Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2024 | Oct. 31, 2024 | |
Document and Entity Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | IGM Biosciences, Inc. | |
Entity Central Index Key | 0001496323 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Title of 12(b) Security | Common Stock, par value $0.01 per share | |
Trading Symbol | IGMS | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-39045 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 77-0349194 | |
Entity Address, Address Line One | 325 E. Middlefield Road | |
Entity Address, City or Town | Mountain View | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94043 | |
City Area Code | 650 | |
Local Phone Number | 965-7873 | |
Common Stock | ||
Document and Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 34,077,198 | |
Non-Voting Common Stock | ||
Document and Entity Information [Line Items] | ||
Entity Common Stock, Shares Outstanding | 25,386,983 |
Condensed Balance Sheets (Unaud
Condensed Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 42,875 | $ 112,520 |
Restricted cash | 190 | 592 |
Marketable securities | 175,912 | 225,157 |
Prepaid expenses and other current assets | 10,654 | 9,328 |
Total current assets | 229,631 | 347,597 |
Property, plant and equipment, net | 34,650 | 38,232 |
Operating lease right-of-use assets | 39,088 | 35,773 |
Other non-current assets | 1,139 | 1,809 |
Total assets | 304,508 | 423,411 |
Current liabilities: | ||
Accounts payable | 3,545 | 1,326 |
Accrued liabilities | 31,071 | 31,544 |
Lease liabilities | 6,695 | 5,834 |
Deferred revenue | 2,653 | 3,777 |
Total current liabilities | 43,964 | 42,481 |
Lease liabilities, non-current | 39,162 | 34,672 |
Deferred revenue, non-current | 141,881 | 143,024 |
Other liabilities, non-current | 554 | 0 |
Total liabilities | 225,561 | 220,177 |
Commitments and contingencies (Note 5) | ||
Stockholders' equity: | ||
Preferred stock, $0.01 par value; 200,000,000 shares authorized as of September 30, 2024 and December 31, 2023; no shares issued and outstanding as of September 30, 2024 and December 31, 2023 | 0 | 0 |
Additional paid-in-capital | 1,058,322 | 1,023,739 |
Accumulated other comprehensive income | 421 | 151 |
Accumulated deficit | (980,390) | (821,242) |
Total stockholders' equity | 78,947 | 203,234 |
Total liabilities and stockholders' equity | 304,508 | 423,411 |
Common Stock Class Undefined [Member] | ||
Stockholders' equity: | ||
Common stock, value | 340 | 331 |
Non-Voting Common Stock | ||
Stockholders' equity: | ||
Common stock, value | $ 254 | $ 255 |
Condensed Balance Sheets (Una_2
Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2024 | Dec. 31, 2023 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 200,000,000 | 200,000,000 |
Preferred Stock, shares Issued | 0 | 0 |
Preferred Stock, shares outstanding | 0 | 0 |
Common stock, shares authorized | 120,000,000 | 120,000,000 |
Common Stock Class Undefined [Member] | ||
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 1,000,000,000 | 1,000,000,000 |
Common stock, shares issued | 34,060,315 | 33,180,749 |
Common stock, shares outstanding | 34,060,315 | 33,180,749 |
Non-Voting Common Stock | ||
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 25,386,983 | 25,500,383 |
Common stock, shares outstanding | 25,386,983 | 25,500,383 |
Condensed Statements of Operati
Condensed Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Income Statement [Abstract] | ||||
Collaboration revenue | $ 516 | $ 509 | $ 2,267 | $ 1,479 |
Operating expenses: | ||||
Research and development | 46,142 | 54,762 | 131,919 | 161,329 |
General and administrative | 18,761 | 12,507 | 39,948 | 38,492 |
Total operating expenses | 64,903 | 67,269 | 171,867 | 199,821 |
Loss from operations | (64,387) | (66,760) | (169,600) | (198,342) |
Other income (expense): | ||||
Interest income | 2,957 | 5,011 | 10,452 | 13,077 |
Other expense | 0 | 0 | 0 | (20) |
Total other income (expense) | 2,957 | 5,011 | 10,452 | 13,057 |
Loss before income tax expense | (61,430) | (61,749) | (159,148) | (185,285) |
Income tax expense | 0 | (240) | 0 | (436) |
Net loss | $ (61,430) | $ (61,989) | $ (159,148) | $ (185,721) |
Net loss per share, basic | $ (1.01) | $ (1.04) | $ (2.63) | $ (3.73) |
Net loss per share, diluted | $ (1.01) | $ (1.04) | $ (2.63) | $ (3.73) |
Weighted-average common shares outstanding, basic | 60,657,797 | 59,580,402 | 60,403,056 | 49,778,716 |
Weighted-average common shares outstanding, diluted | 60,657,797 | 59,580,402 | 60,403,056 | 49,778,716 |
Condensed Statements of Compreh
Condensed Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Statement of Comprehensive Income [Abstract] | ||||
Net Income (Loss) | $ (61,430) | $ (61,989) | $ (159,148) | $ (185,721) |
Other comprehensive income: | ||||
Unrealized loss on marketable securities | 616 | 175 | 270 | 424 |
Comprehensive loss | $ (60,814) | $ (61,814) | $ (158,878) | $ (185,297) |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Common Stock Non-Voting Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Balance at Dec. 31, 2022 | $ 287,263 | $ 294 | $ 137 | $ 862,359 | $ (701) | $ (574,826) |
Balance, shares at Dec. 31, 2022 | 29,394,436 | 13,687,883 | ||||
Exercise of stock options | 75 | 75 | ||||
Exercise of stock options, shares | 40,774 | |||||
Issuance of common stock connection with public offering | $ 1 | (1) | ||||
Issuance of common stock connection with public offering, shares | 64,863 | |||||
Unrealized loss on marketable securities | 354 | 354 | ||||
Stock-based compensation expense | 11,047 | 11,047 | ||||
Net Income (Loss) | (59,309) | (59,309) | ||||
Balance at Mar. 31, 2023 | 239,430 | $ 295 | $ 137 | 873,480 | (347) | (634,135) |
Balance, shares at Mar. 31, 2023 | 29,500,073 | 13,687,883 | ||||
Balance at Dec. 31, 2022 | 287,263 | $ 294 | $ 137 | 862,359 | (701) | (574,826) |
Balance, shares at Dec. 31, 2022 | 29,394,436 | 13,687,883 | ||||
Unrealized loss on marketable securities | 424 | |||||
Net Income (Loss) | (185,721) | |||||
Balance at Sep. 30, 2023 | 253,862 | $ 329 | $ 255 | 1,014,102 | (277) | (760,547) |
Balance, shares at Sep. 30, 2023 | 32,884,846 | 25,500,383 | ||||
Balance at Mar. 31, 2023 | 239,430 | $ 295 | $ 137 | 873,480 | (347) | (634,135) |
Balance, shares at Mar. 31, 2023 | 29,500,073 | 13,687,883 | ||||
Exercise of stock options | 14 | 14 | ||||
Exercise of stock options, shares | 10,788 | |||||
Issuance of common stock connection with public offering | $ 1 | (1) | ||||
Issuance of common stock connection with public offering, shares | 81,136 | |||||
Issuance of common stock in connection with public offering and private placement, net of offering costs | 68,391 | $ 32 | $ 62 | 68,297 | ||
Issuance of common stock in connection with public offering and private placement, net of offering costs, Shares | 3,187,500 | 6,187,500 | ||||
Purchases under employee stock purchase plan, value | 991 | $ 1 | 990 | |||
Purchases under employee stock purchase plan, shares | 84,559 | |||||
Unrealized loss on marketable securities | (105) | (105) | ||||
Stock-based compensation expense | 14,309 | 14,309 | ||||
Net Income (Loss) | (64,423) | (64,423) | ||||
Balance at Jun. 30, 2023 | 258,607 | $ 329 | $ 199 | 957,089 | (452) | (698,558) |
Balance, shares at Jun. 30, 2023 | 32,864,056 | 19,875,383 | ||||
Exercise of stock options | 22 | 22 | ||||
Exercise of stock options, shares | 16,576 | |||||
Issuance of common stock connection with public offering | 45,000 | $ 56 | 44,944 | |||
Issuance of common stock connection with public offering, shares | 5,625,000 | |||||
Vest of restricted stock units, shares | 4,214 | |||||
Offering costs in connection with public offering and private placement | 93 | 93 | ||||
Unrealized loss on marketable securities | 175 | 175 | ||||
Stock-based compensation expense | 11,954 | 11,954 | ||||
Net Income (Loss) | (61,989) | (61,989) | ||||
Balance at Sep. 30, 2023 | 253,862 | $ 329 | $ 255 | 1,014,102 | (277) | (760,547) |
Balance, shares at Sep. 30, 2023 | 32,884,846 | 25,500,383 | ||||
Balance at Dec. 31, 2023 | 203,234 | $ 331 | $ 255 | 1,023,739 | 151 | (821,242) |
Balance, shares at Dec. 31, 2023 | 33,180,749 | 25,500,383 | ||||
Conversion of non-voting common stock into voting common stock | $ 1 | $ (1) | ||||
Conversion of non-voting common stock into voting common stock, shares | 113,400 | (113,400) | ||||
Exercise of stock options, net of shares withheld for taxes and exercise costs | 192 | $ 1 | 191 | |||
Exercise of stock options, net of shares withheld for taxes and exercise costs, shares | 113,314 | |||||
Issuance of common stock connection with public offering | $ 2 | (2) | ||||
Issuance of common stock connection with public offering, shares | 156,439 | |||||
Unrealized loss on marketable securities | (279) | (279) | ||||
Stock-based compensation expense | 7,922 | 7,922 | ||||
Net Income (Loss) | (49,816) | (49,816) | ||||
Balance at Mar. 31, 2024 | 161,253 | $ 335 | $ 254 | 1,031,850 | (128) | (871,058) |
Balance, shares at Mar. 31, 2024 | 33,563,902 | 25,386,983 | ||||
Balance at Dec. 31, 2023 | $ 203,234 | $ 331 | $ 255 | 1,023,739 | 151 | (821,242) |
Balance, shares at Dec. 31, 2023 | 33,180,749 | 25,500,383 | ||||
Exercise of stock options, shares | 315,993 | |||||
Unrealized loss on marketable securities | $ 270 | |||||
Net Income (Loss) | (159,148) | |||||
Balance at Sep. 30, 2024 | 78,947 | $ 340 | $ 254 | 1,058,322 | 421 | (980,390) |
Balance, shares at Sep. 30, 2024 | 34,060,315 | 25,386,983 | ||||
Balance at Mar. 31, 2024 | 161,253 | $ 335 | $ 254 | 1,031,850 | (128) | (871,058) |
Balance, shares at Mar. 31, 2024 | 33,563,902 | 25,386,983 | ||||
Exercise of stock options, net of shares withheld for taxes and exercise costs | 64 | $ 1 | 63 | |||
Exercise of stock options, net of shares withheld for taxes and exercise costs, shares | 76,339 | |||||
Issuance of common stock connection with public offering | $ 1 | (1) | ||||
Issuance of common stock connection with public offering, shares | 96,550 | |||||
Purchases under employee stock purchase plan, value | 582 | $ 1 | 581 | |||
Purchases under employee stock purchase plan, shares | 115,793 | |||||
Unrealized loss on marketable securities | (67) | (67) | ||||
Stock-based compensation expense | 8,428 | 8,428 | ||||
Net Income (Loss) | (47,902) | (47,902) | ||||
Balance at Jun. 30, 2024 | 122,358 | $ 338 | $ 254 | 1,040,921 | (195) | (918,960) |
Balance, shares at Jun. 30, 2024 | 33,852,584 | 25,386,983 | ||||
Exercise of stock options, net of shares withheld for taxes and exercise costs | 1,201 | $ 1 | 1,200 | |||
Exercise of stock options, net of shares withheld for taxes and exercise costs, shares | 122,315 | |||||
Issuance of common stock connection with public offering | $ 1 | (1) | ||||
Issuance of common stock connection with public offering, shares | 85,416 | |||||
Unrealized loss on marketable securities | 616 | 616 | ||||
Stock-based compensation expense | 16,202 | 16,202 | ||||
Net Income (Loss) | (61,430) | (61,430) | ||||
Balance at Sep. 30, 2024 | $ 78,947 | $ 340 | $ 254 | $ 1,058,322 | $ 421 | $ (980,390) |
Balance, shares at Sep. 30, 2024 | 34,060,315 | 25,386,983 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2024 | Sep. 30, 2023 | |
Cash flows from operating activities: | ||
Net Income (Loss) | $ (159,148) | $ (185,721) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 6,759 | 6,096 |
Stock-based compensation expense | 32,552 | 37,310 |
Purchase of net discount on marketable securities | 3,487 | 6,959 |
Net accretion of discounts on marketable securities | (5,697) | (7,151) |
Non-cash lease expense | 4,113 | 4,035 |
Other | 35 | 299 |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | (642) | 72 |
Other non-current assets | 670 | 20 |
Accounts payable | 2,049 | 1,526 |
Accrued liabilities | 1,436 | (4,670) |
Lease liabilities, net | (2,077) | (1,519) |
Deferred revenue | (2,267) | (1,479) |
Other non-current liabilities | 554 | 0 |
Net cash used in operating activities | (118,176) | (144,223) |
Cash flows from investing activities: | ||
Purchase of property, plant and equipment | (4,990) | (10,933) |
Purchases of marketable securities | (183,056) | (275,475) |
Proceeds from maturities and sales of marketable securities | 234,168 | 369,456 |
Proceeds from sales of property, plant and equipment | 39 | 0 |
Net cash provided by investing activities | 46,161 | 83,048 |
Cash flows from financing activities: | ||
Proceeds from exercise of stock options | 1,458 | 111 |
Proceeds from purchases under the employee stock purchase plan | 582 | 991 |
Proceeds from issuance of common stock in public offering and private placement, net of offering costs | 0 | 113,564 |
Payment of deferred offering costs | (71) | 0 |
Payment of employee taxes and exercise costs for shares withheld | (1) | 0 |
Net cash provided by financing activities | 1,968 | 114,666 |
Net (decrease) increase in cash, cash equivalents, and restricted cash | (70,047) | 53,491 |
Beginning of period | 113,112 | 121,920 |
End of period | 43,065 | 175,411 |
Cash and cash equivalents | 42,875 | 174,794 |
Restricted cash | 190 | 617 |
Cash, cash equivalents, and restricted cash | 43,065 | 175,411 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Right-of-use assets recognized in exchange for lease obligations | 7,428 | 1,537 |
Unpaid amounts related to purchase of property, plant and equipment | $ 669 | $ 322 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2024 | Jun. 30, 2024 | Mar. 31, 2024 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | |
Pay vs Performance Disclosure | ||||||||
Net Income (Loss) | $ (61,430) | $ (47,902) | $ (49,816) | $ (61,989) | $ (64,423) | $ (59,309) | $ (159,148) | $ (185,721) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Sep. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Organization
Organization | 9 Months Ended |
Sep. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Note 1. Organization Description of the Business IGM Biosciences, Inc. (the Company) was incorporated in the state of Delaware in August 1993 under the name Palingen, Inc. and the name was subsequently changed to IGM Biosciences, Inc. in 2010. The Company’s headquarters are in Mountain View, California. IGM Biosciences, Inc. is a clinical-stage biotechnology company engaged in the development of IgM antibody therapeutics for the treatment of autoimmune and inflammatory diseases. Prior to September 30, 2024, the Company consolidated two wholly owned subsidiaries. To simplify the corporate structure, the Company’s board of directors approved the merger (Merger) of the subsidiaries with and into the Company, with the Company being the surviving corporation, effective August 30, 2024. Because the Merger was a reorganization of entities under common control, the net assets were transferred from its subsidiaries at historical carrying value and the effects of the transaction were applied retrospectively as if the Merger had occurred at the earliest date presented in the Company’s financial statements in accordance with Accounting Standard Codification (ASC) Topic 250, Accounting changes and error corrections (Topic 250). The Merger did not have an impact on the financial statements as the Company's financials have historically been presented on a consolidated basis. Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP), as defined by the Financial Accounting Standards Board (FASB), and applicable rules and regulations of the Securities and Exchange Commission (SEC) regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted, and accordingly the balance sheet as of December 31, 2023 has been derived from the audited financial statements at that date but does not include all of the information required by GAAP for complete financial statements. These unaudited interim condensed financial statements are derived from the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments which are necessary for a fair statement of the Company’s financial information. The interim results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or for any other interim period or for any other future year. The accompanying interim unaudited condensed financial statements should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 7, 2024 . Liquidity The Company has incurred net operating losses and negative cash flows from operations since its inception and had an accumulated deficit of $ 980.4 million as of September 30, 2024. As of September 30, 2024, the Company had cash, cash equivalents, and marketable securities of $ 218.8 million . Management believes that the existing financial resources are sufficient to continue operating activities at least one year past the issuance date of these condensed financial statements. The Company has historically financed its operations primarily through the sale of common stock and pre-funded warrants in its public offerings and private placement, the sale of convertible preferred stock and issuance of unsecured promissory notes in private placements, and funding received from our collaboration partners. To date, none of the Company’s product candidates have been approved for sale, and the Company has not generated any product revenue since inception. Management expects operating losses to continue and increase for the foreseeable future, as the Company progresses its planned research and development activities for its product candidates. The Company’s prospects are subject to risks, expenses and uncertainties frequently encountered by companies in the biotechnology industry as discussed below. While the Company has been able to raise multiple rounds of financing, there can be no assurance that in the event the Company requires additional financing, such financing will be available on terms which are favorable or at all. Failure to raise sufficient capital when needed or generate sufficient cash flow from operations would impact the ability to pursue business strategies and could require the Company to delay, scale back or discontinue one or more product development programs, or other aspects of the Company's business objectives. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements and accompanying notes. Such management estimates include, but are not limited to, those related to revenue recognition, marketable securities, manufacturing accruals, accrued research and development expenses, stock-based compensation, operating lease right-of-use (ROU) assets and liabilities, income tax uncertainties and the valuation of deferred tax assets. The Company bases its estimates on its historical experience and also on assumptions that it believes are reasonable; however, actual results could significantly differ from those estimates. The most significant estimates and assumptions that management considers in the preparation of our financial statements relate to revenue recognition, accrued research and development costs, and leases. Segments The Company operates and manages its business as one reportable and operating segment, which is the business of developing engineered IgM antibodies for the treatment of autoimmune and inflammatory diseases. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for allocating and evaluating financial performance. All long-lived assets are maintained in, and all losses are attributable to, the United States of America. Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to a concentration of credit risk consist primarily of cash, cash equivalents, and marketable securities. The Company invests in money market funds, U.S. treasury securities, corporate bonds, commercial paper, and U.S. government agency securities. The Company maintains bank deposits in federally insured financial institutions and these deposits may exceed federally insured limits. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents, and restricted cash, and bond issuers to the extent recorded on the balance sheets. The Company’s investment policy limits investments to high credit quality securities issued by the U.S. government and its agencies, highly rated banks, and corporate issuers, subject to certain concentration limits and restrictions on maturities. The Company has not experienced any material losses on its deposits of cash, cash equivalents, and marketable securities. The Company’s future results of operations involve a number of other risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, the Company’s early stages of clinical drug development; uncertainties related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; the Company’s ability to advance product candidates into, and successfully complete, clinical trials on the timelines it projects; the Company’s ability to adequately demonstrate sufficient safety and efficacy of its product candidates; the Company’s ability to enroll patients in its ongoing and future clinical trials; the Company’s ability to successfully manufacture and supply its product candidates for clinical trials; the occurrence of any event or circumstance that could give rise to the termination of the Company’s collaborations with third parties; the Company’s ability to obtain additional capital to finance its operations; uncertainties related to the projections of the size of patient populations suffering from the diseases the Company is targeting; the Company’s ability to obtain, maintain, and protect its intellectual property rights; developments relating to the Company’s competitors and its industry, including competing product candidates and therapies; general economic and market conditions; and other risks and uncertainties, including those more fully described in the “Risk Factors” section of this Quarterly Report on Form 10-Q. The Company’s product candidates will require approvals from the U.S. Food and Drug Administration (FDA) and comparable foreign regulatory agencies prior to commercial sales in their respective jurisdictions. There can be no assurance that any product candidates will receive the necessary approvals. If the Company was denied approval, approval was delayed or the Company was unable to maintain approval for any product candidate, it could have a materially adverse impact on the Company. Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be cash and cash equivalents. Cash equivalents consist primarily of amounts invested in money market funds, commercial paper, U.S. treasury securities, and U.S. government agency securities and are stated at fair value. Restricted cash consists of the remaining unused portion of a grant received from a non-profit organization which the Company will continue to utilize as it incurs expenses for services performed under the grant agreement. Marketable Securities The Company’s marketable securities have been classified and accounted for as available-for-sale securities. Fixed income securities consist of U.S. treasury securities, U.S. government agency securities, corporate bonds, and commercial paper. The specific identification method is used to determine the cost basis of fixed income securities sold. These securities are recorded on the condensed balance sheets at fair value. Unrealized gains and losses on these securities are included as a separate component of accumulated other comprehensive loss. The cost of marketable securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in other income (expense). All available-for-sale securities are considered available to support current operations and are classified as current assets. The Company presents any credit losses identified as an allowance rather than as a reduction in the amortized cost of the available-for-sale securities. For available-for-sale debt securities in an unrealized loss position, the Company first assesses whether it intends to sell, or it is more likely than not that it will be required to sell the security before recovery of its amortized cost basis. If either of the criteria regarding intent or requirement to sell is met, the security’s amortized cost basis is written down to fair value and recognized in other income (expense) in the condensed statements of operations. If neither criteria is met, the Company evaluates whether the decline in fair value is related to credit-related factors or other factors. In making this assessment, management considers the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and adverse conditions specifically related to the security, among other factors. Credit-related impairment losses, limited by the amount that the fair value is less than the amortized cost basis, are recorded through an allowance for credit losses in other income (expense). Any unrealized losses from declines in fair value below the amortized cost basis as a result of non-credit factors are recognized in accumulated other comprehensive income (loss), net of tax as a separate component of stockholders’ equity, along with unrealized gains. Realized gains and losses and declines in fair value, if any, on available-for-sale securities are included in other income (expense) in the condensed statements of operations. For purposes of identifying and measuring credit-related impairments, the Company’s policy is to exclude applicable accrued interest from both the fair value and amortized cost basis of the related security. The Company has elected to write-off uncollectible accrued interest receivable balances in a timely manner, which is defined by the Company as when interest due becomes 90 days delinquent. The accrued interest write-off will be recorded by reversing interest income. Accrued interest receivable is recorded to prepaid expenses and other current assets on the condensed balance sheets. Property, Plant and Equipment Property, plant and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is determined using the straight-line method over the estimated useful lives of the respective assets, generally three to five years . Leasehold improvements are depreciated using the straight-line method over the shorter of the lease term or the estimated useful economic lives of the related assets. Assets are held in construction in progress until placed in service, upon which date, we begin to depreciate these assets. Upon retirement or sale of the assets, the cost and related accumulated depreciation and amortization are removed from the condensed balance sheets and the resulting gain or loss are recorded to the condensed statements of operations. Repairs and maintenance are charged to the condensed statements of operations as incurred. Leases The Company determines if an arrangement is a lease at inception. In addition, the Company determines whether leases meet the classification criteria of a finance or operating lease at the lease commencement date considering: (1) whether the lease transfers ownership of the underlying asset to the lessee at the end of the lease term, (2) whether the lease grants the lessee an option to purchase the underlying asset that the lessee is reasonably certain to exercise, (3) whether the lease term is for a major part of the remaining economic life of the underlying asset, (4) whether the present value of the sum of the lease payments and residual value guaranteed by the lessee equals or exceeds substantially all of the fair value of the underlying asset, and (5) whether the underlying asset is of such a specialized nature that it is expected to have no alternative use to the lessor at the end of the lease term. As of September 30, 2024, the Company's lease population consisted of real estate leases and the Company did not have finance leases. Operating leases are included in operating lease ROU assets and lease liabilities in the Company’s condensed balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the present value of lease payments, the Company uses its incremental borrowing rate based on the information available at the lease commencement date if the rate implicit in the lease is not readily determinable. The Company determines the incremental borrowing rate based on an analysis of corporate bond yields with a credit rating similar to the Company. The determination of the Company’s incremental borrowing rate requires management judgment including the development of a synthetic credit rating and cost of debt as the Company currently does not carry any debt. The Company believes that the estimates used in determining the incremental borrowing rate are reasonable based upon current facts and circumstances. Applying different judgments to the same facts and circumstances could result in the estimated amounts to vary. The operating lease ROU assets also include adjustments for prepayments and accrued lease payments and exclude lease incentives. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise such options. Operating lease cost is recognized on a straight-line basis over the expected lease term. Variable lease costs represent payments that are dependent on usage, a rate or index. Variable lease cost primarily relates to common area maintenance charges. Lease agreements that include lease and non-lease components are accounted for as a single lease component. Lease agreements with a noncancelable term of less than 12 months are not recorded on the Company’s condensed balance sheets. Impairment of Long-Lived Assets The Company evaluates the carrying amount of its long-lived assets, such as property and equipment, whenever events or changes in circumstances indicate that the assets may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition are less than the carrying amount of the asset. There were no impairments of long-lived assets for the three and nine months ended September 30, 2024 and 2023 . Fair Value Measurement The Company applies fair value accounting for all financial assets and liabilities and non-financial assets and liabilities that are recognized or disclosed at fair value in the condensed financial statements on a recurring basis. Fair value is an 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 such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1—Observable inputs, such as quoted prices in active markets for identical assets or liabilities at the measurement date. Level 2—Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3—Unobservable inputs which reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value. Financial instruments classified within Level 2 of the fair value hierarchy are valued based on other observable inputs, including broker or dealer quotations or alternative pricing sources. When quoted prices in active markets for identical assets or liabilities are not available, the Company relies on non-binding quotes from its investment managers, which are based on proprietary valuation models of independent pricing services. These models generally use inputs such as observable market data, quoted market prices for similar instruments, or historical pricing trends of a security relative to its peers. Revenue Recognition For arrangements or transactions between participants determined to be within the scope of ASC Topic 606, Revenue from Contracts with Customers (Topic 606) the Company performs the following steps to determine the appropriate amount of revenue to be recognized as the Company fulfills its obligations: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (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 has entered into and may enter into additional collaboration agreements in the future under which it may obtain upfront payments, milestone payments, royalty payments, profit sharing, and other fees. Promises under these arrangements may include intellectual property licenses, research and development services, and the participation in joint committees. At contract inception, the Company assesses the goods or services promised and enforceable in a contract with a customer and identifies those distinct goods and services that represent a performance obligation. In assessing whether a promised good or service is distinct, and therefore a performance obligation, the Company considers factors such as the nature of the research, stage of development of the targets, manufacturing and commercialization capabilities of the customer and the availability of the associated expertise in the general marketplace. The Company also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract. If a promised good or service is not distinct, the Company combines that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct. Promised goods and services that are not material in the context of the contract are not considered performance obligations. Additional goods or services that are exercisable at a customer’s discretion, including substitution rights, are assessed to determine if they provide a material right to the customer and if so, they are considered performance obligations. The transaction price is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods or services to a customer. The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Non-refundable upfront payments are considered fixed consideration and included in the transaction price. If an arrangement includes development, regulatory or commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. The Company includes the amount of estimated variable consideration, including milestones, in the transaction price to the extent that it is probable that a significant reversal of cumulative revenue recognized will not occur. Milestone payments that are not within the Company’s control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. For arrangements with licenses of intellectual property that include sales-based royalties, including milestone payments based on the level of sales, and if the license is deemed to be the predominant item to which the royalties relate, the Company recognizes royalty revenue and sales-based milestones at the later of (i) when the related sales occur, or (ii) when the performance obligation to which the royalty has been allocated has been satisfied. If it is determined that multiple performance obligations exist, the transaction price is allocated at the inception of the agreement to all identified performance obligations based on the relative standalone selling prices (SSP), unless the consideration is variable and meets the criteria to be allocated entirely to one or more, but not all, performance obligations in the contract. The relative SSP for each deliverable is estimated using objective evidence if it is available. If SSP is not directly observable the Company estimates the SSP at an amount that would result in the allocation of the transaction price in an amount that depicts the amount of consideration to which the entity expects to be entitled in exchange for transferring the promised goods or services to the customer, using methods such as the expected cost plus margin approach. Once the transaction price has been allocated to a performance obligation using the applicable methodology, it is not subject to reassessment for subsequent changes in standalone selling prices. Collaboration revenue is recognized when, or as, the Company satisfies a performance obligation. The Company recognizes revenue over time by measuring the progress toward complete satisfaction of the relevant performance obligation using an appropriate input method based on the nature of the good or service promised to the customer. After contract inception, the transaction price is reassessed at every period end and updated for changes such as resolution of uncertain events. Management may be required to exercise considerable judgment in estimating revenue to be recognized. Judgment is required in identifying performance obligations, estimating the transaction price, including variable consideration, estimating the standalone selling prices of identified performance obligations, and applying the input method for revenue recognition, including the estimated budgets for each performance obligation. Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in the Company’s condensed balance sheets. If the related performance obligation is expected to be satisfied within the next twelve months this will be classified in current liabilities. Amounts recognized as revenue prior to receipt are recorded as contract assets in the Company’s condensed balance sheets. If the Company expects to have an unconditional right to receive consideration in the next twelve months, this will be classified in current assets. A net contract asset or liability is presented for each contract with a customer. Contract modifications occur when the price and /or scope of an arrangement changes. If the modification consists of adding new distinct goods or services in exchange for consideration that reflects standalone selling prices of these goods and services, the modification is accounted for as a separate contract with the customer. Otherwise, if the remaining goods and services are distinct from those previously provided, the existing contract is considered terminated, and the remaining consideration is allocated to the remaining goods and services as if this was a newly signed contract. If the remaining goods and services are not distinct from those previously provided, the effects of the modification are accounted for in a manner similar to the effect of a change in the estimated measure of progress, with cumulative catch-up in revenue recorded at the time of the modification. If some of the remaining goods and services are distinct from those previously provided and others are not, the Company applies principles consistent with the objectives of the modification guidance to account for the effects of the modification. Collaborative Arrangements The Company analyzes its agreements to assess 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 and therefore within the scope of ASC Topic 808, Collaborative Arrangements (Topic 808). These assessments are performed throughout the life of the arrangements based on changes in the responsibilities of all parties in the arrangement. Research and Development Expenses The Company expenses research and development costs as they are incurred. Research and development expenses consist primarily of: (i) personnel-related expenses, including salaries, benefits and stock-based compensation expense, for personnel in the Company’s research and development functions; (ii) fees paid to third parties such as contractors, consultants and contract research organizations (CROs) for conducting clinical trials, and other costs related to clinical and preclinical testing; (iii) costs related to acquiring and manufacturing research and clinical trial materials, including under agreements with third parties such as contract manufacturing organizations (CMOs), and other vendors; (iv) costs related to the preparation of regulatory submissions; (v) expenses related to laboratory supplies and services; (vi) fees under license agreements where no alternative future use exists; and (vii) depreciation of equipment and facilities expenses. Accrued Research and Development Expenses The Company records accruals for estimated costs of research, preclinical studies, clinical trials, and manufacturing, which are significant components of research and development expenses. A substantial portion of the Company’s ongoing research and development activities is conducted by third-party service providers, CROs and CMOs. The Company’s contracts with CROs generally include pass-through fees such as laboratory supplies and services, regulatory expenses, investigator fees, travel costs and other miscellaneous costs, including shipping and printing fees. The Company’s contracts with the CMOs generally include fees such as initiation fees, reservation fees, verification run costs, materials and reagents expenses, taxes, etc. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The Company accrues the costs incurred under agreements with these third parties based on estimates of actual work completed in accordance with the respective agreements. The Company determines the estimated costs through discussions with internal personnel and external service providers as to the progress, or stage of completion or actual timeline (start-date and end-date) of the services and the agreed-upon fees to be paid for such services. In the event the Company makes advance payments, the payments are recorded as a prepaid expense and recognized as the services are performed. As actual costs become known, the Company adjusts its accruals. Although the Company does not expect its estimates to be materially different from amounts actually incurred, such estimates for the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in the Company reporting amounts that are too high or too low in any particular period. The Company’s accrual is dependent, in part, upon the receipt of timely and accurate reporting from CROs and other third-party vendors. Variations in the assumptions used to estimate accruals including, but not limited to, the number of patients enrolled, the rate of patient enrollment and the actual services performed, may vary from the Company’s estimates, resulting in adjustments to clinical trial expenses in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect its financial condition and results of operations. Through September 30, 2024 , there have been no material differences from the Company’s estimated accrued research and development expenses to actual expenses. Acquired In-Process Research and Development Expenses The Company has entered into agreements (see Note 5 – License Agreements) with third parties to acquire the rights to develop and potentially commercialize certain products. Such agreements generally require an initial payment by the Company when the contract is executed. The purchase of license rights for use in research and development activities, including product development, are expensed as incurred and are classified as research and development expense. Additionally, the Company may be obligated to make future royalty payments in the event the Company commercializes the technology and achieves a certain sales volume. In accordance with ASC Topic 730, Research and Development (Topic 730), expenditures for research and development, including upfront licensing fees and milestone payments associated with products not yet been approved by the FDA, are charged to research and development expense as incurred. Future contract milestone and/or royalty payments will be recognized as expense after the achievement of the milestone and the corresponding milestone payment is legally due. Stock-Based Compensation The Company accounts for stock-based compensation by measuring and recognizing compensation expense for all share-based awards made to employees, non-employees and directors based on estimated grant-date fair values. The Company uses the straight-line method to allocate compensation cost to reporting periods over the requisite service period, which is generally the vesting period. The grant date fair value of restricted stock units is estimated based on the closing stock price of the Company’s common stock on the date of grant. The grant date fair value of stock options granted to employees and directors is estimated using the Black-Scholes option-pricing model. The Company accounts for forfeitures as they occur. The Company accounts for any changes in the terms or conditions of an award as a modification in accordance with ASC 718, Compensation - Stock Compensation (Topic 718). In calculating the incremental compensation cost of a modification, the fair value of the modified award is compared to the fair value of the original award measured immediately before its terms or conditions were modified. The fair value of each purchase right under the employee stock purchase plan (ESPP) is estimated at the beginning of the offering period using the Black-Scholes option pricing model and recorded as expense over the service period using the straight-line method . Income Taxes The Company accounts for income taxes using the liability method, whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance when it is more likely than not that some portion, or all of the Company’s deferred tax assets will not be realized. The Company accounts for income tax contingencies using a benefit recognition model. If it considers that a tax position is more likely than not to be sustained upon audit, based solely on the technical merits of the position, it recognizes the benefit. The Company measures the benefit by determining the amount that is greater than 50% likely of being realized upon settlement, presuming that the tax position is examined by the appropriate taxing authority that has full knowledge of all relevant information. The Company is subject to taxation in the United States federal jurisdiction, and various state jurisdictions. The net operating loss and research and development credit carryforwards that are available for utilization in future years may be subject to examination by federal and state tax authorities. The Company’s policy is to recognize interest expense and penalties related to income tax matters as a component of income tax expense. As of September 30, 2024 , there were no significant accruals for interest related to unrecognized tax benefits or tax penalties. Comprehensive Loss Comprehensive loss represents the net loss for the period and other comprehensive loss. Other comprehensive loss reflects certain gains and losses that are recorded as a component of stockholders’ equity and are not reflected in the condensed statements of operations. The Company’s other comprehensive loss consists of changes in unrealized gains and losses on available-for-sale securities. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock (including non-voting common stock and pre-funded warrants) outstanding during the period, without consideration for all other common stock equivalents. Shares of common stock into which the pre-funded warrants may be exercised are considered outstanding for the purposes of computing net loss per share because the shares may be issued for little or no consideration, are fully vested, and are exercisable after the original issuance date. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given the net loss for each period presente d. Recently Issued Accounting Pronouncements In October 2023, the FASB issued Accounting Sta |
Fair Value Measurement
Fair Value Measurement | 9 Months Ended |
Sep. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | Note 3. Fair Value Measurement The Company measures and reports certain financial instruments as assets and liabilities at fair value on a recurring basis. The following tables set forth the fair value of the Company’s financial assets, which consist of cash equivalents and marketable securities measured and recognized at fair value (in thousands): September 30, 2024 Fair Value Amortized Gross Gross Fair Value Cash equivalents: Money market funds Level 1 $ 27,018 $ — $ — $ 27,018 U.S. government agency securities Level 2 1,984 — — 1,984 Commercial paper Level 2 10,467 — ( 1 ) 10,466 Marketable securities: U.S. treasury securities Level 1 114,445 249 ( 2 ) 114,692 Corporate bonds Level 2 20,367 83 — 20,450 Commercial paper Level 2 19,866 18 — 19,884 U.S. government agency securities Level 2 20,812 74 — 20,886 Total $ 214,959 $ 424 $ ( 3 ) $ 215,380 December 31, 2023 Fair Value Amortized Gross Gross Fair Value Cash equivalents: Money market funds Level 1 $ 21,458 $ — $ — $ 21,458 U.S. treasury securities Level 1 25,896 2 — 25,898 Commercial paper Level 2 54,427 — ( 27 ) 54,400 U.S. government agency securities Level 2 4,951 1 — 4,952 Marketable securities: U.S. treasury securities Level 1 182,289 214 ( 14 ) 182,489 Corporate bonds Level 2 13,986 — ( 8 ) 13,978 Commercial paper Level 2 20,216 — ( 17 ) 20,199 U.S. government agency securities Level 2 8,491 11 ( 11 ) 8,491 Total $ 331,714 $ 228 $ ( 77 ) $ 331,865 The Company evaluates transfers between levels at the end of each reporting period. There were no transfers between Levels 1, 2 and 3 during the three and nine months ended September 30, 2024 and 2023. As of September 30, 2024 and December 31, 2023 , there were no financial instruments classified as Level 3. The following table summarizes the available-for-sale securities in an unrealized loss position for which an allowance for credit losses has not been recorded as of September 30, 2024 and December 31, 2023, aggregated by major security type and length of time in a continuous unrealized loss position: September 30, 2024 Less than 12 months Greater than 12 months Total Fair Value Unrealized Losses Fair Value Unrealized Losses Fair Value Unrealized Losses U.S. treasury securities $ 8,937 $ ( 2 ) $ — $ — $ 8,937 $ ( 2 ) Commercial paper 9,987 ( 1 ) — — 9,987 ( 1 ) Total $ 18,924 $ ( 3 ) $ — $ — $ 18,924 $ ( 3 ) December 31, 2023 Less than 12 months Greater than 12 months Total Fair Value Unrealized Losses Fair Value Unrealized Losses Fair Value Unrealized Losses U.S. treasury securities $ 28,137 $ ( 14 ) $ — $ — $ 28,137 $ ( 14 ) Corporate bonds 13,978 ( 8 ) — — 13,978 ( 8 ) Commercial paper 74,599 ( 44 ) — — 74,599 ( 44 ) U.S. government agency securities 4,771 ( 11 ) — — 4,771 ( 11 ) Total $ 121,485 $ ( 77 ) $ — $ — $ 121,485 $ ( 77 ) As of September 30, 2024 and December 31, 2023, the Company held 10 and 35 debt securities, respectively, with an unrealized loss position. The Company evaluated its securities for credit losses and considered the decline in market value to be primarily attributable to current economic and market conditions and not to a credit loss or other factors. Additionally, the Company does not intend to sell the securities in an unrealized loss position and does not expect it will be required to sell the securities before recovery of the unamortized cost basis. As of September 30, 2024 and December 31, 2023, an allowance for credit losses has not been recognized. Given the Company's intent and ability to hold such securities until recovery, and the lack of significant change in credit risk of these investments, it does not consider these marketable securities impaired as of September 30, 2024 and December 31, 2023. There were no realized gains or losses on marketable securities for the three and nine months ended September 30, 2024 and 2023. Interest on marketable securities is included in interest income. As of September 30, 2024 and December 31, 2023, the Company had accrued interest receivable of $ 1.0 million and $ 0.8 million , respectively, which was included in prepaid expenses and other current assets on the condensed balance sheets. The following table summarizes the contractual maturities of the Company’s cash equivalents and marketable securities as of September 30, 2024 and December 31, 2023 at estimated fair value (in thousands): September 30, December 31, 2024 2023 Due in less than one year $ 200,588 $ 312,554 Due in more than one year 14,792 19,311 Total $ 215,380 $ 331,865 |
Accrued Liabilities
Accrued Liabilities | 9 Months Ended |
Sep. 30, 2024 | |
Balance Sheet Related Disclosures [Abstract] | |
Accrued Liabilities | Note 4. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): September 30, December 31, 2024 2023 Accrued research and development materials and services $ 16,703 $ 14,625 Accrued professional services 1,333 3,147 Accrued compensation 12,176 13,527 Other 859 245 Total accrued liabilities $ 31,071 $ 31,544 |
License Agreements
License Agreements | 9 Months Ended |
Sep. 30, 2024 | |
License Agreement [Abstract] | |
