Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 15, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | HTGM | ||
Entity Registrant Name | HTG Molecular Diagnostics, Inc | ||
Entity Central Index Key | 0001169987 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity File Number | 001-37369 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 86-0912294 | ||
Entity Address, Address Line One | 3430 E. Global Loop | ||
Entity Address, City or Town | Tucson | ||
Entity Address, State or Province | AZ | ||
Entity Address, Postal Zip Code | 85706 | ||
City Area Code | (877) | ||
Local Phone Number | 289-2615 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Interactive Data Current | Yes | ||
ICFR Auditor Attestation Flag | false | ||
Entity Common Stock, Shares Outstanding | 2,214,155 | ||
Entity Public Float | $ 11,333,475 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Security Exchange Name | NASDAQ | ||
Auditor Name | BDO USA, LLP | ||
Auditor Location | Los Angeles, California | ||
Auditor Firm ID | 243 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 12,210,857 | $ 9,599,950 |
Short-term investments available-for-sale, at fair value | 0 | 12,343,456 |
Accounts receivable, net of allowance of $0 at December 31, 2022 and $20,315 at December 31, 2021 | 1,421,695 | 2,092,466 |
Inventory, net | 909,328 | 1,987,753 |
Prepaid expenses and other | 1,109,571 | 1,163,339 |
Total current assets | 15,651,451 | 27,186,964 |
Operating lease right-of-use assets | 1,007,202 | 1,345,361 |
Property and equipment, net | 598,006 | 1,118,886 |
Other non-current assets | 520,996 | 809,476 |
Total assets | 17,777,655 | 30,460,687 |
Current liabilities: | ||
Accounts payable | 1,157,449 | 1,649,440 |
Accrued liabilities | 2,209,606 | 2,022,569 |
Current portion of long-term debt, net of discount and debt issuance costs | 3,812,498 | 5,167,586 |
NuvoGen obligation - current | 446,031 | 548,301 |
Operating lease liabilities - current | 475,126 | 413,865 |
Other current liabilities | 170,047 | 141,749 |
Total current liabilities | 8,270,757 | 9,943,510 |
NuvoGen obligation - non-current, net of discount | 3,519,058 | 3,900,880 |
Long-term debt, net of current portion, discount and debt issuance costs | 5,178,629 | |
Operating lease liabilities non-current, net of discount | 546,324 | 949,461 |
Other non-current liabilities | 49,819 | 88,383 |
Total liabilities | 12,385,958 | 20,060,863 |
Commitments and Contingencies (Note 15) | ||
Stockholders' Equity Attributable to Parent [Abstract] | ||
Series A convertible preferred stock, $0.001 par value; no shares authorized,issued and outstanding at December 31, 2022; 23,770 shares authorized, issued and outstanding at December 31, 2021 | 24 | |
Common stock, $0.001 par value; 26,666,667 shares authorized at December 31, 2022 and December 31, 2021, 2,213,897 shares issued and outstanding at December 31, 2022 and 632,340 shares issued and outstanding at December 31, 2021 | 2,214 | 632 |
Additional paid-in-capital | 235,314,311 | 218,730,305 |
Accumulated other comprehensive income | 2,679 | 1,894 |
Accumulated deficit | (229,927,507) | (208,333,031) |
Total stockholders' equity | 5,391,697 | 10,399,824 |
Total liabilities and stockholders' equity | $ 17,777,655 | $ 30,460,687 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Allowance On Accounts Receivable | $ 0 | $ 20,315 |
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | |
Preferred Stock, Shares Authorized | 10,000,000 | |
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 26,666,667 | 26,666,667 |
Common Stock, Shares, Issued | 2,213,897 | 632,340 |
Common Stock, Shares, Outstanding | 2,213,897 | 632,340 |
Series A Redeemable Convertible Preferred Stock [Member] | ||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Preferred Stock, Shares Authorized | 0 | 23,770 |
Preferred Stock, Shares Issued | 0 | 23,770 |
Preferred Stock, Shares Outstanding | 0 | 23,770 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | ||
Product and product-related services revenue | $ 6,366,220 | $ 8,906,828 |
Operating expenses: | ||
Cost of product and product-related services revenue | 4,572,134 | 4,094,980 |
Selling, general and administrative | 15,841,790 | 16,546,740 |
Research and development | 6,781,892 | 6,088,934 |
Total operating expenses | 27,195,816 | 26,730,654 |
Operating loss | (20,829,596) | (17,823,826) |
Other income (expense): | ||
Interest expense | (856,731) | (1,064,545) |
Interest income | 94,355 | 29,884 |
Other income | 8,333 | 0 |
Gain on forgiveness of PPP Loan | 0 | 1,735,792 |
Total other income (expense) | (754,043) | 701,131 |
Net loss before income taxes | (21,583,639) | (17,122,695) |
Provision for income taxes | (10,837) | (22,475) |
Net loss | $ (21,594,476) | $ (17,145,170) |
Net loss per share, basic | $ (24.28) | $ (29.66) |
Net loss per share, diluted | $ (24.28) | $ (29.66) |
Shares used in computing net loss per share, basic | 889,284 | 578,011 |
Shares used in computing net loss per share, diluted | 889,284 | 578,011 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (21,594,476) | $ (17,145,170) |
Other comprehensive loss, net of tax effect: | ||
Foreign currency translation adjustment | 785 | (3,404) |
Comprehensive loss | $ (21,593,691) | $ (17,148,574) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Total | Series A Convertible Preferred Stock | Common Stock | Additional Paid-in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Purchase Agreement | Purchase Agreement Common Stock | Purchase Agreement Additional Paid-in Capital [Member] | March Two Thousand Twenty Two Purchase Agreement [Member] | March Two Thousand Twenty Two Purchase Agreement [Member] Common Stock | March Two Thousand Twenty Two Purchase Agreement [Member] Additional Paid-in Capital [Member] | December Two Thousand Twenty Two secuirities purchase agreement [Member] | December Two Thousand Twenty Two secuirities purchase agreement [Member] Common Stock | ATM Offering | ATM Offering Common Stock | ATM Offering Additional Paid-in Capital [Member] | Public Offering [Member] | Public Offering [Member] Common Stock | Public Offering [Member] Additional Paid-in Capital [Member] |
Balance at Dec. 31, 2020 | $ 14,484,660 | $ 24 | $ 433 | $ 205,666,766 | $ 5,298 | $ (191,187,861) | ||||||||||||||
Balance, shares at Dec. 31, 2020 | 23,770 | 433,333 | ||||||||||||||||||
Stock-based compensation expense | 1,317,351 | 1,317,351 | ||||||||||||||||||
Release of restricted stock awards | 4 | $ 1 | 3 | |||||||||||||||||
Release of restricted stock awards, shares | 377 | |||||||||||||||||||
Net share settlement of restricted stock awards | (3,239) | (3,239) | ||||||||||||||||||
Net share settlement of restricted stock awards, shares | (50) | |||||||||||||||||||
Employee stock purchase plan expense | 57,669 | 57,669 | ||||||||||||||||||
Stock issued under stock purchase plans | 125,828 | $ 3 | 37,560 | |||||||||||||||||
Stock issued under stock purchase plans, shares | 2,830 | |||||||||||||||||||
Conversion of Series A convertible preferred stock for common stock, shares | 12,073 | |||||||||||||||||||
Issuance of common stock | $ 899,980 | $ 12 | $ 899,968 | $ 10,665,819 | $ 171 | $ 10,665,648 | ||||||||||||||
Issuance of common stock, shares | 12,864 | 170,907 | ||||||||||||||||||
Exercise of pre-funded warrants | $ 12 | (12) | ||||||||||||||||||
Exercise of pre-funded warrants, shares | 12,073 | |||||||||||||||||||
Exercise of stock options | 326 | 326 | ||||||||||||||||||
Exercise of stock options, shares | 6 | |||||||||||||||||||
Net loss | (17,145,170) | (17,145,170) | ||||||||||||||||||
Foreign currency translation adjustment | (3,404) | (3,404) | ||||||||||||||||||
Balance at Dec. 31, 2021 | 10,399,824 | $ 24 | $ 632 | 218,730,305 | 1,894 | (208,333,031) | ||||||||||||||
Balance, shares at Dec. 31, 2021 | 23,770 | 632,340 | ||||||||||||||||||
Stock-based compensation expense | 774,160 | 774,160 | ||||||||||||||||||
Release of restricted stock awards | $ 1 | (1) | ||||||||||||||||||
Release of restricted stock awards, shares | 1,139 | |||||||||||||||||||
Net share settlement of restricted stock awards | (11,190) | (11,190) | ||||||||||||||||||
Net share settlement of restricted stock awards, shares | (355) | |||||||||||||||||||
Employee stock purchase plan expense | 40,347 | 40,347 | ||||||||||||||||||
Stock issued under stock purchase plans | 37,567 | $ 7 | 125,825 | |||||||||||||||||
Stock issued under stock purchase plans, shares | 6,876 | |||||||||||||||||||
Conversion of Series A convertible preferred stock for common stock | $ (24) | $ 13 | 11 | |||||||||||||||||
Conversion of Series A convertible preferred stock for common stock, shares | (23,770) | 13,206 | ||||||||||||||||||
Issuance of common stock | $ 7,034,049 | $ 70 | $ 7,033,979 | $ 8,707,399 | $ 102 | $ 8,707,297 | ||||||||||||||
Issuance of common stock, shares | 69,505 | 102,000 | ||||||||||||||||||
Exercise of pre-funded warrants | $ 2,411 | $ 201 | $ 2,210 | $ 1,188 | $ 1,188 | |||||||||||||||
Exercise of pre-funded warrants, shares | 1,188,322 | 200,911 | ||||||||||||||||||
Cash in lieu of fractional shares | (367) | (367) | ||||||||||||||||||
Cash in lieu of fractional shares, shares | (47) | |||||||||||||||||||
Net loss | (21,594,476) | (21,594,476) | ||||||||||||||||||
Foreign currency translation adjustment | 785 | 785 | ||||||||||||||||||
Balance at Dec. 31, 2022 | $ 5,391,697 | $ 0 | $ 2,214 | $ 235,314,311 | $ 2,679 | $ (229,927,507) | ||||||||||||||
Balance, shares at Dec. 31, 2022 | 0 | 2,213,897 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' Equity (Parenthetical) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Issuance costs | $ 0.5 | |
At the market offering, commissions and issuance costs | $ 0.3 | |
Public Offering [Member] | ||
Issuance costs | $ 1.3 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating activities | ||
Net loss | $ (21,594,476) | $ (17,145,170) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 587,138 | 721,246 |
Accretion of interest on NuvoGen obligation | (11,467) | (12,288) |
Provision for excess inventory | 1,211,114 | 174,589 |
Amortization of SVB Term Loan discount and issuance costs | 412,857 | 470,281 |
Stock-based compensation expense | 774,160 | 1,317,355 |
Employee stock purchase plan expense | 40,347 | 57,669 |
Bad debt expense | 0 | 20,315 |
Non-cash operating lease expense | 415,544 | 458,001 |
Accrued interest on available-for-sale securities investments | 4,179 | (25,018) |
Gain on forgiveness of PPP Loan | 0 | (1,735,792) |
(Gain) loss on abandonment and disposal of assets, net | (104,000) | 180,008 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 670,771 | (805,736) |
Inventory | 140,828 | (1,365,384) |
Prepaid expenses and other | 110,976 | 619,226 |
Accounts payable | (525,175) | 453,337 |
Accrued liabilities | (135,890) | 616,447 |
Contract liabilities | 14,564 | (38,314) |
Operating lease liabilities | (419,261) | (469,326) |
Net cash used in operating activities | (18,407,791) | (16,508,554) |
Investing activities | ||
Purchase of property and equipment | (23,044) | (644,381) |
Proceeds from the sale of property and equipment | 104,000 | 0 |
Maturities of available-for-sale securities | 19,950,000 | 12,600,000 |
Purchase of available-for-sale securities | (7,610,723) | (18,620,363) |
Net cash (used in) provided by investing activities | 12,420,233 | (6,664,744) |
Financing activities | ||
Proceeds from ATM Offering, net of commissions of approximately $0.3 million | 0 | 10,665,819 |
Proceeds from March 2022 Purchase Agreement, net of issuance costs of approximately $0.5 million | 7,034,049 | 0 |
Proceeds from LP Purchase Agreement | 0 | 899,980 |
Payments on NuvoGen obligation | (472,625) | (530,656) |
Payments on SVB Term Loan | (6,764,706) | 0 |
Payments on SVB Term Loan Amendment issuance costs | (14,282) | 0 |
Payments on deferred offering costs | (80,692) | 0 |
Payments on financing leases | (16,804) | (22,563) |
Proceeds from exercise of stock options | 0 | 326 |
Taxes paid for net share settlement of restricted stock awards | (11,190) | (3,239) |
Proceeds from shares purchased under stock purchase plans | 37,567 | 125,828 |
Proceeds from Public Offering, net of commissions and issuance costs of approximately $0.9 million | 9,057,857 | 0 |
Cash in lieu of fractional shares related to reverse stock split | (367) | 0 |
Proceeds from insurance note | 822,889 | 0 |
Payments on insurance notes | (990,475) | (743,873) |
Net cash provided by financing activities | 8,604,820 | 10,391,622 |
Effect of exchange rates on cash | (6,355) | (16,186) |
Increase (decrease) in cash and cash equivalents | 2,610,907 | (12,797,862) |
Cash and cash equivalents at beginning of period | 9,599,950 | 22,397,812 |
Cash and cash equivalents at end of period | 12,210,857 | 9,599,950 |
Supplemental disclosure of noncash investing and financing activities | ||
Fixed asset purchases payable and accrued at period end | 6,238 | 0 |
Issuance costs payable and accrued at year end | 350,458 | 0 |
Issuance of common stock upon conversion of Series A convertible preferred stock | 1,402,430 | |
Issuance of common stock from cashless exercise of pre-funded warrants | 0 | 12 |
2021 Insurance Note issued for insurance premiums | 0 | 746,360 |
Gain on forgiveness of PPP Loan | 0 | 1,735,792 |
Operating lease right-of-use assets obtained in exchange for operating lease liabilities | 77,385 | 1,302,457 |
Carrying value of demonstration units transferred from property and equipment to inventory | 0 | 16,128 |
Disposal of fully depreciated assets | 1,075,715 | 635,870 |
Reclassification of instrument from inventory to property and equipment | 36,976 | 0 |
Supplemental cash flow information | ||
Cash paid for interest | 477,625 | 599,922 |
Cash paid for taxes | 8,973 | 12,665 |
March Two Thousand Twenty Two Purchase Agreement [Member] | ||
Financing activities | ||
Proceeds from exercise of pre-funded warrants | 2,411 | 0 |
December Two Thousand Twenty Two secuirities purchase agreement [Member] | ||
Financing activities | ||
Proceeds from exercise of pre-funded warrants | $ 1,188 | $ 0 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Issuance costs | $ 0.5 | |
ATM Offering | ||
Underwriting discounts, commissions and issuance costs | 0.3 | $ 0.3 |
Issuance costs | 0.3 | |
March Two Thousand Twenty Two Purchase Agreement Member | ||
Issuance costs | 0.5 | 0.5 |
December Two Thousand Twenty Two secuirities purchase agreement [Member] | ||
Underwriting discounts, commissions and issuance costs | $ 0.9 | $ 0.9 |
Description of Business and Bas
Description of Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Description of Business and Basis of Presentation | Note 1. Description of Business and Basis of Presentation HTG Molecular Diagnostics, Inc. (the “Company”) is a life science company whose mission is to advance precision medicine through its innovative transcriptome-wide profiling technology and advanced medicinal chemistry technology. The Company derives revenue primarily from sales of its HTG EdgeSeq system and integrated next-generation sequencing-based (“NGS-based”) HTG EdgeSeq research use only (“RUO”) assays and from sample processing services performed in its VERI/O laboratory. The Company operates in one segment and its customers and distributors are located primarily in the United States and Europe. Revenue is reported based upon the geographic locations of the customers or distributors who purchase the Company's products and services. For sales to distributors, their locations may be different from the locations of the end customers. For the year ended December 31, 2022, approximately 35 % of the Company’s revenue was generated from sales originated by customers located outside of the United States, compared with 31 % for the year ended December 31, 2021. Basis of Presentation The consolidated financial statements and accompanying notes were prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). In December 2022, the Company completed a reverse stock split of its outstanding shares of common stock pursuant to which every twelve shares of issued and outstanding common stock were exchanged for one share of common stock. All share and per share amounts within the consolidated financial statements and notes thereto have been adjusted to reflect the reverse stock split for all periods and dates presented. See Note 14 for more information about the Company’s reverse stock split. Principles of Consolidation The Company formed a French subsidiary, HTG Molecular Diagnostics France SARL, in November 2018. The consolidated financial statements include the accounts of the Company and this wholly owned subsidiary after elimination of intercompany transactions and balances as of December 31, 2022 and 2021 . Going Concern and Liquidity Management has assessed the Company’s ability to continue as a going concern within one year of issuance of these consolidated financial statements. The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of the assets and satisfaction of liabilities in the normal course of business. However, the Company has had recurring operating losses and negative operating cash flows since its inception and has an accumulated deficit of approximately $ 229.9 million as of December 31, 2022. As of December 31, 2022, the Company had working capital of approximately $ 7.4 million and long-term liabilities of approximately $ 4.1 million. The Company’s liability balances consist primarily of its debt obligations, including an asset-secured loan with Silicon Valley Bank (currently named Silicon Valley Bridge Bank, N.A. following the closure of Silicon Valley Bank on March 10, 2023 by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation ("FDIC") as receiver) (“SVB”), as lender, (the “SVB Term Loan”) (see Note 8), as well as an obligation to NuvoGen Research, LLC (the “NuvoGen obligation”) (see Note 10). The Company currently expects that its existing resources will be sufficient to fund its planned operations and expenditures until at least July 2023. In addition, potentially changing circumstances, including those related to a resurgence of COVID-19, inflation and high interest rates, may result in the depletion of the Company’s capital resources more rapidly than it currently anticipates. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying consolidated financial statements do not include any adjustments that may result from the outcome of these uncertainties. The Company will need to raise additional capital to fund its operations and service its long-term debt obligations until its revenue reaches a level sufficient to provide for self-sustaining cash flows. There can be no assurance that additional capital will be available on acceptable terms, or at all, or that the Company’s revenue will reach a level sufficient to provide for self-sustaining cash flows. If the Company is not able to generate additional capital, the Company may have to delay, scale back or discontinue one or more of its therapeutics development programs, curtail its commercial activities, significantly reduce expenses, sell assets (potentially at a discount to their fair value or carrying value), enter into relationships with third parties to develop or commercialize products or technologies that the Company otherwise would have sought to develop or commercialize independently, cease operations altogether, pursue a sale of the Company at a price that may result in a significant loss on investment for its stockholders, file for bankruptcy or seek other protection from creditors. In addition, if the Company defaults under any of the provisions of the Loan and Security Agreement for the SVB Term Loan (the "Loan Agreement"), SVB could charge an interest rate of 5 % above the otherwise applicable floating rate, accelerate the payment of the SVB Term Loan and ultimately foreclose on the Company’s assets. COVID-19 Pandemic and Relief The Company experienced a significant slowing of product and product-related services revenue generation beginning in March 2020 as a result of COVID-19. The extent of this impact has varied from customer to customer depending upon how they have been directly or indirectly impacted by local stay-at-home orders and other social distancing measures, how they have prioritized studies and previously planned trials as the immediate impacts of the pandemic have passed, and how significantly their workforces and supplier networks have been impacted by the pandemic. The Company has not experienced delays in development even with its efforts to prioritize the safety of its employees during the pandemic. In addition, the impact of COVID-19 on the Company’s ability to source raw materials and other supplies has not been significant to date. However, a change in or loss of suppliers or other supply chain or distribution network partners due to the ongoing impacts of the pandemic or a resurgence of COVID-19 on the global economy could adversely affect the Company’s business and the business of its vendors, partners and customers, and could result in future reductions in sales and operating results. While there remains uncertainty as to the future impact of COVID-19, the Company has considered the known impacts on its business as of the date these consolidated financial statements were issued and has reflected any known or expected impacts in its consolidated financial statements, including consideration of potential impairment risks to its long-lived assets, potential accounts receivable collection risks and potential impacts to its overall liquidity position. As a result of various government programs enacted to address the ongoing impacts of COVID-19, the Company was able to qualify for and receive Employee Retention Credits (“ERC”) during the year ended December 31, 2021. ERC benefits of approximately $ 0.5 million, $ 0.8 million, and $ 0.4 million were included in cost of product and product-related services revenue, selling, general and administrative and research and development, respectively, as an offset to the related compensation costs in the accompanying consolidated statements of operations for the year ended December 31, 2021. In November 2021, the Infrastructure Investment and Jobs Act was signed into law, making wages paid after September 30, 2021 ineligible for these credits. As such, no further ERC benefits were received for the year ended December 31, 2022. ERC benefits receivable of approximately $ 0.4 million were included in prepaid expenses and other in the accompanying consolidated balance sheets as of both December 31, 2022 and 2021. In April 2020, the Company received proceeds from a loan pursuant to the Paycheck Protection Program (“PPP”) of the CARES Act (the “PPP Loan”) in the amount of approximately $ 1.7 million from SVB, as lender. The Company applied for full forgiveness of the PPP Loan in October 2020. In May 2021, the Company received notification that the PPP Loan and related interest, totaling approximately $ 1.7 million, were forgiven by the U.S. Small Business Administration (“SBA”), and that the PPP Loan had been canceled. Accordingly, the Company recorded a gain on forgiveness of the PPP Loan for the year ended December 31, 2021, included in other income (expense) in the accompanying consolidated statements of operations. Laws and regulations concerning government programs, including the ERC and PPP Loan, are complex and subject to varying interpretations. Claims made under these programs may also be subject to retroactive audit and review. While the Company does not believe there is a basis for estimation of an audit or recapture risk at this time, there can be no assurance that regulatory authorities will not challenge the Company’s claim to the ERC or PPP Loan in a future period. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosures of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. The Company’s estimates include revenue recognition, stock-based compensation expense, bonus and warranty accrual, income tax valuation allowances and reserves, recovery of long‑lived assets, lease liability, inventory valuation, allowance for doubtful accounts and available-for-sale securities. Actual results could materially differ from those estimates. