Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Mar. 13, 2023 | Jun. 30, 2022 | |
Document and Entity Information [Abstract] | ||||
Document Type | 10-K | |||
Document Annual Report | true | |||
Document Period End Date | Dec. 31, 2022 | |||
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 | 665 Stockton Drive | |||
Entity Address, Address Line Two | Suite 300 | |||
Entity Address, City or Town | Exton | |||
Entity Address State Or Province | PA | |||
Entity Address, Postal Zip Code | 19341 | |||
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 | No | |||
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 | |||
ICFR Auditor Attestation Flag | false | |||
Entity Ex Transition Period | false | |||
Entity Shell Company | false | |||
Entity Public Float | $ 34.1 | |||
Entity Common Stock, Shares Outstanding | 12,215,018 | |||
Auditor Name | Ernst & Young LLP | Deloitte & Touche LLP | ||
Auditor Firm ID | 42 | 34 | ||
Auditor Location | Philadelphia, Pennsylvania | Philadelphia, Pennsylvania | ||
Entity Central Index Key | 0001472012 | |||
Document Fiscal Year Focus | 2022 | |||
Document Fiscal Period Focus | FY | |||
Amendment Flag | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 20,323 | $ 49,229 |
Prepaid expenses and other current assets | 2,326 | 7,409 |
Total current assets | 22,649 | 56,638 |
Property and equipment, net | 681 | 855 |
Operating right-of-use asset, net | 284 | |
Restricted cash | 100 | 100 |
Deferred offering costs | 332 | 332 |
Total assets | 24,046 | 57,925 |
Current liabilities: | ||
Accounts payable | 2,400 | 3,077 |
Accrued expenses and other current liabilities | 4,931 | 6,651 |
Total current liabilities | 7,331 | 9,728 |
Other long-term liabilities | 62 | 12 |
Total liabilities | 7,393 | 9,740 |
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, 2022 and December 31, 2021 | ||
Common stock, $0.0001 par value; 200,000,000 shares authorized; 12,128,843 shares issued and outstanding at December 31, 2022 and 12,110,373 shares issued and outstanding at December 31, 2021 | 1 | 1 |
Additional paid-in capital | 132,653 | 127,289 |
Accumulated deficit | (116,001) | (79,105) |
Total stockholders' equity | 16,653 | 48,185 |
Total liabilities and stockholders' equity | $ 24,046 | $ 57,925 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Condensed 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) | 12,128,843 | 12,110,373 |
Common stock, shares outstanding (in shares) | 12,128,843 | 12,110,373 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses: | ||
Research and development | $ 23,272 | $ 14,110 |
General and administrative | 13,629 | 11,094 |
Total operating expenses | 36,901 | 25,204 |
Loss from operations | (36,901) | (25,204) |
Other income (expense): | ||
Other income | 503 | |
Interest income (expense), net | 5 | (10) |
Total other income | 5 | 493 |
Net loss | (36,896) | (24,711) |
Deemed dividend arising from warrant modification | (622) | |
Net loss attributable to common stockholders | $ (37,518) | $ (24,711) |
Per share information: | ||
Net loss per common share, Basic | $ (3.09) | $ (2.14) |
Net loss per common share, Diluted | $ (3.09) | $ (2.14) |
Weighted-average common shares outstanding, Basic | 12,126,573 | 11,538,668 |
Weighted-average common shares outstanding, Diluted | 12,126,573 | 11,538,668 |
Condensed Statements of Changes
Condensed Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common stock. | Additional paid-in capital | Accumulated deficit | Total |
Balance at Dec. 31, 2020 | $ 1 | $ 95,738 | $ (54,394) | $ 41,345 |
Balance (shares) at Dec. 31, 2020 | 10,634,245 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Sale of common stock and common stock warrants | 26,666 | 26,666 | ||
Sale of common stock and common stock warrants, shares | 1,014,115 | |||
Share-based compensation expense | 3,448 | 3,448 | ||
Exercise of common stock warrants | 1,338 | 1,338 | ||
Exercise of common stock warrants (shares) | 200,979 | |||
Exercise of stock options and vesting of restricted stock | 99 | 99 | ||
Exercise of stock options and vesting of restricted stock (shares) | 261,034 | |||
Net loss | (24,711) | (24,711) | ||
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 | 18,470 | ||
Net 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 |
Condensed Statements of Chang_2
Condensed Statements of Changes in Stockholders' Equity (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2021 USD ($) | |
Condensed Statements of Changes in Stockholders' Equity | |
Common stock and common stock warrants offering costs | $ 559 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (36,896) | $ (24,711) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 422 | 755 |
Amortization of right-of-use asset | 209 | |
Share-based compensation | 5,332 | 3,448 |
Deferred rent | 4 | |
Forgiveness of PPP Loan | (500) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 5,071 | (4,281) |
Accounts payable | (677) | 1,780 |
Accrued expenses and other current liabilities | (1,922) | 5,279 |
Other long-term liabilities | (229) | |
Net cash used in operating activities | (28,690) | (18,226) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (248) | (79) |
Net cash used in investing activities | (248) | (79) |
Cash flows from financing activities: | ||
Proceeds from exercise of stock options | 32 | 99 |
Proceeds from exercise of common stock warrants | 1,338 | |
Proceeds from sale of common stock and common stock warrants | 27,225 | |
Payment of issuance costs related to the sale of common stock and common stock warrants | (559) | |
Payment of equipment loan payable | (113) | |
Payment of offering costs | (222) | |
Net cash provided by financing activities | 32 | 27,768 |
Net (decrease) increase in cash and cash equivalents and restricted cash | (28,906) | 9,463 |
Cash and cash equivalents and restricted cash at beginning of year | 49,329 | 39,866 |
Cash and cash equivalents and restricted cash at end of year | 20,423 | 49,329 |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | 14 | |
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 | |
Offering costs included in accounts payable | $ 110 |
Nature of the business
Nature of the business | 12 Months Ended |
Dec. 31, 2022 | |
Nature of the business | |
Nature of the business | Immunome, Inc. Notes to financial statements 1. Nature of the business Organization Immunome, Inc., the Company or Immunome, is a biopharmaceutical company. The Company was incorporated as a Pennsylvania corporation on March 2, 2006 and was converted to a Delaware corporation on December 2, 2015. The Company is utilizing a proprietary human memory B cell platform to discover and develop antibody therapeutics to improve patient care. The Company’s primary focus areas are oncology and other diseases, including COVID-19. Since its inception, the Company has devoted substantially all its resources to research and development, raising capital, building its management team and extending its intellectual property portfolio. 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 the successful research, development and manufacturing of programs and development candidates, uncertain results of preclinical and clinical testing, development of new technological innovations and products by competitors, dependence on key personnel and third-party vendors, protection of proprietary technology, compliance with government regulations, regulatory approval of programs and development candidates and the ability to secure additional capital to fund operations. Liquidity The Company has incurred net losses since inception, including net losses of $36.9 million and $24.7 million for the years ended December 31, 2022 and 2021, 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, 2022, the Company had an accumulated deficit of $116.0 million. The Company expects to generate operating losses for the foreseeable future. Through December 31, 2022, the Company raised an aggregate of $125.1 million in gross proceeds from sales of our common stock, Series A convertible preferred stock and warrants, warrant and stock option exercises, the issuance of convertible promissory notes, and the Payment Protection, or PPP, loan that was forgiven in May 2021. In addition, in July 2020, the Company entered into an Other Transaction Authority for Prototype Agreement, or the OTA Agreement, with the Department of Defense, or the DoD, to fund the Company’s efforts in developing an antibody cocktail therapeutic to treat COVID-19. As of December 31, 2022, the Company has received $17.6 million in expense reimbursement from the DoD under the OTA Agreement. On October 1, 2021, the Company entered into an Open Market Sale Agreement, or 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 Securities and Exchange Commission, or 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. The Company has not sold any shares under