/stocks — the workspaceLOADING

CADL · All filings · Read this filing

What changed 10-K

Item 9A. Controls and Procedures

2026-03-12 compared with 2025-03-13 · 272 added, 156 removed, 694 unchanged (38% of the section changed)

7 unchanged sentences

Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their control objectives.

Our management, with the participation of our Chief Executive Officer and Interim Chief Financial Officer (our principal executive officer and principal financial officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2024.

Based on the evaluation of our disclosure controls and procedures as of December 31, 2024, our Chief Executive Officer and Interim Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2025.

Based on the evaluation of our disclosure controls and procedures as of December 31, 2025, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Management's Report on Internal Control Over Financial Reporting

13 unchanged sentences

Other Information.

(b) The following table describes contracts, instructions or written plans for the sale or purchase of our securities adopted by our directors and certain officers during the fourth quarter of 2024, each of which is intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c), referred to as Rule 10b5-1 trading plans.

Nature of Trading Arrangement

Duration of Trading Arrangement

Aggregate Number of Securities

Paul Peter Tak , M.D., Ph.D., FMedSci ( Chief Executive Officer, President and Director )

Adoption ( November 19, 2024 )

Trading plan intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c)

Earlier of (i) 466 days and (ii) the completed sale of the maximum aggregate number of securities under the plan

Up to 868,783 shares

Charles Schoch ( Interim Chief Financial Officer, Treasurer and Secretary )

Adoption ( November 15, 2024 )

Trading plan intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c)

Earlier of (i) 379 days and (ii) the completed sale of the maximum aggregate number of securities under the plan

Up to 20,000 shares

Francesca Barone , M.D., Ph.D.

( Chief Scientific Officer )

Adoption ( November 22, 2024 )

Trading plan intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c)

Earlier of (i) 372 days and (ii) the completed sale of the maximum aggregate number of securities under the plan

Up to 38,646 shares

Garrett Nichols , M.D., M.S.

( Chief Medical Officer )

Adoption ( November 22, 2024 )

Trading plan intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c)

Earlier of (i) 372 days and (ii) the completed sale of the maximum aggregate number of securities under the plan

Up to 49,848 shares

Seshu Tyagarajan , Ph.D.

RAC ( Chief Technical Development Director )

Adoption ( November 15, 2024 )

Trading plan intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c)

Earlier of (i) 470 days and (ii) the completed sale of the maximum aggregate number of securities under the plan

Up to 61,278 shares

During the three months ended December 31, 2025, none of our directors or officers (as defined in Rule 16a-1(f) of the Securities Exchange Act of 1934, as amended) adopted , terminated or modified a Rule 10b5-1 trading arrangement or any “non-Rule 10b5-1 trading agreement” (as defined in Item 408(c) of Regulation S-K).

On March 10, 2026, we entered into that certain First Amendment to Loan and Security Agreement among the Company and Trinity Capital Inc.

(the First Amendment to Trinity LSA).

The First Amendment to Trinity LSA amended our financial covenant such that the period in which we are required, if our market capitalization is less than $550 million, to maintain minimum cash and cash equivalents of 67.5% of all of the aggregate principal amount of outstanding obligations under the Trinity LSA shall be through the date that we have raised at least $93.5 million in unrestricted net cash proceeds from one or more bona fide equity financings and/or upfront proceeds from business development after the Closing Date (as defined in the Trinity LSA).

The First Amendment to Trinity LSA also makes corresponding amendments and additions to defined terms.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections .

22 unchanged sentences

333- 257444) filed with the SEC on July 16, 2021)

Description of Securities

Description of Securities (incorporated by reference to Exhibit 4.2 to the Registrant’s Form 10-K filed with the SEC on March 13, 2025)

Investors’ Rights Agreement (incorporated by reference to Exhibit 4.2 to the Registrant’s Registration Statement on Form S-1/A (File No.

6 unchanged sentences

333- 257444) filed with the SEC on June 25, 2021)

Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on December 13, 2024)

Form of Lender Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on October 14, 2025)

2015 Stock Plan, as amended, and forms of award agreements thereunder (incorporated by reference to Exhibit 10.1 to the Registrant’s Registration Statement on Form S-1/A (File No.

23 unchanged sentences

333- 257444) filed with the SEC on July 16, 2021)

Loan and Security Agreement by and between the Registrant and Silicon Valley Bank, dated February 24, 2022 (incorporated by reference to Exhibit 10.11 to the Registrant's Annual Report on Form 10-K filed with the SEC on March 29, 2022)

Employment Agreement by and between Candel Therapeutics and Francesca Barone dated February 3, 2022 (incorporated by reference to Exhibit 10.12 to the Registrant's Annual Report on Form 10-K filed with the SEC on March 29, 2022)

Employment Agreement by and between Candel Therapeutics, Inc.

and Francesca Barone dated February 3, 2022 (incorporated by reference to Exhibit 10.12 to the Registrant's Annual Report on Form 10-K filed with the SEC on March 29, 2022)

Consulting Agreement by and between Candel Therapeutics, Inc.

and Susan Stewart dated October 19, 2021 (incorporated by reference to Exhibit 10.13 to the Registrant's Annual Report on Form 10-K filed with the SEC on March 29, 2022)

Employment Agreement by and between Candel Therapeutics and Seshu Tyagarajan dated April 14, 2022 (incorporated by reference to Exhibit 10.8 to the Registrant’s Quarterly Report on Form 10-Q filed with the SEC on May 12, 2022)

Employment Agreement by and between Candel Therapeutics and Jason A.

