Entry into a Material Definitive Agreement · Results of Operations and Financial Condition · Regulation FD Disclosure · Other Events
Item 1.01. Entry into a Material Definitive Agreement. On February 19, 2026, Candel Therapeutics, Inc. (the “Company”) announced its entry into a purchase and sale agreement (the “Purchase Agreement”) with funds managed by RTW Investments, LP (the “Purchaser”).…
Filed Feb 19, 2026Accepted Feb 19, 2026, 4:03 PM ESTCIK 1841387Accession 0001193125-26-059334
Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical-stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. Aglatimagene besadenovec (aglatimagene) is the lead product candidate from the adenovirus platform. The Company completed successful phase 2a clinical trials of aglatimagene in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of aglatimagene in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the U.S. Food and Drug Administration (FDA) and published in The Lancet Oncology. The FDA also granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the
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Item 1.01Item 1.01 - Entry into Material Agreement
Item 1.01. Entry into a Material Definitive Agreement.
On February 19, 2026, Candel Therapeutics, Inc. (the “Company”) announced its entry into a purchase and sale agreement (the “Purchase Agreement”) with funds managed by RTW Investments, LP (the “Purchaser”). Under the terms of the Purchase Agreement, the Purchaser has agreed to pay the Company $100 million (the “Purchase Price”) upon the marketing approval of the Company’s product referred to as CAN-2409 (aglatimagene besadenovec) (the “Product”) for the treatment of intermediate-risk and high-risk localized prostate cancer by the U.S. Food and Drug Administration (the “FDA Approval”) in exchange for a tiered royalty on future net sales of the Product in the United States. The Purchaser 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 the Product in the United States and end upon the Purchaser’s receipt of $250 million in royalty payments (the “Royalty Cap”). If the Company undergoes a change of control (as defined in the Purchase Agreement) with, or sells the Product and all of the Product rights to, a third party, the Purchase Agreement provides the Company and the Purchaser with an option for the Company to pay certain specified amounts to terminate the Purchase Agreement, depending upon the timing for such transaction, up to the Royalty Cap (the “Buy-Out Option”). If either party exercises the Buy-Out Option, the 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 the Company’s indebtedness and other customary closing conditions. The Purchase Agreement also contains customary representations, warranties and indemnities on the part of the Company and the Purchaser and customary covenants on the part of the Company, including around the Company’s indebtedness as well as licensing and other activities related to the Product and Product rights.
The foregoing description of the Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Purchase Agreement, a copy of which will be included as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2025 to be filed with the Securities and Exchange Commission.
Item 2.02Item 2.02 - Results of Operations
Item 2.02. Results of Operations and Financial Condition.
The information contained in Item 8.01 of this Current Report on Form 8-K (this “Current Report”), to the extent required, is incorporated into this Item 2.02 by reference.
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure.
On February 19, 2026, the Company issued a press release announcing the Purchase Agreement described above. A copy of the press release is furnished as Exhibit 99.1 and incorporated herein by reference.
The information contained under Item 7.01 of this Current Report (including Exhibit 99.1) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as may be expressly set forth by specific reference in such filing.
Item 8.01Item 8.01 - Other Events
Item 8.01. Other Events.
The Company is providing the following information about its preliminary cash and cash equivalents as of December 31, 2025.
Based upon preliminary estimates and currently available information, the Company estimates that its cash and cash equivalents were approximately $119.7 million as of December 31, 2025. This amount is unaudited and preliminary and is subject to completion of the Company’s financial closing procedures. As a result, this amount may differ from the amount that will be reflected in the Company’s consolidated financial statements as of and for the year ended December 31, 2025.
Filed exhibits (1)
EX-99.1 (by filename) cadl-ex99_1.htm
Exhibit 99.1
Candel Therapeutics Announces $100M Royalty Funding Agreement with RTW to Support the Potential Launch of Aglatimagene Besadenovec (CAN-2409) in Localized Prostate Cancer
• RTW committed $100M in U.S. launch funding, subject to U.S. Food and Drug Administration (FDA) approval of aglatimagene besadenovec (aglatimagene or CAN-2409) for intermediate- to high-risk localized prostate cancer
• Royalties based on annual net sales of aglatimagene in the U.S.
• Funds will strengthen the Company’s balance sheet for potential U.S. commercial launch of aglatimagene in intermediate- to high-risk localized prostate cancer
NEEDHAM, Mass., Feb. 19, 2026 (GLOBE NEWSWIRE). Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced a $100 million royalty funding agreement with funds managed by RTW Investments, LP (RTW), subject to FDA approval of aglatimagene in intermediate- to high-risk, localized prostate cancer.
“This non-dilutive strategic financing will support the U.S. launch of aglatimagene besadenovec, assuming FDA app…