Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 06, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
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 Interactive Data Current | Yes | |
Entity Current Reporting Status | Yes | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Small Business | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 29,744,731 | |
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 $0.01 per share | |
Trading Symbol | CADL | |
Security Exchange Name | NASDAQ | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 25,713 | $ 35,413 |
Prepaid expenses and other current assets | 1,423 | 1,384 |
Total current assets | 27,136 | 36,797 |
Fixed assets, net | 2,962 | 3,206 |
Lease right of use assets | 751 | 816 |
Restricted cash | 266 | 266 |
Other assets | 102 | 116 |
Total assets | 31,217 | 41,201 |
Current liabilities: | ||
Accounts payable | 472 | 422 |
Accrued expenses | 2,772 | 4,356 |
Current portion of term loan payable to a bank | 9,767 | 8,893 |
Current portion of lease liability | 526 | 513 |
Total current liabilities | 13,537 | 14,184 |
Term loan payable to a bank | 9,174 | 11,632 |
Other long-term debt | 781 | 751 |
Lease liability, net of current portion | 837 | 973 |
Warrant liability | 909 | 916 |
Total liabilities | 25,238 | 28,456 |
Commitments and contingencies (Note 14) | ||
Stockholders' equity | ||
Preferred stock, $0.01 par value; 10,000,000 shares authorized at March 31, 2024 and December 31, 2023; no shares issued or outstanding at March 31, 2024 and December 31, 2023, respectively. | ||
Common stock, $0.01 par value; 150,000,000 shares authorized at March 31, 2024 and December 31, 2023; 29,470,076 and 29,213,627 shares issued at March 31, 2024 and December 31, 2023, respectively; 29,347,468 and 29,091,019 shares outstanding at March 31, 2024 and December 31, 2023, respectively.. | 292 | 290 |
Treasury stock (at cost) | (448) | (448) |
Additional paid-in capital | 151,384 | 149,931 |
Accumulated deficit | (145,249) | (137,028) |
Total stockholders' equity | 5,979 | 12,745 |
Total liabilities and stockholders' equity | $ 31,217 | $ 41,201 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) (Unaudited) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 | Sep. 30, 2023 | Dec. 31, 2022 |
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 | 29,470,076 | 29,213,627 | ||
Common stock, shares, outstanding | 29,347,468 | 29,091,019 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating expenses: | ||
Research and development | $ 4,102 | $ 5,469 |
General and administrative | 3,800 | 4,164 |
Total operating expenses | 7,902 | 9,633 |
Loss from operations | (7,902) | (9,633) |
Other income (expense): | ||
Grant income | 12 | |
Interest income | 320 | 711 |
Interest expense | (646) | (609) |
Change in fair value of warrant liability | 7 | 724 |
Total other income (expense), net | (319) | 838 |
Net loss and comprehensive loss | $ (8,221) | $ (8,795) |
Net loss per share - basic | $ (0.28) | $ (0.3) |
Net loss per share - diluted | $ (0.28) | $ (0.3) |
Weighted-average common shares outstanding, basic | 29,197,537 | 28,919,810 |
Weighted-average common shares outstanding, diluted | 29,197,537 | 28,919,810 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | At The Market Offerings | Common Stock | Common Stock At The Market Offerings | Treasury Stock Member | Additional Paid In Capital | Additional Paid In Capital At The Market Offerings | Accumulated Deficit |
Beginning Balance at Dec. 31, 2022 | $ 47,714 | $ 290 | $ (448) | $ 146,961 | $ (99,089) | |||
Beginning Balance, Shares at Dec. 31, 2022 | 29,042,418 | (122,608) | ||||||
Stock-based compensation | 798 | 798 | ||||||
Change in fair value of NC Ohio Trust Warrants | (65) | (65) | ||||||
Net Income (Loss) | (8,795) | (8,795) | ||||||
Ending Balance at Mar. 31, 2023 | 39,652 | $ 290 | $ (448) | 147,694 | (107,884) | |||
Ending Balance, Shares at Mar. 31, 2023 | 29,042,418 | (122,608) | ||||||
Beginning Balance at Dec. 31, 2023 | $ 12,745 | $ 290 | $ (448) | 149,931 | (137,028) | |||
Beginning Balance, Shares at Dec. 31, 2023 | 29,091,019 | 29,213,627 | (122,608) | |||||
Options exercised | $ 226 | $ 1 | 225 | |||||
Options exercised, Shares | 146,964 | 146,964 | ||||||
Stock-based compensation | $ 1,030 | 1,030 | ||||||
Change in fair value of NC Ohio Trust Warrants | 13 | 13 | ||||||
Sale of common stock, net of issuance costs | $ 186 | $ 1 | $ 185 | |||||
Sale of common stock, net of issuance costs, Shares | 109,485 | 109,485 | ||||||
Net Income (Loss) | (8,221) | (8,221) | ||||||
Ending Balance at Mar. 31, 2024 | $ 5,979 | $ 292 | $ (448) | $ 151,384 | $ (145,249) | |||
Ending Balance, Shares at Mar. 31, 2024 | 29,347,468 | 29,470,076 | (122,608) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (8,221) | $ (8,795) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 251 | 230 |
Loss on the sale of fixed assets | 0 | 74 |
Non-cash stock compensation expense | 1,043 | 733 |
Non-cash lease expense | 65 | 57 |
Non-cash interest expense | 30 | 26 |
Change in fair value of warrant liability | (7) | (724) |
Accretion of debt discount | 83 | 75 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (39) | (730) |
Other assets | 14 | |
Accounts payable | 50 | 149 |
Accrued expenses | (1,584) | (1,790) |
Deferred income | 0 | (12) |
Lease liability | (123) | (112) |
Net cash used in operating activities | (8,438) | (10,819) |
Cash Flows from Investing Activities: | ||
Purchase of fixed assets | (7) | (138) |
Proceeds from the sale of fixed assets | 0 | 157 |
Net cash (used in) provided by investing activities | (7) | 19 |
Cash Flows from Financing Activities: | ||
Proceeds from option exercises | 226 | |
Principal payments on term loan | (1,667) | |
Net cash used in financing activities | (1,255) | 0 |
Net decrease in cash | (9,700) | (10,800) |
Cash, cash equivalents and restricted cash at beginning of period | 35,679 | 70,324 |
Cash, cash equivalents and restricted cash at end of period | 25,979 | 59,524 |
Supplemental cash flow information: | ||
Cash paid for interest | 549 | 500 |
Supplemental disclosures of non-cash information: | ||
