Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2022 | Apr. 29, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2022 | |
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, $0.0001 par value per share | |
Trading Symbol | SELB | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Smaller Reporting Company | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 151,809,416 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001453687 | |
Current Fiscal Year End Date | --12-31 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 113,437 | $ 114,057 |
Marketable securities | 3,997 | 13,998 |
Accounts receivable | 7,153 | 9,914 |
Prepaid expenses and other current assets | 5,420 | 6,474 |
Total current assets | 130,007 | 144,443 |
Property and equipment, net | 2,689 | 2,142 |
Right-of-use asset, net | 9,536 | 9,829 |
Long-term restricted cash | 1,379 | 1,379 |
Investments | 2,000 | 2,000 |
Other assets | 85 | 90 |
Total assets | 145,696 | 159,883 |
Current liabilities: | ||
Accounts payable | 264 | 224 |
Accrued expenses | 8,889 | 10,533 |
Loan payable | 696 | 5,961 |
Lease liability | 1,087 | 1,049 |
Income taxes payable | 320 | 601 |
Deferred revenue | 27,990 | 53,883 |
Total current liabilities | 39,246 | 72,251 |
Non-current liabilities: | ||
Loan payable, net of current portion | 25,042 | 19,673 |
Lease liability | 8,316 | 8,598 |
Deferred revenue | 10,420 | 11,417 |
Warrant liabilities | 6,908 | 25,423 |
Total liabilities | 89,932 | 137,362 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding at March 31, 2022 and December 31, 2021 | 0 | 0 |
Common stock, $0.0001 par value; 200,000,000 shares authorized; 124,380,844 and 123,622,965 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively | 12 | 12 |
Additional paid-in capital | 461,888 | 457,391 |
Accumulated deficit | (401,538) | (430,316) |
Accumulated other comprehensive loss | (4,598) | (4,566) |
Total stockholders’ equity | 55,764 | 22,521 |
Total liabilities and stockholders’ equity | $ 145,696 | $ 159,883 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
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) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 124,380,844 | 123,622,965 |
Common stock, shares outstanding (in shares) | 124,380,844 | 123,622,965 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | ||
Collaboration and license revenue | $ 33,999 | $ 11,050 |
Operating expenses: | ||
Research and development | 17,689 | 13,004 |
General and administrative | 5,537 | 5,204 |
Total operating expenses | 23,226 | 18,208 |
Operating income (loss) | 10,773 | (7,158) |
Investment income | 15 | 12 |
Foreign currency transaction, net | 28 | 7 |
Interest expense | (707) | (711) |
Change in fair value of warrant liabilities | 18,515 | (16,747) |
Other income, net | 154 | 0 |
Net income (loss) | 28,778 | (24,597) |
Other comprehensive income (loss): | ||
Foreign currency translation adjustment | (32) | (6) |
Unrealized (losses) on marketable securities | 0 | (1) |
Total comprehensive income (loss) | $ 28,746 | $ (24,604) |
Net income (loss) per share: | ||
Basic (in dollars per share) | $ 0.23 | $ (0.22) |
Diluted (in dollars per share) | $ 0.08 | $ (0.22) |
Weighted average common shares outstanding: | ||
Basic (in shares) | 124,232,799 | 110,742,150 |
Diluted (in shares) | 127,573,485 | 110,742,150 |
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, 2020 | 108,071,249 | ||||
Beginning balance at Dec. 31, 2020 | $ (18,006) | $ 11 | $ 391,175 | $ (404,629) | $ (4,563) |
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 34,696 | ||||
Issuance of common stock under Employee Stock Purchase Plan | 72 | 72 | |||
Issuance of common stock upon exercise of options (in shares) | 153,278 | ||||
Issuance of common stock upon exercise of options | 244 | 244 | |||
Issuance of vested restricted stock units (in shares) | 10,937 | ||||
Issuance of vested restricted stock units | 0 | ||||
Issuance of common stock through at-the-market offering, net (in shares) | 4,706,844 | ||||
Issuance of common stock through at-the-market offering, net | 20,943 | 20,943 | |||
Stock-based compensation expense | 1,780 | 1,780 | |||
Foreign currency translation adjustment | (6) | (6) | |||
Unrealized (losses) on marketable securities | (1) | (1) | |||
Net income (loss) | (24,597) | (24,597) | |||
Ending balance (in shares) at Mar. 31, 2021 | 112,977,004 | ||||
Ending balance at Mar. 31, 2021 | $ (19,571) | $ 11 | 414,214 | (429,226) | (4,570) |
Beginning balance (in shares) at Dec. 31, 2021 | 123,622,965 | 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 | |||
Foreign currency translation adjustment | (32) | (32) | |||
Unrealized (losses) on marketable securities | 0 | ||||
Net income (loss) | $ 28,778 | 28,778 | |||
Ending balance (in shares) at Mar. 31, 2022 | 124,380,844 | 124,380,844 | |||
Ending balance at Mar. 31, 2022 | $ 55,764 | $ 12 | $ 461,888 | $ (401,538) | $ (4,598) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash flows from operating activities | ||
Net income (loss) | $ 28,778 | $ (24,597) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 351 | 207 |
Amortization of premiums and discounts on marketable securities | 1 | 14 |
Non-cash lease expense | 293 | 272 |
(Gain) on disposal of property and equipment | (147) | 0 |
Stock-based compensation expense | 2,753 | 1,780 |
Non-cash interest expense | 383 | 387 |
Warrant liabilities revaluation | (18,515) | 16,747 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 2,761 | (1,118) |
Prepaid expenses, deposits and other assets | 853 | (1,512) |
Accounts payable | 18 | 151 |
Income taxes payable | (281) | 0 |
Deferred revenue | (26,890) | (2,728) |
Accrued expenses and other liabilities | (2,222) | (1,736) |
Net cash (used in) operating activities | (11,864) | (12,133) |
Cash flows from investing activities | ||
Proceeds from maturities of marketable securities | 10,000 | 0 |
Purchases of marketable securities | 0 | (22,420) |
Purchases of property and equipment | (455) | (25) |
Net cash provided by (used in) investing activities | 9,545 | (22,445) |
Cash flows from financing activities | ||
Debt amendment fee included in Debt Discount | (110) | 0 |
Net proceeds from issuance of common stock | 1,690 | 20,991 |
Proceeds from exercise of stock options | 21 | 244 |
Proceeds from issuance of common stock under Employee Stock Purchase Plan | 127 | 72 |
Net cash provided by financing activities | 1,728 | 21,307 |
Effect of exchange rate changes on cash | (29) | (7) |
Net change in cash, cash equivalents, and restricted cash | (620) | (13,278) |
Cash, cash equivalents, and restricted cash at beginning of period | 115,436 | 140,064 |
Cash, cash equivalents, and restricted cash at end of period | 114,816 | 126,786 |
Supplemental cash flow information | ||
Cash paid for interest | 494 | 494 |
Noncash investing and financing activities | ||
Purchase of property and equipment not yet paid | 91 | 10 |
Equity offering costs in accrued liabilities | $ 94 | $ 48 |
Description of the Business
Description of the Business | 3 Months Ended |
Mar. 31, 2022 | |
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 biopharmaceutical company. The Company’s ImmTOR ® platform encapsulates rapamycin, also known as sirolimus, an FDA approved immunomodulator, in biodegradable nanoparticles. ImmTOR is designed to induce antigen-specific immune tolerance. The Company believes, by combining ImmTOR with antigens of interest, the Company’s precision immune tolerance platform has the potential to restore self-tolerance to auto-antigens in autoimmune diseases, amplify the efficacy of biologics (including gene therapies) and mitigate the formation of anti-drug antibodies, or ADAs, against biologic drugs. 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, 2022 and 2021 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, 2021 included in the Company’s Annual Report on Form 10-K that was filed with the SEC on March 10, 2022. 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, 2022, the consolidated results of operations for the three months ended March 31, 2022, and cash flows for the three months ended March 31, 2022. Such adjustments are of a normal and recurring nature. The results of operations for the three months ended March 31, 2022 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2022. 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 the initial public offering of its common stock, private placements of its common stock, issuances of common and preferred stock, debt, research grants, research collaborations and licenses. 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, 2022, the Company’s cash, cash equivalents, restricted cash and marketable securities were $118.8 million, of which $1.4 million was restricted cash related to lease commitments and $0.3 million was held by its Russian subsidiary designated solely for use in its operations. The Company believes the cash, cash equivalents, restricted cash and marketable securities as of March 31, 2022 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 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. At this time, any impact of COVID-19 on the Company’s business, revenues, results of operations and financial condition will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the pandemic, the emergence of new virus variants, travel restrictions and social distancing in the United States and other countries, business closures or disruptions, supply chain disruptions, the ultimate impact on financial markets and the global economy, and the effectiveness of actions taken in the United States and other countries to contain and treat the disease. 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, 2022, 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, 2022 | |
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, 2021. There have been no material changes during the three months ended March 31, 2022, with the exception of the matters discussed in recent accounting pronouncements. Recent Accounting Pronouncements Recently Adopted In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt – Modifications and Extinguishments (Subtopic 470-50), Compensation – Stock Compensation (Topic 718), and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer's Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options . ASU 2021-04 provides guidance as to how entities should account for a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option (i.e., a warrant) that remains equity-classified after modification or exchange as an exchange of the original instrument for a new instrument. An entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring on or after the effective date. This new standard was effective for all entities for fiscal years beginning after December 15, 2021. The adoption of ASU 2021-04 did not have an impact on the Company’s financial position or results of operations upon adoption. Not Yet Adopted In August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) . ASU 2020-06 simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. This new standard will be effective for smaller reporting companies for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. The Company is assessing the impact this standard will have on its consolidated financial statements and disclosures. 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 |