the ATM Agreement or the shelf registration statement as of December 31, 2022. On January 4, 2023, the Company entered into a collaboration and option agreement, or the Collaboration Agreement, with AbbVie Global Enterprises Ltd, or AbbVie, directed to the discovery of up to 10 novel target-antibody pairs leveraging our discovery engine. Under the terms of the Collaboration Agreement, Immunome will grant AbbVie the option to purchase worldwide rights for up to 10 novel target-antibody pairs arising from the selected tumors. AbbVie will pay the Company an option exercise fee in the low single digit millions for each of the validated target pairs for which it exercises an option. The Company received a non-refundable upfront payment of $30.0 million in January 2023 and will be eligible to receive additional platform access payments in the aggregate amount of up to $70.0 million based on AbbVie’s election for the Company to continue research using its discovery engine. The Company is also eligible to receive development and first commercial sale milestones of up to $120.0 million per target with respect to certain products derived from target-antibody pairs that AbbVie elects to purchase, sales-based milestones based on achievement of specified levels of net sales of products up to $150.0 million in the aggregate per target, and tiered low single digit royalties on net sales of products. The Company is potentially eligible to receive up to $2.8 billion from AbbVie under the Collaboration Agreement from the sources described above. However, there are no assurances that the Company will receive additional payments from AbbVie beyond the $30.0 million upfront payment. The Company expects that its cash as of December 31, 2022, together with the $30.0 million received in January 2023 from AbbVie under the Collaboration Agreement, will be sufficient to fund its operations 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, scale back or eliminate some or all of its research and development programs or 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); consider various other strategic alternatives, including a possible merger or sale of the Company; or reduce or cease operations. If the Company engages in collaborations under these circumstances, it may receive lower consideration than if it had not entered into such arrangements or if it entered into such arrangements at later stages in the research and development process. 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. The Company is also subject to risks and uncertainties as a result of the ongoing COVID-19 pandemic. Although there is uncertainty as to the extent of the continued impact of the COVID-19 pandemic, including the continued impact to capital markets and economies worldwide in the form of economic slowdowns or recession, there has not been a significant impact to the Company’s operations or financial statements to date. |
Summary of significant accounti
Summary of significant accounting policies | 12 Months Ended |
Dec. 31, 2022 | |
Summary of significant accounting policies | |
Summary of significant accounting policies | 2. Summary of significant accounting policies Basis of presentation The accompanying 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. Use of estimates The preparation of 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 financial statements include, but are not limited to, the expected volatility used to estimate fair value of stock options and accrued research and development expenses. 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 and a money market account. 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, 2022 and 2021, respectively. The following table provides a reconciliation of the components of cash and cash equivalents and restricted cash presented in the statements of cash flows: (in thousands) December 31, 2022 December 31, 2021 Cash and cash equivalents $ 20,323 $ 49,229 Restricted cash 100 100 $ 20,423 $ 49,329 Concentration of credit risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash and cash equivalents. As of December 31, 2022, the Company held deposits at Silicon Valley Bank (“SVB”) in excess of government insured limits. On March 10, 2023, SVB was closed by the California Department of Financial Protection and Innovation, and the Federal Deposit Insurance Corporation (“FDIC”) was appointed as receiver. No losses were incurred by the Company on the Company’s deposits that were held at SVB. Subsequent to this event the Company’s deposits were transferred to a financial institution that management believes to be of high credit quality, therefore management believes that the Company currently is not exposed to significant credit risk. 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 statements of operations. 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, 2022 and 2021. Equity issuance costs The Company capitalized costs that were directly associated with establishing the ATM Agreement and shelf registration statement in 2021. These costs will remain capitalized until such financings are consummated, at which time such costs will be recorded against the gross proceeds from the applicable financing. If a financing is abandoned, deferred offering costs are expensed. Ongoing costs that are directly associated with the ATM Agreement are expensed as incurred. Deferred offering costs were $0.3 million as of each of December 31, 2022 and 2021, respectively, in the balance sheets. Government assistance programs The Company accounts for amounts received under the DoD expense reimbursement contract as contra-research and development expenses in the statements of operations. The Company accounts for the employee retention credit received under the U.S. Department of Treasury Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, as contra-expense to personnel related costs within research and development and general and administrative expenses in the statements of operations. Research and development costs 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 9, 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 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 statements of operations. Leases Effective January 1, 2022, the Company adopted ASU No. 2016-02, Leases At the inception of an arrangement, the Company determines whether an arrangement contains a lease based on facts and circumstances present in the arrangement. An arrangement is or contains a lease if the arrangement conveys the right to control the use of an identified asset for a period of time in exchange for consideration. Typically, lessees are required to recognize leases with a term greater than one year in the balance sheets as an operating or finance lease liability and right-of-use asset. Right-of-use assets represent the Company’s right to use an underlying asset during the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. The Company has elected the practical expedient to not recognize leases with a term of 12 months or less. The Company does not have any financing leases as of December 31, 2022. Operating lease liabilities and their corresponding right-of-use assets are recorded based on their 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. Leases are discounted to its present value using either the interest rate implicit in the Company’s lease or its 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 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 judgement. Accordingly, the degree of judgement 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. Cash and cash equivalents are Level 1 assets for the years ended December 31, 2022 and 2021. 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, 2022 and 2021 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, 2022 2021 Stock options (1) 2,519,405 2,005,756 Common stock warrants (1) 1,303,112 1,303,112 3,822,517 3,308,868 (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, 2022 and 2021. Recently adopted accounting standards ASC Topic 842, Leases On January 1, 2022, the Company adopted ASC 842 which supersedes the lease accounting guidance under ASC 840. The standard generally requires lessees to recognize operating and finance lease liabilities and corresponding right-of-use, or ROU, assets in the balance sheets and provide enhanced disclosures on the amount, timing, and uncertainty of cash flows arising from lease arrangements. The Company adopted ASC 842 using the modified retrospective approach. The Company elected the package of practical expedients available for existing contracts, which allowed the Company to carry forward its historical assessments of lease identification, lease classification, and initial direct costs. The Company also elected a policy to not apply the recognition requirements of ASC 842 for short-term leases with a term of 12 months of less. As of January 1, 2022, the effective date, the Company identified one operating lease arrangement relating to the Company’s headquarters facility and a short-term lease relating to laboratory equipment. The adoption of ASC 842 resulted in a recognition of an ROU asset and lease liability ASU Topic 832, Government Assistance In November 2021, the FASB issued ASU 2021-10, Government Assistance ASU 2021-04, Earnings Per Share In May 2021, the FASB issued ASU 2021-04 Earnings Per Share (Topic 260), Debt— Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40) |