License Agreements | Note 5. License Agreements The Company enters into arrangements to in-license research and development technology rights with third parties relating to its clinical and pre-clinical programs and product candidates. These arrangements may include non-refundable, upfront payments, payments for options to acquire additional rights relating to its product candidates, as well as contingent obligations for potential development, regulatory and commercial performance milestone payments, and royalty payments. The Company’s obligation to make payments for contingent obligations is contingent upon the respective milestones being achieved as well as its continued involvement in the programs and/or the lack of any adverse events which could cause the discontinuance of the programs. The activities under these license agreements are performed with no guarantee of either technological or commercial success. The Company recorded no license fees and $ 0.6 million of license fees, for the three and nine months ended September 30, 2024, respectively, as research and development expense in our condensed statements of operations related to license agreements, and $ 1.2 million and $ 1.7 million , for the three and nine months ended September 30, 2023. As of September 30, 2024, the Company’s license agreements for technologies optioned by the Company, including the Medivir agreement described below, included potential future payments for development, regulatory, and sales milestones totaling approximately $ 361.9 million plus royalties on net sales that range from single digits to mid-teens. No milestones were achieved or deemed probable as of September 30, 2024. Medivir Agreement In January 2021, the Company entered into an exclusive license agreement with Medivir AB (Medivir) through which the Company received global, exclusive development and commercialization rights for birinapant, a clinical-stage Second Mitochondrial-derived Activator of Caspases (SMAC) mimetic. Under the terms of the agreement, the Company made an upfront payment of $ 1.0 million upon signing the agreement, and made an additional $ 1.5 million payment in November 2021 due to the Company's initiation of a Phase 1 clinical trial of aplitabart in combination with birinapant. Under the terms of the agreement, should birinapant be successfully developed and approved, the Company would be obligated to make additional milestone payments up to a total of approximately $ 348.5 million, plus tiered royalties from the mid-single digits up to mid-teens on net sales. No milestones were achieved or deemed probable as of September 30, 2024 . |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2024 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | Note 6. Stockholders' Equity Common Stock and Non-Voting Common Stock As of September 30, 2024 and December 31, 2023 , the Company’s certificate of incorporation authorized the Company to issue 1,200,000,00 shares of common stock (including 200,000,000 shares of non-voting common stock) and 200,000,000 shares of preferred stock, at a par value of $ 0.01 per share. Each share of common stock (excluding non-voting common stock) is entitled to one vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when declared by the Company’s Board of Directors, subject to prior rights of the preferred stockholders. As of September 30, 2024 and December 31, 2023 , no dividends have been declared. The Company had reserved common stock, on an as-converted basis, for future issuance as follows: September 30, December 31, 2024 2023 Stock options, issued and outstanding 5,663,644 6,766,340 Restricted stock units 2,358,515 658,792 Stock options and restricted stock units, future issuance 4,624,399 3,536,312 Employee stock purchase plan, available for future grants 1,821,195 1,376,988 Pre-funded warrants 1,334,332 1,334,332 Total 15,802,085 13,672,764 Pre-Funded Warrants In December 2020, the Company issued pre-funded warrants to purchase up to 1,334,332 shares of common stock in an underwritten public offering at the offering price of the common stock, less the $ 0.01 per share exercise price of each warrant and were issued to two separate related party affiliates. The pre-funded warrants were recorded as a component of stockholders’ equity within additional paid-in-capital and will expire on the date any such warrant is exercised in full. Subject to applicable law, upon exercise of a pre-funded warrant, a holder may elect to receive the same number of shares of non-voting common stock as the shares of common stock for which the pre-funded warrant is exercisable, provided that (i) at the time of such election there is a sufficient number of authorized but unissued and otherwise unreserved shares of non-voting common stock and (ii) the Company consents to such election. The outstanding pre-funded warrants to purchase shares of common stock are exercisable at any time after their original issuance. However, the Company may not affect the exercise of any pre-funded warrants, and a holder will not be entitled to exercise any portion of any pre-funded warrants that, upon giving effect to such exercise, would cause: (i) the aggregate number of shares of the Company’s common stock beneficially owned by such holder (together with its affiliates) to exceed 9.99 % of the number of shares of the Company’s common stock outstanding immediately after giving effect to the exercise; or (ii) the combined voting power of the Company’s securities beneficially owned by such holder (together with its affiliates) to exceed 9.99 % of the combined voting power of all of the Company’s securities outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the pre-funded warrants. However, any holder of a pre-funded warrant may increase or decrease such percentage to any other percentage not in excess of 19.99 % upon at least 61 days’ prior notice from the holder to the Company. As of September 30, 2024, no shares underlying the pre-funded warrants had been exercised. All of the outstanding pre-funded warrants are included in the weighted-average number of shares of common stock used to calculate basic net loss per share attributable to common stockholders (see Note 10 – Net Loss Per Share Attributable to Common Stockholders). |
Sanofi Agreement
Sanofi Agreement | 9 Months Ended |
Sep. 30, 2024 | |
Sanofi Agreement [Abstract] | |
Sanofi Agreement | Note 7. Sanofi Agreement In March 2022, the Company entered into a global collaboration and license agreement (the Sanofi Agreement) with Genzyme Corporation, a wholly owned subsidiary of Sanofi (Sanofi), which became effective in May 2022. Under the terms of the Sanofi Agreement, the Company agreed to generate, develop, manufacture and commercialize IgM antibodies directed to six primary targets, three of which were oncology targets and three of which were immunology targets. In April 2024, Sanofi exercised its right to terminate the oncology collaboration targets effective June 2024. As a result of this termination, the Company has no further obligations to conduct research and development activities for such terminated targets and Sanofi retains no substitution rights for such terminated targets, pursuant to the terms of the agreement, and the collaboration will now focus exclusively on the immunology collaboration targets. The termination of the oncology targets will not affect any rights and obligations under the Sanofi Agreement with respect to the immunology targets. For each immunology target collaboration program, the Company will continue to lead research and development activities, and assume related costs, through the completion of the first Phase 1 clinical trials for up to two candidates directed to each immunology target, after which Sanofi will be responsible for all future development and commercialization activities and related costs, in exchange for up to $ 1.065 billion in aggregate development, regulatory and commercial milestones per immunology target. Following the completion of the first Phase 1 clinical trials for each immunology target, Sanofi will be responsible for subsequent development activities, commercialization efforts, and related costs. The Company is eligible to receive tiered high single-digit to low-teen royalties on global net sales for licensed products related to immunology targets, subject to certain reductions and offsets. Subject to earlier expiration in certain circumstances, the Sanofi Agreement expires on a licensed product-by-licensed product and country-by-country basis until the expiration of the applicable profit and loss share term or royalty term, as the case may be. Sanofi has the right to terminate the Sanofi Agreement on a collaboration target-by-collaboration target basis or country-by-country basis with or without cause, upon specified prior notice. At the inception of the Sanofi Agreement, the Company identified promised goods and services, which consisted of the granting of intellectual property licenses and the performance of specified research, development and other various activities. The Company determined that for each of the six targets, the identified promised goods and services were not distinct from each other on a target-by-target basis. The licenses, considered to be functional intellectual property, were determined to not be capable of being distinct due to the specialized nature of the research, development, and other activities to be provided by the Company. Accordingly, the promised goods and services were combined together as one single performance obligation, on a target-by-target basis. The Company determined that the underlying promised goods and services for each of the six targets were both capable of being distinct and distinct within the context of the contract from each of the other targets. Therefore, the Company concluded that there were six performance obligations in the Sanofi Agreement, one for each target, that were comprised of the underlying promised goods and services. Other components and options within the Sanofi Agreement were determined to not provide Sanofi with free or discounted goods or services and therefore did not constitute a material right or were deemed immaterial in the context of the contract. To determine the transaction price, the Company evaluates all the payments to be received during the duration of the contract. In May 2022, the Company received a $ 150.0 million upfront payment as part of the Sanofi Agreement. Additionally, in April 2022, Sanofi purchased non-voting common stock in connection with the Company’s public common stock offering. The Company concluded that at inception and as of September 30, 2024 , the transaction price was $ 150.0 million and was comprised solely of the fixed non-refundable upfront payment. No consideration received from Sanofi as part of the April 2022 offering was deemed necessary to include in the transaction price as Sanofi purchased the shares at the same offering price as the other participating investors. The potential development and regulatory milestone payments that the Company is eligible to receive were excluded from the transaction price, as the milestone amounts were fully constrained, since the milestones relate to successful achievement of certain development results and regulatory approvals, which might not be achieved. The Company determined that the royalties and commercial milestone payments relate predominantly to the license of intellectual property and are therefore excluded from the transaction price under the sales- or usage-based royalty exception of ASC 606. The Company will reevaluate the transaction price, including all constrained amounts, at the end of each reporting period and as uncertain events are resolved or other changes in circumstances occur, and the Company will adjust its estimate of the transaction price as necessary. The Company will recognize the royalties and commercial milestone payments as revenue when the associated sales occur, and relevant sales-based thresholds are met. At the inception of the Sanofi Agreement, the Company allocated the transaction price based on the estimated SSP of each of the six performance obligations. The Company determined the SSP for each of the six performance obligations based on the estimated costs to complete the underlying activities of each performance obligation and included factors such as forecasted internal costs, estimated third-party expenditures, development timelines and scenarios, probability of target failures and selection of substitute targets, and program-specific factors. These estimated cost forecasts were based on observable data for both market and entity specific factors, such as considering the actual and expected costs of the Company’s existing research and development programs and adjusting for factors specific to the targets identified. The Company recognizes revenue using an input method of costs incurred as a percentage of total estimated costs for each of the performance obligations under the contract. Costs consist primarily of internal personnel costs and third-party contract expenses related to the programs of the Sanofi Agreement. The cumulative effect of revisions to estimated costs to complete the Company’s performance obligations is recorded in the period in which changes are identified and amounts can be reasonably estimated. The Company determined that Sanofi’s exercise of its right to terminate the oncology collaboration targets in April 2024 was a contract modification because it changed the scope of the contract by reducing the number of performance obligations under the agreement. The remaining performance obligations relating to the three immunology collaboration targets are not distinct from themselves before and after the contract modification occurred; however, they are distinct from the terminated oncology target performance obligations. As a result, the Company allocated the unrecognized transaction price to the three remaining performance obligations based on their relative estimated SSP and calculated a cumulative catch-up adjustment of $ 0.8 million, which was recognized as collaboration revenue during the three months ended June 30, 2024. The Company recognized collaboration revenue related to the Sanofi Agreement of $ 0.5 million and $ 2.3 million for the three and nine months ended September 30, 2024, respectively, and $ 0.5 million and $ 1.5 million for the three and nine months ended September 30, 2023. As of September 30, 2024 and December 31, 2023, $ 144.5 million and $ 146.8 million were recorded as deferred revenue related to the Sanofi Agreement, respectively, of which $ 2.7 million and $ 3.8 million , respectively, were classified as current, on the condensed balance sheets. The deferred revenue is expected to be recognized over the research and development period of the programs through the completion of Phase 1 clinical trials. Contract Balances from Customer Contract The timing of revenue recognition, billings and cash collections results in contract assets and contract liabilities on the condensed balance sheets. The Company recognizes license and development receivables based on billed services, which are settled upon reimbursement. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded. Contract liabilities are recognized as revenue after control of the goods or services is transferred to the customer and all revenue recognition criteria have been met. The following tables present changes in the Company’s customer contract liabilities for the periods presented (in thousands): Nine Months Ended September 30, 2024 December 31, 2023 Additions Deductions September 30, 2024 Contract liabilities: Deferred revenue $ 146,801 $ — $ ( 2,267 ) $ 144,534 Nine Months Ended September 30, 2023 December 31, 2022 Additions Deductions September 30, 2023 Contract liabilities: Deferred revenue $ 148,931 $ — $ ( 1,479 ) $ 147,452 The Company had no customer contract assets during the three and nine months ended September 30, 2024 and 2023 . |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Note 8. Stock-Based Compensation The 2018 Omnibus Incentive Plan (the 2018 Plan) provides for an increase in the number of shares reserved for issuance on the first day of each fiscal year equal to the least of (i) 8,768,800 shares, (ii) 4 % of the Company’s common stock and non-voting common stock outstanding at December 31 of the immediately preceding year, or (iii) such number of shares as determined by the Company’s Board of Directors. As a result of this provision, on January 1, 2024 and 2023, an additional 2,347,245 and 1,723,292 shares, respectively, became available for issuance under the 2018 Plan. As of September 30, 2024, the 2018 Plan had 4,624,399 shares of common stock available for future issuance. On June 20, 2024, the Company commenced a stock option exchange program (the Exchange Offer) pursuant to which eligible employees were provided the opportunity to exchange eligible stock options for restricted stock units (RSUs). The eligible options had exercise prices equal to or greater than $ 17.70 per share, were granted on or prior to March 1, 2023, and could be exchanged into a number of RSUs with an aggregate fair value substantially similar to the aggregate fair value of the options surrendered, subject to a 2-for-1 exchange ratio floor. The Exchange Offer concluded on July 19, 2024. In connection with the Exchange Offer, the Company canceled 1,583,305 eligible options and granted 657,427 replacement RSUs with no incremental compensation expense associated with those RSUs issued in exchange for options. The unamortized stock-compensation expense from the exchanged options will be amortized over the vesting period of the replacement RSUs. The RSUs vest 50 % on either the 1-year anniversary or 18-months after the exchange date and then quarterly thereafter over a total vesting period of two to three years , depending on the vesting status of the exchanged options, in each case subject to the continued service of the employees to the Company through the applicable vesting date. Stock Options The following table summarizes stock option activity: Shares Issuable Under Options Weighted- Weighted- Aggregate (in years) (in thousands) Outstanding as of December 31, 2023 6,766,340 $ 27.81 7.0 $ 6,823 Granted 1,552,298 $ 9.95 Exercised ( 315,993 ) $ 4.69 Forfeited / Canceled ( 2,339,001 ) $ 46.68 Outstanding as of September 30, 2024 5,663,644 $ 16.41 6.9 $ 4,062 Options exercisable as of September 30, 2024 3,159,121 $ 19.26 6.0 $ 4,042 Restricted Stock Units (RSUs) The following table summarizes restricted stock unit activity: Shares Weighted- Unvested restricted stock units as of December 31, 2023 658,792 $ 13.77 Granted 2,220,538 $ 10.12 Vested ( 348,397 ) $ 12.13 Forfeited ( 172,418 ) $ 10.96 Unvested restricted stock units as of September 30, 2024 2,358,515 $ 10.79 Stock-Based Compensation Expense Total stock-based compensation expense related to the Company’s equity incentive plan and employee stock purchase plan was recorded in the condensed statements of operations as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Research and development $ 5,792 $ 7,391 $ 14,961 $ 22,078 General and administrative 10,410 4,563 17,591 15,232 Total stock-based compensation expense (1) $ 16,202 $ 11,954 $ 32,552 $ 37,310 (1) The stock-based compensation expense for the three and nine months ended September 30, 2024 includes the modification of two former employees' equity awards. See Note 9 - Restructuring Charges for additional information . |
Restructuring Charges
Restructuring Charges | 9 Months Ended |