Marketable Securities and Inves
Marketable Securities and Investments | 3 Months Ended |
Mar. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities and Investments | Marketable Securities and Investments The following table summarizes the marketable securities held as of March 31, 2022 and December 31, 2021 (in thousands): Amortized Unrealized gains Unrealized losses Fair March 31, 2022 Commercial paper 3,997 — — 3,997 Total $ 3,997 $ — $ — $ 3,997 December 31, 2021 Corporate bonds $ 2,007 $ — $ (1) $ 2,006 Commercial paper 11,992 — — 11,992 Total $ 13,999 $ — $ (1) $ 13,998 All marketable securities held at March 31, 2022 and December 31, 2021 had maturities of less than 12 months when purchased and are classified as short-term marketable securities on the accompanying consolidated balance sheet. During the three months ended March 31, 2022, there were no marketable securities adjusted for other than temporary declines in fair value. The Company does not intend to sell its investments and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost bases, which may be at maturity. Investments As of March 31, 2022 and December 31, 2021, 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 Income (Loss) Per Share
Net Income (Loss) Per Share | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) Per Share | Net Income (Loss) Per Share The Company has reported a net income for the three months ended March 31, 2022 and a net loss for the three months ended March 31, 2021. The following table sets forth the computation of basic and diluted net income (loss) per share (in thousands, except share and per-share data): Three Months Ended 2022 2021 Numerator: Net income (loss) $ 28,778 $ (24,597) Less: Change in fair value of 2019 Warrants (18,515) — Adjusted net income (loss) $ 10,263 $ (24,597) Denominator: Weighted-average common shares outstanding - basic 124,232,799 110,742,150 Dilutive effect of employee equity incentive plans and outstanding 2019 warrants 3,340,686 — Weighted-average common shares used in per share calculations - diluted 127,573,485 110,742,150 Net income (loss) per share: Basic $ 0.23 $ (0.22) Diluted $ 0.08 $ (0.22) The following table represents the potential dilutive shares of common stock excluded from the computation of the diluted net loss per share for all periods presented, as the effect would have been anti-dilutive: Three Months Ended 2022 2021 Options, RSUs and ESPP shares 15,292,967 10,864,811 Warrants to purchase common stock 292,469 12,378,016 Total 15,585,436 23,242,827 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2022 | |
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, 2022 and December 31, 2021 (in thousands): March 31, 2022 Total Level 1 Level 2 Level 3 Assets: Money market funds (included in cash equivalents) $ 76,622 $ 76,622 $ — $ — Marketable securities: Commercial paper 3,997 — 3,997 — Total assets $ 80,619 $ 76,622 $ 3,997 $ — Liabilities: Warrant liabilities $ 6,908 $ — $ — $ 6,908 Total liabilities $ 6,908 $ — $ — $ 6,908 December 31, 2021 Total Level 1 Level 2 Level 3 Assets: Money market funds (included in cash equivalents) $ 66,563 $ 66,563 $ — $ — Marketable securities: Corporate bonds 2,006 — 2,006 — Commercial paper 11,992 — 11,992 — Total assets $ 80,561 $ 66,563 $ 13,998 $ — Liabilities: Warrant liabilities $ 25,423 $ — $ — $ 25,423 Total liabilities $ 25,423 $ — $ — $ 25,423 There were no transfers within the fair value hierarchy during the three months ended March 31, 2022 or year ended December 31, 2021. Cash, Cash Equivalents, and Restricted Cash As of March 31, 2022 and December 31, 2021, 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, 2022, the Company had restricted cash balances relating to a secured letter of credit in connection with its lease for the Company’s headquarters. The Company’s consolidated statements of cash flows include the following as of March 31, 2022 and 2021 (in thousands): March 31, 2022 2021 Cash and cash equivalents $ 113,437 $ 125,407 Long-term restricted cash 1,379 1,379 Total cash, cash equivalents, and restricted cash $ 114,816 $ 126,786 Marketable Securities As of March 31, 2022, marketable securities classified as Level 2 within the valuation hierarchy consist of 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, 2022, 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, 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 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 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 upon issuance using the Black-Scholes valuation model and is required to revalue the 2019 Warrants at each reporting date with any changes in fair value recorded in the statement of operations and comprehensive income (loss). The valuation of the 2019 Warrants is considered Level 3 of the fair value hierarchy due to the need to use assumptions in the valuation that are both significant to the fair value measurement and unobservable including the volatility rate and the estimated term of the 2019 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 changes in the fair values of the Level 3 warrant liability are reflected in the statement of operations and comprehensive income (loss) for the three months ended March 31, 2022 and 2021. The estimated fair value of 2019 Warrants is 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 is assumed to be equivalent to their remaining contractual term which expires on December 23, 2024. 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 2019 Warrants. A summary of the Black-Scholes pricing model assumptions used to record the fair value of the warrant liability is as follows: March 31, December 31, 2022 2021 Risk-free interest rate 2.45 % 0.97 % Dividend yield — — Expected life (in years) 2.73 2.98 Expected volatility 93.60 % 96.10 % 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), for the three months ended March 31, 2022 (in thousands): Warrant liabilities Fair value as of December 31, 2021 $ 25,423 Change in fair value (18,515) Fair value as of March 31, 2022 $ 6,908 |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment Property and equipment consists of the following (in thousands): March 31, December 31, 2022 2021 Laboratory equipment $ 5,771 $ 5,134 Computer equipment and software 683 731 Leasehold improvements 48 45 Furniture and fixtures 331 332 Office equipment 163 163 Construction in process 354 534 Total property and equipment 7,350 6,939 Less accumulated depreciation (4,661) (4,797) Property and equipment, net $ 2,689 $ 2,142 Depreciation expense was $0.1 million for each of the three months ended March 31, 2022 and 2021, respectively. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consist of the following (in thousands): March 31, December 31, 2022 2021 Payroll and employee related expenses $ 1,116 $ 3,179 Accrued patent fees 711 309 Accrued external research and development costs 4,973 4,339 Accrued professional and consulting services 1,560 815 Accrued interest 179 170 Other 350 1,721 Accrued expenses $ 8,889 $ 10,533 Other accrued expenses as of March 31, 2022 and December 31, 2021 include a $0.9 million estimated liability for the settlement of litigation relating to the two lawsuits described further within Note 17. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Leases | Leases For the three months ended March 31, 2022 and 2021 the components of lease costs were as follows (in thousands): Three Months Ended 2022 2021 Operating lease cost $ 506 $ 444 Variable lease cost 220 288 Short-term lease cost 3 3 Total lease cost $ 729 $ 735 The maturity of the Company’s operating lease liabilities as of March 31, 2022 were as follows (in thousands): March 31, 2022 2022 (remainder) 1,409 2023 1,922 2024 1,980 2025 2,039 2026 2,101 Thereafter 2,844 Total future minimum lease payments 12,295 Less imputed interest 2,892 Total operating lease liabilities $ 9,403 The supplemental disclosure for the statement of cash flows related to operating leases were as follows (in thousands): March 31, 2022 2021 Cash paid for amounts included in the measurement of lease liabilities: $ 457 $ 444 Other than the initial recording of the right-of-use asset and lease liability for the Headquarters Lease in 2020, which was non-cash, the changes in the Company’s right-of-use asset and lease liability for the three months ended March 31, 2022 and 2021 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, 2022 2021 Weighted-average remaining lease term 6.1 years 7.1 years Weighted-average discount rate 8.9 % 8.9 % |
Debt
Debt | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Debt | Debt 2020 Term Loan On March 21, 2022, the Company entered into a Second Amendment to its 2020 Term Loan. The Second Amendment extends the date on which amortization payments in respect of the 2020 Term Loan will commence by twelve months to April 1, 2023. Thereafter, amortization payments will be paid monthly in equal installments of principal and interest to fully amortize the outstanding principal over the remaining term of the 2020 Term Loan, subject to recalculation upon a change in the prime rate. The Second Amendment was determined to be a loan modification, and the $0.1 million fee is recorded as an addition to the debt discount on the effective date. As of March 31, 2022 and December 31, 2021, 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, 2022 are as follows (in thousands): Face value $ 25,000 Venture debt termination fee 2,250 Less: Debt discount (1,512) Less: Current portion of loan payable (696) Loan payable, net of current portion $ 25,042 Future minimum principal payments on the 2020 Term Loan as of March 31, 2022 are as follows (in thousands): Year ended: 2023 7,759 2024 10,345 2025 6,896 Total minimum principal payments $ 25,000 |
Equity
Equity | 3 Months Ended |
Mar. 31, 2022 | |
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), aggregate gross sales proceeds of up to $75.0 million. During the three months ended March 31, 2022, the Company sold 576,418 shares of its common stock pursuant to the 2021 Sales Agreement for aggregate net proceeds of $1.7 million, after deducting commissions and other transaction costs. Warrants During the three months ended March 31, 2022, there were no warrants issued, exercised, or canceled. Refer to Note 10 to the consolidated financial statements within our 2021 Annual Report on Form 10-K 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, 2022 292,469 10,443,511 10,735,980 $ 1.62 Reserved Shares The Company has authorized shares of common stock for future issuance as follows: As of March 31, 2022 December 31, 2021 Exercise of warrants 10,735,980 10,735,980 Shares available for future stock incentive awards 7,006,788 6,039,564 Unvested restricted stock units 1,118,508 394,450 Outstanding common stock options 15,349,539 11,039,873 Total 34,210,815 28,209,867 |