Prepaid expenses and other asse
Prepaid expenses and other assets | 12 Months Ended |
Dec. 31, 2022 | |
Prepaid expenses and other assets | |
Prepaid expenses and other assets | 3. Prepaid expenses and other current assets Prepaid expenses and other current assets consisted of the following: December 31, (in thousands) 2022 2021 Prepaid subscriptions, prepaid service contracts and short-term deposits $ 876 $ 492 CARES Act employee retention credit receivable 847 — Research and development advance payments 445 586 Prepaid insurance 158 2,019 Reimbursement receivable from the DoD — 2,674 Unbilled reimbursement receivable from the DoD — 1,638 $ 2,326 $ 7,409 |
Property and equipment, net
Property and equipment, net | 12 Months Ended |
Dec. 31, 2022 | |
Property and equipment, net | |
Property and equipment, net | 4. Property and equipment, net Property and equipment consisted of the following: December 31, (in thousands) 2022 2021 Lab equipment $ 3,681 $ 3,513 Leasehold improvements 194 193 Computer equipment 235 156 Office equipment and furniture and fixtures 22 22 4,132 3,884 Less accumulated depreciation and amortization (3,451) (3,029) Property and equipment, net $ 681 $ 855 Depreciation and amortization expense was $0.4 million and $0.8 million for the years ended December 31, 2022 and 2021, respectively. There were no assets under capital leases as of December 31, 2022 and 2021. |
Government assistance programs
Government assistance programs | 12 Months Ended |
Dec. 31, 2022 | |
Government assistance programs | |
Government assistance programs | 5. Government assistance programs DoD expense reimbursement contract In July 2020, the Company entered into the OTA Agreement with the DoD 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 The Company recorded contra-research and development expense of $0.6 million and $15.2 million for the years ended December 31, 2022 and 2021, respectively, in the statements of operations. There was no expense reimbursement receivable due from the DoD as of December 31, 2022. The Company had an expense reimbursement receivable balance of $2.7 million due from the DoD in prepaid expenses and other current assets as of December 31, 2021 in the accompanying balance sheets. DoD reimbursable services that have been performed but not yet billed are recorded as an unbilled receivable in prepaid expenses and other current assets in the accompanying balance sheets. There was Costs that have been reimbursed by the DoD but not yet expensed by the Company are recorded as a deferred research obligation liability for the period. The deferred research obligation liability is inconsequential for the year ended December 31, 2022. As of December 31, 2021, the deferred research liability of $2.0 million is included in accrued expenses and other liabilities in the accompanying balance sheets. CARES Act employee retention credit Under the CARES Act, the Company met eligibility criteria for a $0.8 million refundable employee retention credit. The Company recorded contra-expense to personnel related costs within research and development expense of $0.6 million and general and administrative expense of $0.2 million for the year ended December 31, 2022. No such amounts were recorded for the year ended December 31, 2021. The Company had an employee retention credit receivable due from the U.S. Department of Treasury of |
Accrued expenses and other liab
Accrued expenses and other liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Accrued expenses and other liabilities | |
Accrued expenses and other liabilities | 6. Accrued expenses and other liabilities Accrued expenses and other liabilities consisted of the following: December 31, (in thousands) 2022 2021 Research and development $ 2,261 $ 2,840 Compensation and related benefits 1,874 1,246 Professional fees 481 227 Short-term operating lease liability and other liabilities 293 317 Deferred research obligations 22 2,021 $ 4,931 $ 6,651 |
Long-term debt
Long-term debt | 12 Months Ended |
Dec. 31, 2022 | |
Long-term debt | |
Long-term debt | 7. Long-term debt On April 30, 2020, the Company entered into a loan agreement with Silicon Valley Bank as the lender, or Lender, for a loan in an aggregate principal amount of $0.5 million pursuant to the Paycheck Protection Program under the CARES Act and implemented by the U.S. Small Business Administration. The Company used the proceeds of the PPP Loan for payroll and other qualifying expenses. The entire PPP Loan was forgiven on May 21, 2021 and recognized as other income in the statement of operations for the year ended December 31, 2021. |
Commitments and contingencies
Commitments and contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and contingencies | |
Commitments and contingencies | 8. 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 and $0.1 million to the 401(k) Plan for the years ended December 31, 2022 and 2021, respectively. Legal proceedings The Company is not a party to any material litigation and does not have contingency reserves established for any litigation liabilities. At each reporting date, the Company evaluates whether a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. |
Licensing arrangements
Licensing arrangements | 12 Months Ended |
Dec. 31, 2022 | |
Licensing arrangements | |
Licensing arrangements | 9. Licensing arrangements The Company has entered into various license agreements to further discover, develop and commercialize certain technologies and treatments. The Company may need to pay developmental and regulatory milestone payments of up to approximately $2.6 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 $1.5 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 statements of operations. There were no development and regulatory milestone payments during the year ended December 31, 2021. 2022 Amendment to Exclusive License Agreement In December 2022, the Company and Arrayjet Limited, or Arrayjet, amended the Exclusive License Agreement, effective as of June 28, 2019 and amended July 10, 2020. The agreement was amended, among other things, to increase the recurring exclusivity annual fee and make certain adjustments to the termination rights. 2021 Patent License Agreement In June 2021, the Company entered into an exclusive worldwide patent license agreement with several Philadelphia based universities and hospitals (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 in initiation and minimum annual payments related to this agreement for each of the years ended December 31, 2022 and 2021, respectively, in research and development expenses in the statement of operations. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases | |
Leases | 10. Leases In May 2017, the Company entered into a 62-month office and laboratory space lease commencing on July 1, 2017 for approximately 11,000 square feet of space in Exton, Pennsylvania. The Company has an option to extend the lease for up to two additional five-year terms. In December 2021, the Company extended the lease for an additional eighteen-month term ending in March 2024. Beginning July 2021, the Company leased laboratory equipment on a month-to- month basis. In April 2022, the Company terminated the agreement through exercising the option to purchase the leased laboratory equipment under the lease agreement. Supplemental balance sheet information related to leases as of December 31, 2022 was as follows (in thousands): Operating leases: Operating lease right-of-use assets $ 284 Operating lease liability $ 229 Operating lease liability, net of current portion 62 Total operating lease liability $ 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 balance sheets. Operating lease expense recorded as research and development and general and administrative expenses in the statements of operations is as follows (in thousands): Operating lease cost (in thousands) Year Ended December 31, 2022 General and administrative $ 78 Research and development 163 Total lease expense $ 241 Short term lease expense recorded as research and development expense in the statements of operations was $0.1 million for year ended December 31, 2022. Under ASC 840, lease expense was $0.5 million for the year ended December 31, 2021. Other information related to the operating lease where the Company is the lessee was as follows: Year Ended December 31, 2022 Weighted-average remaining lease term (in years) 1.25 Weighted-average discount rate 9.0% Supplemental cash flow information related to the operating lease was as follows (in thousands): Year Ended December 31, 2022 Cash paid for operating lease liability $ 234 As of December 31, 2022, minimum rental commitments under the operating lease were as follows (in thousands): Years ending December 31, Amount 2023 $ 246 2024 63 Total lease payments 309 Less imputed interest (18) Present value of lease liability $ 291 |