Sep. 30, 2024 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Charges | Note 9. Restructuring Charges In September 2024, the Company announced a strategic pivot to focus exclusively on autoimmunity. The Company also announced an extension of cash runway, driven by a reduction in workforce and a reduction in future spending on the research and development of aplitabart and other oncology candidates (the 2024 Restructuring). The 2024 Restructuring activities are expected to be substantially complete by June 30, 2025. In connection with the 2024 Restructuring, the Company recognized restructuring charges of $ 14.0 million during the three months ended September 30, 2024. The restructuring charges included severance and one-time termination payments of $ 5.5 million, non-cash incentive and stock-based compensation e xpense of $ 8.2 million, and contract termination and other costs of $ 0.3 million. The incentive and stock-based compensation charges of $ 8.2 million, partially consisted of $ 9.4 million in stock-based compensation expense resulting from the modification of two former employees' equity awards. As part of the 2024 Restructuring, the Company's Chief Executive Officer (CEO) and Chief Scientific Officer (CSO) resigned and entered into Transition and Consulting Agreements (TC Agreements) to provide consulting services through September 2026 and March 2026, respectively. Pursuant to the original terms of the awards, the CEO and CSO will continue to vest in their outstanding awards through the termination dates of the consulting agreements, subject to certain terms and conditions. In accordance with ASC 718, the Company recognized expense related to all awards expected to vest over the duration of the TC Agreements immediately as an equity-based severance cost as the consulting services are not considered substantive. Additionally, the CEO and CSO will receive cash payments of approximately $ 0.8 million and $ 0.5 million, respectively, under the TC Agreements, which were recognized as severance and one-time termination expenses upon approval of the agreements. The stock-based compensation expense was offset by a $ 1.2 million reversal of previously recognized non-cash incentive compensation expense. The Company recorded these restructuring charges based on each former employee’s classification within the research and development and general and administrative operating expense categories on its condensed statement of operations. In December 2023, the Company announced a strategic pipeline prioritization. The Company also announced an extension of cash runway, driven by a reduction in workforce of approximately 22 % and a suspension of clinical development activities for certain product candidates in specific indications (2023 Restructuring), and recognized $ 1.8 million in restructuring charges during the year ended December 31, 2023. Headcount and all severance and one-time termination payments of $ 2.4 million were completed by March 31, 2024. In connection with the 2024 Restructuring and 2023 Restructuring, the Company recognized restructuring charges of $ 14.1 million during the nine months ended September 30, 2024. The following table summarizes the changes in the Company's accrued restructuring balance related to the 2024 Restructuring and 2023 Restructuring in the condensed balance sheets (in thousands): Beginning Balance Charges Payments Ending Balance Accrued severance $ 2,397 $ 5,539 $ ( 2,397 ) $ 5,539 Accrued contract termination costs — 300 ( 107 ) 193 Total accrued restructuring liability $ 2,397 $ 5,839 $ ( 2,504 ) $ 5,732 As of September 30, 2024 and December 31, 2023, $ 5.2 million and $ 2.4 million of the restructuring liability, respectively, was classified as current within accrued liabilities and $ 0.5 million of the restructuring liability as of September 30, 2024 was classified as non-current within other liabilities on the condensed balance sheets. There was no non-current restructuring liability as of December 31, 2023. A summary of the charges related to the restructuring activities is as follows (in thousands): Three Months Ended September 30, 2024 Severance and Related Compensation Incentive and Stock-Based Compensation Contract Termination and Other Costs Total Restructuring Costs Research and development $ 3,696 $ 1,619 $ 193 $ 5,508 General and administrative 1,842 6,534 106 8,482 Total $ 5,538 $ 8,153 $ 299 $ 13,990 Nine Months Ended September 30, 2024 Severance and Related Compensation Incentive and Stock-Based Compensation Contract Termination and Other Costs Total Restructuring Costs Research and development $ 3,699 $ 1,601 $ 373 $ 5,673 General and administrative 1,843 6,534 106 8,483 Total $ 5,542 $ 8,135 $ 479 $ 14,156 |
Net Loss Per Share Attributable
Net Loss Per Share Attributable to Common Stockholders | 9 Months Ended |
Sep. 30, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share Attributable to Common Stockholders | Note 10. Net Loss Per Share Attributable to Common Stockholders Basic and diluted net loss per share is computed by dividing net loss by the weighted-average number of common stock and pre-funded warrants outstanding for the period. Shares of common stock into which the pre-funded warrants may be exercised are considered outstanding for the purposes of computing net loss per share because the shares may be issued for little or no consideration, are fully vested, and are exercisable after the original issuance date. For periods in which the Company generated a net loss, the Company does not include the potential impact of dilutive securities in diluted net loss per share, as the impact of these items is anti-dilutive. The following equity instruments were excluded from the calculation of diluted net loss per share because their effect would have been anti-dilutive for the periods presented: September 30, 2024 2023 Stock options 5,663,644 7,296,153 Estimated shares issuable under the employee stock purchase plan 78,986 51,620 Unvested restricted stock units 2,358,515 958,426 Total 8,101,145 8,306,199 |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2024 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 11. Related Party Transaction In August 2024, a non-employee member of the Company’s Board of Directors entered into a consulting agreement with the Company, under which the board member would receive $ 250,000 per year for consulting services and receive 125,000 shares of RSUs with quarterly vesting through April 30, 2026 . The Company paid $ 0.1 million during the three and nine months ended September 30, 2024 to the board member under the consulting agreement. As of September 30, 2024, the Company had no outstanding liability to the related party. In September 2024 as part of the 2024 Restructuring, the Company entered into TC Agreements with two former employees (See Note 9 - Restructuring Charges for additional information). The Company did not make any payments under the TC Agreements during the three and nine months ended September 30, 2024. As of September 30, 2024, the Company had an outstanding liability of $ 1.3 million to the related parties. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2024 | |
Accounting Policies [Abstract] | |
Description of the Business | Description of the Business IGM Biosciences, Inc. (the Company) was incorporated in the state of Delaware in August 1993 under the name Palingen, Inc. and the name was subsequently changed to IGM Biosciences, Inc. in 2010. The Company’s headquarters are in Mountain View, California. IGM Biosciences, Inc. is a clinical-stage biotechnology company engaged in the development of IgM antibody therapeutics for the treatment of autoimmune and inflammatory diseases. |
Merger | Prior to September 30, 2024, the Company consolidated two wholly owned subsidiaries. To simplify the corporate structure, the Company’s board of directors approved the merger (Merger) of the subsidiaries with and into the Company, with the Company being the surviving corporation, effective August 30, 2024. Because the Merger was a reorganization of entities under common control, the net assets were transferred from its subsidiaries at historical carrying value and the effects of the transaction were applied retrospectively as if the Merger had occurred at the earliest date presented in the Company’s financial statements in accordance with Accounting Standard Codification (ASC) Topic 250, Accounting changes and error corrections (Topic 250). The Merger did not have an impact on the financial statements as the Company's financials have historically been presented on a consolidated basis. |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP), as defined by the Financial Accounting Standards Board (FASB), and applicable rules and regulations of the Securities and Exchange Commission (SEC) regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted, and accordingly the balance sheet as of December 31, 2023 has been derived from the audited financial statements at that date but does not include all of the information required by GAAP for complete financial statements. These unaudited interim condensed financial statements are derived from the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments which are necessary for a fair statement of the Company’s financial information. The interim results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or for any other interim period or for any other future year. The accompanying interim unaudited condensed financial statements should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 7, 2024 . |
Liquidity | Liquidity The Company has incurred net operating losses and negative cash flows from operations since its inception and had an accumulated deficit of $ 980.4 million as of September 30, 2024. As of September 30, 2024, the Company had cash, cash equivalents, and marketable securities of $ 218.8 million . Management believes that the existing financial resources are sufficient to continue operating activities at least one year past the issuance date of these condensed financial statements. The Company has historically financed its operations primarily through the sale of common stock and pre-funded warrants in its public offerings and private placement, the sale of convertible preferred stock and issuance of unsecured promissory notes in private placements, and funding received from our collaboration partners. To date, none of the Company’s product candidates have been approved for sale, and the Company has not generated any product revenue since inception. Management expects operating losses to continue and increase for the foreseeable future, as the Company progresses its planned research and development activities for its product candidates. The Company’s prospects are subject to risks, expenses and uncertainties frequently encountered by companies in the biotechnology industry as discussed below. While the Company has been able to raise multiple rounds of financing, there can be no assurance that in the event the Company requires additional financing, such financing will be available on terms which are favorable or at all. Failure to raise sufficient capital when needed or generate sufficient cash flow from operations would impact the ability to pursue business strategies and could require the Company to delay, scale back or discontinue one or more product development programs, or other aspects of the Company's business objectives. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements and accompanying notes. Such management estimates include, but are not limited to, those related to revenue recognition, marketable securities, manufacturing accruals, accrued research and development expenses, stock-based compensation, operating lease right-of-use (ROU) assets and liabilities, income tax uncertainties and the valuation of deferred tax assets. The Company bases its estimates on its historical experience and also on assumptions that it believes are reasonable; however, actual results could significantly differ from those estimates. The most significant estimates and assumptions that management considers in the preparation of our financial statements relate to revenue recognition, accrued research and development costs, and leases. |
Segments | Segments The Company operates and manages its business as one reportable and operating segment, which is the business of developing engineered IgM antibodies for the treatment of autoimmune and inflammatory diseases. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for allocating and evaluating financial performance. All long-lived assets are maintained in, and all losses are attributable to, the United States of America. |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to a concentration of credit risk consist primarily of cash, cash equivalents, and marketable securities. The Company invests in money market funds, U.S. treasury securities, corporate bonds, commercial paper, and U.S. government agency securities. The Company maintains bank deposits in federally insured financial institutions and these deposits may exceed federally insured limits. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents, and restricted cash, and bond issuers to the extent recorded on the balance sheets. The Company’s investment policy limits investments to high credit quality securities issued by the U.S. government and its agencies, highly rated banks, and corporate issuers, subject to certain concentration limits and restrictions on maturities. The Company has not experienced any material losses on its deposits of cash, cash equivalents, and marketable securities. The Company’s future results of operations involve a number of other risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, the Company’s early stages of clinical drug development; uncertainties related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; the Company’s ability to advance product candidates into, and successfully complete, clinical trials on the timelines it projects; the Company’s ability to adequately demonstrate sufficient safety and efficacy of its product candidates; the Company’s ability to enroll patients in its ongoing and future clinical trials; the Company’s ability to successfully manufacture and supply its product candidates for clinical trials; the occurrence of any event or circumstance that could give rise to the termination of the Company’s collaborations with third parties; the Company’s ability to obtain additional capital to finance its operations; uncertainties related to the projections of the size of patient populations suffering from the diseases the Company is targeting; the Company’s ability to obtain, maintain, and protect its intellectual property rights; developments relating to the Company’s competitors and its industry, including competing product candidates and therapies; general economic and market conditions; and other risks and uncertainties, including those more fully described in the “Risk Factors” section of this Quarterly Report on Form 10-Q. The Company’s product candidates will require approvals from the U.S. Food and Drug Administration (FDA) and comparable foreign regulatory agencies prior to commercial sales in their respective jurisdictions. There can be no assurance that any product candidates will receive the necessary approvals. If the Company was denied approval, approval was delayed or the Company was unable to maintain approval for any product candidate, it could have a materially adverse impact on the Company. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be cash and cash equivalents. Cash equivalents consist primarily of amounts invested in money market funds, commercial paper, U.S. treasury securities, and U.S. government agency securities and are stated at fair value. Restricted cash consists of the remaining unused portion of a grant received from a non-profit organization which the Company will continue to utilize as it incurs expenses for services performed under the grant agreement. |
Marketable Securities | Marketable Securities The Company’s marketable securities have been classified and accounted for as available-for-sale securities. Fixed income securities consist of U.S. treasury securities, U.S. government agency securities, corporate bonds, and commercial paper. The specific identification method is used to determine the cost basis of fixed income securities sold. These securities are recorded on the condensed balance sheets at fair value. Unrealized gains and losses on these securities are included as a separate component of accumulated other comprehensive loss. The cost of marketable securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in other income (expense). All available-for-sale securities are considered available to support current operations and are classified as current assets. The Company presents any credit losses identified as an allowance rather than as a reduction in the amortized cost of the available-for-sale securities. For available-for-sale debt securities in an unrealized loss position, the Company first assesses whether it intends to sell, or it is more likely than not that it will be required to sell the security before recovery of its amortized cost basis. If either of the criteria regarding intent or requirement to sell is met, the security’s amortized cost basis is written down to fair value and recognized in other income (expense) in the condensed statements of operations. If neither criteria is met, the Company evaluates whether the decline in fair value is related to credit-related factors or other factors. In making this assessment, management considers the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and adverse conditions specifically related to the security, among other factors. Credit-related impairment losses, limited by the amount that the fair value is less than the amortized cost basis, are recorded through an allowance for credit losses in other income (expense). Any unrealized losses from declines in fair value below the amortized cost basis as a result of non-credit factors are recognized in accumulated other comprehensive income (loss), net of tax as a separate component of stockholders’ equity, along with unrealized gains. Realized gains and losses and declines in fair value, if any, on available-for-sale securities are included in other income (expense) in the condensed statements of operations. For purposes of identifying and measuring credit-related impairments, the Company’s policy is to exclude applicable accrued interest from both the fair value and amortized cost basis of the related security. The Company has elected to write-off uncollectible accrued interest receivable balances in a timely manner, which is defined by the Company as when interest due becomes 90 days delinquent. The accrued interest write-off will be recorded by reversing interest income. Accrued interest receivable is recorded to prepaid expenses and other current assets on the condensed balance sheets. |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is determined using the straight-line method over the estimated useful lives of the respective assets, generally three to five years . Leasehold improvements are depreciated using the straight-line method over the shorter of the lease term or the estimated useful economic lives of the related assets. Assets are held in construction in progress until placed in service, upon which date, we begin to depreciate these assets. Upon retirement or sale of the assets, the cost and related accumulated depreciation and amortization are removed from the condensed balance sheets and the resulting gain or loss are recorded to the condensed statements of operations. Repairs and maintenance are charged to the condensed statements of operations as incurred. |