Amello dated September 21, 2022 (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed with the SEC on November 10, 2022)

Employment Agreement by and between Candel Therapeutics, Inc.

and Seshu Tyagarajan dated April 14, 2022 (incorporated by reference to Exhibit 10.8 to the Registrant’s Quarterly Report on Form 10-Q filed with the SEC on May 12, 2022)

Master Production Services Agreement by and between Candel Therapeutics and SAFC Carlsbad, Inc., effective November 3, 2022 (incorporated by reference to Exhibit 10.16 to the Registrant’s Annual Report on Form 10-K filed with the SEC on March 30, 2023)

2 unchanged sentences

dated June 7, 2023 (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed with the SEC on August 10, 2023)

First Amendment to Loan and Security Agreement by and between Candel Therapeutics, Inc.

and Silicon Valley Bank, dated June 14, 2023 (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q filed with the SEC on August 10, 2023)

Consulting by and between Candel Therapeutics, Inc.

Amello, dated as of January 12, 2024 (incorporated by reference to Exhibit 10.19 to the Registrant's Annual Report on Form 10-K filed with the SEC on March 28, 2024)

First Amendment to Lease of Premises at 117 Kendrick Street, Needham, Massachusetts by and between 117 Kendrick DE, LLC and the Registrant dated as of August 18, 2025 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on August 21, 2025).

Loan and Security Agreement, by and among the Registrant, Trinity Capital Inc.

and the other parties thereto, dated as of October 14, 2025 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on October 14, 2025).

Form of Omnibus Amendment, Release and Waiver to Warrants to Purchase Common Stock, by and among the Registrant and the other parties thereto, dated as of October 14, 2025 (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed with the SEC on October 14, 2025).

Candel Therapeutics, Inc.

Insider Trading Policy

2025 Inducement Plan and forms of award agreements thereunder

Candel Therapeutics, Inc.

Non-Employee Director Compensation Policy

Purchase Agreement by and between Candel Therapeutics, Inc.

and RTW Investments, LP, dated as of February 19, 2026

First Amendment to Loan and Security Agreement, by and among the Registrant, Trinity Capital Inc., and the other parties thereto, dated as of March 10, 2026.

Candel Therapeutics, Inc.

Insider Trading Policy (incorporated by reference to Exhibit 19.1 to the Registrant’s Form 10-K filed with the SEC on March 13, 2025)

List of Subsidiary (incorporated by reference to Exhibit 21.1 to the Registrant's Annual Report on Form 10-K filed with the SEC on March 29, 2022)

61 unchanged sentences

Accrued expenses

Current portion of term loan payable to a bank

Current portion of term loans

Current portion of lease liability

Warrant liability

Warrant liabilities

Other current liabilities

Total current liabilities

Term loan payable to a bank

Deferred revenue

Term loans, net of current portion

Other long-term debt

Lease liability, net of current portion

Warrant liability

Warrant liabilities

Total liabilities

26 unchanged sentences

Interest expense

Change in fair value of warrant liability

Change in fair value of warrant liabilities

Total other income (expense), net

10 unchanged sentences

Balance as of December 31, 2023

Stock-based compensation

Restricted stock unit vesting, net

of shares withheld for taxes

Change in fair value of

NC Ohio Trust Warrants

Balance as of December 31, 2023

Issuance of common stock and

11 unchanged sentences

Balance as of December 31, 2024

Issuance of common stock

in registered direct offering, net of

issuance costs of $ 0.7 million

Sale of common stock through

at-the-market offerings, net of

issuance costs of $ 0.2 million

Options exercised

Stock-based compensation

Restricted stock unit vesting

Change in fair value of

NC Ohio Trust Warrants

Exercise of pre-funded warrants

Issuance costs related to common stock

and accompanying pre-funded

warrants in public offering

Balance as of December 31, 2025

The accompanying notes are an integral part of these consolidated financial statements.

6 unchanged sentences

Impairment of fixed assets

Loss on the sale of fixed assets

Loss on the sale and disposal of fixed assets

Non-cash stock compensation expense

1 unchanged sentence

Non-cash interest expense

Change in fair value of warrant liability

Change in fair value of warrant liabilities

Accretion of debt discount

11 unchanged sentences

Cash Flows from Financing Activities:

Proceeds from issuance of common stock and accompanying pre-funded warrants in public offering, net of issuance costs

Proceeds from term loan, net of issuance costs

Proceeds from issuance of common stock in registered direct offering, net of issuance costs

Proceeds from sale of common stock through at-the-market offerings, net of issuance costs

Proceeds from option exercises

Principal payments on term loan

Payments related to tax withholding for vested restricted stock units

Net cash provided by (used in) financing activities

Net increase (decrease) in cash, cash equivalents and restricted cash

Proceeds from issuance of common stock and accompanying pre-funded warrants in public offering, net of issuance costs

Principal payments on term loan payable to a bank

Net cash provided by financing activities

Net increase in cash, cash equivalents and restricted cash

Cash, cash equivalents and restricted cash at beginning of period

2 unchanged sentences

Cash paid for interest

Supplemental disclosures of non-cash information:

Change in right of use asset and lease liability due to lease amendment

Initial fair value of warrant liability in connection with debt financing

Capital expenditures in accounts payable and accrued expenses

Deferred offering issuance costs in accounts payable and accrued expenses

The accompanying notes are an integral part of these consolidated financial statements.

7 unchanged sentences

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.

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 its two product candidates, aglatimagene and linoserpaturev, are in clinical trials for a number of tumor types.

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.

2 unchanged sentences

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 $ 55.2 million and $ 37.9 million for the years ended December 31, 2024, and 2023, respectively.

The Company had a net loss of $ 38.2 million and $ 55.2 million for the years ended December 31, 2025, and 2024, respectively.

In addition, as of December 31, 2025, the Company had an accumulated deficit of $ 230.4 million .

