Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 20, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | ONCORUS, INC. | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Central Index Key | 0001671818 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Entity Shell Company | false | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity File Number | 001-39575 | ||
Entity Address, Address Line One | 4 Corporate Drive | ||
Entity Address, City or Town | Andover | ||
Entity Address, State or Province | MA | ||
Entity Tax Identification Number | 47-3779757 | ||
Entity Address, Postal Zip Code | 01810 | ||
Entity Incorporation, State or Country Code | DE | ||
City Area Code | (339) | ||
Local Phone Number | 240-3330 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Interactive Data Current | Yes | ||
Entity Common Stock, Shares Outstanding | 26,095,363 | ||
Entity Public Float | $ 25.9 | ||
Security Exchange Name | NASDAQ | ||
Trading Symbol | ONCR | ||
Title of 12(b) Security | Common Stock, $0.0001 par value per share | ||
ICFR Auditor Attestation Flag | false | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE The Registrant intends to file a definitive proxy statement pursuant to Regulation 14A relating to the 2022 Annual Meeting of Stockholders within 120 days of the end of the Registrant’s fiscal year ended December 31 , 2022. Portions of such definitive proxy statement are incorporated by reference into Part III of this Annual Report on Form 10-K to the extent stated herein. | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | Boston, Massachusetts | ||
Auditor Firm ID | 42 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 25,709 | $ 100,752 |
Investments | 36,487 | 23,173 |
Prepaid expenses and other current assets | 2,422 | 5,185 |
Total current assets | 64,618 | 129,110 |
Property and equipment, net | 44,360 | 23,233 |
Right-of-use asset | 32,560 | 45,218 |
Restricted cash | 3,437 | 3,437 |
Other assets | 611 | 589 |
Total assets | 145,586 | 201,587 |
Current liabilities: | ||
Accounts payable | 5,694 | 13,009 |
Accrued expenses | 10,948 | 6,281 |
Lease liability - current portion | 1,129 | 1,684 |
Term loan, net of debt discount | 19,436 | 0 |
Total current liabilities | 37,207 | 20,974 |
Lease liability - net of current portion | 47,854 | 50,388 |
Other long term liabilities | 0 | 203 |
Total liabilities | 85,061 | 71,565 |
Stockholders’ equity (deficit): | ||
Preferred stock, $0.0001 par value; authorized 10,000 shares at December 31, 2022 and 2021; issued and outstanding no shares at December 31, 2022 and 2021 | 0 | 0 |
Common stock, $0.0001 par value; authorized 100,000 shares at December 31, 2022 and 2021; issued and outstanding 26,095 and 25,848 shares at December 31, 2022 and 2021, respectively | 3 | 3 |
Additional paid-in capital | 332,583 | 324,620 |
Accumulated other comprehensive loss | (52) | (14) |
Accumulated deficit | (272,009) | (194,587) |
Total stockholders’ equity (deficit) | 60,525 | 130,022 |
Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) | $ 145,586 | $ 201,587 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Preferred Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 |
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 |
Common Stock, Shares Authorized | 100,000,000 | 100,000,000 |
Common Stock, Shares Issued | 26,095,000 | 25,848,000 |
Common Stock, Shares Outstanding | 26,095,000 | 25,848,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses: | ||
Research and development | $ 54,744 | $ 44,682 |
General and administrative | 21,793 | 20,136 |
Total operating expenses | 76,537 | 64,818 |
Loss from operations | (76,537) | (64,818) |
Other income (expense): | ||
Interest income (expense) | (1,095) | 65 |
Other income (expense) | 210 | (9) |
Total other income (expense), net | (885) | 56 |
Net loss | (77,422) | (64,762) |
Comprehensive income (loss): | ||
Net unrealized loss on investments | (52) | (14) |
Comprehensive loss | $ (77,474) | $ (64,776) |
Net loss per share - basic | $ (2.99) | $ (2.56) |
Net loss per share - diluted | $ (2.99) | $ (2.56) |
Weighted-average number of common shares outstanding - basic | 25,924 | 25,320 |
Weighted-average number of common shares outstanding - diluted | 25,924 | 25,320 |
Consolidated Statements of Rede
Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | ACCUMULATED OTHER COMPRENSIVE LOSS | Accumulated Deficit [Member] |
Balance at Dec. 31, 2020 | $ 134,664 | $ 2 | $ 264,487 | $ (129,825) | |
Balance (in shares) at Dec. 31, 2020 | 22,599,048 | ||||
Issuance of common stock in follow-on public offering, net of $4,017 in offering costs | 52,983 | $ 1 | 52,982 | ||
Issuance of common stock in initial public offering, net of $4,017 in offering costs (in shares) | 3,000,000 | ||||
Stock-based compensation expense | 6,573 | 6,573 | |||
Vesting of restricted common stock | 17,236 | ||||
Exercise of options to purchase common stock | 578 | 578 | |||
Exercise of options to purchase common stock (Shares) | 231,945 | ||||
Other comprehensive loss | (14) | $ (14) | |||
Net loss | (64,762) | (64,762) | |||
Balance (in shares) at Dec. 31, 2021 | 25,848,229 | ||||
Balance at Dec. 31, 2021 | 130,022 | $ 3 | 324,620 | (14) | (194,587) |
Stock-based compensation expense | 7,211 | 7,211 | |||
Exercise of options to purchase common stock | $ 64 | 64 | |||
Exercise of options to purchase common stock (Shares) | 34,863 | 35,278 | |||
Issuance of common stock under employee stock purchase plans | $ 121 | 121 | |||
Issuance of common stock under employee stock purchase plans, Shares | 211,340 | ||||
Issuance of warrants in connection with term loan | 567 | 567 | |||
Other comprehensive loss | (38) | (38) | |||
Net loss | (77,422) | (77,422) | |||
Balance (in shares) at Dec. 31, 2022 | 26,094,847 | ||||
Balance at Dec. 31, 2022 | $ 60,525 | $ 3 | $ 332,583 | $ (52) | $ (272,009) |
Consolidated Statements of Re_2
Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' (Deficit) Equity (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2021 USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Offering costs related to IPO | $ 4,017 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating activities: | ||
Net loss | $ (77,422) | $ (64,762) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 3,632 | 1,948 |
Stock-based compensation | 7,211 | 6,573 |
Loss on disposal of assets | 94 | 0 |
Non-cash interest expense related to term loan | 535 | 0 |
Amortization of premium/discount on investments | (278) | 24 |
Non-cash interest income | 0 | (30) |
Gain on lease termination | (520) | 0 |
Changes in: | ||
Prepaid expenses and other current assets | 2,700 | (2,252) |
Operating lease right-of-use asset | 1,723 | 2,718 |
Tenant improvement allowance reimbursements | 9,744 | 1,737 |
Accounts payable | (8,301) | 1,529 |
Accrued expenses and other liabilities | 573 | 1,526 |
Operating lease liability | (1,379) | 1,165 |
Net cash used in operating activities | (61,688) | (49,824) |
Investing activities | ||
Purchase of property and equipment | (19,933) | (9,549) |
Purchase of investments | (43,186) | (23,181) |
Proceeds from maturities of investments | 30,111 | 0 |
Net cash used in investing activities | (33,008) | (32,730) |
Financing activities | ||
Proceeds from exercise of options to purchase common stock | 65 | 578 |
Proceeds from purchases of common stock under emloyee stock purchase plan | 121 | 0 |
Proceeds from borrowings under term loan, net of issuance costs | 19,467 | 0 |
Proceeds from issuance of common stock, net of issuance costs | 0 | 52,983 |
Net cash provided by financing activities | 19,653 | 53,561 |
Net decrease in cash, cash equivalents and restricted cash | (75,043) | (28,993) |
Cash, cash equivalents, and restricted cash at beginning of period | 104,189 | 133,182 |
Cash, cash equivalents, and restricted cash at end of period | 29,146 | 104,189 |
Supplemental disclosure of operating cash flow information: | ||
Cash paid for interest | 1,471 | 0 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Purchase of property and equipment in accounts payable and accrued expenses | 4,879 | 11,447 |
Issuance of warrants in connection with term loan | 567 | 0 |
Assets acquired under operating leases | $ 0 | $ 8,301 |
Nature of the Business and Liqu
Nature of the Business and Liquidity | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Nature of the Business and Liquidity | 1. Nature of the Business and Liquidity Oncorus, Inc. (the "Company") is a preclinical-stage biopharmaceutical company focused on the intravenous administration of self-amplifying RNA to transform outcomes for cancer patients. The Company believes that its product candidates have the potential to bring significant benefit to patients who are currently underserved by approved immuno-oncology therapies, including other viral immunotherapies and immune checkpoint inhibitors. The Company's approach involves encapsulating genomes of RNA viruses known to kill cancer cells within a lipid nanoparticle, creating a selectively self-amplifying vRNA immunotherapy to be administered intravenously. The Company’s operations to date have focused on organization and staffing, business planning, raising capital, acquiring and developing the Company’s technology, establishing the Company’s intellectual property portfolio, identifying potential product candidates and undertaking preclinical studies, commencing a clinical trial and manufacturing scale-up activities. The Company does not have any product candidates approved for sale and has not generated any revenue from product sales. The Company’s product candidates are subject to long development cycles and the Company may be unsuccessful in its efforts to develop, obtain regulatory approval for or market its product candidates. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, possible failure of preclinical studies or clinical trials, the need to obtain marketing approval for its product candidates, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, the need to successfully commercialize and gain market acceptance of any of the Company’s products that are approved and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing, and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure, and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. Liquidity In accordance with the Financial Accounting Standards Board ("FASB") Accounting Standards Update ("ASU") 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. The Company has incurred recurring losses since its inception, including a net loss of $ 77.4 million for the year ended December 31, 2022. In addition, as of December 31, 2022, the Company had an accumulated deficit of $ 272.0 million. The Company expects to continue to generate operating losses for the foreseeable future. The Company expects that its cash, cash equivalents and investments as of December 31, 2022 may not be sufficient to fund operations for at least the next twelve months from the date of issuance of these consolidated financial statements which raises substantial doubt about the Company's ability to continue as a going concern, and the Company will need to obtain additional funding. The Company expects to finance its operations through potential public or private equity financings, debt financings, collaboration agreements, and or other capital sources. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations. The Company’s inability to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. There can be no assurance that the Company's current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all. As of December 31, 2022, the Company had approximately $ 19.4 million in debt, net of debt discount, which is classified as a short-term liability on the Company's Consolidated Balance Sheet. For more details, see Note 7. Despite the debt's maturity date of April 1, 2026, the Company classified its debt obligations as a short-term liability based on the going concern disclosure in this Form 10-K and the Company's consideration of the subjective acceleration clause in its loan and security agreement. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation These consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the FASB. COVID-19 Pandemic In response to the COVID-19 pandemic, the Company implemented a work-from-home policy allowing employees who can work from home to do so. The Company has transitioned back to in-office work for the majority of our employees. The Company has taken measures to secure its research and development project activities, while work in laboratories has been organized to reduce risk of COVID-19 transmission. Business travel was previously suspended but is now becoming more frequent, and online and teleconference technology continues to be used regularly. Given the global impact and the other risks and uncertainties associated with the pandemic and other public health crises, the Company’s business, financial condition and results of operations could be materially adversely affected. The Company continues to monitor guidance from the CDC and other relevant health regulatory authorities and may adjust its plans to the extent there are changes in such guidance. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. Actual results could differ from those estimates, and any such differences may be material to the Company’s financial statements. Principles of Consolidation The accompanying consolidated financial statements of the Company include the accounts of its wholly owned subsidiary, Oncorus Securities Corporation. All intercompany transactions have been eliminated in consolidation. The Company has one operating segment. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not limited to, the estimated fair value of the Company’s common stock prior to its IPO and share-based awards utilized for stock-based compensation purposes, accrued expenses and amounts of expenses during the reported period, and determination of an incremental borrowing rate for any identified leases for which an implicit discount rate is not easily determinable. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. Concentration of Credit Risk and of Significant Suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents and short-term investments. The Company has all of its cash at one financial institution that management believes to be of high credit quality, in amounts that exceed federally insured limits. The Company invests its excess cash, in line with its investment policy, primarily in money market funds and high credit quality debt instruments . The Company is dependent upon a third-party contract manufacturer and third-party contract research organizations for the performance of portions of its testing for pre-clinical and clinical studies. The Company believes that its relationships with these organizations are satisfactory, and that alternative suppliers of these services are available in the event of the loss of one or more of these suppliers. Research and Development Expenses Research and development expenses are expensed as incurred. Research and development expenses consist of costs incurred to discover, research and develop drug candidates, including compensation-related expenses for research and development personnel, including stock-based compensation expense, preclinical and clinical activities, costs of manufacturing, overhead expenses including facilities and laboratory expenses, materials and supplies, amounts paid to consultants and outside service providers, and depreciation and amortization. Upfront and annual license payments related to acquired technologies or technology licenses which have not yet reached technological feasibility and have no alternative future use are also included in research and development expense for the period in which they are incurred. General and Administrative Expenses General and administrative expenses consist primarily of compensation-related expenses, including stock-based compensation expense, for personnel in executive, finance and accounting, business development, operations and administrative functions. General and administrative expenses also include fees for legal, consulting, accounting and audit services as well as insurance, outside service providers, direct and allocated facility- and office-related costs, and depreciation and amortization. Interest Income on Investments Interest income is separately presented on the consolidated statements of operations and comprehensive loss and consists of interest on cash and cash equivalents and investments. Cash and Cash Equivalents The primary objectives for the Company’s investment portfolio are the preservation of capital and maintenance of liquidity. The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. At December 31, 2022 and 2021, cash and cash equivalents include bank demand deposits and money market funds that invest primarily in U.S. government-backed securities and treasuries. Cash equivalents are stated at cost, which is substantially