Document and Entity Information
Document and Entity Information | 9 Months Ended |
Sep. 30, 2023 | |
Cover [Abstract] | |
Entity Registrant Name | SYROS PHARMACEUTICALS, INC. |
Trading Symbol | SYRS |
Entity Central Index Key | 0001556263 |
Document Type | 10-Q |
Document Period End Date | Sep. 30, 2023 |
Amendment Flag | false |
Current Fiscal Year End Date | --12-31 |
Entity Filer Category | Non-accelerated Filer |
Document Fiscal Year Focus | 2023 |
Document Fiscal Period Focus | Q3 |
Entity Small Business | true |
Entity Emerging Growth Company | false |
Entity Current Reporting Status | Yes |
Entity Shell Company | false |
Entity File Number | 001-37813 |
Entity Tax Identification Number | 45-3772460 |
Entity Address, Address Line One | 35 CambridgePark Drive |
Entity Address, Address Line Two | 4th Floor |
Entity Address, City or Town | Cambridge |
Entity Address, State or Province | MA |
Entity Address, Postal Zip Code | 02140 |
City Area Code | 617 |
Local Phone Number | 744-1340 |
Document Quarterly Report | true |
Document Transition Report | false |
Entity Interactive Data Current | Yes |
Entity Incorporation, State or Country Code | DE |
Title of 12(b) Security | Common Stock, $0.001 par value |
Security Exchange Name | NASDAQ |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 112,219 | $ 167,467 |
Marketable securities | 34,837 | |
Unbilled receivable | 1,665 | 1,694 |
Prepaid expenses and other current assets | 8,631 | 7,394 |
Total current assets | 122,515 | 211,392 |
Property and equipment, net | 7,614 | 11,353 |
Other long-term assets | 2,113 | 5,348 |
Restricted cash | 3,086 | 3,086 |
Right-of-use asset – operating lease | 12,464 | 13,231 |
Right-of-use assets – financing leases | 3 | 76 |
Total assets | 147,795 | 244,486 |
Current liabilities: | ||
Accounts payable | 2,855 | 6,411 |
Accrued expenses | 21,489 | 17,966 |
Deferred revenue, current portion | 139 | 4,330 |
Financing lease obligations, current portion | 3 | 65 |
Operating lease obligation, current portion | 2,241 | 2,006 |
Debt, current portion | 1,667 | |
Total current liabilities | 28,394 | 30,778 |
Operating lease obligation, net of current portion | 19,144 | 20,851 |
Warrant liabilities | 24,549 | 24,472 |
Debt, net of debt discount, long term | 39,406 | 40,649 |
Commitments and contingencies (See Note 10) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at September 30, 2023 and December 31,2022; 0 shares issued and outstanding at September 30, 2023 and December 31,2022 | ||
Common stock, $0.001 par value; 70,000,000 and 70,000,000 shares authorized at September 30, 2023 and December 31,2022, respectively; 20,720,447 and 20,263,116 shares issued and outstanding at September 30, 2023 and December 31,2022, respectively | 21 | 20 |
Additional paid-in capital | 694,704 | 685,847 |
Accumulated other comprehensive income | 102 | |
Accumulated deficit | (658,423) | (558,233) |
Total stockholders' equity | 36,302 | 127,736 |
Total liabilities and stockholders' equity | $ 147,795 | $ 244,486 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (Unaudited) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 70,000,000 | 70,000,000 |
Common stock, shares issued | 20,720,447 | 20,263,116 |
Common stock, shares outstanding | 20,720,447 | 20,263,116 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
Revenue | $ 3,762 | $ 3,891 | $ 9,550 | $ 15,634 |
Operating expenses: | ||||
Research and development | 28,280 | 25,759 | 86,650 | 84,030 |
General and administrative | 7,764 | 8,076 | 22,394 | 21,970 |
Transaction related expenses | 9,510 | 9,510 | ||
Restructuring (Note 13) | 2,354 | 2,354 | ||
Total operating expenses | 38,398 | 43,345 | 111,398 | 115,510 |
Loss from operations | (34,636) | (39,454) | (101,848) | (99,876) |
Interest income | 1,633 | 392 | 5,533 | 539 |
Interest expense | (1,303) | (1,051) | (3,798) | (3,008) |
Change in fair value of warrant liabilities | (5,837) | 9,860 | (77) | 12,465 |
Net loss applicable to common stockholders | $ (40,143) | $ (30,253) | $ (100,190) | $ (89,880) |
Net loss per share applicable to common stockholders - basic | $ (1.43) | $ (3.21) | $ (3.59) | $ (11.93) |
Net loss per share applicable to common stockholders - diluted | $ (1.43) | $ (3.21) | $ (3.59) | $ (11.93) |
Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic | 27,990,558 | 9,417,069 | 27,915,951 | 7,536,149 |
Weighted-average number of common shares used in net loss per share applicable to common stockholders - diluted | 27,990,558 | 9,417,069 | 27,915,951 | 7,536,149 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (40,143) | $ (30,253) | $ (100,190) | $ (89,880) |
Other comprehensive (loss) gain: | ||||
Unrealized holding (loss) gain on marketable securities, net of tax | (49) | 87 | (102) | (147) |
Comprehensive loss | $ (40,192) | $ (30,166) | $ (100,292) | $ (90,027) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDER'S EQUITY - USD ($) $ in Thousands | Total | Private Placement | Common Stock | Common Stock Private Placement | Additional Paid-In Capital | Additional Paid-In Capital Private Placement | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Balance at Dec. 31, 2021 | $ 85,218 | $ 6 | $ 548,870 | $ (79) | $ (463,579) | |||
Balance (in shares) at Dec. 31, 2021 | 6,202,403 | |||||||
Exercise of stock options | 1 | 1 | ||||||
Exercise of stock options, Shares | 3,770 | |||||||
Vesting of restricted stock units | 1 | $ 1 | ||||||
Vesting of restricted stock units, Shares | 83,569 | |||||||
Issuance of shares under Employee Stock Purchase Plan | 108 | 108 | ||||||
Issuance of shares under Employee Stock Purchase Plan, Shares | 13,293 | |||||||
Issuance of common stock, net of issuance cost | $ 60,112 | $ 6 | $ 60,106 | |||||
Issuance of common stock, net of issuance costs, Shares | 6,387,173 | |||||||
Stock-based compensation expense | 8,507 | 8,507 | ||||||
Issuance of shares in merger, net of issuance cost | 65,332 | $ 7 | 65,325 | |||||
Issuance of shares in merger, net of issuance cost, shares | 7,546,014 | |||||||
Redemption of fractional shares due to reverse stock split | (81) | (81) | ||||||
Redemption of fractional shares due to reverse stock split, shares | (10,870) | |||||||
Other comprehensive gain (loss) | (147) | (147) | ||||||
Net loss | (89,880) | (89,880) | ||||||
Balance at Sep. 30, 2022 | 129,171 | $ 20 | 682,836 | (226) | (553,459) | |||
Balance (in shares) at Sep. 30, 2022 | 20,225,352 | |||||||
Balance at Jun. 30, 2022 | 31,019 | $ 7 | 554,531 | (313) | (523,206) | |||
Balance (in shares) at Jun. 30, 2022 | 6,298,898 | |||||||
Vesting of restricted stock units, Shares | 4,137 | |||||||
Issuance of common stock, net of issuance cost | $ 60,112 | $ 6 | $ 60,106 | |||||
Issuance of common stock, net of issuance costs, Shares | 6,387,173 | |||||||
Stock-based compensation expense | 2,955 | 2,955 | ||||||
Issuance of shares in merger, net of issuance cost | 65,332 | $ 7 | 65,325 | |||||
Issuance of shares in merger, net of issuance cost, shares | 7,546,014 | |||||||
Redemption of fractional shares due to reverse stock split | (81) | (81) | ||||||
Redemption of fractional shares due to reverse stock split, shares | (10,870) | |||||||
Other comprehensive gain (loss) | 87 | 87 | ||||||
Net loss | (30,253) | (30,253) | ||||||
Balance at Sep. 30, 2022 | 129,171 | $ 20 | 682,836 | (226) | (553,459) | |||
Balance (in shares) at Sep. 30, 2022 | 20,225,352 | |||||||
Balance at Dec. 31, 2022 | $ 127,736 | $ 20 | 685,847 | 102 | (558,233) | |||
Balance (in shares) at Dec. 31, 2022 | 20,263,116 | 20,263,116 | ||||||
Vesting of restricted stock units | $ 1 | (1) | ||||||
Vesting of restricted stock units, Shares | 132,418 | |||||||
Exercise of prefunded warrants, Shares | 246,831 | |||||||
Issuance of restricted stock awards | 24,000 | |||||||
Issuance of shares under Employee Stock Purchase Plan | $ 144 | 144 | ||||||
Issuance of shares under Employee Stock Purchase Plan, Shares | 54,082 | |||||||
Stock-based compensation expense | 8,714 | 8,714 | ||||||
Other comprehensive gain (loss) | (102) | (102) | ||||||
Net loss | (100,190) | (100,190) | ||||||
Balance at Sep. 30, 2023 | $ 36,302 | $ 21 | 694,704 | (658,423) | ||||
Balance (in shares) at Sep. 30, 2023 | 20,720,447 | 20,720,447 | ||||||
Balance at Jun. 30, 2023 | $ 73,239 | $ 20 | 691,450 | 49 | (618,280) | |||
Balance (in shares) at Jun. 30, 2023 | 20,708,356 | |||||||
Vesting of restricted stock units | $ 1 | (1) | ||||||
Vesting of restricted stock units, Shares | 12,091 | |||||||
Stock-based compensation expense | 3,255 | 3,255 | ||||||
Other comprehensive gain (loss) | (49) | $ (49) | ||||||
Net loss | (40,143) | (40,143) | ||||||
Balance at Sep. 30, 2023 | $ 36,302 | $ 21 | $ 694,704 | $ (658,423) | ||||
Balance (in shares) at Sep. 30, 2023 | 20,720,447 | 20,720,447 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDER'S EQUITY (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 | Sep. 30, 2022 | |
Merger | ||
Issuance costs | $ 3,136 | $ 3,136 |
Private Placement | ||
Issuance costs | $ 5,068 | $ 5,068 |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Operating activities | ||
Net loss | $ (100,190) | $ (89,880) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,900 | 2,001 |
Impairment | 373 | |
Non-cash lease expense | 73 | 196 |
Transaction costs allocated to warrants issued in connection with private placement | 5,015 | |
Stock-based compensation expense | 8,714 | 8,507 |
Change in fair value of warrant liabilities | 77 | (12,465) |
Net amortization of premiums and discounts on marketable securities | (1,314) | 198 |
Amortization of debt-discount and accretion of deferred debt costs | 424 | 557 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 463 | (1,466) |
Unbilled receivable | 29 | 1,208 |
Other long-term assets | 3,235 | (726) |
Accounts payable | (3,556) | 323 |
Accrued expenses | 3,523 | 3,727 |
Deferred revenue | (4,191) | (8,556) |
Operating lease liabilities | (705) | (621) |
Net cash used in operating activities | (91,145) | (91,982) |
Investing activities | ||
Purchases of property and equipment | (234) | (567) |
Purchases of marketable securities | (50,968) | |
Maturities of marketable securities | 87,017 | 30,031 |
Net cash provided by investing activities | 35,815 | 29,464 |
Financing activities | ||
Payments on financing lease obligations | (62) | (216) |
Proceeds from the issuance of common stock through employee stock purchase plan | 144 | 109 |
Proceeds from the issuance of common stock through exercise of stock options | 1 | |
Payment to creditor related to debt modification | (300) | |
Cash and cash equivalents acquired in connection with merger, net of issuance costs paid | 14,166 | |
Proceeds from issuance of common stock and accompanying warrants and pre-funded warrants in private placement, net of issuance costs | 128,069 | |
Redemption of fractional shares due to the reverse stock split | (81) | |
Net cash provided by financing activities | 82 | 141,748 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (55,248) | 79,230 |
Cash and cash equivalents, Beginning of period | 170,553 | 95,388 |
Cash and cash equivalents, End of period | 115,305 | 174,618 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | $ 3,323 | 2,417 |
Non-cash investing and financing activities: | ||
Property and equipment received but unpaid as of period end | 678 | |
Offering costs incurred but unpaid as of period end | $ 10,746 |
Nature of Business
Nature of Business | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | 1. Nature of Business Syros Pharmaceuticals, Inc. (the "Company"), a Delaware corporation formed in November 2011, is a biopharmaceutical company committed to developing new standards of care for the frontline treatment of patients with hematologic malignancies. The Company is subject to a number of risks similar to those of other early stage companies, including dependence on key individuals; risks inherent in the development and commercialization of medicines to treat human disease; competition from other companies, many of which are larger and better capitalized; risks relating to obtaining and maintaining necessary intellectual property protection; and the need to obtain adequate additional financing to fund the development of tamibarotene and any of its other product candidates. If the Company is unable to raise capital when needed or on favorable terms, it would be forced to delay, reduce, eliminate or out-license certain of its research and development programs or future commercialization rights to its product candidates. The Company has incurred significant net operating losses in every year since its inception. It expects to continue to incur significant and increasing net operating losses for at least the next several years. As of September 30, 2023, the Company had cash and cash equivalents of $ 112.2 million and an accumulated deficit of $ 658.4 million. The Company has not generated any revenues from product sales, has not completed the development of any product candidate and may never have a product candidate approved for commercialization. The Company has financed its operations to date primarily through a credit facility, the sale of equity securities and through license and collaboration agreements. The Company has devoted substantially all of its financial resources and efforts to research and development and general and administrative activities to support such research and development. The Company’s net losses may fluctuate significantly from quarter to quarter and year to year. Net losses and negative cash flows have had, and will continue to have, an adverse effect on the Company’s stockholders’ equity and working capital. On September 16, 2022, the Company filed an amendment to its Restated Certificate of Incorporation (the “Restated Certificate of Incorporation”) with the Secretary of State of the State of Delaware to effect the reverse stock split of its common stock, such that every 10 shares of the Company’s common stock held by a stockholder immediately prior to the reverse stock split were combined and reclassified into one share of the Company’s common stock (the “Reverse Stock Split”). On September 16, 2022, the Company completed its acquisition of Tyme Technologies, Inc., a Delaware corporation (“Tyme”), in accordance with an Agreement and Plan of Merger, dated as of July 3, 2022 (the “Merger Agreement”). The Company issued approximately 7.5 million shares of its common stock to the former Tyme stockholders in exchange for all of the shares of Tyme common stock issued and outstanding immediately prior to the merger, with Tyme surviving as a wholly-owned subsidiary of the Company (the “Merger”). In connection with the closing of the Merger, and in accordance with the terms of the Merger Agreement, the Company acquired net cash, cash equivalents and marketable securities of approximately $ 67.1 million. On September 16, 2022, the Company issued in a private placement (the “2022 Private Placement”) 6,387,173 shares of common stock, and, in lieu of shares of common stock, pre-funded warrants (the “2022 Pre-Funded Warrants”) to purchase an aggregate of up to 7,426,739 shares of common stock, and, in each case, accompanying warrants (the “2022 Warrants”) to purchase an aggregate of up to 13,813,912 additional shares of common stock (or 2022 Pre-Funded Warrants to purchase common stock in lieu thereof) at a price of $ 10.34 per share and accompanying 2022 Warrant (or $ 10.33 per 2022 Pre-Funded Warrant and accompanying 2022 Warrant). The 2022 Private Placement resulted in aggregate gross proceeds of $ 129.9 million, before $ 10.1 million of transaction costs. On April 6, 2023, the Company filed a universal shelf registration statement on Form S-3, or the 2023 Registration Statement, with the SEC to register for sale from time to time up to $ 250.0 million of common stock, preferred stock, debt securities, warrants and/or units in one or more registered offerings. The 2023 Registration Statement was declared effective on April 28, 2023. Further, in April 2023, the Company entered into an at-the-market sales agreement with Cowen pursuant to which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $ 50.0 million through Cowen pursuant to the 2023 Registration Statement. On October 2, 2023, the Company announced a strategic realignment to prioritize key development and pre-launch activities to advance tamibarotene for the treatment of newly diagnosed higher-risk myelodysplastic syndrome and newly diagnosed acute myeloid leukemia. The Company will stop further investment in the clinical development of SY-2101 (oral arsenic trioxide) for the treatment of newly diagnosed acute promyelocytic leukemia, as well as in the Company’s preclinical and discovery-stage programs. In connection with these decisions, the Company instituted certain expense reduction measures (the “Restructuring”), including a reduction of approximately 35 % of the Company’s employee base (excluding members of the Company’s drug discovery organization whose employment ended concurrently with the termination, effective October 16, 2023, of its collaboration with Pfizer, Inc. related to the discovery, development and commercialization of novel therapies for sickle cell disease and beta thalassemia (the “Pfizer Agreement Termination”). The Restructuring, which is explained in more detail in Note 13, is expected to be complete by the end of 2023. Based on its current operating plan, the Company’s management believes that as of September 30, 2023 , the Company will meet its liquidity requirements for a period of at least 12 months from the issuance date of this Quarterly Report on Form 10-Q. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The Company’s consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements. In the opinion of the Company’s management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments that are necessary to present fairly the Company’s financial position as of September 30, 2023, the results of its operations for the three and nine months ended September 30, 2023 and 2022, statements of stockholders’ equity for the three and nine months ended September 30, 2023 and 2022, and statements of cash flows for the nine months ended September 30, 2023 and 2022. Such adjustments are of a normal and recurring nature. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results for the year ending December 31, 2023 , or for any future period. Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, (i) Syros Securities Corporation, a Massachusetts corporation formed by the Company in December 2014 to exclusively engage in buying, selling and holding securities on its own behalf, (ii) Syros Pharmaceuticals (Ireland) Limited, an Irish limited liability company formed by the Company in January 2019, and (iii) Tyme Technologies, Inc., a Delaware corporation, which is the surviving corporation in connection with the filing of a certificate of merger with the Secretary of State of the State of Delaware on September 16, 2022, pursuant to which Tack Acquisition Corp., a Delaware corporation formed by the Company in June 2022 to effect the Merger, merged with and into Tyme Technologies, Inc. (refer to Note 1). All intercompany transactions and balances have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Management considers many factors in selecting appropriate financial accounting policies and in developing the estimates and assumptions that are used in the preparation of the financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, which include, but are not limited to, expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates and whether historical trends are expected to be representative of future trends. Management’s estimation process may yield a range of potentially reasonable estimates and management must select an amount that falls within that range of reasonable estimates. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not limited to, estimates related to revenue recognition, warrant liability, stock-based compensation expense, accrued expenses, income taxes and the evaluation of the existence of conditions and events that raise substantial doubt regarding the Company’s ability to continue as a going concern. Actual results may differ from those estimates or assumptions. Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. The Company’ s chief operating decision maker is its chief executive officer. The Company and the chief operating decision maker view the Company’s operations and manage its business in one operating segment. The Company operates only in the United States. Cash and Cash Equivalents The Company considers all highly liquid instruments that have original maturities of three months or less when acquired to be cash equivalents. Cash equivalents, which consist of money market funds that invest in U.S. Treasury obligations, as well as overnight repurchase agreements and corporate debt securities, are stated at fair value. The Company maintains its bank accounts in major financial institutions. Off-Balance Sheet Risk and Concentrations of Credit Risk The Company has no financial instruments with off-balance sheet risk, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash equivalents and marketable securities. Under its investment policy, the Company limits amounts invested in such securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. The Company is not exposed to any significant concentrations of credit risk from these financial instruments. The goals of the Company’s investment policy, in order of priority, are safety and preservation of principal and liquidity of investments sufficient to meet cash flow requirements. Fair Value of Financial Instruments ASC 820, Fair Value Measurement (“ASC 820”), established a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are those that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are those that reflect the Company’s assumption about the inputs that market participants would use in pricing the asset or liability. These are developed based on the best information available under the circumstances. ASC 820 identified fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 established a three-tier fair value hierarchy that distinguishes between the following: Level 1—Quoted market prices (unadjusted) in active markets for identical assets or liabilities. Level 2—Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable, such as quoted market prices, interest rates and yield curves. Level 3—Unobservable inputs developed using estimates or assumptions developed by the Company, which reflect those that a market participant would use. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized as Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The carrying amounts reflected in the condensed consolidated balance sheets for cash and cash equivalents, prepaid expenses, other current assets, restricted cash, accounts payable, accrued expenses and deferred revenue approximate their respective fair values due to their short-term nature. Property and Equipment Property and equipment consists of laboratory equipment, computer equipment, furniture and fixtures and leasehold improvements, all of which are stated at cost, less accumulated depreciation. Expenditures for maintenance and repairs that do not improve or extend the lives of the respective assets are recorded to expense as incurred. Major betterments are capitalized as additions to property and equipment. Depreciation and amortization are recognized over the estimated useful lives of the assets using the straight-line method. Construction-in-progress is stated at cost, which relates to the cost of leasehold improvements not yet placed into service. No depreciation expense is recorded on construction-in-progress until such time as the relevant assets are completed and put into use. Asset Held for Sale An asset is considered to be held for sale when all of the following criteria are met: (i) management commits to a plan to sell the asset; (ii) it is unlikely that the disposal plan will be significantly modified or discontinued; (iii) the asset is available for immediate sale in its present condition; (iv) actions required to complete the sale of the asset have been initiated; (v) sale of the asset is probable and the completed sale is expected to occur within one year; and (vi) the asset is actively being marketed for sale at a price that is reasonable given its current market value. Impairment of Long-Lived Assets The Company evaluates long-lived assets for potential impairment when events or changes in circumstances indicate the carrying value of the assets may not be recoverable. Recoverability is measured by comparing the carrying values of the assets to the expected future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying values of the assets exceed their fair value. A long-lived asset classified as held for sale is measured at the lower of its carrying amount or fair value less cost to sell. A long-lived asset is not depreciated or amortized while it is classified as held for sale, and an impairment loss would be recognized to the extent the carrying amount exceeds the asset's fair value less cost to sell. In connection with the Restructuring, the Company entered into an exclusive auction agreement in October 2023 to sell all of its laboratory equipment by public auction. The Company concluded that the assets met the held for sale criteria and has written the assets down to their fair value less cost to sell of $ 1.7 million which resulted in an impairment charge of $ 0.4 million. These assets held for sale are recorded in prepaid and other current assets in the Company's condensed consolidated balance sheet as of September 30, 2023 . Revenue Recognition To date, the Company’s only revenue has consisted of collaboration and license revenue. The Company has not generated any revenue from product sales and does not expect to generate any revenue from product sales for the foreseeable future. The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. If a contract is determined to be within the scope of ASC 606 at inception, the Company assesses the goods or services promised within such contract, determines which of those goods and services are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. If the Company performs by transferring goods or services to a customer before the customer pays consideration or before payment is due, the Company records a contract asset, excluding any amounts presented as accounts receivable. The Company includes unbilled accounts receivable as contract assets on its consolidated balance sheets. The Company records accounts receivable for amounts billed to the customer for which the Company has an unconditional right to consideration. The Company assesses contract assets and accounts receivable for impairment and, to date, no impairment losses have been recorded. From time to time, the Company may enter into agreements that are within the scope of ASC 606. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees or prepaid research and development services; development, regulatory and commercial milestone payments; and royalties on net sales of licensed products. Each of these payments results in license and collaboration revenues, except for revenues from royalties on net sales of licensed products, which will be classified as royalty revenues. The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements (“ASC 808”), to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and therefore within the scope of ASC 606. For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently, generally by analogy to ASC 606. For those elements of the arrangement that are accounted for pursuant to ASC 606, the Company applies the five-step model described above. Research and Development Expenditures relating to research and development are expensed in the period incurred. Research and development expenses consist of both internal and external costs associated with the development of the Company’s gene control platform and product candidates. Research and development costs include salaries and benefits, materials and supplies, external research, preclinical and clinical development expenses, stock-based compensation expense and facilities costs. Facilities costs primarily include the allocation of rent, utilities, depreciation and amortization. In certain circumstances, the Company is required to make non-refundable advance payments to vendors for goods or services that will be received in the future for use in research and development activities. In such circumstances, the non-refundable advance payments are deferred and capitalized, even when there is no alternative future use for the research and development, until related goods or services are provided. The Company records accruals for estimated ongoing research costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the work being performed, including the phase or completion of the event, invoices received and costs. Significant judgements and estimates may be made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company may in-license the rights to develop and commercialize product candidates. For each in-license transaction the Company evaluates whether it has acquired processes or activities along with inputs that would be sufficient to constitute a “business” as defined under U.S. GAAP. A “business” as defined under U.S. GAAP consists of inputs and processes applied to those inputs that have the ability to create outputs. Although businesses usually have outputs, outputs are not required for an integrated set of activities to qualify as a business. When the Company determines that it has not acquired sufficient processes or activities to constitute a business, any up-front payments, as well as milestone payments, are immediately expensed as acquired research and development in the period in which they are incurred. Warrants The Company accounts for issued warrants either as a liability or equity in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity (“ASC 480-10”) or ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock (“ASC 815-40”). Under ASC 480-10, warrants are considered a liability if they are mandatorily redeemable and they require settlement in cash, other assets, or a variable number of shares. If warrants do not meet liability classification under ASC 480-10, the Company considers the requirements of ASC 815-40 to determine whether the warrants should be classified as a liability or as equity. Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after the issuance date is recorded in the consolidated statements of operations as a gain or loss. If warrants do not require liability classification under ASC 815-40, in order to conclude warrants should be classified as equity, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP standard. Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date. Stock-Based Compensation Expense The Company accounts for its stock-based compensation awards in accordance with ASC 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees and directors, including grants of restricted stock units and stock option awards, to be recognized as expense in the consolidated statements of operations based on their grant date fair values. Consistent with the grants for employees and directors, grants of restricted stock units and stock option awards to other service providers, referred to as non-employees, are measured based on the grant-date fair value of the award and expensed in the Company’s condensed consolidated statement of operations over the vesting period. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to non-employees can be determined using either the contractual term of the option award or the “simplified” method. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The Company uses the value of its common stock to determine the fair value of restricted stock awards. The Company expenses the fair value of its stock-based awards to employees and non-employees on a straight-line basis over the associated service period, which is generally the vesting period. The Company accounts for forfeitures as they occur instead of estimating forfeitures at the time of grant. Ultimately, the actual expense recognized over the vesting period will be for only those options that vest. Compensation expense for discounted purchases under the employee stock purchase plan is measured using the Black-Scholes model to compute the fair value of the lookback provision plus the purchase discount and is recognized as compensation expense over the offering period. For stock-based awards that contain performance-based milestones, the Company records stock-based compensation expense in accordance with the accelerated attribution model. Management evaluates when the achievement of a performance-based milestone is probable based on the expected satisfaction of the performance conditions as of the reporting date. Income Taxes The Company accounts for uncertain tax positions using a more-likely-than-not threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors including, but not limited to, changes in the law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity, and changes in facts or circumstances related to a tax position. Net Loss per Share Basic net earnings per share applicable to common stockholders is calculated by dividing net earnings applicable to common stockholders by the weighted average shares outstanding during the period, without consideration for common stock equivalents. Diluted net earnings per share applicable to common stockholders is calculated by adjusting the weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method and the if-converted method. For purposes of the calculation of dilutive net loss per share applicable to common stockholders, stock options, unvested restricted stock units, and warrants are considered to be common stock equivalents but are excluded from the calculation of diluted net loss per share applicable to common stockholders, as their effect would be anti-dilutive; therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented. As of September 30, 2023 , 100,000 pre-funded warrants to purchase common stock issued in connection with the December 2020 private placement (the “2020 Pre-Funded Warrants”) (refer to Note 11), and 7,279,819 2022 Pre-Funded Warrants issued in connection with the September 2022 private placement (refer to Note 11) were included in the basic and diluted net loss per share calculation. As of September 30, 2022, the 2020 Pre-Funded Warrants were included in the basic and diluted net loss per share calculation. The following common stock equivalents were excluded from the calculation of diluted net loss per share applicable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: As of September 30, 2023 2022 Stock options 1,746,177 1,547,190 Unvested restricted stock units 2,417,891 521,316 Warrants* 14,142,298 14,354,007 Total 18,306,366 16,422,513 * As of September 30, 2023 , this is comprised of 2,754 warrants to purchase common stock issued in connection with the execution and first draw of the Company’s loan agreement in February 2020 (refer to Note 8), 1,738 warrants to purchase common stock issued in connection with the second draw on this loan agreement in December 2020 (refer to Note 8), 282,809 warrants to purchase common stock issued in connection with the private placement in December 2020 (refer to Note 11), 13,813,912 warrants to purchase common stock issued in connection with the private placement in September 2022 (refer to Note 11), and 41,085 warrants to purchase common stock that were issued upon the assumption and conversion of Tyme warrants in connection with the Merger (refer to Note 3). As of September 30, 2022 , this is comprised of 211,709 warrants to purchase common stock issued in connection with the Company’s April 2019 financing (refer to Note 11), 2,754 warrants to purchase common stock issued in connection with the execution and first draw of the Company’s loan agreement in February 2020 (refer to Note 8), 1,738 warrants to purchase common stock issued in connection with the second draw on this loan agreement in December 2020 (refer to Note 8), 282,809 warrants to purchase common stock issued in connection with the private placement in December 2020 (refer to Note 11), 13,813,912 warrants to purchase common stock issued in connection with the private placement in September 2022 (refer to Note 11), and 41,085 warrants to purchase common stock that were issued upon the assumption and conversion of Tyme warrants in connection with the Merger (refer to Note 3). Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the incurred loss impairment model with an expected loss model that requires the use of forward-looking information to calculate credit loss estimates. It also eliminates the concept of other-than-temporary impairment and requires credit losses on available-for-sale debt securities to be recorded through an allowance for credit losses instead of as a reduction in the amortized cost basis of the securities. ASU 2016-13 becomes effective for smaller reporting companies for fiscal years beginning after December 15, 2022, and early adoption is permitted. The Company adopted this new standard on January 1, 2023 , and it did not have a material impact on its condensed consolidated financial statements and related disclosures. |
Recapitalization
Recapitalization | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Recapitalization | 3. Recapitalization On September 16, 2022, the Company issued approximately 7.5 million shares of its common stock to the former Tyme stockholders in connection with the Merger. The Company also issued options and warrants to purchase 733,545 shares of the Company’s common stock to certain holders of Tyme options and warrants that were outstanding immediately before the consummation of the Merger. The Merger is accounted for as a recapitalization because the Company was determined to be a legal and accounting acquirer under Financial Accounting Standards Board’s Accounting Standards Codification Topic 805, Business Combinations (“ASC 805”). This determination was primarily based on the following facts and circumstances: • The pre-combination equity holders of the Company hold the relative majority of voting rights in the combined entity; • The pre-combination equity holders of the Company have the right to appoint the majority of the directors on the combined entity’s board of directors; • Senior management of the Company comprises the senior management of the combined entity; • Operations of the Company comprise the ongoing operations of the combined entity; and • Upon effectiveness of the Merger, the primary assets of Tyme at the effective date were primarily cash, cash equivalents and marketable securities. Under the recapitalization accounting model, the net assets acquired are recognized at fair value and any excess consideration transferred over the fair value of the net assets are reflected as a reduction to equity. Transaction costs incurred attributable to the Merger are also reflected as a reduction to the equity. The carrying value of Tyme’s net assets as of September 16, 2022, which approximates fair value because of its short-term nature, is set forth below: Fair Value Cash and cash equivalents $ 14,898 Marketable securities 52,220 Prepaid expenses 1,350 Total $ 68,468 No value has been ascribed to the development programs acquired from Tyme in the Merger. The Company incurred $ 3.1 million of transaction costs attributable to the Merger which are reflected as a reduction of additional paid-in capital. In addition, the Company paid $ 4.5 million of severance to former Tyme employees which was expensed at the closing of the transaction. |