Capital expenditures in accounts payable and accrued expenses | 0 | $ 66 |
At The Market Offerings | ||
Cash Flows from Financing Activities: | ||
Proceeds from sale of common stock, net of issuance costs | $ 186 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (8,221) | $ (8,795) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Rule 10b51 Arr Modified Flag | false |
Non Rule 10b51 Arr Modified Flag | false |
Organization and Basis of Prese
Organization and Basis of Presentation | 3 Months Ended |
Mar. 31, 2024 | |
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 clinical stage biopharmaceutical 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 off-the-shelf viral immunotherapies that elicit an individualized, systemic anti-tumor immune response 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. This is intended to lead to in-situ vaccination against the injected tumor and uninjected distant metastases. The Company has established two off-the-shelf viral immunotherapy platforms and its two product candidates, CAN-2409 and CAN-3110, are in clinical trials for a number of tumor types. Additionally, the Company and the University of Pennsylvania (UPenn) are collaborating to study the impact of novel viral immunotherapies based on Candel's propriety enLIGHTEN Discovery Platform, a systematic, iterative herpes simplex virus based platform leveraging human biology and advanced analytics, to strengthen the effects of UPenn's investigational CAR-T cell therapies in solid tumors. 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. Since inception, 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 $ 8.2 million and $ 8.8 million for the three months ended March 31, 2024 and 2023, respectively. In addition, as of March 31, 2024, the Company had an accumulated deficit of $ 145.2 million . The Company expects to continue to generate operating losses and negative cash flows from operations for the foreseeable future. On August 5, 2022, the Company filed a shelf registration statement on Form S-3 (as amended to date, the Shelf) with the U.S. Securities and Exchange Commission (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 March 31, 2024, the Company has sold and issued 109,485 shares of common stock under the ATM Program, with total net proceeds of $ 0.2 million . Subsequent to March 31, 2024 , no additional sales have been made under the ATM Program. The Company’s cash and cash equivalents were $ 25.7 million as of March 31, 2024. In accordance with the Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC), 205-40, Presentation of Financial Statements - Going Concern, management is required to assess the Company’s ability to continue as a going concern for the one-year look forward period following the date that the condensed consolidated financial statements are issued. The Company expects to continue to generate operating losses and negative cash flows from operations. Based on these conditions, the Company has determined that substantial doubt exists regarding its ability to continue as a going concern for the one-year period following the date these condensed consolidated financial statements are issued. To sustain its future operations beyond such one-year period, the Company will require additional funding. The Company expects to finance its cash needs through a combination of public or private equity or debt financings, government grants, and other sources, which may include collaborations, strategic alliances and licensing arrangements with third parties. There is no assurance that the Company will be successful in obtaining sufficient funding on acceptable terms, if at all, and the Company could be forced to delay, reduce, or eliminate some or all of its research, clinical trials, product development or future commercialization efforts, which could materially adversely affect its business prospects or its ability to continue as a going concern. The accompanying condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Accordingly, the condensed consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and that 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 | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in accordance with accounting standards set by the 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 ASC . The Company has reclassified certain amounts relating to its prior period results to conform to its current period presentation. Principles of Consolidation The condensed 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 condensed consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. Unaudited Interim Financial Information The accompanying condensed consolidated balance sheet as of March 31, 2024, the condensed consolidated statements of operations for the three months ended March 31, 2024 and 2023, the condensed consolidated statements of stockholders’ equity for the three months ended March 31, 2024 and 2023, the condensed consolidated statements of cash flows for the three months ended March 31, 2024 and 2023, and the related interim disclosures are unaudited. These condensed consolidated financial statements include all adjustments necessary, consisting of only normal recurring adjustments, to fairly state the financial position and the results of the Company’s operations and cash flows for interim periods in accordance with U.S. GAAP. Interim period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period. The accompanying condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K on file with the SEC. Use of Estimates The preparation of the Company’s condensed 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. Restricted Cash The Company had $ 0.3 million of restricted cash as of both March 31, 2024 and December 31, 2023 , which represents cash held as a security deposit under the terms of the Company’s Needham, Massachusetts facility lease. Recently Issued Accounting Standards In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC's Disclosure Update and Simplification Initiative, which modifies the disclosure or presentation requirements related to a variety of FASB Accounting