equivalent to fair value. Restricted cash The Company maintains a balance in a segregated bank account in connection with a letter of credit for the benefit of the landlord in connection with an operating lease. As of December 31, 2022 and 2021, restricted cash consisted of $ 3.4 million held for the benefit of the landlord. This amount has been classified as part of non-current assets on the Company's consolidated balance sheets. The Company includes its restricted cash balance in the cash, cash equivalents and restricted cash reconciliation of operating, investing and financing activities in the consolidated statements of cash flows. The following table provides a reconciliation of cash, cash equivalents and restricted cash in the consolidated balance sheets that sum to the total of the same such amounts shown in the consolidated statements of cash flows: DECEMBER 31, 2022 2021 (in thousands) Cash and cash equivalents $ 25,709 $ 100,752 Restricted cash 3,437 3,437 Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows $ 29,146 $ 104,189 Investments Short-term investments consist of commercial paper, corporate bonds, asset-backed securities, and U.S. Treasury securities with original maturities greater than three months. The Company may sell investments at any time for use in current operations even if the investments have not yet reached maturity. As a result, the Company classifies its investments, including securities with maturities beyond twelve months, as current assets. As of December 31, 2022, all investments are classified as available-for-sale securities, which are recorded at fair value . Unrealized holding gains and losses on available-for-sale securities are reported as a net amount in accumulated other comprehensive income or loss in stockholders’ equity until realized. Purchase premiums and discounts are amortized to interest income over the terms of the related securities. Realized gains and losses and declines in fair value that are deemed to be other than temporary are reflected in the statements of operations and comprehensive loss using the specific-identification method. The Company periodically reviews all available-for-sale securities for other than temporary declines in fair value below the cost basis whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company also evaluates whether it has plans or is required to sell short-term investments before recovery of their amortized cost bases. For the year ended December 31, 2022, the Company has not identified any other than temporary declines in fair value of its short-term investments. Property and Equipment, Net Property and equipment are recorded at cost. Expenditures for major renewals or betterments that extend the useful lives of property and equipment are capitalized; expenditures for maintenance and repairs are charged to expense as incurred. Depreciation expense is recognized on a straight-line basis over the estimated useful lives of the related assets. Property and equipment are depreciated as follows: ASSET TYPE ESTIMATED USEFUL LIFE Computer equipment and software 3 - 5 years Furniture and fixtures 5 years Laboratory equipment 5 years Manufacturing equipment 5 years Leasehold improvements Shorter of lease term or estimated useful life Upon retirement or sale, the cost and related accumulated depreciation of assets disposed of are removed from the accounts, and any resulting gain or loss is included in the Company's consolidated statements of operations as a component of other income (expense) . Impairment of Long-Lived Assets Long-lived assets consist of property and equipment. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends, and significant changes or planned changes in the use of the long-lived assets. If an impairment review were to be performed to evaluate a long-lived asset for recoverability, the Company would compare forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized if estimated undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset over its fair value, determined based on discounted cash flows. For the years ended December 31, 2022 and 2021, the Company has not recorded any impairment losses on long-lived assets. Fair Value Measurements Certain assets and liabilities of the Company are carried at fair value under GAAP. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: Level 1 —Valuations based on quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 —Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant inputs are observable, either directly or indirectly, such as quoted market prices, interest rates, and yield curves. Level 3 —Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and unobservable. To the extent a valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair values requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized as Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Company believes that the carrying amounts of prepaid expenses, other current assets, accounts payable, and accrued expenses approximate their fair values due to the short-term nature of those instruments. Research Contract Costs and Accruals The Company has entered into various research service arrangements under which vendors perform various services. The Company records accrued expenses for estimated costs incurred under the arrangements. When evaluating the adequacy of the accrued expenses, the Company analyzes the progress of the studies, trials or other services performed, including invoices received and contracted costs. Judgments and estimates are made in determining the accrued expense balances at the end of each reporting period . Operating Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on specific facts and circumstances, the existence of an identified asset(s), if any, and the Company’s control over the use of the identified asset(s), if applicable. The lease liability is measured at the present value of future lease payments, discounted using the discount rate as of the lease commencement date. Future lease payments may include payments that depend on an index or a rate (such as the consumer price index or other market index). The Company initially measures payments based on an index or rate by using the applicable rate at lease commencement and subsequent changes in such rates are recognized as variable lease costs. Variable payments that do not depend on a rate or index are not included in the lease liability and are recognized as they are incurred. The Company’s contracts typically do not have variable payments based on index or rate. The Company’s contracts that include a lease component generally include additional services that are transferred to the lessee (e.g., common-area maintenance services), which are non-lease components. Contracts typically also include other costs and fees that do not provide a separate service to the lessee, such as costs paid by the lessee to reimburse the lessor for administrative costs or payment for the lessor’s costs for property taxes, insurance related to the leased asset, and other lessor costs. The Company elected the practical expedient to account for the lease and its associated non-lease components as a single lease component for its real estate leases, including the office, lab, and its manufacturing space. When readily determinable, the discount rate used to calculate the lease liability is the rate implicit in the lease. As the Company's leases typically do not provide an implicit rate, the Company uses its incremental borrowing rate based on the lease term and economic environment at the lease commencement date. The lease term used to calculate the lease liability includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. With limited exceptions, the nature of the Company's facility leases is such that there are no economic or other conditions that would indicate that it is reasonably certain at lease commencement that the Company will exercise options to extend the term. The Company recognizes a corresponding lease right of use (“ROU”) asset, initially measured as the amount of lease liability, adjusted for any initial lease costs or lease payments made before or at the commencement of the lease, and reduced by any lease incentives. In some instances, as construction related to leasehold improvements is performed over the life of the lease, the right-of-use asset and lease liability will be adjusted on a prospective basis to reflect any payments relating to the lease incentives. The Company’s leases consist of only operating leases. Operating leases are recognized on the balance sheet as ROU lease assets, lease liabilities current and lease liabilities non-current. Fixed rents are included in the calculation of the lease balances while certain variable costs paid for certain operating and pass-through costs are excluded. Lease expense is recognized over the expected lease term on a straight-line basis. For leases with a term of one year or less, or short-term leases, the Company has elected to not recognize the lease liability for these arrangements and the lease payments are recognized in the consolidated statements of operations and comprehensive loss. Patent Costs The Company expenses patent costs as incurred and records such costs within general and administrative expenses. Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s income tax returns. Deferred taxes are determined based on the difference between the consolidated financial statement and tax bases of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes in the Company's consolidated statements of operations and comprehensive loss. The Company assesses the likelihood that its deferred tax assets will be realized and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. The potential for recovery of deferred tax assets is evaluated by analyzing carryback capacity in periods with taxable income, reversal of existing taxable temporary differences and estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50 % likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. The Company recognizes any interest and penalties related to uncertain tax positions in income tax expense. Stock-Based Compensation The Company measures all stock options and other stock-based awards granted based on the fair value of the award on the date of the grant and recognizes stock-based compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective award. The Company has elected to recognize forfeitures as they occur. The reversal of compensation cost previously recognized for an award that is forfeited because of a failure to satisfy a service or performance condition is recognized in the period of the forfeiture. Generally, the Company issues stock options and restricted stock awards with only service-based vesting conditions and records the expense for these awards using the straight-line method over the requisite service period. For performance-based awards that are awarded, the Company applies the graded-vesting method to the awards once achievement of the performance conditions is considered probable. The Company classifies stock-based compensation expense in its consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipients’ service payments are classified. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model, which requires inputs based on certain subjective assumptions, including the fair value of the Company’s common stock, expected stock price volatility, the expected term of the stock option, the risk-free interest rate for a period that approximates the expected term of the stock option, and the Company’s expected dividend yield. The closing sale price per share of the Company’s common stock as reported on The Nasdaq Global Market on the date of grant is used to determine the fair value, which is then used to establish the exercise price per share of share-based awards to purchase common stock. As there was no public market for its common stock prior to October 2, 2020, which was the first day of trading upon completion of its IPO, the Company estimates its expected share price volatility based on the historical volatility of publicly-traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded share price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain vanilla” stock options. We use the simplified method to calculate the expected term for options granted to employees and directors. We utilize this method as we do not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. The fair value of each restricted common stock award is estimated on the date of grant based on the fair value of the Company’s common stock on that same date. Net Loss Per Share Basic and diluted net loss per common share is calculated by dividing net loss by the weighted-average number of common shares outstanding for the periods. Diluted net loss per share is computed by dividing the diluted net loss by the weighted average number of common shares, including potential dilutive common shares assuming the dilutive effect of outstanding stock options and unvested restricted stock units. For periods in which we have reported net losses, diluted net loss per common share is the same as basic net loss per share, since dilutive common shares are not included if their effect is anti-dilutive. Deferred Offering Costs The Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process equity issuances or debt financings as deferred offering costs until such equity issuances or debt financings are consummated. After consummation, these costs are recorded as a reduction in the capitalized amount associated with the equity issuance or debt financing. Debt Related Costs The carrying value of the Company’s Term Loan (see Note 7) is recorded net of issuance costs and discount relating to the issuance of warrants and fees paid to the lender. Debt-related costs are amortized over the term of the debt using the effective interest method and recognized as interest expense. Recently Issued Accounting Pronouncements In September 2022, the FASB issued ASU 2022-04, Liabilities—Supplier Finance Programs (Subtopic 405-50): Disclosure of Supplier Finance Program Obligations. This amendment requires a buyer that uses supplier finance programs to make annual disclosures about the program’s key terms, the balance sheet presentation of related amounts, the confirmed amount outstanding at the end of the period, and associated rollforward information. Only the amount outstanding at the end of the period must be disclosed in interim periods. The amendments are effective for all entities for fiscal years beginning after December 15, 2022 on a retrospective basis, including interim periods within those fiscal years, except for the requirement to disclose rollforward information, which is effective prospectively for fiscal years beginning after December 15, 2023. Early adoption is permitted. The Company is currently reviewing the provisions of this new pronouncement, but does not expect this guidance will have a material impact on its consolidated financial statements. In August 2020, the FASB issued ASU No. 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This amendment simplifies accounting for convertible instruments by removing major separation models required under current U.S. GAAP. It also removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception, and simplifies the diluted earnings per share calculation in certain areas. ASU No. 2020-06 is effective for public companies for annual periods beginning after December 15, 2021, including interim periods within those fiscal years. The Company early adopted the provisions of ASU 2020-06 effective January 1, 2022, using the modified retrospective method for transition with no significant impact on its consolidated financial statements at the time of adoption. In June 2016, the FASB issued ASU 2016-13 (Topic 326), Financial Instruments — Credit Losses — Measurement of Credit Losses on Financial Instruments , which is codified in Topic 326 . The ASU changes how entities will measure credit losses on Held-to-Maturity (HTM) and Available-for-Sale debt securities. After the adoption of ASU 2016-13 (Topic 326), additional disclosures are required for HTM debt securities. The standard is effective for annual periods beginning after December 15, 2022 since the Company is a Smaller Reporting Company. The Company is currently reviewing the provisions of this new pronouncement, but does not expect this guidance will have a material impact on its consolidated financial statements. There have been no other issued accounting pronouncements other than those described in the Company’s audited financial statements as of and for the year ended December 31, 2022, and the notes thereto, which are included in the Annual Report, that will have a material effect on the Company's consolidated financial statements. |
Cash Equivalents and Investment
Cash Equivalents and Investments | 12 Months Ended |