Stock Incentive Plans
Stock Incentive Plans | 3 Months Ended |
Mar. 31, 2022 | |
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 2022 and 2021, the number of shares of common stock that may be issued under the 2016 Plan was increased by 4,944,919 and 4,322,850 shares, respectively. As of March 31, 2022, 1,737,589 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, 2022, there are 1,591,661 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 2022 2021 Research and development $ 1,018 $ 754 General and administrative 1,735 1,026 Total stock-based compensation expense $ 2,753 $ 1,780 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 2022 2021 Risk-free interest rate 1.48 % 0.44 % Dividend yield — — Expected term 6.03 5.28 Expected volatility 91.84 % 83.26 % Weighted-average fair value of common stock $ 3.26 $ 3.13 The weighted average grant date fair value of stock options granted to employees during the three months ended March 31, 2022 and 2021 was $2.45 and $1.99, respectively. As of March 31, 2022, total unrecognized compensation expense related to unvested employee stock options was $18.5 million, which is expected to be recognized over a weighted average period of 3.0 years. The following table summarizes the stock option activity under the 2008 Plan, 2016 Plan, and 2018 Inducement Incentive Award Plan: Weighted-average remaining Aggregate Number of Weighted-average contractual term intrinsic value options exercise price ($) (in years) (in thousands) Employees Outstanding at December 31, 2021 10,616,800 $ 3.99 8.19 $ 4,982 Granted 4,476,500 $ 3.26 Exercised (10,000) $ 2.10 Outstanding at March 31, 2022 15,083,300 $ 3.78 8.49 $ — Vested at March 31, 2022 5,602,046 $ 4.46 7.30 $ — Vested and expected to vest at March 31, 2022 13,738,523 $ 3.82 8.40 $ — Non-employee consultants Outstanding at December 31, 2021 423,073 $ 6.34 3.85 $ 42 Forfeited (156,834) $ 3.44 Outstanding at March 31, 2022 266,239 $ 8.05 5.83 $ — Vested at March 31, 2022 266,239 $ 8.05 5.83 $ — Vested and expected to vest at March 31, 2022 266,239 $ 8.05 5.83 $ — Restricted Stock Units During the three months ended March 31, 2022, the Company granted 813,200 restricted stock awards with a weighted average fair value of $3.31 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 attrition trends. Unrecognized compensation expense for all restricted stock units was $2.8 million as of March 31, 2022, which is expected to be recognized over a weighted average period of 3.4 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, 2021 394,450 $ 3.45 Granted 813,200 3.31 Vested (89,142) 3.36 Unvested at March 31, 2022 1,118,508 $ 3.36 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 2022 and 2021, the number of shares of common stock authorized for issuance under the ESPP was increased by 1,236,229 shares and 1,080,711 shares, respectively. During the three months ended March 31, 2022, the Company issued 81,057 shares of common stock under the ESPP. As of March 31, 2022, 3,677,538 shares remain available for future issuance under the ESPP. For each of the three months ended March 31, 2022 and 2021, the Company recognized less than $0.1 million of stock-based compensation expense under the ESPP, respectively. |
Revenue Arrangements
Revenue Arrangements | 3 Months Ended |
Mar. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Arrangements | Revenue Arrangements 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. The Company determined the Takeda Agreement represents a service arrangement under the scope of ASC 606, and given the reversion of the rights under the Takeda Agreement represents a penalty in substance for a termination by Takeda, the contract term would remain the stated term of the Takeda Agreement. The Company determined that the research license, the licensed know-how, and the manufactured supply and delivery of materials represent a single promise and performance obligation to be transferred to Takeda over time due to the nature of the promises in the contract. The delivery of the manufactured supply is the predominant promise within the arrangement, as it is essential to the utility of the licensed intellectual property. The material to be supplied by the Company to Takeda is unique to the Company and cannot be obtained by other vendors. As such, consideration in the initial transaction price will be allocated to the single performance obligation and the recognition period would not extend beyond the initial contractual period. The Company will recognize the revenue associated with the upfront payment and combined single performance obligation utilizing the output method over the term that manufactured supply is delivered to Takeda. In determining the transaction price, the Company concluded the payment associated with all the performance milestones will be fully constrained and only be included in the transaction price when the respective 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 study 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. Takeda has the right to exercise covenant release rights on a field-by-field basis. If Takeda exercises its covenant release rights, we could receive exercise payments per indication and would be entitled to significant development and commercial milestone payments and tiered royalties on commercial sales. The Company determined that a significant financing component does not exist in its arrangement with Takeda. The Company also determined the options to negotiate additional fields, pursue other products, enter into a supply agreement explore additional fields, and pursue additional development under the initial fields do not represent material rights under the agreement. Takeda has the right to terminate the Takeda Agreement in its entirety or on a field-by-field basis, upon 90 days’ written notice to the Company. As of March 31, 2022, the Company recorded $1.0 million, as a long-term contract liability, representing deferred revenue associated with this agreement. Revenue of $1.0 million related to the Takeda Agreement was recognized during the three months ended March 31, 2022. As of December 31, 2021, the Company recorded $1.0 million as a short term contract liability and $1.0 million, as a long-term contract liability, respectively, representing deferred revenue associated with this agreement. Swedish Orphan Biovitrum License and Development Agreement In June 2020, the Company and Sobi entered into 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 SEL-037, 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. Pursuant to the Sobi License, the Company has agreed to supply (at cost) quantities of the Compound and ImmTOR as necessary for completion of the two Phase 3 clinical trials of SEL-212 (DISSOLVE I and DISSOLVE II) and a 6-month placebo extension. The Company is required to supply quantities of the Compound until all rights to the Compound and any materials needed to manufacture the Compound are transferred to Sobi. Sobi has agreed to reimburse the Company for all budgeted costs incurred to complete development of SEL-212, including but not limited to costs incurred while conducting and completing the Phase 3 DISSOLVE trials, except for any costs of additional development activities required that are related to ImmTOR and that are unrelated to SEL-212. Sobi will have control and responsibility over all regulatory filings, including any investigational drug applications, biologics license applications, and marketing authorization applications relating to the licensed product. Sobi may terminate the Sobi License for any reason upon 180 days’ written notice to the Company, whereby all rights granted under the Sobi License would revert back to the Company. In addition, if Sobi were to terminate the Sobi License, the Company has the option to obtain a license to all patents and know-how necessary to exploit SEL-212 in existence as of the termination date from Sobi in return for making an equitable royalty payment to Sobi. Additionally, on June 11, 2020, the Company entered into the Sobi Purchase Agreement for the sale of 5,416,390 shares of common stock for aggregate gross proceeds of $25.0 million in connection with the Sobi License. The closing of the Sobi Private Placement occurred on July 31, 2020, following the closing of the transactions contemplated under the Sobi License. The Company determined that the Sobi License represents a service arrangement under the scope of ASC 606. In addition, given the Sobi License and Sobi Purchase Agreement were executed contemporaneously and negotiated as a package with a single commercial objective, the Company will account for the two agreements as a single contract. The term of the Sobi License commenced upon the effective date of July 28, 2020 and will continue on a product-by-product basis until the royalty terms for each country have expired. The royalty term for a given product begins upon the first commercial sale of the product in a country and ends at the later of ten years from the first commercial sale, expiration of the last valid patent claim covering the product and expiration of all regulatory exclusivity periods for the product in a country. Given the reversion of the rights under the Sobi License represents a penalty in substance for a termination by Sobi, the contract term would remain the stated term of the Sobi License. The Company determined that the Sobi License contains three distinct performance obligations due to the nature of the promises in the contract, which includes conducting the Phase 3 DISSOLVE trials, Sobi’s option to set-up a second source supplier, and a combined obligation comprised of the delivery of the license to SEL-212, transfer of the know-how and the manufacturing and delivery of SEL-212 supply for development, or the Combined License Obligation. As the set-up of a second source supplier is optional for Sobi and the Company will be reimbursed at cost for its efforts in the subsequent set-up and technology transfer, the option for this future service was determined to be at a significant and incremental discount to its standalone selling price and treated as a material right in the arrangement, namely a distinct performance obligation. In determining the transaction price, the Company concluded the upfront payment of $75.0 million and the $5.0 million development milestone associated with the dosing of the first patient in the Phase 3 DISSOLVE trials will be included in the transaction price. All other development milestones will be fully constrained and only be included in the transaction price when the respective milestone is deemed probable of achievement. Each of these variable consideration items was 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 the evaluation of the constraint, the Company considered numerous factors, including that receipt of such 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. 