Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 26, 2024 | Jun. 30, 2023 | |
Document and Entity Information [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-39580 | ||
Entity Registrant Name | IMMUNOME, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 77-0694340 | ||
Entity Address, Address Line One | 18702 N. Creek Parkway | ||
Entity Address, Address Line Two | Suite 100 | ||
Entity Address, City or Town | Bothell | ||
Entity Address State Or Province | WA | ||
Entity Address, Postal Zip Code | 98011 | ||
City Area Code | 610 | ||
Local Phone Number | 321-3700 | ||
Title of 12(b) Security | Common Stock, $0.0001 Par Value | ||
Trading Symbol | IMNM | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 75.5 | ||
Entity Common Stock, Shares Outstanding | 59,694,243 | ||
Auditor Firm ID | 42 | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | Philadelphia, Pennsylvania | ||
Entity Central Index Key | 0001472012 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 98,679 | $ 20,323 |
Marketable securities | 39,463 | |
Prepaid expenses and other current assets | 6,561 | 2,326 |
Total current assets | 144,703 | 22,649 |
Property and equipment, net | 2,073 | 681 |
Operating right-of-use asset, net | 1,564 | 284 |
Restricted cash | 100 | 100 |
Deferred offering costs | 332 | |
Other long-term assets | 100 | |
Total assets | 148,540 | 24,046 |
Current liabilities: | ||
Accounts payable | 3,311 | 2,400 |
Accrued expenses and other current liabilities | 8,025 | 4,931 |
Deferred revenue, current | 10,493 | |
Total current liabilities | 21,829 | 7,331 |
Deferred revenue, non-current | 5,489 | |
Other long-term liabilities | 1,340 | 62 |
Total liabilities | 28,658 | 7,393 |
Commitments and contingencies (Note 8) | ||
Stockholders' equity: | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued or outstanding at December 31, 2023 and 2022 | ||
Common stock, $0.0001 par value; 200,000,000 shares authorized; 43,251,778 shares issued and outstanding at December 31, 2023 and 12,128,843 shares issued and outstanding at December 31, 2022 | 4 | 1 |
Additional paid-in capital | 342,663 | 132,653 |
Accumulated other comprehensive income | 22 | |
Accumulated deficit | (222,807) | (116,001) |
Total stockholders' equity | 119,882 | 16,653 |
Total liabilities and stockholders' equity | $ 148,540 | $ 24,046 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Consolidated Balance Sheets | ||
Preferred stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 43,251,778 | 12,128,843 |
Common stock, shares outstanding (in shares) | 43,251,778 | 12,128,843 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Sep. 02, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Consolidated Statements of Operations and Comprehensive Loss | |||
Collaboration revenue | $ 14,018 | ||
Operating expenses: | |||
In-process research and development | 80,802 | ||
Research and development | 23,089 | $ 23,272 | |
General and administrative | 19,657 | 13,629 | |
Total operating expenses | 123,548 | 36,901 | |
Loss from operations | (109,530) | (36,901) | |
Interest income | 2,724 | 5 | |
Net loss | (106,806) | (36,896) | |
Deemed dividend arising from warrant modification | $ (600) | (622) | |
Net loss attributable to common stockholders | $ (106,806) | $ (37,518) | |
Per share information: | |||
Net loss per common share, Basic | $ (5.38) | $ (3.09) | |
Net loss per common share, Diluted | $ (5.38) | $ (3.09) | |
Weighted-average common shares outstanding, Basic | 19,843,651 | 12,126,573 | |
Weighted-average common shares outstanding, Diluted | 19,843,651 | 12,126,573 | |
Comprehensive loss | |||
Net loss | $ (106,806) | $ (37,518) | |
Unrealized gain on marketable securities | 22 | ||
Comprehensive loss | $ (106,784) | $ (37,518) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | ATM Common stock | ATM Additional paid-in capital | ATM | PIPE Funding Common stock | PIPE Funding Additional paid-in capital | PIPE Funding | Common stock | Additional paid-in capital | Accumulated Other Comprehensive Income | Accumulated deficit | Total |
Balance at Dec. 31, 2021 | $ 1 | $ 127,289 | $ (79,105) | $ 48,185 | |||||||
Balance (shares) at Dec. 31, 2021 | 12,110,373 | ||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Share-based compensation expense | 5,332 | 5,332 | |||||||||
Exercise of stock options | 32 | 32 | |||||||||
Exercise of stock options (shares) | 18,470 | ||||||||||
Net Income (Loss) | (36,896) | (36,896) | |||||||||
Balance at Dec. 31, 2022 | $ 1 | 132,653 | (116,001) | 16,653 | |||||||
Balance (shares) at Dec. 31, 2022 | 12,128,843 | ||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Unrealized gain on marketable securities | $ 22 | 22 | |||||||||
Share-based compensation expense | 6,153 | 6,153 | |||||||||
Issuance of common stock | $ 34 | $ 34 | $ 2 | $ 116,001 | $ 116,003 | 221 | 221 | ||||
Issuance of common stock ( in shares) | 5,925 | 21,690,871 | 55,250 | ||||||||
Vesting of restricted stock awards | 70 | 70 | |||||||||
Vesting of restricted stock awards (shares) | 12,498 | ||||||||||
Exercise of stock options | 371 | $ 371 | |||||||||
Exercise of stock options (shares) | 522,681 | 651,240 | |||||||||
Issuance of common stock and stock-based equity awards for MorphImmune merger | $ 1 | 87,160 | $ 87,161 | ||||||||
Issuance of common stock and stock-based equity awards for MorphImmune merger (shares) | 8,835,710 | ||||||||||
Net Income (Loss) | (106,806) | (106,806) | |||||||||
Balance at Dec. 31, 2023 | $ 4 | $ 342,663 | $ 22 | $ (222,807) | $ 119,882 | ||||||
Balance (shares) at Dec. 31, 2023 | 43,251,778 |
Consolidated Statements of Ch_2
Consolidated Statements of Changes in Stockholders' Equity (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
ATM | |
Net of issuance costs | $ 1 |
PIPE Funding | |
Net of issuance costs | $ 9,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (106,806) | $ (36,896) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 457 | 422 |
Amortization of right-of-use asset | 271 | 209 |
Accretion of discount related to marketable securities | (512) | |
Share-based compensation | 6,223 | 5,332 |
Charge for purchase of in-process research and development assets | 80,802 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (4,144) | 5,071 |
Accounts payable | (608) | (677) |
Accrued expenses and other current liabilities | 614 | (1,922) |
Deferred revenue | 15,982 | |
Other long-term liabilities | 153 | (229) |
Net cash used in operating activities | (7,568) | (28,690) |
Cash flows from investing activities: | ||
Purchases of marketable securities | (38,929) | |
Cash acquired in connection with MorphImmune merger, net of transaction costs | 9,276 | |
Purchases of property and equipment | (831) | (248) |
Net cash used in investing activities | (30,484) | (248) |
Cash flows from financing activities: | ||
Payment of offering costs | (8,997) | |
Proceeds from PIPE transaction | 125,000 | |
Proceeds from exercise of stock options | 371 | 32 |
Proceeds from issuance of common stock under ATM, net | 34 | |
Net cash provided by financing activities | 116,408 | 32 |
Net increase (decrease) in cash and cash equivalents and restricted cash | 78,356 | (28,906) |
Cash and cash equivalents and restricted cash at beginning of year | 20,423 | 49,329 |
Cash and cash equivalents and restricted cash at end of year | $ 98,779 | 20,423 |
Supplemental disclosures of non-cash investing and financing activities: | ||
Operating lease right-of-use asset and lease liability recorded upon adoption of ASC 842 | $ 492 | |
Issuance of common stock and stock-based equity awards for the MorphImmune merger | 87,161 | |
Remeasurement of operating right-of-use asset and lease liability due to lease extension | $ 226 | |
Right-of-use asset and lease liability recognized for new operating lease liabilities | 1,325 | |
Issuance of common stock to certain board of directors in lieu of accrued compensation | 221 | |
Property and equipment included in accounts payable | $ 372 |
Nature of the business
Nature of the business | 12 Months Ended |
Dec. 31, 2023 | |
Nature of the business | |
Nature of the business | 1. Nature of the business Organization Immunome, Inc., or the Company, is a biopharmaceutical company focused on the development of targeted oncology therapies. The Company believes that the pursuit of novel or underexplored targets will be central to the next generation of transformative therapies. For that reason, Immunome pursues therapeutics that it believes have best-in-class or first-in-class potential. The Company’s goal is to establish a broad pipeline of preclinical and clinical assets which it can efficiently develop through successive value inflection points. To support that goal, the Company pairs business development activity with significant investment in its internal discovery programs. Immunome is advancing a named pipeline comprising one clinical and three preclinical assets. The clinical asset is AL102, an investigational gamma secretase inhibitor, currently under evaluation in a Phase 3 trial for the treatment of desmoid tumors that was acquired from Ayala Pharmaceuticals, Inc. on March 25, 2024. The preclinical assets are IM-1021, a receptor tyrosine kinase-like orphan receptor 1, or ROR1, antibody-drug conjugates, or ADC; IM-3050, a fibroblast activation protein, or FAP, targeted radioligand therapy, or RLT, candidate; and IM-4320, an anti-IL-38 immunotherapy candidate. The Company was incorporated as a Pennsylvania corporation on March 2, 2006, and was converted to a Delaware corporation on December 2, 2015. Since its inception, the Company has devoted substantially all its resources to research and development, raising capital, building its management team, extending its intellectual property portfolio, and executing strategic partnerships and transactions. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry including, but not limited to, risks associated with research, development, and manufacturing activities, uncertain results of preclinical and clinical testing, development of new technological innovations and products by competitors, dependence on key personnel, partners and third-party vendors, protection of proprietary technology, compliance with government regulations, regulatory approval of products and the ability to secure additional capital to fund operations. On October 2, 2023, the Company completed its merger with Morphimmune Inc., or Morphimmune, a preclinical biotechnology company focused on developing targeted oncology therapies. Under the terms of the Agreement and Plan of Merger and Reorganization dated as of June 28, 2023, or the Merger Agreement, among the Company, Morphimmune and Ibiza Merger Sub, Inc., a wholly owned subsidiary of the Company, or Merger Sub, Morphimmune merged with and into Merger Sub, with Morphimmune surviving as a wholly-owned subsidiary of Immunome, or the Merger. Liquidity The Company has incurred net losses since inception, including net losses of $106.8 million and $36.9 million for the years ended December 31, 2023 and 2022, respectively, and it expects to generate losses from operations for the foreseeable future primarily due to research and development costs for its programs and development candidates. As of December 31, 2023, the Company had an accumulated deficit of $222.8 million. The Company expects to generate operating losses for the foreseeable future. Through December 31, 2023, the Company has funded its operations primarily through sales expense reimbursement from the Department of Defense, or DoD, under the Other Transaction Authority for Prototype Agreement, or the OTA Agreement In February 2024, the Company raised $230.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company, from a public offering of 11,500,000 shares of the Company’s common stock, or the 2024 Financing. In June 2023, the Company entered into subscription agreements with certain investors pursuant to which the Company sold The Company expects that its existing cash, cash equivalents and marketable securities at December 31, 2023, in combination with the proceeds from the 2024 Financing, will enable the Company to fund its current and planned operating expenses and capital expenditures for at least 12 months from the filing date of this Annual Report on Form 10-K. Beyond that date, more funding will be necessary to fund additional research and development activities and operations in order to pursue the Company’s growth strategy. If the Company cannot obtain the necessary funding, it will need to delay or scale back some of its research and development programs, enter into collaborations with third parties relative to potential programs, products or technologies that it might otherwise seek to progress independently (or enter into these collaborations sooner than it might otherwise have intended to), or reduce operations. Additionally, volatility in the capital markets generally and the biotechnology sector specifically, as well as general economic conditions in the United States may be a significant obstacle to raising the required funds on satisfactory terms, if at all. Operations of the Company are subject to certain risks and uncertainties including various internal and external factors that will affect whether and when the Company’s programs and development candidates become approved drugs and how significant their market share will be, many of which are outside of the Company’s control. The length of time and cost of developing and commercializing these programs and development candidates and/or failure of them at any stage of the drug approval process will materially affect the Company’s financial condition and future operations. |
Summary of significant accounti
Summary of significant accounting policies | 12 Months Ended |
Dec. 31, 2023 | |
Summary of significant accounting policies | |