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on deposit with financial institutions, money market instruments and high credit quality corporate debt securities purchased with a term of three months or less. Accounts Receivable Accounts receivable represent valid claims against debtors. Management reviews accounts receivable regularly to determine, using the specific identification method, if any receivable amounts will potentially be uncollectible and to estimate the amount of allowance for doubtful accounts necessary to reduce accounts receivable to its estimated net realizable value. Investments in Available-for-Sale Securities The Company classifies its debt securities, which are reported at estimated fair value with unrealized gains and losses included in accumulated other comprehensive income, net of tax, as available-for-sale securities. Investments in securities with maturities of less than one year , or where management’s intent is to use the investments to fund current operations, or to make them available for current operations, are classified as short-term investments. Realized gains, realized losses and declines in value of securities judged to be other-than-temporary, are included in other income (expense) within the consolidated statements of operations. The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. Interest earned on securities is also included in other income (expense) within the consolidated statements of operations. The Company recognizes other-than-temporary impairment (“OTTI”) of a debt security for which there has been a decline in fair value below amortized cost if (i) management intends to sell the security, (ii) it is more likely than not that the Company will be required to sell the security before recovery of its amortized cost basis, or (iii) the Company does not expect to recover the entire amortized cost basis of the security. The amount by which amortized cost exceeds the fair value of a debt security that is considered to have OTTI is separated into a component representing the credit loss, which is recognized in earnings, and a component related to all other factors, which is recognized in other comprehensive loss. The measurement of the credit loss component is equal to the difference between the debt security’s amortized cost basis and the present value of its expected future cash flows discounted at the security’s effective yield. If the Company intends to sell the security, or if it is more likely than not it will be required to sell the security before recovery, an OTTI write-down is recognized in earnings equal to the entire difference between the amortized cost basis and fair value of the security. As the Company did no t have available-for-sale securities as of December 31, 2022 and did no t have any unrealized losses as of December 31, 2021, there was no OTTI of its available-for-sale securities as of either balance sheet date. Fair Value of Financial Instruments Fair value measurements are based on the premise that fair value is an exit price representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the following three-tier fair value hierarchy has been used in determining the inputs used in measuring fair value: Level 1 – Quoted prices in active markets for identical assets or liabilities on the reporting date. Level 2 – Pricing inputs are based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant assumptions are observable in the market or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 – Pricing inputs are generally unobservable and include situations where there is little, if any, market activity for the investment. The inputs into the determination of fair value require management’s judgment or estimation of assumptions that market participants would use in pricing the assets or liabilities. The fair values are therefore determined using factors that involve considerable judgment and interpretations, including but not limited to private and public comparables, third-party appraisals, discounted cash flow models, and fund manager estimates. The carrying value of financial instruments classified as current assets and current liabilities approximate fair value due to their liquidity and short-term nature. Investments that are classified as available-for-sale are recorded at fair value, which is determined using quoted market prices, broker or dealer quotations or alternative pricing sources with reasonable levels of price transparency. The carrying value of the SVB Term Loan (see Note 8) is estimated to approximate its fair value as the interest rate approximates the market rate for debt with similar terms and risk characteristics. The NuvoGen obligation relates to an asset purchase transaction with a then-common stockholder of the Company (see Note 10). As of December 31, 2022, the estimated aggregate fair value of the NuvoGen obligation is approximately $ 3.9 million, determined using a Monte Carlo simulation with key assumptions including future revenue, volatility, discount and risk-free rates. The estimated fair value of the NuvoGen obligation represents a Level 3 measurement. Inventory Inventory is stated at the lower of cost or net realizable value. The Company determines the cost of inventory using the first-in, first out method. The Company estimates the recoverability of inventory by reference to internal estimates of future demands and product life cycles, including expiration. The Company periodically analyzes its inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value and records a charge to expense for such inventory as appropriate. The Company classifies inventory as long-term when it expects to utilize the inventory beyond its normal operating cycle. The Company charges cost of sales for inventory provisions to write-down our inventory to the lower of cost or net realizable value or for obsolete or excess inventory. Most of its inventory provisions relate to excess quantities of products, based on our inventory levels and future product purchase commitments compared to assumptions about future demand and market conditions. Once inventory has been written-off or written-down, it creates a new cost basis for the inventory that is not subsequently written-up, any increase in demand forecasted or inventory value of such inventory is not realized until such inventory is sold. Equipment that is under evaluation for purchase remains in inventory as the Company maintains title to the equipment throughout the evaluation period. The period of time customers use to evaluate the Company’s equipment generally ranges from 90 to 180 days , and in certain circumstances the evaluation period may need to be extended beyond that period. However, in no case will the evaluation period exceed one year. If the customer has not purchased the equipment or entered into a reagent rental agreement with the Company after evaluating the product for one year, the equipment is returned to the Company or the customer is allowed to continue use of the equipment, in which case the equipment is written off to selling, general and administrative expense in the consolidated statements of operations. HTG EdgeSeq instruments at customer locations under evaluation agreements are included in finished goods inventory. Finished goods inventory under evaluation was approximately $ 0.1 million and $ 0.2 million as of December 31, 2022 and 2021, respectively. Property and Equipment Property and equipment are stated at historical cost and depreciated over their useful lives, which range from three to five years , using the straight-line method. Equipment used in the field is amortized using the straight-line method over the lesser of the period of the related reagent rental or the estimated useful life. Leasehold improvements are amortized using the straight-line method over the lesser of the remaining lease term or the estimated useful life. Costs incurred in the development and installation of software for internal use and in the development of the Company’s website are expensed or capitalized, depending on whether they are incurred in the preliminary project stage (expensed), application development stage (capitalized), or post-implementation stage (expensed). Amounts capitalized following project completion are amortized on a straight-line basis over the useful life of the developed asset, which is generally three years . Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset group to the estimated undiscounted future cash flows expected to be generated by the asset group. If the carrying amount of an asset group exceeds its estimated future cash flow, an impairment charge is recognized in the amount by which the carrying amount of the asset group exceeds the fair value of the asset group. Although the Company has accumulated losses since inception, the Company believes the future cash flows will be sufficient to exceed the carrying value of the Company’s long-lived assets. There were no impairments of long-lived assets during the years ended December 31, 2022 and 2021 . Leases Arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the consolidated balance sheets as both a right-of-use asset and a lease liability for each type of lease, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s 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. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. For financing leases, interest on the lease liability and the amortization of the right-of-use asset results in front-loaded expense over the lease term. Variable lease expenses are recorded to rent expense as incurred. In calculating the right-of-use asset and lease liability, the Company elects to combine lease and non-lease components for all classes of assets currently under lease, including facilities and computer equipment. The Company excludes short-term leases having initial terms of 12 months or less as an accounting policy election and recognizes rent expense on short-term leases on a straight-line basis over the lease term for these leases. Debt Issuance Costs and Debt Discounts Costs incurred to issue non-revolving debt instruments are recognized as a reduction to the related debt balance in the consolidated balance sheets and amortized to interest expense over the contractual term of the related debt using the effective interest method. Costs incurred to issue the Loan Agreement with SVB were deferred as an asset in the consolidated balance sheets and are being amortized on a straight-line basis to interest expense over the term of the loan (see Note 8). Contract Liabilities Contract liabilities represent cash receipts for products or services to be delivered in future periods. When products or services are delivered to customers, contract liabilities are recognized as earned. Up-front fees received for custom RUO assay design are recognized over time based on the costs incurred to date compared with total expected costs as design or development procedures are completed and outputs are produced. Revenue Recognition Revenue from contracts with customers is recognized when, or as, the Company satisfies its performance obligations by delivering the promised goods or service deliverables to the customers. A good or service deliverable is transferred to a customer when, or as, the customer obtains control of that good or service deliverable. A performance obligation may be satisfied over time or at a point in time. Revenue from a performance obligation satisfied over time is recognized by measuring the Company’s progress in satisfying the performance obligation in a manner that depicts the transfer of the goods or services to the customer. Revenue from a performance obligation satisfied at a point in time is recognized at the point in time that the Company determines the customer obtains control over the promised good or service deliverable. The amount of revenue recognized reflects the consideration the Company expects to be entitled to in exchange for those promised goods or services ( i.e. , the “transaction price”). In determining the transaction price, the Company considers multiple factors, including the effects of variable consideration. Variable consideration is included in the transaction price only to the extent it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainties with respect to the amount are resolved. In determining when to include variable consideration in the transaction price, the Company considers the range of possible outcomes, the predictive value of its past experiences, the time period of when uncertainties expect to be resolved and the amount of consideration that is susceptible to factors outside of the Company’s influence, such as the judgment and actions of third parties. 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. As the Company’s agreements for product and product-related services revenue have an expected duration of one year or less, the Company has elected the practical expedient to not disclose information about its remaining performance obligations. The Company has also made a policy election to exclude from the measurement of the transaction price all taxes assessed by a government authority that are both imposed on and concurrent with a specific revenue producing transaction and collected by the Company from a customer. Such taxes may include but are not limited to sales, use, value added and certain excise taxes. See Note 9 for additional discussion of the Company’s revenue recognition policies. Product Warranty The Company generally provides a one-year warranty on its HTG EdgeSeq platform covering the performance of system hardware and software in conformance with customer specifications under normal use and protecting against defects in materials and workmanship. The Company may, at its option, replace, repair or exchange products covered under valid warranty claims. A provision for estimated warranty costs is recognized at the time of sale, through cost of product and product-related services revenue, based upon recent historical experience and other relevant information as it becomes available. Customers have the option to purchase an extended warranty after the one-year warranty period expires. The Company continuously assesses the adequacy of its product warranty accrual by reviewing actual claims and adjusts the provision as needed. Warranty accrual is included in accrued liabilities and other non-current liabilities in the consolidated balance sheets. Research and Development Expenses Research and development expenses represent costs incurred internally for and externally in support of research and development activities. These costs include those generated through research and development efforts for the improvement and expansion of the Company’s proprietary profiling technology and product offerings, and payroll, related expenses, consulting expenses, laboratory supplies, facilities and equipment costs incurred to complete development milestones associated with the Company's transcriptome-informed drug discovery business, HTG Therapeutics. Stock-based Compensation The Company incurs stock-based compensation expense relating to grants of restricted stock units (“RSUs”) and stock options to employees, consultants and non-employee directors under its equity incentive plans, and stock purchase rights granted under its employee stock purchase plans. The Company recognizes expense for stock-based awards based on the fair value of awards on the date of grant. The fair value of RSUs is based on the quoted market price of the Company’s common stock on the date of grant. The fair value of stock purchase rights and stock options granted pursuant to the Company’s equity incentive plans is estimated on the date of grant using the Black-Scholes option pricing model. The determination of the fair value utilizing the Black-Scholes option pricing model is affected by the fair value of the Company’s stock price and several assumptions, including volatility, expected term, risk-free interest rate, and dividend yield. Generally, these assumptions are based on historical information and judgment is required to determine if historical trends may be indicators of future outcomes. The Company accounts for forfeitures as they occur. Income Taxes The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to the differences between the financial statement carrying amounts and tax base of assets and liabilities using enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is established against net deferred tax assets for the uncertainty it presents of our ability to use the net deferred tax assets, in this case, primarily carryforwards of net operating tax losses and research and development tax credits. In assessing the realizability of net deferred tax assets the Company has assessed the likelihood that net deferred tax assets will be recovered from future taxable income, and to the extent that it is “more likely than not” that the assets will not be recovered or there is an insufficient history of operating profits, a valuation allowance is established. The Company records the valuation allowance in the period it determines that it is more likely than not that net deferred tax assets will not be realized. For the years ended December 31, 2022 and 2021, the Company has provided a full valuation allowance for all net deferred tax assets due to their current realization being considered remote in the near term. Uncertain tax positions taken or expected to be taken in a tax return are accounted for using the more likely than not threshold for financial statement recognition and measurement. Therefore, for income tax positions where it is not more likely than not that a tax benefit will be sustained in a court of last resort, the Company does not recognize a tax benefit in its financial statements. Foreign Currency Translation and Foreign Currency Transactions The Company has assets and liabilities, including accounts receivable and accounts payable, which are denominated in currencies other than its functional currency. These assets and liabilities are subject to re-measurement, the impact of which is recorded in selling, general and administrative expense within the consolidated statements of operations. Adjustments resulting from translating foreign functional currency financial statements of the Company’s wholly owned subsidiary into U.S. Dollars are included in the foreign currency translation adjustment, a component of accumulated other comprehensive income in the consolidated statements of changes in stockholders' equity. Comprehensive Loss Comprehensive loss includes certain changes in equity that are excluded from net loss. Specifically, unrealized gains and losses on short-term available-for-sale investments and adjustments resulting from translating foreign functional currency financial statements into U.S. Dollars are included in comprehensive loss. Concentration Risks Financial instruments that potentially subject the Company to credit risk consist principally of cash and cash equivalents and accounts receivable. The Company maintains the majority of its cash balances in the form of cash deposits in checking and money market accounts in amounts in excess of federally insured limits. In accordance with the Loan Agreement, as of December 31, 2022, the Company's cash balances were held in operating accounts at and in a custodial account at U.S. Bank subject to a control agreement with Silicon Valley Bank. On March 12, 2023, the U.S. Treasury, Federal Reserve and FDIC announced that SVB depositors will have access to all of their money beginning on March 13, 2023. Management believes that the credit risk with regard to these deposits is not significant based on the quality of the financial institution or, with respect to deposits with SVB, as a result of the guarantee provided by the U.S. Treasury, Federal Reserve and FDIC. The Company sells its instruments, consumables, sample processing services, custom RUO assay design and collaborative development services primarily to biopharmaceutical companies, academic institutions and molecular labs. The Company routinely assesses the financial strength of its customers and credit losses have been minimal to date. The Company’s top two customers accounted for 16 % and 14 % of the Company’s total revenue for the year ended December 31, 2022 , compared with the top two customers accounting for 20 % and 10 % of the Company’s total revenue for the year ended December 31, 2021 . The largest three customers accounted for approximately 37 % , 24 % and 13 % of the Company’s accounts receivable as of December 31, 2022 . The largest two customers accounted for approximately 18 % and 17 % of the Company’s accounts receivable as of December 31, 2021. The third and fourth largest customers accounted for approximately 10 % each of the Company’s accounts receivable as of December 31, 2021. One vendor accounted for 13 % of the Company’s accounts payable as of December 31, 2022 , compared with two vendors who accounted for 28 % and 16 % of the Company’s accounts payable as of December 31, 2021. The Company is also subject to supply chain risks related to the reliance on a single supplier to manufacture a subcomponent used in its HTG EdgeSeq instruments. Although there are a limited number of manufacturers for components of this type, the Company believes that other suppliers could provide similar products on comparable terms. However, a change in or loss of this supplier could significantly delay the delivery of products, which in turn would materially affect the Company’s ability to generate revenue. Recent Accounting Pronouncements The following are new FASB Accounting Standard Updates ("ASU") that had not been adopted by the Company as of December 31, 2022. The Company's management does not believe that any other recently issued, but not yet effective, accounting standards updates, if currently adopted, would have a material effect on the accompanying consolidated financial statements. In June 2022, the FASB issued ASU 2022-03, Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions ("ASU 2022-03"), which amends ASC 820 to clarify that a contractual sales restriction is not considered in measuring an equity security at fair value and to introduce new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value. ASU 2022-03 applies to both holders and issuers of equity and equity-linked securities measured at fair value. The amendments in this ASU are effective for the Company in fiscal years and interim periods within those fiscal years, beginning after December 15, 2023. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance. The Company is still evaluating the impact of this pronouncement on the financial statements. In August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. ASU 2020-06 removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and also simplifies the diluted earnings per share calculation in certain areas. The standard is effective for the Company effective for fiscal years beginning after December 15, 2023. Early adoption is permitted, and adoption must be as of the beginning of the Company’s annual fiscal year. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses , which was subsequently amended by ASU 2018-19, ASU 2019-10 and ASU 2020-02, and requires the measurement of expected credit losses for financial instruments carried at amortized cost held at the reporting date based on historical experience, current conditions and reasonable forecasts. The updated guidance also amends the current other-than-temporary impairment model for available-for-sale debt securities by requiring the recognition of impairments relating to credit losses through an allowance account and limits the amount of credit loss to the difference between a security’s amortized cost basis and its fair value. In addition, the length of time a security has been in an unrealized loss position will no longer impact the determination of whether a credit loss exists. The main objective of this ASU is to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. With the issuance of ASU 2019-10 in November 2019, the standard will be effective for the Company for fiscal years and interim periods within those fiscal years beginning after December 15, 2022. The Company's adoption of this standard on January 1, 2023 is not expected to have a material impact on its consolidated financial statements or related footnote disclosures, given the high credit quality of the obligors to its available-for-sale debt securities and its history of minimal bad debt expense relating to trade accounts receivable. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | Note 3. Inventory Inventory - current, net of allowance, consisted of the following as of the dates indicated: December 31, 2022 2021 Raw materials $ 426,516 $ 1,253,111 Work in process 113,063 312,803 Finished goods 394,016 447,145 Total gross inventory - current 933,595 2,013,059 Less general inventory allowance ( 24,267 ) ( 25,306 ) $ 909,328 $ 1,987,753 Inventory - non-current, net of excess inventory allowance, included in other non-current assets on the consolidated balance sheets, consisted of the following as of the dates indicated: December 31, 2022 2021 Raw materials - non-current, net $ 244,915 $ 711,296 Work in process - non-current, net 81,958 — Finished goods - non-current 73,930 — $ 400,803 $ 711,296 For the year ended December 31, 2022, the Company recorded adjustments to its specific inventory reserve of $ 49,249 , to reflect the projected obsolescence of a specific inventory item, and to the general inventory allowance for estimated shrinkage, obsolescence and cycle count adjustments of $ 44,762 . In addition, the Company recorded a provision for excess inventory of approximately $ 1.1 million, primarily related to the write-down of estimated excess quantities of raw materials, whose inventory levels are higher than our updated forecasts of future demand for those products. For the year ended December 31, 2021, the Company recorded adjustments to the general inventory allowance of approximately $ 0.2 million. Adjustments in these periods to the general, specific and excess inventory allowances have been included in cost of product and product-related services revenue in the accompanying consolidated statements of operations. |
Fair Value Instruments
Fair Value Instruments | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Disclosures [Text Block] | Note 4. Fair Value Financial assets and liabilities measured at fair value are classified in their entirety in the fair value hierarchy, based on the lowest level input significant to the fair value measurement. The following table classifies the Company’s financial assets measured at fair value on a recurring basis as of December 31, 2022 and 2021, respectively, in the fair value hierarchy: December 31, 2022 Level 1 Level 2 Level 3 Total Asset included in: Cash and cash equivalents Money market securities $ 10,753,684 $ — $ — $ 10,753,684 Total $ 10,753,684 $ — $ — $ 10,753,684 December 31, 2021 Level 1 Level 2 Level 3 Total Asset included in: Cash and cash equivalents Money market securities $ 9,083,302 $ — $ — $ 9,083,302 Investments available-for-sale at fair value Corporate debt securities — 12,343,456 — 12,343,456 Total $ 9,083,302 $ 12,343,456 $ — $ 21,426,758 There were no other financial instruments subject to fair value measurement on a recurring basis. Transfers to and from Levels 1, 2 and 3 are recognized at the end of the reporting period. There were no transfers between levels for the years ended December 31, 2022 and 2021. Level 1 instruments include investments in money market securities . These instruments are valued using quoted market prices for identical unrestricted instruments in active markets. The Company defines active markets for debt instruments based on both the average daily trading volume and the number of days with trading activity. Level 2 instruments as of December 31, 2021 included corporate debt securities, including commercial paper and corporate bonds. Valuations of Level 2 instruments can be verified to quoted prices, recent trading activity for identical or similar instruments, broker or dealer quotations or alternative pricing sources with reasonable levels of price transparency. Consideration is given to the nature of the quotations (e.g. indicative or firm) and the relationship of recent market activity to the prices provided from alternative pricing sources. Fair values of these assets are based on prices provided by independent market participants that are based on observable inputs using market-based valuation techniques. These valuation models and analytical tools use market pricing or similar instruments that are both objective and publicly available, including matrix pricing or reported trades, benchmark yields, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids and/or offers. The Company did not adjust any of the valuations received from these third parties with respect to any of its Level 1 or 2 securities for either of the years ended December 31, 2022 or 2021 and did not have any Level 3 financial assets or liabilities during either of these periods. |
Available-for-Sale Securities
Available-for-Sale Securities | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Available-for-Sale Securities | Note 5. Available-for-Sale Securities The Company did no t have any investments in available-for-sale securities as of December 31, 2022. The Company's portfolio of available-for-sale securities as of December 31, 2021 consisted of high credit quality corporate debt securities. The following is a summary of the securities as of that date: December 31, 2021 Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) Corporate debt securities $ 12,343,456 $ — $ — $ 12,343,456 Total available-for-sale securities $ 12,343,456 $ — $ — $ 12,343,456 There were no gross unrealized gains or losses related to the Company's available-for-sale securities investments as of December 31, 2022 or 2021 . There were no net adjustments to unrealized holding gains on short-term investments, net of tax in other comprehensive income for the years ended December 31, 2022 and 2021 . |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Note 6. Property and Equipment Property and equipment, net consisted of the following as of the dates indicated: December 31, 2022 2021 Furniture & fixtures $ 756,065 $ 872,877 Leasehold improvements 1,938,981 1,931,762 Equipment used in manufacturing 1,863,976 2,432,242 Equipment used in research & development 2,080,319 2,343,930 Equipment used in the field 159,563 216,218 Software 469,408 480,740 Property and equipment 7,268,312 8,277,769 Less: accumulated depreciation and amortization ( 6,670,306 ) ( 7,158,883 ) $ 598,006 $ 1,118,886 Depreciation and leasehold improvement amortization expense was approximately $ 0.6 million and $ 0.7 million for the years ended December 31, 2022 and 2021 , respectively. |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Liabilities | Note 7. Accrued Liabilities Accrued liabilities consisted of the following as of the dates indicated: December 31, 2022 2021 Accrued employee bonuses $ 1,252,622 $ 1,254,355 Payroll and employee benefit accruals 416,070 389,385 Accrued professional fees 355,377 47,594 Other accrued liabilities 185,537 331,235 $ 2,209,606 $ 2,022,569 |