Common stock
Common stock | 12 Months Ended |
Dec. 31, 2022 | |
Common stock | |
Common stock | 11. 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. 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. The company has not sold any shares under the ATM Agreement or the shelf registration statement as of December 31, 2022. On August 4, 2021, the Company sold 14,115 shares of the Company’s common stock for $15.94 per share to a purchaser in accordance with the Stock Purchase Agreement, or Stock Purchase Agreement. On April 28, 2021, the Company sold 1,000,000 units, each unit comprising one share of the Company’s common stock and one Series B Warrant (each, a “Series B Warrant”) to purchase one-half of a share of common stock. The units were issued in a private placement at a price of $27.00 per unit for gross proceeds of $27.0 million. The Series B Warrants are equity-classified, exercisable at any time, have an exercise price of $45.00 per share and will terminate three years from the date of issuance. The fair value of the warrants on the date of issuance was $6.0 million. The fair value of the warrants was estimated using a Black-Scholes Option Pricing Model. The significant assumptions used in preparing the option pricing model for valuing the Company's warrants to purchase shares of common stock as of April 28, 2021 included (i) volatility of 82.7%, (ii) risk free interest rate of 0.35%, (iii) strike price of $45.00 per share, (iv) fair value of common stock of $28.70 per share, and (v) expected life of three years. As described below, in September 2022, the Series B Warrants were modified to reduce the strike price to $10.00 per share and to remove the Company’s call right. 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 statement of operations 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 statements of changes in stockholders’ equity was zero because the warrants were equity classified before and after the modification. At December 31, 2022 common stock warrants outstanding were as follows: Warrants Warrants Outstanding Exercise Price per Share Expiration Date Series A 803,112 $ 9.00 June 2, 2023 Series B 500,000 $ 10.00 April 28, 2024 For the year ended December 31, 2022, no warrants were exercised. For the year ended December 31, 2021, 148,653 warrants exercisable for $9.00 per share were exercised, and the Company received proceeds of $1.3 million and 148,653 shares of the Company’s common stock were issued. Additionally, 83,431 warrants exercisable for $9.00 per share were exercised in cashless transactions during the year ended December 31, 2021 and 52,326 shares of the Company’s common stock were issued. |
Share-based compensation
Share-based compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-based compensation | |
Share-based compensation | 12. Share-based compensation On September 18, 2020, the Company adopted the 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. As of December 31, 2022, there were 1,325,192 shares available for future issuance under the 2020 Plan. On January 1, 2023, the number of shares available for future issuance under the 2020 Plan increased by 485,153 shares. 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. As of December 31, 2022, there were 352,445 shares available under the ESPP. No shares of common stock have been issued under the ESPP as of December 31, 2022. On January 1, 2023, the number of shares available for future issuance under the ESPP increased by 121,288 shares. 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 Share-based compensation expense recorded as research and development and general and administrative expenses in the statements of operations is as follows (in thousands): Year Ended December 31, In thousands) 2022 2021 General and administrative $ 3,471 $ 2,071 Research and development 1,861 1,377 $ 5,332 $ 3,448 Unrecognized compensation cost related to unvested options was $9.2 million as of December 31, 2022 and will be recognized over an estimated weighted average period of 2.6 years. Stock options The weighted average assumptions used in the Black-Scholes option-pricing model for stock options granted were: Year ended December 31, 2022 2021 Expected volatility 85.6 % 83.0 % Risk-free interest rate 2.7 % 1.0 % Expected term (in years) 6.0 6.0 Expected dividend yield — — Fair value of common stock $ 3.63 $ 23.04 A summary of option activity under the 2020 Plan and prior Plans during the year ended December 31, 2022 is as follows: Weighted Weighted average average remaining Number of exercise price contractual shares per share term (years) Outstanding at January 1, 2022 2,005,756 $ 11.26 8.50 Granted 563,900 3.63 9.19 Forfeited (24,990) 11.97 — Expired (6,791) 17.54 — Exercised (18,470) 1.76 6.62 Outstanding at December 31, 2022 2,519,405 9.60 7.90 Exercisable at December 31, 2022 1,239,114 8.86 7.30 The weighted-average grant date fair value per share of stock options granted during the years ended December 31, 2022 and 2021 was $2.65 and $16.49, respectively. The aggregate intrinsic value of stock options exercised during the year ended December Restricted Stock Awards During August 2021, the Company granted 13,500 fully vested restricted stock awards. The Company recorded share-based compensation expense of $0.2 million for the year ended December 31, 2021 related to the restricted stock awards granted. No such transaction occurred for the year ended December 31, 2022. |
Income taxes
Income taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income taxes | |
Income taxes | 13. Income taxes A reconciliation of the federal income tax rate to the Company’s effective tax rate is as follows: Year ended December 31, 2022 2021 Federal tax benefit at statutory rate 21.0 % 21.0 % State tax, net of federal benefit 4.3 8.0 Effects of state tax legislation, net of federal benefit (7.1) — Research and development credits 1.9 2.4 Permanent differences (0.2) 0.3 Change in valuation allowance (19.9) (31.7) — % — % The components of the Company’s deferred taxes are as follows (in thousands): December 31, (in thousands) 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 20,523 $ 19,925 Research and development intangibles 4,839 — Research and development credits 2,878 2,157 Share-based compensation 2,016 886 Accrued bonus 383 331 Other 1 1 Gross deferred tax assets 30,640 23,300 Less: valuation allowance (30,609) (23,255) Net deferred tax asset 31 45 Deferred tax liability Depreciation (31) (45) Total deferred tax liabilities $ — $ — The Company had no income tax expense due to the operating losses incurred for the years ended December 31, 2022 and 2021. 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, 2022 and 2021. The valuation allowance increased by $7.4 million and $7.8 million in 2022 and 2021, respectively, due to the increase in deferred tax assets, primarily due to 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. The Company has not currently completed an evaluation of ownership changes through December 31, 2022 to assess whether utilization of the Company’s net operating loss or research and development credit carryforwards would be subject to an annual limitation under Sections 382 and 383. To the extent an ownership change occurs in the future, the net operating loss and credit carryforwards may be subject to limitation. Further, until a study is completed and any limitation is known, no amounts are presented as an uncertain tax position. As a result, the Company is not able to estimate the effect of the change in control, if any, on the Company’s ability to utilize net operating loss and research and development credit carryforwards in the future. The Company has not yet conducted a study of its research and development credit carryforwards. This study may result in an increase or decrease to the Company’s credit carryforwards; however, until a study is completed and any adjustment is known, no amounts are presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s credits, and if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. As a result, there would be no impact to the Company’s financial statements. As of December 31, 2022, the Company had $81.0 million of federal and $81.4 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 $64.0 million of net operating loss generated from 2018 to 2022 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, 2022, the Company had cumulative federal R&D tax credits of $2.7 million. These tax credit carryforwards will expire at various dates through 2042. As of December 31, 2022 and 2021, the Company had no uncertain tax positions. 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 |
