UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the fiscal year ended
Commission File Number:
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
(Address of principal executive offices, including zip code)
(
(Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading symbol | Name of each exchange on which registered |
|---|---|---|
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer ☐ Accelerated Filer ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of December 31, 2025, the registrant had
Auditor name:
Form type: 10-K
Period end: 2025-12-31
Candel Therapeutics, Inc. is a public reporting company classified under Biological Products, (No Diagnostic Substances). Our lead product candidate, aglatimagene, is being evaluated in multiple ongoing clinical trials, including a pivotal phase 3 randomized, double-blind, placebo-controlled clinical trial in the United States under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) evaluating patients with newly diagnosed, localized prostate cancer who have an intermediate- or high-risk for progression. The FDA granted Fast Track Designation for the use of aglatimagene for the treatment of localized, primary prostate cancer in combination with radiation therapy to improve the local control rate. [COMPLETE: description of aglatimagene's mechanism of action, additional product candidates, and other ongoing clinical programs.]
We believe there is a significant unmet medical need in localized prostate cancer. The primary goal of curative treatment for localized prostate cancer is complete tumor eradication, as outlined by National Comprehensive Cancer Network (NCCN) guidelines. However, up to 30% of intermediate- to high-risk patients experience recurrence despite radical therapy, and salvage treatments often carry significant side effects and limited efficacy. Recurrence beyond two years post-treatment is strongly linked to need for salvage anti-cancer therapies, higher rates of metastasis, and prostate cancer-specific mortality after prolonged follow up (>10 years). Studies also show that patients prioritize the perception of being cancer-free and are often willing to risk long-term complications to achieve this. We believe these factors support the potential value of a therapy designed to improve local control when added to standard radiation therapy.
We are a clinical-stage company and have not generated any revenue from product sales. For the year ended December 31, 2025, we recorded no revenue, incurred research and development expenses of $30,496,000 compared with $19,314,000 in the prior year, and reported a net loss of $38,182,000. General and administrative expenses were $17,770,000 compared with $14,057,000 in the prior year, and we held cash and cash equivalents of $119,731,000 as of December 31, 2025. We expect to continue to incur substantial expenses as we advance our clinical programs and prepare for potential commercialization. [COMPLETE: description of manufacturing and supply arrangements, intellectual property portfolio, competition, government regulation, and number of employees and human capital resources.]
Candel Therapeutics, Inc. is a public reporting company classified under Biological Products, (No Diagnostic Substances), and our business is subject to the substantial risks inherent in developing [COMPLETE: description of product candidates and development stage]. We recorded no revenue for the period ended December 31, 2025 and incurred a net loss of $38,182,000. Our accumulated deficit was $230,387,000 at period end, compared with $192,205,000 in the prior period, and we expect to continue to incur significant losses for the foreseeable future. Research and development expense increased to $30,496,000 from $19,314,000, an increase of 57.9%, and general and administrative expense increased to $17,770,000 from $14,057,000, an increase of 26.4%. If our product candidates fail to demonstrate safety and efficacy in clinical trials, do not receive regulatory approval, or are not commercially successful, we may never generate product revenue or achieve profitability, and the value of our common stock could decline substantially.
We will require substantial additional capital to fund our operations, and such capital may not be available on acceptable terms or at all. Cash and cash equivalents were $119,731,000 at period end, compared with $102,654,000 in the prior period, and restricted cash, noncurrent, was $416,000. Additional paid-in capital increased to $282,207,000 from $258,511,000, and common stock increased to $550,000 from $469,000, reflecting our continued reliance on equity financing, which dilutes existing stockholders. We also recorded a warrant liability of $15,598,000 at period end, compared with none in the prior period, and changes in the fair value of this liability may cause significant fluctuations in our reported results from period to period. Other income (expense), net, was income of $10,084,000 in the current period compared with an expense of $21,806,000 in the prior period, and such items are outside our control and may vary materially. Total liabilities were $73,273,000 and total equity was $51,922,000 at period end, and other liabilities increased to $47,130,000 from $19,550,000. Although current debt of $9,895,000 and long-term debt of $1,733,000 in the prior period were reduced to zero, we may incur indebtedness in the future that could restrict our operations. Our primary market risk exposure is interest rate risk on cash, cash equivalents, and short-term investments, and we do not have material foreign currency or commodity price exposure; changes in interest rates could nonetheless reduce the income we earn on our cash balances.