Collaboration and Research Arra
Collaboration and Research Arrangements | 9 Months Ended |
Sep. 30, 2023 | |
Collaborative Arrangement Disclosure [Abstract] | |
Collaboration and Research Arrangements | 4. Collaboration and Research Arrangements Collaboration with Global Blood Therapeutics On December 17, 2019, the Company entered into a license and collaboration agreement (the “GBT Collaboration Agreement”) with Global Blood Therapeutics, Inc. (“GBT”), now a subsidiary of Pfizer Inc., pursuant to which the parties agreed to a research collaboration to discover novel targets that induce fetal hemoglobin in order to develop new small molecule treatments for sickle cell disease and beta thalassemia. The research term (the “Research Term”) was for an initial period of three years and could be extended for up to two additional one-year terms upon mutual agreement. In November 2022, the Company and GBT agreed to extend the Research Term for an additional one-year period. Pfizer, as successor to GBT, elected to exercise its right to terminate the GBT Collaboration Agreement, effective October 16, 2023 . Pursuant to the terms of the GBT Collaboration Agreement, GBT paid the Company an upfront payment of $ 20.0 million. GBT also agreed to reimburse the Company for full-time employee and out-of-pocket costs and expenses incurred by the Company in accordance with the agreed-upon research budget, which was anticipated to total approximately $ 40.0 million over the initial Research Term. The Company granted to GBT an option (the “Option”) to obtain an exclusive, worldwide license, with the right to sublicense, under relevant intellectual property rights and know-how of the Company arising from the collaboration to develop, manufacture and commercialize any compounds or products resulting from the collaboration. This Option terminated simultaneously with the effective date of termination of the GBT Collaboration Agreement, and the Company is no longer eligible to receive any milestone or royalty-based payments from GBT. GBT Collaboration Revenue The Company analyzed the GBT Collaboration Agreement and concluded that it represented a contract with a customer within the scope of ASC 606. The Company identified a single performance obligation, which included a (i) non-exclusive research license that GBT had access to during the initial Research Term and (ii) research and development services provided during the initial Research Term. The GBT Collaboration Agreement includes the Option. The Option did not provide a material right to GBT that it would receive without entering into the GBT Collaboration Agreement, principally because the Option exercise fee was at least equal to the standalone selling price for the underlying goods. The non-exclusive research license was not distinct as GBT could not benefit from the license without the research and development services that were separately identifiable in the contract. The non-exclusive research license only allowed GBT to evaluate the candidate compounds developed under the research plan or to conduct work allocated to it during the Research Term. GBT could not extract any benefit from the non-exclusive research license without the research and development services performed by the Company, including the provision of data package information. As such, these two promises are inputs to a combined output (the delivery of data package allowing GBT to make an Option exercise decision) and are bundled into a single performance obligation (the non-exclusive research license and research and development service performance obligation). At inception, the total transaction price was determined to be approximately $ 60.0 million, which consisted of a $ 20.0 million upfront non-refundable and non-creditable technology access fee and approximately $ 40.0 million in reimbursable costs for employee and external research and development expenses. The GBT Collaboration Agreement also provided for development and regulatory milestones which were only payable subsequent to the exercise of the Option, and therefore were excluded from the transaction price at inception. As of September 30, 2023 , the transaction price was estimated at $ 54.6 million, which reflects a reduction in the initial estimate of $ 60.0 million due to a lower reimbursable cost incurred and the termination of the GBT Collaboration Agreement that became effective on October 16, 2023, partially offset by additional consideration of $ 7.1 million related to the one year extension of the Research Term. The Company accounted for the contract amendment as if it were part of the existing contract, since the remaining goods and services are not distinct, and form part of a single performance obligation that was partially satisfied at the date of the amendment. ASC 606 requires an entity to recognize revenue only when it satisfies a performance obligation by transferring a promised good or service to a customer. A good or service is considered to be transferred when the customer obtains control. As the non-exclusive research license and research and development services represent one performance obligation, the Company has determined that it would satisfy its performance obligation over a period of time as services are performed and GBT receives the benefit of the services, as the overall purpose of the arrangement is for the Company to perform the services. The Company will recognize revenue associated with the performance obligation as the research and development services are provided using an input method, according to the costs incurred as related to the research and development activities and the costs expected to be incurred in the future to satisfy the performance obligation. The transfer of control occurs during this time and is the best measure of progress towards satisfying the performance obligation. During the three and nine months ended September 30, 2023 , the Company recognized revenue of $ 3.8 million and $ 9.5 million, respectively, under the GBT Collaboration Agreement. During the three and nine months ended September 30, 2022 , the Company recognized revenue of $ 3.7 million and $ 14.4 million, respectively, under the GBT Collaboration Agreement. As of September 30, 2023 , the Company had deferred revenue outstanding under the GBT Collaboration Agreement of approximately $ 0.1 million, all of which is classified as deferred revenue, current portion on the Company’s condensed consolidated balance sheets. Agreements with Incyte Corporation In January 2018, the Company and Incyte entered into a Target Discovery, Research Collaboration and Option Agreement (the “Incyte Collaboration Agreement”). The Incyte Collaboration Agreement was amended in November 2019. Under the terms of the Incyte Collaboration Agreement, Incyte paid the Company $ 10.0 million in up-front consideration, consisting of $ 2.5 million in cash and $ 7.5 million in pre-paid research funding (the “Prepaid Research Amount”). On August 9, 2023, Incyte elected to terminate the Incy te Collaboration Agreement. In January 2018, the Company also entered into a Stock Purchase Agreement with Incyte (the “Stock Purchase Agreement”) whereby, for an aggregate purchase price of $ 10.0 million, Incyte purchased 79,302 shares of the Company’s common stock at $ 126.10 per share. Under the terms of the Stock Purchase Agreement, the shares were purchased at a 30 % premium over the volume-weighted sale price of the shares of the Company’s common stock over the 15 -trading day period immediately preceding the date of the Stock Purchase Agreement. Incyte Collaboration Revenue The Company analyzed the Incyte Collaboration Agreement and concluded that it represents a contract with a customer within the scope of ASC 606. The Company identified a single performance obligation which included (i) a research license that Incyte retained as long as there remained an unexercised option (the “Research License”), and (ii) research and development services provided during the research term. The Incyte Collaboration Agreement included options to (x) obtain additional time to exercise the license options for certain targets designated as definitive validation targets, and (y) obtain license rights to each validated target, both of which were not considered by the Company’s management to be material rights, and therefore not performance obligations, at inception. The total transaction price following the November 2019 amendment was $ 12.8 million, consisting of a $ 2.5 million upfront non-refundable and non-creditable payment, the $ 7.5 million Prepaid Research Amount, $ 2.3 million in premium paid on the equity investment made pursuant the Stock Purchase Agreement, and $ 0.5 million of additional consideration. The Company accounted for the contract amendment as a modification as if it were part of the existing contract as the remaining goods and services are not distinct, and therefore form part of a single performance obligation that was partially satisfied at the date of the amendment. The Company recognizes revenue associated with the performance obligation as the research and development services are provided using an input method, according to the costs incurred as related to the research and development activities and the costs expected to be incurred in the future to satisfy the performance obligation. The transfer of control occurs during this time and is the best measure of progress towards satisfying the performance obligation. As of December 31, 2022, the Company has completed all of the target validation activities allocated to it under the research plan and all deferred revenue were recognized. The Company did no t recognize any revenue under the Incyte Collaboration Agreement during the three and nine months ended September 30, 2023. For three and nine months ended September 30, 2022 , the Company recognized revenue of $ 0.2 million and $ 1.2 million, respectively, under the Incyte Collaboration Agreement. The following table presents the changes in contract liabilities for the nine months ended September 30, 2023 (in thousands): Balance at Additions Deductions Balance at September 30, 2023 Contract liabilities: Deferred revenue - GBT $ 4,330 $ 173 $ 4,364 $ 139 Total contract liabilities $ 4,330 $ 173 $ 4,364 $ 139 |
Cash, Cash Equivalents and Mark
Cash, Cash Equivalents and Marketable Securities | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Cash, Cash Equivalents and Marketable Securities | 5. Cash, Cash Equivalents and Marketable Securities Cash equivalents are highly liquid investments that are readily convertible into cash with original maturities of three months or less when purchased. Marketable securities consist of securities with original maturities greater than 90 days when purchased. The Company classifies these marketable securities as available-for-sale and records them at fair value in the accompanying condensed consolidated balance sheets. Unrealized gains or losses are included in accumulated other comprehensive loss. Premiums or discounts from par value are amortized to interest income over the life of the underlying security. Cash, cash equivalents and marketable securities consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands): Unrealized Unrealized Fair September 30, 2023 Amortized Cost Gains Losses Value Cash and cash equivalents: Cash and money market funds $ 112,219 $ — $ — $ 112,219 Total: $ 112,219 $ — $ — $ 112,219 Unrealized Unrealized Fair December 31, 2022 Amortized Cost Gains Losses Value Cash and cash equivalents: Cash and money market funds $ 167,467 $ — $ — $ 167,467 Marketable securities: Corporate debt securities - due in one year or less 22,257 116 ( 53 ) 22,320 Commercial paper 2,491 — — 2,491 Municipal bonds 5,987 51 — 6,038 US Treasury obligation - due in one year or less 4,000 — ( 12 ) 3,988 Total $ 202,202 $ 167 $ ( 65 ) $ 202,304 Although available to be sold to meet operating needs or otherwise, securities are generally held through maturity. The cost of securities sold is determined based on the specific identification method for purposes of recording realized gains and losses. During the nine months ended September 30, 2023 and 2022 , there were no realized gains or losses on sales of investments, and no investments were adjusted for other-than-temporary declines in fair value. As of September 30, 2023 , the Company had no investments in marketable securities. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 6. Fair Value Measurements Assets and liabilities measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022 were as follows (in thousands): Active Observable Unobservable Markets Inputs Inputs Description September 30, 2023 (Level 1) (Level 2) (Level 3) Assets: Cash and cash equivalents: Cash and money market funds $ 112,219 $ 112,219 $ — $ — Total: $ 112,219 $ 112,219 $ — $ — Liabilities: Warrant liabilities $ 24,549 $ — $ — $ 24,549 Total $ 24,549 $ — $ — $ 24,549 Active Observable Unobservable Markets Inputs Inputs Description December 31, 2022 (Level 1) (Level 2) (Level 3) Assets: Cash and cash equivalents: Cash and money market funds $ 167,467 $ 167,467 $ — $ — Marketable securities: Corporate debt securities - due in one year or less 22,320 — 22,320 — Commercial paper 2,491 — 2,491 — Municipal bonds 6,038 — 6,038 — US Treasury obligation - due in one year or less 3,988 3,988 — — Total $ 202,304 $ 171,455 $ 30,849 $ — Liabilities: Warrant liabilities $ 24,472 $ — $ — $ 24,472 Total $ 24,472 $ — $ — $ 24,472 Assumptions Used in Determining Fair Value of Warrants The Company issued the 2022 Warrants to purchase an aggregate of up to 13,813,912 shares of common stock in connection with the 2022 Private Placement (see Note 11) and warrants to purchase an aggregate of up to 282,809 shares of common stock in connection with a private placement on December 8, 2020 (the “2020 Warrants”) (see Note 11). The Company accounted for the 2022 Warrants and 2020 Warrants as liabilities. The Company recorded the fair value of these warrants upon issuance using the Black-Scholes valuation model and is required to revalue these warrants at each reporting date with any changes in fair value recorded on the Company's statement of operations. The valuation of the 2022 Warrants and 2020 Warrants is considered under Level 3 of the fair value hierarchy and influenced by the fair value of the underlying common stock of the Company. A summary of the Black Scholes pricing model assumptions used to record the fair value of the Warrants is as follows: September 30, 2023 December 31, 2022 Stock price $ 3.95 $ 3.59 Average risk-free interest rate 4.71 % 4.02 % Average expected life (in years) 3.92 4.67 Average expected volatility 85.96 % 86.79 % Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis The following table reflects the change in the Company’s Level 3 warrant liability for the nine months ended September 30, 2023 and the year ended December 31, 2022 (in thousands): September 30, 2023 December 31, 2022 Fair value of warrant liabilities as of beginning of year $ 24,472 $ 3,029 Warrants issued in connection with 2022 Private Placement — 64,664 Change in fair value 77 ( 43,221 ) Fair value of warrant liabilities as of end of period $ 24,549 $ 24,472 |
Restricted Cash
Restricted Cash | 9 Months Ended |
Sep. 30, 2023 | |
Restricted Cash [Abstract] | |
Restricted Cash | 7. Restricted Cash As of September 30, 2023 and December 31, 2022 , the Company had $ 3.1 million in restricted cash, which was classified as long-term on the Company’s condensed consolidated balance sheets, and all of which was attributable to the HQ Lease (See Note 10). In connection with the execution of the HQ Lease, the Company was required to provide the landlord with a letter of credit in the amount of $ 3.1 million that will expire 95 days after expiration or early termination of the HQ Lease. The Company will have the right, under certain conditions, to reduce the amount of the letter of credit to $ 2.1 million in October 2023. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the amounts shown in the Company’s condensed consolidated statement of cash flows as of September 30, 2023 and 2022 (in thousands): September 30, 2023 2022 Cash and cash equivalents $ 112,219 $ 171,532 Restricted cash, net of current portion $ 3,086 3,086 Total cash, cash equivalents and restricted cash $ 115,305 $ 174,618 |
Oxford Finance Loan Agreement