Dec. 31, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Cash Equivalents and Investments | 3. Cash Equivalents and Investments The following tables summarize the amortized cost and fair value of our cash equivalents and investments (in thousands): DECEMBER 31, 2022 AMORTIZED COST BASIS GROSS UNREALIZED GAINS GROSS UNREALIZED LOSSES ESTIMATED FAIR VALUE Cash Equivalents Money market funds $ 19,881 $ — $ — $ 19,881 Total Cash Equivalents $ 19,881 $ $ $ 19,881 Investments Commercial paper $ 25,094 $ — $ — $ 25,094 Corporate bonds 3,028 — ( 13 ) 3,015 U.S. Treasury securities 8,417 — ( 39 ) 8,378 Total Investments $ 36,539 $ $ ( 52 ) $ 36,487 DECEMBER 31, 2021 AMORTIZED COST BASIS GROSS UNREALIZED GAINS GROSS UNREALIZED LOSSES ESTIMATED FAIR VALUE Cash Equivalents Money market funds $ 98,900 $ — $ — $ 98,900 Total Cash Equivalents $ 98,900 $ — $ — $ 98,900 Investments Commercial paper $ 11,084 $ — $ — $ 11,084 Asset-backed securities 2,020 — ( 2 ) 2,018 U.S. treasury securities 4,812 — ( 8 ) 4,804 Corporate bonds 5,271 — ( 4 ) 5,267 Total Investments $ 23,187 $ — $ ( 14 ) $ 23,173 As of December 31, 2022, the Company held seven investments with unrealized losses. All investments in an unrealized loss position were in this position for less than 12 months. The Company evaluated its securities for potential other-than-temporary impairment and considered the decline in market value to be primarily attributable to current economic and market conditions. Additionally, the Company does not intend to sell the securities in an unrealized loss position and does not expect it will be required to sell the securities before recovery of the unamortized cost basis. Given the Company's intent and ability to hold such securities until recovery, and the lack of a significant change in credit risk for these investments, the Company does not consider these investments to be impaired as of December 31, 2022. There were no realized gains or losses recognized on investments for the year ended December 31, 2022. Interest on investments is recognized as interest income in the consolidated statements of operations and comprehensive loss. All investments held as of December 31, 2022, were classified as available-for-sale securities and had contractual maturities of less than one year. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements The following table presents information about the Company’s financial assets measured at fair value on a recurring basis (in thousands): FAIR VALUE MEASUREMENTS LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Assets: Money market funds $ 19,881 $ — $ — $ 19,881 U.S. treasury securities 8,378 — — 8,378 Commercial paper — 25,094 — 25,094 Corporate bonds — 3,015 — 3,015 Total Assets $ 28,259 $ 28,109 $ — $ 56,368 FAIR VALUE MEASUREMENTS LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Assets: Money market funds $ 98,900 $ — $ — $ 98,900 U.S. treasury securities 4,804 — — 4,804 Commercial paper — 11,084 — 11,084 Asset-backed securities — 2,018 — 2,018 Corporate bonds — 5,267 — 5,267 Total Assets $ 103,704 $ 18,369 $ — $ 122,073 The Company classifies its money market funds and U.S. treasury securities as Level 1 assets since it measures fair value using quoted prices in active markets for identical assets. The Level 2 assets include commercial paper, asset-backed securities, and corporate bonds and are valued based on quoted prices for similar assets in active markets and inputs other than quoted prices that are derived from observable market data. The Company did not hold any Level 3 assets during the periods presented. The Company evaluates transfers between levels at the end of each reporting period. There were no transfers between Level 1 and Level 2 assets during the periods presented. |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | 5. Property and Equipment, net Property and equipment, net as of December 31, 2022 and 2021 consisted of the following (in thousands): DECEMBER 31, 2022 2021 Laboratory equipment $ 6,512 $ 6,084 Computer equipment and software 730 478 Furniture and fixtures 1,399 769 Leasehold improvements 37,721 9,266 Manufacturing equipment 495 — Fixed assets not yet placed in service 2,855 12,790 Total property and equipment, gross 49,712 29,387 Less accumulated depreciation ( 5,352 ) ( 6,154 ) Total property and equipment, net $ 44,360 $ 23,233 Depreciation expense was $ 3.6 million and $ 1.9 million for the years ended December 31, 2022 and 2021, respectively, which is recognized included within operating expenses in the consolidated statement of operations and comprehensive loss. |
Accrued Expenses and Other Long
Accrued Expenses and Other Long-Term Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Long-Term Liabilities | 6. Accrued Expenses and Other Long-Term Liabilities At December 31, 2022 and 2021, accrued expenses and other long-term liabilities consisted of the following (in thousands): AS OF DECEMBER 31, 2022 2021 Accrued research and development costs $ 2,661 $ 1,474 Accrued leasehold improvement costs 4,079 999 Accrued compensation 2,612 2,697 Accrued professional fees 752 846 Accrued interest 198 — Other accrued expenses 645 468 Total accrued expenses and other long-term liabilities $ 10,948 $ 6,484 |
Term Loan, net of debt discount
Term Loan, net of debt discount | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Term Loan, net of debt discount | 7. Term Loan, net of debt discount On April 1, 2022, the Company entered into a loan and security agreement (the "Loan Agreement") with K2 HealthVentures LLC ("K2HV"), and together with any other lender from time to time party thereto, the “Lenders”), K2HV as administrative agent for the Lenders, and Ankura Trust Company, LLC, as collateral agent for the Lenders. The Loan Agreement provides term loan commitments of up to $ 45.0 million in four potential tranches: (i) a $ 20.0 million term loan funded on April 1, 2022, (the “First Tranche Term Loan”), (ii) a $ 5.0 million term loan commitment (the “Second Tranche Term Loan Commitment”), (iii) a $ 15.0 million term loan commitment (reduced to $ 10.0 million if a second tranche term loan is made) (the “Third Tranche Term Loan Commitment”), and (iv) a $ 10.0 million term loan commitment (the “Fourth Tranche Term Commitment”). The timing and availability of the tranche term loan commitments are subject to various conditions, including that no events of default have occurred. The availability period of the Second Tranche Term Loan Commitment ended on December 31, 2022. The availability of the Third Tranche Term Loan Commitment begins January 1, 2023 and ends no later than July 31, 2023 and is subject to the achievement of a clinical milestone event. The Fourth Term Loan Commitment availability ends May 1, 2024, unless the third tranche milestone is met, which would adjust such date to May 1, 2025. The Fourth Tranche Term Loan Commitment is subject to a satisfactory loan review by the Lenders who may provide the advances in their sole discretion, and is also subject to an additional 1 % facility fee. The facility carries a 48-month term with interest only payments for 24 months, subject to increase to up to 36 months upon the Company drawing on the Third Tranche Loan Commitment and no event of default having occurred. Subsequent to the interest-only period, the Company is required to make equal monthly payments of principal plus interest until the loans mature on April 1, 2026. The term loans bear a variable interest rate equal to the greater of 7.75 % and (ii) the sum of (A) the prime rate last quoted in The Wall Street Journal (or a comparable replacement rate if The Wall Street Journal ceases to quote such rate) and (B) 4.25 %. The variable interest rate at December 31, 2022, was 11.75 %. Upon final payment or prepayment of the loans, the Company must pay a final payment equal to 5.45 % of the loans borrowed (the "Final Fee"), which is being accrued to interest expense over the term of the loan. The Company has an option to prepay the loans in whole, subject to a prepayment fee of 3 % prior to the first anniversary of the April 1, 2022, funding date, 2 % after the first anniversary but prior the second anniversary of the funding date, and 1 % thereafter if prior to the maturity date. The Lenders may elect at any time prior to the full repayment of the term loans to convert any portion of the principal amount of the term loans then outstanding, up to an aggregate of $ 5.0 million in principal amount, into shares of the Company's common stock at a conversion price of $ 2.2689 , subject to customary beneficial ownership limitations. The Loan Agreement contains customary representations and warranties, events of default and affirmative and negative covenants, including covenants that limit or restrict the Company’s ability to, among other things, dispose of assets, make changes to the Company’s business, management, ownership or business locations, merge or consolidate, incur additional indebtedness, pay dividends or other distributions or repurchase equity, make investments, and enter into certain transactions with affiliates, in each case subject to certain exceptions. As security for its obligations under the Loan Agreement, the Company granted the Lenders a first priority security interest on substantially all of the Company’s assets (other than intellectual property), subject to certain exceptions. Upon occurrence of an event of default, which includes the failure to maintain solvency and a subjective acceleration clause, the Company, at the Lender's request, may have to prepay the term loans in an amount equal to the sum of the (a) outstanding principal together with accrued interest, (b) prepayment fee, and (c) Final Fee. The subjective acceleration clause can be activated at the Lenders' discretion in the event of certain events or circumstances including a material adverse effect upon the prospect of repayment of any part of the amounts due to the Lenders. Based upon an assessment of this clause and the Company's going concern audit opinion and its significant operating losses, the Company determined that its otherwise long-term debt should be classified as a current liability on its consolidated balance sheet as of December 31, 2022. Upon an event of default, a default interest rate of an additional 5.00% per annum may, at the Lender’s request, also be applied to the outstanding loan balances. The Lender’s right to demand prepayment of the term loan and/or require the default interest rate represent an embedded derivative of the term loan. The Company has determined that the fair value of this embedded derivative is de minimis as of December 31, 2022. In connection with entering into the Loan Agreement, the Company also issued to K2HV a warrant to purchase a number of shares of Common Stock equal to the quotient of 2.95 % of the aggregate funded term loan amount divided by $ 1.5126 , the exercise price, up to a maximum of 877,627 shares (the "Warrant"). The Warrant expires on April 1, 2032 . The Warrant has been classified within equity since it (i) is indexed to the Company’s own equity and (ii) meets the equity classification conditions. As of December 31, 2022, the Warrant is exercisable for 390,056 shares of common stock. The Company allocated the proceeds between the term loan and the Warrant on a relative fair value basis, resulting in a discount on the term loan. The Loan Agreement and the Warrant each provide the Lenders with certain piggyback registration rights with respect to the shares of common stock issuable upon conversion under the Loan Agreement or upon exercise of the Warrant. The Company incurred fees and issuance costs associated with the Loan Agreement of $ 0.5 million, which was capitalized as a reduction to the Term Loan balance. The Company recorded contractual interest expense related to the Loan Agreement of $ 1.5 million and additional interest expense related to the amortization of the debt discount and issuance costs and accretion of the Final Fee of $ 0.5 million in the year ended December 31, 2022. The effective interest rate at December 31, 2022, which includes the non-cash interest components noted above, was 15.25 %. Future principal debt payments on the Loan Agreement are as follows (in thousands): AS OF DECEMBER 31, 2022 2021 2022 $ — $ — 2023 — — 2024 6,131 — 2025 10,161 — 2026 3,708 — Total principal payments 20,000 — Final Fee 1,090 — Total principal payments and Final Fee 21,090 — Less: Unamortized debt discount ( 767 ) — Less: Unamortized debt issuance costs ( 64 ) — Less: Unaccreted Final Fee ( 823 ) — Term loan, net (current) $ 19,436 $ — |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2022 | |
Statement of Stockholders' Equity [Abstract] | |
Common Stock | 8. Common Stock Each share of common stock is entitled to one vote. The holders of shares of common stock are entitled to receive dividends, if and when declared by the Board of Directors. Prior to the IPO, the voting, dividend, and liquidation rights of the holders of common stock were subject to, and qualified by, the rights, powers, and preferences of the holders of preferred stock. Upon the closing of the IPO, the Company changed its authorized capital stock to include 100,000,000 shares designated as common stock with a par value of $ 0.0001 per share as part of its authorized capital. Restricted Stock The Company issued restricted stock to its founders and certain officers of the Company. In general, the shares of restricted stock vest over a four-year period, with 25 % of the shares vesting after one year, followed by monthly vesting over the remaining three years. As of December 31, 2022, all restricted stock awards were fully vested. Common Stock Warrants The Company issued warrants to purchase common stock in connection with a preferred stock financing in March 2016. These common stock warrants allow for the holders to purchase 71,544 shares of common stock at $ 1.21 per share. As of December 31, 2022, all of the common stock warrants were fully exercisable. The common stock warrants expire in 2031. As described in Note 7, on April 1, 2022, the Company issued a warrant to K2HV to purchase 390,056 shares of common stock. This warrant expires in 2032. Reserved Shares The Company has reserved shares of common stock for the conversion or exercise of the following securities: DECEMBER 31, DECEMBER 31, Exercise of common stock warrants 949,171 71,544 Exercise of options to purchase common stock 4,391,207 3,681,793 Shares available for issuance under employee stock purchase plan — — Shares available for issuance under equity incentive plans 2,680,248 2,132,067 Shares available for issuance under term loan conversion 2,203,711 — Total 10,224,337 5,885,404 |
Equity Incentive Plan