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. In connection with the Sobi Purchase Agreement, the Company determined that the gross proceeds of $25.0 million from the Sobi Private Placement included a premium to the fair value of the Company’s shares as of July 28, 2020 equal to approximately $14.5 million. The premium amount will be included in the transaction price for revenue recognition. The Company will estimate and include in the transaction price the total reimbursements to be received from Sobi for both the manufacturing and delivery of the Compound and ImmTOR as well as conducting the Phase 3 DISSOLVE trials. The Company determined that a significant financing component does not exist in its arrangement with Sobi. The Company allocated the transaction price based on the relative standalone selling prices of the three distinct performance obligations. The Company estimated the standalone selling price of conducting the Phase 3 DISSOLVE trials by forecasting its anticipated costs and applying a margin reflective of the industry. The Company must determine the standalone selling price of the second source supplier option by determining the discount given to Sobi multiplied by the likelihood that Sobi will exercise the option in the future. Similar to the Phase 3 program estimate, the Company estimated the discount of the option by forecasting the set-up costs and applying a margin that is reflective of the industry. As the Company will be providing the set-up and technology transfer services and the future supply at cost, the discount of the option is equal to the margin amount. The Company considered discussions with Sobi as well as probability of regulatory success of SEL-212 in determining the likelihood of exercise. The Company estimated the standalone selling price of the Combined License Obligation by utilizing a discounted cash flow model. The Company determined that the delivery of the supply to Sobi best represents the pattern of delivery of the Combined License Obligation as the supply is essential to the utility of the license and know-how. The Company will recognize the revenue allocated to the Combined License Obligation by utilizing the output method. The Company estimated the total supply of the Compound and ImmTOR to be required during the clinical trial period and will recognize revenue as this supply is shipped for use in the clinical trials. The Company will recognize the revenue allocated to the conducting of the Phase 3 DISSOLVE trials obligation by utilizing the input method. The Company estimated the total budgeted costs to be incurred over the Phase 3 DISSOLVE trials and will recognize revenue as these costs are incurred. The Company’s costs best represent the pattern of transfer as these will capture all performance of the trials completed to date and can be readily measured. The Company will recognize the revenue allocated to the second source supplier option when the future services and goods are transferred. As of March 31, 2022 and December 31, 2021, the Company recorded $21.7 million and $37.5 million, respectively, as a short-term contract liability and $4.1 million and $5.1 million, respectively, as a long-term contract liability, representing deferred revenue associated with this agreement. In addition, as of March 31, 2022, the Company has recorded an immaterial amount of contract assets related to incremental costs that would not have been incurred if the Sobi License had not been obtained. As of March 31, 2022 and December 31, 2021, the Company recorded a total outstanding receivable of $7.1 million and $9.9 million, respectively, representing billings for the Phase 3 DISSOLVE program that are subject to reimbursement by Sobi. Revenue of $23.8 million and $11.1 million related to the Sobi License was recognized during the three months ended March 31, 2022 and 2021, respectively. 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 will have an option term of 24 months during which it can 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 will supply ImmTOR to Sarepta for clinical supply on a cost-plus basis. Sarepta paid a $2.0 million upfront payment to the Company upon signing of the Sarepta Agreement, and the Company is eligible to receive additional preclinical payments during the option term. If Sarepta opts-in to an exclusive license agreement, the Company could receive option exercise payments per Indication upon execution of the exclusive license, and the Company would be entitled to significant development and commercial milestone payments and tiered royalties ranging from the mid-to-high single digits based on net sales. Pursuant to the Sarepta Agreement, the Company determined the Sarepta Agreement represents a service arrangement under the scope of ASC 606, with a 24 month contract duration. Given the reversion of the rights under the Sarepta Agreement represents a penalty in substance for a termination by Sarepta, the contract term would remain the stated term of the Sarepta Agreement. The Company determined that the Sarepta Agreement and supply obligation including the delivery of the research license, the licensed know-how, the manufactured supply and delivery of materials represent a single promise and performance obligation to be transferred to Sarepta over time due to the nature of the promises in the contract. The delivery of the manufactured supply is the predominant promise within the arrangement, as it is essential to the utility of the licensed intellectual property. As such, consideration in the initial transaction price will be allocated to the single performance obligation based on the contractual price. In determining the transaction price, the Company concluded the payment associated with all the performance milestones will be fully constrained and only be included in the transaction price when the respective milestone is deemed probable of achievement. Each of these variable consideration items was 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 of such study milestones is outside the control of the Company and probability of success criteria is estimated. The Company also determined the option to enter into a future commercial license agreement and extend the term of the option does not represent a material right since it was not priced at an incremental discount. Sarepta may terminate the Sarepta Agreement for any reason upon 30 days’ written notice to the Company. The Sarepta Agreement contains other customary terms and conditions, including representations and warranties, covenants, termination, and indemnification obligations in favor of each party. During the year ended December 31, 2020, the Company and Sarepta entered into two amendments relating to an additional feasibility study. During the year ended December 31, 2021, the Company and Sarepta entered into a third amendment relating to the additional feasibility study. On April 13, 2021, the Company was notified by Sarepta of the achievement of the milestone event related to the completion of a non-clinical study for Duchenne muscular dystrophy and certain limb-girdle muscular dystrophies under the Sarepta Agreement. Accordingly, the Company received a milestone payment of $3.0 million during the three months ended June 30, 2021. As of March 31, 2022 and December 31, 2021, two milestones remained constrained. The Company will re-evaluate the transaction price in each reporting period, as uncertain events are resolved. The Company will recognize the revenue associated with the upfront payment and combined single performance obligation utilizing the output method, over the 24-month term as the manufactured supply is delivered to Sarepta. At each of March 31, 2022 and December 31, 2021, the Company recorded $4.6 million as a short-term contract liability representing deferred revenue associated with this agreement. Revenue of less than $0.1 million related to the Sarepta Agreement was recognized during the three months ended March 31, 2022. No revenue related to the Sarepta Agreement was recognized during the three months ended March 31, 2021. Asklepios Biopharmaceutical, Inc. License Agreement for Pompe Disease In December 2019, the Company and Asklepios Biopharmaceutical, Inc., or AskBio, entered into a license agreement, or the AskBio License Agreement. Pursuant to the AskBio License Agreement, AskBio has exercised its option to exclusively license the Company’s intellectual property rights covering the Company’s ImmTOR platform to research, develop, and commercialize certain adeno-associated viral, or AAV, gene therapy products utilizing ImmTOR, and targeting the lysosomal alpha-glucosidase, or GAA, gene, or derivatives thereof, to treat Pompe Disease. Pursuant to the AskBio License Agreement and ancillary documents, AskBio agreed to pay to the Company upfront fees of an aggregate of $7.0 million. Assuming successful development and commercialization, the Company could receive up to an additional $237.0 million in development, regulatory, and sales milestone payments. If commercialized, the Company would be eligible to receive tiered royalties on global net sales at percentages ranging from mid-to-high single digits. Under the terms of the agreement, the Company will be eligible to receive these royalties commencing on the first commercial sale of the licensed product until the expiration of the later of (i) ten years after the first commercial sale and (ii) expiration of the last to expire valid claim on patents covering the licensed product. Pursuant to the AskBio License Agreement, the Company will supply AskBio with its ImmTOR platform, or the Supply Obligation, and AskBio will be responsible for all preclinical, clinical and commercial manufacture and supply of licensed products (other than ImmTOR) and carry out all other activities related to the research, development, and commercialization of licensed products at its sole expense, including all regulatory activities related thereto. The Company determined that the AskBio License Agreement and Supply Obligation represent a single promise and performance obligation. This is because AskBio cannot derive benefit from the license without the simultaneous transfer of the patent protected ImmTOR supply. Therefore, the License Obligation and Supply Obligation represent the only promise in the arrangement and are combined as a single performance obligation. In determining the transaction price, the Company concluded that the future development milestones, regulatory milestones, sales milestones, and sales royalties all represent variable consideration. Each of these variable consideration items was 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 of such milestones is outside the control of the Company. Consideration related to sales-based milestones as well as royalties on net sales upon commercialization by AskBio, will be recognized when the related sales occur, as they were determined to relate predominantly to the intellectual property granted to AskBio and, therefore, have also been excluded from the transaction price in accordance with the royalty recognition constraint. As of March 31, 2022 and December 31, 2021, all milestones were constrained. The Company will re-evaluate the transaction price in each reporting period, as uncertain events are resolved, or as other changes in circumstances occur. The total initial transaction price of the contract on the effective date was $7.0 million, comprised of a $2.0 million initial upfront payment upon agreement of terms, and a $5.0 million initial upfront execution fee. At each of March 31, 2022 and December 31, 2021, the Company recorded $1.7 million as short-term contract liability and $5.3 million as a long-term contract liability, representing deferred revenue associated with this agreement. Revenue will be recognized over the period in which the particles are delivered. No revenue related to the AskBio License Agreement was recognized during the three months ended March 31, 2022 and 2021 as no deliveries were made during these periods. 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, 2022, the aggregate amount of the transaction price allocated to remaining performance obligations was $38.4 million. Contract Balances from Contracts with Customers ( Takeda, Sobi, Sarepta, and AskBio ) The following table presents changes in the Company’s contract liabilities during the three months ended March 31, 2022 (in thousands): Balance at Balance at beginning of period Additions Deductions end of period Three Months Ended March 31, 2022 Contract liabilities: Deferred revenue $ 65,300 $ — $ (26,890) $ 38,410 Total contract liabilities $ 65,300 $ — $ (26,890) $ 38,410 |