1 unchanged sentence

On August 5, 2022, the Company filed a shelf registration statement on Form S-3 (as amended to date, the 2022 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.

Securities and Exchange Commission (SEC), which covered 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 2022 Shelf (the 2022 ATM Program).

The 2022 Shelf was declared effective by the SEC on August 12, 2022 and expired on August 12, 2025.

As of August 12, 2025, the Company had sold and issued 3,923,829 shares of common stock under the 2022 ATM Program, with total net proceeds of $ 20.9 million.

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 com pleted 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.

On August 14, 2025, the Company filed a shelf registration statement on Form S-3 (the 2025 Shelf) with the SEC, which covers the offering, issuance, and sale by us of up to an aggregate of $ 300.0 million of our common stock, preferred stock, debt securities, warrants and/or units of any combination thereof.

The Company simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, to provide for the issuance and sale by the Company of up to $ 50.0 million of our common stock from time to time in “at-the-market” offerings under the 2025 Shelf (the 2025 ATM Program).

The 2025 Shelf was declared effective by the SEC on August 22, 2025.

As of December 31, 2024 , the Company has sold and issued 2,936,057 shares of common stock under the ATM Program, with total net proceeds of $ 15.8 million .

Subsequent to December 31, 2024 and through March 6, 2025, the Company has sold and issued 40,334 additional shares of common stock under the ATM Program, with total net proceeds of $ 0.4 million .

As of December 31, 2025 and through March 5, 2026 , the Company has no t sold any shares of common stock under the 2025 ATM Program.

The future viability of the Company is dependent on its ability to raise additional capital to finance its operations.

The Company’s inability to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies.

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.

1 unchanged sentence

Accordingly, the 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.

December 2024 Public Offering

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.

Summary of Significant Accounting Policies

2 unchanged sentences

The FASB sets generally accepted accounting principles (GAAP) that the Company follows to ensure its financial condition, results of operations, and cash flows are consistently reported.

References to GAAP issued by the FASB in these notes to the financial statements are to the FASB Accounting Standards Codification (ASC).

References to GAAP issued by the FASB in these notes to the consolidated financial statements are to the FASB Accounting Standards Codification (ASC).

Principles of Consolidation

16 unchanged sentences

Restricted Cash

The Company had $ 0.3 million of restricted cash as of both December 31, 2024 and 2023 , which represents cash held as a security deposit under the terms of the Company’s Needham, Massachusetts facility lease.

The Company had $ 0.4 million and $ 0.3 million of restricted cash as of December 31, 2025 and 2024 , respectively, which represents cash held as a security deposit under the terms of the Company’s Needham, Massachusetts facility lease and as security for the Company credit card program.

Fair Value Measurements

8 unchanged sentences

The carrying value of the Company's term loan approximates fair value due to the variable interest rate.

The Company’s warrant liability is carried at fair value and is classified as Level 3 measurement.

The Company’s warrant liabilities are carried at fair value and are classified as Level 3 measurement.

Property and Equipment

27 unchanged sentences

Long-lived assets consist of fixed assets and operating lease assets.

During the years ended December 31, 2024 and 2023 , the Company recorded impairment charges totaling approximately $ 41,000 and $ 0.4 million, respectively, related to manufacturing equipment that the Company has determined it does not plan to use for its intended use, and the Company recorded an impairment to reduce the carrying value to its estimated fair value.

During the years ended December 31, 2025 and 2024, the Company recorded impairment charges totaling approximately $ 90,000 and $ 41,000 , respectively, related to manufacturing equipment that the Company has determined it does not plan to use for its intended use, and the Company recorded an impairment to reduce the carrying value to its estimated fair value.

The Company has not recorded any other impairment losses on such long-lived assets.

43 unchanged sentences

Government grants are recorded as grant income and classified in other income in the consolidated statements of operations.

The Company did no t recognize any government grants for the years ended December 31, 2024 and 2023 .

The Company recognized government grant income of $ 88,800 and zero for the years ended December 31, 2025 and 2024 , respectively.

The Company accounts for income taxes using the asset and liability method in accordance with ASC Topic 740, Income Taxes (ASC 740) which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the financial statements or in the Company’s tax returns.

16 unchanged sentences

Recently Adopted Accounting Standards

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.

The Company adopted ASU 2023-07 for the year ended December 31, 2024 (see Note 17).

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 a single

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 17).

In December 2023, the FASB issued ASU No.

2023-09, Income Taxes (Topic 740):

Improvements to Income Tax Disclosures, which focuses on the rate reconciliation and income taxes paid.

2023-09 requires a public business entity (PBE) to disclose, on an annual basis, a tabular rate reconciliation using both percentages and currency amounts, broken out into specified categories with certain reconciling items further broken out by nature and jurisdiction to the extent those items exceed a specified threshold.

In addition, all entities are required to disclose income taxes paid, net of refunds received disaggregated by federal, state/local, and foreign and by jurisdiction if the amount is at least 5% of total income tax payments, net of refunds received.

For PBEs, the new standard is effective for annual periods beginning after December 15, 2024, with early adoption permitted.

For entities other than PBEs, the requirements will be effective for annual periods beginning after December 15, 2025.

An entity may apply the amendments in this ASU prospectively by providing the revised disclosures for the period ending December 31, 2025 and continuing to provide the pre-ASU disclosures for the prior periods, or may apply the amendments retrospectively by providing the revised disclosures for all period presented.

As of December 31, 2025 , the Company adopted this new ASU retrospectively (see Note 12) and it only impacts the Company's income tax disclosures with no impact to its operations, cash flows, or financial condition.

Recently Issued Accounting Standards

4 unchanged sentences

The Company is currently evaluating the potential impact that ASU 2023-06 may have on its 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 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):

2 unchanged sentences

Early adoption is permitted.