Equity Incentive Plan | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Equity Incentive Plan | 9. Equity Incentive Plans The Company adopted the 2016 Equity Incentive Plan (the “2016 Plan”) on March 31, 2016. The Plan, as amended, provided for the granting of stock options, restricted stock awards, restricted stock units, stock appreciation rights and other stock awards to employees, directors and non-employees. All option awards were granted with an exercise price equal to or greater than the market price of the Company's stock at the date of grant. Option awards generally vest over three to four years . Certain option awards provide for accelerated vesting if there is a change in control as defined in the 2016 Plan. The provisions of the 2016 Plan allow for early exercises for options that have not yet vested. Early exercises have historically been for a de minimis number of shares. On September 23, 2020, the Company adopted the 2020 Equity Incentive Plan (the “2020 Plan”), which became effective upon the execution of the underwriting agreement related to the IPO and serves as the successor to the 2016 Plan. The 2020 Plan authorizes the award of stock options, restricted stock awards, stock appreciation rights, restricted stock units, cash awards, performance awards, and stock bonus awards. The number of shares reserved for issuance under the 2020 Plan will increase automatically on January 1 of each fiscal year, starting on January 1, 2021 and ending on and including January 1, 2030, by the number of shares equal to 5 % of the aggregate number of outstanding shares of common stock as of the immediately preceding December 31, or a lesser number of shares as may be determined by the board of directors (or an authorized committee thereof). O n January 1, 2022, the board of directors authorized an increase in the number of shares reserved for issuance under the 2020 Plan by 1,292,458 shares of common stock. At December 31, 2022, there were 2,680,248 shares of common stock available for issuance under the 2020 Plan. On September 23, 2020, the Company adopted the 2020 Employee Stock Purchase Plan (the “ESPP”), which became effective upon the execution of the underwriting agreement related to the IPO. The Company has initially reserved 280,000 shares of common stock for sale under the ESPP. The aggregate number of shares reserved for sale under the ESPP will increase automatically on January 1 of each fiscal year starting on January 1, 2021 and ending on and including January 1, 2030, by the number of shares equal to the lesser of (a) 1% of the total number of shares of common stock outstanding on the last day of the fiscal year prior to the date of such automatic increase and (b) 560,000 shares, provided that prior to the date of any such increase, the board of directors may determine a less number of shares for such increase. In December 2021, the board of directors determined that there would be no automatic increase in the number of shares of common stock reserved for sale under the ESPP in 2022. For 2023, the increase in the number of shares of common stock reserved for sale under the ESPP went into effect automatically on January 1, 2023. The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option-pricing model using the range of assumptions for the years ended December 31, 2022 and 2021 as noted in the following table: YEARS ENDED DECEMBER 31, 2022 2021 Expected volatility 84.2 % - 88.2 % 81.4 % - 88.3 % Expected dividends 0.0 % 0.0 % Expected term (in years) 5.3 - 6.2 5.3 - 10 Risk-free rate 1.5 % - 4.2 % 0.5 % - 1.6 % Total stock-based compensation expense (including both stock option awards and restricted stock) was as follows: YEARS ENDED DECEMBER 31, 2022 2021 (in thousands) General and administrative $ 4,786 $ 4,240 Research and development 2,426 2,333 Total stock-based compensation $ 7,211 $ 6,573 In December 2020, the Company granted an employee an option to purchase 113,000 shares of the Company’s common stock with an exercise price per share equal to the fair value of the Company’s common stock on the date of grant. This grant is included in the outstanding options in the summary table below. The option grant includes three separate tranches (each tranche representing one-third of the total grant) that will each vest four years from the date of grant. This option grant and its tranches are subject to accelerated vesting in the event that the Company achieves certain defined milestones related to the Company’s manufacturing efforts. As of December 31, 2022, the Company determined that the requisite service period for two of the three tranches of this award is four years and recognized $ 0.4 million of stock-based compensation expense for the year ended December 31, 2022. Accelerated vesting was considered to be probable for one of the tranches as of December 31, 2022. Accordingly, the Company recognized stock-based compensation expense of $ 0.3 million for this tranche in the year ended December 31, 2022, which included a cumulative adjustment reflecting the retroactive application of the accelerated vesting. A summary of stock option activity for the year ended December 31, 2022 is presented below: SHARES WEIGHTED- WEIGHTED- AGGREGATE Outstanding at December 31, 2021 3,681,793 $ 10.84 Granted 2,040,368 $ 1.60 Exercised ( 34,863 ) $ 1.77 Canceled, expired, or forfeited ( 1,296,091 ) $ 7.61 Outstanding at December 31, 2022 4,391,207 $ 7.57 8.00 $ — Vested and expected to vest at December 31, 2022 4,391,207 $ 7.57 8.00 $ — Exercisable at December 31, 2022 1,867,964 $ 8.11 6.89 $ — The weighted average grant date fair value of options granted to employees, directors and non-employee consultants during the years ended December 31, 2022 and 2021 was $ 1.17 and $ 11.05 , respectively. The total intrinsic value of stock options exercised was less than $ 0.1 million and $ 2.4 million for the years ended December 31, 2022 and 2021, respectively. Total unrecognized stock-based compensation expense related to stock options amounted to $ 11.2 million at December 31, 2022 and is expected to be recognized over a weighted-average period of 2.4 years. The total fair value of restricted shares vested during each of the years ended December 31, 2022 and 2021 was less than $ 0.1 million. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income Taxes Total (benefit from) provision for income taxes for the years ended December 31, 2022 and 2021 consisted of the following (in thousands): DECEMBER 31, 2022 2021 Current income tax expense $ — $ — Deferred income tax benefit 22,991 19,943 Valuation allowance for deferred tax assets ( 22,991 ) ( 19,943 ) Deferred income tax expense, net — — Total (benefit from) provision for income taxes $ — $ — A reconciliation of income tax expense (benefit) at the statutory federal income tax rate and income taxes as reflected in the consolidated financial statements is as follows: DECEMBER 31, 2022 2021 Federal income tax benefit at statutory rate 21.0 % 21.0 % State income tax, net of federal benefit 5.8 6.1 Permanent differences - stock-based compensation ( 1.1 ) ( 0.4 ) Research and development credit benefit 4.7 3.8 Change in valuation allowance ( 30.4 ) ( 30.5 ) Effective income tax rate — % — % The Company had a net loss for 2022 and 2021 and no income tax benefit has been recorded due to the full valuation allowance for deferred tax assets. The components of the Company’s deferred taxes at December 31, 2022 and 2021 are as follows (in thousands): DECEMBER 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards (federal and state) $ 47,852 $ 41,610 Tax credits (federal and state) 10,583 6,967 Accrued expenses and other liabilities 393 316 Capitalized research and development expenditures 14,115 835 Intangible assets 437 322 Stock based compensation 1,901 1,499 Lease liabilities 13,382 14,226 Total deferred tax assets 88,663 65,775 Valuation allowance ( 75,973 ) ( 53,139 ) Net deferred income tax assets 12,690 12,636 Deferred tax liabilities: Fixed assets ( 3,568 ) ( 283 ) Right-of-use assets ( 8,895 ) ( 12,353 ) Debt discount amortization ( 227 ) — Net deferred tax liabilities ( 12,690 ) ( 12,636 ) Net deferred income taxes $ — $ — The Company has evaluated the positive and negative evidence bearing upon its ability to realize the deferred tax assets. Management has considered the Company’s history of cumulative net losses incurred since inception and its lack of commercialization of any products or generation of any revenue from product sales since inception and has concluded that it is more likely than not that the Company will not realize the benefits of the deferred income tax assets. Accordingly, a full valuation allowance has been established against the net deferred income tax assets for each period presented. Management evaluates the positive and negative evidence at each reporting period. The valuation allowance was $ 76.0 million as of December 31, 2022 and $ 53.1 million as of December 31, 2021. The increase in the valuation allowance of approximately $ 22.9 million in 2022 was primarily a result of capitalized R&D expenses for tax and net losses generated with no corresponding financial statement benefit. As of December 31, 2022, the Company had net operating loss (“NOLs”) carryforwards for federal income tax purposes of $ 176.2 million, of which $ 18.1 million will begin to expire in 2035, and approximately $ 158.1 million can be carried forward indefinitely. The Company also has $ 171.6 million of state net operating losses which expire at various dates through 2042. As of December 31, 2022, the Company also had available research and development tax credit carryforwards for federal and state income tax purposes of $ 7.4 million and $ 4.0 million, respectively, which begin to expire in 2035 and 2030 , respectively. Utilization of the net operating loss carryforwards and research and development tax credit carryforwards may be subject to a substantial annual limitation under Section 382 and Section 383 of the Internal Revenue Code of 1986, as amended (the "Code"), due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as defined by Section 382 of the Code, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50 % over a three-year period. The Company has not conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control since inception due to the significant complexity and cost associated with such a study. If the Company has experienced a change of control, as defined by Section 382 of the Code, at any time since inception, utilization of the NOLs or research and development tax credit carryforwards would be subject to an annual limitation under Section 382 of the Code, which is determined by first multiplying the value of the Company’s stock at the time of the ownership change by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the NOLs or research and development tax credit carryforwards before utilization. Further, until a study is completed, and any limitation is known, no adjustments have been reflected in the deferred income tax asset for NOL carryforwards or credits. For the year ended December 31, 2022, the Company generated research credits but has not conducted a study to document the qualified activities. This study may result in an adjustment to the Company’s research and development credit carryforwards; however, until a study is completed and any adjustment is known, no amounts have been recognized as an uncertain tax position. A full valuation allowance has been provided against the Company’s research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the deferred income tax asset established for the research and development credit carryforwards and the valuation allowance. The Company had no unrecognized tax benefits or related interest and penalties for the years ended December 31, 2022 and 2021. The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending income tax examinations. The Company’s tax years are still open under statute from the year of formation to the present. The Company’s policy is to record interest and penalties related to income taxes as part of its income tax provision. The Company established a Massachusetts securities corporation in 2019. The securities corporation is taxed on its investment income at the rate of 1.32 %. The income tax associated with investment income from the securities corporation was not material to the 2022 income tax provision. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Leases | 11. Leases The Company has an operating lease for approximately 33,518 square feet (the “Pod 4 Portion”), approximately 54,666 square feet (the “Pod 5 Portion”), and approximately 17,150 square feet ("Pod 3 Portion") of a manufacturing facility located in Andover, Massachusetts, that also serves as its corporate headquarters. This lease expires in December 2036 and the Company has two options to extend the term of the lease for a period of ten years each . As of December 31, 2022, the Company had not exercised its options to extend the lease term and did not consider it reasonably certain that these options would be exercised. The Company agreed to provide the landlord with a $ 3.4 million letter of credit as support for its obligations under the Andover facility lease. The lease provides a lease incentive in the form of reimbursable leasehold improvements of $ 14.9 million. Due to the unpredictability of the payout of leasehold improvement reimbursements, the right-of-use asset will be adjusted on a prospective basis to reflect any payments relating to the lease incentive as construction related to these improvements is performed over the life of the lease. As of December 31, 2022, the Company had capitalized $ 37.7 million of leasehold improvement costs, of which $ 9.7 million was reimbursed through the lease incentive. The lease payments include fixed base rent payments and variable rents for certain shared facility operating and other costs. The Company was also party to an operating lease in Cambridge, Massachusetts, which served as its corporate headquarters until September 2022. On September 13, 2022, the Company executed an amendment to its Cambridge lease which accelerated the lease termination date to November 15, 2022, from the previous date of January 12, 2024. In connection with this amendment, the Company remeasured the remaining lease liability and right-of-use-asset and recognized a gain of $ 0.5 million, which is included as a reduction of operating expenses in the consolidated statements of operations and comprehensive loss for the year ended December 31, 2022. During the years ended December 31, 2022 and 2021, the Company recognized total rent expense related to the leases described above of $ 5.2 million and $ 5.7 million, respectively. The amount of variable rent expense and rent for short-term leases for the years ended December 31, 2022 and 2021, was $ 3.1 million, and $ 2.4 million, respectively. Other supplemental information related to leases is as follows: (in thousands) 2022 2021 Weighted average remaining lease term 14.0 years 13.8 years Weighted average discount rate 7.7 % 8.1 % Cash paid for amounts included in the measurement of lease liabilities $ 5,505 $ 1,777 Maturities of operating lease liabilities were as follows as of December 31, 2022 (in thousands): Year Amount 2023 $ 4,850 2024 4,995 2025 5,145 2026 5,299 2027 5,458 Thereafter 57,114 Total lease payments 82,861 Less imputed interest ( 33,878 ) Total lease liabilities $ 48,983 Current portion $ 1,129 Long-term portion $ 47,854 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. Commitments and Contingencies License and Royalty Agreements The Company has entered into license and royalty agreements for intellectual property with certain parties. Such arrangements require ongoing payments, including payments upon the achievement of certain development, regulatory and commercial milestones, receipt of sublicense income, as well as royalties on commercial sales. Payments under these arrangements are expensed as incurred. The Company’s material license and collaboration agreements are summarized below. Ospedale San Raffaele S.r.l. and Fondazione Telethon In December 2015, the Company entered into a license agreement with Ospedale San Raffaele S.r.l. and Fondazione Telethon, as amended, for the use of certain patents and technology. The Company made an initial payment of $ 0.1 million, which amount was recorded as research and development expense. Under the terms of the license, the Company is required to pay an annual maintenance fee, up to $ 3.9 million in milestone payments for the first indication, up to $ 5.7 million in milestone payments for each subsequent indication, and a low single digit tiered royalty on net sales of any covered products. The agreement terminates upon the expiration of the last remaining royalty obligation for a licensed product. University of Pittsburgh In March 2016, the Company entered into a license agreement, as amended, with University of Pittsburgh for the use of certain patents and technology. The Company made an initial payment of $ 0.1 million, which amount was recorded as research and development expense. Under the terms of the license, the Company is required to pay an annual maintenance fee and up to $ 2.6 million in milestone payments through first commercial product sale and a low single digit royalty on net product revenue, subject to annual minimum amounts, through the expiration of the patent claims. Northwestern University In December 2018, the Company entered into a license agreement with Northwestern University for the use of certain patents and technology. The Company made an initial payment of $ 0.1 million, which amount was recorded as research and development expense. Under the terms of the license, the Company is required to pay an annual maintenance fee and up to $ 4.1 million in milestone payments through the first commercial product sale and an annual low single digit royalty on net sales, subject to annual minimum amounts, through the later of ten years from the first commercial sale or the expiration of the patent claims. WuXi Biologics Ireland Limited In July 2019, the Company entered into a license agreement with Wuxi Biologics Ireland Limited for the use of certain patents and technology. Under the terms of the license, the Company agreed to an initial license payment of $ 0.3 million and is required to pay milestone payments for the first product developed, as well as additional products, in addition to royalties on net product revenue. For the first product developed, the Company is required to pay up to $ 8.0 million in certain clinical milestone payments. For the first three products developed, the Company is also required to pay up to $ 27.0 million in commercial milestone payments for each product that achieves specified net sales levels along with product approvals in several countries. The Company also agreed to pay tiered royalties on net sales of licensed products ranging in the low-single digits. The obligation to pay royalties under the license agreement expires on a licensed product-by-licensed product and country-by-country basis upon expiry of the last valid claim of the licensed patents that cover such licensed product in such country. In June 2021, the Company satisfied a $ 0.5 million milestone event related the development