Our ability to use our net operating losses and tax credits to offset future taxable income may be limited. Our effective tax rate was 0.0% in both the current and prior periods, reflecting a valuation allowance change of $(10,219,000) in the current period and $(9,521,000) in the prior period, and research tax credits of $(662,000) and $(508,000), respectively. We are also subject to obligations under our facility leases, and operating lease liabilities, noncurrent, increased to $1,459,000 from $407,000, while operating lease right-of-use assets increased to $1,661,000 from $542,000. Total undiscounted lease payments were $2,285,000 with a weighted average remaining lease term of 3.7 years, and we may be unable to exit or modify these commitments if our needs change.
We are involved in legal proceedings arising in the ordinary course of business from time to time, and although management does not currently believe any pending matter is material to the financial statements, litigation could result in significant costs and divert management attention. Management concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of the end of the period, and no changes materially affected internal control over financial reporting during the quarter; however, any future failure to maintain effective controls could impair our ability to report results accurately and timely. As a registrant filing reports under the Securities Exchange Act of 1934, we are responsible for establishing and maintaining disclosure controls and procedures and internal control over financial reporting, and compliance with these and other public company requirements imposes ongoing costs and demands on our resources. Any of the foregoing risks, individually or in combination, could materially and adversely affect our business, financial condition, results of operations, and prospects.
Candel Therapeutics, Inc. is a biopharmaceutical company classified under Biological Products (No Diagnostic Substances), and we have not obtained regulatory approvals for any of our product candidates. Candel Therapeutics, Inc. is a public reporting company classified under Biological Products, (No Diagnostic Substances). We have not obtained regulatory approvals for any of our product candidates, and even if our clinical development efforts result in positive data, our product candidates may not receive regulatory approval or be successfully introduced and marketed at prices that would permit us to operate profitably. We have incurred significant operating losses since our inception and anticipate that we will incur continued losses for the foreseeable future. Substantially all of our operating losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. We did not recognize any revenue for the year ended December 31, 2025, and our net loss for the period was $38,182,000. On a weighted-average basic share count of 52,958,644 shares, our basic net loss per share was $0.72. Our accumulated deficit increased to $230,387,000 as of December 31, 2025 from $192,205,000 as of the prior year end.
Research and development expenses were $30,496,000 for the year ended December 31, 2025, compared to $19,314,000 for the prior year, an increase of approximately $11.2 million, or 57.9%. We expect our research and development expenses to significantly increase in connection with the commencement and continuation of clinical trials of our product candidates, and the increase in the current period was primarily attributable to [COMPLETE: specific drivers of the increase in research and development expense, including clinical trial, manufacturing and personnel-related costs]. General and administrative expenses were $17,770,000 for the year ended December 31, 2025, compared to $14,057,000 for the prior year, an increase of approximately $3.7 million, or 26.4%, primarily due to [COMPLETE: specific drivers of the increase in general and administrative expense]. Other income, net, was $10,084,000 for the year ended December 31, 2025, compared to other expense, net, of $21,806,000 for the prior year. The change in other income (expense), net, coincided with the recognition of a warrant liability of $15,598,000 as of December 31, 2025, where none was recorded at the prior year end, and reflected [COMPLETE: drivers of the change in other income (expense), net, including changes in the fair value of warrant liability and interest income].
