Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 01, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | MCRB | |
Entity Registrant Name | Seres Therapeutics, Inc. | |
Entity Central Index Key | 0001609809 | |
Entity Current Reporting Status | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity File Number | 001-37465 | |
Entity Tax Identification Number | 27-4326290 | |
Entity Address, Address Line One | 200 Sidney Street - 4th Floor | |
Entity Address, City or Town | Cambridge | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02139 | |
City Area Code | 617 | |
Local Phone Number | 945-9626 | |
Entity Common Stock Shares Outstanding | 124,071,555 | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common Stock, par value $0.001 | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | |
Current assets: | |||
Cash and cash equivalents | $ 126,824 | $ 180,002 | |
Short term investments | 68,971 | 110,704 | |
Prepaid expenses and other current assets | 13,785 | 12,922 | |
Total current assets | 209,580 | 303,628 | |
Property and equipment, net | 19,520 | 17,938 | |
Operating lease assets | 25,001 | 18,208 | |
Restricted cash | 8,185 | 8,000 | |
Restricted investments | 1,401 | 1,401 | |
Long term investments | 0 | 495 | |
Other non-current assets | 9,509 | 5,189 | |
Total assets | 273,196 | 354,859 | |
Current liabilities: | |||
Accounts payable | 13,992 | 13,735 | |
Accrued expenses and other current liabilities | [1] | 56,889 | 45,094 |
Operating lease liabilities | 7,058 | 6,610 | |
Deferred revenue - related party | 11,098 | 16,819 | |
Total current liabilities | 89,037 | 82,258 | |
Long term portion of note payable, net of discount | 50,632 | 24,643 | |
Operating lease liabilities, net of current portion | 19,516 | 17,958 | |
Deferred revenue, net of current portion - related party | 90,010 | 86,998 | |
Other long-term liabilities | [2] | 943 | 11,495 |
Total liabilities | 250,138 | 223,352 | |
Commitments and contingencies (Note 12) | |||
Stockholders' equity: | |||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at June 30, 2022 and December 31, 2021; no shares issued and outstanding at June 30, 2022 and December 31, 2021 | 0 | 0 | |
Common stock, $0.001 par value; 200,000,000 shares authorized at June 30, 2022 and December 31, 2021; 91,841,974 and 91,459,239 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 92 | 92 | |
Additional paid-in capital | 758,935 | 745,829 | |
Accumulated other comprehensive income (loss) | (256) | (60) | |
Accumulated deficit | (735,713) | (614,354) | |
Total stockholders’ equity | 23,058 | 131,507 | |
Total liabilities and stockholders’ equity | $ 273,196 | $ 354,859 | |
[1] Includes related party amounts of $ 33,062 and $ 21,098 at June 30, 2022 and December 31, 2021, respectively (see Note 11) Includes related party amounts of $ 0 and $ 10,585 at June 30, 2022 and December 31, 2021, respectively (s ee Note 11) |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 92,306,944 | 91,889,418 |
Common stock, shares outstanding | 92,306,944 | 91,889,418 |
Related party amounts included in accrued expenses and other current liabilities | $ 33,062 | $ 21,098 |
Related party amounts included in other long-term liabilities | $ 0 | $ 10,585 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue: | ||||
Collaboration revenue - related party | $ 1,216 | $ 5,263 | $ 2,709 | $ 9,911 |
Type of Revenue [Extensible List] | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember |
Grant revenue | $ 0 | $ 0 | $ 0 | $ 1,070 |
Total revenue | 1,216 | 5,263 | 2,709 | 10,981 |
Operating expenses: | ||||
Research and development expenses | 43,935 | 35,954 | 83,584 | 65,257 |
General and administrative expenses | 20,335 | 17,451 | 38,906 | 29,192 |
Collaboration (profit) loss sharing - related party | 271 | 0 | (705) | 0 |
Total operating expenses | 64,541 | 53,405 | 121,785 | 94,449 |
Loss from operations | (63,325) | (48,142) | (119,076) | (83,468) |
Other (expense) income: | ||||
Interest income | 395 | 829 | 779 | 1,795 |
Interest expense | (1,501) | (732) | (2,413) | (1,428) |
Other expense | (304) | (285) | (649) | (694) |
Total other (expense) income, net | (1,410) | (188) | (2,283) | (327) |
Net loss | $ (64,735) | $ (48,330) | $ (121,359) | $ (83,795) |
Net loss per share attributable to common stockholders, basic | $ (0.70) | $ (0.53) | $ (1.32) | $ (0.91) |
Net loss per share attributable to common stockholders, diluted | $ (0.70) | $ (0.53) | $ (1.32) | $ (0.91) |
Weighted average common shares outstanding, basic | 92,255,416 | 91,659,829 | 92,224,382 | 91,593,845 |
Weighted average common shares outstanding, diluted | 92,255,416 | 91,659,829 | 92,224,382 | 91,593,845 |
Other comprehensive income (loss): | ||||
Unrealized (loss) gain on investments, net of tax of $0 | $ (41) | $ 27 | $ (196) | $ 59 |
Total other comprehensive (loss) income | (41) | 27 | (196) | 59 |
Comprehensive loss | $ (64,776) | $ (48,303) | $ (121,555) | $ (83,736) |
Condensed Consolidated Statem_2
Condensed Consolidated Statement of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Income (Loss) [Member] |
Beginning balance at Dec. 31, 2020 | $ 174,750 | $ 91 | $ 723,482 | $ (548,776) | $ (47) |
Beginning balance, shares at Dec. 31, 2020 | 91,459,239 | ||||
Issuance of common stock upon exercise of stock options, value | 372 | $ 1 | 371 | ||
Issuance of common stock upon exercise of stock options, shares | 104,184 | ||||
Issuance of common stock upon vesting of RSUs, net of tax withholdings, shares | 650 | ||||
Issuance of common stock under ESPP, value | 392 | 392 | |||
Issuance of common stock under ESPP, shares | 24,191 | ||||
Stock-based compensation expense | 3,624 | 3,624 | |||
Other comprehensive income loss | 32 | 32 | |||
Net loss | (35,465) | (35,465) | |||
Ending balance at Mar. 31, 2021 | 143,705 | $ 92 | 727,869 | (584,241) | (15) |
Ending balance, shares at Mar. 31, 2021 | 91,588,264 | ||||
Beginning balance at Dec. 31, 2020 | 174,750 | $ 91 | 723,482 | (548,776) | (47) |
Beginning balance, shares at Dec. 31, 2020 | 91,459,239 | ||||
Net loss | (83,795) | ||||
Ending balance at Jun. 30, 2021 | 101,066 | $ 92 | 733,533 | (632,571) | 12 |
Ending balance, shares at Jun. 30, 2021 | 91,713,810 | ||||
Beginning balance at Mar. 31, 2021 | 143,705 | $ 92 | 727,869 | (584,241) | (15) |
Beginning balance, shares at Mar. 31, 2021 | 91,588,264 | ||||
Issuance of common stock upon exercise of stock options, value | 586 | 586 | |||
Issuance of common stock upon exercise of stock options, shares | 125,546 | ||||
Stock-based compensation expense | 5,078 | 5,078 | |||
Other comprehensive income loss | 27 | 27 | |||
Net loss | (48,330) | (48,330) | |||
Ending balance at Jun. 30, 2021 | 101,066 | $ 92 | 733,533 | (632,571) | 12 |
Ending balance, shares at Jun. 30, 2021 | 91,713,810 | ||||
Beginning balance at Dec. 31, 2021 | $ 131,507 | $ 92 | 745,829 | (614,354) | (60) |
Beginning balance, shares at Dec. 31, 2021 | 91,889,418 | 91,889,418 | |||
Issuance of common stock upon exercise of stock options, value | $ 257 | 257 | |||
Issuance of common stock upon exercise of stock options, shares | 92,478 | ||||
Issuance of common stock upon vesting of RSUs, net of tax withholdings, shares | 69,195 | ||||
Issuance of common stock under ESPP, value | 892 | 892 | |||
Issuance of common stock under ESPP, shares | 159,214 | ||||
Stock-based compensation expense | 5,079 | 5,079 | |||
Other comprehensive income loss | (155) | (155) | |||
Net loss | (56,624) | (56,624) | |||
Ending balance at Mar. 31, 2022 | 80,956 | $ 92 | 752,057 | (670,978) | (215) |
Ending balance, shares at Mar. 31, 2022 | 92,210,305 | ||||
Beginning balance at Dec. 31, 2021 | $ 131,507 | $ 92 | 745,829 | (614,354) | (60) |
Beginning balance, shares at Dec. 31, 2021 | 91,889,418 | 91,889,418 | |||
Issuance of common stock upon exercise of stock options, shares | 131,686 | ||||
Net loss | $ (121,359) | ||||
Ending balance at Jun. 30, 2022 | $ 23,058 | $ 92 | 758,935 | (735,713) | (256) |
Ending balance, shares at Jun. 30, 2022 | 92,306,944 | 92,306,944 | |||
Beginning balance at Mar. 31, 2022 | $ 80,956 | $ 92 | 752,057 | (670,978) | (215) |
Beginning balance, shares at Mar. 31, 2022 | 92,210,305 | ||||
Issuance of common stock upon exercise of stock options, value | 130 | 130 | |||
Issuance of common stock upon exercise of stock options, shares | 39,208 | ||||
Issuance of common stock upon vesting of RSUs, net of tax withholdings, shares | 57,431 | ||||
Stock-based compensation expense | 6,748 | 6,748 | |||
Other comprehensive income loss | (41) | (41) | |||
Net loss | (64,735) | (64,735) | |||
Ending balance at Jun. 30, 2022 | $ 23,058 | $ 92 | $ 758,935 | $ (735,713) | $ (256) |
Ending balance, shares at Jun. 30, 2022 | 92,306,944 | 92,306,944 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | ||
Cash flows from operating activities: | |||
Net loss | $ (121,359) | $ (83,795) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation expense | 11,827 | 8,702 | |
Depreciation and amortization expense | 3,255 | 2,902 | |
Non-cash operating lease cost | 2,305 | 1,465 | |
Amortization of premiums on investments | 547 | 1,581 | |
Amortization of debt issuance costs | 328 | 241 | |
Collaboration (profit) loss sharing - related party | (705) | 0 | |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other current and other non-current assets | (10,145) | (3,579) | |
Accounts receivable | 0 | 8,136 | |
Deferred revenue - related party | (2,709) | (9,911) | |
Accounts payable | 709 | 1,684 | |
Operating lease liabilities | (2,130) | (1,012) | |
Accrued expenses and other current and long-term liabilities (3) | [1] | 1,735 | 4,395 |
Net cash used in operating activities | (116,342) | (69,191) | |
Cash flows from investing activities: | |||
Purchases of property and equipment | (5,113) | (3,896) | |
Purchases of investments | (36,138) | (51,942) | |
Sales and maturities of investments | 77,622 | 82,378 | |
Purchase of restricted investments | 0 | (750) | |
Net cash provided by investing activities | 36,371 | 25,790 | |
Cash flows from financing activities: | |||
Proceeds from exercise of stock options | 387 | 957 | |
Issuance of common stock under ESPP | 892 | 392 | |
Proceeds from issuance of debt, net of issuance costs | 27,606 | ||
Repayment of notes payable | (1,907) | 0 | |
Net cash provided by financing activities | 26,978 | 1,349 | |
Net decrease in cash, cash equivalents, and restricted cash | (52,993) | (42,052) | |
Cash, cash equivalents and restricted cash at beginning of period | 188,002 | 116,049 | |
Cash, cash equivalents and restricted cash at end of period | 135,009 | 73,997 | |
Supplemental disclosure of cash flow information: | |||
Cash paid for interest | 1,836 | 1,220 | |
Supplemental disclosure of non-cash investing and financing activities: | |||
Property and equipment purchases included in accounts payable and accrued expenses | 597 | 606 | |
Prepaid rent reclassified to right-of-use assets | 4,962 | ||
Lease liability arising from obtaining right-of-use assets | $ 4,370 | $ 4,839 | |
[1] Includes related party amoun ts of $ 1,379 and $ 0 a t June 30, 2022 and June 30, 2021, respectively (see Note 11) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Statement of Cash Flows [Abstract] | ||
Accrued Expenses and Other current and Long-term Liabilities Related Party Amounts | $ 1,379 | $ 0 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Nature of the Business and Basis of Presentation | 1. Nature of the Business and Basis of Presentation Seres Therapeutics, Inc. (the “Company”) was incorporated under the laws of the State of Delaware in October 2010 under the name Newco LS21, Inc. In October 2011, the Company changed its name to Seres Health, Inc., and in May 2015, the Company changed its name to Seres Therapeutics, Inc. The Company is a microbiome therapeutics platform company developing a novel class of biological drugs, which are designed to treat disease by modulating the microbiome to restore health by repairing the function of a disrupted microbiome to a non-disease state. The Company’s lead product candidate, SER-109, is designed to reduce further recurrences of Clostridioides difficile infection (“CDI”), a debilitating infection of the colon, in patients who have received antibiotic therapy for recurrent CDI by restructuring the colonic microbiome and changing its function. If approved by the U.S. Food and Drug Administration (“FDA”), the Company believes SER-109 will be a first-in-field oral microbiome drug. Building upon SER-109, the Company is developing therapeutic candidates, such as SER-155, to specifically target infections and antimicrobial resistance. SER-155, a microbiome therapeutic candidate consisting of a consortium of cultivated bacteria, is designed to reduce incidences of gastrointestinal infections, bloodstream infections and graft versus host disease ("GvHD”) in patients receiving allogeneic hematopoietic stem cell transplantation (“allo-HSCT”). The Company is evaluating additional preclinical stage programs to reduce incidence of infection, which the Company refers to as Infection Protection, in indications such as cancer neutropenia, chronic liver disease, solid organ transplant, and antimicrobial resistant infections more broadly. The Company is also continuing its research activities in ulcerative colitis ("UC"), including evaluating the potential to utilize biomarker-based patient selection and stratification for future studies. In addition, the Company continues to leverage microbiome pharmacokinetic and pharmacodynamic data from across its clinical and preclinical portfolios, using its reverse translation microbiome therapeutics capabilities to conduct research on various indications, including inflammatory