of its first product and paid Wuxi Biologics Ireland Limited, which was recorded to research and development expense. Gaeta Therapeutics Ltd. In November 2021, the Company entered into a license agreement with Gaeta Therapeutics Ltd. for the use of certain patent rights in connection with usage of a certain transgene, IL-12, with a systemic checkpoint inhibitor and with respect to the development of products that would otherwise infringe on such rights. The Company made an initial payment of $ 0.2 million, which was recorded as research and development expense in the year ended December 31, 2021. Under the terms of the license, t he Company is obligated to make certain milestone payments including a low six-figure payment related to the achievement of a certain patent milestone in the United States, certain clinical and regulatory milestone payments which amount to $ 7.5 million in the aggregate for a given developed product or indication, and additional annual payments of low single digit millions following regulatory approval of each product. The Company is also obligated to pay tiered royalties on cumulative net sales of all developed products up to $ 2.5 million in the aggregate for cumulative net sales in excess of certain thresholds of net sales reached, with additional payments in the mid single-digit millions thereafter upon the achievement of additional net sales milestones. The Company achieved the first clinical milestone in December 2021 and paid Gaeta Therapeutics Ltd. $ 0.5 million, which was recorded to research and development expense. NOF Corporation On October 31, 2022, the Company entered into a license agreement with NOF Corporation ("NOF"). Under this license agreement, the Company obtained a non-exclusive, worldwide (except with respect to China and other specified territories in Asia), sublicensable (subject to certain limitations) license from NOF under certain patent claims of NOF relating to NOF’s cationic lipid, or NOF Lipid. The NOF Lipid is one of multiple lipids that comprise the proprietary LNP associated with ONCR-021. NOF will supply NOF Lipid to be used for the development, manufacture, and commercialization of Oncorus Products pursuant to a supply agreement to be negotiated and entered into by the parties. The NOF Agreement provides for an initial license payment of $ 0.5 million to NOF upon signing, which will be recorded to research and development expense in October 2022. Additionally, the Company may be obligated to make milestone payments to NOF of up to approximately $ 25.0 million in the aggregate upon the achievement of specified development and regulatory milestones. In the event that more than one Oncorus Product achieves such milestones, or if an Oncorus Product achieves the specified milestones for additional indications, the Company will be obligated to make additional milestone payments. Such payments would be between approximately $ 5.0 million and approximately $ 10.0 million for each such additional product and/or indication. The Company is also obligated to pay NOF royalties on net sales of Oncorus Products at a percentage in the low single digits, subject to standard reductions. The obligation to pay royalties under the NOF Agreement commences on the first commercial sale of the first Oncorus Product anywhere in the licensed territory, and expires on a jurisdiction-by-jurisdiction basis after a specified number of years following the first commercial sale of the first Oncorus Product anywhere in the licensed territory, or if later, the date upon which no licensed patent claim validly exists in such jurisdiction. Related Party License and Royalty Agreements Certain investors are entitled to receive, in the aggregate, a royalty from the Company equal to 1 % of net sales of Company products discovered or developed prior to an IPO by the Company. The royalty obligation expires upon the later of twelve years from the first commercial sale or the expiration of the patent. The Company entered into a patent assignment agreement with an investor under which that investor would receive $ 1.0 million upon regulatory approval of a product in the United States and an annual low single-digit royalty on net product revenue. The Company is not currently developing any product candidates using the patent that was assigned to the Company. In September 2016, the Company entered into a sublicense agreement with an entity affiliated with a stockholder of the Company for the use of certain patents and technology. Under the terms of the license, the Company is required to pay up to $ 7.6 million in milestone payments through first commercial product sale and an annual mid-single digit royalty on net sales through the expiration of the patent claims. This agreement was terminated in May 2020. Litigation The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not 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. The Company expenses as incurred the costs related to such legal proceedings. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 13. Net Loss Per Share The following securities that could potentially dilute basic net loss per share in the future were not included in the computation of diluted net loss per share for the periods presented, because to do so would have been antidilutive: YEARS ENDED DECEMBER 31, 2022 2021 Outstanding stock options 4,391,207 3,681,793 Common stock warrants 461,600 71,544 Shares available for purchase under employee stock purchase plan — — Potential conversion of note payable 2,203,711 — Total 7,056,518 3,753,337 |
Retirement Plan
Retirement Plan | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
Retirement Plan | 14. Retirement Plan The Company has a tax-qualified employee savings and retirement plan under Section 401(k) of the Code, covering all qualified employees. Participants may elect a salary deferral up to the statutorily prescribed annual limit for tax-deferred contributions. The Company paid matching contributions of $ 0.4 million for the years ended December 31, 2022 and 2021. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Subsequent Events The Company has evaluated subsequent events from the balance sheet date through the date on which these financial statements were issued. Subsequent to the issuance of the financial statements, there were no events that occurred that required disclosure, or revision to, the financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation These consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the FASB. |
COVID-19 Pandemic | COVID-19 Pandemic In response to the COVID-19 pandemic, the Company implemented a work-from-home policy allowing employees who can work from home to do so. The Company has transitioned back to in-office work for the majority of our employees. The Company has taken measures to secure its research and development project activities, while work in laboratories has been organized to reduce risk of COVID-19 transmission. Business travel was previously suspended but is now becoming more frequent, and online and teleconference technology continues to be used regularly. Given the global impact and the other risks and uncertainties associated with the pandemic and other public health crises, the Company’s business, financial condition and results of operations could be materially adversely affected. The Company continues to monitor guidance from the CDC and other relevant health regulatory authorities and may adjust its plans to the extent there are changes in such guidance. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. Actual results could differ from those estimates, and any such differences may be material to the Company’s financial statements. |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements of the Company include the accounts of its wholly owned subsidiary, Oncorus Securities Corporation. All intercompany transactions have been eliminated in consolidation. The Company has one operating segment. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not limited to, the estimated fair value of the Company’s common stock prior to its IPO and share-based awards utilized for stock-based compensation purposes, accrued expenses and amounts of expenses during the reported period, and determination of an incremental borrowing rate for any identified leases for which an implicit discount rate is not easily determinable. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. |
Concentration of Credit Risk and of Significant Suppliers | Concentration of Credit Risk and of Significant Suppliers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents and short-term investments. The Company has all of its cash at one financial institution that management believes to be of high credit quality, in amounts that exceed federally insured limits. The Company invests its excess cash, in line with its investment policy, primarily in money market funds and high credit quality debt instruments . The Company is dependent upon a third-party contract manufacturer and third-party contract research organizations for the performance of portions of its testing for pre-clinical and clinical studies. The Company believes that its relationships with these organizations are satisfactory, and that alternative suppliers of these services are available in the event of the loss of one or more of these suppliers. |
Research and Development Expense | Research and Development Expenses Research and development expenses are expensed as incurred. Research and development expenses consist of costs incurred to discover, research and develop drug candidates, including compensation-related expenses for research and development personnel, including stock-based compensation expense, preclinical and clinical activities, costs of manufacturing, overhead expenses including facilities and laboratory expenses, materials and supplies, amounts paid to consultants and outside service providers, and depreciation and amortization. Upfront and annual license payments related to acquired technologies or technology licenses which have not yet reached technological feasibility and have no alternative future use are also included in research and development expense for the period in which they are incurred. |
General and Administrative Expenses | General and Administrative Expenses General and administrative expenses consist primarily of compensation-related expenses, including stock-based compensation expense, for personnel in executive, finance and accounting, business development, operations and administrative functions. General and administrative expenses also include fees for legal, consulting, accounting and audit services as well as insurance, outside service providers, direct and allocated facility- and office-related costs, and depreciation and amortization. |
Interest Income on Investments | Interest Income on Investments Interest income is separately presented on the consolidated statements of operations and comprehensive loss and consists of interest on cash and cash equivalents and investments. |
Cash and Cash Equivalents | Cash and Cash Equivalents The primary objectives for the Company’s investment portfolio are the preservation of capital and maintenance of liquidity. The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. At December 31, 2022 and 2021, cash and cash equivalents include bank demand deposits and money market funds that invest primarily in U.S. government-backed securities and treasuries. Cash equivalents are stated at cost, which is substantially equivalent to fair value. |
Restricted Cash | Restricted cash The Company maintains a balance in a segregated bank account in connection with a letter of credit for the benefit of the landlord in connection with an operating lease. As of December 31, 2022 and 2021, restricted cash consisted of $ 3.4 million held for the benefit of the landlord. This amount has been classified as part of non-current assets on the Company's consolidated balance sheets. The Company includes its restricted cash balance in the cash, cash equivalents and restricted cash reconciliation of operating, investing and financing activities in the consolidated statements of cash flows. The following table provides a reconciliation of cash, cash equivalents and restricted cash in the consolidated balance sheets that sum to the total of the same such amounts shown in the consolidated statements of cash flows: DECEMBER 31, 2022 2021 (in thousands) Cash and cash equivalents $ 25,709 $ 100,752 Restricted cash 3,437 3,437 Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows $ 29,146 $ 104,189 |
Investments | Investments Short-term investments consist of commercial paper, corporate bonds, asset-backed securities, and U.S. Treasury securities with original maturities greater than three months. The Company may sell investments at any time for use in current operations even if the investments have not yet reached maturity. As a result, the Company classifies its investments, including securities with maturities beyond twelve months, as current assets. As of December 31, 2022, all investments are classified as available-for-sale securities, which are recorded at fair value . Unrealized holding gains and losses on available-for-sale securities are reported as a net amount in accumulated other comprehensive income or loss in stockholders’ equity until realized. Purchase premiums and discounts are amortized to interest income over the terms of the related securities. Realized gains and losses and declines in fair value that are deemed to be other than temporary are reflected in the statements of operations and comprehensive loss using the specific-identification method. The Company periodically reviews all available-for-sale securities for other than temporary declines in fair value below the cost basis whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company also evaluates whether it has plans or is required to sell short-term investments before recovery of their amortized cost bases. For the year ended December 31, 2022, the Company has not identified any other than temporary declines in fair value of its short-term investments. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are recorded at cost. Expenditures for major renewals or betterments that extend the useful lives of property and equipment are capitalized; expenditures for maintenance and repairs are charged to expense as incurred. Depreciation expense is recognized on a straight-line basis over the estimated useful lives of the related assets. Property and equipment are depreciated as follows: ASSET TYPE ESTIMATED USEFUL LIFE Computer equipment and software 3 - 5 years Furniture and fixtures 5 years Laboratory equipment 5 years Manufacturing equipment 5 years Leasehold improvements Shorter of lease term or estimated useful life Upon retirement or sale, the cost and related accumulated depreciation of assets disposed of are removed from the accounts, and any resulting gain or loss is included in the Company's consolidated statements of operations as a component of other income (expense) |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets consist of property and equipment. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends, and significant changes or planned changes in the use of the long-lived assets. If an impairment review were to be performed to evaluate a long-lived asset for recoverability, the Company would compare forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized if estimated undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset over its fair value, determined based on discounted cash flows. For the years ended December 31, 2022 and 2021, the Company has not recorded any impairment losses on long-lived assets. |
Fair Value Measurements | Fair Value Measurements Certain assets and liabilities of the Company are carried at fair value under GAAP. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: Level 1 —Valuations based on quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 —Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant inputs are observable, either directly or indirectly, such as quoted market prices, interest rates, and yield curves. Level 3 —Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and unobservable. To the extent a valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair values requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized as Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Company believes that the carrying amounts of prepaid expenses, other current assets, accounts payable, and accrued expenses approximate their fair values due to the short-term nature of those instruments. |
Research Contract Costs and Accruals | Research Contract Costs and Accruals The Company has entered into various research service arrangements under which vendors perform various services. The Company records accrued expenses for estimated costs incurred under the arrangements. When evaluating the adequacy of the accrued expenses, the Company analyzes the progress of the studies, trials or other services performed, including invoices received and contracted costs. Judgments and estimates are made in determining the accrued expense balances at the end of each reporting period |