Standard Codification topics. The effective date for each amendment will be the date on which the SEC's removal of that related disclosure from Regulation S-X or Regulation S-K is effective, with early adoption prohibited. If by June 30, 2027, the SEC has not removed the applicable requirement from Regulation S-X or Regulation S-K, the pending content of the associated amendment will be removed from the Codification and will not become effective for any entities. The Company is currently evaluating the potential impact that ASU 2023-06 may have on its condensed consolidated financial statements and related disclosures. In November 2023, the FASB issued ASU 2023-07, Segment Reporting: Improvements to Reportable Segment Disclosures, which amends guidance in ASC 280, Segment Reporting The amendments in this ASU expand segment disclosure requirements, including new segment disclosure requirements for entities with a single reportable segment, among other disclosure requirements. The ASU’s amendments are effective for public business entities for annual periods beginning after December 15, 2023. Early adoption is permitted. The Company is currently evaluating the potential impact that the adoption of ASU 2023-07 may have on its condensed consolidated financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which amends the guidance in ASC 740, Income Taxes. The ASU is intended to improve the transparency of income tax disclosures by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. The ASU’s amendments are effective for public business entities for annual periods beginning after December 15, 2024. Early adoption is permitted. Adoption can be either prospectively or retrospectively applied, and the Company will adopt this ASU on a prospective basis. The Company is currently evaluating the potential impact that ASU 2023-09 may have on its condensed consolidated financial statements and related disclosures. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 3 Months Ended |
Mar. 31, 2024 | |
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 s uch fair values (in thousands): FAIR VALUE MEASUREMENTS AS OF LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Liabilities: Warrant liability — — 909 909 Total $ — $ — $ 909 $ 909 FAIR VALUE MEASUREMENTS AS OF LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Liabilities: Warrant liability — — 916 916 Total $ — $ — $ 916 $ 916 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, 2023 $ 916 Change in fair value ( 7 ) Balance at March 31, 2024 $ 909 |
Fixed Assets, Net
Fixed Assets, Net | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment [Abstract] | |
Fixed Assets, Net | 4. Fixed Assets, Net Fixed assets, net consisted of the following (in thousands): MARCH 31, DECEMBER 31, Laboratory equipment $ 1,213 $ 1,209 Manufacturing equipment 733 730 Furniture and fixtures 159 159 Networking and computer equipment 88 88 Leasehold improvements 3,109 3,109 Total fixed assets $ 5,302 $ 5,295 Less: accumulated depreciation ( 2,340 ) ( 2,089 ) Fixed assets, net $ 2,962 $ 3,206 Depreciation expense was $ 0.3 million and $ 0.2 million for the three months ended March 31, 2024 and 2023 , respectively. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 5. Accrued Expenses Accrued expenses consisted of the following (in thousands): MARCH 31, DECEMBER 31, Payroll and employee related expenses $ 1,192 $ 2,017 Third-party research and development expenses 749 1,811 Professional fees and other 831 528 $ 2,772 $ 4,356 |
Term Loan
Term Loan | 3 Months Ended |
Mar. 31, 2024 | |
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 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 each of the three months ended March 31, 2024 and 2023, the Company recorded interest expense relating to the Loan Agreement of $ 0.6 million . The weighted average effective interest rate as of March 31, 2024 was 11.40 %. 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, 2024 (remaining nine months) $ 7,500 2025 10,000 2026 833 Total principal 18,333 Final payment fee 900 Less: debt discount ( 989 ) Accretion of debt discount 697 Net carrying amount 18,941 Less current portion ( 9,767 ) Long-term portion $ 9,174 The carrying value of the Company's term loan approximates fair value. |
Other Long-Term Debt
Other Long-Term Debt | 3 Months Ended |
Mar. 31, 2024 | |
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. (Periphagen), 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 % as of December 9, 2019. 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 March 31, 2024, the carrying value of the note is $ 0.8 million . The carrying value of the note approximates fair value. Upon maturity, the Company will pay Periphagen $ 1.4 million for the outstanding balance and accrued interest due. |
Lease
Lease | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Lease | 8. Lease On February 4, 2019, the Company signed a lease agreement for its 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 . For each of the three months ended March 31, 2024 and 2023, the Company recorded $ 0.1 million of operating lease cost and for the three months ended March 31, 2024 and 2023, the Company has recorded $ 38,000 and $ 49,000 , respectively, of variable lease cost. The total lease expense for each of the three months ended March 31, 2024 and 2023 was $ 0.1 million . Cash paid for amounts included in the lease liability for each of the three months ended March 31, 2024 and 2023 was $ 0.1 million . THREE MONTHS ENDED Other Information 2024 2023 Operating cash flows used for operating leases $ 148 $ 144 Weighted-average remaining lease term (years) 2.4 3.4 Weighted-average incremental borrowing rate 7.02 % 7.02 % The future lease payments under non-cancelable leases at March 31, 2024, are as follows (in thousands): 2024 450 2025 613 2026 415 Total future lease payments 1,478 Less: imputed interest ( 115 ) Total lease liability $ 1,363 |
Common Stock
Common Stock | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