and immune diseases, cancer, and metabolic diseases. The Company has built and deploys a reverse translational platform for the discovery and development of microbiome therapeutics. This platform incorporates high-resolution analysis of human clinical data to identify microbiome biomarkers associated with disease and non-disease states; preclinical screening using human cell-based assays and in vitro/ex vivo and in vivo disease models customized for microbiome therapeutics; and microbiological capabilities and a strain library that spans broad biological and functional breadth to both identify specific microbes and microbial metabolites that are associated with disease and to design consortia of bacteria with specific pharmacological properties. The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance-reporting capabilities. The Company’s product candidates are in development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, or maintained, that any product candidate developed will obtain necessary government regulatory approval, or that any approved product will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees and consultants. On June 29, 2022, the Company entered into securities purchase agreements with new and existing investors and certain directors and officers in a registered direct offering of an aggregate of 31,746,030 shares of common stock at a purchase price of $ 3.15 per share (the "Registered Direct Offering"). Total net proceeds to the Company were approximately $ 96,841 , after deducting placement agent’s fees and other estimated offering expenses. The closing date of the Registered Direct Offering was July 5, 2022. Under Accounting Standards Update (“ASU”) 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40) (“ASC 205-40”), the Company has the responsibility to evaluate whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date that the financial statements are issued. As required by ASC 205-40, this evaluation shall initially not take into consideration the potential mitigating effects of plans that have not been fully implemented as of the date the financial statements are issued. As of June 30, 2022, the Company had an accumulated deficit of $ 735,713 and cash, cash equivalents and investments of $ 195,795 . For the six months ended June 30, 2022, the Company incurred a net loss of $ 121,359 . The Company expects that its operating losses and negative cash flows will continue for the foreseeable future. T he Company expects that its cash, cash equivalents and investments as of June 30, 2022, together with the additional $ 96,841 in net proceeds from the Registered Direct Offering, will be sufficient to fund its operating expenses, capital expenditure requirements, and debt service obligations for at least the next 12 months from issuance of the financial statements. The future viability of the Company beyond that point is dependent on its ability to raise additional capital to finance its operations. The Company is eligible to receive contingent milestone payments under its license and collaboration agreements with Société des Produits Nestlé S.A., successor in interest to Nestec Ltd., and NHSc Pharma Partners (collectively, “Nestlé”) if certain development, regulatory approval or sales target milestones are achieved. NHSc Pharma Partners is affiliated with Société des Produits Nestlé S.A., a significant stockholder of the Company. The milestone payments are uncertain and there is no assurance that the Company will receive any of them. Until such time, if ever, as the Company can generate substantial product revenue, the Company will finance its cash needs through a combination of public or private equity offerings, debt financings, governmental funding, collaborations, strategic partnerships, or marketing, distribution or licensing arrangements with third parties. The Company may not be able to obtain funding on acceptable terms, or at all. If the Company is unable to raise additional funds as and when needed, it would have a negative impact on the Company’s financial condition, which may require the Company to delay, reduce or eliminate certain research and development activities and reduce or eliminate discretionary operating expenses, which could constrain the Company’s ability to pursue its business strategies. Unaudited Interim Financial Information The accompanying unaudited condensed consolidated financial statements as of June 30, 2022 and for the three and six months ended June 30, 2022 and 2021 have been prepared by the Company, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2021 included in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2021, which was filed with the SEC on March 1, 2022 (the “Annual Report”). The unaudited condensed consolidated interim financial statements have been prepared on the same basis as the audited consolidated financial statements. The condensed consolidated balance sheet at December 31, 2021 was derived from audited annual financial statements, but does not contain all of the footnote disclosures from the annual financial statements. In the opinion of management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments which are necessary for a fair statement of the Company’s financial position, results of operations, and cash flows for the periods presented. Such adjustments are of a normal and recurring nature. The results of operations for the three and six months ended June 30, 2022 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2022. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies The significant accounting policies and estimates used in preparation of the condensed consolidated financial statements are described in the Company’s audited financial statements as of and for the year ended December 31, 2021, and the notes thereto, which are included in the Annual Report. There have been no material changes to the Company’s significant accounting policies during the six months ended June 30, 2022. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenue and expenses during the reporting periods. In the condensed consolidated financial statements, the Company uses estimates and assumptions related to revenue recognition and the accrual of research and development expenses. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Restricted Cash The Company held restricted cash of $ 8,185 and $ 8,000 as of June 30, 2022 and December 31, 2021, respectively, which represents cash held for the benefit of the landlord for the Company's leases. The Company has classified the restricted cash as long-term on its consolidated balance sheet as the underlying leases are greater than 1 year. Cash, cash equivalents and restricted cash were comprised of the following (in thousands): June 30, December 31, 2022 2021 Cash and cash equivalents $ 126,824 $ 180,002 Restricted cash, non-current 8,185 8,000 Total cash, cash equivalents and restricted cash $ 135,009 $ 188,002 Recently Adopted Accounting Standards In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (‘‘ASU 2016-13’’), which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model. It also eliminates the concept of other-than-temporary impairment and requires credit losses related to available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. These changes may result in earlier recognition of credit losses. In November 2018, the FASB issued ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses , which narrowed the scope and changed the effective date for non-public entities for ASU 2016-13. The FASB subsequently issued supplemental guidance within ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief (‘‘ASU 2019-05’’). ASU 2019-05 provides an option to irrevocably elect the fair value option for certain financial assets previously measured at amortized cost basis. For public entities that are Securities and Exchange Commission filers, excluding entities eligible to be smaller reporting companies, ASU 2016-13 is effective for annual periods beginning after December 15, 2019, including interim periods within those fiscal years. For all other entities, ASU 2016-13 is effective for annual periods beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. The Company adopted the new standard as of January 1, 2022. The adoption of this standard did not have a material impact on the Company's condensed consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The following tables present the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis (in thousands): Fair Value Measurements as of June 30, 2022 Using: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 54,233 $ — $ — $ 54,233 Commercial paper — 12,489 — 12,489 Government securities — — — — Investments: Corporate bonds $ — $ 11,992 $ — $ 11,992 Government securities — 56,979 — 56,979 $ 54,233 $ 81,460 $ — $ 135,693 Fair Value Measurements as of December 31, 2021 Using: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 70,322 $ — $ — $ 70,322 Commercial paper — 3,999 — 3,999 Investments: Commercial paper $ — $ 6,250 $ — $ 6,250 Corporate bonds — 40,095 — 40,095 Government securities — 64,854 — 64,854 $ 70,322 $ 115,198 $ — $ 185,520 Money market funds were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy. Commercial paper, corporate bonds, and government securities were valued by the Company using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy. There were no transfers between Level 1 or Level 2 during the three and six months ended June 30, 2022 and 2021. As of June 30, 2022 and December 31, 2021, the Company held a restricted investment of $ 1,401 in both periods, which represent a certificate of deposit that is classified as Level 2 in the fair value hierarchy. |
Investments
Investments | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | Investments Investments by security type consisted of the following at June 30, 2022 and December 31, 2021 (in thousands): June 30, 2022 Amortized Gross Gross Fair Investments: Corporate bonds $ 12,043 $ — $ ( 51 ) $ 11,992 Government securities 57,184 — ( 205 ) 56,979 $ 69,227 $ — $ ( 256 ) $ 68,971 December 31, 2021 Amortized Gross Gross Fair Investments: Commercial paper $ 6,250 $ — $ — $ 6,250 Corporate bonds 40,123 — ( 28 ) 40,095 Government securities 64,885 — ( 31 ) 64,854 $ 111,258 $ — $ ( 59 ) $ 111,199 Investments with original maturities of less than 90 days are included in cash and cash equivalents on the condensed consolidated balance sheets and are not included in the table above. Investments with maturities of less than 12 months are considered current and those investments with maturities greater than 12 months are considered non-current assets. Excluded from the tables above are restricted investments of $ 1,401 and $ 1,401 as the cost approximates current fair value as of June 30, 2022 and December 31, 2021, respectively. The amortized cost and fair value of investments in commercial paper, corporate bonds and government securities by contractual maturity, as of June 30, 2022 and December 31, 2021 were as follows (in thousands): Available-for-Sale as of Available-for-Sale as of Cost Fair Value Cost Fair Value Due in 1-year or less $ 69,227 $ 68,971 $ 110,762 $ 110,704 Due after 1-year through 5-years — — 496 495 $ 69,227 $ 68,971 $ 111,258 $ 111,199 |
Property and Equipment, Net
Property and Equipment, Net | 6 Months Ended |
Jun. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 5. Property and Equipment, Net Property and equipment, net consisted of the following (in thousands): June 30, 2022 December 31, 2021 Laboratory equipment $ 21,884 $ 19,137 Computer equipment 3,416 3,255 Furniture and office equipment 1,482 1,219 Leasehold improvements 33,394 32,925 Construction in progress 2,867 1,670 63,043 58,206 Less: Accumulated depreciation and amortization ( 43,523 ) ( 40,268 ) $ 19,520 $ 17,938 Depreciation and amortization expense was $ 1,685 , $ 3,255 , $ 1,426 and $ 2,902 for the three and six months ended June 30, 2022 and 2021 , respectively. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 6. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, 2022 December 31, 2021 Development and manufacturing costs $ 9,877 $ 11,147 Payroll and payroll-related costs 8,503 9,216 Liability related to 2021 License Agreement (Note 11) 33,062 21,098 Facility and other 5,447 3,633 $ 56,889 $ 45,094 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Leases | 7. Leases The Company leases real estate, primarily laboratory, office and manufacturing space. The Company’s leases have remaining terms ranging from 1 year to 10 years. Certain leases include one or more options to renew, exercisable at the Company’s sole discretion, with renewal terms that can extend the lease from one year to five years . The Company evaluated the renewal options in its leases to determine if it was reasonably certain that the renewal option would be exercised, given the Company’s current business structure, uncertainty of future growth, and the associated impact to real estate, the Company concluded that it is not reasonably certain that any renewal options would be exercised. Therefore, the operating lease assets and operating lease liabilities only contemplate the initial lease terms. All the Company’s leases qualify as operating leases. In July 2021, the Company entered into a lease agreement for a donor collection facility in Tempe, Arizona with a lease term of 10 years, commencing in March 2022, subject to certain renewal options, which are not deemed reasonably certain. Minimum lease payments total $ 4,052 , net of tenant improvement allowance of $ 770 , through the lease term. At lease commencement, the Company recorded a right-of-use asset of $ 5,900 , which consists of the lease liability of $ 2,327 and $ 3,573 of leasehold improvements that revert back to the lessor at the termination of the lease. In August 2021, the Company entered into a lease for additional laboratory space in Waltham, Massachusetts with a lease term of 10 years, commencing in March 2022, subject to certain renewal options, which are not deemed reasonably certain. Minimum lease payments total $ 2,449 , net of tenant improvement allowance of $ 767 , through the lease term. At lease commencement, the Company recorded a right-of-use asset of $ 2,662 , which consists of the lease liability of $ 1,273 and $ 1,389 of leasehold improvements that revert back to the lessor at the termination of the lease. The following table summarizes the presentation in the Company’s consolidated balance sheets of its operating leases (in thousands): June 30, 2022 December 31, 2021 Assets: Operating lease assets $ 25,001 $ 18,208 Liabilities: Operating lease liabilities $ 7,058 $ 6,610 Operating lease liabilities, net of current portion 19,516 17,958 Total operating lease liabilities $ 26,574 $ 24,568 Three Months Ended Six Months Ended 2022 2021 2022 2021 Operating lease costs $ 1,948 $ 1,277 $ 3,620 $ 2,317 Short-term lease costs 354 363 709 729 Variable lease costs 1,271 721 2,302 1,424 Sublease income - 464 - 925 Total lease costs $ 3,573 $ 2,825 $ 6,631 $ 5,395 During the three and six months ended June 30, 2022 and 2021 the Company made cash payments for operating leases of $ 1,332 , $ 3,445 , $ 245 and $ 1,863 , respectively. As of June 30, 2022, future payments of operating lease liabilities are as follows (in thousands): As of 2022 (remaining 6 months) $ 4,392 2023 8,446 2024 3,387 2025 3,277 2026 and thereafter 16,199 Total future minimum lease payments $ 35,701 Less: interest ( 9,127 ) Present value of operating lease liabilities $ 26,574 As of June 30, 2022, the weighted average remaining lease term was 4.75 years and the weighted average incremental borrowing rate used to determine the operating lease liability was 10 % . As of June 30, 2021, the weighted average remaining lease term was 3.25 years and the weighted average incremental borrowing rate used to determine the operating lease liability was 10 % . |
Note Payable
Note Payable | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Note Payable | 8. Note Payable On October 29, 2019 (the “Closing Date”), the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with Hercules Capital, Inc. (“Hercules”) pursuant to which a term loan in an aggregate principal amount of up to $ 50,000 (the “Original Credit Facility”) was available to the Company in three tranches, subject to certain terms and conditions. The first tranche of $ 25,000 was advanced to the Company on the Closing Date. The Company did not meet the milestone requirements for the second tranche under the Original Credit Facility, and as such, the additional amount up to $ 12,500 was not available for the Company to borrow. The Company elected not to borrow the third tranche of $ 12,500 , which was available upon Hercules’ approval until June 30, 2021. Effective as of February 24, 2022 (the “Effective Date”), the Company entered into a Second Amendment to the Loan and Security Agreement (the “Second Amendment”), with the lenders party thereto (the “Lenders”), and Hercules in its capacity as the administrative agent and the collateral agent for the Lenders, which amended the Original Credit Facility. Pursuant to the Second Amendment, term loans in an aggregate principal amount of up to $ 100,000 (the “New Credit Facility”) became available to the Company in five tranches, subject to certain terms and conditions. The first tranche in an aggregate principal amount of $ 25,000 was outstanding as of the Effective Date, after taking into account reborrowing by the Company on the Effective Date of a previously-repaid principal amount of approximately $ 2,900 . The second tranche in an aggregate principal amount of $ 12,500 and the third tranche in an aggregate principal amount of $ 12,500 have been advanced to the Company and were outstanding as of the Effective Date. The fourth tranche in an aggregate principal amount of $ 25,000 is available upon satisfaction of certain conditions, including the approval by the FDA of a biologics license application in respect of SER-109 (the "Regulatory Approval Milestone") by no later than December 15, 2023. The fifth tranche in an aggregate principal amount of up to $ 25,000 is available through the Amortization Date (as defined below) upon satisfaction of certain conditions, including the Lenders’ investment committee approval. All advances outstanding under the New Credit Facility will bear interest at a rate equal to the greater of either (i) the Prime Rate (as reported in The Wall Street Journal) plus 6.40 %, and (ii) 9.65 %. For all advances outstanding under the New Credit Facility, the Company will make interest only payments through December 31, 2023, extendable to December 31, 2024 upon satisfaction of certain conditions (such applicable date, the “Amortization Date”). The principal balance and interest of the advances will be repaid in equal monthly installments after the Amortization Date and continuing through October 1, 2024, extendable to October 1, 2025, upon satisfaction of certain conditions (such applicable date, the “Maturity Date”). The Company may prepay advances under the New Credit Facility, in whole or in part, at any time subject to a prepayment charge equal to: (a) 2.0 % of amounts so prepaid, if such prepayment occurs during the first year following the Effective Date; (b) 1.5 % of the amount so prepaid, if such prepayment occurs during the second year following the Effective Date, and (c) 1.0 % of the amount so prepaid, if such prepayment occurs during the third year following the Effective Date. The Company will pay an end of term charge of 4.85 % of the aggregate amount of the advances made under the Original Credit Facility on the earliest date of (i) November 1, 2023; (ii) the date that the Company prepays all of the outstanding principal in full, or (iii) the date the loan payments are accelerated due to an event of default. The Company will pay an additional end of term charge of 1.75 % of the aggregate amount of the advances under the New Credit Facility (including the first tranche of $ 25,000 ) on the earliest date of (i) the Maturity Date; (ii) the date that the Company prepays all of the outstanding principal in full, or (iii) the date the loan payments are accelerated due to an event of default. Other terms of the New Credit Facility remain generally identical to those under the Original Credit Facility, with certain covenants amended by the Second Amendment to provide the Company with additional operational flexibility, including the ability for the Company to issue up to $ 350,000 in convertible notes. The New Credit Facility includes a conditional liquidity covenant commencing on June 15, 2023, which ceases to apply if certain conditions are satisfied. The New Credit Facility is secured by substantially all of the Company’s assets, other than the Company’s intellectual property. The Company has agreed to not pledge or secure its intellectual property to others. The Company accounted for the New Credit Facility as a modification in accordance with the guidance in ASC 470-50, Debt. Amounts paid to the lenders were recorded as debt discount and a new effective interest rate was established. Upon issuance, the New Credit Facility was recorded as a liability with an initial carrying value of $ 50,586 , net of debt issuance costs. The initial carrying value will be accreted to the repayment amount, which includes the outstanding principal plus the end of term charge, through interest expense using the effective interest rate method over the term of the debt. The effective interest rate in effect as of June 30, 2022 is 12.40%. As of June 30, 2022, the carrying value of the debt is $ 50,632 , which is classified as a long-term liability on the condensed consolidated balance sheet. As of December 31, 2021, the carrying value of the debt was $ 24,643 , which was classified as a long-term liability on the condensed consolidated balance sheet. As of June 30, 2022 the future principal payments due under the arrangement, excluding interest and the end of term charge, are as follows (in thousands): Year Ending December 31, Principal 2022 (remaining 6 months) $ — 2023 — 2024 50,000 Total $ 50,000 During the three and six months ended June 30, 2022 and 2021, the Company recognized $ 1,501 , $ 2,413 , $ 732 and $ 1,453 , respectively, of interest expense related to the Loan Agreement, which is reflected in interest expense on the condensed consolidated statement of operations and comprehensive (loss) income. |
Common Stock and Stock-Based Aw
Common Stock and Stock-Based Awards | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Common Stock and Stock-Based Awards | 9. Common Stock and Stock-Based Awards On June 29, 2022, the Company entered into securities purchase agreements with new and existing investors and certain directors and officers in a registered direct offering of an aggregate of 31,746,030 shares of common stock at a purchase price of $ 3.15 per share. Total net proceeds to the Company were approximately $ 96,841 , after deducting placement agent’s fees and other estimated offering expenses. Net proceeds included $ 27,525 received from Flagship Pioneering (“Flagship”), one of the Company’s significant stockholders, in exchange for 8,738,243 shares. The closing date of the Registered Direct Offering was July 5, 2022. On May 21, 2021, the Company entered into a Sales Agreement (the “Sales Agreement”) with Cowen and Company, LLC (“Cowen”) to sell shares of the Company’s common stock, with aggregate gross sales proceeds of up to $ 150,000 , from time to time, through an “at the market” equity offering program under which Cowen acts as sales agent. As of June 30, 2022 , the Company had no t sold any shares of common stock under the Sales Agreement. Stock Options The following table summarizes the Company’s stock option activity since December 31, 2021: Number Weighted Weighted Aggregate (in years) Outstanding as of December 31, 2021 11,517,189 $ 11.10 7.42 $ 28,006,768 Granted 4,161,997 7.00 Exercised ( 131,686 ) 2.94 Forfeited ( 560,457 ) 10.41 Outstanding as of June 30, 2022 14,987,043 $ 10.06 7.65 $ 854,131 Options exercisable as of June 30, 2022 6,696,344 $ 10.10 6.11 $ 589,051 The weighted average grant-date fair value of stock options granted during the three and six months ended June 30, 2022 and 2021 was $ 3.50 , $ 5.60 , $ 16.26 and $ 18.51 per share, respectively. During the year ended December 31, 2021, the Company granted performance-based stock options to employees for the purchase of an aggregate of 562 thousand shares of common stock with a grant date fair value of $ 5.53 per share. These stock options are exercisable only upon achievement of specified performance targets. As of June 30, 2022 , none of these options were exercisable because none of the specified performance targets had been achieved. Because achievement of the specified performance targets was not deemed probable as of June 30, 2022 , the Company did no t record any expense for these stock options from the dates of issuance through June 30, 2022. Restricted Stock Units The Company has granted restricted stock units ("RSUs") with time-based vesting conditions. The table below summarizes the Company’s restricted stock unit activity since December 31, 2021: Number Weighted Unvested restricted stock units as of December 31, 2021 734,755 $ 17.68 Granted 1,109,894 $ 7.20 Vested ( 126,626 ) $ 22.54 Forfeited ( 139,402 ) $ 12.42 Unvested restricted stock units as of June 30, 2022 1,578,621 $ 10.38 The Company has granted RSUs with service-based vesting conditions. RSUs represent the right to receive shares of common stock upon meeting specified vesting requirements. Unvested shares of restricted common stock may not be sold or transferred by the holder. These restrictions lapse according to the service-based vesting conditions of each award. During the six months ended June 30, 2022, the Company granted 1,109,894 RSUs. RSU’s generally vest over four years , with 25 % vesting after one year, and the remaining 75 % vesting quarterly over the next 3 years, subject to continued service to the Company through the applicable vesting date. During the year ended December 31, 2021, the Company granted performance-based restricted stock awards to two employees for the purchase of an aggregate of 85 thousand shares of common stock with a grant date fair value of $ 9.59 per share and 40 thousand shares with a grant date fair value of $ 20.35 per share. These restricted stock awards vest only upon achievement of specified performance targets. As of June 30, 2022 , none of these awards were vested because none of the specified performance targets had been achieved. Because achievement of the specified performance targets was not deemed probable as of June 30, 2022 , the Company did no t record any expense for these awards from the dates of issuance through June 30, 2022. Stock-based Compensation Expense The Company recorded stock-based compensation expense in the following expense categories of its condensed consolidated statements of operations and comprehensive (loss) income (in thousands): Three Months Ended June 30, Six Months Ended 2022 2021 2022 2021 Research and development expenses $ 3,430 $ 2,709 $ 6,026 $ 4,846 General and administrative expenses 3,318 2,369 5,801 3,856 $ 6,748 $ 5,078 $ 11,827 $ 8,702 |
Net Income (Loss) per Share
