Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 15, 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 | CANDEL THERAPEUTICS, INC. | ||
Entity Central Index Key | 0001841387 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Interactive Data Current | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 28,919,810 | ||
Entity Public Float | $ 72.3 | ||
Entity File Number | 001-40629 | ||
Entity Tax Identification Number | 52-2214851 | ||
Entity Address, Address Line One | 117 Kendrick St | ||
Entity Address, Address Line Two | Suite 450 | ||
Entity Address, City or Town | Needham | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02494 | ||
Entity Incorporation, State or Country Code | DE | ||
City Area Code | 617 | ||
Local Phone Number | 916-5445 | ||
Title of 12(b) Security | Common Stock, par value $0.01 per share | ||
Trading Symbol | CADL | ||
Security Exchange Name | NASDAQ | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive proxy statement for its 2023 Annual Meeting of Stockholders (the Proxy Statement) are incorporated by reference in Part III of this Annual Report on Form 10-K. Such Proxy Statement will be filed with the U.S. Securities and Exchange Commission within 120 days after the end of the fiscal year to which this report relates. Except with respect to information specifically incorporated by reference in this Form 10-K, the Proxy Statement is not deemed to be filed as part of this Form 10-K | ||
Auditor Name | KPMG LLP | ||
Auditor Location | Boston, Massachusetts | ||
Auditor Firm ID | 185 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 70,058 | $ 82,642 |
Prepaid expenses and other current assets | 1,887 | 2,303 |
Total current assets | 71,945 | 84,945 |
Fixed assets, net | 4,424 | 3,836 |
Lease right of use assets | 1,056 | |
Restricted cash | 266 | 424 |
Total assets | 77,691 | 89,205 |
Current liabilities: | ||
Accounts payable | 380 | 1,590 |
Accrued expenses | 4,723 | 3,438 |
Current portion of lease liability | 464 | |
Other current liabilities | 48 | 334 |
Total current liabilities | 5,615 | 5,362 |
Deferred revenue | 144 | |
Deferred rent | 894 | |
Term loan payable to a bank | 20,202 | |
Other long-term debt | 648 | 560 |
Lease liability, net of current portion | 1,486 | |
Warrant liability | 1,882 | 18,252 |
Total liabilities | 29,977 | 25,068 |
Commitments and contingencies (Note 15) | ||
Stockholders’ deficit: | ||
Preferred stock, $0.01 par value; 10,000,000 shares authorized at December 31, 2022 and 2021; no shares issued or outstanding at December 31, 2022 and 2021, respectively. | ||
Common stock, $0.01 par value; 150,000,000 shares authorized at December 31, 2022 and 2021; 29,042,418 and 28,689,842 shares issued at December 31, 2022 and 2021, respectively; and 28,919,810 and 28,689,842 shares outstanding at December 31, 2022 and 2021, respectively. | 290 | 286 |
Treasury stock (at cost) | (448) | |
Additional paid-in capital | 146,961 | 144,146 |
Accumulated deficit | (99,089) | (80,295) |
Total stockholders' equity (deficit) | 47,714 | 64,137 |
Total liabilities, convertible preferred stock and stockholders' equity (deficit) | $ 77,691 | $ 89,205 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Preferred stock par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares, issued | 29,042,418 | 28,689,842 |
Common stock, shares, outstanding | 28,919,810 | 28,689,842 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | ||
Research and development service revenue, related party | $ 125 | $ 125 |
Operating expenses: | ||
Research and development | 20,787 | 15,178 |
General and administrative | 14,060 | 10,673 |
Total operating expenses | 34,847 | 25,851 |
Loss from operations | (34,722) | (25,726) |
Other income (expense): | ||
Grant income | 48 | 1,076 |
Interest and dividend income (expense), net | (490) | (53) |
Change in fair value of warrant liability | 16,370 | (11,421) |
Total other income (expense), net | 15,928 | (10,398) |
Net loss | $ (18,794) | $ (36,124) |
Net loss per share - basic | $ (0.65) | $ (1.91) |
Net loss per share - diluted | $ (0.65) | $ (1.91) |
Weighted-average common shares outstanding, basic | 28,823,480 | 18,873,048 |
Weighted-average common shares outstanding, diluted | 28,823,480 | 18,873,048 |
Consolidated Statements of Conv
Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Series B Convertible Preferred Stock | Series C Convertible Preferred Stock | Common Stock | Common Stock Series B Convertible Preferred Stock | Common Stock Series C Convertible Preferred Stock | Treasury Stock | Additional Paid In Capital | Additional Paid In Capital Series B Convertible Preferred Stock | Additional Paid In Capital Series C Convertible Preferred Stock | Accumulated Deficit |
Beginning Balance at Dec. 31, 2020 | $ (23,562) | $ 116 | $ 20,493 | $ (44,171) | |||||||
Temporary Equity, Beginning Balance, Shares at Dec. 31, 2020 | 11,155,506 | 6,032,170 | |||||||||
Temporary Equity, Beginning Balance at Dec. 31, 2020 | $ 26,560 | $ 22,500 | |||||||||
Beginning Balance, Shares at Dec. 31, 2020 | 11,635,094 | ||||||||||
Options exercised | 35 | 35 | |||||||||
Options exercised, Shares | 24,410 | ||||||||||
Warrants exercised | 430 | $ 1 | 429 | ||||||||
Warrants exercised, Shares | 75,946 | ||||||||||
Stock-based compensation | 2,588 | 2,588 | |||||||||
Change in fair value of NC Ohio Trust Warrants | 375 | 375 | |||||||||
Temporary equity, Conversion of Series Preferred Stock to common stock | $ (26,560) | $ (22,500) | |||||||||
Temporary equity, Conversion of Series Preferred Stock to common stock, Shares | (11,155,506) | (6,032,170) | |||||||||
Conversion of Series Preferred Stock to common stock | $ 26,560 | $ 22,500 | $ 45 | $ 25 | $ 26,515 | $ 22,475 | |||||
Conversion of Series Preferred Stock to common stock, Shares | 4,538,578 | 2,527,820 | |||||||||
Proceeds from IPO, net | 71,335 | $ 99 | 71,236 | ||||||||
Proceeds from IPO, net, Shares | 9,887,994 | ||||||||||
Net loss | (36,124) | (36,124) | |||||||||
Ending Balance at Dec. 31, 2021 | $ 64,137 | $ 286 | 144,146 | (80,295) | |||||||
Ending Balance, Shares at Dec. 31, 2021 | 28,689,842 | 28,689,842 | |||||||||
Options exercised | $ 512 | $ 4 | 508 | ||||||||
Options exercised, Shares | 352,576 | 352,576 | |||||||||
Treasury stock acquired | $ (448) | $ (448) | |||||||||
Treasury stock acquired, Shares | (122,608) | ||||||||||
Stock-based compensation | 3,145 | 3,145 | |||||||||
Change in fair value of NC Ohio Trust Warrants | (838) | (838) | |||||||||
Net loss | (18,794) | (18,794) | |||||||||
Ending Balance at Dec. 31, 2022 | $ 47,714 | $ 290 | $ (448) | $ 146,961 | $ (99,089) | ||||||
Ending Balance, Shares at Dec. 31, 2022 | 28,919,810 | 29,042,418 | (122,608) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (18,794) | $ (36,124) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 778 | 232 |
Impairment on manufacturing equipment | 553 | |
Non-cash stock compensation expense | 2,307 | 2,963 |
Non-cash lease expense | 209 | |
Non-cash interest expense | 89 | 76 |
Change in fair value of warrant liability | (16,370) | 11,421 |
Accretion of debt discount | 291 | |
Paycheck protection program loan forgiveness | (463) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 416 | (2,210) |
Other long term assets | 83 | |
Accounts payable | (1,213) | 669 |
Accrued expenses | 1,265 | 297 |
Deferred revenue | 67 | (125) |
Deferred rent | 410 | |
Lease liability | (464) | |
Net cash used in operating activities | (31,419) | (22,218) |
Cash Flows from Investing Activities: | ||
Purchase of fixed assets | (1,297) | (1,835) |
Net cash used in investing activities | (1,297) | (1,835) |
Cash Flows from Financing Activities: | ||
Net proceeds from initial public offering | 71,335 | |
Net proceeds from bank term loan | 19,910 | |
Proceeds from option exercises | 64 | 35 |
Proceeds from warrant exercises | 430 | |
Net cash provided by financing activities | 19,974 | 71,800 |
Net increase (decrease) in cash | (12,742) | 47,747 |
Cash, cash equivalents and restricted cash at beginning of period | 83,066 | 35,319 |
Cash, cash equivalents and restricted cash at end of period | 70,324 | 83,066 |
Supplemental Cash Flow Information: | ||
Cash paid for taxes | 183 | $ 29 |
Cash paid for interest | 1,152 | |
Supplemental disclosures of non-cash information: | ||
Lease liability arising from obtaining right-of-use assets | 2,368 | |
Capital expenditures in accounts payable and accrued expenses | 69 | |
Common stock exchange for option exercise | $ 448 |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and basis of presentation | 1. Organization and Basis of Presentation Candel Therapeutics, Inc., formerly known as Advantagene, Inc. (the Company) is a late clinical stage biotechnology company that was incorporated in Delaware in June 2003. On November 30, 2020, the Company changed its name to Candel Therapeutics, Inc. The Company is focused on developing and commercializing viral immunotherapies to help patients fight cancer. The Company’s engineered viruses are designed to induce immunogenic cell death through direct viral – mediated cytotoxicity in cancer cells, thus releasing tumor neo-antigens and creating a pro-inflammatory microenvironment at the site of injection. The Company has established two clinical stage viral immunotherapy platforms and its two product candidates, CAN-2409 and CAN-3110, are in clinical trials for a number of tumor types. In addition, the Company recently announced a collaboration with the University of Pennsylvania (Penn) to study the impact of novel viral immunotherapies based on Candel's propriety enLIGHTEN Discovery Platform to strengthen the effects of Penn's investigational CAR-T cell therapies in solid tumor models. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including 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 product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales. The Company has funded its operations primarily with proceeds from the sale of its convertible notes and capital stock and from debt borrowings. The Company has incurred recurring losses since its inception, including a net loss of $ 18.8 million and $ 36.1 million for the years ended December 31, 2022, and 2021, respectively. In addition, as of December 31, 2022, the Company had an accumulated deficit of $ 99.1 million . The Company expects to continue to generate operating losses for the foreseeable future. On July 29, 2021, the Company completed its initial public offering of common stock (the IPO) at which time the Company issued 9,000,000 shares of its common stock at a price to the public of $ 8.00 per share, and on August 13, 2021, the Company issued an additional 887,994 shares of common stock at $ 8.00 per share as a partial exercise of the underwriters’ option to purchase additional shares, resulting in net proceeds to the Company of $ 71.3 million , after deducting underwriting discounts and commissions and offering expenses. Upon closing of the IPO, all outstanding shares of the Company’s convertible preferred stock automatically converted into 7,066,398 shares of common stock. On August 5, 2022, the Company filed a shelf registration statement on Form S-3 (the Shelf) with the SEC, which covers the offering, issuance, and sale by us of up to an aggregate of $ 200.0 million of our common stock, preferred stock, debt securities, warrants and/or units of any combination thereof. We simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, to provide for the issuance and sale by us of up to $ 75.0 million of our common stock from time to time in “at-the-market” offerings under the Shelf (the ATM Program). The Shelf was declared effective by the SEC on August 12, 2022. As of the date hereof, no sales have been made pursuant to the ATM Program. 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 assurances that additional funding will be available on terms acceptable to the Company, or at all. The Company believes that existing resources will fund planned operations for at least 12 months from the date that these consolidated financial statements were available to be issued. Accordingly, the consolidated financial statements have been prepared on a basis that assumes the Company continues as a going concern and contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business. |
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 The accompanying consolidated financial statements have been prepared in accordance with accounting standards set by the Financial Accounting Standards Board (FASB). The FASB sets generally accepted accounting principles (GAAP) that the Company follows to ensure its financial condition, results of operations, and cash flows are consistently reported. References to GAAP issued by the FASB in these notes to the financial statements are to the FASB Accounting Standards Codification (ASC). Principles of Consolidation The consolidated financial statements include the accounts of Candel Therapeutics, Inc. and its wholly owned subsidiary Candel Therapeutics Securities Corporation. All intercompany transactions and balances have been eliminated. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision-maker in deciding how to allocate resources and assess performance. The Company and the Company's chief operating decision maker, the Company's chief executive officer, views the Company's operations and manages its business as a single operating segment. The Company only operates in the United States. Emerging Growth Company The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the Jobs Act). Under the Jobs Act emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the Jobs Act until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that is (i) no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the Jobs Act. As a result, these consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and related disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. On an ongoing basis, the Company’s management evaluates its estimates, which include but are not limited to management’s judgments of accrued expenses, valuation of stock-based option awards, valuations of warrants, and income taxes. Actual results could differ from those estimates. Prior to the IPO, the Company utilized significant estimates and assumptions in determining the fair value of its common stock. The Company has utilized various valuation methodologies in accordance with the framework of the American Institute of Certified Public Accountants Technical Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation (the Practice Aid), to estimate the fair value of its common stock and warrants. Each valuation methodology includes estimates and assumptions that require the Company’s judgment. These estimates and assumptions include a number of objective and subjective factors, including external market conditions, the prices at which the Company sold shares of preferred stock, the superior rights and preferences of securities senior to the Company’s common stock at the time of, and the likelihood of, achieving a liquidity event, such as an initial public offering or sale. Significant changes to the key assumptions used in the valuations could result in different fair values of common stock at each valuation date. Cash and Cash Equivalents The Company considers all highly liquid investments purchased with original final maturities of 90 days or less from the date of purchase to be cash equivalents. Cash and cash equivalents comprise marketable securities with maturities of less than 90 days when purchased. Cash equivalents are reported at fair value. Restricted Cash The Company has $ 0.3 million and $ 0.4 million of restricted cash as of December 31, 2022 and 2021 , respectively, which represents cash held as a security deposit under the terms of the Company’s Needham, Massachusetts facility lease and at December 31, 2021, as security for the Company credit card. Fair Value Measurements Certain assets and liabilities of the Company are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. 