term | 5 years | ||
Number of days warrants become exercisable after the completion of merger | 30 days | ||
Fair Value per Share on Closing Date | $ 2.80 | ||
Warrants Exercised | 0 |
Stockholders' Equity (Defici_11
Stockholders' Equity (Deficit) - Contingent Earnout Liability (Details) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2021USD ($)Y | Sep. 30, 2021USD ($)YitemD$ / sharesshares | Aug. 26, 2021USD ($) | |
Contingent consideration (in shares) | shares | 15,000,000 | ||
Change in fair value of contingent earnout liability | $ | $ 9,768,000 | $ 9,768,000 | |
Contingent earnout liability | |||
Contingent consideration (in shares) | shares | 15,000,000 | ||
Number of equal tranches | item | 2 | ||
Number of trading days within any 30 consecutive trading day period | D | 20 | ||
Estimated fair value of contingent consideration shares | $ | $ 159,400,000 | ||
Change in fair value of contingent earnout liability | $ | $ 9,800,000 | ||
Contingent earnout liability | Tranche one | |||
shares of common stock per tranche | shares | 7,500,000 | ||
Volume-weighted average closing sale price | $ / shares | $ 15 | ||
Contingent earnout liability | Tranche two | |||
Volume-weighted average closing sale price | $ / shares | $ 20 | ||
Current stock price | Contingent earnout liability | |||
Measurement input | 11.61 | 11.61 | 10.96 |
Expected share price volatility | Contingent earnout liability | |||
Measurement input | 78.9 | 78.9 | 79.6 |
Risk-free interest rate | Contingent earnout liability | |||
Measurement input | 1.55 | 1.55 | 1.34 |
Estimated dividend yield | Contingent earnout liability | |||
Measurement input | 0 | 0 | 0 |
Expected term | Contingent earnout liability | |||
Measurement input | 10 | 10 | 10 |
Stock-based Compensation (Det_2
Stock-based Compensation (Details) | Aug. 25, 2021plan | Jan. 31, 2021$ / sharesshares | Sep. 30, 2021$ / sharesshares | Dec. 31, 2020$ / sharesshares | Dec. 31, 2019$ / sharesshares | Aug. 26, 2021shares | Dec. 31, 2018shares |
Number of options remaining available for grant | 7,730,503 | 2,948,598 | |||||
Outstanding awards | 6,399,888 | 4,813,262 | 5,220,236 | 5,638,773 | |||
Contractual term | 10 years | 10 years | |||||
Vesting period | 3 years | 36 months | |||||
Commencement of involuntary termination term prior to effective date of corporate transaction | 30 days | 30 days | |||||
End of involuntary termination term after effective date of corporate transaction | 12 months | 12 months | |||||
Granted | 1,838,029 | 480,856 | 621,031 | ||||
Exercise price | $ / shares | $ 10.28 | $ 9.79 | $ 8.49 | ||||
Long-Term Incentive Plan, 2021 [Member] | |||||||
Number of options remaining available for grant | 7,730,503 | ||||||
Annual increase (as a percent) | 5.00% | ||||||
Employee Stock Purchase Plan, 2021[Member] | |||||||
Number of options remaining available for grant | 1,030,033 | ||||||
Annual increase (as a percent) | 1.00% | ||||||
Purchase price as percent of trading price | 85.00% | ||||||
Minimum | |||||||
Vesting period | 36 months | ||||||
Maximum | |||||||
Vesting period | 48 months | ||||||
Chief Executive Officer [Member] | |||||||
Vesting period | 3 years | ||||||
Granted | 1,312,984 | ||||||
Exercise price | $ / shares | $ 10.28 | ||||||
Humacyte, Inc. | |||||||
Share Based Compensation Number Of Plans | plan | 2 | ||||||
Humacyte, Inc. | Omnibus Incentive Plan, 2015 [Member] | |||||||
Outstanding awards | 5,886,706 | ||||||
Humacyte, Inc. | Stock Option Plan, 2005 [Member] | |||||||
Outstanding awards | 518,432 |
Stock-based Compensation - Fa_2
Stock-based Compensation - Fair value of the stock options (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Assumptions on the date of grant to estimate the fair value of the stock options | ||||||
Estimated dividend yield | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | |
Expected price volatility | 91.60% | 91.40% | 91.40% | |||
Expected share price volatility, minimum | 91.00% | 89.40% | 89.40% | 70.10% | ||
Expected share price volatility, maximum | 92.10% | 91.60% | 91.60% | 87.70% | ||