Net Income (Loss) per Share | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) per Share | 10. Net Loss per Share Basic and diluted net income (loss) per share attributable to common stockholders was calculated as follows (in thousands, except share and per share data): Three Months Ended Six Months Ended 2022 2021 2022 2021 Numerator: Net loss $ ( 64,735 ) $ ( 48,330 ) $ ( 121,359 ) $ ( 83,795 ) Denominator: Weighted-average shares outstanding 92,255,416 91,659,829 92,224,382 91,593,845 Net loss per share applicable to common stockholders - basic and diluted $ ( 0.70 ) $ ( 0.53 ) $ ( 1.32 ) $ ( 0.91 ) Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share: Stock options to purchase common stock 14,987,043 11,687,959 14,987,043 11,687,959 Unvested restricted stock units 1,578,621 461,248 1,578,621 461,248 Shares issuable under ESPP 250,002 28,687 250,002 28,687 The anti-dilutive potential common stock equivalents for the three and six months ended June 30, 2022 and 2021 were excluded from the computation of diluted net income per share attributable to common stockholders because those stock options to purchase common stock and restricted stock units had an anti-dilutive impact due to the assumed proceeds per share using the treasury stock method being greater than the average fair value of the Company’s common shares for those periods. |
Collaboration Revenue
Collaboration Revenue | 6 Months Ended |
Jun. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Collaboration Revenue | 11. Collaboration Revenue License Agreement with NHSc Pharma Partners (Nestlé) Summary of Agreement In July 2021, the Company entered into a license agreement (the “2021 License Agreement”) with Nestlé. Under the terms of the Agreement, the Company granted Nestlé a co-exclusive, sublicensable (under certain circumstances) license to develop, commercialize and conduct medical affairs activities for (i) therapeutic products based on the Company's microbiome technology (including the Company's SER-109 product candidate) that are developed by the Company or on the Company's behalf for the treatment of CDI and recurrent CDI, as well as any other indications pursued for the products upon mutual agreement of the parties (the “2021 Field”) in the United States and Canada (the “2021 Licensed Territory”), and (ii) the Company's SER-109 product candidate and any improvements and modifications thereto developed pursuant to the terms of the 2021 License Agreement (the "2021 Collaboration Products") for any indications in the 2021 Licensed Territory. The Company is responsible for completing development of SER-109 in the 2021 Field in the United States until first regulatory approval for SER-109 is obtained. Nestlé has the sole right to commercialize SER-109 in the 2021 Licensed Territory in accordance with a commercialization plan. Both parties will perform medical affairs activities in the 2021 Licensed Territory in accordance with a medical affairs plan. The Company will be responsible for the manufacturing and supply for commercialization under a supply agreement that will be entered into between the parties. Both parties will perform pre-launch activities of SER-109 prior to the first commercial sale in the United States. The Company is responsible for funding the pre-launch activities until first commercial sale of SER-109 in the 2021 Licensed Territory and in accordance with a pre-launch plan, up to a specified cap. Following first commercial sale of SER-109, the Company will be entitled to an amount equal to 50 % of the commercial profits. In connection with the 2021 License Agreement, the Company received an upfront payment of $ 175,000 . The Company is eligible to receive additional payments of up to $ 360,000 if certain regulatory and sales milestones are achieved. The potential future milestone payments include up to $ 135,000 for the achievement of specified regulatory milestones and up to $ 225,000 for the achievement of specified net sales milestones. The 2021 License Agreement continues in effect until all development and commercialization activities for all 2021 Collaboration Products in the 2021 Licensed Territory have permanently ceased. The 2021 License Agreement may be terminated by either party upon sixty days ’ written notice for the other party’s material breach that remains uncured during such sixty-day period, or immediately upon written notice for the other party’s insolvency. Nestlé may also terminate the 2021 License Agreement at-will (i) with twelve months’ prior written notice, effective only on or after the third anniversary of first commercial sale of the first 2021 Collaboration Product in the 2021 Licensed Territory, (ii) if first commercial sale of the first 2021 Collaboration Product in the 2021 Licensed Territory has not occurred by the fifth anniversary of the effective date of the 2021 License Agreement, with one hundred eighty days’ prior written notice, which must be provided during a specified period set forth in the 2021 License Agreement, or (iii) if regulatory approval for SER-109 is not granted after submission by the Company of a filing seeking first regulatory approval as set forth in the development and regulatory activity plan, and the parties fail to agree on further development of SER-109 in accordance with the terms of the 2021 License Agreement, with one hundred eighty days’ prior written notice, which must be provided within a specified period set forth in the 2021 License Agreement. The Company may also terminate the 2021 License Agreement immediately upon written notice if Nestlé challenges any licensed patent in the 2021 Licensed Territory. Upon termination of the 2021 License Agreement, all licenses granted to Nestlé by the Company will terminate. If the Company commits a material breach of the 2021 License Agreement, Nestlé may elect not to terminate the 2021 License Agreement but instead apply specified adjustments to the payment terms and other terms and conditions of the 2021 License Agreement. Accounting Analysis The 2021 License Agreement represents a separate contract between Nestlé and the Company. The 2021 License Agreement is within the scope of Accounting Standard Update 2018-18, Collaborative Arrangements (Topic 808), and has elements that are within the scope of Topic 606 and Topic 808. The Company identified the following promises in the 2021 License Agreement that were evaluated under the scope of Topic 606: (i) delivery of a co-exclusive license for SER-109 to develop, commercialize and conduct medical affairs in the United States and Canada; (ii) services to be performed in accordance with the development and regulatory activity plan to obtain regulatory approval of SER-109 in the United States. The Company also evaluated whether certain options outlined within the 2021 License Agreement represented material rights that would give rise to a performance obligation and concluded that none of the options convey a material right to Nestlé and therefore are not considered separate performance obligations within the 2021 License Agreement. The Company assessed the above promises and determined that the co-exclusive license for SER-109 and the services to obtain regulatory approval of SER-109 in the United States are reflective of a vendor-customer relationship and therefore represent performance obligations within the scope of Topic 606. The co-exclusive license for SER-109 in the United States and Canada is considered functional intellectual property and distinct from other promises under the contract as Nestlé can benefit from the license on its own or together with other readily available resources. The services performed by the Company to obtain regulatory approval of SER-109 are not complex or specialized, could be performed by another qualified third party, are not expected to significantly modify or customize the license given that SER-109 is late-stage intellectual property that has completed clinical development and the services are expected to be performed over a short period of time. Therefore, the license and the services each represents a separate performance obligation within a contract with a customer under the scope of Topic 606 at contract inception. The Company considers the collaborative pre-launch activities and commercialization activities to be separate units of account within the scope of Topic 808 and are not deliverables under Topic 606. The Company and Nestlé are both active participants in the pre-launch activities and commercialization activities and are exposed to significant risks and rewards that are dependent on the commercial success of the activities in the arrangement. The up-front payment of $ 175,000 compensated the Company for: (i) the co-exclusive license for SER-109 to develop, commercialize and conduct medical affairs in the United States and Canada, (ii) services performed in accordance with the development and regulatory activity plan to obtain regulatory approval of SER-109 in the United States and (iii) pre-launch activities performed by Nestlé and the Company until the first commercial sale of SER-109 in the United States. The commercialization activities, which include the commercial manufacturing, participation on joint steering committees and medical affairs work, that occur after regulatory approval of SER-109 in the United States, are part of the 50 / 50 sharing of commercial profits. Therefore, the up-front payment of $ 175,000 does not compensate the Company for these activities. The Company allocated the $ 175,000 between the Topic 606 unit of account and the Topic 808 unit of account by determining the standalone selling price (SSP) of each good or service. The selling price of each good or service was determined based on the Company’s SSP with the objective of determining the price at which it would sell such an item if it were to be sold regularly on a standalone basis. The Company determined the transaction price under Topic 606 to be $ 139,500 and the Topic 808 amount to be $ 35,500 at the inception of the 2021 License Agreement. The Company determined that any variable consideration related to regulatory milestones is deemed to be fully constrained and therefore excluded from the transaction price due to the high degree of uncertainty and risk associated with these potential payments, as the Company determined that it could not assert that it was probable that a significant reversal in the amount of cumulative revenue recognized will not occur. The Company also determined that sales milestones relate solely to the license of intellectual property and are therefore excluded from the transaction price under the sales- or usage-based royalty exception of Topic 606. Revenue related to these sales milestones will only be recognized when the associated sales occur, and relevant thresholds are met. The Topic 606 transaction price of $ 139,500 has been allocated to the co-exclusive license for SER-109 and the services performed in accordance with the development and regulatory activity plan to obtain regulatory approval of SER-109 in the United States based on the Company’s SSP. The Company recognizes revenue for the license performance obligation at a point in time, that is upon transfer of the license to Nestlé. As control of the license was transferred in July 2021, the Company recognized $ 131,343 of collaboration revenue - related party during the year ended December 31, 2021 pertaining to the license performance obligation. The remaining amount of the Topic 606 transaction price was allocated to the services performance obligation and is being recognized over time as the services are performed. During the three and six months ended June 30, 2022, the Company recognized $ 1,413 and $ 2,181 of collaboration revenue - related party, respectively, related to the services performance obligation under the 2021 License Agreement. The amount allocated to the Topic 808 unit of accounting relates to the pre-launch activities performed prior to the first commercial sale of SER-109 and was determined to be $ 35,500 based on standalone selling price. The Company recorded the $ 35,500 in total liabilities on its condensed consolidated balance sheet at the inception of the arrangement. On a quarterly basis, the Company and Nestlé provide financial information about the pre-launch activities performed by both parties. The Company reduces the $ 35,500 liability as the pre-launch activities are performed and it makes payments to Nestl é for the pre-launch costs Nestlé incurs. As of June 30, 2022, there was $ 33,062 included in accrued expenses and other current liabilities which represents Nestlé incurred costs not yet reimbursed. The cost associated with pre-launch activities performed by the Company will be recorded within total operating expenses in the Company’s condensed consolidated statements of operations and comprehensive (loss) income. In the three and six months ended June 30, 2022, the Company recognized $ 1,538 and $ 3,173 , respectively, in research and development expenses and $ 2,176 and $ 4,614 , respectively, in general and administrative expenses associated with pre-launch activities performed. As the Company and Nestlé are both active participants in the pre-launch activities, the sharing of 50 % of the pre-launch costs will be recognized in collaboration (profit) loss sharing - related party in the Company’s condensed consolidated statements of operations and comprehensive (loss) income. The Company recorded $ 271 of expense and $ 705 of income in the collaboration (profit) loss sharing line for the three and six months ended June 30, 2022, respectively. Collaboration and License Agreement with Société des Produits Nestlé S.A. (Nestlé) Summary of Agreement In January 2016, the Company entered into a collaboration