Summary of significant accounting policies | 2. Summary of significant accounting policies Basis of presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted, or GAAP, in the United States. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification, or ASC, and Accounting Standards Updates, or ASU, promulgated by the Financial Accounting Standards Board, or FASB. Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Use of estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses. The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the expected volatility used to estimate fair value of stock options, accrued research and development expenses, the fair value of acquired in-process research and development assets, and the estimated costs which drive the revenue recognition for the Collaboration Agreement with AbbVie. Estimates and assumptions are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from these estimates. Segment and geographic information Operating segments are defined as components of an entity about which separate discrete information is available for evaluation by the chief operating decision maker, or CODM, or decision-making group, in deciding how to allocate resources and in assessing performance. The CODM is the Company’s Chief Executive Officer. The Company views its operations as and manages its business in one operating segment operating exclusively in the United States. Cash and cash equivalents Cash and cash equivalents consist of standard checking accounts, a money market account and three-month treasury bills. The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. Restricted cash Restricted cash represents collateral provided for a letter of credit issued as a security deposit in connection with the Company’s lease of its corporate facilities. Cash will be released from restriction upon termination of the lease. Restricted cash was $100,000 at both December 31, 2023 and 2022, respectively. The following table provides a reconciliation of the components of cash and cash equivalents and restricted cash presented in the consolidated statements of cash flows: (in thousands) December 31, 2023 December 31, 2022 Cash and cash equivalents $ 98,679 $ 20,323 Restricted cash 100 100 $ 98,779 $ 20,423 Marketable Securities The Company’s marketable securities consist of investments in U.S. Treasury debt securities. Debt securities are classified as available-for-sale and are carried at fair value with the unrealized gains and losses, net of tax, included in accumulated other comprehensive income, a component of stockholders’ equity. These debt securities have an original maturity period greater than 90 days, but less than one year. The Company classifies marketable securities that are available for use in current operations as current assets on the consolidated balance sheets. Unrealized losses are evaluated for impairment under ASC 326 , Financial Instruments - Credit Losses, or Concentration of credit risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash and cash equivalents and marketable securities. The Company maintains deposits in a financial institution in excess of government insured limits. Management believes that the Company is not exposed to significant credit risk as the Company’s deposits are held at a financial institution that management believes to be of high credit quality, and the Company has not experienced any losses on these deposits. Management also believes that the Company is not exposed to significant credit risk as it relates to marketable securities because the Company only invests in U.S government securities. Property and equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset as follows: Asset category Estimates useful life Lab equipment 5 years Leasehold improvements Lesser of lease term or 5 years Computer equipment 3 years Office equipment 5 years Furniture and fixtures 5 years Expenditures for repairs and maintenance of assets are charged to expense as incurred, while major betterments are capitalized. Upon retirement or sale, the cost and related accumulated depreciation and amortization of assets disposed of are removed from the accounts and any resulting gain or loss is included in the consolidated statements of operations and comprehensive loss. Asset Acquisitions Acquisitions of assets or a group of assets that do not meet the definition of a business are accounted for as asset acquisitions, with a cost accumulation model used to determine the cost of the acquisition. Common stock issued as consideration in an acquisition of assets is generally measured based on the acquisition date fair value of the equity interests issued. Direct transaction costs are recognized as part of the cost of an acquisition of assets. Intangible assets that are acquired in an asset acquisition for use in research and development activities that have an alternative future use are capitalized as in-process research and development, or IPR&D. Acquired IPR&D that has no alternative future use is expensed immediately in the consolidated statements of operations and comprehensive loss. For further disclosures related to asset acquisitions see Note 3 to the consolidated financial statements. Impairment of long-lived assets The Company evaluates its long-lived assets, which consist primarily of property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset exceeds the fair value of the asset. There were no impairment losses recognized during the years ended December 31, 2023 and 2022. Equity issuance costs The Company capitalizes costs directly associated with equity financings as deferred offering costs on its consolidated balance sheet. These costs remain capitalized until such financings are consummated, at which time such costs are recorded against the gross proceeds from the applicable financing. If a financing is abandoned, deferred offering costs are expensed. As of December 31, 2022, there were $0.3 million of deferred offering costs related to the Open Market Sale Agreement, or the ATM Agreement, and shelf registration that were expensed in 2023 as a result of the termination of the ATM Agreement. There were no deferred offering costs as of December 31, 2023. Government assistance programs The Company accounts for amounts received under its DoD expense reimbursement contract as contra-research and development expenses in the consolidated statements of operations and comprehensive loss. Collaboration revenue The Company evaluates its collaborative arrangements pursuant to ASC 808, Collaborative Arrangements Revenue from Contracts with Customers Payments pursuant to collaborative arrangements may include non-refundable upfront payments, research option and license option payments, milestone payments upon the achievement of significant regulatory and development events, commercial sales milestones, and royalties on product sales. The amount of variable consideration is constrained until it is probable that the revenue is not at a significant risk of reversal in a future period. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under a collaboration arrangement, the Company applies the five-step model of ASC 606: (i) identify the contract with a customer; (ii) identify the performance obligations in the contract, including whether they are capable of being distinct; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company applies significant judgment when evaluating whether contractual obligations represent distinct performance obligations, allocating transaction price to performance obligations within a contract, determining when performance obligations have been met, and assessing the recognition of variable consideration. When consideration is received prior to the Company completing its performance obligation under the terms of a contract, a contract liability is recorded as deferred revenue. Deferred revenue expected to be recognized as revenue within the twelve months following the balance sheet date is classified as a current liability. In January 2023, the Company entered into the Collaboration Agreement with AbbVie, which was determined to be within the scope of ASC 606. Please see Note 4 for further information related to the accounting for the Collaboration Agreement. Research and development expenses Research and development costs are charged to expense as incurred. Research and development costs consist of costs incurred in performing research and development activities, including salaries and bonuses, share-based compensation, employee benefits, facilities costs, laboratory supplies, depreciation and amortization, preclinical and clinical development expenses, including manufacture and testing of clinical supplies, consulting and other contracted services. Additionally, under the terms of the license agreements described in Note 10, the Company is obligated to make future payments should certain development, regulatory, and sales milestones be achieved. Costs for certain research and development activities are recognized based on the terms of the individual arrangements, which may differ from the timing of receipt of invoices and payment of invoices and are reflected in the financial statements as a prepaid or accrued expense. Share-based compensation The Company’s share-based compensation program allows for grants of stock options and restricted stock awards. Grants are awarded to employees and non-employees, including directors. The Company accounts for its share-based compensation awards granted to employees and non-employees based on the estimated fair value on the date of grant and recognized compensation expense of those awards over the requisite service period, which is the vesting period of the respective award. The Company accounts for forfeitures as they occur. For share-based awards with service-based vesting conditions, the Company recognized compensation expense on a straight-line basis over the service period. The Company classified share-based compensation expense in its statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. The Company estimates the fair value of options granted using the Black-Scholes option pricing model for stock option grants to both employees and non-employees. The Black-Scholes option pricing model requires inputs based on certain subjective assumptions, including (i) the expected stock price volatility, (ii) the expected term of the award, (iii) the risk-free interest rate and (iv) expected dividends. Due to the lack of Company-specific historical and implied volatility data, the Company has based its computation of expected volatility on the historical volatility of a representative group of public companies with similar characteristics to the Company, including stage of product development and biopharmaceutical industry focus. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. The Company uses the simplified method to calculate the expected term for options granted to employees and non-employees whereby, the expected term equals the arithmetic average of the vesting term and the original contractual term of the options due to its lack of sufficient historical data. The risk-free interest rate is based on U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock. The exercise price is the fair value of the common stock as of the measurement date. Patent costs All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses in the accompanying consolidated statements of operations and comprehensive loss. Leases The Company accounts for leases in accordance with ASC 842, Leases Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the remaining lease term. Options to extend the lease term are included in the Company’s assessment of the lease term only if there is a reasonable assessment that the Company will renew. Lease payments are discounted to their present value using either the interest rate implicit in the lease or the Company’s incremental borrowing rate, which reflects the fixed rate in which the Company could borrow on a collateralized basis the amount of lease payments in the same currency, for a similar term, in a similar economic environment. Income taxes The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the Company’s consolidated financial statements and tax returns. Deferred tax assets and liabilities are determined based upon the differences between the financial statement carrying amounts and the tax bases of existing assets and liabilities and for loss and credit carryforwards, using enacted tax rates expected to be in effect in the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that these assets may not be realized. The Company determines whether it is more likely than not that a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more-likely-than-not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency. The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes. Fair value of financial instruments ASC Topic 820, Fair Value Measurement ● Level 1: Quoted market prices in active markets for identical assets or liabilities. ● Level 2: Inputs other than Level 1 inputs that are either directly or indirectly observable, such as quoted market prices, interest rates and yield curves. ● Level 3: Unobservable inputs for the asset or liability (i.e., supported by little or no market activity). Level 3 inputs include management’s own assumptions about the assumptions that market participants would use in pricing the asset or liability (including assumptions about risk). To the extent the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair values requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized as Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. In accordance with the fair value hierarchy described above, the following tables set forth the Company’s assets and liabilities measured at fair value on a recurring basis: Level 1 Level 2 Level 3 Total Fair Value December 31, 2023 Assets: Cash equivalents – money market funds $ 73,988 $ — $ — $ 73,988 Cash equivalents – short-term U.S. Treasury securities — 22,993 — 22,993 Marketable securities – U.S. Treasury securities — 39,463 — 39,463 Total $ 73,988 $ 62,456 $ — $ 136,444 December 31, 2022 Assets: Cash equivalents – money market funds $ 20,013 $ — $ — $ 20,013 The Company’s marketable securities consist of U.S. Treasury debt securities with a contractual maturity date of 6 months. The following is a summary of available-for-sale marketable securities which provides a reconciliation of historical cost basis to fair value as of December 31, 2023, including cumulative unrealized gains and losses. Amortized Cost Unrealized Gain Unrealized Loss Fair Value December 31, 2023 U.S. Treasury securities $ 39,441 $ 22 $ — $ 39,463 Net loss per share Basic net loss per share of common stock is computed by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period. Diluted net loss per share of common stock is computed by adjusting net loss attributable to common stockholders to reallocate undistributed earnings based on the potential impact of dilutive securities. Diluted net loss per share of common stock is computed by dividing the diluted net loss by the weighted average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of common stock equivalents. The following potentially dilutive securities outstanding as of December 31, 2023 and 2022 have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive: Year ended December 31, 2023 2022 Stock options (1) 7,978,291 2,519,405 Common stock warrants (1) 500,000 1,303,112 8,478,291 3,822,517 (1) Represents common stock equivalents In periods in which the Company reports a net loss per share of common stock, diluted net loss per share of common stock is the same as basic net loss per share of common stock since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss per share of common stock for the years ended December 31, 2023 and 2022. Recently adopted accounting standards ASU 2016-13, Credit Losses On January 1, 2023, we adopted ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments . This standard amended the guidance on the recognition of impairment losses of certain financial instruments. The ASU established the current expected credit loss model, which is based on expected losses rather than incurred losses. Adoption of this standard had no impact on our consolidated financial statements. Recent accounting standards not yet adopted ASU 2023-09, Income Tax Disclosures In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures disclosures |
