TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a global, clinical-stage biopharmaceutical company focused on creating innovative cancer treatments that leverage the patient’s own immune system, today announces that the first patient has been enrolled in the Phase 1b/2 BEXAR investigator-initiated trial.

The BEXAR trial evaluates Faron's lead asset, bexmarilimab, in combination with standard-of-care doxorubicin as a first-line treatment for patients with metastatic soft-tissue sarcoma.

The trial is sponsored by the international oncology research company MEDSIR and currently conducted at six hospitals across Spain, led by the Vall d’Hebron University Hospital in Barcelona. The Phase 1b/2 BEXAR trial is designed to evaluate the safety and tolerability of bexmarilimab in combination with doxorubicin in the Phase 1b stage, followed by a contingent randomized Phase 2 assessment of preliminary efficacy versus doxorubicin alone.

Dr. César Serrano, Group Leader of the Sarcoma Translational Research Program at the Vall d’Hebron Institute of Oncology and a member of the Sarcoma Faculty of the European Society of Medical Oncology, and scientific and clinical lead of the trial said, “Metastatic soft-tissue sarcoma has seen limited therapeutic progress in decades, and remains particularly difficult to treat. By combining doxorubicin with bexmarilimab, we aim to test whether reprogramming immunosuppressive macrophages can help ignite an anti-tumor response and translate into clinical benefit.”

This enrollment marks the first patient treated with bexmarilimab in the BEXAR trial and the first clinical evaluation of an anti-Clever-1 strategy in combination with doxorubicin in patients with soft-tissue sarcoma. Soft-tissue sarcomas are highly aggressive malignancies and many subtypes are characterized by an immunologically inactive tumor microenvironment heavily dominated by immunosuppressive macrophages. These tumors express some of the highest levels of Clever-1, the target receptor of bexmarilimab, providing a strong mechanistic rationale for this combination strategy.

Dr. Petri Bono, Chief Medical Officer at Faron, commented, “The initiation of patient enrollment in the BEXAR trial is a significant milestone for our solid tumor strategy. Sarcomas express exceptionally high levels of Clever-1, providing a strong biological rationale for investigating an anti-Clever-1 approach in this setting. By combining bexmarilimab with chemotherapy, this trial is the first opportunity to generate clinical evidence for bexmarilimab’s mechanism in soft-tissue sarcomas. If this combination shows evidence of synergy, it could support the rationale for exploring bexmarilimab with other chemotherapy backbones across Clever-1-expressing tumor types. We are proud to support the world-class team at Vall d'Hebron and look forward to the data this trial will generate."

About bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes by targeting myeloid cell function. It binds to Clever-1, a receptor on immunosuppressive macrophages that helps cancer evade the immune system. By targeting Clever-1, bexmarilimab reprograms the tumor microenvironment to ignite a potent anti-tumor immune response.

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase 1/2 clinical trials as a potential therapy for patients with hematological cancers or solid tumors in combination with other standard treatments. Further information is available at www.faron.com.

Forward-Looking Statements

Certain statements in this announcement are, or may be deemed to be, forward-looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, “hope”, “seek”, ”envisage”, ”estimate”, ”intend”, ”may”, ”plan”, ”potentially”, ”will” or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward-looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors. Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

For more information, please contact:

IR Partners, Finland (Media) Riina Tuominen Kare Laukkanen	+358 44 313 5005 [email protected] +358 50 553 9535 / +44 7 469 766 223 [email protected]
FINN Partners, US (Media)  Alyssa Paldo	+1 847 791-8085  [email protected]
Cairn Financial Advisers LLP (Nominated Adviser and Broker) Sandy Jamieson, Jo Turner	+44 (0) 207 213 0880
Sisu Partners Oy (Certified Adviser on Nasdaq First North) Juha Karttunen Jukka Järvelä	+358 (0)40 555 4727 +358 (0)50 553 8990