Common Stock | 9. Common Stock Common Stock 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: MARCH 31, DECEMBER 31, Stock options outstanding 5,112,673 5,666,621 Unvested restricted stock 2,306,889 2,526,432 Shares available for future grant under stock option plan 2,042,216 252,053 Warrants 7,507,708 7,507,708 16,969,486 15,952,814 Shelf Registration and At-the-Market Offerings On August 5, 2022, the Company filed 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 Shelf was declared effective by the SEC on August 12, 2022. As of March 31, 2024, the Company has sold and issued 109,485 shares of common stock under the ATM Program, with total net proceeds of $ 0.2 million . Subsequent to March 31, 2024 , no additional sales have been made under the ATM Program. |
Warrants
Warrants | 3 Months Ended |
Mar. 31, 2024 | |
Warrants and Rights Note Disclosure [Abstract] | |
Warrants | 10. Warrants The Company has the following warrants outstanding for the purchase of common stock as of March 31, 2024 and December 31, 2023: WARRANTS SHARES OF EXERCISE EXPIRATION 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 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 Company’ s initial public offering, 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 condensed 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 condensed consolidated statements of operations and comprehensive loss. The Company will continue to recognize changes in the fair value of the Conditional Series B Warrants u ntil each Conditional Series B Warrant is exercised, expires or qualifies for equity classification. The warrant liability fair value was $ 0.9 million as of both March 31, 2024 and December 31, 2023. 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 condensed consolidated statement of operations and comprehensive loss 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 March 31, 2024 and December 31, 2023 , 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 as of both March 31, 2024 and December 31, 2023, and was recorded as stock compensation expense within research and development expense and a credit to stockholders’ equity in the condensed consolidated financial statements. |
Stock Options, Restricted Stock
Stock Options, Restricted Stock and Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024 , 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. 6,645,259 shares of common stock are reserved under the 2021 Plan, of which 2,042,216 shares remain available for future grants as of March 31, 2024. Stock Options Stock option activity is summarized a s follows: NUMBER OF WEIGHTED- WEIGHTED- AGGREGATE Outstanding as of December 31, 2023 5,666,621 $ 2.47 6.61 Granted 67,500 1.59 Exercised ( 146,964 ) 1.54 Cancelled, forfeited or expired ( 474,484 ) 3.42 Outstanding as of March 31, 2024 5,112,673 $ 2.40 6.66 $ 378 Exercisable as of March 31, 2024 3,500,102 $ 2.41 5.80 $ 133 Unvested as of March 31, 2024 1,612,571 $ 2.37 8.53 $ 245 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 tendere d are recorded as treasury stock within the Company’s condensed consolidated financial statements at March 31, 2024. The fair value of stock options granted was estimated on the grant date using the Black-Scholes option pricing model based on the following assumptions: THREE MONTHS ENDED 2024 2023 Expected option life (years) 6.08 6.08 Risk-free interest rate 4.21 % - 4.27 % 3.58 % - 4.13 % Expected volatility 99.30 % - 99.45 % 91.33 % - 92.25 % Expected dividend yield 0 % 0 % The total intrinsic value of stock options vested during each of the three months ended March 31, 2024 and 2023 was zero . Restricted Stock Units 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 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, 2023 2,526,432 $ 1.06 Granted — $ — Vested — $ — Forfeited ( 219,543 ) $ 1.13 Unvested at March 31, 2024 2,306,889 $ 1.06 The aggregate fair value of restricted stock units that vested during each of the three months ended March 31, 2024 and 2023 was zero . Stock-Based Compensation Stock-based compensation expense for th e three months ended March 31, 2024 and 2023 was classified in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands): THREE MONTHS ENDED 2024 2023 Research and development $ 553 $ 311 General and administrative 490 422 Total stock-based compensation expense $ 1,043 $ 733 As of March 31, 2024, total unrecognized compensation cost related to unvested stock-based awards was $ 4.4 million , which is expected to be recognized over a weighted average period of 2.30 years . |
Exclusive Licensing Agreement w
Exclusive Licensing Agreement with a Related Party | 3 Months Ended |
Mar. 31, 2024 | |
License Agreement [Abstract] | |
Exclusive Licensing Agreement with a Related party | 12. 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 had completely recognized the $ 1.0 million upfront license fee as research and development service revenue as of December 31, 2022. |
Technology License Agreement
Technology License Agreement | 3 Months Ended |
Mar. 31, 2024 | |
Technology License Agreement [Abstract] | |
Technology License Agreement | 13. 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. During the three months ended March 31, 2024 and 2023, the Company did no t expense any 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 | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 14. 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 March 31, 2024, 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). 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. On March 10, 2023, Periphagen filed its answer and counterclaims to our demand for arbitration. In its counterclaims, Periphagen sought 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. We denied Periphagen’s counterclaims. On June 7, 2023, the parties entered into an amendment to the Exclusive License Agreement that resolved the dispute and resulted in termination of the arbitration without any financial impact. 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 | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 15. 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): THREE MONTHS ENDED Numerator: 2024 2023 Net loss $ ( 8,221 ) $ ( 8,795 ) Denominator: Weighted-average shares of common stock 29,197,537 28,919,810 Net loss per share – basic and diluted $ ( 0.28 ) $ ( 0.30 ) 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. AS OF MARCH 31, 2024 2023 Outstanding warrants for common stock 7,507,708 7,507,708 Outstanding stock options (as converted to common stock) 5,112,673 5,479,355 Unvested restricted stock 2,306,889 612,366 14,927,270 13,599,429 |