and license agreement with Nestlé (the “2016 License Agreement”) for the development and commercialization of certain product candidates for the treatment and management of CDI and inflammatory bowel disease ("IBD"), including UC and Crohn’s disease. The 2016 License Agreement supports the development of the Company’s portfolio of products for CDI and IBD in markets outside of the United States and Canada (the “2016 Licensed Territory”). Under the 2016 License Agreement, the Company granted to Nestlé an exclusive, royalty-bearing license to develop and commercialize, in the 2016 Licensed Territory, certain products based on its microbiome technology that are being developed for the treatment of CDI and IBD, including SER-109, SER-262, SER-287 and SER-301 (collectively, the “2016 Collaboration Products”). The 2016 License Agreement sets forth the Company’s and Nestlé’s respective obligations for development, commercialization, regulatory and manufacturing and supply activities for the 2016 Collaboration Products with respect to the licensed fields and the 2016 Licensed Territory. Under the 2016 License Agreement, Nestlé agreed to pay the Company an upfront cash payment of $ 120,000 , which the Company received in February 2016. The Company is eligible to receive up to $ 285,000 in development milestone payments, $ 375,000 in regulatory payments and up to an aggregate of $ 1,125,000 for the achievement of certain commercial milestones related to the sales of the 2016 Collaboration Products. Nestlé also agreed to pay the Company tiered royalties, at percentages ranging from the high single digits to high teens, of net sales of 2016 Collaboration Products in the 2016 Licensed Territory. Under the 2016 License Agreement, the Company is entitled to receive a $ 20,000 milestone payment from Nestlé following initiation of a SER-287 Phase 2 study and a $ 20,000 milestone payment from Nestlé following the initiation of a SER-287 Phase 3 study. In November 2018, the Company entered into a letter agreement with Nestlé which modified the 2016 License Agreement to address the current clinical plans for SER-287. Pursuant to the letter agreement, the Company and Nestlé agreed that following initiation of the SER-287 Phase 2b study, the Company would be entitled to receive $ 40,000 in milestone payments from Nestlé, which represent the milestone payments due to the Company for the initiation of a SER-287 Phase 2 study and a Phase 3 study. The SER-287 Phase 2b study was initiated and the $ 40,000 of milestone payments were received in December 2018. The letter agreement also provides scenarios under which Nestlé’s reimbursement to the Company for certain Phase 3 development costs would be reduced or delayed depending on the outcomes of the SER-287 Phase 2b study. The 2016 License Agreement continues in effect until terminated by either party on the following bases: (i) Nestlé may terminate the 2016 License Agreement in the event of serious safety issues related to any of the 2016 Collaboration Products; (ii) the Company may terminate the 2016 License Agreement if Nestlé challenges the validity or enforceability of any of the Company’s licensed patents; and (iii) either party may terminate the 2016 License Agreement in the event of the other party’s uncured material breach or insolvency. Upon termination of the 2016 License Agreement, all licenses granted to Nestlé by the Company will terminate, and all rights in and to the 2016 Collaboration Products in the 2016 Licensed Territory will revert to the Company. If the Company commits a material breach of the 2016 License Agreement, Nestlé may elect not to terminate the 2016 License Agreement but instead apply specified adjustments to its payment obligations and other terms and conditions of the 2016 License Agreement. Accounting Analysis The Company assessed the 2016 License Agreement in accordance with ASC 606— Revenue From Contracts with Customers (“ASC 606”) and concluded that Nestlé is a customer. The Company identified the following promises under the contract: (i) a license to develop and commercialize the 2016 Collaboration Products in the 2016 Licensed Territory, (ii) obligation to perform research and development services, (iii) participation on a joint steering committee, and (iv) manufacturing services to provide clinical supply to complete future clinical trials. In addition, the Company identified a contingent obligation to perform manufacturing services to provide commercial supply if commercialization occurs, which is contingent upon regulatory approval. This contingent obligation is not a performance obligation at inception and has been excluded from the initial allocation as it represents a separate buying decision at market rates, rather than a material right in the contract. The Company assessed the promised goods and services to determine if they are distinct. Based on this assessment, the Company determined that Nestlé cannot benefit from the promised goods and services separately from the others as they are highly interrelated and therefore not distinct. Accordingly, the promised goods and services represent one combined performance obligation and the entire transaction price will be allocated to that single combined performance obligation. At contract inception, the Company determined that the $ 120,000 non-refundable upfront amount constituted the entirety of the consideration to be included in the transaction price as the development, regulatory, and commercial milestones were fully constrained. During the year ended December 31, 2016, the Company received $ 10,000 from Nestlé in connection with the initiation of the Phase 1b study for SER-262 in CDI. During the year ended December 31, 2017, the Company received $ 20,000 from Nestlé in connection with the initiation of the Phase 3 study for SER-109. During the year ended December 31, 2018, the Company received $ 40,000 from Nestlé in connection with the initiation of the Phase 2b study for SER-287. During the year ended December 31, 2020, the Company received $ 10,000 from Nestlé in connection with the initiation of the Phase 1b SER-301 study. As of June 30, 2022, the aggregate amount of the transaction price allocated to the performance obligation of the 2016 License Agreement was approximately $ 200,000 . During the three and six months ended June 30, 2022 and 2021, using the cost-to-cost method, which best depicts the transfer of control to the customer, the Company recognized ($ 197 ) , $ 528 , $ 5,263 and $ 9,911 of collaboration revenue – related party, respectively. As of June 30, 2022 and December 31, 2021, there was $ 101,108 and $ 103,817 , respectively, of deferred revenue related to the unsatisfied portion of the performance obligation under the Nestlé agreements. As of June 30, 2022, the deferred revenue is classified as current or non-current in the condensed consolidated balance sheets based on the Company’s estimate of revenue that will be recognized within the next 12 months, which is determined by the cost-to-cost method which measures the extent of progress towards completion based on the ratio of actual costs incurred to the total estimated costs expected upon satisfying the performance obligation. All costs associated with the 2016 License Agreement are recorded in research and development expense in the condensed consolidated statements of operations and comprehensive (loss) income. Contract Balances from Contracts with Customers The following table presents changes in the Company’s contract liabilities during the six months ended June 30, 2022 and 2021 (in thousands): Balance as of December 31, 2021 Additions Deductions Balance as of June 30, 2022 Six Months Ended June 30, 2022 Contract liabilities: Deferred revenue - related party $ 103,817 — ( 2,709 ) $ 101,108 Balance as of December 31, 2020 Additions Deductions Balance as of June 30, 2021 Six Months Ended June 30, 2021 Contract liabilities: Deferred revenue - related party $ 108,174 — ( 9,911 ) $ 98,263 During the three and six months ended June 30, 2022 and 2021 the Company recognized the following revenues as a result of changes in the contract liability balances in the respective periods (in thousands): Three Months Ended Six Months Ended 2022 2021 2022 2021 Revenue recognized in the period from: Amounts included in the contract liability at the beginning of the period $ 1,216 $ 5,263 $ 2,709 $ 9,911 When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded. Revenue is recognized from the contract liability over time using the cost-to-cost method. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. Commitments and Contingencies Leases Refer to Note 7 “Leases” for discussion of the commitments associated with the Company’s lease portfolio. Indemnification Agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and its officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company does not believe that the outcome of any claims under indemnification arrangements will have a material effect on its financial position, results of operations or cash flows, and it has no t accrued any liabilities related to such obligations in its condensed consolidated financial statements as of June 30, 2022 or December 31, 2021. Legal Contingencies The Company accrues a liability for legal contingencies when it believes that it is both probable that a liability has been incurred and that the Company can reasonably estimate the amount of the loss. The Company reviews these accruals and adjusts them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and the views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in the Company’s accrued liabilities would be recorded in the period in which such determination is made. In addition, in accordance with the relevant authoritative guidance, for any matters in which the likelihood of material loss is at least reasonably possible, the Company will provide disclosure of the possible loss or range of loss. If a reasonable estimate cannot be made, however, the Company will provide disclosure to that effect. The Company expenses legal costs as they are incurred. The Company did no t accrue any liabilities related to legal contingencies in its condensed consolidated financial statements as of June 30, 2022 or December 31, 2021 . |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 13. Income Taxes The Company did no t provide for any income taxes in its condensed consolidated statement of operations and comprehensive (loss) income for the three and six months ended June 30, 2022 and 2021. The Company has evaluated the positive and negative evidence bearing upon its ability to realize the deferred tax assets. Management has considered the Company’s history of cumulative net losses incurred since inception and its lack of commercialization of any products or generation of any revenue from product sales since inception and has concluded that it is more likely than not that the Company will not realize the benefits of the deferred tax assets. Accordingly, a full valuation allowance has been established against the deferred tax assets as of June 30, 2022 and December 31, 2021. Management reevaluates the positive and negative evidence at each reporting period. As of June 30, 2022 and December 31, 2021 , the Company had no accrued interest or tax penalties recorded. The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. The Company is currently under examination by the Internal Revenue Service ("IRS") for the period ended December 31, 2018 related to its R&D tax credits. The Company's tax years are still open under statute from 2011 to present. All years may be examined to the extent the tax credit or net operating loss carryforwards are used in future periods. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 14. Related Party Transactions As described in Note 11, in July 2021, the Company entered into the 2021 License Agreement with NHSc Pharma Partners (together with Société des Produits Nestlé S.A., “Nestlé”). NHSc Pharma Partners is an affiliate of one of the Company's significant stockholders, Société des Produits Nestlé S.A. During the three and six months ended June 30, 2022, the Company recognized $ 1,413 and $ 2,181 , respectively, of related party revenue associated with the 2021 License Agreement. As of June 30, 2022 and December 31, 2021, there was $ 3,908 and $ 6,089 of deferred revenue related to the 2021 License Agreement, respectively, which is classified as current in the condensed consolidated balance sheets. As of June 30, 2022 and December 31, 2021 there was $ 33,062 and $ 31,683 included in accrued expenses and other liabilities related to the 2021 License Agreement. The Company made no payments to Nestlé during the three and six months ended June 30, 2022 . There is no amount due from Nestlé as of June 30, 2022. As described in Note 11, in January 2016, the Company entered into the 2016 License Agreement with Société des Produits Nestlé S.A. (successor in interest to Nestec, Ltd.) for the development and commercialization of certain product candidates in development for the treatment and management of CDI and IBD, including UC and Crohn’s disease. Société des Produits Nestlé S.A. is one of the Company's significant stockholders. During the three and six months ended June 30, 2022, the Company recognized ($ 197 ) and $ 528 , respectively, of related party revenue associated with the 2016 License Agreement. As of June 30, 2022 and December 31, 2021 there was $ 97,200 and $ 97,728 of deferred revenue related to the 2016 License Agreement, which is classified as current or non-current in the condensed consolidated balance sheets. The Company has made no payments to Nestlé during the three and six months ended June 30, 2022. There was no amount due from Nestlé as of June 30, 2022. As described in Note 9, the Company entered into a securities purchase agreement with Flagship, one of the Company's significant stockholders, for the sale of 8,738,243 shares of its common stock at a purchase price of $ 3.15 per share as part of the Registered Direct Offering, which closed on July 5, 2022. The Company received proceeds from Flagship of $ 27,525 . In July 2019, the Company entered into a sublease agreement with Flagship to sublease a portion of its office and laboratory space in Cambridge, Massachusetts. The term of the sublease agreement commenced in July 2019 and ended in November 2021. Under this agreement, the Company recorded other income of $ 464 and $ 925 during the three and six months ended June 30, 2021, respectively. The Company received cash payments of $ 464 and $ 925 during the three and six months ended June 30, 2021, respectively. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenue and expenses during the reporting periods. In the condensed consolidated financial statements, the Company uses estimates and assumptions related to revenue recognition and the accrual of research and development expenses. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. |
