Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 04, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
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 | 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 | 128,204,614 | |
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, 2023 | Dec. 31, 2022 | |
Current assets: | |||
Cash and cash equivalents | $ 229,520 | $ 163,030 | |
Short term investments | 0 | 18,311 | |
Collaboration receivable - related party | 7,559 | 0 | |
Inventories | 5,340 | 0 | |
Prepaid expenses and other current assets | 8,819 | 13,423 | |
Total current assets | 251,238 | 194,764 | |
Property and equipment, net | 24,026 | 22,985 | |
Operating lease assets | 110,283 | 110,984 | |
Restricted cash | 8,185 | 8,185 | |
Restricted investments | 1,401 | 1,401 | |
Other non-current assets | 11,254 | 10,465 | |
Total assets | 406,387 | 348,784 | |
Current liabilities: | |||
Accounts payable | 12,922 | 17,440 | |
Accrued expenses and other current liabilities | [1] | 55,878 | 59,840 |
Operating lease liabilities | 5,470 | 3,601 | |
Short term portion of note payable, net of discount | 0 | 456 | |
Deferred income - related party | 2,817 | 0 | |
Deferred revenue - related party | 811 | 4,259 | |
Total current liabilities | 77,898 | 85,596 | |
Long term portion of note payable, net of discount | 100,742 | 50,591 | |
Operating lease liabilities, net of current portion | 106,706 | 107,942 | |
Deferred revenue, net of current portion - related party | 94,927 | 92,430 | |
Derivative Liability, Noncurrent | 1,968 | 0 | |
Other long-term liabilities | 1,532 | 1,442 | |
Total liabilities | 383,773 | 338,001 | |
Commitments and contingencies (Note 14) | |||
Stockholders' equity: | |||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at June 30, 2023 and December 31, 2022; no shares issued and outstanding at June 30, 2023 and December 31, 2022 | 0 | 0 | |
Common stock, $0.001 par value; 240,000,000 and 200,000,000 shares authorized at June 30, 2023 and December 31, 2022, respectively; 128,037,679 and 125,222,273 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 128 | 125 | |
Additional paid-in capital | 911,620 | 875,181 | |
Accumulated other comprehensive loss | (1) | (12) | |
Accumulated deficit | (889,133) | (864,511) | |
Total stockholders' equity | 22,614 | 10,783 | |
Total liabilities and stockholders' equity | $ 406,387 | $ 348,784 | |
[1] Includes related party amounts of $ 31,372 and $ 34,770 at June 30, 2023 and December 31, 2022, respectively (see Note 16) |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
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 | 240,000,000 | 200,000,000 |
Common stock, shares issued | 128,037,679 | 125,222,273 |
Common stock, shares outstanding | 128,037,679 | 125,222,273 |
Related Party | ||
Related parties, current | $ 31,372 | $ 34,770 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Revenue: | ||||
Collaboration revenue - related party | $ 126,473 | $ 1,216 | $ 125,951 | $ 2,709 |
Type of Revenue [Extensible List] | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember | us-gaap:LicenseAndServiceMember |
Total revenue | $ 126,473 | $ 1,216 | $ 125,951 | $ 2,709 |
Operating expenses: | ||||
Research and development expenses | 46,792 | 43,935 | 90,761 | 83,584 |
General and administrative expenses | 28,051 | 20,335 | 50,521 | 38,906 |
Collaboration (profit) loss sharing - related party | 2,106 | 271 | 5,713 | (705) |
Total operating expenses | 76,949 | 64,541 | 146,995 | 121,785 |
Income (loss) from operations | 49,524 | (63,325) | (21,044) | (119,076) |
Other income (expense): | ||||
Interest income | 1,726 | 395 | 2,758 | 779 |
Interest expense | (3,187) | (1,501) | (5,135) | (2,413) |
Other expense | (1,511) | (304) | (1,201) | (649) |
Total other expense, net | (2,972) | (1,410) | (3,578) | (2,283) |
Net income (loss) | $ 46,552 | $ (64,735) | $ (24,622) | $ (121,359) |
Net income (loss) per share attributable to common stockholders, basic | $ 0.36 | $ (0.7) | $ (0.19) | $ (1.32) |
Net income (loss) per share attributable to common stockholders, diluted | $ 0.36 | $ (0.7) | $ (0.19) | $ (1.32) |
Weighted average common shares outstanding, basic | 127,713,486 | 92,255,416 | 126,793,342 | 92,224,382 |
Weighted average common shares outstanding, diluted | 129,844,931 | 92,255,416 | 126,793,342 | 92,224,382 |
Other comprehensive (loss) income: | ||||
Unrealized (loss) gain on investments, net of tax of $0 | $ (2) | $ (41) | $ 10 | $ (196) |
Currency translation adjustment | (1) | 0 | 1 | 0 |
Total other comprehensive (loss) income | (3) | (41) | 11 | (196) |
Comprehensive income (loss) | $ 46,549 | $ (64,776) | $ (24,611) | $ (121,555) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Unrealized (loss) gain on investments, net of tax | $ 0 | $ 0 | $ 0 | $ 0 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Loss (Income) [Member] |
Beginning balance at Dec. 31, 2021 | $ 131,507 | $ 92 | $ 745,829 | $ (614,354) | $ (60) |
Beginning balance, shares at Dec. 31, 2021 | 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 and PSUs, net of tax withholdings | 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 income (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 | ||||
Net income (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 | ||||
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 and PSUs, net of tax withholdings | 57,431 | ||||
Stock-based compensation expense | 6,748 | 6,748 | |||
Other comprehensive income loss | (41) | (41) | |||
Net income (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 | ||||
Beginning balance at Dec. 31, 2022 | $ 10,783 | $ 125 | 875,181 | (864,511) | (12) |
Beginning balance, shares at Dec. 31, 2022 | 125,222,273 | 125,222,273 | |||
Issuance of common stock upon exercise of stock options, value | $ 188 | 188 | |||
Issuance of common stock upon exercise of stock options, shares | 56,523 | ||||
Issuance of common stock upon vesting of RSUs and PSUs, net of tax withholdings | 259,023 | ||||
Issuance of common stock under ESPP, value | 1,229 | $ 1 | 1,228 | ||
Issuance of common stock under ESPP, shares | 267,615 | ||||
Issuance of common stock from at the market equity offering, value | 4,239 | $ 1 | 4,238 | ||
Issuance of common stock from at the market equity offering, shares | 787,170 | ||||
Stock-based compensation expense | 6,850 | 6,850 | |||
Other comprehensive income loss | 14 | 14 | |||
Net income (loss) | (71,174) | (71,174) | |||
Ending balance at Mar. 31, 2023 | (47,871) | $ 127 | 887,685 | (935,685) | 2 |
Ending balance, shares at Mar. 31, 2023 | 126,592,604 | ||||
Beginning balance at Dec. 31, 2022 | $ 10,783 | $ 125 | 875,181 | (864,511) | (12) |
Beginning balance, shares at Dec. 31, 2022 | 125,222,273 | 125,222,273 | |||
Issuance of common stock upon exercise of stock options, shares | 105,592 | ||||
Net income (loss) | $ (24,622) | ||||
Ending balance at Jun. 30, 2023 | $ 22,614 | $ 128 | 911,620 | (889,133) | (1) |
Ending balance, shares at Jun. 30, 2023 | 128,037,679 | 128,037,679 | |||
Beginning balance at Mar. 31, 2023 | $ (47,871) | $ 127 | 887,685 | (935,685) | 2 |
Beginning balance, shares at Mar. 31, 2023 | 126,592,604 | ||||
Issuance of common stock upon exercise of stock options, value | 168 | 168 | |||
Issuance of common stock upon exercise of stock options, shares | 49,069 | ||||
Issuance of common stock upon vesting of RSUs and PSUs, net of tax withholdings | 177,629 | ||||
Issuance of common stock from at the market equity offering, value | 7,491 | $ 1 | 7,490 | ||
Issuance of common stock from at the market equity offering, shares | 1,218,377 | ||||
Issuance of warrants, Shares | 2,785 | 2,785 | |||
Stock-based compensation expense | 13,492 | 13,492 | |||
Other comprehensive income loss | (3) | (3) | |||
Net income (loss) | 46,552 | 46,552 | |||
Ending balance at Jun. 30, 2023 | $ 22,614 | $ 128 | $ 911,620 | $ (889,133) | $ (1) |
Ending balance, shares at Jun. 30, 2023 | 128,037,679 | 128,037,679 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity (Deficit)(Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Jun. 30, 2023 | Mar. 31, 2023 | |
Market Equity Offering [Member] | ||
Issuance costs | $ 304 | $ 225 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | ||
Cash flows from operating activities: | |||
Net income (loss) | $ (24,622) | $ (121,359) | |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | |||
Stock-based compensation expense | 20,342 | 11,827 | |
Depreciation and amortization expense | 2,927 | 3,255 | |
Non-cash operating lease cost | 4,247 | 2,305 | |
Net (accretion) amortization of (discounts) premiums on investments | (236) | 547 | |
Amortization of debt issuance costs | 337 | 328 | |
Loss on extinguishment of debt | 1,625 | 0 | |
Change in fair value of warrant liabilities | (132) | 0 | |
Collaboration (profit) loss sharing - related party | 5,713 | (705) | |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other current and other non-current assets | 3,579 | (10,145) | |
Collaboration receivable - related party | (7,559) | 0 | |
Inventories | (5,340) | 0 | |
Deferred income - related party | 2,817 | ||
Deferred revenue - related party | (951) | (2,709) | |
Accounts payable | (3,092) | 709 | |
Operating lease liabilities | (577) | (2,130) | |
Accrued expenses and other current and long-term liabilities (3) | [1] | (9,678) | 1,735 |
Net cash used in operating activities | (10,600) | (116,342) | |
Cash flows from investing activities: | |||
Purchases of property and equipment | (5,301) | (5,113) | |
Purchases of investments | (4,426) | (36,138) | |
Sales and maturities of investments | 22,983 | 77,622 | |
Net cash provided by investing activities | 13,256 | 36,371 | |
Cash flows from financing activities: | |||
Proceeds from exercise of stock options | 356 | 387 | |
Proceeds from issuance of common stock from at the market equity offering | 11,730 | 0 | |
Issuance of common stock under ESPP | 1,229 | 892 | |
Proceeds from issuance of debt, net of issuance costs | 103,378 | 27,606 | |
Repayment of notes payable | (52,860) | (1,907) | |
Net cash provided by financing activities | 63,833 | 26,978 | |
Net increase (decrease) in cash, cash equivalents, and restricted cash | 66,489 | (52,993) | |
Effect of exchange rate changes on cash, cash equivalents, and restricted cash | 1 | 0 | |
Cash, cash equivalents and restricted cash at beginning of period | 171,215 | 188,002 | |
Cash, cash equivalents and restricted cash at end of period | 237,705 | 135,009 | |
Supplemental disclosure of cash flow information: | |||
Cash paid for interest | 2,869 | 1,836 | |
Supplemental disclosure of non-cash investing and financing activities: | |||
Property and equipment purchases included in accounts payable and accrued expenses | 943 | 597 | |
Prepaid rent reclassified to right-of-use assets | 2,336 | 4,962 | |
Lease liability arising from obtaining right-of-use assets | 1,210 | 4,370 | |
Recognition of warrant liabilities | 2,100 | 0 | |
Warrants issued related to Term Loan and recorded as debt discount | $ 2,785 | $ 0 | |
[1] Includes related party amoun ts of ($ 3,398 ) and $ 1,379 at June 30, 2023 and 2022, respectively (see Note 16) |
Condensed Consolidated Statem_6
Condensed Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Statement of Cash Flows [Abstract] | ||
Accrued Expenses and Other current and Long-term Liabilities Related Party Amounts | $ (3,398) | $ (1,379) |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Pay vs Performance Disclosure | ||||||
Net Income (Loss) | $ 46,552 | $ (71,174) | $ (64,735) | $ (56,624) | $ (24,622) | $ (121,359) |
Insider Trading Arrangements
Insider Trading Arrangements | 6 Months Ended |
Jun. 30, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 6 Months Ended |
Jun. 30, 2023 | |
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 commercial-stage microbiome therapeutics company focused on the development and commercialization of 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 product, VOWST (fecal microbiota spores, live brpk), formerly called SER-109, was approved by the U.S. Food and Drug Administration (“FDA”) on April 26, 2023 and is the first and only orally administered microbiome therapeutic. VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (“CDI”) in patients 18 or older following antibacterial treatment for recurrent CDI. The Company launched VOWST in the United States with its collaborator, Nestlé Health Science (“Nestlé”), in June 2023. Beginning with the commercial launch of VOWST, pursuant to the 2021 License Agreement (as defined below), Nestlé records total net sales of VOWST, which are reduced by costs incurred by each collaborator, and the resulting profit or loss is shared equally between the Company and Nestlé. For additional information, see Note 13, Collaboration Profit and Loss . Building upon VOWST, 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 16-strain consortium of cultivated bacteria, is designed to prevent enteric-derived infections and resulting blood stream infections, as well as induce immune tolerance responses to reduce the incidence of Graft versus Host Disease ("GvHD") in patients undergoing allogeneic hematopoietic stem cell transplantation (“allo-HSCT”). Gastrointestinal microbiome data from the first 100 days of SER-155 Phase 1b open-label study cohort 1 showed the successful engraftment of SER-155 bacterial strains, and a substantial reduction in the cumulative incidence of pathogen domination, a biomarker associated with the risk of serious enteric infections and resulting bloodstream infections, as well as GvHD. The tolerability profile observed was favorable, with no serious adverse events attributed to SER-155 administration. Enrollment in the placebo-controlled cohort 2 portion of the study is ongoing and 100-day topline results are anticipated in mid-2024. The Company is progressing additional preclinical stage programs to evaluate how microbiome therapeutics may 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 in settings of high-risk such as intensive care units. 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 translational microbiome therapeutic development platform 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. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies. The Company's primary focus in recent months has been and will continue to be supporting commercialization, including the manufacture of VOWST, which requires capital and resources. Other than VOWST, the Company’s product candidates are in development, and will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to potential commercialization. 