Merger
Merger | 12 Months Ended |
Dec. 31, 2023 | |
Merger | |
Merger | 3. Merger On October 2, 2023 the Company closed the Merger transaction contemplated by the Merger Agreement. As a result of the Merger, the Company acquired 100% of the outstanding equity interests of Morphimmune through the issuance of 8,835,710 shares of the Company’s common stock to Morphimmune stockholders, based upon an exchange ratio of 0.3042 shares of the Company’s common stock for each outstanding share of Morphimmune capital stock. Upon completion of the Merger, 8,128,096 options to purchase shares of Morphimmune capital stock pursuant to the Morphimmune 2020 Equity Incentive Plan, or Morphimmune Plan, were converted into 2,472,563 options to purchase shares of the Company’s common stock with a weighted average exercise price of $1.29 per share. The Company assumed the Morphimmune Plan and all other terms and conditions associated with these options, including vesting and exercisability, are governed by the original terms and conditions of the Morphimmune’s Plan. The Company accounted for the acquisition of Morphimmune as an asset acquisition as substantially all of the fair value of the gross assets acquired of Morphimmune was concentrated within two programs that are considered a group of similar assets. These programs are deemed to be similar IPR&D assets being acquired based on the similarity of: (i) their current preclinical stage of development, (ii) solid tumor therapeutic indications, (iii) risks for development, (iv) regulatory pathway, and (v) economics of commercialization. The consideration paid for an acquisition of assets is allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis. The fair value of the consideration transferred for the acquisition of Morphimmune was calculated based on the closing stock price of Immunome’s common stock on October 2, 2023, which was $8.20 per share, and based upon the vested and unvested balances of Morphimmune share-based awards as of the same date. Direct transaction costs for an asset acquisition are typically deferred and recognized as part of the consideration paid; however, the Company expensed $2.7 million of transaction costs for the Merger as incurred because substantially all of the fair value acquired relates to Morphimmune IPR&D assets that have no alternative future use and were immediately expensed following the closing of the Merger. Transaction costs capitalized as part of consideration paid were costs that were contingent on the closing of the Merger. The consideration paid and the relative fair values of assets acquired and liabilities assumed were as follows: Common stock issued to Morphimmune shareholders $ 72,453 Share-based equity awards allocated to consideration paid 14,708 Transaction costs 792 Consideration paid $ 87,953 Assets acquired: Cash and cash equivalents $ 10,068 Prepaid expenses and other current assets 191 Property and equipment 646 In-process research and development 80,802 Total assets acquired $ 91,707 Liabilities assumed: Accounts payable $ 1,147 Accrued expenses 2,607 Total liabilities assumed $ 3,754 Net assets acquired $ 87,953 Under the asset acquisition model, an entity that acquires IPR&D assets follows the guidance in ASC 730, Research and Development |
Collaboration Agreement with Ab
Collaboration Agreement with AbbVie | 12 Months Ended |
Dec. 31, 2023 | |
Collaboration Agreement with AbbVie | |
Collaboration Agreement with AbbVie | 4. Collaboration Agreement with AbbVie In January 2023, the Company entered into the Collaboration Agreement with AbbVie, pursuant to which the Company will use its discovery platform to discover and validate targets derived from patients with three specified tumor types, and antibodies that bind to such targets, which may be the subject of further development and commercialization by AbbVie. Pursuant to the terms of the Collaboration Agreement, the Company granted to AbbVie an exclusive option to purchase all rights to each novel target-antibody pair, or a Validated Target Pair or VTP, that the Company generates that meets certain mutually agreed criteria, up to a maximum of 10 in total, for all human and non-human diagnostic, prophylactic and therapeutic uses throughout the world, including the development and commercialization of certain products, or Products, derived from the assigned VTP. AbbVie paid the Company a nonrefundable upfront payment of $30.0 million in January 2023 and will pay certain additional platform access payments in the aggregate amount of up to $70.0 million based on the Company’s use of its discovery platform in connection with activities under each stage of the research plan, and delivery of VTPs to AbbVie. AbbVie will also pay an option exercise fee in the low single digit millions for each of up to 10 VTPs for which it exercises an option. If AbbVie progresses development and commercialization of a Product, AbbVie will pay the Company development and commercial sale milestones of up to $120.0 million per target, and sales milestones based on achievement of specified levels of net sales of Products of up to $150.0 million in the aggregate per Product, subject to specified deductions in certain circumstances. On a Product-by-Product basis, AbbVie will pay the Company tiered royalties on net sales of Products at a percentage in the low single digits, subject to specified reductions and offsets in certain circumstances. AbbVie’s royalty payment obligation will commence, on a Product-by-Product and country-by-country basis, on the first commercial sale of such Product in such country and will expire on the earlier of (a) the later of (i) the ten-year anniversary of the first commercial sale for such Product in such country, or (ii) solely with respect to a Product that incorporates an antibody comprising a VTP (or certain other antibodies derived from such delivered antibody), the expiration of all valid claims of patent rights covering the composition of matter of any such antibody and (b) the expiration of regulatory exclusivity for such Product in such country. The Collaboration Agreement will expire upon the expiration of the last to expire royalty payment obligation with respect to all Products in all countries, subject to earlier expiration if all option exercise periods for all VTPs expire without AbbVie exercising any option, if AbbVie does not elect to make certain platform access payments at specified points during the research term, or upon the uncured material breach or any insolvency event of either party. AbbVie may also terminate the Collaboration Agreement for convenience upon a specified period prior written notice, or upon the Company’s breach of representations and warranties with respect to debarment or compliance with anti-bribery and anti-corruption laws. The Company assessed the Collaboration Agreement under ASC 808 and ASC 606 and concluded that it represents a contract with a customer. The Company applied the relevant guidance of ASC 606 to evaluate the accounting under the Collaboration Agreement and identified one performance obligation under the arrangement: a promise to provide research and development services to AbbVie, or R&D Services. The Company evaluated the options to continue the R&D services and options to purchase licenses to each VTP and concluded that these options did not represent material rights. The Company determined the initial transaction price of the single performance obligation to be $30.0 million, as the variable consideration for additional R&D services, option exercise payments, and development milestone payments Collaboration revenue from the single performance obligation will be recognized over the estimated performance of the R&D services using the cost-to-cost input method which the Company believes best depicts the transfer of control to the customer. Under the cost-to-cost input method, the extent of progress towards completion is measured based on the ratio of actual costs incurred to the total estimated costs expected upon satisfying the performance obligation. The Company recognized $14.0 million of collaboration revenue for the year ended December 31, 2023. The following table summarizes the change in deferred revenue (in thousands): Year Ended December 31, 2023 Balance at the beginning of the period $ — Deferral of revenue 30,000 Recognition of unearned revenue (14,018) Balance at the end of the period $ 15,982 As of December 31, 2023, the Company expects to recognize the deferred revenue associated with the non-refundable upfront fee over the estimated remaining research and development period of approximately 1.5 years. |
Prepaid expenses and other curr
Prepaid expenses and other current assets | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid expenses and other current assets | |
Prepaid expenses and other current assets | 5. Prepaid expenses and other current assets Prepaid expenses and other current assets consisted of the following: December 31, (in thousands) 2023 2022 Short-term deposits $ 4,009 $ — Prepaid subscriptions and prepaid service contracts 718 876 Tax credit receivable — 847 Research and development advance payments 336 445 Prepaid insurance 950 158 Interest income receivable 289 — Other 259 — $ 6,561 $ 2,326 |
Property and equipment, net
Property and equipment, net | 12 Months Ended |
Dec. 31, 2023 | |
Property and equipment, net | |
Property and equipment, net | 6. Property and equipment, net Property and equipment consisted of the following: December 31, (in thousands) 2023 2022 Lab equipment $ 5,386 $ 3,681 Leasehold improvements 233 194 Computer equipment 326 235 Office equipment and furniture and fixtures 36 22 5,981 4,132 Less accumulated depreciation and amortization (3,908) (3,451) Property and equipment, net $ 2,073 $ 681 Depreciation and amortization expense was $0.5 million and $0.4 million for the years ended December 31, 2023 and 2022, respectively. |
Government assistance programs
Government assistance programs | 12 Months Ended |
Dec. 31, 2023 | |
Government assistance programs | |
Government assistance programs | 7. Government assistance programs DoD expense reimbursement contract In July 2020, the Company entered into the OTA Agreement with the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, or JPEO-CBRND, in collaboration with the Defense Health Agency, to fund the Company’s efforts in developing an antibody cocktail therapeutic to treat COVID-19. The amount of funding originally made available to the Company under the OTA Agreement was $13.3 million. In May 2021, the Company and the DoD amended the OTA Agreement, pursuant to which the DoD award was increased from $13.3 million to $17.6 million. In January 2023, the Company and the DoD modified the OTA Agreement to extend the termination date of the agreement to July 2023, at no additional cost to the government. Under the OTA Agreement, the DoD is required to pay the Company, upon submission of invoices for approved budgeted supplies delivered and services rendered in carrying out the prototype project, within 30 calendar days of receipt of request for payment. The Company received the maximum $17.6 million in expense reimbursement from the DoD under the OTA Agreement from inception through 2022. The Company recorded contra-research and development expense of $0.6 million for the year ended December 31, 2022, in the consolidated statements of operations and comprehensive loss. No contra-research and development expense related to the OTA Agreement was recorded during the year ended December 31, 2023. |
Accrued expenses and other liab
Accrued expenses and other liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Accrued expenses and other liabilities | |
Accrued expenses and other liabilities | 8. Accrued expenses and other liabilities Accrued expenses and other liabilities consisted of the following: December 31, (in thousands) 2023 2022 Research and development $ 1,680 $ 2,261 Compensation and related benefits 2,734 1,874 Severance accruals 1,436 — Professional fees 1,670 481 Short-term operating lease liability 310 229 Other 195 86 $ 8,025 $ 4,931 |
Commitments and contingencies
Commitments and contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and contingencies | |
Commitments and contingencies | 9. Commitments and contingencies Employment agreements The Company entered into employment agreements, or the Employment Agreements, with certain key personnel providing for compensation and severance in certain circumstances, as defined in the respective Employment Agreements. The Employment Agreements may be terminated by either the Company or the employees in accordance with the respective Employment Agreements (subject to the payment of severance upon certain terminations) and provide for annual pay adjustments and bonuses at the discretion of the Board of Directors. Employee benefit plan The Company maintains a defined-contribution plan under Section 401(k) of the Internal Revenue Code, or the 401(k) Plan. The 401(k) Plan covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. The Company assumes all administrative costs of the 401(k) Plan and makes matching contributions as defined in the 401(k) Plan document. The Company made matching contributions of $0.2 million to the 401(k) Plan for the years ended December 31, 2023 and 2022, respectively. |
Licensing arrangements
Licensing arrangements | 12 Months Ended |
Dec. 31, 2023 | |
Licensing arrangements | |