Restricted Cash | Restricted Cash The Company held restricted cash of $ 8,185 and $ 8,000 as of June 30, 2022 and December 31, 2021, respectively, which represents cash held for the benefit of the landlord for the Company's leases. The Company has classified the restricted cash as long-term on its consolidated balance sheet as the underlying leases are greater than 1 year. Cash, cash equivalents and restricted cash were comprised of the following (in thousands): June 30, December 31, 2022 2021 Cash and cash equivalents $ 126,824 $ 180,002 Restricted cash, non-current 8,185 8,000 Total cash, cash equivalents and restricted cash $ 135,009 $ 188,002 |
Recently Issued Accounting Standards | Recently Adopted Accounting Standards In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (‘‘ASU 2016-13’’), which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model. It also eliminates the concept of other-than-temporary impairment and requires credit losses related to available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. These changes may result in earlier recognition of credit losses. In November 2018, the FASB issued ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses , which narrowed the scope and changed the effective date for non-public entities for ASU 2016-13. The FASB subsequently issued supplemental guidance within ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief (‘‘ASU 2019-05’’). ASU 2019-05 provides an option to irrevocably elect the fair value option for certain financial assets previously measured at amortized cost basis. For public entities that are Securities and Exchange Commission filers, excluding entities eligible to be smaller reporting companies, ASU 2016-13 is effective for annual periods beginning after December 15, 2019, including interim periods within those fiscal years. For all other entities, ASU 2016-13 is effective for annual periods beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. The Company adopted the new standard as of January 1, 2022. The adoption of this standard did not have a material impact on the Company's condensed consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Cash, Cash Equivalents and Restricted Cash | Cash, cash equivalents and restricted cash were comprised of the following (in thousands): June 30, December 31, 2022 2021 Cash and cash equivalents $ 126,824 $ 180,002 Restricted cash, non-current 8,185 8,000 Total cash, cash equivalents and restricted cash $ 135,009 $ 188,002 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Fair Value Hierarchy for Assets and Liabilities Measured at Fair Value on Recurring Basis | The following tables present the Company’s fair value hierarchy for its assets and liabilities that are measured at fair value on a recurring basis (in thousands): Fair Value Measurements as of June 30, 2022 Using: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 54,233 $ — $ — $ 54,233 Commercial paper — 12,489 — 12,489 Government securities — — — — Investments: Corporate bonds $ — $ 11,992 $ — $ 11,992 Government securities — 56,979 — 56,979 $ 54,233 $ 81,460 $ — $ 135,693 Fair Value Measurements as of December 31, 2021 Using: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 70,322 $ — $ — $ 70,322 Commercial paper — 3,999 — 3,999 Investments: Commercial paper $ — $ 6,250 $ — $ 6,250 Corporate bonds — 40,095 — 40,095 Government securities — 64,854 — 64,854 $ 70,322 $ 115,198 $ — $ 185,520 |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Investments by Security Type | Investments by security type consisted of the following at June 30, 2022 and December 31, 2021 (in thousands): June 30, 2022 Amortized Gross Gross Fair Investments: Corporate bonds $ 12,043 $ — $ ( 51 ) $ 11,992 Government securities 57,184 — ( 205 ) 56,979 $ 69,227 $ — $ ( 256 ) $ 68,971 December 31, 2021 Amortized Gross Gross Fair Investments: Commercial paper $ 6,250 $ — $ — $ 6,250 Corporate bonds 40,123 — ( 28 ) 40,095 Government securities 64,885 — ( 31 ) 64,854 $ 111,258 $ — $ ( 59 ) $ 111,199 |
Schedule of Amortized Cost and Fair Value of Investments by Contractual Maturity | The amortized cost and fair value of investments in commercial paper, corporate bonds and government securities by contractual maturity, as of June 30, 2022 and December 31, 2021 were as follows (in thousands): Available-for-Sale as of Available-for-Sale as of Cost Fair Value Cost Fair Value Due in 1-year or less $ 69,227 $ 68,971 $ 110,762 $ 110,704 Due after 1-year through 5-years — — 496 495 $ 69,227 $ 68,971 $ 111,258 $ 111,199 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consisted of the following (in thousands): June 30, 2022 December 31, 2021 Laboratory equipment $ 21,884 $ 19,137 Computer equipment 3,416 3,255 Furniture and office equipment 1,482 1,219 Leasehold improvements 33,394 32,925 Construction in progress 2,867 1,670 63,043 58,206 Less: Accumulated depreciation and amortization ( 43,523 ) ( 40,268 ) $ 19,520 $ 17,938 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, 2022 December 31, 2021 Development and manufacturing costs $ 9,877 $ 11,147 Payroll and payroll-related costs 8,503 9,216 Liability related to 2021 License Agreement (Note 11) 33,062 21,098 Facility and other 5,447 3,633 $ 56,889 $ 45,094 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Summary of Operating Lease Assets and Liabilities | The following table summarizes the presentation in the Company’s consolidated balance sheets of its operating leases (in thousands): June 30, 2022 December 31, 2021 Assets: Operating lease assets $ 25,001 $ 18,208 Liabilities: Operating lease liabilities $ 7,058 $ 6,610 Operating lease liabilities, net of current portion 19,516 17,958 Total operating lease liabilities $ 26,574 $ 24,568 |
Summary of Lease Costs | Three Months Ended Six Months Ended 2022 2021 2022 2021 Operating lease costs $ 1,948 $ 1,277 $ 3,620 $ 2,317 Short-term lease costs 354 363 709 729 Variable lease costs 1,271 721 2,302 1,424 Sublease income - 464 - 925 Total lease costs $ 3,573 $ 2,825 $ 6,631 $ 5,395 |
Schedule of Future Payments of Operating Lease Liabilities | As of June 30, 2022, future payments of operating lease liabilities are as follows (in thousands): As of 2022 (remaining 6 months) $ 4,392 2023 8,446 2024 3,387 2025 3,277 2026 and thereafter 16,199 Total future minimum lease payments $ 35,701 Less: interest ( 9,127 ) Present value of operating lease liabilities $ 26,574 |
Note Payable (Tables)
Note Payable (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Summary of Future Principal Payments Due Under Arrangement, Excluding Interest and End of Term Charge | As of June 30, 2022 the future principal payments due under the arrangement, excluding interest and the end of term charge, are as follows (in thousands): Year Ending December 31, Principal 2022 (remaining 6 months) $ — 2023 — 2024 50,000 Total $ 50,000 |
Common Stock and Stock-Based _2
Common Stock and Stock-Based Awards (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Summary of Stock Option Activity | The following table summarizes the Company’s stock option activity since December 31, 2021: Number Weighted Weighted Aggregate (in years) Outstanding as of December 31, 2021 11,517,189 $ 11.10 7.42 $ 28,006,768 Granted 4,161,997 7.00 Exercised ( 131,686 ) 2.94 Forfeited ( 560,457 ) 10.41 Outstanding as of June 30, 2022 14,987,043 $ 10.06 7.65 $ 854,131 Options exercisable as of June 30, 2022 6,696,344 $ 10.10 6.11 $ 589,051 |
Summary of Restricted Stock Unit Activity | The Company has granted restricted stock units ("RSUs") with time-based vesting conditions. The table below summarizes the Company’s restricted stock unit activity since December 31, 2021: Number Weighted Unvested restricted stock units as of December 31, 2021 734,755 $ 17.68 Granted 1,109,894 $ 7.20 Vested ( 126,626 ) $ 22.54 Forfeited ( 139,402 ) $ 12.42 Unvested restricted stock units as of June 30, 2022 1,578,621 $ 10.38 |
Summary of Stock Based Compensation Expense | The Company recorded stock-based compensation expense in the following expense categories of its condensed consolidated statements of operations and comprehensive (loss) income (in thousands): Three Months Ended June 30, Six Months Ended 2022 2021 2022 2021 Research and development expenses $ 3,430 $ 2,709 $ 6,026 $ 4,846 General and administrative expenses 3,318 2,369 5,801 3,856 $ 6,748 $ 5,078 $ 11,827 $ 8,702 |
Net Income (Loss) per Share (Ta
Net Income (Loss) per Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Basic and Diluted Net Income (Loss) per Share Attributable to Common Stockholders | Basic and diluted net income (loss) per share attributable to common stockholders was calculated as follows (in thousands, except share and per share data): Three Months Ended Six Months Ended 2022 2021 2022 2021 Numerator: Net loss $ ( 64,735 ) $ ( 48,330 ) $ ( 121,359 ) $ ( 83,795 ) Denominator: Weighted-average shares outstanding 92,255,416 91,659,829 92,224,382 91,593,845 Net loss per share applicable to common stockholders - basic and diluted $ ( 0.70 ) $ ( 0.53 ) $ ( 1.32 ) $ ( 0.91 ) Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share: Stock options to purchase common stock 14,987,043 11,687,959 14,987,043 11,687,959 Unvested restricted stock units 1,578,621 461,248 1,578,621 461,248 Shares issuable under ESPP 250,002 28,687 250,002 28,687 |
Collaboration Revenue (Tables)
Collaboration Revenue (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Changes in Contract Liabilities | The following table presents changes in the Company’s contract liabilities during the six months ended June 30, 2022 and 2021 (in thousands): Balance as of December 31, 2021 Additions Deductions Balance as of June 30, 2022 Six Months Ended June 30, 2022 Contract liabilities: Deferred revenue - related party $ 103,817 — ( 2,709 ) $ 101,108 Balance as of December 31, 2020 Additions Deductions Balance as of June 30, 2021 Six Months Ended June 30, 2021 Contract liabilities: Deferred revenue - related party $ 108,174 — ( 9,911 ) $ 98,263 During the three and six months ended June 30, 2022 and 2021 the Company recognized the following revenues as a result of changes in the contract liability balances in the respective periods (in thousands): Three Months Ended Six Months Ended 2022 2021 2022 2021 Revenue recognized in the period from: Amounts included in the contract liability at the beginning of the period $ 1,216 $ 5,263 $ 2,709 $ 9,911 |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||||
Jun. 29, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||||
Entity incorporated month and year | 2010-10 | |||||||
Entity incorporation, state or country code | DE | |||||||
Accumulated deficit | $ 735,713 | $ 735,713 | $ 614,354 | |||||
Net Income (Loss) Attributable to Parent | (64,735) | $ (56,624) | $ (48,330) | $ (35,465) | (121,359) | $ (83,795) | ||
Cash, cash equivalents and short and long-term investments | $ 195,795 | 195,795 | ||||||
Total net proceeds | $ 96,841 | $ 96,841 | ||||||
Common stock issued | 31,746,030 | 92,306,944 | 92,306,944 | 91,889,418 | ||||
Common stock at a purchase price | $ 3.15 | $ 0.001 | $ 0.001 | $ 0.001 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | ||
Restricted cash | $ 8,185 | $ 8,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 126,824 | $ 180,002 | ||
Restricted cash, non-current | 8,185 | 8,000 | ||
Total cash, cash equivalents and restricted cash | $ 135,009 | $ 188,002 | $ 73,997 | $ 116,049 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Fair Value Hierarchy for Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Investments: | ||
Investments | $ 68,971 | $ 111,199 |
Fair Value, Measurements, Recurring [Member] | ||
Investments: | ||
Investments | 135,693 | 185,520 |
Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Cash equivalents: | ||
Cash equivalents | 54,233 | 70,322 |
Commercial Paper [Member] | ||
Investments: | ||
Investments | 6,250 | |
Commercial Paper [Member] | Fair Value, Measurements, Recurring [Member] | ||
Cash equivalents: | ||
Cash equivalents | 12,489 | 3,999 |
Investments: | ||
Investments | 6,250 | |
Corporate Bonds [Member] | ||
Investments: | ||
Investments | 11,992 | 40,095 |
Corporate Bonds [Member] | Fair Value, Measurements, Recurring [Member] | ||
Investments: | ||
Investments | 11,992 | 40,095 |
US Government Agencies Debt Securities [Member] | ||
Investments: | ||
Investments | 56,979 | 64,854 |