Related party transactions
Related party transactions | 12 Months Ended |
Dec. 31, 2022 | |
Related party transactions | |
Related party transactions | 14. Related party transactions Broadband services agreement In November 2015, the Company entered into a management services agreement, or MSA, with BCM Advisory Partners LLC and Broadband Capital Partners LLC, or Broadband Capital. Certain directors of the Company are principals of Broadband Capital. Under the Broadband MSA, the Company engages Broadband Capital as a consultant for advice in connection with senior management matters related to the Company’s business, administration and policies in exchange for a cash fee to Broadband Capital of |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent events. | |
Subsequent events | 15. Subsequent events Collaboration Agreement with AbbVie On January 4, 2023, the Company entered into the Collaboration Agreement with AbbVie, pursuant to which the Company will use its proprietary discovery engine 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. The research term is at least 66 months, subject to extension in certain circumstances by specified extension periods. Pursuant to the terms of the Collaboration Agreement, with respect to each novel target-antibody pair that the Company generates that meets certain mutually agreed criteria (each, a Validated Target Pair or VTP), the Company granted to AbbVie an exclusive option (up to a maximum of 10 in total) to purchase all rights in and to such Validated Target Pair, for all human and non-human diagnostic, prophylactic and therapeutic uses throughout the world, including without limitation the development and commercialization of certain products derived from the assigned Validated Target Pair and directed to the target comprising such VTP (Products). No rights are granted by the Company to AbbVie under any of Company’s platform technology covering the Company’s discovery engine. Until the expiration of the research term, the Company is not permitted to conduct any activities in connection with targets or antibodies derived from patients with the specified tumor types, whether independently or with other third parties, except in limited circumstances with respect to certain target-antibody pairs that are no longer subject to the collaboration with AbbVie. In addition, during the term of the Collaboration Agreement, the Company is not permitted to develop products directed to targets that are included in VTPs purchased by AbbVie, or to which AbbVie still has rights under the Collaboration Agreement, whether independently or with other third parties. Under the Collaboration Agreement, AbbVie will pay the Company an upfront payment of $30.0 million, plus certain additional platform access payments in the aggregate amount of up to $70.0 million based on the Company’s use of its discovery engine 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 the 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 first 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 target, in each case, 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) (i) the ten 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 Validated Target Pairs expire without AbbVie exercising any option. In addition, the research term will terminate if AbbVie does not elect to make certain platform access payments at specified points during the research term, in order for the Company to continue the target discovery activities under the collaboration. The Collaboration Agreement may be terminated by (a) either party upon the other party’s uncured material breach, or upon any insolvency event of the other party, (b) AbbVie for convenience upon a specified period prior written notice, or (c) AbbVie for the Company’s breach of representations and warranties with respect to debarment or compliance with anti-bribery and anti-corruption laws. If AbbVie has the right to terminate the Collaboration Agreement for the Company’s uncured material breach or a breach of representations and warranties with respect to debarment or compliance with anti-bribery and anti-corruption laws, AbbVie may elect to continue the Collaboration Agreement, subject to certain specified reductions applicable to certain of AbbVie’s payment obligations (with a specified floor on such reductions). 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). 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. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Summary of significant accounting policies | |
Basis of presentation | Basis of presentation The accompanying 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. |
Use of estimates | Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the 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 financial statements include, but are not limited to, the expected volatility used to estimate fair value of stock options and accrued research and development expenses. 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 and a money market account. 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, 2022 and 2021, respectively. The following table provides a reconciliation of the components of cash and cash equivalents and restricted cash presented in the statements of cash flows: (in thousands) December 31, 2022 December 31, 2021 Cash and cash equivalents $ 20,323 $ 49,229 Restricted cash 100 100 $ 20,423 $ 49,329 |
Property and Equipment | Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash and cash equivalents. As of December 31, 2022, the Company held deposits at Silicon Valley Bank (“SVB”) in excess of government insured limits. On March 10, 2023, SVB was closed by the California Department of Financial Protection and Innovation, and the Federal Deposit Insurance Corporation (“FDIC”) was appointed as receiver. No losses were incurred by the Company on the Company’s deposits that were held at SVB. Subsequent to this event the Company’s deposits were transferred to a financial institution that management believes to be of high credit quality, therefore management believes that the Company currently is not exposed to significant credit risk. 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 statements of operations. |
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, 2022 and 2021. |
Equity issuance costs | Equity issuance costs The Company capitalized costs that were directly associated with establishing the ATM Agreement and shelf registration statement in 2021. These costs will remain capitalized until such financings are consummated, at which time such costs will be recorded against the gross proceeds from the applicable financing. If a financing is abandoned, deferred offering costs are expensed. Ongoing costs that are directly associated with the ATM Agreement are expensed as incurred. Deferred offering costs were $0.3 million as of each of December 31, 2022 and 2021, respectively, in the balance sheets. |
Government assistance programs | Government assistance programs The Company accounts for amounts received under the DoD expense reimbursement contract as contra-research and development expenses in the statements of operations. The Company accounts for the employee retention credit received under the U.S. Department of Treasury Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, as contra-expense to personnel related costs within research and development and general and administrative expenses in the statements of operations. |
Research and development costs | Research and development costs 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 9, 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 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 statements of operations. |
Leases | Leases Effective January 1, 2022, the Company adopted ASU No. 2016-02, Leases At the inception of an arrangement, the Company determines whether an arrangement contains a lease based on facts and circumstances present in the arrangement. An arrangement is or contains a lease if the arrangement conveys the right to control the use of an identified asset for a period of time in exchange for consideration. Typically, lessees are required to recognize leases with a term greater than one year in the balance sheets as an operating or finance lease liability and right-of-use asset. Right-of-use assets represent the Company’s right to use an underlying asset during the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. The Company has elected the practical expedient to not recognize leases with a term of 12 months or less. The Company does not have any financing leases as of December 31, 2022. Operating lease liabilities and their corresponding right-of-use assets are recorded based on their 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. Leases are discounted to its present value using either the interest rate implicit in the Company’s lease or its 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 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 judgement. Accordingly, the degree of judgement 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. Cash and cash equivalents are Level 1 assets for the years ended December 31, 2022 and 2021. |