Operating Leases | Operating Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on specific facts and circumstances, the existence of an identified asset(s), if any, and the Company’s control over the use of the identified asset(s), if applicable. The lease liability is measured at the present value of future lease payments, discounted using the discount rate as of the lease commencement date. Future lease payments may include payments that depend on an index or a rate (such as the consumer price index or other market index). The Company initially measures payments based on an index or rate by using the applicable rate at lease commencement and subsequent changes in such rates are recognized as variable lease costs. Variable payments that do not depend on a rate or index are not included in the lease liability and are recognized as they are incurred. The Company’s contracts typically do not have variable payments based on index or rate. The Company’s contracts that include a lease component generally include additional services that are transferred to the lessee (e.g., common-area maintenance services), which are non-lease components. Contracts typically also include other costs and fees that do not provide a separate service to the lessee, such as costs paid by the lessee to reimburse the lessor for administrative costs or payment for the lessor’s costs for property taxes, insurance related to the leased asset, and other lessor costs. The Company elected the practical expedient to account for the lease and its associated non-lease components as a single lease component for its real estate leases, including the office, lab, and its manufacturing space. When readily determinable, the discount rate used to calculate the lease liability is the rate implicit in the lease. As the Company's leases typically do not provide an implicit rate, the Company uses its incremental borrowing rate based on the lease term and economic environment at the lease commencement date. The lease term used to calculate the lease liability includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. With limited exceptions, the nature of the Company's facility leases is such that there are no economic or other conditions that would indicate that it is reasonably certain at lease commencement that the Company will exercise options to extend the term. The Company recognizes a corresponding lease right of use (“ROU”) asset, initially measured as the amount of lease liability, adjusted for any initial lease costs or lease payments made before or at the commencement of the lease, and reduced by any lease incentives. In some instances, as construction related to leasehold improvements is performed over the life of the lease, the right-of-use asset and lease liability will be adjusted on a prospective basis to reflect any payments relating to the lease incentives. The Company’s leases consist of only operating leases. Operating leases are recognized on the balance sheet as ROU lease assets, lease liabilities current and lease liabilities non-current. Fixed rents are included in the calculation of the lease balances while certain variable costs paid for certain operating and pass-through costs are excluded. Lease expense is recognized over the expected lease term on a straight-line basis. For leases with a term of one year or less, or short-term leases, the Company has elected to not recognize the lease liability for these arrangements and the lease payments are recognized in the consolidated statements of operations and comprehensive loss. |
Patent Costs | Patent Costs The Company expenses patent costs as incurred and records such costs within general and administrative expenses. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s income tax returns. Deferred taxes are determined based on the difference between the consolidated financial statement and tax bases of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes in the Company's consolidated statements of operations and comprehensive loss. The Company assesses the likelihood that its deferred tax assets will be realized and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. The potential for recovery of deferred tax assets is evaluated by analyzing carryback capacity in periods with taxable income, reversal of existing taxable temporary differences and estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50 % likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties. The Company recognizes any interest and penalties related to uncertain tax positions in income tax expense. |
Stock-Based Compensation | Stock-Based Compensation The Company measures all stock options and other stock-based awards granted based on the fair value of the award on the date of the grant and recognizes stock-based compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective award. The Company has elected to recognize forfeitures as they occur. The reversal of compensation cost previously recognized for an award that is forfeited because of a failure to satisfy a service or performance condition is recognized in the period of the forfeiture. Generally, the Company issues stock options and restricted stock awards with only service-based vesting conditions and records the expense for these awards using the straight-line method over the requisite service period. For performance-based awards that are awarded, the Company applies the graded-vesting method to the awards once achievement of the performance conditions is considered probable. The Company classifies stock-based compensation expense in its consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipients’ service payments are classified. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model, which requires inputs based on certain subjective assumptions, including the fair value of the Company’s common stock, expected stock price volatility, the expected term of the stock option, the risk-free interest rate for a period that approximates the expected term of the stock option, and the Company’s expected dividend yield. The closing sale price per share of the Company’s common stock as reported on The Nasdaq Global Market on the date of grant is used to determine the fair value, which is then used to establish the exercise price per share of share-based awards to purchase common stock. As there was no public market for its common stock prior to October 2, 2020, which was the first day of trading upon completion of its IPO, the Company estimates its expected share price volatility based on the historical volatility of publicly-traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded share price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain vanilla” stock options. We use the simplified method to calculate the expected term for options granted to employees and directors. We utilize this method as we do not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. The fair value of each restricted common stock award is estimated on the date of grant based on the fair value of the Company’s common stock on that same date. |
Net Loss Per Share | Net Loss Per Share Basic and diluted net loss per common share is calculated by dividing net loss by the weighted-average number of common shares outstanding for the periods. Diluted net loss per share is computed by dividing the diluted net loss by the weighted average number of common shares, including potential dilutive common shares assuming the dilutive effect of outstanding stock options and unvested restricted stock units. For periods in which we have reported net losses, diluted net loss per common share is the same as basic net loss per share, since dilutive common shares are not included if their effect is anti-dilutive. |
Deferred Offering Costs | Deferred Offering Costs The Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process equity issuances or debt financings as deferred offering costs until such equity issuances or debt financings are consummated. After consummation, these costs are recorded as a reduction in the capitalized amount associated with the equity issuance or debt financing. |
Debt Related Costs | Debt Related Costs The carrying value of the Company’s Term Loan (see Note 7) is recorded net of issuance costs and discount relating to the issuance of warrants and fees paid to the lender. Debt-related costs are amortized over the term of the debt using the effective interest method and recognized as interest expense. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In September 2022, the FASB issued ASU 2022-04, Liabilities—Supplier Finance Programs (Subtopic 405-50): Disclosure of Supplier Finance Program Obligations. This amendment requires a buyer that uses supplier finance programs to make annual disclosures about the program’s key terms, the balance sheet presentation of related amounts, the confirmed amount outstanding at the end of the period, and associated rollforward information. Only the amount outstanding at the end of the period must be disclosed in interim periods. The amendments are effective for all entities for fiscal years beginning after December 15, 2022 on a retrospective basis, including interim periods within those fiscal years, except for the requirement to disclose rollforward information, which is effective prospectively for fiscal years beginning after December 15, 2023. Early adoption is permitted. The Company is currently reviewing the provisions of this new pronouncement, but does not expect this guidance will have a material impact on its consolidated financial statements. In August 2020, the FASB issued ASU No. 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This amendment simplifies accounting for convertible instruments by removing major separation models required under current U.S. GAAP. It also removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception, and simplifies the diluted earnings per share calculation in certain areas. ASU No. 2020-06 is effective for public companies for annual periods beginning after December 15, 2021, including interim periods within those fiscal years. The Company early adopted the provisions of ASU 2020-06 effective January 1, 2022, using the modified retrospective method for transition with no significant impact on its consolidated financial statements at the time of adoption. In June 2016, the FASB issued ASU 2016-13 (Topic 326), Financial Instruments — Credit Losses — Measurement of Credit Losses on Financial Instruments , which is codified in Topic 326 . The ASU changes how entities will measure credit losses on Held-to-Maturity (HTM) and Available-for-Sale debt securities. After the adoption of ASU 2016-13 (Topic 326), additional disclosures are required for HTM debt securities. The standard is effective for annual periods beginning after December 15, 2022 since the Company is a Smaller Reporting Company. The Company is currently reviewing the provisions of this new pronouncement, but does not expect this guidance will have a material impact on its consolidated financial statements. There have been no other issued accounting pronouncements other than those described in the Company’s audited financial statements as of and for the year ended December 31, 2022, and the notes thereto, which are included in the Annual Report, that will have a material effect on the Company's consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Summary Of Significant Accounting Policies [Abstract] | |
Summary of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash in the consolidated balance sheets that sum to the total of the same such amounts shown in the consolidated statements of cash flows: DECEMBER 31, 2022 2021 (in thousands) Cash and cash equivalents $ 25,709 $ 100,752 Restricted cash 3,437 3,437 Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows $ 29,146 $ 104,189 |
Summary of Estimated Useful Lives of Property, Plant and Equipment | Property and equipment are depreciated as follows: ASSET TYPE ESTIMATED USEFUL LIFE Computer equipment and software 3 - 5 years Furniture and fixtures 5 years Laboratory equipment 5 years Manufacturing equipment 5 years Leasehold improvements Shorter of lease term or estimated useful life |
Cash Equivalents and Investme_2
Cash Equivalents and Investments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Summary of amortized cost and fair value of our cash equivalents and investments | The following tables summarize the amortized cost and fair value of our cash equivalents and investments (in thousands): DECEMBER 31, 2022 AMORTIZED COST BASIS GROSS UNREALIZED GAINS GROSS UNREALIZED LOSSES ESTIMATED FAIR VALUE Cash Equivalents Money market funds $ 19,881 $ — $ — $ 19,881 Total Cash Equivalents $ 19,881 $ $ $ 19,881 Investments Commercial paper $ 25,094 $ — $ — $ 25,094 Corporate bonds 3,028 — ( 13 ) 3,015 U.S. Treasury securities 8,417 — ( 39 ) 8,378 Total Investments $ 36,539 $ $ ( 52 ) $ 36,487 DECEMBER 31, 2021 AMORTIZED COST BASIS GROSS UNREALIZED GAINS GROSS UNREALIZED LOSSES ESTIMATED FAIR VALUE Cash Equivalents Money market funds $ 98,900 $ — $ — $ 98,900 Total Cash Equivalents $ 98,900 $ — $ — $ 98,900 Investments Commercial paper $ 11,084 $ — $ — $ 11,084 Asset-backed securities 2,020 — ( 2 ) 2,018 U.S. treasury securities 4,812 — ( 8 ) 4,804 Corporate bonds 5,271 — ( 4 ) 5,267 Total Investments $ 23,187 $ — $ ( 14 ) $ 23,173 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following table presents information about the Company’s financial assets measured at fair value on a recurring basis (in thousands): FAIR VALUE MEASUREMENTS LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Assets: Money market funds $ 19,881 $ — $ — $ 19,881 U.S. treasury securities 8,378 — — 8,378 Commercial paper — 25,094 — 25,094 Corporate bonds — 3,015 — 3,015 Total Assets $ 28,259 $ 28,109 $ — $ 56,368 FAIR VALUE MEASUREMENTS LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Assets: Money market funds $ 98,900 $ — $ — $ 98,900 U.S. treasury securities 4,804 — — 4,804 Commercial paper — 11,084 — 11,084 Asset-backed securities — 2,018 — 2,018 Corporate bonds — 5,267 — 5,267 Total Assets $ 103,704 $ 18,369 $ — $ 122,073 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Propertyplantandequipmentabstract [Abstract] | |
Summary of Property and Equipment, Net | Property and equipment, net as of December 31, 2022 and 2021 consisted of the following (in thousands): DECEMBER 31, 2022 2021 Laboratory equipment $ 6,512 $ 6,084 Computer equipment and software 730 478 Furniture and fixtures 1,399 769 Leasehold improvements 37,721 9,266 Manufacturing equipment 495 — Fixed assets not yet placed in service 2,855 12,790 Total property and equipment, gross 49,712 29,387 Less accumulated depreciation ( 5,352 ) ( 6,154 ) Total property and equipment, net $ 44,360 $ 23,233 |
Accrued Expenses and Other Lo_2
Accrued Expenses and Other Long-Term Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses and Other Long-Term Liabilities | At December 31, 2022 and 2021, accrued expenses and other long-term liabilities consisted of the following (in thousands): AS OF DECEMBER 31, 2022 2021 Accrued research and development costs $ 2,661 $ 1,474 Accrued leasehold improvement costs 4,079 999 Accrued compensation 2,612 2,697 Accrued professional fees 752 846 Accrued interest 198 — Other accrued expenses 645 468 Total accrued expenses and other long-term liabilities $ 10,948 $ 6,484 |
Term Loan, net of debt discou_2
Term Loan, net of debt discount (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Future Principal Debt Payments on the Loan Agreement | Future principal debt payments on the Loan Agreement are as follows (in thousands): AS OF DECEMBER 31, 2022 2021 2022 $ — $ — 2023 — — 2024 6,131 — 2025 10,161 — 2026 3,708 — Total principal payments 20,000 — Final Fee 1,090 — Total principal payments and Final Fee 21,090 — Less: Unamortized debt discount ( 767 ) — Less: Unamortized debt issuance costs ( 64 ) — Less: Unaccreted Final Fee ( 823 ) — Term loan, net (current) $ 19,436 $ — |
Common Stock (Tables)
Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Reserved Shares of Common Stock | The Company has reserved shares of common stock for the conversion or exercise of the following securities: DECEMBER 31, DECEMBER 31, Exercise of common stock warrants 949,171 71,544 Exercise of options to purchase common stock 4,391,207 3,681,793 Shares available for issuance under employee stock purchase plan — — Shares available for issuance under equity incentive plans 2,680,248 2,132,067 Shares available for issuance under term loan conversion 2,203,711 — Total 10,224,337 5,885,404 |
Equity Incentive Plan (Tables)