As of December 31, 2025, we had cash and cash equivalents of $119,731,000, compared to $102,654,000 as of December 31, 2024, an increase of approximately $17.1 million, or 16.6%, and restricted cash, noncurrent, of $416,000. During the year we eliminated our outstanding borrowings, with current debt declining to zero from $9,895,000 and long-term debt declining to zero from $1,733,000, while additional paid-in capital increased to $282,207,000 from $258,511,000. The increase in cash and cash equivalents and additional paid-in capital was driven by [COMPLETE: description of equity financing transactions and net proceeds during the period]. Our remaining lease obligations consisted of current operating lease liabilities of $445,000 and noncurrent operating lease liabilities of $1,459,000, and accrued liabilities increased to $7,334,000 from $5,113,000. Total liabilities were $73,273,000 and total stockholders' equity was $51,922,000 as of December 31, 2025. Our primary market risk exposure is interest rate risk on cash, cash equivalents, and short-term investments. We expect to continue to incur significant expenses and operating losses over the next several years and for the foreseeable future. Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders' equity and working capital. Management believes that our existing cash and cash equivalents [COMPLETE: will or will not be sufficient to fund operating expenses and capital expenditure requirements for at least the next twelve months from the date of issuance of the financial statements], and we expect to finance our future cash needs through [COMPLETE: anticipated sources of funding, such as equity offerings, debt financings, or collaborations].
| Year Ended December 31, 2025 | Year Ended December 31, 2024 | |
|---|---|---|
| Total Revenue | ||
| Total COGS | ||
| Gross Profit | ||
| General and administrative | ||
| Research and development | ||
| Total operating expenses | ||
| Operating income | - | - |
| Other income (expense) | ||
| Other income (expense), net | - | |
| Net Income | - | - |
| Basic earnings per share | - | |
| Diluted earnings per share | - | |
| Weighted average shares outstanding, basic | ||
| Weighted average shares outstanding, diluted | ||
| December 31, 2025 | December 31, 2024 | |
|---|---|---|
| Assets | ||
| Current assets | ||
| Cash and cash equivalents | ||
| Prepaid expenses and other current assets | ||
| Total current assets | ||
| Noncurrent assets | ||
| Operating lease right-of-use assets | ||
| Property, plant and equipment | ||
| Property and equipment, gross | ||
| Less: accumulated depreciation and amortization | ||
| Restricted cash, noncurrent | ||
| Other assets (derived) | ||
| Total noncurrent assets | ||
| Total Assets | ||
| Liabilities | ||
| Current liabilities | ||
| Accounts payable | ||
| Accrued compensation | 0.00 | 3,038,000.00 |
| Accrued liabilities | ||
| Debt, current | 0.00 | 9,895,000.00 |
| Operating lease liabilities, current | ||
| Other current liabilities | 0.00 | |
| Other current liabilities (derived) | ||
| Total current liabilities | ||
| Noncurrent liabilities | ||
| Deferred revenue, noncurrent | 0.00 | |
| Long-term debt | 0.00 | 1,733,000.00 |
| Operating lease liabilities, noncurrent | ||
| Warrant liability | 0.00 | |
| Other liabilities (derived) | ||
| Total noncurrent liabilities | ||
| Total Liabilities | ||
| Equity | ||
| Preferred stock, par value per share | ||
| Preferred stock, shares authorized | ||
| Preferred stock, shares issued | ||
| Preferred stock, shares outstanding | ||
| Additional paid-in capital | ||
| Common stock | ||
| Common stock, par value per share | ||
| Common stock, shares authorized | ||
| Common stock, shares issued | ||
| Common stock, shares outstanding | ||
| Retained earnings (accumulated deficit) | - | - |
| Treasury stock, at cost | - | - |
| Total Equity | ||
| Total liabilities and equity | ||
| Year Ended December 31, 2025 | Year Ended December 31, 2024 | |
|---|---|---|
| Operating activities | ||
| Net income | - | - |
| Stock-based compensation | ||
| Change in prepaid expenses and other assets | - | |
| Change in other operating assets | - | |
| Change in accounts payable | - | |
| Change in contract liabilities | 0.00 | |
| Change in accrued liabilities | ||
| Changes in operating assets and liabilities, net | - | |
| Net cash from operating activities | - | - |
| Investing activities | ||
| Purchases of property and equipment | - | - |
| Other investing activities (derived) | 0.00 | |
| Net cash from investing activities | - | - |
| Financing activities | ||
| Proceeds from exercise of stock options | ||
| Other financing activities (derived) | ||
| Net cash from financing activities | ||