Licensing arrangements | 10. Licensing arrangements License Agreement with Purdue Research Foundation Upon closing of the merger with Morphimmune, the Company assumed certain license agreements that Morphimmune had entered into prior to the Merger. In January 2022, Morphimmune entered into a Master License Agreement, or the Purdue License Agreement, with Purdue Research Foundation, or PRF. Under the Purdue License Agreement, PRF granted Morphimmune a royalty-bearing, transferable, worldwide, exclusive license, sublicensable through multiple tiers, under certain intellectual property owned by PRF to research, develop, manufacture, and commercialize the licensed products in all fields of use with limited exceptions. Under the Purdue License Agreement, Morphimmune paid PRF a one-time upfront payment of $0.2 million upon execution and $0.1 million on each of the first and second anniversary of the effective date of the Purdue License Agreement. During the period commencing on the date of first commercial sale of a licensed product and ending upon the date of expiration of the last valid claim of the licensed patents covering such licensed product in a country, referred to as the royalty term, the Company will pay PRF an earned unit royalty of a low single-digit percentage on gross receipts from sale of the licensed product, and beginning with the first sale of a licensed product, a tiered minimum annual royalty from the low to mid six-digit figure range less the unit royalties due for the annual period. Upon the achievement of specified development and commercialization milestones, Morphimmune will pay PRF the milestone payments as specified in the Purdue License Agreement, which may be up to $3.8 million in the aggregate. The Company is also required to pay PRF an annual maintenance fee ranging from a low five-digit figure to a low six-digit figure prior to first sale of a licensed product and a low double-digit percentage of sublicense income received for sublicenses of licensed intellectual property, the percentage depending upon the timing of execution of the sublicense. The Purdue License Agreement expires on a licensed product-by-licensed product and country-by-country basis, upon expiration of the royalty term for such licensed product for the applicable country. The Company may terminate the Purdue License Agreement upon at least one month’s prior written notice to PRF. PRF may terminate the Purdue License Agreement and the licenses granted thereunder if the Company fails to cure a payment default or other material breach of the Purdue License Agreement after written notice from PRF, or if Morphimmune becomes insolvent. 2023 Amendment to Exclusive License Agreement In June 2019, the Company entered into an exclusive license agreement, or the Arrayjet Agreement, with Arrayjet Limited, or Arrayjet, amended on July 10, 2020, December 30, 2022 and December 24, 2023. Immunome and Arrayjet terminated the Arrayjet Agreement pursuant to the December 2023 amendment. 2021 Patent License Agreement In June 2021, the Company entered into an exclusive worldwide patent license agreement with several Philadelphia based universities and hospitals, or the Licensors, to further discover, develop and commercialize human antibodies, identified using Immunome’s human hybridoma technology, for the treatment of diseases associated with the formation of bacterial biofilms. The Licensors are eligible to receive up to $2.2 million in the aggregate for certain regulatory, developmental, and commercial milestone payments. In addition, the Licensors are eligible to receive low single digit royalty rates for net product sales, which are subject to adjustment in the event the Company sublicenses the approved technology. The Company recorded $0.1 million and $0.1 million in initiation and minimum annual payments related to this agreement for the years ended December 31, 2023 and 2022, respectively, in research and development expenses in the statement of operations and comprehensive loss. Effective December 12, 2023, the Patent License Agreement was terminated, and the Company has no remaining obligations under this agreement. Other License Agreements The Company has entered into various other license agreements to further discover, develop and commercialize certain technologies and treatments. As of December 31, 2023, the Company may need to pay developmental and regulatory milestone payments of up to approximately $2.9 million. In addition, the Company may need to pay royalty rates on net product sales, a portion of certain sublicense and collaboration payments, and certain commercial milestone payments of up to approximately $2.8 million, if any. The Company recorded $0.1 million in development and regulatory milestone payments during the year ended December 31, 2022 in research and development expenses in the consolidated statements of operations and comprehensive loss. There was no similar expense for the year ended December 31, 2023. Whitehead Letter Agreement On November 17, 2022, the Company entered into a Letter Agreement, or the Letter Agreement, with the Whitehead Institute of Biomedical Research, or Whitehead, which became effective on January 4, 2023 upon the satisfaction of the conditions described therein. The Letter Agreement supplements the Exclusive Patent License Agreement entered into between the Company and Whitehead on June 25, 2009 (as amended on December 17, 2009, March 21, 2013, August 21, 2017 and July 21, 2020, the License Agreement), which has since expired. Pursuant to the Letter Agreement, Whitehead and the Company agreed that certain payments received by the Company from the Collaborator (as defined in the Letter Agreement) (i.e., a corporate partner, as defined in the License Agreement) would be excluded from the Company’s payment obligations to Whitehead. The Company and Whitehead further agreed, among other things, that the Company will make certain payments to Whitehead (i) as Net Sales (as defined in the License Agreement) as long as the Company receives those payments from the Collaborator on a specified number of products purchased by the Collaborator and (ii) upon the achievement of certain milestones whether by the Company or the Collaborator. . |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
Leases | 11. Leases The Company currently leases approximately 11,000 square feet of office and laboratory space in Exton, Pennsylvania under a lease that expires on March 31, 2025. The Company currently leases approximately 14,000 square feet of office and laboratory space in Bothell, Washington, under a lease that expires on October 31, 2028. Supplemental balance sheet information related to leases as of December 31, 2023 and 2022 are as follows (in thousands): Year Ended December 31, 2023 Year Ended December 31, 2022 Operating leases: Operating lease right-of-use assets $ 1,564 $ 284 Operating lease liability, current portion $ 310 $ 229 Operating lease liability, net of current portion 1,340 62 Total operating lease liability $ 1,650 $ 291 Operating lease liability and operating lease liability, net of current portion is included in accrued expenses and other current liabilities and other long-term liabilities, respectively, in the accompanying consolidated balance sheets. Operating lease expense recorded as research and development and general and administrative expenses in the consolidated statements of operations and comprehensive loss is as follows (in thousands): Operating lease cost (in thousands) Year Ended December 31, 2023 Year Ended December 31, 2022 General and administrative $ 161 $ 78 Research and development 164 163 Total lease expense $ 325 $ 241 Short term lease expense recorded as research and development expense in the consolidated statements of operations and comprehensive loss was $0.2 million and $0.1 million for years ended December 31, 2023 and 2022, respectively. Other information related to the operating leases where the Company is the lessee was as follows: Year Ended December 31, 2023 Year Ended December 31, 2022 Weighted-average remaining lease term (in years) 4.81 1.25 Weighted-average discount rate 8.3% 9.0% Supplemental cash flow information related to the operating leases was as follows (in thousands): Year Ended December 31, 2023 Year Ended December 31, 2022 Cash paid for operating lease liability $ 246 $ 234 As of December 31, 2023, minimum rental commitments under the operating leases were as follows (in thousands): Years ending December 31, Amount 2024 $ 451 2025 464 2026 412 2027 422 2028 433 Total lease payments 2,182 Less imputed interest (532) Present value of lease liability $ 1,650 |
Common stock
Common stock | 12 Months Ended |
Dec. 31, 2023 | |
Common stock. | |
Common stock | 12. Common stock Common stock The holders of common stock are entitled to one vote for each share of common stock. Subject to the approval of the majority of shareholders, the holders of common stock shall be entitled to receive dividends out of funds legally available. In the event of any voluntary or involuntary liquidation, dissolution, or winding up of the Company, the holders of common stock shall be entitled to share ratably in the remaining assets of the Company available for distribution. In June 2023, in connection with the Merger Agreement, the Company entered into subscription agreements with certain investors pursuant to which the Company sold 21,690,871 shares of its common stock, immediately following the completion of the Merger, in exchange for gross proceeds of $125.0 million. The Company also incurred $9.0 million of offering costs which were netted against the proceeds in the consolidated balance sheet. On January 15, 2023, the Company issued 55,250 shares of common stock in the aggregate to certain non-employee board of directors pursuant to the 2020 Equity Incentive Plan in lieu of the non-employee director board and committee cash retainers owed for service on the board of directors in 2022. On October 1, 2021, the Company entered into the ATM Agreement with Jefferies Group LLC, which provides that, upon the terms and subject to the conditions and limitations in the ATM Agreement, the Company may elect, from time to time, to offer and sell shares of common stock under the registration statement having an aggregate offering price of up to $75.0 million through Jefferies Group LLC acting as sales agent. The Company filed a shelf registration statement on Form S-3, which was declared effective by the SEC on October 14, 2021, pursuant to which the Company may issue from time-to-time securities with an aggregate value of up to $200.0 million. In January 2023, the Company sold 5,925 shares of common stock under the ATM Agreement resulting in net proceeds of approximately $34,000 . In November 2023, the Company the ATM Agreement. Warrants to acquire shares of common stock On September 2, 2022, the Company notified holders of the Company’s Series B Warrants, or the Holders, of the Company’s agreement to permit Holders to exercise the Series B Warrants at an exercise price of $10.00 per share (reduced from the previous exercise price of $45.00 per share) at any time prior to the expiration date of the Series B Warrants. The Company recognized a deemed dividend of $0.6 million, which represents the incremental fair value of the outstanding warrants as a result of the modification. This deemed dividend is recorded in the Company's consolidated statement of operations and comprehensive loss as an increase to the net loss attributable to common stockholders for purposes of computing net loss per share, basic and diluted. The net impact to the consolidated statements of changes in stockholders’ equity was zero because the warrants were equity classified before and after the modification. At December 31, 2023 common stock warrants outstanding were as follows: Warrants Warrants Outstanding Exercise Price per Share Expiration Date Series B 500,000 $ 10.00 April 28, 2024 For the years ended December 31, 2023 and 2022, no warrants were exercised. |
Share-based compensation
Share-based compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-based compensation | |
Share-based compensation | 13. Share-based compensation On September 18, 2020, the Company adopted the 2020 Equity Incentive Plan, or the 2020 Plan, which supersedes all prior equity incentive plans. Under the 2020 Plan, the number of shares of common stock reserved for issuance under the 2020 Plan will automatically increase on January 1 of each year, beginning on January 1, 2021 and continuing through and including January 1, 2030, by 4% of the total number of shares of the Company’s capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Company’s Board of Directors. On January 1, 2023, the number of shares available for future issuance under the 2020 Plan increased by 485,153 shares. Through a board resolution related to the Merger, the number of shares available for future issuance under the 2020 Plan increased by 2,955,280 shares on September 29, 2023. As of December 31, 2023, there were 3,320,601 shares available for future issuance under the 2020 Plan. On January 1, 2024, the number of shares available for future issuance under the 2020 Plan increased by 1,730,071. The Company also adopted the 2020 Employee Stock Purchase Plan, or the ESPP, on September 18, 2020 which provides for the grant of purchase rights to purchase shares of the Company’s common stock to eligible employees, as defined by the ESPP. The maximum number of shares of common stock that may be issued under the ESPP will not exceed 125,000 shares of common stock, plus the number of shares of common stock that are automatically added on January 1 of each calendar year for a period of up to ten years, commencing on the first January 1 following the year in which an IPO occurs and ending on, and including, January 1, 2030, in an amount equal to the lesser of (i) 1% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year, and (ii) 1,000,000 shares of common stock. On January 1, 2023, the number of shares available for future issuance under the ESPP increased by 121,288 shares. As of December 31, 2023, there were 473,733 shares available under the ESPP. No shares of common stock have been issued under the ESPP as of December 31, 2023. On January 1, 2024, the number of shares available for future issuance under the ESPP increased by 432,518. The 2020 Plan and the ESPP are administered by the Board of Directors subject to the Board’s right to delegate to a committee. The exercise prices, vesting and other restrictions are determined at the discretion of the Board of Directors. Stock options awarded under the 2020 Plan generally expire 10 years after the grant date unless the Board of Directors sets a shorter term. Vesting periods for awards under the 2020 Plan are determined at the discretion of the Board of Directors. Stock options granted to employees, officers, members of the Board of Directors and consultants of the Company typically vest over one On October 2, 2023, the Morphimmune Plan was assumed by the Company in conjunction with the Merger (Note 3). There were 929,702 shares available for issuance under the Morphimmune Plan as of December 31, 2023. Stock Options Granted for New Chief Executive Officer On June 28, 2023 and contingent upon completion of the Merger, the Company entered into an employment agreement with Dr. Clay Siegall, the President and CEO of Morphimmune whereby Dr. Siegall was granted 2,137,080 options to purchase shares of the Company’s common stock at an initial exercise price of $5.91 per share, or the inducement grant. The options vest over time