Equity Incentive Plan (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Fair Valuation Assumptions of Option Awards | The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option-pricing model using the range of assumptions for the years ended December 31, 2022 and 2021 as noted in the following table: YEARS ENDED DECEMBER 31, 2022 2021 Expected volatility 84.2 % - 88.2 % 81.4 % - 88.3 % Expected dividends 0.0 % 0.0 % Expected term (in years) 5.3 - 6.2 5.3 - 10 Risk-free rate 1.5 % - 4.2 % 0.5 % - 1.6 % |
Summary of Total Stock-based Compensation Including Both Stock Option Awards And Restricted Stock | Total stock-based compensation expense (including both stock option awards and restricted stock) was as follows: YEARS ENDED DECEMBER 31, 2022 2021 (in thousands) General and administrative $ 4,786 $ 4,240 Research and development 2,426 2,333 Total stock-based compensation $ 7,211 $ 6,573 |
Summary of Option Activity | A summary of stock option activity for the year ended December 31, 2022 is presented below: SHARES WEIGHTED- WEIGHTED- AGGREGATE Outstanding at December 31, 2021 3,681,793 $ 10.84 Granted 2,040,368 $ 1.60 Exercised ( 34,863 ) $ 1.77 Canceled, expired, or forfeited ( 1,296,091 ) $ 7.61 Outstanding at December 31, 2022 4,391,207 $ 7.57 8.00 $ — Vested and expected to vest at December 31, 2022 4,391,207 $ 7.57 8.00 $ — Exercisable at December 31, 2022 1,867,964 $ 8.11 6.89 $ — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Summary of Total (Benefit From) Provision for Income Taxes | Total (benefit from) provision for income taxes for the years ended December 31, 2022 and 2021 consisted of the following (in thousands): DECEMBER 31, 2022 2021 Current income tax expense $ — $ — Deferred income tax benefit 22,991 19,943 Valuation allowance for deferred tax assets ( 22,991 ) ( 19,943 ) Deferred income tax expense, net — — Total (benefit from) provision for income taxes $ — $ — |
Summary of Reconciliation of Income Tax Expense (Benefit) at the Statutory Federal Income Tax Rate | A reconciliation of income tax expense (benefit) at the statutory federal income tax rate and income taxes as reflected in the consolidated financial statements is as follows: DECEMBER 31, 2022 2021 Federal income tax benefit at statutory rate 21.0 % 21.0 % State income tax, net of federal benefit 5.8 6.1 Permanent differences - stock-based compensation ( 1.1 ) ( 0.4 ) Research and development credit benefit 4.7 3.8 Change in valuation allowance ( 30.4 ) ( 30.5 ) Effective income tax rate — % — % |
Summary of Deferred Tax Assets and Liabilities | The Company had a net loss for 2022 and 2021 and no income tax benefit has been recorded due to the full valuation allowance for deferred tax assets. The components of the Company’s deferred taxes at December 31, 2022 and 2021 are as follows (in thousands): DECEMBER 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards (federal and state) $ 47,852 $ 41,610 Tax credits (federal and state) 10,583 6,967 Accrued expenses and other liabilities 393 316 Capitalized research and development expenditures 14,115 835 Intangible assets 437 322 Stock based compensation 1,901 1,499 Lease liabilities 13,382 14,226 Total deferred tax assets 88,663 65,775 Valuation allowance ( 75,973 ) ( 53,139 ) Net deferred income tax assets 12,690 12,636 Deferred tax liabilities: Fixed assets ( 3,568 ) ( 283 ) Right-of-use assets ( 8,895 ) ( 12,353 ) Debt discount amortization ( 227 ) — Net deferred tax liabilities ( 12,690 ) ( 12,636 ) Net deferred income taxes $ — $ — |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Summary of Other Supplemental Information Related to Leases | Other supplemental information related to leases is as follows: (in thousands) 2022 2021 Weighted average remaining lease term 14.0 years 13.8 years Weighted average discount rate 7.7 % 8.1 % Cash paid for amounts included in the measurement of lease liabilities $ 5,505 $ 1,777 |
Summary of Maturities of Operating Lease Liabilities | Maturities of operating lease liabilities were as follows as of December 31, 2022 (in thousands): Year Amount 2023 $ 4,850 2024 4,995 2025 5,145 2026 5,299 2027 5,458 Thereafter 57,114 Total lease payments 82,861 Less imputed interest ( 33,878 ) Total lease liabilities $ 48,983 Current portion $ 1,129 Long-term portion $ 47,854 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Summary of Antidilutive Securities Excluded From Computation of Earnings Per Share | The following securities that could potentially dilute basic net loss per share in the future were not included in the computation of diluted net loss per share for the periods presented, because to do so would have been antidilutive: YEARS ENDED DECEMBER 31, 2022 2021 Outstanding stock options 4,391,207 3,681,793 Common stock warrants 461,600 71,544 Shares available for purchase under employee stock purchase plan — — Potential conversion of note payable 2,203,711 — Total 7,056,518 3,753,337 |
Nature of the Business and Li_2
Nature of the Business and Liquidity - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Accounting Policies [Line Items] | ||
Net loss | $ (77,422) | $ (64,762) |
Retained Earnings (Accumulated Deficit) | (272,009) | $ (194,587) |
Debt, net of debt discount | $ 19,400 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 USD ($) Segment | Dec. 31, 2021 USD ($) | |
Accounting Policies [Line Items] | ||
Number of operating segments | Segment | 1 | |
Restricted cash | $ 3,437 | $ 3,437 |
Income tax examination, likelihood of unfavorable settlement | greater than 50 | |
Share based compensation expenses | $ 7,211 | 6,573 |
Operating lease liabilities | 48,983 | |
Short-term lease liabilities | 1,129 | 1,684 |
Long-term lease liabilities | 47,854 | 50,388 |
Right-of-use asset | $ 32,560 | $ 45,218 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 25,709 | $ 100,752 | |
Restricted cash | 3,437 | 3,437 | |
Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows | $ 29,146 | $ 104,189 | $ 133,182 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Estimated Useful Lives of Property, Plant and Equipment (Detail) | 12 Months Ended |
Dec. 31, 2022 | |
Computer Equipment and Software [Member] | Minimum [Member] | |
Property Plant And Equipment [Line Items] | |
Property and equipment estimated useful lives | 3 years |
Computer Equipment and Software [Member] | Maximum [Member] | |
Property Plant And Equipment [Line Items] | |
Property and equipment estimated useful lives | 5 years |
Furniture and Fixtures [Member] | |
Property Plant And Equipment [Line Items] | |
Property and equipment estimated useful lives | 5 years |
Laboratory Equipment [Member] | |
Property Plant And Equipment [Line Items] | |
Property and equipment estimated useful lives | 5 years |
Manufacturing Equipment [Member] | |
Property Plant And Equipment [Line Items] | |
Property and equipment estimated useful lives | 5 years |
Leasehold Improvements [Member] | Maximum [Member] | |
Property Plant And Equipment [Line Items] | |
Property and equipment estimated useful lives, term | Shorter of lease term or estimated useful life |
Cash Equivalents and Investme_3
Cash Equivalents and Investments - Summary of amortized cost and fair value of our cash equivalents and investments (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash and Cash Equivalents [Line Items] | ||
Amortized Cost | $ 36,539 | $ 23,187 |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (52) | (14) |
Estimated Fair Value | 36,487 | 23,173 |
Money Market Funds [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Amortized Cost, Cash Equivalents | 19,881 | 98,900 |
Gross Unrealized Gains, Cash Equivalents | 0 | 0 |
Gross Unrealized Losses, Cash Equivalents | 0 | 0 |
Estimated Fair Value, Cash Equivalents | 19,881 | 98,900 |
Commercial Paper [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Amortized Cost | 25,094 | 11,084 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 25,094 | 11,084 |
Asset-Backed Securities [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Amortized Cost | 2,020 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (2) | |
Estimated Fair Value | 2,018 | |
US Treasury Securities [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Amortized Cost | 8,417 | 4,812 |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (39) | (8) |
Estimated Fair Value | 8,378 | 4,804 |
Corporate Bonds [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Amortized Cost | 3,028 | 5,271 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (13) | (4) |
Estimated Fair Value | 3,015 | 5,267 |
Cash Equivalents [Member] | ||
Cash and Cash Equivalents [Line Items] | ||
Amortized Cost, Cash Equivalents | 19,881 | 98,900 |
Gross Unrealized Gains, Cash Equivalents | 0 | |
Gross Unrealized Losses, Cash Equivalents | 0 | |
Estimated Fair Value, Cash Equivalents | $ 19,881 | $ 98,900 |
Cash Equivalents and Investme_4
Cash Equivalents and Investments - Additional Information (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Cash and Cash Equivalents [Abstract] | |
Realized gains or losses recognized | $ 0 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Assets and Liabilities Measured at Fair Value On a Recurring Basis (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | $ 56,368 | $ 122,073 |
Money Market Funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 19,881 | 98,900 |
US Treasury Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 8,378 | 4,804 |
Commercial Paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 25,094 | 11,084 |
Asset-Backed Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 2,018 | |
Corporate Bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 3,015 | 5,267 |
Level 1 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 28,259 | 103,704 |
Level 1 [Member] | Money Market Funds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 19,881 | 98,900 |
Level 1 [Member] | US Treasury Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 8,378 | 4,804 |
Level 1 [Member] | Commercial Paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 0 | 0 |
Level 1 [Member] | Asset-Backed Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 0 | |
Level 1 [Member] | Corporate Bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 0 | 0 |
Level 2 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 28,109 | 18,369 |
Level 2 [Member] | Commercial Paper [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 25,094 | 11,084 |
Level 2 [Member] | Asset-Backed Securities [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 2,018 | |
Level 2 [Member] | Corporate Bonds [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | $ 3,015 | $ 5,267 |
Property and Equipment, net - P
Property and Equipment, net - Property and equipment, net (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 49,712 | $ 29,387 |
Less accumulated depreciation | (5,352) | (6,154) |
Total property and equipment, net | 44,360 | 23,233 |
Laboratory Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 6,512 | 6,084 |
Computer Equipment and Software [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 730 | 478 |
Furniture and Fixtures [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 1,399 | 769 |
Leaseholds and Leasehold Improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 37,721 | 9,266 |
Manufacturing equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 495 | 0 |
Fixed assets not yet placed in service [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 2,855 | $ 12,790 |
Property and Equipment, net - A
Property and Equipment, net - Additional Details (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property Plant And Equipment Additional Details [Abstract] | ||
Depreciation and amortization | $ 3,632 | $ 1,948 |
Accrued Expenses and Other Lo_3
Accrued Expenses and Other Long-Term Liabilities - Summary of Accrued Expenses and Other Long-Term Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued research and development costs | $ 2,661 | $ 1,474 |
Accrued leasehold improvement costs | 4,079 | 999 |
Accrued compensation | 2,612 | 2,697 |
Accrued professional fees | 752 | 846 |
Accrued interest | 198 | 0 |
Other accrued expenses | 645 | 468 |
Total accrued expenses and other long-term liabilities | $ 10,948 | $ 6,484 |
Accrued Expenses and Other Lo_4
Accrued Expenses and Other Long-Term Liabilities - Additional Information (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Other long term liabilities | $ 0 | $ 203 |
Term Loan, net of debt discou_3
Term Loan, net of debt discount (Additional Information) (Details) - USD ($) | 12 Months Ended | ||
Apr. 01, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Debt Instrument [Line Items] | |||
Final Fee | $ 1,090,000 | $ 0 | |
Warrants exercisable for common stock | 390,056 | ||
Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Maximum borrowing capacity | $ 45,000,000 | ||
Principal in Term Loans | $ 5,000,000 | ||
Term Loan Variable Interest Rate | 4.25% | 11.75% | |
Final Fee | 5.45% | ||
Debt Instrument interest rate, terms | The term loans bear a variable interest rate equal to the greater of 7.75% and (ii) the sum of (A) the prime rate last quoted in The Wall Street Journal (or a comparable replacement rate if The Wall Street Journal ceases to quote such rate) and (B) 4.25%. The variable interest rate at December 31, 2022, was 11.75%. Upon final payment or prepayment of the loans, the Company must pay a final payment equal to 5.45% of the loans borrowed (the "Final Fee"), which is being accrued to interest expense over the term of the loan. The Company has an option to prepay the loans in whole, subject to a prepayment fee of 3% prior to the first anniversary of the April 1, 2022, funding date, 2% after the first anniversary but prior the second anniversary of the funding date, and 1% thereafter if prior to the maturity date. | ||
Common Stock Conversion Price | $ 2,268.9000 | ||
Warrant to purchase a number of shares | 2.95% | ||
Warrants or rights, exercise price | $ 1.5126 | ||
Warrant to purchase a maximum number of shares | 877,627 | ||
Warrant Expiry Date | Apr. 01, 2032 | ||
Warrants exercisable for common stock | 390,056 | ||
Issuance cost | $ 500,000 | ||
Interest rate | 15.25% | ||
Interest expense | $ 1,500,000 | ||
Interest expense, debt amortization | $ 500,000 | ||
Debt Instrument, terms upon default | Upon an event of default, a default interest rate of an additional 5.00% per annum may, at the Lender’s request, also be applied to the outstanding loan balances. | ||
Term Loan [Member] | Maximum [Member] | |||
Debt Instrument [Line Items] | |||
Term Loan Variable Interest Rate | 7.75% | ||
Tranche One [Member] | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Principal amount | $ 20,000,000 | ||
Tranche Two [Member] | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Principal amount | 5,000,000 | ||
Tranche Three [Member] | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Principal amount | 15,000,000 | ||
Tearm loan reduced | 10,000,000 | ||
Tranche Four [Member] | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Principal amount | $ 10,000,000 | ||
Facility fee | 1% | ||
Prior To First Anniversary [Member] | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Prepayment fee | 3% | ||
Prior To Second Anniversary [Member] | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Prepayment fee | 2% | ||
Prior To Maturity [Member] | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Prepayment fee | 1% |
Term Loan, net of debt discou_4
Term Loan, net of debt discount- Schedule of Future Principal Debt Payments on the Loan Agreement (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Long-Term Debt, Rolling Maturity [Abstract] | ||
2022 | $ 0 | $ 0 |
2023 | 0 | 0 |
2024 | 6,131 | 0 |
2025 | 10,161 | 0 |
2026 | 3,708 | 0 |
Total principal payments | 20,000 | 0 |
Final Fee | 1,090 | 0 |
Total principal payments and Final Fee | 21,090 | 0 |
Less: Unamortized debt discount | (767) | 0 |
Less: Unamortized debt issuance cost | (64) | 0 |
Less: Unaccreted Final Fee | (823) | 0 |
Term loan, net (current) | $ 19,436 | $ 0 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Common stock, voting rights | Each share of common stock is entitled to one vote. | |
Common Stock, Shares Authorized | 100,000,000 | 100,000,000 |
Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 |
Warrants or rights, number of shares called | 949,171 | 71,544 |
Common Stock Warrants [Member] | ||
Warrants or rights, number of shares called | 71,544 | |
Warrants or rights, exercise price | $ 1.21 | |
Restricted Stock [Member] | Founders [Member] | ||
Share-based payment award, award vesting percentage | 25% | |
Share based payment award, award vesting period | 4 years |
Common Stock - Summary of Non-V
Common Stock - Summary of Non-Vested Restricted Stock Activity (Detail) - shares shares in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Vested | (0.1) | (0.1) |
Common Stock - Summary of Reser
Common Stock - Summary of Reserved Shares of Common Stock (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Sep. 23, 2020 | |
Exercise of common stock warrants | 949,171 | 71,544 | |