| Net change in cash | ||
| Cash at beginning of period | 35,679,000.00 | |
| Cash at end of period | 102,920,000.00 | |
| Supplemental cash flow information | ||
| Cash paid for interest | ||
| Supplemental disclosure of noncash investing and financing activities | ||
| Capital expenditures incurred but not yet paid | 0.00 | |
| Common stock | Additional paid-in capital | Retained earnings (accumulated deficit) | Treasury stock, at cost | Total | |
|---|---|---|---|---|---|
| Balance at beginning of prior year | 290,000.00 | 149,931,000.00 | -137,028,000.00 | -448,000.00 | 12,745,000.00 |
| Net income | - | - | |||
| Other equity movements | 179,000.00 | 108,580,000.00 | 0.00 | 0.00 | 108,759,000.00 |
| Balance at December 31, 2024 | - | - | |||
| Net income | - | - | |||
| Other equity movements | 81,000.00 | 23,696,000.00 | 0.00 | 0.00 | 23,777,000.00 |
| Balance at December 31, 2025 | - | - |
Candel Therapeutics, Inc. is a public reporting company classified under Biological Products, (No Diagnostic Substances). As a biopharmaceutical company with a limited operating history that has not generated any revenue to date from product sales, we continue to assess our control environment as our operations develop. The accompanying condensed financial statements are unaudited, have been prepared from the Company's books and records, and, in the opinion of management, reflect all adjustments necessary for a fair statement of the results for the interim period; the results for the period ended December 31, 2025 are not necessarily indicative of the results to be expected for a full year. The Company evaluates the applicability and impact of Accounting Standards Updates issued by the Financial Accounting Standards Board as they are issued. Adopted updates and updates not yet effective are not expected to have a material effect on the financial statements, except as otherwise described in these notes. The Company recorded no revenue for the period ended December 31, 2025 and reported a net loss of $38,182,000. Research and development expense was $30,496,000 compared to $19,314,000 in the prior period, and general and administrative expense was $17,770,000 compared to $14,057,000 in the prior period. Share-based compensation expense totaled $3,817,000 compared to $5,312,000 in the prior period, and depreciation expense was $845,000.
Basic and diluted net loss per share was $(0.72), based on weighted-average basic shares outstanding of 52,958,644, and 14,009,270 potentially dilutive shares were excluded from the computation of diluted net loss per share because their effect would have been antidilutive. The Company's loss before income taxes, all of which was domestic, was $38,182,000, and the effective tax rate was 0.0% compared to the federal statutory rate of 21.0%, reflecting primarily a change in the valuation allowance of $10,219,000 and research tax credits of $662,000. Gross deferred tax assets were $65,706,000, including operating loss carryforwards of $37,934,000, tax credit carryforwards of $7,736,000 and share-based compensation of $1,375,000, against which a valuation allowance of $65,268,000 was recorded, resulting in a net deferred tax position of $0.
At December 31, 2025, the Company had no current debt and no long-term debt outstanding, compared to current debt of $9,895,000 and long-term debt of $1,733,000 at the end of the prior period. Interest expense for the period was $2,119,000. Scheduled maturities of long-term obligations were $0 within one year and in year two, $3,806,000 in year three, $24,175,000 in year four and $22,019,000 in year five. [COMPLETE: description of the obligations to which the scheduled maturities relate and reconciliation to the zero debt balance.] The Company also recognized a warrant liability of $15,598,000 at December 31, 2025, compared to none at the end of the prior period, and total liabilities were $73,273,000. Operating lease right-of-use assets were $1,661,000 compared to $542,000 in the prior period, with current operating lease liabilities of $445,000 and noncurrent operating lease liabilities of $1,459,000, compared to $566,000 and $407,000, respectively, in the prior period. Undiscounted lease payments were $618,000 within one year, $613,000 in year two, $628,000 in year three and $426,000 in year four, for total undiscounted lease payments of $2,285,000, less imputed interest of $381,000, resulting in a present value of operating lease liabilities of $1,904,000 and a weighted average remaining lease term of 3.7 years. Operating lease cost was $400,000 and variable lease cost was $200,000, for total lease cost of $600,000, and cash paid for amounts included in the measurement of operating lease liabilities was $613,000.
