Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2023 | Apr. 28, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-37798 | |
Entity Registrant Name | Selecta Biosciences, Inc | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 26-1622110 | |
Entity Address, Address Line One | 65 Grove Street, | |
Entity Address, City or Town | Watertown, | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02472 | |
City Area Code | 617 | |
Local Phone Number | 923-1400 | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Trading Symbol | SELB | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Smaller Reporting Company | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 153,426,983 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001453687 | |
Current Fiscal Year End Date | --12-31 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 125,925 | $ 106,438 |
Marketable securities | 0 | 28,164 |
Accounts receivable | 6,839 | 6,596 |
Unbilled receivables | 1,843 | 3,162 |
Prepaid expenses and other current assets | 3,785 | 3,778 |
Total current assets | 138,392 | 148,138 |
Property and equipment, net | 2,765 | 2,794 |
Right-of-use asset, net | 11,201 | 11,617 |
Long-term restricted cash | 1,311 | 1,311 |
Investments | 2,000 | 2,000 |
Other assets | 24 | 26 |
Total assets | 155,693 | 165,886 |
Current liabilities: | ||
Accounts payable | 1,063 | 316 |
Accrued expenses | 9,347 | 14,084 |
Loan payable | 10,218 | 8,476 |
Lease liability | 1,671 | 1,608 |
Deferred revenue | 4,232 | 593 |
Total current liabilities | 26,531 | 25,077 |
Non-current liabilities: | ||
Loan payable, net of current portion | 16,228 | 17,786 |
Lease liability | 9,617 | 10,055 |
Deferred revenue | 5,519 | 0 |
Warrant liabilities | 23,219 | 19,140 |
Total liabilities | 81,114 | 72,058 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding as of March 31, 2023 and December 31, 2022 | 0 | 0 |
Common stock, $0.0001 par value; 350,000,000 shares authorized as of March 31, 2023 and December 31, 2022; 153,426,983 and 153,042,435 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 15 | 15 |
Additional paid-in capital | 495,733 | 493,308 |
Accumulated deficit | (416,600) | (394,937) |
Accumulated other comprehensive loss | (4,569) | (4,558) |
Total stockholders’ equity | 74,579 | 93,828 |
Total liabilities and stockholders’ equity | $ 155,693 | $ 165,886 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 350,000,000 | 350,000,000 |
Common stock, shares issued (in shares) | 153,426,983 | 153,042,435 |
Common stock, shares outstanding (in shares) | 153,426,983 | 153,042,435 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Statement of Comprehensive Income [Abstract] | ||
Collaboration and license revenue | $ 5,938 | $ 33,999 |
Operating expenses: | ||
Research and development | 18,624 | 17,689 |
General and administrative | 5,695 | 5,537 |
Total operating expenses | 24,319 | 23,226 |
Operating (loss) income | (18,381) | 10,773 |
Investment income | 1,331 | 15 |
Foreign currency transaction, net | 19 | 28 |
Interest expense | (808) | (707) |
Change in fair value of warrant liabilities | (4,079) | 18,515 |
Other income, net | 255 | 154 |
Net (loss) income | (21,663) | 28,778 |
Other comprehensive income (loss): | ||
Foreign currency translation adjustment | (22) | (32) |
Unrealized gain on marketable securities | 11 | 0 |
Total comprehensive income (loss) | $ (21,674) | $ 28,746 |
Net (loss) income per share: | ||
Basic (in dollars per share) | $ (0.14) | $ 0.23 |
Diluted (in dollars per share) | $ (0.14) | $ 0.08 |
Weighted average common shares outstanding: | ||
Basic (in shares) | 153,345,554 | 124,232,799 |
Diluted (in shares) | 153,345,554 | 127,573,485 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders’ (Deficit) Equity - USD ($) $ in Thousands | Total | Common stock | Additional paid-in capital | Accumulated deficit | Accumulated other comprehensive loss |
Beginning balance (in shares) at Dec. 31, 2021 | 123,622,965 | ||||
Beginning balance at Dec. 31, 2021 | $ 22,521 | $ 12 | $ 457,391 | $ (430,316) | $ (4,566) |
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 81,057 | ||||
Issuance of common stock under Employee Stock Purchase Plan | 127 | 127 | |||
Issuance of common stock upon exercise of options (in shares) | 11,262 | ||||
Issuance of common stock upon exercise of options | 21 | 21 | |||
Issuance of vested restricted stock units (in shares) | 89,142 | ||||
Issuance of vested restricted stock units | 0 | ||||
Issuance of common stock through at-the-market offering, net (in shares) | 576,418 | ||||
Issuance of common stock through at-the-market offering, net | 1,675 | 1,675 | |||
Other financing fees | (79) | (79) | |||
Stock-based compensation expense | 2,753 | 2,753 | |||
Currency translation adjustment | (32) | (32) | |||
Unrealized gain on marketable securities | 0 | ||||
Net (loss) income | 28,778 | 28,778 | |||
Ending balance (in shares) at Mar. 31, 2022 | 124,380,844 | ||||
Ending balance at Mar. 31, 2022 | $ 55,764 | $ 12 | 461,888 | (401,538) | (4,598) |
Beginning balance (in shares) at Dec. 31, 2022 | 153,042,435 | 153,042,435 | |||
Beginning balance at Dec. 31, 2022 | $ 93,828 | $ 15 | 493,308 | (394,937) | (4,558) |
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 108,068 | ||||
Issuance of common stock under Employee Stock Purchase Plan | 149 | 149 | |||
Issuance of vested restricted stock units (in shares) | 276,480 | ||||
Issuance of vested restricted stock units | 0 | ||||
Stock-based compensation expense | 2,276 | 2,276 | |||
Currency translation adjustment | (22) | (22) | |||
Unrealized gain on marketable securities | 11 | 11 | |||
Net (loss) income | $ (21,663) | (21,663) | |||
Ending balance (in shares) at Mar. 31, 2023 | 153,426,983 | 153,426,983 | |||
Ending balance at Mar. 31, 2023 | $ 74,579 | $ 15 | $ 495,733 | $ (416,600) | $ (4,569) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities | ||
Net (loss) income | $ (21,663) | $ 28,778 |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Depreciation and amortization | 206 | 351 |
Amortization of premiums and discounts on marketable securities | (79) | 1 |
Non-cash lease expense | 416 | 293 |
Gain on disposal of property and equipment | 0 | (147) |
Stock-based compensation expense | 2,276 | 2,753 |
Non-cash interest expense | 398 | 383 |
Warrant liabilities revaluation | 4,079 | (18,515) |
Changes in operating assets and liabilities: | ||
Accounts receivable | (243) | 2,761 |
Unbilled receivable | 1,319 | 0 |
Prepaid expenses, deposits and other assets | (20) | 853 |
Accounts payable | 747 | 18 |
Income taxes payable | 0 | (281) |
Deferred revenue | 9,158 | (26,890) |
Accrued expenses and other liabilities | (5,359) | (2,222) |
Net cash used in operating activities | (8,765) | (11,864) |
Cash flows from investing activities | ||
Proceeds from maturities of marketable securities | 28,254 | 10,000 |
Purchases of property and equipment | (130) | (455) |
Net cash provided by investing activities | 28,124 | 9,545 |
Cash flows from financing activities | ||
Debt amendment fee included in debt discount | 0 | (110) |
Proceeds from exercise of stock options | 0 | 21 |
Proceeds from issuance of common stock under Employee Stock Purchase Plan | 149 | 127 |
Net cash provided by financing activities | 149 | 1,728 |
Effect of exchange rate changes on cash | (21) | (29) |
Net change in cash, cash equivalents, and restricted cash | 19,487 | (620) |
Cash, cash equivalents, and restricted cash at beginning of period | 108,038 | 115,436 |
Cash, cash equivalents, and restricted cash at end of period | 127,525 | 114,816 |
Supplemental cash flow information | ||
Cash paid for interest | 625 | 494 |
Noncash investing and financing activities | ||
Purchase of property and equipment not yet paid | 48 | 91 |
Equity offering costs in accrued liabilities | 0 | 94 |
At-The-Market Offering | ||
Cash flows from financing activities | ||
Net proceeds from issuance of common stock- at-the-market offering | $ 0 | $ 1,690 |
Description of the Business
Description of the Business | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of the Business | Description of the Business Selecta Biosciences, Inc., or the Company, was incorporated in Delaware on December 10, 2007, and is based in Watertown, Massachusetts. The Company is a clinical-stage biotechnology company leveraging the Company's ImmTOR ® platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses. With a proven ability to induce tolerance to highly immunogenic proteins, the Company believes ImmTOR has the potential to amplify the efficacy of biologic therapies, including redosing of life-saving gene therapies, as well as restore the body's natural self-tolerance in autoimmune diseases. The Company has several proprietary and partnered programs in its pipeline focused on enzyme therapies, gene therapies, and autoimmune diseases. In April 2023, in light of current market conditions, the Company’s Board of Directors, or the Board, took steps to extend cash runway by pausing further development of SEL-302 for the treatment of methylmalonic acidemia, or MMA, and conducting a targeted headcount reduction of approximately 25%. The Company intends to continue evaluating its development programs and operating expenses on an ongoing basis. As part of this ongoing evaluation, the Company may also seek collaboration partners for one or more of its development programs. In particular, the Company plans to prioritize the Company’s support of its collaboration with Swedish Orphan Biovitrum AB (publ.), or Sobi, for SEL-212, the development of ImmTOR-IL for diseases of the liver and the Company’s support of its collaboration with Astellas Gene Therapies, or Astellas, for Xork. Since inception, the Company has devoted its efforts principally to research and development of its technology and product candidates, recruiting management and technical staff, acquiring operating assets, and raising capital. The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance-reporting capabilities. The Company’s product candidates are in development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, or maintained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees and consultants. Unaudited Interim Financial Information The accompanying unaudited consolidated financial statements for the three months ended March 31, 2023 and 2022 have been prepared by the Company, pursuant to the rules and regulations of the Securities and Exchange Commission, or 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, or U.S. GAAP, have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K that was filed with the SEC on March 2, 2023. The unaudited interim financial statements have been prepared on the same basis as the audited consolidated financial statements. In the opinion of management, the accompanying unaudited interim consolidated financial statements contain all adjustments that are necessary for a fair statement of the Company’s financial position as of March 31, 2023, the consolidated results of operations for the three months ended March 31, 2023, and cash flows for the three months ended March 31, 2023. Such adjustments are of a normal and recurring nature. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023. Liquidity and Management’s Plan The future success of the Company is dependent on its ability to develop its product candidates and ultimately upon its ability to attain and sustain profitable operations. The Company is subject to a number of risks similar to other early-stage life science companies, including, but not limited to, successful development of its product candidates, raising additional capital with favorable terms, protection of proprietary technology and market acceptance of any approved future products. The successful development of product candidates requires substantial working capital, which may not be available to the Company on favorable terms or at all. To date, the Company has financed its operations primarily through public offerings and private placements of its securities, funding received from research grants, collaboration and license arrangements and its credit facility. The Company currently has no source of product revenue, and it does not expect to generate product revenue for the foreseeable future. To date, the Company’s revenue has primarily been from collaboration and license agreements. The Company has devoted substantially all of its financial resources and efforts to developing its ImmTOR platform, identifying potential product candidates and conducting preclinical studies and clinical trials. The Company is in the early stages of development of its product candidates, and it has not completed development of any ImmTOR-enabled therapies. As of March 31, 2023, the Company’s cash, cash equivalents and restricted cash were $127.5 million, of which $1.6 million was restricted cash related to lease commitments and $0.2 million was held by its Russian subsidiary designated solely for use in its operations. In April 2023, in light of current market conditions, the Board took steps to extend cash runway by pausing further development of SEL-302 for the treatment of MMA and conducting a targeted headcount reduction of approximately 25%. The Company intends to continue evaluating its development programs and operating expenses on an ongoing basis. The Company believes the cash, cash equivalents and restricted cash as of March 31, 2023 will enable it to fund its current planned operations for at least the next twelve months from the date of issuance of these financial statements, though it may realize additional cash resources upon the achievement of certain contingent collaboration milestones or it may pursue additional cash resources through public or private equity or debt financings or by establishing collaborations with other companies. Management’s expectations with respect to its ability to fund current and long term planned operations are based on estimates that are subject to risks and uncertainties. If actual results are different from management’s estimates, the Company may need to seek additional strategic or financing opportunities sooner than would otherwise be expected. However, there is no guarantee that any collaboration milestones will be achieved or that any of these strategic or financing opportunities will be executed on favorable terms, and some could be dilutive to existing stockholders. If the Company is unable to obtain additional funding on a timely basis, it may be forced to significantly curtail, delay, or discontinue one or more of its planned research or development programs or be unable to expand or maintain its operations or otherwise capitalize on its commercialization of its product candidates. The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research and development of its product candidates and its administrative organization. Guarantees and Indemnifications As permitted under Delaware law, the Company indemnifies its officers, directors, consultants and employees for certain events or occurrences that happen by reason of the relationship with, or position held at the Company. Through March 31, 2023, the Company had not experienced any losses related to these indemnification obligations, and no claims were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies The Company disclosed its significant accounting policies in Note 2 – Summary of Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2023, with the exception of the matters discussed in recent accounting pronouncements. Recent Accounting Pronouncements Recently Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments . Subsequently, in November 2018, the FASB issued ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments-Credit Losses . ASU 2016-13 requires entities to measure all expected credit losses for most financial assets held at the reporting date based on an expected loss model which includes historical experience, current conditions, and reasonable and supportable forecasts. ASU 2016-13 also requires enhanced disclosures to help financial statement users better understand significant estimates and judgments used in estimating credit losses. This ASU is effective for smaller reporting companies for fiscal years beginning after December 15, 2022, with early adoption permitted. The Company adopted the new standard effective January 1, 2023, using a modified retrospective transition method, and there was no impact on its consolidated financial statements or results of operations upon adoption. |