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—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The carrying values of cash and cash equivalents (considered as Level 1 measurement), accounts payable, and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. The Company’s warrant liability is carried at fair value and is classified as Level 3 measurement. Property and Equipment Property and equipment consist of laboratory and manufacturing equipment, networking and computer equipment, furniture and fixtures and leasehold improvements. Property and equipment are recorded at cost, and depreciated using the straight-line method over the estimated useful lives of the respective assets: ASSET ESTIMATED USEFUL LIFE Networking and computer equipment 5 years Laboratory equipment 5 years Manufacturing equipment 5 years Furniture and fixtures 5 years Leasehold improvements Shorter of the useful life or remaining lease term Leases The Company adopted ASC 842 as of January 1, 2022 and elected the transition method under ASU 2016-02 whereby the Company records a right-of-use asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. The Company also elected to apply the practical expedients intended to ease transition. Accordingly, the Company has only applied ASC 842 to leases existing as of January 1, 2022. The Company determines if an arrangement is, or contains, a lease at inception. Lease right of use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Lease right of use assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments to be made over the lease term. The lease right of use asset is equal to the lease liability and adjusted for prepaid rent, initial direct costs, and incentives. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. The lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term. The Company has elected to not apply the recognition requirements of ASC 842 for short-term leases, which is defined as a lease that, at the lease commencement date, has a lease term of 12 months or less and does not include an option to purchase the underlying asset that the Company is reasonably certain to exercise. For real estate lease agreements entered into or modified after the adoption of ASC 842 that include lease and non-lease components, the Company has elected to account for the lease and non-lease components, such as common area maintenance charges, as a single lease component term. Concentrations of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents and marketable securities. Periodically, the Company maintains deposits and investments in accredited financial institutions in-excess of the federally insured limits. The Company deposits its cash in financial institutions with a high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal risk associated with commercial banking relationships. Impairment of Long-lived Assets 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 assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value, determined based on discounted cash flows. Long-lived assets consist of fixed assets and operating lease assets. In the fourth quarter of 2021, the Company recorded an impairment charge of approximately $ 0.6 million related to manufacturing equipment that the Company does not plan to use for its intended use and recorded a reserve to reduce the carrying value to its estimated realizable value. The Company has not recorded any additional impairment losses on such long-lived assets. Revenue Recognition The Company applies Accounting Standards Codification (ASC), Topic 606, Revenue from Contracts with Customers, (ASC 606). This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and then assesses whether or not each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Research and Development Costs and Accruals Research and development expenses include salaries and benefits, materials and supplies, preclinical and clinical trial expenses, stock-based compensation expense, depreciation of equipment, contract services and other outside expenses. The Company has entered into various research and development-related contracts with clinical and research institutions, contract research organizations, and other companies. These agreements are generally cancelable, and related payments are recorded as research and development expenses as incurred. Costs of certain development activities, such as manufacturing, pre-clinical and clinical trial expenses, are recognized based on an evaluation of the progress to completion of specific tasks. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development costs. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. Costs incurred in obtaining technology licenses and intellectual property are charged to research and development expenses as acquired in-process research and development if the technology licensed or intellectual property acquired has not reached technological feasibility and has no alternative future use. Patent Costs All patent-related costs incurred in connection with preparing, filing, maintaining and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified in general and administrative expenses. Stock-Based Compensation The Company accounts for its stock-based compensation in accordance with ASC Topic 718, Compensation—Stock Compensation (ASC 718). ASC 718 requires all share-based payments to employees and directors to be recognized as expense in the consolidated statements of operations based on their grant date fair values. In addition, in accordance with FASB Accounting Standards Update (ASU) 2016-09 which identifies areas for simplification of several areas of share-based payment transactions, the Company treats non-employee grants the same as employee grants. The Company estimates the fair value of options granted using the Black-Scholes option pricing model for stock option grants to both employees and non-employees. The Company believes the fair value of the stock options granted to non-employees is more reliably determinable than the fair value of the services provided. The Black-Scholes option pricing model requires inputs based on certain subjective assumptions, including (a) the expected stock price volatility, (b) the expected term of the award, (c) the risk-free interest rate and (d) expected dividends. Due to a lack of company-specific historical and implied volatility data, the Company has based its computation of expected volatility on the historical volatility of a representative group of public companies with similar characteristics to the Company, including stage of product development and life science industry focus. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. The Company uses the simplified method as prescribed by the SEC Staff Accounting Bulletin No. 107, Share-Based Payment, to calculate the expected term for options granted to employees as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. The expected term is applied to the stock option grant group as a whole, as the Company does not expect substantially different exercise or post-vesting termination behavior among its employee population. For options granted to non-employees, the Company utilizes the contractual term of the share-based payment as the basis for the expected term assumption. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected term of the stock options. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock. Prior to the IPO, there were significant judgments and estimates inherent in the determination of the fair value of the Company’s common stock. These estimates and assumptions included a number of objective and subjective factors, including external market conditions, the prices at which the Company sold shares of preferred stock, the superior rights and preferences of securities senior to its common stock at the time of, and the likelihood of, achieving a liquidity event, such as an initial public offering or sale. The Company generally expenses the fair value of its share-based compensation awards to employees and non-employees on a straight-line basis over the requisite service period, which is generally the vesting period. Government Grants The Company has applied for grants for the reimbursement of expenditures with the National Institutes of Health (NIH) and the Massachusetts Life Sciences Center for certain qualified operating expenditures, including employee-related costs. The Company recognizes government grants when there is reasonable assurance that the Company will comply with the conditions attached to the grant arrangement and the grant will be received. Government grants for research and development efforts are recorded as grant income and classified in other income in the consolidated statements of operations. The Company recognized government grants of $ 48,000 and $ 1.1 million for the years ended December 31, 2022 and 2021 , respectively. Grant income is recognized as a component of other income/(expense), net in the consolidated statements of operations. The Company's grant with the NIH was completed at the end of 2021. The Company's grant with the Massachusetts Life Sciences Center began in 2022. Income Taxes The Company accounts for income taxes using the asset and liability method in accordance with ASC Topic 740, Income Taxes (ASC 740) which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income 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. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. At December 31, 2022 and 2021, the Company has concluded that a full valuation allowance is necessary for its deferred tax assets (see Note 12). The Company accounts for uncertainty in income taxes, by applying the two-step process to determine the amount of tax benefit to be recognized in the financial statements. 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 is then assessed as the amount of benefits to be recognized in the consolidated financial statements. The amount of benefits that may be used are the largest amounts that have 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 received. Net Loss Per Share Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share is computed using the weighted-average number of shares of common stock outstanding during the period and, if dilutive, the weighted-average number of potential shares of common stock. In periods where the Company reports a net loss attributable to common stockholders, diluted net loss per share is the same as basic net loss per share, since dilutive shares of common stock are not assumed to have been issued if their effect is anti-dilutive. Diluted net loss per share is the same as basic net loss per share for the years ended December 31, 2022 and 2021 since all potential shares of common stock instruments are anti-dilutive as a result of the loss for such periods. Recently Adopted Accounting Standards In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) (ASU 2016-02), as amended by various subsequently issued ASUs. The standard requires lessees to recognize an operating lease with a term greater than one year on their balance sheets as a right-of-use asset and corresponding lease liability, measured at the present value of the lease payments. Lessees are required to classify leases as either finance or operating leases. If the lease is effectively a financed purchase by the lessee, it is classified as a financing lease, otherwise it is classified as an operating lease. This classification will determine the pattern of recognition of lease cost on our consolidated statement of operations over the term of the lease. In July 2018, the FASB also issued ASU 2018-11, Leases (Topic 842): Targeted Improvements (ASU 2018-11), which permits entities to continue applying legacy guidance in ASC 840, Leases, including its disclosure requirements, in the comparative periods presented in the year that the entity adopts the new leasing standard. The Company elected the package of practical expedients permitted under the transition guidance within the standard. Accordingly, the Company did not reassess the conclusion of whether the existing arrangements contain a lease, lease classification and initial direct costs under ASC 842. In June 2020, the FASB also issued ASU 2020-05, Revenue from contracts with customers (Topic 606) and Leases (Topic 842): effective dates for certain entities, which deferred the effective date certain entities were required to adopt ASC 842. The update extended the effective date for adoption of ASC 842 until fiscal years beginning after December 15, 2021. As an emerging growth company we were not required to adopt ASC 842 until January 1, 2022. The Company adopted the standard on January 1, 2022 using the effective date method. As such, the consolidated balance sheets and statements of operations for prior periods will not be comparable in the year of adoption of ASC 842. As a result of the adoption of ASC 842, the Company recorded a lease right of use asset of $ 1.3 million and a lease liability of $ 2.4 million on the consolidated balance sheets as of January 1, 2022 related to an operating lease. The Company derecognized deferred rent liabilities, which makes up the difference between the lease right of use asset and lease liability. The adoption of the standard did not have a material impact on the Company’s consolidated statement of operations or consolidated statement of cash flows. In August 2020, the FASB issued ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity's Own Equity (Subtopic 815-40). The guidance simplifies the complexity associated with applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. This ASU (1) simplifies the accounting for convertible debt instruments and convertible preferred stock by removing guidance in ASC 470-20, Debt: Debt with Conversion and Other Options, that requires entities to account for beneficial conversion features and cash conversion features in equity, separately from the host convertible debt or preferred stock; (2) revises the scope exception from derivative accounting in ASC 815-40 for freestanding financial instruments and embedded features that are both indexed to the issuers own stock and classified in stockholders' equity, by removing certain criteria required for equity classification; and (3) revises the guidance in ASC 260, Earnings Per Share, to require entities to calculate diluted earnings per share for convertible instruments by using the if-converted method. As an emerging growth company, we are not required to adopt ASU 2020-06 until January 1, 2024, however early adoption is permitted. The Company elected to early adopt the standard on January 1, 2022 and upon adoption, there was no impact to our consolidated statement of operations and cash flows and our basic and diluted net loss per share amounts. In November 2021, the FASB issued ASU 2021-10, which created Topic 832, Government Assistance, which requires business entities to disclose information about certain government assistance they receive. The ASU requires qualitative and quantitative disclosures around the nature of transactions and related accounting policy used, the line items on the balance sheet and income statement that are affected, and the significant terms and conditions of the transactions. The ASU is effective for fiscal years beginning after December 15, 2021 . The Company believes its historical disclosure already met the requirements of the new standard. As such, no changes or additional disclosure was determined to be necessary . |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities | 3. Fair Value of Financial Assets and Liabilities The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands): FAIR VALUE MEASUREMENTS AS OF LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Liabilities: Warrant liability — — 1,882 1,882 Total $ — $ — $ 1,882 $ 1,882 FAIR VALUE MEASUREMENTS AS OF LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Liabilities: Warrant liability — — 18,252 18,252 Total $ — $ — $ 18,252 $ 18,252 Valuation of Warrant Liability In connection with the November 13, 2018 issuance of Series B convertible preferred stock, the Company issued warrants to purchase shares of common stock of which certain warrants are shown as a liability on the balance sheet, see Note 10. The fair value of the warrant liability was determined based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. The fair value of the warrant liability uses various valuation methods, including the Monte Carlo method, the option-pricing method, probability-weighted expected return and the hybrid method, all of which incorporate assumptions and estimates, to value the common stock warrants. The hybrid method is often used when a company is expecting a liquidity event in the near future and is a combination of the option-pricing and probability-weighted expected return methods. Estimates and assumptions impacting the fair value measurement include the fair value per share of the underlying shares of common stock, risk-free interest rate, expected dividend yield, expected volatility of the price of the underlying common stock, and the remaining contractual term of the warrants. The most significant assumption in the model impacting the fair value of the common stock warrants is the fair value of the Company’s common stock as of each remeasurement date. Prior to the IPO, the Company determined the fair value per share of the underlying common stock by taking into consideration the most recent sales of preferred stock, results obtained from third-party valuations and additional factors that are deemed relevant. The following table provides a roll forward of the aggregate fair values of the Company’s warrant liability, for which fair value is determined by Level 3 inputs (in thousands): SERIES B Balance at December 31, 2020 $ 6,831 Change in fair value 11,421 Balance at December 31, 2021 $ 18,252 Change in fair value ( 16,370 ) Balance at December 31, 2022 $ 1,882 |
