TX2100

Aug. 6, 2026: Tectonic Therapeutic, Inc. (NASDAQ: TECX) reported clinical milestones for TX45 and TX2100. For TX45 in pulmonary hypertension associated with HFpEF (PH-HFpEF), enrollment was completed in June 2026 in the global randomized, placebo-controlled 24-week APEX Phase 2 trial; 191 patients were enrolled across 14 countries, including 137 with combined pre- and post-capillary PH (CpcPH) and baseline PVR >3 Wood Units. Mean baseline PVR was 4.2 WU overall and 5.2 WU in the CpcPH/PVR >3 WU subgroup. In July 2026, the IDMC reviewed unblinded safety and efficacy data covering about 80% of expected patient exposure and recommended continuing the trial without modification. The primary endpoint is change from baseline in PVR in the CpcPH subgroup, with topline results expected in early Q1 2027.

For TX2100, a potential HHT treatment, dosing was completed in July 2026 for all six single-ascending-dose healthy volunteer cohorts in the randomized, placebo-controlled, double-blind Phase 1a trial. Topline Phase 1a results are expected by end of Q3 2026, with detailed data to follow at a scientific meeting. Subject to favorable safety, tolerability, and PK, the company plans a Phase 1b trial in hematologic-support dependent HHT and a placebo-controlled Phase 2 in moderate-to-severe HHT, with Phase 2 planned to start in early 2027.