Marketable Securities and Inves
Marketable Securities and Investments | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities and Investments | Marketable Securities and Investments No marketable securities were held as of March 31, 2023. The following table summarizes the marketable securities held as of December 31, 2022 (in thousands): Amortized Unrealized losses Fair December 31, 2022 U.S. government agency securities and treasuries $ 13,566 $ (9) $ 13,557 Corporate bonds $ 1,953 $ (2) $ 1,951 Commercial paper 12,656 — 12,656 Total $ 28,175 $ (11) $ 28,164 Investments As of March 31, 2023 and December 31, 2022, the Company has a $2.0 million investment in Cyrus Biotechnology, Inc., or Cyrus, pursuant to an investment agreement entered into in connection with the Collaboration and License Agreement with Cyrus. The Company’s maximum exposure to loss related to this variable interest entity is limited to the carrying value of the investment. |
Net (Loss) Income Per Share
Net (Loss) Income Per Share | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net (Loss) Income Per Share | Net (Loss) Income Per Share The following table sets forth the computation of basic and diluted net (loss) income per share for the three months ended March 31, 2023 and 2022 (in thousands, except share and per-share data): Three Months Ended 2023 2022 Numerator: Net (loss) income $ (21,663) $ 28,778 Less: Change in fair value of liability warrants — (18,515) Adjusted net (loss) income $ (21,663) $ 10,263 Denominator: Weighted-average common shares outstanding - basic 153,345,554 124,232,799 Dilutive effect of employee equity incentive plans and outstanding warrants — 3,340,686 Weighted-average common shares used in per share calculations - diluted 153,345,554 127,573,485 Net (loss) income per share: Basic $ (0.14) $ 0.23 Diluted $ (0.14) $ 0.08 The following table represents the potential dilutive shares of common stock excluded from the computation of the diluted net (loss) income per share for all periods presented, as the effect would have been anti-dilutive: Three Months Ended 2023 2022 Options, RSUs and ESPP shares 23,204,649 15,292,967 Warrants to purchase common stock 31,228,279 292,469 Total 54,432,928 15,585,436 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The following tables present the Company’s assets and liabilities that are measured at fair value on a recurring basis as of March 31, 2023 and December 31, 2022 (in thousands): March 31, 2023 Total Level 1 Level 2 Level 3 Assets: Money market funds (included in cash equivalents) $ 82,393 $ 82,393 $ — $ — Total assets $ 82,393 $ 82,393 $ — $ — Liabilities: Warrant liabilities $ 23,219 $ — $ — $ 23,219 Total liabilities $ 23,219 $ — $ — $ 23,219 December 31, 2022 Total Level 1 Level 2 Level 3 Assets: Money market funds (included in cash equivalents) $ 53,552 $ 53,552 $ — $ — Marketable securities: U.S. government agency securities and treasuries 13,557 — 13,557 — Corporate bonds 1,951 — 1,951 — Commercial paper 12,656 — 12,656 — Total assets $ 81,716 $ 53,552 $ 28,164 $ — Liabilities: Warrant liabilities $ 19,140 $ — $ — $ 19,140 Total liabilities $ 19,140 $ — $ — $ 19,140 There were no transfers within the fair value hierarchy during the three months ended March 31, 2023 or year ended December 31, 2022. Cash, Cash Equivalents, and Restricted Cash As of March 31, 2023 and December 31, 2022, money market funds were classified as cash and cash equivalents on the accompanying consolidated balance sheets as they mature within 90 days from the date of purchase. As of March 31, 2023, the Company had restricted cash balances relating to a secured letter of credit in connection with its lease for the Company’s headquarters. Short-term restricted cash is included within prepaid expenses and other current assets in the consolidated balance sheets. The Company’s consolidated statements of cash flows include the following as of March 31, 2023 and 2022 (in thousands): March 31, 2023 2022 Cash and cash equivalents $ 125,925 $ 113,437 Short-term restricted cash 289 — Long-term restricted cash 1,311 1,379 Total cash, cash equivalents, and restricted cash $ 127,525 $ 114,816 Marketable Securities No marketable securities were held as of March 31, 2023. As of December 31, 2022, marketable securities classified as Level 2 within the valuation hierarchy consist of U.S. government agency securities and treasuries, corporate bonds and commercial paper which are available-for-sale securities in accordance with the Company’s investment policy. The Company estimates the fair value of these marketable securities by taking into consideration valuations that include market pricing based on real-time trade data for the same or similar securities, and other observable inputs. The amortized cost of available-for-sale debt securities is adjusted for amortization of premiums and accretion of discounts to the earliest call date for premiums or to maturity for discounts. Loans Payable At March 31, 2023, in light of the issuance of the first tranche under the Company’s term loan pursuant the Loan and Security Agreement, dated August 31, 2020, as amended, among the Company, Oxford Finance LLC, or Oxford, as Collateral Agent and a Lender, and Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (successor by purchase to the Federal Deposit Insurance Corporation as Receiver for Silicon Valley Bridge Bank, N.A. (as successor to Silicon Valley Bank)), or SVB, as a Lender, or the Loan and Security Agreement, the Company believes the carrying value approximates the fair value of the loan. Warrants In December 2019, the Company issued warrants to purchase common stock in connection with a private placement of shares of common stock, or the 2019 Warrants. Pursuant to the terms of the 2019 Warrants, the Company could be required to settle the 2019 Warrants in cash in the event of certain acquisitions of the Company and, as a result, the 2019 Warrants were required to be measured at fair value and reported as a liability on the balance sheet. On December 20, 2022, the Company amended the terms of the outstanding 2019 Warrants held by certain members of the Board, or the Amended 2019 Warrants, to remove the cash settlement provision. As a result, the Amended 2019 Warrants were remeasured at fair value on December 20, 2022 and reclassified from a liability to equity on the balance sheet. See Note 10 to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022 for further discussion on the equity-classified Amended 2019 Warrants. In April 2022, the Company issued warrants in connection with an underwritten offering of shares of common stock and warrants to purchase shares of common stock, or the 2022 Warrants. Pursuant to the terms of the 2022 Warrants, the Company could be required to settle the 2022 Warrants in cash in the event of an acquisition of the Company under certain circumstances and, as a result, the 2022 Warrants are required to be measured at fair value and reported as a liability on the balance sheet. The Company recorded the fair value of the 2019 Warrants and the 2022 Warrants upon issuance using the Black-Scholes valuation model and is required to revalue the 2019 Warrants and the 2022 Warrants at each reporting date, with any changes in fair value recorded in the statement of operations and comprehensive income (loss). The valuations of the 2019 Warrants and the 2022 Warrants are classified as Level 3 of the fair value hierarchy due to the need to use assumptions in the valuations that are both significant to the fair value measurement and unobservable, including the stock price volatility and the expected life of the 2019 Warrants and the 2022 Warrants. Generally, increases (decreases) in the fair value of the underlying stock and estimated term would result in a directionally similar impact to the fair value measurement. The estimated fair values of the 2019 Warrants and the 2022 Warrants were determined using the following inputs to the Black-Scholes simulation valuation: Estimated fair value of the underlying stock . The Company estimates the fair value of the common stock based on the closing stock price at the end of each reporting period. Risk-free interest rate . The risk-free interest rate is based on the U.S. Treasury at the valuation date commensurate with the expected remaining life assumption. Dividend rate . The dividend rate is based on the historical rate, which the Company anticipates will remain at zero. Expected life . The expected life of the 2019 Warrants and the 2022 Warrants is assumed to be equivalent to their remaining contractual terms which expire on December 23, 2024 and April 11, 2027, respectively. Volatility . The Company estimates stock price volatility based on the Company’s historical volatility and the historical volatility of peer companies for a period of time commensurate with the expected remaining life of the warrants. A summary of the Black-Scholes pricing model assumptions used to record the fair value of the 2019 Warrants liability is as follows: March 31, December 31, 2023 2022 Risk-free interest rate 4.06 % 4.74 % Dividend yield — — Expected life (in years) 1.73 1.98 Expected volatility 78.69 % 79.92 % A summary of the Black-Scholes pricing model assumptions used to record the fair value of the 2022 Warrants liability is as follows: March 31, December 31, 2023 2022 Risk-free interest rate 3.60 % 4.22 % Dividend yield — — Expected life (in years) 4.03 4.28 Expected volatility 91.39 % 98.05 % Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis The following table reflects a roll-forward of fair value for the Company’s Level 3 warrant liabilities (see Note 10 to these unaudited consolidated financial statements), for the three months ended March 31, 2023 (in thousands): Warrant liabilities Fair value as of December 31, 2022 $ 19,140 Change in fair value 4,079 Fair value as of March 31, 2023 $ 23,219 |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment Property and equipment consists of the following (in thousands): March 31, December 31, 2023 2022 Laboratory equipment $ 6,253 $ 6,001 Computer equipment and software 702 697 Leasehold improvements 61 57 Furniture and fixtures 453 453 Office equipment 196 192 Construction in process 492 599 Total property and equipment 8,157 7,999 Less accumulated depreciation (5,392) (5,205) Property and equipment, net $ 2,765 $ 2,794 Depreciation expense was $0.2 million and $0.1 million for the three months ended March 31, 2023 and 2022, respectively. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consist of the following (in thousands): March 31, December 31, 2023 2022 Payroll and employee related expenses $ 2,206 $ 4,242 Accrued patent fees 594 696 Accrued external research and development costs 4,724 7,274 Accrued professional and consulting services 1,132 985 Accrued interest 215 222 Other 476 665 Accrued expenses $ 9,347 $ 14,084 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Leases | Leases For the three months ended March 31, 2023 and 2022, the components of lease costs were as follows (in thousands): Three Months Ended 2023 2022 Operating lease cost $ 696 $ 506 Variable lease cost 142 220 Short-term lease cost 3 3 Less sublease income (255) — Total lease cost $ 586 $ 729 The maturity of the Company’s operating lease liabilities as of March 31, 2023 were as follows (in thousands): March 31, 2023 2023 (remainder) $ 2,015 2024 2,740 2025 2,818 2026 2,902 2027 2,990 Thereafter 946 Total future minimum lease payments 14,411 Less imputed interest 3,123 Total operating lease liabilities $ 11,288 The supplemental disclosure for the statement of cash flows related to operating leases was as follows (in thousands): March 31, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: $ 653 $ 457 The changes in the Company’s right-of-use assets and lease liabilities for the three months ended March 31, 2023 and 2022 are reflected in the non-cash lease expense and accrued expenses and other liabilities, respectively, in the consolidated statements of cash flows. The following summarizes additional information related to operating leases: March 31, 2023 2022 Weighted-average remaining lease term 5.1 years 6.1 years Weighted-average discount rate 9.7 % 8.9 % |
Debt