Related-party Transactions
Related-party Transactions | 3 Months Ended |
Mar. 31, 2022 | |
Related Party Transactions [Abstract] | |
Related-party Transactions | Related-party Transactions Consulting Services During the three months ended March 31, 2022, there were no related party transactions. The Company incurred expenses for consulting services provided by its founders to serve on its Scientific Advisory Board, totaling less than $0.1 million during the three months ended March 31, 2021. |
Collaboration and License Agree
Collaboration and License Agreements | 3 Months Ended |
Mar. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Collaboration and License Agreements | Collaboration and License Agreements Ginkgo Bioworks Holdings, Inc. Collaboration and License Agreement 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 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 both upfront research and development fees and milestone payments, including certain milestone payments for fixed fair values in the form of shares of the Company’s common stock, clinical and commercial milestone payments of up to $85.0 million in cash. 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. 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 development and sales-based milestones. 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. 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 potentially 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 an aggregate purchase price of $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 determined its equity interest to be within the scope of ASC 321 and elected to record the $2.0 million investment of Cyrus’ Series B Preferred Stock at cost on the purchase date. As of March 31, 2022, 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 with AskBio, or the AskBio Collaboration Agreement. 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 it intended to opt-out of development of the MMA indication. The feasibility study and license agreement with AskBio, or AskBio Collaboration Agreement, otherwise remains in effect. Consequently, the Company has assumed all rights to the MMA program and intends to continue to progress the SEL-302 program through clinical development. The Company filed an IND to conduct a Phase 1/2 clinical trial of its SEL-302 product candidate in pediatric patients with methylmalonic acidemia in the third quarter of 2021. On November 23, 2021, this trial was placed on clinical hold by the FDA, with questions specifically relating to chemistry, manufacturing and controls, or CMC, of the AAV vector. On March 9, 2022, the Company received a letter from the FDA indicating the clinical hold was removed and the trial may proceed. The SEL-399 program combined an empty AAV capsid (EMC-101), which is an AAV capsid containing no transgene, with ImmTOR and was 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 and development 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 have 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 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. 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. For the three months ended March 31, 2022 and 2021, the Company recognized $0.4 million and $1.2 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, 2022, 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, and $0.4 million relative to the calculated premium paid by Spark for the equity investments made under the Spark Purchase Agreement. The Company made no additional payments during the three months ended March 31, 2022. 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, 2022. 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, 2022 | |
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, 2022, the Company has performed a high-level analysis of the impact of this legislation enactment and determined the projected taxable loss position for 2022 does not result in income tax due. As of December 31, 2021, the Company has $51.1 million of federal net operating losses available, subject to an 80% limitation. The Company also has $1.2 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 R&D tax credit study. 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, 2022 | |
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. As of January 2022, all matching contributions vest ratably over 2 years and participant contributions vest immediately. Contributions by the Company totaled less than $0.1 million during each of the three months ended March 31, 2022 and 2021, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies As of March 31, 2022, 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. On August 3, 2020, a stockholder of Selecta filed a stockholder derivative action, purportedly on behalf of Selecta and against certain current and former members of the Company’s Board of Directors, as well as one affiliated company owned by a current board member, in the Court of Chancery of the State of Delaware, namely Franchi v. Barabe, et al. The complaint alleges that the individual defendants breached their fiduciary duties and committed corporate waste when they authorized a private placement transaction, announced on December 19, 2019, at a price allegedly below fair value. The complaint further alleges that the four defendant directors who participated in the private placement were unjustly enriched in connection with the transaction. On September 25, 2020, the defendants filed a motion to dismiss the lawsuit. On November 6, 2020, the plaintiff filed an amended complaint, and the defendants filed a second motion to dismiss on January 8, 2021. On December 31, 2020, the Company received a litigation demand letter from two other putative stockholders relating to the same private placement transaction. On April 12, 2021, the Court of Chancery in the State of Delaware granted a motion to stay the litigation pending a review by a Special Committee appointed by the Company’s Board of Directors. While the litigation was stayed, the parties reached an agreement in principle to settle the matter, and on March 18, 2022, they submitted a Stipulation and Agreement of Settlement and other documentation to the Court for its approval of the settlement. As of March 31, 2022, the Company accrued an estimated liability of $0.9 million for the litigation, as the liability has been determined to be probable. Other As permitted under Delaware law, the Company indemnifies its directors for certain events or occurrences while the director is, or was, serving at the Company’s request in such capacity. The term of the indemnification is for the director’s lifetime. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ 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, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Underwritten Offering On April 6, 2022, the Company entered into an underwriting agreement, or the Underwriting Agreement, with SVB Leerink, as representative of the several underwriters named therein, relating to an underwritten offering, or the Offering, of 27,428,572 shares, or the Shares, of the Company’s common stock and warrants, or the 2022 Warrants, and together with the Shares, the Securities, to purchase up to 20,571,429 shares of common stock. Each Share and accompanying Warrant to purchase 0.75 shares of common stock was sold at a combined offering price of $1.41. The exercise price for the 2022 Warrants is $1.55 per share. The Company received gross proceeds from the Offering of approximately $38.7 million. The 2022 Warrants are subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Company’s common stock and also upon any distributions for no consideration of assets to the Company’s stockholders. Each 2022 Warrant is exercisable at any time and from time to time after issuance. In the event of certain corporate transactions, the holders of the 2022 Warrants will be entitled to receive, upon exercise of the 2022 Warrants, the kind and amount of securities, cash or other property that the holders would have received |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Recently Adopted In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt – Modifications and Extinguishments (Subtopic 470-50), Compensation – Stock Compensation (Topic 718), and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer's Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options . ASU 2021-04 provides guidance as to how entities should account for a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option (i.e., a warrant) that remains equity-classified after modification or exchange as an exchange of the original instrument for a new instrument. An entity should apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring on or after the effective date. This new standard was effective for all entities for fiscal years beginning after December 15, 2021. The adoption of ASU 2021-04 did not have an impact on the Company’s financial position or results of operations upon adoption. Not Yet Adopted In August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) . ASU 2020-06 simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. This new standard will be effective for smaller reporting companies for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. The Company is assessing the impact this standard will have on its consolidated financial statements and disclosures. 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 |