during Dr. Siegall’s continued employment, which commenced on October 2, 2023 in connection with the closing of the Merger, to which 25% of the options granted will vest after one year of employment with the Company and the remaining 75% of the options granted will vest monthly over the remaining 36 months following the one year anniversary. Dr. Siegall’s stock option is subject to acceleration if he resigns for “good reason” or the Company terminates his employment without “cause” within a “change of control period” (each as defined in Dr. Siegall’s employment agreement). The estimated grant date fair value of Dr. Siegall’s award was $14.2 million or $6.65 per share. The inducement grant, 2020 Morphimmune Plan, and the 2020 Plan are collectively known as the “Plans”. Share-based compensation expense recorded as research and development and general and administrative expenses in the consolidated statements of operations and comprehensive loss is as follows (in thousands): Year Ended December 31, In thousands) 2023 2022 General and administrative $ 4,242 $ 3,471 Research and development 1,981 1,861 $ 6,223 $ 5,332 Unrecognized compensation cost related to unvested options was $22.8 million as of December 31, 2023 and will be recognized over an estimated weighted average period of 1.9 years. Stock options The weighted average assumptions used in the Black-Scholes option-pricing model for stock options granted were: Year ended December 31, 2023 2022 Expected volatility 92.1 % 85.6 % Risk-free interest rate 4.6 % 2.7 % Expected term (in years) 5.6 6.0 Expected dividend yield — — Fair value of common stock $ 7.92 $ 3.63 A summary of option activity under the Plans during the year ended December 31, 2023 is as follows: Weighted Weighted average average remaining Number of exercise price contractual shares per share term (years) Outstanding at January 1, 2023 2,519,405 9.60 Replacement options issued at asset acquisition 2,472,563 1.29 Granted 4,007,552 6.42 Forfeited (314,319) 6.67 Expired (55,670) 16.59 Exercised (651,240) 1.57 Outstanding at December 31, 2023 7,978,291 6.15 8.62 Exercisable at December 31, 2023 3,151,799 5.86 7.54 The weighted-average grant date fair value per share of stock options granted during the years ended December 31, 2023 and 2022 was $6.09 and $2.65 , respectively. The weighted-average grant date fair value per share of the replacement awards issued to Morphimmune stockholders on October 2, 2023 was $7.55 . The aggregate intrinsic value for options exercised during the years ended December 31, 2023 and December 31, 2022 was $5.9 million and $0.2 million, respectively. The aggregate intrinsic value for options exercisable at December 31, 2023 was $21.9 million. The aggregate intrinsic value of stock options outstanding at December 31, 2023 was $45.4 million. Accelerated Vesting Due to Termination Effective October 2, 2023, in accordance with the Merger, the former CEO’s employment with the Company was terminated. Based on the terms of his severance agreement, any options that were scheduled to vest through October 2, 2025 were accelerated to vest at termination with an exercise window of 3-months after termination. The Company accounted for the change in vesting terms as an improbable-to-probable modification of his stock options and recognized |
Income taxes
Income taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income taxes | |
Income taxes | 14. Income taxes A reconciliation of the federal income tax rate to the Company’s effective tax rate is as follows: Year ended December 31, 2023 2022 Federal tax benefit at statutory rate 21.0 % 21.0 % State tax, net of federal benefit (1.3) 4.3 Effects of state tax legislation, net of federal benefit — (7.1) Research and development credits 0.7 1.9 Permanent differences (0.9) (0.2) Write-off of IPR&D (15.9) — Change in valuation allowance (3.6) (19.9) — % — % The components of the Company’s deferred taxes are as follows (in thousands): December 31, (in thousands) 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 22,784 $ 20,523 Research and development intangibles 10,135 4,839 Research and development credits 3,782 2,878 Share-based compensation 2,533 2,016 Accrued bonus 546 383 Lease liability 350 — Other 75 1 Gross deferred tax assets 40,205 30,640 Less: valuation allowance (39,827) (30,609) Net deferred tax asset 378 31 Deferred tax liability Depreciation (46) (31) Right-of-use asset (332) — Total deferred tax liabilities (378) (31) Net deferred taxes $ — $ — The Company had no income tax expense due to the operating losses utilization for the year ended December 31, 2023 and 2022. Management has evaluated the positive and negative evidence bearing upon the realizability of the Company’s net deferred tax assets and has determined that it is more likely than not that the Company will not recognize the benefits of the net deferred tax assets. As a result, the Company has recorded a full valuation allowance at December 31, 2023 and 2022. The valuation allowance increased by $9.2 million and $7.4 million in 2023 and 2022, respectively, due to the acquisition of Morphimmune, increase in net operating loss carryforwards and research and development tax credits, and deductible accrued expenses. Realization of the future tax benefits is dependent on many factors, including the Company’s ability to generate taxable income within the net operating loss carryforward period. Under the provisions of the Internal Revenue Code, certain substantial changes in the Company’s ownership, including a sale of the Company or significant changes in ownership due to sales of equity, may have limited, or may limit in the future, the amount of net operating loss and other attributes including research and development credit carry forwards which could be used annually to offset future taxable income. Utilization of the net operating loss carryforwards and research and development tax credit carryforwards may be subject to a substantial annual limitation under Sections 382 and 383 of the Internal Revenue Code of 1986 due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of net operating loss and research and development credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. Based upon a preliminary evaluation of ownership changes through December 31, 2023, the Company believes that an ownership change likely occurred as a result of the Morphimmune transaction on October 2, 2023 that could limit the Company’s ability to utilize its net operating loss or research and development credit carryforwards. The evaluation has not been finalized as of the date of these consolidated financial statements. As of December 31, 2023, the Company had $92.6 million of federal and $84.3 million of state net operating loss carryforwards. If not utilized, the federal and state net operating loss carryforwards expire starting in 2027. Included in the federal net operating loss carryforwards are $75.6 million of net operating losses generated from 2018 to 2023 that will not expire and are limited to offset 80% of the Company’s taxable income for years beginning after December 31, 2020. Certain federal and state net operating loss carryforwards expire at various dates through 2042. As of December 31, 2023, the Company had cumulative $3.5 million of federal and $0.2 million of state R&D tax credits As of December 31, 2023 and 2022, the Company has $37,000 of uncertain tax positions on the research and development credits from Morphimmune. The Company recognizes both interest and penalties associated with unrecognized tax benefits as a component of income tax expense. The Company has not recorded any interest or penalties for unrecognized tax benefits since its inception. The Company filed income tax returns in the United States and Pennsylvania in all tax years since inception. The tax years 2006 and beyond |
Subsequent events
Subsequent events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent events. | |
Subsequent events | 15. Subsequent events Zentalis Pharmaceuticals, Inc. License Agreement On January 5, 2024, the Company entered into a license agreement with Zentalis Pharmaceuticals, Inc., or the Zentalis License, pursuant to which the Company received an exclusive, worldwide, royalty-bearing, sublicensable license under certain intellectual property relating to Zentalis’ proprietary antibody-drug conjugate, or ADC, platform technology, ROR1 antibodies and ADCs targeting ROR1 to exploit products covered by or incorporating the licensed intellectual property rights. Under the Zentalis License, the Company is required to use commercially reasonable efforts to develop an ADC targeting ROR1, two additional ADCs, and commercialize any product that has received regulatory approval. Under the Zentalis Agreement, the Company paid to Zentalis upfront consideration totaling $15 million in cash and $20 million in shares of Company common stock, with the shares valued at the trailing 30-day The Zentalis License will continue until the expiration of all royalty payment obligations. The Zentalis License may be terminated early by (a) either party in its entirety upon (i) the other party’s uncured material breach, subject to a notice and cure period, (ii) any insolvency event of the other party or (iii) prolonged force majeure, (b) the Company, either in its entirety or in part, for convenience upon a specified period prior written notice, or (c) Zentalis (i) in its entirety if the Company challenges one of the licensed patents or (ii) fails to meet certain development activity benchmarks within specified time periods. Asset Purchase Agreement On February 5, 2024, the Company and Ayala Pharmaceuticals, Inc., or Ayala, entered into an Asset Purchase Agreement, or the Ayala Purchase Agreement, pursuant to which the Company will acquire Ayala’s AL101 and AL102 programs and assume certain of Ayala’s liabilities associated with the acquired assets, or the Ayala Asset Purchase. On March 25, 2024, the Company consummated the Ayala Asset Purchase, or the Ayala Closing. At the Ayala Closing, the Company (i) paid Ayala $20.0 million, less certain adjustments, (ii) issued Ayala 2,175,489 shares of Company common stock, or the Ayala Shares, with the shares valued at the trailing 30-day volume-weighted average price and (iii) assumed specified liabilities. The Company is obligated to pay Ayala up to $37.5 million in development and commercial milestones. Follow-On Public Offering On February 16, 2024, the Company completed a public offering of 11,500,000 shares of the Company’s common stock at a price of $20.00 per share. The gross proceeds to the Company from the offering were $230.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. Atreca On December 22, 2023, the Company announced that it had reached agreement with Atreca, Inc., or Atreca, on the terms of a cash acquisition pursuant to which the Company would acquire certain antibody-related assets and materials for an upfront payment of $5.5 million and up to $7.0 million in clinical development milestones. The closing of the transaction is subject to customary conditions, including the approval of Atreca’s stockholders. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Summary of significant accounting policies | |
Basis of presentation | Basis of presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted, or GAAP, in the United States. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification, or ASC, and Accounting Standards Updates, or ASU, promulgated by the Financial Accounting Standards Board, or FASB. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Use of estimates | Use of estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses. The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the expected volatility used to estimate fair value of stock options, accrued research and development expenses, the fair value of acquired in-process research and development assets, and the estimated costs which drive the revenue recognition for the Collaboration Agreement with AbbVie. Estimates and assumptions are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from these estimates. |
Segment and geographic information | Segment and geographic information Operating segments are defined as components of an entity about which separate discrete information is available for evaluation by the chief operating decision maker, or CODM, or decision-making group, in deciding how to allocate resources and in assessing performance. The CODM is the Company’s Chief Executive Officer. The Company views its operations as and manages its business in one operating segment operating exclusively in the United States. |
Cash and Cash Equivalents | Cash and cash equivalents Cash and cash equivalents consist of standard checking accounts, a money market account and three-month treasury bills. The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. |
Restricted cash | Restricted cash Restricted cash represents collateral provided for a letter of credit issued as a security deposit in connection with the Company’s lease of its corporate facilities. Cash will be released from restriction upon termination of the lease. Restricted cash was $100,000 at both December 31, 2023 and 2022, respectively. The following table provides a reconciliation of the components of cash and cash equivalents and restricted cash presented in the consolidated statements of cash flows: (in thousands) December 31, 2023 December 31, 2022 Cash and cash equivalents $ 98,679 $ 20,323 Restricted cash 100 100 $ 98,779 $ 20,423 |
Marketable Securities | Marketable Securities The Company’s marketable securities consist of investments in U.S. Treasury debt securities. Debt securities are classified as available-for-sale and are carried at fair value with the unrealized gains and losses, net of tax, included in accumulated other comprehensive income, a component of stockholders’ equity. These debt securities have an original maturity period greater than 90 days, but less than one year. The Company classifies marketable securities that are available for use in current operations as current assets on the consolidated balance sheets. Unrealized losses are evaluated for impairment under ASC 326 , Financial Instruments - Credit Losses, or |
Concentration of credit risk | Concentration of credit risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash and cash equivalents and marketable securities. The Company maintains deposits in a financial institution in excess of government insured limits. Management believes that the Company is not exposed to significant credit risk as the Company’s deposits are held at a financial institution that management believes to be of high credit quality, and the Company has not experienced any losses on these deposits. Management also believes that the Company is not exposed to significant credit risk as it relates to marketable securities because the Company only invests in U.S government securities. |