Debt | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Debt | Debt 2020 Term Loan On August 31, 2020, the Company entered into the Loan and Security Agreement with Oxford and Silicon Valley Bank. On March 10, 2023, Silicon Valley Bank was closed by the California Department of Financial Protection and Innovation, and the Federal Deposit Insurance Corporation, or the FDIC, was appointed as receiver. On March 13, 2023, the FDIC announced that all of Silicon Valley Bank’s deposits and substantially all of its assets had been transferred to a newly created, full-service, FDIC-operated bridge bank, Silicon Valley Bridge Bank, N.A., or SVBB. SVBB assumed all loans that were previously held by Silicon Valley Bank. On March 27, 2023, First-Citizens Bank & Trust Company assumed all of SVBB’s customer deposits and certain other liabilities and acquired substantially all of SVBB’s loans and certain other assets from the FDIC, including the Loan and Security Agreement. On March 31, 2023, the Company entered into a Fourth Amendment to Loan and Security Agreement or the Fourth Amendment, with Oxford as Collateral Agent and a Lender and SVB. The Fourth Amendment relieved the Company of the requirement to maintain all Collateral Accounts (as such term is defined in the Loan and Security Agreement) with SVB and instead requires us to hold an amount equal to the lesser of (i) 100% of our consolidated cash and (ii) 150% of the then-outstanding Obligations (as such term is defined in the Loan and Security Agreement) in Collateral Accounts with SVB that are subject to a Control Agreement (as such term is defined in the Loan and Security Agreement) in favor of SVB. As of March 31, 2023 and December 31, 2022, the outstanding principal balance under the 2020 Term Loan was $25.0 million. Total 2020 Term Loan and unamortized debt discount balances as of March 31, 2023 are as follows (in thousands): Face value $ 25,000 Venture debt termination fee 2,250 Less: Debt discount (804) Less: Current portion of loan payable (10,218) Loan payable, net of current portion $ 16,228 Future minimum principal payments on the 2020 Term Loan as of March 31, 2023 are as follows (in thousands): Year ended: 2023 (remainder) $ 7,759 2024 10,345 2025 6,896 Total minimum principal payments $ 25,000 |
Equity
Equity | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Equity | Equity Equity Financings “At-the-Market” Offerings On October 25, 2021, the Company entered into a Sales Agreement, or the 2021 Sales Agreement, with SVB Leerink LLC (now known as SVB Securities LLC), or SVB Leerink, pursuant to which the Company may sell shares of the Company’s common stock, from time to time, through an “at the market” equity offering program under which SVB Leerink will act as sales agent. The shares of common stock sold pursuant to the 2021 Sales Agreement will be issued pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-241692), for aggregate gross sales proceeds of up to $75.0 million. During the year ended December 31, 2022, the Company sold 774,544 shares of its common stock pursuant to the 2021 Sales Agreement for aggregate net proceeds of $2.1 million, after deducting commissions and other transaction costs. During the three months ended March 31, 2023, the Company sold no shares of its common stock pursuant to the 2021 Sales Agreement. Warrants During the three months ended March 31, 2022, there were no warrants issued, exercised, or canceled. See Note 10 to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022 for further discussion of the terms related to the Company’s warrants. Number of Warrants Equity Liability classified Total Weighted average Outstanding at March 31, 2023 2,236,326 28,991,953 31,228,279 $ 1.53 Reserved Shares The Company has authorized shares of common stock for future issuance as of March 31, 2023 as follows: Exercise of warrants 31,228,279 Shares available for future stock incentive awards 7,497,840 RSUs reserved for issuance 713 Unvested restricted stock units 2,454,915 Outstanding common stock options 20,646,905 Total 61,828,652 |
Stock Incentive Plans
Stock Incentive Plans | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock Incentive Plans | Stock Incentive Plans The Company maintains the 2008 Stock Incentive Plan, or the 2008 Plan, for employees, consultants, advisors, and directors. The 2008 Plan provided for the granting of incentive and non-qualified stock option and restricted stock awards as determined by the Board. In June 2016, the Company’s stockholders approved the 2016 Incentive Award Plan, or the 2016 Plan, which authorized 1,210,256 shares of common stock for future issuance under the 2016 Plan and the Company ceased granting awards under the 2008 Plan. Upon the effective date of the 2016 Plan, awards issued under the 2008 Plan remain subject to the terms of the 2008 Plan. Awards granted under the 2008 Plan that expire, lapse or terminate become available under the 2016 Plan as shares available for future grants. Additionally, pursuant to the terms of the 2016 Plan, the Board is authorized to grant awards with respect to common stock, and may delegate to a committee of one or more members of the Board or executive officers of the Company the authority to grant options and restricted stock units. On December 9, 2020, the Board established a Stock Option Committee authorized to grant awards to certain employees and consultants subject to conditions and limitations within the 2016 Plan. In January 2023, the number of shares of common stock that may be issued under the 2016 Plan was increased by 6,121,697 shares. As of March 31, 2023, 2,011,908 shares remain available for future issuance under the 2016 Plan. In September 2018, the Company’s 2018 Employment Inducement Incentive Award Plan, or the 2018 Inducement Incentive Award Plan was adopted by the Board without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Stock Market LLC listing rules, which authorized 1,175,000 shares of its common stock for issuance. In March 2019, the Board approved the amendment and restatement of the 2018 Inducement Incentive Award Plan to reserve an additional 2,000,000 shares of the Company’s common stock for issuance thereunder. As of March 31, 2023, there are 425,858 shares available for future grant under the 2018 Inducement Incentive Award Plan. Stock-Based Compensation Expense Stock-based compensation expense by classification included within the consolidated statements of operations and comprehensive income (loss) was as follows (in thousands): Three Months Ended 2023 2022 Research and development $ 1,192 $ 1,018 General and administrative 1,084 1,735 Total stock-based compensation expense $ 2,276 $ 2,753 Stock Options The estimated grant date fair values of employee stock option awards granted under the 2016 Plan and the 2018 Inducement Incentive Award Plan were calculated using the Black-Scholes option pricing model, based on the following weighted-average assumptions: Three Months Ended 2023 2022 Risk-free interest rate 3.95 % 1.48 % Dividend yield — — Expected term 5.94 6.03 Expected volatility 94.64 % 91.84 % Weighted-average fair value of common stock $ 1.15 $ 3.26 The expected term of the Company's stock options granted to employees has been determined utilizing the "simplified" method for awards that qualify as "plain-vanilla" options. Under the simplified method, the expected term is presumed to be the midpoint between the vesting date and the end of the contractual term. The Company utilizes this method due to lack of historical exercise data and the plain nature of its stock-based awards. The weighted average grant date fair value of stock options granted to employees was $0.90 and $2.45 during the three months ended March 31, 2023 and 2022, respectively. As of March 31, 2023, total unrecognized compensation expense related to unvested employee stock options was $15.1 million, which is expected to be recognized over a weighted average period of 2.9 years. The following table summarizes the stock option activity under the 2008 Plan, the 2016 Plan, and the 2018 Inducement Incentive Award Plan: Weighted-average remaining Aggregate Number of Weighted-average contractual term intrinsic value options exercise price ($) (in years) (in thousands) Employees Outstanding at December 31, 2022 15,578,412 $ 3.44 7.57 $ 4 Granted 5,437,200 $ 1.15 Forfeited (634,946) $ 3.10 Outstanding at March 31, 2023 20,380,666 $ 2.84 8.15 $ 1,507 Vested at March 31, 2023 8,528,078 $ 3.98 6.77 $ 2 Vested and expected to vest at March 31, 2023 18,819,248 $ 2.93 8.05 $ 1,257 Non-employee consultants Outstanding at December 31, 2022 266,239 $ 8.05 5.08 $ — Outstanding at March 31, 2023 266,239 $ 8.05 4.83 $ — Vested at March 31, 2023 266,239 $ 8.05 4.83 $ — Vested and expected to vest at March 31, 2023 266,239 $ 8.05 4.83 $ — Restricted Stock Units During the three months ended March 31, 2023, the Company granted 1,054,600 restricted stock awards with a weighted average fair value of $1.13 per share based on the closing price of the Company’s common stock on the date of grant to employees under the 2016 Plan, which will vest over a four-year term. Forfeitures are estimated at the time of grant and are adjusted, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company has estimated a forfeiture rate of 10% for restricted stock awards to employees based on historical experience. Unrecognized compensation expense for all restricted stock units was $3.4 million as of March 31, 2023, which is expected to be recognized over a weighted average period of 2.8 years. The following table summarizes the Company’s restricted stock units under the 2016 Plan and 2018 Inducement Incentive Award Plan: Number of shares Weighted average Unvested at December 31, 2022 1,705,558 $ 2.62 Granted 1,054,600 1.13 Vested (277,193) 3.22 Forfeited (28,050) 2.06 Unvested at March 31, 2023 2,454,915 $ 1.92 Employee Stock Purchase Plan In June 2016, the Company approved the 2016 Employee Stock Purchase Plan, or the ESPP, which authorized 173,076 shares of common stock for future issuance under the ESPP to participating employees. In January 2023, the number of shares of common stock authorized for issuance under the ESPP was increased by 1,530,424 shares. During the three months ended March 31, 2023, the Company issued 108,068 shares of common stock under the ESPP. As of March 31, 2023, 5,060,074 shares remain available for future issuance under the ESPP. For each of the three months ended March 31, 2023 and 2022, the Company recognized less than $0.1 million of stock-based compensation expense under the ESPP. |
Revenue Arrangements
Revenue Arrangements | 3 Months Ended |
Mar. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Arrangements | Revenue Arrangements Astellas Gene Therapies In January 2023, the Company entered into a License and Development Agreement, or the Astellas Agreement, with Audentes Therapeutics, Inc., doing business as Astellas. Under the Astellas Agreement, the Company granted Astellas an exclusive license to the Company’s IdeXork technology arising from Xork (defined below), to develop and commercialize Xork for use in Pompe Disease in combination with an Astellas gene therapy investigational or authorized product. Xork, Genovis’ IgG Protease, is licensed by the Genovis Agreement, as described in Note 14 to these consolidated financial statements, Astellas paid a $10.0 million upfront payment to the Company upon signing of the Astellas Agreement, and the Company is entitled to receive up to $340.0 million in future additional payments over the course of the partnership that are contingent on the achievement of various development and regulatory milestones and, if commercialized, sales thresholds for annual net sales where Xork is used as a pre-treatment for an Astellas investigational or authorized product, and tiered royalty payments ranging from low to high single digits. Pursuant to the Astellas Agreement, the Company will have the exclusive right and responsibility to complete research and development of Xork products and to conduct all preclinical studies and clinical trials for Xork for use in Pompe Disease with an Astellas gene therapy investigational or authorized product, or the Xork Development Services. Astellas will reimburse the Company for 25% of all budgeted costs incurred to complete the development of Xork for use in Pompe Disease with an Astellas gene therapy investigational or authorized product. The Company will have control and responsibility over regulatory filings, including any investigational drug applications, biologics license applications, and marketing authorization applications relating to the licensed product. Astellas will have the exclusive right and responsibility to research, develop, and commercialize Astellas products used in combination with Xork and will have control and responsibility over all regulatory filings, including any investigational drug applications, biologics license applications, and marketing authorization applications, relating to Astellas products and Astellas products used in combination with Xork. The Company determined the Astellas Agreement represents a service arrangement under the scope of ASC 606. The Company determined that the sublicense of Xork to Astellas, the licensed know-how, and the Xork Development Services represent a single promise and performance obligation to be transferred to Astellas over time due to the nature of the promises in the contract. As such, the Company will recognize the transaction price as revenue utilizing the input method to measure the progress of satisfying the single performance obligation to Astellas. In determining the transaction price, the Company concluded the upfront payment of $10.0 million and development cost reimbursements of $5.5 million will be included in the initial transaction price. All other development milestones will be fully constrained and will only be included in the transaction price when the applicable milestone is deemed probable of achievement. Each of these variable consideration items were evaluated under the most likely amount method to determine whether such amounts were probable of occurrence, or whether such amounts should be constrained until they become probable. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt and timing of such development milestones is outside the control of the Company and probability of success criteria is estimated. The Company will re-evaluate the transaction price in each reporting period, as uncertain events are resolved, or as other changes in circumstances occur. In accordance with ASC 606, the Company will only recognize revenue associated with sales-based milestones and royalties when the subsequent sales thresholds are reached and underlying sales occur, respectively. The Company determined that a significant financing component does not exist in its arrangement with Astellas. The Company also determined the options to negotiate additional fields, enter into a clinical supply agreement, and enter into a commercial supply agreement do not represent material rights under the Astellas Agreement. Astellas has the right to terminate the Astellas Agreement in its entirety or on a field-by-field basis, upon 90 days’ written notice to the Company. As of March 31, 2023, the Company recorded $4.1 million as a short-term contract liability and $5.5 million as a long-term contract liability, representing deferred revenue associated with the Astellas Agreement. As of March 31, 2023, the Company recorded a receivable of $0.2 million, representing billings for the Xork Development Services that are subject to reimbursement by Astellas. Revenue of $0.6 million related to the Astellas Agreement was recognized during the three months ended March 31, 2023. Takeda Pharmaceuticals USA, Inc. License and Development Agreement In October 2021, the Company entered into a License Agreement, or the Takeda Agreement, with Takeda Pharmaceuticals USA, Inc., or Takeda. Under the Takeda Agreement, the Company granted Takeda an exclusive license to the Company’s ImmTOR technology initially for two specified disease indications within the field of lysosomal storage disorders. Takeda paid a $3.0 million upfront payment to the Company upon signing of the Takeda Agreement, and the Company is entitled to receive up to $1.124 billion in future additional payments over the course of the partnership that are contingent on the achievement of development or commercial milestones or Takeda’s election to continue its activities at specified development stages. The Company is also eligible for tiered royalties on future commercial sales of any licensed products. A more detailed description of the Takeda Agreement and the Company's evaluation of this agreement under ASC 606 can be found in Note 12 to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022. On March 9, 2023, the Company was notified by Takeda of the achievement of the milestone event related to the completion of a non-clinical milestone for one of the specified disease indications within the field of lysosomal storage disorders under the Takeda Agreement. Accordingly, the Company recorded a receivable for $0.5 million as of March 31, 2023. In April 2023, the Company was notified by Takeda of its intention to terminate the Takeda Agreement effective July 25, 2023. As of March 31, 2023 and December 31, 2022, the Company recorded $0.2 million and $0.1 million, respectively, as a short-term contract liability, representing deferred revenue associated with the Takeda Agreement. Revenue of $0.5 million related to the Takeda Agreement was recognized during the three months ended March 31, 2023, all from performance obligations related to prior periods as a result of the change in transaction price. Revenue of $1.0 million related to the Takeda Agreement was recognized during the three months ended March 31, 2022. Swedish Orphan Biovitrum AB (publ.) License and Development Agreement In June 2020, the Company and Sobi entered into a License and Development Agreement, or the Sobi License. Pursuant to the Sobi License, the Company agreed to grant Sobi an exclusive, worldwide (except as to Greater China) license to develop, manufacture and commercialize the Company’s SEL-212 drug candidate, which is currently in development for the treatment of chronic refractory gout. The SEL-212 drug candidate is a pharmaceutical composition containing a combination of pegadricase, or the Compound, and ImmTOR. Pursuant to the Sobi License, in consideration of the license, Sobi agreed to pay the Company a one-time, upfront payment of $75.0 million. Sobi has also agreed to make milestone payments totaling up to $630.0 million to the Company upon the achievement of various development and regulatory milestones and, if commercialized, sales thresholds for annual net sales of SEL-212, and tiered royalty payments ranging from the low double digits on the lowest sales tier to the high teens on the highest sales tier. A more detailed description of the Sobi License and the Company's evaluation of this agreement under ASC 606 can be found in Note 12 to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022. As of March 31, 2023 and December 31, 2022, the Company recorded a total outstanding receivable of $5.7 million and $5.0 million, respectively, representing billings for the Phase 3 DISSOLVE program that are subject to reimbursement by Sobi. Additionally, as of March 31, 2023 and December 31, 2022, the Company recorded a total unbilled receivable of $1.8 million and $3.2 million, respectively, representing revenue earned but not yet billed for the Phase 3 DISSOLVE program. Revenue of $4.4 million and $23.8 million related to the Sobi License was recognized during the three months ended March 31, 2023 and 2022, respectively. In addition, as of March 31, 2023, the Company has recorded $0.1 million of contract assets related to incremental costs that would not have been incurred if the Sobi License had not been obtained, of which $0.1 million is presented in prepaid expenses and other current assets and less than $0.1 million is presented in other assets in the accompanying unaudited consolidated balance sheets. Sarepta Therapeutics, Inc. Research License and Option Agreement In June 2020, the Company and Sarepta Therapeutics, Inc., or Sarepta, entered into a Research License and Option Agreement, or the Sarepta Agreement. Pursuant to the Sarepta Agreement, the Company agreed to grant Sarepta a license under the Company’s intellectual property rights covering the Company’s antigen-specific biodegradable nanoparticle encapsulating ImmTOR to research and evaluate ImmTOR in combination with Sarepta’s adeno-associated virus gene therapy technology, or gene editing technology, using viral or non-viral delivery, to treat Duchenne Muscular Dystrophy and certain Limb-Girdle Muscular Dystrophy subtypes, or the Indications. Sarepta initially had an option term of 24 months during which it could opt-in to obtain an exclusive license to further develop and commercialize the product to treat at least one indication, with a potential to extend the option term for an additional fee. The Company agreed to supply ImmTOR to Sarepta for clinical supply on a cost-plus basis under the Sarepta Agreement. A more detailed description of the Sarepta Agreement and the Company's evaluation of this agreement under ASC 606 can be found in Note 12 to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022. On March 13, 2023, the Company was notified by Sarepta that Sarepta would not be exercising its exclusive option under the Sarepta Agreement. Therefore, the remaining deferred revenue balance as of December 31, 2022 of $0.5 million was recognized as revenue during the three months ended March 31, 2023. Revenue of less than $0.1 million was recognized during the three months ended March 31, 2022. Spark Therapeutics, Inc. Spark License Agreement In December 2016, the Company entered into a License and Option Agreement, or the Spark License Agreement, with Spark Therapeutics, Inc., or Spark, pursuant to which the Company and Spark agreed to collaborate on the development of gene therapies for certain targets utilizing the ImmTOR platform. The Spark License Agreement provides Spark with certain exclusive, worldwide, royalty bearing licenses to the Company’s intellectual property, allowing Spark to develop and commercialize gene therapies in combination with ImmTOR for Factor VIII, an essential blood clotting protein relevant to the treatment of hemophilia A, the initial target. On January 18, 2022, both parties agreed to mutually terminate the Spark License Agreement. Therefore, the short-term contract liability of $9.2 million as of December 31, 2021 was recognized as revenue during the three months ended March 31, 2022. Transaction Price Allocated to Future Performance Obligations Remaining performance obligations represent the transaction price of contracts for which work has not been performed, or has been partially performed. As of March 31, 2023, the aggregate amount of the transaction price allocated to remaining performance obligations was $9.8 million. Contract Balances from Contracts with Customers The following table presents changes in the Company’s contract liabilities during the three months ended March 31, 2023 (in thousands): Balance at Balance at beginning of period Additions Deductions end of period Three Months Ended March 31, 2023 Contract liabilities: Deferred revenue $ 593 $ 10,500 $ (1,342) $ 9,751 Total contract liabilities $ 593 $ 10,500 $ (1,342) $ 9,751 |
Related-party Transactions
Related-party Transactions | 3 Months Ended |
Mar. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related-party Transactions | Related-Party TransactionsDuring the three months ended March 31, 2023 and 2022, there were no related party transactions. |
Collaboration and License Agree
Collaboration and License Agreements | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Collaboration and License Agreements | Collaboration and License Agreements Ginkgo Bioworks Holdings, Inc. Collaboration and License Agreements On January 3, 2022, the Company entered into a Collaboration and License Agreement, or the Second Ginkgo Agreement, with Ginkgo Bioworks Holdings, Inc., or Ginkgo. Under this agreement, the Company will engage with Ginkgo to develop adeno-associated virus, or AAV, capsids designed to enhance transduction efficiency and transgene expression. In return, Ginkgo is eligible to earn both upfront research and development fees and milestone payments, including certain milestone payments in the form of shares of the Company’s common stock, clinical and commercial milestone payments of up to $207 million in cash. The Second Ginkgo Agreement was assessed for collaboration components and was determined not to be within the scope of ASC 808 as the risk and rewards are not shared by both parties. The Company will expense costs related to the Second Ginkgo Agreement as incurred until regulatory approval is received in accordance with ASC 730. The Company is accounting for the contingently issuable shares of common stock to be issued in exchange for the license obtained from Ginkgo as a liability-classified, stock-based compensation arrangement with a non-employee which will be recognized when achievement of the milestones is probable. The Company will assess the capitalization of costs incurred after the receipt of regulatory approval and, if applicable, will amortize these payments based on the expected useful life of each asset, typically based on the expected commercial exclusivity period. The Company is also obligated to pay Ginkgo tiered royalties ranging from low-single digit to high-single digit percentages of annual net sales of collaboration products which will be expensed as the commercial sales occur. In October 2021, the Company entered into a Collaboration and License Agreement, or the First Ginkgo Agreement, with Ginkgo. Under the First Ginkgo Agreement, Ginkgo will design next generation IgA proteases with potentially transformative therapeutic potential. In return, Ginkgo is eligible to earn research and development fees, clinical and commercial milestone payments of up to $85.0 million in cash, as well as certain milestone payments for fixed fair values in the form of shares of the Company’s common stock. The First Ginkgo Agreement was assessed for collaboration components and was determined not to be within the scope of ASC 808 as the risk and rewards are not shared by both parties. The Company will expense costs related to the First Ginkgo Agreement as incurred until regulatory approval is received in accordance with ASC 730. The Company is accounting for the contingently issuable shares of common stock to be issued in exchange for the license obtained from Ginkgo as a liability-classified, stock-based compensation arrangement with a non-employee which will be recognized when achievement of the milestones is probable. The Company will assess the capitalization of costs incurred after the receipt of regulatory approval and, if applicable, will amortize these payments based on the expected useful life of each asset, typically based on the expected commercial exclusivity period. The Company is also obligated to pay Ginkgo tiered royalties ranging from low-single digit to high-single digit percentages of annual net sales of collaboration products which will be expensed as the commercial sales occur. On June 13, 2022, the Company was notified of the achievement of the midpoint of the technical development plan under the First Ginkgo Agreement by Ginkgo. This milestone resulted in the payment of $0.5 million and issuance of 892,857 shares of the Company’s common stock then-valued at $1.0 million to Ginkgo during the year ended December 31, 2022. Genovis AB (publ.) License Agreement In October 2021, the Company entered into an Exclusive License Agreement, or the Genovis Agreement, with Genovis AB (publ.), or Genovis. Under the Genovis Agreement, the Company paid to Genovis an upfront payment in exchange for an exclusive license to Genovis’ IgG Protease, or Xork, enzyme technology across all therapeutic uses in humans, excluding research, preclinical, diagnostic and other potential non-therapeutic applications of the enzyme. Genovis is eligible to earn from the Company development and sales-based milestones and sublicensing fees. The Genovis Agreement was assessed for collaboration components and was determined not to be within the scope of ASC 808 as the risk and rewards are not shared by both parties. The Company will expense costs related to the Genovis Agreement as incurred until regulatory approval is received in accordance with ASC 730. The Company will assess the capitalization of costs incurred after the receipt of regulatory approval and, if applicable, will amortize these