Risk-free interest rate | 0.34% | 0.68% | 0.40% | |||
Risk-free interest rate, minimum | 0.62% | 0.34% | 0.34% | 1.76% | ||
Risk-free interest rate, maximum | 1.02% | 0.75% | 0.75% | 2.46% | ||
Expected term of options (in years) | 6 years | 6 years | 6 years | 6 years | 6 years |
Stock-based Compensation - Addi
Stock-based Compensation - Additional information (Details) - shares | Sep. 30, 2021 | Dec. 31, 2020 |
Stock-based Compensation | ||
Number of options remaining available for grant | 7,730,503 | 2,948,598 |
Stock-based Compensation - Ex_2
Stock-based Compensation - Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||
Stock-based compensation expense | $ 1,877 | $ 1,170 | $ 7,335 | $ 3,466 | $ 4,694 | $ 4,457 |
Research and development | ||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||
Stock-based compensation expense | 486 | 308 | 1,837 | 781 | 1,135 | 914 |
General and administrative | ||||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||||
Stock-based compensation expense | $ 1,391 | $ 862 | $ 5,498 | $ 2,685 | $ 3,559 | $ 3,543 |
Stock-based Compensation - Un_2
Stock-based Compensation - Unrecognized cost (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Stock-based Compensation | |||
Unrecognized share-based compensation cost | $ 12,480 | $ 5,789 | $ 7,919 |
Expected weighted average period compensation costs to be recognized (years) | 2 years 1 month 6 days | 1 year 8 months 12 days | 1 year 9 months 18 days |
Stock-based Compensation - Op_2
Stock-based Compensation - Option activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Number of Shares | ||||
Options outstanding at the beginning | 4,813,262 | 5,220,236 | 5,638,773 | |
Granted | 1,838,029 | 480,856 | 621,031 | |
Exercised | (188,006) | (195,239) | (620,831) | |
Forfeited | (63,397) | (692,591) | (418,737) | |
Options outstanding at the end | 6,399,888 | 4,813,262 | 5,220,236 | 5,638,773 |
Vested and exercisable at the end of period | 4,092,342 | 3,392,302 | ||
Vested and expected to vest at the end | 6,399,888 | 4,813,262 | ||
Weighted Average Exercise Price Per Share | ||||
Options outstanding at the beginning (in dollars per share) | $ 6.04 | $ 5.22 | $ 4.69 | |
Granted (in dollars per share) | 10.28 | 9.79 | 8.49 | |
Exercised (in dollars per share) | 2.97 | 1.55 | 1.97 | |
Forfeited (in dollars per share) | 7.87 | 3.76 | 7.62 | |
Options outstanding at the end (in dollars per share) | 7.33 | 6.04 | $ 5.22 | $ 4.69 |
Vested and exercisable at the end of period (in dollars per share) | 5.74 | 4.99 | ||
Vested and expected to vest at the end (in dollars per share) | $ 7.33 | $ 6.04 | ||
Weighted Average Remaining Contractual Term and Aggregate Intrinsic Value | ||||
Options outstanding (in years) | 6 years 7 months 6 days | 6 years 7 months 6 days | 6 years 6 months | 7 years 4 months 24 days |
Vested and exercisable at the end of period (in years) | 5 years 1 month 6 days | 5 years 10 months 24 days | ||
Vested and expected to vest at the end (in years) | 6 years 7 months 6 days | 6 years 7 months 6 days | ||
Options outstanding at the beginning (in dollars) | $ 20,422 | $ 17,044 | $ 21,354 | |
Options outstanding at the end (in dollars) | 26,705 | 20,422 | $ 17,044 | $ 21,354 |
Vested and exercisable at the end of period (in years) | 23,345 | 17,925 | ||
Vested and expected to vest at the end (in dollars) | $ 26,705 | $ 20,422 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes | ||||||
Income tax benefit at statutory rate, Amount | $ (13,970) | $ (17,939) | ||||
State income taxes, net of federal benefit, Amount | (1,338) | (1,739) | ||||
Tax credits, Amount | (2,625) | (1,821) | ||||
Other nondeductible expenses, Amount | 90 | 54 | ||||
Deferred rate changes, Amount | 16 | 16 | ||||
Other, Amount | (1,736) | 449 | ||||
Change in valuation allowance, Amount | $ 19,563 | $ 20,980 | ||||
Income tax benefit at statutory rate, Rate | 21.00% | 21.00% | ||||
State income taxes, net of federal benefit, Rate | 2.00% | 2.00% | ||||
Tax credits, Rate | 3.90% | 2.10% | ||||