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 accompanying condensed consolidated financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. As of June 30, 2023, the Company had an accumulated deficit of $ 889,133 and cash and cash equivalents of $ 229,520 . For the six months ended June 30, 2023, the Company incurred a net loss of $ 24,622 and had net operating cash outflows of $ 10,600 . The Company expects that its operating losses and negative cash flows will continue for the foreseeable future. In the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, the Company disclosed that there was substantial doubt about its ability to continue as a going concern as a result of conditions that existed as of the date of issuance of the consolidated financial statements included therein. At that time, primarily as a result of the increased and costly efforts to prepare for potential commercialization of VOWST, in conjunction with the Company's research and development efforts for other preclinical and product candidates, the Company determined that it would need additional funding in early 2024. Because certain elements of management's plans to mitigate the conditions that raised substantial doubt about the Company’s ability to continue as a going concern were contingent upon the approval by the FDA of the Biologics License Application ("BLA") for VOWST, and such approval was outside the Company's control, those elements could not be considered probable according to Accounting Standards Codification (“ASC”) 205-40, Going Concern ("ASC 205-40"), and therefore also could not be considered in the evaluation of mitigating factors. In May 2023, after FDA approval of VOWST, the Company received a $ 125,000 milestone payment under its license agreement with Nestlé executed in July 2021 (“2021 License Agreement,” see Note 12, Revenue from Contracts with Customers ). Additionally, the Company is eligible to receive payments from Nestlé for the supply of VOWST, and is entitled to share equally in its commercial profits and losses. As of the date of issuance of these condensed consolidated financial statements, management’s plans to mitigate the conditions that raised substantial doubt about the Company’s ability to continue as a going concern include receipt of payments from Nestlé for the supply of VOWST, and sharing equally in commercial profits and losses with Nestlé pursuant to the 2021 License Agreement. Management concluded these plans are probable of being effectively implemented and of mitigating the conditions that raised substantial doubt about the Company’s ability to continue as a going concern. The Company expects that its cash and cash equivalents as of June 30, 2023 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 these condensed consolidated financial statements. The Company may seek to raise additional capital through financing or other transactions, including through at the market equity offerings. The future viability of the Company beyond 12 months from issuance of these condensed consolidated financial statements is dependent on its ability to raise additional capital to finance its operations. Unaudited Interim Financial Information The accompanying unaudited condensed consolidated financial statements as of June 30, 2023 and for the three and six months ended June 30, 2023 and 2022 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 condensed consolidated financial statements and the notes thereto for the year ended December 31, 2022 included in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the SEC on March 7, 2023 (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, 2022 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, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023 . |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
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 unaudited condensed consolidated financial statements are described in the Company’s audited financial statements as of and for the year ended December 31, 2022, 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, 2023, with the exception of those detailed below. Inventories Inventories are stated at the lower of cost or estimated net realizable value with cost based on the first-in first-out method. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in clinical trials. Prior to the regulatory approval of its product candidates, the Company incurs expenses for the manufacture of drug product supplies to support clinical development that could potentially be available to support the commercial launch of those drugs. Until the date at which regulatory approval has been received or is otherwise considered probable, the Company records all such costs as research and development expenses. 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 unaudited condensed consolidated financial statements and the reported amounts of revenue and expenses during the reporting periods. In the unaudited 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. Actual results could differ from those estimates. Restricted Cash The Company held restricted cash of $ 8,185 as of June 30, 2023 and December 31, 2022, which represents cash held for the benefit of the landlords for certain of the Company’s leases. The Company has classified the restricted cash as long-term on its condensed consolidated balance sheets as the terms of the underlying leases are greater than one year. Cash, cash equivalents and restricted cash were comprised of the following (in thousands): June 30, December 31, 2023 2022 Cash and cash equivalents $ 229,520 $ 163,030 Restricted cash, non-current 8,185 8,185 Total cash, cash equivalents and restricted cash $ 237,705 $ 171,215 |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended | |
Jun. 30, 2023 | Apr. 27, 2023 | |
Fair Value Disclosures [Abstract] | ||
Fair Value Measurements | 3. 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, 2023 Using: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 20,620 $ — $ — $ 20,620 Total assets $ 20,620 $ — $ — $ 20,620 Warrant liabilities $ — $ — $ 1,968 $ 1,968 Total liabilities $ — $ — $ 1,968 $ 1,968 Fair Value Measurements as of December 31, 2022 Using: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 47,863 $ — $ — $ 47,863 Commercial paper — 11,691 — 11,691 Government securities — 4,966 — 4,966 Investments: Commercial paper $ — $ 2,465 $ — $ 2,465 Corporate bonds — 2,957 — 2,957 Government securities — 12,889 — 12,889 $ 47,863 $ 34,968 $ — $ 82,831 Money market funds are 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 are valued by the Company using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy. As of both June 30, 2023 and December 31, 2022, the Company held a restricted investment of $ 1,401 , which represents a certificate of deposit that is classified as Level 2 in the fair value hierarchy. Level 3 financial liabilities consist of the warrant liabilities for which there is no current market such that the determination of fair value requires significant judgment or estimation. Changes in fair value measurements categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded through other income (expense). The Company uses a Monte-Carlo simulation model which includes the Black-Scholes option pricing model to value the Level 3 warrant liabilities at inception and on each subsequent reporting date. This model incorporates transaction details such as the Company’s stock price, contractual terms of the underlying warrants, maturity, risk free rates, volatility, as well as the term to achievement of estimated sales targets. The unobservable inputs for all of the Level 3 warrant liabilities are volatility and the term to achievement of estimated sales targets. The Company utilizes its historical and implied volatility, using its closing common stock prices and market data, to reflect future volatility over the expected term of the warrants. The Company estimates the time to achievement of sales targets of VOWST using information and forecasts generated by the Company in consideration of the terms of the 2021 License Agreement. On the Closing Date (as defined in Note 9, Notes Payable ) and as of June 30, 2023, the Level 3 inputs to the warrant liabilities are as follows: Closing Date June 30, 2023 Volatility 83.0 % 82.0 % Term (in years) 1.7 1.5 A reconciliation of the beginning and ending balances for the three and six months ended June 30, 2023 for liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands): Warrant Liabilities Balance as of December 31, 2022 $ — Issuance of warrants 2,100 Adjustment to fair value ( 132 ) Balance as of June 30, 2023 1,968 There were no assets or liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) during the three and six months ended June 30, 2022 . There were no transfers between Level 1, Level 2, or Level 3 during the three and six months ended June 3 0 , 2 0 23 and 2022 . | |
Derivative Liability Expected Term | 1 year 6 months | 1 year 8 months 12 days |
Investments
Investments | 6 Months Ended |
Jun. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | 4. Investments Investments by security type consisted of the following at December 31, 2022 (in thousands): December 31, 2022 Amortized Gross Gross Fair Investments: Commercial paper $ 2,465 $ — $ — $ 2,465 Corporate bonds 2,958 — ( 1 ) 2,957 Government securities 12,898 3 ( 12 ) 12,889 $ 18,321 $ 3 $ ( 13 ) $ 18,311 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 assets and those investments with maturities greater than 12 months are considered non-current assets. As of December 31, 2022, all of the Company’s investments were classified as available-for-sale and mature within 12 months of the balance sheet date. Excluded from the tables above are restricted investments of $ 1,401 as the cost approximates current fair value as of June 30, 2023 and December 31, 2022 , respectively. The Company did not hold any other investments as of June 30, 2023. |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories | 5. Inventories Capitalized inventories consist of the following at June 30, 2023 (in thousands): June 30, 2023 Raw materials $ 547 Work in process 4,750 Finished goods 43 Total $ 5,340 There were no inventories capitalized as of December 31, 2022, because the Company obtained approval for VOWST from the FDA on April 26, 2023. Prior to this approval, all costs for the manufacture of product supplies to support clinical development and commercial launch, including pre-launch inventory, were expensed as incurred or otherwise accounted for pursuant to the 2021 License Agreement. Pre-launch inventory manufactured prior to the FDA approval of VOWST, which was not capitalized into inventory but instead was expensed as research and development in previous periods, will be used in commercial production until it is depleted. Pre-launch inventory expensed as research and development totaled $ 11,181 and $ 26,794 for the three and six months ended June 30, 2023. Inventory amounts written down as a result of excess, obsolescence, or unmarketability and determined not to be recoverable pursuant to the 2021 License Agreement are expensed in the period in which they are identified. There were no such write-downs during the three and six months ended June 30, 2023 . |
Property and Equipment, Net
Property and Equipment, Net | 6 Months Ended |
Jun. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 6. Property and Equipment, Net Property and equipment, net consisted of the following (in thousands): June 30, 2023 December 31, 2022 Laboratory equipment $ 28,053 $ 24,533 Computer equipment 4,134 3,557 Furniture and office equipment 4,911 3,491 Leasehold improvements 32,963 32,474 Construction in progress 1,932 3,970 71,993 68,025 Less: Accumulated depreciation and amortization ( 47,967 ) ( 45,040 ) $ 24,026 $ 22,985 Depreciation and amortization expense was $ 1,527 , $ 2,927 , $ 1,685 , and $ 3,255 for the three and six months ended June 30, 2023 and 2022, respectively. During the six months ended June 30, 2023 the Company disposed of certain fully-depreciated assets with a cost basis of $ 9 . |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 7. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, 2023 December 31, 2022 Clinical and development costs $ 2,157 $ 6,717 Manufacturing and quality costs 2,707 — Payroll and payroll-related costs 11,688 14,709 Collaboration payable - related party (Note 16) 31,372 34,770 Facility and other 7,954 3,644 $ 55,878 $ 59,840 As of June 30, 2023, the Company accrued a total of $ 3,850 payable to third parties for transaction and milestone payments resulting from the FDA approval of VOWST and subsequent commercial launch. This amount is included in the Facility and other category above. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2023 | |
Leases [Abstract] | |
Leases | 8. Leases The Company leases real estate, primarily laboratory, office and manufacturing space. The Company’s leases have remaining terms ranging from approximately two to ten 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 approximately 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 April 2022, the Company entered into a lease for additional laboratory and office space in Spring House, Pennsylvania, with a lease term of ten years and a renewal option, subject to certain conditions, for an additional five-year term. The undiscounted minimum lease payments are $ 2,991 , net of a tenant improvement allowance of $ 1,223 , over the original ten-year term. The lease commenced in April 2023, at which point, the Company recorded a right-of-use asset of $ 3,546 , which consists of the lease liability of $ 1,210 , and $ 2,336 of leasehold improvements that revert back to the lessor at the termination of the lease. In June 2023, the Company entered into a lease for a donor collection facility in Irvine, California, with a lease term of seven years and a renewal option, subject to certain conditions, for an additional five-year term. The undiscounted minimum lease payments are $ 1,084 over the original seven-year term. As of June 30, 2023, the lease has not yet commenced, and accordingly the Company has no t recorded a right-of-use asset or a lease liability with respect thereto. The following table summarizes the presentation in the Company’s condensed consolidated balance sheets of its operating leases (in thousands): June 30, 2023 December 31, 2022 Assets: Operating lease assets $ 110,283 $ 110,984 Liabilities: Operating lease liabilities $ 5,470 $ 3,601 Operating lease liabilities, net of current portion 106,706 107,942 Total operating lease liabilities $ 112,176 $ 111,543 Three Months Ended Six Months Ended 2023 2022 2023 2022 Operating lease costs $ 5,543 $ 1,948 $ 10,953 $ 3,620 Short-term lease costs 372 354 740 709 Variable lease costs 2,180 1,271 3,943 2,302 Total lease costs $ 8,095 $ 3,573 $ 15,636 $ 6,631 During the three and six months ended June 30, 2023 and 2022, the Company made cash payments for operating leases of $ 3,875 , $ 7,289 , $ 1,332 , and $ 3,445 respectively. As of June 30, 2023, future payments of operating lease liabilities are as follows (in thousands): As of 2023 (remaining 6 months) $ 8,600 2024 $ 19,437 2025 $ 21,555 2026 $ 22,155 2027 and thereafter $ 111,164 Total future minimum lease payments $ 182,911 Less: interest ( 70,735 ) Present value of operating lease liabilities $ 112,176 As of June 30, 2023, the weighted average remaining lease term was 8.47 years and the weighted average incremental borrowing rate used to determine the operating lease liability was 13 % . 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 % . |