payments based on the expected useful life of each asset, typically based on the expected commercial exclusivity period. The Company is also obligated to pay Genovis tiered royalties of low double digit percentages of worldwide annual net sales of collaboration products which will be expensed as the commercial sales occur. In February 2023, the Company made a $4.0 million payment to Genovis as a result of the sublicense of Xork to Astellas. See Note 12 to these consolidated financial statements for further discussion on the Astellas Agreement. Cyrus Biotechnology, Inc. Collaboration and License Agreement In September 2021, the Company and Cyrus entered into a collaboration and license agreement, or the Cyrus Agreement. Pursuant to the Cyrus Agreement, Cyrus agreed to grant the Company an exclusive, worldwide license to certain intellectual property to form a protein engineering collaboration combining the Company’s ImmTOR platform with Cyrus’ ability to redesign protein therapeutics. The lead program is a proprietary interleukin-2, or IL-2, protein agonist designed to selectively promote expansion of regulatory T cells for treatment of patients with autoimmune diseases and other deleterious immune conditions. In return for the licensed intellectual property, the Company made an upfront payment and is obligated to pay certain discovery, development, and sales-based milestones which could total up to approximately $1.5 billion across multiple programs. The Cyrus Agreement was assessed for collaboration components and was determined not to be within the scope of ASC 808 as the risk and rewards are not shared by both parties. The Company will expense costs related to the Cyrus Agreement as incurred until regulatory approval is received in accordance with ASC 730. The Company will assess the capitalization of costs incurred after the receipt of regulatory approval and, if applicable, will amortize these payments based on the expected useful life of each asset, typically based on the expected commercial exclusivity period. The Company is also obligated to pay Cyrus tiered royalties ranging from mid-single digit to low-double digit percentages of annual net sales of collaboration products which will be expensed as the commercial sales occur. Additionally, on September 7, 2021, the Company entered into a stock purchase agreement, or the Series B Preferred Stock Purchase Agreement, in connection with the Cyrus Agreement. Pursuant to the Series B Preferred Stock Purchase Agreement, the Company purchased 2,326,934 shares of Cyrus’ Series B Preferred Stock, par value $0.0001 per share, at a purchase price of $0.8595 per share for $2.0 million. In accordance with ASC 810, the Company has a variable interest in Cyrus resulting from its equity investment. The Company will share in Cyrus’ expected losses or receive a portion of its expected returns and absorb the variability associated with changes in the entity’s net assets. However, the Company is not the primary beneficiary as it does not have the power to direct the activities most significant to Cyrus, and therefore it is not required to consolidate Cyrus. The Company has recognized the $2.0 million investment of Cyrus’ Series B Preferred Stock at cost on the purchase date. On June 13, 2022, the Company and Cyrus mutually agreed that the preclinical key in-vitro success milestone had been achieved. As of March 31, 2023, no impairment indicators are present and therefore the carrying value of the investment in Cyrus is $2.0 million on the accompanying consolidated balance sheet. The Company’s maximum exposure to loss related to this variable interest entity is limited to the carrying value of the investment. The Company has not provided financing to Cyrus other than the amount contractually required by the Series B Preferred Stock Purchase Agreement. Asklepios Biopharmaceutical, Inc. Feasibility Study and License Agreement In August 2019, the Company entered into a feasibility study and license agreement, or the AskBio Collaboration Agreement, with Asklepios Biopharmaceutical, Inc., or AskBio. Pursuant to the AskBio Collaboration Agreement, the Company and AskBio agreed to license intellectual property rights to each other as part of a collaboration to research, develop, and commercialize certain AAV gene therapy products utilizing the Company’s ImmTOR platform to enable re-dosing of such AAV gene therapy products to treat serious rare and orphan genetic diseases for which there is a significant unmet medical need. Pursuant to the AskBio Collaboration Agreement, the Company and AskBio agreed to conduct proof of concept studies to potentially validate the use of ImmTOR in conjunction with AskBio’s AAV gene therapy, or SEL-302 (previously disclosed as MMA-101, in combination with ImmTOR), for the treatment of MMA to mitigate the formation of neutralizing anti-AAV capsid antibodies, or the POC Studies. On April 29, 2021, the Company was notified by AskBio that AskBio intended to opt-out of development of the MMA indication. The AskBio Collaboration Agreement otherwise remains in effect. Consequently, the Company has assumed all rights to the MMA program. The Company filed an investigational new drug application, or IND, to conduct a Phase 1/2 clinical trial of its SEL-302 product candidate in pediatric patients with MMA in the third quarter of 2021. In December 2022, the Company initiated ReiMMAgine, the Phase 1/2 clinical trial of SEL-302, however, the Company has since paused further development of SEL-302 for the treatment of MMA. The SEL-399 program combined an empty AAV capsid (EMC-101), which is an AAV capsid containing no transgene, with ImmTOR and is being conducted in partnership with AskBio. Building on the preclinical data the Company has generated showing ImmTOR’s effect on mitigating or reducing the formation of neutralizing antibodies to AAV gene therapies, the Company completed a clinical trial of SEL-399 in healthy adult volunteers in Belgium. The goal of the SEL-399 clinical trial was to demonstrate the appropriate dose of ImmTOR in humans to mitigate the formation of antibodies to AAV capsids used in gene therapies. The Company believes this promising study in healthy volunteers provides support for the potential use of ImmTOR for the inhibition of neutralizing antibodies to AAV8 in gene therapy clinical trials. The Company and AskBio will share responsibility for the research, development and commercialization of products developed under the SEL-399 program collaboration. The parties will also share research, development, and commercialization costs equally for all collaboration products, but with a right of either party to opt out of certain products, and thereby no longer be required to share costs for such products. Each party will receive a percentage of net profits under the collaboration equal to the percentage of shared costs borne by such party in the development of such product. Pursuant to the AskBio Collaboration Agreement, AskBio is responsible for manufacturing the AAV capsids and AAV vectors and the Company is responsible for manufacturing ImmTOR. The AskBio Collaboration Agreement is considered to be within the scope of ASC 808, as both parties are active participants and exposed to the risks and rewards of the collaborative activity. The Company evaluated the terms of the AskBio Collaboration Agreement and has identified the following promises in the arrangement (1) conducting research and development activities to develop and commercialize products under the collaboration, or the R&D Services, (2) granting a non-exclusive, non-transferable, royalty-free, fully paid up, worldwide license to certain intellectual property of the Company, or the IP Rights, for the purpose of performing the POC Studies, or the Research License, (3) granting an exclusive, nontransferable, worldwide license to the IP Rights for use in certain indications, or the Collaboration License, (4) providing manufactured supply of preclinical and clinical ImmTOR, or the Manufactured Supply, (5) participation on identified steering committees responsible for the oversight of the collaboration, or the JSC Participation, and (6) granting an exclusive option to obtain a license under the IP Rights to research, develop and commercialize licensed products. The Company determined that the R&D Services, Research License, Collaboration License, Manufactured Supply, and JSC Participation were not capable of being distinct, and therefore must be combined into a single performance obligation. Therefore, promises (1) through (5) identified above were combined into a single performance obligation. Furthermore, the Company evaluated the related option agreement and determined that it does not provide AskBio with a material right under ASC 606 as the option was not priced at a discount. The Company noted that AskBio did not meet the definition of a customer within the scope of ASC 606 for any distinct performance obligations as the Company concluded that such items were not an output of the Company’s ordinary activities. As such, the Company determined that the entire arrangement would be accounted for within the scope of ASC 808. In accordance with ASC 808, collaboration expenses are recognized within research and development expense and selling, general and administrative expense on the Company’s condensed consolidated statements of operations and comprehensive income (loss). Under certain collaborative arrangements, the Company is entitled to reimbursement of certain research and development expense. Activities under collaborative arrangements for which the Company is entitled to reimbursement are considered to be collaborative activities under the scope of ASC 808. For these units of account, the Company does not analogize to ASC 606 or recognize revenue. Rather, the Company analogizes to the guidance in ASC 730, which requires that reimbursements from counterparties be recognized as an offset to the related costs. In accordance with ASC 730, the Company records reimbursement payments received from collaborators as reductions to research and development expense. During the three months ended March 31, 2023 and 2022, the Company recognized $0.1 million and $0.4 million, respectively, of collaboration expense under the AskBio Collaboration Agreement in which actual costs incurred by both parties approximate a 50% cost share. Massachusetts Institute of Technology In November 2008, the Company entered into an Exclusive Patent License Agreement, or the MIT License, with the Massachusetts Institute of Technology, or MIT, under which the Company received an exclusive royalty-bearing license to utilize patents held by MIT in exchange for upfront consideration and annual license maintenance fees. Such fees are expensed as incurred and have not been material to any period presented. In June 2020, the Company entered into a Fifth Amendment, or the MIT Amendment, to the MIT License, which is effective as of May 15, 2020. Pursuant to the MIT Amendment, certain of the Company’s diligence obligations were extended. The extension included the obligation to commence a Phase 3 trial for a licensed product by the second quarter of 2021 or to file an IND (or equivalent) with the FDA or comparable European regulatory agency for a licensed product by the second quarter of 2023. Additionally, certain of the Company’s development and regulatory milestones and payments upon achievement of such milestones were adjusted. As of March 31, 2023, and in connection with the execution of the Spark License Agreement, the Company has made contractual payments pursuant to the MIT License totaling $2.2 million. In connection with the Spark Purchase Agreement and the calculated premium paid by Spark for the equity investments made as described in Note 12 to the consolidated financial statements within the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, the Company has made additional contractual payments pursuant to the MIT License which totaled $0.4 million as of March 31, 2023. The Company made no additional payments during the three months ended March 31, 2023. Shenyang Sunshine Pharmaceutical Co., Ltd In May 2014, the Company entered into a license agreement, or the 3SBio License, with Shenyang Sunshine Pharmaceutical Co., Ltd., or 3SBio. The Company has paid to 3SBio an aggregate of $7.0 million in upfront and milestone-based payments under the 3SBio License as of March 31, 2023. The Company is required to make future payments to 3SBio contingent upon the occurrence of events related to the achievement of clinical and regulatory approval milestones of up to an aggregate of $15.0 million for products containing the Company’s ImmTOR platform. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company provides for income taxes under ASC 740. Under ASC 740, the Company provides deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax bases of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. The Company has provided a full valuation allowance against its net deferred tax assets, as the Company believes that it is more likely than not that the deferred tax assets will not be realized. Effective for tax years beginning on or after January 1, 2022, research and experimental expenditures under IRC Section 174 must be capitalized over five years when performed in the U.S. and 15 years for research and experimental expenditures performed outside of the U.S. As of March 31, 2023, the Company has performed a high-level analysis of the impact of this legislation enactment and determined the projected taxable loss position for 2023 does not result in income tax due. As of December 31, 2022, the Company has $62.4 million of federal net operating losses available, subject to an 80% limitation. The Company also has $2.3 million of federal tax credits, subject to a 75% limitation. The Company maintains its full valuation allowance. Utilization of the net operating loss and research and development credit carryforwards may be subject to a substantial annual limitation under Section 382 and 383 of the Internal Revenue Code due to ownership change limitations that have occurred previously, or that could occur in the future. These ownership changes may limit the amount of net operating loss and research and development credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. As of December 31, 2021, the Company completed both a Section 382 and research and development tax credit study through December 31, 2020. The Company generated research credits for the years ended December 31, 2022 and 2021, but has not conducted a formal study to document its qualified activities. The statute of limitations for assessment by the Internal Revenue Service and Massachusetts tax authorities is open for tax years since inception as the Company claimed research tax credits on its 2020 tax return which remains open for examination for the 2020 year as well as for any year in which a credit has been claimed. The Company files income tax returns in the United States and Massachusetts. There are currently no federal, state or foreign audits in progress. |