Exercise of options to purchase common stock | 4,391,207 | 3,681,793 | |
Shares available for issuance under employee stock purchase plan | 10,224,337 | 5,885,404 | |
Total | 10,224,337 | 5,885,404 | |
Employee Stock Purchase Plan [Member] | |||
Shares available for issuance under employee stock purchase plan | 0 | 0 | 280,000 |
Shares available for issuance under equity incentive plans | 2,680,248 | 2,132,067 | |
Shares available for issuance under term loan conversion | 2,203,711 | 0 | |
Total | 0 | 0 | 280,000 |
Exercise of options to purchase common stock [Member] | |||
Exercise of options to purchase common stock | 4,391,207 | 3,681,793 |
Equity Incentive Plan - Additio
Equity Incentive Plan - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Jan. 01, 2022 | Sep. 23, 2020 | Dec. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Shares available for issuance under employee stock purchase plan | 10,224,337 | 5,885,404 | |||
Share based payments shares increase decrease | 1,292,458 | ||||
Share based payment awards options granted | 2,040,368 | ||||
Share-based payment arrangement, expense | $ 7,211,000 | $ 6,573,000 | |||
Unrecognized compensation expense related to stock options weighted average period | 2 years 4 months 24 days | ||||
Fair value of restricted shares vested | 100,000 | 100,000 | |||
2020 Plan [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Shares available for issuance under the 2016 and 2020 Plans | 2,680,248 | ||||
2020 Plan [Member] | Restricted Stock [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share based payment award description | The number of shares reserved for issuance under the 2020 Plan will increase automatically on January 1 of each fiscal year, starting on January 1, 2021 and ending on and including January 1, 2030, by the number of shares equal to 5% of the aggregate number of outstanding shares of common stock as of the immediately preceding December 31, or a lesser number of shares as may be determined by the board of directors (or an authorized committee thereof). | ||||
Share based payments shares percent increase decrease | 5% | ||||
Employee Stock Purchase Plan [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Shares available for issuance under employee stock purchase plan | 280,000 | 0 | 0 | ||
Share based payment award description | The aggregate number of shares reserved for sale under the ESPP will increase automatically on January 1 of each fiscal year starting on January 1, 2021 and ending on and including January 1, 2030, by the number of shares equal to the lesser of (a) 1% of the total number of shares of common stock outstanding on the last day of the fiscal year prior to the date of such automatic increase and (b) 560,000 shares, provided that prior to the date of any such increase, the board of directors may determine a less number of shares for such increase. In December 2021, the board of directors determined that there would be no automatic increase in the number of shares of common stock reserved for sale under the ESPP in 2022. | ||||
Shares available for issuance under the 2016 and 2020 Plans | 2,680,248 | 2,132,067 | |||
Share based payments shares increase decrease | 560,000 | 0 | |||
2016 Plan [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Grant date fair value of stock options granted | $ 1.17 | $ 11.05 | |||
Intrinsic value of options exercised | $ 100,000 | $ 2,400,000 | |||
Unrecognized compensation expense related to stock options | $ 11,200,000 | ||||
2016 Plan [Member] | Restricted Stock [Member] | Minimum [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Vesting period | 3 years | ||||
2016 Plan [Member] | Restricted Stock [Member] | Maximum [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Vesting period | 4 years | ||||
2016 Plan [Member] | Performance Shares [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Vesting period | 4 years | ||||
Share based payment awards options granted | 113,000 | ||||
Share based payment award, requisite service period | 4 years | ||||
Share-based payment arrangement, expense | $ 400,000 | ||||
2016 Plan [Member] | Performance Shares [Member] | Third Tranche [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share-based payment arrangement, expense | $ 300 |
Equity Incentive Plan - Summary
Equity Incentive Plan - Summary of Fair Valuation Assumptions of Option Awards (Detail) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility | 84.20% | 81.40% |
Expected term (in years) | 5 years 3 months 18 days | |
Risk-free rate | 1.50% | 0.50% |
Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility | 88.20% | 88.30% |
Expected term (in years) | 6 years 2 months 12 days | |
Risk-free rate | 4.20% | 1.60% |
Option Pricing Model [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected dividends | 0% | 0% |
Option Pricing Model [Member] | Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (in years) | 5 years 3 months 18 days | |
Option Pricing Model [Member] | Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (in years) | 10 years |
Equity Incentive Plan - Summa_2
Equity Incentive Plan - Summary of Total Stock-based Compensation Including Both Stock Option Awards and Restricted Stock (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share based compensation expenses | $ 7,211 | $ 6,573 |
General and administrative [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share based compensation expenses | 4,786 | 4,240 |
Research and development [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share based compensation expenses | $ 2,426 | $ 2,333 |
Equity Incentive Plan - Summa_3
Equity Incentive Plan - Summary of Option Activity (Detail) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Share-Based Payment Arrangement [Abstract] | |
Shares, Outstanding | shares | 3,681,793 |
Shares, Granted | shares | 2,040,368 |
Shares, Exercised | shares | (34,863) |
Shares, Canceled, expired or forfeited | shares | (1,296,091) |
Shares, Outstanding | shares | 4,391,207 |
Shares, Vested and expected to vest | shares | 4,391,207 |
Shares, Exercisable | shares | 1,867,964 |
Weighted average exercise price, Outstanding | $ / shares | $ 10.84 |
Weighted average exercise price, Granted | $ / shares | 1.60 |
Weighted average exercise price, Exercised | $ / shares | 1.77 |
Weighted average exercise price, Canceled, expired or forfeited | $ / shares | 7.61 |
Weighted average exercise price, Outstanding | $ / shares | 7.57 |
Weighted average exercise price, Vested and expected to vest | $ / shares | 7.57 |
Weighted average exercise price, Exercisable | $ / shares | $ 8.11 |
Weighted- Average remaining contractual term (years), Outstanding | 8 years |
Weighted- Average remaining contractual term (years), Vested and expected to vest | 8 years |
Weighted- Average remaining contractual term (years), Exercisable | 6 years 10 months 20 days |
Aggregate intrinsic value, Outstanding | $ | $ 0 |
Aggregate intrinsic value, Vested and expected to vest | $ | 0 |
Aggregate intrinsic value, Exercisable | $ | $ 0 |
Income Taxes - Summary of Total
Income Taxes - Summary of Total (Benefit From) Provision for Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Current income tax expense | $ 0 | $ 0 |
Deferred income tax benefit | 22,991,000 | 19,943,000 |
Valuation allowance for deferred tax assets | (22,991,000) | (19,943,000) |
Deferred income tax expense, net | 0 | 0 |
Total (benefit from) provision for income taxes | $ 0 | $ 0 |
Income Taxes - Summary of Recon
Income Taxes - Summary of Reconciliation of Income Tax Expense (Benefit) at Statutory Federal Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | ||
Federal income tax benefit at statutory rate | 21% | 21% |
State income tax, net of federal benefit | 5.80% | 6.10% |
Permanent differences - stock-based compensation | (1.10%) | (0.40%) |
Research and development credit benefit | 4.70% | 3.80% |
Change in valuation allowance | (30.40%) | (30.50%) |
Effective income tax rate | 0% | 0% |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Mar. 27, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | |||
Income tax benefit | $ 0 | $ 0 | |
Valuation allowance | 75,973,000 | 53,139,000 | |
Increase in valuation allowance | 22,991,000 | 19,943,000 | |
Net operating loss carry forward for federal income tax purpose | 176,200,000 | ||
Net opertaing loss carryforward for state income tax purpose | 171,600,000 | ||
Capitalized research and development expenditures | $ 14,115,000 | 835,000 | |
Minimum percentage of increase in ownership of stockholders for ownership change | 50% | ||
Period over which a minimum 50 percent of increase in ownership is required for ownership change | 3 years | ||
Unrecognized tax benefits, interest and penalties | $ 0 | $ 0 | |
Tax credit, investment, percent | 1.32% | ||
Research and Development Expense [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Increase in valuation allowance | 22,900,000 | ||
Domestic Tax Authority [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carry forward subject to expiration | $ 18,100,000 | ||
Operating loss carry forwards expiration year | 2035 | ||
Net opertaing loss carry forward not subject to expiration | $ 158,100,000 | ||
Domestic Tax Authority [Member] | 2035 [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Capitalized research and development expenditures | $ 7,400,000 | ||
State and Local Jurisdiction [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carry forwards expiration year | 2030 | ||
State and Local Jurisdiction [Member] | 2030 [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Capitalized research and development expenditures | $ 4,000,000 |
Income Taxes - Summary of Compo
Income Taxes - Summary of Components of Deferred Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Net operating loss carryforwards (federal and state) | $ 47,852 | $ 41,610 |
Tax credits (federal and state) | 10,583 | 6,967 |
Accrued expenses and other liabilities | 393 | 316 |
Capitalized research and development expenditures | 14,115 | 835 |
Intangible assets | 437 | 322 |
Stock based compensation | 1,901 | 1,499 |
Lease liabilities | 13,382 | 14,226 |
Total deferred tax assets | 88,663 | 65,775 |
Valuation allowance | (75,973) | (53,139) |
Net deferred income tax assets | 12,690 | 12,636 |
Deferred tax liabilities: | ||
Fixed assets | (3,568) | (283) |
Right-of-use assets | (8,895) | (12,353) |
Debt discount amortization | (227) | 0 |
Net deferred tax liabilities | (12,690) | (12,636) |
Net deferred income taxes | $ 0 | $ 0 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Thousands | 12 Months Ended | ||
Sep. 13, 2022 USD ($) | Dec. 31, 2022 USD ($) ft² | Dec. 31, 2021 USD ($) | |
Lessee Lease Description [Line Items] | |||
Leasehold Improvement Costs Capitalized | $ 37,700 | ||
Leasehold Improvement Costs reimbursed | 9,700 | ||
Operating lease liabilities | 48,983 | ||
Lease incentive related to leasehold improvements | 14,900 | ||
Letter of Credit [Member] | |||
Lessee Lease Description [Line Items] | |||
Pledged letter of credit | 3,400 | ||
Lab Space [Member] | |||
Lessee Lease Description [Line Items] | |||
Rent expense for lease | 5,200 | $ 5,700 | |
Short Term Lease Expense [Member] | |||
Lessee Lease Description [Line Items] | |||
Rent expense for lease | $ 3,100 | $ 2,400 | |
POD 3 [Member] | |||
Lessee Lease Description [Line Items] | |||
Lease space | ft² | 17,150 | ||
POD 4 [Member] | |||
Lessee Lease Description [Line Items] | |||
Lease space | ft² | 33,518 | ||
POD 5 [Member] | |||
Lessee Lease Description [Line Items] | |||
Lease space | ft² | 54,666 | ||
CambridgeMassachusetts [Member] | |||
Lessee Lease Description [Line Items] | |||
Operating lease liability right of use asset gain recognized | $ 500 | ||
Andover, Massachusetts [Member | |||
Lessee Lease Description [Line Items] | |||
Lessee, operating lease, option to extend | the Company has two options to extend the term of the lease for a period of ten years each |
Leases - Summary of Other Suppl
Leases - Summary of Other Supplemental Information Related to Leases (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Leases [Abstract] | ||
Weighted average remaining lease term | 14 years | 13 years 9 months 18 days |
Weighted average discount rate | 7.70% | 8.10% |
Cash paid for amounts included in the measurement of lease liabilities | $ 5,505 | $ 1,777 |
Leases - Summary of Maturities
Leases - Summary of Maturities of Operating Lease Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Lessee, Operating Lease, Liability, to be Paid [Abstract] | ||
2023 | $ 4,850 | |
2024 | 4,995 | |
2025 | 5,145 | |
2026 | 5,299 | |
2027 | 5,458 | |
Thereafter | 57,114 | |
Total lease payments | 82,861 | |
Less imputed interest | (33,878) | |
Total lease liabilities | 48,983 | |
Lease liability - current portion | 1,129 | $ 1,684 |
Lease liability - net of current portion | $ 47,854 | $ 50,388 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | 12 Months Ended | |||||||||
Oct. 31, 2022 | Nov. 30, 2021 | Jun. 30, 2021 | Dec. 31, 2020 | Jul. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2022 | Dec. 31, 2021 | |
Research and development | $ 54,744,000 | $ 44,682,000 | ||||||||
Conversion of Series A-1 [Member] | ||||||||||
Percentage of net sales of company products discovered or developed prior to an IPO | 1% | |||||||||
Approval Of Product [Member] | Conversion of Series A-1 [Member] | ||||||||||
Potential future milestone payments | $ 1,000,000 | |||||||||
Ospedale San Raffaele Srl and Fondazione Telethon [Member] | ||||||||||
Potential future milestone payments | $ 5,700,000 | |||||||||
Ospedale San Raffaele Srl and Fondazione Telethon [Member] | Annual Membership Fees [Member] | ||||||||||
Potential future milestone payments | 3,900,000 | |||||||||
University of Pittsburgh [Member] | ||||||||||
Potential future milestone payments | $ 2,600,000 | |||||||||
Northwestern University [Member] | ||||||||||
Potential future milestone payments | $ 4,100,000 | |||||||||
WuXi Biologics Ireland Limited [Member] | ||||||||||
Initial payment made | $ 300,000 | |||||||||
WuXi Biologics Ireland Limited [Member] | Clinical milestone payments [Member] | ||||||||||
Potential future milestone payments | 8,000,000 | |||||||||
WuXi Biologics Ireland Limited [Member] | Commercial milestone payments [Member] | ||||||||||
Potential future milestone payments | $ 27,000,000 | |||||||||
Gaeta Therapeutics Ltd [Member] | ||||||||||
payment for future royalties | $ 2,500,000 | |||||||||
Gaeta Therapeutics Ltd [Member] | Clinical milestone payments [Member] | ||||||||||
Milestone Payments | $ 7,500 | |||||||||
Affiliated Entity [Member] | ||||||||||
Potential future milestone payments | $ 7,600,000 | |||||||||
Research and Development Expense [Member] | Ospedale San Raffaele Srl and Fondazione Telethon [Member] | ||||||||||
Initial payment made | $ 100,000 | |||||||||
Research and Development Expense [Member] | University of Pittsburgh [Member] | ||||||||||
Initial payment made | $ 100,000 | |||||||||
Research and Development Expense [Member] | Northwestern University [Member] | ||||||||||
Initial payment made | $ 100,000 | |||||||||
Research and Development Expense [Member] | WuXi Biologics Ireland Limited [Member] | ||||||||||
Milestone Payments | $ 500,000 | |||||||||
Research and Development Expense [Member] | Gaeta Therapeutics Ltd [Member] | ||||||||||
Initial payment made | 200,000 | |||||||||
Research and Development Expense [Member] | Gaeta Therapeutics Ltd [Member] | Clinical milestone payments [Member] | ||||||||||
Milestone Payments | $ 500,000 | |||||||||
Research and Development Expense [Member] | NOF Corporation [Member] | ||||||||||
Milestone payments for first product achieving such milestones | $ 25,000,000 | |||||||||
Milestone payments for each additional product achieving such milestones | 5,000,000 | |||||||||
Milestone payments for each additional indication on same product achieving such milestones | 10,000,000 | |||||||||
Initial payment made | $ 500,000 |
Net Loss Per Share - Summary of
Net Loss Per Share - Summary of Antidilutive Securities Excluded From Computation of Earnings Per Share (Detail) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive Securities dilute basic net loss per share | 7,056,518 | 3,753,337 |
Outstanding Stock Options [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive Securities dilute basic net loss per share | 4,391,207 | 3,681,793 |
Common stock warrants [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive Securities dilute basic net loss per share | 461,600 | 71,544 |
Employee Stock Purchase Plan [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive Securities dilute basic net loss per share | 0 | 0 |
Potential Conversion of Note Payable [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive Securities dilute basic net loss per share | 2,203,711 | 0 |
Retirement Plan - Additional In
Retirement Plan - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Retirement Benefits [Abstract] | ||
Company's matching contributions | $ 0.4 | $ 0.4 |