Fixed Assets, Net
Fixed Assets, Net | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Fixed Assets, Net | 4. Fixed Assets, Net Fixed assets, net consisted of the following (in thousands): DECEMBER 31, 2022 2021 Laboratory equipment $ 1,055 $ 77 Manufacturing equipment 1,201 933 Furniture and fixtures 159 112 Networking and computer equipment 81 72 Leasehold improvements 3,057 2,994 Total fixed assets $ 5,553 $ 4,188 Less accumulated depreciation ( 1,129 ) ( 352 ) Fixed assets, net $ 4,424 $ 3,836 Depreciation and amortization expense was $ 0.8 million and $ 0.2 million for the years ended December 31, 2022 and 2021 , respectively. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 5. Accrued Expenses Accrued expenses consisted of the following (in thousands): DECEMBER 31, 2022 2021 Payroll and employee related expenses $ 2,647 $ 2,096 Third-party research and development expenses 1,486 632 Professional fees and other 590 710 $ 4,723 $ 3,438 |
Term Loan
Term Loan | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Term Loan | 6. Term Loan On February 24, 2022 , the Company entered into a four-year loan and security agreement (the Loan Agreement) with Silicon Valley Bank (SVB) pursuant to which SVB has agreed to provide term loans to the Company in an aggregate principal amount of up to $ 25.0 million. The Company borrowed $ 20.0 million upon entering into the Loan Agreement. The Company could have borrowed up to an additional aggregate principal amount not to exceed $ 5.0 million, at any time on or prior to December 31, 2022, upon the achievement of all of the following milestones, inclusively: (a) positive Phase 2 clinical activity data from the Company’s CAN-2409 NSCLC clinical trial, (b) dosing of its first patient in its Phase 3 CAN-2409 high-grade glioma clinical trial; and (c) receipt on or prior to December 31, 2022, of net cash proceeds in an amount equal to at least $ 75.0 million from the issuance and sale of equity securities to investors acceptable to SVB. The Company did not borrow any of the additional aggregate principal amount on or prior to December 31, 2022. The term loan is secured by substantially all of the Company’s properties, rights and assets, except for its intellectual property, which is subject to a negative pledge under the Loan Agreement. The term loans bear interest at a floating rate per annum equal to the greater of (A) 5.75 % and (B) the prime rate (as published in the money rates section of The Wall Street Journal) plus 2.50 %. The Company is required to make monthly interest payments, and commencing on February 1, 2024 , 24 consecutive installments of principal plus monthly payments of accrued interest. The term loans mature on January 1, 2026 . Upon repayment in full of the term loans, the Company will be required to pay a final payment fee equal to 4.50 % of the original principal amount of any funded term loan being repaid. The Loan Agreement permits voluntary prepayment of all, but not less than all, of the SVB term loans, subject to a prepayment premium of 1 % to 3 % based upon the timing of the repayment. During the year ended December 31, 2022 , the Company recorded interest expense relating to the Loan Agreement of $ 1.6 million . The weighted average effective interest rate as of December 31, 2022 was 9.54 %. The Company incurred $ 89,000 of debt issuance costs and will incur a $ 0.9 million final payment fee, which were recorded as debt discount and are being amortized over the term of the Loan Agreement. The scheduled principal payments and net carrying amount of the term loan are as follows (in thousands): YEAR ENDING DECEMBER 31, 2023 $ — 2024 8,870 2025 10,232 2026 898 Total principal 20,000 Final payment fee 900 Less: debt discount ( 989 ) Accretion of debt discount 291 Net carrying amount $ 20,202 The carrying amount of the Company's term loan approximates fair value. |
Other Long-Term Debt
Other Long-Term Debt | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Other Long-Term Debt | 7. Other Long-term Debt Periphagen Note On December 9, 2019, the Company entered into a series of asset purchase agreements with Periphagen, Inc., a biopharmaceutical company focused on the development of gene therapy vectors. Under the terms of the asset purchase agreements, the Company assumed a $ 1.0 million promissory note bearing a contractual interest rate of 2 % compounded annually, with the outstanding balance and accrued interest due upon maturity in November 2027 , with no interim installments due. The estimated market rate for the Company for an unsecured loan with a maturity in November 2027 was determined to be 15.83 %. Although the Company does not have a public credit rating, management estimates a CCC credit rating based on the Company’s financial position and stage of development. Using the commensurate rate for a CCC rated company and based on the amount due at maturity, the present value of the future cash outflow was determined to be $ 0.4 million at the transaction date. As of December 31, 2022 , the carrying value of the note is $ 0.6 million. |
Lease
Lease | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Lease | 8. Lease On February 4, 2019, the Company signed a lease agreement for its new corporate headquarters at 117 Kendrick Street in Needham, Massachusetts. The facility consists of a 15,197 square foot property which houses the corporate, clinical, laboratory and manufacturing operations for the Company. The lease term ends on August 31, 2026 . Prior to occupying the new space, the Company had construction performed to modify the space to meet its needs. The Company received $ 0.8 million as a reimbursement by our landlord for a tenant improvement. The $ 0.8 million lease incentive was recorded as reduction to the lease right of use asset recorded to the Company's consolidated balance sheet upon adoption of ASC 842 on January 1, 2022. Disclosures under ASC 842 For the year ended December 31, 2022, the Company has recorded $ 0.4 million of operating lease cost and $ 0.1 million of variable lease cost. The total lease expense for the year ended December 31, 2022 was $ 0.5 million . Cash paid for amounts included in the lease liability for the year ended December 31, 2022 was $ 0.6 million . Other Information DECEMBER 31, Operating cash flows used for operating leases (in thousands) $ 567 Weighted-average remaining lease term (years) 3.7 Weighted-average incremental borrowing rate 7.02 % The future lease payments under non-cancelable leases at December 31, 2022, are as follows (in thousands): 2023 $ 583 2024 598 2025 613 2026 415 Total future lease payments 2,209 Less: imputed interest ( 259 ) Total lease liability $ 1,950 Disclosures under ASC 842 For the year ended December 31, 2021, the Company recorded rent expense of $ 0.5 million. The following table summarizes the future minimum lease payments due under the Company's facility lease as of December 31, 2021, presented in accordance with ASC 840, the relevant accounting standard at that time (in thousands): 2022 $ 567 2023 583 2024 598 2025 613 Thereafter 415 Total minimum lease payments $ 2,776 |
Common Stock and Preferred Stoc
Common Stock and Preferred Stock | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Common Stock and Preferred Stock | 9. Common Stock and Preferred Stock Preferred Stock The Company has authorized 10,000,000 shares of $ 0.01 par value preferred stock at December 31, 2022 and 2021. Common Stock The Company has authorized 150,000,000 shares of $ 0.01 par value common stock at December 31, 2022 and 2021 of which 29,042,418 and 28,689,842 were issued as of December 31, 2022 and 2021, respectively. The Company had 28,919,810 and 28,689,842 outstanding shares as of December 31, 2022 and 2021, respectively. Common shares are voting and dividends may be paid when, as and if declared by the board of directors. Common Stock Reserved The Company has reserved the following shares of common stock for future issuance as of: DECEMBER 31, 2022 2021 Stock options outstanding 5,645,420 4,783,333 Unvested restricted stock 612,366 — Shares available for future grant under stock option plan 1,311,915 1,878,997 Warrants 7,507,708 7,507,708 15,077,409 14,170,038 Reverse Stock Split In connection with the Company's IPO, on July 14, 2021, the Company’s board of directors and stockholders approved a one-for-2.4579 reverse stock split of the Company’s issued and outstanding common stock and a proportional adjustment to the existing conversion ratios for the outstanding shares of convertible preferred stock which became effective on July 15, 2021. Accordingly, all share and per share amounts for all periods presented in the accompanying consolidated financial statements and notes thereto have been retroactively adjusted, where applicable, to reflect the reverse stock split. Initial Public Offering The Company completed its IPO on July 29, 2021 and issued 9,000,000 shares of its common stock at a price to the public of $ 8.00 per share. On August 13, 2021, the Company issued an additional 887,994 shares of its common stock at $ 8.00 per share pursuant to a partial exercise of the underwriters' purchase option. Total net proceeds to the Company from the issuance of the 9,877,994 shares of common stock were $ 71.3 million , after deducting underwriting discounts and commissions and offering expenses. Upon closing of the IPO, all outstanding shares of the Company’s Preferred Stock automatically converted into 7,066,398 shares of common stock. Shelf Registration and At-the-Market Offerings On August 5, 2022, the Company filed a shelf registration statement on Form S-3 (the Shelf) with the SEC, which covers the offering, issuance, and sale by us of up to an aggregate of $ 200.0 million of our common stock, preferred stock, debt securities, warrants and/or units of any combination thereof. We simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, to provide for the issuance and sale by us of up to $ 75.0 million of our common stock from time to time in “at-the-market” offerings under the Shelf (the ATM Program). The Shelf was declared effective by the SEC on August 12, 2022. As of the date hereof, no sales have been made pursuant to the ATM Program. |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2022 | |
Warrants and Rights Note Disclosure [Abstract] | |
Warrants | 10. Warrants The Company has the following warrants outstanding for the purchase of common stock as of December 31, 2022 and 2021: WARRANTS SHARES OF EXERCISE EXPIRATION DATES Series B Warrants 3,672,484 $ 6.81 November 2025 Conditional Series B Warrants 3,672,484 $ 6.81 November 2025 NC Ohio Trust 162,740 $ 1.46 March 2029 Series A Warrants Series A Warrants were issued in connection with the Series A Preferred Stock in 2016. In 2018, upon the conversion of the Series A Preferred Stock into common stock, the Series A Warrants became exercisable for common stock at an exercise price of $ 5.67 per share. Subsequent to the IPO, 75,946 Series A Warrants were exercised and the remaining 48,850 Series A Warrants expired in August 2021 . Series B Warrants In connection with the November 13, 2018 issuance of Series B convertible preferred stock (the Series B Preferred), the Company issued to the purchaser of the Series B Preferred warrants to purchase 3,672,484 shares of common stock for $ 6.81 per share (the Series B Warrants), which became fully exercisable upon issuance. The Series B Warrants contain provisions allowing cashless exercise. In addition, the Company issued to the same stockholder additional five-year warrants for the purchase of 3,672,484 shares of common stock for $ 6.81 per share (the Conditional Series B Warrants), which become exercisable in the event that the Company completes a future financing that meets certain financial milestones or achieves certain share prices as follows: • 918,121 shares vest upon (1) a financing event effected through the sale of our equity securities to third parties resulting in at least $ 20,000,000 in gross proceeds with a per share price of $ 12.47 , or (2) an average market price (determined over a consecutive 10 -day period) of $ 12.47 per share; • an additional 918,121 shares vest upon (1) a financing event with a price per share of $ 13.20 , or (2) an average market price (determined over a consecutive 10 -day period) of, $ 13.20 per share; • an additional 918,121 shares vest upon (1) a financing event with a per share price of $ 13.94 , or (2) an average market price (determined over a consecutive 10 -day period) of, $ 13.94 per share; and • an additional 918,121 shares vest upon (1) a financing event with a per share price of $ 14.68 , or (2) an average market price (determined over a consecutive 10 -day period) of, $ 14.68 per share. On June 24, 2021, the Company’s board of directors approved and on July 14, 2021 the stockholders approved, effective upon the closing of the IPO, an amendment to the terms of the Series B Warrants and the Conditional Series B Warrants to extend the expiration date from November 2023 to November 2025 . In addition, the exercise period for the Conditional Series B Warrants was amended such that in the event the future financing milestones or certain share price targets described above are achieved, the Conditional Series B Warrants can only be exercised in conjunction with the sale of the Company, on a cash or cashless exercise basis, or otherwise in November 2025 through a cashless exercise. The Company recorded the Series B Warrants as a component of stockholder’s equity at the time of issuance at their estimated fair value of $ 2.1 million and recorded the Conditional Series B Warrants as a liability on the consolidated balance sheet as the number of shares used to calculate the settlement is not a fixed number of shares. The Conditional Series B Warrants are remeasured to their fair value at each reporting date with changes in the fair value recognized as a component of other income (expense), net in the consolidated statements of operations. The Company will continue to recognize changes in the fair value of the Conditional Series B Warrants until each Conditional Series B Warrant is exercised, expires or qualifies for equity classification. The warrant liability fair value was $ 1.9 million and $ 18.3 million as of December 31, 2022 and 2021, respectively. NC Ohio Trust Warrants On March 20, 2019, the Company established the NC Incorporated Ohio Trust, an irrevocable trust funded by the Company. The beneficiary in the trust agreement has provided past services to the Company for more than 15 years and is a non-employee. The warrant provides the beneficiary the right to purchase 162,740 shares of the Company’s common stock, $ 0.01 par value at an exercise price of $ 1.46 per share, subject to adjustments as specified in the warrant agreement. The Company recognizes the warrants as compensation expense within the consolidated statement of operations when the warrants are granted or at the service inception date if the service inception date precedes the grant date. In the period in which the grant date occurs, cumulative compensation cost shall be adjusted to reflect the cumulative effect of measuring compensation cost based on the fair value at the grant date rather than the fair value previously used at the service inception date or subsequent reporting dates. As of December 31, 2022 and 2021 , a grant date was not established as there was not a mutual understanding of key terms. The Company remeasures the fair value of the award at each reporting date, as the service date preceded the grant date. The value of the warrants for 162,740 shares of common stock was $ 0.2 million and $ 1.1 million as of December 31, 2022 and 2021 , respectively, and changes in the fair values were recorded as stock compensation expense within research and development expense and a credit to stockholders’ equity in the consolidated financial statements. |