Defined Contribution Plan
Defined Contribution Plan | 3 Months Ended |
Mar. 31, 2023 | |
Retirement Benefits [Abstract] | |
Defined Contribution Plan | Defined Contribution PlanThe Company maintains a defined contribution plan, or the 401(k) Plan, under Section 401(k) of the Internal Revenue Code. The 401(k) Plan covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pretax basis. The 401(k) Plan provides for matching contributions on a portion of participant contributions pursuant to the 401(k) Plan’s matching formula. Commencing in January 2022, all matching contributions vest ratably over two years and participant contributions vest immediately. Contributions by the Company totaled $0.1 million during each of the three months ended March 31, 2023 and 2022. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies As of March 31, 2023, the Company was not a party to any litigation that could have a material adverse effect on the Company’s business, financial position, results of operations or cash flows. Other As permitted under Delaware law, the Company has agreed to indemnify its directors and officers for certain events or occurrences while the director or officer is, or was, serving at the Company’s request in such capacity. The term of the indemnification is for the director’s or officer’s lifetime. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ and officers’ insurance coverage that limits its exposure and enables it to recover a portion of any future amounts paid. The Company also has indemnification arrangements under certain of its facility leases that require it to indemnify the landlord against certain costs, expenses, fines, suits, claims, demands, liabilities, and actions directly resulting from certain breaches, violations, or non-performance of any covenant or condition of the Company’s lease. The term of the indemnification is for the term of the related lease agreement. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited. To date, the Company had not experienced any material losses related to any of its indemnification obligations, and no material claims with respect thereto were outstanding. The Company is a party in various other contractual disputes and potential claims arising in the ordinary course of business. The Company does not believe that the resolution of these matters will have a material adverse effect the Company’s business, financial position, results of operations or cash flows. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent EventsIn April 2023, the Board took steps to extend cash runway by pausing further development of SEL-302 for the treatment of methylmalonic acidemia, or MMA, and by conducting a targeted headcount reduction of approximately 25%. As a result of the headcount reduction, the Company estimates that it will incur approximately $1.0 million of cash charges related to severance and benefit costs, all of which the Company expects to incur in 2023. The Company intends to continue evaluating its development programs and operating expenses on an ongoing basis. As part of this ongoing evaluation, the Company may also seek collaboration partners for one or more of its development programs. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Recently Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments . Subsequently, in November 2018, the FASB issued ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments-Credit Losses . ASU 2016-13 requires entities to measure all expected credit losses for most financial assets held at the reporting date based on an expected loss model which includes historical experience, current conditions, and reasonable and supportable forecasts. ASU 2016-13 also requires enhanced disclosures to help financial statement users better understand significant estimates and judgments used in estimating credit losses. This ASU is effective for smaller reporting companies for fiscal years beginning after December 15, 2022, with early adoption permitted. The Company adopted the new standard effective January 1, 2023, using a modified retrospective transition method, and there was no impact on its consolidated financial statements or results of operations upon adoption. |
Marketable Securities and Inv_2
Marketable Securities and Investments (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Available-for-Sale Marketable Securities | The following table summarizes the marketable securities held as of December 31, 2022 (in thousands): Amortized Unrealized losses Fair December 31, 2022 U.S. government agency securities and treasuries $ 13,566 $ (9) $ 13,557 Corporate bonds $ 1,953 $ (2) $ 1,951 Commercial paper 12,656 — 12,656 Total $ 28,175 $ (11) $ 28,164 |
Net (Loss) Income Per Share (Ta
Net (Loss) Income Per Share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Net Loss Per Share | The following table sets forth the computation of basic and diluted net (loss) income per share for the three months ended March 31, 2023 and 2022 (in thousands, except share and per-share data): Three Months Ended 2023 2022 Numerator: Net (loss) income $ (21,663) $ 28,778 Less: Change in fair value of liability warrants — (18,515) Adjusted net (loss) income $ (21,663) $ 10,263 Denominator: Weighted-average common shares outstanding - basic 153,345,554 124,232,799 Dilutive effect of employee equity incentive plans and outstanding warrants — 3,340,686 Weighted-average common shares used in per share calculations - diluted 153,345,554 127,573,485 Net (loss) income per share: Basic $ (0.14) $ 0.23 Diluted $ (0.14) $ 0.08 |
Schedule of Potential Common Shares Issuable Upon Conversion of Warrants | The following table represents the potential dilutive shares of common stock excluded from the computation of the diluted net (loss) income per share for all periods presented, as the effect would have been anti-dilutive: Three Months Ended 2023 2022 Options, RSUs and ESPP shares 23,204,649 15,292,967 Warrants to purchase common stock 31,228,279 292,469 Total 54,432,928 15,585,436 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets Measured at Fair Value on a Recurring Basis | The following tables present the Company’s assets and liabilities that are measured at fair value on a recurring basis as of March 31, 2023 and December 31, 2022 (in thousands): March 31, 2023 Total Level 1 Level 2 Level 3 Assets: Money market funds (included in cash equivalents) $ 82,393 $ 82,393 $ — $ — Total assets $ 82,393 $ 82,393 $ — $ — Liabilities: Warrant liabilities $ 23,219 $ — $ — $ 23,219 Total liabilities $ 23,219 $ — $ — $ 23,219 December 31, 2022 Total Level 1 Level 2 Level 3 Assets: Money market funds (included in cash equivalents) $ 53,552 $ 53,552 $ — $ — Marketable securities: U.S. government agency securities and treasuries 13,557 — 13,557 — Corporate bonds 1,951 — 1,951 — Commercial paper 12,656 — 12,656 — Total assets $ 81,716 $ 53,552 $ 28,164 $ — Liabilities: Warrant liabilities $ 19,140 $ — $ — $ 19,140 Total liabilities $ 19,140 $ — $ — $ 19,140 |
Schedule of Cash and Cash Equivalents | The Company’s consolidated statements of cash flows include the following as of March 31, 2023 and 2022 (in thousands): March 31, 2023 2022 Cash and cash equivalents $ 125,925 $ 113,437 Short-term restricted cash 289 — Long-term restricted cash 1,311 1,379 Total cash, cash equivalents, and restricted cash $ 127,525 $ 114,816 |
Schedule of Restricted Cash and Cash Equivalents | The Company’s consolidated statements of cash flows include the following as of March 31, 2023 and 2022 (in thousands): March 31, 2023 2022 Cash and cash equivalents $ 125,925 $ 113,437 Short-term restricted cash 289 — Long-term restricted cash 1,311 1,379 Total cash, cash equivalents, and restricted cash $ 127,525 $ 114,816 |
Schedule of Fair Value Measurement Inputs and Valuation Techniques | A summary of the Black-Scholes pricing model assumptions used to record the fair value of the 2019 Warrants liability is as follows: March 31, December 31, 2023 2022 Risk-free interest rate 4.06 % 4.74 % Dividend yield — — Expected life (in years) 1.73 1.98 Expected volatility 78.69 % 79.92 % A summary of the Black-Scholes pricing model assumptions used to record the fair value of the 2022 Warrants liability is as follows: March 31, December 31, 2023 2022 Risk-free interest rate 3.60 % 4.22 % Dividend yield — — Expected life (in years) 4.03 4.28 Expected volatility 91.39 % 98.05 % |
Schedule Of Changes In The Warrant Liabilities | The following table reflects a roll-forward of fair value for the Company’s Level 3 warrant liabilities (see Note 10 to these unaudited consolidated financial statements), for the three months ended March 31, 2023 (in thousands): Warrant liabilities Fair value as of December 31, 2022 $ 19,140 Change in fair value 4,079 Fair value as of March 31, 2023 $ 23,219 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consists of the following (in thousands): March 31, December 31, 2023 2022 Laboratory equipment $ 6,253 $ 6,001 Computer equipment and software 702 697 Leasehold improvements 61 57 Furniture and fixtures 453 453 Office equipment 196 192 Construction in process 492 599 Total property and equipment 8,157 7,999 Less accumulated depreciation (5,392) (5,205) Property and equipment, net $ 2,765 $ 2,794 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following (in thousands): March 31, December 31, 2023 2022 Payroll and employee related expenses $ 2,206 $ 4,242 Accrued patent fees 594 696 Accrued external research and development costs 4,724 7,274 Accrued professional and consulting services 1,132 985 Accrued interest 215 222 Other 476 665 Accrued expenses $ 9,347 $ 14,084 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Schedule of Lease, Cost | For the three months ended March 31, 2023 and 2022, the components of lease costs were as follows (in thousands): Three Months Ended 2023 2022 Operating lease cost $ 696 $ 506 Variable lease cost 142 220 Short-term lease cost 3 3 Less sublease income (255) — Total lease cost $ 586 $ 729 The following summarizes additional information related to operating leases: March 31, 2023 2022 Weighted-average remaining lease term 5.1 years 6.1 years Weighted-average discount rate 9.7 % 8.9 % |
Schedule of Lessee, Operating Lease, Liability, Maturity | The maturity of the Company’s operating lease liabilities as of March 31, 2023 were as follows (in thousands): March 31, 2023 2023 (remainder) $ 2,015 2024 2,740 2025 2,818 2026 2,902 2027 2,990 Thereafter 946 Total future minimum lease payments 14,411 Less imputed interest 3,123 Total operating lease liabilities $ 11,288 |
Schedule of Operating Lease, Lease Income | The supplemental disclosure for the statement of cash flows related to operating leases was as follows (in thousands): March 31, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: $ 653 $ 457 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Term Loan And Unamortized Debt Discount Balances | Total 2020 Term Loan and unamortized debt discount balances as of March 31, 2023 are as follows (in thousands): Face value $ 25,000 Venture debt termination fee 2,250 Less: Debt discount (804) Less: Current portion of loan payable (10,218) Loan payable, net of current portion $ 16,228 |
Schedule of Future Minimum Payments on the Term Loans | Future minimum principal payments on the 2020 Term Loan as of March 31, 2023 are as follows (in thousands): Year ended: 2023 (remainder) $ 7,759 2024 10,345 2025 6,896 Total minimum principal payments $ 25,000 |
Equity (Tables)
Equity (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Schedule of Stockholders' Equity Note, Warrants or Rights | During the three months ended March 31, 2022, there were no warrants issued, exercised, or canceled. See Note 10 to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022 for further discussion of the terms related to the Company’s warrants. Number of Warrants Equity Liability classified Total Weighted average Outstanding at March 31, 2023 2,236,326 28,991,953 31,228,279 $ 1.53 |
Schedule of Authorized Shares of Common Stock for Future Issuance | The Company has authorized shares of common stock for future issuance as of March 31, 2023 as follows: Exercise of warrants 31,228,279 Shares available for future stock incentive awards 7,497,840 RSUs reserved for issuance 713 Unvested restricted stock units 2,454,915 Outstanding common stock options 20,646,905 Total 61,828,652 |
Stock Incentive Plans (Tables)
Stock Incentive Plans (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock-Based Compensation | Stock-based compensation expense by classification included within the consolidated statements of operations and comprehensive income (loss) was as follows (in thousands): Three Months Ended 2023 2022 Research and development $ 1,192 $ 1,018 General and administrative 1,084 1,735 Total stock-based compensation expense $ 2,276 $ 2,753 |
Schedule of Weighted Average Assumptions Used | The estimated grant date fair values of employee stock option awards granted under the 2016 Plan and the 2018 Inducement Incentive Award Plan were calculated using the Black-Scholes option pricing model, based on the following weighted-average assumptions: Three Months Ended 2023 2022 Risk-free interest rate 3.95 % 1.48 % Dividend yield — — Expected term 5.94 6.03 Expected volatility 94.64 % 91.84 % Weighted-average fair value of common stock $ 1.15 $ 3.26 |
