UNITED STATES
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CURRENT REPORT
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Item 2.05 Costs Associated with Exit or Disposal Activities.
On June 26, 2024, in furtherance of its revised operating plan, Carisma Therapeutics Inc. (the “Company”) notified Novartis Pharmaceuticals Corporation (“Novartis”) of its termination of the Company’s Manufacturing and Supply Agreement, by and between the Company and Novartis, dated March 1, 2023, relating to the manufacture of the Company’s first product candidate to enter clinical development, CT-0508 (the “Manufacturing Agreement”). The termination is effective July 31, 2024. Pursuant to the Company’s revised operating plan, the Company determined to focus its ex vivo oncology clinical development efforts on its follow-on product candidate CT-0525 and has suspended enrollment of new patients in its Phase 1 clinical trial for CT-0508. As a result of the termination of the Manufacturing Agreement, the Company will incur a termination fee equal to $4.0 million (the “Termination Fee”), which is expected to be paid in the third quarter of 2024. The Company has separately agreed with Novartis that if Novartis and the Company enter into an agreement for the tech transfer of another product (a “Substitute Product”) to Novartis on or before December 31, 2024, then the Termination Fee shall be credited in full or in part against any amounts due from the Company to Novartis under such agreement relating to the Substitute Product.
Cautionary Note on Forward-Looking Statements
Statements in this Current Report on Form 8-K about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Carisma’s business, strategy, future operations, the advancement of the Company’s product candidates and product pipeline, and clinical development the Company’s product candidates, including expectations regarding entry into any manufacturing agreement for CT-0525 and the related terms thereof. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “goals,” “intend,” “may,” “might,” “outlook,” “plan,” “project,” “potential,” “predict,” “target,” “possible,” “will,” “would,” “could,” “should,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. For a discussion of these risks and uncertainties, and other important factors, any of which could cause Carisma’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as well as discussions of potential risks, uncertainties, and other important factors in Carisma’s other recent filings with the Securities and Exchange Commission. Any forward-looking statements that are made in this press release speak as of the date of this press release. Carisma undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CARISMA THERAPEUTICS INC. | ||
| By: | /s/ Steven Kelly | |
| Date: July 2, 2024 | Steven Kelly | |
| President and Chief Executive Officer | ||