Summary of Tectonic Therapeutic FY Conference Call Company Overview - **Company**: Tectonic Therapeutic (NasdaqGM: TECX) - **Event**: FY Conference on December 02, 2025 Key Industry Insights - **Focus**: The conference highlighted the significance of the APEX study, which is expected to be pivotal for Tectonic in 2026, marking the beginning of a critical two-year period for the company [1][2] Core Points and Arguments 1. **Enrollment Progress**: - Tectonic met its mid-year recruitment objectives and is on track to meet its end-of-year recruitment goal. As of November, recruitment has shifted to patients with a pulmonary vascular resistance (PVR) greater than three [4][5] - 70% of the total patient population falls within the PVR greater than three category [11][13] 2. **Data Safety Monitoring**: - The last data safety monitoring committee (DSMB) meeting occurred at the end of September, with no safety signals reported. Continuous monitoring is in place [5][6] 3. **Patient Population and Study Design**: - The study is enriched for patients with chronic stable heart failure and high PVR, aiming to improve outcomes in this specific group [30][34] - The primary endpoint focuses on PVR reduction, with a previous phase 1b study showing a 30% decrease in PVR [23][24] 4. **Comparison with Competitors**: - Tectonic's TX45 is differentiated from competitors like AstraZeneca and Lilly based on patient selection and study design. Tectonic's study focuses on a more homogeneous population with specific PVR criteria [30][37] - The mechanism of action for TX45 includes vasodilation and potential antifibrotic effects, which may provide advantages over competitors [39][41] 5. **Future Development Plans**: - Tectonic is considering various options for future studies in heart failure with preserved ejection fraction (HFpEF), including standalone phase 2 or phase 2/3 studies [29][30] - The company plans to start a healthy volunteer study for TX2100 in early 2026, focusing on pharmacokinetics and safety [47] Other Important Information - **Financial Position**: Tectonic reported approximately $268 million in cash, providing a runway into the fourth quarter of 2028 [49] - **Market Context**: The discussion emphasized the complexity of the heart failure market, with multiple mechanisms and treatment options available, indicating a significant opportunity for Tectonic's therapies [43][44]

Summary of Tectonic Therapeutics Conference Call Company Overview - Tectonic Therapeutics is focused on the discovery and development of GPCR targeted biologics, founded in 2019 and went public via reverse merger in June 2024 [2][3] Leadership and Experience - The leadership team has led to over 20 drug approvals across various therapeutic areas, allowing for a target-agnostic approach to maximize success probability [3] Key Programs - The primary focus is on a long-acting relaxant program currently in Phase II, with promising Phase Ib data, targeting group two pulmonary hypertension associated with preserved ejection fraction left-sided heart failure (PH HFpEF) [3][4] - The program aims to address a large underserved patient population of over 1 million in the U.S. with high mortality rates and no approved therapies, representing a multibillion-dollar opportunity [5] Competitive Landscape - Competitors include AstraZeneca (AZ), which is also exploring PH HFpEF and PH HFrEF, with Tectonic recently expanding its Phase Ib study into PH HFrEF [5][21] Clinical Data and Efficacy - Phase Ib data showed significant improvements: - 18% decrease in pulmonary capillary wedge pressure, indicating improved left heart function [14] - 32-35% decrease in pulmonary vascular resistance (PVR) [15] - 18% improvement in cardiac output driven by stroke volume [15] - 26% reduction in total pulmonary resistance [15] - The drug was well tolerated with no serious adverse events reported, and the most common adverse event was transient fatigue [17] Future Milestones - Upcoming data from Phase Ib study in PH HFrEF expected later this year, with Phase II data anticipated in 2026 [6] - The design of the Phase II study includes right heart catheterization at baseline, randomization to treatment arms, and evaluation of PVR as the primary endpoint [20] Market Potential - The company has a strong financial position with over $300 million in cash, providing a runway into Q4 2028 [6] - Tectonic is positioned to deliver value-creating milestones with two pipeline candidates targeting significant market opportunities [23] Conclusion - Tectonic Therapeutics is well-capitalized and has a proven leadership team, with a focus on addressing unmet medical needs in pulmonary hypertension, supported by promising clinical data and a clear strategy for future development [23]