Schedule of Options Activity | The following table summarizes the stock option activity under the 2008 Plan, the 2016 Plan, and the 2018 Inducement Incentive Award Plan: Weighted-average remaining Aggregate Number of Weighted-average contractual term intrinsic value options exercise price ($) (in years) (in thousands) Employees Outstanding at December 31, 2022 15,578,412 $ 3.44 7.57 $ 4 Granted 5,437,200 $ 1.15 Forfeited (634,946) $ 3.10 Outstanding at March 31, 2023 20,380,666 $ 2.84 8.15 $ 1,507 Vested at March 31, 2023 8,528,078 $ 3.98 6.77 $ 2 Vested and expected to vest at March 31, 2023 18,819,248 $ 2.93 8.05 $ 1,257 Non-employee consultants Outstanding at December 31, 2022 266,239 $ 8.05 5.08 $ — Outstanding at March 31, 2023 266,239 $ 8.05 4.83 $ — Vested at March 31, 2023 266,239 $ 8.05 4.83 $ — Vested and expected to vest at March 31, 2023 266,239 $ 8.05 4.83 $ — |
Schedule of Disclosure of Share-based Compensation Arrangements by Share-based Payment Award | The following table summarizes the Company’s restricted stock units under the 2016 Plan and 2018 Inducement Incentive Award Plan: Number of shares Weighted average Unvested at December 31, 2022 1,705,558 $ 2.62 Granted 1,054,600 1.13 Vested (277,193) 3.22 Forfeited (28,050) 2.06 Unvested at March 31, 2023 2,454,915 $ 1.92 |
Revenue Arrangements (Tables)
Revenue Arrangements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Changes in Contract Liabilities | The following table presents changes in the Company’s contract liabilities during the three months ended March 31, 2023 (in thousands): Balance at Balance at beginning of period Additions Deductions end of period Three Months Ended March 31, 2023 Contract liabilities: Deferred revenue $ 593 $ 10,500 $ (1,342) $ 9,751 Total contract liabilities $ 593 $ 10,500 $ (1,342) $ 9,751 |
Description of the Business (De
Description of the Business (Details) - USD ($) $ in Millions | 1 Months Ended | |
Apr. 30, 2023 | Mar. 31, 2023 | |
Cash and Cash Equivalents [Line Items] | ||
Cash, cash equivalents, restricted cash and marketable securities | $ 127.5 | |
Restricted cash and cash equivalents | 1.6 | |
Russian subsidiary | ||
Cash and Cash Equivalents [Line Items] | ||
Cash maintained in Russian bank accounts | $ 0.2 | |
Subsequent Event | ||
Cash and Cash Equivalents [Line Items] | ||
Number of positions eliminated, period percent | 25% |
Marketable Securities and Inv_3
Marketable Securities and Investments - Summary of Available-for-Sale Marketable Securities (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Debt Securities, Available-for-sale [Line Items] | |
Amortized cost | $ 28,175 |
Unrealized losses | (11) |
Fair value | 28,164 |
U.S. government agency securities and treasuries | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized cost | 13,566 |
Unrealized losses | (9) |
Fair value | 13,557 |
Corporate bonds | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized cost | 1,953 |
Unrealized losses | (2) |
Fair value | 1,951 |
Commercial paper | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized cost | 12,656 |
Unrealized losses | 0 |
Fair value | $ 12,656 |
Marketable Securities and Inv_4
Marketable Securities and Investments - Narrative (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | Sep. 07, 2021 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Investments | $ 2,000 | $ 2,000 | |
Cyrus Biotechnology, Inc. | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Investments | $ 2,000 | $ 2,000 | $ 2,000 |
Net (Loss) Income Per Share - C
Net (Loss) Income Per Share - Computation of Basic and Diluted Net Income (Loss) Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Numerator: | ||
Net (loss) income | $ (21,663) | $ 28,778 |
Less: Change in fair value of liability warrants | 0 | (18,515) |
Adjusted net (loss) income | (21,663) | 10,263 |
Adjusted net (loss) income | $ (21,663) | $ 10,263 |
Denominator: | ||
Weighted-average common shares outstanding - basic (in shares) | 153,345,554 | 124,232,799 |
Dilutive effect of employee equity incentive plans and outstanding warrants (in shares) | 0 | 3,340,686 |
Weighted-average common shares used in per share calculations - diluted (in shares) | 153,345,554 | 127,573,485 |
Net (loss) income per share: | ||
Basic (in dollars per share) | $ (0.14) | $ 0.23 |
Diluted (in dollars per share) | $ (0.14) | $ 0.08 |
Net (Loss) Income Per Share - S
Net (Loss) Income Per Share - Schedule of Potential Common Shares Issuable Upon Conversion of Warrants (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Potential common shares | ||
Total (in shares) | 54,432,928 | 15,585,436 |
Employees | ||
Potential common shares | ||
Total (in shares) | 23,204,649 | 15,292,967 |
Warrants to purchase common stock | ||
Potential common shares | ||
Total (in shares) | 31,228,279 | 292,469 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Assets Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Assets: | ||
Marketable securities: | $ 28,164 | |
Liabilities: | ||
Warrant liabilities | $ 23,219 | 19,140 |
U.S. government agency securities and treasuries | ||
Assets: | ||
Marketable securities: | 13,557 | |
Corporate bonds | ||
Assets: | ||
Marketable securities: | 1,951 | |
Commercial paper | ||
Assets: | ||
Marketable securities: | 12,656 | |
Recurring | ||
Assets: | ||
Total assets | 82,393 | 81,716 |
Liabilities: | ||
Warrant liabilities | 23,219 | 19,140 |
Total liabilities | 23,219 | 19,140 |
Recurring | U.S. government agency securities and treasuries | ||
Assets: | ||
Marketable securities: | 13,557 | |
Recurring | Corporate bonds | ||
Assets: | ||
Marketable securities: | 1,951 | |
Recurring | Commercial paper | ||
Assets: | ||
Marketable securities: | 12,656 | |
Recurring | Money market funds (included in cash equivalents) | ||
Assets: | ||
Money market funds (included in cash equivalents) | 82,393 | 53,552 |
Recurring | Level 1 | ||
Assets: | ||
Total assets | 82,393 | 53,552 |
Liabilities: | ||
Warrant liabilities | 0 | 0 |
Total liabilities | 0 | 0 |
Recurring | Level 1 | U.S. government agency securities and treasuries | ||
Assets: | ||
Marketable securities: | 0 | |
Recurring | Level 1 | Corporate bonds | ||
Assets: | ||
Marketable securities: | 0 | |
Recurring | Level 1 | Commercial paper | ||
Assets: | ||
Marketable securities: | 0 | |
Recurring | Level 1 | Money market funds (included in cash equivalents) | ||
Assets: | ||
Money market funds (included in cash equivalents) | 82,393 | 53,552 |
Recurring | Level 2 | ||
Assets: | ||
Total assets | 0 | 28,164 |
Liabilities: | ||
Warrant liabilities | 0 | 0 |
Total liabilities | 0 | 0 |
Recurring | Level 2 | U.S. government agency securities and treasuries | ||
Assets: | ||
Marketable securities: | 13,557 | |
Recurring | Level 2 | Corporate bonds | ||
Assets: | ||
Marketable securities: | 1,951 | |
Recurring | Level 2 | Commercial paper | ||
Assets: | ||
Marketable securities: | 12,656 | |
Recurring | Level 2 | Money market funds (included in cash equivalents) | ||
Assets: | ||
Money market funds (included in cash equivalents) | 0 | 0 |
Recurring | Level 3 | ||
Assets: | ||
Total assets | 0 | 0 |
Liabilities: | ||
Warrant liabilities | 23,219 | 19,140 |
Total liabilities | 23,219 | 19,140 |
Recurring | Level 3 | U.S. government agency securities and treasuries | ||
Assets: | ||
Marketable securities: | 0 | |
Recurring | Level 3 | Corporate bonds | ||
Assets: | ||
Marketable securities: | 0 | |
Recurring | Level 3 | Commercial paper | ||
Assets: | ||
Marketable securities: | 0 | |
Recurring | Level 3 | Money market funds (included in cash equivalents) | ||
Assets: | ||
Money market funds (included in cash equivalents) | $ 0 | $ 0 |
Fair Value Measurements - Narra
Fair Value Measurements - Narrative (Details) | 3 Months Ended | 6 Months Ended |
Mar. 31, 2023 USD ($) | Jun. 30, 2022 USD ($) | |
Fair Value Disclosures [Abstract] | ||
Fair value, measurement with unobservable inputs reconciliation, recurring basis, asset, transfers, net | $ 0 | |
Fair value, measurement with unobservable inputs reconciliation, recurring basis, liability, transfers, net | $ 0 | |
Dividend yield | Valuation technique, option pricing model | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Warrants and rights outstanding, measurement input | 0 |
Fair Value Measurements - Sch_2
Fair Value Measurements - Schedule of Cash and Cash Equivalents (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Fair Value Disclosures [Abstract] | ||||
Cash and cash equivalents | $ 125,925 | $ 106,438 | $ 113,437 | |
Short-term restricted cash | 289 | 0 | ||
Long-term restricted cash | 1,311 | 1,311 | 1,379 | |
Total cash, cash equivalents, and restricted cash | $ 127,525 | $ 108,038 | $ 114,816 | $ 115,436 |
Fair Value Measurements - Assum
Fair Value Measurements - Assumptions Used to Record the Fair Value of the Warrants (Details) - Valuation technique, option pricing model | Mar. 31, 2023 | Dec. 31, 2022 |
Risk-free interest rate | 2019 Warrants | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 0.0406 | 0.0474 |
Risk-free interest rate | 2022 Warrants | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 0.0360 | 0.0422 |
Dividend yield | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 0 | |
Dividend yield | 2019 Warrants | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 0 | 0 |
Dividend yield | 2022 Warrants | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 0 | 0 |
Expected life (in years) | 2019 Warrants | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, term | 1 year 8 months 23 days | 1 year 11 months 23 days |
Expected life (in years) | 2022 Warrants | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, term | 4 years 10 days | 4 years 3 months 10 days |
Expected volatility | 2019 Warrants | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 0.7869 | 0.7992 |
Expected volatility | 2022 Warrants | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 0.9139 | 0.9805 |
Fair Value Measurements - Chang
Fair Value Measurements - Change in the Warrant Liabilities (Details) - Warrant liabilities $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Fair value as of December 31, 2022 | $ 19,140 |
Change in fair value | 4,079 |
Fair value as of March 31, 2023 | $ 23,219 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 8,157 | $ 7,999 |
Less accumulated depreciation | (5,392) | (5,205) |
Property and equipment, net | 2,765 | 2,794 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 6,253 | 6,001 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 702 | 697 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 61 | 57 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 453 | 453 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 196 | 192 |
Construction in process | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 492 | $ 599 |
Property and Equipment - Narrat
Property and Equipment - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 0.2 | $ 0.1 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Payroll and employee related expenses | $ 2,206 | $ 4,242 |
Accrued patent fees | 594 | 696 |
Accrued external research and development costs | 4,724 | 7,274 |
Accrued professional and consulting services | 1,132 | 985 |
Accrued interest | 215 | 222 |
Other | 476 | 665 |
Accrued expenses | $ 9,347 | $ 14,084 |
Leases - Components of Lease Co
Leases - Components of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Leases [Abstract] | ||
Operating lease cost | $ 696 | $ 506 |
Variable lease cost | 142 | 220 |
Short-term lease cost | 3 | 3 |
Less sublease income | (255) | 0 |
Total lease cost | $ 586 | $ 729 |
Leases - Operating Lease, Liabi
Leases - Operating Lease, Liability, Maturity (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
Leases [Abstract] | |
2023 (remainder) | $ 2,015 |
2024 | 2,740 |
2025 | 2,818 |
2026 | 2,902 |
2027 | 2,990 |
Thereafter | 946 |
Total future minimum lease payments | 14,411 |
Less imputed interest | 3,123 |
Lease liabilities | $ 11,288 |
Leases - Other Information (Det
Leases - Other Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Leases [Abstract] | ||
Cash paid for amounts included in the measurement of lease liabilities: | $ 653 | $ 457 |
Leases - Lease Term and Discoun
Leases - Lease Term and Discount Rate (Details) | Mar. 31, 2023 | Mar. 31, 2022 |
Leases [Abstract] | ||
Operating lease, weighted average remaining lease term | 5 years 1 month 6 days | 6 years 1 month 6 days |
Operating lease, weighted average discount rate, percent | 9.70% | 8.90% |
Debt - Term Loans (Narrative) (
Debt - Term Loans (Narrative) (Details) - 2020 Term Loans - USD ($) $ in Millions | Mar. 31, 2023 | Dec. 31, 2022 |
Line of Credit Facility [Line Items] | ||
Loan and security agreement, percentage of consolidated cash | 100% | |
Loan and security agreement, percentage of then-outstanding obligations | 150% | |
Term loan facility | $ 25 | $ 25 |
Debt - Term Loan And Unamortize
Debt - Term Loan And Unamortized Debt Discount Balances (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Debt Instrument [Line Items] | ||
Loan payable, net of current portion | $ 16,228 | $ 17,786 |
2020 Term Loans | ||
Debt Instrument [Line Items] | ||
Face value | 25,000 | |
Venture debt termination fee | 2,250 | |
Less: Debt discount | (804) | |
Less: Current portion of loan payable | (10,218) | |
Loan payable, net of current portion | $ 16,228 |
Debt - Schedule of Future Minim
Debt - Schedule of Future Minimum Payments on the Term Loans (Details) - 2020 Term Loans $ in Thousands | Mar. 31, 2023 USD ($) |
Long-term Debt, Fiscal Year Maturity [Abstract] | |
2023 (remainder) | $ 7,759 |
2024 | 10,345 |
2025 | 6,896 |
Total minimum principal payments | $ 25,000 |
Equity - Narrative (Details)
Equity - Narrative (Details) - At-The-Market Offering - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Oct. 25, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Subsidiary, Sale of Stock [Line Items] | ||||
Sale common stock | $ 75,000 | |||
Sale of stock, number of shares issued in transaction (in shares) | 0 | 774,544 | ||
Net proceeds from issuance of common stock | $ 0 | $ 1,690 | $ 2,100 |
Equity - Warranty Activity (Det
Equity - Warranty Activity (Details) | Mar. 31, 2023 $ / shares shares |
Class of Warrant or Right [Line Items] | |
Class of warrant or right, outstanding (in shares) | 31,228,279 |
Exercise price (in dollars per share) | $ / shares | $ 1.53 |
Warrants to purchase common stock | |
Class of Warrant or Right [Line Items] | |
Class of warrant or right, outstanding (in shares) | 28,991,953 |
Warrants to purchase common stock | |
Class of Warrant or Right [Line Items] | |
Class of warrant or right, outstanding (in shares) | 2,236,326 |
Equity - Schedule of Authorized