Notes Payable
Notes Payable | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Notes Payables | 9. Notes Payable On October 29, 2019 (“Hercules Closing Date”), the Company entered into a Loan and Security Agreement (the “Hercules 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. Effective as of February 24, 2022 (the “Effective Date”), the Company entered into an Amendment to the Hercules Loan Agreement (the “Amendment”), with the lenders party thereto (the “Hercules Lenders”), and Hercules in its capacity as the administrative agent and the collateral agent for the Hercules Lenders, which amended the Original Credit Facility. Pursuant to the Amendment, term loans in an aggregate principal amount of up to $ 100,000 (the “Hercules 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 and fifth tranches, in aggregate principal amounts of $ 25,000 each, were available upon satisfaction of certain conditions, but were not drawn before the repayment and extinguishment of the Hercules Credit Facility. All advances outstanding under the Hercules Credit Facility bore 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 %. The Company had the option to prepay advances under the Hercules Credit Facility, in whole or in part, at any time subject to a prepayment charge, and the Hercules Loan Agreement included an end of term charge of 4.85 % of the aggregate amount of the advances made under the Original Credit Facility, as well as an additional end of term charge of 1.75 % of the aggregate amount of the advances under the Hercules Credit Facility (including the first tranche of $ 25,000 ), each due as specified in the Amendment. The Hercules Credit Facility was secured by substantially all of the Company’s assets, other than the Company’s intellectual property. The Company agreed to not pledge or secure its intellectual property to others. The Company accounted for the Amendment as a modification in accordance with the guidance in ASC 470-50, Debt ("ASC 470"). Amounts paid to the Hercules Lenders were recorded as debt discount and a new effective interest rate was established. Upon issuance, the Hercules Credit Facility was recorded as a liability with an initial carrying value of $ 50,586 , net of debt issuance costs. The initial carrying value was 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. As of December 31, 2022, the carrying value of the debt was $ 51,047 . During the three and six months ended June 30, 2023 and 2022 the Company recognized $ 520 , $ 2,468 , $ 1,501 , and $ 2,413 , respectively, of interest expense related to the Hercules Loan Agreement, which is reflected in interest expense on the condensed consolidated statements of operations and comprehensive income (loss). On April 27, 2023 (the “Closing Date”), the Company entered into the Credit Agreement and Guaranty (the “Oaktree Credit Agreement”) among the Company, the subsidiary guarantors from time to time party thereto, the lenders from time to time party thereto (the “Lenders”), and Oaktree Fund Administration, LLC, in its capacity as administrative agent for the Lenders (in such capacity, the “Agent”). The Oaktree Credit Agreement establishes a term loan facility of $ 250,000 (the “Term Loan”) consisting of (i) $ 80,000 (“Tranche A-1”) and (ii) $ 30,000 (“Tranche A-2” and collectively, “Tranche A Loan”), funded on the Closing Date. The Term Loan also consists of (i) $ 45,000 (the “Tranche B Loan”) and (iii) $ 45,000 (the “Tranche C Loan”), each of whic h the Company may borrow subject to certain conditions, and (iv) $ 50,000 (the “Tranche D Loan”) available in Oaktree’s sole discretion. The Tranche B Loan may be drawn by the Company until September 30, 2024, if VOWST net sales for the trailing six consecutive months are at least $ 35,000 and at least 4.5 % greater in the calendar quarter prior to the Applicable Funding Date (as defined in the Oaktree Credit Agreement) over the calendar quarter immediately preceding it. The Tranche C Loan may be drawn until September 30, 2025, if VOWST net sales for the trailing 12 consecutive months are at least $ 120,000 and at least 4.5 % greater in each of the two calendar quarters prior to the Applicable Funding Date relative, in each case, to the calendar quarter immediately preceding it. The Term Loan ha s a maturity date of April 27, 2029 (the “Maturity Date”). Of the $ 110,000 Tranche A Loan advanced by the Lenders at closing, approximately $ 53,380 repaid the Company’s existing credit facility with Hercules. After deducting other transaction expenses and fees, the Company received net proceeds of approximately $ 50,446 . The Company accounted for the repayment of the Hercules Credit Facility as an extinguishment in accordance with the guidance in ASC 470-50, and recognized a loss on extinguishment of $ 1,625 in other income (expense) in the accompanying condensed consolidated statements of operations and comprehensive income (loss) for the three and six months ended June 30, 2023. Borrowings under the Term Loan bear interest at a rate per annum equal to the three-month term Secured Overnight Financing Rate (“SOFR”) (subject to a 2.50 % floor and a 5.00 % cap), plus an applicable margin of 7.875 %, payable quarterly in arrears. If certain VOWST net sales targets are met, the applicable margin will be reduced from 7.875 % to 7.50 % through the Maturity Date. The Company is permitted to make quarterly interest-only payments on the Term Loan for the first three years after the Closing Date. Beginning on June 30, 2026, the Company will be required to make quarterly payments of interest, plus repay 7.50 % of the outstanding principal of the Term Loan in quarterly installments until the Maturity Date, unless the interest only period is extended based upon the achievement of certain VOWST net sales targets. The Company is obligated to pay the Lenders an exit fee equal to 1.50 % of the aggregate amount of the Term Loan funded, such exit fee to be due and payable upon the earliest to occur of (1) the Maturity Date, (2) the acceleration of the outstanding Term Loan, and (3) the prepayment of the outstanding Term Loan. The Company may voluntarily prepay the outstanding Term Loan, subject to a customary make-whole for the first two years following the Closing Date plus 4.0 % of the principal amount of the Term Loan prepaid, and thereafter a prepayment premium equal to (i) 4.0 % of the principal amount of the Term Loan prepaid, if prepaid after the second anniversary of the Closing Date through and including the third anniversary of the Closing Date, (ii) 2.0 % of the principal amount of the Term Loan if prepaid after the third anniversary of the Closing Date through and including the fourth anniversary of the Closing Date, (iii) 1.0 % of the principal amount of the Term Loan if prepaid after the fourth anniversary of the Closing Date through and including the fifth anniversary of the Closing Date, with no prepayment premium due after the fifth anniversary of the Closing Date through the Maturity Date. The Company’s obligations under the Oaktree Credit Agreement and the other Loan Documents (as defined in the Oaktree Credit Agreement) will be guaranteed by any domestic subsidiaries of the Company that become Guarantors (as defined in the Oaktree Credit Agreement), subject to certain exceptions. The Company’s and the Guarantors’ (collectively, the “Loan Parties”) respective obligations under the Oaktree Credit Agreement and the other Loan Documents are secured by first priority security interests in substantially all assets of the Loan Parties, including intellectual property, subject to certain customary thresholds and exceptions. As of June 30, 2023, there are no Guarantors. The Oaktree Credit Agreement contains customary representations, warranties and affirmative and negative covenants, including a financial covenant requiring the Company to maintain certain levels of cash and cash equivalents in accounts subject to a control agreement in favor of the Agent of at least $ 30,000 at all times commencing from 30 days after the Closing Date and decreasing to $ 25,000 of cash and cash equivalents in such controlled accounts after the Company borrows any Tranche B Loan. In addition, the Oaktree Credit Agreement contains certain events of default that entitle the Agent to cause the Company’s indebtedness under the Oaktree Credit Agreement to become immediately due and payable, and to exercise remedies against the Loan Parties and the collateral securing the Term Loan, including cash. In an event of default and for its duration, as defined in the Oaktree Credit Agreement, an additional default interest rate equal to 2.0 % per annum may apply to all obligations owed under the Oaktree Credit Agreement. On the Closing Date, the Company issued to the Lenders warrants to purchase 647,589 shares (subject to certain adjustments) of the Company’s common stock (the “Tranche A Warrant”), at an exercise price per share of $ 6.69 . The Tranche A Warrant is immediately exercisable and the exercise period expires on April 26, 2030. Upon the funding of each of the Tranche B Loan and the Tranche C Loan, the Company is required to issue to the Lenders warrants to purchase 264,922 shares (subject to certain adjustments) of the Company’s common stock on each such funding date at an exercise price equal to the trailing volume weighted average price of the Company’s common stock for the 30 trading days prior to the funding date for each tranche (the “Tranche B Warrant” and the “Tranche C Warrant,” respectively, and together the “Additional Warrants”). The Additional Warrants will be immediately exercisable upon issuance, and the exercise period will expire seven years from the date of issuance. The Company determined that the Tranche A Loan, the Tranche A Warrant, the commitment by the Lenders to fund the Tranche B Loan and the Tranche C Loan, and the Tranche B Warrant and Tranche C Warrant, are all freestanding financial instruments. On the Closing Date, the Company evaluated the Tranche A Warrant and determined that it meets the requirements for equity classification under ASC 815, Derivatives and Hedging (“ASC 815”). The net proceeds from the Tranche A Loan were allocated to the Tranche A Warrant and the Tranche A Loan using the relative fair value method, and the relative fair value of the Tranche A Warrant, $ 2,785 , is recorded as an increase to additional paid-in-capital on the consolidated statements of stockholder’s equity (deficit), and as a discount to the Tranche A Loan that will be amortized over the life of the Tranche A Loan using the effective interest method. The Company used the Black-Scholes option pricing model to determine the fair value of the Tranche A Warrant. Assumptions used in the Black-Scholes model included the fair market value per share of common stock on the valuation date of $ 5.32 , the exercise price per warrant equal to $ 6.69 , the expected volatility of 111.6 %, the risk-free interest rate of 3.57 %, the expected term of 7 years and the absence of a dividend. The Additional Warrants are considered outstanding instruments at the Closing Date of the Oaktree Credit Agreement and in accordance with ASC 815, are initially recognized at their respective fair values as derivative liabilities given the variable settlement amount of their respective aggregate exercise prices. The Company adjusts the carrying values of the Additional Warrants to their respective fair values at each reporting period, until such time that the Additional Warrants are issued and their respective exercise prices become fixed, and the value of the Additional Warrants is reclassified to additional paid-in capital. The Company uses a simulation model to determine the fair value of the Additional Warrants, as described in Note 3, Fair Value Measurements . The fair value of the Tranche B Warrant and Tranche C Warrant derivative liabilities was $ 1,077 , $ 1,023 , $ 1,012 , and $ 956 on the Closing Date and at June 30, 2023, respectively. Changes in the fair values of the Additional Warrants are recorded as other income (expense) in the consolidated statements of operations and comprehensive income (loss). In addition to the relative fair value of the Tranche A Warrant, the original issue discount and certain debt issuance costs were recorded as a discount to the Tranche A Loan, the total of which will be accreted to the Tranche A Loan as interest expense over the life of the Tranche A Loan using the effective interest method. The fair values of the derivative liabilities associated with the Tranche B Warrant and Tranche C Warrant are recorded as loan commitment prepaid assets on the Closing Date, which are included in the condensed consolidated balance sheets in Other non-current assets, and will be reclassified as discounts to the associated Term Loan balances at such time that they are drawn. The effective interest rate in effect as of June 30, 2023 was 15.9 %. As of June 30, 2023, the carrying value of the Term Loan was $ 100,742 , which is classified as a long-term liability on the condensed consolidated balance sheets. The future principal payments due under the Oaktree Credit Agreement, excluding interest and the end of term charge, are as follows: Year Ending December 31, Principal 2023 (remaining 6 months) $ — 2024 — 2025 — 2026 24,750 2027 33,000 Thereafter 52,250 Total $ 110,000 During the three and six months ended June 30, 2023, the Company recognized $ 2,518 of interest expense related to the Term Loan, which is reflected in interest expense on the condensed consolidated statements of operations and comprehensive income (loss). |
Common Stock and Stock-Based Aw
