Candel Therapeutics, Inc.
For the period ended Jun 30, 2025. Filed Aug 14, 2025.
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Jun 30, 2025 · Filed Aug 14, 2025
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Notes to Condensed Consolidated Financial Statements (Unaudited)
Notes to Condensed Consoli dated Financial Statements
- 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 immunization against the injected tumor and uninjected distant metastases. The Company has established two off-the-shelf viral immunotherapy platforms and itstwo 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 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 had net income of$2.6 million and a net loss of$30.5 million for the six months ended June 30, 2025 and 2024, respectively. In addition, as of June 30, 2025, the Company had an accumulated deficit of$189.6 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 and expired on August 12, 2025. As of June 30, 2025, the Company sold and issued 3,923,829 shares of common stock under the ATM Program, with total net proceeds of$20.9 million. Subsequent to June 30, 2025 and through August 5, 2025, the Company has not sold any additional shares of common stock under the ATM Program.
On December 16, 2024, the Company completed a public offering of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. The Company issued and sold 12,000,001 shares of common stock, including full exercise of the underwriters’ option to purchase an additional 2,000,000 shares, at a public offering price of $6.00 per share. Additionally, in lieu of common stock to certain investors, the Company issued and sold pre-funded warrants to purchase 3,333,333 shares of its common stock at a public offering price of $5.99 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.01 per share exercise price for each pre-funded warrant. The aggregate gross proceeds before deducting underwriting discounts and commissions, and other estimated offering expenses payable by the Company were approximately $92.0 million.
On June 25, 2025, the Company completed a registered direct offering of its common stock. The Company issued and sold 3,221,395 shares of common stock, at a price of $4.67 per share to purchasers including existing healthcare-focused institutional investors, executive officers, and directors of the Company. The aggregate gross proceeds before deducting estimated offering expenses payable by the Company were approximately $15.0 million.
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 issuance date of these condensed consolidated financial statements.
Accordingly, the condensed consolidated financial statements have been prepared on a basis that assumes the Company will continueas 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 Accounting Policies
Basis of Presentation
The accompanying condensed 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 condensed consolidated financial statements are to the FASB Accounting Standards Codification (ASC).
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.
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 June 30, 2025, the condensed consolidated statements of operations and comprehensive income (loss) for the three and six months ended June 30, 2025 and 2024, the condensed consolidated statements of stockholders’ equity (deficit) for the three and six months ended June 30, 2025 and 2024, the condensed consolidated statements of cash flows for the six months ended June 30, 2025 and 2024, and the related interim disclosures are unaudited. These unaudited 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 unaudited 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, 2024 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 June 30, 2025 and December 31, 2024, which represents cash held as a security deposit under the terms of the Company’s Needham, Massachusetts facility lease.
Recently Adopted Accounting Standards
In November 2023, the FASB issued Accounting Standards Update (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 asingle reportable segment, among other disclosure requirements. The ASU’s amendments are effective for public business entities for interim periods beginning after December 15, 2024. The Company adopted ASU 2023-07 on an interim basis beginning on January 1, 2025 (see Note 16).
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 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.
In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires additional disclosure in the notes to the financial statements of the nature of certain expenses included in the income statement. The ASU's amendments are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. Adoption can be either prospectively or retrospectively applied. The Company is currently evaluating the potential impact that ASU 2024-03 may have on its consolidated financial statements and related disclosures.
- 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 OFJUNE 30, 2025 USING: | ||||
|---|---|---|---|---|
| LEVEL 1 | LEVEL 2 | LEVEL 3 | TOTAL | |
| Liabilities: | ||||
| Warrant liability | — | — | 1,146 | 1,146 |
| Total | $— | $— | $1,146 | $1,146 |
| FAIR VALUE MEASUREMENTS AS OFDECEMBER 31, 2024 USING: | ||||
|---|---|---|---|---|
| LEVEL 1 | LEVEL 2 | LEVEL 3 | TOTAL | |
| Liabilities: | ||||
| Warrant liability | — | — | 21,718 | 21,718 |
| Total | $— | $— | $21,718 | $21,718 |
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 BWARRANTLIABILITY | |
|---|---|
| Balance at December 31, 2024 | $21,718 |
| Change in fair value | (20,572) |
| Balance at June 30, 2025 | $1,146 |
The carrying value of cash equivalents (considered as Level 1 measurements) approximates the fair value due to the short-term nature of these assets.