Corporate Restructuring
Corporate Restructuring | 3 Months Ended |
Mar. 31, 2024 | |
Restructuring and Related Activities [Abstract] | |
Corporate Restructuring | 16. Corporate Restructuring In November 2023, the Company’s board of directors authorized a restructuring plan to focus on continuation and expansion of development of CAN-3110 as well as the enLIGHTEN TM Discovery Platform, which resulted in a reduction of the Company’s workforce by approximately 45 %. Each affected employee’s separation occurred in December 2023. As a result, the Company incurred costs of $ 0.7 million related to severance benefits for the affected employees, including severance payments and limited reimbursement of medical insurance premiums. The restructuring plan was completed in the first quarter of 2024 when the final severance payments of $ 46,000 were made. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in accordance with accounting standards set by the 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 ASC . The Company has reclassified certain amounts relating to its prior period results to conform to its current period presentation. |
Principles of Consolidation | Principles of Consolidation The condensed 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 condensed consolidated financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying condensed consolidated balance sheet as of March 31, 2024, the condensed consolidated statements of operations for the three months ended March 31, 2024 and 2023, the condensed consolidated statements of stockholders’ equity for the three months ended March 31, 2024 and 2023, the condensed consolidated statements of cash flows for the three months ended March 31, 2024 and 2023, and the related interim disclosures are unaudited. These condensed consolidated financial statements include all adjustments necessary, consisting of only normal recurring adjustments, to fairly state the financial position and the results of the Company’s operations and cash flows for interim periods in accordance with U.S. GAAP. Interim period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period. The accompanying condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K on file with the SEC. |
Use of Estimates | Use of Estimates The preparation of the Company’s condensed 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. |
Restricted Cash | Restricted Cash The Company had $ 0.3 million of restricted cash as of both March 31, 2024 and December 31, 2023 , which represents cash held as a security deposit under the terms of the Company’s Needham, Massachusetts facility lease. |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC's Disclosure Update and Simplification Initiative, which modifies the disclosure or presentation requirements related to a variety of FASB Accounting Standard Codification topics. The effective date for each amendment will be the date on which the SEC's removal of that related disclosure from Regulation S-X or Regulation S-K is effective, with early adoption prohibited. If by June 30, 2027, the SEC has not removed the applicable requirement from Regulation S-X or Regulation S-K, the pending content of the associated amendment will be removed from the Codification and will not become effective for any entities. The Company is currently evaluating the potential impact that ASU 2023-06 may have on its condensed consolidated financial statements and related disclosures. In November 2023, the FASB issued ASU 2023-07, Segment Reporting: Improvements to Reportable Segment Disclosures, which amends guidance in ASC 280, Segment Reporting The amendments in this ASU expand segment disclosure requirements, including new segment disclosure requirements for entities with a single reportable segment, among other disclosure requirements. The ASU’s amendments are effective for public business entities for annual periods beginning after December 15, 2023. Early adoption is permitted. The Company is currently evaluating the potential impact that the adoption of ASU 2023-07 may have on its condensed consolidated financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which amends the guidance in ASC 740, Income Taxes. The ASU is intended to improve the transparency of income tax disclosures by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. The ASU’s amendments are effective for public business entities for annual periods beginning after December 15, 2024. Early adoption is permitted. Adoption can be either prospectively or retrospectively applied, and the Company will adopt this ASU on a prospective basis. The Company is currently evaluating the potential impact that ASU 2023-09 may have on its condensed consolidated financial statements and related disclosures. |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 s uch fair values (in thousands): FAIR VALUE MEASUREMENTS AS OF LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Liabilities: Warrant liability — — 909 909 Total $ — $ — $ 909 $ 909 FAIR VALUE MEASUREMENTS AS OF LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Liabilities: Warrant liability — — 916 916 Total $ — $ — $ 916 $ 916 |
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, 2023 $ 916 Change in fair value ( 7 ) Balance at March 31, 2024 $ 909 |
Fixed Assets, Net (Tables)
Fixed Assets, Net (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment [Abstract] | |
Summary of Fixed Assets, Net | Fixed assets, net consisted of the following (in thousands): MARCH 31, DECEMBER 31, Laboratory equipment $ 1,213 $ 1,209 Manufacturing equipment 733 730 Furniture and fixtures 159 159 Networking and computer equipment 88 88 Leasehold improvements 3,109 3,109 Total fixed assets $ 5,302 $ 5,295 Less: accumulated depreciation ( 2,340 ) ( 2,089 ) Fixed assets, net $ 2,962 $ 3,206 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following (in thousands): MARCH 31, DECEMBER 31, Payroll and employee related expenses $ 1,192 $ 2,017 Third-party research and development expenses 749 1,811 Professional fees and other 831 528 $ 2,772 $ 4,356 |