Common Stock and Stock-Based Awards | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Common Stock and Stock-Based Awards | 10. Common Stock and Stock-Based Awards On March 29, 2023, the Company’s board of directors adopted a resolution to amend the Restated Certificate of Incorporation, subject to stockholder approval, by increasing the number of authorized shares of the Company’s Common Stock from 200,000,000 shares to 240,000,000 shares (the “Share Increase Amendment”). At the Company’s annual meeting of stockholders held on June 22, 2023, the Company’s stockholders approved the Share Increase Amendment. On June 27, 2023, the Company amended its Restated Certificate of Incorporation to reflect the Share Increase Amendment. 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. During the three and six months ended June 30, 2023, the Company sold 1,218,377 and 2,005,547 shares, respectively, of common stock under the Sales Agreement, at an average price of approximately $ 6.40 and $ 6.11 per share, respectively, raising aggregate net proceeds of approximately and $ 7,491 and $ 11,730 , respectively, after deducting an aggregate commission of approximately 3 % and other issuance costs. During the three and six months ended June 30, 2022, the Company did no t sell any shares of common stock under the Sales Agreement. Stock Options The following table summarizes the Company’s stock option activity since December 31, 2022: Number Weighted Weighted Aggregate (in years) Outstanding as of December 31, 2022 14,940,034 $ 10.03 7.25 $ 11,608 Granted 2,430,545 $ 5.49 Exercised ( 105,592 ) $ 3.37 Forfeited ( 509,388 ) $ 9.39 Outstanding as of June 30, 2023 16,755,599 $ 9.43 6.90 $ 6,828 Options exercisable as of June 30, 2023 9,772,084 $ 9.94 5.64 $ 5,882 The weighted average grant-date fair value of stock options granted during the three and six months ended June 30, 2023 and 2022 was $ 4.54 , $ 4.56 , $ 3.50 , and $ 5.60 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 approximately 562,000 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. In April 2023, the performance target associated with 50 % of the performance-based stock options was achieved. Accordingly the Company recorded $ 2,373 of compensation expense during the three and six months ended June 30, 2023 , with respect to these performance-based stock options, which represents a cumulative catch-up from the grant date through the achievement of the performance targets. The remaining 50 % of these performance-based stock options began vesting in April 2023, and the remaining associated compensation expense will be recognized ratably through April 2024, for all such options for which ongoing performance targets are achieved and service requirements are met. Restricted Stock Units The following table summarizes the Company’s restricted stock unit activity since December 31, 2022: Number Weighted Unvested restricted stock units as of December 31, 2022 1,549,540 $ 9.37 Granted 3,043,510 $ 5.50 Vested ( 436,652 ) $ 9.69 Forfeited ( 217,530 ) $ 8.94 Unvested restricted stock units as of June 30, 2023 3,938,868 $ 6.36 The Company has granted restricted stock units with service-based vesting conditions (“RSUs”) and performance-based vesting conditions (“PSUs”). RSUs and PSUs represent the right to receive shares of common stock upon meeting specified vesting requirements. RSUs and PSUs may not be sold or transferred by the holder and vest according to the service-based or performance-based vesting conditions of the award. During the three and six months ended June 30, 2023 and 2022, the Company granted 28,700 , 1,720,795 , 120,350 , and 1,109,894 RSUs, respectively. During the three and six months ended June 30, 2023, the Company granted 0 and 1,322,715 PSUs, respectively. The Company did not grant any PSUs during the three and six months ended June 30, 2022. RSUs 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. PSUs vest according to the performance requirements of the awards, generally when the Company has determined that the specified performance targets have been achieved. During the year ended December 31, 2021, the Company granted PSUs to two employees for the purchase of an aggregate of 85,000 shares of common stock with a grant date fair value of $ 9.59 per share and 40,000 shares of common stock with a grant date fair value of $ 20.35 per share. These PSUs vest only upon achievement of specified performance targets. In October 2022, 42,500 of the PSUs with a grant date fair value of $ 9.59 , and 20,000 of the PSUs with a grant date fair value of $ 20.35 , vested fully, as the associated performance targets were achieved. Accordingly, the Company recorded $ 815 in compensation expense during the year ended December 31, 2022, with respect to these PSUs. In April 2023, the remaining PSUs underlying these awards vested because the associated targets were achieved. Accordingly, the Company recorded the remaining $ 815 in compensation expense during the three and six months ended June 30, 2023, with respect to these PSUs. During the three months ended March 31, 2023, the Company granted PSUs to employees for the purchase of an aggregate of 1,322,715 shares of common stock with a grant date fair value of $ 5.50 . These PSUs begin to vest ratably only upon achievement of specified performance targets, which were achieved in April 2023. Accordingly, the Company recorded $ 2,768 in compensation expense during the three and six months ended June 30, 2023 , with respect to these PSUs. The remaining $ 4,260 in compensation expense with respect to these PSUs will be recognized ratably through October 2024. 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 income (loss) (in thousands): Three Months Ended June 30, Six Months Ended 2023 2022 2023 2022 Research and development expenses $ 7,851 $ 3,430 $ 11,582 $ 6,026 General and administrative expenses 5,641 3,318 8,760 5,801 $ 13,492 $ 6,748 $ 20,342 $ 11,827 |
Net Income (Loss) per Share
Net Income (Loss) per Share | 6 Months Ended |
Jun. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) per Share | 11. Net Income (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 June 30, Six Months Ended June 30, 2023 2022 2023 2022 Basic Earnings Per Share: Numerator: Net income (loss) $ 46,552 $ ( 64,735 ) $ ( 24,622 ) $ ( 121,359 ) Income (loss) attributable to common stockholders - basic $ 46,552 $ ( 64,735 ) $ ( 24,622 ) $ ( 121,359 ) Denominator: Weighted-average shares outstanding 127,713,486 92,255,416 126,793,342 92,224,382 Net income (loss) per share applicable to common stockholders - basic $ 0.36 $ ( 0.70 ) $ ( 0.19 ) $ ( 1.32 ) Diluted Earnings Per Share Numerator: Net income (loss) $ 46,552 $ ( 64,735 ) $ ( 24,622 ) $ ( 121,359 ) Income (loss) attributable to common stockholders - diluted $ 46,552 $ ( 64,735 ) $ ( 24,622 ) $ ( 121,359 ) Denominator: Weighted-average shares outstanding 127,713,486 92,255,416 126,793,342 92,224,382 Dilutive impact from: Stock options to purchase common stock 1,597,058 — — — Unvested restricted stock units 519,338 — — — Shares issuable under employee stock purchase plan 15,049 — — — Weighted-average shares outstanding - diluted 129,844,931 92,255,416 126,793,342 92,224,382 Net income (loss) per share applicable to common stockholders - diluted $ 0.36 $ ( 0.70 ) $ ( 0.19 ) $ ( 1.32 ) Anti-dilutive potential common stock equivalents excluded from the calculation of net income (loss) per share: Stock options to purchase common stock 11,946,170 14,987,043 16,755,599 14,987,043 Unvested restricted stock units 879,557 1,578,621 3,938,868 1,578,621 Shares issuable under employee stock purchase plan — 250,002 193,454 250,002 Warrants to purchase common stock 1,177,433 — 1,177,433 — The effect of dilutive securities was calculated using the treasury stock method. The anti-dilutive potential common stock equivalents for the three months ended June 30, 2023 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. For that same period, the warrants to purchase common stock were excluded because the exercise price of the Tranche A Warrants is greater than the average fair value of the Company's common shares, and the necessary conditions for exercise of the Tranche B and Tranche C Warrants had not been met. The anti-dilutive potential common stock equivalents for the six months ended June 30, 2023 and the three and six months ended June 30, 2022 were excluded from the computation of diluted net loss per share attributable to common stockholders because those stock options to purchase common stock, restricted stock units, and shares issuable under employee stock purchase plan had an anti-dilutive impact as the Company reported a net loss attributable to common stockholders for those periods. |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 6 Months Ended |
Jun. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue from Contracts with Customers | 12. Revenue from Contracts with Customers License Agreement with NHSc Rx License GmbH (Nestlé) Summary of Agreement In July 2021, the Company entered into the 2021 License Agreement with NHSc Pharma Partners, succeeded by NHSc Rx License GmbH (together with Société des Produits Nestlé S.A., their affiliates, and their subsidiaries, “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 VOWST, previously 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) VOWST 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 was responsible for completing development of the first 2021 Collaboration Product, which is VOWST, in the 2021 Field in the United States until first regulatory approval, which was obtained on April 26, 2023. Nestlé has the sole right to commercialize the 2021 Collaboration Products 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 is responsible for the manufacturing and supply for commercialization under a supply agreement that has been executed between the parties. Both parties performed pre-launch activities of VOWST prior to the first commercial sale in the United States, which occurred in June 2023. The Company was responsible for funding the pre-launch activities until first commercial sale of VOWST in the 2021 Licensed Territory and in accordance with a pre-launch plan, up to a specified cap. The Company is entitled to share equally in the commercial profits and losses of VOWST. In connection with the 2021 License Agreement, the Company received an upfront payment of $ 175,000 , and the Company received an additional $ 125,000 milestone payment in May 2023 after FDA approval of VOWST. The Company is eligible to receive additional payments of up to $ 235,000 if certain regulatory and sales milestones are achieved. The potential future milestone payments include up to $ 10,000 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 with twelve months’ prior written notice, effective only on or after the third anniversary of first commercial sale of VOWST in the 2021 Licensed Territory. 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) (see Note 13 , Collaboration Profit and Loss), and has elements that are within the scope of ASC 606 - Revenue From Contracts with Customers (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 VOWST 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 VOWST 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 VOWST and the services to obtain regulatory approval of VOWST 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 VOWST 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 VOWST were not complex or specialized, could be performed by another qualified third party, were not expected to significantly modify or customize the license given that VOWST was late-stage intellectual property that completed clinical development and the services were 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 up-front payment of $ 175,000 compensated the Company for: (i) the co-exclusive license for VOWST 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 VOWST in the United States and (iii) pre-launch activities performed by Nestlé and the Company until the first commercial sale of VOWST 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 VOWST 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 (see Note 13 , Collaboration Profit and Loss) . The Topic 606 transaction price of $ 139,500 was allocated to the co-exclusive license for VOWST and the services performed in accordance with the development and regulatory activity plan to obtain regulatory approval of VOWST in the United States based on the Company’s SSP. The Company recognized 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 of $ 8,157 was allocated to the services performance obligation and was recognized over time as the Company performed the services, which it completed in April 2023. During the three and six months ended June 30, 2023 and 2022 the Company recognized $ 853 , $ 1,975 , $ 1,413 , and $ 2,181 of collaboration revenue - related party, respectively, related to the services performance obligation under the 2021 License Agreement. The Company determined that any variable consideration related to the remaining 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 Company recognized the $ 125,000 regulatory milestone payment received in May 2023, which was fully allocated to the license performance obligation, as revenue in the consolidated statements of operations and comprehensive income (loss) during the three and six months ended June 30, 2023. 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 Nestec Ltd., succeeded by Société des Produits Nestlé S.A. (together with NHSc Rx License GmbH, their affiliates and their subsidiaries, “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 or commercialized, as applicable, for the treatment of CDI and IBD, including VOWST, 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 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 Topic 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 VOWST, then 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, 2023, 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, 2023 and 2022, using the cost-to-cost method, which best depicts the transfer of control to the customer, the Company recognized $ 620 , ($ 1,024 ) , ($ 197 ) , and $ 528 of collaboration revenue – related party, respectively. As of June 30, 2023 and December 31, 2022, there was $ 95,738 and $ 96,689 , respectively, of deferred revenue related to the unsatisfied portion of the performance obligations under the Nestlé agreements. As of June 30, 2023 and December 31, 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. Contract Balances from Contracts with Customers The following table presents changes in the Company’s contract liabilities during the six months ended June 30, 2023 and 2022 (in thousands): Balance as of December 31, 2022 Additions Deductions Balance as of June 30, 2023 Six Months Ended June 30, 2023 Contract liabilities: Deferred revenue - related party $ 96,689 1,644 ( 2,595 ) $ 95,738 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 During the three and six months ended June 30, 2023 and 2022 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 2023 2022 2023 2022 Revenue recognized in the period from: Amounts included in the contract liability at the beginning of the period $ 1,473 $ 1,216 $ 951 $ 2,709 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. During the three months ended March 31, 2023, the Company’ s estimate of total costs expected to be incurred increased, resulting in a reversal of revenue based on its cost-to-cost methodology. |
Collaboration Profit and Loss