Oxford Finance Loan Agreement | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Oxford Finance Loan Agreement | 8. Oxford Finance Loan Agreement On February 12, 2020, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with Oxford Finance LLC (the “Lender”). Pursuant to the Loan Agreement, a term loan of up to an aggregate principal amount of $ 60.0 million is available to the Company. A first tranche term loan for $ 20.0 million was funded on February 12, 2020, and a second tranche term loan for $ 20.0 million was funded on December 23, 2020. The remaining $ 20.0 million is still available under the Loan Agreement, at the sole discretion of the Lender. The term loan initially bore interest at an annual rate equal to the greater of (i) 7.75 % and (ii) the sum of 5.98 % and the greater of (A) one-month LIBOR or (B) 1.77 %. The Loan Agreement initially provided for interest-only payments until March 1, 2023, and repayment of the aggregate outstanding principal balance of the term loan in monthly installments starting on March 1, 2023 and continuing through February 1, 2025 (the “Maturity Date”). Pursuant to the terms of an amendment to the Loan Agreement dated July 3, 2022 (the “Loan Agreement Amendment”), effective September 16, 2022, Oxford agreed to extend the interest-only period from March 1, 2023 to March 1, 2024 and to extend the Maturity Date from February 1, 2025 to February 1, 2026 , and upon the achievement of certain milestones and subject to the payment of certain fees, further extend the interest only period to September 1, 2024 and the Maturity Date to August 1, 2026 . Pursuant to the terms of a subsequent amendment to the Loan Agreement dated November 15, 2022, the floating annual rate for each term loan was amended to equal the greater of (i) 7.75 % and (ii) the sum of (a) the 1-month CME Term SOFR reference rate, (b) 0.10 %, and (c) 5.98 %. The Company paid a facility fee of $ 0.1 million upon the funding of the first tranche, paid a facility fee of $ 75,000 upon funding of the second tranche and must pay a $ 50,000 facility fee if and when the third loan tranche is funded. The Company also paid fees of $ 300,000 related to the Loan Agreement Amendment. The Company will be required to make a final payment fee of 5.00 % of the amount of the term loan drawn payable on the earlier of (i) the prepayment of the term loan or (ii) the Maturity Date. At the Company’s option, the Company may elect to prepay the loans subject to a prepayment fee equal to the following percentage of the principal amount being prepaid: 2 % if an advance is prepaid during the first 12 months following the applicable advance date, 1 % if an advance is prepaid after 12 months but prior to 24 months following the applicable advance date, and 0.5 % if an advance is prepaid any time after 24 months following the applicable advance date but prior to the Maturity Date. In connection with the Loan Agreement, the Company granted the Lender a security interest in all of the Company’s personal property now owned or hereafter acquired, excluding intellectual property (but including the right to payments and proceeds of intellectual property), and a negative pledge on intellectual property. The Loan Agreement also contains certain events of default, representations, warranties and non-financial covenants of the Company. In connection with the funding of the first tranche in February 2020, the Company issued the Lender warrants to purchase 2,754 shares of the Company’s common stock at an exercise price per share of $ 72.60 . In connection with the funding of the second tranche in December 2020, the Company issued the Lender warrants to purchase 1,738 shares of the Company’s common stock at an exercise price of $ 115.00 per share (collectively, the “Oxford Warrants”). The Oxford Warrants are exercisable within five years from their respective dates of issuance. The Oxford Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, the Oxford Warrants do not provide any guarantee of value or return. The Company has the following minimum aggregate future loan payments as of September 30, 2023 (in thousands): Three months ending December 31, 2023 $ — Year ending December 31, 2024 6,667 Year ending December 31, 2025 20,000 Year ending December 31, 2026 13,333 Total minimum payments 40,000 Less unamortized debt discount ( 381 ) Plus accumulated accretion of final fees 1,454 Less current portion ( 1,667 ) Long-term debt, net of current portion $ 39,406 For the three and nine months ended September 30, 2023 , interest expense related to the Loan Agreement was approximately $ 1.3 million and $ 3.7 million, respectively. For three and nine months ended September 30, 2022 , interest expense related to the Loan Agreement was approximately $ 1.0 million and $ 3.0 million, respectively. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 9. Accrued Expenses Accrued expenses consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands): September 30, 2023 December 31, 2022 External research and preclinical development $ 11,643 $ 8,219 Employee compensation and benefits (Note 13) 7,941 8,529 Professional fees 1,300 1,164 Facilities and other 605 54 Accrued expenses $ 21,489 $ 17,966 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 10. Commitments and Contingencies Operating Lease On January 8, 2019, the Company entered into a lease (the “HQ Lease”) with respect to approximately 52,859 square feet of space in Cambridge, Massachusetts for a lease term commencing in January 2019 and ending in February 2030. The Company has the option to extend the lease term for one additional ten-year period. The HQ Lease has escalating rent payments and the Company records rent expense on a straight-line basis over the term of the HQ Lease, including any rent-free periods. In connection with the execution of the HQ Lease, the Company was required to provide the landlord with a letter of credit in the amount of $ 3.1 million (See Note 7). The Company determined that, for purposes of applying the lease accounting guidance codified in ASU No. 2016-02, Leases (Topic 842) (“ASC 842”), the commencement date of the HQ Lease occurred on May 1, 2019. The Company recorded a right-of-use asset and lease liability of $ 15.8 million using an incremental borrowing rate of 9.3 %, net of tenant allowances expected to be received of $ 9.3 million, on the May 1, 2019 lease commencement date. The Company is amortizing the tenant allowance to offset rent expenses over the term of the HQ Lease starting at the lease commencement date on a straight-line basis. On the Company’s condensed consolidated balance sheets, the Company classified $ 2.2 million of the lease liability as short-term and $ 19.1 million of the lease liability as long-term as of September 30, 2023. The Company elected the practical expedient provided under ASC 842 and therefore combined all lease and non-lease components when determining the right-of-use asset and lease liability for the HQ Lease. The following is a maturity analysis of the annual undiscounted cash flows reconciled to the carrying value of the operating lease liabilities as of September 30, 2023 (in thousands): Operating Three Months ending December 31, 2023 $ 1,027 Year ending December 31, 2024 4,166 Year ending December 31, 2025 4,287 Year ending December 31, 2026 4,412 Year ending December 31, 2027 and beyond 14,844 Total minimum lease payments 28,736 Less imputed interest ( 7,351 ) Total lease liability $ 21,385 The following table outlines the total lease cost for the Company’s operating leases as well as weighted average information for these leases as of September 30, 2023 (in thousands): Nine Months Ended September 30, 2023 Lease cost: Operating lease cost $ 2,316 Cash paid for amounts included in the measurement of liabilities: Operating cash flows from operating lease $ 3,021 Other information: Nine Months Ended September 30, 2023 Weighted-average remaining lease term (in years) - operating lease 6.67 Weighted-average discount rate - operating lease 9.30 Following the adoption of ASC 842, the Company has a right-of-use asset and lease liability that results in recording a temporary tax difference. This temporary tax difference is the result of recognizing a right-of-use asset and related lease liability while such asset and liability have no corresponding tax basis. Asset Purchase Agreement Orsenix, LLC On December 4, 2020, the Company entered into an asset purchase agreement (the “Asset Purchase Agreement”) with Orsenix, LLC (“Orsenix”), pursuant to which the Company acquired Orsenix’s assets related to a novel oral form of arsenic trioxide, which the Company refers to as SY-2101. Under the terms of the Asset Purchase Agreement, the Company is required to pay to Orsenix: • an upfront fee of $ 12.0 million, which was paid with cash on hand upon the closing of the transaction; • single-digit million dollar milestone payments related to the development of SY-2101 in indications other than APL; • $ 6.0 million following the achievement of a regulatory milestone related to the development of SY-2101 in APL; and • up to $ 10.0 million upon the achievement of certain commercial milestones with respect to SY-2101. The Company’s obligation to pay the commercial milestone payments expires following the tenth anniversary of the first commercial sale of SY-2101. The Asset Purchase Agreement requires the Company to use commercially reasonable efforts to develop and commercialize SY-2101 for APL in the United States during such period, and to use commercially reasonable efforts to dose the first patient in a Phase 3 clinical trial of SY-2101 on or before the third anniversary of the closing of the transaction; however, the Company retains sole discretion to operate the acquired assets as it determines. The assets acquired from Orsenix do not meet the definition of a business under ASC 805 “Business Combinations” (“ASC 805”) because substantially all of the fair value of the assets acquired is concentrated in a single identifiable asset, the rights to SY-2101. Furthermore, as the acquired asset does not include a substantive process, the asset does not meet the minimum requirements to be considered a business under ASC 805. As SY-2101 does not have an alternative future use, the Company recorded the $ 12.0 million upfront cash payment as research and development expense on the date of acquisition in December 2020. The Company will expense any future milestone payments made prior to the time an alternative future use for SY-2101 has been established. Once an alternative future use for SY-2101 has been established, the Company will capitalize milestone payments as an addition to the carrying value of SY-2101. License Agreement TMRC Co. Ltd. In September 2015, the Company entered into an exclusive license agreement with TMRC Co. Ltd. ("TMRC") to develop and commercialize tamibarotene in North America and Europe for the treatment of cancer. This agreement was amended and restated in April 2016, and further amended in January 2021 to expand the territory under which the Company is licensed to include Central and South America, Australia, Israel and Russia. In exchange for this license, the Company agreed to a non-refundable upfront payment of $ 1.0 million, for which $ 0.5 million was paid in September 2015 upon execution of the agreement, and the remaining $ 0.5 million was paid in May 2016. Under the agreement, the Company is also obligated to make payments upon the successful achievement of clinical and regulatory milestones totaling approximately $ 13.0 million per indication, defined as a distinct tumor type. The Company paid $ 1.0 million to TMRC for a development milestone achieved upon the successful dosing of the first patient in its Phase 2 clinical trial of tamibarotene in 2016. In May 2021, the Company paid $ 2.0 million to TMRC for a development milestone achieved upon the successful dosing of the first patient in its Phase 3 clinical trial of tamibarotene in MDS patients. In September 2021, the Company paid $ 1.0 million to TMRC for a development milestone achieved upon the successful dosing of the first patient in its Phase 2 clinical trial of tamibarotene in AML patients. In addition, the Company is obligated to pay TMRC a single-digit percentage royalty, on a country-by-country and product-by-product basis, on net product sales of tamibarotene using know-how and patents licensed from TMRC in North America and Europe for a defined royalty term. The Company also entered into a supply management agreement with TMRC under which the Company agreed to pay TMRC a fee for each kilogram of tamibarotene that is produced. The Company incurred fees of $ 1.8 million under this supply management agreement during both the three and nine months ended September 30, 2023 . The Company incurred fees of $ 1.8 million under this supply management agreement during both the three and nine months ended September 30, 2022 . |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | 11. Stockholders’ Equity Increase of Authorized Shares and Reverse Stock Split Effective on September 15, 2022 , the number of authorized shares of the Company’s common stock was increased from 200,000,000 shares (on a pre-split basis) to 700,000,000 shares (on a pre-split basis). On September 16, 2022, the number of authorized shares of the Company’s common stock was proportionately adjusted from 700,000,000 to 70,000,000 as a result of the Reverse Stock Split. Immediately following the Reverse Stock Split, and without giving effect to the shares of the Company’s common stock issued in connection with the Merger and the 2022 Private Placement, there were approximately 6.3 million shares of the Company’s common stock outstanding. The Company’s common stock began trading on The Nasdaq Global Select Market on a split-adjusted basis on September 19, 2022. No fractional shares were issued in connection with the Reverse Stock Split. Any fractional shares resulting from the Reverse Stock Split were rounded down to the nearest whole number, and each stockholder who would have otherwise been entitled to a fraction of a share of common stock upon the Reverse Stock Split (after aggregating all fractions of a share to which such stockholder would have otherwise been entitled) was, in lieu thereof, entitled to receive a cash payment. Issuance of Securities through a Private Placement On September 16, 2022, the Company issued in a private placement 6,387,173 shares of common stock, and, in lieu of shares of common stock, the 2022 Pre-Funded Warrants to purchase an aggregate of 7,426,739 shares of common stock, and, in each case, the accompanying 2022 Warrants to purchase an aggregate of up to 13,813,912 additional shares of common stock (or 2022 Pre-Funded Warrants to purchase common stock in lieu thereof) at a price of $ 10.34 per share and accompanying 2022 Warrant (or $ 10.33 per 2022 Pre-Funded Warrant and accompanying 2022 Warrant). The 2022 Private Placement resulted in aggregate gross proceeds of $ 129.9 million, before $ 10.1 million of transaction costs. On December 8, 2020, the Company issued in a private placement (the "2020 Private Placement") 1,031,250 shares of common stock, and, in lieu of shares of common stock, the 2020 Pre-Funded Warrants to purchase an aggregate of 100,000 shares of common stock, and, in each case, the accompanying 2020 Warrants to purchase an aggregate of up to 282,809 additional shares of common stock (or 2020 Pre-Funded Warrants to purchase common stock in lieu thereof) at a price of $ 80.00 per share and accompanying 2020 Warrant (or $ 79.90 per 2020 Pre-Funded Warrant and accompanying 2020 Warrant). The 2020 Private Placement resulted in aggregate gross proceeds of $ 90.5 million, before $ 0.4 million of transaction costs. In the event of certain fundamental transactions involving the Company, the holders of the 2022 Warrants and 2020 Warrants may require the Company to make a payment based on a Black-Scholes valuation, using specified inputs. The holders of 2022 Pre-Funded Warrants and 2020 Pre-Funded Warrants do not have similar rights. Therefore, the Company accounted for the 2022 Warrants and 2020 Warrants as liabilities, while the 2022 Pre-Funded Warrants and 2020 Pre-Funded Warrants met the permanent equity criteria classification. The 2022 Pre-Funded Warrants and 2020 Pre-Funded Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, the 2022 Pre-Funded Warrants and 2020 Pre-Funded Warrants do not provide any guarantee of value or return. The initial fair value of the 2022 Warrants and the 2020 Warrants at issuance was $ 64.7 million and $ 19.3 million, respectively, determined using the Black-Scholes valuation model. For the three and nine months ended September 30, 2023 , the Company recorded a change in fair value of $ 5.8 million and $ 0.1 million, respectively, in its condensed statement of operations for the remeasurement of the aggregate fair value of the 2022 Warrants and the 2020 Warrants as of September 30, 2023 and December 31, 2022 of $ 24.6 million and $ 24.5 million, respectively. For the three and nine months ended September 30, 2022 , the Company recorded a change in fair value of $ 9.9 million and $1 2.5 million, respectively, in its condensed statement of operations. Convertible Preferred Stock and 2019 Warrants On April 9, 2019, the Company completed two concurrent underwritten public offerings of its equity securities. In the first public offering, the Company sold 866,733 shares of its common stock and accompanying Class A warrants (the “2019 Warrants”) to purchase 195,184 shares of the Company’s common stock at a combined price to the public of $ 75.0 per common share and accompanying 2019 Warrant. In the second public offering, the Company sold 666 shares of its Series A convertible preferred stock (the “Series A Preferred Stock”) and accompanying 2019 Warrants to purchase 16,650 shares of the Company’s common stock at a combined public offering price of $ 75,000 per share and accompanying 2019 Warrant. The offerings resulted in aggregate gross proceeds to the Company of $ 70.0 million, before underwriting discounts and commissions and offering expenses payable by the Company of approximately $ 5.0 million. In November 2019, all 666 shares of Series A Preferred Stock were converted by the holder into 66,600 shares of common stock. As of September 30, 2023 , there were no shares of Series A Preferred Stock outstanding. Each 2019 Warrant had an exercise price per share of common stock of $ 86.25 , subject to adjustment in certain circumstances. Each 2019 Warrant was immediately exercisable, provided that the holder was prohibited, subject to certain exceptions, from exercising the 2019 Warrant for shares of the Company’s common stock to the extent that immediately prior to or after giving effect to such exercise, the holder, together with its affiliates and other attribution parties, would own more than 4.99 % of the total number of shares of the Company’s common stock then issued and outstanding. This percentage could be changed at the holders’ election to a higher or lower percentage upon 61 days’ notice to the Company. The remaining unexercised 2019 Warrants expired on October 10, 2022 . |
Stock-Based Payments