Marketable Securities and Inv_2
Marketable Securities and Investments (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Available-for-Sale Marketable Securities | The following table summarizes the marketable securities held as of March 31, 2022 and December 31, 2021 (in thousands): Amortized Unrealized gains Unrealized losses Fair March 31, 2022 Commercial paper 3,997 — — 3,997 Total $ 3,997 $ — $ — $ 3,997 December 31, 2021 Corporate bonds $ 2,007 $ — $ (1) $ 2,006 Commercial paper 11,992 — — 11,992 Total $ 13,999 $ — $ (1) $ 13,998 |
Net Income (Loss) Per Share (Ta
Net Income (Loss) Per Share (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Loss Per Share | The following table sets forth the computation of basic and diluted net income (loss) per share (in thousands, except share and per-share data): Three Months Ended 2022 2021 Numerator: Net income (loss) $ 28,778 $ (24,597) Less: Change in fair value of 2019 Warrants (18,515) — Adjusted net income (loss) $ 10,263 $ (24,597) Denominator: Weighted-average common shares outstanding - basic 124,232,799 110,742,150 Dilutive effect of employee equity incentive plans and outstanding 2019 warrants 3,340,686 — Weighted-average common shares used in per share calculations - diluted 127,573,485 110,742,150 Net income (loss) per share: Basic $ 0.23 $ (0.22) Diluted $ 0.08 $ (0.22) |
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 per share for all periods presented, as the effect would have been anti-dilutive: Three Months Ended 2022 2021 Options, RSUs and ESPP shares 15,292,967 10,864,811 Warrants to purchase common stock 292,469 12,378,016 Total 15,585,436 23,242,827 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary 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, 2022 and December 31, 2021 (in thousands): March 31, 2022 Total Level 1 Level 2 Level 3 Assets: Money market funds (included in cash equivalents) $ 76,622 $ 76,622 $ — $ — Marketable securities: Commercial paper 3,997 — 3,997 — Total assets $ 80,619 $ 76,622 $ 3,997 $ — Liabilities: Warrant liabilities $ 6,908 $ — $ — $ 6,908 Total liabilities $ 6,908 $ — $ — $ 6,908 December 31, 2021 Total Level 1 Level 2 Level 3 Assets: Money market funds (included in cash equivalents) $ 66,563 $ 66,563 $ — $ — Marketable securities: Corporate bonds 2,006 — 2,006 — Commercial paper 11,992 — 11,992 — Total assets $ 80,561 $ 66,563 $ 13,998 $ — Liabilities: Warrant liabilities $ 25,423 $ — $ — $ 25,423 Total liabilities $ 25,423 $ — $ — $ 25,423 |
Schedule of Cash and Cash Equivalents | The Company’s consolidated statements of cash flows include the following as of March 31, 2022 and 2021 (in thousands): March 31, 2022 2021 Cash and cash equivalents $ 113,437 $ 125,407 Long-term restricted cash 1,379 1,379 Total cash, cash equivalents, and restricted cash $ 114,816 $ 126,786 |
Schedule of Restricted Cash and Cash Equivalents | The Company’s consolidated statements of cash flows include the following as of March 31, 2022 and 2021 (in thousands): March 31, 2022 2021 Cash and cash equivalents $ 113,437 $ 125,407 Long-term restricted cash 1,379 1,379 Total cash, cash equivalents, and restricted cash $ 114,816 $ 126,786 |
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 warrant liability is as follows: March 31, December 31, 2022 2021 Risk-free interest rate 2.45 % 0.97 % Dividend yield — — Expected life (in years) 2.73 2.98 Expected volatility 93.60 % 96.10 % |
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), for the three months ended March 31, 2022 (in thousands): Warrant liabilities Fair value as of December 31, 2021 $ 25,423 Change in fair value (18,515) Fair value as of March 31, 2022 $ 6,908 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consists of the following (in thousands): March 31, December 31, 2022 2021 Laboratory equipment $ 5,771 $ 5,134 Computer equipment and software 683 731 Leasehold improvements 48 45 Furniture and fixtures 331 332 Office equipment 163 163 Construction in process 354 534 Total property and equipment 7,350 6,939 Less accumulated depreciation (4,661) (4,797) Property and equipment, net $ 2,689 $ 2,142 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following (in thousands): March 31, December 31, 2022 2021 Payroll and employee related expenses $ 1,116 $ 3,179 Accrued patent fees 711 309 Accrued external research and development costs 4,973 4,339 Accrued professional and consulting services 1,560 815 Accrued interest 179 170 Other 350 1,721 Accrued expenses $ 8,889 $ 10,533 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Schedule of Lease, Cost | For the three months ended March 31, 2022 and 2021 the components of lease costs were as follows (in thousands): Three Months Ended 2022 2021 Operating lease cost $ 506 $ 444 Variable lease cost 220 288 Short-term lease cost 3 3 Total lease cost $ 729 $ 735 The following summarizes additional information related to operating leases: March 31, 2022 2021 Weighted-average remaining lease term 6.1 years 7.1 years Weighted-average discount rate 8.9 % 8.9 % |
Schedule of Lessee, Operating Lease, Liability, Maturity | The maturity of the Company’s operating lease liabilities as of March 31, 2022 were as follows (in thousands): March 31, 2022 2022 (remainder) 1,409 2023 1,922 2024 1,980 2025 2,039 2026 2,101 Thereafter 2,844 Total future minimum lease payments 12,295 Less imputed interest 2,892 Total operating lease liabilities $ 9,403 |
Schedule of Operating Lease, Lease Income | The supplemental disclosure for the statement of cash flows related to operating leases were as follows (in thousands): March 31, 2022 2021 Cash paid for amounts included in the measurement of lease liabilities: $ 457 $ 444 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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, 2022 are as follows (in thousands): Face value $ 25,000 Venture debt termination fee 2,250 Less: Debt discount (1,512) Less: Current portion of loan payable (696) Loan payable, net of current portion $ 25,042 |
Schedule of Future Minimum Payments on the Term Loans | Future minimum principal payments on the 2020 Term Loan as of March 31, 2022 are as follows (in thousands): Year ended: 2023 7,759 2024 10,345 2025 6,896 Total minimum principal payments $ 25,000 |
Equity (Tables)
Equity (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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. Refer to Note 10 to the consolidated financial statements within our 2021 Annual Report on Form 10-K 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, 2022 292,469 10,443,511 10,735,980 $ 1.62 |
Schedule of Authorized Shares of Common Stock for Future Issuance | The Company has authorized shares of common stock for future issuance as follows: As of March 31, 2022 December 31, 2021 Exercise of warrants 10,735,980 10,735,980 Shares available for future stock incentive awards 7,006,788 6,039,564 Unvested restricted stock units 1,118,508 394,450 Outstanding common stock options 15,349,539 11,039,873 Total 34,210,815 28,209,867 |
Stock Incentive Plans (Tables)
Stock Incentive Plans (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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 2022 2021 Research and development $ 1,018 $ 754 General and administrative 1,735 1,026 Total stock-based compensation expense $ 2,753 $ 1,780 |
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 2022 2021 Risk-free interest rate 1.48 % 0.44 % Dividend yield — — Expected term 6.03 5.28 Expected volatility 91.84 % 83.26 % Weighted-average fair value of common stock $ 3.26 $ 3.13 |
Summary of Options Activity | The following table summarizes the stock option activity under the 2008 Plan, 2016 Plan, and 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, 2021 10,616,800 $ 3.99 8.19 $ 4,982 Granted 4,476,500 $ 3.26 Exercised (10,000) $ 2.10 Outstanding at March 31, 2022 15,083,300 $ 3.78 8.49 $ — Vested at March 31, 2022 5,602,046 $ 4.46 7.30 $ — Vested and expected to vest at March 31, 2022 13,738,523 $ 3.82 8.40 $ — Non-employee consultants Outstanding at December 31, 2021 423,073 $ 6.34 3.85 $ 42 Forfeited (156,834) $ 3.44 Outstanding at March 31, 2022 266,239 $ 8.05 5.83 $ — Vested at March 31, 2022 266,239 $ 8.05 5.83 $ — Vested and expected to vest at March 31, 2022 266,239 $ 8.05 5.83 $ — |
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, 2021 394,450 $ 3.45 Granted 813,200 3.31 Vested (89,142) 3.36 Unvested at March 31, 2022 1,118,508 $ 3.36 |
Revenue Arrangements (Tables)
Revenue Arrangements (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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, 2022 (in thousands): Balance at Balance at beginning of period Additions Deductions end of period Three Months Ended March 31, 2022 Contract liabilities: Deferred revenue $ 65,300 $ — $ (26,890) $ 38,410 Total contract liabilities $ 65,300 $ — $ (26,890) $ 38,410 |
Description of the Business (De
Description of the Business (Details) $ in Millions | Mar. 31, 2022USD ($) |
Cash and Cash Equivalents [Line Items] | |
Cash, cash equivalents, restricted cash and marketable securities | $ 118.8 |
Restricted cash and cash equivalents | 1.4 |
Russian subsidiary | |
Cash and Cash Equivalents [Line Items] | |
Cash maintained in Russian bank accounts | $ 0.3 |
Marketable Securities and Inv_3
Marketable Securities and Investments - Summary of Available-for-Sale Marketable Securities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | $ 3,997 | $ 13,999 |
Unrealized gains | 0 | 0 |
Unrealized losses | 0 | (1) |
Fair value | 3,997 | 13,998 |
Corporate bonds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | 2,007 | |
Unrealized gains | 0 | |
Unrealized losses | (1) | |
Fair value | 2,006 | |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | 3,997 | 11,992 |
Unrealized gains | 0 | 0 |
Unrealized losses | 0 | 0 |
Fair value | $ 3,997 | $ 11,992 |
Marketable Securities and Inv_4
Marketable Securities and Investments - Narrative (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2022 | Dec. 31, 2021 | Sep. 07, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Marketable securities adjusted for other than temporary declines in fair value | $ 0 | ||
Investments | 2,000,000 | $ 2,000,000 | |
Cyrus Biotechnology, Inc. | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Investments | $ 2,000,000 | $ 2,000,000 | $ 2,000,000 |
Net Income (Loss) Per Share- Co
Net Income (Loss) Per Share- Computation of Basic and Diluted Net Income (Loss) Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Numerator: | ||
Net income (loss) | $ 28,778 | $ (24,597) |
Less: Change in fair value of 2019 Warrants | (18,515) | 0 |
Adjusted net income (loss) | 10,263 | (24,597) |
Adjusted net income (loss) | $ 10,263 | $ (24,597) |
Denominator: | ||
Weighted-average common shares outstanding, basic (in shares) | 124,232,799 | 110,742,150 |
Dilutive effect of employee equity incentive plans and outstanding warrants (in shares) | 3,340,686 | 0 |
Weighted‑average common shares outstanding—diluted (in shares) | 127,573,485 | 110,742,150 |
Net income (loss) per share: | ||
Basic (in dollars per share) | $ 0.23 | $ (0.22) |
Diluted (in dollars per share) | $ 0.08 | $ (0.22) |
Net Income (Loss) Per Share - S
Net Income (Loss) Per Share - Schedule of Potential Common Shares Issuable Upon Conversion of Warrants (Details) - shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Potential common shares | ||
Total (in shares) | 15,585,436 | 23,242,827 |
Shares available for future stock incentive awards | ||
Potential common shares | ||
Total (in shares) | 15,292,967 | 10,864,811 |
Warrants to purchase common stock | ||
Potential common shares | ||
Total (in shares) | 292,469 | 12,378,016 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Assets Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Assets: | ||
Marketable securities: | $ 3,997 | $ 13,998 |
Liabilities: | ||
Warrant liabilities | 6,908 | 25,423 |
Corporate bonds | ||
Assets: | ||
Marketable securities: | 2,006 | |
Commercial paper | ||
Assets: | ||
Marketable securities: | 3,997 | 11,992 |
Recurring | ||
Assets: | ||
Total assets | 80,619 | 80,561 |
Liabilities: | ||
Warrant liabilities | 6,908 | 25,423 |
Total liabilities | 6,908 | 25,423 |
Recurring | Level 1 | ||
Assets: | ||
Total assets | 76,622 | 66,563 |
Liabilities: | ||
Warrant liabilities | 0 | 0 |
Total liabilities | 0 | 0 |
Recurring | Level 2 | ||
Assets: | ||
Total assets | 3,997 | 13,998 |
Liabilities: | ||
Warrant liabilities | 0 | 0 |
Total liabilities | 0 | 0 |
Recurring | Level 3 | ||
Assets: | ||
Total assets | 0 | 0 |
Liabilities: | ||
Warrant liabilities | 6,908 | 25,423 |
Total liabilities | 6,908 | 25,423 |
Recurring | Corporate bonds | ||
Assets: | ||
Marketable securities: | 2,006 | |
Recurring | Corporate bonds | Level 1 | ||
Assets: | ||
Marketable securities: | 0 | |
Recurring | Corporate bonds | Level 2 | ||
Assets: | ||
Marketable securities: | 2,006 | |
Recurring | Corporate bonds | Level 3 | ||
Assets: | ||
Marketable securities: | 0 | |
Recurring | Commercial paper | ||
Assets: | ||
Marketable securities: | 3,997 | 11,992 |
Recurring | Commercial paper | Level 1 | ||
Assets: | ||
Marketable securities: | 0 | 0 |
Recurring | Commercial paper | Level 2 | ||
Assets: | ||
Marketable securities: | 3,997 | 11,992 |
Recurring | Commercial paper | Level 3 | ||
Assets: | ||
Marketable securities: | 0 | 0 |
Recurring | Money market funds (included in cash equivalents) | ||
Assets: | ||
Money market funds (included in cash equivalents) | 76,622 | 66,563 |
Recurring | Money market funds (included in cash equivalents) | Level 1 | ||
Assets: | ||
Money market funds (included in cash equivalents) | 76,622 | 66,563 |
Recurring | Money market funds (included in cash equivalents) | Level 2 | ||
Assets: | ||
Money market funds (included in cash equivalents) | 0 | 0 |
Recurring | Money market funds (included in cash equivalents) | Level 3 | ||
Assets: | ||
Money market funds (included in cash equivalents) | $ 0 | $ 0 |
Fair Value Measurements - Narra
Fair Value Measurements - Narrative (Details) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022USD ($) | Dec. 31, 2021USD ($) | |
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 | 0 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Cash and Cash Equivalents (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2021 | Dec. 31, 2020 |
Fair Value Disclosures [Abstract] | ||||
Cash and cash equivalents | $ 113,437 | $ 114,057 | $ 125,407 | |
Long-term restricted cash | 1,379 | 1,379 | 1,379 | |
Total cash, cash equivalents, and restricted cash | $ 114,816 | $ 115,436 | $ 126,786 | $ 140,064 |
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, 2022 | Dec. 31, 2021 |
Risk-free interest rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 0.0245 | 0.0097 |
Dividend yield | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 0 | 0 |
Expected life (in years) | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, term | 2 years 8 months 23 days | 2 years 11 months 23 days |
Expected volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants and rights outstanding, measurement input | 0.9360 | 0.9610 |
Fair Value Measurements - Chang
Fair Value Measurements - Change in the warrant liabilities (Details) - Warrant liabilities $ in Thousands | 3 Months Ended |
Mar. 31, 2022USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Fair value as of December 31, 2021 | $ 25,423 |
Change in fair value | (18,515) |
Fair value as of March 31, 2022 | $ 6,908 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 7,350 | $ 6,939 |
Less accumulated depreciation | (4,661) | (4,797) |
Property and equipment, net | 2,689 | 2,142 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 5,771 | 5,134 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 683 | 731 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 48 | 45 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 331 | 332 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 163 | 163 |
Construction in process | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 354 | $ 534 |
Property and Equipment - Narrat
Property and Equipment - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 0.1 | $ 0.1 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Payroll and employee related expenses | $ 1,116 | $ 3,179 |
Accrued patent fees | 711 | 309 |
Accrued external research and development costs | 4,973 | 4,339 |
Accrued professional and consulting services | 1,560 | 815 |
Accrued interest | 179 | 170 |
Other | 350 | 1,721 |
Accrued expenses | $ 8,889 | $ 10,533 |
Accrued Expenses - Narrative (D
Accrued Expenses - Narrative (Details) $ in Millions | 12 Months Ended | |
Dec. 31, 2021USD ($)lawsuit | Mar. 31, 2022USD ($) | |
Payables and Accruals [Abstract] | ||
Loss contingency accrual | $ | $ 0.9 | $ 0.9 |
Number of claims settled | lawsuit | 2 |
Leases - Components of lease co
Leases - Components of lease costs (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Leases [Abstract] | ||
Operating lease cost | $ 506 | $ 444 |
Variable lease cost | 220 | 288 |
Short-term lease cost | 3 | 3 |
Total lease cost | $ 729 | $ 735 |
Leases - Operating Lease, Liabi
Leases - Operating Lease, Liability, Maturity (Details) $ in Thousands | Mar. 31, 2022USD ($) |
Leases [Abstract] | |
2022 (remainder) | $ 1,409 |
2023 | 1,922 |
2024 | 1,980 |
2025 | 2,039 |
2026 | 2,101 |
Thereafter | 2,844 |
Total future minimum lease payments | 12,295 |
Less imputed interest | 2,892 |
Lease liabilities | $ 9,403 |
Leases - Other Information (Det
Leases - Other Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Leases [Abstract] | ||
Cash paid for amounts included in the measurement of lease liabilities: | $ 457 | $ 444 |
Leases - Lease Term and Discoun
Leases - Lease Term and Discount Rate (Details) | Mar. 31, 2022 | Mar. 31, 2021 |
Leases [Abstract] | ||
Operating lease, weighted average remaining lease term | 6 years 1 month 6 days | 7 years 1 month 6 days |
Operating lease, weighted average discount rate, percent | 8.90% | 8.90% |
Debt - Term Loans (Narrative) (
Debt - Term Loans (Narrative) (Details) - 2020 Term Loans - USD ($) $ in Millions | Mar. 31, 2022 | Dec. 31, 2021 | Aug. 31, 2020 |
Line of Credit Facility [Line Items] | |||
Debt discount | $ 0.1 | ||
Term loan facility | $ 25 | $ 25 |
Debt - Term Loan And Unamortize
Debt - Term Loan And Unamortized Debt Discount Balances (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||
Loan payable, net of current portion | $ 25,042 | $ 19,673 |
2020 Term Loans | ||
Debt Instrument [Line Items] | ||
Face value | 25,000 | |
Venture debt termination fee | 2,250 | |
Less: Debt discount | (1,512) | |
Less: Current portion of loan payable | (696) | |
Loan payable, net of current portion | $ 25,042 |
Debt - Schedule of Future Minim
Debt - Schedule of Future Minimum Payments on the Term Loans (Details) - 2020 Term Loans $ in Thousands | Mar. 31, 2022USD ($) |
Long-term Debt, Fiscal Year Maturity [Abstract] | |
2023 | $ 7,759 |
2024 | 10,345 |
2025 | 6,896 |
Total minimum principal payments | $ 25,000 |
Equity - Narrative (Details)
Equity - Narrative (Details) - USD ($) $ in Thousands | Oct. 25, 2021 | Mar. 31, 2022 | Mar. 31, 2021 |
Subsidiary, Sale of Stock [Line Items] | |||
Shares issued, value | $ 1,690 | $ 20,991 | |
At-The-Market Offering | |||
Subsidiary, Sale of Stock [Line Items] | |||
Sale common stock | $ 75,000 | ||
Sale of stock, number of shares issued in transaction (in shares) | 576,418 | ||
Shares issued, value | $ 1,700 |
Equity - Warranty Activity (Det
Equity - Warranty Activity (Details) | Mar. 31, 2022$ / sharesshares |
Class of Warrant or Right [Line Items] | |
Class of warrant or right, outstanding (in shares) | 10,735,980 |
Exercise price (in dollars per share) | $ / shares | $ 1.62 |
Exercise of warrants | |
Class of Warrant or Right [Line Items] | |
Class of warrant or right, outstanding (in shares) | 292,469 |
Exercise of warrants | |
Class of Warrant or Right [Line Items] | |
Class of warrant or right, outstanding (in shares) | 10,443,511 |
Equity - Schedule of Authorized
Equity - Schedule of Authorized Shares of Common Stock for Future Issuance (Details) - shares | Mar. 31, 2022 | Dec. 31, 2021 |
Class of Stock [Line Items] | ||
Total (in shares) | 34,210,815 | 28,209,867 |
Shares available for future stock incentive awards | ||
Class of Stock [Line Items] | ||
Total (in shares) | 7,006,788 | 6,039,564 |
Unvested restricted stock units | ||
Class of Stock [Line Items] | ||
Total (in shares) | 1,118,508 | 394,450 |
Outstanding common stock options | ||
Class of Stock [Line Items] | ||
Total (in shares) | 15,349,539 | 11,039,873 |
Exercise of warrants | ||
Class of Stock [Line Items] | ||
Total (in shares) | 10,735,980 | 10,735,980 |
Stock Incentive Plans - Narrati
Stock Incentive Plans - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | ||||||
Jan. 31, 2022 | Jan. 31, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | 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) | 34,210,815 | 28,209,867 | ||||||
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) | 7,006,788 | 6,039,564 | ||||||
Weighted average grant date fair value of stock options (in dollars per share) | $ 2.45 | $ 1.99 | ||||||
Unrecognized compensation expense related to unvested employee stock options | $ 18.5 | |||||||
Weighted average period for recognition | 3 years | |||||||
Estimated forfeitures rate | 10.00% | |||||||
Restricted Stock Units (RSUs) | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Grants in period (in shares) | 813,200 | |||||||
Grants in period (in dollars per share) | $ 3.31 | |||||||
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) | 4,944,919 | 4,322,850 | ||||||
Common stock authorized and reserved for future issuance (in shares) | 1,737,589 | |||||||
2016 Plan | Restricted Stock Units (RSUs) | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Grants in period (in shares) | 813,200 | |||||||
Grants in period (in dollars per share) | $ 3.31 | |||||||
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) | 1,591,661 | |||||||
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 | 3 years 4 months 24 days | |||||||