Property and equipment | Property and equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset as follows: Asset category Estimates useful life Lab equipment 5 years Leasehold improvements Lesser of lease term or 5 years Computer equipment 3 years Office equipment 5 years Furniture and fixtures 5 years Expenditures for repairs and maintenance of assets are charged to expense as incurred, while major betterments are capitalized. Upon retirement or sale, the cost and related accumulated depreciation and amortization of assets disposed of are removed from the accounts and any resulting gain or loss is included in the consolidated statements of operations and comprehensive loss. |
Asset Acquisitions | Asset Acquisitions Acquisitions of assets or a group of assets that do not meet the definition of a business are accounted for as asset acquisitions, with a cost accumulation model used to determine the cost of the acquisition. Common stock issued as consideration in an acquisition of assets is generally measured based on the acquisition date fair value of the equity interests issued. Direct transaction costs are recognized as part of the cost of an acquisition of assets. Intangible assets that are acquired in an asset acquisition for use in research and development activities that have an alternative future use are capitalized as in-process research and development, or IPR&D. Acquired IPR&D that has no alternative future use is expensed immediately in the consolidated statements of operations and comprehensive loss. For further disclosures related to asset acquisitions see Note 3 to the consolidated financial statements. |
Impairment of long-lived assets | Impairment of long-lived assets The Company evaluates its long-lived assets, which consist primarily of property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset exceeds the fair value of the asset. There were no impairment losses recognized during the years ended December 31, 2023 and 2022. |
Equity issuance costs | Equity issuance costs The Company capitalizes costs directly associated with equity financings as deferred offering costs on its consolidated balance sheet. These costs remain capitalized until such financings are consummated, at which time such costs are recorded against the gross proceeds from the applicable financing. If a financing is abandoned, deferred offering costs are expensed. As of December 31, 2022, there were $0.3 million of deferred offering costs related to the Open Market Sale Agreement, or the ATM Agreement, and shelf registration that were expensed in 2023 as a result of the termination of the ATM Agreement. There were no deferred offering costs as of December 31, 2023. |
Government assistance programs | Government assistance programs The Company accounts for amounts received under its DoD expense reimbursement contract as contra-research and development expenses in the consolidated statements of operations and comprehensive loss. |
Collaboration revenue | Collaboration revenue The Company evaluates its collaborative arrangements pursuant to ASC 808, Collaborative Arrangements Revenue from Contracts with Customers Payments pursuant to collaborative arrangements may include non-refundable upfront payments, research option and license option payments, milestone payments upon the achievement of significant regulatory and development events, commercial sales milestones, and royalties on product sales. The amount of variable consideration is constrained until it is probable that the revenue is not at a significant risk of reversal in a future period. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under a collaboration arrangement, the Company applies the five-step model of ASC 606: (i) identify the contract with a customer; (ii) identify the performance obligations in the contract, including whether they are capable of being distinct; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company applies significant judgment when evaluating whether contractual obligations represent distinct performance obligations, allocating transaction price to performance obligations within a contract, determining when performance obligations have been met, and assessing the recognition of variable consideration. When consideration is received prior to the Company completing its performance obligation under the terms of a contract, a contract liability is recorded as deferred revenue. Deferred revenue expected to be recognized as revenue within the twelve months following the balance sheet date is classified as a current liability. In January 2023, the Company entered into the Collaboration Agreement with AbbVie, which was determined to be within the scope of ASC 606. Please see Note 4 for further information related to the accounting for the Collaboration Agreement. |
Research and development expenses | Research and development expenses Research and development costs are charged to expense as incurred. Research and development costs consist of costs incurred in performing research and development activities, including salaries and bonuses, share-based compensation, employee benefits, facilities costs, laboratory supplies, depreciation and amortization, preclinical and clinical development expenses, including manufacture and testing of clinical supplies, consulting and other contracted services. Additionally, under the terms of the license agreements described in Note 10, the Company is obligated to make future payments should certain development, regulatory, and sales milestones be achieved. Costs for certain research and development activities are recognized based on the terms of the individual arrangements, which may differ from the timing of receipt of invoices and payment of invoices and are reflected in the financial statements as a prepaid or accrued expense. |
Share-based compensation | Share-based compensation The Company’s share-based compensation program allows for grants of stock options and restricted stock awards. Grants are awarded to employees and non-employees, including directors. The Company accounts for its share-based compensation awards granted to employees and non-employees based on the estimated fair value on the date of grant and recognized compensation expense of those awards over the requisite service period, which is the vesting period of the respective award. The Company accounts for forfeitures as they occur. For share-based awards with service-based vesting conditions, the Company recognized compensation expense on a straight-line basis over the service period. The Company classified share-based compensation expense in its statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified. The Company estimates the fair value of options granted using the Black-Scholes option pricing model for stock option grants to both employees and non-employees. The Black-Scholes option pricing model requires inputs based on certain subjective assumptions, including (i) the expected stock price volatility, (ii) the expected term of the award, (iii) the risk-free interest rate and (iv) expected dividends. Due to the lack of Company-specific historical and implied volatility data, the Company has based its computation of expected volatility on the historical volatility of a representative group of public companies with similar characteristics to the Company, including stage of product development and biopharmaceutical industry focus. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. The Company uses the simplified method to calculate the expected term for options granted to employees and non-employees whereby, the expected term equals the arithmetic average of the vesting term and the original contractual term of the options due to its lack of sufficient historical data. The risk-free interest rate is based on U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock. The exercise price is the fair value of the common stock as of the measurement date. |
Patent costs | Patent costs All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses in the accompanying consolidated statements of operations and comprehensive loss. |
Leases | Leases The Company accounts for leases in accordance with ASC 842, Leases Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the remaining lease term. Options to extend the lease term are included in the Company’s assessment of the lease term only if there is a reasonable assessment that the Company will renew. Lease payments are discounted to their present value using either the interest rate implicit in the lease or the Company’s incremental borrowing rate, which reflects the fixed rate in which the Company could borrow on a collateralized basis the amount of lease payments in the same currency, for a similar term, in a similar economic environment. |
Income taxes | Income taxes The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the Company’s consolidated financial statements and tax returns. Deferred tax assets and liabilities are determined based upon the differences between the financial statement carrying amounts and the tax bases of existing assets and liabilities and for loss and credit carryforwards, using enacted tax rates expected to be in effect in the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that these assets may not be realized. The Company determines whether it is more likely than not that a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more-likely-than-not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency. The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes. |
Fair value of financial instruments | Fair value of financial instruments ASC Topic 820, Fair Value Measurement ● Level 1: Quoted market prices in active markets for identical assets or liabilities. ● Level 2: Inputs other than Level 1 inputs that are either directly or indirectly observable, such as quoted market prices, interest rates and yield curves. ● Level 3: Unobservable inputs for the asset or liability (i.e., supported by little or no market activity). Level 3 inputs include management’s own assumptions about the assumptions that market participants would use in pricing the asset or liability (including assumptions about risk). To the extent the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair values requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized as Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. In accordance with the fair value hierarchy described above, the following tables set forth the Company’s assets and liabilities measured at fair value on a recurring basis: Level 1 Level 2 Level 3 Total Fair Value December 31, 2023 Assets: Cash equivalents – money market funds $ 73,988 $ — $ — $ 73,988 Cash equivalents – short-term U.S. Treasury securities — 22,993 — 22,993 Marketable securities – U.S. Treasury securities — 39,463 — 39,463 Total $ 73,988 $ 62,456 $ — $ 136,444 December 31, 2022 Assets: Cash equivalents – money market funds $ 20,013 $ — $ — $ 20,013 The Company’s marketable securities consist of U.S. Treasury debt securities with a contractual maturity date of 6 months. The following is a summary of available-for-sale marketable securities which provides a reconciliation of historical cost basis to fair value as of December 31, 2023, including cumulative unrealized gains and losses. Amortized Cost Unrealized Gain Unrealized Loss Fair Value December 31, 2023 U.S. Treasury securities $ 39,441 $ 22 $ — $ 39,463 |
Net loss per share | Net loss per share Basic net loss per share of common stock is computed by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period. Diluted net loss per share of common stock is computed by adjusting net loss attributable to common stockholders to reallocate undistributed earnings based on the potential impact of dilutive securities. Diluted net loss per share of common stock is computed by dividing the diluted net loss by the weighted average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of common stock equivalents. The following potentially dilutive securities outstanding as of December 31, 2023 and 2022 have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive: Year ended December 31, 2023 2022 Stock options (1) 7,978,291 2,519,405 Common stock warrants (1) 500,000 1,303,112 8,478,291 3,822,517 (1) Represents common stock equivalents In periods in which the Company reports a net loss per share of common stock, diluted net loss per share of common stock is the same as basic net loss per share of common stock since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss per share of common stock for the years ended December 31, 2023 and 2022. |
Recently adopted accounting standards | Recently adopted accounting standards ASU 2016-13, Credit Losses On January 1, 2023, we adopted ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments . This standard amended the guidance on the recognition of impairment losses of certain financial instruments. The ASU established the current expected credit loss model, which is based on expected losses rather than incurred losses. Adoption of this standard had no impact on our consolidated financial statements. Recent accounting standards not yet adopted ASU 2023-09, Income Tax Disclosures In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures disclosures |
Summary of significant accoun_3
Summary of significant accounting policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Summary of significant accounting policies | |
Schedule of reconciliation of the components of cash and restricted cash reported in balance sheet | (in thousands) December 31, 2023 December 31, 2022 Cash and cash equivalents $ 98,679 $ 20,323 Restricted cash 100 100 $ 98,779 $ 20,423 |
Schedule of useful lives of property and equipment | Asset category Estimates useful life Lab equipment 5 years Leasehold improvements Lesser of lease term or 5 years Computer equipment 3 years Office equipment 5 years Furniture and fixtures 5 years |
Schedule of assets and liabilities measured at fair value on a recurring basis | Level 1 Level 2 Level 3 Total Fair Value December 31, 2023 Assets: Cash equivalents – money market funds $ 73,988 $ — $ — $ 73,988 Cash equivalents – short-term U.S. Treasury securities — 22,993 — 22,993 Marketable securities – U.S. Treasury securities — 39,463 — 39,463 Total $ 73,988 $ 62,456 $ — $ 136,444 December 31, 2022 Assets: Cash equivalents – money market funds $ 20,013 $ — $ — $ 20,013 |
Summary of available-for-sale marketable securities | Amortized Cost Unrealized Gain Unrealized Loss Fair Value December 31, 2023 U.S. Treasury securities $ 39,441 $ 22 $ — $ 39,463 |
Schedule of potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive | Year ended December 31, 2023 2022 Stock options (1) 7,978,291 2,519,405 Common stock warrants (1) 500,000 1,303,112 8,478,291 3,822,517 |