Leases | Leases The Company determines if an arrangement is a lease at inception. In addition, the Company determines whether leases meet the classification criteria of a finance or operating lease at the lease commencement date considering: (1) whether the lease transfers ownership of the underlying asset to the lessee at the end of the lease term, (2) whether the lease grants the lessee an option to purchase the underlying asset that the lessee is reasonably certain to exercise, (3) whether the lease term is for a major part of the remaining economic life of the underlying asset, (4) whether the present value of the sum of the lease payments and residual value guaranteed by the lessee equals or exceeds substantially all of the fair value of the underlying asset, and (5) whether the underlying asset is of such a specialized nature that it is expected to have no alternative use to the lessor at the end of the lease term. As of September 30, 2024, the Company's lease population consisted of real estate leases and the Company did not have finance leases. Operating leases are included in operating lease ROU assets and lease liabilities in the Company’s condensed balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the present value of lease payments, the Company uses its incremental borrowing rate based on the information available at the lease commencement date if the rate implicit in the lease is not readily determinable. The Company determines the incremental borrowing rate based on an analysis of corporate bond yields with a credit rating similar to the Company. The determination of the Company’s incremental borrowing rate requires management judgment including the development of a synthetic credit rating and cost of debt as the Company currently does not carry any debt. The Company believes that the estimates used in determining the incremental borrowing rate are reasonable based upon current facts and circumstances. Applying different judgments to the same facts and circumstances could result in the estimated amounts to vary. The operating lease ROU assets also include adjustments for prepayments and accrued lease payments and exclude lease incentives. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise such options. Operating lease cost is recognized on a straight-line basis over the expected lease term. Variable lease costs represent payments that are dependent on usage, a rate or index. Variable lease cost primarily relates to common area maintenance charges. Lease agreements that include lease and non-lease components are accounted for as a single lease component. Lease agreements with a noncancelable term of less than 12 months are not recorded on the Company’s condensed balance sheets. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company evaluates the carrying amount of its long-lived assets, such as property and equipment, whenever events or changes in circumstances indicate that the assets may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition are less than the carrying amount of the asset. There were no impairments of long-lived assets for the three and nine months ended September 30, 2024 and 2023 . |
Fair Value Measurement | Fair Value Measurement The Company applies fair value accounting for all financial assets and liabilities and non-financial assets and liabilities that are recognized or disclosed at fair value in the condensed financial statements on a recurring basis. Fair value is an 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 such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1—Observable inputs, such as quoted prices in active markets for identical assets or liabilities at the measurement date. Level 2—Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3—Unobservable inputs which reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value. Financial instruments classified within Level 2 of the fair value hierarchy are valued based on other observable inputs, including broker or dealer quotations or alternative pricing sources. When quoted prices in active markets for identical assets or liabilities are not available, the Company relies on non-binding quotes from its investment managers, which are based on proprietary valuation models of independent pricing services. These models generally use inputs such as observable market data, quoted market prices for similar instruments, or historical pricing trends of a security relative to its peers. |
Revenue Recognition | Revenue Recognition For arrangements or transactions between participants determined to be within the scope of ASC Topic 606, Revenue from Contracts with Customers (Topic 606) the Company performs the following steps to determine the appropriate amount of revenue to be recognized as the Company fulfills its obligations: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (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 has entered into and may enter into additional collaboration agreements in the future under which it may obtain upfront payments, milestone payments, royalty payments, profit sharing, and other fees. Promises under these arrangements may include intellectual property licenses, research and development services, and the participation in joint committees. At contract inception, the Company assesses the goods or services promised and enforceable in a contract with a customer and identifies those distinct goods and services that represent a performance obligation. In assessing whether a promised good or service is distinct, and therefore a performance obligation, the Company considers factors such as the nature of the research, stage of development of the targets, manufacturing and commercialization capabilities of the customer and the availability of the associated expertise in the general marketplace. The Company also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract. If a promised good or service is not distinct, the Company combines that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct. Promised goods and services that are not material in the context of the contract are not considered performance obligations. Additional goods or services that are exercisable at a customer’s discretion, including substitution rights, are assessed to determine if they provide a material right to the customer and if so, they are considered performance obligations. The transaction price is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods or services to a customer. The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Non-refundable upfront payments are considered fixed consideration and included in the transaction price. If an arrangement includes development, regulatory or commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. The Company includes the amount of estimated variable consideration, including milestones, in the transaction price to the extent that it is probable that a significant reversal of cumulative revenue recognized will not occur. Milestone payments that are not within the Company’s control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. For arrangements with licenses of intellectual property that include sales-based royalties, including milestone payments based on the level of sales, and if the license is deemed to be the predominant item to which the royalties relate, the Company recognizes royalty revenue and sales-based milestones at the later of (i) when the related sales occur, or (ii) when the performance obligation to which the royalty has been allocated has been satisfied. If it is determined that multiple performance obligations exist, the transaction price is allocated at the inception of the agreement to all identified performance obligations based on the relative standalone selling prices (SSP), unless the consideration is variable and meets the criteria to be allocated entirely to one or more, but not all, performance obligations in the contract. The relative SSP for each deliverable is estimated using objective evidence if it is available. If SSP is not directly observable the Company estimates the SSP at an amount that would result in the allocation of the transaction price in an amount that depicts the amount of consideration to which the entity expects to be entitled in exchange for transferring the promised goods or services to the customer, using methods such as the expected cost plus margin approach. Once the transaction price has been allocated to a performance obligation using the applicable methodology, it is not subject to reassessment for subsequent changes in standalone selling prices. Collaboration revenue is recognized when, or as, the Company satisfies a performance obligation. The Company recognizes revenue over time by measuring the progress toward complete satisfaction of the relevant performance obligation using an appropriate input method based on the nature of the good or service promised to the customer. After contract inception, the transaction price is reassessed at every period end and updated for changes such as resolution of uncertain events. Management may be required to exercise considerable judgment in estimating revenue to be recognized. Judgment is required in identifying performance obligations, estimating the transaction price, including variable consideration, estimating the standalone selling prices of identified performance obligations, and applying the input method for revenue recognition, including the estimated budgets for each performance obligation. Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in the Company’s condensed balance sheets. If the related performance obligation is expected to be satisfied within the next twelve months this will be classified in current liabilities. Amounts recognized as revenue prior to receipt are recorded as contract assets in the Company’s condensed balance sheets. If the Company expects to have an unconditional right to receive consideration in the next twelve months, this will be classified in current assets. A net contract asset or liability is presented for each contract with a customer. Contract modifications occur when the price and /or scope of an arrangement changes. If the modification consists of adding new distinct goods or services in exchange for consideration that reflects standalone selling prices of these goods and services, the modification is accounted for as a separate contract with the customer. Otherwise, if the remaining goods and services are distinct from those previously provided, the existing contract is considered terminated, and the remaining consideration is allocated to the remaining goods and services as if this was a newly signed contract. If the remaining goods and services are not distinct from those previously provided, the effects of the modification are accounted for in a manner similar to the effect of a change in the estimated measure of progress, with cumulative catch-up in revenue recorded at the time of the modification. If some of the remaining goods and services are distinct from those previously provided and others are not, the Company applies principles consistent with the objectives of the modification guidance to account for the effects of the modification. |
Collaborative Arrangements | Collaborative Arrangements The Company analyzes its agreements to assess 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 and therefore within the scope of ASC Topic 808, Collaborative Arrangements (Topic 808). These assessments are performed throughout the life of the arrangements based on changes in the responsibilities of all parties in the arrangement. |
Research and Development Expenses | Research and Development Expenses The Company expenses research and development costs as they are incurred. Research and development expenses consist primarily of: (i) personnel-related expenses, including salaries, benefits and stock-based compensation expense, for personnel in the Company’s research and development functions; (ii) fees paid to third parties such as contractors, consultants and contract research organizations (CROs) for conducting clinical trials, and other costs related to clinical and preclinical testing; (iii) costs related to acquiring and manufacturing research and clinical trial materials, including under agreements with third parties such as contract manufacturing organizations (CMOs), and other vendors; (iv) costs related to the preparation of regulatory submissions; (v) expenses related to laboratory supplies and services; (vi) fees under license agreements where no alternative future use exists; and (vii) depreciation of equipment and facilities expenses. |
Accrued Research and Development Expenses | Accrued Research and Development Expenses The Company records accruals for estimated costs of research, preclinical studies, clinical trials, and manufacturing, which are significant components of research and development expenses. A substantial portion of the Company’s ongoing research and development activities is conducted by third-party service providers, CROs and CMOs. The Company’s contracts with CROs generally include pass-through fees such as laboratory supplies and services, regulatory expenses, investigator fees, travel costs and other miscellaneous costs, including shipping and printing fees. The Company’s contracts with the CMOs generally include fees such as initiation fees, reservation fees, verification run costs, materials and reagents expenses, taxes, etc. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The Company accrues the costs incurred under agreements with these third parties based on estimates of actual work completed in accordance with the respective agreements. The Company determines the estimated costs through discussions with internal personnel and external service providers as to the progress, or stage of completion or actual timeline (start-date and end-date) of the services and the agreed-upon fees to be paid for such services. In the event the Company makes advance payments, the payments are recorded as a prepaid expense and recognized as the services are performed. As actual costs become known, the Company adjusts its accruals. Although the Company does not expect its estimates to be materially different from amounts actually incurred, such estimates for the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in the Company reporting amounts that are too high or too low in any particular period. The Company’s accrual is dependent, in part, upon the receipt of timely and accurate reporting from CROs and other third-party vendors. Variations in the assumptions used to estimate accruals including, but not limited to, the number of patients enrolled, the rate of patient enrollment and the actual services performed, may vary from the Company’s estimates, resulting in adjustments to clinical trial expenses in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect its financial condition and results of operations. Through September 30, 2024 , there have been no material differences from the Company’s estimated accrued research and development expenses to actual expenses. |
Acquired In-Process Research and Development Expenses | Acquired In-Process Research and Development Expenses The Company has entered into agreements (see Note 5 – License Agreements) with third parties to acquire the rights to develop and potentially commercialize certain products. Such agreements generally require an initial payment by the Company when the contract is executed. The purchase of license rights for use in research and development activities, including product development, are expensed as incurred and are classified as research and development expense. Additionally, the Company may be obligated to make future royalty payments in the event the Company commercializes the technology and achieves a certain sales volume. In accordance with ASC Topic 730, Research and Development (Topic 730), expenditures for research and development, including upfront licensing fees and milestone payments associated with products not yet been approved by the FDA, are charged to research and development expense as incurred. Future contract milestone and/or royalty payments will be recognized as expense after the achievement of the milestone and the corresponding milestone payment is legally due. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation by measuring and recognizing compensation expense for all share-based awards made to employees, non-employees and directors based on estimated grant-date fair values. The Company uses the straight-line method to allocate compensation cost to reporting periods over the requisite service period, which is generally the vesting period. The grant date fair value of restricted stock units is estimated based on the closing stock price of the Company’s common stock on the date of grant. The grant date fair value of stock options granted to employees and directors is estimated using the Black-Scholes option-pricing model. The Company accounts for forfeitures as they occur. The Company accounts for any changes in the terms or conditions of an award as a modification in accordance with ASC 718, Compensation - Stock Compensation (Topic 718). In calculating the incremental compensation cost of a modification, the fair value of the modified award is compared to the fair value of the original award measured immediately before its terms or conditions were modified. The fair value of each purchase right under the employee stock purchase plan (ESPP) is estimated at the beginning of the offering period using the Black-Scholes option pricing model and recorded as expense over the service period using the straight-line method . |