Debt Obligations
Debt Obligations | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Debt Obligations | Note 8. Debt Obligations Current portion of long-term debt consisted of the following as of the dates indicated: December 31, 2022 2021 SVB Term Loan, net of discount and debt issuance costs $ 3,812,498 $ 5,000,000 2021 Insurance Note — 167,586 $ 3,812,498 $ 5,167,586 Long-term debt, net of current portion, discount and debt issuance costs, consisted of the following as of the dates indicated: December 31, 2022 2021 SVB Term Loan, net of discount and debt issuance costs $ - $ 5,178,629 SVB Term Loan On June 24, 2020 (the “Closing Date”), the Company entered into the SVB Term Loan with SVB, which provided a secured term loan in the principal amount of $ 10.0 million. The proceeds from the SVB Term Loan were fully funded on June 25, 2020. The SVB Term Loan bears interest at a floating rate equal to the greater of 2.50 % above the Prime Rate (as defined in the Loan Agreement) and 5.75 %. Interest on the SVB Term Loan is due and payable monthly in arrears. The SVB Term Loan originally required interest-only payments through June 30, 2021. As a result of the Company’s achievement of an equity milestone defined in the Loan Agreement during the quarter ended June 30, 2021, the interest-only period was extended for six months through December 31, 2021. Following the extended interest-only period, the Loan Agreement required equal monthly payments of principal and interest through the maturity date of December 1, 2023 . Prepayments of the SVB Term Loan, in whole or in part, are subject to early termination fees in an amount equal to 1.0 % of principal prepaid if prepayment occurs after the second anniversary of the Closing Date and prior to the maturity date. Upon termination of the Loan Agreement, the Company is required to pay a final fee premium equal to 8.00 % of the principal amount of the SVB Term Loan. In July 2022, the Company and SVB entered into an amendment to the SVB Term Loan (the "Term Loan Amendment"). Under the Term Loan Amendment, the Company and SVB agreed to remove the financial covenant under the Loan Agreement that had required the Company to maintain unrestricted cash, including short term investments available-for-sale, of not less than the greater of (i) $ 12.5 million and (ii) an amount equal to six times the amount of the Company's average monthly Cash Burn (as defined in the Loan Agreement) over the trailing three months. In exchange for this accommodation, the Company prepaid $ 2.5 million of outstanding principal under the Term Loan (the "Prepayment"). SVB waived the prepayment fee that otherwise would have applied to the Prepayment. The remaining outstanding principal amount due under the Term Loan will continue to be paid in equal monthly payments of principal and interest through the maturity date of December 1, 2023 . The Term Loan Amendment was accounted for as a modification of the original SVB Term Loan. On March 10, 2023, the FDIC took control and was appointed receiver of SVB. The SVB Term Loan remains intact and the Company will continue to make required payments through the end of the current year, at which time the SVB Term Loan will be repaid in full. The Company’s obligations under the Loan Agreement are secured by a security interest in substantially all of its assets, excluding intellectual property (which is subject to a negative pledge), and the Company’s future subsidiaries, if any, may be required to become co-borrowers or guarantors under the Loan Agreement. If we default under our obligations under the SVB Term Loan, including as a result of a material adverse change, as defined in the SVB Term Loan, the lender could proceed against the collateral granted to them to secure our indebtedness or declare all obligations under the SVB Term Loan to be due and payable. The determination as to whether a material adverse change has occurred is not within the Company's control and it is unclear how the current managers of Silicon Valley Bridge Bank will view the SVB Term Loan from a risk standpoint and what actions they may elect to take under the SVB Term Loan to protect the financial interests of the lender. The remaining principal repayments due under the SVB Term Loan as of December 31, 2022 are as follows: 2023 $ 3,235,294 Less discount and deferred financing costs ( 222,796 ) Plus final fee premium 800,000 Total SVB Term Loan, net $ 3,812,498 The Company included $ 0.2 million and $ 0.6 million of debt discount associated with the SVB Term Loan, resulting from fees and debt issuance costs, inclusive of the fair value of warrants issued, in current portion of long-term debt, net of discount and debt issuance costs and long-term debt, net of current portion, discount and debt issuance costs, respectively, in the accompanying consolidated balance sheets as of December 31, 2022 and 2021, respectively. Amortization of the debt discount associated with the SVB Term Loan was $ 0.4 million and $ 0.5 million for the years ended December 31, 2022 and 2021, respectively, and was included in interest expense in the consolidated statements of operations. The effective interest rates for the years ended December 31, 2022 and 2021 were 16.15 % and 10.47 %, respectively. Insurance Note In May 2021, the Company entered into a new commercial financing agreement to extend the payment period related to its directors and officers insurance policy (the “2021 Insurance Note”). The 2021 Insurance Note required a down payment to be made upon signing the agreement equal to approximately $ 0.4 million. The remaining unpaid premium balance of approximately $ 0.7 million was financed at an annual rate of 3.57 % and was repaid in nine equal monthly payments of principal and interest through February 2022 . In May 2022, the Company entered into a new commercial financing agreement to extend the payment period related to its directors and officers insurance policy (the "2022 Insurance Note"). The 2022 Insurance Note required a down payment to be made upon signing the agreement equal to approximately $ 0.3 million. The remaining unpaid premium balance of approximately $ 0.8 million was financed at an annual rate of 3.32 % and was to be repaid in nine equal monthly payments of principal and interest beginning in June 2022 . The 2022 Insurance Note contained customary events of default relating to, among other things, payment defaults and breaches of representations, warranties or terms of the 2022 Insurance Note documents, and may be prepaid by the Company at any time prior to maturity with no prepayment penalties. In November 2022, the Company prepaid the remainder of the 2022 Insurance Note. |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 12 Months Ended |
Dec. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Revenue from Contracts with Customers | Note 9. Revenue from Contracts with Customers Product and Product-related Services Revenue The Company had product and product-related services revenue consisting of revenue from the sale of instruments and consumables and the use of the HTG EdgeSeq proprietary technology to process samples and design custom RUO assays for the years ended December 31, 2022 and 2021 as follows: Years Ended December 31, 2022 2021 Product revenue: Instrument $ 609,627 $ 1,385,665 Consumables 3,140,420 3,786,923 Total product revenue 3,750,047 5,172,588 Product-related services revenue: Custom RUO assay design 20,000 48,350 RUO sample processing 2,596,173 3,685,890 Total product-related services revenue 2,616,173 3,734,240 Total product and product-related services revenue $ 6,366,220 $ 8,906,828 Revenue by primary geographic market for the years ended December 31, 2022 and 2021 was as follows: December 31, 2022 United States Europe Other Product revenue 1,904,025 1,839,445 6,577 Product-related services revenue 2,237,691 358,905 19,577 Total product and product-related services revenue $ 4,141,716 $ 2,198,350 $ 26,154 December 31, 2021 United States Europe Other Product revenue 3,114,818 2,026,728 31,042 Product-related services revenue 3,063,381 198,336 472,523 Total product and product-related services revenue $ 6,178,199 $ 2,225,064 $ 503,565 Sale of instruments and consumables The delivery of each instrument and the related installation and calibration are considered to be a single performance obligation, as the HTG EdgeSeq instrument must be professionally installed and calibrated prior to use. Instrument product revenue is generally recognized upon installation and calibration of the instrument by field service engineers, which represents the point at which the customer has the ability to use the instrument and has accepted the asset. Installation generally occurs within one month of instrument shipment. The delivery of each consumable is a separate performance obligation. Consumables revenue is recognized upon transfer of control, which represents the point when the customer has legal title and the significant risks of ownership of the asset. The Company’s standard terms and conditions provide that no right of return exists for instruments and consumables, unless replacement is necessary due to delivery of defective or damaged product. Customer payment terms vary but are typically between 30 and 90 days of revenue being earned from shipment or delivery, as applicable. Shipping and handling fees charged to customers for instruments shipped are included in the consolidated statements of operations as part of product and product-related services revenue. Shipping and handling costs for products shipped to customers are included in the consolidated statements of operations as part of cost of product and product-related services revenue. We have elected the practical expedient to account for shipping and handling as activities to fulfill the promise to transfer the consumables. The Company provides instruments to certain customers under reagent rental agreements. Under these agreements, the Company installs an instrument in the customer’s facility without a fee and the customer agrees to purchase consumable products at a stated price over the term of the agreement; in some instances, the agreements do not contain a minimum purchase requirement. Terms range from several months to multiple years and may automatically renew in several month or multiple year increments unless either party notifies the other in advance that the agreement will not renew. The Company measures progress toward complete satisfaction of this performance obligation to provide the instrument and deliver the consumables using an output method based on the number of consumables delivered in relation to the total consumables to be provided under the reagent rental agreement. This is considered to be representative of the delivery of outputs under the arrangement and the best measure of progress because the customer benefits from the instrument only in conjunction with the consumables. The Company expects to recover the cost of the instrument under the agreement through the fees charged for consumables, to the extent sold, over the term of the agreement. RUO Sample Processing The Company also provides sample preparation and processing services and molecular profiling of retrospective cohorts for its customers through its VERI/O laboratory, whereby the customer provides samples to be processed using HTG EdgeSeq technology specified in the order. Customers are charged a per sample fee for sample processing services which is recognized as revenue upon delivery of a data file to the customer showing the results of testing and completing delivery of the agreed upon service. This is when the customer can use and benefit from the results of testing and the Company has the present right to payment. Custom RUO Assay Design The Company enters into custom RUO assay design agreements that may generate up-front fees and subsequent payments that may be earned upon completion of design process phases. The Company measures progress toward complete satisfaction of its performance obligation to perform custom RUO assay design procedures using an output method based on the costs incurred to date compared with total expected costs, as this is representative of the delivery of outputs under the arrangements and the best measure of progress. However, because in most instances the assay development fees are contingent upon completion of each phase of the design project and the decision of the customer to proceed to the next phase, the amount to be included in the transaction price and recognized as revenue is limited to that which the customer is contractually obligated to pay upon completion of that phase, which is when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. Changes in estimates of total expected costs are accounted for prospectively as a change in estimate. From period to period, custom RUO design services revenue can fluctuate substantially based on the completion of design-related phases. The Company did no t recognize any custom RUO assay design revenue from performance obligations that were satisfied in previous periods during the years ended December 31, 2022 or 2021. Contract Liabilities The Company may receive up-front payments from customers for custom RUO assay design and sample processing services. In addition, payments for instrument extended warranty contracts are required to be made in advance. The Company recognizes such up-front payments as contract liabilities. The contract liabilities are subsequently reduced as revenue is recognized. Contract liabilities of approximately $ 0.2 million and $ 0.1 million were included in other current liabilities as of December 31, 2022 and 2021, respectively, and an additional immaterial amount of contract liabilities were included in other non-current liabilities as of each date in the consolidated balance sheets reflecting the period in which the Company expects to realize the deferred revenue. Changes in the Company’s contract liabilities were as follows as of the dates indicated: Product Sample Total Contract Balance at January 1, 2022 $ 128,529 $ 30,621 $ 159,150 Deferral of revenue 293,158 197,904 491,062 Recognition of deferred revenue ( 274,973 ) ( 201,525 ) ( 476,498 ) Balance at December 31, 2022 $ 146,714 $ 27,000 $ 173,714 Product Sample Total Contract Balance at January 1, 2021 $ 103,580 $ 93,884 $ 197,464 Deferral of revenue 286,349 587,091 873,440 Recognition of deferred revenue ( 261,400 ) ( 650,354 ) ( 911,754 ) Balance at December 31, 2021 $ 128,529 $ 30,621 $ 159,150 |
Other Agreements
Other Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Other Agreements [Abstract] | |
Other Agreements | Note 10. Other Agreements NuvoGen Obligation The Company entered into an asset purchase agreement in 2001, as amended, with NuvoGen Research, LLC (“NuvoGen”) to acquire certain intellectual property from NuvoGen. The Company accounted for the transaction as an asset acquisition. However, as the intellectual property was determined to not have an alternative future use, the upfront consideration was expensed. In exchange for the intellectual property, the Company agreed to pay total aggregate cash compensation to NuvoGen under the agreement of $ 15.0 million. Certain terms of the agreement were amended in November 2003, September 2004, November 2012 and February 2014. Pursuant to the latest amendment to the agreement, the Company is obligated to pay the greater of $ 0.4 million or 6 % of annual revenue until the obligation is paid in full. The Company paid yearly fixed fees, in quarterly installments, to NuvoGen of $ 0.4 million as well as revenue-based payments of approximately $ 0.1 million during the years ended December 31, 2022 and 2021 , respectively, for the amount by which 6% of revenue exceeded the applicable fixed fee. Beginning on January 1, 2019 and continuing until the remaining obligation has been paid in full, interest on the remaining unpaid obligation is being accrued and will compound annually at a rate of 2.5 % per year. Accrued interest related to this obligation is payable on the date that the remaining obligation is paid in full. Minimum payments to be made in 2023 include $ 46,031 of revenue-based payments payable as of December 31, 2022 and an estimate of additional revenue-based payments to be made throughout the remainder of 2023 relating to revenue generated in the first, second and third quarters of 2023 using actual revenue generated in the same quarters in 2022. Minimum payments for the remaining years include only the minimum payments for each year. Actual payments could be significantly more than provided in the table, to the extent that 6% of the Company’s annual revenue in those years exceeds $ 0.4 million: 2023 $ 446,031 2024 400,000 2025 400,000 2026 400,000 2027 400,000 2028 and beyond 1,863,438 Total NuvoGen obligation payments 3,909,469 Plus interest accretion 55,620 Total NuvoGen obligation, net $ 3,965,089 The Company recorded the obligation at the estimated present value of the future payments using a discount rate of 2.5 %, which represented the Company’s estimate of its effective borrowing rate for similar obligations. The unamortized interest accretion was $( 55,620 ) and $( 67,088 ) as of December 31, 2022 and 2021, respectively. Discount accreted during the years ended December 31, 2022 and 2021 was $( 11,467 ) , and $( 12,288 ) , respectively, and was included in interest expense in the consolidated statements of operations. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Leases | Note 11. Leases Operating Leases The Company leases office space under agreements classified as operating leases. The Company’s active leases as of December 31, 2022 relate to the Company’s office and manufacturing space in Tucson, Arizona, and expire in 2025 . The Company’s leases do not include any contingent rental payments, impose any financial restrictions, or contain any residual value guarantees. The Company amended its Tucson facility leases in September 2021 to extend the terms of the leases for three years through January 31, 2025. The lease extension was treated as a lease modification for accounting purposes, and allows for an additional extension of two years on the same terms and conditions of the existing amended lease agreement, except that the lease rates would be adjusted to reflect lease rates applicable to like-kind buildings within the market at the time that the Company elects to exercise the extension options, but in no event less than the last applicable rental rate. The Company has not accounted for these renewal options in the calculation of the lease liabilities and right-of-use assets as the Company is not reasonably certain to exercise the options. In the fourth quarter of 2022, the Company recorded an increase to its operating lease liability as the result of leasehold improvements financed by the landlord, to be repaid in equal installments over the remaining term of the lease. In the first quarter of 2021, the Company closed its development laboratory in San Carlos, California and, as a result, $ 0.2 million of operating right-of-use assets related to the abandonment of the laboratory were written off to research and development expense for the year ended December 31, 2021. Variable expenses generally represent the Company’s share of the landlord’s operating expenses and are recorded when incurred. Incremental borrowing rates used to discount future lease payments in calculating lease liabilities were estimated by reference to the rates for similar length secured lines of credit to the Company’s lease agreements provided by the Company’s lenders at the time that the lease liabilities were recorded, as these rates represented the cost of borrowing for secured loans of similar duration. The Company does not have any operating lease arrangements where it acts as a lessor. The components of lease cost for operating leases were as follows: Years Ended December 31, 2022 2021 Operating leases Operating lease cost $ 483,956 $ 503,130 Variable lease cost 99,989 88,708 Total rent expense $ 583,945 $ 591,838 The table below summarizes other information related to the Company’s operating leases: Years Ended December 31, 2022 2021 Cash paid for amounts included in measurement of operating lease liabilities $ 487,673 $ 514,453 Establishment of operating lease liabilities arising from obtaining right-of-use- assets 77,385 1,302,457 Weighted-average remaining lease term – operating leases 2.1 3.1 Weighted-average discount rate – operating leases 5.8 % 5.8 % Remaining maturities of the Company’s operating leases, included in operating lease liabilities – current and operating lease liabilities - non-current, net of discount, in the consolidated balance sheets as of December 31, 2022, are as follows: 2023 $ 521,467 2024 521,379 2025 43,444 Total 1,086,290 Less present value discount ( 64,840 ) Total operating lease liabilities 1,021,450 Less operating lease liabilities - current ( 475,126 ) Operating lease liabilities - non-current $ 546,324 Financing Leases The Company has a small number of computer and copier equipment leases that are classified as financing leases. Incremental borrowing rates used to discount future lease payments in calculating lease liabilities were estimated by reference to information received by the Company from bankers regarding estimated current borrowing rates for collateralized loans with similar amount and duration as the leases. The Company did not have any material financing leases as of either the year ended December 31, 2022 or 2021. |
Net Loss per Share
Net Loss per Share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Note 12. Net Loss Per Share Basic loss per common share is computed by dividing the net loss allocable to common stockholders by the weighted-average number of shares of common stock or common stock equivalents outstanding. Diluted loss per common share is computed similar to basic loss per common share except that it reflects the potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised or converted into common stock. The following table provides a reconciliation of the numerator and denominator used in computing basic and diluted net loss per share for the periods presented: Years Ended December 31, 2022 2021 Numerator: Net loss $ ( 21,594,476 ) $ ( 17,145,170 ) Denominator: Weighted-average shares outstanding-basic and diluted * 889,284 578,011 Net loss per share, basic and diluted $ ( 24.28 ) $ ( 29.66 ) *Reflects the retrospective adjustment related to the reverse stock split completed on December 20, 2022. The following common stock equivalents were excluded from the computation of diluted net loss per share for the periods presented because their effect would have been anti-dilutive: Years Ended December 31, 2022 2021 Options to purchase common stock 76,099 46,611 Series A Preferred — 13,212 Common stock warrants 3,164,267 4,890 Unvested restricted stock units 1,041 2,598 |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2022 | |
Proceeds from Issuance of Preferred Stock, Preference Stock, and Warrants [Abstract] | |
