Faron Announces First Patient Dosed in BLAZE Investigator-Initiated Trial

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 dosed in the Phase 1/2 BLAZE investigator-initiated trial.

The trial evaluates Faron’s lead asset, bexmarilimab, in combination with the widely used anti-PD-1 checkpoint inhibitor nivolumab (OPDIVO®) in patients with metastatic non-small cell lung cancer (NSCLC) and melanoma who have developed resistance to and experienced disease progression on prior immunotherapy. The trial will evaluate the safety and antitumor activity of the combination in this treatment-resistant setting. For more information on the IIT: NCT07718243.

The BLAZE trial is led by The Institute of Cancer Research, London, operating in partnership with The Royal Marsden NHS Foundation Trust.

Anna Minchom, MD, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, Group Leader at The Institute of Cancer Research, and Principal Investigator of the trial, said, “Overcoming secondary resistance to immunotherapy is an urgent priority for advanced lung cancer and melanoma patients. Tumor-associated macrophages are increasingly recognized as key drivers of immune resistance in these tumors, and bexmarilimab offers a mechanistically distinct approach to potentially addressing this. Treating our first patient moves us into a true proof-of-concept setting that we hope will translate into a meaningful clinical advance for patients.”

The enrollment marks the first patient treated in the BLAZE trial and first clinical evaluation of bexmarilimab in combination with a checkpoint inhibitor in patients with acquired resistance to immunotherapy. The BLAZE trial leverages a mechanism-driven sequential priming strategy: patients receive an initial run-in dose of bexmarilimab, aiming to reprogram the immunosuppressive tumor microenvironment, before transitioning to a combination of bexmarilimab and nivolumab to restore sensitivity to checkpoint inhibition. The rationale rests on emerging evidence that tumor-associated macrophages are a primary driver of secondary resistance to anti-PD-1 therapy — and that Clever-1 blockade may be uniquely positioned to reverse this resistance mechanism.

Petri Bono, MD, PhD, Chief Medical Officer of Faron, stated, “We are proud to see initiation of the BLAZE trial. Overcoming checkpoint resistance is one of the major frontiers in oncology, and clinical responses in this setting would represent proof-of-concept of resistance reversal. This is particularly meaningful given that patients have previously responded to and received at least six months of anti-PD-1 treatment before entering the trial. Given the large NSCLC and melanoma populations and the broad use of nivolumab, a positive signal here could have significant implications beyond this trial. Expanding bexmarilimab into a combination setting with a widely used PD-1 inhibitor is a core pillar of our clinical development strategy. We are pleased to support the work led by the exceptional teams at the ICR and The Royal Marsden and look forward to the data generated through the trial.”

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 and 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) Kare Laukkanen	+358 50 553 9535 / +44 7 469 766 223 [email protected]
LifeSci Advisors, US (Investors) Daniel Ferry	+1 617 430-7576 [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