Adoption can be either prospectively or retrospectively applie d.

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.

In September 2025, the FASB issued ASU 2025-06, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40):

Targeted Improvements to the Accounting for Internal-Use Software, which removes references to prescriptive and sequential development stages, requiring companies to capitalize internal-use software costs when management commits to funding the software project and it is probable the project will be completed.

The ASU's amendments are effective for annual reporting periods beginning after December 15, 2027, and interim reporting periods within those annual reporting periods.

Early adoption is permitted as of the beginning of an annual reporting period.

Adoption can be applied prospectively, retrospectively or with a modified transition approach.

The Company is currently evaluating the potential impact that ASU 2025-06 may have on its consolidated financial statements and related disclosures.

In December 2025, the FASB issued ASU 2025-10, Government Grants (Topic 832):

Accounting for Government Grants Received by Business Entities, which provides recognition, measurement, presentation, and disclosure requirements for government grants.

The ASU's amendments are effective for annual reporting periods beginning after December 15, 2028, and interim reporting periods within those annual reporting periods.

Early adoption is permitted in both interim and annual reporting periods.

Adoption can be applied with a modified prospective approach, a modified retrospective approach or retrospectively.

The Company is currently evaluating the potential impact that ASU 2025-10 may have on its consolidated financial statements and related disclosures.

In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270):

Narrow-Scope Improvements, which is intended to clarify and improve certain aspects of interim financial reporting, including the requirements for interim disclosures and the application of recognition and measurement guidance in interim periods.

ASU 2025-11 is effective for interim reporting periods within annual reporting periods beginning after December 15, 2027, with early adoption permitted.

Adoption can be applied prospectively or retrospectively.

The Company is currently evaluating the potential impact that ASU 2025-11 may have on its consolidated financial statements and related disclosures.

Fair Value of Financial Assets and Liabilities

2 unchanged sentences

DECEMBER 31, 2025 USING:

Warrant liability

Warrant liabilities

FAIR VALUE MEASUREMENTS AS OF

1 unchanged sentence

Warrant liability

Valuation of Warrant Liability

Valuation of Warrant Liabilities

Series B Warrants

In connection with the November 13, 2018 issuance of Series B convertible preferred stock, the Company issued warrants to purchase shares of common stock of which certain warrants are shown as a liability on the balance sheet, see Note 10.

The fair value of the warrant liability was determined based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy.

The fair value of the warrant liability uses various valuation methods, including the Monte Carlo method, the option-pricing method, probability-weighted expected return and the hybrid method, all of which incorporate assumptions and estimates, to value the common stock warrants.

The fair value of the warrant liability use various valuation methods, including the Monte Carlo method, the option-pricing method, probability-weighted expected return and the hybrid method, all of which incorporate assumptions and estimates, to value the common stock warrants.

The hybrid method is often used when a company is expecting a liquidity event in the near future and is a combination of the option-pricing and probability-weighted expected return methods.

Estimates and assumptions impacting the fair value measurement include the fair value per share of the underlying shares of common stock, risk-free interest rate, expected dividend yield, expected volatility of the price of the underlying common stock, and the

remaining contractual term of the warrants.

Estimates and assumptions impacting the fair value measurement include the fair value per share of the underlying shares of common stock, risk-free interest rate, expected dividend yield, expected volatility of the price of the underlying common stock, and the remaining contractual term of the warrants.

The most significant assumption in the model impacting the fair value of the common stock warrants is the fair value of the Company’s common stock as of each remeasurement date.

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):

Lender Warrants

In connection with the October 14, 2025 Trinity LSA, the Company is required to issue to the Lenders warrants to purchase shares of common stock of which certain warrants are shown as a liability on the balance sheet, see Note 10.

The fair value of the associated warrant liability is determined based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy.

The fair value of the warrants is determined using a hybrid Monte Carlo simulation and Black-Scholes methodology, which incorporates assumptions and estimates to value the common stock warrants.

Key inputs, estimates, and assumptions impacting the fair value measurement include the Company stock price, risk-free interest rate, expected dividend yield, volatility, remaining contractual term of the warrants, timing of milestone achievements, and expected stock price increases and decreases in success and failure scenarios related to the milestones.

The most significant assumptions in the model impacting the fair value of the common stock warrants is the volatility of the Company’s common stock, and expected stock price increases or decreases on the respective milestone dates.

The following table provides a roll forward of the aggregate fair values of the Company’s warrant liabilities, for which fair value is determined by Level 3 inputs (in thousands):

Balance at December 31, 2023

1 unchanged sentence

Balance at December 31, 2024

Lender warrants in connection with debt financing

Change in fair value

10 unchanged sentences

Fixed assets, net

Depreciation expense was $ 1.0 million for each of the years ended December 31, 2024 and 2023 .

Depreciation expense was $ 0.8 million and $ 1.0 million for the years ended December 31, 2025 and 2024.

The Company recorded a $ 0.3 million loss on the sale and disposal of fixed assets for the year ended December 31, 2025 .

The Company did no t record any loss on the sale and disposal of fixed assets for the year ended December 31, 2024 .

Accrued Expenses

1 unchanged sentence

Payroll and employee related expenses

Professional fees

Third-party research and development expenses

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 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 years ended December 31, 2024 and 2023, the Company recorded interest expense relating to the Loan Agreement of $ 2.0 million and $ 2.5 million , respectively.

Professional fees

On February 24, 2022 , the Company entered into a four-year loan and security agreement (the SVB 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 SVB Loan Agreement.

The term loan was secured by substantially all of the Company’s properties, rights and assets, except for its intellectual property, which was subject to a negative pledge under the Loan Agreement.