- Fixed Assets, Net
Fixed assets, net consisted of the following (in thousands):
| JUNE 30,2025 | DECEMBER 31,2024 | |
|---|---|---|
| Laboratory equipment | $1,208 | $1,219 |
| Manufacturing equipment | 609 | 695 |
| Furniture and fixtures | 159 | 159 |
| Networking and computer equipment | 131 | 85 |
| Leasehold improvements | 3,109 | 3,109 |
| Total fixed assets | $5,216 | $5,267 |
| Less: accumulated depreciation | (3,558) | (3,076) |
| Fixed assets, net | $1,658 | $2,191 |
Depreciation expense was$0.2 million and$0.5 million for each of the three and six months ended June 30, 2025 and 2024, respectively.
- Accrued Expenses
Accrued expenses consisted of the following (in thousands):
| JUNE 30,2025 | DECEMBER 31,2024 | |
|---|---|---|
| Payroll and employee related expenses | $1,933 | $3,038 |
| Professional fees | 1,110 | 920 |
| Third-party research and development expenses | 1,009 | 765 |
| Other | 266 | 390 |
| $4,318 | $5,113 |
- Term Loan
On February 24, 2022, the Company entered into afour-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 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 three and six months ended June 30, 2025, the Company recorded interest expense relating to the Loan Agreement of$0.2 million and$0.5 million, respectively. During the three and six months ended June 30, 2024, the Company recorded interest expense relating to the Loan Agreement of $0.5 million and$1.2 million, respectively. The weighted average effective interest rate as of June 30, 2025 was 11.79%.
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, | |
|---|---|
| 2025 (remaining six months) | $5,000 |
| 2026 | 833 |
| Total principal | 5,833 |
| Final payment fee | 900 |
| Less: debt discount | (989) |
| Accretion of debt discount | 960 |
| Net carrying amount | $6,704 |
The carrying value of the Company's term loan approximates fair value.
- 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 (the Periphagen 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. Asof June 30, 2025, the carrying value of the note is$0.9 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
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 the three and six months ended June 30, 2025, the Company recorded$90,000 and$0.2 million of operating lease cost, respectively, and for the three and six months ended June 30, 2025, the Company recorded$39,000 and$80,000, respectively, of variable lease cost. The total lease expense for each of the three and six months ended June 30, 2025 was$0.1 million and$0.3 million, respectively.
For the three and six months ended June 30, 2024, the Company recorded$90,000 and$0.2 million of operating lease cost, respectively, and for the three and six months ended June 30, 2024, the Company recorded$44,000 and$83,000, respectively, of variable lease cost. The total lease expense for each of the three and six months ended June 30, 2024 was$0.1 million and$0.3 million, respectively.
Cash paid for amounts included in the lease liability for the three and six months ended June 30, 2025 was$0.2 million and$0.3 million, respectively. Cash paid for amounts included in the lease liability for the three and six months ended June 30, 2024 was$0.1 million and$0.3 million, respectively.
| SIX MONTHS ENDEDJUNE 30, | ||
|---|---|---|
| Other Information | 2025 | 2024 |
| Operating cash flows used for operating leases (in thousands) | $304 | $296 |
| Weighted-average remaining lease term (years) | 1.2 | 2.2 |
| Weighted-average incremental borrowing rate | 7.02% | 7.02% |
The future lease payments under non-cancelable leases at June 30, 2025, are as follows (in thousands):
| 2025 | $309 |
| 2026 | 415 |
| Total future lease payments | 724 |
| Less: imputed interest | (26) |
| Total lease liability | $698 |
- 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:
| JUNE 30,2025 | DECEMBER 31,2024 | |
|---|---|---|
| Stock options outstanding | 6,135,068 | 4,486,181 |
| Unvested restricted stock | — | 330,779 |
| Shares available for future grant under stock option plan | 2,020,770 | 2,008,379 |
| Warrants | 7,507,708 | 7,507,708 |
| Pre-funded warrants | — | 3,333,333 |
| 15,663,546 | 17,666,380 |
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 and expired on August 12, 2025. As of June 30, 2025, the Company sold and issued 3,923,829 shares of common stock under the ATM Program, with total net proceeds of$20.9 million. Subsequent to June 30, 2025 and through August 5, 2025, the Company hasnot sold any additional shares of common stock under the ATM Program.