Stock Options, Restricted Stock
Stock Options, Restricted Stock and Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock Options, Restricted Stock and Stock-Based Compensation | 11. Stock Options, Restricted Stock and Stock-Based Compensation Equity Incentive Plans The Company’s 2015 Stock Plan, as amended, (the 2015 Plan) provides for the Company to sell or issue common shares or restricted common stock, or to grant incentive stock options or nonqualified stock options for the purchase of common stock, to employees, members of the board of directors and consultants of the Company. The 2015 Plan is administered by the board of directors and exercise prices, vesting and other restrictions are determined at its discretion. All stock option grants are non-statutory stock options except option grants to employees intended to qualify as incentive stock options under the Internal Revenue Code of 1986, as amended. Incentive stock options may not be granted at less than the fair market value of the Company’s common stock on the date of grant, as determined in good faith by the board of directors at its sole discretion. Nonqualified stock options may be granted at an exercise price established by the board of directors at its sole discretion and the vesting periods may vary. Vesting periods are generally four years and are determined by the board of directors. Stock options become exercisable as they vest. Options granted under the 2015 Plan expire no more than ten years from the date of grant. As of December 31, 2022 , there are no shares available for grants under the 2015 Plan and the 2015 Plan continues to govern the terms and conditions of the outstanding awards under the 2015 Plan. On July 14, 2021, the Company’s 2021 Equity Incentive Plan (the 2021 Plan) was approved by the Company’s stockholders, and became effective upon completion of the IPO and serves as the successor to the 2015 Plan. 3,201,594 shares of common stock are reserved under the 2021 Plan, of which 1,311,915 shares remain available for future grants as of December 31, 2022. Stock Options Stock option activity is summarized as follows: NUMBER OF WEIGHTED- WEIGHTED- AGGREGATE Outstanding as of December 31, 2021 4,783,333 $ 2.34 Granted 1,873,340 3.92 Exercised ( 352,576 ) 1.47 Cancelled or forfeited ( 658,677 ) 3.48 Outstanding as of December 31, 2022 5,645,420 $ 2.77 7.73 $ 881 Exercisable as of December 31, 2022 2,876,293 $ 2.30 6.86 $ 606 Unvested as of December 31, 2022 2,769,127 $ 3.27 8.63 $ 275 The 2015 Plan permits participants to use common stock they previously acquired to pay for the exercise of stock options based upon the fair value on the date of exercise. In connection with the exercise of a stock options to purchase 306,518 shares of our common stock at an exercise price of $ 1.46 , option holders tendered 122,608 shares of our common stock previously acquired in consideration of the full aggregate exercise price in accordance with the terms of the option and the 2015 Plan. The shares tendered are recorded as treasury stock within the Company's consolidated financial statements at December 31, 2022. The fair value of stock options granted was estimated on the grant date using the Black-Scholes option pricing model based on the following weighted-average assumptions: YEAR ENDED DECEMBER 31, 2022 2021 Expected option life (years) 5.33 - 6.08 5.00 - 10.00 Risk-free interest rate 1.69 % - 4.23 % 0.89 % - 1.35 % Expected volatility 85.09 % - 87.67 % 83.80 % - 89.02 % Expected dividend yield 0 % 0 % Exercise price $ 1.75 - $ 5.19 $ 4.97 - $ 11.23 Fair value of common stock $ 1.75 - $ 5.19 $ 4.97 - $ 11.23 The total intrinsic value of stock options vested during the years ended December 31, 2022 and 2021 was zero and $ 6.6 million, respectively. Restricted Stock Under the terms of the restricted stock unit agreements covering the common stock, shares of common stock related to restricted stock units are subject to time-based and performance-based vesting. The restricted stock units will immediately be forfeited to the Company if the relationship between the recipient and the Company ceases. Restricted stock activity is summarized as follows: NUMBER OF WEIGHTED- Unvested at December 31, 2021 — $ — Granted 612,366 $ 1.71 Vested — $ — Forfeited — $ — Unvested at December 31, 2022 612,366 $ 1.71 The aggregate fair value of restricted stock units that vested during each of the years ended December 31, 2022 and 2021 was zero . Stock-Based Compensation Stock-based compensation expense for the years ended December 31, 2022 and 2021 was classified in the consolidated statements of operations as follows (in thousands): YEAR ENDED DECEMBER 31, 2022 2021 Research and development $ 774 $ 1,226 General and administrative 1,533 1,737 Total stock based compensation expense $ 2,307 $ 2,963 As of December 31, 2022 and 2021, total unrecognized compensation cost related to the unvested stock-based awards was $ 7.6 million and $ 6.3 million, respectively. As of December 31, 2022 and 2021, these amounts are expected to be recognized over a weighted average period of 2.42 and 2.26 years, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 12. Income Taxes Due to the Company's net losses for 2022 and 2021, as well as the full valuation allowance on its net deferred tax assets as discussed below, the Company did no t record any income tax expense or benefit for the years ended December 31, 2022 and 2021. A reconciliation of income tax expense at the federal statutory income tax rate to the income tax expense at the Company’s effective income tax rate is as follows: YEAR ENDED 2022 2021 Income at US statutory rate 21.00 % 21.00 % Permanent adjustments ( 2.84 )% ( 0.59 )% Mark to market 18.29 % ( 6.64 )% State taxes, net of federal benefit 12.78 % 4.01 % Valuation allowance ( 56.79 )% ( 19.86 )% Tax credits 7.56 % 2.08 % — — Net deferred tax assets as of December 31, 2022 and 2021 consist of the following (in thousands): YEAR ENDED 2022 2021 Deferred tax assets: Net operating losses $ 17,748 $ 13,892 Intangibles 572 654 Accrued expenses and other 601 243 Deferred revenue — 34 Lease liability 524 — Stock Compensation 863 820 Capitalized R&D expenditures 4,931 — Credits 4,755 2,850 Total deferred tax assets 29,994 18,493 Valuation allowance ( 29,166 ) ( 18,493 ) Deferred tax assets 828 — Deferred tax liabilities: Right of use asset ( 284 ) — Other ( 544 ) — Total deferred tax liabilities ( 828 ) — Net deferred tax assets (liabilities) $ — $ — As of December 31, 2022 , the Company has gross federal and state net operating loss carryforwards of approximately $ 65.9 million and $ 61.9 million which begin to expire in 2027 and 2032 , respectively. Additionally, the Company has $ 57.1 million of the federal net operating loss carryforwards that can be carried forward indefinitely. As of December 31, 2022 , the Company has gross federal and state tax credit carryforwards of approximately $ 3.4 million and $ 1.8 million, respectively, which begin to expire in 2036 and 2028 , respectively. Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, which are comprised principally of net operating loss carryforwards and certain tax credits. Management has considered the Company’s history of cumulative net losses incurred since inception, as well as its lack of product revenue since inception, and has determined that it is more likely than not that the Company will not realize the benefits of its deferred tax assets. As a result, a full valuation allowance has been established at December 31, 2022 and 2021. Section 382 of the Internal Revenue Code of 1986, as amended (“Section 382”), contains rules that limit the ability of a company that undergoes in ownership change to utilize its net operating losses (“NOLs”) and tax credits existing as of the date of such ownership change. Under the rules, such an ownership change is generally any change in ownership of more than 50% of a company’s stock within a rolling three-year period. The rules generally operate by focusing on changes in ownership of all stock considered by the rules as owning, directly or indirectly, 5% or more of the stock of a company and any change in ownership arising from new issuances of stock by the company. The Company has not yet determined if such a limitation would be placed against its available net operating losses. The Company will make such a determination prior to the utilization of any future net operating losses. A summary of changes in the valuation allowance for deferred tax assets during the year ended December 31, 2022 and 2021 were as follows (in thousands): YEAR ENDED 2022 2021 Valuation allowance $ 18,493 $ 11,318 Increases recorded to income tax provision 10,673 7,175 Decreases recorded to income tax provision — — Valuation allowance $ 29,166 $ 18,493 The Company files income tax returns in the United States and various state and local jurisdictions. The federal and state tax returns are generally subject to examination for the years ended December 31, 2014 through December 31, 2022 . There are currently no pending tax examinations . To the extent the Company has tax attribute carryforwards, the tax year in which the attribute was generated may still be adjusted upon examination. |
Exclusive Licensing Agreement w
Exclusive Licensing Agreement with a Related Party | 12 Months Ended |
Dec. 31, 2022 | |
License Agreement [Abstract] | |
Exclusive Licensing Agreement with a Related Party | 13. Exclusive Licensing Agreement with a Related Party In March 2014, the Company entered into an exclusive licensing agreement with Ventagen, LLC (Ventagen) which provides Ventagen the right to develop products for commercial sale and distribution within Mexico, Belize, Guatemala, Honduras, El Salvador, Costa Rica, Nicaragua, Panama, Colombia, and Bolivia (the Territory). Ventagen paid the Company $ 1.0 million upon the signing of the agreement and agreed to a fixed future payment to the Company of $ 2.5 million. The future payment will be made upon the achievement of $ 5.0 million of sales of an approved product by Ventagen and is subject to reduction if Ventagen’s costs to develop an approved product exceeds $ 4.0 million. In addition to the upfront payment and the future payment, Ventagen agreed to purchase from the Company all manufactured product that is required for clinical or commercial purposes at a price of cost plus 25 % of the wholesale price of the approved product subject to a minimum or maximum price. In the event the Company is unable or unwilling to manufacture supply under the terms of the agreement, Ventagen has the right to manufacture its own supply and will be required to pay a fixed fee per dose sold. The Company also agreed to provide certain services to Ventagen related to Ventagen’s development plan. Stockholders of the Company own 49.5 % of the voting stock of Ventagen, including 47 % by the Company’s founders who are currently significant stockholders of the Company, and trusts for the benefit of their children. The Company is recognizing the $ 1.0 million upfront license fee as research and development service revenue, related party, as the Company’s license agreement with Ventagen is within the scope of ASC 606. The license agreement met the contract existence criteria and contained distinct, identifiable performance obligations for which the stand-alone selling prices were readily determinable and allocable. The terms of the agreement contained multiple, distinct performance obligations, including transfer of a license for the Territory, research and development oversight for the trials run by Ventagen, and clinical data sharing. The Company estimated the transaction prices, including any variable consideration, at contract inception and determined the fair value of such obligations. The performance obligation associated with the license transfer was satisfied at a point in time, or at contract inception; however, the Company assigned no value to the license transfer. The remaining $ 1.0 million transaction price was allocated between the research and development oversight and clinical data sharing. The Company is recognizing revenue for these obligations over an 8-year period, beginning in 2015, by measuring the progress towards satisfaction of the performance obligations. As clinical oversight and clinical data sharing occurs over the 8 —year clinical trial period, the revenue is recognized over the same period in which the cost for these services is incurred. The Company defers recognition of the portion of the $ 1.0 million non-refundable upfront license fee for the portion of the performance obligations that are not satisfied. The Company recognized revenue of $ 0.1 million in the years ended December 31, 2022 and 2021 . The license agreement includes a $ 2.5 million potential future milestone payment due to the Company upon successful completion of certain separate, distinct events. At this time, the Company cannot estimate when the milestone-related performance obligations are expected to be achieved and will recognize revenue once satisfaction is probable. There was no additional variable consideration, significant financing components, non-cash consideration, or consideration payable to the customer in this agreement. |
Technology License Agreement
Technology License Agreement | 12 Months Ended |
Dec. 31, 2022 | |
Technology License Agreement [Abstract] | |