The term loan bore 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 was 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 loan had a maturity date of January 1, 2026 .

Upon repayment in full of the term loans, the Company was required to pay a final payment fee equal to 4.50 % of the original principal amount of any funded term loan being repaid.

The SVB Loan Agreement permitted voluntary prepayment of all, but not less than all, of the SVB term loan, subject to a prepayment premium of 1 % to 3 % based upon the timing of the repayment.

During the years ended December 31, 2025 and 2024, the Company recorded interest expense relating to the SVB Loan Agreement of $ 0.6 million and $ 2.0 million , respectively.

The Company incurred $ 89,000 of debt issuance costs and a $ 0.9 million final payment fee, which were recorded as debt discount and amortized over the term of the SVB Loan Agreement.

The Company used a portion of the proceeds from the First Tranche of the Trinity LSA to repay the SVB Loan Agreement on October 14, 2025 (see below).

On October 14, 2025 , the Company entered into a Loan and Security Agreement, as amended by that certain First Amendment to Loan and Security Agreement dated as of March 10, 2026 (the Trinity LSA), with the lenders party thereto (the Lenders) and Trinity Capital Inc., as administrative agent and collateral agent (the Agent).

Under the Trinity LSA, the Lenders agreed to extend debt capital to the Company, at the Company's request, in the form of a term loan, in tranches totaling an aggregate principal amount of up to $ 130.0 million as follows:

(a) at closing, the aggregate principal amount of $ 50.0 million (the First Tranche), (b) until May 30, 2027, subject to the achievement of certain regulatory, clinical and operational milestones by March 31, 2027, the aggregate principal amount of $ 20.0 million (the Second Tranche), (c) following funding of the Second Tranche, until February 29, 2028, subject to the

achievement of certain regulatory and operational milestones by December 31, 2027, the aggregate principal amount of $ 30.0 million (the Third Tranche), and (d) following funding of the Third Tranche, in Lenders’ sole discretion, the aggregate principal amount of $ 30.0 million (the Fourth Tranche and collectively with the First Tranche, the Second Tranche and the Third Tranche, the Tranches).

The obligations of the Lenders to extend such debt capital are subject to certain conditions precedent described in the Trinity LSA.

The Company is required to pay a commitment fee of 1.0 % of the amount drawn, plus related documentation and funding fees, in connection with each drawdown.

On October 14, 2025 (the Closing Date), the Company drew down the First Tranche.

The Company’s obligations under the facility are secured by a first priority security interest in substantially all assets of the Company.

All Tranches will mature on October 1, 2030 (the Maturity Date), unless earlier accelerated under the terms of the Trinity LSA.

At maturity, the Company is required to repay the then-outstanding principal amount, together with any accrued and unpaid interest thereon.

In addition, at maturity or early termination of the Trinity LSA, the Company is required to pay the Lenders a 4.25 % final payment fee of the amounts drawn down by the Company under the Trinity LSA.

Interest accrues on the Tranches that the Company has drawn down at a floating rate per annum, calculated based on a 360-day year, equal to the greater of (a) the sum of (i) The Wall Street Journal Prime Rate and (ii) 3.0 %, and (b) 9.75 %.

For the first 36 months after the Closing Date, the Company is required to make monthly payments of interest only in arrears.

Upon the achievement of a certain commercial milestone by June 30, 2028, the Interest Only Period will be extended by twelve months.

In the event of such extension of the Interest Only Period, the duration of the Amortization Period will decrease by the same amount.

In any event, the total term of all Tranches shall not exceed 60 months.

The Company may voluntarily prepay the outstanding loan balance at any time, in whole or in part, subject to the payment of prepayment premiums and payment of the Exit Fee on the principal amount then prepaid.

If prepayment occurs on or before the first anniversary of the Closing Date, the premium shall equal 3.0 % of the principal being repaid.

Thereafter, if prepayment occurs on or before the second anniversary of the Closing Date, the premium shall equal 2.0 % of the principal being repaid.

Thereafter, if prepayment occurs on or before the Maturity Date, the premium shall equal 1.0 % of the principal being repaid.

The Trinity LSA contains customary affirmative and negative covenants, including with respect to notice obligations, limitations on new indebtedness, liens, investments and transactions with affiliates of the Company, restrictions on the payment of dividends, maintenance of collateral and accounts and maintenance of insurance.

The Trinity LSA also contains financial covenants requiring, if the Company’s market capitalization is less than $ 550 million, the Company to maintain minimum cash and cash equivalents pledged to secure the obligations under the Trinity LSA, less certain accounts payable, of at least (i) beginning from July 1, 2026 through the date, that the Company has raised at least $ 93.5 million in unrestricted net cash proceeds from one or more bona fide equity financings and/or upfront proceeds from business development after the Closing Date, 67.5 % of all of the aggregate principal amount of outstanding obligations under the Trinity LSA, and (ii) beginning from the earlier of (x) October 1, 2027 and (ii) the date upon which the Company receives written notice of certain regulatory outcomes, through the date that the Company obtains certain regulatory approvals, 75 % of the aggregate outstanding principal amount of the obligations under the Trinity LSA.

During the year ended December 31, 2025, the Company recorded interest expense relating to the Trinity LSA of $ 1.3 million and zero , respectively.

The weighted average effective interest rate as of December 31, 2025 was 14.08 %.

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):

The Company incurred $ 2.1 million of financing costs and a $ 2.1 million final payment fee, which were recorded as debt discount and are being amortized to interest expense over the term of the Trinity LSA.

The scheduled principal payments and net carrying amount of the Trinity LSA are as follows (in thousands):

YEAR ENDING DECEMBER 31,

4 unchanged sentences

Net carrying amount

Less current portion

Long-term portion

The carrying value of the Company's term loan approximates fair value.