Merger (Tables)
Merger (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Merger | |
Schedule of fair values of assets acquired and liabilities | Common stock issued to Morphimmune shareholders $ 72,453 Share-based equity awards allocated to consideration paid 14,708 Transaction costs 792 Consideration paid $ 87,953 Assets acquired: Cash and cash equivalents $ 10,068 Prepaid expenses and other current assets 191 Property and equipment 646 In-process research and development 80,802 Total assets acquired $ 91,707 Liabilities assumed: Accounts payable $ 1,147 Accrued expenses 2,607 Total liabilities assumed $ 3,754 Net assets acquired $ 87,953 |
Collaboration Agreement with _2
Collaboration Agreement with AbbVie (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Collaboration Agreement with AbbVie | |
Summarizes the change in deferred revenue | The following table summarizes the change in deferred revenue (in thousands): Year Ended December 31, 2023 Balance at the beginning of the period $ — Deferral of revenue 30,000 Recognition of unearned revenue (14,018) Balance at the end of the period $ 15,982 |
Prepaid expenses and other cu_2
Prepaid expenses and other current assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid expenses and other current assets | |
Schedule of prepaid expenses and other current assets | December 31, (in thousands) 2023 2022 Short-term deposits $ 4,009 $ — Prepaid subscriptions and prepaid service contracts 718 876 Tax credit receivable — 847 Research and development advance payments 336 445 Prepaid insurance 950 158 Interest income receivable 289 — Other 259 — $ 6,561 $ 2,326 |
Property and equipment, net (Ta
Property and equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property and equipment, net | |
Schedule of property and equipment | December 31, (in thousands) 2023 2022 Lab equipment $ 5,386 $ 3,681 Leasehold improvements 233 194 Computer equipment 326 235 Office equipment and furniture and fixtures 36 22 5,981 4,132 Less accumulated depreciation and amortization (3,908) (3,451) Property and equipment, net $ 2,073 $ 681 |
Accrued expenses and other li_2
Accrued expenses and other liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accrued expenses and other liabilities | |
Schedule of accrued expenses and other liabilities | December 31, (in thousands) 2023 2022 Research and development $ 1,680 $ 2,261 Compensation and related benefits 2,734 1,874 Severance accruals 1,436 — Professional fees 1,670 481 Short-term operating lease liability 310 229 Other 195 86 $ 8,025 $ 4,931 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
Supplemental balance sheet information | Year Ended December 31, 2023 Year Ended December 31, 2022 Operating leases: Operating lease right-of-use assets $ 1,564 $ 284 Operating lease liability, current portion $ 310 $ 229 Operating lease liability, net of current portion 1,340 62 Total operating lease liability $ 1,650 $ 291 |
Supplemental lease expense | Operating lease expense recorded as research and development and general and administrative expenses in the consolidated statements of operations and comprehensive loss is as follows (in thousands): Operating lease cost (in thousands) Year Ended December 31, 2023 Year Ended December 31, 2022 General and administrative $ 161 $ 78 Research and development 164 163 Total lease expense $ 325 $ 241 |
Schedule of other information related to the operating lease | Year Ended December 31, 2023 Year Ended December 31, 2022 Weighted-average remaining lease term (in years) 4.81 1.25 Weighted-average discount rate 8.3% 9.0% |
Supplemental cash flow information | Supplemental cash flow information related to the operating leases was as follows (in thousands): Year Ended December 31, 2023 Year Ended December 31, 2022 Cash paid for operating lease liability $ 246 $ 234 |
Schedule of future minimum lease payments under operating lease | As of December 31, 2023, minimum rental commitments under the operating leases were as follows (in thousands): Years ending December 31, Amount 2024 $ 451 2025 464 2026 412 2027 422 2028 433 Total lease payments 2,182 Less imputed interest (532) Present value of lease liability $ 1,650 |
Common stock (Tables)
Common stock (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Common stock. | |
Schedule of warrants outstanding | Warrants Warrants Outstanding Exercise Price per Share Expiration Date Series B 500,000 $ 10.00 April 28, 2024 |
Share-based compensation (Table
Share-based compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-based compensation | |
Schedule of stock-based compensation expense | Share-based compensation expense recorded as research and development and general and administrative expenses in the consolidated statements of operations and comprehensive loss is as follows (in thousands): Year Ended December 31, In thousands) 2023 2022 General and administrative $ 4,242 $ 3,471 Research and development 1,981 1,861 $ 6,223 $ 5,332 |
Schedule of weighted average assumptions used in option-pricing | Year ended December 31, 2023 2022 Expected volatility 92.1 % 85.6 % Risk-free interest rate 4.6 % 2.7 % Expected term (in years) 5.6 6.0 Expected dividend yield — — Fair value of common stock $ 7.92 $ 3.63 |
Schedule of option activity | Weighted Weighted average average remaining Number of exercise price contractual shares per share term (years) Outstanding at January 1, 2023 2,519,405 9.60 Replacement options issued at asset acquisition 2,472,563 1.29 Granted 4,007,552 6.42 Forfeited (314,319) 6.67 Expired (55,670) 16.59 Exercised (651,240) 1.57 Outstanding at December 31, 2023 7,978,291 6.15 8.62 Exercisable at December 31, 2023 3,151,799 5.86 7.54 |
Income taxes (Tables)
Income taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income taxes | |
Schedule of reconciliation of the federal income tax rate | Year ended December 31, 2023 2022 Federal tax benefit at statutory rate 21.0 % 21.0 % State tax, net of federal benefit (1.3) 4.3 Effects of state tax legislation, net of federal benefit — (7.1) Research and development credits 0.7 1.9 Permanent differences (0.9) (0.2) Write-off of IPR&D (15.9) — Change in valuation allowance (3.6) (19.9) — % — % |
Schedule of Components of the Company's deferred taxes | December 31, (in thousands) 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 22,784 $ 20,523 Research and development intangibles 10,135 4,839 Research and development credits 3,782 2,878 Share-based compensation 2,533 2,016 Accrued bonus 546 383 Lease liability 350 — Other 75 1 Gross deferred tax assets 40,205 30,640 Less: valuation allowance (39,827) (30,609) Net deferred tax asset 378 31 Deferred tax liability Depreciation (46) (31) Right-of-use asset (332) — Total deferred tax liabilities (378) (31) Net deferred taxes $ — $ — |
Nature of the business (Details
Nature of the business (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Feb. 29, 2024 USD ($) shares | Jun. 30, 2023 USD ($) shares | Dec. 31, 2023 USD ($) item | Dec. 31, 2022 USD ($) | |
Number of clinical assets | item | 1 | |||
Number of preclinical assets | item | 3 | |||
Net loss | $ 106,806 | $ 36,896 | ||
Accumulated deficit | 222,807 | $ 116,001 | ||
Proceeds from issuance of common stock | $ 34 | |||
Subscription Agreements | ||||
Proceeds from issuance of common stock | $ 125,000 | |||
Issuance of common stock ( in shares) | shares | 21,690,871 | |||
Public offering | Subsequent Event [Member] | ||||
Proceeds from issuance of common stock | $ 230,000 | |||
Issuance of common stock ( in shares) | shares | 11,500,000 |
Summary of significant accoun_4
Summary of significant accounting policies - Narrative (Details) | 12 Months Ended | |
Dec. 31, 2023 USD ($) segment | Dec. 31, 2022 USD ($) | |
Summary of significant accounting policies | ||
Number of operating segments | segment | 1 | |
Restricted cash | $ 100,000 | $ 100,000 |
Impairment losses | 0 | 0 |
Deferred offering costs | $ 0 | $ 300,000 |
Expected dividend yield | 0% |
Summary of significant accoun_5
Summary of significant accounting policies - Components of cash and restricted cash (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Summary of significant accounting policies | |||
Cash and cash equivalents | $ 98,679 | $ 20,323 | |
Restricted cash | 100 | 100 | |
Cash and restricted cash | $ 98,779 | $ 20,423 | $ 49,329 |
Summary of significant accoun_6
Summary of significant accounting policies - Property and Equipment (Details) | Dec. 31, 2023 |
Lab equipment | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Leasehold improvements | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Computer equipment | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 3 years |
Office equipment | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Summary of significant accoun_7
Summary of significant accounting policies - Assets and liabilities measured at fair value (Details) - Recurring - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Summary of significant accounting policies | ||
Total | $ 136,444 | |
Money market funds | ||
Summary of significant accounting policies | ||
Cash and cash equivalents | 73,988 | $ 20,013 |
U.S. Treasury securities | ||
Summary of significant accounting policies | ||
Cash and cash equivalents | 22,993 | |
Marketable securities | 39,463 | |
Level 1 | ||
Summary of significant accounting policies | ||
Total | 73,988 | |
Level 1 | Money market funds | ||
Summary of significant accounting policies | ||
Cash and cash equivalents | 73,988 | $ 20,013 |
Level 2 | ||
Summary of significant accounting policies | ||
Total | 62,456 | |
Level 2 | U.S. Treasury securities | ||
Summary of significant accounting policies | ||
Cash and cash equivalents | 22,993 | |
Marketable securities | $ 39,463 |
Summary of significant accoun_8
Summary of significant accounting policies - (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Available-for-sale marketable securities | |
Unrealized gain on marketable securities | $ 22 |
Contractual maturity term | 6 months |
U.S. Treasury securities | |
Available-for-sale marketable securities | |
Amortized Cost | $ 39,441 |
Unrealized gain on marketable securities | 22 |
Fair value | $ 39,463 |
Summary of significant accoun_9
Summary of significant accounting policies - Anti-dilutive (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Earnings Per Share, Diluted, Other Disclosures [Abstract] | ||
Anti-dilutive securities | 8,478,291 | 3,822,517 |
Employee Stock Option [Member] | ||
Earnings Per Share, Diluted, Other Disclosures [Abstract] | ||
Anti-dilutive securities | 7,978,291 | 2,519,405 |
Common stock warrants | ||
Earnings Per Share, Diluted, Other Disclosures [Abstract] | ||
Anti-dilutive securities | 500,000 | 1,303,112 |
Merger - Narrative (Details)
Merger - Narrative (Details) - Morphimmune Inc - USD ($) $ / shares in Units, $ in Millions | Oct. 02, 2023 | Dec. 31, 2023 |
Asset Acquisition [Line Items] | ||
Percentage of ownership interest acquired | 100% | |
Number of shares issuable | 8,835,710 | |
Exchange ratio | 0.3042 | |
Options to purchase shares of common stock | 2,472,563 | |
Exercise price | $ 1.29 | |
Acquisitions Expensed Transaction Costs | $ 2.7 | |
Share Price | $ 8.20 | |
Morphimmune Common Stock [Member] | ||
Asset Acquisition [Line Items] | ||
Options to purchase shares of common stock | 8,128,096 |
Merger - Fair values of assets
Merger - Fair values of assets acquired and liabilities assumed - (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Assets acquired: | ||
Cash and cash equivalents | $ 98,679 | $ 20,323 |
Prepaid expenses and other current assets | 6,561 | 2,326 |
Property and equipment, net | 2,073 | 681 |
Total assets | 148,540 | 24,046 |
Liabilities assumed: | ||
Accounts payable | 3,311 | 2,400 |
Accrued expenses and other current liabilities | 8,025 | 4,931 |
Total liabilities | 28,658 | $ 7,393 |
Morphimmune Inc | ||
Merger | ||
Common stock issued to Morphimmune shareholders | 72,453 | |
Share-based equity awards allocated to consideration paid | 14,708 | |
Transaction costs | 792 | |
Consideration paid | 87,953 | |
Assets acquired: | ||
Cash and cash equivalents | 10,068 | |
Prepaid expenses and other current assets | 191 | |
Property and equipment, net | 646 | |
In Process Research and Development | 80,802 | |
Total assets | 91,707 | |
Liabilities assumed: | ||
Accounts payable | 1,147 | |
Accrued expenses and other current liabilities | 2,607 | |
Total liabilities | 3,754 | |
Net assets acquired | $ 87,953 |
Collaboration Agreement with _3
Collaboration Agreement with AbbVie - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended |
Jan. 31, 2023 | Dec. 31, 2023 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Collaboration revenue | $ 14,018 | |
Collaboration agreement with AbbVie | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Upfront payment | $ 30,000 | |
Anniversary of first commercial sale (in years) | 10 years | |
Performance obligation | $ 30,000 | |
Collaboration revenue | $ 14,018 | |
Estimated research and development period | 1 year 6 months | |
Collaboration agreement with AbbVie | Maximum | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Additional platform access payments | 70,000 | |
Development and commercial sale milestone receivable per target | 120,000 | |
Sales based milestone based on achievement | $ 150,000 |
Collaboration Agreement with _4
Collaboration Agreement with AbbVie - Change in deferred revenue (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Deferral of revenue | $ 15,982 |
Recognition of unearned revenue | (14,018) |
Collaboration agreement with AbbVie | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Deferral of revenue | 30,000 |
Recognition of unearned revenue | (14,018) |
Balance at the end of the period | $ 15,982 |
Prepaid expenses and other cu_3
Prepaid expenses and other current assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Prepaid expenses and other current assets | ||
Short-term deposits | $ 4,009 | |
Prepaid subscriptions and prepaid service contracts | 718 | $ 876 |
Tax credit receivable | 847 | |
Research and development advance payments | 336 | 445 |
Prepaid insurance | 950 | 158 |
Interest income receivable | 289 | |
Other | 259 | |
Prepaid expenses and other assets | $ 6,561 | $ 2,326 |
Property and equipment, net (De
Property and equipment, net (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property, Plant, and Equipment and Finance Lease Right-of-Use Asset, after Accumulated Depreciation and Amortization [Abstract] | ||
Property, plant and equipment, gross | $ 5,981 | $ 4,132 |
Less accumulated depreciation and amortization | (3,908) | (3,451) |
Property and equipment, net | 2,073 | 681 |
Lab equipment | ||
Property, Plant, and Equipment and Finance Lease Right-of-Use Asset, after Accumulated Depreciation and Amortization [Abstract] | ||