Income Taxes | Income Taxes The Company accounts for income taxes using the liability method, whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance when it is more likely than not that some portion, or all of the Company’s deferred tax assets will not be realized. The Company accounts for income tax contingencies using a benefit recognition model. If it considers that a tax position is more likely than not to be sustained upon audit, based solely on the technical merits of the position, it recognizes the benefit. The Company measures the benefit by determining the amount that is greater than 50% likely of being realized upon settlement, presuming that the tax position is examined by the appropriate taxing authority that has full knowledge of all relevant information. The Company is subject to taxation in the United States federal jurisdiction, and various state jurisdictions. The net operating loss and research and development credit carryforwards that are available for utilization in future years may be subject to examination by federal and state tax authorities. The Company’s policy is to recognize interest expense and penalties related to income tax matters as a component of income tax expense. As of September 30, 2024 , there were no significant accruals for interest related to unrecognized tax benefits or tax penalties. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss represents the net loss for the period and other comprehensive loss. Other comprehensive loss reflects certain gains and losses that are recorded as a component of stockholders’ equity and are not reflected in the condensed statements of operations. The Company’s other comprehensive loss consists of changes in unrealized gains and losses on available-for-sale securities. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock (including non-voting common stock and pre-funded warrants) outstanding during the period, without consideration for all other common stock equivalents. Shares of common stock into which the pre-funded warrants may be exercised are considered outstanding for the purposes of computing net loss per share because the shares may be issued for little or no consideration, are fully vested, and are exercisable after the original issuance date. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given the net loss for each period presente d. |
Recently Adopted Accounting Pronouncements | Recently Issued Accounting Pronouncements In October 2023, the FASB issued Accounting Standards Update (ASU) 2023-06, Disclosure Improvements - Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative , which will impact various disclosure areas. The amendments in ASU 2023-06 will be effective on the date the related disclosures are removed from Regulation S-X or Regulation S-K by the SEC, and will no longer be effective if the SEC has not removed the applicable disclosure requirement by June 30, 2027. The Company is currently evaluating the impacts of this standard on its related disclosures. In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280) , which improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. This ASU is effective for fiscal years beginning after December 15, 2023 and is applicable to public entities, including those that have a single reportable segment. Early adoption is permitted. The Company is currently evaluating the impacts of this standard on its condensed financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures , which amends the guidance in ASC 740, Income Taxes . The ASU is intended to improve the transparency of income tax disclosures by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. The ASU's amendments are effective for public business entities for annual periods beginning after December 15, 2024. Entities are permitted to early adopt the standard for annual financial statements that have not yet been issued or made available for issuance. Adoption is permitted either prospectively or retrospectively. The Company will adopt this ASU on a prospective basis. The Company is currently evaluating the impact of this standard but does not expect any material impacts on its condensed financial statements and related disclosures. |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Summary of Investments Measured and Recognized at Fair Value | The following tables set forth the fair value of the Company’s financial assets, which consist of cash equivalents and marketable securities measured and recognized at fair value (in thousands): September 30, 2024 Fair Value Amortized Gross Gross Fair Value Cash equivalents: Money market funds Level 1 $ 27,018 $ — $ — $ 27,018 U.S. government agency securities Level 2 1,984 — — 1,984 Commercial paper Level 2 10,467 — ( 1 ) 10,466 Marketable securities: U.S. treasury securities Level 1 114,445 249 ( 2 ) 114,692 Corporate bonds Level 2 20,367 83 — 20,450 Commercial paper Level 2 19,866 18 — 19,884 U.S. government agency securities Level 2 20,812 74 — 20,886 Total $ 214,959 $ 424 $ ( 3 ) $ 215,380 December 31, 2023 Fair Value Amortized Gross Gross Fair Value Cash equivalents: Money market funds Level 1 $ 21,458 $ — $ — $ 21,458 U.S. treasury securities Level 1 25,896 2 — 25,898 Commercial paper Level 2 54,427 — ( 27 ) 54,400 U.S. government agency securities Level 2 4,951 1 — 4,952 Marketable securities: U.S. treasury securities Level 1 182,289 214 ( 14 ) 182,489 Corporate bonds Level 2 13,986 — ( 8 ) 13,978 Commercial paper Level 2 20,216 — ( 17 ) 20,199 U.S. government agency securities Level 2 8,491 11 ( 11 ) 8,491 Total $ 331,714 $ 228 $ ( 77 ) $ 331,865 |
Schedule of Unrealized Loss on Marketable Securities | The following table summarizes the available-for-sale securities in an unrealized loss position for which an allowance for credit losses has not been recorded as of September 30, 2024 and December 31, 2023, aggregated by major security type and length of time in a continuous unrealized loss position: September 30, 2024 Less than 12 months Greater than 12 months Total Fair Value Unrealized Losses Fair Value Unrealized Losses Fair Value Unrealized Losses U.S. treasury securities $ 8,937 $ ( 2 ) $ — $ — $ 8,937 $ ( 2 ) Commercial paper 9,987 ( 1 ) — — 9,987 ( 1 ) Total $ 18,924 $ ( 3 ) $ — $ — $ 18,924 $ ( 3 ) December 31, 2023 Less than 12 months Greater than 12 months Total Fair Value Unrealized Losses Fair Value Unrealized Losses Fair Value Unrealized Losses U.S. treasury securities $ 28,137 $ ( 14 ) $ — $ — $ 28,137 $ ( 14 ) Corporate bonds 13,978 ( 8 ) — — 13,978 ( 8 ) Commercial paper 74,599 ( 44 ) — — 74,599 ( 44 ) U.S. government agency securities 4,771 ( 11 ) — — 4,771 ( 11 ) Total $ 121,485 $ ( 77 ) $ — $ — $ 121,485 $ ( 77 ) |
Summary of Contractual Maturities of Marketable Securities | The following table summarizes the contractual maturities of the Company’s cash equivalents and marketable securities as of September 30, 2024 and December 31, 2023 at estimated fair value (in thousands): September 30, December 31, 2024 2023 Due in less than one year $ 200,588 $ 312,554 Due in more than one year 14,792 19,311 Total $ 215,380 $ 331,865 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): September 30, December 31, 2024 2023 Accrued research and development materials and services $ 16,703 $ 14,625 Accrued professional services 1,333 3,147 Accrued compensation 12,176 13,527 Other 859 245 Total accrued liabilities $ 31,071 $ 31,544 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Number of Common Stock Reserved for Future Issuance | The Company had reserved common stock, on an as-converted basis, for future issuance as follows: September 30, December 31, 2024 2023 Stock options, issued and outstanding 5,663,644 6,766,340 Restricted stock units 2,358,515 658,792 Stock options and restricted stock units, future issuance 4,624,399 3,536,312 Employee stock purchase plan, available for future grants 1,821,195 1,376,988 Pre-funded warrants 1,334,332 1,334,332 Total 15,802,085 13,672,764 |
Sanofi Agreement (Tables)
Sanofi Agreement (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Sanofi Agreement [Abstract] | |
Schedule of contract liabilities for the periods | The following tables present changes in the Company’s customer contract liabilities for the periods presented (in thousands): Nine Months Ended September 30, 2024 December 31, 2023 Additions Deductions September 30, 2024 Contract liabilities: Deferred revenue $ 146,801 $ — $ ( 2,267 ) $ 144,534 Nine Months Ended September 30, 2023 December 31, 2022 Additions Deductions September 30, 2023 Contract liabilities: Deferred revenue $ 148,931 $ — $ ( 1,479 ) $ 147,452 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Option Activity | The following table summarizes stock option activity: Shares Issuable Under Options Weighted- Weighted- Aggregate (in years) (in thousands) Outstanding as of December 31, 2023 6,766,340 $ 27.81 7.0 $ 6,823 Granted 1,552,298 $ 9.95 Exercised ( 315,993 ) $ 4.69 Forfeited / Canceled ( 2,339,001 ) $ 46.68 Outstanding as of September 30, 2024 5,663,644 $ 16.41 6.9 $ 4,062 Options exercisable as of September 30, 2024 3,159,121 $ 19.26 6.0 $ 4,042 |
Schedule of Restricted Stock Unit Activity | The following table summarizes restricted stock unit activity: Shares Weighted- Unvested restricted stock units as of December 31, 2023 658,792 $ 13.77 Granted 2,220,538 $ 10.12 Vested ( 348,397 ) $ 12.13 Forfeited ( 172,418 ) $ 10.96 Unvested restricted stock units as of September 30, 2024 2,358,515 $ 10.79 |
Summary of Stock-Based Compensation Expense | Total stock-based compensation expense related to the Company’s equity incentive plan and employee stock purchase plan was recorded in the condensed statements of operations as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Research and development $ 5,792 $ 7,391 $ 14,961 $ 22,078 General and administrative 10,410 4,563 17,591 15,232 Total stock-based compensation expense (1) $ 16,202 $ 11,954 $ 32,552 $ 37,310 (1) The stock-based compensation expense for the three and nine months ended September 30, 2024 includes the modification of two former employees' equity awards. See Note 9 - Restructuring Charges for additional information . |
Restructuring Charges (Tables)
Restructuring Charges (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Restructuring and Related Activities [Abstract] | |
Summary of Changes in Company's Accrued Restructuring Balance | Beginning Balance Charges Payments Ending Balance Accrued severance $ 2,397 $ 5,539 $ ( 2,397 ) $ 5,539 Accrued contract termination costs — 300 ( 107 ) 193 Total accrued restructuring liability $ 2,397 $ 5,839 $ ( 2,504 ) $ 5,732 As of September 30, 2024 and December 31, 2023, $ 5.2 million and $ 2.4 million of the restructuring liability, respectively, was classified as current within accrued liabilities and $ 0.5 million of the restructuring liability as of September 30, 2024 was classified as non-current within other liabilities on the condensed balance sheets. There was no non-current restructuring liability as of December 31, 2023. |
Summary of Charges Related to Restructuring Activities | A summary of the charges related to the restructuring activities is as follows (in thousands): Three Months Ended September 30, 2024 Severance and Related Compensation Incentive and Stock-Based Compensation Contract Termination and Other Costs Total Restructuring Costs Research and development $ 3,696 $ 1,619 $ 193 $ 5,508 General and administrative 1,842 6,534 106 8,482 Total $ 5,538 $ 8,153 $ 299 $ 13,990 Nine Months Ended September 30, 2024 Severance and Related Compensation Incentive and Stock-Based Compensation Contract Termination and Other Costs Total Restructuring Costs Research and development $ 3,699 $ 1,601 $ 373 $ 5,673 General and administrative 1,843 6,534 106 8,483 Total $ 5,542 $ 8,135 $ 479 $ 14,156 |
Net Loss Per Share Attributab_2
Net Loss Per Share Attributable to Common Stockholders (Tables) | 9 Months Ended |
Sep. 30, 2024 | |
Earnings Per Share [Abstract] | |
Summary of Potentially Dilutive Securities Not Included in the Diluted Per Share Calculations | The following equity instruments were excluded from the calculation of diluted net loss per share because their effect would have been anti-dilutive for the periods presented: September 30, 2024 2023 Stock options 5,663,644 7,296,153 Estimated shares issuable under the employee stock purchase plan 78,986 51,620 Unvested restricted stock units 2,358,515 958,426 Total 8,101,145 8,306,199 |
Organization - Additional Infor
Organization - Additional Information (Details) - USD ($) $ in Thousands | Sep. 30, 2024 | Dec. 31, 2023 |
Subsidiary Sale Of Stock [Line Items] | ||
Accumulated deficit | $ (980,390) | $ (821,242) |
Cash, and investments | $ 218,800 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2024 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2024 USD ($) Segment | Sep. 30, 2023 USD ($) | |
Summary of Significant Accounting Policies [Line Items] | ||||
Number of reportable segments | Segment | 1 | |||
Number of operating segment | Segment | 1 | |||
Impairment of long-lived assets | $ | $ 0 | $ 0 | $ 0 | $ 0 |
Interest or penalties charged in relation to unrecognized tax benefits | $ | $ 0 | |||
Minimum | ||||
Summary of Significant Accounting Policies [Line Items] | ||||
Property and equipment estimated useful life | 3 years | 3 years | ||
Maximum | ||||
Summary of Significant Accounting Policies [Line Items] | ||||
Property and equipment estimated useful life | 5 years | 5 years |
Fair Value Measurement - Additi
Fair Value Measurement - Additional Information (Details) $ in Millions | Sep. 30, 2024 USD ($) Instrument | Dec. 31, 2023 USD ($) Instrument |
Fair Value Disclosures [Abstract] | ||
Number of financial instruments classified as level 3 | 0 | 0 |
Number of debt securities held | 10 | 35 |
Accrued interest receivable | $ | $ 1 | $ 0.8 |
Fair Value Measurement - Summar
Fair Value Measurement - Summary of Investments Measured and Recognized at Fair Value (Details) - USD ($) $ in Thousands | Sep. 30, 2024 | Dec. 31, 2023 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Amortized Cost | $ 214,959 | $ 331,714 |
Gross Unrealized Gains | 424 | 228 |
Gross Unrealized Losses | (3) | (77) |
Fair Value | 215,380 | 331,865 |
Financial Assets Included Within Cash and Cash Equivalents | Money Market Funds | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Included within cash and cash equivalents, Amortized Cost | 27,018 | 21,458 |
Included within cash and cash equivalents, Gross Unrealized Gains | 0 | 0 |
Included within cash and cash equivalents, Gross Unrealized Losses | 0 | 0 |
Included within cash and cash equivalents, Fair Value | 27,018 | 21,458 |
Financial Assets Included Within Cash and Cash Equivalents | U.S. Treasury Securities | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Included within cash and cash equivalents, Amortized Cost | 25,896 | |
Included within cash and cash equivalents, Gross Unrealized Gains | 2 | |
Included within cash and cash equivalents, Gross Unrealized Losses | 0 | |
Included within cash and cash equivalents, Fair Value | 25,898 | |
Financial Assets Included Within Cash and Cash Equivalents | Commercial Paper | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Included within cash and cash equivalents, Amortized Cost | 10,467 | 54,427 |
Included within cash and cash equivalents, Gross Unrealized Gains | 0 | 0 |
Included within cash and cash equivalents, Gross Unrealized Losses | (1) | (27) |
Included within cash and cash equivalents, Fair Value | 10,466 | 54,400 |
Financial Assets Included Within Cash and Cash Equivalents | U.S. Government Agency Securities | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Included within cash and cash equivalents, Amortized Cost | 1,984 | 4,951 |
Included within cash and cash equivalents, Gross Unrealized Gains | 0 | 1 |
Included within cash and cash equivalents, Gross Unrealized Losses | 0 | 0 |
Included within cash and cash equivalents, Fair Value | 1,984 | 4,952 |
Financial Assets Included Within Marketable Securities [Member] | U.S. Treasury Securities | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Included within cash and cash equivalents, Amortized Cost | 114,445 | 182,289 |
Included within cash and cash equivalents, Gross Unrealized Gains | 249 | 214 |
Included within cash and cash equivalents, Gross Unrealized Losses | (2) | (14) |
Included within cash and cash equivalents, Fair Value | 114,692 | 182,489 |
Financial Assets Included Within Marketable Securities [Member] | Corporate Bonds | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Included within cash and cash equivalents, Amortized Cost | 20,367 | 13,986 |
Included within cash and cash equivalents, Gross Unrealized Gains | 83 | 0 |
Included within cash and cash equivalents, Gross Unrealized Losses | 0 | (8) |
Included within cash and cash equivalents, Fair Value | 20,450 | 13,978 |
Financial Assets Included Within Marketable Securities [Member] | Commercial Paper | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Included within cash and cash equivalents, Amortized Cost | 19,866 | 20,216 |
Included within cash and cash equivalents, Gross Unrealized Gains | 18 | 0 |
Included within cash and cash equivalents, Gross Unrealized Losses | 0 | (17) |
Included within cash and cash equivalents, Fair Value | 19,884 | 20,199 |
Financial Assets Included Within Marketable Securities [Member] | U.S. Government Agency Securities | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Included within cash and cash equivalents, Amortized Cost | 20,812 | 8,491 |