3 unchanged sentences

(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.

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.

6 unchanged sentences

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 years ended December 31, 2024 and 2023, the Company recorded $ 0.4 million of operating lease cost and $ 0.1 millio n of variable lease cost.

The total lease expense for each of the years ended December 31, 2024 and 2023 was $ 0.5 million .

On August 18, 2025, the Company entered into a first amendment to the existing lease agreement dated February 4, 2019, extending the end-date of the term under the existing lease from August 31, 2026 to August 31, 2029 .

For each of the years ended December 31, 2025 and 2024, the Company recorded $ 0.4 million of operating lease cost.

For the years ended December 31, 2025 and 2024, the Company recorded $ 0.2 million and $ 0.1 million, respectively, of variable lease cost.

The total lease expense for the years ended December 31, 2025 and 2024 was $ 0.6 million and $ 0.5 million , respectively.

Cash paid for amounts included in the lease liability for each of the years ended December 31, 2025 and 2024 was $ 0.6 million .

18 unchanged sentences

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 2022 Shelf.

The 2022 Shelf was declared effective by the SEC on August 12, 2022 and expired on August 12, 2025.

As of August 12, 2025, the Company had sold and issued 3,923,829 shares of common stock under the 2022 ATM Program, with total net proceeds of $ 20.9 million.

On August 14, 2025, the Company filed the 2025 Shelf with the SEC, which covers the offering, issuance, and sale by the Company of up to an aggregate of $ 300.0 million of our common stock, preferred stock, debt securities, warrants and/or units of any combination thereof.

The Company simultaneously entered into a sales agreement with Jefferies LLC, as sales agent, to provide for the issuance and sale by the Company of up to $ 50.0 million of our common stock from time to time in “at-the-market” offerings under the 2025 Shelf.

The 2025 Shelf was declared effective by the SEC on August 22, 2025.

As of December 31, 2024 , the Company has sold and issued 2,936,057 shares of common stock under the ATM program, with total net proceeds of $ 15.8 million .

Subsequent to December 31, 2024 and through March 6, 2025, the Company has sold and issued 40,334 additional shares of common stock under the ATM Program, with total net proceeds of $ 0.4 million .

The Company has the following warrants outstanding for the purchase of common stock as of December 31, 2024 and 2023 (except the Pre-Funded Warrants which were only outstanding as of December 31, 2024):

As of December 31, 2025 and through March 5, 2026 , the Company has no t sold any shares of common stock under the 2025 ATM Program.

The Company has the following warrants outstanding for the purchase of common stock as of December 31, 2025:

STOCK SUBJECT

1 unchanged sentence

Series B Warrants

September 2027

Conditional Series B Warrants

September 2027

NC Ohio Trust

Lender Warrants

The Company has the following warrants outstanding for the purchase of common stock as of December 31, 2024:

STOCK SUBJECT

EXPIRATION DATES

Series B Warrants

November 2025

5 unchanged sentences

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.

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.

6 unchanged sentences

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.

On October 14, 2025, the Company entered into an amendment (the Warrant Amendment) with holders, including affiliates of Paul Manning and Chris Martell, who are directors of the Company, of the Series B Warrants and the Conditional Series B Warrants.

Pursuant to the Warrant Amendment, the holders agreed (i) to extend the expiration date of the Series B Warrants and the Conditional Series B Warrants from November 2025 to September 2027;

(ii) to irrevocably release the Company and its directors, officers and affiliates (collectively, the Releasees) from any and all claims that the holders may have against the Releasees related to any alleged breach of or wrongful act under that certain Series B Preferred Stock Purchase Agreement dated November 13, 2018 by and between the Company and PBM ADV Holdings, LLC (the Purchase Agreement) and the issuance of shares of the Company’s Series B preferred stock or existing warrants under the Purchase Agreement;

(iii) to not, during the six months following the Warrant Amendment, (x) transfer or dispose of any shares of Common Stock or any securities convertible into or exercisable or exchangeable for Common Stock, or (y) enter into any swap or other arrangement that transfers to another any of the economic consequences of ownership of such securities, subject to certain exceptions set forth in the Warrant Amendment;

and (iv) that, if requested by the underwriters in any equity financing transaction undertaken by the Company prior to September 30, 2027, to execute a standard lock-up agreement in connection with such equity financing.

The Company recorded the Series B Warrants as a component of stockholder’s equity at the time of issuance at their estimated fair value of $ 2.1 million and recorded the Conditional Series B Warrants as a liability on the consolidated balance sheet as the number of shares used to calculate the settlement is not a fixed number of shares.

6 unchanged sentences

The warrant provides the beneficiary the right to purchase 162,740 shares of the Company’s common stock, $ 0.01 par value at an exercise price of $ 1.46 per share, subject to adjustments as specified in the warrant agreement.

The Company recognizes the warrants as compensation expense within the consolidated statement of operations when the warrants are granted or at the service inception date if the service inception date precedes the grant date.

The Company recognizes the warrants as compensation expense within the consolidated statements of operations when the warrants are granted or at the service inception date if the service inception date precedes the grant date.

In the period in which the grant date occurs, cumulative compensation cost shall be adjusted to reflect the cumulative effect of measuring compensation cost based on the fair value at the grant date rather than the fair value previously used at the service inception date or subsequent reporting dates.

1 unchanged sentence

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 $ 1.3 million and $ 0.2 million as of December 31, 2024 and 2023, respectively, and was recorded as stock compensation expense within research and development expense and a credit to stockholders’ equity in the consolidated financial statements.

the warrants for 162,740 shares of common stock was $ 0.8 million and $ 1.3 million as of December 31, 2025 and 2024, respectively.

