CARGO Therapeutics to Discontinue FIRCE-1 Phase 2 Study of Firi-cel; Advances Remaining Programs While Evaluating Strategic Options

CARGO intends to present an analysis of the FIRCE-1 Phase 2 study at a future medical conference.

About CARGO Therapeutics

CARGO Therapeutics, Inc. is a clinical-stage biotechnology company advancing next-generation, best-in-class, and potentially curative cell therapies for cancer patients. CARGO’s programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and availability. CARGO has a focused pipeline that includes its CRG-023 product candidate, a CD19/CD20/CD22 tri-specific CAR T developed using a tri-cistronic construct and designed to address several known causes of relapse, resulting in a potential best-in-class CAR T-cell therapy across a broad range of B-cell malignancies with the goal of providing more patients with a durable complete response. CARGO’s latest program advancement, a novel allogeneic platform, is a universal vector solution designed to limit immune-based rejection and enable durable response of CAR T-cell therapy. The universal allogeneic-enabling vector is intended to be paired with any CAR vector to create an allogeneic CAR T-cell therapy, with the potential to maintain the efficacy, durability, and safety of autologous cell therapy while broadening availability to more people with cancer. CARGO’s leadership and team have significant experience in designing, developing and delivering oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at https://cargo-tx.com/.

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⁽¹⁾ Firicabtagene autoleucel (firi-cel) is CARGO Therapeutics’ autologous CD22 CAR T-cell product candidate. The underlying CAR of which CARGO exclusively in-licensed from the National Cancer Institute was the construct evaluated by Stanford Medicine in a Phase 1 clinical trial in patients with large B-cell lymphoma whose disease relapsed or was refractory to CD19 CAR T-cell therapy. CARGO’s firi-cel Investigational New Drug application included a comprehensive package in which CARGO performed and demonstrated analytical comparability of CRG-022 produced using the intended commercial process to the CRG-022 produced using the process used for the Stanford Phase 1 clinical trials. CARGO cannot assure that the FDA will agree with its claim of comparability and the sufficiency of the data to support it when it files its Biologics License Application.

⁽²⁾ The Company’s actual consolidated cash, cash equivalents, marketable securities as of December 31, 2024 may differ from this preliminary estimate due to the completion of the Company’s year-end closing and auditing procedures.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: the indication, timing, progress, advancement and results of CARGO’s clinical and preclinical programs; CARGO’s strategic plans for its business and product candidates, including its ongoing evaluation of strategic options; the Company’s expectations and estimates regarding the planned reduction in force and discontinuation of the clinical development of firi-cel; and CARGO’s estimated cash, cash equivalents and marketable securities as of December 31, 2024 and CARGO’s expectations that its current cash, cash equivalents and marketable securities will be sufficient to fund its expected operations into mid-2028. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the Company’s ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the Company’s product candidates and the product candidates involving novel technologies; clinical and preclinical development being a lengthy and expensive process with uncertain outcomes; data from the Company’s clinical trials and preclinical studies, including the performance and characteristics of the Company’s product candidates, including any undesirable side effects or other properties discovered or detected in the Company’s clinical trials and preclinical studies; the Company’s ability to obtain regulatory approval of and successfully commercialize its product candidates, if approved; the Company’s reliance on third-party suppliers and manufacturers, including CROs; the outcomes of future collaboration agreements; and the Company’s ability to adequately maintain intellectual property rights for its product candidates. For a detailed discussion of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to CARGO’s business in general, please refer to the risk factors identified in the Company’s filings with the Securities and Exchange Commission, including but not limited to its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 filed on November 12, 2024. Any forward-looking statements that the Company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

Media Contact:
Denise Powell
denise@redhousecomms.com

Investor Contact:
Jessica Serra
jserra@cargo-tx.com

Laurence Watts
laurence@newstreetir.com