Tectonic Therapeutic Announces Positive Topline Data from Phase 1b Part B Clinical Trial for TX45 in Patients with Group 2 Pulmonary Hypertension in HFrEF

• TX45 improved both left heart function and pulmonary hemodynamics in patients with Group 2 Pulmonary Hypertension in Heart Failure with reduced Ejection Fraction (“PH‑HFrEF”)
• TX45 was well tolerated in patients with PH‑HFrEF with no serious or severe adverse events, no clinically significant changes in blood pressure and no immune related reactions
• Results support potential expansion of TX45’s addressable Group 2 PH patient population to PH‑HFrEF
• Company to host webcast today, October 29^th at 4:30 p.m. ET

Excerpt from the Press Release:

WATERTOWN, Mass., Oct. 29, 2025 (GLOBE NEWSWIRE) — Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic”), today announced positive topline results from the Phase 1b Part B acute hemodynamic clinical trial of TX45, a long-acting, Fc-relaxin fusion protein, in patients with Group 2 PH‑HFrEF. The topline data showed that a single intravenous dose of TX45 was well tolerated in this patient population and resulted in meaningful improvements in both left heart function and pulmonary hemodynamics.

The Phase 1b Part B trial was designed to evaluate TX45 in the expanded patient population of Group 2 PH-HFrEF, building on the positive results from the Phase 1b Part A trial of TX45 in patients with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction (“PH-HFpEF”). Tectonic is currently conducting the APEX Phase 2 clinical trial to evaluate TX45 over a 24-week treatment period in patients with PH-HFpEF, with topline results expected in 2026 (ClinicalTrials.gov NCT06616974). The APEX clinical trial is enriched for patients with combined pre- and post-capillary pulmonary hypertension (“CpcPH”) with pulmonary vascular resistance >3, and the primary endpoint is in this patient population.

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