Collaboration Profit and Loss | 6 Months Ended |
Jun. 30, 2023 | |
Nestle Health Science [Member] | |
Business Combinations [Abstract] | |
Collaboration profit and loss | 13. Collaboration Profit and Loss License Agreement with NHSc Rx License GmbH (Nestlé) Accounting Analysis The 2021 License Agreement represents a separate contract between Nestlé and the Company. The 2021 License Agreement is within the scope of Topic 808 , and has elements that are within the scope of Topic 606 (see Note 12 , Revenue from Contracts with Customers) and Topic 808. 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 performance obligations under Topic 606. The Company and Nestlé were both active participants in the pre-launch activities and commercialization activities and were exposed to significant risks and rewards that were dependent on the commercial success of the activities in the arrangement. The amount allocated to the Topic 808 unit of accounting relates to the pre-launch activities performed prior to the first commercial sale of VOWST and was determined to be $ 35,500 based on standalone selling price. The Company recorded the $ 35,500 in total liabilities on its consolidated balance sheets at the inception of the arrangement. On a quarterly basis, the Company and Nestlé provided financial information about the pre-launch activities performed by both parties. The Company reduced the $ 35,500 liability as the pre-launch activities were performed and it made payments to Nestl é for the pre-launch costs Nestlé incurred. As of June 30, 2023 and December 31, 2022, there was $ 31,372 and $ 34,770 , respectively, included in accrued expenses and other current liabilities which includes Nestlé incurred costs not yet reimbursed. The cost associated with pre-launch activities performed by the Company is recorded within total operating expenses in the Company’s condensed consolidated statements of operations and comprehensive income (loss). In the three and six months ended June 30, 2023 and 2022, the Company recognized $ 645 , $ 1,446 , $ 1,538 and $ 3,173 respectively, in research and development expenses and $ 1,539 , $ 4,242 , $ 2,176 and $ 4,614 respectively, in general and administrative expenses associated with pre-launch activities performed. The pre-launch activities were completed prior to the first commercial sale of VOWST, which occurred in June 2023. Under the 2021 License Agreement with Nestlé, beginning with the first commercial sale of VOWST, which occurred in June 2023, net sales of VOWST are recorded by Nestlé and include gross sales net of discounts, rebates, allowances, and other applicable deductions. These amounts include the use of estimates and judgments, which could be adjusted based on actual results in the future. The Company records its share of the profits or losses from the sales of VOWST, including commercial and medical affairs expenses incurred by the Company, on a net basis, as collaboration (profit) loss sharing - related party. This treatment is in accordance with the Company’s revenue recognition and collaboration policy, given that Nestlé and the Company are both active participants in commercialization activities and are exposed to significant risks and rewards that are dependent on the commercial success of the activities in the 2021 License Agreement. Nestlé provides the Company with reporting related to net sales of VOWST in accordance with U.S. generally accepted accounting principles in order to calculate and record collaboration profit or loss. The collaboration (profit) loss sharing - related party line item also includes the Company's profit on the transfer of VOWST inventory to Nestlé, which represents the excess of the supply price paid by Nestlé over the Company's cost to manufacture VOWST, subject to a supply price cap applicable to product manufactured prior to commercial launch. The collaboration (profit) loss sharing - related party line item also includes the Company's 50 % share of the loss related to pre-launch activities, which were completed prior to the first commercial sale of VOWST. The components of the collaboration profit (loss) sharing for the three and six months ended June 30, 2023 are as follows: Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Share of VOWST net loss $ 2,141 $ — $ 2,141 $ — Profit on transfer of VOWST inventory to Nestlé ( 1,273 ) — $ ( 1,273 ) — Collaboration (profit)/loss related to pre-launch activities 1,238 271 4,845 ( 705 ) Total collaboration (profit) loss sharing - related party $ 2,106 $ 271 $ 5,713 $ ( 705 ) |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 14. Commitments and Contingencies Leases Refer to Note 8, 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 consolidated financial statements as of June 30, 2023 or December 31, 2022. 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 consolidated financial statements as of June 30, 2023 or December 31, 2022 . |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 15. Income taxes The Company did no t provide for any income taxes in its condensed consolidated statement of operations and comprehensive income (loss) for the three and six months ended June 30, 2023 and 2022. While the Company has net income for the three months ended June 30, 2023, the Company is projecting book and tax losses for the twelve months ended December 31, 2023, for which it is more likely than not that the Company will not realize a benefit as the Company has recorded a full valuation allowance against its deferred tax assets. Therefore, the Company has not recorded any income taxes for the three and six months ended June 30, 2023. 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 early stage of commercialization of VOWST 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, 2023 and December 31, 2022 . Management reevaluates the positive and negative evidence at each reporting period. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 16. Related Party Transactions As described in Notes 12 and 13, in July 2021, the Company entered into the 2021 License Agreement with NHSc Pharma Partners, succeeded by NHSc Rx License GmbH (together with Société des Produits Nestlé S.A., their affiliates, and their subsidiaries, “Nestlé”). NHSc Rx License GmbH 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, 2023 and 2022 , the Company recognized $ 125,853 , $ 126,975 , $ 1,413 , and $ 2,181 , respectively, of related party revenue associated with the 2021 License Agreement. As of June 30, 2023 and December 31, 2022, there was $ 0 and $ 1,976 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, 2023 and December 31, 2022, there was $ 31,372 and $ 34,770 included in accrued expenses related to the 2021 License Agreement, which represents amounts due to Nestlé pursuant to the 2021 License Agreement. As of June 30, 2023 and December 31, 2022 there was $ 2,817 and $ 0 of deferred income - related party included on the accompanying condensed consolidated balance sheets, which represents the inventory transferred to Nestlé that Nestlé has not yet sold through to customers or transferred as free goods. The Company recognizes deferred income - related party as collaboration profit upon Nestlé's sale or transfer of such inventory to third parties. During the three and six months ended June 30, 2023 , the Company paid Nestlé $ 0 and $ 13,419 , respectively, for Nestlé ’ s share of the collaboration expenses pursuant to the 2021 License Agreement. The Company made no payments to Nestlé during the three and six months ended June 30, 2022. As of June 30, 2023 , there is $ 7,559 in Collaboration receivable - related party due from Nestlé pursuant to the 2021 License Agreement. There is no amount due from Nestlé pursuant to the 2021 License Agreement as of December 31, 2022. As described in Note 12, Revenue from Contracts with Customers , in January 2016, the Company entered into the 2016 License Agreement with Nestec, Ltd, succeeded by Société des Produits Nestlé S.A. 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, 2023 and 2022, the Company recognized $ 620 , ($ 1,024 ) , ($ 197 ) , and $ 528 , respectively, of related party revenue associated with the 2016 License Agreement. As of June 30, 2023 and December 31, 2022, there was $ 95,738 and $ 94,713 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, 2023 . There is no amount due from Nestlé pursuant to the 2016 License Agreement as of June 30, 2023 or December 31, 2022. In July 2022, the Company entered into a Pledge and Utilization Agreement with Flagship Pioneering Labs TPC, Inc., an affiliate of Flagship Pioneering, one of its significant stockholders, for an option to lease certain manufacturing space. The Company paid $ 833 for this option which is classified in other non-current assets on the Company ’ s condensed consolidated balance sheet as of December 31, 2022. In June 2023, the Company elected not to renew the option and accordingly at such time, expensed the $ 833 option payment. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Inventories | Inventories Inventories are stated at the lower of cost or estimated net realizable value with cost based on the first-in first-out method. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in clinical trials. Prior to the regulatory approval of its product candidates, the Company incurs expenses for the manufacture of drug product supplies to support clinical development that could potentially be available to support the commercial launch of those drugs. Until the date at which regulatory approval has been received or is otherwise considered probable, the Company records all such costs as research and development expenses. |
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 unaudited condensed consolidated financial statements and the reported amounts of revenue and expenses during the reporting periods. In the unaudited 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. Actual results could differ from those estimates. |
Restricted Cash | Restricted Cash The Company held restricted cash of $ 8,185 as of June 30, 2023 and December 31, 2022, which represents cash held for the benefit of the landlords for certain of the Company’s leases. The Company has classified the restricted cash as long-term on its condensed consolidated balance sheets as the terms of the underlying leases are greater than one year. Cash, cash equivalents and restricted cash were comprised of the following (in thousands): June 30, December 31, 2023 2022 Cash and cash equivalents $ 229,520 $ 163,030 Restricted cash, non-current 8,185 8,185 Total cash, cash equivalents and restricted cash $ 237,705 $ 171,215 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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, 2023 2022 Cash and cash equivalents $ 229,520 $ 163,030 Restricted cash, non-current 8,185 8,185 Total cash, cash equivalents and restricted cash $ 237,705 $ 171,215 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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, 2023 Using: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 20,620 $ — $ — $ 20,620 Total assets $ 20,620 $ — $ — $ 20,620 Warrant liabilities $ — $ — $ 1,968 $ 1,968 Total liabilities $ — $ — $ 1,968 $ 1,968 Fair Value Measurements as of December 31, 2022 Using: Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 47,863 $ — $ — $ 47,863 Commercial paper — 11,691 — 11,691 Government securities — 4,966 — 4,966 Investments: Commercial paper $ — $ 2,465 $ — $ 2,465 Corporate bonds — 2,957 — 2,957 Government securities — 12,889 — 12,889 $ 47,863 $ 34,968 $ — $ 82,831 |
Schedule Of Level 3 Inputs to Warrant Liabilities | On the Closing Date (as defined in Note 9, Notes Payable ) and as of June 30, 2023, the Level 3 inputs to the warrant liabilities are as follows: Closing Date June 30, 2023 Volatility 83.0 % 82.0 % Term (in years) 1.7 1.5 |
Schedule of Reconciliation Company's Liabilities Measured at Fair Value on Recurring Basis | A reconciliation of the beginning and ending balances for the three and six months ended June 30, 2023 for liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands): Warrant Liabilities Balance as of December 31, 2022 $ — Issuance of warrants 2,100 Adjustment to fair value ( 132 ) Balance as of June 30, 2023 1,968 |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Investments by Security Type | Investments by security type consisted of the following at December 31, 2022 (in thousands): December 31, 2022 Amortized Gross Gross Fair Investments: Commercial paper $ 2,465 $ — $ — $ 2,465 Corporate bonds 2,958 — ( 1 ) 2,957 Government securities 12,898 3 ( 12 ) 12,889 $ 18,321 $ 3 $ ( 13 ) $ 18,311 |
Inventories (Table)
Inventories (Table) | 6 Months Ended |
Jun. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Capitalized Inventories | Capitalized inventories consist of the following at June 30, 2023 (in thousands): June 30, 2023 Raw materials $ 547 Work in process 4,750 Finished goods 43 Total $ 5,340 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consisted of the following (in thousands): June 30, 2023 December 31, 2022 Laboratory equipment $ 28,053 $ 24,533 Computer equipment 4,134 3,557 Furniture and office equipment 4,911 3,491 Leasehold improvements 32,963 32,474 Construction in progress 1,932 3,970 71,993 68,025 Less: Accumulated depreciation and amortization ( 47,967 ) ( 45,040 ) $ 24,026 $ 22,985 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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, 2023 December 31, 2022 Clinical and development costs $ 2,157 $ 6,717 Manufacturing and quality costs 2,707 — Payroll and payroll-related costs 11,688 14,709 Collaboration payable - related party (Note 16) 31,372 34,770 Facility and other 7,954 3,644 $ 55,878 $ 59,840 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Leases [Abstract] | |
Summary of Operating Lease Assets and Liabilities | The following table summarizes the presentation in the Company’s condensed consolidated balance sheets of its operating leases (in thousands): June 30, 2023 December 31, 2022 Assets: Operating lease assets $ 110,283 $ 110,984 Liabilities: Operating lease liabilities $ 5,470 $ 3,601 Operating lease liabilities, net of current portion 106,706 107,942 Total operating lease liabilities $ 112,176 $ 111,543 |
Summary of Lease Costs | Three Months Ended Six Months Ended 2023 2022 2023 2022 Operating lease costs $ 5,543 $ 1,948 $ 10,953 $ 3,620 Short-term lease costs 372 354 740 709 Variable lease costs 2,180 1,271 3,943 2,302 Total lease costs $ 8,095 $ 3,573 $ 15,636 $ 6,631 |
Schedule of Future Payments of Operating Lease Liabilities | As of June 30, 2023, future payments of operating lease liabilities are as follows (in thousands): As of 2023 (remaining 6 months) $ 8,600 2024 $ 19,437 2025 $ 21,555 2026 $ 22,155 2027 and thereafter $ 111,164 Total future minimum lease payments $ 182,911 Less: interest ( 70,735 ) Present value of operating lease liabilities $ 112,176 |