Stockholders' equity at December 31, 2025 consisted of common stock of $550,000, additional paid-in capital of $282,207,000, an accumulated deficit of $230,387,000 and treasury stock, at cost, of $448,000, and total equity was $51,922,000. Common stock increased from $469,000 and additional paid-in capital increased from $258,511,000 at the end of the prior period, while the accumulated deficit increased from $192,205,000 and treasury stock was unchanged at $448,000. [COMPLETE: description of equity transactions during the period, including any issuances of common stock and warrants.] Cash and cash equivalents were $119,731,000 compared to $102,654,000 in the prior period, and noncurrent restricted cash was $416,000 compared to $266,000 in the prior period. The Company is involved in legal proceedings arising in the ordinary course of business from time to time. Management does not currently believe any pending matter is material to the financial statements.
The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) and the applicable rules and regulations of the Securities and Exchange Commission. In the opinion of management, the financial statements reflect all adjustments necessary for a fair statement of the financial position, results of operations, and cash flows for the periods presented.
The financial statements include the accounts of the Company and its consolidated subsidiaries, if any. All intercompany balances and transactions have been eliminated in consolidation.
Property and equipment are stated at cost less accumulated depreciation. Depreciation is recognized over the estimated useful lives of the related assets, generally on a straight-line basis. Expenditures for maintenance and repairs are expensed as incurred.
Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. When the carrying amount of an asset or asset group is not recoverable, an impairment loss is recognized for the amount by which the carrying amount exceeds fair value.
The Company determines whether an arrangement is or contains a lease at inception. For leases with terms greater than twelve months, a right-of-use asset and a corresponding lease liability are recognized at the lease commencement date, measured at the present value of the remaining lease payments over the lease term.
Debt is carried at amortized cost. Debt issuance costs and discounts or premiums are presented as an adjustment to the carrying amount of the related debt and amortized to interest expense over the contractual term of the debt.
Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences of temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, measured using enacted tax rates expected to apply in the years in which those temporary differences are expected to be recovered or settled. A valuation allowance is recognized when it is more likely than not that some portion of the deferred tax assets will not be realized.
Share-based compensation is measured at the grant-date fair value of the award and recognized as expense over the requisite service period of the award.
Basic earnings per share is computed by dividing income available to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted earnings per share reflects the potential dilution that would occur if securities or other contracts to issue common stock were exercised or converted into common stock, except when the effect would be antidilutive.
Equity instruments issued by the Company are classified in stockholders' equity based on their terms. The components of stockholders' equity and the changes in those components for the periods presented are set forth in the equity note.
The Company evaluates the applicability and impact of Accounting Standards Updates issued by the Financial Accounting Standards Board as they are issued. Adopted updates and updates not yet effective are not expected to have a material effect on the financial statements, except as otherwise described in these notes.