Unrecognized compensation expense | $ 2.8 | |||||||
ESPP | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of shares authorized, increase (in shares) | 1,236,229 | 1,080,711 | ||||||
Common stock authorized and reserved for future issuance (in shares) | 3,677,538 | 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 | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 2,753 | $ 1,780 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 1,018 | 754 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 1,735 | $ 1,026 |
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, 2022 | Mar. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 1.48% | 0.44% |
Dividend yield | 0.00% | 0.00% |
Expected term | 6 years 10 days | 5 years 3 months 10 days |
Expected volatility | 91.84% | 83.26% |
Weighted-average fair value of common stock (in dollars per share) | $ 3.26 | $ 3.13 |
Stock Incentive Plans - Summary
Stock Incentive Plans - Summary 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, 2022 | Dec. 31, 2021 | |
Employees | ||
Number of Options | ||
Beginning balance (in shares) | 10,616,800 | |
Granted (in shares) | 4,476,500 | |
Exercised (in shares) | (10,000) | |
Ending balance (in shares) | 15,083,300 | 10,616,800 |
Vested (in shares) | 5,602,046 | |
Vested and expected to vest (in shares) | 13,738,523 | |
Weighted-average exercise price | ||
Beginning balance (in dollars per share) | $ 3.99 | |
Granted (in dollars per share) | 3.26 | |
Exercised (in dollars per share) | 2.10 | |
Ending balance (in dollars per share) | 3.78 | $ 3.99 |
Vested (in dollars per share) | 4.46 | |
Vested and expected to vest (in dollars per share) | $ 3.82 | |
Weighted-average remaining contractual term | ||
Outstanding, term | 8 years 5 months 26 days | 8 years 2 months 8 days |
Vested, term | 7 years 3 months 18 days | |
Vested and expected to vest, term | 8 years 4 months 24 days | |
Aggregate intrinsic value | ||
Outstanding | $ 0 | $ 4,982 |
Vested | 0 | |
Vested and expected to vest | $ 0 | |
Non-employee consultants | ||
Number of Options | ||
Beginning balance (in shares) | 423,073 | |
Forfeited (in shares) | (156,834) | |
Ending balance (in shares) | 266,239 | 423,073 |
Vested (in shares) | 266,239 | |
Vested and expected to vest (in shares) | 266,239 | |
Weighted-average exercise price | ||
Beginning balance (in dollars per share) | $ 6.34 | |
Forfeited (in dollars per share) | 3.44 | |
Ending balance (in dollars per share) | 8.05 | $ 6.34 |
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 | 5 years 9 months 29 days | 3 years 10 months 6 days |
Vested, term | 5 years 9 months 29 days | |
Vested and expected to vest, term | 5 years 9 months 29 days | |
Aggregate intrinsic value | ||
Outstanding | $ 0 | $ 42 |
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, 2022$ / sharesshares | |
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 | 394,450 |
Grants in period (in shares) | shares | 813,200 |
Vested in period (in shares) | shares | (89,142) |
Unvested at end of period (in shares) | shares | 1,118,508 |
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 | $ 3.45 |
Grants in period (in dollars per share) | $ / shares | 3.31 |
Vested in period (in dollars per share) | $ / shares | 3.36 |
Unvested at end of period (in dollars per share) | $ / shares | $ 3.36 |
Stock Incentive Plans - Employe
Stock Incentive Plans - Employee Stock Purchase Plan (Narrative) (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | ||||
Jan. 31, 2022 | Jan. 31, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | Jun. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock authorized and reserved for future issuance (in shares) | 34,210,815 | 28,209,867 | ||||
Stock-based compensation expense | $ 2,753 | $ 1,780 | ||||
ESPP | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock authorized and reserved for future issuance (in shares) | 3,677,538 | 173,076 | ||||
Number of shares authorized, increase (in shares) | 1,236,229 | 1,080,711 | ||||
Shares of common stock issued to employees under the ESPP (in shares) | 81,057 | |||||
Stock-based compensation expense | $ 100 | $ 100 |
Revenue Arrangements - Narrativ
Revenue Arrangements - Narrative (Details) | Oct. 01, 2021USD ($) | Jul. 28, 2020USD ($) | Jun. 13, 2020USD ($) | Jun. 11, 2020USD ($)obligationshares | Dec. 17, 2019USD ($) | Jun. 30, 2020USD ($) | Dec. 31, 2019USD ($) | Mar. 31, 2022USD ($) | Jun. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Jun. 30, 2021amendment | Dec. 31, 2021USD ($) |
Disaggregation of Revenue [Line Items] | ||||||||||||
Long-term contract liability | $ 10,420,000 | $ 11,417,000 | ||||||||||
Revenue recognized | 26,890,000 | |||||||||||
Short-term contract liability | 27,990,000 | 53,883,000 | ||||||||||
Accounts receivable | 7,153,000 | 9,914,000 | ||||||||||
Deferred revenue related to agreement | 38,410,000 | 65,300,000 | ||||||||||
Remaining performance obligation | 38,400,000 | |||||||||||
SOBI Purchase Agreement | ||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||
Long-term contract liability | 4,100,000 | 5,100,000 | ||||||||||
Revenue recognized | 23,800,000 | $ 11,100,000 | ||||||||||
Short-term contract liability | 21,700,000 | 37,500,000 | ||||||||||
Sale common stock | $ 25,000,000 | |||||||||||
Redemption premium | $ 14,500,000 | |||||||||||
Accounts receivable | 7,100,000 | 9,900,000 | ||||||||||
Sale of stock, number of shares issued in transaction (in shares) | shares | 5,416,390 | |||||||||||
Takeda Agreement | ||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||
Upfront cash payment | $ 3,000,000 | |||||||||||
Future additional payments, expected | $ 1,124,000,000 | |||||||||||
Long-term contract liability | 1,000,000 | 1,000,000 | ||||||||||
Revenue recognized | 1,000,000 | |||||||||||
Short-term contract liability | 1,000,000 | |||||||||||
Collaborative Arrangement | ||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||
Upfront cash payment | $ 75,000,000 | $ 75,000,000 | ||||||||||
Sales milestone payments | $ 630,000,000 | |||||||||||
License and option agreement, written day notice period before cancellation | 180 days | |||||||||||
Period after first commercial sale when the Company is eligible to receive royalties | 10 years | |||||||||||
Number of obligations | obligation | 3 | |||||||||||
Development milestone | $ 5,000,000 | |||||||||||
Sarepta Therapeutics, Inc. | ||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||
Upfront cash payment | $ 2,000,000 | |||||||||||
Revenue recognized | 100,000 | 0 | ||||||||||
Short-term contract liability | 4,600,000 | |||||||||||
Sales milestone payments | $ 3,000,000 | |||||||||||
License and option agreement, written day notice period before cancellation | 30 days | |||||||||||
Option term | 24 months | |||||||||||
Number of amendments | amendment | 2 | |||||||||||
License Agreement For Pompe Disease | ||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||
Upfront cash payment | $ 7,000,000 | $ 7,000,000 | ||||||||||
Long-term contract liability | 5,300,000 | |||||||||||
Revenue recognized | 0 | $ 0 | ||||||||||
Short-term contract liability | $ 1,700,000 | 1,700,000 | ||||||||||
Sales milestone payments | $ 237,000,000 | |||||||||||
Period after first commercial sale when the Company is eligible to receive royalties | 10 years | |||||||||||
Initial up-front cash payment | 2,000,000 | |||||||||||
Initial upfront execution fee payment | $ 5,000,000 | |||||||||||
Spark License Agreement | ||||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||||
Deferred revenue related to agreement | $ 9,200,000 |
Revenue Arrangements - Schedule
Revenue Arrangements - Schedule of Changes in Contract Liabilities (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2022USD ($) | |
Contract liabilities: | |
Deferred revenue, beginning of period | $ 65,300 |
Deferred revenue, additions | 0 |
Deferred revenue, deductions | (26,890) |
Deferred revenue, end of period | 38,410 |
Contract liabilities, beginning of period | 65,300 |
Contract liabilities, additions | 0 |
Contract liabilities, deductions | (26,890) |
Contract liabilities, end of period | $ 38,410 |
Related-party Transactions - Na
Related-party Transactions - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Founders | ||
Related Party Transaction [Line Items] | ||
Consulting services expenses (less than) | $ 0 | $ 0.1 |
Collaboration and License Agr_2
Collaboration and License Agreements - Ginkgo Agreement (Details) - USD ($) $ in Millions | Jan. 03, 2022 | Oct. 31, 2021 |
Ginkgo Agreement | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Clinical and commercial milestone payment, expected | $ 207 | $ 85 |
Collaboration and License Agr_3
Collaboration and License Agreements - Cyrus Biotechnology, Inc. (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands | Sep. 07, 2021 | Mar. 31, 2022 | Dec. 31, 2021 |
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_4
Collaboration and License Agreements - AskBio (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Collaboration expense | $ 23,226 | $ 18,208 |
AskBio License | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Collaboration expense | $ 400 | $ 1,200 |
Cost share percentage | 50.00% |
Collaboration and License Agr_5
Collaboration and License Agreements - MIT (Narrative) (Details) - Spark License Agreement | 3 Months Ended |
Mar. 31, 2022USD ($) | |
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_6
Collaboration and License Agreements - Shenyang Sunshine Pharmaceutical Co., Ltd (Narrative) (Details) - 3SBio License $ in Millions | 3 Months Ended |
Mar. 31, 2022USD ($) | |
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, 2021USD ($) |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Federal operating loss carryforwards | $ 51.1 |
Domestic Tax Authority | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Research and development credits | $ 1.2 |
Defined Contribution Plan - Nar
Defined Contribution Plan - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Retirement Benefits [Abstract] | ||
Vesting period | 2 years | |
Employer contribution made | $ 0.1 | $ 0.1 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) $ in Millions | Mar. 31, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
Loss contingency accrual | $ 0.9 | $ 0.9 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Millions | Apr. 06, 2022 | Mar. 31, 2022 |
Subsequent Event [Line Items] | ||
Exercise price (in dollars per share) | $ 1.62 | |
Subsequent Event | Underwriting Agreement | ||
Subsequent Event [Line Items] | ||
Sale of stock, number of shares issued in transaction (in shares) | 27,428,572 | |
Sale common stock | $ 38.7 | |
Subsequent Event | Underwriting Agreement - 2022 Warrants | ||
Subsequent Event [Line Items] | ||
Sale of stock, number of shares issued in transaction (in shares) | 20,571,429 | |
Class of warrant or right, number of securities called by warrants or rights (in shares) | 0.75 | |
Share price (in dollars per share) | $ 1.41 | |
Exercise price (in dollars per share) | $ 1.55 |