Other nondeductible expenses, Rate | (0.10%) | 0.00% | ||||
Deferred rate changes, Rate | 0.00% | 0.00% | ||||
Other, Rate | 2.60% | (0.50%) | ||||
Change in valuation allowance, Rate | (29.40%) | (24.60%) | ||||
Effective tax rate | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% | 0.00% |
Commitments and Contingencies_4
Commitments and Contingencies - Patent License Agreements (Details) - Duke university - License agreement - shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Agreement expiration term after first commercial sale | 4 years | 4 years |
Threshold notice period required to terminate the agreement | 3 months | 3 months |
Collaborative Arrangement, Shares Issued In Connection With License Agreement | 52,693 | 52,693 |
Commitments and Contingencies_5
Commitments and Contingencies - Duke Agreement (Details) - Yale university - USD ($) $ in Millions | 1 Months Ended | 9 Months Ended | 12 Months Ended | |
Aug. 31, 2019 | Feb. 28, 2014 | Sep. 30, 2021 | Dec. 31, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Milestone payments upon achievement of certain regulatory milestones | $ 0.2 | |||
Milestone payments upon achievement of certain commercial milestones | $ 0.6 | |||
License agreement | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Threshold notice period required to terminate the agreement | 90 days | 90 days | ||
License agreement related to coatings for small diameter vessels to inhibit clotting | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Collaborative Arrangement, Maximum Annual Maintenance Fee | $ 0.1 | $ 0.1 | ||
License agreement related to bioartificial vascular pancreas | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Collaborative Arrangement, Maximum Annual Maintenance Fee | $ 0.1 | |||
License agreement related to tubular prostheses | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Collaborative Arrangement, Maximum Annual Maintenance Fee | $ 0.1 |
Related Party Transactions (D_2
Related Party Transactions (Details) - USD ($) $ in Millions | Aug. 26, 2021 | Aug. 31, 2021 | Jun. 30, 2018 | Sep. 30, 2020 | Sep. 30, 2020 | Dec. 31, 2023 | Dec. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2021 |
Related Party Transaction [Line Items] | |||||||||
Proceeds from PIPE | $ 175 | ||||||||
Common stock, shares issued | 5,822,396 | 5,627,157 | 103,003,384 | ||||||
Fresenius Medical Care | |||||||||
Related Party Transaction [Line Items] | |||||||||
Financing amount | $ 150 | ||||||||
Shares issued for conversion of preferred shares | 15,812,735 | ||||||||
Proceeds from PIPE | $ 25 | ||||||||
Common stock, shares issued | 2,500,000 | ||||||||
Dr. Niklason, President, CEO and member of board of directors | |||||||||
Related Party Transaction [Line Items] | |||||||||
Aggregate amount | $ 2.5 | ||||||||
Payments made | $ 0.1 | $ 0.4 | $ 0.5 | $ 0.4 |
Related Party Transactions - _2
Related Party Transactions - Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Related Party Transaction [Line Items] | ||||||
Total | $ 2 | $ 149 | $ 168 | $ 462 | $ 620 | $ 571 |
Expenses under MOU | ||||||
Related Party Transaction [Line Items] | ||||||
Total | 125 | 375 | 500 | 422 | ||
License expenses | ||||||
Related Party Transaction [Line Items] | ||||||
Total | 20 | 85 | 70 | 92 | 110 | |
Other | ||||||
Related Party Transaction [Line Items] | ||||||
Total | $ 2 | $ 4 | $ 83 | $ 17 | $ 28 | $ 39 |
Subsequent Events - (Details)
Subsequent Events - (Details) - USD ($) | Oct. 13, 2021 | Mar. 31, 2021 |
Term loan agreement | ||
Subsequent Event [Line Items] | ||
Amount of loan drawn | $ 10,000,000 | $ 20,000,000 |
Number of warrants that becomes exercisable for no probable funding | 123,302 | |
Exercise price of warrants that became exercisable for no probable funding (USD per share) | $ 10.28 | |
Subsequent event | ||
Subsequent Event [Line Items] | ||
Amount of loan drawn | $ 10 | |
Number of warrants that becomes exercisable for no probable funding | 123,302 | |
Exercise price of warrants that became exercisable for no probable funding (USD per share) | $ 10.28 |