The value of the warrants at each reporting date is recorded as stock compensation expense within research and development expense and to stockholders’ equity in the consolidated financial statements.

Pre-Funded Warrants

4 unchanged sentences

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 year ended December 31, 2024 , no pre-funded warrants were exercised.

As of December 31, 2024 , there were 3,333,333 pre-funded warrants outstanding.

During the year ended December 31, 2025 , 3,328,064 shares of common stock were issued upon the cashless exercise of pre-funded warrants.

As of December 31, 2025, all pre-funded warrants were exercised.

Lender Warrants

In connection with the drawdown of any Tranche under the Trinity LSA entered into on October 14, 2025 (see Note 6), the Company is required to issue to the Lenders warrants (the Lender Warrants) to purchase shares of the Company’s common stock, $ 0.01 par value per share.

The exercise price for the Lender Warrants is equal to $ 5.89 per share.

The number of shares of common stock for which each Lender Warrant is exercisable is equal to 3.0 % of the applicable drawn down amount, divided by the exercise price.

The Lender Warrants shall have a term of ten years from the date of issuance and shall permit cashless net exercise, all in accordance with their terms.

In connection with the drawdown of the First Tranche, the Company issued a Lender Warrant to purchase up to 254,642 shares of Common Stock.

The initial fair value of the Lender Warrants was recognized as debt discount to the term loan and a corresponding warrant liability.

The Lender Warrants are remeasured to their fair value at each reporting date with changes in the fair value recognized as a component of other income (expense), net in the consolidated statements of operations.

The Company will continue to recognize changes in the fair value of the Lender Warrants until each Lender Warrant is exercised, expires or qualifies for equity classification.

The warrant liability fair value was $ 2.0 million and zero as of December 31, 2025 and 2024, respectively.

During the year ended December 31, 2025 , no Lender Warrants were exercised.

As of December 31, 2025 , there were 254,642 Lender Warrants outstanding.

Stock Options, Restricted Stock and Stock-Based Compensation

1 unchanged sentence

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.

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.

7 unchanged sentences

8,558,685 shares of common stock are reserved under the 2021 Plan, of which 1,900,246 shares remain available for future grants as of December 31, 2025.

Equity Inducement Plan

On December 24, 2025, the Company's board of directors approved the Company's 2025 Inducement Plan (the 2025 Inducement Plan) which permits the granting of non-qualified stock options, stock appreciation rights, restricted stock

awards, restricted stock units, and other stock-based awards to employees as an inducement pursuant to Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market, LLC.

The 2025 Inducement Plan became effective upon approval.

The 2025 Inducement Plan provides for an overall share limit of 1,000,000 shares of common stock.

As of December 31, 2025, 1,000,000 shares remain available for future grants under the 2025 Inducement Plan.

Stock Options

8 unchanged sentences

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.

In connection with the exercise of stock options to purchase 306,518 shares of our common stock at an exercise price of $ 1.46 in 2022, option holders tendered 122,608 shares of our common stock previously acquired in consideration of the full aggregate exercise price in accordance with the terms of the option and the 2015 Plan.

The shares tendered are recorded as treasury stock within the Company's consolidated financial statements at December 31, 2025.

10 unchanged sentences

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 years ended December 31, 2024 and 2023 was $ 5.7 million and zero , respectively .

The total intrinsic value of stock options exercised during the years ended December 31, 2025 and 2024 was $ 0.7 million and $ 5.7 million , respectively.

Restricted Stock Units

15 unchanged sentences

As of December 31, 2025 and 2024, these amounts are expected to be recognized over a weighted average period of 2.86 and 2.29 years , respectively.

The components of net loss before income tax expense are as follows (in thousands):

Due to the Company's net losses for 2025 and 2024 , as well as the full valuation allowance on its net deferred tax assets as discussed below, the Company did no t record any income tax expense or benefit for the years ended December 31, 2025 and 2024 .

A reconciliation of the Company's statutory income tax rate to the Company’s effective income tax rate is as follows:

Income at US statutory rate

Permanent adjustments

A reconciliation of the Company's statutory income tax rate to the Company’s effective income tax rate is as follows (in thousands):

US Federal Statutory Tax Rate

Tax Credits - Orphan Drug

Tax Credits - Federal R&D

Change in valuation allowance

Nontaxable or Nondeductible Items:

Mark to Market

Equity Compensation

State taxes, net of federal benefit

Valuation allowance

The Company’s effective tax rate differs from the statutory rate primarily due to continued losses and the maintenance of a full valuation allowance on deferred tax assets, resulting in zero income tax expense for the period.

Net deferred tax assets as of December 31, 2025 and 2024 consist of the following (in thousands):

24 unchanged sentences

The Company will make such a determination prior to the utilization of any future net operating losses.

For tax years beginning after December 31, 2024, OBBBA enacted a new rule under Section 174A allowing companies to immediately expense any domestic research and developmental (R&D) expenditures.

For domestic R&D, companies may either immediately expense or elect to capitalize and amortize over at least 60 months under Section 174A.

However, foreign R&D continues to require capitalization subject to the mandatory 15-year amortization period under Section 174.

The Company has elected to continue amortizing the previously capitalized costs over their remaining life.

Beginning in tax year 2025, instead of immediately expensing domestic R&D expenditures under Section 174A, the Company elected to capitalize and amortize its domestic R&D expenditures under Section 59(e) over a 10 year period.

Any foreign R&D costs will continue to be capitalized and amortized over 15 years in accordance with the requirements of Section 174.

A summary of changes in the valuation allowance for deferred tax assets during the years ended December 31, 2025 and 2024 were as follows (in thousands):

14 unchanged sentences

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.

15 unchanged sentences

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;

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.