Warrants | Note 13. Warrants In connection with certain of its redeemable convertible preferred stock issuances, debt agreements, convertible debt and other financing arrangements, the Company has issued warrants for shares of its common stock and various issues of its redeemable convertible preferred stock which have since been converted to common stock warrants. In connection with the March 2022 Securities Purchase Agreement (see Note 14), the Company issued and sold pre-funded warrants exercisable for an aggregate of 200,911 shares of common stock. The pre-funded warrants had an exercise price of $ 0.012 per share and were exercised in full in May 2022 for proceeds of $ 2,411 . The Company also issued and sold to the investor common warrants to purchase 270,415 shares of common stock that will expire on March 17, 2024 and common warrants to purchase an additional 270,415 shares of common stock that will expire on September 17, 2027 . Each of these common warrants became exercisable commencing September 21, 2022 and has an exercise price of $ 24.744 per share. In connection with the December 2022 Securities Purchase Agreement (see Note 14), the Company issued and sold pre-funded warrants exercisable for an aggregate of 1,188,322 shares of common stock. The pre-funded warrants had an exercise price of $ 0.001 per share and were exercised in full in December 2022 for proceeds of $ 1,188 . The Company also issued and sold to the investor warrants to purchase 1,290,322 shares of common stock that will expire on December 23, 2027 and warrants to purchase an additional 1,290,322 shares of common stock that will expire on December 23, 2024 . Each of these common warrants became exercisable commencing December 23, 2022 and has an exercise price of $ 7.50 per share. Also in connection with the December 2022 Securities Purchase Agreement, the Company issued warrants to purchase up to an aggregate of 38,709 shares of common stock to designees of the placement agent for the transaction. The warrants issued to the placement agent have substantially the same terms as the warrants above, except the placement agent warrants have an exercise price of $ 9.6875 per share and expire on December 21, 2027 . The following table shows the common stock warrants outstanding as of December 31, 2022: Warrant Issuance Date Shares of Stock Exercise Expiration Date August 2014 159 $ 4,231.80 2024 March 2016 251 496.80 2026 March 2018 100 1,391.40 2028 June 2020 3,574 139.878 2030 March 2022 270,415 24.74 2024 March 2022 270,415 24.74 2027 December 2022 1,290,322 7.50 2024 December 2022 1,290,322 7.50 2027 December 2022 38,709 9.6875 2027 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | Note 14. Stock holders’ Equity Reverse Stock Split On December 20, 2022, the Company completed a reverse stock split of its outstanding shares of common stock pursuant to which every 12 shares of issued and outstanding common stock were exchanged for one share of common stock. No fractional shares were issued in the reverse stock split. Instead, fractional shares that would have otherwise resulted from the stock split were purchased by us at the applicable percentage of $ 8.20 per share. All share and per share amounts included within these consolidated financial statements have been retrospectively adjusted to reflect the reverse stock split. Equity Offerings September 2019 Securities Purchase Agreement In September 2019, concurrently with the closing of an underwritten public offering, the Company entered into a Securities Purchase Agreement (the "September 2019 Securities Purchase Agreement") with certain institutional accredited investors (the "Purchasers"), pursuant to which the Company sold the Purchasers, in a private placement transaction, warrants to purchase up to an aggregate of 30,064 shares of its common stock ("Warrant Shares"), at a price of $ 115.20 per warrant (which $ 115.20 price related to the pre-funded portion of the total $ 117.00 exercise price per share). Each pre-funded warrant had a remaining exercise price of $ 1.80 per share and became immediately exercisable upon issuance, subject to certain beneficial ownership limitations. In June 2021, the remaining 12,416 pre-funded warrants were exercised on a cashless, net exercise basis, resulting in the issuance of 12,073 shares of common stock. ATM Offering In November 2019, the Company entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. ("Cantor") as sales agent, pursuant to which the Company was able to offer and sell, from time to time, through Cantor, shares of its common stock, par value $ 0.001 per share, by any method deemed to be an "at the market offering" as defined by rule 415(a)(4) under the Securities Act (the "ATM Offering"). During the year ended December 31, 2021, the Company sold 170,907 shares of common stock under the ATM Offering at then-market prices for net proceeds of approximately $ 10.7 million after paying sales commissions of approximately $ 0.3 million. LP Purchase Agreement In March 2020, the Company entered into a purchase agreement ("LP Purchase Agreement") with Lincoln Park Capital Fund, LLC ("Lincoln Park"), pursuant to which, upon the terms and subject to the conditions and limitations set forth therein, the Company had the right to sell to Lincoln Park up to $ 20.0 million of shares of its common stock ("Purchase Shares") from time to time over the 36-month term of the LP Purchase Agreement. During the year ended December 31, 2021, the Company sold 12,864 shares of common stock under the LP Purchase Agreement at a weighted average price of $ 69.96 per share for total gross proceeds of approximately $ 0.9 million. The LP Purchase Agreement is no longer in effect. Exchange and Private Placement In February 2020, the Company entered into an Exchange and Purchase Agreement with certain accredited investors pursuant to which the Company agreed to (i) issue the investors an aggregate of 41,100 shares of its newly designated Series A Convertible Preferred Stock, par value $ 0.001 per share ("Series A Preferred"), in exchange for the investors surrendering to the Company for cancellation an aggregate of 22,833 shares of its common stock and (ii) sell and issue to the investors an aggregate of 10,170 shares of Series A Preferred for an aggregate purchase price of $ 0.6 million, or $ 59.00 per share. In March 2022, the remaining 23,770 shares of Series A Preferred were converted by the investors into an aggregate of 13,206 shares of common stock. Accordingly, no shares of Series A Preferred are outstanding as of December 31, 2022. All of the previously designated Series A Preferred have resumed the status of authorized, unissued and undesignated preferred stock, which may be designated from time to time by the Company's Board of Directors. March 2022 Securities Purchase Agreement In March 2022, the Company entered into a Securities Purchase Agreement (the “March 2022 Securities Purchase Agreement”) with a single investor pursuant to which it agreed to issue to the investor 270,415 units at a price of $ 27.744 per unit (less $ 0.012 for each pre-funded warrant purchased in lieu of a share of common stock) for net proceeds, after deducting the placement agent fees and other estimated fees and expenses, of approximately $ 7.0 million. Each unit consists of one share of common stock (or one pre-funded warrant in lieu thereof), a common warrant to purchase one share of common stock with a term of 24 months from the issuance date, and a common warrant to purchase one share of common stock with a term of 66 months from the issuance date. Each of the common warrants became exercisable commencing on September 21, 2022 and has an exercise price of $ 24.744 per share. Each pre-funded warrant has an exercise price of $ 0.012 per share and does not expire until exercised in full. The pre-funded warrants may not be exercised if the aggregate number of shares of common stock beneficially owned by the holder thereof would exceed 9.99 % immediately after exercise thereof. In May 2022, the 200,911 pre-funded warrants were exercised for proceeds of $ 2,411 . The common warrants issued in this transaction may not be exercised if the aggregate number of shares of common stock beneficially owned by the holder thereof would exceed 4.99 % immediately after exercise thereof, which ownership cap may be increased by the holder up to 9.99 % upon 61 days’ prior notice. Cantor served as the placement agent in connection with the March 2022 Securities Purchase Agreement. The Company paid Cantor a fee of approximately $ 0.3 million plus reimbursement for certain out-of-pocket expenses for its role as placement agent and has incurred approximately $ 0.2 million of additional transaction costs. December 2022 Securities Purchase Agreement In December 2022, in connection with a best-efforts public offering, the Company entered into a Securities Purchase Agreement (the "December 2022 Securities Purchase Agreement") with a certain institutional investor, pursuant to which the Company sold the investor 1,290,322 units at a combined public offering price of $ 7.75 per share (less $ 0.001 for each pre-funded warrant purchased in lieu of a share of common stock) for net proceeds, after deducting the Placement Agent fees and expenses and other estimated fees and expenses, of approximately $ 8.7 million. Each unit consisted of one share of common stock (or one pre-funded warrant in lieu thereof), a common warrant to purchase one share of common stock with a term of 24 months from the issuance date, and a common warrant to purchase one share of common stock with a term of 60 months from the issuance date. The common warrants issued in this transaction may not be exercised if the aggregate number of shares of common stock beneficially owned by the holder thereof would exceed 4.99 % immediately after exercise thereof, which ownership cap may be increased by the holder up to 9.99 % upon 61 days’ prior notice. Each pre-funded warrant had an exercise price of $ 0.001 per share and did not expire until exercised in full. In December 2022, the 1,188,322 pre-funded warrants were exercised for proceeds of $ 1,188 . Each of the common warrants became immediately exercisable upon issuance and has an exercise price of $ 7.50 per share. The exercise price of the warrants issued in this agreement is subject to adjustment for stock split, reverse splits and similar capital transactions as described in the warrants. H.C. Wainwright & Co., LLC (the "Placement Agent") served as the exclusive placement agent in connection with the December 2022 Securities Purchase Agreement. The Company paid the Placement Agent a cash fee of 6.5 % of the aggregate gross proceeds raised at the closing of the December 2022 Securities Purchase Agreement, plus a management fee equal to 0.5 % of the gross proceeds raised at the closing, and reimbursement of certain expenses and legal fees in the amount of $ 125,000 . The Company also issued to designees of the Placement Agent warrants to purchase up to an aggregate of 38,709 shares of common stock (the “Placement Agent warrants”). The Placement Agent warrants have substantially the same terms as the warrants issued under the December 2022 Securities Purchase Agreement, except the Placement Agent warrants have an exercise price of $ 9.6875 per share and expire on December 21, 2027. Common Stock Pursuant to its amended and restated certificate of incorporation, the Company is authorized to issue 26,666,667 shares of common stock at a par value of $ 0.001 per share. Each share of common stock is entitled to one vote. The shares of common stock have no preemptive or conversion rights, no redemption or sinking fund provisions, no liability for further call or assessment, and are not entitled to cumulative voting rights. Preferred Stock Pursuant to its amended and restated certificate of incorporation, the Company has been authorized to issue 10,000,000 shares of preferred stock, each having a par value of $ 0.001 . The preferred stock may be issued from time to time in one or more series with the authorization of the Company’s Board of Directors. The Board of Directors can determine voting power for each series issued, as well as designation, preferences, and relative, participating, optional or other rights and such qualifications, limitations or restrictions thereof. Series A Preferred Stock In October 2022, the Company entered into a Purchase Agreement (the "Purchase Agreement" with Ann Hanham, Ph.D., the Chair of the Company's Board of Directors (the "Purchaser"), pursuant to which the Company agreed to issue and sell one share of the Company's newly designated Series A Preferred Stock, par value $ 0.001 per share (the "Series A Preferred Stock"), to the Purchaser for a purchase price of $ 100.00 . The Series A Preferred Stock was non-convertible, generally had voting rights only with respect to a proposal to authorize a reverse split of our common stock, and was automatically redeemed in an event certain to occur. On November 29, 2022, the one share of Series A Preferred Stock was redeemed for $ 100.00 upon stockholder approval of a reverse stock split. Stock-based Compensation The Company incurs stock-based compensation expense relating to the grants of RSUs and stock options to employees, non-employee directors and consultants under its equity incentive plans and through stock purchase rights granted under the ESPP. Equity Incentive Plans In August 2020, the Company’s stockholders, upon the recommendation of the Company’s Board of Directors, approved the 2020 Equity Incentive Plan (the “2020 Plan”) as a successor to and continuation of the previous 2001 Stock Option Plan, 2011 Equity Incentive Plan and 2014 Equity Incentive Plan (the "2014 Plan"). Upon approval of the 2020 Plan, 62,057 shares, including 5,712 remaining shares reserved for issuance under the 2014 Plan (excluding shares available for the granting of inducement awards under the 2014 Plan’s inducement share pool), were reserved for issuance under the 2020 Plan. No new awards may be granted under the 2001, 2011 or 2014 equity plans. There were 16,668 shares of the Company’s common stock available for issuance under the 2020 Plan as of December 31, 2022 in addition to shares that may become available from time to time as shares of our common stock subject to outstanding awards granted under the 2014 Plan (excluding Inducement Awards) or the 2011 Plan that, following the effective date of the 2020 Plan (i) are not issued because such award or any portion thereof expires or otherwise terminates without all of the shares covered by such award having been issued; (ii) are not issued because such award or any portion thereof is settled in cash; or (iii) are forfeited back to or repurchased by the Company because of the failure to meet a contingency or condition required for the vesting of such shares. The 2020 Plan does not contain an evergreen provision. In July 2021, the Company’s Board of Directors adopted the Company’s 2021 Inducement Plan (the “2021 Inducement Plan”), pursuant to which 25,000 shares were initially authorized and reserved for issuance exclusively for the grant of awards to individuals who were not previously employees or non-employee directors of the Company, as inducement material to the individuals’ entering into employment with the Company (“Inducement Awards”). There were 13,961 shares of the Company’s stock available for issuance under the 2021 Inducement Plan as of December 31, 2022, in addition to shares that may become available from time to time as shares of the Company’s common stock subject to outstanding awards granted under the 2021 Inducement Plan are forfeited back to or repurchased by the Company because of the failure to meet a contingency or condition required for the vesting of such shares. The Company’s Board of Directors determines the grant date for all awards granted under the equity plans. The exercise price of stock options granted is generally equal to the closing price of the Company’s common stock on the date of grant. All stock options granted have a ten-year term. The vesting period of stock options and RSUs is established by the Company’s Board of Directors but typically ranges between one and four years . Amounts recognized in the consolidated statements of operations with respect to the Company’s equity incentive plans were as follows: Years Ended December 31, 2022 2021 Selling, general and administrative $ 559,226 $ 1,154,000 Research and development 197,705 141,281 Cost of product and product-related services revenue 17,229 22,074 $ 774,160 $ 1,317,355 The following table summarizes stock option activity (including Inducement Award activity) during the two-year period ended December 31, 2022: Number of Weighted- Weighted- Aggregate Balance at January 1, 2021 40,602 $ 201.36 8.6 $ 1,536 Granted 12,819 65.40 Exercised ( 6 ) 52.20 $ 107 Forfeited ( 4,406 ) 143.76 Expired/Cancelled ( 2,398 ) 244.68 Balance at December 31, 2021 46,611 $ 167.16 8.2 $ 30,267 Granted 39,667 12.91 Exercised — — Forfeited ( 4,944 ) 66.58 Expired/Cancelled ( 5,235 ) 292.56 Balance at December 31, 2022 76,099 $ 84.73 8.3 $ - Exercisable at December 31, 2021 24,915 $ 241.68 7.4 $ 6,269 Exercisable at December 31, 2022 38,096 $ 142.34 7.6 $ - The weighted-average fair value of stock options granted was $ 10.50 and $ 52.56 for the years ended December 31, 2022 and 2021 , respectively. Stock option activity includes 8,748 Inducement Awards outstanding as of December 31, 2022, including 3,332 Inducement Awards granted and 3,750 Inducement Awards cancelled or forfeited during the year ended December 31, 2022 and 9,166 Inducement Awards granted during the year ended December 31, 2021. As of December 31, 2022, total unrecognized compensation cost related to non-vested stock options was approximately $ 0.8 million, which is expected to be recognized over approximately 1.87 years . The fair value of each stock option granted has been determined using the Black-Scholes option pricing model. The material factors incorporated in the Black-Scholes model in estimating the fair value of the stock options granted for the periods presented were as follows: 2022 2021 Fair value of common stock on grant date $ 8.28 - 49.27 $ 48.84 - 75.00 Risk-free interest rate 1.53 % - 3.64 % 0.85 % - 1.20 % Expected volatility 89.6 % - 110.7 % 104.2 % - 107.3 % Expected term 5.5 to 5.8 years 5.2 to 6.1 years Expected dividend yield 0 % 0 % • Expected stock price volatility . The expected volatility assumption is derived from the volatility of the Company’s common stock during the years ended December 31, 2022 and 2021. • Risk-free interest rate . The risk-free interest rate assumption is based on observed interest rates on the date of grant with maturities approximately equal to the expected term. • Expected term . The expected term represents the period that the stock-based awards are expected to be outstanding. The Company’s historical share option exercise experience does not provide a reasonable basis upon which to estimate an expected term because of a lack of sufficient data. Therefore, the Company estimates the expected term by using the simplified method provided by the SEC. The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life of the stock options. • Expected dividend yield . The expected dividend is assumed to be zero as the Company has never paid dividends and does not anticipate paying any dividends on its common stock. In preparing its Black-Scholes option-pricing model fair value calculations, the Company does not estimate a forfeiture rate to calculate stock-based compensation. The Company uses judgment in evaluating the expected volatility and expected terms utilized for the Company’s stock-based compensation calculations on a prospective basis. The following table summarizes RSU activity (including Inducement Award activity) during the two-year period ended December 31, 2022: Number of Weighted- Balance at January 1, 2021 1,017 $ 343.32 Granted 2,500 62.40 Released ( 377 ) 349.56 Forfeited ( 542 ) 290.16 Balance at December 31, 2021 2,598 $ 83.16 Granted 416 8.29 Released ( 1,139 ) 110.47 Forfeited ( 626 ) 62.50 Balance at December 31, 2022 1,249 $ 44.40 Vested and unissued at December 31, 2022 208 $ 62.42 The weighted-average fair value of RSUs granted was $ 8.29 and $ 62.40 for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, total unrecognized compensation cost related to non-vested RSUs was approximately $ 41,600 , which is expected to be recognized over approximately 0.91 years . RSU activity includes 1,249 Inducement Awards outstanding as of December 31, 2022, including 416 Inducement Awards granted, 1,041 Inducement Awards released and 626 Inducement Awards forfeited during the year ended December 31, 2022 and 2,500 Inducement Awards granted in the year ended December 31, 2021. Vested and unissued awards at December 31, 2022 represents RSU awards granted in November 2021 for which a portion of the awards vested on December 31, 2022 , but for which issuance of shares occurred in January 2023. 2014 Employee Stock Purchase Plan In April 2015, the Company’s stockholders approved the 2014 Employee Stock Purchase Plan (the “2014 ESPP"), which became effective in May 2015. Under the 2014 ESPP, the number of shares of common stock reserved for issuance automatically increased on January 1 of each calendar year, from January 1, 2016 to January 1, 2021 by the lesser of (i) 1% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, (ii) 1,083 shares, or (iii) a number determined by the Company’s Board of Directors that is less than (i) and (ii) . The 2014 ESPP enables participants to contribute up to 15 % of such participant’s eligible compensation during a defined period (not to exceed 27 months) to purchase common stock of the Company. The purchase price of common stock under the 2014 ESPP is the lesser of: (i) 85 % of the fair market value of a share of the Company’s common stock on the first day of an offering or (ii) 85 % of the fair market value of the Company’s common stock at the applicable purchase date. In August 2021, the Company’s stockholders, upon the recommendation of the Company’s Board of Directors, approved the Amended and Restated 2014 Employee Stock Purchase Plan (the “Amended 2014 ESPP”). Upon approval of the Amended 2014 ESPP, 41,666 shares of the Company’s common stock were reserved for issuance under the Amended 2014 ESPP in addition to 2,023 shares of the Company’s common stock reserved for issuance under the original 2014 ESPP. The Amended 2014 ESPP does not contain an evergreen provision; all other provisions of the 2014 ESPP remained unchanged. Amounts recognized in the consolidated statements of operations with respect to the Amended 2014 ESPP were as follows: Years Ended December 31, 2022 2021 Selling, general and administrative $ 22,187 $ 34,219 Research and development 11,046 11,643 Cost of product and product-related services revenue 7,114 11,807 $ 40,347 $ 57,669 During the year ended December 31, 2022, employees purchased the following shares at the end of each of the six-month purchase periods: June 2022 December 2022 Number of Price Number of Price Total number of shares purchased 4,083 $ 5.71 2,792 $ 5.10 During the year ended December 31, 2021, employees entering the plan at various times throughout the offering period purchased the following shares at the end of each of the six-month purchase periods: June 2021 December 2021 Number of Price Number of Price Total number of shares purchased 1,136 $ 47.04 1,693 $ 42.72 As of December 31, 2022, approximately 35,120 shares of the Company’s common stock were reserved for future issuance under the Amended 2014 ESPP. The Company recognizes employee stock purchase plan expense based on the fair value of stock purchase rights, estimated for each six-month purchase period using the Black-Scholes option pricing model. The model requires the Company to make subjective assumptions, including expected stock price volatility, risk free rate of return and estimated life. The fair value of equity-based awards is amortized straight-line over the vesting period of the award. The material factors incorporated in the Black-Scholes model in estimating the fair value of employee stock purchase plan stock purchase rights for the periods presented were as follows: 2022 2021 Fair value of common stock $ 6.00 - 49.80 $ 56.04 - 70.20 Risk-free interest rate 0.11 % - 2.25 % 0.04 % - 0.08 % Expected volatility 64.9 % - 96.7 % 71.9 % - 89.2 % Expected term 0.5 years 0.5 years Expected dividend yield 0 % 0 % • Fair value of common stock . Estimated as the price of the Company’s common stock on the first day of each offering period. • Expected stock price volatility . The expected volatility assumption is derived from the volatility of the Company’s common stock in recent periods for the years ended December 31, 2022 and 2021. • Risk-free interest rate . The risk-free interest rate assumption is based on observed interest rates on the first day of the purchase period with maturities approximately equal to the expected term. • Expected term . The expected term represents the length of a purchase period under the Amended 2014 ESPP. • Expected dividend yield . The expected dividend is assumed to be zero as the Company has never paid dividends and does not anticipate paying any dividends on its common stock. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 15. Commitments and Contingencies Legal Matters The Company’s industry is characterized by frequent claims and litigation, including claims regarding intellectual property and product liability. As a result, the Company may be subject to various legal proceedings from time to time. The results of any current or future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors. Any current litigation is considered immaterial and counter claims have been assessed as remote. Employee Agreements The Company has entered into Severance and Change in Control Plan agreements with certain named executive officers and various other members of management, which provide salary continuation payments, bonuses and, in certain instances, the acceleration of the vesting of certain equity awards to individuals in the event that the individual is terminated other than for cause, as defined in the applicable agreement. Indemnification Agreements In the course of operating its business, the Company has entered into, and continues to enter into, separate indemnification agreements with the Company’s directors and executive officers, in addition to the indemnification provided for in the Company’s amended and restated bylaws. These agreements may require the Company to indemnify its directors and executive officers for certain expenses incurred in any action or proceeding arising out of their services as one of the Company’s directors or executive officers. Product Warranty The following is a summary of the Company’s general product warranty liability. Product warranty liabilities of approximately $ 73,000 and $ 15,000 were included in accrued liabilities and other non-current liabilities, respectively, in the accompanying consolidated balance sheets as of December 31, 2022. Expense relating to the recording of this reserve is recorded in cost of product and product-related services revenue within the accompanying consolidated statements of operations. December 31, 2022 2021 Beginning balance $ 120,385 $ 92,696 Cost of warranty claims ( 147,192 ) ( 166,641 ) Increase in warranty reserve 115,089 194,330 Ending balance $ 88,282 $ 120,385 Defined Contribution Plan In January 2003, the Company established a defined contribution plan (“401(k) Plan”) under section 401(k) of the Internal Revenue Code of 1986, as amended. All employees who are over the age of 21 and who are expected to work at least 1,000 hours in a calendar year are eligible for participation in the 401(k) Plan upon commencement of employment with the Company. The Company may make discretionary contributions to the 401(k) Plan but has no t done so during the years ended December 31, 2022 and 2021 . |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 16. Income Taxes The Company provides for income taxes based upon management’s estimate of taxable income or loss for each respective period. The Company recognizes an asset or liability for the deferred tax consequences of temporary differences between the tax bases of assets and liabilities and their reported amounts in the financial statements. These temporary differences would result in deductible or taxable amounts in future years, when the reported amounts of the assets are recovered or liabilities are settled, respectively. In each period since inception, the Company has recorded a valuation allowance for the full amount of its net deferred tax assets, as the realization of the net deferred tax assets is uncertain. As a result, the Company has not recorded any federal or state income tax benefit in the accompanying consolidated statements of operations; however, income tax expense has been recorded for state minimum and foreign income taxes. The Company periodically reviews its filing positions for all open tax years in all U.S. federal, state and international jurisdictions where the Company is or might be required to file tax returns or other required reports. The Company applies a two-step approach to recognizing and measuring uncertain tax positions. The Company evaluates the tax position for recognition by determining if the weight of available evidence indicates that it is “more likely than not” that the position will be sustained on audit, including resolution of related appeals or litigation process, if any. The term “more likely than not” means a likelihood of more than 50 percent. If the tax position is not more likely than not to be sustained in a court of last resort, the Company may not recognize any of the potential tax benefit associated with the position. The Company recognizes a benefit for a tax position that meets the more likely than not criterion at the largest amount of tax benefit that is greater than 50 percent likely of being realized upon its effective resolution. Unrecognized tax benefits involve management’s judgment regarding the likelihood of the benefit being sustained. The final resolution of uncertain tax positions could result in adjustments to recorded amounts and may affect the Company’s results of operations, financial position and cash flows. As discussed below, the Company has estimated $3.4 million and $3.2 million of uncertain tax positions as of December 31, 2022 and 2021, respectively, related to certain tax credit carryforwards. The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company had no accrual for interest or penalties at December 31, 2022 or 2021, and has not recognized interest or penalties during the years ended December 31, 2022 and 2021, since there was no reduction in income taxes paid due to uncertain tax positions. Management of the Company believes no significant change to the amount of unrecognized tax benefits will occur within the next 12 months. The following table summarizes loss before income taxes: Years Ended December 31, 2022 2021 U.S. pre-tax loss $ ( 21,611,254 ) $ ( 17,156,070 ) Foreign pre-tax gain (loss) 27,615 33,375 Loss before income taxes $ ( 21,583,639 ) $ ( 17,122,695 ) The components of income tax expense are as follows: Years Ended December 31, 2022 2021 Current: Federal $ — $ — State 3,270 13,769 Foreign 7,567 8,706 Total current income tax expense $ 10,837 $ 22,475 Deferred: Federal $ — $ — State — — Foreign — — Total deferred income tax expense $ — $ — Total income tax expense $ 10,837 $ 22,475 The Company’s actual income tax expense for the years ended December 31, 2022 and 2021 differ from the expected amount computed by applying the statutory federal income tax rate to loss before income taxes as follows: Years Ended December 31, 2022 2021 Computed tax (benefit) at 21 % $ ( 4,532,565 ) $ ( 3,586,925 ) State taxes, net of federal benefit ( 989,018 ) ( 1,177,951 ) Stock-based compensation 128,789 240,177 Foreign tax rate differential 5,635 ( 2,171 ) Return to provision 13,047 53,340 Nontaxable loan forgiveness — ( 360,570 ) Other 17,615 9,048 Research and development tax credit - state ( 234,971 ) ( 265,362 ) Research and development tax credit - federal ( 235,910 ) ( 212,408 ) Uncertain tax position adjustment for prior periods ( 8,856 ) ( 6,395 ) Increase in valuation allowance 5,847,071 5,331,692 $ 10,837 $ 22,475 Deferred tax assets and liabilities comprise the following: Years Ended December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 50,968,402 $ 47,752,053 Research and development credits 4,393,368 3,940,199 R&D expenditures capitalization 2,001,908 — Deferred revenue 45,373 42,802 Inventory reserve 310,983 6,806 Fixed assets and intangibles 291,244 304,019 Accrued NuvoGen liability 1,035,659 1,196,563 Lease liability 266,797 366,653 Other 755,029 711,343 Gross deferred tax assets 60,068,763 54,320,438 Valuation allowance ( 59,805,688 ) ( 53,958,617 ) Deferred tax assets, net 263,075 361,821 Deferred tax liabilities: Right of use asset 263,075 361,821 Total deferred tax liabilities 263,075 361,821 Net deferred tax assets (liabilities) $ - $ - As of December 31, 2022, the Company has estimated federal and state net operating loss (“NOL”) carryforwards of approximately $ 206.2 million and $ 155.2 million, respectively. $ 121.6 million of the federal NOLs are scheduled to expire from 2023 through 2037 , while the remaining NOLs do not expire. $ 154.2 million of the state NOLs are scheduled to expire from 2024 through 2042 , while the remaining NOLs do not expire. The Company’s federal and state tax credit carryforwards begin expiring in 2023. For financial reporting purposes, valuation allowances of $ 59.8 million and $ 54.0 million at December 31, 2022 and 2021, respectively, have been established to offset deferred tax assets relating primarily to NOLs and research and development credits. The increase in the valuation allowance of $ 5.8 million for the year ended December 31, 2022 was primarily due to increased operating losses. The Company has established a valuation allowance against its entire net deferred tax asset. As a result, the Company does not recognize any tax benefit until it is in a taxpaying position or there is no longer negative evidence leading to the conclusion that it is more likely than not that the benefits will not be realized. Pursuant to Sections 382 and 383 of the IRC, annual use of the Company’s NOLs and research and development credit carryforwards may be limited if there is a cumulative change in ownership of greater than 50 % within a three-year period. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. If limited, the related tax asset would be removed from the deferred tax asset schedule with a corresponding reduction in the valuation allowance. A preliminary analysis of past and subsequent equity offerings by the Company, and other transactions that have an impact on the Company’s ownership structure, concluded that the Company may have experienced one or more ownership changes under Sections 382 and 383 of the IRC. As such, the Company has established a valuation allowance as the realization of its deferred tax assets has not met the more likely than not threshold requirement. Due to the existence of the valuation allowance, further changes in the Company’s unrecognized tax benefits will not impact the Company’s effective tax rate. A reconciliation of the Company’s gross unrecognized tax benefits is as follows: Years Ended December 31, 2022 2021 Balance at beginning of year $ 3,193,331 $ 2,960,842 Increases to prior positions — — Decreases to prior positions ( 8,856 ) ( 6,395 ) Increases for current year positions 235,441 238,884 Balance at end of year $ 3,419,916 $ 3,193,331 As of December 31, 2022, the Company had $ 3.4 million of gross unrecognized tax benefits, related to research and experimental tax credits. The Company had no unrecognized tax benefits as of December 31, 2022, which, if recognized, would affect the annual effective tax rate, due to the full valuation allowance on the deferred tax assets. Although it is possible that the amount of unrecognized benefits with respect to our uncertain tax positions will increase or decrease in the next twelve months, the Company does not expect material changes. On August 16, 2022, the President signed into law the Inflation Reduction Act of 2022 which contained provisions effective January 1, 2023, including a 15% corporate minimum tax and a 1% excise tax on stock buybacks, both of which we expect to be immaterial to our financial results, financial position and cash flows. The Company files income tax returns in the United States, Arizona, California, Texas, various other state jurisdictions, and France, with varying statutes of limitations. As of December 31, 2022, the earliest year subject to examination is 2019 for U.S. federal tax purposes. The earliest year subject to examination is 2018 for the state jurisdictions, and 2019 for France. However, the Company’s federal and state NOLs and tax credit carryforwards for periods ending December 31, 2003 and thereafter remain subject to examination by the United States and certain states. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements and accompanying notes were prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). In December 2022, the Company completed a reverse stock split of its outstanding shares of common stock pursuant to which every twelve shares of issued and outstanding common stock were exchanged for one share of common stock. All share and per share amounts within the consolidated financial statements and notes thereto have been adjusted to reflect the reverse stock split for all periods and dates presented. See Note 14 for more information about the Company’s reverse stock split. |
Principles of Consolidation | Principles of Consolidation The Company formed a French subsidiary, HTG Molecular Diagnostics France SARL, in November 2018. The consolidated financial statements include the accounts of the Company and this wholly owned subsidiary after elimination of intercompany transactions and balances as of December 31, 2022 and 2021 . |
Going Concern and Liquidity | Going Concern and Liquidity Management has assessed the Company’s ability to continue as a going concern within one year of issuance of these consolidated financial statements. The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of the assets and satisfaction of liabilities in the normal course of business. However, the Company has had recurring operating losses and negative operating cash flows since its inception and has an accumulated deficit of approximately $ 229.9 million as of December 31, 2022. As of December 31, 2022, the Company had working capital of approximately $ 7.4 million and long-term liabilities of approximately $ 4.1 million. The Company’s liability balances consist primarily of its debt obligations, including an asset-secured loan with Silicon Valley Bank (currently named Silicon Valley Bridge Bank, N.A. following the closure of Silicon Valley Bank on March 10, 2023 by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation ("FDIC") as receiver) (“SVB”), as lender, (the “SVB Term Loan”) (see Note 8), as well as an obligation to NuvoGen Research, LLC (the “NuvoGen obligation”) (see Note 10). The Company currently expects that its existing resources will be sufficient to fund its planned operations and expenditures until at least July 2023. In addition, potentially changing circumstances, including those related to a resurgence of COVID-19, inflation and high interest rates, may result in the depletion of the Company’s capital resources more rapidly than it currently anticipates. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying consolidated financial statements do not include any adjustments that may result from the outcome of these uncertainties. The Company will need to raise additional capital to fund its operations and service its long-term debt obligations until its revenue reaches a level sufficient to provide for self-sustaining cash flows. There can be no assurance that additional capital will be available on acceptable terms, or at all, or that the Company’s revenue will reach a level sufficient to provide for self-sustaining cash flows. If the Company is not able to generate additional capital, the Company may have to delay, scale back or discontinue one or more of its therapeutics development programs, curtail its commercial activities, significantly reduce expenses, sell assets (potentially at a discount to their fair value or carrying value), enter into relationships with third parties to develop or commercialize products or technologies that the Company otherwise would have sought to develop or commercialize independently, cease operations altogether, pursue a sale of the Company at a price that may result in a significant loss on investment for its stockholders, file for bankruptcy or seek other protection from creditors. In addition, if the Company defaults under any of the provisions of the Loan and Security Agreement for the SVB Term Loan (the "Loan Agreement"), SVB could charge an interest rate of 5 % above the otherwise applicable floating rate, accelerate the payment of the SVB Term Loan and ultimately foreclose on the Company’s assets. |
COVID-19 Pandemic | COVID-19 Pandemic and Relief The Company experienced a significant slowing of product and product-related services revenue generation beginning in March 2020 as a result of COVID-19. The extent of this impact has varied from customer to customer depending upon how they have been directly or indirectly impacted by local stay-at-home orders and other social distancing measures, how they have prioritized studies and previously planned trials as the immediate impacts of the pandemic have passed, and how significantly their workforces and supplier networks have been impacted by the pandemic. The Company has not experienced delays in development even with its efforts to prioritize the safety of its employees during the pandemic. In addition, the impact of COVID-19 on the Company’s ability to source raw materials and other supplies has not been significant to date. However, a change in or loss of suppliers or other supply chain or distribution network partners due to the ongoing impacts of the pandemic or a resurgence of COVID-19 on the global economy could adversely affect the Company’s business and the business of its vendors, partners and customers, and could result in future reductions in sales and operating results. While there remains uncertainty as to the future impact of COVID-19, the Company has considered the known impacts on its business as of the date these consolidated financial statements were issued and has reflected any known or expected impacts in its consolidated financial statements, including consideration of potential impairment risks to its long-lived assets, potential accounts receivable collection risks and potential impacts to its overall liquidity position. As a result of various government programs enacted to address the ongoing impacts of COVID-19, the Company was able to qualify for and receive Employee Retention Credits (“ERC”) during the year ended December 31, 2021. ERC benefits of approximately $ 0.5 million, $ 0.8 million, and $ 0.4 million were included in cost of product and product-related services revenue, selling, general and administrative and research and development, respectively, as an offset to the related compensation costs in the accompanying consolidated statements of operations for the year ended December 31, 2021. In November 2021, the Infrastructure Investment and Jobs Act was signed into law, making wages paid after September 30, 2021 ineligible for these credits. As such, no further ERC benefits were received for the year ended December 31, 2022. ERC benefits receivable of approximately $ 0.4 million were included in prepaid expenses and other in the accompanying consolidated balance sheets as of both December 31, 2022 and 2021. In April 2020, the Company received proceeds from a loan pursuant to the Paycheck Protection Program (“PPP”) of the CARES Act (the “PPP Loan”) in the amount of approximately $ 1.7 million from SVB, as lender. The Company applied for full forgiveness of the PPP Loan in October 2020. In May 2021, the Company received notification that the PPP Loan and related interest, totaling approximately $ 1.7 million, were forgiven by the U.S. Small Business Administration (“SBA”), and that the PPP Loan had been canceled. Accordingly, the Company recorded a gain on forgiveness of the PPP Loan for the year ended December 31, 2021, included in other income (expense) in the accompanying consolidated statements of operations. Laws and regulations concerning government programs, including the ERC and PPP Loan, are complex and subject to varying interpretations. Claims made under these programs may also be subject to retroactive audit and review. While the Company does not believe there is a basis for estimation of an audit or recapture risk at this time, there can be no assurance that regulatory authorities will not challenge the Company’s claim to the ERC or PPP Loan in a future period. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosures of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. The Company’s estimates include revenue recognition, stock-based compensation expense, bonus and warranty accrual, income tax valuation allowances and reserves, recovery of long‑lived assets, lease liability, inventory valuation, allowance for doubtful accounts and available-for-sale securities. Actual results could materially differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on deposit with financial institutions, money market instruments and high credit quality corporate debt securities purchased with a term of three months or less. |
Accounts Receivable | Accounts Receivable Accounts receivable represent valid claims against debtors. Management reviews accounts receivable regularly to determine, using the specific identification method, if any receivable amounts will potentially be uncollectible and to estimate the amount of allowance for doubtful accounts necessary to reduce accounts receivable to its estimated net realizable value. |
Investments in Available-for-Sale Securities | Investments in Available-for-Sale Securities The Company classifies its debt securities, which are reported at estimated fair value with unrealized gains and losses included in accumulated other comprehensive income, net of tax, as available-for-sale securities. Investments in securities with maturities of less than one year , or where management’s intent is to use the investments to fund current operations, or to make them available for current operations, are classified as short-term investments. Realized gains, realized losses and declines in value of securities judged to be other-than-temporary, are included in other income (expense) within the consolidated statements of operations. The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. Interest earned on securities is also included in other income (expense) within the consolidated statements of operations. The Company recognizes other-than-temporary impairment (“OTTI”) of a debt security for which there has been a decline in fair value below amortized cost if (i) management intends to sell the security, (ii) it is more likely than not that the Company will be required to sell the security before recovery of its amortized cost basis, or (iii) the Company does not expect to recover the entire amortized cost basis of the security. The amount by which amortized cost exceeds the fair value of a debt security that is considered to have OTTI is separated into a component representing the credit loss, which is recognized in earnings, and a component related to all other factors, which is recognized in other comprehensive loss. The measurement of the credit loss component is equal to the difference between the debt security’s amortized cost basis and the present value of its expected future cash flows discounted at the security’s effective yield. If the Company intends to sell the security, or if it is more likely than not it will be required to sell the security before recovery, an OTTI write-down is recognized in earnings equal to the entire difference between the amortized cost basis and fair value of the security. As the Company did no t have available-for-sale securities as of December 31, 2022 and did no t have any unrealized losses as of December 31, 2021, there was no OTTI of its available-for-sale securities as of either balance sheet date. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value measurements are based on the premise that fair value is an exit price representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the following three-tier fair value hierarchy has been used in determining the inputs used in measuring fair value: Level 1 – Quoted prices in active markets for identical assets or liabilities on the reporting date. Level 2 – Pricing inputs are based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant assumptions are observable in the market or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 – Pricing inputs are generally unobservable and include situations where there is little, if any, market activity for the investment. The inputs into the determination of fair value require management’s judgment or estimation of assumptions that market participants would use in pricing the assets or liabilities. The fair values are therefore determined using factors that involve considerable judgment and interpretations, including but not limited to private and public comparables, third-party appraisals, discounted cash flow models, and fund manager estimates. The carrying value of financial instruments classified as current assets and current liabilities approximate fair value due to their liquidity and short-term nature. Investments that are classified as available-for-sale are recorded at fair value, which is determined using quoted market prices, broker or dealer quotations or alternative pricing sources with reasonable levels of price transparency. The carrying value of the SVB Term Loan (see Note 8) is estimated to approximate its fair value as the interest rate approximates the market rate for debt with similar terms and risk characteristics. The NuvoGen obligation relates to an asset purchase transaction with a then-common stockholder of the Company (see Note 10). As of December 31, 2022, the estimated aggregate fair value of the NuvoGen obligation is approximately $ 3.9 million, determined using a Monte Carlo simulation with key assumptions including future revenue, volatility, discount and risk-free rates. The estimated fair value of the NuvoGen obligation represents a Level 3 measurement. |
Inventory | Inventory Inventory is stated at the lower of cost or net realizable value. The Company determines the cost of inventory using the first-in, first out method. The Company estimates the recoverability of inventory by reference to internal estimates of future demands and product life cycles, including expiration. The Company periodically analyzes its inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value and records a charge to expense for such inventory as appropriate. The Company classifies inventory as long-term when it expects to utilize the inventory beyond its normal operating cycle. The Company charges cost of sales for inventory provisions to write-down our inventory to the lower of cost or net realizable value or for obsolete or excess inventory. Most of its inventory provisions relate to excess quantities of products, based on our inventory levels and future product purchase commitments compared to assumptions about future demand and market conditions. Once inventory has been written-off or written-down, it creates a new cost basis for the inventory that is not subsequently written-up, any increase in demand forecasted or inventory value of such inventory is not realized until such inventory is sold. Equipment that is under evaluation for purchase remains in inventory as the Company maintains title to the equipment throughout the evaluation period. The period of time customers use to evaluate the Company’s equipment generally ranges from 90 to 180 days , and in certain circumstances the evaluation period may need to be extended beyond that period. However, in no case will the evaluation period exceed one year. If the customer has not purchased the equipment or entered into a reagent rental agreement with the Company after evaluating the product for one year, the equipment is returned to the Company or the customer is allowed to continue use of the equipment, in which case the equipment is written off to selling, general and administrative expense in the consolidated statements of operations. HTG EdgeSeq instruments at customer locations under evaluation agreements are included in finished goods inventory. Finished goods inventory under evaluation was approximately $ 0.1 million and $ 0.2 million as of December 31, 2022 and 2021, respectively. |
Property and Equipment | Property and Equipment Property and equipment are stated at historical cost and depreciated over their useful lives, which range from three to five years , using the straight-line method. Equipment used in the field is amortized using the straight-line method over the lesser of the period of the related reagent rental or the estimated useful life. Leasehold improvements are amortized using the straight-line method over the lesser of the remaining lease term or the estimated useful life. Costs incurred in the development and installation of software for internal use and in the development of the Company’s website are expensed or capitalized, depending on whether they are incurred in the preliminary project stage (expensed), application development stage (capitalized), or post-implementation stage (expensed). Amounts capitalized following project completion are amortized on a straight-line basis over the useful life of the developed asset, which is generally three years . Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset group to the estimated undiscounted future cash flows expected to be generated by the asset group. If the carrying amount of an asset group exceeds its estimated future cash flow, an impairment charge is recognized in the amount by which the carrying amount of the asset group exceeds the fair value of the asset group. Although the Company has accumulated losses since inception, the Company believes the future cash flows will be sufficient to exceed the carrying value of the Company’s long-lived assets. There were no impairments of long-lived assets during the years ended December 31, 2022 and 2021 . |
Leases | Leases Arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the consolidated balance sheets as both a right-of-use asset and a lease liability for each type of lease, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s 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. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. For financing leases, interest on the lease liability and the amortization of the right-of-use asset results in front-loaded expense over the lease term. Variable lease expenses are recorded to rent expense as incurred. In calculating the right-of-use asset and lease liability, the Company elects to combine lease and non-lease components for all classes of assets currently under lease, including facilities and computer equipment. The Company excludes short-term leases having initial terms of 12 months or less as an accounting policy election and recognizes rent expense on short-term leases on a straight-line basis over the lease term for these leases. |
Debt Issuance Costs and Debt Discounts | Debt Issuance Costs and Debt Discounts Costs incurred to issue non-revolving debt instruments are recognized as a reduction to the related debt balance in the consolidated balance sheets and amortized to interest expense over the contractual term of the related debt using the effective interest method. Costs incurred to issue the Loan Agreement with SVB were deferred as an asset in the consolidated balance sheets and are being amortized on a straight-line basis to interest expense over the term of the loan (see Note 8). |
Contract Liabilities | Contract Liabilities Contract liabilities represent cash receipts for products or services to be delivered in future periods. When products or services are delivered to customers, contract liabilities are recognized as earned. Up-front fees received for custom RUO assay design are recognized over time based on the costs incurred to date compared with total expected costs as design or development procedures are completed and outputs are produced. |
Revenue Recognition | Revenue Recognition Revenue from contracts with customers is recognized when, or as, the Company satisfies its performance obligations by delivering the promised goods or service deliverables to the customers. A good or service deliverable is transferred to a customer when, or as, the customer obtains control of that good or service deliverable. A performance obligation may be satisfied over time or at a point in time. Revenue from a performance obligation satisfied over time is recognized by measuring the Company’s progress in satisfying the performance obligation in a manner that depicts the transfer of the goods or services to the customer. Revenue from a performance obligation satisfied at a point in time is recognized at the point in time that the Company determines the customer obtains control over the promised good or service deliverable. The amount of revenue recognized reflects the consideration the Company expects to be entitled to in exchange for those promised goods or services ( i.e. , the “transaction price”). In determining the transaction price, the Company considers multiple factors, including the effects of variable consideration. Variable consideration is included in the transaction price only to the extent it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainties with respect to the amount are resolved. In determining when to include variable consideration in the transaction price, the Company considers the range of possible outcomes, the predictive value of its past experiences, the time period of when uncertainties expect to be resolved and the amount of consideration that is susceptible to factors outside of the Company’s influence, such as the judgment and actions of third parties. 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. As the Company’s agreements for product and product-related services revenue have an expected duration of one year or less, the Company has elected the practical expedient to not disclose information about its remaining performance obligations. The Company has also made a policy election to exclude from the measurement of the transaction price all taxes assessed by a government authority that are both imposed on and concurrent with a specific revenue producing transaction and collected by the Company from a customer. Such taxes may include but are not limited to sales, use, value added and certain excise taxes. See Note 9 for additional discussion of the Company’s revenue recognition policies. |