Technology License Agreement | 14. Technology License Agreement On January 20, 2018 the Company entered into an exclusive option agreement (Option Agreement) with MGB. Pursuant to the Option Agreement, the Company has obtained the exclusive right from MGB to negotiate an exclusive license to make, develop and commercialize rQNestin, a genetically modified oncolytic herpes simplex virus for the treatment of certain types of cancers. Pursuant to the Option Agreement, the Company will support a clinical trial to be conducted at MGB pursuant to the terms of a clinical trial agreement to be negotiated and the Company has committed to remitting $ 0.8 million in support of such clinical trial over the course of approximately three years . Upon execution of the Option Agreement, the Company remitted a non-refundable fee of $ 40,000 to MGB to be applied toward the Company’s on-going obligations to reimburse patent expenses. In the years ended December 31, 2022 and 2021 , respectively, the Company expensed zero and $ 28,000 , respectively, for startup and patient fees for clinical trials performed by MGB. On September 15, 2020, the Company exercised the Option Agreement with MGB and entered into an exclusive worldwide patent license agreement with MGB (the MGB License). In connection with the MGB License, the Company paid a fee of $ 0.1 million and agreed to reimburse patent costs incurred by MGB, including $ 0.1 million paid at the time of entering into the MGB License. Prior to the first commercial sale, the Company is required to pay MGB an annual license fee of $ 50,000 beginning following the fourth anniversary of the effective date. The MGB License contains cumulative milestone payments equaling a maximum amount of $ 39.0 million upon the achievement of various clinical, commercial and sales milestones of both primary and secondary products. Following the first commercial sale, the Company is required to pay royalties to MGB, which are paid at an increasing rate as net sales increase, ranging from low single digits to high single digits. In addition, after the first commercial sale, the Company is required to pay MGB a pre-determined fixed annual minimum royalty, which amount may be credited against earned royalties starting in the fourth year following the first commercial sale. The Company also agreed to pay a single digit royalty rate on net sales of any derived products. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 15. Commitments and Contingencies Guarantees The Company has identified the guarantees described below as disclosable, in accordance with ASC 460, Guarantees. As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is, or was, serving at the Company’s request in such capacity. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ and officers’ insurance coverage that should limit its exposure and enable it to recover a portion of any future amounts paid. The Company is a party to a number of agreements entered into in the ordinary course of business that contain typical provisions that obligate the Company to indemnify the other parties to such agreements upon the occurrence of certain events. Such indemnification obligations are usually in effect from the date of execution of the applicable agreement for a period equal to the applicable statute of limitations. The aggregate maximum potential future liability of the Company under such indemnification provisions is uncertain. The Company leases office space under a noncancelable operating lease expiring in 2026 . The Company has standard indemnification arrangements under this lease that require it to indemnify the landlord against all costs, expenses, fines, suits, claims, demands, liabilities, and actions directly resulting from any breach, violation, or nonperformance of any covenant or condition of the lease. As of December 31, 2022 , the Company had no t experienced any losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves have been established. Legal Proceedings From time to time, we may become involved in litigation or other legal proceedings. On December 15, 2022, Periphagen notified us by letter of its claim that we have failed to use commercially reasonable efforts to complete a human proof of concept clinical trial of an NT-3 Asset under an Exclusive License Agreement dated December 9, 2019 between us and Periphagen (the “Periphagen License Agreement”). We have denied Periphagen’s claims. On January 13, 2023, we filed a demand for arbitration against Periphagen with the American Arbitration Association, seeking a declaration that Periphagen’s December 15 letter failed to comply with the dispute and escalation provisions in the Periphagen License Agreement. After filing the demand, the parties began engaging in the dispute and escalation process under the Periphagen License Agreement. On March 10, 2023, Periphagen filed its answer and counterclaims to our demand for arbitration. In its counterclaims, Periphagen seeks a declaration that we have not used commercially reasonable efforts to complete a human proof of concept clinical trial of the NT-3 Asset and a declaration that any further extension of time would not be scientifically or commercially reasonable. Periphagen also seeks a declaration that Candel must use commercially reasonable efforts to develop the NT-3 Asset during any remaining time under the agreement. We have denied Periphagen’s counterclaims. In the event the parties are unable to resolve the dispute as part of the escalation process, an arbitrator will decide whether we have used commercially reasonable efforts. In the event that the arbitrator determines that we have not used commercially reasonable efforts, then we may submit a specified payment in lieu of satisfying such obligations. Aside from the proceeding with Periphagen, we are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are probable to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources and other factors. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 16. Net Loss Per Share Net Loss Per Share Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share data): YEAR ENDED DECEMBER 31, 2022 2021 Numerator: Net loss $ ( 18,794 ) $ ( 36,124 ) Denominator: Weighted-average shares of common stock outstanding-basic and diluted 28,823,480 18,873,048 Net loss per share -basic and diluted $ ( 0.65 ) $ ( 1.91 ) The Company’s potentially dilutive securities have been excluded from the computation of dilutive net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of shares of common stock outstanding used to calculate both basic and diluted net loss per share is the same. The Company excluded the following potential shares of common stock from the computation of diluted net loss per share because including them would have had an anti-dilutive effect. YEAR ENDED DECEMBER 31, 2022 2021 Outstanding warrants for common stock 7,507,708 7,507,708 Outstanding stock options (as converted to common stock) 5,645,420 4,783,333 Unvested restricted stock 612,366 — 13,765,494 12,291,041 |
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 The accompanying consolidated financial statements have been prepared in accordance with accounting standards set by the Financial Accounting Standards Board (FASB). The FASB sets generally accepted accounting principles (GAAP) that the Company follows to ensure its financial condition, results of operations, and cash flows are consistently reported. References to GAAP issued by the FASB in these notes to the financial statements are to the FASB Accounting Standards Codification (ASC). |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of Candel Therapeutics, Inc. and its wholly owned subsidiary Candel Therapeutics Securities Corporation. All intercompany transactions and balances have been eliminated. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision-maker in deciding how to allocate resources and assess performance. The Company and the Company's chief operating decision maker, the Company's chief executive officer, views the Company's operations and manages its business as a single operating segment. The Company only operates in the United States. |
Emerging Growth Company | Emerging Growth Company The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the Jobs Act). Under the Jobs Act emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the Jobs Act until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that is (i) no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided in the Jobs Act. As a result, these consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. |
Use of Estimates | Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and related disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. On an ongoing basis, the Company’s management evaluates its estimates, which include but are not limited to management’s judgments of accrued expenses, valuation of stock-based option awards, valuations of warrants, and income taxes. Actual results could differ from those estimates. Prior to the IPO, the Company utilized significant estimates and assumptions in determining the fair value of its common stock. The Company has utilized various valuation methodologies in accordance with the framework of the American Institute of Certified Public Accountants Technical Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation (the Practice Aid), to estimate the fair value of its common stock and warrants. Each valuation methodology includes estimates and assumptions that require the Company’s judgment. These estimates and assumptions include a number of objective and subjective factors, including external market conditions, the prices at which the Company sold shares of preferred stock, the superior rights and preferences of securities senior to the Company’s common stock at the time of, and the likelihood of, achieving a liquidity event, such as an initial public offering or sale. Significant changes to the key assumptions used in the valuations could result in different fair values of common stock at each valuation date. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments purchased with original final maturities of 90 days or less from the date of purchase to be cash equivalents. Cash and cash equivalents comprise marketable securities with maturities of less than 90 days when purchased. Cash equivalents are reported at fair value. |
Restricted Cash | Restricted Cash The Company has $ 0.3 million and $ 0.4 million of restricted cash as of December 31, 2022 and 2021 , respectively, which represents cash held as a security deposit under the terms of the Company’s Needham, Massachusetts facility lease and at December 31, 2021, as security for the Company credit card. |
Fair Value Measurements | Fair Value Measurements Certain assets and liabilities of the Company are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. 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—Quoted prices in active markets for identical assets or liabilities. • Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The carrying values of cash and cash equivalents (considered as Level 1 measurement), accounts payable, and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. The Company’s warrant liability is carried at fair value and is classified as Level 3 measurement. |
Property and Equipment | Property and Equipment Property and equipment consist of laboratory and manufacturing equipment, networking and computer equipment, furniture and fixtures and leasehold improvements. Property and equipment are recorded at cost, and depreciated using the straight-line method over the estimated useful lives of the respective assets: ASSET ESTIMATED USEFUL LIFE Networking and computer equipment 5 years Laboratory equipment 5 years Manufacturing equipment 5 years Furniture and fixtures 5 years Leasehold improvements Shorter of the useful life or remaining lease term |
Leases | Leases The Company adopted ASC 842 as of January 1, 2022 and elected the transition method under ASU 2016-02 whereby the Company records a right-of-use asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. The Company also elected to apply the practical expedients intended to ease transition. Accordingly, the Company has only applied ASC 842 to leases existing as of January 1, 2022. The Company determines if an arrangement is, or contains, a lease at inception. Lease right of use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Lease right of use assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments to be made over the lease term. The lease right of use asset is equal to the lease liability and adjusted for prepaid rent, initial direct costs, and incentives. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. The lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term. The Company has elected to not apply the recognition requirements of ASC 842 for short-term leases, which is defined as a lease that, at the lease commencement date, has a lease term of 12 months or less and does not include an option to purchase the underlying asset that the Company is reasonably certain to exercise. For real estate lease agreements entered into or modified after the adoption of ASC 842 that include lease and non-lease components, the Company has elected to account for the lease and non-lease components, such as common area maintenance charges, as a single lease component term. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents and marketable securities. Periodically, the Company maintains deposits and investments in accredited financial institutions in-excess of the federally insured limits. The Company deposits its cash in financial institutions with a high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal risk associated with commercial banking relationships. |
Impairment of Long-lived Assets | Impairment of Long-lived Assets 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 assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value, determined based on discounted cash flows. Long-lived assets consist of fixed assets and operating lease assets. In the fourth quarter of 2021, the Company recorded an impairment charge of approximately $ 0.6 million related to manufacturing equipment that the Company does not plan to use for its intended use and recorded a reserve to reduce the carrying value to its estimated realizable value. The Company has not recorded any additional impairment losses on such long-lived assets. |
Revenue Recognition | Revenue Recognition The Company applies Accounting Standards Codification (ASC), Topic 606, Revenue from Contracts with Customers, (ASC 606). This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and then assesses whether or not each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. |
Research and Development Costs and Accruals | Research and Development Costs and Accruals Research and development expenses include salaries and benefits, materials and supplies, preclinical and clinical trial expenses, stock-based compensation expense, depreciation of equipment, contract services and other outside expenses. The Company has entered into various research and development-related contracts with clinical and research institutions, contract research organizations, and other companies. These agreements are generally cancelable, and related payments are recorded as research and development expenses as incurred. Costs of certain development activities, such as manufacturing, pre-clinical and clinical trial expenses, are recognized based on an evaluation of the progress to completion of specific tasks. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development costs. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. Costs incurred in obtaining technology licenses and intellectual property are charged to research and development expenses as acquired in-process research and development if the technology licensed or intellectual property acquired has not reached technological feasibility and has no alternative future use. |
