Tectonic Therapeutic (TECX) investor relations material

Lead program overview

• TX45 is a long-acting relaxin mimetic with vasodilatory, leisotropic, and antifibrotic properties, targeting heart failure with preserved ejection fraction and pulmonary hypertension.

• Focus is on patients with combined pre- and postcapillary pulmonary hypertension (CPCPH), a population with high unmet need and reduced exercise tolerance.

• The target US patient population for CPCPH is estimated at 700,000 to 1 million.

Competitive landscape and differentiation

• Recent Lilly data showed fluid retention issues in decompensated heart failure patients, but the studied population and drug design differ from TX45.

• AstraZeneca's relaxin program targets a similar population and recently completed Phase II, with interim data suggesting continued study viability.

• Merck's sotatercept is also being studied in CPCPH, with data expected later this year; multiple mechanisms and broader patient coverage are seen as positives.

Clinical trial progress and endpoints

• Phase Ib data for TX45 showed 32–35% reduction in pulmonary vascular resistance (PVR), 18–19% reduction in pulmonary capillary wedge pressure, and 18% increase in cardiac output.

• Phase II APeX trial is over 30% enrolled, enriched for high PVR patients, with primary endpoint of PVR and secondary endpoints including six-minute walk test.

• Pivotal trial will use six-minute walk test as the primary endpoint; a 20-meter increase is considered clinically meaningful.