Stock-Based Payments | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Payments | 12. Stock-Based Payments 2016 Stock Incentive Plan The 2016 Stock Incentive Plan (the “2016 Plan”) was adopted by the board of directors on December 15, 2015, approved by the stockholders on June 17, 2016, and became effective on July 6, 2016 upon the closing of the Company’s initial public offering (“IPO”). The 2016 Plan replaced the 2012 Equity Incentive Plan (the “2012 Plan”). Any options or awards outstanding under the 2012 Plan remained outstanding and effective. The 2016 Plan was replaced by 2022 Equity Incentive Plan (the “2022 EIP”) on September 16, 2022, and no further awards may be made under the 2016 Plan. 2016 Employee Stock Purchase Plan The 2016 Employee Stock Purchase Plan (the “2016 ESPP”) was adopted by the board of directors on December 15, 2015, approved by the stockholders on June 17, 2016, and became effective on July 6, 2016 upon the closing of the IPO. The number of shares of the Company’s common stock reserved for issuance under the 2016 ESPP automatically increases on the first day of each calendar year through the 2025 calendar year, in an amount equal to the least of (i) 117,333 shares of the Company’s common stock, (ii) 1.0 % of the total number of shares of the Company’s common stock outstanding on the first day of the applicable year, and (iii) an amount determined by the Company’s board of directors. For the calendar year beginning January 1, 2023, the number of shares reserved for issuance under the 2016 ESPP was increased by 202,631 shares. As of September 30, 2023 , 385,718 shares remained available for future issuance under the 2016 ESPP. Inducement Grants During the year ended December 31, 2021, the Company granted non-statutory stock options to purchase an aggregate of 111,000 shares of the Company’s common stock. These stock options were granted outside of the 2016 Plan as an inducement material to the applicable employee’s acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). These stock options will vest over a four-year period, with 25 % of the shares underlying each option award vesting on the one-year anniversary of the applicable employee’s employment commencement date and the remaining 75 % of the shares underlying each award vesting monthly thereafter for three-years . Vesting of each option is subject to such employee’s continued service with the Company through the applicable vesting dates. 2022 Inducement Stock Incentive Plan On January 25, 2022, the Company’s board of directors adopted the 2022 Inducement Stock Incentive Plan (the “2022 Plan”), pursuant to which the Company may grant non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units and other stock-based awards with respect to an aggregate of 100,000 shares of common stock. Awards under the 2022 Plan may only be granted to persons who (i) were not previously an employee or director of the Company or (ii) are commencing employment with the Company following a bona fide period of non-employment, in either case as an inducement material to the individual’s entering into employment with the Company and in accordance with the requirements of Nasdaq Stock Market Rule 5635(c)(4). In January 2023, the Company's board of directors amended the 2022 Plan to increase the aggregate number of shares that can be granted by 750,000 shares of common stock of the Company. As of September 30, 2023 , 661,622 shares remained available for future issuance under the 2022 Plan. 2022 Equity Incentive Plan The 2022 EIP was adopted by the board of directors on July 14, 2022, approved by the stockholders and became effective on September 15, 2022. The 2022 EIP replaced the 2016 Plan. Any options or awards outstanding under the 2016 Plan remained outstanding and effective. Under the 2022 EIP, the Company may grant incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units and other stock-based awards. 4,737,534 shares of the Company’s common stock are reserved for issuance under the 2022 EIP. As of September 30, 2023 , 731,107 shares remained available for future issuance under the 2022 EIP. Under the 2022 EIP, stock options may not be granted at less than fair value on the date of grant. Stock Options Terms of stock option agreements, including vesting requirements, are determined by the board of directors, subject to the provisions of the applicable stock plan. Stock option awards granted by the Company generally vest over four years , with 25 % vesting on the first anniversary of the vesting commencement date and 75 % vesting ratably, on a monthly basis, over the remaining three years . Such awards have a contractual term of ten years from the grant date. A summary of the status of stock options as of December 31, 2022 and September 30, 2023 and changes during the nine months ended September 30, 2023 is presented below: Aggregate Weighted Remaining Intrinsic Average Contractual Value Shares Exercise Price Life (in years) (in thousands) Outstanding at December 31, 2022 1,727,237 $ 39.94 5.7 $ — Granted 54,000 3.70 Cancelled ( 35,060 ) Outstanding at September 30, 2023 1,746,177 $ 38.22 5.2 $ 13,880 Exercisable at September 30, 2023 1,155,463 $ 49.51 3.2 $ 380 Pursuant to the terms of the Merger Agreement, the Company assumed certain Tyme stock options that were outstanding and unexercised immediately prior to the completion of the Merger. The Company issued options to purchase 692,460 shares of the Company’s common stock at the completion of the Merger on September 16, 2022. The original terms and restrictions on such Tyme options shall continue in full force and effect except for certain options held by certain Tyme employees which were modified to extend the exercise period to up to two years . The Company recorded $ 0.4 million of one-time additional stock-based compensation expense related to the modification. There were no stock options exercised during the nine months ended September 30, 2023. The intrinsic value of stock options exercised during the nine months ended September 30, 2022 was $ 0.1 million. As of September 30, 2023 , there was $ 6.2 million of total unrecognized compensation cost related to unvested stock options granted to employees, which is expected to be recognized over a weighted-average period of 1.4 years. Restricted Stock Units and Restricted Stock Awards From time to time, upon approval by the Company’s board of directors, certain employees have been granted restricted stock units with time-based vesting criteria. The majority of these restricted stock units vest annually over a three-year or four-year term. In addition, pursuant to the Company's director compensation policy, members of the Company's board of directors have been granted, at their election, either restricted stock units or restricted stock awards, which awards vest annually over a three-year term with 33.33 % vesting on each anniversary of the grant date. The fair value of restricted stock units and restricted stock awards are calculated based on the closing sale price of the Company’s common stock on the date of grant. The Company has granted performance-based restricted stock units to management for which vesting occurs upon the achievement of certain clinical development milestones. Stock-based compensation expense associated with these performance-based restricted stock units is recognized when the achievement of the vesting conditions becomes probable. The Company did not recognize any stock-based compensation expense relating to the achievement of performance-based milestones during the nine months ended September 30, 2023. A summary of the status of restricted stock units and restricted stock awards as of December 31, 2022 and September 30, 2023 and changes during the nine months ended September 30, 2023 is presented below: Shares Subject to Restricted Stock Units and Weighted Restricted Stock Average Grant Awards Date Fair Value Outstanding at December 31, 2022 1,204,421 $ 14.68 Granted 1,462,636 3.99 Vested ( 84,418 ) 32.02 Forfeited ( 116,748 ) 17.17 Outstanding at September 30, 2023 2,465,891 $ 7.54 As of September 30, 2023 , there was $ 11.8 million of unrecognized stock-based compensation expense related to outstanding restricted stock units and restricted stock awards, with an expected recognition period of 1.9 years. Stock-based Compensation Expense There were no stock options granted during the three months ended September 30, 2023. The fair value of each stock option granted during the nine months ended September 30, 2023 and the three and nine months ended September 30, 2022 was estimated on the date of grant using the Black-Scholes option-pricing model based on the following weighted-average assumptions: Three Months Ended September 30, Nine Months Ended September 30, 2022 2023 2022 Weighted-average risk-free interest rate 3.60 % 3.93 % 2.85 % Expected option term (in years) 5.79 5.32 5.88 Volatility 83.27 % 84.44 % 82.18 % The weighted-average grant date fair value per share of options granted in the nine months ended September 30, 2023 and 2022 was $ 2.60 and $ 7.82 , respectively. The following table summarizes the stock-based compensation expense for stock options, restricted stock units and restricted common stock granted to employees and non-employees and from the 2016 ESPP recorded in the Company’s condensed consolidated statements of operations: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development $ 1,586 $ 1,496 $ 4,236 $ 4,324 General and administrative 1,501 1,459 4,310 4,183 Restructuring 168 — 168 — Total stock-based compensation expense $ 3,255 $ 2,955 $ 8,714 $ 8,507 Due to an operating loss, the Company does not record tax benefits associated with stock‑based compensation or option exercises. Tax benefits will be recorded when realized. |
Restructuring
Restructuring | 9 Months Ended |
Sep. 30, 2023 | |
Restructuring and Related Activities [Abstract] | |
Restructuring | 13. Restructuring As a result of the Restructuring, the Company incurred $ 2.4 million in costs for the three and nine months ended September 30, 2023. Restructuring costs were comprised of $ 2.0 million of severance, post employment benefits, stock-based compensation and outplacement services, and $ 0.4 million of asset impairment charges related to the laboratory equipment that is classified as assets held for sale. As of September 30, 2023, $ 1.8 million of Restructuring costs remain unpaid and are included in the accrued expenses in the Company's condensed consolidated balance sheet. The accrued Restructuring costs are expected to be paid by the end of 2023. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company’s consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements. In the opinion of the Company’s management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments that are necessary to present fairly the Company’s financial position as of September 30, 2023, the results of its operations for the three and nine months ended September 30, 2023 and 2022, statements of stockholders’ equity for the three and nine months ended September 30, 2023 and 2022, and statements of cash flows for the nine months ended September 30, 2023 and 2022. Such adjustments are of a normal and recurring nature. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results for the year ending December 31, 2023 , or for any future period. |
Principles of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, (i) Syros Securities Corporation, a Massachusetts corporation formed by the Company in December 2014 to exclusively engage in buying, selling and holding securities on its own behalf, (ii) Syros Pharmaceuticals (Ireland) Limited, an Irish limited liability company formed by the Company in January 2019, and (iii) Tyme Technologies, Inc., a Delaware corporation, which is the surviving corporation in connection with the filing of a certificate of merger with the Secretary of State of the State of Delaware on September 16, 2022, pursuant to which Tack Acquisition Corp., a Delaware corporation formed by the Company in June 2022 to effect the Merger, merged with and into Tyme Technologies, Inc. (refer to Note 1). All intercompany transactions and balances have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Management considers many factors in selecting appropriate financial accounting policies and in developing the estimates and assumptions that are used in the preparation of the financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, which include, but are not limited to, expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates and whether historical trends are expected to be representative of future trends. Management’s estimation process may yield a range of potentially reasonable estimates and management must select an amount that falls within that range of reasonable estimates. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not limited to, estimates related to revenue recognition, warrant liability, stock-based compensation expense, accrued expenses, income taxes and the evaluation of the existence of conditions and events that raise substantial doubt regarding the Company’s ability to continue as a going concern. Actual results may differ from those estimates or assumptions. |
Segment Information | Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. The Company’ s chief operating decision maker is its chief executive officer. The Company and the chief operating decision maker view the Company’s operations and manage its business in one operating segment. The Company operates only in the United States. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid instruments that have original maturities of three months or less when acquired to be cash equivalents. Cash equivalents, which consist of money market funds that invest in U.S. Treasury obligations, as well as overnight repurchase agreements and corporate debt securities, are stated at fair value. The Company maintains its bank accounts in major financial institutions. |
Off-Balance Sheet Risk and Concentrations of Credit Risk | Off-Balance Sheet Risk and Concentrations of Credit Risk The Company has no financial instruments with off-balance sheet risk, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of cash equivalents and marketable securities. Under its investment policy, the Company limits amounts invested in such securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. The Company is not exposed to any significant concentrations of credit risk from these financial instruments. The goals of the Company’s investment policy, in order of priority, are safety and preservation of principal and liquidity of investments sufficient to meet cash flow requirements. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments ASC 820, Fair Value Measurement (“ASC 820”), established a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are those that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are those that reflect the Company’s assumption about the inputs that market participants would use in pricing the asset or liability. These are developed based on the best information available under the circumstances. ASC 820 identified fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 established a three-tier fair value hierarchy that distinguishes between the following: Level 1—Quoted market prices (unadjusted) in active markets for identical assets or liabilities. Level 2—Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable, such as quoted market prices, interest rates and yield curves. Level 3—Unobservable inputs developed using estimates or assumptions developed by the Company, which reflect those that a market participant would use. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized as Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The carrying amounts reflected in the condensed consolidated balance sheets for cash and cash equivalents, prepaid expenses, other current assets, restricted cash, accounts payable, accrued expenses and deferred revenue approximate their respective fair values due to their short-term nature. |
Property and Equipment | Property and Equipment Property and equipment consists of laboratory equipment, computer equipment, furniture and fixtures and leasehold improvements, all of which are stated at cost, less accumulated depreciation. Expenditures for maintenance and repairs that do not improve or extend the lives of the respective assets are recorded to expense as incurred. Major betterments are capitalized as additions to property and equipment. Depreciation and amortization are recognized over the estimated useful lives of the assets using the straight-line method. Construction-in-progress is stated at cost, which relates to the cost of leasehold improvements not yet placed into service. No depreciation expense is recorded on construction-in-progress until such time as the relevant assets are completed and put into use. |
Asset Held for Sale | Asset Held for Sale An asset is considered to be held for sale when all of the following criteria are met: (i) management commits to a plan to sell the asset; (ii) it is unlikely that the disposal plan will be significantly modified or discontinued; (iii) the asset is available for immediate sale in its present condition; (iv) actions required to complete the sale of the asset have been initiated; (v) sale of the asset is probable and the completed sale is expected to occur within one year; and (vi) the asset is actively being marketed for sale at a price that is reasonable given its current market value. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company evaluates long-lived assets for potential impairment when events or changes in circumstances indicate the carrying value of the assets may not be recoverable. Recoverability is measured by comparing the carrying values of the assets to the expected future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying values of the assets exceed their fair value. A long-lived asset classified as held for sale is measured at the lower of its carrying amount or fair value less cost to sell. A long-lived asset is not depreciated or amortized while it is classified as held for sale, and an impairment loss would be recognized to the extent the carrying amount exceeds the asset's fair value less cost to sell. In connection with the Restructuring, the Company entered into an exclusive auction agreement in October 2023 to sell all of its laboratory equipment by public auction. The Company concluded that the assets met the held for sale criteria and has written the assets down to their fair value less cost to sell of $ 1.7 million which resulted in an impairment charge of $ 0.4 million. These assets held for sale are recorded in prepaid and other current assets in the Company's condensed consolidated balance sheet as of September 30, 2023 . |
Revenue Recognition | Revenue Recognition To date, the Company’s only revenue has consisted of collaboration and license revenue. The Company has not generated any revenue from product sales and does not expect to generate any revenue from product sales for the foreseeable future. The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. If a contract is determined to be within the scope of ASC 606 at inception, the Company assesses the goods or services promised within such contract, determines which of those goods and services are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. If the Company performs by transferring goods or services to a customer before the customer pays consideration or before payment is due, the Company records a contract asset, excluding any amounts presented as accounts receivable. The Company includes unbilled accounts receivable as contract assets on its consolidated balance sheets. The Company records accounts receivable for amounts billed to the customer for which the Company has an unconditional right to consideration. The Company assesses contract assets and accounts receivable for impairment and, to date, no impairment losses have been recorded. From time to time, the Company may enter into agreements that are within the scope of ASC 606. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees or prepaid research and development services; development, regulatory and commercial milestone payments; and royalties on net sales of licensed products. Each of these payments results in license and collaboration revenues, except for revenues from royalties on net sales of licensed products, which will be classified as royalty revenues. The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements (“ASC 808”), to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and therefore within the scope of ASC 606. For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently, generally by analogy to ASC 606. For those elements of the arrangement that are accounted for pursuant to ASC 606, the Company applies the five-step model described above. |