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, 2022 and 2021 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, 2022 2021 Stock options (1) 2,519,405 2,005,756 Common stock warrants (1) 1,303,112 1,303,112 3,822,517 3,308,868 (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, 2022 and 2021. |
Recent Accounting Pronouncements | Recently adopted accounting standards ASC Topic 842, Leases On January 1, 2022, the Company adopted ASC 842 which supersedes the lease accounting guidance under ASC 840. The standard generally requires lessees to recognize operating and finance lease liabilities and corresponding right-of-use, or ROU, assets in the balance sheets and provide enhanced disclosures on the amount, timing, and uncertainty of cash flows arising from lease arrangements. The Company adopted ASC 842 using the modified retrospective approach. The Company elected the package of practical expedients available for existing contracts, which allowed the Company to carry forward its historical assessments of lease identification, lease classification, and initial direct costs. The Company also elected a policy to not apply the recognition requirements of ASC 842 for short-term leases with a term of 12 months of less. As of January 1, 2022, the effective date, the Company identified one operating lease arrangement relating to the Company’s headquarters facility and a short-term lease relating to laboratory equipment. The adoption of ASC 842 resulted in a recognition of an ROU asset and lease liability ASU Topic 832, Government Assistance In November 2021, the FASB issued ASU 2021-10, Government Assistance ASU 2021-04, Earnings Per Share In May 2021, the FASB issued ASU 2021-04 Earnings Per Share (Topic 260), Debt— Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40) |
Summary of significant accoun_3
Summary of significant accounting policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Summary of significant accounting policies | |
Schedule of reconciliation of the components of cash and restricted cash reported in balance sheet | (in thousands) December 31, 2022 December 31, 2021 Cash and cash equivalents $ 20,323 $ 49,229 Restricted cash 100 100 $ 20,423 $ 49,329 |
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 potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of common stock outstanding, as they would be anti-dilutive | The following potentially dilutive securities outstanding as of December 31, 2022 and 2021 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, 2022 2021 Stock options (1) 2,519,405 2,005,756 Common stock warrants (1) 1,303,112 1,303,112 3,822,517 3,308,868 |
Prepaid expenses and other as_2
Prepaid expenses and other assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Prepaid expenses and other assets | |
Schedule of prepaid expenses and other current assets | Prepaid expenses and other current assets consisted of the following: December 31, (in thousands) 2022 2021 Prepaid subscriptions, prepaid service contracts and short-term deposits $ 876 $ 492 CARES Act employee retention credit receivable 847 — Research and development advance payments 445 586 Prepaid insurance 158 2,019 Reimbursement receivable from the DoD — 2,674 Unbilled reimbursement receivable from the DoD — 1,638 $ 2,326 $ 7,409 |
Property and equipment, net (Ta
Property and equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property and equipment, net | |
Schedule of property and equipment | Property and equipment consisted of the following: December 31, (in thousands) 2022 2021 Lab equipment $ 3,681 $ 3,513 Leasehold improvements 194 193 Computer equipment 235 156 Office equipment and furniture and fixtures 22 22 4,132 3,884 Less accumulated depreciation and amortization (3,451) (3,029) Property and equipment, net $ 681 $ 855 |
Accrued expenses and other li_2
Accrued expenses and other liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accrued expenses and other liabilities | |
Schedule of accrued expenses and other liabilities | Accrued expenses and other liabilities consisted of the following: December 31, (in thousands) 2022 2021 Research and development $ 2,261 $ 2,840 Compensation and related benefits 1,874 1,246 Professional fees 481 227 Short-term operating lease liability and other liabilities 293 317 Deferred research obligations 22 2,021 $ 4,931 $ 6,651 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases | |
Supplemental balance sheet information | Supplemental balance sheet information related to leases as of December 31, 2022 was as follows (in thousands): Operating leases: Operating lease right-of-use assets $ 284 Operating lease liability $ 229 Operating lease liability, net of current portion 62 Total operating lease liability $ 291 |
Supplemental lease expense | Operating lease expense recorded as research and development and general and administrative expenses in the statements of operations is as follows (in thousands): Operating lease cost (in thousands) Year Ended December 31, 2022 General and administrative $ 78 Research and development 163 Total lease expense $ 241 |
Schedule of other information related to the operating lease | Year Ended December 31, 2022 Weighted-average remaining lease term (in years) 1.25 Weighted-average discount rate 9.0% |
Supplemental cash flow information | Supplemental cash flow information related to the operating lease was as follows (in thousands): Year Ended December 31, 2022 Cash paid for operating lease liability $ 234 |
Schedule of future minimum lease payments under operating lease | As of December 31, 2022, minimum rental commitments under the operating lease were as follows (in thousands): Years ending December 31, Amount 2023 $ 246 2024 63 Total lease payments 309 Less imputed interest (18) Present value of lease liability $ 291 |
Common stock (Tables)
Common stock (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Common stock | |
Schedule of warrants outstanding | Warrants Warrants Outstanding Exercise Price per Share Expiration Date Series A 803,112 $ 9.00 June 2, 2023 Series B 500,000 $ 10.00 April 28, 2024 |
Share-based compensation (Table
Share-based compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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 statements of operations is as follows (in thousands): Year Ended December 31, In thousands) 2022 2021 General and administrative $ 3,471 $ 2,071 Research and development 1,861 1,377 $ 5,332 $ 3,448 |
Weighted average assumptions used in option-pricing | The weighted average assumptions used in the Black-Scholes option-pricing model for stock options granted were: Year ended December 31, 2022 2021 Expected volatility 85.6 % 83.0 % Risk-free interest rate 2.7 % 1.0 % Expected term (in years) 6.0 6.0 Expected dividend yield — — Fair value of common stock $ 3.63 $ 23.04 |
Summary of option activity | Weighted Weighted average average remaining Number of exercise price contractual shares per share term (years) Outstanding at January 1, 2022 2,005,756 $ 11.26 8.50 Granted 563,900 3.63 9.19 Forfeited (24,990) 11.97 — Expired (6,791) 17.54 — Exercised (18,470) 1.76 6.62 Outstanding at December 31, 2022 2,519,405 9.60 7.90 Exercisable at December 31, 2022 1,239,114 8.86 7.30 |
Income taxes (Tables)
Income taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income taxes | |
Schedule of reconciliation of the federal income tax rate | A reconciliation of the federal income tax rate to the Company’s effective tax rate is as follows: Year ended December 31, 2022 2021 Federal tax benefit at statutory rate 21.0 % 21.0 % State tax, net of federal benefit 4.3 8.0 Effects of state tax legislation, net of federal benefit (7.1) — Research and development credits 1.9 2.4 Permanent differences (0.2) 0.3 Change in valuation allowance (19.9) (31.7) — % — % |
Schedule of Components of the Company's deferred taxes | Year ended December 31, 2022 2021 Federal tax benefit at statutory rate 21.0 % 21.0 % State tax, net of federal benefit 4.3 8.0 Effects of state tax legislation, net of federal benefit (7.1) — Research and development credits 1.9 2.4 Permanent differences (0.2) 0.3 Change in valuation allowance (19.9) (31.7) — % — % |