Patent Costs | Patent Costs All patent-related costs incurred in connection with preparing, filing, maintaining and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified in general and administrative expenses. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for its stock-based compensation in accordance with ASC Topic 718, Compensation—Stock Compensation (ASC 718). ASC 718 requires all share-based payments to employees and directors to be recognized as expense in the consolidated statements of operations based on their grant date fair values. In addition, in accordance with FASB Accounting Standards Update (ASU) 2016-09 which identifies areas for simplification of several areas of share-based payment transactions, the Company treats non-employee grants the same as employee grants. The Company estimates the fair value of options granted using the Black-Scholes option pricing model for stock option grants to both employees and non-employees. The Company believes the fair value of the stock options granted to non-employees is more reliably determinable than the fair value of the services provided. The Black-Scholes option pricing model requires inputs based on certain subjective assumptions, including (a) the expected stock price volatility, (b) the expected term of the award, (c) the risk-free interest rate and (d) expected dividends. Due to a lack of company-specific historical and implied volatility data, the Company has based its computation of expected volatility on the historical volatility of a representative group of public companies with similar characteristics to the Company, including stage of product development and life science industry focus. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. The Company uses the simplified method as prescribed by the SEC Staff Accounting Bulletin No. 107, Share-Based Payment, to calculate the expected term for options granted to employees as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. The expected term is applied to the stock option grant group as a whole, as the Company does not expect substantially different exercise or post-vesting termination behavior among its employee population. For options granted to non-employees, the Company utilizes the contractual term of the share-based payment as the basis for the expected term assumption. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected term of the stock options. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock. Prior to the IPO, there were significant judgments and estimates inherent in the determination of the fair value of the Company’s common stock. These estimates and assumptions included a number of objective and subjective factors, including external market conditions, the prices at which the Company sold shares of preferred stock, the superior rights and preferences of securities senior to its common stock at the time of, and the likelihood of, achieving a liquidity event, such as an initial public offering or sale. The Company generally expenses the fair value of its share-based compensation awards to employees and non-employees on a straight-line basis over the requisite service period, which is generally the vesting period. |
Government Grants | Government Grants The Company has applied for grants for the reimbursement of expenditures with the National Institutes of Health (NIH) and the Massachusetts Life Sciences Center for certain qualified operating expenditures, including employee-related costs. The Company recognizes government grants when there is reasonable assurance that the Company will comply with the conditions attached to the grant arrangement and the grant will be received. Government grants for research and development efforts are recorded as grant income and classified in other income in the consolidated statements of operations. The Company recognized government grants of $ 48,000 and $ 1.1 million for the years ended December 31, 2022 and 2021 , respectively. Grant income is recognized as a component of other income/(expense), net in the consolidated statements of operations. The Company's grant with the NIH was completed at the end of 2021. The Company's grant with the Massachusetts Life Sciences Center began in 2022. |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method in accordance with ASC Topic 740, Income Taxes (ASC 740) which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the financial statements or in the Company’s tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income 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. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. At December 31, 2022 and 2021, the Company has concluded that a full valuation allowance is necessary for its deferred tax assets (see Note 12). The Company accounts for uncertainty in income taxes, by applying the two-step process to determine the amount of tax benefit to be recognized in the financial statements. 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 is then assessed as the amount of benefits to be recognized in the consolidated financial statements. The amount of benefits that may be used are the largest amounts that have 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 received. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share is computed using the weighted-average number of shares of common stock outstanding during the period and, if dilutive, the weighted-average number of potential shares of common stock. In periods where the Company reports a net loss attributable to common stockholders, diluted net loss per share is the same as basic net loss per share, since dilutive shares of common stock are not assumed to have been issued if their effect is anti-dilutive. Diluted net loss per share is the same as basic net loss per share for the years ended December 31, 2022 and 2021 since all potential shares of common stock instruments are anti-dilutive as a result of the loss for such periods. |
Recently Adopted Accounting Standards | Recently Adopted Accounting Standards In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) (ASU 2016-02), as amended by various subsequently issued ASUs. The standard requires lessees to recognize an operating lease with a term greater than one year on their balance sheets as a right-of-use asset and corresponding lease liability, measured at the present value of the lease payments. Lessees are required to classify leases as either finance or operating leases. If the lease is effectively a financed purchase by the lessee, it is classified as a financing lease, otherwise it is classified as an operating lease. This classification will determine the pattern of recognition of lease cost on our consolidated statement of operations over the term of the lease. In July 2018, the FASB also issued ASU 2018-11, Leases (Topic 842): Targeted Improvements (ASU 2018-11), which permits entities to continue applying legacy guidance in ASC 840, Leases, including its disclosure requirements, in the comparative periods presented in the year that the entity adopts the new leasing standard. The Company elected the package of practical expedients permitted under the transition guidance within the standard. Accordingly, the Company did not reassess the conclusion of whether the existing arrangements contain a lease, lease classification and initial direct costs under ASC 842. In June 2020, the FASB also issued ASU 2020-05, Revenue from contracts with customers (Topic 606) and Leases (Topic 842): effective dates for certain entities, which deferred the effective date certain entities were required to adopt ASC 842. The update extended the effective date for adoption of ASC 842 until fiscal years beginning after December 15, 2021. As an emerging growth company we were not required to adopt ASC 842 until January 1, 2022. The Company adopted the standard on January 1, 2022 using the effective date method. As such, the consolidated balance sheets and statements of operations for prior periods will not be comparable in the year of adoption of ASC 842. As a result of the adoption of ASC 842, the Company recorded a lease right of use asset of $ 1.3 million and a lease liability of $ 2.4 million on the consolidated balance sheets as of January 1, 2022 related to an operating lease. The Company derecognized deferred rent liabilities, which makes up the difference between the lease right of use asset and lease liability. The adoption of the standard did not have a material impact on the Company’s consolidated statement of operations or consolidated statement of cash flows. In August 2020, the FASB issued ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity's Own Equity (Subtopic 815-40). The guidance simplifies the complexity associated with applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. This ASU (1) simplifies the accounting for convertible debt instruments and convertible preferred stock by removing guidance in ASC 470-20, Debt: Debt with Conversion and Other Options, that requires entities to account for beneficial conversion features and cash conversion features in equity, separately from the host convertible debt or preferred stock; (2) revises the scope exception from derivative accounting in ASC 815-40 for freestanding financial instruments and embedded features that are both indexed to the issuers own stock and classified in stockholders' equity, by removing certain criteria required for equity classification; and (3) revises the guidance in ASC 260, Earnings Per Share, to require entities to calculate diluted earnings per share for convertible instruments by using the if-converted method. As an emerging growth company, we are not required to adopt ASU 2020-06 until January 1, 2024, however early adoption is permitted. The Company elected to early adopt the standard on January 1, 2022 and upon adoption, there was no impact to our consolidated statement of operations and cash flows and our basic and diluted net loss per share amounts. In November 2021, the FASB issued ASU 2021-10, which created Topic 832, Government Assistance, which requires business entities to disclose information about certain government assistance they receive. The ASU requires qualitative and quantitative disclosures around the nature of transactions and related accounting policy used, the line items on the balance sheet and income statement that are affected, and the significant terms and conditions of the transactions. The ASU is effective for fiscal years beginning after December 15, 2021 . The Company believes its historical disclosure already met the requirements of the new standard. As such, no changes or additional disclosure was determined to be necessary . |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Property and Equipment Estimated Useful Lives | Property and equipment are recorded at cost, and depreciated using the straight-line method over the estimated useful lives of the respective assets: ASSET ESTIMATED USEFUL LIFE Networking and computer equipment 5 years Laboratory equipment 5 years Manufacturing equipment 5 years Furniture and fixtures 5 years Leasehold improvements Shorter of the useful life or remaining lease term |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Information About Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands): FAIR VALUE MEASUREMENTS AS OF LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Liabilities: Warrant liability — — 1,882 1,882 Total $ — $ — $ 1,882 $ 1,882 FAIR VALUE MEASUREMENTS AS OF LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Liabilities: Warrant liability — — 18,252 18,252 Total $ — $ — $ 18,252 $ 18,252 |
Schedule of Aggregate Fair Values of Warrant Liabilities, for Which Fair Value Determined by Level 3 Inputs | The following table provides a roll forward of the aggregate fair values of the Company’s warrant liability, for which fair value is determined by Level 3 inputs (in thousands): SERIES B Balance at December 31, 2020 $ 6,831 Change in fair value 11,421 Balance at December 31, 2021 $ 18,252 Change in fair value ( 16,370 ) Balance at December 31, 2022 $ 1,882 |
Fixed Assets, Net (Tables)
Fixed Assets, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Summary of Fixed Assets, Net | Fixed assets, net consisted of the following (in thousands): DECEMBER 31, 2022 2021 Laboratory equipment $ 1,055 $ 77 Manufacturing equipment 1,201 933 Furniture and fixtures 159 112 Networking and computer equipment 81 72 Leasehold improvements 3,057 2,994 Total fixed assets $ 5,553 $ 4,188 Less accumulated depreciation ( 1,129 ) ( 352 ) Fixed assets, net $ 4,424 $ 3,836 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following (in thousands): DECEMBER 31, 2022 2021 Payroll and employee related expenses $ 2,647 $ 2,096 Third-party research and development expenses 1,486 632 Professional fees and other 590 710 $ 4,723 $ 3,438 |
Term Loan (Tables)
Term Loan (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Principal Payments and Net Carrying Amount of Term Loan | The scheduled principal payments and net carrying amount of the term loan are as follows (in thousands): YEAR ENDING DECEMBER 31, 2023 $ — 2024 8,870 2025 10,232 2026 898 Total principal 20,000 Final payment fee 900 Less: debt discount ( 989 ) Accretion of debt discount 291 Net carrying amount $ 20,202 |
Lease (Tables)
Lease (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Schedule of Other Information | Other Information DECEMBER 31, Operating cash flows used for operating leases (in thousands) $ 567 Weighted-average remaining lease term (years) 3.7 Weighted-average incremental borrowing rate 7.02 % |
Summary of Future Lease Payments Under Non-cancelable Leases | The future lease payments under non-cancelable leases at December 31, 2022, are as follows (in thousands): 2023 $ 583 2024 598 2025 613 2026 415 Total future lease payments 2,209 Less: imputed interest ( 259 ) Total lease liability $ 1,950 The following table summarizes the future minimum lease payments due under the Company's facility lease as of December 31, 2021, presented in accordance with ASC 840, the relevant accounting standard at that time (in thousands): 2022 $ 567 2023 583 2024 598 2025 613 Thereafter 415 Total minimum lease payments $ 2,776 |
Common Stock and Preferred St_2
Common Stock and Preferred Stock (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Schedule of Common Stock Reserved For Future Issuance | Common Stock Reserved The Company has reserved the following shares of common stock for future issuance as of: DECEMBER 31, 2022 2021 Stock options outstanding 5,645,420 4,783,333 Unvested restricted stock 612,366 — Shares available for future grant under stock option plan 1,311,915 1,878,997 Warrants 7,507,708 7,507,708 15,077,409 14,170,038 |
Capital Stock (Tables)
Capital Stock (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Capital Stock [Abstract] | |
Schedule of Common Stock Reserved For Future Issuance | Common Stock Reserved The Company has reserved the following shares of common stock for future issuance as of: DECEMBER 31, 2022 2021 Stock options outstanding 5,645,420 4,783,333 Unvested restricted stock 612,366 — Shares available for future grant under stock option plan 1,311,915 1,878,997 Warrants 7,507,708 7,507,708 15,077,409 14,170,038 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Warrants and Rights Note Disclosure [Abstract] | |
Summary of Warrants Outstanding for Purchase of Common Stock | The Company has the following warrants outstanding for the purchase of common stock as of December 31, 2022 and 2021: WARRANTS SHARES OF EXERCISE EXPIRATION DATES Series B Warrants 3,672,484 $ 6.81 November 2025 Conditional Series B Warrants 3,672,484 $ 6.81 November 2025 NC Ohio Trust 162,740 $ 1.46 March 2029 |
Stock Options, Restricted Sto_2
Stock Options, Restricted Stock and Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Option Activity | Stock option activity is summarized as follows: NUMBER OF WEIGHTED- WEIGHTED- AGGREGATE Outstanding as of December 31, 2021 4,783,333 $ 2.34 Granted 1,873,340 3.92 Exercised ( 352,576 ) 1.47 Cancelled or forfeited ( 658,677 ) 3.48 Outstanding as of December 31, 2022 5,645,420 $ 2.77 7.73 $ 881 Exercisable as of December 31, 2022 2,876,293 $ 2.30 6.86 $ 606 Unvested as of December 31, 2022 2,769,127 $ 3.27 8.63 $ 275 |
Schedule of Fair Value of Stock Options Granted Was Estimated on Black-Scholes Options | The fair value of stock options granted was estimated on the grant date using the Black-Scholes option pricing model based on the following weighted-average assumptions: YEAR ENDED DECEMBER 31, 2022 2021 Expected option life (years) 5.33 - 6.08 5.00 - 10.00 Risk-free interest rate 1.69 % - 4.23 % 0.89 % - 1.35 % Expected volatility 85.09 % - 87.67 % 83.80 % - 89.02 % Expected dividend yield 0 % 0 % Exercise price $ 1.75 - $ 5.19 $ 4.97 - $ 11.23 Fair value of common stock $ 1.75 - $ 5.19 $ 4.97 - $ 11.23 |
Summary of Restricted Stock Activity | Restricted stock activity is summarized as follows: NUMBER OF WEIGHTED- Unvested at December 31, 2021 — $ — Granted 612,366 $ 1.71 Vested — $ — Forfeited — $ — Unvested at December 31, 2022 612,366 $ 1.71 |