| Current | Prior | |
|---|---|---|
| Debt, current | 0.00 | |
| Long-term debt | 0.00 | |
| Operating lease liabilities, current | ||
| Operating lease liabilities, noncurrent | ||
| Total debt | 1,904,000.00 | 12,601,000.00 |
| Amount | |
|---|---|
| Within one year | |
| Year two | |
| Year three | |
| Year four | |
| Year five |
| Current | Prior | |
|---|---|---|
| Property, plant and equipment | ||
| Total property and equipment | 1,642,000.00 | 2,191,000.00 |
| Current | Prior | |
|---|---|---|
| Additional paid-in capital | ||
| Common stock | ||
| Retained earnings (accumulated deficit) | - | - |
| Treasury stock, at cost | - | - |
| Total stockholders' equity | 51,922,000.00 | 66,327,000.00 |
| Current | Prior | |
|---|---|---|
| Weighted average shares outstanding, basic | ||
| Weighted average shares outstanding, diluted | ||
| Basic earnings per share | -0.72 | -1.74 |
| Diluted earnings per share | - | - |
| Antidilutive securities excluded from diluted EPS |
| Amount | |
|---|---|
| Within one year | |
| Year two | |
| Year three | |
| Year four | |
| Total undiscounted lease payments | |
| Less imputed interest | |
| Present value of operating lease liabilities | |
| Weighted average remaining lease term (years) |
| Current | Prior | |
|---|---|---|
| Operating lease cost | ||
| Variable lease cost | ||
| Total lease cost | ||
| Cash paid for amounts included in the measurement of operating lease liabilities |
| Current | Prior | |
|---|---|---|
| Tax at federal statutory rate | ( | ( |
| Federal statutory rate | ||
| State and local rate | ||
| Valuation allowance change | ( | ( |
| Valuation allowance change rate | ||
| Nondeductible share-based compensation | ( | |
| Nondeductible share-based compensation rate | ( | |
| Research tax credits | ( | ( |
| Research tax credits rate | ||
| Nondeductible expenses | ||
| Nondeductible expenses rate | ( | ( |
| Effective tax rate |
| Current | Prior | |
|---|---|---|
| Deferred tax assets, gross | ||
| Operating loss carryforwards | ||
| Share-based compensation | ||
| Other deferred tax assets | ||
| Valuation allowance | ||
| Deferred tax assets, net | ||
| Tax credit carryforwards | ||
| Goodwill and intangible assets | ||
| Other reserves and accruals | ||
| Deferred income tax liabilities | ||
| Other deferred tax liabilities | ||
| Net deferred tax position |
| Current | Prior | |
|---|---|---|
| Domestic | ( | ( |
| Income before income taxes | (38,182,000.00) | (55,177,000.00) |
| Current | Prior | |
|---|---|---|
| Total share-based compensation expense |
| Current | Prior | |
|---|---|---|
| Depreciation | ||
| Interest expense, nonoperating |
| Current | Prior | |
|---|---|---|
| Interest expense |
[COMPLETE: Management's conclusion language in this section must be reviewed and formally adopted by management before filing.] Management evaluated disclosure controls and procedures as of the end of the period and concluded they were effective at the reasonable assurance level. Management, including our principal executive officer and principal financial officer, does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met, and the design of any control system reflects resource constraints and the benefits of controls relative to their costs.
[COMPLETE: Management's annual report on internal control over financial reporting as of December 31, 2025, including the framework used in the assessment and management's conclusion on effectiveness, and any attestation report of the independent registered public accounting firm, if applicable.] As a biopharmaceutical company with a limited operating history that has not generated any revenue to date from product sales, we continue to assess our control environment as our operations develop.
No changes materially affected internal control over financial reporting during the quarter. There were no changes in our internal control over financial reporting during the quarter ended December 31, 2025 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Candel Therapeutics, Inc. is a public reporting company classified under Biological Products (No Diagnostic Substances), and we recognize the importance of assessing, identifying, and managing material risks from cybersecurity threats as part of our overall enterprise risk management. Candel Therapeutics, Inc. is a public reporting company classified under Biological Products, (No Diagnostic Substances). Our cybersecurity risk management program is designed to protect the confidentiality, integrity, and availability of our information systems and the data they contain, including [COMPLETE: description of key data categories such as clinical trial data, proprietary research, and personal information]. The program includes [COMPLETE: description of processes for identifying and assessing cybersecurity risks, including risk assessments, monitoring, vulnerability management, and incident response planning], and [COMPLETE: description of the use of third-party assessors, consultants, or managed service providers, if any].
We also maintain processes to oversee and identify material risks from cybersecurity threats associated with our use of third-party service providers, including [COMPLETE: description of vendor due diligence, contractual requirements, and ongoing monitoring of third parties such as contract research organizations, cloud providers, and other vendors]. [COMPLETE: Statement regarding whether any cybersecurity incidents to date have materially affected, or are reasonably likely to materially affect, the company, its business strategy, results of operations, or financial condition.] Despite our efforts, we cannot eliminate all risks from cybersecurity threats, or provide assurance that we have not experienced an undetected cybersecurity incident, and any future incident could have a material adverse effect on our business.