Nature of the business (Details
Nature of the business (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Jan. 04, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Oct. 14, 2021 | Oct. 01, 2021 | |
Net loss | $ 36,896 | $ 24,711 | |||
Accumulated deficit | 116,001 | 79,105 | |||
Proceeds from sales of equity and debt | 125,100 | ||||
Reimbursement expenses received | 17,600 | ||||
Securities aggregate price | $ 200,000 | ||||
Cash and cash equivalents | $ 20,323 | $ 49,229 | |||
Collaboration agreement with AbbVie | Subsequent events | |||||
Upfront payment | $ 30,000 | ||||
Additional platform access payments | 70,000 | ||||
Additional upfront payment | 30,000 | ||||
Proceeds from non-refunded upfront payment | 30,000 | ||||
Collaboration agreement with AbbVie | Subsequent events | Maximum | |||||
Additional platform access payments | 70,000 | ||||
Development and commercial sale milestone receivable per target | 120,000 | ||||
Sales based milestone based on achievement | 150,000 | ||||
Potentially eligible amount receivable | $ 2,800 | ||||
Shelf Registration Statement | Maximum | |||||
Securities aggregate price | $ 200,000 | ||||
Open Market Sale | Maximum | |||||
Securities aggregate price | $ 75,000 |
Summary of significant accoun_4
Summary of significant accounting policies - Narrative (Details) | 12 Months Ended | ||||||
Sep. 02, 2022 USD ($) $ / shares | Dec. 31, 2022 USD ($) segment | Dec. 31, 2021 USD ($) | Mar. 10, 2023 USD ($) | Sep. 30, 2022 $ / shares | Sep. 01, 2022 $ / shares | Jan. 01, 2022 USD ($) | |
Summary of significant accounting policies | |||||||
Number of operating segments | segment | 1 | ||||||
Restricted cash | $ 100,000 | $ 100,000 | |||||
Deferred offering costs | 300,000 | 300,000 | |||||
Operating lease liability | $ 500,000 | ||||||
Operating Lease, Liability, Statement of Financial Position [Extensible Enumeration] | Accrued Liabilities and Other Liabilities | ||||||
Operating right-of-use asset, net | $ 284,000 | $ 500,000 | |||||
Expected dividend yield | 0% | ||||||
Impairment losses | $ 0 | $ 0 | |||||
Deemed dividend | $ 600,000 | $ 622,000 | |||||
Impact of deemed dividend in stockholder' equity | $ 0 | ||||||
SVB [Member] | Subsequent events | |||||||
Summary of significant accounting policies | |||||||
Losses On Deposits | $ 0 | ||||||
Series B Warrants | |||||||
Summary of significant accounting policies | |||||||
Exercise price | $ / shares | $ 10 | $ 10 | $ 45 |
Summary of significant accoun_5
Summary of significant accounting policies - Components of cash and restricted cash (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Summary of significant accounting policies | |||
Cash and cash equivalents | $ 20,323 | $ 49,229 | |
Restricted cash | 100 | 100 | |
Cash and restricted cash | $ 20,423 | $ 49,329 | $ 39,866 |
Summary of significant accoun_6
Summary of significant accounting policies - Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2022 | |
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 - Anti-dilutive (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share, Diluted, Other Disclosures [Abstract] | ||
Anti-dilutive securities | 3,822,517 | 3,308,868 |
Stock options | ||
Earnings Per Share, Diluted, Other Disclosures [Abstract] | ||
Anti-dilutive securities | 2,519,405 | 2,005,756 |
Common stock warrants | ||
Earnings Per Share, Diluted, Other Disclosures [Abstract] | ||
Anti-dilutive securities | 1,303,112 | 1,303,112 |
Prepaid expenses and other as_3
Prepaid expenses and other assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid expenses and other assets | ||
Prepaid subscriptions, prepaid service contracts and short-term deposits | $ 876 | $ 492 |
CARES Act employee retention credit receivable | 847 | 0 |
Research and development advance payments | 445 | 586 |
Prepaid insurance | 158 | 2,019 |
Reimbursement receivable from the DoD | 2,674 | |
Unbilled reimbursement receivable from the DoD | 1,638 | |
Prepaid expenses and other assets | $ 2,326 | $ 7,409 |
Property and equipment, net (De
Property and equipment, net (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant, and Equipment and Finance Lease Right-of-Use Asset, after Accumulated Depreciation and Amortization [Abstract] | ||
Property, plant and equipment, gross | $ 4,132 | $ 3,884 |
Less accumulated depreciation and amortization | (3,451) | (3,029) |
Property and equipment, net | 681 | 855 |
Lab equipment | ||
Property, Plant, and Equipment and Finance Lease Right-of-Use Asset, after Accumulated Depreciation and Amortization [Abstract] | ||
Property, plant and equipment, gross | 3,681 | 3,513 |
Leasehold improvements | ||
Property, Plant, and Equipment and Finance Lease Right-of-Use Asset, after Accumulated Depreciation and Amortization [Abstract] | ||
Property, plant and equipment | 194 | 193 |
Computer equipment | ||
Property, Plant, and Equipment and Finance Lease Right-of-Use Asset, after Accumulated Depreciation and Amortization [Abstract] | ||
Property, plant and equipment | 235 | 156 |
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 | $ 22 | $ 22 |
Property and equipment, net - N
Property and equipment, net - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property and equipment, net | ||
Depreciation and amortization | $ 422 | $ 755 |
Assets under capital lease | $ 0 | $ 0 |
Government assistance programs
Government assistance programs (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Jan. 31, 2023 | Jul. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | May 31, 2021 | Mar. 27, 2020 | |
Unusual or Infrequent Item, or Both [Line Items] | ||||||
Contra-research and development expense | $ 600 | |||||
Refundable employee retention credit | $ 800 | |||||
Contra General And Administrative Expense | 200 | |||||
Contra expenses | $ 0 | |||||
Employee retention credit receivable | 847 | 0 | ||||
Other Transaction Authority for Prototype Agreement | ||||||
Unusual or Infrequent Item, or Both [Line Items] | ||||||
Grants Receivable | $ 13,300 | $ 17,600 | ||||
Expenses relating to extension of an agreement | $ 0 | |||||
Payment period of reimbursement contract | 30 days | |||||
Contra-research and development expense | 600 | 15,200 | ||||
Prepaid expenses and other current assets | 0 | 2,700 | ||||
Deferred research obligation liability | 2,000 | |||||
Grant expected to be received | 0 | $ 1,600 | ||||
Reimbursement expenses received | $ 17,600 |
Accrued expenses and other li_3
Accrued expenses and other liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued expenses and other liabilities | ||
Compensation and related benefits | $ 2,261 | $ 2,840 |
Research and development | 1,874 | 1,246 |
Professional fees | 481 | 227 |
Short-term operating lease liability and other liabilities | 293 | 317 |
Deferred research obligations | 22 | 2,021 |
Accrued expenses and other liabilities | $ 4,931 | $ 6,651 |
Long-term debt (Details)
Long-term debt (Details) $ in Millions | Apr. 30, 2020 USD ($) |
Paycheck Protection Program | |
Debt Instrument [Line Items] | |
Debt amount | $ 0.5 |
Commitments and contingencies (
Commitments and contingencies (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Commitments and contingencies | ||
Defined contribution | $ 0.2 | $ 0.1 |
Licensing arrangements (Details
Licensing arrangements (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Product development and regulatory approval milestone payments | $ 2.6 | ||
Commercial milestone payments | 1.5 | ||
Collaborative agreement, milestone payments made | 0.1 | $ 0 | |
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) - Office and laboratory space | 1 Months Ended | |
Dec. 31, 2021 | May 31, 2017 ft² item | |
Lessee, Lease, Description [Line Items] | ||
Lease term | 62 months | |
Area | ft² | 11,000 | |
Number of extension | item | 2 | |
Period of extension | 18 months | 5 years |
Leases - Balance Sheet related
Leases - Balance Sheet related information (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Jan. 01, 2022 |
Lessee, Lease, Description [Line Items] | ||
Operating lease right-of-use assets | $ 284 | $ 500 |
Total operating lease liability | $ 500 | |
Office and laboratory space | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease right-of-use assets | 284 | |
Operating lease liability | 229 | |
Operating lease liability, net of current portion | 62 | |
Total operating lease liability | $ 291 |
Leases - Lease expense (Details
Leases - Lease expense (Details) - Office and laboratory space - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Lessee, Lease, Description [Line Items] | ||
Operating lease cost | $ 241 | |
Lease expense | $ 500 | |
General and administrative | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease cost | 78 | |
Research and development | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease cost | 163 | |
Short-term lease cost | $ 100 |
Leases - Additional lease relat