Notes Payables (Tables)
Notes Payables (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Summary of Future Principal Payments Due Under the Oaktree Credit Arrangement, Excluding Interest and End of Term Charge | The future principal payments due under the Oaktree Credit Agreement, excluding interest and the end of term charge, are as follows: Year Ending December 31, Principal 2023 (remaining 6 months) $ — 2024 — 2025 — 2026 24,750 2027 33,000 Thereafter 52,250 Total $ 110,000 |
Common Stock and Stock-Based _2
Common Stock and Stock-Based Awards (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Summary of Stock Option Activity | The following table summarizes the Company’s stock option activity since December 31, 2022: Number Weighted Weighted Aggregate (in years) Outstanding as of December 31, 2022 14,940,034 $ 10.03 7.25 $ 11,608 Granted 2,430,545 $ 5.49 Exercised ( 105,592 ) $ 3.37 Forfeited ( 509,388 ) $ 9.39 Outstanding as of June 30, 2023 16,755,599 $ 9.43 6.90 $ 6,828 Options exercisable as of June 30, 2023 9,772,084 $ 9.94 5.64 $ 5,882 |
Summary of Restricted Stock Unit Activity | The following table summarizes the Company’s restricted stock unit activity since December 31, 2022: Number Weighted Unvested restricted stock units as of December 31, 2022 1,549,540 $ 9.37 Granted 3,043,510 $ 5.50 Vested ( 436,652 ) $ 9.69 Forfeited ( 217,530 ) $ 8.94 Unvested restricted stock units as of June 30, 2023 3,938,868 $ 6.36 |
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 income (loss) (in thousands): Three Months Ended June 30, Six Months Ended 2023 2022 2023 2022 Research and development expenses $ 7,851 $ 3,430 $ 11,582 $ 6,026 General and administrative expenses 5,641 3,318 8,760 5,801 $ 13,492 $ 6,748 $ 20,342 $ 11,827 |
Net Income (Loss) per Share (Ta
Net Income (Loss) per Share (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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 June 30, Six Months Ended June 30, 2023 2022 2023 2022 Basic Earnings Per Share: Numerator: Net income (loss) $ 46,552 $ ( 64,735 ) $ ( 24,622 ) $ ( 121,359 ) Income (loss) attributable to common stockholders - basic $ 46,552 $ ( 64,735 ) $ ( 24,622 ) $ ( 121,359 ) Denominator: Weighted-average shares outstanding 127,713,486 92,255,416 126,793,342 92,224,382 Net income (loss) per share applicable to common stockholders - basic $ 0.36 $ ( 0.70 ) $ ( 0.19 ) $ ( 1.32 ) Diluted Earnings Per Share Numerator: Net income (loss) $ 46,552 $ ( 64,735 ) $ ( 24,622 ) $ ( 121,359 ) Income (loss) attributable to common stockholders - diluted $ 46,552 $ ( 64,735 ) $ ( 24,622 ) $ ( 121,359 ) Denominator: Weighted-average shares outstanding 127,713,486 92,255,416 126,793,342 92,224,382 Dilutive impact from: Stock options to purchase common stock 1,597,058 — — — Unvested restricted stock units 519,338 — — — Shares issuable under employee stock purchase plan 15,049 — — — Weighted-average shares outstanding - diluted 129,844,931 92,255,416 126,793,342 92,224,382 Net income (loss) per share applicable to common stockholders - diluted $ 0.36 $ ( 0.70 ) $ ( 0.19 ) $ ( 1.32 ) Anti-dilutive potential common stock equivalents excluded from the calculation of net income (loss) per share: Stock options to purchase common stock 11,946,170 14,987,043 16,755,599 14,987,043 Unvested restricted stock units 879,557 1,578,621 3,938,868 1,578,621 Shares issuable under employee stock purchase plan — 250,002 193,454 250,002 Warrants to purchase common stock 1,177,433 — 1,177,433 — |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
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, 2023 and 2022 (in thousands): Balance as of December 31, 2022 Additions Deductions Balance as of June 30, 2023 Six Months Ended June 30, 2023 Contract liabilities: Deferred revenue - related party $ 96,689 1,644 ( 2,595 ) $ 95,738 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 During the three and six months ended June 30, 2023 and 2022 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 2023 2022 2023 2022 Revenue recognized in the period from: Amounts included in the contract liability at the beginning of the period $ 1,473 $ 1,216 $ 951 $ 2,709 |
Collaboration Profit and Loss (
Collaboration Profit and Loss (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Business Combinations [Abstract] | |
Schedule of Collaboration Profit (Loss) | The components of the collaboration profit (loss) sharing for the three and six months ended June 30, 2023 are as follows: Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Share of VOWST net loss $ 2,141 $ — $ 2,141 $ — Profit on transfer of VOWST inventory to Nestlé ( 1,273 ) — $ ( 1,273 ) — Collaboration (profit)/loss related to pre-launch activities 1,238 271 4,845 ( 705 ) Total collaboration (profit) loss sharing - related party $ 2,106 $ 271 $ 5,713 $ ( 705 ) |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
May 31, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Nature Of Business And Basis Of Presentation [Line Items] | ||||||||
Entity incorporated month and year | 2010-10 | |||||||
Entity incorporation, state or country code | DE | |||||||
Accumulated deficit | $ 889,133,000 | $ 889,133,000 | $ 864,511,000 | |||||
Cash and cash equivalents | 229,520,000 | 229,520,000 | $ 163,030,000 | |||||
Net operating cash outflows | (10,600,000) | $ (116,342,000) | ||||||
Net Income (Loss) | 46,552,000 | $ (71,174,000) | $ (64,735,000) | $ (56,624,000) | (24,622,000) | $ (121,359,000) | ||
Twenty Twenty One License Agreement [Member] | ||||||||
Nature Of Business And Basis Of Presentation [Line Items] | ||||||||
Milestones payments received | $ 125,000,000 | $ 125,000,000 | $ 125,000,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Restricted cash | $ 8,185 | $ 8,185 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 | Jun. 30, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 229,520 | $ 163,030 | ||
Restricted cash, non-current | 8,185 | 8,185 | ||
Total cash, cash equivalents and restricted cash | $ 237,705 | $ 171,215 | $ 135,009 | $ 188,002 |
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, 2023 | Dec. 31, 2022 |
Investments: | ||
Investments | $ 18,311 | |
Fair Value, Measurements, Recurring [Member] | ||
Equity, Fair Value Disclosure [Abstract] | ||
Total liabilities | $ 1,968 | |
Investments: | ||
Investments | 20,620 | 82,831 |
Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Cash equivalents: | ||
Cash equivalents | 20,620 | 47,863 |
Commercial Paper [Member] | ||
Investments: | ||
Investments | 2,465 | |
Commercial Paper [Member] | Fair Value, Measurements, Recurring [Member] | ||
Cash equivalents: | ||
Cash equivalents | 11,691 | |
Investments: | ||
Investments | 2,465 | |
Corporate Bonds [Member] | ||
Investments: | ||
Investments | 2,957 | |
Corporate Bonds [Member] | Fair Value, Measurements, Recurring [Member] | ||
Investments: | ||
Investments | 2,957 | |
Government Securities [Member] | ||
Investments: | ||
Investments | 12,889 | |
Government Securities [Member] | Fair Value, Measurements, Recurring [Member] | ||
Cash equivalents: | ||
Cash equivalents | 4,966 | |
Investments: | ||
Investments | 12,889 | |
Level 1 [Member] | Fair Value, Measurements, Recurring [Member] | ||
Equity, Fair Value Disclosure [Abstract] | ||
Total liabilities | 0 | |
Investments: | ||
Investments | 20,620 | 47,863 |
Level 1 [Member] | Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Cash equivalents: | ||
Cash equivalents | 20,620 | 47,863 |
Level 2 [Member] | Fair Value, Measurements, Recurring [Member] | ||
Investments: | ||
Investments | 34,968 | |
Level 2 [Member] | Commercial Paper [Member] | Fair Value, Measurements, Recurring [Member] | ||
Cash equivalents: | ||
Cash equivalents | 11,691 | |
Investments: | ||
Investments | 2,465 | |
Level 2 [Member] | Corporate Bonds [Member] | Fair Value, Measurements, Recurring [Member] | ||
Investments: | ||
Investments | 2,957 | |
Level 2 [Member] | Government Securities [Member] | Fair Value, Measurements, Recurring [Member] | ||
Cash equivalents: | ||
Cash equivalents | 4,966 | |
Investments: | ||
Investments | $ 12,889 | |
Level 3 [Member] | Fair Value, Measurements, Recurring [Member] | ||
Equity, Fair Value Disclosure [Abstract] | ||
Total liabilities | $ 1,968 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 | Jun. 30, 2022 |
Fair Value Disclosures [Abstract] | |||
Assets measured at fair value | $ 0 | ||
Liabilities measured at fair value | 0 | ||
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 | |
Fair value, assets transfers from Level 1 to Level 3 measurement | 0 | 0 | |
Fair value, assets transfers from Level 2 to Level 3 measurement | 0 | 0 | |
Fair value, assets transfers from Level 3 to Level 1 measurement | 0 | 0 | |
Fair value, assets transfers from Level 3 to Level 2 measurement | 0 | $ 0 | |
Restricted investments | $ 1,401 | $ 1,401 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Reconciliation Company's Liabilities Measured at Fair Value on Recurring Basis (Detail) - Warrant [Member] $ in Thousands | 6 Months Ended |
Jun. 30, 2023 USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Balance as of December 31, 2022 | $ 0 |
Issuance of warrants | 2,100 |
Adjustment to fair value | (132) |
Balance as of June 30, 2023 | $ 1,968 |
Investments - Schedule of Inves
Investments - Schedule of Investments by Security Type (Detail) $ in Thousands | Dec. 31, 2022 USD ($) |
Schedule of Available-for-sale Securities [Line Items] | |
Amortized Cost | $ 18,321 |
Gross Unrealized Gain | 3 |
Gross Unrealized Loss | (13) |
Fair Value | 18,311 |
Commercial Paper [Member] | |
Schedule of Available-for-sale Securities [Line Items] | |
Amortized Cost | 2,465 |
Gross Unrealized Gain | 0 |
Gross Unrealized Loss | 0 |
Fair Value | 2,465 |
Corporate Bonds [Member] | |
Schedule of Available-for-sale Securities [Line Items] | |
Amortized Cost | 2,958 |
Gross Unrealized Gain | 0 |
Gross Unrealized Loss | (1) |
Fair Value | 2,957 |
Government Securities [Member] | |
Schedule of Available-for-sale Securities [Line Items] | |
Amortized Cost | 12,898 |
Gross Unrealized Gain | 3 |
Gross Unrealized Loss | (12) |
Fair Value | $ 12,889 |
Investments - Additional Inform
Investments - Additional Information (Detail) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
Investments [Abstract] | ||
Maximum maturity days for cash equivalents | 90 days | 90 days |
Restricted investments | $ 1,401 | $ 1,401 |
Inventories - Schedule of Capit
Inventories - Schedule of Capitalized Inventories (Detail) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 547 | |
Work in process | 4,750 | |
Finished goods | 43 | |
Total | $ 5,340 | $ 0 |
Inventories - Additional Inform
Inventories - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2023 | Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |||
Inventories | $ 5,340 | $ 5,340 | $ 0 |
Pre-launch inventory research and development expense | 11,181 | 26,794 | |
Inventory Write-down | $ 0 | $ 0 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 71,993 | $ 68,025 |
Less: Accumulated depreciation and amortization | (47,967) | (45,040) |
Property and equipment, net | 24,026 | 22,985 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 28,053 | 24,533 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 4,134 | 3,557 |
Furniture and Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 4,911 | 3,491 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 32,963 | 32,474 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,932 | $ 3,970 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation and amortization expense | $ 1,527 | $ 1,685 | $ 2,927 | $ 3,255 |
Disposal of fully depreciated assets cost basis | $ 9 |
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, 2023 | Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |||
Clinical and development costs | $ 2,157 | $ 6,717 | |
Manufacturing and quality costs | 2,707 | ||
Payroll and payroll-related costs | 11,688 | 14,709 | |
Collaboration payable - related party (Note 16) | 31,372 | 34,770 | |
Facility and other | 7,954 | 3,644 | |
Total accrued expenses and other current liabilities | [1] | $ 55,878 | $ 59,840 |
[1] Includes related party amounts of $ 31,372 and $ 34,770 at June 30, 2023 and December 31, 2022, respectively (see Note 16) |
Accrued Expenses and Other Cu_4
Accrued Expenses and Other Current Liabilities - Additional Information (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Accounts payable | $ 12,922 | $ 17,440 |
VOWST Member | ||
Accounts payable | $ 3,850 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2023 | Apr. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Apr. 01, 2022 | |
Operating Leased Assets [Line Items] | ||||||||
Existence of option to extend | true | |||||||
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 approximately one year to five years. | |||||||
Lease renewal term (in years) | 5 years | |||||||
Lease term | 10 years | |||||||
Right-of-use asset | $ 110,283 | $ 110,283 | $ 110,283 | $ 110,984 | ||||
Present value of operating lease liabilities | $ 112,176 | 112,176 | 112,176 | $ 111,543 | ||||
Leases Payments | $ 3,875 | $ 1,332 | $ 7,289 | $ 3,445 | ||||
Weighted average remaining lease term | 8 years 5 months 19 days | 8 years 5 months 19 days | 4 years 9 months | 8 years 5 months 19 days | 4 years 9 months | |||
Weighted average incremental borrowing rate | 13% | 13% | 10% | 13% | 10% | |||
Spring House, PA [Member] | ||||||||
Operating Leased Assets [Line Items] | ||||||||
Right-of-use asset | $ 3,546 | |||||||
Tenant improvement allowance | $ 1,223 | |||||||
Present value of operating lease liabilities | 1,210 | |||||||
Leasehold Improvements | $ 2,336 | |||||||
Irvine, CA [Member] | ||||||||
Operating Leased Assets [Line Items] | ||||||||
Lease renewal term (in years) | 5 years | 5 years | 5 years | |||||
Lease term | 7 years | 7 years | 7 years | |||||
Right-of-use asset | $ 0 | $ 0 | $ 0 | |||||
Present value of operating lease liabilities | ||||||||
Maximum [Member] | ||||||||
Operating Leased Assets [Line Items] | ||||||||
Operating lease, remaining term | 10 years | |||||||
Lease renewal term (in years) | 5 years | 5 years | 5 years | |||||
Minimum [Member] | ||||||||
Operating Leased Assets [Line Items] | ||||||||
Operating lease, remaining term | 2 years | |||||||
Lease renewal term (in years) | 1 year | 1 year | 1 year | |||||
Minimum [Member] | Spring House, PA [Member] | ||||||||
Operating Leased Assets [Line Items] | ||||||||
Leases Payments | $ 2,991 | |||||||
Minimum [Member] | Irvine, CA [Member] | ||||||||
Operating Leased Assets [Line Items] | ||||||||
Leases Payments | $ 1,084 |
Leases - Summary of Operating L
Leases - Summary of Operating Lease Assets and Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Assets: | ||