Product Warranty | Product Warranty The Company generally provides a one-year warranty on its HTG EdgeSeq platform covering the performance of system hardware and software in conformance with customer specifications under normal use and protecting against defects in materials and workmanship. The Company may, at its option, replace, repair or exchange products covered under valid warranty claims. A provision for estimated warranty costs is recognized at the time of sale, through cost of product and product-related services revenue, based upon recent historical experience and other relevant information as it becomes available. Customers have the option to purchase an extended warranty after the one-year warranty period expires. The Company continuously assesses the adequacy of its product warranty accrual by reviewing actual claims and adjusts the provision as needed. Warranty accrual is included in accrued liabilities and other non-current liabilities in the consolidated balance sheets. |
Research and Development Expenses | Research and Development Expenses Research and development expenses represent costs incurred internally for and externally in support of research and development activities. These costs include those generated through research and development efforts for the improvement and expansion of the Company’s proprietary profiling technology and product offerings, and payroll, related expenses, consulting expenses, laboratory supplies, facilities and equipment costs incurred to complete development milestones associated with the Company's transcriptome-informed drug discovery business, HTG Therapeutics. |
Stock-based Compensation | Stock-based Compensation The Company incurs stock-based compensation expense relating to grants of restricted stock units (“RSUs”) and stock options to employees, consultants and non-employee directors under its equity incentive plans, and stock purchase rights granted under its employee stock purchase plans. The Company recognizes expense for stock-based awards based on the fair value of awards on the date of grant. The fair value of RSUs is based on the quoted market price of the Company’s common stock on the date of grant. The fair value of stock purchase rights and stock options granted pursuant to the Company’s equity incentive plans is estimated on the date of grant using the Black-Scholes option pricing model. The determination of the fair value utilizing the Black-Scholes option pricing model is affected by the fair value of the Company’s stock price and several assumptions, including volatility, expected term, risk-free interest rate, and dividend yield. Generally, these assumptions are based on historical information and judgment is required to determine if historical trends may be indicators of future outcomes. The Company accounts for forfeitures as they occur. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to the differences between the financial statement carrying amounts and tax base of assets and liabilities using enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is established against net deferred tax assets for the uncertainty it presents of our ability to use the net deferred tax assets, in this case, primarily carryforwards of net operating tax losses and research and development tax credits. In assessing the realizability of net deferred tax assets the Company has assessed the likelihood that net deferred tax assets will be recovered from future taxable income, and to the extent that it is “more likely than not” that the assets will not be recovered or there is an insufficient history of operating profits, a valuation allowance is established. The Company records the valuation allowance in the period it determines that it is more likely than not that net deferred tax assets will not be realized. For the years ended December 31, 2022 and 2021, the Company has provided a full valuation allowance for all net deferred tax assets due to their current realization being considered remote in the near term. Uncertain tax positions taken or expected to be taken in a tax return are accounted for using the more likely than not threshold for financial statement recognition and measurement. Therefore, for income tax positions where it is not more likely than not that a tax benefit will be sustained in a court of last resort, the Company does not recognize a tax benefit in its financial statements. |
Foreign Currency Translation and Foreign Currency Transactions | Foreign Currency Translation and Foreign Currency Transactions The Company has assets and liabilities, including accounts receivable and accounts payable, which are denominated in currencies other than its functional currency. These assets and liabilities are subject to re-measurement, the impact of which is recorded in selling, general and administrative expense within the consolidated statements of operations. Adjustments resulting from translating foreign functional currency financial statements of the Company’s wholly owned subsidiary into U.S. Dollars are included in the foreign currency translation adjustment, a component of accumulated other comprehensive income in the consolidated statements of changes in stockholders' equity. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss includes certain changes in equity that are excluded from net loss. Specifically, unrealized gains and losses on short-term available-for-sale investments and adjustments resulting from translating foreign functional currency financial statements into U.S. Dollars are included in comprehensive loss. |
Concentration Risks | Concentration Risks Financial instruments that potentially subject the Company to credit risk consist principally of cash and cash equivalents and accounts receivable. The Company maintains the majority of its cash balances in the form of cash deposits in checking and money market accounts in amounts in excess of federally insured limits. In accordance with the Loan Agreement, as of December 31, 2022, the Company's cash balances were held in operating accounts at and in a custodial account at U.S. Bank subject to a control agreement with Silicon Valley Bank. On March 12, 2023, the U.S. Treasury, Federal Reserve and FDIC announced that SVB depositors will have access to all of their money beginning on March 13, 2023. Management believes that the credit risk with regard to these deposits is not significant based on the quality of the financial institution or, with respect to deposits with SVB, as a result of the guarantee provided by the U.S. Treasury, Federal Reserve and FDIC. The Company sells its instruments, consumables, sample processing services, custom RUO assay design and collaborative development services primarily to biopharmaceutical companies, academic institutions and molecular labs. The Company routinely assesses the financial strength of its customers and credit losses have been minimal to date. The Company’s top two customers accounted for 16 % and 14 % of the Company’s total revenue for the year ended December 31, 2022 , compared with the top two customers accounting for 20 % and 10 % of the Company’s total revenue for the year ended December 31, 2021 . The largest three customers accounted for approximately 37 % , 24 % and 13 % of the Company’s accounts receivable as of December 31, 2022 . The largest two customers accounted for approximately 18 % and 17 % of the Company’s accounts receivable as of December 31, 2021. The third and fourth largest customers accounted for approximately 10 % each of the Company’s accounts receivable as of December 31, 2021. One vendor accounted for 13 % of the Company’s accounts payable as of December 31, 2022 , compared with two vendors who accounted for 28 % and 16 % of the Company’s accounts payable as of December 31, 2021. The Company is also subject to supply chain risks related to the reliance on a single supplier to manufacture a subcomponent used in its HTG EdgeSeq instruments. Although there are a limited number of manufacturers for components of this type, the Company believes that other suppliers could provide similar products on comparable terms. However, a change in or loss of this supplier could significantly delay the delivery of products, which in turn would materially affect the Company’s ability to generate revenue. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements The following are new FASB Accounting Standard Updates ("ASU") that had not been adopted by the Company as of December 31, 2022. The Company's management does not believe that any other recently issued, but not yet effective, accounting standards updates, if currently adopted, would have a material effect on the accompanying consolidated financial statements. In June 2022, the FASB issued ASU 2022-03, Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions ("ASU 2022-03"), which amends ASC 820 to clarify that a contractual sales restriction is not considered in measuring an equity security at fair value and to introduce new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value. ASU 2022-03 applies to both holders and issuers of equity and equity-linked securities measured at fair value. The amendments in this ASU are effective for the Company in fiscal years and interim periods within those fiscal years, beginning after December 15, 2023. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance. The Company is still evaluating the impact of this pronouncement on the financial statements. In August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. ASU 2020-06 removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and also simplifies the diluted earnings per share calculation in certain areas. The standard is effective for the Company effective for fiscal years beginning after December 15, 2023. Early adoption is permitted, and adoption must be as of the beginning of the Company’s annual fiscal year. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses , which was subsequently amended by ASU 2018-19, ASU 2019-10 and ASU 2020-02, and requires the measurement of expected credit losses for financial instruments carried at amortized cost held at the reporting date based on historical experience, current conditions and reasonable forecasts. The updated guidance also amends the current other-than-temporary impairment model for available-for-sale debt securities by requiring the recognition of impairments relating to credit losses through an allowance account and limits the amount of credit loss to the difference between a security’s amortized cost basis and its fair value. In addition, the length of time a security has been in an unrealized loss position will no longer impact the determination of whether a credit loss exists. The main objective of this ASU is to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. With the issuance of ASU 2019-10 in November 2019, the standard will be effective for the Company for fiscal years and interim periods within those fiscal years beginning after December 15, 2022. The Company's adoption of this standard on January 1, 2023 is not expected to have a material impact on its consolidated financial statements or related footnote disclosures, given the high credit quality of the obligors to its available-for-sale debt securities and its history of minimal bad debt expense relating to trade accounts receivable. |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory - current, net of allowance, consisted of the following as of the dates indicated: December 31, 2022 2021 Raw materials $ 426,516 $ 1,253,111 Work in process 113,063 312,803 Finished goods 394,016 447,145 Total gross inventory - current 933,595 2,013,059 Less general inventory allowance ( 24,267 ) ( 25,306 ) $ 909,328 $ 1,987,753 Inventory - non-current, net of excess inventory allowance, included in other non-current assets on the consolidated balance sheets, consisted of the following as of the dates indicated: December 31, 2022 2021 Raw materials - non-current, net $ 244,915 $ 711,296 Work in process - non-current, net 81,958 — Finished goods - non-current 73,930 — $ 400,803 $ 711,296 |
Fair Value Instruments (Tables)
Fair Value Instruments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | The following table classifies the Company’s financial assets measured at fair value on a recurring basis as of December 31, 2022 and 2021, respectively, in the fair value hierarchy: December 31, 2022 Level 1 Level 2 Level 3 Total Asset included in: Cash and cash equivalents Money market securities $ 10,753,684 $ — $ — $ 10,753,684 Total $ 10,753,684 $ — $ — $ 10,753,684 December 31, 2021 Level 1 Level 2 Level 3 Total Asset included in: Cash and cash equivalents Money market securities $ 9,083,302 $ — $ — $ 9,083,302 Investments available-for-sale at fair value Corporate debt securities — 12,343,456 — 12,343,456 Total $ 9,083,302 $ 12,343,456 $ — $ 21,426,758 |
Available-for-Sale Securities (
Available-for-Sale Securities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Available-for-sale Securities | The following is a summary of the securities as of that date: December 31, 2021 Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) Corporate debt securities $ 12,343,456 $ — $ — $ 12,343,456 Total available-for-sale securities $ 12,343,456 $ — $ — $ 12,343,456 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property and Equipment | Property and equipment, net consisted of the following as of the dates indicated: December 31, 2022 2021 Furniture & fixtures $ 756,065 $ 872,877 Leasehold improvements 1,938,981 1,931,762 Equipment used in manufacturing 1,863,976 2,432,242 Equipment used in research & development 2,080,319 2,343,930 Equipment used in the field 159,563 216,218 Software 469,408 480,740 Property and equipment 7,268,312 8,277,769 Less: accumulated depreciation and amortization ( 6,670,306 ) ( 7,158,883 ) $ 598,006 $ 1,118,886 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Liabilities, Current [Abstract] | |
Summary of Accrued Liabilities | Accrued liabilities consisted of the following as of the dates indicated: December 31, 2022 2021 Accrued employee bonuses $ 1,252,622 $ 1,254,355 Payroll and employee benefit accruals 416,070 389,385 Accrued professional fees 355,377 47,594 Other accrued liabilities 185,537 331,235 $ 2,209,606 $ 2,022,569 |
Debt Obligations (Tables)
Debt Obligations (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Current Portion of Long-term Debt, Net | Current portion of long-term debt consisted of the following as of the dates indicated: December 31, 2022 2021 SVB Term Loan, net of discount and debt issuance costs $ 3,812,498 $ 5,000,000 2021 Insurance Note — 167,586 $ 3,812,498 $ 5,167,586 |
Schedule of Long Term Debt, Net of Current Portion and Discount and Debt Issuance Costs | Long-term debt, net of current portion, discount and debt issuance costs, consisted of the following as of the dates indicated: December 31, 2022 2021 SVB Term Loan, net of discount and debt issuance costs $ - $ 5,178,629 |
Schedule of Remaining Principal Repayments due Under SVB Term Loan | The remaining principal repayments due under the SVB Term Loan as of December 31, 2022 are as follows: 2023 $ 3,235,294 Less discount and deferred financing costs ( 222,796 ) Plus final fee premium 800,000 Total SVB Term Loan, net $ 3,812,498 |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Product and Product-Related Service Revenue from Sale of Instruments and Consumables | The Company had product and product-related services revenue consisting of revenue from the sale of instruments and consumables and the use of the HTG EdgeSeq proprietary technology to process samples and design custom RUO assays for the years ended December 31, 2022 and 2021 as follows: Years Ended December 31, 2022 2021 Product revenue: Instrument $ 609,627 $ 1,385,665 Consumables 3,140,420 3,786,923 Total product revenue 3,750,047 5,172,588 Product-related services revenue: Custom RUO assay design 20,000 48,350 RUO sample processing 2,596,173 3,685,890 Total product-related services revenue 2,616,173 3,734,240 Total product and product-related services revenue $ 6,366,220 $ 8,906,828 |
Schedule Of Revenue By Primary Geographic Market | Revenue by primary geographic market for the years ended December 31, 2022 and 2021 was as follows: December 31, 2022 United States Europe Other Product revenue 1,904,025 1,839,445 6,577 Product-related services revenue 2,237,691 358,905 19,577 Total product and product-related services revenue $ 4,141,716 $ 2,198,350 $ 26,154 December 31, 2021 United States Europe Other Product revenue 3,114,818 2,026,728 31,042 Product-related services revenue 3,063,381 198,336 472,523 Total product and product-related services revenue $ 6,178,199 $ 2,225,064 $ 503,565 |
Schedule of Changes in Contract Liability | Changes in the Company’s contract liabilities were as follows as of the dates indicated: Product Sample Total Contract Balance at January 1, 2022 $ 128,529 $ 30,621 $ 159,150 Deferral of revenue 293,158 197,904 491,062 Recognition of deferred revenue ( 274,973 ) ( 201,525 ) ( 476,498 ) Balance at December 31, 2022 $ 146,714 $ 27,000 $ 173,714 Product Sample Total Contract Balance at January 1, 2021 $ 103,580 $ 93,884 $ 197,464 Deferral of revenue 286,349 587,091 873,440 Recognition of deferred revenue ( 261,400 ) ( 650,354 ) ( 911,754 ) Balance at December 31, 2021 $ 128,529 $ 30,621 $ 159,150 |
Other Agreements (Tables)
Other Agreements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Other Agreements [Abstract] | |
Schedule of Remaining Minimum Principal Payments Due | Minimum payments to be made in 2023 include $ 46,031 of revenue-based payments payable as of December 31, 2022 and an estimate of additional revenue-based payments to be made throughout the remainder of 2023 relating to revenue generated in the first, second and third quarters of 2023 using actual revenue generated in the same quarters in 2022. Minimum payments for the remaining years include only the minimum payments for each year. Actual payments could be significantly more than provided in the table, to the extent that 6% of the Company’s annual revenue in those years exceeds $ 0.4 million: 2023 $ 446,031 2024 400,000 2025 400,000 2026 400,000 2027 400,000 2028 and beyond 1,863,438 Total NuvoGen obligation payments 3,909,469 Plus interest accretion 55,620 Total NuvoGen obligation, net $ 3,965,089 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Summary of Components of Lease Cost | The components of lease cost for operating leases were as follows: Years Ended December 31, 2022 2021 Operating leases Operating lease cost $ 483,956 $ 503,130 Variable lease cost 99,989 88,708 Total rent expense $ 583,945 $ 591,838 |
Summary of Other Information Related to Operating Leases | The table below summarizes other information related to the Company’s operating leases: Years Ended December 31, 2022 2021 Cash paid for amounts included in measurement of operating lease liabilities $ 487,673 $ 514,453 Establishment of operating lease liabilities arising from obtaining right-of-use- assets 77,385 1,302,457 Weighted-average remaining lease term – operating leases 2.1 3.1 Weighted-average discount rate – operating leases 5.8 % 5.8 % |
Summary of Remaining Maturities of Operating Leases | Remaining maturities of the Company’s operating leases, included in operating lease liabilities – current and operating lease liabilities - non-current, net of discount, in the consolidated balance sheets as of December 31, 2022, are as follows: 2023 $ 521,467 2024 521,379 2025 43,444 Total 1,086,290 Less present value discount ( 64,840 ) Total operating lease liabilities 1,021,450 Less operating lease liabilities - current ( 475,126 ) Operating lease liabilities - non-current $ 546,324 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Reconciliation of Numerator and Denominator Used in Computing Basic and Diluted Net Loss per Share | The following table provides a reconciliation of the numerator and denominator used in computing basic and diluted net loss per share for the periods presented: Years Ended December 31, 2022 2021 Numerator: Net loss $ ( 21,594,476 ) $ ( 17,145,170 ) Denominator: Weighted-average shares outstanding-basic and diluted * 889,284 578,011 Net loss per share, basic and diluted $ ( 24.28 ) $ ( 29.66 ) |
Common Stock Equivalents Excluded from Computation of Diluted Net Loss per Share | The following common stock equivalents were excluded from the computation of diluted net loss per share for the periods presented because their effect would have been anti-dilutive: Years Ended December 31, 2022 2021 Options to purchase common stock 76,099 46,611 Series A Preferred — 13,212 Common stock warrants 3,164,267 4,890 Unvested restricted stock units 1,041 2,598 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Proceeds from Issuance of Preferred Stock, Preference Stock, and Warrants [Abstract] | |
Summary of outstanding warrants | The following table shows the common stock warrants outstanding as of December 31, 2022: Warrant Issuance Date Shares of Stock Exercise Expiration Date August 2014 159 $ 4,231.80 2024 March 2016 251 496.80 2026 March 2018 100 1,391.40 2028 June 2020 3,574 139.878 2030 March 2022 270,415 24.74 2024 March 2022 270,415 24.74 2027 December 2022 1,290,322 7.50 2024 December 2022 1,290,322 7.50 2027 December 2022 38,709 9.6875 2027 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Class of Stock [Line Items] | |
Summary of Stock Based Compensation Recognized in Consolidated Statement of Operations | Amounts recognized in the consolidated statements of operations with respect to the Company’s equity incentive plans were as follows: Years Ended December 31, 2022 2021 Selling, general and administrative $ 559,226 $ 1,154,000 Research and development 197,705 141,281 Cost of product and product-related services revenue 17,229 22,074 $ 774,160 $ 1,317,355 |
Summary of Stock Option Plans Activity | The following table summarizes stock option activity (including Inducement Award activity) during the two-year period ended December 31, 2022: Number of Weighted- Weighted- Aggregate Balance at January 1, 2021 40,602 $ 201.36 8.6 $ 1,536 Granted 12,819 65.40 Exercised ( 6 ) 52.20 $ 107 Forfeited ( 4,406 ) 143.76 Expired/Cancelled ( 2,398 ) 244.68 Balance at December 31, 2021 46,611 $ 167.16 8.2 $ 30,267 Granted 39,667 12.91 Exercised — — Forfeited ( 4,944 ) 66.58 Expired/Cancelled ( 5,235 ) 292.56 Balance at December 31, 2022 76,099 $ 84.73 8.3 $ - Exercisable at December 31, 2021 24,915 $ 241.68 7.4 $ 6,269 Exercisable at December 31, 2022 38,096 $ 142.34 7.6 $ - |
Summary of Material Factors Incorporated in Black-Scholes Model In Estimating Fair Value of Options Granted | The material factors incorporated in the Black-Scholes model in estimating the fair value of the stock options granted for the periods presented were as follows: 2022 2021 Fair value of common stock on grant date $ 8.28 - 49.27 $ 48.84 - 75.00 Risk-free interest rate 1.53 % - 3.64 % 0.85 % - 1.20 % Expected volatility 89.6 % - 110.7 % 104.2 % - 107.3 % Expected term 5.5 to 5.8 years 5.2 to 6.1 years Expected dividend yield 0 % 0 % |
Summary of Restricted Stock Unit ("RSU") Award Activity | The following table summarizes RSU activity (including Inducement Award activity) during the two-year period ended December 31, 2022: Number of Weighted- Balance at January 1, 2021 1,017 $ 343.32 Granted 2,500 62.40 Released ( 377 ) 349.56 Forfeited ( 542 ) 290.16 Balance at December 31, 2021 2,598 $ 83.16 Granted 416 8.29 Released ( 1,139 ) 110.47 Forfeited ( 626 ) 62.50 Balance at December 31, 2022 1,249 $ 44.40 Vested and unissued at December 31, 2022 208 $ 62.42 |
Employee Stock [Member] | |
Class of Stock [Line Items] | |
Summary of Stock Based Compensation Recognized in Consolidated Statement of Operations | Amounts recognized in the consolidated statements of operations with respect to the Amended 2014 ESPP were as follows: Years Ended December 31, 2022 2021 Selling, general and administrative $ 22,187 $ 34,219 Research and development 11,046 11,643 Cost of product and product-related services revenue 7,114 11,807 $ 40,347 $ 57,669 |
Summary of Material Factors Incorporated in Black-Scholes Model In Estimating Fair Value of Options Granted | The material factors incorporated in the Black-Scholes model in estimating the fair value of employee stock purchase plan stock purchase rights for the periods presented were as follows: 2022 2021 Fair value of common stock $ 6.00 - 49.80 $ 56.04 - 70.20 Risk-free interest rate 0.11 % - 2.25 % 0.04 % - 0.08 % Expected volatility 64.9 % - 96.7 % 71.9 % - 89.2 % Expected term 0.5 years 0.5 years Expected dividend yield 0 % 0 % |
Summary of Shares Purchased under ESPP'S Six Month Purchase Periods | During the year ended December 31, 2022, employees purchased the following shares at the end of each of the six-month purchase periods: June 2022 December 2022 Number of Price Number of Price Total number of shares purchased 4,083 $ 5.71 2,792 $ 5.10 During the year ended December 31, 2021, employees entering the plan at various times throughout the offering period purchased the following shares at the end of each of the six-month purchase periods: June 2021 December 2021 Number of Price Number of Price Total number of shares purchased 1,136 $ 47.04 1,693 $ 42.72 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Product Warranty Liability | The following is a summary of the Company’s general product warranty liability. Product warranty liabilities of approximately $ 73,000 and $ 15,000 were included in accrued liabilities and other non-current liabilities, respectively, in the accompanying consolidated balance sheets as of December 31, 2022. Expense relating to the recording of this reserve is recorded in cost of product and product-related services revenue within the accompanying consolidated statements of operations. December 31, 2022 2021 Beginning balance $ 120,385 $ 92,696 Cost of warranty claims ( 147,192 ) ( 166,641 ) Increase in warranty reserve 115,089 194,330 Ending balance $ 88,282 $ 120,385 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Summary of Loss Before Income taxes | The following table summarizes loss before income taxes: Years Ended December 31, 2022 2021 U.S. pre-tax loss $ ( 21,611,254 ) $ ( 17,156,070 ) Foreign pre-tax gain (loss) 27,615 33,375 Loss before income taxes $ ( 21,583,639 ) $ ( 17,122,695 ) |
Components of Income Tax Expense | The components of income tax expense are as follows: Years Ended December 31, 2022 2021 Current: Federal $ — $ — State 3,270 13,769 Foreign 7,567 8,706 Total current income tax expense $ 10,837 $ 22,475 Deferred: Federal $ — $ — State — — Foreign — — Total deferred income tax expense $ — $ — Total income tax expense $ 10,837 $ 22,475 |