Research and Development | Research and Development Expenditures relating to research and development are expensed in the period incurred. Research and development expenses consist of both internal and external costs associated with the development of the Company’s gene control platform and product candidates. Research and development costs include salaries and benefits, materials and supplies, external research, preclinical and clinical development expenses, stock-based compensation expense and facilities costs. Facilities costs primarily include the allocation of rent, utilities, depreciation and amortization. In certain circumstances, the Company is required to make non-refundable advance payments to vendors for goods or services that will be received in the future for use in research and development activities. In such circumstances, the non-refundable advance payments are deferred and capitalized, even when there is no alternative future use for the research and development, until related goods or services are provided. The Company records accruals for estimated ongoing research costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the work being performed, including the phase or completion of the event, invoices received and costs. Significant judgements and estimates may be made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company may in-license the rights to develop and commercialize product candidates. For each in-license transaction the Company evaluates whether it has acquired processes or activities along with inputs that would be sufficient to constitute a “business” as defined under U.S. GAAP. A “business” as defined under U.S. GAAP consists of inputs and processes applied to those inputs that have the ability to create outputs. Although businesses usually have outputs, outputs are not required for an integrated set of activities to qualify as a business. When the Company determines that it has not acquired sufficient processes or activities to constitute a business, any up-front payments, as well as milestone payments, are immediately expensed as acquired research and development in the period in which they are incurred. |
Warrants | Warrants The Company accounts for issued warrants either as a liability or equity in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity (“ASC 480-10”) or ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock (“ASC 815-40”). Under ASC 480-10, warrants are considered a liability if they are mandatorily redeemable and they require settlement in cash, other assets, or a variable number of shares. If warrants do not meet liability classification under ASC 480-10, the Company considers the requirements of ASC 815-40 to determine whether the warrants should be classified as a liability or as equity. Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after the issuance date is recorded in the consolidated statements of operations as a gain or loss. If warrants do not require liability classification under ASC 815-40, in order to conclude warrants should be classified as equity, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP standard. Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date. |
Stock-Based Compensation Expense | Stock-Based Compensation Expense The Company accounts for its stock-based compensation awards in accordance with ASC 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees and directors, including grants of restricted stock units and stock option awards, to be recognized as expense in the consolidated statements of operations based on their grant date fair values. Consistent with the grants for employees and directors, grants of restricted stock units and stock option awards to other service providers, referred to as non-employees, are measured based on the grant-date fair value of the award and expensed in the Company’s condensed consolidated statement of operations over the vesting period. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to non-employees can be determined using either the contractual term of the option award or the “simplified” method. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The Company uses the value of its common stock to determine the fair value of restricted stock awards. The Company expenses the fair value of its stock-based awards to employees and non-employees on a straight-line basis over the associated service period, which is generally the vesting period. The Company accounts for forfeitures as they occur instead of estimating forfeitures at the time of grant. Ultimately, the actual expense recognized over the vesting period will be for only those options that vest. Compensation expense for discounted purchases under the employee stock purchase plan is measured using the Black-Scholes model to compute the fair value of the lookback provision plus the purchase discount and is recognized as compensation expense over the offering period. For stock-based awards that contain performance-based milestones, the Company records stock-based compensation expense in accordance with the accelerated attribution model. Management evaluates when the achievement of a performance-based milestone is probable based on the expected satisfaction of the performance conditions as of the reporting date. |
Income Taxes | Income Taxes The Company accounts for uncertain tax positions using a more-likely-than-not threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors including, but not limited to, changes in the law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity, and changes in facts or circumstances related to a tax position. |
Net Loss per Share | Net Loss per Share Basic net earnings per share applicable to common stockholders is calculated by dividing net earnings applicable to common stockholders by the weighted average shares outstanding during the period, without consideration for common stock equivalents. Diluted net earnings per share applicable to common stockholders is calculated by adjusting the weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method and the if-converted method. For purposes of the calculation of dilutive net loss per share applicable to common stockholders, stock options, unvested restricted stock units, and warrants are considered to be common stock equivalents but are excluded from the calculation of diluted net loss per share applicable to common stockholders, as their effect would be anti-dilutive; therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented. As of September 30, 2023 , 100,000 pre-funded warrants to purchase common stock issued in connection with the December 2020 private placement (the “2020 Pre-Funded Warrants”) (refer to Note 11), and 7,279,819 2022 Pre-Funded Warrants issued in connection with the September 2022 private placement (refer to Note 11) were included in the basic and diluted net loss per share calculation. As of September 30, 2022, the 2020 Pre-Funded Warrants were included in the basic and diluted net loss per share calculation. The following common stock equivalents were excluded from the calculation of diluted net loss per share applicable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: As of September 30, 2023 2022 Stock options 1,746,177 1,547,190 Unvested restricted stock units 2,417,891 521,316 Warrants* 14,142,298 14,354,007 Total 18,306,366 16,422,513 * As of September 30, 2023 , this is comprised of 2,754 warrants to purchase common stock issued in connection with the execution and first draw of the Company’s loan agreement in February 2020 (refer to Note 8), 1,738 warrants to purchase common stock issued in connection with the second draw on this loan agreement in December 2020 (refer to Note 8), 282,809 warrants to purchase common stock issued in connection with the private placement in December 2020 (refer to Note 11), 13,813,912 warrants to purchase common stock issued in connection with the private placement in September 2022 (refer to Note 11), and 41,085 warrants to purchase common stock that were issued upon the assumption and conversion of Tyme warrants in connection with the Merger (refer to Note 3). As of September 30, 2022 , this is comprised of 211,709 warrants to purchase common stock issued in connection with the Company’s April 2019 financing (refer to Note 11), 2,754 warrants to purchase common stock issued in connection with the execution and first draw of the Company’s loan agreement in February 2020 (refer to Note 8), 1,738 warrants to purchase common stock issued in connection with the second draw on this loan agreement in December 2020 (refer to Note 8), 282,809 warrants to purchase common stock issued in connection with the private placement in December 2020 (refer to Note 11), 13,813,912 warrants to purchase common stock issued in connection with the private placement in September 2022 (refer to Note 11), and 41,085 warrants to purchase common stock that were issued upon the assumption and conversion of Tyme warrants in connection with the Merger (refer to Note 3). |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the incurred loss impairment model with an expected loss model that requires the use of forward-looking information to calculate credit loss estimates. It also eliminates the concept of other-than-temporary impairment and requires credit losses on available-for-sale debt securities to be recorded through an allowance for credit losses instead of as a reduction in the amortized cost basis of the securities. ASU 2016-13 becomes effective for smaller reporting companies for fiscal years beginning after December 15, 2022, and early adoption is permitted. The Company adopted this new standard on January 1, 2023 , and it did not have a material impact on its condensed consolidated financial statements and related disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Common Stock Equivalents Excluded from the Calculation of Diluted Net Loss Per Share | The following common stock equivalents were excluded from the calculation of diluted net loss per share applicable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: As of September 30, 2023 2022 Stock options 1,746,177 1,547,190 Unvested restricted stock units 2,417,891 521,316 Warrants* 14,142,298 14,354,007 Total 18,306,366 16,422,513 * As of September 30, 2023 , this is comprised of 2,754 warrants to purchase common stock issued in connection with the execution and first draw of the Company’s loan agreement in February 2020 (refer to Note 8), 1,738 warrants to purchase common stock issued in connection with the second draw on this loan agreement in December 2020 (refer to Note 8), 282,809 warrants to purchase common stock issued in connection with the private placement in December 2020 (refer to Note 11), 13,813,912 warrants to purchase common stock issued in connection with the private placement in September 2022 (refer to Note 11), and 41,085 warrants to purchase common stock that were issued upon the assumption and conversion of Tyme warrants in connection with the Merger (refer to Note 3). As of September 30, 2022 , this is comprised of 211,709 warrants to purchase common stock issued in connection with the Company’s April 2019 financing (refer to Note 11), 2,754 warrants to purchase common stock issued in connection with the execution and first draw of the Company’s loan agreement in February 2020 (refer to Note 8), 1,738 warrants to purchase common stock issued in connection with the second draw on this loan agreement in December 2020 (refer to Note 8), 282,809 warrants to purchase common stock issued in connection with the private placement in December 2020 (refer to Note 11), 13,813,912 warrants to purchase common stock issued in connection with the private placement in September 2022 (refer to Note 11), and 41,085 warrants to purchase common stock that were issued upon the assumption and conversion of Tyme warrants in connection with the Merger (refer to Note 3). |
Recapitalization (Tables)
Recapitalization (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Schedule of Net Assets Current | The carrying value of Tyme’s net assets as of September 16, 2022, which approximates fair value because of its short-term nature, is set forth below: Fair Value Cash and cash equivalents $ 14,898 Marketable securities 52,220 Prepaid expenses 1,350 Total $ 68,468 |
Collaboration and Research Ar_2
Collaboration and Research Arrangements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Collaborative Arrangement Disclosure [Abstract] | |
Schedule of Change in Accounts Receivable, Contract Assets and Liabilities | The following table presents the changes in contract liabilities for the nine months ended September 30, 2023 (in thousands): Balance at Additions Deductions Balance at September 30, 2023 Contract liabilities: Deferred revenue - GBT $ 4,330 $ 173 $ 4,364 $ 139 Total contract liabilities $ 4,330 $ 173 $ 4,364 $ 139 |
Cash, Cash Equivalents and Ma_2
Cash, Cash Equivalents and Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Cash, Cash Equivalents and Marketable Securities | Cash, cash equivalents and marketable securities consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands): Unrealized Unrealized Fair September 30, 2023 Amortized Cost Gains Losses Value Cash and cash equivalents: Cash and money market funds $ 112,219 $ — $ — $ 112,219 Total: $ 112,219 $ — $ — $ 112,219 Unrealized Unrealized Fair December 31, 2022 Amortized Cost Gains Losses Value Cash and cash equivalents: Cash and money market funds $ 167,467 $ — $ — $ 167,467 Marketable securities: Corporate debt securities - due in one year or less 22,257 116 ( 53 ) 22,320 Commercial paper 2,491 — — 2,491 Municipal bonds 5,987 51 — 6,038 US Treasury obligation - due in one year or less 4,000 — ( 12 ) 3,988 Total $ 202,202 $ 167 $ ( 65 ) $ 202,304 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis | Assets and liabilities measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022 were as follows (in thousands): Active Observable Unobservable Markets Inputs Inputs Description September 30, 2023 (Level 1) (Level 2) (Level 3) Assets: Cash and cash equivalents: Cash and money market funds $ 112,219 $ 112,219 $ — $ — Total: $ 112,219 $ 112,219 $ — $ — Liabilities: Warrant liabilities $ 24,549 $ — $ — $ 24,549 Total $ 24,549 $ — $ — $ 24,549 Active Observable Unobservable Markets Inputs Inputs Description December 31, 2022 (Level 1) (Level 2) (Level 3) Assets: Cash and cash equivalents: Cash and money market funds $ 167,467 $ 167,467 $ — $ — Marketable securities: Corporate debt securities - due in one year or less 22,320 — 22,320 — Commercial paper 2,491 — 2,491 — Municipal bonds 6,038 — 6,038 — US Treasury obligation - due in one year or less 3,988 3,988 — — Total $ 202,304 $ 171,455 $ 30,849 $ — Liabilities: Warrant liabilities $ 24,472 $ — $ — $ 24,472 Total $ 24,472 $ — $ — $ 24,472 |
Summary of Assumptions Used to Record Fair Value of Warrants | A summary of the Black Scholes pricing model assumptions used to record the fair value of the Warrants is as follows: September 30, 2023 December 31, 2022 Stock price $ 3.95 $ 3.59 Average risk-free interest rate 4.71 % 4.02 % Average expected life (in years) 3.92 4.67 Average expected volatility 85.96 % 86.79 % |
Summary of Changes in Level 3 Warrant Liability Measured at Fair Value on Recurring Basis | The following table reflects the change in the Company’s Level 3 warrant liability for the nine months ended September 30, 2023 and the year ended December 31, 2022 (in thousands): September 30, 2023 December 31, 2022 Fair value of warrant liabilities as of beginning of year $ 24,472 $ 3,029 Warrants issued in connection with 2022 Private Placement — 64,664 Change in fair value 77 ( 43,221 ) Fair value of warrant liabilities as of end of period $ 24,549 $ 24,472 |
Restricted Cash (Tables)
Restricted Cash (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Restricted Cash [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the amounts shown in the Company’s condensed consolidated statement of cash flows as of September 30, 2023 and 2022 (in thousands): September 30, 2023 2022 Cash and cash equivalents $ 112,219 $ 171,532 Restricted cash, net of current portion $ 3,086 3,086 Total cash, cash equivalents and restricted cash $ 115,305 $ 174,618 |
Oxford Finance Loan Agreement (
Oxford Finance Loan Agreement (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Minimum Aggregate Future Loan Payments | The Company has the following minimum aggregate future loan payments as of September 30, 2023 (in thousands): Three months ending December 31, 2023 $ — Year ending December 31, 2024 6,667 Year ending December 31, 2025 20,000 Year ending December 31, 2026 13,333 Total minimum payments 40,000 Less unamortized debt discount ( 381 ) Plus accumulated accretion of final fees 1,454 Less current portion ( 1,667 ) Long-term debt, net of current portion $ 39,406 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands): September 30, 2023 December 31, 2022 External research and preclinical development $ 11,643 $ 8,219 Employee compensation and benefits (Note 13) 7,941 8,529 Professional fees 1,300 1,164 Facilities and other 605 54 Accrued expenses $ 21,489 $ 17,966 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Reconciliation of Maturity Analysis of Annual Undiscounted Cash Flows | The following is a maturity analysis of the annual undiscounted cash flows reconciled to the carrying value of the operating lease liabilities as of September 30, 2023 (in thousands): Operating Three Months ending December 31, 2023 $ 1,027 Year ending December 31, 2024 4,166 Year ending December 31, 2025 4,287 Year ending December 31, 2026 4,412 Year ending December 31, 2027 and beyond 14,844 Total minimum lease payments 28,736 Less imputed interest ( 7,351 ) Total lease liability $ 21,385 |
Schedule of Total Lease Cost for Operating and Financing Leases as well as Weighted Average Information for Leases | The following table outlines the total lease cost for the Company’s operating leases as well as weighted average information for these leases as of September 30, 2023 (in thousands): Nine Months Ended September 30, 2023 Lease cost: Operating lease cost $ 2,316 Cash paid for amounts included in the measurement of liabilities: Operating cash flows from operating lease $ 3,021 Other information: Nine Months Ended September 30, 2023 Weighted-average remaining lease term (in years) - operating lease 6.67 Weighted-average discount rate - operating lease 9.30 |
Stock-Based Payments (Tables)
Stock-Based Payments (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Status of Stock Options | A summary of the status of stock options as of December 31, 2022 and September 30, 2023 and changes during the nine months ended September 30, 2023 is presented below: Aggregate Weighted Remaining Intrinsic Average Contractual Value Shares Exercise Price Life (in years) (in thousands) Outstanding at December 31, 2022 1,727,237 $ 39.94 5.7 $ — Granted 54,000 3.70 Cancelled ( 35,060 ) Outstanding at September 30, 2023 1,746,177 $ 38.22 5.2 $ 13,880 Exercisable at September 30, 2023 1,155,463 $ 49.51 3.2 $ 380 |
Summary of Status of Restricted Stock Units | A summary of the status of restricted stock units and restricted stock awards as of December 31, 2022 and September 30, 2023 and changes during the nine months ended September 30, 2023 is presented below: Shares Subject to Restricted Stock Units and Weighted Restricted Stock Average Grant Awards Date Fair Value Outstanding at December 31, 2022 1,204,421 $ 14.68 Granted 1,462,636 3.99 Vested ( 84,418 ) 32.02 Forfeited ( 116,748 ) 17.17 Outstanding at September 30, 2023 2,465,891 $ 7.54 |
Schedule of Weighted-Average Assumptions used in Black-Scholes Option-Pricing Model | The fair value of each stock option granted during the nine months ended September 30, 2023 and the three and nine months ended September 30, 2022 was estimated on the date of grant using the Black-Scholes option-pricing model based on the following weighted-average assumptions: Three Months Ended September 30, Nine Months Ended September 30, 2022 2023 2022 Weighted-average risk-free interest rate 3.60 % 3.93 % 2.85 % Expected option term (in years) 5.79 5.32 5.88 Volatility 83.27 % 84.44 % 82.18 % |