US Government Agencies Debt Securities [Member] | Fair Value, Measurements, Recurring [Member] | ||
Investments: | ||
Investments | 56,979 | 64,854 |
Level 1 [Member] | Fair Value, Measurements, Recurring [Member] | ||
Investments: | ||
Investments | 54,233 | 70,322 |
Level 1 [Member] | Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Cash equivalents: | ||
Cash equivalents | 54,233 | 70,322 |
Level 2 [Member] | Fair Value, Measurements, Recurring [Member] | ||
Investments: | ||
Investments | 81,460 | 115,198 |
Level 2 [Member] | Commercial Paper [Member] | Fair Value, Measurements, Recurring [Member] | ||
Cash equivalents: | ||
Cash equivalents | 12,489 | 3,999 |
Investments: | ||
Investments | 6,250 | |
Level 2 [Member] | Corporate Bonds [Member] | Fair Value, Measurements, Recurring [Member] | ||
Investments: | ||
Investments | 11,992 | 40,095 |
Level 2 [Member] | US Government Agencies Debt Securities [Member] | Fair Value, Measurements, Recurring [Member] | ||
Investments: | ||
Investments | $ 56,979 | $ 64,854 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 30, 2021 |
Fair Value Disclosures [Abstract] | |||
Fair value, assets transfers from Level 1 to Level 2 measurement | $ 0 | $ 0 | |
Fair value, assets transfers from Level 2 to Level 1 measurement | 0 | $ 0 | |
Restricted investments | $ 1,401 | $ 1,401 |
Investments - Schedule of Inves
Investments - Schedule of Investments by Security Type (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 69,227 | $ 111,258 |
Gross Unrealized Gain | 0 | |
Gross Unrealized Loss | (256) | (59) |
Fair Value | 68,971 | 111,199 |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 6,250 | |
Fair Value | 6,250 | |
Corporate Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 12,043 | 40,123 |
Gross Unrealized Gain | 0 | |
Gross Unrealized Loss | (51) | (28) |
Fair Value | 11,992 | 40,095 |
Government Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 57,184 | 64,885 |
Gross Unrealized Gain | 0 | |
Gross Unrealized Loss | (205) | (31) |
Fair Value | $ 56,979 | $ 64,854 |
Investments - Additional Inform
Investments - Additional Information (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Dec. 31, 2021 | |
Investments [Abstract] | ||
Maximum maturity days for cash equivalents | 90 days | |
Restricted investments | $ 1,401 | $ 1,401 |
Investments - Schedule of Amort
Investments - Schedule of Amortized Cost and Fair Value of Investments by Contractual Maturity (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Available-for-sale, amortized cost | ||
Due in 1-year or less | $ 69,227 | $ 110,762 |
Due after 1-year through 5-years | 0 | 496 |
Amortized Cost | 69,227 | 111,258 |
Available-for-sale, fair value | ||
Due in 1-year or less | 68,971 | 110,704 |
Due after 1-year through 5-years | 0 | 495 |
Fair value | $ 68,971 | $ 111,199 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 63,043 | $ 58,206 |
Less: Accumulated depreciation and amortization | (43,523) | (40,268) |
Property and equipment, net | 19,520 | 17,938 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 21,884 | 19,137 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,416 | 3,255 |
Furniture and Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,482 | 1,219 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 33,394 | 32,925 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 2,867 | $ 1,670 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation and amortization expense | $ 1,685 | $ 1,426 | $ 3,255 | $ 2,902 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |||
Development and manufacturing costs | $ 9,877 | $ 11,147 | |
Payroll and payroll-related costs | 8,503 | 9,216 | |
Liability related to 2021 License Agreement | 33,062 | 21,098 | |
Facility and other | 5,447 | 3,633 | |
Total accrued expenses and other current liabilities | [1] | $ 56,889 | $ 45,094 |
[1] Includes related party amounts of $ 33,062 and $ 21,098 at June 30, 2022 and December 31, 2021, respectively (see Note 11) |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||
Aug. 31, 2021 | Jul. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | Aug. 01, 2021 | Jul. 01, 2021 | |
Operating Leased Assets [Line Items] | |||||||||
Option to extend, description | Certain leases include one or more options to renew, exercisable at the Company’s sole discretion, with renewal terms that can extend the lease from one year to five years. | ||||||||
Lease term | 10 years | 10 years | |||||||
Right-of-use asset | $ 25,001 | $ 25,001 | $ 18,208 | $ 2,662 | $ 5,900 | ||||
Tenant improvement allowance | $ 767 | $ 770 | |||||||
Present value of operating lease liabilities | 26,574 | 26,574 | $ 24,568 | 1,273 | 2,327 | ||||
Leasehold Improvements | $ 1,389 | $ 3,573 | |||||||
Leases Payments | $ 1,332 | $ 245 | $ 3,445 | $ 1,863 | |||||
Weighted average remaining lease term | 4 years 9 months | 3 years 3 months | 4 years 9 months | 3 years 3 months | |||||
Weighted average incremental borrowing rate | 10% | 10% | 10% | 10% | |||||
Maximum [Member] | |||||||||
Operating Leased Assets [Line Items] | |||||||||
Operating lease, remaining term | 10 years | ||||||||
Lease term | 5 years | 5 years | |||||||
Minimum [Member] | |||||||||
Operating Leased Assets [Line Items] | |||||||||
Operating lease, remaining term | 1 year | ||||||||
Lease term | 1 year | 1 year | |||||||
Leases Payments | $ 2,449 | $ 4,052 |
Leases - Summary of Operating L
Leases - Summary of Operating Lease Assets and Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | Aug. 01, 2021 | Jul. 01, 2021 |
Assets [Abstract] | ||||
Operating lease assets | $ 25,001 | $ 18,208 | $ 2,662 | $ 5,900 |
Liabilities [Abstract] | ||||
Operating lease liabilities | 7,058 | 6,610 | ||
Operating lease liabilities, net of current portion | 19,516 | 17,958 | ||
Total operating lease liabilities | $ 26,574 | $ 24,568 | $ 1,273 | $ 2,327 |
Leases - Summary of Lease Costs
Leases - Summary of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Leases [Abstract] | ||||
Operating lease costs | $ 1,948 | $ 1,277 | $ 3,620 | $ 2,317 |
Short-term lease costs | 354 | 363 | 709 | 729 |
Variable lease costs | 1,271 | 721 | 2,302 | 1,424 |
Sublease income | 0 | 464 | 0 | 925 |
Total lease costs | $ 3,573 | $ 2,825 | $ 6,631 | $ 5,395 |
Leases - Schedule of Future Pay
Leases - Schedule of Future Payments of Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | Aug. 01, 2021 | Jul. 01, 2021 |
Leases [Abstract] | ||||
2022 (remaining 6 months) | $ 4,392 | |||
2023 | 8,446 | |||
2024 | 3,387 | |||
2025 | 3,277 | |||
2026 and thereafter | 16,199 | |||
Total future minimum lease payments | 35,701 | |||
Less: interest | (9,127) | |||
Present value of operating lease liabilities | $ 26,574 | $ 24,568 | $ 1,273 | $ 2,327 |
Note Payable - Additional Infor
Note Payable - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Feb. 24, 2022 | Oct. 29, 2019 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Debt Instrument [Line Items] | |||||||
Interest expense | $ 1,501 | $ 732 | $ 2,413 | $ 1,428 | |||
Convertible Debt [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt Instrument, Face Amount | $ 350,000,000 | ||||||
Second Amendment to Loan and Security Agreement [Member] | New Credit Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, payment terms | For all advances outstanding under the New Credit Facility, the Company will make interest only payments through December 31, 2023, extendable to December 31, 2024 upon satisfaction of certain conditions (such applicable date, the “Amortization Date”). The principal balance and interest of the advances will be repaid in equal monthly installments after the Amortization Date and continuing through October 1, 2024, extendable to October 1, 2025, upon satisfaction of certain conditions (such applicable date, the “Maturity Date”). | ||||||
Repayments of Debt | $ 2,900 | ||||||
Additional advance prepayment or repayment percentage | 1.75% | ||||||
Loan and Security Agreement [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Interest expense | 1,501 | $ 732 | $ 2,413 | $ 1,453 | |||
Loan and Security Agreement [Member] | Original Credit Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Percentage of prepayment amount during first year | 2% | ||||||
Percentage of prepayment amount during second year | 1.50% | ||||||
Percentage of prepayment amount during third year | 1% | ||||||
Prepayment or repayment percentage | 4.85% | ||||||
Loan and Security Agreement [Member] | New Credit Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, interest rate | 9.65% | ||||||
Loan and Security Agreement [Member] | New Credit Facility [Member] | Prime Rate [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, variable rate | 6.40% | ||||||
Loan and Security Agreement [Member] | Term Loan Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Carrying value of debt | 50,632 | $ 50,632 | $ 24,643 | ||||
Lenders [Member] | Second Amendment to Loan and Security Agreement [Member] | New Credit Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, aggregate principal amount | $ 100,000 | ||||||
Hercules Capital, Inc. [Member] | Loan and Security Agreement [Member] | Original Credit Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, aggregate principal amount | $ 50,000 | ||||||
Debt Instrument Tranche Four [Member] | Lenders [Member] | Second Amendment to Loan and Security Agreement [Member] | New Credit Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, aggregate principal amount | 25,000 | ||||||
Debt Instrument Tranche Five [Member] | Lenders [Member] | Second Amendment to Loan and Security Agreement [Member] | New Credit Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, aggregate principal amount | 25,000 | ||||||
First Tranche [Member] | Second Amendment to Loan and Security Agreement [Member] | New Credit Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, aggregate principal amount | 25,000 | ||||||
First Tranche [Member] | Loan and Security Agreement [Member] | Original Credit Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Carrying value of debt | $ 50,586 | $ 50,586 | |||||
First Tranche [Member] | Lenders [Member] | Second Amendment to Loan and Security Agreement [Member] | New Credit Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, aggregate principal amount | 25,000 | ||||||
First Tranche [Member] | Hercules Capital, Inc. [Member] | Loan and Security Agreement [Member] | Original Credit Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Gross proceeds from debt | 25,000 | ||||||
Second Tranche Unavailable to Borrow Due to Not Met Milestone Requirements [Member] | Lenders [Member] | Second Amendment to Loan and Security Agreement [Member] | New Credit Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, aggregate principal amount | 12,500 | ||||||
Second Tranche Unavailable to Borrow Due to Not Met Milestone Requirements [Member] | Hercules Capital, Inc. [Member] | Loan and Security Agreement [Member] | Original Credit Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, aggregate principal amount | 12,500 | ||||||
Third Tranche Available Upon Approval Until June 30, 2021 [Member] | Lenders [Member] | Second Amendment to Loan and Security Agreement [Member] | New Credit Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, aggregate principal amount | $ 12,500 | ||||||
Third Tranche Available Upon Approval Until June 30, 2021 [Member] | Hercules Capital, Inc. [Member] | Loan and Security Agreement [Member] | Original Credit Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, aggregate principal amount | $ 12,500 |
Note Payable - Summary of Futur
Note Payable - Summary of Future Principal Payments Due Under Arrangement, Excluding Interest and End of Term Charge (Detail) $ in Thousands | Jun. 30, 2022 USD ($) |
Debt Disclosure [Abstract] | |
2022 (remaining 6 months) | $ 0 |
2023 | 0 |
2024 | 50,000 |
Total | $ 50,000 |
Common Stock and Stock-Based _3
Common Stock and Stock-Based Awards - Additional Information (Details) - USD ($) | 6 Months Ended | |||
Jun. 29, 2022 | May 21, 2021 | Jun. 30, 2022 | Dec. 31, 2021 | |
Subsidiary, Sale of Stock [Line Items] | ||||
Common stock, shares issued | 31,746,030 | 92,306,944 | 91,889,418 | |
Common stock, shares issued | 8,738,243 | |||
Total net proceeds | $ 96,841,000 | $ 96,841,000 | ||
Proceeds from issuance of common stock | $ 27,525,000 | |||
Common stock at a purchase price | $ 3.15 | $ 0.001 | $ 0.001 | |
At The Market Equity Offering Program [Member] | Sales Agreement [Member] | Cowen And Company, LLC [Member] | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Common stock, shares issued | 0 | |||
At The Market Equity Offering Program [Member] | Sales Agreement [Member] | Cowen And Company, LLC [Member] | Maximum [Member] | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Gross proceeds from sale of common stock | $ 150,000,000 | |||
IPO[Member] | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Common stock, shares issued | 31,746,030 |
Common Stock and Stock-Based _4
Common Stock and Stock-Based Awards - Summary of Stock Option Activity (Detail) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | |
Equity [Abstract] | ||
Number of Shares, Beginning Balance | shares | 11,517,189 | |
Number of Shares, Granted | shares | 4,161,997 | |
Number of Shares, Exercised | shares | (131,686) | |
Number of Shares, Forfeited | shares | (560,457) | |
Number of Shares, Ending Balance | shares | 14,987,043 | 11,517,189 |
Number of Shares, Options exercisable | shares | 6,696,344 | |
Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 11.10 | |
Weighted Average Exercise Price, Granted | $ / shares | 7 | |
Weighted Average Exercise Price, Exercised | $ / shares | 2.94 | |
Weighted Average Exercise Price, Forfeited | $ / shares | 10.41 | |