Leases - Additional lease related information (Details) - Office and laboratory space | Dec. 31, 2022 |
Lessee, Lease, Description [Line Items] | |
Weighted-average remaining lease term | 1 year 3 months |
Weighted-average discount rate | 9% |
Leases - Cash flow information
Leases - Cash flow information (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Office and laboratory space | |
Lessee, Lease, Description [Line Items] | |
Cash paid for operating lease liability | $ 234 |
Leases - Lease maturity (Detail
Leases - Lease maturity (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Jan. 01, 2022 |
Lessee, Lease, Description [Line Items] | ||
Total operating lease liability | $ 500 | |
Office and laboratory space | ||
Lessee, Lease, Description [Line Items] | ||
2023 | $ 246 | |
2024 | 63 | |
Total lease payments | 309 | |
Less imputed interest | (18) | |
Total operating lease liability | $ 291 |
Common stock (Details)
Common stock (Details) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||
Aug. 04, 2021 $ / shares shares | Apr. 28, 2021 USD ($) $ / shares item shares | Dec. 31, 2022 Vote $ / shares | Dec. 31, 2021 USD ($) $ / shares | Oct. 14, 2021 USD ($) | Oct. 01, 2021 USD ($) | |
Common stock voting right | Vote | 1 | |||||
Securities aggregate price | $ | $ 200,000 | |||||
Stock issued | shares | 14,115 | |||||
Share price | $ / shares | $ 15.94 | |||||
Proceeds from issuance of common stock | $ | $ 1,338 | |||||
Fair value of common stock | $ / shares | $ 3.63 | $ 23.04 | ||||
Shelf Registration Statement | Maximum | ||||||
Securities aggregate price | $ | $ 200,000 | |||||
Open Market Sale | Maximum | ||||||
Securities aggregate price | $ | $ 75,000 | |||||
Private offering | ||||||
Stock issued | shares | 1,000,000 | |||||
Number of share for company's common stock | item | 1 | |||||
Number of warrants | shares | 1 | |||||
Share price | $ / shares | $ 27 | |||||
Proceeds from issuance of common stock | $ | $ 27,000 | |||||
Exercise price | $ / shares | $ 45 | |||||
Warrants and Rights Outstanding, Term | 3 years | |||||
Fair Value of Warrants | $ | $ 6,000 | |||||
Fair value of common stock | $ / shares | $ 28.70 | |||||
Volatility rate | ||||||
Warrants and Rights Outstanding, Measurement Input | 0.827 | |||||
Risk-free interest rate | ||||||
Warrants and Rights Outstanding, Measurement Input | 0.0035 | |||||
Strike price (per share) | ||||||
Warrants and Rights Outstanding, Measurement Input | $ / shares | 45 |
Common stock - Warrants (Detail
Common stock - Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||||
Sep. 02, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2022 | Sep. 01, 2022 | |
Class of Warrant or Right [Line Items] | |||||
Deemed dividend | $ 600 | $ 622 | |||
Impact of deemed dividend in stockholder' equity | $ 0 | ||||
Series B Warrants | |||||
Class of Warrant or Right [Line Items] | |||||
Exercise price | $ 10 | $ 10 | $ 45 | ||
Strike price | $ 10 | $ 10 | $ 45 | ||
Warrants | |||||
Class of Warrant or Right [Line Items] | |||||
Exercise price | $ 9 | ||||
Warrants exercised, numbers | 0 | 148,653 | |||
Gross proceeds from issuance of warrants | $ 1,300 | ||||
Exercise of common stock warrants (shares) | 148,653 | ||||
Additional warrants exercised on cashless | 83,431 | ||||
Shares issued in cashless exercise | 52,326 | ||||
Additional warrants exercise price | $ 9 | ||||
Strike price | $ 9 | ||||
Warrants | Series A Warrants | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants outstanding | 803,112 | ||||
Exercise price | $ 9 | ||||
Strike price | $ 9 | ||||
Warrants | Series B Warrants | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants outstanding | 500,000 | ||||
Exercise price | $ 10 | ||||
Strike price | $ 10 |
Share-based compensation - Plan
Share-based compensation - Plans (Details) - shares | 1 Months Ended | 12 Months Ended | |
Jan. 01, 2023 | Aug. 31, 2021 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expiration period | 10 years | ||
Restricted Stock | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Awards granted | 13,500 | ||
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 | 1,325,192 | ||
Increase in shares available for future issuance | 485,153 | ||
Employee Stock Purchase Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares available for grant | 352,445 | ||
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 |
Share-based compensation - Cost
Share-based compensation - Costs (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 5,332 | $ 3,448 |
Unrecognized compensation cost | $ 9,200 | |
Recognition period | 2 years 7 months 6 days | |
Restricted Stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 0 | 200 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 1,861 | 1,377 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 3,471 | $ 2,071 |
Share-based compensation - Assu
Share-based compensation - Assumptions (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based compensation | ||
Expected volatility | 85.60% | 83% |
Risk-free interest rate | 2.70% | 1% |
Expected term (in years) | 6 years | 6 years |
Expected dividend yield | 0% | |
Fair value of common stock | $ 3.63 | $ 23.04 |
Share-based compensation - Opti
Share-based compensation - Option Activity and Restricted Stock (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Number of shares | ||
Options, Beginning balance | 2,005,756 | |
Options, Granted | 563,900 | |
Options, Forfeited | (24,990) | |
Options, Expired | (6,791) | |
Options, Exercised | (18,470) | |
Options, Ending balance | 2,519,405 | 2,005,756 |
Options, Exercisable | 1,239,114 | |
Weighted Average Exercise price | ||
Beginning price | $ 11.26 | |
Granted | 3.63 | |
Forfeited | 11.97 | |
Expired | 17.54 | |
Exercised | 1.76 | |
Ending price | 9.60 | $ 11.26 |
Exercisable | $ 8.86 | |
Additional information | ||
Weighted Average Remaining Contractual Term | 7 years 10 months 24 days | 8 years 6 months |
Weighted Average Remaining Contractual Term, Granted | 9 years 2 months 8 days | |
Weighted Average Remaining Contractual Term, Exercised | 6 years 7 months 13 days | |
Weighted Average Remaining Contractual Term, Exercisable | 7 years 3 months 18 days | |
Weighted average grant date fair value | $ 2.65 | $ 16.49 |
Intrinsic value, exercised | $ 0.2 | |
Intrinsic value, exercisable | 0.8 | |
Intrinsic value, outstanding | $ 0.9 |
Income taxes - Federal income t
Income taxes - Federal income tax (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income taxes | ||
Federal tax benefit at statutory rate | 21% | 21% |
State tax, net of federal benefit | 4.30% | 8% |
Effects of state tax legislation, net of federal benefit | (7.10%) | |
Research and development credits | 1.90% | 2.40% |
Permanent differences | (0.20%) | 0.30% |
Change in valuation allowance | (19.90%) | (31.70%) |
Total |
Income taxes - Deferred taxes (
Income taxes - Deferred taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 20,523 | $ 19,925 |
Research and development intangibles | 4,839 | |
Research and development credits | 2,878 | 2,157 |
Share-based compensation | 2,016 | 886 |
Accrued bonus | 383 | 331 |
Amortization | 1 | 1 |
Gross deferred tax assets | 30,640 | 23,300 |
Less: valuation allowance | (30,609) | (23,255) |
Net deferred tax asset | 31 | 45 |
Deferred tax liability | ||
Depreciation | (31) | (45) |
Total deferred tax liabilities |
Income taxes (Details)
Income taxes (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Operating Loss Carryforwards [Line Items] | |||
Income tax expense | $ 0 | $ 0 | |
Increase in valuation allowance | 7.4 | 7.8 | |
Federal operating loss | 81 | ||
State net operating loss | 81.4 | ||
Net operating loss generated not subject to expiration | 64 | ||
Uncertain tax positions | 0 | $ 0 | |
Percentage of taxable income offset from net operating loss | 80% | ||
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
R&D tax credits | $ 2.7 |
Related party transactions (Det
Related party transactions (Details) - Broadband services agreement - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Nov. 15, 2015 | |
Related Party Transaction [Line Items] | |||
Monthly cash fee payment | $ 20,000 | ||
Related party transaction, expenses | $ 100,000 | $ 200,000 | |
Due to related party | $ 100,000 | $ 0 |
Subsequent events (Details)
Subsequent events (Details) - Subsequent events - Collaboration agreement with AbbVie $ in Millions | Jan. 04, 2023 USD ($) |
Subsequent Event [Line Items] | |
Research term (in months) | 66 months |
Upfront payment | $ 30 |
Additional platform access payments | $ 70 |
Anniversary of first commerical sale (in years) | 10 years |
Maximum | |
Subsequent Event [Line Items] | |
Additional platform access payments | $ 70 |
Development and commercial sale milestone receivable per target | 120 |
Sales based milestone based on achievement | 150 |
Potentially eligible amount receivable | $ 2.8 |