Summary of Stock-based Compensation Expense for Stock Options and Restricted Stock Units | The following table summarizes the stock-based compensation expense for stock options, restricted stock units and restricted common stock granted to employees and non-employees and from the 2016 ESPP recorded in the Company’s condensed consolidated statements of operations: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development $ 1,586 $ 1,496 $ 4,236 $ 4,324 General and administrative 1,501 1,459 4,310 4,183 Restructuring 168 — 168 — Total stock-based compensation expense $ 3,255 $ 2,955 $ 8,714 $ 8,507 |
Nature of Business - Additional
Nature of Business - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||
Oct. 02, 2023 | Apr. 06, 2023 | Sep. 16, 2022 | Jul. 03, 2022 | Dec. 08, 2020 | Sep. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2023 | Dec. 31, 2022 | |
Class Of Stock [Line Items] | |||||||||
Cash and cash equivalents | $ 171,532 | $ 171,532 | $ 112,219 | $ 167,467 | |||||
Accumulated deficit | $ (658,423) | $ (558,233) | |||||||
Warrants to purchase common stock | 211,709 | 211,709 | |||||||
Common stock, shares issued | 20,720,447 | 20,263,116 | |||||||
Subsequent Event | |||||||||
Class Of Stock [Line Items] | |||||||||
Percentage of reduction in employee base | 35% | ||||||||
Private Placement | |||||||||
Class Of Stock [Line Items] | |||||||||
Gross proceeds of private placement | $ 129,900 | $ 90,500 | |||||||
Transaction costs | $ 10,100 | $ 400 | |||||||
Aggregated offering price | $ 60,112 | $ 60,112 | |||||||
Private Placement | Twenty Twenty Two Pre Funded Warrants | |||||||||
Class Of Stock [Line Items] | |||||||||
Warrants to purchase common stock | 7,426,739 | ||||||||
Share price (in dollars per share) | $ 10.34 | ||||||||
Private Placement | 2022 Warrants | |||||||||
Class Of Stock [Line Items] | |||||||||
Share price (in dollars per share) | $ 10.33 | ||||||||
Private Placement | Common Stock | |||||||||
Class Of Stock [Line Items] | |||||||||
Shares issued | 6,387,173 | 1,031,250 | 6,387,173 | 6,387,173 | |||||
Aggregated offering price | $ 6 | $ 6 | |||||||
Maximum [Member] | |||||||||
Class Of Stock [Line Items] | |||||||||
Sale of stock | $ 50,000 | ||||||||
Aggregated offering price | $ 250,000 | ||||||||
Maximum [Member] | Private Placement | 2022 Warrants | |||||||||
Class Of Stock [Line Items] | |||||||||
Warrants to purchase common stock | 13,813,912 | 282,809 | |||||||
Tyme | Merger Agreement | |||||||||
Class Of Stock [Line Items] | |||||||||
Common stock, shares issued | 7,500,000 | ||||||||
Acquired net cash, cash equivalents and marketable securities | $ 67,100 | ||||||||
Stock Split Amendment | |||||||||
Class Of Stock [Line Items] | |||||||||
Description of reverse stock split | the reverse stock split of its common stock, such that every 10 shares of the Company’s common stock held by a stockholder immediately prior to the reverse stock split were combined and reclassified into one share of the Company’s common stock |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 9 Months Ended | |
Sep. 30, 2023 USD ($) Item Segment shares | Sep. 30, 2022 USD ($) shares | |
Summary Of Significant Accounting Policies [Line Items] | ||
Number of operating segment | Segment | 1 | |
Number of financial instruments with off-balance sheet risk | Item | 0 | |
Depreciation and amortization | $ | $ 1,900,000 | $ 2,001,000 |
Impairment Charge | $ | 400,000 | |
Fair value cost | $ | $ 1,700,000 | |
Warrants issued to purchase common stock | 211,709 | |
ASU 2016-13 | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Change in accounting principle, accounting standards update, adopted | true | |
Change in accounting principle, accounting standards update, adoption date | Jan. 01, 2023 | |
Change in accounting principle, accounting standards update, immaterial effect | true | |
Private Placement - December 2020 | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Warrants issued to purchase common stock | 282,809 | 282,809 |
Private Placement - September 2022 | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Warrants issued to purchase common stock | 13,813,912 | 13,813,912 |
Pre-Funded Warrant | Private Placement - December 2020 | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Warrants issued to purchase common stock | 100,000 | |
Pre-Funded Warrant | Private Placement - September 2022 | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Warrants issued to purchase common stock | 7,279,819 | |
Construction in progress | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Depreciation and amortization | $ | $ 0 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Common Stock Equivalents Excluded from the Calculation of Diluted Net Loss Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Anti-dilutive securities | ||
Total shares excluded from diluted net loss per share applicable to common stockholders | 18,306,366 | 16,422,513 |
Stock options | ||
Anti-dilutive securities | ||
Total shares excluded from diluted net loss per share applicable to common stockholders | 1,746,177 | 1,547,190 |
Unvested Restricted Stock Units | ||
Anti-dilutive securities | ||
Total shares excluded from diluted net loss per share applicable to common stockholders | 2,417,891 | 521,316 |
Warrants | ||
Anti-dilutive securities | ||
Total shares excluded from diluted net loss per share applicable to common stockholders | 14,142,298 | 14,354,007 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Common Stock Equivalents Excluded from the Calculation of Diluted Net Loss Per Share (Parenthetical) (Details) - shares | Sep. 30, 2023 | Sep. 30, 2022 |
Anti-dilutive securities | ||
Warrants issued to purchase common stock | 211,709 | |
Private Placement - December 2020 | ||
Anti-dilutive securities | ||
Warrants issued to purchase common stock | 282,809 | 282,809 |
Private Placement - September 2022 | ||
Anti-dilutive securities | ||
Warrants issued to purchase common stock | 13,813,912 | 13,813,912 |
Tyme Merger | ||
Anti-dilutive securities | ||
Warrants issued to purchase common stock | 41,085 | 41,085 |
First Draw of Loan Agreement | ||
Anti-dilutive securities | ||
Warrants issued to purchase common stock | 2,754 | 2,754 |
Second Draw on Loan Agreement | ||
Anti-dilutive securities | ||
Warrants issued to purchase common stock | 1,738 | 1,738 |
Recapitalization - Additional I
Recapitalization - Additional Information (Details) - USD ($) $ in Millions | 9 Months Ended | |
Sep. 16, 2022 | Sep. 30, 2023 | |
Business Acquisition [Line Items] | ||
Severance costs | $ 2 | |
Tyme Therapeutics, Inc. | ||
Business Acquisition [Line Items] | ||
Shares issued | 7,500,000 | |
Number of options and warrants issued | 733,545 | |
Transaction costs | $ 3.1 | |
Severance costs | $ 4.5 |
Recapitalization - Schedule of
Recapitalization - Schedule of Net current assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Sep. 16, 2022 |
Cash and cash equivalents | $ 112,219 | $ 167,467 | $ 171,532 | |
Marketable securities | $ 34,837 | |||
Tyme Therapeutics, Inc. | ||||
Cash and cash equivalents | $ 14,898 | |||
Marketable securities | 52,220 | |||
Prepaid expenses | 1,350 | |||
Total | $ 68,468 |
Collaboration and Research Ar_3
Collaboration and Research Arrangements - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Dec. 17, 2019 | Nov. 30, 2022 | Jan. 31, 2018 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized | $ 3,762 | $ 3,891 | $ 9,550 | $ 15,634 | |||
Global Blood Therapeutics | Collaboration Agreement | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Initial period of research term | 3 years | ||||||
Additional extension period for research term upon mutual agreement | 1 year | ||||||
Upfront payment receivable | $ 20,000 | ||||||
Additional extension period for research term | 1 year | 1 year | |||||
Reimbursements receivable of full-time employee and out-of-pocket costs and expenses | 40,000 | ||||||
Research agreement additional consideration | $ 7,100 | ||||||
Deferred revenue, short-term | 100 | 100 | |||||
Estimated transaction price | 54,600 | 54,600 | |||||
Total transaction price | 60,000 | ||||||
Upfront non-refundable and non-creditable payment | 20,000 | ||||||
Reimbursable costs | 40,000 | ||||||
Revenue recognized | 3,800 | 3,700 | $ 9,500 | 14,400 | |||
Effective date of termination | Oct. 16, 2023 | ||||||
Milestone-based payment receivable | $ 0 | ||||||
Global Blood Therapeutics | Collaboration Agreement | Maximum | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Period of extension of initial research term | 2 years | ||||||
Incyte | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue recognized | $ 0 | $ 200 | $ 0 | $ 1,200 | |||
Incyte | Stock Purchase Agreement | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Aggregate purchase price | $ 10,000 | ||||||
Shares issued | 79,302 | ||||||
Share price (in dollars per share) | $ 126.1 | ||||||
Premium to volume-weighted sale price of shares (as a percent) | 30% | ||||||
Trading days within which the purchase price represents a thirty percent (30%) premium to the volume-weighted sale price of the shares | 15 days | ||||||
Incyte | Collaboration Agreement | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Total transaction price | 12,800 | ||||||
Upfront non-refundable and non-creditable payment | 2,500 | ||||||
Up-front consideration | $ 10,000 | ||||||
Up-front consideration, cash | 2,500 | ||||||
Up-front consideration, pre-paid research funding | $ 7,500 | ||||||
Prepaid research amount | 7,500 | ||||||
Premium paid on equity investment | 2,300 | ||||||
Collaboration agreement additional consideration incurred | $ 500 |
Collaboration and Research Ar_4
Collaboration and Research Arrangements - Schedule of Change in Accounts Receivable, Contract Assets and Liabilities (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Disaggregation Of Revenue [Line Items] | |
Contract liabilities, Balance at Beginning of Period | $ 4,330 |
Contract liabilities, Additions | 173 |
Contract liabilities, Deductions | 4,364 |
Contract liabilities, Balance at End of Period | 139 |
Global Blood Therapeutics | |
Disaggregation Of Revenue [Line Items] | |
Contract liabilities, Balance at Beginning of Period | 4,330 |
Contract liabilities, Additions | 173 |
Contract liabilities, Deductions | 4,364 |
Contract liabilities, Balance at End of Period | $ 139 |
Cash, Cash Equivalents and Ma_3
Cash, Cash Equivalents and Marketable Securities - Schedule of Cash, Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Cash Equivalents and Marketable Securities | ||
Cash Equivalents, Amortized Cost | $ 112,219 | |
Cash Equivalents, Fair value | 112,219 | |
Cash Equivalents and Marketable Securities, Amortized Cost | $ 202,202 | |
Cash Equivalents and Marketable Securities, Unrealized Gains | 167 | |
Cash Equivalents and Marketable Securities, Unrealized Losses | (65) | |
Cash Equivalents and Marketable Securities, Fair Value | 202,304 | |
Corporate Debt Securities - Due in One Year or Less | ||
Cash Equivalents and Marketable Securities | ||
Marketable Securities, Amortized Cost | 22,257 | |
Marketable Securities, Unrealized Gains | 116 | |
Marketable Securities, Unrealized Losses | (53) | |
Marketable Securities, Fair Value | 22,320 | |
Commercial Paper | ||
Cash Equivalents and Marketable Securities | ||
Marketable Securities, Amortized Cost | 2,491 | |
Marketable Securities, Fair Value | 2,491 | |
Municipal Bonds | ||
Cash Equivalents and Marketable Securities | ||
Marketable Securities, Amortized Cost | 5,987 | |
Marketable Securities, Unrealized Gains | 51 | |
Marketable Securities, Fair Value | 6,038 | |
Us Treasury Obligation - Due in One Year or Less | ||
Cash Equivalents and Marketable Securities | ||
Marketable Securities, Amortized Cost | 4,000 | |
Marketable Securities, Unrealized Losses | (12) | |
Marketable Securities, Fair Value | 3,988 | |
Cash and Money Market Funds | ||
Cash Equivalents and Marketable Securities | ||
Cash Equivalents, Amortized Cost | 112,219 | 167,467 |
Cash Equivalents, Fair value | $ 112,219 | $ 167,467 |
Cash, Cash Equivalents and Ma_4
Cash, Cash Equivalents and Marketable Securities - Additional Information (Details) | 9 Months Ended | |
Sep. 30, 2023 USD ($) Item | Sep. 30, 2022 USD ($) Item | |
Investments, Debt and Equity Securities [Abstract] | ||
Realized gains (losses) | $ 0 | $ 0 |
Number of investments adjusted for other-than-temporary declines in fair value | Item | 0 | 0 |
Investments in marketable securities | $ 0 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and Cash Equivalents | $ 112,219 | |
Cash and Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and Cash Equivalents | 112,219 | $ 167,467 |
Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Assets | 112,219 | 202,304 |
Total Liabilities | 24,549 | 24,472 |
Recurring | Cash and Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and Cash Equivalents | 112,219 | 167,467 |
Recurring | Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Assets | 2,491 | |
Recurring | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Assets | 112,219 | 171,455 |
Recurring | Level 1 | Cash and Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and Cash Equivalents | 112,219 | 167,467 |
Recurring | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Assets | 30,849 | |
Recurring | Level 2 | Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Assets | 2,491 | |
Recurring | Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Liabilities | 24,549 | 24,472 |
Corporate Debt Securities - Due in One Year or Less | Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Assets | 22,320 | |
Corporate Debt Securities - Due in One Year or Less | Recurring | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Assets | 22,320 | |
Municipal Bonds | Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Assets | 6,038 | |
Municipal Bonds | Recurring | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Assets | 6,038 | |
Us Treasury Obligation - Due in One Year or Less | Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Assets | 3,988 | |
Us Treasury Obligation - Due in One Year or Less | Recurring | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Assets | 3,988 | |
Warrants | Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Liabilities | 24,549 | 24,472 |
Warrants | Recurring | Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total Liabilities | $ 24,549 | $ 24,472 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - shares | Sep. 30, 2022 | Sep. 16, 2022 | Dec. 08, 2020 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants issued to purchase common stock | 211,709 | ||
Private Placement | Maximum | 2022 Warrants | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Warrants issued to purchase common stock | 13,813,912 | 282,809 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Assumptions Used to Record Fair Value of Warrants (Details) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 $ / shares | Dec. 31, 2022 $ / shares | |
Stock Price | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Stock price | $ 3.95 | $ 3.59 |
Average risk-free interest rate | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Warrants liability measurement input | 4.71 | 4.02 |
Average expected life (in years) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Expected life (in years) | 3 years 11 months 1 day | 4 years 8 months 1 day |
Average expected volatility | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Warrants liability measurement input | 85.96 | 86.79 |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary of Changes in Level 3 Warrant Liability Measured at Fair Value on Recurring Basis (Details) - Level 3 - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Fair value of warrant liabilities as of beginning of year | $ 24,472 | $ 3,029 |
Warrants issued in connection with 2022 private placement | 64,664 | |
Change in fair value | 77 | (43,221) |
Fair value of warrant liabilities as of end of period | $ 24,549 | $ 24,472 |
Restricted Cash - Additional In
Restricted Cash - Additional Information (Details) - USD ($) $ in Thousands | 9 Months Ended | ||
Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | |
Restricted Cash | |||
Long term restricted cash | $ 3,086 | $ 3,086 | $ 3,086 |
HQ Lease | |||
Restricted Cash | |||
Letter of credit outstanding | $ 3,100 | ||
Letter of credit expiration period | 95 days | ||
Operating Lease, October 2023 | |||
Restricted Cash | |||
Expected letter of credit amount | $ 2,100 |
Restricted Cash - Schedule of R
Restricted Cash - Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Cash, Cash Equivalents, Restricted Cash, and Restricted Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 112,219 | $ 167,467 | $ 171,532 | |
Restricted cash, net of current portion | 3,086 | 3,086 | 3,086 | |
Total cash, cash equivalents and restricted cash | $ 115,305 | $ 170,553 | $ 174,618 | $ 95,388 |
Oxford Finance Loan Agreement -
Oxford Finance Loan Agreement - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||||
Nov. 15, 2022 | Jul. 03, 2022 | Jul. 02, 2022 | Feb. 12, 2020 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 23, 2020 | |
Debt Instrument [Line Items] | ||||||||||
Term loan | $ 40,000,000 | $ 40,000,000 | ||||||||
Warrants to purchase common stock | 211,709 | 211,709 | ||||||||
Long-term portion of debt | 39,406,000 | $ 39,406,000 | $ 40,649,000 | |||||||
Loan Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Term loan, aggregate principal amount | $ 60,000,000 | |||||||||
Additional term loan advances, description | A first tranche term loan for $20.0 million was funded on February 12, 2020, and a second tranche term loan for $20.0 million was funded on December 23, 2020. The remaining $20.0 million is still available under the Loan Agreement, at the sole discretion of the Lender. | |||||||||
Each of available additional term loan advances | $ 20,000,000 | |||||||||
Term loan, interest rate terms | the floating annual rate for each term loan was amended to equal the greater of (i) 7.75% and (ii) the sum of (a) the 1-month CME Term SOFR reference rate, (b) 0.10%, and (c) 5.98%. | The term loan initially bore interest at an annual rate equal to the greater of (i) 7.75% and (ii) the sum of 5.98% and the greater of (A) one-month LIBOR or (B) 1.77%. | ||||||||
Term loan, interest rate | 7.75% | 7.75% | ||||||||
Term loan, effective interest rate | 5.98% | 5.98% | ||||||||
Term loan, variable interest rate basis | 1-month CME Term SOFR | one-month LIBOR | ||||||||
Term loan, variable interest rate basis spread | 0.10% | 1.77% | ||||||||
Term loan, maturity date | Feb. 01, 2025 | |||||||||
Extended interest only period upon consummation of merger and private placement | Mar. 01, 2024 | Mar. 01, 2023 | ||||||||
Extended maturity date upon consummation of merger and private placement | Feb. 01, 2026 | Feb. 01, 2025 | ||||||||
Extended interest only period upon achievement of certain milestones | Sep. 01, 2024 | |||||||||
Extended maturity upon consummation of merger and private placement | Aug. 01, 2026 | |||||||||
Term Loan, facilities fee | $ 300,000 | |||||||||
Term loan, final payment fee percentage | 5% | |||||||||
Warrant exercisable period from date of issuance | 5 years | |||||||||
Interest expense | $ 1,300,000 | $ 1,000,000 | $ 3,700,000 | $ 3,000,000 | ||||||