Operating lease assets | $ 110,283 | $ 110,984 |
Liabilities: | ||
Operating lease liabilities | 5,470 | 3,601 |
Operating lease liabilities, net of current portion | 106,706 | 107,942 |
Total operating lease liabilities | $ 112,176 | $ 111,543 |
Leases - Summary of Lease Costs
Leases - Summary of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Leases [Abstract] | ||||
Operating lease costs | $ 5,543 | $ 1,948 | $ 10,953 | $ 3,620 |
Short-term lease costs | 372 | 354 | 740 | 709 |
Variable lease costs | 2,180 | 1,271 | 3,943 | 2,302 |
Total lease costs | $ 8,095 | $ 3,573 | $ 15,636 | $ 6,631 |
Leases - Schedule of Future Pay
Leases - Schedule of Future Payments of Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
2023 (remaining 6 months) | $ 8,600 | |
2024 | 19,437 | |
2025 | 21,555 | |
2026 | 22,155 | |
2027 and thereafter | 111,164 | |
Total future minimum lease payments | 182,911 | |
Less: interest | (70,735) | |
Present value of operating lease liabilities | $ 112,176 | $ 111,543 |
Notes Payables - Additional Inf
Notes Payables - Additional Information (Detail) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | |||||||
Jun. 30, 2026 | Apr. 27, 2023 USD ($) TradingDays $ / shares shares | Feb. 24, 2022 USD ($) | Oct. 29, 2019 USD ($) | Jun. 30, 2023 USD ($) $ / shares | Jun. 30, 2022 USD ($) $ / shares | Jun. 30, 2023 USD ($) $ / shares | Jun. 30, 2022 USD ($) $ / shares | Dec. 31, 2022 USD ($) | |
Debt Instrument [Line Items] | |||||||||
Net proceeds received from credit facility | $ 50,446 | ||||||||
Loss on extinguishment | $ (1,625) | $ 0 | |||||||
Trading days prior to the funding date | TradingDays | 30 | ||||||||
Adjustments To Additional Paid In Capital, Warrant Issued | $ 2,785 | ||||||||
Fair market value per share of common stock | $ / shares | $ 4.54 | $ 3.5 | $ 4.56 | $ 5.6 | |||||
Interest expense | $ 3,187 | $ 1,501 | $ 5,135 | $ 2,413 | |||||
Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility, interest rate | 7.875% | ||||||||
Percentage of prepayment amount after the first year | 4% | ||||||||
Percentage of prepayment amount after the second year | 4% | ||||||||
Percentage of prepayment amount after the third year | 2% | ||||||||
Percentage of prepayment amount after the fourth year | 1% | ||||||||
Line of credit facility exit fee percentage | 1.50% | ||||||||
Second Amendment to Loan and Security Agreement [Member] | Hercules Credit Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Repayments of Debt | $ 2,900 | ||||||||
Additional advance prepayment or repayment percentage | 1.75% | ||||||||
Loan and Security Agreement [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Interest expense | 520 | $ 1,501 | $ 2,468 | $ 2,413 | |||||
Loan and Security Agreement [Member] | Original Credit Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Prepayment or repayment percentage | 4.85% | ||||||||
Loan and Security Agreement [Member] | Hercules Credit Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility, interest rate | 9.65% | ||||||||
Carrying value of debt | $ 51,047 | ||||||||
Loan and Security Agreement [Member] | Hercules Credit Facility [Member] | Prime Rate [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, variable rate | 6.40% | ||||||||
Hercules Lenders [Member] | Second Amendment to Loan and Security Agreement [Member] | Hercules Credit Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility, aggregate principal amount | $ 100,000 | ||||||||
Oaktree Credit Agreement [Member] | Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Interest expense | $ 2,518 | $ 2,518 | |||||||
Oaktree Credit Agreement [Member] | Loan and Security Agreement [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument interest rate | 15.90% | 15.90% | |||||||
Oaktree Credit Agreement [Member] | Loan and Security Agreement [Member] | Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Carrying value of debt | $ 100,742 | $ 100,742 | |||||||
Oaktree Fund Administration, LLC [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Additional default interest rate | 2% | ||||||||
Oaktree Fund Administration, LLC [Member] | Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility, aggregate principal amount | $ 250,000 | ||||||||
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] | Hercules Lenders [Member] | Second Amendment to Loan and Security Agreement [Member] | Hercules Credit Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility, aggregate principal amount | 25,000 | ||||||||
Tranche A Loan [Member] | Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Loss on extinguishment | (1,625) | ||||||||
Tranche A Loan [Member] | Oaktree Fund Administration, LLC [Member] | Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility, aggregate principal amount | 110,000 | ||||||||
Tranche A Loan [Member] | Hercules Capital, Inc. [Member] | Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Repayments of existing credit facility | 53,380 | ||||||||
Tranche B Loan [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Net sales target | $ 35,000 | ||||||||
Percentage increase in net sales rate | 4.50% | ||||||||
Tranche B Loan [Member] | Oaktree Fund Administration, LLC [Member] | Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility, aggregate principal amount | $ 45,000 | ||||||||
Tranche C Loan [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Net sales target | $ 120,000 | ||||||||
Percentage increase in net sales rate | 4.50% | ||||||||
Tranche C Loan [Member] | Oaktree Fund Administration, LLC [Member] | Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility, aggregate principal amount | $ 45,000 | ||||||||
Tranche D Loan [Mmeber] | Oaktree Fund Administration, LLC [Member] | Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility, aggregate principal amount | 50,000 | ||||||||
First Tranche [Member] | Second Amendment to Loan and Security Agreement [Member] | Hercules 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] | Hercules Lenders [Member] | Second Amendment to Loan and Security Agreement [Member] | Hercules Credit Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility, aggregate principal amount | 25,000 | ||||||||
First Tranche [Member] | Oaktree Fund Administration, LLC [Member] | Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility, aggregate principal amount | 80,000 | ||||||||
Second Tranche Unavailable to Borrow Due to Not Met Milestone Requirements [Member] | Hercules Lenders [Member] | Second Amendment to Loan and Security Agreement [Member] | Hercules 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] | Oaktree Fund Administration, LLC [Member] | Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility, aggregate principal amount | $ 30,000 | ||||||||
Third Tranche Available Upon Approval Until June 30, 2021 [Member] | Hercules Lenders [Member] | Second Amendment to Loan and Security Agreement [Member] | Hercules Credit Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility, aggregate principal amount | $ 12,500 | ||||||||
Interest Rate Floor [Member] | Term Loan Facility [Member] | SOFR [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, variable rate | 2.50% | ||||||||
Interest rate cap [Member] | Term Loan Facility [Member] | SOFR [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, variable rate | 5% | ||||||||
Maximum [Member] | Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility, interest rate | 7.875% | ||||||||
Minimum [Member] | Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Credit facility, interest rate | 7.50% | ||||||||
Minimum [Member] | Oaktree Fund Administration, LLC [Member] | Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Cash | $ 30,000 | ||||||||
Minimum [Member] | Tranche B Loan [Member] | Oaktree Fund Administration, LLC [Member] | Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Cash | 25,000 | ||||||||
Forecast [Member] | Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Percentage of the outstanding principal amount repaid | 7.50% | ||||||||
Tranche A Warrant [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Adjustments To Additional Paid In Capital, Warrant Issued | $ 2,785 | ||||||||
Volatility | 111.60% | ||||||||
Term (in years) | 7 years | ||||||||
Risk free interest rate | 3.57% | ||||||||
Fair value of common stock price per share on the valuation date | $ / shares | $ 5.32 | ||||||||
Warrants exercise price | $ / shares | $ 6.69 | ||||||||
Tranche A Warrant [Member] | Term Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument conversion warrants or options issued | shares | 647,589 | ||||||||
Warrants exercise price | $ / shares | $ 6.69 | ||||||||
Tranche B Warrant [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument conversion warrants or options issued | shares | 264,922 | ||||||||
Derivative liabilities | $ 1,077 | 1,023 | 1,023 | ||||||
Tranche C Warrant [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument conversion warrants or options issued | shares | 264,922 | ||||||||
Derivative liabilities | $ 1,012 | $ 956 | $ 956 |
Notes Payable - Summary of Futu
Notes Payable - Summary of Future Principal Payments Due Under the Oaktree Credit Arrangement, Excluding Interest and End of Term Charge (Detail) $ in Thousands | Jun. 30, 2023 USD ($) |
Debt Disclosure [Abstract] | |
2023 (remaining 6 months) | $ 0 |
2024 | 0 |
2025 | 0 |
2026 | 24,750 |
2027 | 33,000 |
Thereafter | 52,250 |
Total | $ 110,000 |
Common Stock and Stock-Based _3
Common Stock and Stock-Based Awards - Additional Information (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||||
May 21, 2021 USD ($) | Jun. 30, 2023 USD ($) $ / shares shares | Jun. 30, 2022 shares | Jun. 30, 2023 USD ($) $ / shares shares | Jun. 30, 2022 shares | Mar. 29, 2023 shares | Mar. 28, 2023 shares | Dec. 31, 2022 $ / shares shares | |
Subsidiary, Sale of Stock [Line Items] | ||||||||
Common stock, shares issued | 128,037,679 | 128,037,679 | 125,222,273 | |||||
Common stock, shares authorized | 240,000,000 | 240,000,000 | 240,000,000 | 200,000,000 | 200,000,000 | |||
Common stock at a purchase price | $ / shares | $ 0.001 | $ 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] | ||||||||
Gross proceeds from sale of common stock | $ | $ 150,000,000 | |||||||
Common stock, shares issued | 1,218,377 | 0 | 2,005,547 | 0 | ||||
Common stock, average share price | $ / shares | $ 6.4 | $ 6.11 | ||||||
Proceeds from issuance of common stock | $ | $ 7,491 | $ 11,730 | ||||||
Percentage of commission on sale of common stock | 3 | 3 |
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, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | |
Equity [Abstract] | ||
Number of Shares, Beginning Balance | shares | 14,940,034 | |
Number of Shares, Granted | shares | 2,430,545 | |
Number of Shares, Exercised | shares | (105,592) | |
Number of Shares, Forfeited | shares | (509,388) | |
Number of Shares, Ending Balance | shares | 16,755,599 | 14,940,034 |
Number of Shares, Options exercisable | shares | 9,772,084 | |
Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 10.03 | |
Weighted Average Exercise Price, Granted | $ / shares | 5.49 | |
Weighted Average Exercise Price, Exercised | $ / shares | 3.37 | |
Weighted Average Exercise Price, Forfeited | $ / shares | 9.39 | |
Weighted Average Exercise Price, Ending Balance | $ / shares | 9.43 | $ 10.03 |
Weighted Average Exercise Price, Options exercisable | $ / shares | $ 9.94 | |
Weighted Average Remaining Contractual Term, Outstanding | 6 years 10 months 24 days | 7 years 3 months |
Weighted Average Remaining Contractual Term, Options exercisable | 5 years 7 months 20 days | |
Aggregate Intrinsic Value, Outstanding | $ | $ 6,828 | $ 11,608 |
Aggregate Intrinsic Value, Options exercisable | $ | $ 5,882 |
Common Stock and Stock-Based _5
Common Stock and Stock-Based Awards - Stock Options - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Apr. 30, 2024 | Apr. 30, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Weighted average grant-date fair value of stock options | $ 4.54 | $ 3.5 | $ 4.56 | $ 5.6 | |||
Performance-based stock options to granted | 2,430,545 | ||||||
Stock based compensation expense for stock options | $ 13,492 | $ 6,748 | $ 20,342 | $ 11,827 | |||
Performance Shares [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Percentage of performance-based stock options | 50% | ||||||
Percentage of Performance-Based Stock Options Vesting | 50% | ||||||
Weighted average grant-date fair value of stock options | $ 5.53 | ||||||
Performance-based stock options to granted | 562,000 | ||||||
Stock based compensation expense for stock options | $ 2,373 | $ 2,373 |
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, 2023 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Unvested restricted stock units, Beginning balance | shares | 1,549,540 |
Number of Shares, Granted | shares | 3,043,510 |
Number of Shares, Vested | shares | (436,652) |
Number of Shares, Forfeited | shares | (217,530) |
Number of Shares, Unvested restricted stock units, Ending balance | shares | 3,938,868 |
Weighted Average Grant Date Fair Value, Unvested restricted stock units, Beginning balance | $ / shares | $ 9.37 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 5.5 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 9.69 |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | 8.94 |
Weighted Average Grant Date Fair Value, Unvested restricted stock units, Ending balance | $ / shares | $ 6.36 |
Common Stock and Stock-Based _7
Common Stock and Stock-Based Awards - Restricted Stock Units - Additional Information (Detail) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||
Oct. 31, 2024 USD ($) | Oct. 31, 2022 $ / shares shares | Jun. 30, 2023 USD ($) shares | Mar. 31, 2023 $ / shares shares | Jun. 30, 2022 USD ($) shares | Jun. 30, 2023 USD ($) shares | Jun. 30, 2022 USD ($) shares | Dec. 31, 2022 USD ($) | Dec. 31, 2021 Employee $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock based compensation expense for stock options | $ | $ 13,492 | $ 6,748 | $ 20,342 | $ 11,827 | |||||
Performance Based Restricted Stock Units (PSUs) [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Employee share based compensation expense | $ | 815 | 815 | $ 815 | ||||||
Weighted average grant-date fair value of stock options | $ / shares | $ 5.5 | ||||||||
Stock based compensation expense for stock options | $ | $ 2,768 | $ 2,768 | |||||||
Number of employees granted | Employee | 2 | ||||||||
Number of shares granted | 0 | 1,322,715 | 1,322,715 | ||||||
Service Based Restricted Stock Units (RSUs)[Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Number of shares granted | 28,700 | 120,350 | 1,720,795 | 1,109,894 | |||||
Vesting period | 4 years | ||||||||
Service Based Restricted Stock Units (RSUs)[Member] | Vesting After One Year | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Vesting rights percentage | 25% | ||||||||