- Warrants
The Company has the following warrants outstanding for the purchase of common stock as of June 30, 2025 and December 31, 2024 (except for the Pre-Funded Warrants, which had 3,333,333 shares of common stock with an exercise price of $0.01 subject to warrants outstanding as of December 31, 2024):
| WARRANTS | SHARES OFCOMMONSTOCKSUBJECT TOWARRANTS | EXERCISEPRICE PERSHARE | EXPIRATIONDATES |
|---|---|---|---|
| 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 (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 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 income (loss). 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$1.1 million and$21.7 million as of June 30, 2025 and December 31, 2024, 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 pershare, subject to adjustments as specified in the warrant agreement. The Company recognizes the warrants as compensation expense within the condensed consolidated statements of operations and comprehensive income (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 June 30, 2025 and December 31, 2024, 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$0.7 million and$1.3 million as of June 30, 2025 and December 31, 2024, respectively, and was recorded as stock compensation expense within research and development expense and a credit to stockholders’ equity (deficit) in the condensed consolidated financial statements.
Pre-Funded Warrants
In connection with the public offering on December 16, 2024 (see Note 1), the Company has issued pre-funded warrants to purchase common stock in lieu of common stock. As the pre-funded warrants are indexed to the Company’s common stock (and otherwise meet the requirements to be classified in equity), the Company recorded the consideration received from the issuance of the pre-funded warrants as additional paid-in capital on the Company’s consolidated balance sheet. The pre-funded warrants are exercisable at any time. The holders of Pre-Funded Warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than 4.99% of the number of shares of the Common Stock outstanding immediately after giving effect to such exercise. The holders of Pre-Funded Warrants may increase or decrease such percentages not in excess of 19.99% by providing at least 61 days’ prior notice to the Company.
During the six months ended June 30, 2025,3,328,064 shares of common stock were issued upon exercise of pre-funded warrants. As of June 30, 2025, all pre-funded warrants were exercised.
- 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 thanten years from the date of grant. As of June 30, 2025, there areno 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.8,558,685 shares of common stock are reserved under the 2021 Plan, of which 2,020,770 shares remain available for future grants as of June 30, 2025.
Stock Options
Stock option activity is summarized as follows:
| NUMBER OFSTOCKOPTIONS | WEIGHTED-AVERAGEEXERCISEPRICE | WEIGHTED-AVERAGEREMAININGCONTRACTUALTERM (IN YEARS) | AGGREGATEINTRINSICVALUE(IN THOUSANDS) | |
|---|---|---|---|---|
| Outstanding as of December 31, 2024 | 4,486,181 | $2.54 | 6.61 | $27,599 |
| Granted | 1,981,350 | 7.87 | ||
| Exercised | (211,141) | 2.33 | ||
| Cancelled, forfeited or expired | (121,322) | 6.06 | ||
| Outstanding as of June 30, 2025 | 6,135,068 | $4.20 | 7.25 | $11,273 |
| Exercisable as of June 30, 2025 | 3,731,279 | $2.71 | 6.02 | $9,717 |
| Unvested as of June 30, 2025 | 2,403,789 | $6.51 | 9.16 | $1,556 |
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 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 condensed consolidated financial statements at June 30, 2025.
The fair value of stock options granted was estimated on the grant date using the Black-Scholes option pricing model based on the following range of assumptions:
| SIX MONTHS ENDEDJUNE 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Expected option life (years) | 5.50 - 6.08 | 5.50 - 6.08 |
| Risk-free interest rate | 3.83% - 4.52% | 4.21% - 4.32% |
| Expected volatility | 118.46% - 121.09% | 99.30% - 114.68% |
| Expected dividend yield | 0% | 0% |
The aggregate intrinsic value of options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the common stock as of the end of the period. The total intrinsic value of stock options exercised during the six months ended June 30, 2025 and 2024 was$0.6 million and$3.0 million, respectively.
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 OFSHARES OPTIONS | WEIGHTED-AVERAGE GRANTDATE FAIR VALUE | |
|---|---|---|
| Unvested at December 31, 2024 | 330,779 | $0.98 |
| Granted | — | — |
| Vested | (330,779) | 0.98 |
| Forfeited | — | — |
| Unvested at June 30, 2025 | — | $— |
The aggregate fair value of restricted stock units that vested during the six months ended June 30, 2025 and 2024 was$1.7 million and$4.4 million, respectively.
Stock-Based Compensation
Stock-based compensation expense for the three and six months ended June 30, 2025 and 2024 was classified in the condensed consolidated statements of operations and comprehensive income (loss) as follows (in thousands):
| THREE MONTHS ENDEDJUNE 30, | SIX MONTHS ENDEDJUNE 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Research and development | $424 | $1,269 | $298 | $1,822 |
| General and administrative | 626 | 572 | 1,066 | 1,062 |
| Total stock-based compensation expense | $1,050 | $1,841 | $1,364 | $2,884 |
As of June 30, 2025, total unrecognized compensation cost related to the unvested stock-based awards was$13.0 million, which is expected to be recognized over a weighted average period of 3.10 years.