Loan Agreement | Advance Prepaid in First 12 Months | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Term loan, prepayment fee, equal to percentage of the principal amount being prepaid | 2% | |||||||||
Loan Agreement | Advance Prepaid After 12 Months But Prior to 24 Months | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Term loan, prepayment fee, equal to percentage of the principal amount being prepaid | 1% | |||||||||
Loan Agreement | Advance Prepaid After 24 Months But Prior to Maturity Date | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Term loan, prepayment fee, equal to percentage of the principal amount being prepaid | 0.50% | |||||||||
Loan Agreement | First Loan Tranche | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Term loan | $ 20,000,000 | |||||||||
Term Loan, facilities fee | $ 100,000 | |||||||||
Warrants to purchase common stock | 2,754 | |||||||||
Warrant exercise price of common stock per share | $ 72.60 | |||||||||
Loan Agreement | Second Loan Tranche | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Term loan | $ 20,000,000 | |||||||||
Term Loan, facilities fee | $ 75,000 | |||||||||
Warrants to purchase common stock | 1,738 | |||||||||
Warrant exercise price of common stock per share | $ 115 | |||||||||
Loan Agreement | Third Loan Tranche | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Term loan, facilities fee | $ 50,000 |
Oxford Finance Loan Agreement_2
Oxford Finance Loan Agreement - Schedule of Minimum Aggregate Future Loan Payments (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
Year ending December 31, 2024 | $ 6,667 | |
Year ending December 31, 2025 | 20,000 | |
Year ending December 31, 2026 | 13,333 | |
Total minimum payments | 40,000 | |
Less unamortized debt discount | (381) | |
Plus accumulated accretion of final fees | 1,454 | |
Less current portion | (1,667) | |
Long-term debt, net of current portion | $ 39,406 | $ 40,649 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Liabilities, Current [Abstract] | ||
External research and preclinical development | $ 11,643 | $ 8,219 |
Employee compensation and benefits (Note 13) | 7,941 | 8,529 |
Professional fees | 1,300 | 1,164 |
Facilities and other | 605 | 54 |
Accrued expenses | $ 21,489 | $ 17,966 |
Commitments and Contingencies -
Commitments and Contingencies - Operating Leases - Additional Information (Details) $ in Thousands | 9 Months Ended | ||
Jan. 08, 2019 ft² | Sep. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Lessee Lease Description [Line Items] | |||
Operating lease, right-of-use asset | $ 12,464 | $ 13,231 | |
Operating lease liability, short term | 2,241 | 2,006 | |
Operating lease liability, long-term | 19,144 | $ 20,851 | |
Accounting Standards Update 2016-02 | |||
Lessee Lease Description [Line Items] | |||
Operating lease, right-of-use asset | 15,800 | ||
Operating lease liability, long-term | $ 15,800 | ||
Lease operating, discounted borrowing rate | 9.30% | ||
Net of tenant allowances expected to be received | $ 9,300 | ||
Lease practical expedient | true | ||
HQ Lease | |||
Lessee Lease Description [Line Items] | |||
Area of office and laboratory space leased | ft² | 52,859 | ||
Term of option to extend the lease | 10 years | ||
Letter of credit outstanding | $ 3,100 | ||
HQ Lease | Accounting Standards Update 2016-02 | |||
Lessee Lease Description [Line Items] | |||
Operating lease liability, short term | 2,200 | ||
Operating lease liability, long-term | $ 19,100 |
Commitment and Contingencies -
Commitment and Contingencies - Schedule of Reconciliation of Maturity Analysis of Annual Undiscounted Cash Flows (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Three Months ending December 31, 2023 | $ 1,027 |
Year ending December 31, 2024 | 4,166 |
Year ending December 31, 2025 | 4,287 |
Year ending December 31, 2026 | 4,412 |
Year ending December 31, 2027 and beyond | 14,844 |
Operating Lease, Total minimum lease payments | 28,736 |
Operating Lease, Less imputed interest | (7,351) |
Operating lease liability | $ 21,385 |
Commitment and Contingencies _2
Commitment and Contingencies - Schedule of Total Lease Cost for Operating and Financing Leases as well as Weighted Average Information for Leases (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Lease cost: | |
Operating lease cost | $ 2,316 |
Cash paid for amounts included in the measurement of liabilities: | |
Operating cash flows from operating lease | $ 3,021 |
Other information: | |
Weighted-average remaining lease term (in years) - operating lease | 6 years 8 months 1 day |
Weighted-average discount rate - operating lease | 9.30% |
Commitments and Contingencies_2
Commitments and Contingencies - Asset Purchase Agreement (Details) - Orsenix, LLC - Asset Purchase Agreement $ in Millions | Dec. 04, 2020 USD ($) |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Upfront fee payments | $ 12 |
Payments made upon achievement of regulatory milestone | 6 |
Payments made upon achievement of commercial milestone | $ 10 |
Commitments and Contingencies_3
Commitments and Contingencies - License Agreements - Additional Information (Details) - TMRC - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2021 | May 31, 2021 | May 31, 2016 | Sep. 30, 2015 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2016 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||
Up-front license fee | $ 1 | ||||||||
Payment of up-front license fee | $ 0.5 | 0.5 | |||||||
Payments per indication due upon the successful achievement of clinical and regulatory milestones | $ 13 | ||||||||
Payments made upon achievement of development milestone | $ 1 | $ 2 | $ 1 | ||||||
Fees incurred under supply management agreement | $ 1.8 | $ 1.8 | $ 1.8 | $ 1.8 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||||||||
Sep. 16, 2022 USD ($) $ / shares shares | Sep. 15, 2022 shares | Dec. 08, 2020 USD ($) $ / shares shares | Apr. 09, 2019 USD ($) Agreement $ / shares shares | Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) shares | Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) shares | Jun. 30, 2023 shares | Dec. 31, 2022 USD ($) shares | Sep. 14, 2022 shares | Jun. 30, 2022 shares | Dec. 31, 2021 shares | Nov. 30, 2019 shares | |
Class Of Stock [Line Items] | ||||||||||||||
Increase in common stock authorized | 700,000,000 | 70,000,000 | 70,000,000 | 70,000,000 | 200,000,000 | |||||||||
Effective date of share increase amendment | Sep. 15, 2022 | |||||||||||||
Reverse stock split number of authorized common stock proportionately adjusted | 70,000,000 | 700,000,000 | ||||||||||||
Remeasured fair value of warrants | $ | $ 24,549 | $ 24,549 | $ 24,472 | |||||||||||
Change in fair value of warrant liabilities | $ | $ (5,837) | $ 9,860 | $ (77) | $ 12,465 | ||||||||||
Common stock, shares outstanding | 20,720,447 | 20,720,447 | 20,263,116 | |||||||||||
Reverse stock split fractional shares issued | 0 | |||||||||||||
Number of underwriting agreements | Agreement | 2 | |||||||||||||
Aggregate gross proceeds from public offerings | $ | $ 70,000 | |||||||||||||
Underwriting discounts and commissions and estimated offering expenses payable | $ | $ 5,000 | |||||||||||||
Preferred stock, shares outstanding | 0 | 0 | 0 | |||||||||||
Warrants issued to purchase common stock | 211,709 | 211,709 | ||||||||||||
Series A Preferred Stock | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Preferred stock, shares outstanding | 0 | 0 | 666 | |||||||||||
Class A Warrants | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Warrant exercise price of common stock per share | $ / shares | $ 86.25 | $ 86.25 | ||||||||||||
Warrants expiration date | Oct. 10, 2022 | |||||||||||||
Maximum ownership percentage to total number stock issued and outstanding holder is prohibited from conversion | 4.99% | |||||||||||||
Notice period for change in owning percentage | 61 days | |||||||||||||
Common Stock | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Common stock, shares outstanding | 20,720,447 | 20,225,352 | 20,720,447 | 20,225,352 | 20,708,356 | 20,263,116 | 6,298,898 | 6,202,403 | ||||||
Common Stock | Series A Preferred Stock | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Conversion of series A stock into common stock | 66,600 | |||||||||||||
Private Placement | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Gross proceeds of private placement | $ | $ 129,900 | $ 90,500 | ||||||||||||
Transaction costs | $ | $ 10,100 | $ 400 | ||||||||||||
Change in fair value of warrant liabilities | $ | $ (5,800) | $ (9,900) | $ (100) | $ (2,500) | ||||||||||
Private Placement | Common Stock | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Shares issued | 6,387,173 | 1,031,250 | 6,387,173 | 6,387,173 | ||||||||||
Private Placement | 2022 Pre-Funded Warrants | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Share price (in dollars per share) | $ / shares | $ 10.34 | |||||||||||||
Warrants issued to purchase common stock | 7,426,739 | |||||||||||||
Private Placement | 2020 Pre-Funded Warrants | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Share price (in dollars per share) | $ / shares | $ 80 | |||||||||||||
Warrants issued to purchase common stock | 100,000 | |||||||||||||
Private Placement | 2020 Warrants | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Share price (in dollars per share) | $ / shares | $ 79.9 | |||||||||||||
Initial fair value of warrants at issuance | $ | $ 19,300 | |||||||||||||
Private Placement | 2020 Warrants | Maximum | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Warrants issued to purchase common stock | 282,809 | |||||||||||||
Private Placement | 2022 Warrants | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Share price (in dollars per share) | $ / shares | $ 10.33 | |||||||||||||
Initial fair value of warrants at issuance | $ | $ 64,700 | |||||||||||||
Remeasured fair value of warrants | $ | $ 24,600 | $ 24,600 | $ 24,500 | |||||||||||
Private Placement | 2022 Warrants | Maximum | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Warrants issued to purchase common stock | 13,813,912 | 282,809 | ||||||||||||
Private Placement | Merger Agreement | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Common stock, shares outstanding | 6,300,000 | |||||||||||||
Public Offering | Common Stock Agreement | Class A Warrants | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Share price (in dollars per share) | $ / shares | $ 75 | |||||||||||||
Warrants issued to purchase common stock | 195,184 | |||||||||||||
Public Offering | Preferred Stock Agreement | Series A Preferred Stock | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Shares issued | 666 | |||||||||||||
Public Offering | Preferred Stock Agreement | Class A Warrants | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Share price (in dollars per share) | $ / shares | $ 75,000 | |||||||||||||
Warrants issued to purchase common stock | 16,650 | |||||||||||||
Public Offering | Common Stock | Common Stock Agreement | ||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||
Shares issued | 866,733 |
Stock-Based Payments - 2016 Emp
Stock-Based Payments - 2016 Employee Stock Purchase Plan (Details) - 2016 ESPP - shares | Jan. 01, 2023 | Jul. 06, 2016 | Sep. 30, 2023 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Increase in number of shares of common stock reserved for issuance of awards on the first day of each calendar year (in shares) | 117,333 | ||
Increase in number of shares of common stock reserved for issuance of awards on the first day of each calendar year, as a percentage of outstanding shares | 1% | ||
Increase in number of shares of common stock reserved for issuance (in shares) | 202,631 | ||
Common stock available for future issuance (in shares) | 385,718 |
Stock-Based Payments - Induceme
Stock-Based Payments - Inducement Grants (Details) | 9 Months Ended |
Sep. 30, 2023 shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Granted and outstanding (in shares) | 54,000 |
Vesting ratably on a monthly basis | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting (as a percent) | 75% |
Inducement Grants | Non Statutory Stock options | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Granted and outstanding (in shares) | 111,000 |
Vesting period | 4 years |
Term of award | 3 years |
Inducement Grants | Non Statutory Stock options | Vesting on one year anniversary of vesting commencement date | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting (as a percent) | 25% |
Inducement Grants | Non Statutory Stock options | Vesting ratably on a monthly basis | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting (as a percent) | 75% |
Stock-Based Payments - 2022 Ind
Stock-Based Payments - 2022 Inducement Stock Incentive Plan (Details) - 2022 Inducement Stock Incentive Plan - shares | Sep. 30, 2023 | Jan. 31, 2023 | Jan. 25, 2022 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of common stock shares grant | 750,000 | 100,000 | |
Common stock available for future issuance (in shares) | 661,622 |
Stock-Based Payments - 2022 Equ
Stock-Based Payments - 2022 Equity Incentive Plan (Details) - 2022 Equity Incentive Plan | Sep. 30, 2023 shares |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of common stock shares grant | 4,737,534 |
Common stock available for future issuance (in shares) | 731,107 |
Stock-Based Payments - Summary
Stock-Based Payments - Summary of Status of Stock Options (Details) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | Dec. 31, 2022 $ / shares shares | |
Share-Based Payment Arrangement [Abstract] | ||
Outstanding at beginning of year (in shares) | 1,727,237 | |
Granted (in shares) | 54,000 | |
Cancelled (in shares) | (35,060) | |
Outstanding at end of period (in shares) | 1,746,177 | 1,727,237 |
Exercisable (in shares) | 1,155,463 | |
Outstanding at beginning of year (in dollars per share) | $ / shares | $ 39.94 | |
Granted (in dollars per share) | $ / shares | 3.7 | |
Outstanding at end of period (in dollars per share) | $ / shares | 38.22 | $ 39.94 |
Exercisable (in dollars per share) | $ / shares | $ 49.51 | |
Remaining Contractual Life, Outstanding | 5 years 2 months 12 days | 5 years 8 months 12 days |
Remaining Contractual Life, Exercisable | 3 years 2 months 12 days | |
Aggregate Intrinsic Value, Outstanding | $ | $ 13,880 | |
Aggregate Intrinsic Value, Options Exercisable | $ | $ 380 |
Stock-Based Payments - Stock Op
Stock-Based Payments - Stock Options (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 16, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Unrecognized compensation costs | $ 6,200 | $ 6,200 | |||
Period in which compensation costs will be recognized | 1 year 4 months 24 days | ||||
Intrinsic value of options exercised | $ 0 | $ 100 | |||
Extend employees exercise period | 3 years 2 months 12 days | ||||
Granted (in shares) | 54,000 | ||||
Stock-based compensation expense | $ 3,255 | $ 2,955 | $ 8,714 | $ 8,507 | |
Vesting ratably on a monthly basis | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Vesting (as a percent) | 75% | ||||
Stock Option | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Vesting period | 4 years | ||||
Term of award | 3 years | ||||
Granted (in shares) | 0 | ||||
Stock Option | Tyme | Merger Agreement | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Extend employees exercise period | 2 years | ||||
Granted (in shares) | 692,460 | ||||
Stock-based compensation expense | $ 400 | ||||
Stock Option | Vesting on one year anniversary of vesting commencement date | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Vesting (as a percent) | 25% | ||||
Stock Option | Vesting ratably on a monthly basis | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Vesting period | 10 years |
Stock-Based Payments - Restrict
Stock-Based Payments - Restricted Stock Units and Restricted Stock Awards (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unrecognized compensation costs | $ 6.2 |
Period in which compensation costs will be recognized | 1 year 4 months 24 days |
Restricted Stock Units and Restricted Stock Awards | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unrecognized compensation costs | $ 11.8 |
Period in which compensation costs will be recognized | 1 year 10 months 24 days |
Restricted Stock Units and Restricted Stock Awards | Maximum | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting period | 4 years |
Restricted Stock Units and Restricted Stock Awards | Minimum | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting period | 3 years |
Restricted Stock Units and Restricted Stock Awards | Board of Directors | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting period | 3 years |
Vesting (as a percent) | 33.33% |
Stock-Based Payments - Summar_2
Stock-Based Payments - Summary of Status of Restricted Stock Units (Details) - Restricted Stock Units and Restricted Stock Awards | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Outstanding at beginning of year (in shares) | shares | 1,204,421 |
Granted (in shares) | shares | 1,462,636 |
Vested (in shares) | shares | (84,418) |
Forfeited (in shares) | shares | (116,748) |
Outstanding at end of period (in shares) | shares | 2,465,891 |
Weighted Average Grant Date Fair Value, Outstanding at beginning of year (in dollars per share) | $ / shares | $ 14.68 |
Weighted Average Grant Date Fair Value, Granted (in dollars per share) | $ / shares | 3.99 |
Weighted Average Grant Date Fair Value, Vested (in dollars per share) | $ / shares | 32.02 |
Weighted Average Grant Date Fair Value, Forfeited (in dollars per share) | $ / shares | 17.17 |
Weighted Average Grant Date Fair Value, Outstanding at end of period (in dollars per share) | $ / shares | $ 7.54 |
Stock-Based Payments - Schedule
Stock-Based Payments - Schedule of Weighted-Average Assumptions used in Black-Scholes Option-Pricing Model (Details) - Stock Option | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Weighted-average risk-free interest rate | 3.60% | 3.93% | 2.85% |
Expected option term (in years) | 5 years 9 months 14 days | 5 years 3 months 25 days | 5 years 10 months 17 days |
Volatility | 83.27% | 84.44% | 82.18% |
Stock-Based Payments - Weighted
Stock-Based Payments - Weighted-Average Assumptions to Estimate Fair Value of Stock Options (Details) - $ / shares | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Granted (in shares) | 54,000 | ||
Stock Option | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Granted (in shares) | 0 | ||
Weighted-average grant date fair value of options granted (in dollars per share) | $ 2.6 | $ 7.82 |
Stock-Based Payments - Summar_3
Stock-Based Payments - Summary of Stock-based Compensation Expense for Stock Options and Restricted Stock Units (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 3,255 | $ 2,955 | $ 8,714 | $ 8,507 |
Research and development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 1,586 | 1,496 | 4,236 | 4,324 |
General and administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 1,501 | $ 1,459 | 4,310 | $ 4,183 |
Restructuring | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 168 | $ 168 |
Restructuring - Additional Info
Restructuring - Additional Information (Details) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 USD ($) | Sep. 30, 2023 USD ($) | |
Restructuring and Related Activities [Abstract] | ||
Restructuring costs | $ 2,354 | $ 2,354 |
Severance Costs | 2,000 | |
Asset impairment charges | 373 | |
Unpaid restructuring costs | $ 1,800 | $ 1,800 |