Term Loan (Tables)
Term Loan (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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, 2024 (remaining nine months) $ 7,500 2025 10,000 2026 833 Total principal 18,333 Final payment fee 900 Less: debt discount ( 989 ) Accretion of debt discount 697 Net carrying amount 18,941 Less current portion ( 9,767 ) Long-term portion $ 9,174 |
Lease (Tables)
Lease (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Schedule of Other Information | THREE MONTHS ENDED Other Information 2024 2023 Operating cash flows used for operating leases $ 148 $ 144 Weighted-average remaining lease term (years) 2.4 3.4 Weighted-average incremental borrowing rate 7.02 % 7.02 % |
Summary of Future Lease Payments Under Non-cancelable Leases | The future lease payments under non-cancelable leases at March 31, 2024, are as follows (in thousands): 2024 450 2025 613 2026 415 Total future lease payments 1,478 Less: imputed interest ( 115 ) Total lease liability $ 1,363 |
Common Stock (Tables)
Common Stock (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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: MARCH 31, DECEMBER 31, Stock options outstanding 5,112,673 5,666,621 Unvested restricted stock 2,306,889 2,526,432 Shares available for future grant under stock option plan 2,042,216 252,053 Warrants 7,507,708 7,507,708 16,969,486 15,952,814 |
Warrants (Tables)
Warrants (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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 March 31, 2024 and December 31, 2023: WARRANTS SHARES OF EXERCISE EXPIRATION 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) | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Option Activity | Stock option activity is summarized a s follows: NUMBER OF WEIGHTED- WEIGHTED- AGGREGATE Outstanding as of December 31, 2023 5,666,621 $ 2.47 6.61 Granted 67,500 1.59 Exercised ( 146,964 ) 1.54 Cancelled, forfeited or expired ( 474,484 ) 3.42 Outstanding as of March 31, 2024 5,112,673 $ 2.40 6.66 $ 378 Exercisable as of March 31, 2024 3,500,102 $ 2.41 5.80 $ 133 Unvested as of March 31, 2024 1,612,571 $ 2.37 8.53 $ 245 |
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 assumptions: THREE MONTHS ENDED 2024 2023 Expected option life (years) 6.08 6.08 Risk-free interest rate 4.21 % - 4.27 % 3.58 % - 4.13 % Expected volatility 99.30 % - 99.45 % 91.33 % - 92.25 % Expected dividend yield 0 % 0 % |
Summary of Restricted Stock Activity | Restricted stock activity is summarized as follows: NUMBER OF WEIGHTED- Unvested at December 31, 2023 2,526,432 $ 1.06 Granted — $ — Vested — $ — Forfeited ( 219,543 ) $ 1.13 Unvested at March 31, 2024 2,306,889 $ 1.06 |
Schedule of Stock-based Compensation Expense | Stock-based compensation expense for th e three months ended March 31, 2024 and 2023 was classified in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands): THREE MONTHS ENDED 2024 2023 Research and development $ 553 $ 311 General and administrative 490 422 Total stock-based compensation expense $ 1,043 $ 733 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
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): THREE MONTHS ENDED Numerator: 2024 2023 Net loss $ ( 8,221 ) $ ( 8,795 ) Denominator: Weighted-average shares of common stock 29,197,537 28,919,810 Net loss per share – basic and diluted $ ( 0.28 ) $ ( 0.30 ) |
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. AS OF MARCH 31, 2024 2023 Outstanding warrants for common stock 7,507,708 7,507,708 Outstanding stock options (as converted to common stock) 5,112,673 5,479,355 Unvested restricted stock 2,306,889 612,366 14,927,270 13,599,429 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Details) | 3 Months Ended | ||||
May 14, 2024 shares | Aug. 05, 2022 USD ($) | Mar. 31, 2024 USD ($) Candidate $ / shares shares | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) $ / shares shares | |
Organization And Basis Of Presentation [Line Items] | |||||
Number of product candidates | Candidate | 2 | ||||
Net Income (Loss) | $ (8,221,000) | $ (8,795,000) | |||
Accumulated deficit | $ (145,249,000) | $ (137,028,000) | |||
Common stock, shares, issued | shares | 29,470,076 | 29,213,627 | |||
Common stock par value | $ / shares | $ 0.01 | $ 0.01 | |||
Cash and cash equivalents | $ 25,713,000 | $ 35,413,000 | |||
Combination of Common Stock, Preferred Stock, Debt Securities, Warrants and/or Units | Maximum [Member] | |||||
Organization And Basis Of Presentation [Line Items] | |||||
Stock Issued During Period, Value, New Issues | $ 200,000,000 | ||||
ATM Program | |||||
Organization And Basis Of Presentation [Line Items] | |||||
Stock Issued During Period, Value, New Issues | $ 186,000 | ||||
Shares of common stock sold and issued | shares | 109,485 | ||||
Net proceeds | $ 186,000 | ||||
ATM Program | Subsequent Event | |||||
Organization And Basis Of Presentation [Line Items] | |||||
Additional sales | shares | 0 | ||||
ATM Program | Maximum [Member] | |||||
Organization And Basis Of Presentation [Line Items] | |||||
Stock Issued During Period, Value, New Issues | $ 75,000,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2024 USD ($) Segment | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Significant Accounting Policies [Line Items] | |||
Number of operating segment | Segment | 1 | ||
Restricted cash | $ 300 | $ 300 | |
Grant revenue | $ 12 |
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 | Mar. 31, 2024 | Dec. 31, 2023 |
Liabilities: | ||
Warrant liability | $ 909 | $ 916 |
Total | 909 | 916 |
Level 3 | ||
Liabilities: | ||
Warrant liability | 909 | 916 |
Total | $ 909 | $ 916 |
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 $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |
Balance at December 31, 2023 | $ 916 |
Change in fair value | (7) |