Equity - Schedule of Authorized Shares of Common Stock for Future Issuance (Details) | Mar. 31, 2023 shares |
Class of Stock [Line Items] | |
Total (in shares) | 61,828,652 |
Shares available for future stock incentive awards | |
Class of Stock [Line Items] | |
Total (in shares) | 7,497,840 |
RSUs reserved for issuance | |
Class of Stock [Line Items] | |
Total (in shares) | 713 |
Unvested restricted stock units | |
Class of Stock [Line Items] | |
Total (in shares) | 2,454,915 |
Outstanding common stock options | |
Class of Stock [Line Items] | |
Total (in shares) | 20,646,905 |
Exercise of warrants | |
Class of Stock [Line Items] | |
Total (in shares) | 31,228,279 |
Stock Incentive Plans - Narrati
Stock Incentive Plans - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | ||||
Jan. 31, 2023 | Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2019 | Sep. 30, 2018 | Jun. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock authorized and reserved for future issuance (in shares) | 61,828,652 | |||||
Employee stock option grants | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock authorized and reserved for future issuance (in shares) | 7,497,840 | |||||
Weighted average grant date fair value of stock options (in dollars per share) | $ 0.90 | $ 2.45 | ||||
Unrecognized compensation expense related to unvested employee stock options | $ 15.1 | |||||
Weighted average period for recognition | 2 years 10 months 24 days | |||||
Estimated forfeitures rate | 10% | |||||
Restricted Stock Units (RSUs) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Grants in period (in shares) | 1,054,600 | |||||
Grants in period (in dollars per share) | $ 1.13 | |||||
2016 Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares authorized for grants (in shares) | 1,210,256 | |||||
Number of shares authorized, increase (in shares) | 6,121,697 | |||||
Common stock authorized and reserved for future issuance (in shares) | 2,011,908 | |||||
2016 Plan | Restricted Stock Units (RSUs) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Grants in period (in shares) | 1,054,600 | |||||
Grants in period (in dollars per share) | $ 1.13 | |||||
Award vesting term | 4 years | |||||
Employment Inducement Incentive Award Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares authorized for grants (in shares) | 425,858 | |||||
Common stock authorized and reserved for future issuance (in shares) | 2,000,000 | 1,175,000 | ||||
Employment Inducement Incentive Award Plan | Restricted Stock Units (RSUs) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Weighted average period for recognition | 2 years 9 months 18 days | |||||
Unrecognized compensation expense | $ 3.4 | |||||
ESPP | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares authorized, increase (in shares) | 1,530,424 | |||||
Common stock authorized and reserved for future issuance (in shares) | 5,060,074 | 173,076 |
Stock Incentive Plans - Schedul
Stock Incentive Plans - Schedule of Stock-Based Compensation Expense Related to Stock Options and Restricted Common Stock (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Total stock-based compensation expense | $ 2,276 | $ 2,753 | |
Ginkgo Agreement | |||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Sale of stock, consideration received on transaction | $ 1,000 | ||
Research and development | |||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Total stock-based compensation expense | 1,192 | 1,018 | |
General and administrative | |||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | |||
Total stock-based compensation expense | $ 1,084 | $ 1,735 |
Stock Incentive Plans - Sched_2
Stock Incentive Plans - Schedule of Assumptions (Details) - Shares available for future stock incentive awards - $ / shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 3.95% | 1.48% |
Dividend yield | 0% | 0% |
Expected term | 5 years 11 months 8 days | 6 years 10 days |
Expected volatility | 94.64% | 91.84% |
Weighted-average fair value of common stock (in dollars per share) | $ 1.15 | $ 3.26 |
Stock Incentive Plans - Sched_3
Stock Incentive Plans - Schedule of Options Activity (Details) - 2008 Plan, 2016 Plan, and 2018 Inducement Incentive Award Plan - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Employees | ||
Number of Options | ||
Beginning balance (in shares) | 15,578,412 | |
Granted (in shares) | 5,437,200 | |
Forfeited (in shares) | (634,946) | |
Ending balance (in shares) | 20,380,666 | 15,578,412 |
Vested (in shares) | 8,528,078 | |
Vested and expected to vest (in shares) | 18,819,248 | |
Weighted-average exercise price | ||
Beginning balance (in dollars per share) | $ 3.44 | |
Granted (in dollars per share) | 1.15 | |
Forfeited (in dollars per share) | 3.10 | |
Ending balance (in dollars per share) | 2.84 | $ 3.44 |
Vested (in dollars per share) | 3.98 | |
Vested and expected to vest (in dollars per share) | $ 2.93 | |
Weighted-average remaining contractual term | ||
Outstanding, term | 8 years 1 month 24 days | 7 years 6 months 25 days |
Vested, term | 6 years 9 months 7 days | |
Vested and expected to vest, term | 8 years 18 days | |
Aggregate intrinsic value | ||
Outstanding | $ 1,507 | $ 4 |
Vested | 2 | |
Vested and expected to vest | $ 1,257 | |
Non-employee consultants | ||
Number of Options | ||
Beginning balance (in shares) | 266,239 | |
Ending balance (in shares) | 266,239 | 266,239 |
Vested (in shares) | 266,239 | |
Vested and expected to vest (in shares) | 266,239 | |
Weighted-average exercise price | ||
Beginning balance (in dollars per share) | $ 8.05 | |
Ending balance (in dollars per share) | 8.05 | $ 8.05 |
Vested (in dollars per share) | 8.05 | |
Vested and expected to vest (in dollars per share) | $ 8.05 | |
Weighted-average remaining contractual term | ||
Outstanding, term | 4 years 9 months 29 days | 5 years 29 days |
Vested, term | 4 years 9 months 29 days | |
Vested and expected to vest, term | 4 years 9 months 29 days | |
Aggregate intrinsic value | ||
Outstanding | $ 0 | $ 0 |
Vested | 0 | |
Vested and expected to vest | $ 0 |
Stock Incentive Plans - Restric
Stock Incentive Plans - Restricted Stock Units (Details) - Restricted Stock Units (RSUs) | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Unvested at beginning of period (in shares) | shares | 1,705,558 |
Grants in period (in shares) | shares | 1,054,600 |
Vested in period (in shares) | shares | (277,193) |
Forfeited in period (in shares) | shares | (28,050) |
Unvested at end of period (in shares) | shares | 2,454,915 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |
Unvested at beginning of period (in dollars per share) | $ / shares | $ 2.62 |
Grants in period (in dollars per share) | $ / shares | 1.13 |
Vested in period (in dollars per share) | $ / shares | 3.22 |
Forfeited in period (in dollars per share) | $ / shares | 2.06 |
Unvested at end of period (in dollars per share) | $ / shares | $ 1.92 |
Stock Incentive Plans - Employe
Stock Incentive Plans - Employee Stock Purchase Plan (Narrative) (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Jan. 31, 2023 | Mar. 31, 2023 | Mar. 31, 2022 | Jun. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock authorized and reserved for future issuance (in shares) | 61,828,652 | |||
Stock-based compensation expense | $ 2,276 | $ 2,753 | ||
ESPP | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock authorized and reserved for future issuance (in shares) | 5,060,074 | 173,076 | ||
Number of shares authorized, increase (in shares) | 1,530,424 | |||
Shares of common stock issued to employees under the ESPP (in shares) | 108,068 | |||
Stock-based compensation expense | $ 100 | $ 100 |
Revenue Arrangements - Narrativ
Revenue Arrangements - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |||||
Jan. 31, 2023 | Oct. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation of Revenue [Line Items] | |||||||
Short-term contract liability | $ 4,232 | $ 593 | |||||
Long-term contract liability | 5,519 | 0 | |||||
Revenue recognized | (1,342) | ||||||
Accounts receivable | 6,839 | 6,596 | |||||
Collaboration and license revenue | 5,938 | $ 33,999 | |||||
Remaining performance obligation | 9,800 | ||||||
SOBI Purchase Agreement | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Revenue recognized | 23,800 | ||||||
Accounts receivable | 5,700 | 5,000 | |||||
Collaboration and license revenue | 4,400 | ||||||
Contract assets | 100 | ||||||
Contract assets, current | 100 | ||||||
Contract assets, noncurrent | 100 | ||||||
SOBI Purchase Agreement | Unbilled Revenues | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Accounts receivable | 1,800 | 3,200 | |||||
Takeda Agreement | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Upfront cash payment | $ 3,000 | ||||||
Short-term contract liability | 200 | 100 | |||||
Asset, reclassified to receivable | 500 | ||||||
Revenue recognized | 1,000 | ||||||
Future additional payments, expected | $ 1,124,000 | ||||||
Collaboration and license revenue | $ 500 | ||||||
Collaborative Arrangement | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Upfront cash payment | $ 75,000 | ||||||
Sales milestone payments | $ 630,000 | ||||||
Astellas Gene Therapies | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Upfront payment | $ 10,000 | ||||||
Development and commercial milestones plus royalties | 340,000 | ||||||
Reimbursement percentage, budgeted costs incurred to complete the development | 25% | ||||||
Upfront cash payment | 10,000 | ||||||
Development cost reimbursements | $ 5,500 | ||||||
Short-term contract liability | $ 4,100 | ||||||
Long-term contract liability | 5,500 | ||||||
Asset, reclassified to receivable | 200 | ||||||
Revenue recognized | 600 | ||||||
Sarepta Therapeutics, Inc. | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Short-term contract liability | $ 500 | ||||||
Revenue recognized | $ 500 | 100 | |||||
Option term | 24 months | ||||||
Spark License Agreement | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Short-term contract liability | $ 9,200 | ||||||
Revenue recognized | $ 9,200 |
Revenue Arrangements - Schedule
Revenue Arrangements - Schedule of Changes in Contract Liabilities (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Contract liabilities: | |
Deferred revenue, beginning of period | $ 593 |
Deferred revenue, additions | 10,500 |
Deferred revenue, deductions | (1,342) |
Deferred revenue, end of period | 9,751 |
Contract liabilities, beginning of period | 593 |
Contract liabilities, additions | 10,500 |
Contract liabilities, deductions | (1,342) |
Contract liabilities, end of period | $ 9,751 |
Collaboration and License Agr_2
Collaboration and License Agreements - Ginkgo Agreement (Details) - Ginkgo Agreement - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Jan. 03, 2023 | Jun. 13, 2022 | Oct. 31, 2021 | Dec. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Clinical and commercial milestone payment, expected | $ 207 | $ 85 | ||
Milestone payment | $ 0.5 | |||
Sale of stock, number of shares issued in transaction (in shares) | 892,857 | |||
Sale common stock | $ 1 |
Collaboration and License Agr_3
Collaboration and License Agreements - Genovis (Details) - USD ($) $ in Millions | 1 Months Ended | |
Jun. 13, 2022 | Feb. 28, 2023 | |
Ginkgo Agreement | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Milestone payment | $ 0.5 | |
Genovis AB | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Milestone payment | $ 4 |
Collaboration and License Agr_4
Collaboration and License Agreements - Cyrus Biotechnology, Inc. (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands | Sep. 07, 2021 | Mar. 31, 2023 | Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Equity securities without readily determinable fair value, amount | $ 2,000 | $ 2,000 | |
Cyrus Biotechnology, Inc. | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Milestone payment | $ 1,500,000 | ||
Equity securities, stock purchase agreement, shares purchased (in shares) | 2,326,934 | ||
Equity securities without readily determinable fair value, amount | $ 2,000 | $ 2,000 | $ 2,000 |
Cyrus Biotechnology, Inc. | Series B Preferred Stock Purchase Agreement | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Equity securities, stock purchase agreement, par value per share (in dollars per share) | $ 0.0001 | ||
Equity securities, stock purchase agreement, purchase price per share (in dollars per share) | $ 0.8595 |
Collaboration and License Agr_5
Collaboration and License Agreements - AskBio (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Collaboration expense | $ 24,319 | $ 23,226 |
AskBio License | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Collaboration expense | $ 100 | $ 400 |
Cost share percentage | 50% |
Collaboration and License Agr_6
Collaboration and License Agreements - MIT (Narrative) (Details) - Spark License Agreement | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Contractual payments defined in the Exclusive Patent License agreement | $ 0 |
MIT | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Contractual payments defined in the Exclusive Patent License agreement | 2,200,000 |
License and option agreement, payments made relative to calculated premium paid for initial equity investment made under the purchase agreement | $ 400,000 |
Collaboration and License Agr_7
Collaboration and License Agreements - Shenyang Sunshine Pharmaceutical Co., Ltd (Narrative) (Details) - 3SBio License $ in Millions | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Aggregate amount of upfront and milestone-based payments | $ 7 |
Aggregate amount for future payments upon achievement of clinical and regulatory approval milestones for products containing ImmTOR platform | $ 15 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) $ in Millions | Dec. 31, 2022 USD ($) |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Federal operating loss carryforwards | $ 62.4 |
Domestic Tax Authority | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Research and development credits | $ 2.3 |
Defined Contribution Plan (Deta
Defined Contribution Plan (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Retirement Benefits [Abstract] | ||
Vesting period | 2 years | |
Employer contribution made, net | $ 0.1 | $ 0.1 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event $ in Millions | 1 Months Ended |
Apr. 30, 2023 USD ($) | |
Subsequent Event [Line Items] | |
Number of positions eliminated, period percent | 25% |
Severance and benefit costs | $ 1 |