3 unchanged sentences

The Company leases office space under a noncancelable operating lease expiring in 2029 .

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.

The Company has standard indemnification arrangements under this lease that require it to indemnify the landlord against all costs, expenses, fines, suits, claims, demands, liabilities, and actions directly resulting from any breach, violation, or nonperformance of any covenant or condition of the lease.

As of December 31, 2025 , the Company had no t experienced any losses related to these indemnification obligations, and no material claims with respect thereto were outstanding.

2 unchanged sentences

From time to time, we may become involved in litigation or other legal proceedings.

W e 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.

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.

1 unchanged sentence

Net Loss Per Share

Basic and diluted net loss per share attributable to common stockholders was computed by dividing net loss by the weighted-average common shares outstanding for the period, including the pre-funded warrants given their nominal exercise price (in thousands, except share and per share data):

Basic and diluted net loss per share attributable to common stockholders was computed by dividing net loss by the weighted-average common shares outstanding for the period, including the pre-funded warrants given their nominal exercise price for the year ended December 31, 2024 (in thousands, except share and per share data):

YEAR ENDED DECEMBER 31,

16 unchanged sentences

Research and development:

Employee-related

Clinical development

Employee-related

Facility and equipment costs

5 unchanged sentences

Professional and consulting fees

Commercial readiness

Other general and administrative segment expenses (1)

4 unchanged sentences

Interest expense

Change in fair value of warrant liability

(1) Other general and administrative segment expenses primarily consists of insurance, occupancy, and information technology costs.

Corporate Restructuring

In November 2023, the Company’s board of directors authorized a restructuring plan to focus on key clinical data readouts for CAN-2409 and 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.

Of the $ 0.7 million in costs recognized related to the restructuring plan, $ 0.5 million and $ 0.2 million were included in research and development and general and administrative expenses, respectively, in the accompanying consolidated statement of operations for the year ended December 31, 2023.

During the year ended December 31, 2023, the Company paid $ 0.7 million in severance benefits to separating employees related to the restructuring plan.

Change in fair value of warrant liabilities

(1) Other general and administrative segment expenses primarily consist of insurance, occupancy, and information technology costs.

Subsequent Events

2026 Follow-On Offering

On February 23, 2026, the Company issued and sold 18,348,624 shares of common stock at a price to the public of $ 5.45 per share for aggregate gross proceeds of approximately $ 100 million (the 2026 Follow-On Offering).

The Company received approximately $ 93.5 million in net proceeds from the 2026 Follow-On Offering after deducting underwriting discounts and commissions and offering expenses.

The Company also granted the underwriters a 30-day option to purchase up to 2,752,293 additional shares of common stock at the public offering price, less the underwriting discount.

RTW Purchase Agreement

On February 19, 2026, the Company entered into a purchase and sale agreement (the RTW Purchase Agreement) with funds managed by RTW Investments, LP (RTW).

Under the terms of the RTW Purchase Agreement, RTW has agreed to pay the Company $100 million (the RTW Purchase Price) upon the marketing approval of aglatimagene for the treatment of intermediate-risk and high-risk localized prostate cancer by the FDA in exchange for a tiered royalty on future net sales of aglatimagene in the United States.

RTW will be entitled to a 4.67% royalty on the portion of annual net sales in the United States that is less than or equal to $1 billion, and a 1.33% royalty on the portion of annual net sales in the United States, exceeding $1 billion.

The 4.67% tier will increase to 6.67% if annual net sales do not achieve certain specified levels (the Ratchet), subject to a cure opportunity by the Company (provided that such Ratchet and cure opportunity may each subsequently occur more than once).

The royalty payments become payable following the first commercial sale of aglatimagene in the United States and end upon RTW’s receipt of $250 million in royalty payments (the RTW Royalty Cap).

If the Company undergoes a change of control with, or sells aglatimagene and all of the aglatimagene rights to, a third party, the RTW Purchase Agreement provides the Company and RTW with an option for the Company to pay certain specified amounts to terminate the RTW Purchase Agreement, depending upon the timing for such transaction, up to the RTW Royalty Cap (the Buy-Out Option).

If either party exercises the Buy-Out Option, the RTW Purchase Agreement will automatically terminate upon payment of the specified amount.

The transaction is subject to certain closing conditions, including that FDA approval must occur by a specified date, conditions related to our indebtedness and other customary closing conditions.

The RTW Purchase Agreement also contains customary representations, warranties and indemnities on the part of the Company and RTW and customary covenants on the part of the Company, including around the Company's indebtedness as well as licensing and other activities related to aglatimagene and its rights.

Trinity LSA Amendment

On March 10, 2026, we entered into that certain First Amendment to Loan and Security Agreement among the Company and Trinity Capital Inc.

(the First Amendment to Trinity LSA).

The First Amendment to Trinity LSA amended our financial covenant such that the period in which we are required, if our market capitalization is less than $550 million, to maintain minimum cash and cash equivalents of 67.5% of all of the aggregate principal amount of outstanding obligations under the Trinity LSA shall be through the date that we have raised at least $93.5 million in unrestricted net cash proceeds from one or more bona fide equity financings and/or upfront proceeds from business development after the Closing Date (as defined in the Trinity LSA).

The First Amendment to Trinity LSA also makes corresponding amendments and additions to defined terms.

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized .

13 unchanged sentences

/s/ Charles Schoch

Interim Chief Financial Officer (Principal Financial and Accounting Officer)

Chief Financial Officer

(Principal Financial and Accounting Officer)

March 12, 2026

20 unchanged sentences

Nicoletta Loggia, Ph.D., R.Ph

/s/ Maha Radhakrishnan

March 12, 2026

Maha Radhakrishnan, M.D.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.