Tectonic Therapeutic (NasdaqGM:TECX) FY Conference September 10, 2025 03:20 PM ET Company ParticipantsAlise Reicin - CEO and President[Analyst]I'm going to read this disclosure statement. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales rep. Alise, welcome. It's a pleasure to have you today. I think we're going to spend a lot of time talking about your le ...

Core Insights - Tectonic Therapeutic, Inc. announced complete results from Part A of the Phase 1b clinical trial of TX45 for patients with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction (PH-HFpEF) [1][2] - The trial demonstrated that TX45 is well tolerated and showed significant hemodynamic improvements, including a 19.0% reduction in pulmonary capillary wedge pressure (PCWP) and over 30% reduction in pulmonary vascular resistance (PVR) in a specific patient subgroup [2][11] - The results were presented at the European Society of Cardiology Heart Failure 2025 Congress, highlighting the potential of TX45 as a best-in-class therapy for a condition with high morbidity and no approved treatments [3][4] Clinical Trial Results - The Phase 1b trial included a cohort of 19 patients, confirming the tolerability and hemodynamic effects of TX45 previously reported in interim data [2][6] - TX45 treatment resulted in sustained hemodynamic effects for up to 29 days, with improvements in left ventricular function and pulmonary hemodynamics across various left ventricular ejection fractions (LVEF) [4][5] - Specific improvements included a 19.7% reduction in PCWP for patients with LVEF≥50% and an 18.4% reduction for those with LVEF 41-49% [5] Safety Profile - TX45 was well tolerated with no serious or severe adverse events reported during the trial [7][11] - There were no clinically significant changes in vital signs or safety laboratory values, indicating a favorable safety profile for TX45 [11] Mechanism of Action - TX45 is a long-acting Fc-relaxin fusion protein that activates the RXFP1 receptor, providing both pulmonary and systemic vasodilatory effects [13] - The differentiated mechanism of TX45 improves both left ventricular function and pulmonary hemodynamics, particularly beneficial for patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) [11][12] Future Outlook - The topline data from Part B of the Phase 1b study, which will evaluate TX45 in patients with Heart Failure with reduced Ejection Fraction (HFrEF), is expected in the second half of 2025 [3][9] - The ongoing APEX Phase 2 clinical trial is anticipated to provide further insights into the efficacy of TX45 in PH-HFpEF, with topline results expected in 2026 [2][9]

Core Viewpoint - Tectonic Therapeutic, Inc. reported significant progress in its proprietary pipeline and strengthened its cash position, with over three years of cash runway, while preparing to present key clinical trial data in 2025 [2][5]. Financial and Operating Results - As of March 31, 2025, Tectonic had cash and cash equivalents of $306.2 million, a substantial increase from $141.2 million as of December 31, 2024 [5][17]. - Research and development expenses for Q1 2025 were $13.0 million, up from $10.8 million in Q1 2024, primarily due to increased costs related to the development of TX2100 [13]. - General and administrative expenses rose to $5.3 million in Q1 2025 from $2.2 million in Q1 2024, driven by higher professional service costs and increased employee-related expenses [13]. - The net loss for Q1 2025 was $15.9 million, compared to a net loss of $15.2 million in Q1 2024 [13][15]. Recent Business Highlights - Tectonic announced positive interim results from Part A of the TX45 Phase 1b trial, showing a 17.9% reduction in Pulmonary Capillary Wedge Pressure (PCWP) and over 30% reduction in Pulmonary Vascular Resistance (PVR) in a subpopulation with more severe disease [6][7]. - A private placement raised approximately $185.0 million in February 2025, enhancing the company's financial position [7]. - Enrollment for Part B of the TX45 Phase 1b trial began in March 2025, focusing on patients with Pulmonary Hypertension in Heart Failure with reduced Ejection Fraction (PH-HFrEF) [7]. Upcoming Milestones - Full results from the Phase 1b Part A trial will be presented at the ESC Heart Failure 2025 Congress on May 17, 2025 [6][7]. - Topline results from Part B of the Phase 1b trial are expected in the second half of 2025 [6][7]. - The ongoing APEX Phase 2 trial is expected to yield topline results in 2026 [6][7].

Core Insights - Tectonic Therapeutic, Inc. announced a late-breaking oral presentation at the ESC Heart Failure 2025 Congress, focusing on Phase 1b data for TX45, a long-acting relaxin therapy targeting Group 2 PH-HFpEF patients [1][2] Group 1: Company Overview - Tectonic Therapeutic is a clinical-stage biotechnology company specializing in the discovery and development of therapeutic proteins and antibodies that modulate GPCR activity [5] - The company utilizes its proprietary GEODe™ technology platform to develop biologic medicines aimed at addressing significant unmet medical needs [5] Group 2: Product Information - TX45 is an Fc-relaxin fusion protein designed to activate the RXFP1 receptor, exhibiting pharmacokinetics and biophysical properties that enhance its therapeutic potential [3] - Relaxin, the hormone targeted by TX45, functions as a pulmonary and systemic vasodilator with additional anti-fibrotic and anti-inflammatory properties [3] Group 3: Disease Focus - Tectonic is concentrating on Group 2 pulmonary hypertension, specifically PH-HFpEF, which arises from left-sided heart disease and leads to increased pulmonary artery pressure and right-sided heart failure [4] - Approximately one third to one half of the 1.4 million PH-HFpEF patients in the U.S. are affected by the more severe Combined pre- and post-capillary PH (CpcPH) [4]