Balance at March 31, 2024 | $ 909 |
Fixed Assets, Net - Summary of
Fixed Assets, Net - Summary of Fixed Assets, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Property Plant And Equipment [Line Items] | ||
Total fixed assets | $ 5,302 | $ 5,295 |
Less accumulated depreciation | (2,340) | (2,089) |
Fixed assets, net | 2,962 | 3,206 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Total fixed assets | 1,213 | 1,209 |
Manufacturing Equipment | ||
Property Plant And Equipment [Line Items] | ||
Total fixed assets | 733 | 730 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Total fixed assets | 159 | 159 |
Networking and Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Total fixed assets | 88 | 88 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Total fixed assets | $ 3,109 | $ 3,109 |
Fixed Assets, Net - Additional
Fixed Assets, Net - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 251 | $ 230 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Payroll and employee related expenses | $ 1,192 | $ 2,017 |
Third-party research and development expenses | 749 | 1,811 |
Professional fees and other | 831 | 528 |
Accrued expenses | $ 2,772 | $ 4,356 |
Term Loan - Additional Informat
Term Loan - Additional Information (Details) | 3 Months Ended | |||
Dec. 30, 2022 USD ($) | Feb. 24, 2022 USD ($) Installment | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | |
Debt Instrument [Line Items] | ||||
Loan, maximum borrowing capacity | $ 5,000,000 | |||
Long-term debt | $ 18,941,000 | |||
Cash proceeds amount equal to at least from the issuance and sale of equity securities | $ 75,000,000 | |||
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 | $ 600,000 | $ 600,000 | ||
Weighted average effective interest rate | 11.40% | |||
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) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Debt Instrument [Line Items] | ||
2024 (remaining nine months) | $ 7,500 | |
2025 | 10,000 | |
2026 | 833 | |
Total principal | 18,333 | |
Final payment fee | 900 | |
Less: debt discount | (989) | |
Accretion of debt discount | 697 | |
Net carrying amount | 18,941 | |
Less current portion | (9,767) | $ (8,893) |
Long-term portion | $ 9,174 |
Other Long-Term Debt - Addition
Other Long-Term Debt - Additional Information (Details) - Periphagen, Inc. - USD ($) $ in Millions | 3 Months Ended | |
Dec. 09, 2019 | Mar. 31, 2024 | |
Debt Instrument [Line Items] | ||
Asset acquisition, assumption of promissory note | $ 1 | |
Payment for outstanding note balance and accrued interest due | $ 1.4 | |
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 | $ 0.8 |
Lease - Additional Information
Lease - Additional Information (Details) | 3 Months Ended | ||
Feb. 04, 2019 Squrefoot | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | |
Lessee, Lease, Description [Line Items] | |||
Operating lease cost | $ 100,000 | $ 100,000 | |
Variable lease cost | 38,000 | 49,000 | |
Total lease expense | 100,000 | 100,000 | |
Cash paid for amounts included in measurement of lease liability | $ 148,000 | $ 144,000 | |
Corporate, Clinical and Manufacturing Operations | Massachusetts | |||
Lessee, Lease, Description [Line Items] | |||
Area of lease property | Squrefoot | 15,197 | ||
Lease expiration date | Aug. 31, 2026 |
Lease - Schedule of Other Infor
Lease - Schedule of Other Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Leases [Abstract] | ||
Operating cash flows used for operating leases | $ 148 | $ 144 |
Weighted-average remaining lease term (years) | 2 years 4 months 24 days | 3 years 4 months 24 days |
Weighted-average incremental borrowing rate | 7.02% | 7.02% |
Lease - Summary of Future Lease
Lease - Summary of Future Lease Payments Under Non-cancellable Leases (Details) $ in Thousands | Mar. 31, 2024 USD ($) |
Leases [Abstract] | |
2024 | $ 450 |
2025 | 613 |
2026 | 415 |
Total future lease payments | 1,478 |
Less: imputed interest | (115) |
Operating lease liability | $ 1,363 |
Common Stock - Additional Infor
Common Stock - Additional Information (Details) - USD ($) | 3 Months Ended | ||
May 14, 2024 | Aug. 05, 2022 | Mar. 31, 2024 | |
ATM Program | |||
Class of Stock [Line Items] | |||
Shares of common stock sold and issued | 109,485 | ||
Net proceeds | $ 186,000 | ||
Sale of stock under Shelf | $ 186,000 | ||
Subsequent Event | ATM Program | |||
Class of Stock [Line Items] | |||
Additional sales | 0 | ||
Maximum | Combination of Common Stock, Preferred Stock, Debt Securities, Warrants and/or Units | |||
Class of Stock [Line Items] | |||
Sale of stock under Shelf | $ 200,000,000 | ||
Maximum | ATM Program | |||
Class of Stock [Line Items] | |||
Sale of stock under Shelf | $ 75,000,000 |
Common Stock - Schedule of Comm
Common Stock - Schedule of Common Stock Reserved For Future Issuance (Details) - shares | Mar. 31, 2024 | Dec. 31, 2023 |
Class of Stock [Line Items] | ||
Common stock reserved for future issuance | 16,969,486 | 15,952,814 |
Warrants | ||
Class of Stock [Line Items] | ||
Common stock reserved for future issuance | 7,507,708 | 7,507,708 |
Stock Options Outstanding | ||
Class of Stock [Line Items] | ||
Common stock reserved for future issuance | 5,112,673 | 5,666,621 |
Unvested Restricted Stock | ||
Class of Stock [Line Items] | ||
Common stock reserved for future issuance | 2,306,889 | 2,526,432 |
Shares Available for Future Grant Under Stock Option Plan | ||
Class of Stock [Line Items] | ||
Common stock reserved for future issuance | 2,042,216 | 252,053 |
Warrants - Summary of Warrants
Warrants - Summary of Warrants Outstanding for Purchase of Common Stock (Details) - $ / shares | 3 Months Ended | 12 Months Ended | |||
Jun. 24, 2021 | Mar. 31, 2024 | Dec. 31, 2023 | 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 | 3 Months Ended | 12 Months Ended | |||
Jun. 24, 2021 | Mar. 20, 2019 $ / shares shares | Mar. 31, 2024 USD ($) TradingDays $ / shares shares | Dec. 31, 2023 USD ($) $ / shares shares | Nov. 13, 2018 $ / shares shares | |
Class Of Warrant Or Right [Line Items] | |||||
Fair value of warrant liability | $ | $ 909 | $ 916 | |||
Common stock, par value | $ 0.01 | $ 0.01 | |||
