Tectonic Therapeutic (TECX) investor relations material

Study design and patient population

• Phase 1b Part B was a single-dose, open-label trial in 14 PH-HFrEF patients, enriched for CpcPH (PVR ≥3 WU), focusing on safety and hemodynamic effects.

• Baseline characteristics included mean LVEF of 34%, elevated NT-proBNP, 50% female, and 100% on ACEI/ARB/ARNI.

• Baseline hemodynamics showed elevated PCWP, PVR, and mPAP, consistent with PH-HFrEF.

• The trial enrolled subgroups with CpcPH and IpcPH, measuring multiple hemodynamic endpoints.

• Dosing ranged from 0.3 to 3 mg/kg, with most patients receiving 3 mg/kg.

Safety and tolerability

• TX45 was well tolerated with no serious or severe adverse events, discontinuations, or drug-related adverse events.

• All treatment-emergent adverse events were mild or moderate and self-limited, most commonly procedural back pain.

• No clinically significant changes in vital signs, ECG, or labs; transient, asymptomatic decreases in systolic BP observed.

• No signs or symptoms of congestion or worsening heart failure; no fatigue-related AEs in Part B.

• DSMB review found no safety concerns; heart failure hospitalization rate was as expected for this population.

Hemodynamic and echocardiographic outcomes

• TX45 led to >6 mm Hg (29%) reduction in wedge pressure and ~20% reduction in PVR in PVR ≥3 WU subgroup.

• Cardiac output increased by ~17%, total pulmonary resistance decreased by ~29%, and mean pulmonary artery pressure dropped by 19%.

• LVEF improved by 19.4%, TAPSE/SPAP up 36.3%, and RV fractional area change up 20.3% at day 29.

• Hemodynamic and echocardiographic improvements persisted through day 29 post-dose.

• Improvements were observed in PCWP, PVR, CO, TPR, and mPAP, with persistent effects at day 29.