Schedule of Difference in Actual Income Tax Expense Computed by Applying the Statutory Federal Income Tax Rate to Loss Before Income Taxes | The Company’s actual income tax expense for the years ended December 31, 2022 and 2021 differ from the expected amount computed by applying the statutory federal income tax rate to loss before income taxes as follows: Years Ended December 31, 2022 2021 Computed tax (benefit) at 21 % $ ( 4,532,565 ) $ ( 3,586,925 ) State taxes, net of federal benefit ( 989,018 ) ( 1,177,951 ) Stock-based compensation 128,789 240,177 Foreign tax rate differential 5,635 ( 2,171 ) Return to provision 13,047 53,340 Nontaxable loan forgiveness — ( 360,570 ) Other 17,615 9,048 Research and development tax credit - state ( 234,971 ) ( 265,362 ) Research and development tax credit - federal ( 235,910 ) ( 212,408 ) Uncertain tax position adjustment for prior periods ( 8,856 ) ( 6,395 ) Increase in valuation allowance 5,847,071 5,331,692 $ 10,837 $ 22,475 |
Schedule of Deferred Tax Assets and Liabilities | Deferred tax assets and liabilities comprise the following: Years Ended December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 50,968,402 $ 47,752,053 Research and development credits 4,393,368 3,940,199 R&D expenditures capitalization 2,001,908 — Deferred revenue 45,373 42,802 Inventory reserve 310,983 6,806 Fixed assets and intangibles 291,244 304,019 Accrued NuvoGen liability 1,035,659 1,196,563 Lease liability 266,797 366,653 Other 755,029 711,343 Gross deferred tax assets 60,068,763 54,320,438 Valuation allowance ( 59,805,688 ) ( 53,958,617 ) Deferred tax assets, net 263,075 361,821 Deferred tax liabilities: Right of use asset 263,075 361,821 Total deferred tax liabilities 263,075 361,821 Net deferred tax assets (liabilities) $ - $ - As of December 31, 2022, the Company has estimated federal and state net operating loss (“NOL”) carryforwards of approximately $ 206.2 million and $ 155.2 million, respectively. $ 121.6 million of the federal NOLs are scheduled to expire from 2023 through 2037 , while the remaining NOLs do not expire. $ 154.2 million of the state NOLs are scheduled to expire from 2024 through 2042 , while the remaining NOLs do not expire. The Company’s federal and state tax credit carryforwards begin expiring in 2023. For financial reporting purposes, valuation allowances of $ 59.8 million and $ 54.0 million at December 31, 2022 and 2021, respectively, have been established to offset deferred tax assets relating primarily to NOLs and research and development credits. The increase in the valuation allowance of $ 5.8 million for the year ended December 31, 2022 was primarily due to increased operating losses. The Company has established a valuation allowance against its entire net deferred tax asset. As a result, the Company does not recognize any tax benefit until it is in a taxpaying position or there is no longer negative evidence leading to the conclusion that it is more likely than not that the benefits will not be realized. |
Schedule of Reconciliation of Gross Unrecognized Tax Benefits | A reconciliation of the Company’s gross unrecognized tax benefits is as follows: Years Ended December 31, 2022 2021 Balance at beginning of year $ 3,193,331 $ 2,960,842 Increases to prior positions — — Decreases to prior positions ( 8,856 ) ( 6,395 ) Increases for current year positions 235,441 238,884 Balance at end of year $ 3,419,916 $ 3,193,331 |
Description of Business and B_2
Description of Business and Basis of Presentation - Additional Information (Details) | 1 Months Ended | 12 Months Ended | |||
Apr. 21, 2020 USD ($) | Dec. 31, 2022 USD ($) | May 31, 2021 USD ($) | Dec. 31, 2022 USD ($) Segment | Dec. 31, 2021 USD ($) | |
Significant Accounting Policies [Line Items] | |||||
Number of operating segments | Segment | 1 | ||||
Reverse stock split, description | On December 20, 2022, the Company completed a reverse stock split of its outstanding shares of common stock pursuant to which every 12 shares of issued and outstanding common stock were exchanged for one share of common stock. | ||||
Employee retention credit benefits | $ 0 | ||||
Employee retention credits benefits receivable | $ 400,000 | 400,000 | $ 400,000 | ||
Gain on forgiveness of PPP Loan | $ 1,700,000 | 0 | 1,735,792 | ||
Accumulated deficit | (229,927,507) | (229,927,507) | (208,333,031) | ||
Working capital | 7,400,000 | 7,400,000 | |||
Long-term liabilities | $ 4,100,000 | $ 4,100,000 | |||
SVB Term Loan | |||||
Significant Accounting Policies [Line Items] | |||||
Proceeds from SVB Term Loan | $ 1,700,000 | ||||
SVB Term Loan | Minimum | |||||
Significant Accounting Policies [Line Items] | |||||
Debt instrument, interest at floating rate | 5% | ||||
Cost of Product and Product-related Services Revenue | |||||
Significant Accounting Policies [Line Items] | |||||
Employee retention credit benefits | 500,000 | ||||
Selling, General and Administrative | |||||
Significant Accounting Policies [Line Items] | |||||
Employee retention credit benefits | 800,000 | ||||
Research And Development Expense | |||||
Significant Accounting Policies [Line Items] | |||||
Employee retention credit benefits | $ 400,000 | ||||
Common Stock | |||||
Significant Accounting Policies [Line Items] | |||||
Reverse stock split, description | In December 2022, the Company completed a reverse stock split of its outstanding shares of common stock pursuant to which every twelve shares of issued and outstanding common stock were exchanged for one share of common stock. | ||||
Stock split conversion ratio | 0.12 | ||||
Sales Revenue Net | Customer Concentration Risk | Customers Located Outside Of United States | |||||
Significant Accounting Policies [Line Items] | |||||
Sales revenue percentage | 35% | 31% |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2022 USD ($) Customer Vendor | Dec. 31, 2021 USD ($) Customer Vendor | |
Significant Accounting Policies [Line Items] | ||
Maturity period of investments | less than one year | |
Available-for-sale securities investments, gross unrealized losses | $ 0 | $ 0 |
Debt Securities, Available-for-Sale | 0 | 12,343,456 |
OTTI of available-for-sale securities | 0 | 0 |
Finished goods inventory | 394,016 | 447,145 |
Impairment of Long-lived assets | 0 | 0 |
NuvoGen Asset Purchase Agreement | ||
Significant Accounting Policies [Line Items] | ||
Convertible debt, fair value | 3,900,000 | |
HTG EdgeSeq | ||
Significant Accounting Policies [Line Items] | ||
Finished goods inventory | $ 100,000 | $ 200,000 |
Minimum | ||
Significant Accounting Policies [Line Items] | ||
Period of time customers use to evaluate the Company's equipment | 90 days | |
Long-term asset, estimated life | 3 years | |
Maximum | ||
Significant Accounting Policies [Line Items] | ||
Period of time customers use to evaluate the Company's equipment | 180 days | |
Long-term asset, estimated life | 5 years | |
Software and Software Development Costs | ||
Significant Accounting Policies [Line Items] | ||
Long-term asset, estimated life | 3 years | |
Sales Revenue Net | Customer Concentration Risk | ||
Significant Accounting Policies [Line Items] | ||
Number of customers | Customer | 2 | 2 |
Sales Revenue Net | Customer Concentration Risk | Customer One | ||
Significant Accounting Policies [Line Items] | ||
Sales revenue percentage | 16% | 20% |
Sales Revenue Net | Customer Concentration Risk | Customer Two | ||
Significant Accounting Policies [Line Items] | ||
Sales revenue percentage | 14% | 10% |
Accounts Receivable | Customer Concentration Risk | ||
Significant Accounting Policies [Line Items] | ||
Number of customers | Customer | 3 | 2 |
Accounts Receivable | Customer Concentration Risk | Customer One | ||
Significant Accounting Policies [Line Items] | ||
Sales revenue percentage | 37% | 18% |
Accounts Receivable | Customer Concentration Risk | Customer Two | ||
Significant Accounting Policies [Line Items] | ||
Sales revenue percentage | 24% | 17% |
Accounts Receivable | Customer Concentration Risk | Customer Three | ||
Significant Accounting Policies [Line Items] | ||
Sales revenue percentage | 13% | 10% |
Accounts Receivable | Customer Concentration Risk | Customer Four | ||
Significant Accounting Policies [Line Items] | ||
Sales revenue percentage | 10% | |
Accounts Payable | Supplier Concentration Risk | ||
Significant Accounting Policies [Line Items] | ||
Number of vendors | Vendor | Vendor | 1 | 2 |
Accounts Payable | Supplier Concentration Risk | Vendor One | ||
Significant Accounting Policies [Line Items] | ||
Sales revenue percentage | 13% | 28% |
Accounts Payable | Supplier Concentration Risk | Vendor Two | ||
Significant Accounting Policies [Line Items] | ||
Sales revenue percentage | 16% |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Inventory [Line Items] | ||
Inventory reserve | $ 49,249 | |
Provision for specific and general Inventory | 44,762 | $ 200,000 |
Provision for excess inventory related to write down | $ 1,100,000 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 426,516 | $ 1,253,111 |
Work in process | 113,063 | 312,803 |
Finished goods | 394,016 | 447,145 |
Total gross inventory - current | 933,595 | 2,013,059 |
Less general inventory allowance | (24,267) | (25,306) |
Inventory, net | 909,328 | 1,987,753 |
Raw materials - non-current, net | 244,915 | 711,296 |
Work in process - non-current, net | 81,958 | 0 |
Finished goods - non-current | 73,930 | 0 |
Inventory, Noncurrent, Total | $ 400,803 | $ 711,296 |
Fair Value Instruments - Additi
Fair Value Instruments - Additional Information (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value Disclosures [Abstract] | ||
Fair value assets, Level 1 to Level 2 transfers, Amount | $ 0 | $ 0 |
Fair value, assets, Level 2 to Level 1 transfers, Amount | $ 0 | $ 0 |
Fair Value Instruments - Financ
Fair Value Instruments - Financial Assets and Liabilities Measured at Fair Value On Recurring Basis (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Assets, Fair Value Disclosure [Abstract] | ||
Debt Securities, Available-for-Sale | $ 0 | $ 12,343,456 |
Corporate Debt Securities | ||
Assets, Fair Value Disclosure [Abstract] | ||
Debt Securities, Available-for-Sale | 12,343,456 | |
Fair Value, Measurements, Recurring | ||
Assets, Fair Value Disclosure [Abstract] | ||
Assets, Fair Value Disclosure, Total | 10,753,684 | 21,426,758 |
Fair Value, Measurements, Recurring | Money market securities | ||
Assets, Fair Value Disclosure [Abstract] | ||
Cash and Cash Equivalents, Fair Value Disclosure | 10,753,684 | 9,083,302 |
Fair Value, Measurements, Recurring | Corporate Debt Securities | ||
Assets, Fair Value Disclosure [Abstract] | ||
Debt Securities, Available-for-Sale | 12,343,456 | |
Fair Value, Measurements, Recurring | Level 1 | ||
Assets, Fair Value Disclosure [Abstract] | ||
Assets, Fair Value Disclosure, Total | 10,753,684 | 9,083,302 |
Fair Value, Measurements, Recurring | Level 1 | Money market securities | ||
Assets, Fair Value Disclosure [Abstract] | ||
Cash and Cash Equivalents, Fair Value Disclosure | $ 10,753,684 | 9,083,302 |
Fair Value, Measurements, Recurring | Level 2 | ||
Assets, Fair Value Disclosure [Abstract] | ||
Assets, Fair Value Disclosure, Total | 12,343,456 | |
Fair Value, Measurements, Recurring | Level 2 | Corporate Debt Securities | ||
Assets, Fair Value Disclosure [Abstract] | ||
Debt Securities, Available-for-Sale | $ 12,343,456 |
Available-for-Sale Securities -
Available-for-Sale Securities - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | ||
Investments in available-for-sale securities | $ 0 | $ 12,343,456 |
Available-for-sale securities investments, gross unrealized losses | 0 | 0 |
Unrealized holding gains on short term investment | $ 0 | $ 0 |
Available-for-Sale Securities_2
Available-for-Sale Securities - Summary of Available-for-sale Securities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | $ 12,343,456 | |
Available-for-sale securities investments, gross unrealized losses | $ 0 | 0 |
Fair Value (Net Carrying Amount) | $ 0 | 12,343,456 |
Corporate Debt Securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 12,343,456 | |
Fair Value (Net Carrying Amount) | $ 12,343,456 |
Property and Equipment - Summar
Property and Equipment - Summary of Property and Equipment (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Abstract] | ||
Furniture & fixtures | $ 756,065 | $ 872,877 |
Leasehold improvements | 1,938,981 | 1,931,762 |
Equipment used in manufacturing | 1,863,976 | 2,432,242 |
Equipment used in research & development | 2,080,319 | 2,343,930 |
Equipment used in the field | 159,563 | 216,218 |
Software | 469,408 | 480,740 |
Property and equipment | 7,268,312 | 8,277,769 |
Less: accumulated depreciation and amortization | (6,670,306) | (7,158,883) |
Property, Plant and Equipment, Net, Total | $ 598,006 | $ 1,118,886 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation and amortization | $ 587,138 | $ 721,246 |
Accrued Liabilities - Summary o
Accrued Liabilities - Summary of Accrued Liabilities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued employee bonuses | $ 1,252,622 | $ 1,254,355 |
Payroll and employee benefit accruals | 416,070 | 389,385 |
Accrued professional fees | 355,377 | 47,594 |
Other accrued liabilities | 185,537 | 331,235 |
Total accrued liabilities | $ 2,209,606 | $ 2,022,569 |
Debt Obligations - Additional I
Debt Obligations - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Jun. 24, 2020 | Jul. 31, 2022 | May 31, 2022 | May 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Debt Instrument [Line Items] | ||||||
Debt instrument, covenant unrestricted cash | $ 12,500,000 | |||||
Outstanding principal under the term loan | $ 6,764,706 | $ 0 | ||||
Insurance Note | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, interest rate | 3.32% | 3.57% | ||||
Debt instrument, maturity date | Jun. 30, 2022 | Feb. 28, 2022 | ||||
Down payment on insurance note | $ 300,000 | $ 400,000 | ||||
Premium payable on insurance note | $ 800,000 | $ 700,000 | ||||
Loan term | 9 months | 9 months | ||||
SVB Term Loan | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, principal amount | $ 10,000,000 | |||||
Debt instrument, interest rate | 5.75% | |||||
Extend the interest-only payments | 6 months | |||||
Debt instrument, maturity date | Dec. 01, 2023 | Dec. 01, 2023 | ||||
Debt instrument after second anniversary early termination fee percentage | 1% | |||||
Debt instrument final payment percentage | 8% | |||||
Outstanding principal under the term loan | $ 2,500,000 | |||||
Debt discount, fees and debt issuance costs | 222,796 | 600,000 | ||||
Debt instrument, amortization expense | $ 400,000 | $ 500,000 | ||||
Debt instrument effective interest rate | 16.15% | 10.47% | ||||
SVB Term Loan | Minimum | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, interest at floating rate | 5% | |||||
SVB Term Loan | Prime Rate | Minimum | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, interest at floating rate | 2.50% |
Debt Obligations - Schedule of
Debt Obligations - Schedule of Current Portion of Long Term Debt, Net (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||
Current portion of long-term debt, net | $ 3,812,498 | $ 5,167,586 |
SVB Term Loan | ||
Debt Instrument [Line Items] | ||
SVB Term Loan | 3,812,498 | 5,000,000 |
2021 Insurance Note | ||
Debt Instrument [Line Items] | ||
Insurance note | $ 0 | $ 167,586 |
Debt Obligations - Schedule o_2
Debt Obligations - Schedule of Long Term Debt, Net of Current Portion and Discount and Debt Issuance Costs (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
SVB Term Loan | ||
Debt Instrument [Line Items] | ||
Loan, net of discount and debt issuance costs | $ 0 | $ 5,178,629 |
Debt Obligations - Schedule o_3
Debt Obligations - Schedule of Remaining Principal Repayments due Under SVB Term Loan (Details) - SVB Term Loan - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||
2023 | $ 3,235,294 | |
Less discount and deferred financing costs | (222,796) | $ (600,000) |
Plus final fee premium | 800,000 | |
Total SVB Term Loan, net | $ 3,812,498 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Custom RUO Assay Design and Related Agreements | ||
Disaggregation of Revenue [Line Items] | ||
Revenue recognized | $ 0 | $ 0 |
Other Current Liabilities | ||
Disaggregation of Revenue [Line Items] | ||
Contract liabilities - current | $ 200,000 | $ 100,000 |
Minimum | ||
Disaggregation of Revenue [Line Items] | ||
Customer payment term | 30 days | |
Maximum | ||
Disaggregation of Revenue [Line Items] | ||
Customer payment term | 90 days |
Revenue from Contracts with C_4
Revenue from Contracts with Customers - Product and Product-Related Service Revenue from Sale of Instrument and Consumables (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation of Revenue [Line Items] | ||
Product and product-related services revenue | $ 6,366,220 | $ 8,906,828 |
HTG EdgeSeq | Instrument | ||
Disaggregation of Revenue [Line Items] | ||
Product and product-related services revenue | 609,627 | 1,385,665 |
HTG EdgeSeq | Consumables | ||
Disaggregation of Revenue [Line Items] | ||
Product and product-related services revenue | 3,140,420 | 3,786,923 |
HTG EdgeSeq | Product | ||
Disaggregation of Revenue [Line Items] | ||
Product and product-related services revenue | 3,750,047 | 5,172,588 |
HTG EdgeSeq | Custom RUO assay design | ||
Disaggregation of Revenue [Line Items] | ||
Product and product-related services revenue | 20,000 | 48,350 |
HTG EdgeSeq | RUO Sample processing | ||
Disaggregation of Revenue [Line Items] | ||
Product and product-related services revenue | 2,596,173 | 3,685,890 |
HTG EdgeSeq | Product-related services revenue | ||
Disaggregation of Revenue [Line Items] | ||
Product and product-related services revenue | 2,616,173 | 3,734,240 |
HTG EdgeSeq | Product and product-related services | ||
Disaggregation of Revenue [Line Items] | ||
Product and product-related services revenue | $ 6,366,220 | $ 8,906,828 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers - Schedule Of Revenue By Primary Geographic Market (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 6,366,220 | $ 8,906,828 |
United States | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 4,141,716 | 6,178,199 |
United States | Product revenue | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 1,904,025 | 3,114,818 |
United States | Product-related services revenue | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 2,237,691 | 3,063,381 |
Europe | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 2,198,350 | 2,225,064 |
Europe | Product revenue | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 1,839,445 | 2,026,728 |
Europe | Product-related services revenue | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 358,905 | 198,336 |
Other | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 26,154 | 503,565 |
Other | Product revenue | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 6,577 | 31,042 |
Other | Product-related services revenue | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 19,577 | $ 472,523 |
Revenue from Contracts with C_6
Revenue from Contracts with Customers - Schedule of Changes in Contract Liability (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation of Revenue [Line Items] | ||
Beginning Balance | $ 159,150 | $ 197,464 |
Deferral of revenue | 491,062 | 873,440 |
Recognition of deferred revenue | (476,498) | (911,754) |
Ending Balance | 173,714 | 159,150 |
Product Revenue | ||
Disaggregation of Revenue [Line Items] | ||
Beginning Balance | 128,529 | 103,580 |
Deferral of revenue | 293,158 | 286,349 |
Recognition of deferred revenue | (274,973) | (261,400) |
Ending Balance | 146,714 | 128,529 |
Sample Processing | ||
Disaggregation of Revenue [Line Items] | ||
Beginning Balance | 30,621 | 93,884 |
Deferral of revenue | 197,904 | 587,091 |
Recognition of deferred revenue | (201,525) | (650,354) |
Ending Balance | $ 27,000 | $ 30,621 |
Other Agreements - Additional I
Other Agreements - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Other Agreements [Line Items] | ||
Asset purchase agreement aggregate cash compensation paid | $ 15,000,000 | |
Measurement Input, Default Rate | ||
Other Agreements [Line Items] | ||
Discount rate used to calculate asset purchase obligation | 2.5 | |
NuvoGen Asset Purchase Agreement | ||
Other Agreements [Line Items] | ||
Percentage on annual revenues for cash consideration to be paid | 6% | |
Asset purchase agreement yearly fixed fees paid | $ 400,000 | $ 400,000 |
Asset purchase agreement fixed quarterly payments | $ 100,000 | 100,000 |
Percentage of compounded annual interest on unpaid Obligation | 2.50% | |
Additional revenue based payments payable | $ 46,031 | |
NuvoGen | ||
Other Agreements [Line Items] | ||
Unamortized interest accretion | (55,620) | (67,088) |
Accretion of discount on NuvoGen obligation | $ (11,467) | $ (12,288) |
Other Agreements - Schedule of
Other Agreements - Schedule of Remaining Minimum Principal Payments Due (Details) - NuvoGen Asset Purchase Agreement | Dec. 31, 2022 USD ($) |
Purchase Obligation Fiscal Year Maturity [Line Items] | |
2023 | $ 446,031 |
2024 | 400,000 |
2025 | 400,000 |
2026 | 400,000 |
2027 | 400,000 |
2028 and beyond | 1,863,438 |
Total NuvoGen obligation payments | 3,909,469 |
Plus interest accretion | 55,620 |
Total NuvoGen obligation, net | $ 3,965,089 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Lessee, Lease, Description [Line Items] | ||
Operating lease, description | The Company’s active leases as of December 31, 2022 relate to the Company’s office and manufacturing space in Tucson, Arizona, and expire in 2025 | |
Lease expiration year | 2025 | |
Operating lease right-of-use assets | $ 1,007,202 | $ 1,345,361 |
Tucson, Arizona [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Extended lease term | The Company amended its Tucson facility leases in September 2021 to extend the terms of the leases for three years through January 31, 2025. The lease extension was treated as a lease modification for accounting purposes, and allows for an additional extension of two years on the same terms and conditions | |
San Carlos, California [Member] | Research and Development [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease right-of-use assets | $ 200,000 |
Leases - Summary of Components
Leases - Summary of Components of Lease Cost for Operating Leases (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Leases [Abstract] | ||
Operating lease cost | $ 483,956 | $ 503,130 |
Variable lease cost | 99,989 | 88,708 |
Total rent expense | $ 583,945 | $ 591,838 |
Leases - Summary of Other Infor
Leases - Summary of Other Information Related to Operating Leases (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Leases [Abstract] | ||
Cash paid for amounts included in measurement of operating lease liabilities | $ 487,673 | $ 514,453 |
Establishment of operating lease liabilities arising from obtaining right-of-use- assets | $ 77,385 | $ 1,302,457 |
Weighted-average remaining lease term - operating leases | 2 years 1 month 6 days | 3 years 1 month 6 days |
Weighted-average discount rate - operating leases | 5.80% | 5.80% |
Leases - Summary of Remaining M
Leases - Summary of Remaining Maturities of Operating Leases (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
2023 | $ 521,467 | |
2024 | 521,379 | |
2025 | 43,444 | |
Total | 1,086,290 | |
Less present value discount | (64,840) | |
Total operating lease liabilities | 1,021,450 | |
Less operating lease liabilities - current | (475,126) | $ (413,865) |
Operating lease liabilities - non-current | $ 546,324 | $ 949,461 |
Net Loss Per Share - Reconcilia
Net Loss Per Share - Reconciliation of Numerator and Denominator Used in Computing Basic and Diluted Net Loss per Share (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Numerator: | ||
Net loss | $ (21,594,476) | $ (17,145,170) |
Denominator: | ||
Shares used in computing net loss per share, basic | 889,284 | 578,011 |
Shares used in computing net loss per share, diluted | 889,284 | 578,011 |
Net loss per share, basic | $ (24.28) | $ (29.66) |
Net loss per share, diluted | $ (24.28) | $ (29.66) |
Net Loss per Share - Common Sto
Net Loss per Share - Common Stock Equivalents Excluded from Computation of Diluted Net Loss per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Series A Preferred | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per share | 13,212 | |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per share | 76,099 | 46,611 |
Warrant | Common Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per share | 3,164,267 | 4,890 |
Unvested Restricted Stock Units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per share | 1,041 | 2,598 |
Warrants - Additional Informati
Warrants - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Dec. 31, 2022 | May 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2022 | |
Class of Warrant or Right [Line Items] | |||||
Exercise price of warrants | $ 9.6875 | $ 9.6875 | |||
Placement Agent | |||||
Class of Warrant or Right [Line Items] | |||||
Warrant to purchase common stock | 38,709 | 38,709 | |||
March Two Thousand Twenty Two Purchase Agreement Member | |||||
Class of Warrant or Right [Line Items] | |||||
Proceeds from exercise of pre-funded warrants | $ 2,411 | $ 0 | |||
March Two Thousand Twenty Two Purchase Agreement Member | Investor | |||||
Class of Warrant or Right [Line Items] | |||||
Exercise price of warrants | $ 27.744 | ||||
Number of securities called by warrants | 270,415 | ||||
Private Placement | |||||
Class of Warrant or Right [Line Items] | |||||
Number of securities called by warrants | 38,709 | 38,709 | |||
Private Placement | March Two Thousand Twenty Two Purchase Agreement Member | Investor | |||||
Class of Warrant or Right [Line Items] | |||||
Exercise price of warrants | $ 24.744 | $ 24.744 | |||
Warrant exercisable commencing date | Sep. 21, 2022 | ||||
Pre Funded Warrants | |||||
Class of Warrant or Right [Line Items] | |||||
Exercise price of warrants | $ 7.50 | $ 7.50 | |||
Pre Funded Warrants | March Two Thousand Twenty Two Purchase Agreement Member | |||||
Class of Warrant or Right [Line Items] | |||||
Exercise price of warrants | $ 24.744 | ||||
Pre Funded Warrants | March Two Thousand Twenty Two Purchase Agreement Member | Investor | |||||
Class of Warrant or Right [Line Items] | |||||
Exercise price of warrants | 0.012 | ||||
Pre Funded Warrants | Private Placement | |||||
Class of Warrant or Right [Line Items] | |||||
Proceeds from exercise of pre-funded warrants | $ 1,188 | $ 2,411 | |||
Pre Funded Warrants | Private Placement | March Two Thousand Twenty Two Purchase Agreement Member | Investor | |||||
Class of Warrant or Right [Line Items] | |||||
Exercise price of warrants | $ 0.001 | $ 0.001 | $ 0.012 | ||
Number of securities called by warrants | 1,188,322 | 1,188,322 | 200,911 | ||
Series A-1 Warrants | Private Placement | March Two Thousand Twenty Two Purchase Agreement Member | Investor | |||||
Class of Warrant or Right [Line Items] | |||||
Exercise price of warrants | $ 9.6875 | $ 9.6875 | |||
Warrant expire date | Dec. 23, 2027 | ||||
Number of securities called by warrants | 1,290,322 | 1,290,322 | |||
Series A-2 Warrants | Private Placement | March Two Thousand Twenty Two Purchase Agreement Member | Investor | |||||
Class of Warrant or Right [Line Items] | |||||
Exercise price of warrants | $ 7.50 | $ 7.50 | |||
Warrant expire date | Dec. 23, 2024 | ||||
Number of securities called by warrants | 1,290,322 | 1,290,322 | |||
Warrant Expiring In March Seventeen Two Thousand And Twenty Four Member | Private Placement | March Two Thousand Twenty Two Purchase Agreement Member | Investor | |||||
Class of Warrant or Right [Line Items] | |||||
Warrant expire date | Mar. 17, 2024 | ||||
Number of securities called by warrants | 270,415 | 270,415 | |||