Schedule of Stock-based Compensation Expense | Stock-based compensation expense for the years ended December 31, 2022 and 2021 was classified in the consolidated statements of operations as follows (in thousands): YEAR ENDED DECEMBER 31, 2022 2021 Research and development $ 774 $ 1,226 General and administrative 1,533 1,737 Total stock based compensation expense $ 2,307 $ 2,963 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Reconciliation of Income Tax Expense | A reconciliation of income tax expense at the federal statutory income tax rate to the income tax expense at the Company’s effective income tax rate is as follows: YEAR ENDED 2022 2021 Income at US statutory rate 21.00 % 21.00 % Permanent adjustments ( 2.84 )% ( 0.59 )% Mark to market 18.29 % ( 6.64 )% State taxes, net of federal benefit 12.78 % 4.01 % Valuation allowance ( 56.79 )% ( 19.86 )% Tax credits 7.56 % 2.08 % — — |
Schedule of Net Deferred Tax Assets | Net deferred tax assets as of December 31, 2022 and 2021 consist of the following (in thousands): YEAR ENDED 2022 2021 Deferred tax assets: Net operating losses $ 17,748 $ 13,892 Intangibles 572 654 Accrued expenses and other 601 243 Deferred revenue — 34 Lease liability 524 — Stock Compensation 863 820 Capitalized R&D expenditures 4,931 — Credits 4,755 2,850 Total deferred tax assets 29,994 18,493 Valuation allowance ( 29,166 ) ( 18,493 ) Deferred tax assets 828 — Deferred tax liabilities: Right of use asset ( 284 ) — Other ( 544 ) — Total deferred tax liabilities ( 828 ) — Net deferred tax assets (liabilities) $ — $ — |
Summary of Changes in Valuation Allowance for Deferred Tax Assets | A summary of changes in the valuation allowance for deferred tax assets during the year ended December 31, 2022 and 2021 were as follows (in thousands): YEAR ENDED 2022 2021 Valuation allowance $ 18,493 $ 11,318 Increases recorded to income tax provision 10,673 7,175 Decreases recorded to income tax provision — — Valuation allowance $ 29,166 $ 18,493 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Future Minimum Lease Payments | The future lease payments under non-cancelable leases at December 31, 2022, are as follows (in thousands): 2023 $ 583 2024 598 2025 613 2026 415 Total future lease payments 2,209 Less: imputed interest ( 259 ) Total lease liability $ 1,950 The following table summarizes the future minimum lease payments due under the Company's facility lease as of December 31, 2021, presented in accordance with ASC 840, the relevant accounting standard at that time (in thousands): 2022 $ 567 2023 583 2024 598 2025 613 Thereafter 415 Total minimum lease payments $ 2,776 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Net Loss Per Share Attributable to Common Stockholders | Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share data): YEAR ENDED DECEMBER 31, 2022 2021 Numerator: Net loss $ ( 18,794 ) $ ( 36,124 ) Denominator: Weighted-average shares of common stock outstanding-basic and diluted 28,823,480 18,873,048 Net loss per share -basic and diluted $ ( 0.65 ) $ ( 1.91 ) |
Schedule of Potential Shares of Common Stock Excluded from Computation of Diluted Net Loss Per Share | The Company excluded the following potential shares of common stock from the computation of diluted net loss per share because including them would have had an anti-dilutive effect. YEAR ENDED DECEMBER 31, 2022 2021 Outstanding warrants for common stock 7,507,708 7,507,708 Outstanding stock options (as converted to common stock) 5,645,420 4,783,333 Unvested restricted stock 612,366 — 13,765,494 12,291,041 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Details) | 12 Months Ended | ||||
Aug. 05, 2022 USD ($) | Jul. 29, 2021 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) Candidate $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Aug. 13, 2021 $ / shares shares | |
Organization And Basis Of Presentation [Line Items] | |||||
Number of product candidates | Candidate | 2 | ||||
Net loss | $ (18,794,000) | $ (36,124,000) | |||
Accumulated deficit | $ (99,089,000) | $ (80,295,000) | |||
Common stock, shares, issued | shares | 29,042,418 | 28,689,842 | |||
Common stock par value | $ / shares | $ 0.01 | $ 0.01 | |||
Sale of stock under Shelf | $ 71,335,000 | ||||
IPO | |||||
Organization And Basis Of Presentation [Line Items] | |||||
Common stock, shares, issued | shares | 9,000,000 | ||||
Common stock par value | $ / shares | $ 8 | ||||
Net proceeds | $ 71,300,000 | ||||
Convertible preferred stock converted into common stock | shares | 7,066,398 | ||||
Underwriters’ Overallotment Option | |||||
Organization And Basis Of Presentation [Line Items] | |||||
Common stock, shares, issued | shares | 887,994 | ||||
Common stock par value | $ / shares | $ 8 | ||||
Combination of Common Stock, Preferred Stock, Debt Securities, Warrants and/or Units | Maximum | |||||
Organization And Basis Of Presentation [Line Items] | |||||
Sale of stock under Shelf | $ 200,000,000 | ||||
ATM Program | Maximum | |||||
Organization And Basis Of Presentation [Line Items] | |||||
Sale of stock under Shelf | $ 75,000,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2021 USD ($) | Dec. 31, 2022 USD ($) Segment | Dec. 31, 2021 USD ($) | Jan. 01, 2022 USD ($) | |
Significant Accounting Policies [Line Items] | ||||
Number of operating segment | Segment | 1 | |||
Cash and cash equivalent maturity period | 90 days | |||
Restricted cash | $ 400,000 | $ 300,000 | $ 400,000 | |
Long-lived assets, impairment charge | $ 600,000 | |||
Impairment, Long-Lived Asset, Held-for-Use, Statement of Income or Comprehensive Income [Extensible Enumeration] | Impairment on Manufacturing Equipment | |||
Expected dividend assumed | 0 | |||
Grant revenue | $ 48,000 | 1,076,000 | ||
Percentage income taxes benefits upon ultimate settlement | 50% | |||
Lease right of use assets | $ 1,056,000 | |||
Lease liability | $ 1,950,000 | |||
ASU 2020-05 | ||||
Significant Accounting Policies [Line Items] | ||||
Change in Accounting Principle, Accounting Standards Update, Adopted [true false] | true | |||
Change in Accounting Principle, Accounting Standards Update, Adoption Date | Jan. 01, 2022 | |||
ASU 2016-02 (Topic 842) | ||||
Significant Accounting Policies [Line Items] | ||||
Lease right of use assets | $ 1,300,000 | |||
Lease liability | $ 2,400,000 | |||
Change in Accounting Principle, Accounting Standards Update, Adopted [true false] | true | |||
Change in Accounting Principle, Accounting Standards Update, Adoption Date | Jan. 01, 2022 | |||
ASU 2021-10 | ||||
Significant Accounting Policies [Line Items] | ||||
Change in Accounting Principle, Accounting Standards Update, Adopted [true false] | true | |||
Change in Accounting Principle, Accounting Standards Update, Adoption Date | Jan. 01, 2022 | |||
ASU 2020-06 | ||||
Significant Accounting Policies [Line Items] | ||||
Change in Accounting Principle, Accounting Standards Update, Adopted [true false] | true | |||
Change in Accounting Principle, Accounting Standards Update, Adoption Date | Jan. 01, 2022 | |||
Change in Accounting Principle, Accounting Standards Update, Early Adoption [true false] | true | |||
Change in Accounting Principle, Accounting Standards Update, Immaterial Effect [true false] | true | |||
Govenment | ||||
Significant Accounting Policies [Line Items] | ||||
Grant revenue | $ 48,000 | $ 1,100,000 | ||
Maximum | ||||
Significant Accounting Policies [Line Items] | ||||
Marketable debt securities maturities duration | 90 days |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Property and Equipment Estimated Useful Lives (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Networking and Computer Equipment | |
Significant Accounting Policies [Line Items] | |
Estimated Useful Life | 5 years |
Laboratory Equipment | |
Significant Accounting Policies [Line Items] | |
Estimated Useful Life | 5 years |
Manufacturing Equipment | |
Significant Accounting Policies [Line Items] | |
Estimated Useful Life | 5 years |
Furniture and Fixtures | |
Significant Accounting Policies [Line Items] | |
Estimated Useful Life | 5 years |
Leasehold Improvements | |
Significant Accounting Policies [Line Items] | |
Estimated Useful Life | Shorter of the useful life or remaining lease term |
Fair Value of Financial Asset_3
Fair Value of Financial Assets and Liabilities - Schedule of Information About Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value, Recurring - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Liabilities: | ||
Warrant liability | $ 1,882 | $ 18,252 |
Total | 1,882 | 18,252 |
Level 3 | ||
Liabilities: | ||
Warrant liability | 1,882 | 18,252 |
Total | $ 1,882 | $ 18,252 |
Fair Value of Financial Asset_4
Fair Value of Financial Assets and Liabilities - Schedule of Aggregate Fair Values of Warrant Liabilities, for Which Fair Value Determined by Level 3 Inputs (Details) - Series B Warrant Liability - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Balance | $ 18,252 | $ 6,831 |
Change in fair value | (16,370) | 11,421 |
Balance | $ 1,882 | $ 18,252 |
Fixed Assets, Net - Summary of
Fixed Assets, Net - Summary of Fixed Assets, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property Plant And Equipment [Line Items] | ||
Total fixed assets | $ 5,553 | $ 4,188 |
Less accumulated depreciation | (1,129) | (352) |
Fixed assets, net | 4,424 | 3,836 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Total fixed assets | 1,055 | 77 |
Manufacturing Equipment | ||
Property Plant And Equipment [Line Items] | ||
Total fixed assets | 1,201 | 933 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Total fixed assets | 159 | 112 |
Networking and Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Total fixed assets | 81 | 72 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Total fixed assets | $ 3,057 | $ 2,994 |
Fixed Assets, Net - Additional
Fixed Assets, Net - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation and amortization expense | $ 0.8 | $ 0.2 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Payroll and employee related expenses | $ 2,647 | $ 2,096 |
Third-party research and development expenses | 1,486 | 632 |
Professional fees and other | 590 | 710 |
Accrued expenses | $ 4,723 | $ 3,438 |
Term Loan - Additional Informat
Term Loan - Additional Information (Details) | 12 Months Ended | ||
Dec. 30, 2022 USD ($) | Feb. 24, 2022 USD ($) Installment | Dec. 31, 2022 USD ($) | |
Debt Instrument [Line Items] | |||
Loan, maximum borrowing capacity | $ 5,000,000 | ||
Cash proceeds amount equal to at least from the issuance and sale of equity securities | $ 75,000,000 | ||
Term Loan | |||
Debt Instrument [Line Items] | |||
Long-term debt | $ 20,000,000 | ||
Final payment fee | 900,000 | ||
Loan Agreement | |||
Debt Instrument [Line Items] | |||
Loan agreement date | Feb. 24, 2022 | ||
Loan, maximum borrowing capacity | $ 25,000,000 | ||
Long-term debt | $ 20,000,000 | ||
Loan agreement period | 4 years | ||
Number of consecutive | Installment | 24 | ||
Interest expense | $ 1,600,000 | ||
Weighted average effective interest rate | 9.54% | ||
Debt issuance costs | $ 89,000 | ||
Final payment fee | $ 900,000 | ||
Loan Agreement | Term Loan | |||
Debt Instrument [Line Items] | |||
Debt instrument, payment | monthly | ||
Debt instrument, commencing date | Feb. 01, 2024 | ||
Debt instrument, maturity date | Jan. 01, 2026 | ||
Debt instrument final payment fee percentage | 4.50% | ||
Loan Agreement | Minimum | |||
Debt Instrument [Line Items] | |||
Debt instrument subject to prepayment premium percentage | 1% | ||
Loan Agreement | Minimum | Prime Rate | Term Loan | |||
Debt Instrument [Line Items] | |||
Interest rate | 2.50% | ||
Loan Agreement | Maximum | |||
Debt Instrument [Line Items] | |||
Debt instrument subject to prepayment premium percentage | 3% | ||
Loan Agreement | Maximum | Term Loan | |||
Debt Instrument [Line Items] | |||
Interest rate | 5.75% |
Term Loan - Schedule of Princip
Term Loan - Schedule of Principal Payments and Net Carrying Amount of Term Loan (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Debt Instrument [Line Items] | |
Net carrying amount | $ 20,202 |
Term Loan | |
Debt Instrument [Line Items] | |
2024 | 8,870 |
2025 | 10,232 |
2026 | 898 |
Total principal | 20,000 |
Final payment fee | 900 |
Less: debt discount | (989) |
Accretion of debt discount | 291 |
Net carrying amount | $ 20,202 |
Other Long-Term Debt - Addition
Other Long-Term Debt - Additional Information (Details) - Periphagen, Inc. - USD ($) $ in Millions | Dec. 09, 2019 | Dec. 31, 2022 |
Debt Instrument [Line Items] | ||
Asset acquisition, assumption of promissory note | $ 1 | |
Promissory note contractual interest rate | 2% | |
Accrued interest due upon maturity period | 2027-11 | |
Estimated market rate for unsecured loan | 15.83% | |
Business acquisition present value of future cash outflow | $ 0.4 | |
Business acquisition carrying value of note | $ 0.6 |
Lease - Additional Information
Lease - Additional Information (Details) | 12 Months Ended | ||
Feb. 04, 2019 USD ($) Squrefoot | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Lessee, Lease, Description [Line Items] | |||
Operating lease cost | $ 400,000 | ||
Variable lease cost | 100,000 | ||
Total lease expense | 500,000 | ||
Cash paid for amounts included in measurement of lease liability | $ 567,000 | ||
Rent expense | $ 500 | ||
Corporate, Clinical and Manufacturing Operations | Massachusetts | |||
Lessee, Lease, Description [Line Items] | |||
Area of lease property | Squrefoot | 15,197 | ||
Lease expiration date | Aug. 31, 2026 | ||
Lessee operating lease reimbursement of tenant improvement received | $ 800,000 | ||
Lease incentive | $ 800,000 |
Lease - Schedule of Other Infor
Lease - Schedule of Other Information (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Leases [Abstract] | |
Operating cash flows used for operating leases | $ 567 |
Weighted-average remaining lease term (years) | 3 years 8 months 12 days |
Weighted-average incremental borrowing rate | 7.02% |
Lease - Summary of Future Lease
Lease - Summary of Future Lease Payments Under Non-cancellable Leases (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
2023 | $ 583 | $ 567 |
2024 | 598 | 583 |
2025 | 613 | 598 |
2026 | 415 | 613 |
Total future lease payments | 2,209 | $ 2,776 |
Less: imputed interest | (259) | |
Operating lease liability | $ 1,950 |
Lease - Summary of Future Minim
Lease - Summary of Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
2022 | $ 583 | $ 567 |
2023 | 598 | 583 |
2024 | 613 | 598 |
2025 | 415 | 613 |
Thereafter | 415 | |
Total future lease payments | $ 2,209 | $ 2,776 |
Common Stock and Preferred St_3
Common Stock and Preferred Stock - Additional Information (Details) - USD ($) | 12 Months Ended | |||||
Aug. 05, 2022 | Jul. 29, 2021 | Jul. 14, 2021 | Dec. 31, 2021 | Dec. 31, 2022 | Aug. 13, 2021 | |
Class of Stock [Line Items] | ||||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | ||||
Preferred stock par value | $ 0.01 | $ 0.01 | ||||
Common stock, shares authorized | 150,000,000 | 150,000,000 | ||||
Common stock, par value | $ 0.01 | $ 0.01 | ||||
Common stock, shares, issued | 28,689,842 | 29,042,418 | ||||
Common stock, shares, outstanding | 28,689,842 | 28,919,810 | ||||
Reverse stock split | one-for-2.4579 | |||||
Sale of stock under Shelf | $ 71,335,000 | |||||
IPO including Underwriters' Option | ||||||
Class of Stock [Line Items] | ||||||
Common stock, shares, issued | 9,877,994 | |||||
Net proceeds after deducting underwriting discounts and commissions and offering expenses | $ 71,300,000 | |||||
IPO | ||||||
Class of Stock [Line Items] | ||||||
Common stock, par value | $ 8 | |||||
Common stock, shares, issued | 9,000,000 | |||||
Net proceeds after deducting underwriting discounts and commissions and offering expenses | $ 71,300,000 | |||||
Convertible preferred stock converted into common stock | 7,066,398 | |||||
Underwriters’ Overallotment Option | ||||||
Class of Stock [Line Items] | ||||||
Common stock, par value | $ 8 | |||||
Common stock, shares, issued | 887,994 | |||||
Combination of Common Stock, Preferred Stock, Debt Securities, Warrants and/or Units | Maximum | ||||||
Class of Stock [Line Items] | ||||||
Sale of stock under Shelf | $ 200,000,000 | |||||
ATM Program | Maximum | ||||||
Class of Stock [Line Items] | ||||||
Sale of stock under Shelf | $ 75,000,000 |
Common Stock and Preferred St_4
Common Stock and Preferred Stock - Schedule of Common Stock Reserved For Future Issuance (Details) - shares | Dec. 31, 2022 | Dec. 31, 2021 |
Class of Stock [Line Items] | ||
Common stock reserved for future issuance | 15,077,409 | 14,170,038 |
Stock Options Outstanding | ||
Class of Stock [Line Items] | ||
Common stock reserved for future issuance | 5,645,420 | 4,783,333 |
Shares Available for Future Grant Under Stock Option Plan | ||
Class of Stock [Line Items] | ||
Common stock reserved for future issuance | 1,311,915 | 1,878,997 |
Unvested Restricted Stock | ||
Class of Stock [Line Items] | ||
Common stock reserved for future issuance | 612,366 | |
Warrants | ||
Class of Stock [Line Items] | ||
Common stock reserved for future issuance | 7,507,708 | 7,507,708 |
Warrants - Summary of Warrants
Warrants - Summary of Warrants Outstanding for Purchase of Common Stock (Details) - $ / shares | 12 Months Ended | ||||
Jun. 24, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Mar. 20, 2019 | Nov. 13, 2018 | |
Series B Warrants | |||||
Class Of Warrant Or Right [Line Items] | |||||
SHARES OF COMMON STOCK SUBJECT TO WARRANTS | 3,672,484 | 3,672,484 | |||
Exercise price per share | $ 6.81 | $ 6.81 | $ 6.81 | ||
EXPIRATION DATES | 2023-11 | 2025-11 | 2025-11 | ||
Conditional Series B Warrants | |||||
Class Of Warrant Or Right [Line Items] | |||||
SHARES OF COMMON STOCK SUBJECT TO WARRANTS | 3,672,484 | 3,672,484 | |||
Exercise price per share | $ 6.81 | $ 6.81 | |||
EXPIRATION DATES | 2025-11 | 2025-11 | |||
NC Ohio Trust | |||||
Class Of Warrant Or Right [Line Items] | |||||
SHARES OF COMMON STOCK SUBJECT TO WARRANTS | 162,740 | 162,740 | 162,740 | ||
Exercise price per share | $ 1.46 | $ 1.46 | $ 1.46 | ||
EXPIRATION DATES | 2029-03 | 2029-03 |
Warrants - Additional Informati
Warrants - Additional Information (Details) $ / shares in Units, $ in Thousands | 12 Months Ended | ||||||
Jun. 24, 2021 | Mar. 20, 2019 $ / shares shares | Dec. 31, 2022 USD ($) TradingDays $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Dec. 31, 2018 $ / shares shares | Jul. 29, 2021 $ / shares | Nov. 13, 2018 $ / shares shares | |
Class Of Warrant Or Right [Line Items] | |||||||
Fair value of warrant liability | $ | $ 1,882 | $ 18,252 | |||||
Common stock, par value | $ 0.01 | $ 0.01 | |||||
IPO | |||||||
Class Of Warrant Or Right [Line Items] | |||||||
Common stock, par value | $ 8 | ||||||
Tranche One | |||||||
Class Of Warrant Or Right [Line Items] | |||||||
Proceeds from stock offering | $ | $ 20,000,000 | ||||||
Class of warrant or right exercise price per share | $ 12.47 | ||||||
Class of warrant or right exercise average market price per share | $ 12.47 | ||||||
Number of consecutive days | TradingDays | 10 | ||||||
Class of warrants issued | shares | 918,121 | ||||||
Tranche Two | |||||||
Class Of Warrant Or Right [Line Items] | |||||||
Class of warrant or right exercise price per share | $ 13.20 | ||||||
Class of warrant or right exercise average market price per share | $ 13.20 | ||||||
Number of consecutive days | TradingDays | 10 | ||||||
Class of warrants issued | shares | 918,121 | ||||||
Tranche Three | |||||||
Class Of Warrant Or Right [Line Items] | |||||||
Class of warrant or right exercise price per share | $ 13.94 | ||||||
Class of warrant or right exercise average market price per share | $ 13.94 | ||||||
Number of consecutive days | TradingDays | 10 | ||||||
Class of warrants issued | shares | 918,121 | ||||||
Tranche Four | |||||||
Class Of Warrant Or Right [Line Items] | |||||||
Class of warrant or right exercise price per share | $ 14.68 | ||||||
Class of warrant or right exercise average market price per share | $ 14.68 | ||||||
Number of consecutive days | TradingDays | 10 | ||||||
Class of warrants issued | shares | 918,121 | ||||||
Series A Warrants | |||||||
Class Of Warrant Or Right [Line Items] | |||||||
Class of warrants issued per share | $ 5.67 | ||||||
Number of warrants outstanding | shares | 48,850 | ||||||
Expiration dates | 2021-08 | ||||||
Series A Warrants | IPO | |||||||
Class Of Warrant Or Right [Line Items] | |||||||
Class of warrants shares exercised | shares | 75,946 | ||||||
Series B Warrants | |||||||
Class Of Warrant Or Right [Line Items] | |||||||
Class of warrant or right issued | shares | 3,672,484 | ||||||
Class of warrant or right period | 5 years | ||||||
Class of warrants issued per share | $ 6.81 | $ 6.81 | $ 6.81 | ||||
Expiration dates | 2023-11 | 2025-11 | 2025-11 | ||||
Estimated fair value of warrants | $ | $ 2,100 | ||||||
Extended expiration dates | 2025-11 | ||||||
Class of warrants issued | shares | 3,672,484 | 3,672,484 | |||||
Series B Conditional Warrants | |||||||
Class Of Warrant Or Right [Line Items] | |||||||
Fair value of warrant liability | $ | $ 1,900 | $ 18,300 | |||||
Conditional Series B Warrants | |||||||
Class Of Warrant Or Right [Line Items] | |||||||
Class of warrants issued per share | $ 6.81 | $ 6.81 | |||||
Expiration dates | 2025-11 | 2025-11 | |||||
Class of warrants issued | shares | 3,672,484 | 3,672,484 | |||||
NC Ohio Trust | |||||||
Class Of Warrant Or Right [Line Items] | |||||||
Class of warrants issued per share | $ 1.46 | $ 1.46 | $ 1.46 | ||||
Expiration dates | 2029-03 | 2029-03 | |||||
Class of warrants issued | shares | 162,740 | 162,740 | 162,740 | ||||
Common stock, par value | $ 0.01 | ||||||
Warrant liability | $ | $ 200 | $ 1,100 | |||||
NC Ohio Trust | Minimum | |||||||
Class Of Warrant Or Right [Line Items] | |||||||
Past services provided by beneficiary | 15 years |
Stock Options, Restricted Sto_3
Stock Options, Restricted Stock and Stock-Based Compensation - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Jul. 14, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Common stock reserved for future issuance | 15,077,409 | 14,170,038 | |
Number of shares available for grant | 1,311,915 | ||
Stock options exercised | 352,576 | ||
Intrinsic value of stock options vested | $ 0 | $ 6,600,000 | |
Unrecognized compensation cost related to unvested stock options | $ 7,600,000 | $ 6,300,000 | |
Stock-based awards are expected to be recognized over a weighted average period | 2 years 5 months 1 day | 2 years 3 months 3 days | |
Restricted Stock Units | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Aggregate fair value of awards that vested | $ 0 | $ 0 | |
2015 Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Share-based compensation arrangement by share-based payment award, award vesting period | 4 years | ||
Share-based compensation arrangement by share-based payment award, expiration period | 10 years | ||
Number of shares available for grant | 0 | ||
Stock options exercised | 306,518 | ||
Exercise price per share | $ 1.46 | ||
Common stock held by option holder in consideration of aggregate exercise price | 122,608 | ||
2021 Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Common stock reserved for future issuance | 3,201,594 |
Stock Options, Restricted Sto_4
Stock Options, Restricted Stock and Stock-Based Compensation - Schedule of Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Share-Based Payment Arrangement [Abstract] | |
Number Of Stock Options, Shares Outstanding | shares | 4,783,333 |
Number Of Stock Options, Shares, Granted | shares | 1,873,340 |
Number Of Stock Options, Shares, Exercised | shares | (352,576) |
Number Of Stock Options, Shares, Cancelled or forfeited | shares | (658,677) |
Number Of Stock Options, Shares Outstanding | shares | 5,645,420 |
Exercisable as of December 31, 2022 | shares | 2,876,293 |
Unvested as of December 31, 2022 | shares | 2,769,127 |
Weighted-Average Exercise Price, Outstanding | $ / shares | $ 2.34 |
Weighted-Average Exercise Price, Granted | $ / shares | 3.92 |
Weighted-Average Exercise Price, Exercised | $ / shares | 1.47 |
Weighted-Average Exercise Price, Cancelled or forfeited | $ / shares | 3.48 |
Weighted-Average Exercise Price, Outstanding | $ / shares | 2.77 |
Exercisable as of December 31, 2022 | $ / shares | 2.30 |
Unvested as of December 31, 2022 | $ / shares | $ 3.27 |
Weighted- Average Remaining Contractual Term (In Years), Outstanding | 7 years 8 months 23 days |
Exercisable as of December 31, 2022 | 6 years 10 months 9 days |
Unvested as of December 31, 2022 | 8 years 7 months 17 days |
Aggregate Intrinsic Value, Outstanding | $ | $ 881 |
Exercisable as of December 31, 2022 | $ | 606 |
Unvested as of December 31, 2022 | $ | $ 275 |
Stock Options, Restricted Sto_5
Stock Options, Restricted Stock and Stock-Based Compensation - Schedule of Fair Value of Stock Options Granted Was Estimated on Black-Scholes Options (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected dividend yield | 0% | 0% |
Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected option life (years) | 5 years 3 months 29 days | 5 years |
Risk-free interest rate | 1.69% | 0.89% |
Expected volatility | 85.09% | 83.80% |
Exercise price | $ 1.75 | $ 4.97 |
Fair value of common stock | $ 1,750 | $ 4,970 |
Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected option life (years) | 6 years 29 days | 10 years |
Risk-free interest rate | 4.23% | 1.35% |
Expected volatility | 87.67% | 89.02% |
Exercise price | $ 5.19 | $ 11.23 |
Fair value of common stock | $ 5,190 | $ 11,230 |
Stock Options, Restricted Sto_6
Stock Options, Restricted Stock and Stock-Based Compensation - Summary of Restricted Stock Activity (Details) - Restricted Stock Units | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of Shares Options, Granted | shares | 612,366 |
Number of Shares Options, Unvested | shares | 612,366 |
Weighted-Average Grant Date Fair Value, Granted | $ / shares | $ 1.71 |
Weighted-Average Grant Date Fair Value, Unvested | $ / shares | $ 1.71 |
Stock Options, Restricted Sto_7
Stock Options, Restricted Stock and Stock-Based Compensation - Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock based compensation expense | $ 2,307 | $ 2,963 |
Research and Development | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock based compensation expense | 774 | 1,226 |
General and Administrative | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock based compensation expense | $ 1,533 | $ 1,737 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Income Tax Expense (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Income at US statutory rate | 21% | 21% |
Permanent adjustments | (2.84%) | (0.59%) |
Mark to market | 18.29% | (6.64%) |
State taxes, net of federal benefit | 12.78% | 4.01% |
Valuation allowance | (56.79%) | (19.86%) |
Tax credits | 7.56% | 2.08% |
Effective income tax rate | 0% | 0% |
Income Taxes - Schedule of Net
Income Taxes - Schedule of Net Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||||
Net operating losses | $ 17,748 | $ 13,892 | ||
Intangibles | 572 | 654 | ||
Accrued expenses & other | 601 | 243 | ||
Deferred revenue | 34 | |||
Lease liability | 524 | |||
Stock Compensation | 863 | 820 | ||
Capitalized R&D expenditures | 4,931 | |||
Credits | 4,755 | 2,850 | ||
Total deferred tax assets | 29,994 | 18,493 | ||
Valuation allowance | (29,166) | $ (29,166) | (18,493) | $ (11,318) |
Deferred tax assets | 828 | |||
Deferred tax liabilities: | ||||
Right of use asset | (284) | |||
Other | (544) | |||
Total deferred tax liabilities | (828) | |||
Net deferred tax assets (liabilities) | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes [Line Items] | ||
Income tax expense (benefit) | $ 0 | $ 0 |
Income tax examination, description | The federal and state tax returns are generally subject to examination for the years ended December 31, 2014 through December 31, 2022. There are currently no pending tax examinations | |
Federal | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards | $ 65,900,000 | |
Operating loss carryforwards indefinite | $ 57,100,000 | |
Operating loss carryforwards, begin to expire year | 2027 | |
Tax credit carryforward | $ 3,400,000 | |
Tax credit carryforward, begin to expire year | 2036 | |
State | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards | $ 61,900,000 | |
Operating loss carryforwards, begin to expire year | 2032 | |
Tax credit carryforward | $ 1,800,000 | |
Tax credit carryforward, begin to expire year | 2028 |
Income Taxes - Summary of Chang
Income Taxes - Summary of Changes in Valuation Allowance for Deferred Tax Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Valuation allowance | $ 18,493 | $ 11,318 |
Increases recorded to income tax provision | 10,673 | 7,175 |
Decreases recorded to income tax provision | 0 | 0 |
Valuation allowance | $ 29,166 | $ 18,493 |
Exclusive Licensing Agreement_2
Exclusive Licensing Agreement with a Related Party - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Mar. 31, 2014 | Dec. 31, 2022 | Dec. 31, 2021 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Research and development service revenue, related party | $ 125 | $ 125 | |
Exclusive Licensing Agreement | Ventagen | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Payment from related party | $ 1,000 | ||
Due from related parties | 2,500 | ||
Future payment made upon the achievement of sales | 5,000 | ||
Related party costs | $ 4,000 | ||
Commercial purposes at a price of cost plus percentage | 25% | ||
Licensing agreement clinical trial period | 8 years | ||
Potential future milestone payment | 2,500 | ||
Additional variable consideration amount payable to customer | $ 0 | ||
Exclusive Licensing Agreement | Ventagen | Voting Stock | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Related party transactions, ownership percentage | 49.50% | ||
Exclusive Licensing Agreement | Ventagen | ASC 606 | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Upfront license fee | $ 1,000 | ||
Exclusive Licensing Agreement | Ventagen | Founders | Voting Stock | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Related party transactions, ownership percentage | 47% |
Exclusive Licensing Agreement_3
Exclusive Licensing Agreement with a Related Party - Additional Information (Details 1) - Exclusive Licensing Agreement - Ventagen - Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2014-04-01 $ in Millions | Mar. 31, 2014 USD ($) |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Revenue, remaining performance obligation, amount | $ 1 |
Revenue, remaining performance obligation, expected timing of satisfaction, period | 8 years |
Technology License Agreement -
Technology License Agreement - Additional Information (Details) - BWH License - USD ($) | 12 Months Ended | |||
Sep. 15, 2020 | Jan. 20, 2018 | Dec. 31, 2022 | Dec. 31, 2021 | |
Technology License Agreement [Line Items] | ||||
Committed amount to remitting in support of clinical trial | $ 800,000 | |||
Committed period to remitting in support of clinical trial | 3 years | |||
Non-refundable fee | $ 40,000 | |||
Expense for startup and patient fees for clinical trials | $ 0 | $ 28,000 | ||
Payment for license fee | $ 100,000 | |||
Payment at the time of entering into license | 100,000 | |||
Payment for annual license fee | 50,000 | |||
Maximum amount upon achievement of various clinical, commercial and sales milestones | $ 39,000,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Commitments And Contingencies Disclosure [Line Items] | |
Office space noncancelable operating lease expiration date | 2026 |
Loss related to indemnification obligations | $ 0 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Basic and Diluted Net Loss Per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Numerator: | ||
Net loss | $ (18,794) | $ (36,124) |
Denominator: | ||
Weighted-average shares of common stock outstanding - basic | 28,823,480 | 18,873,048 |
Weighted-average shares of common stock outstanding - diluted | 28,823,480 | 18,873,048 |
Net loss per share - basic | $ (0.65) | $ (1.91) |
Net loss per share - diluted | $ (0.65) | $ (1.91) |
Net Loss Per Share - Schedule_2
Net Loss Per Share - Schedule of Potential Shares of Common Stock Excluded from Computation of Diluted Net Loss Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 13,765,494 | 12,291,041 |
Outstanding Warrants For Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 7,507,708 | 7,507,708 |
Outstanding Stock Options (As Converted To Common Stock) | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 5,645,420 | 4,783,333 |
Unvested Restricted Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 612,366 |