Included within cash and cash equivalents, Gross Unrealized Gains | 74 | 11 |
Included within cash and cash equivalents, Gross Unrealized Losses | 0 | (11) |
Included within cash and cash equivalents, Fair Value | $ 20,886 | $ 8,491 |
Fair Value Measurement - Summ_2
Fair Value Measurement - Summary of Available-for-sale Securities Unrealized Loss Position (Details) - USD ($) $ in Thousands | Sep. 30, 2024 | Dec. 31, 2023 |
Debt Securities, Available-for-Sale [Line Items] | ||
Less than 12 months, fair value | $ 18,924 | $ 121,485 |
Less than 12 months, unrealized losses | (3) | (77) |
Greater than 12 months, fair value | 0 | 0 |
Greater than 12 months, unrealized losses | 0 | 0 |
Total, fair value | 18,924 | 121,485 |
Total, unrealized losses | (3) | (77) |
U.S. Treasury Securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Less than 12 months, fair value | 8,937 | 28,137 |
Less than 12 months, unrealized losses | (2) | (14) |
Greater than 12 months, fair value | 0 | 0 |
Greater than 12 months, unrealized losses | 0 | 0 |
Total, fair value | 8,937 | 28,137 |
Total, unrealized losses | (2) | (14) |
Corporate Bonds | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Less than 12 months, fair value | 13,978 | |
Less than 12 months, unrealized losses | (8) | |
Greater than 12 months, fair value | 0 | |
Greater than 12 months, unrealized losses | 0 | |
Total, fair value | 13,978 | |
Total, unrealized losses | (8) | |
Commercial Paper | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Less than 12 months, fair value | 9,987 | 74,599 |
Less than 12 months, unrealized losses | (1) | (44) |
Greater than 12 months, fair value | 0 | 0 |
Greater than 12 months, unrealized losses | 0 | 0 |
Total, fair value | 9,987 | 74,599 |
Total, unrealized losses | $ (1) | (44) |
U.S. Government Agency Securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Less than 12 months, fair value | 4,771 | |
Less than 12 months, unrealized losses | (11) | |
Greater than 12 months, fair value | 0 | |
Greater than 12 months, unrealized losses | 0 | |
Total, fair value | 4,771 | |
Total, unrealized losses | $ (11) |
Fair Value Measurement - Summ_3
Fair Value Measurement - Summary of Contractual Maturities of Investments (Details) - Fair Value, Recurring - USD ($) $ in Thousands | Sep. 30, 2024 | Dec. 31, 2023 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Due in less than one year | $ 200,588 | $ 312,554 |
Due in more than one year | 14,792 | 19,311 |
Total | $ 215,380 | $ 331,865 |
Accrued Liabilities - Schedule
Accrued Liabilities - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2024 | Dec. 31, 2023 |
Balance Sheet Related Disclosures [Abstract] | ||
Accrued research and development materials and services | $ 16,703 | $ 14,625 |
Accrued professional services | 1,333 | 3,147 |
Accrued compensation | 12,176 | 13,527 |
Other | 859 | 245 |
Total accrued liabilities | $ 31,071 | $ 31,544 |
License Agreements - Additional
License Agreements - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | Jan. 31, 2021 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Milestone payment based on achievement of specified development | $ 0 | $ 0 | |||
Research And Development Expense | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
License expenses recognized | 0 | $ 1.2 | 0.6 | $ 1.7 | |
License Agreement | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Milestone payment based on achievement of specified development | 361.9 | 361.9 | |||
License Agreement | Medivir AB | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Additional milestone payment | $ 1.5 | ||||
Milestone payment based on achievement of specified development | $ 0 | $ 0 | |||
Upfront payment | 1 | ||||
License Agreement | Medivir AB | Maximum | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Milestone payment based on achievement of specified development | $ 348.5 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2024 USD ($) Vote $ / shares shares | Dec. 31, 2023 USD ($) $ / shares shares | |
Class Of Stock [Line Items] | ||
Common stock, shares authorized | 120,000,000 | 120,000,000 |
Preferred stock, shares authorized | 200,000,000 | 200,000,000 |
Preferred stock, par value | $ / shares | $ 0.01 | $ 0.01 |
Common stock, voting rights | Each share of common stock (excluding non-voting common stock) is entitled to one vote. | |
Number of common stock voting rights held | Vote | 1 | |
Common stock, dividends declared | $ | $ 0 | $ 0 |
Non-Voting Common Stock | ||
Class Of Stock [Line Items] | ||
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, par value | $ / shares | $ 0.01 | $ 0.01 |
Common Stock, Shares, Issued | 25,386,983 | 25,500,383 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Number of Common Stock Reserved for Future Issuance (Details) - shares | Sep. 30, 2024 | Dec. 31, 2023 |
Stockholders' Equity Note [Abstract] | ||
Stock options, issued and outstanding | 5,663,644 | 6,766,340 |
Restricted stock units | 2,358,515 | 658,792 |
Stock options and restricted stock units, future issuance | 4,624,399 | 3,536,312 |
Employee stock purchase plan, available for future grants | 1,821,195 | 1,376,988 |
Pre-funded warrants | 1,334,332 | 1,334,332 |
Total | 15,802,085 | 13,672,764 |
Stockholders' Equity - Pre-Fund
Stockholders' Equity - Pre-Funded Warrants - Additional Information (Details) | Dec. 31, 2020 $ / shares shares |
Class of Warrant or Right [Line Items] | |
Maximum allowed holding percentage of shares after exercise of warrants | 9.99% |
Maximum allowed combined voting percentage of shares after exercise of warrants | 9.99% |
Maximum allowed percentage of pre-funded warrants to exercise | 19.99% |
Minimum notice term to increase or decrease the holding percentage of pre-funded warrants | 61 days |
Underwritten Public Offering | Pre-funded Warrant | |
Class of Warrant or Right [Line Items] | |
Warrants to purchase an additional shares of common stock | shares | 1,334,332 |
Pre-funded warrant, exercise price | $ / shares | $ 0.01 |
Sanofi Agreement (Additional In
Sanofi Agreement (Additional Information) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2024 | Jun. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | May 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Deferred revenue | $ 144,534 | $ 147,452 | $ 144,534 | $ 147,452 | $ 146,801 | $ 148,931 | ||
Contract asset | 0 | 0 | 0 | 0 | ||||
Sanofi Agreement [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Deferred revenue | 144,500 | 144,500 | 146,800 | |||||
Deferred revenue, current | 2,700 | 2,700 | $ 3,800 | |||||
Revenues | $ 500 | $ 500 | 2,300 | $ 1,500 | ||||
Adjustment of collaboration revenue | $ 800 | |||||||
Revenue transaction price | 150,000 | |||||||
Upfront payment received | $ 150,000 | |||||||
Development And Regulatory Milestones Exchange | $ 1,065,000 |
Sanofi Agreement - Schedule of
Sanofi Agreement - Schedule of Contract liabilities for the periods (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2024 | Sep. 30, 2023 | |
Sanofi Agreement [Abstract] | ||
Deferred revenue, beginning balance | $ 146,801 | $ 148,931 |
Additions | 0 | 0 |
Deductions | (2,267) | (1,479) |
Deferred revenue, ending balance | $ 144,534 | $ 147,452 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - $ / shares | 9 Months Ended | |||
Jun. 20, 2024 | Sep. 30, 2024 | Jan. 01, 2024 | Jan. 01, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award Line Items | ||||
Eligible stock options cancelled | 2,339,001 | |||
Options granted in replacement of RSU | 1,552,298 | |||
Restricted Stock Units | ||||
Share Based Compensation Arrangement By Share Based Payment Award Line Items | ||||
Grant date fair value per share | $ 10.12 | |||
Share receives for consulting services | 2,220,538 | |||
Stock Option Exchange Program [Member] | Employee Stock Options | ||||
Share Based Compensation Arrangement By Share Based Payment Award Line Items | ||||
Eligible stock options cancelled | 1,583,305 | |||
Stock Option Exchange Program [Member] | Restricted Stock Units | ||||
Share Based Compensation Arrangement By Share Based Payment Award Line Items | ||||
Options granted in replacement of RSU | 657,427 | |||
RSUs vesting percentage after exchange | 50% | |||
Stock Option Exchange Program [Member] | Restricted Stock Units | Minimum | ||||
Share Based Compensation Arrangement By Share Based Payment Award Line Items | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period | 2 years | |||
Stock Option Exchange Program [Member] | Restricted Stock Units | Employee Stock Options | ||||
Share Based Compensation Arrangement By Share Based Payment Award Line Items | ||||
Exercise price per share for eligible stock options | $ 17.7 | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period | 3 years | |||
2018 Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award Line Items | ||||
Increase in number of shares | 2,347,245 | 1,723,292 | ||
Outstanding stock including non-voting common stock, percent | 4% | |||
Common stock available for future issuance | 4,624,399 | |||
2018 Plan | Maximum | ||||
Share Based Compensation Arrangement By Share Based Payment Award Line Items | ||||
Increase in number of shares | 8,768,800 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock-Based Compensation Expense (Details) - 2010 Plan, 2018 Plan and ESPP - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2024 | Sep. 30, 2023 | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs Line Items | |||||
Total stock-based compensation expense | [1] | $ 16,202 | $ 11,954 | $ 32,552 | $ 37,310 |
Research and Development | |||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs Line Items | |||||
Total stock-based compensation expense | 5,792 | 7,391 | 14,961 | 22,078 | |
General And Administrative | |||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs Line Items | |||||
Total stock-based compensation expense | $ 10,410 | $ 4,563 | $ 17,591 | $ 15,232 | |
[1] The stock-based compensation expense for the three and nine months ended September 30, 2024 includes the modification of two former employees' equity awards. See Note 9 - Restructuring Charges for additional information |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2024 | Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | ||
Outstanding Options, Shares, Beginning balance | 6,766,340 | |
Outstanding Options, Shares, Granted | 1,552,298 | |
Outstanding Options, Shares, Exercised | (315,993) | |
Outstanding Options, Shares, Forfeited / Cancelled | (2,339,001) | |
Outstanding Options, Shares, Ending balance | 5,663,644 | 6,766,340 |
Outstanding Options, Shares, Exercisable | 3,159,121 | |
Outstanding Options, Weighted-Average Exercise Price, Beginning balance | $ 27.81 | |
Outstanding Options, Weighted-Average Exercise Price, Granted | 9.95 | |
Outstanding Options, Weighted-Average Exercise Price, Exercised | 4.69 | |
Outstanding Options, Weighted-Average Exercise Price, Forfeited / Cancelled | 46.68 | |
Outstanding Options, Weighted-Average Exercise Price, Ending balance | 16.41 | $ 27.81 |
Outstanding Options, Weighted-Average Exercise Price, Exercisable | $ 19.26 | |
Outstanding Options, Weighted Average Remaining Contractual Term (Years) | 6 years 10 months 24 days | 7 years |
Outstanding Options, Weighted Average Remaining Contractual Term (Years), Exercisable | 6 years | |
Outstanding Options, Aggregate Intrinsic Value | $ 4,062 | $ 6,823 |
Outstanding Options, Aggregate Intrinsic Value, Exercisable | $ 4,042 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Company's stock awards granted (Details) | 9 Months Ended |
Sep. 30, 2024 shares | |
Share Based Compensation Arrangement By Share Based Payment Award Line Items | |
Outstanding Options, Shares, Granted | 1,552,298 |
Stock-Based Compensation - Su_4
Stock-Based Compensation - Summary of Restricted Stock Unit Activity (Details) - Restricted Stock Units | 9 Months Ended |
Sep. 30, 2024 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Unvested restricted stock units, Beginning Balance (Shares) | shares | 658,792 |
Granted (Shares) | shares | 2,220,538 |
Vested (Shares) | shares | (348,397) |
Forfeited (Shares) | shares | (172,418) |
Unvested restricted stock units, Ending Balance (Shares) | shares | 2,358,515 |
Weighted - Average Grant Date Fair Value | |
Unvested restricted units, Beginning Balance | $ / shares | $ 13.77 |
Granted | $ / shares | 10.12 |
Vested | $ / shares | 12.13 |
Forfeited | $ / shares | 10.96 |
Unvested restricted units, Ending Balance | $ / shares | $ 10.79 |
Restructuring Charges (Addition
Restructuring Charges (Additional Information) (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Dec. 31, 2023 | Sep. 30, 2024 | Sep. 30, 2024 | Sep. 30, 2023 | Dec. 31, 2023 | Mar. 31, 2024 | |
Restructuring Cost and Reserve [Line Items] | ||||||
Workforce Reduced, Percent | 22% | |||||
Restructuring Charges | $ 14,000 | $ 14,100 | $ 1,800 | |||
Contract Termination and Other Costs | 299 | 479 | ||||
Current Accrued Liabilities | $ 245 | 859 | 859 | 245 | ||
Non-Current Other Liabilities | 0 | 554 | 554 | 0 | ||
Severance and Related Compensation | 5,538 | 5,542 | ||||
Non-cash incentive and stock-based compensation expense | 32,552 | $ 37,310 | ||||
Incentive and Stock-Based Compensation | 8,153 | 8,135 | ||||
Restructuring Liability [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Current Accrued Liabilities | 2,400 | 5,200 | 5,200 | 2,400 | ||
Non-Current Other Liabilities | $ 0 | 500 | 500 | $ 0 | ||
EmployeeSeverance [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring Charges | 5,539 | |||||
Restructuring Reserve Payments | $ 2,400 | |||||
Incentive and Stock-Based Compensation | 1,200 | |||||
Restructuring Charges [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Severance and Related Compensation | 5,500 | |||||
Non-cash incentive and stock-based compensation expense | 9,400 | |||||
Incentive and stock-based compensation charges | 8,200 | |||||
Incentive and Stock-Based Compensation | 8,200 | |||||
Restructuring Charges [Member] | CEO Member | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Equity-based severance cost | 800 | |||||
Restructuring Charges [Member] | CSO Member | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Equity-based severance cost | 500 | |||||
Contract Termination [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring Charges | $ 300 | |||||
Contract Termination and Other Costs | $ 300 |
Restructuring Charges - Summary
Restructuring Charges - Summary of Changes in Company's Accrued Restructuring Balance (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended |
Sep. 30, 2024 | Sep. 30, 2024 | Dec. 31, 2023 | |
Restructuring Cost and Reserve [Line Items] | |||
Charges | $ 14,000 | $ 14,100 | $ 1,800 |
Accrued severance [Member] | |||
Restructuring Cost and Reserve [Line Items] | |||
Beginning Balance | 2,397 | ||
Charges | 5,539 | ||
Payments | (2,397) | ||
Ending Balance | 5,539 | 5,539 | 2,397 |
Accrued contract termination costs [Member] | |||
Restructuring Cost and Reserve [Line Items] | |||
Beginning Balance | 0 | ||
Charges | 300 | ||
Payments | (107) | ||
Ending Balance | 193 | 193 | 0 |
Total accrued restructuring liability | |||
Restructuring Cost and Reserve [Line Items] | |||
Beginning Balance | 2,397 | ||
Charges | 5,839 | ||
Payments | (2,504) | ||
Ending Balance | $ 5,732 | $ 5,732 | $ 2,397 |
Restructuring Charges - Summa_2
Restructuring Charges - Summary of Charges Related to Restructuring Activities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2024 | Sep. 30, 2024 | |
Restructuring Cost and Reserve [Line Items] | ||
Severance and Related Compensation | $ 5,538 | $ 5,542 |
Incentive and Stock-Based Compensation | 8,153 | 8,135 |
Contract Termination and Other Costs | 299 | 479 |
Total Restructuring Costs | 13,990 | 14,156 |
Research and Development | ||
Restructuring Cost and Reserve [Line Items] | ||
Severance and Related Compensation | 3,696 | 3,699 |
Incentive and Stock-Based Compensation | 1,619 | 1,601 |
Contract Termination and Other Costs | 193 | 373 |
Total Restructuring Costs | 5,508 | 5,673 |
General And Administrative | ||
Restructuring Cost and Reserve [Line Items] | ||
Severance and Related Compensation | 1,842 | 1,843 |
Incentive and Stock-Based Compensation | 6,534 | 6,534 |
Contract Termination and Other Costs | 106 | 106 |
Total Restructuring Costs | $ 8,482 | $ 8,483 |
Net Loss Per Share Attributab_3
Net Loss Per Share Attributable to Common Stockholders - Summary of Potentially Dilutive Securities Not Included in the Diluted Per Share Calculations (Details) - shares | 9 Months Ended | |
Sep. 30, 2024 | Sep. 30, 2023 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities not included in diluted per share calculations | 8,101,145 | 8,306,199 |
Employee Stock Option | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities not included in diluted per share calculations | 5,663,644 | 7,296,153 |
Estimated Shares Issuable Under Employee Stock Purchase Plan | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities not included in diluted per share calculations | 78,986 | 51,620 |
Unvested Restricted Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Potentially dilutive securities not included in diluted per share calculations | 2,358,515 | 958,426 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended |
Aug. 31, 2024 | Sep. 30, 2024 | Sep. 30, 2024 | |
Related Party Transaction [Line Items] | |||
Outstanding liability to the related party | $ 0 | $ 0 | |
Outstanding liability to the related parties | $ 1,300 | ||
Restricted Stock Units | |||
Related Party Transaction [Line Items] | |||
Share receives for consulting services | 2,220,538 | ||
Consulting Agreement [Member] | |||
Related Party Transaction [Line Items] | |||
Consulting Fees | $ 250,000 | $ 100,000 | $ 100,000 |
Consulting Agreement [Member] | Restricted Stock Units | |||
Related Party Transaction [Line Items] | |||
Share receives for consulting services | 125,000 | ||
Vesting date of RSUs | Apr. 30, 2026 |