Series A1 Warrant Expiring In December Twenty One Two Thousand And Twenty Seven [Member] | Private Placement | March Two Thousand Twenty Two Purchase Agreement Member | Investor | |||||
Class of Warrant or Right [Line Items] | |||||
Warrant expire date | Dec. 21, 2027 | ||||
Warrant Expiring in September 17, 2027 | Private Placement | March Two Thousand Twenty Two Purchase Agreement Member | Investor | |||||
Class of Warrant or Right [Line Items] | |||||
Warrant expire date | Sep. 17, 2027 | ||||
Number of securities called by warrants | 270,415 | 270,415 |
Warrants - Summary of Warrants
Warrants - Summary of Warrants Outstanding (Details) | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Class of Warrant or Right [Line Items] | |
Exercise price of warrants | $ 9.6875 |
Series E Redeemable Convertible Preferred Stock | |
Class of Warrant or Right [Line Items] | |
Warrant Issuance Date | 2014-08 |
Shares of Common Stock Underlying Warrants | shares | 159 |
Exercise price of warrants | $ 4,231.80 |
Expiration Date | 2024 |
SVB Term Loan | |
Class of Warrant or Right [Line Items] | |
Warrant Issuance Date | 2020-06 |
Shares of Common Stock Underlying Warrants | shares | 3,574 |
Exercise price of warrants | $ 139.878 |
Expiration Date | 2030 |
Common Stock Warrants | |
Class of Warrant or Right [Line Items] | |
Warrant Issuance Date | 2016-03 |
Shares of Common Stock Underlying Warrants | shares | 251 |
Exercise price of warrants | $ 496.80 |
Expiration Date | 2026 |
Common Stock Tranche One | |
Class of Warrant or Right [Line Items] | |
Warrant Issuance Date | 2018-03 |
Shares of Common Stock Underlying Warrants | shares | 100 |
Exercise price of warrants | $ 1,391.40 |
Expiration Date | 2028 |
Common Stock Tranche Two | |
Class of Warrant or Right [Line Items] | |
Warrant Issuance Date | 2022-03 |
Shares of Common Stock Underlying Warrants | shares | 270,415 |
Exercise price of warrants | $ 24.74 |
Expiration Date | 2024 |
Common Stock Tranche Three | |
Class of Warrant or Right [Line Items] | |
Warrant Issuance Date | 2022-03 |
Shares of Common Stock Underlying Warrants | shares | 270,415 |
Exercise price of warrants | $ 24.74 |
Expiration Date | 2027 |
Common Stock Tranche Four | |
Class of Warrant or Right [Line Items] | |
Warrant Issuance Date | 2022-12 |
Shares of Common Stock Underlying Warrants | shares | 1,290,322 |
Exercise price of warrants | $ 7.50 |
Expiration Date | 2024 |
Common Stock Tranche Five | |
Class of Warrant or Right [Line Items] | |
Warrant Issuance Date | 2022-12 |
Shares of Common Stock Underlying Warrants | shares | 1,290,322 |
Exercise price of warrants | $ 7.50 |
Expiration Date | 2027 |
Common Stock Tranche Six | |
Class of Warrant or Right [Line Items] | |
Warrant Issuance Date | 2022-12 |
Shares of Common Stock Underlying Warrants | shares | 38,709 |
Exercise price of warrants | $ 9.6875 |
Expiration Date | 2027 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||||||||||||||
Dec. 20, 2022 | Dec. 31, 2022 | May 31, 2022 | Mar. 31, 2022 | May 31, 2021 | Feb. 29, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2019 | Nov. 29, 2022 | Oct. 21, 2022 | Aug. 31, 2021 | Jul. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2020 | Aug. 31, 2020 | Mar. 04, 2020 | Nov. 30, 2019 | Sep. 30, 2019 | |
Class of Stock [Line Items] | |||||||||||||||||||
Reverse stock split, description | On December 20, 2022, the Company completed a reverse stock split of its outstanding shares of common stock pursuant to which every 12 shares of issued and outstanding common stock were exchanged for one share of common stock. | ||||||||||||||||||
Common stock split Price per share | $ 8.20 | ||||||||||||||||||
Fractional shares from reverse stock split share | 0 | ||||||||||||||||||
Exercise price of warrants | $ 9.6875 | $ 9.6875 | |||||||||||||||||
Reimbursement of expenses and legal fees | $ 125,000 | ||||||||||||||||||
Common stock, shares outstanding | 2,213,897 | 2,213,897 | 632,340 | ||||||||||||||||
Common stock, shares issued | 2,213,897 | 2,213,897 | 632,340 | ||||||||||||||||
Common stock, shares authorized | 26,666,667 | 26,666,667 | 26,666,667 | ||||||||||||||||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | |||||||||||||||||
Preferred stock, par value | $ 0.001 | $ 0.001 | |||||||||||||||||
Weighted-average fair value of stock options granted | $ 10.50 | $ 52.56 | |||||||||||||||||
Payments of Stock Issuance Costs | $ 500,000 | ||||||||||||||||||
Employee Stock Option | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Number of Shares, Granted | 39,667 | 12,819 | |||||||||||||||||
Numbe of Awards Outstanding | 76,099 | 76,099 | 46,611 | 40,602 | |||||||||||||||
Number of Shares, Forfeited | 4,944 | 4,406 | |||||||||||||||||
Unrecognized compensation expense | $ 0.8 | $ 0.8 | |||||||||||||||||
Compensation expense period expected to be recognized | 1 year 10 months 13 days | ||||||||||||||||||
Restricted Stock Units R S U | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Number of RSU shares Granted | 416 | 2,500 | |||||||||||||||||
RSU Awards outstanding (in shares) | 1,249 | 1,249 | 2,598 | 1,017 | |||||||||||||||
Number of RSU Shares, Forfeited | 626 | 542 | |||||||||||||||||
Unrecognized compensation expense | $ 41,600 | $ 41,600 | |||||||||||||||||
Compensation expense period expected to be recognized | 10 months 28 days | ||||||||||||||||||
Granted | $ 8.29 | $ 62.40 | |||||||||||||||||
Vested and unissued RSU awards, description | Vested and unissued awards at December 31, 2022 represents RSU awards granted in November 2021 for which a portion of the awards vested on December 31, 2022, but for which issuance of shares occurred in January 2023. | ||||||||||||||||||
Pre Funded Warrants | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Exercise price of warrants | $ 7.50 | $ 7.50 | |||||||||||||||||
Placement Agent Warrants | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Number of securities called by warrants | 38,709 | 38,709 | |||||||||||||||||
Placement Agent Warrants | Pre Funded Warrants | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Warrants exercised | 1,188,322 | 1,188,322 | |||||||||||||||||
Proceeds from exercise of pre-funded warrants | $ 1,188 | $ 2,411 | |||||||||||||||||
ATM Offering | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Issuance of common stock | $ 10,665,819 | ||||||||||||||||||
Net proceeds from issuance of common stock | 10,700,000 | ||||||||||||||||||
Payments of Stock Issuance Costs | $ 300,000 | ||||||||||||||||||
Employee Stock Purchase Plan | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Fair market value of company common stock, shares offering price | 85% | ||||||||||||||||||
Fair market value of company common stock, shares purchase price | 85% | ||||||||||||||||||
Maximum contribution eligible compensation during a period to purchase common stock | 15% | 15% | |||||||||||||||||
Vested and unissued RSU awards, description | Under the 2014 ESPP, the number of shares of common stock reserved for issuance automatically increased on January 1 of each calendar year, from January 1, 2016 to January 1, 2021 by the lesser of (i) 1% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, (ii) 1,083 shares, or (iii) a number determined by the Company’s Board of Directors that is less than (i) and (ii) | ||||||||||||||||||
Shares reserved for issuance | 35,120 | 35,120 | |||||||||||||||||
Public Offering | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Percentage of public offering, cash fee | 6.50% | ||||||||||||||||||
Percentage of public offering, management fee | 0.50% | ||||||||||||||||||
Series A Preferred Stock [Member] | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Preferred stock, par value | $ 0.001 | ||||||||||||||||||
Purchase price of share | $ 100 | ||||||||||||||||||
Preferred stock redemption amount | $ 100 | ||||||||||||||||||
Institutional Accredited Investors | Placement Agent Warrants | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Exercise price of warrants | $ 117 | ||||||||||||||||||
Institutional Accredited Investors | Placement Agent Warrants | Pre Funded Warrants | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Number of securities called by warrants | 30,064 | ||||||||||||||||||
Exercise price of warrants | $ 115.20 | ||||||||||||||||||
Exercise price of warrants, exercisable subject to beneficial ownership limitations | $ 1.80 | ||||||||||||||||||
Warrants exercised | 200,911 | 12,416 | |||||||||||||||||
Proceeds from exercise of pre-funded warrants | $ 2,411 | ||||||||||||||||||
Cantor Sales Agreement | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Common stock price per share | $ 0.001 | ||||||||||||||||||
Exchange Agreement | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Common stock, shares outstanding | 22,833 | ||||||||||||||||||
Exchange Agreement | Series A Preferred | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Issuance of common stock | $ 600,000 | ||||||||||||||||||
Stock issued, price per share | $ 59 | ||||||||||||||||||
Preferred stock, shares outstanding | 0 | 23,770 | 0 | ||||||||||||||||
Preferred stock, shares issued | 41,100 | ||||||||||||||||||
Preferred stock, par value | $ 0.001 | ||||||||||||||||||
Issuance of common stock, shares | 10,170 | ||||||||||||||||||
L P Purchase Agreement | Lincoln Park | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Common stock, shares issued | 12,864 | ||||||||||||||||||
Common stock value right to sell, maximum | $ 20,000,000 | ||||||||||||||||||
Common stock weighted average price per share | $ 69.96 | ||||||||||||||||||
Net proceeds from issuance of common stock from the ATM Offering | $ 900,000 | ||||||||||||||||||
December Two Thousand Twenty Two Purchase Agreement [Member] | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Exercise price of warrants | $ 0.001 | $ 0.001 | |||||||||||||||||
Percentage Of Minimum Aggregate Number Of Shares Beneficially Owned By Holder | 4.99% | ||||||||||||||||||
Percentage Increase In Ownership Cap | 9.99% | ||||||||||||||||||
Warrant issuance, description | Each unit consisted of one share of common stock (or one pre-funded warrant in lieu thereof), a common warrant to purchase one share of common stock with a term of 24 months from the issuance date, and a common warrant to purchase one share of common stock with a term of 60 months from the issuance date. | ||||||||||||||||||
December Two Thousand Twenty Two Purchase Agreement [Member] | Investor | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Number of securities called by warrants | 1,290,322 | 1,290,322 | |||||||||||||||||
Gross Proceeds From Issuance Of Warrants | $ 8,700,000 | ||||||||||||||||||
Combained Offering Price | $ 7.75 | $ 7.75 | |||||||||||||||||
March Two Thousand Twenty Two Purchase Agreement Member | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Percentage Of Minimum Aggregate Number Of Shares Beneficially Owned By Holder | 4.99% | ||||||||||||||||||
Percentage Increase In Ownership Cap | 9.99% | ||||||||||||||||||
Proceeds from exercise of pre-funded warrants | $ 2,411 | 0 | |||||||||||||||||
Warrant issuance, description | Each unit consists of one share of common stock (or one pre-funded warrant in lieu thereof), a common warrant to purchase one share of common stock with a term of 24 months from the issuance date, and a common warrant to purchase one share of common stock with a term of 66 months from the issuance date. | ||||||||||||||||||
Payments of Stock Issuance Costs | $ 500,000 | $ 500,000 | |||||||||||||||||
March Two Thousand Twenty Two Purchase Agreement Member | Pre Funded Warrants | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Exercise price of warrants | $ 24.744 | ||||||||||||||||||
Percentage Of Minimum Aggregate Number Of Shares Beneficially Owned By Holder | 9.99% | ||||||||||||||||||
March Two Thousand Twenty Two Purchase Agreement Member | Investor | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Number of securities called by warrants | 270,415 | ||||||||||||||||||
Exercise price of warrants | $ 27.744 | ||||||||||||||||||
Gross Proceeds From Issuance Of Warrants | $ 7,000,000 | ||||||||||||||||||
March Two Thousand Twenty Two Purchase Agreement Member | Investor | Pre Funded Warrants | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Exercise price of warrants | $ 0.012 | ||||||||||||||||||
March Two Thousand Twenty Two Purchase Agreement Member | Investor | Placement Agent Warrants | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Exercise price of warrants | $ 24.744 | $ 24.744 | |||||||||||||||||
March Two Thousand Twenty Two Purchase Agreement Member | Investor | Placement Agent Warrants | Pre Funded Warrants | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Number of securities called by warrants | 1,188,322 | 200,911 | 1,188,322 | ||||||||||||||||
Exercise price of warrants | $ 0.001 | $ 0.012 | $ 0.001 | ||||||||||||||||
March Two Thousand Twenty Two Purchase Agreement Member | Investor | Placement Agent Warrants | Series A-1 Warrants | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Number of securities called by warrants | 1,290,322 | 1,290,322 | |||||||||||||||||
Exercise price of warrants | $ 9.6875 | $ 9.6875 | |||||||||||||||||
March Two Thousand Twenty Two Purchase Agreement Member | Investor | Placement Agent Warrants | Series A-2 Warrants | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Number of securities called by warrants | 1,290,322 | 1,290,322 | |||||||||||||||||
Exercise price of warrants | $ 7.50 | $ 7.50 | |||||||||||||||||
March Two Thousand Twenty Two Purchase Agreement Member | Cantor Fitzgerald And Co | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Agent fee | $ 300,000 | ||||||||||||||||||
Additional transaction costs | $ 200,000 | ||||||||||||||||||
Common Stock | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Reverse stock split, description | In December 2022, the Company completed a reverse stock split of its outstanding shares of common stock pursuant to which every twelve shares of issued and outstanding common stock were exchanged for one share of common stock. | ||||||||||||||||||
Conversion of Series A convertible preferred stock for common stock, shares | 13,206 | 12,073 | |||||||||||||||||
Common Stock | ATM Offering | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Issuance of common stock | $ 171 | ||||||||||||||||||
Issuance of common stock, shares | 170,907 | ||||||||||||||||||
Common Stock | Exchange Agreement | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Conversion of Series A convertible preferred stock for common stock, shares | 13,206 | ||||||||||||||||||
Minimum | December Two Thousand Twenty Two Purchase Agreement [Member] | Investor | Pre Funded Warrants | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Exercise price of warrants | $ 0.001 | $ 0.001 | |||||||||||||||||
Minimum | March Two Thousand Twenty Two Purchase Agreement Member | Investor | Pre Funded Warrants | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Exercise price of warrants | $ 0.012 | ||||||||||||||||||
2021 Inducement Plan | Restricted Stock Units R S U | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Number of RSU shares Granted | 416 | 2,500 | |||||||||||||||||
Number of RSU Awards released | 1,041 | ||||||||||||||||||
RSU Awards outstanding (in shares) | 1,249 | 1,249 | |||||||||||||||||
Number of RSU Shares, Forfeited | 626 | ||||||||||||||||||
2014 Equity Incentive Plan | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Shares reserved for issuance | 5,712 | ||||||||||||||||||
Options granted in term | 10 years | ||||||||||||||||||
2014 Equity Incentive Plan | Maximum | Board Of Directors | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Options exercise period | 4 years | ||||||||||||||||||
2020 Equity Incentive Plan | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Shares reserved for issuance | 62,057 | ||||||||||||||||||
Number of shares available for issuance | 16,668 | 16,668 | |||||||||||||||||
2021 Inducement Plan | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Shares reserved for issuance | 25,000 | ||||||||||||||||||
Number of shares available for issuance | 13,961 | 13,961 | |||||||||||||||||
Inducement Awards | Employee Stock Option | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Number of Shares, Granted | 3,332 | 9,166 | |||||||||||||||||
Numbe of Awards Outstanding | 8,748 | 8,748 | |||||||||||||||||
Number of Shares, Forfeited | 3,750 | ||||||||||||||||||
Amended And Restated Two Thousand Fourteen Employee Stock Purchase Plan [Member] | |||||||||||||||||||
Class of Stock [Line Items] | |||||||||||||||||||
Shares reserved for issuance | 41,666 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Based Compensation Recognized in Consolidated Statement of Operations (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation | $ 774,160 | $ 1,317,355 |
Amended 2014 ESPP | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation | 40,347 | 57,669 |
Selling, General and Administrative | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation | 559,226 | 1,154,000 |
Selling, General and Administrative | Amended 2014 ESPP | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation | 22,187 | 34,219 |
Research And Development Expense | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation | 197,705 | 141,281 |
Research And Development Expense | Amended 2014 ESPP | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation | 11,046 | 11,643 |
Cost of Product and Product-related Services Revenue | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation | 17,229 | 22,074 |
Cost of Product and Product-related Services Revenue | Amended 2014 ESPP | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation | $ 7,114 | $ 11,807 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Material Factors Incorporated in Black-Scholes Model in Estimating Fair Value of Options Granted (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Common Stock | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected dividend yield | 0% | 0% |
Employee Stock Purchase Plan | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected dividend yield | 0% | 0% |
Maximum | Common Stock | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Fair value of common stock on grant date | $ 49.27 | $ 75 |
Risk-free interest rate, Maximum | 3.64% | 1.20% |
Expected volatility, Maximum | 110.70% | 107.30% |
Expected term | 5 years 9 months 18 days | 6 years 1 month 6 days |
Maximum | Employee Stock Purchase Plan | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Fair value of common stock on grant date | $ 49.80 | |
Risk-free interest rate, Maximum | 2.25% | 0.08% |
Expected volatility, Maximum | 96.70% | 89.20% |
Maximum | Employee Stock Purchase Plan | Common Stock | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Fair value of common stock on grant date | $ 70.20 | |
Minimum | Common Stock | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Fair value of common stock on grant date | $ 8.28 | $ 48.84 |
Risk-free interest rate, minimum | 1.53% | 0.85% |
Expected volatility, minimum | 89.60% | 104.20% |
Expected term | 5 years 6 months | 5 years 2 months 12 days |
Minimum | Employee Stock Purchase Plan | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Fair value of common stock on grant date | $ 6 | $ 56.04 |
Risk-free interest rate, minimum | 0.11% | 0.04% |
Expected volatility, minimum | 64.90% | 71.90% |
Expected term | 6 months | 6 months |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Material Factors Incorporated in Black-Scholes Model in Estimating Fair Value of Options Granted (Parenthetical) (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Class of Stock [Line Items] | |
Expected dividend assumed value | $ 0 |
2014 Employee Stock Purchase Plan | |
Class of Stock [Line Items] | |
Expected dividend assumed value | $ 0 |
Stockholders' Equity - Summar_4
Stockholders' Equity - Summary of RSU Award Activity (Details) - Restricted Stock Units (RSU) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Beginning Balance | 2,598 | 1,017 |
Number of RSU shares Granted | 416 | 2,500 |
Released | (1,139) | (377) |
Forfeited | (626) | (542) |
Ending Balance | 1,249 | 2,598 |
Vested and unissued at December 31, 2022 | 208 | |
Weighted Average Grant Date Fair Value Per Share | ||
Beginning Balance | $ 83.16 | $ 343.32 |
Granted | 8.29 | 62.40 |
Released | 110.47 | 349.56 |
Forfeited | 62.50 | 290.16 |
Ending Balance | 44.40 | $ 83.16 |
Vested and unissued at December 31, 2022 | $ 62.42 |
Stockholders' Equity - Summar_5
Stockholders' Equity - Summary of Stock Option Plans Activity Including Inducement Award Activity (Details) - Employee Stock Option - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Number of Shares, Beginning Balance | 46,611 | 40,602 | |
Number of Shares, Granted | 39,667 | 12,819 | |
Number of Shares, Exercised | (6) | ||
Number of Shares, Forfeited | (4,944) | (4,406) | |
Number of Shares, Expired/Cancelled | (5,235) | (2,398) | |
Number of Shares, Ending Balance | 76,099 | 46,611 | 40,602 |
Number of Shares, Exercisable | 38,096 | 24,915 | |
Weighted-Average Exercise Price Per Share, Beginning Balance | $ 167.16 | $ 201.36 | |
Weighted-Average Exercise Price Per Share, Granted | 12.91 | 65.40 | |
Weighted-Average Exercise Price Per Share, Exercised | 52.20 | ||
Weighted-Average Exercise Price Per Share, Forfeited | 66.58 | 143.76 | |
Weighted-Average Exercise Price Per Share, Expired/Cancelled | 292.56 | 244.68 | |
Weighted-Average Exercise Price Per Share, Ending Balance | 84.73 | 167.16 | $ 201.36 |
Weighted-Average Exercise Price Per Share, Exercisable | $ 142.34 | $ 241.68 | |
Weighted-Average Remaining Contractual Life, Outstanding | 8 years 3 months 18 days | 8 years 2 months 12 days | 8 years 7 months 6 days |
Weighted-Average Remaining Contractual Life, Exercisable | 7 years 7 months 6 days | 7 years 4 months 24 days | |
Aggregate Intrinsic Value, Balance | $ 0 | $ 30,267 | $ 1,536 |
Aggregate Intrinsic Value, Exercised | 107 | ||
Aggregate Intrinsic Value, Exercisable | $ 0 | $ 6,269 |
Stockholders' Equity - Summar_6
Stockholders' Equity - Summary of Shares Purchased under ESPP'S Six Month Purchase Periods (Details) - $ / shares | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Class of Stock [Line Items] | ||||
Number of Shares | 4,083 | 1,136 | 2,792 | 1,693 |
Price per Share | $ 5.71 | $ 47.04 | $ 5.10 | $ 42.72 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Product Warranty Liability [Line Items] | ||
Discretionary Contributions company may take | $ 0 | $ 0 |
Accrued Liabilities | ||
Product Warranty Liability [Line Items] | ||
Accrued product warranty | 73,000 | |
Other Non-Current Liabilities | ||
Product Warranty Liability [Line Items] | ||
Accrued product warranty | $ 15,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Product Warranty Liability (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Beginning balance | $ 120,385 | $ 92,696 |
Cost of warranty claims | (147,192) | (166,641) |
Increase in warranty reserve | 115,089 | 194,330 |
Ending balance | $ 88,282 | $ 120,385 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Line Items] | |||
Valuation allowance | $ 59,805,688 | $ 53,958,617 | |
Change in valuation reserve | $ 5,800,000 | ||
Period for cumulative change in ownership | 3 years | ||
Gross unrecognized tax benefits | $ 3,419,916 | $ 3,193,331 | $ 2,960,842 |
Unrecognized tax benefits if recognized would impact effective tax rate | 0 | ||
Research | |||
Income Tax Disclosure [Line Items] | |||
Gross unrecognized tax benefits | $ 3,400,000 | ||
Minimum | |||
Income Tax Disclosure [Line Items] | |||
Cumulative changes in ownership percentage | 50% | ||
Federal | |||
Income Tax Disclosure [Line Items] | |||
NOL carryforwards | $ 206,200,000 | ||
Federal | With Expiration | |||
Income Tax Disclosure [Line Items] | |||
NOL carryforwards | $ 121,600,000 | ||
Federal | Beginning Expiration Year | |||
Income Tax Disclosure [Line Items] | |||
NOL carryforward expiration year | 2023 | ||
Federal | Ending Expiration Year | |||
Income Tax Disclosure [Line Items] | |||
NOL carryforward expiration year | 2037 | ||
State | |||
Income Tax Disclosure [Line Items] | |||
NOL carryforwards | $ 155,200,000 | ||
State | With Expiration | |||
Income Tax Disclosure [Line Items] | |||
NOL carryforwards | $ 154,200,000 | ||
State | Beginning Expiration Year | |||
Income Tax Disclosure [Line Items] | |||
NOL carryforward expiration year | 2024 | ||
State | Ending Expiration Year | |||
Income Tax Disclosure [Line Items] | |||
NOL carryforward expiration year | 2042 |
Income Taxes - Summary of Loss
Income Taxes - Summary of Loss Before Income taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
U.S. pre-tax loss | $ (21,611,254) | $ (17,156,070) |
Foreign pre-tax gain (loss) | 27,615 | 33,375 |
Net loss before income taxes | $ (21,583,639) | $ (17,122,695) |
Income Taxes - Components of In
Income Taxes - Components of Income Tax Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Current: | ||
State | $ 3,270 | $ 13,769 |
Foreign | 7,567 | 8,706 |
Total current income tax expense | 10,837 | 22,475 |
Deferred: | ||
Total income tax expense | $ 10,837 | $ 22,475 |
Income Taxes - Difference in Ac
Income Taxes - Difference in Actual Income Tax Expense Computed by Applying the Statutory Federal Income Tax Rate to Loss Before Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Line Items] | ||
Computed tax (benefit) at 21% | $ (4,532,565) | $ (3,586,925) |
State taxes, net of federal benefit | (989,018) | (1,177,951) |
Stock-based compensation | 128,789 | 240,177 |
Foreign tax rate differential | 5,635 | (2,171) |
Return to provision | 13,047 | 53,340 |
Nontaxable loan forgiveness | 0 | (360,570) |
Other | 17,615 | 9,048 |
Uncertain tax position adjustment for prior periods | (8,856) | (6,395) |
Increase in valuation allowance | 5,847,071 | 5,331,692 |
Total income tax expense | 10,837 | 22,475 |
State | ||
Income Tax Disclosure [Line Items] | ||
Research and development tax credit | (234,971) | (265,362) |
Federal | ||
Income Tax Disclosure [Line Items] | ||
Research and development tax credit | $ (235,910) | $ (212,408) |
Income Taxes - Difference in _2
Income Taxes - Difference in Actual Income Tax Expense Computed by Applying the Statutory Federal Income Tax Rate to Loss Before Income Taxes (Parenthetical) (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Statutory federal income tax rate | 21% | 21% |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 50,968,402 | $ 47,752,053 |
Research and development credits | 4,393,368 | 3,940,199 |
R&D expenditures capitalization | 2,001,908 | 0 |
Deferred revenue | 45,373 | 42,802 |
Inventory reserve | 310,983 | 6,806 |
Fixed assets and intangibles | 291,244 | 304,019 |
Lease liability | 266,797 | 366,653 |
Other | 755,029 | 711,343 |
Gross deferred tax assets | 60,068,763 | 54,320,438 |
Valuation allowance | (59,805,688) | (53,958,617) |
Deferred tax assets, net | 263,075 | 361,821 |
Right of use asset | 263,075 | 361,821 |
Total deferred tax liabilities | 263,075 | 361,821 |
Net deferred tax assets (liabilities) | 0 | 0 |
NuvoGen | ||
Deferred tax assets: | ||
Accrued liability | $ 1,035,659 | $ 1,196,563 |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of Gross Unrecognized Tax Benefits (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Balance at beginning of year | $ 3,193,331 | $ 2,960,842 |
Decreases to prior positions | (8,856) | (6,395) |
Increases for current year positions | 235,441 | 238,884 |
Balance at end of year | $ 3,419,916 | $ 3,193,331 |