35Pharma Announces Initial HS235 Phase 1 Healthy Volunteer Biomarker Results During Oral Presentation at the 22nd Global Cardiovascular Clinical Trialist Forum.

Phase 1 SAD data indicate HS235 was generally well tolerated, achieved sustained target engagement, and improved body composition and circulating markers of cardiometabolic disease in healthy volunteers ‍ Montreal, QC, Canada (Dec 9, 2025) 35Pharma, a clinical-stage biopharmaceutical company that designs and develops TGF-beta superfamily inhibitors, today presented initial HS235 Phase1 Single Ascending Dose (SAD) healthy volunteer biomarker results during a late breaking oral presentation at the 22 nd Global Cardiovascular Clinical Trialists (CVCT) Forum in Washington DC. HS235 is a next-generation BMP-9/-10 sparing Activin Signalling Inhibitor (ASI) candidate being investigated in patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension due to Heart Failure (PH-HFpEF). HS235 was engineered to achieve high potency against Activin and Growth Differentiation Factor ligands while sparing BMP-9/-10 ligands whose neutralization has been associated with bleeding, telangiectasia and pericardial effusions. Highlights of the presented Phase 1 SAD results include: HS235 demonstrated a generally favorable safety profile following single doses up to 2 mg/kg, the highest dose tested, in overweight or obese healthy volunteers with no adverse events of special interest (including bleeding, telangiectasia or pericardial effusion), no serious adverse events, and no severe adverse events observed; HS235 achieved deep and sustained target engagement, shown by dose-dependent reductions in follicle stimulating hormone (FSH) in postmenopausal female participants following single doses of 0.5 to 2 mg/kg; HS235 produced dose-dependent decreases in visceral fat mass while preserving or increasing lean mass; and HS235 improved circulating proteins dysregulated across pulmonary hypertension groups 1-3, based on unbiased deep plasma proteome profiling. “In this trial, HS235 treatment resulted in deep and sustained target engagement, as well as improvement in key body composition measures,” stated Maureen O’Connor, Ph.D., Chief Scientific Officer of 35Pharma. “Building on these compelling results, we are advancing two ongoing proof-of-concept trials in patients.” Two clinical trials are currently underway to evaluate HS235: NCT07123779 , a Phase 1b study of HS235 in patients with obesity and PH-HFpEF (Group 2 PH); and NCT07143448 , a Phase 1b study of HS235 for treatment of PAH (Group 1 PH). ‍

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