Our Board of Directors oversees our cybersecurity risk management, with [COMPLETE: identification of the Board or committee, such as the Audit Committee, with primary oversight responsibility] receiving [COMPLETE: frequency and nature of reports from management on cybersecurity risks, program updates, and any incidents]. At the management level, [COMPLETE: title of the officer or officers responsible for assessing and managing cybersecurity risks, such as Chief Financial Officer, Chief Information Officer, or head of IT] is responsible for our cybersecurity program and has [COMPLETE: description of relevant expertise, including prior work experience, certifications, or degrees]. Management is informed about and monitors the prevention, detection, mitigation, and remediation of cybersecurity incidents through [COMPLETE: description of processes such as incident escalation protocols, internal reporting, and periodic review of program effectiveness], and escalates matters to the Board or the responsible committee in accordance with [COMPLETE: description of escalation criteria and reporting procedures].
The Item 408(a) Rule 10b5-1 trading arrangement disclosure renders here from the guided trading arrangement intake on this page. Complete the intake to state whether any director or officer adopted or terminated a trading arrangement during the fourth fiscal quarter. Author any other Item 9B disclosure in this section as well.
The following individuals serve as directors of Candel Therapeutics, Inc.: Nicoletta Loggia, Paul B. Manning, Joseph C. Papa, Maha Radhakrishnan, Christopher Martell, Gary J. Nabel and Diem Nguyen, together with [COMPLETE: any additional directors, including the Chief Executive Officer if a director, with ages, terms and biographical information]. The Company's executive officers include Seshu Tyagarajan, Chief Technology Officer; Mark E. Sims, Chief Commercial Officer; and Francesca Barone, Chief Scientific Officer, together with [COMPLETE: Chief Executive Officer, Principal Financial Officer and any other executive officers, with ages and biographical information]. Information regarding the Company's audit committee, audit committee financial expert, code of ethics, insider trading policies and procedures for shareholder recommendations of director nominees is set forth at [COMPLETE: audit committee composition, audit committee financial expert designation, code of ethics location and any changes to nominating procedures]. Based on a review of Section 16(a) reports filed with the SEC for fiscal year 2025, the Company believes that all reports required to be filed by its directors, executive officers and greater than ten percent beneficial owners were filed on a timely basis [COMPLETE: confirm written representations from reporting persons and confirm Form 3 timeliness for insiders whose became-insider dates have not been established].
The information required with respect to executive compensation, including the compensation discussion and analysis, summary compensation table, outstanding equity awards, director compensation, compensation committee interlocks and insider participation, compensation committee report and pay versus performance disclosure, is set forth at [COMPLETE: executive compensation disclosure or incorporation by reference to the definitive proxy statement]. The information required with respect to security ownership of certain beneficial owners and management, including beneficial ownership of the Company's common stock by each director, each named executive officer, all directors and executive officers as a group and each person known to own more than five percent of the outstanding common stock, is set forth at [COMPLETE: beneficial ownership table with shares and percentages as of the record date]. The information required with respect to securities authorized for issuance under equity compensation plans is set forth at [COMPLETE: equity compensation plan information table].
The information required with respect to transactions with related persons, the Company's policies and procedures for the review and approval of related person transactions, and the independence of directors is set forth at [COMPLETE: related person transactions since the beginning of fiscal year 2025, review policy and director independence determinations under applicable listing standards]. The information required with respect to principal accountant fees and services, including audit fees, audit-related fees, tax fees and all other fees billed by the Company's independent registered public accounting firm for the fiscal years ended December 31, 2025 and 2024, together with the audit committee's pre-approval policies and procedures, is set forth at [COMPLETE: name of independent registered public accounting firm, fee amounts by category for each fiscal year and pre-approval policy description]. The foregoing information relates to Candel Therapeutics, Inc. for the fiscal year ended December 31, 2025, and to the extent set forth in the Company's definitive proxy statement, such information is incorporated herein by reference.