Service Based Restricted Stock Units (RSUs)[Member] | Vesting Quarterly Over Next 3 Years | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Vesting rights percentage | 75% | ||||||||
Forecast [Member] | Performance Based Restricted Stock Units (PSUs) [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock based compensation expense for stock options | $ | $ 4,260 | ||||||||
Employee One [Member] | Performance Based Restricted Stock Units (PSUs) [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, vested | 42,500 | ||||||||
Weighted average grant date fair value, vested | $ / shares | $ 9.59 | ||||||||
Number of shares granted | 85,000 | ||||||||
Employee Two [Member] | Performance Based Restricted Stock Units (PSUs) [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, vested | 20,000 | ||||||||
Weighted average grant date fair value, vested | $ / 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, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 13,492 | $ 6,748 | $ 20,342 | $ 11,827 |
Research and development expenses [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | 7,851 | 3,430 | 11,582 | 6,026 |
General and administrative expenses [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation expense | $ 5,641 | $ 3,318 | $ 8,760 | $ 5,801 |
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, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Numerator: | ||||||
Net income (loss) | $ 46,552 | $ (71,174) | $ (64,735) | $ (56,624) | $ (24,622) | $ (121,359) |
Income (loss) attributable to common stockholders - basic | $ 46,552 | $ (64,735) | $ (24,622) | $ (121,359) | ||
Denominator: | ||||||
Weighted-average shares outstanding | 127,713,486 | 92,255,416 | 126,793,342 | 92,224,382 | ||
Net income (loss) per share applicable to common stockholders - basic | $ 0.36 | $ (0.7) | $ (0.19) | $ (1.32) | ||
Numerator: | ||||||
Net Income (Loss) | $ 46,552 | $ (71,174) | $ (64,735) | $ (56,624) | $ (24,622) | $ (121,359) |
Income (loss) attributable to common stockholders - diluted | $ 46,552 | $ (64,735) | $ (24,622) | $ (121,359) | ||
Denominator: | ||||||
Weighted-average shares outstanding | 127,713,486 | 92,255,416 | 126,793,342 | 92,224,382 | ||
Dilutive impact from: | ||||||
Stock options to purchase common stock | 1,597,058 | |||||
Unvested restricted stock units | 519,338 | |||||
Shares issuable under employee stock purchase plan | 15,049 | |||||
Weighted-average shares outstanding - diluted | 129,844,931 | 92,255,416 | 126,793,342 | 92,224,382 | ||
Net income (loss) per share applicable to common stockholders - diluted | $ 0.36 | $ (0.7) | $ (0.19) | $ (1.32) | ||
Employee Stock Option | ||||||
Anti-dilutive potential common stock equivalents excluded from the calculation of net income (loss) per share: | ||||||
Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share: | 11,946,170 | 14,987,043 | 16,755,599 | 14,987,043 | ||
Unvested Restricted Stock Units [Member] | ||||||
Anti-dilutive potential common stock equivalents excluded from the calculation of net income (loss) per share: | ||||||
Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share: | 879,557 | 1,578,621 | 3,938,868 | 1,578,621 | ||
Shares Issuable under employee stock purchase plan [Member] | ||||||
Anti-dilutive potential common stock equivalents excluded from the calculation of net income (loss) per share: | ||||||
Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share: | 250,002 | 193,454 | 250,002 | |||
Common Stock [Member] | Warrants [Member] | ||||||
Anti-dilutive potential common stock equivalents excluded from the calculation of net income (loss) per share: | ||||||
Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share: | 1,177,433 | 1,177,433 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||||||
Jul. 21, 2021 | Jul. 01, 2021 | Jan. 31, 2016 | May 31, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2022 | Nov. 30, 2018 | Feb. 29, 2016 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||
Transaction price allocated under collaborative arrangement | $ 31,372,000 | $ 31,372,000 | $ 34,770,000 | |||||||||||||
Collaboration (profit) loss sharing - related party | (2,106,000) | $ (271,000) | (5,713,000) | $ 705,000 | ||||||||||||
Change in collaboration revenue-related party | 1,473,000 | 1,216,000 | 951,000 | 2,709,000 | ||||||||||||
Upfront collaboration/license fee | $ 120,000,000 | |||||||||||||||
2021 License Agreement [Member] | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||
Collaboration product, percentage of commercial profit | 50% | |||||||||||||||
Milestones payments received | $ 125,000,000 | 125,000,000 | 125,000,000 | |||||||||||||
Collaborative arrangement, sharing of pre-launch costs, percentage | 50% | |||||||||||||||
Nestle Health Science [Member] | ||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||||||||||
Upfront cash payment | 95,738,000 | 95,738,000 | 94,713,000 | $ 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 | 620,000 | (1,024,000) | (197,000) | 528,000 | ||||||||||||
Deferred revenue | 95,738,000 | 95,738,000 | 96,689,000 | |||||||||||||
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 | $ 235,000,000 | |||||||||||||||
Maximum amount to be received on achievement of sales milestones | 225,000,000 | |||||||||||||||
Maximum regulatory payments to be received | 10,000,000 | |||||||||||||||
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] | ||||||||||||||||
Transaction price allocated to remaining performance obligations | $ 8,157,000 | |||||||||||||||
Collaboration revenue - related party | 853,000 | $ 1,975,000 | 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 | $ 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 | $ 31,372,000 | $ 31,372,000 | $ 34,770,000 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers - Changes in Contract Liabilities (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Deferred revenue - related party, Deductions | $ (1,473) | $ (1,216) | $ (951) | $ (2,709) |
ASU 2014-09 [Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Deferred revenue - related party, Balance at beginning of period | 96,689 | 103,817 | ||
Deferred revenue - related party, Additions | 1,644 | 0 | ||
Deferred revenue - related party, Deductions | (2,595) | (2,709) | ||
Deferred revenue - related party, Balance at end of period | $ 95,738 | $ 101,108 | $ 95,738 | $ 101,108 |
Revenue from Contracts with C_5
Revenue from Contracts with Customers - Schedule of Revenue Recognized (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Revenue recognized in the period from: | ||||
Amounts included in the contract liability at the beginning of the period | $ 1,473 | $ 1,216 | $ 951 | $ 2,709 |
Collaboration Profit and Loss -
Collaboration Profit and Loss - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Jul. 01, 2021 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Jul. 21, 2021 | |
Business Acquisition [Line Items] | |||||||
Transaction price allocated under collaborative arrangement | $ 31,372 | $ 31,372 | $ 34,770 | ||||
2021 License Agreement [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Collaborative arrangement sharing of pre-launch costs, percentage | 50% | ||||||
Topic 808 [Member] | Nestle Health Science [Member] | 2021 License Agreement [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Transaction price allocated under collaborative arrangement | $ 35,500 | ||||||
Topic 808 [Member] | Total Liabilities [Member] | Nestle Health Science [Member] | 2021 License Agreement [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Transaction price allocated under collaborative arrangement | $ 35,500 | $ 35,500 | |||||
Topic 808 [Member] | Accrued Expenses and Other Current Liabilities [Member] | Nestle Health Science [Member] | 2021 License Agreement [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Transaction price allocated under collaborative arrangement | 31,372 | 31,372 | $ 34,770 | ||||
Research and Development Expenses [Member] | Topic 808 [Member] | Nestle Health Science [Member] | 2021 License Agreement [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Cost associated with pre-launch activities | 645 | $ 1,538 | 1,446 | $ 3,173 | |||
General and Administrative Expenses [Member] | Topic 808 [Member] | Nestle Health Science [Member] | 2021 License Agreement [Member] | |||||||
Business Acquisition [Line Items] | |||||||
Cost associated with pre-launch activities | $ 1,539 | $ 2,176 | $ 4,242 | $ 4,614 |
Collaboration Profit and Loss_2
Collaboration Profit and Loss - Schedule of Collaboration Profit (Loss) (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Business Combinations [Abstract] | ||||
Share of VOWST net loss | $ 2,141 | $ 0 | $ 2,141 | $ 0 |
Profit on transfer of VOWST inventory to Nestle | (1,273) | 0 | (1,273) | 0 |
Collaboration (profit)/loss related to pre-launch activities | 1,238 | 271 | 4,845 | (705) |
Total collaboration (profit) loss sharing - related party | $ 2,106 | $ 271 | $ 5,713 | $ (705) |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
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 ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income Tax Disclosure [Abstract] | ||||
Income tax expense (benefit) | $ 0 | $ 0 | $ 0 | $ 0 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Jul. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Feb. 29, 2016 | |
Related Party Transaction [Line Items] | |||||||
Transaction price allocated under collaborative arrangement | $ 31,372 | $ 31,372 | $ 34,770 | ||||
Deferred income - related party | $ 2,817 | $ 2,817 | $ 0 | ||||
Common stock at a purchase price | $ 0.001 | $ 0.001 | $ 0.001 | ||||
Nestle Health Science [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Collaboration revenue - related party | $ 620 | $ (1,024) | $ (197) | $ 528 | |||
Deferred revenue | 95,738 | 95,738 | $ 94,713 | $ 120,000 | |||
Payments under agreements with related party | 0 | 0 | |||||
Due from related party | 0 | 0 | 0 | ||||
Nestle Health Science [Member] | 2021 License Agreement [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Collaboration revenue - related party | 125,853 | 1,413 | 126,975 | 2,181 | |||
Deferred revenue | 0 | 0 | 1,976 | ||||
Payments under agreements with related party | 0 | $ 0 | 13,419 | $ 0 | |||
Due from related party | 7,559 | 7,559 | 0 | ||||
TPC, Inc. [Member] | Research and Development Expenses [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Option Payment1 | 833 | 833 | |||||
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 | $ 31,372 | $ 31,372 | $ 34,770 | ||||
Other Noncurrent Assets [Member] | TPC, Inc. [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Option Payment1 | $ 833 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) $ / shares in Units, $ in Thousands | Jun. 30, 2026 | Apr. 27, 2023 USD ($) TradingDays $ / shares shares |
Subsequent Event [Line Items] | ||
Net proceeds received from credit facility | $ 50,446 | |
Trading days prior to the funding date | TradingDays | 30 | |
Tranche A Warrant [Member] | ||
Subsequent Event [Line Items] | ||
Warrants exercise price | $ / shares | $ 6.69 | |
Tranche B Warrant [Member] | ||
Subsequent Event [Line Items] | ||
Debt instrument conversion warrants or options issued | shares | 264,922 | |
Tranche C Warrant [Member] | ||
Subsequent Event [Line Items] | ||
Debt instrument conversion warrants or options issued | shares | 264,922 | |
Oaktree Fund Administration, LLC [Member] | ||
Subsequent Event [Line Items] | ||
Additional default interest rate | 2% | |
Term Loan Facility [Member] | ||
Subsequent Event [Line Items] | ||
Credit facility, interest rate during period | 7.875% | |
Line of credit facility exit fee percentage | 1.50% | |
Percentage of prepayment amount after the first year | 4% | |
Percentage of prepayment amount after the second year | 4% | |
Percentage of prepayment amount after the third year | 2% | |
Percentage of prepayment amount after the fourth year | 1% | |
Term Loan Facility [Member] | Forecast [Member] | ||
Subsequent Event [Line Items] | ||
Percentage of the outstanding principal amount repaid | 7.50% | |
Term Loan Facility [Member] | Tranche A Warrant [Member] | ||
Subsequent Event [Line Items] | ||
Debt instrument conversion warrants or options issued | shares | 647,589 | |
Warrants exercise price | $ / shares | $ 6.69 | |
Term Loan Facility [Member] | Maximum [Member] | ||
Subsequent Event [Line Items] | ||
Credit facility, interest rate during period | 7.875% | |
Term Loan Facility [Member] | Minimum [Member] | ||
Subsequent Event [Line Items] | ||
Credit facility, interest rate during period | 7.50% | |
Term Loan Facility [Member] | Oaktree Fund Administration, LLC [Member] | ||
Subsequent Event [Line Items] | ||
Credit facility, aggregate principal amount | $ 250,000 | |
Interest Rate Cap [Member] | SOFR [Member] | Term Loan Facility [Member] | ||
Subsequent Event [Line Items] | ||
Debt instrument, variable interest rate | 5% | |
Interest Rate Floor [Member] | SOFR [Member] | Term Loan Facility [Member] | ||
Subsequent Event [Line Items] | ||
Debt instrument, variable interest rate | 2.50% | |
Tranche A Loan [Member] | Term Loan Facility [Member] | Oaktree Fund Administration, LLC [Member] | ||
Subsequent Event [Line Items] | ||
Credit facility, aggregate principal amount | $ 110,000 | |
Tranche A Loan [Member] | Term Loan Facility [Member] | Hercules Capital, Inc. [Member] | ||
Subsequent Event [Line Items] | ||
Repayments of existing credit facility | 53,380 | |
Tranche B Loan [Member] | Term Loan Facility [Member] | Oaktree Fund Administration, LLC [Member] | ||
Subsequent Event [Line Items] | ||
Credit facility, aggregate principal amount | 45,000 | |
Tranche C Loan [Member] | Term Loan Facility [Member] | Oaktree Fund Administration, LLC [Member] | ||
Subsequent Event [Line Items] | ||
Credit facility, aggregate principal amount | 45,000 | |
Tranche D Loan [Mmeber] | Term Loan Facility [Member] | Oaktree Fund Administration, LLC [Member] | ||
Subsequent Event [Line Items] | ||
Credit facility, aggregate principal amount | $ 50,000 |
Uncategorized Items - mcrb-2023
Label | Element | Value |
Fair Value, Recurring [Member] | ||
Derivative Liability, Noncurrent | us-gaap_DerivativeLiabilitiesNoncurrent | $ 1,968,000 |
Fair Value, Inputs, Level 3 [Member] | Fair Value, Recurring [Member] | ||
Derivative Liability, Noncurrent | us-gaap_DerivativeLiabilitiesNoncurrent | 1,968,000 |
Fair Value, Inputs, Level 1 [Member] | Fair Value, Recurring [Member] | ||
Derivative Liability, Noncurrent | us-gaap_DerivativeLiabilitiesNoncurrent | 0 |
Fair Value, Inputs, Level 2 [Member] | Fair Value, Recurring [Member] | ||
Derivative Liability, Noncurrent | us-gaap_DerivativeLiabilitiesNoncurrent | $ 0 |
Warrant [Member] | ||
Derivative Liability Expected Volatility | mcrb_DerivativeLiabilityExpectedVolatility | 83% |
Derivative Liability Expected Volatility | mcrb_DerivativeLiabilityExpectedVolatility | 82% |