Weighted Average Exercise Price, Ending Balance | $ / shares | 10.06 | $ 11.10 |
Weighted Average Exercise Price, Options exercisable | $ / shares | $ 10.10 | |
Weighted Average Remaining Contractual Term, Outstanding | 7 years 7 months 24 days | 7 years 5 months 1 day |
Weighted Average Remaining Contractual Term, Options exercisable | 6 years 1 month 9 days | |
Aggregate Intrinsic Value, Outstanding | $ | $ 854,131 | $ 28,006,768 |
Aggregate Intrinsic Value, Options exercisable | $ | $ 589,051 |
Common Stock and Stock-Based _5
Common Stock and Stock-Based Awards - Stock Options - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted average grant-date fair value of stock options | $ 3.50 | $ 16.26 | $ 5.60 | $ 18.51 | |
Performance-based stock options to granted | 4,161,997 | ||||
Stock based compensation expense for stock options | $ 6,748,000 | $ 5,078,000 | $ 11,827,000 | $ 8,702,000 | |
Performance Shares [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted average grant-date fair value of stock options | $ 5.53 | ||||
Performance-based stock options to granted | 562,000 | ||||
Stock options exercisable | 0 | 0 | |||
Stock based compensation expense for stock options | $ 0 |
Common Stock and Stock-Based _6
Common Stock and Stock-Based Awards - Summary of Restricted Stock Unit Activity (Detail) - Restricted Stock Units [Member] | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Unvested restricted stock units, Beginning balance | shares | 734,755 |
Number of Shares, Granted | shares | 1,109,894 |
Number of Shares, Vested | shares | (126,626) |
Number of Shares, Forfeited | shares | (139,402) |
Number of Shares, Unvested restricted stock units, Ending balance | shares | 1,578,621 |
Weighted Average Grant Date Fair Value, Unvested restricted stock units, Beginning balance | $ / shares | $ 17.68 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 7.20 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 22.54 |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | 12.42 |
Weighted Average Grant Date Fair Value, Unvested restricted stock units, Ending balance | $ / shares | $ 10.38 |
Common Stock and Stock-Based _7
Common Stock and Stock-Based Awards - Restricted Stock Units - Additional Information (Detail) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) $ / shares shares | Jun. 30, 2021 USD ($) | Dec. 31, 2021 Employee $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock based compensation expense for stock options | $ | $ 6,748,000 | $ 5,078,000 | $ 11,827,000 | $ 8,702,000 | |
Number of employees granted | Employee | 2 | ||||
Performance Shares [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock based compensation expense for stock options | $ | $ 0 | ||||
Number of Shares, Vested | 0 | ||||
Restricted Stock Units [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted average grant-date fair value of stock options | $ / shares | $ 7.20 | ||||
Number of Shares, Vested | 126,626 | ||||
Number of shares granted | 1,109,894 | ||||
Vesting period | 4 years | ||||
Restricted Stock Units [Member] | Vesting After One Year | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting rights percentage | 25% | ||||
Restricted Stock Units [Member] | Vesting Quarterly Over Next 3 Years | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting rights percentage | 75% | ||||
Employee One [Member] | Performance Shares [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted average grant-date fair value of stock options | $ / shares | $ 9.59 | ||||
Number of shares granted | 85,000 | ||||
Employee Two [Member] | Performance Shares [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted average grant-date fair value of stock options | $ / shares | $ 20.35 | ||||
Number of shares granted | 40,000 |
Common Stock and Stock-Based _8
Common Stock and Stock-Based Awards - Summary of Stock Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 6,748 | $ 5,078 | $ 11,827 | $ 8,702 |
Research and development expenses [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | 3,430 | 2,709 | 6,026 | 4,846 |
General and administrative expenses [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 3,318 | $ 2,369 | $ 5,801 | $ 3,856 |
Net Income (Loss) per Share - B
Net Income (Loss) per Share - Basic and Diluted Net Income (Loss) per Share Attributable to Common Stockholders (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Numerator: | ||||||
Net loss | $ (64,735) | $ (56,624) | $ (48,330) | $ (35,465) | $ (121,359) | $ (83,795) |
Denominator: | ||||||
Weighted-average shares outstanding | 92,255,416 | 91,659,829 | 92,224,382 | 91,593,845 | ||
Net loss per share applicable to common stockholders - basic | $ (0.70) | $ (0.53) | $ (1.32) | $ (0.91) | ||
Net loss per share attributable to common stockholders, diluted | $ (0.70) | $ (0.53) | $ (1.32) | $ (0.91) | ||
Stock Options to Purchase Common Stock [Member] | ||||||
Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share: | ||||||
Stock options to purchase common stock | 14,987,043 | 11,687,959 | 14,987,043 | 11,687,959 | ||
Unvested Restricted Stock Units [Member] | ||||||
Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share: | ||||||
Unvested restricted stock units | 1,578,621 | 461,248 | 1,578,621 | 461,248 | ||
Shares Issuable under ESPP [Member] | ||||||
Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share: | ||||||
Anti-dilutive potential common stock equivalents excluded from the calculation of net income (loss) per share | 250,002 | 28,687 | 250,002 | 28,687 |
Collaboration Revenue - Additio
Collaboration Revenue - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||||
Jul. 21, 2021 | Jul. 01, 2021 | Jan. 31, 2016 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Nov. 30, 2018 | Feb. 29, 2016 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaboration (profit) loss sharing - related party | $ (271,000) | $ 0 | $ 705,000 | $ 0 | ||||||||||
Change in collaboration revenue-related party | 1,216,000 | 5,263,000 | 2,709,000 | 9,911,000 | ||||||||||
Upfront collaboration/license fee | $ 120,000,000 | |||||||||||||
Collaboration revenue - related party | 1,216,000 | 5,263,000 | 2,709,000 | 9,911,000 | ||||||||||
2021 License Agreement [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaboration product, percentage of commercial profit | 50% | |||||||||||||
Collaborative arrangement, sharing of pre-launch costs, percentage | 50% | |||||||||||||
Nestle Health Science [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Upfront cash payment | 97,200,000 | 97,200,000 | $ 97,728,000 | $ 120,000,000 | ||||||||||
Maximum development milestone payments to be received | 285,000,000 | 285,000,000 | ||||||||||||
Maximum regulatory payments to be received | 375,000,000 | 375,000,000 | ||||||||||||
Maximum amount to be received on achievement of certain commercial milestones | 1,125,000,000 | 1,125,000,000 | ||||||||||||
Proceeds on achievement of development milestone | $ 10,000,000 | $ 40,000,000 | $ 20,000,000 | $ 10,000,000 | ||||||||||
Transaction price allocated to remaining performance obligations | 200,000,000 | 200,000,000 | ||||||||||||
Collaboration revenue - related party | (197,000) | $ 5,263,000 | 528,000 | $ 9,911,000 | ||||||||||
Deferred revenue | 101,108,000 | 101,108,000 | 103,817,000 | |||||||||||
Nestle Health Science [Member] | 2021 License Agreement [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaboration product, percentage of commercial profit | 50% | |||||||||||||
Upfront payment received | $ 175,000,000 | |||||||||||||
Maximum Amount To Be Received On Achievement Of Regulatory and Sales Milestones | $ 360,000,000 | |||||||||||||
Maximum amount to be received on achievement of sales milestones | 225,000,000 | |||||||||||||
Collaboration (profit) loss sharing - related party | 271,000 | 705,000 | ||||||||||||
Maximum regulatory payments to be received | $ 135,000,000 | |||||||||||||
Transaction price allocated to remaining performance obligations | $ 139,500,000 | |||||||||||||
Termination notice period | 60 days | |||||||||||||
Nestle Health Science [Member] | Phase 2 [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Upfront collaboration milestone payments receivable | 20,000,000 | |||||||||||||
Nestle Health Science [Member] | Phase 3 [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Upfront collaboration milestone payments receivable | $ 20,000,000 | |||||||||||||
Nestle Health Science [Member] | Phase 2b [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Upfront collaboration milestone payments receivable | $ 40,000,000 | |||||||||||||
Proceeds on achievement of development milestone | $ 40,000,000 | |||||||||||||
License [Member] | Nestle Health Science [Member] | 2021 License Agreement [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaboration revenue - related party | $ 131,343,000 | |||||||||||||
Service [Member] | Nestle Health Science [Member] | 2021 License Agreement [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Collaboration revenue - related party | 1,413,000 | 2,181,000 | ||||||||||||
Topic 808 [Member] | Nestle Health Science [Member] | 2021 License Agreement [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Transaction price allocated under collaborative arrangement | $ 35,500,000 | |||||||||||||
Topic 808 [Member] | Total Liabilities [Member] | Nestle Health Science [Member] | 2021 License Agreement [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Transaction price allocated under collaborative arrangement | $ 35,500,000 | |||||||||||||
Topic 808 [Member] | Accrued Expenses and Other Current Liabilities [Member] | Nestle Health Science [Member] | 2021 License Agreement [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Transaction price allocated under collaborative arrangement | 33,062,000 | 33,062,000 | ||||||||||||
Research and Development Expense [Member] | Topic 808 [Member] | Nestle Health Science [Member] | 2021 License Agreement [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Cost associated with pre-launch activities | 1,538,000 | 3,173,000 | ||||||||||||
General and Administrative Expense [Member] | Topic 808 [Member] | Nestle Health Science [Member] | 2021 License Agreement [Member] | ||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||
Cost associated with pre-launch activities | $ 2,176,000 | $ 4,614,000 |
Collaboration Revenue - Changes
Collaboration Revenue - Changes in Contract Liabilities (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Deferred revenue - related party, Deductions | $ (1,216) | $ (5,263) | $ (2,709) | $ (9,911) |
ASU 2014-09 [Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Deferred revenue - related party, Balance at beginning of period | 103,817 | 108,174 | ||
Deferred revenue - related party, Additions | 0 | 0 | ||
Deferred revenue - related party, Deductions | 2,709 | 9,911 | ||
Deferred revenue - related party, Balance at end of period | $ 101,108 | $ 98,263 | $ 101,108 | $ 98,263 |
Collaboration Revenue - Schedul
Collaboration Revenue - Schedule of Revenue Recognized (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue recognized in the period from: | ||||
Amounts included in the contract liability at the beginning of the period | $ 1,216 | $ 5,263 | $ 2,709 | $ 9,911 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Indemnification Agreement [Member] | ||
Other Commitments [Line Items] | ||
Obligations accrued | $ 0 | $ 0 |
Legal Contingencies [Member] | ||
Other Commitments [Line Items] | ||
Obligations accrued | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||||
Income tax expense (benefit) | $ 0 | $ 0 | $ 0 | $ 0 | |
Accrued interest or tax penalties | $ 0 | $ 0 | $ 0 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||||||
Jun. 29, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | Feb. 29, 2016 | |
Related Party Transaction [Line Items] | ||||||||
Collaboration revenue - related party | $ 1,216,000 | $ 5,263,000 | $ 2,709,000 | $ 9,911,000 | ||||
Proceeds from issuance of common stock | $ 27,525,000 | |||||||
Common stock at a purchase price | $ 3.15 | $ 0.001 | $ 0.001 | $ 0.001 | ||||
Common stock, shares issued | 8,738,243 | |||||||
Nestle Health Science [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Collaboration revenue - related party | $ (197,000) | 5,263,000 | $ 528,000 | 9,911,000 | ||||
Deferred revenue | 97,200,000 | 97,200,000 | $ 97,728,000 | $ 120,000,000 | ||||
Payments under agreements with related party | $ 0 | 0 | ||||||
Due from related party for the reimbursement of development costs | 0 | 0 | ||||||
Nestle Health Science [Member] | 2021 License Agreement [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Collaboration revenue - related party | 1,413,000 | 2,181,000 | ||||||
Deferred revenue | 3,908,000 | 3,908,000 | 6,089,000 | |||||
Payments under agreements with related party | 0 | 0 | ||||||
Due from related party for the reimbursement of development costs | 0 | $ 0 | ||||||
Flagship Pioneering [Member] | Sublease Agreement [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Lessee, term of operating sublease, description | The term of the sublease agreement commenced in July 2019 and ended in November 2021. | |||||||
Sub lease commencement date | 2019-07 | |||||||
Cash received from related party transaction | 464,000 | 925,000 | ||||||
Flagship Pioneering [Member] | Sublease Agreement [Member] | Other Income [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Sublease income | $ 464,000 | $ 925,000 | ||||||
Accrued Expenses and Other Liabilities [Member] | Nestle Health Science [Member] | 2021 License Agreement [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Transaction price allocated under collaborative arrangement | $ 33,062,000 | $ 33,062,000 | $ 31,683,000 |