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 | $ 13.2 | ||||
Class of warrant or right exercise average market price per share | $ 13.2 | ||||
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 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 | $ | $ 900 | $ 900 | |||
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 | $ 200 | |||
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 ($) | 3 Months Ended | |||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Jul. 14, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Common stock reserved for future issuance | 16,969,486 | 15,952,814 | ||
Number of shares available for grant | 2,042,216 | |||
Stock options exercised | 146,964 | |||
Intrinsic value of stock options vested | $ 0 | $ 0 | ||
Unrecognized compensation cost related to unvested stock options | $ 4,400,000 | |||
Stock-based awards are expected to be recognized over a weighted average period | 2 years 3 months 18 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 | 6,645,259 |
Stock Options, Restricted Sto_4
Stock Options, Restricted Stock and Stock-Based Compensation - Schedule of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | ||
Number Of Stock Options, Shares Outstanding | 5,666,621 | |
Number Of Stock Options, Shares, Granted | 67,500 | |
Number Of Stock Options, Shares, Exercised | (146,964) | |
Number Of Stock Options, Shares, Cancelled or forfeited or expired | (474,484) | |
Number Of Stock Options, Shares Outstanding | 5,112,673 | 5,666,621 |
Exercisable as of March 31, 2024 | 3,500,102 | |
Unvested as of March 31, 2024 | 1,612,571 | |
Weighted-Average Exercise Price, Outstanding | $ 2.47 | |
Weighted-Average Exercise Price, Granted | 1.59 | |
Weighted-Average Exercise Price, Exercised | 1.54 | |
Weighted-Average Exercise Price, Cancelled or forfeited or expired | 3.42 | |
Weighted-Average Exercise Price, Outstanding | 2.4 | $ 2.47 |
Exercisable as of March 31, 2024 | 2.41 | |
Unvested as of March 31, 2024 | $ 2.37 | |
Weighted- Average Remaining Contractual Term (In Years), Outstanding | 6 years 7 months 28 days | 6 years 7 months 9 days |
Exercisable as of March 31, 2024 | 5 years 9 months 18 days | |
Unvested as of March 31, 2024 | 8 years 6 months 10 days | |
Aggregate Intrinsic Value, Outstanding | $ 378 | |
Exercisable as of March 31, 2024 | 133 | |
Unvested as of March 31, 2024 | $ 245 |
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) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected option life (years) | 6 years 29 days | 6 years 29 days |
Expected dividend yield | 0% | 0% |
Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate | 4.21% | 3.58% |
Expected volatility | 99.30% | 91.33% |
Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate | 4.27% | 4.13% |
Expected volatility | 99.45% | 92.25% |
Stock Options, Restricted Sto_6
Stock Options, Restricted Stock and Stock-Based Compensation - Summary of Restricted Stock Activity (Details) - Restricted Stock Units | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of Shares Options, Unvested | shares | 2,526,432 |
Number of Shares Options, Forfeited | shares | (219,543) |
Number of Shares Options, Unvested | shares | 2,306,889 |
Weighted-Average Grant Date Fair Value, Unvested | $ / shares | $ 1.06 |
Weighted-Average Grant Date Fair Value, Forfeited | $ / shares | 1.13 |
Weighted-Average Grant Date Fair Value, Unvested | $ / shares | $ 1.06 |
Stock Options, Restricted Sto_7
Stock Options, Restricted Stock and Stock-Based Compensation - Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 1,043 | $ 733 |
Research and Development | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation expense | 553 | 311 |
General and Administrative | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 490 | $ 422 |
Exclusive Licensing Agreement_2
Exclusive Licensing Agreement with a Related Party - Additional Information (Details) - Exclusive Licensing Agreement - Ventagen - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended |
Mar. 31, 2014 | Dec. 31, 2022 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Payment from related party | $ 1 | |
Future payment made upon the achievement of sales | $ 5 | |
Commercial purposes at a price of cost plus percentage | 25% | |
Upfront license fee | $ 1 | |
Voting Stock | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Related party transactions, ownership percentage | 49.50% | |
Founders | Voting Stock | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Related party transactions, ownership percentage | 47% | |
Related Party [Member] | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Due from related parties | $ 2.5 | |
Related party costs | $ 4 |
Technology License Agreement -
Technology License Agreement - Additional Information (Details) - BWH License - USD ($) | 3 Months Ended | |||
Sep. 15, 2020 | Jan. 20, 2018 | Mar. 31, 2024 | Mar. 31, 2023 | |
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 | $ 0 | ||
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) | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
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 | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Numerator: | ||
Net Income (Loss) | $ (8,221) | $ (8,795) |
Denominator: | ||
Weighted-average shares of common stock outstanding - basic | 29,197,537 | 28,919,810 |
Weighted-average shares of common stock outstanding - diluted | 29,197,537 | 28,919,810 |
Net loss per share - basic | $ (0.28) | $ (0.3) |
Net loss per share - diluted | $ (0.28) | $ (0.3) |
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 | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 14,927,270 | 13,599,429 |
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 | 5,112,673 | 5,479,355 |
Unvested Restricted Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 2,306,889 | 612,366 |
Corporate Restructuring - Addit
Corporate Restructuring - Additional Information (Details) - USD ($) | 1 Months Ended | |
Nov. 30, 2023 | Mar. 31, 2024 | |
Restructuring Cost and Reserve [Line Items] | ||
Percentage of reduction in workforce positions | 45% | |
Severance cost | $ 700,000 | |
Final severance costs | $ 46,000 |