- 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 recognized the $1.0 million upfront license fee as research and development service revenue as of December 31, 2022.
- 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 each of the six months ended June 30, 2025 and 2024, the Company didnot 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
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 June 30, 2025, the Company hadnot 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. 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 Income (Loss) Per Share
Net Income (Loss) Per Share
Basic net income (loss) per share attributable to common stockholders was computed by dividing net income (loss) by the weighted-average common shares outstanding for the period (in thousands, except share and per share data). Diluted net income (loss) per share attributable to common stockholders was computed by dividing net income (loss) by the weighted-average common shares outstanding and potentially dilutive shares for the period (in thousands, except share and per share data):
| THREE MONTHS ENDEDJUNE 30, | SIX MONTHS ENDEDJUNE 30, | |||
|---|---|---|---|---|
| Numerator: | 2025 | 2024 | 2025 | 2024 |
| Net income (loss) | $(4,796) | $(22,237) | $2,583 | $(30,458) |
| Denominator: | ||||
| Weighted-average shares of common stock outstanding, basic | 51,489,929 | 29,878,210 | 50,988,887 | 29,537,874 |
| Net income (loss) per share, basic | $(0.09) | $(0.74) | $0.05 | $(1.03) |
| Add potentially dilutive shares: | ||||
| Dilutive effect of outstanding stock options (as converted to common stock) | — | — | 2,253,771 | — |
| Dilutive effect of outstanding warrants for common stock | — | — | 126,924 | — |
| Weighted-average shares of common stock outstanding, diluted | 51,489,929 | 29,878,210 | 53,369,582 | 29,537,874 |
| Net income (loss) per share, diluted | $(0.09) | $(0.74) | $0.05 | $(1.03) |
The Company’s potentially dilutive securities have been excluded from the computation of dilutive net loss per share for the three months ended June 30, 2025 and the three and six months ended June 30, 2024, 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 income (loss) per share because including them would have had an anti-dilutive effect.
| AS OF JUNE 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Outstanding warrants for common stock | 7,507,708 | 7,507,708 |
| Outstanding stock options (as converted to common stock) | 6,135,068 | 4,676,338 |
| Unvested restricted stock | — | 1,603,462 |
| 13,642,776 | 13,787,508 | |
- Segment Reporting
The Company operates inone business segment, which includes all activities related to the discovery, development, and potential commercialization of off-the-shelf viral immunotherapies that help patients fight cancer. The determination of a single business segment is consistent with the consolidated financial information regularly provided to the Company’s chief operating decision maker (CODM). The Company’s CODM is its Chief Executive Officer, who reviews and evaluates consolidated net income (loss) for purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods.
In addition to the significant expense categories included within consolidated net income (loss) presented on the Company's condensed consolidated statements of operations and comprehensive income (loss), see below for disaggregated amounts that comprise research and development and general and administrative expenses:
| THREE MONTHS ENDEDJUNE 30, | SIX MONTHS ENDEDJUNE 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Operating expenses: | ||||
| Research and development: | ||||
| Clinical development | $3,051 | $921 | $4,296 | $1,747 |
| Employee-related | 2,957 | 3,411 | 5,109 | 6,139 |
| Facility and equipment costs | 490 | 379 | 868 | 756 |
| Pre-clinical research | 127 | 149 | 244 | 201 |
| Other research and development segment expenses | 366 | 119 | 490 | 238 |
| Total research and development | 6,991 | 4,979 | 11,007 | 9,081 |
| General and administrative: | ||||
| Employee-related | 1,945 | 1,867 | 3,661 | 3,506 |
| Professional and consulting fees | 1,436 | 1,208 | 3,238 | 2,876 |
| Commercial readiness | 343 | — | 475 | — |
| Other general and administrative segment expenses (1) | 462 | 517 | 926 | 1,010 |
| Total general and administrative | 4,186 | 3,592 | 8,300 | 7,392 |
| Total operating expenses | 11,177 | 8,571 | 19,307 | 16,473 |
| Loss from operations | (11,177) | (8,571) | (19,307) | (16,473) |
| Interest income | 926 | 240 | 1,860 | 560 |
| Interest expense | (236) | (567) | (542) | (1,213) |
| Change in fair value of warrant liability | 5,691 | (13,339) | 20,572 | (13,332) |
| Net income (loss) | $(4,796) | $(22,237) | $2,583 | $(30,458) |
(1) Other general and administrative segment expenses primarily consist of insurance, occupancy, and information technology costs.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.