Tectonic completes APEX enrollment for TX45 in PH-HFpEF, IDMC backs continuation

Tectonic Therapeutic reported second quarter 2026 results on August 6, 2026, alongside a set of pipeline updates. The company finished patient enrollment in June 2026 for the APEX trial, a global, randomized, placebo-controlled study running 24 weeks that is testing TX45 in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF)¹.

In July 2026, an Independent Data Monitoring Committee reviewed unblinded safety and efficacy data covering about 80% of expected patient exposure and recommended that the trial continue without modification¹. The trial design targets an enriched population with a more severe subtype called combined pre- and post-capillary pulmonary hypertension (CpcPH), defined by pulmonary vascular resistance above 3 Wood Units at baseline¹. Total enrollment reached 191 patients across 14 countries, of whom 137 had CpcPH with PVR above 3 Wood Units, in line with a target of about 70% of the study population¹. Topline results are expected in early Q1 2027, now that enrollment is complete¹.

On the HHT program, Tectonic completed dosing of six single-dose cohorts in the Phase 1a trial of TX2100 in healthy volunteers in July 2026¹. That study is randomized, placebo-controlled, and double-blind, designed to assess safety and tolerability with pharmacokinetics as a secondary endpoint¹. The company said it expects topline Phase 1a results by the end of Q3 2026, with detailed data to follow at a scientific meeting¹, and plans, pending favorable safety and PK findings, to run parallel Phase 1b and Phase 2 trials, with Phase 2 anticipated to start in early 2027¹.

On cash, Tectonic reported $227.1 million in cash and equivalents as of June 30, 2026, down from $236.9 million at the end of March 2026¹. The company said this is expected to fund operations into Q1 2029, covering Phase 2 readouts for TX45 in both PH-HFpEF and PH-ILD and key milestones in the TX2100 program¹.