Property, plant and equipment, gross | 5,386 | 3,681 |
Leasehold improvements | ||
Property, Plant, and Equipment and Finance Lease Right-of-Use Asset, after Accumulated Depreciation and Amortization [Abstract] | ||
Property, plant and equipment | 233 | 194 |
Computer equipment | ||
Property, Plant, and Equipment and Finance Lease Right-of-Use Asset, after Accumulated Depreciation and Amortization [Abstract] | ||
Property, plant and equipment | 326 | 235 |
Office equipment and furniture and fixtures | ||
Property, Plant, and Equipment and Finance Lease Right-of-Use Asset, after Accumulated Depreciation and Amortization [Abstract] | ||
Property, plant and equipment | $ 36 | $ 22 |
Property and equipment, net - N
Property and equipment, net - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property and equipment, net | ||
Depreciation and amortization | $ 457 | $ 422 |
Government assistance programs
Government assistance programs (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Jan. 31, 2023 | Jul. 31, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | May 31, 2021 | |
Unusual or Infrequent Item, or Both [Line Items] | |||||
Employee retention credit receivable | $ 847,000 | ||||
Other Transaction Authority for Prototype Agreement | |||||
Unusual or Infrequent Item, or Both [Line Items] | |||||
Grants Receivable | $ 13,300,000 | $ 17,600,000 | |||
Expenses relating to extension of an agreement | $ 0 | ||||
Payment period of reimbursement contract | 30 days | ||||
Contra-research and development expense | $ 0 | 600,000 | |||
Reimbursement expenses received | $ 17,600,000 |
Accrued expenses and other li_3
Accrued expenses and other liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued expenses and other liabilities | ||
Research and development | $ 1,680 | $ 2,261 |
Compensation and related benefits | 2,734 | 1,874 |
Severance accruals | 1,436 | |
Professional fees | 1,670 | 481 |
Short-term operating lease liability | 310 | 229 |
Other | 195 | 86 |
Accrued expenses and other liabilities | $ 8,025 | $ 4,931 |
Commitments and contingencies (
Commitments and contingencies (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Commitments and contingencies | ||
Defined contribution | $ 0.2 | $ 0.2 |
Licensing arrangements (Details
Licensing arrangements (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Product development and regulatory approval milestone payments | $ 2.9 | ||
Commercial milestone payments | 2.8 | ||
Collaborative agreement, milestone payments made | 0 | $ 0.1 | |
License Agreement with Purdue Research Foundation | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
License Agreement, Maximum Aggregate Payment Payable | 3.8 | ||
License Agreement with Purdue Research Foundation | Morphimmune Inc | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
License Agreement, upfront payment on execution | 0.2 | ||
License Agreement, upfront payment on first and second anniversary | 0.1 | ||
2021 Patent License Agreement | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Certain regulatory, developmental, and commercial milestone payables | $ 2.2 | ||
License fee payment | $ 0.1 | $ 0.1 |
Leases (Details)
Leases (Details) | Dec. 31, 2023 ft² |
Office and Laboratory Space in Exton | PENNSYLVANIA | |
Lessee, Lease, Description [Line Items] | |
Area | 11,000 |
Office and Laboratory Space in Bothwell | WASHINGTON | |
Lessee, Lease, Description [Line Items] | |
Area | 14,000 |
Leases - Balance Sheet related
Leases - Balance Sheet related information (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Lessee, Lease, Description [Line Items] | ||
Operating lease right-of-use assets | $ 1,564 | $ 284 |
Office and laboratory space | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease right-of-use assets | 1,564 | 284 |
Operating lease liability | 310 | 229 |
Operating lease liability, net of current portion | 1,340 | 62 |
Total operating lease liability | $ 1,650 | $ 291 |
Leases - Lease expense (Details
Leases - Lease expense (Details) - Office and laboratory space - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Lessee, Lease, Description [Line Items] | ||
Total lease expense | $ 325 | $ 241 |
General and administrative | ||
Lessee, Lease, Description [Line Items] | ||
Total lease expense | 161 | 78 |
Research and development | ||
Lessee, Lease, Description [Line Items] | ||
Short-term lease cost | 200 | 100 |
Total lease expense | $ 164 | $ 163 |
Leases - Additional lease relat
Leases - Additional lease related information (Details) - Office and laboratory space | Dec. 31, 2023 | Dec. 31, 2022 |
Lessee, Lease, Description [Line Items] | ||
Weighted-average remaining lease term (in years) | 4 years 9 months 21 days | 1 year 3 months |
Weighted-average discount rate | 8.30% | 9% |
Leases - Cash flow information
Leases - Cash flow information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Office and laboratory space | ||
Lessee, Lease, Description [Line Items] | ||
Cash paid for operating lease liability | $ 246 | $ 234 |
Leases - Lease maturity (Detail
Leases - Lease maturity (Details) - Office and laboratory space - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Lessee, Lease, Description [Line Items] | ||
2024 | $ 451 | |
2025 | 464 | |
2026 | 412 | |
2027 | 422 | |
2028 | 433 | |
Total lease payments | 2,182 | |
Less imputed interest | (532) | |
Total operating lease liability | $ 1,650 | $ 291 |
Common stock (Details)
Common stock (Details) | 1 Months Ended | 12 Months Ended | |||
Jan. 15, 2023 shares | Jun. 30, 2023 USD ($) shares | Jan. 31, 2023 USD ($) shares | Dec. 31, 2023 USD ($) Vote | Oct. 01, 2021 USD ($) | |
Common stock voting right | Vote | 1 | ||||
Payment of offering costs | $ 8,997,000 | ||||
Proceeds from issuance of common stock | $ 34,000 | ||||
Subscription Agreements | |||||
Stock issued | shares | 21,690,871 | ||||
Payment of offering costs | $ 9,000,000 | ||||
Proceeds from issuance of common stock | $ 125,000,000 | ||||
2020 Plan | Non-employee | |||||
Shares issued | shares | 55,250 | ||||
Shelf Registration Statement | Maximum | |||||
Securities aggregate price | $ 200,000,000 | ||||
Open Market Sale | |||||
Stock issued | shares | 5,925 | ||||
Proceeds from issuance of common stock | $ 34,000 | ||||
Open Market Sale | Maximum | |||||
Securities aggregate price | $ 75,000,000 |
Common stock - Warrants (Detail
Common stock - Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | 24 Months Ended | ||
Sep. 02, 2022 | Dec. 31, 2023 | Sep. 01, 2022 | |
Class of Warrant or Right [Line Items] | |||
Impact of deemed dividend in stockholder' equity | $ 0 | ||
Series B Warrants | |||
Class of Warrant or Right [Line Items] | |||
Exercise price | $ 10 | $ 45 | |
Warrants | |||
Class of Warrant or Right [Line Items] | |||
Warrants exercised, numbers | 0 | ||
Warrants | Series B Warrants | |||
Class of Warrant or Right [Line Items] | |||
Warrants outstanding | 500,000 | ||
Exercise price | $ 10 |
Share-based compensation - Plan
Share-based compensation - Plans (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||||||
Jan. 01, 2024 | Oct. 02, 2023 | Sep. 29, 2023 | Jan. 01, 2023 | Sep. 18, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Expiration period | 10 years | ||||||
Options, Granted | 4,007,552 | ||||||
Weighted average grant date fair value | $ 6.09 | $ 2.65 | |||||
Morphimmune Inc | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Exercise price | $ 1.29 | ||||||
Dr. Clay Siegall | Morphimmune Inc | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Options, Granted | 2,137,080 | ||||||
Exercise price | $ 5.91 | ||||||
Estimated grant date fair value | $ 14.2 | ||||||
Weighted average grant date fair value | $ 6.65 | ||||||
Dr. Clay Siegall | Morphimmune Inc | One-year anniversary | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Percentage of vesting | 25% | ||||||
Dr. Clay Siegall | Morphimmune Inc | Over next 36 months | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting period | 36 months | ||||||
Percentage of vesting | 75% | ||||||
Maximum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting period | 4 years | ||||||
Minimum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting period | 1 year | ||||||
2020 Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Threshold Percentage Of Total Number Of Common Stock Outstanding | 4% | ||||||
Shares available for future issuance | 3,320,601 | ||||||
Increase in shares available for future issuance | 2,955,280 | 485,153 | |||||
2020 Plan | Subsequent Event [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Increase in shares available for future issuance | 1,730,071 | ||||||
MorphImmune Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares available for future issuance | 929,702 | ||||||
Employee Stock Purchase Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares available for grant | 473,733 | ||||||
Increase in shares available for future issuance | 121,288 | ||||||
Authorized stock options | 125,000 | ||||||
Employee Stock Purchase Plan, Threshold Period For Which Common Stock Is Automatically Added To Arrive At Authorized Shares | 10 years | ||||||
Percentage of outstanding capital stock | 1% | ||||||
Number of common shares added in authorized | 1,000,000 | ||||||
Awards granted | 0 | ||||||
Employee Stock Purchase Plan | Subsequent Event [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Increase in shares available for future issuance | 432,518 |
Share-based compensation - Cost
Share-based compensation - Costs (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 6,223 | $ 5,332 |
Unrecognized compensation cost | $ 22,800 | |
Recognition period | 1 year 10 months 24 days | |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 1,981 | 1,861 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 4,242 | $ 3,471 |
Share-based compensation - Assu
Share-based compensation - Assumptions (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based compensation | ||
Expected volatility | 92.10% | 85.60% |
Risk-free interest rate | 4.60% | 2.70% |
Expected term (in years) | 5 years 7 months 6 days | 6 years |
Expected dividend yield | 0% | |
Fair value of common stock | $ 7.92 | $ 3.63 |
Share-based compensation - Opti
Share-based compensation - Option Activity (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Oct. 02, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Number of shares | |||
Options, Beginning balance | 2,519,405 | ||
Replacement options issued at asset acquisition | 2,472,563 | ||
Options, Granted | 4,007,552 | ||
Options, Forfeited | (314,319) | ||
Options, Expired | (55,670) | ||
Options, Exercised | (651,240) | ||
Options, Ending balance | 7,978,291 | 2,519,405 | |
Options, Exercisable | 3,151,799 | ||
Weighted Average Exercise price | |||
Beginning price | $ 9.60 | ||
Replacement options issued at asset acquisition | 1.29 | ||
Granted | 6.42 | ||
Forfeited | 6.67 | ||
Expired | 16.59 | ||
Exercised | 1.57 | ||
Ending price | 6.15 | $ 9.60 | |
Exercisable | $ 5.86 | ||
Weighted average remaining contractual term | |||
Weighted Average Remaining Contractual Term | 8 years 7 months 13 days | ||
Weighted Average Remaining Contractual Term, Exercisable | 7 years 6 months 14 days | ||
Weighted average grant date fair value | $ 6.09 | $ 2.65 | |
Intrinsic value, exercisable | $ 21.9 | ||
Intrinsic value, outstanding | 45.4 | ||
Intrinsic value, exercised | $ 5.9 | $ 0.2 | |
Modification of stock options and recognized | $ 0.7 | ||
Morphimmune Inc | |||
Weighted average remaining contractual term | |||
Weighted average grant fair value | $ 7.55 |
Income taxes - Federal income t
Income taxes - Federal income tax (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income taxes | ||
Federal tax benefit at statutory rate | 21% | 21% |
State tax, net of federal benefit | (1.30%) | 4.30% |
Effects of state tax legislation, net of federal benefit | (7.10%) | |
Research and development credits | 0.70% | 1.90% |
Permanent differences | (0.90%) | (0.20%) |
Write-off of IPR&D | (15.90%) | |
Change in valuation allowance | (3.60%) | (19.90%) |
Total |
Income taxes - Deferred taxes (
Income taxes - Deferred taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 22,784 | $ 20,523 |
Research and development intangibles | 10,135 | 4,839 |
Research and development credits | 3,782 | 2,878 |
Share-based compensation | 2,533 | 2,016 |
Accrued bonus | 546 | 383 |
Lease liability | 350 | |
Other | 75 | 1 |
Gross deferred tax assets | 40,205 | 30,640 |
Less: valuation allowance | (39,827) | (30,609) |
Net deferred tax asset | 378 | 31 |
Deferred tax liability | ||
Depreciation | (46) | (31) |
Right-of-use asset | (332) | |
Total deferred tax liabilities | $ (378) | $ (31) |
Income taxes (Details)
Income taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | ||
Income tax expense | $ 0 | $ 0 |
Increase in valuation allowance | 9,200,000 | 7,400,000 |
Federal operating loss | 92,600,000 | |
State net operating loss | 84,300,000 | |
Net operating loss generated not subject to expiration | $ 75,600,000 | |
Percentage of taxable income offset from net operating loss | 80% | |
R&D tax credits | $ 200,000 | |
Uncertain tax positions | 37,000 | $ 37,000 |
Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Federal tax | $ 3,500,000 |
Subsequent events - Zentalis Ph
Subsequent events - Zentalis Pharmaceuticals, Inc. License Agreement (Details) - Subsequent events - License agreement with Zentalis Pharmaceuticals, Inc $ in Millions | Jan. 05, 2024 USD ($) |
Subsequent events | |
Upfront consideration paid in cash | $ 15 |
Upfront consideration paid in shares | $ 20 |
Trailing period of shares | 30 days |
Maximum amount payable | $ 150 |
Additional amount payable | $ 25 |
Subsequent events - Asset Purch
Subsequent events - Asset Purchase Agreement (Details) - Subsequent events - Ayala Purchase Agreement $ in Millions | Feb. 05, 2024 USD ($) shares |
Subsequent events | |
Amount paid | $ 20 |
Number of shares issued | shares | 2,175,489 |
Maximum amount payable in development and commercial milestones | $ 37.5 |
Subsequent events - Follow-On P
Subsequent events - Follow-On Public Offering (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Feb. 16, 2024 | Dec. 31, 2023 | |
Subsequent events | ||
Proceeds from exercise of common stock warrants | $ 34 | |
Subsequent events | Public offering | ||
Subsequent events | ||
Sale of common stock | 11,500,000 | |
Price per share | $ 20 | |
Proceeds from exercise of common stock warrants | $ 230,000 |
Subsequent events - Atreca (Det
Subsequent events - Atreca (Details) - Atreca $ in Millions | Dec. 22, 2023 USD ($) |
Subsequent events | |
Upfront consideration paid in cash | $ 5.5 |
Maximum amount payable | $ 7 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (106,806) | $ (36,896) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |