Tectonic Therapeutic (TECX) investor relations material

Key clinical program updates

• Enrollment for the APEX study is on track, with internal mid-year and end-of-year recruitment goals met; guidance on enrollment completion will be refined by end of Q1 2026.

• Recruitment now focuses on patients with PVR greater than three, representing 70% of the study population, to maximize the likelihood of demonstrating benefit.

• No safety signals have been observed in recent DSMB reviews, and hospitalization rates remain low and as expected for the patient population.

• The study is powered to detect a reduction in PVR, with prior phase 1b data showing a 1.3 mmHg (30%) decrease; six-minute walk test is not a powered endpoint but trends will be evaluated.

• No open-label extension is currently available, but one may be considered in the future.

Study design and patient selection

• The trial enriches for CpcPH patients with high PVR, as these are hypothesized to benefit most from relaxin due to both improved left heart function and reduced pulmonary resistance.

• Inclusion criteria require preserved ejection fraction, a six-minute walk distance between 150 and 450 meters, and allow for a range of comorbidities to ensure broad recruitment.

• The primary endpoint is PVR reduction in the high PVR group, with exploratory analysis in other subgroups.

Competitive landscape and differentiation

• Differentiation from competitors is based on patient selection, study design, and molecular construct; APEX focuses on chronic, stable, well-characterized patients, unlike Eli Lilly’s acute heart failure cohort.

• The relaxin molecule used has a lower isoelectric point, improving pharmacokinetics and enabling monthly dosing, compared to weekly or biweekly dosing for competitors.

• AstraZeneca’s trial includes both HFpEF and HFrEF and is less enriched for high PVR, resulting in a more heterogeneous population.