Core Insights - The conference call focuses on the top line results from Part B of the Phase Ib clinical trial evaluating TX45 for patients with pulmonary hypertension associated with reduced ejection fraction heart failure (PH-HFrEF) [2][3] Group 1: Clinical Trial Overview - The clinical trial involved 14 patients and aimed to assess the safety and tolerability of TX45 in the PH-HFrEF patient population [3] - The trial also sought to explore the hemodynamic effects of TX45, with expectations of observing effects similar to previous studies [3]

Tectonic Therapeutic (NasdaqGM:TECX) Update / Briefing October 29, 2025 04:30 PM ET Speaker2Good day and welcome to the TX45 Phase 1B Part B PHFREF Data Conference Call. After the speaker's presentation, there will be a question and answer session. To ask a question, please press *11. If your question has been answered and you would like to move yourself from the queue, please press *11 again. As a reminder, this call may be recorded. I would now like to turn the call over to Dr. Alise Reicin. Please go ahe ...

TX45 Phase 1b (Part B) PH-HFrEF Data Release Single Dose Hemodynamic Trial O c t o b e r 2025 DISCLAIMER Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Ea ...

TX45 improved both left heart function and pulmonary hemodynamics in patients with Group 2 Pulmonary Hypertension in Heart Failure with reduced Ejection Fraction (“PH‑HFrEF”)TX45 was well tolerated in patients with PH‑HFrEF with no serious or severe adverse events, no clinically significant changes in blood pressure and no immune related reactionsResults support potential expansion of TX45’s addressable Group 2 PH patient population to PH‑HFrEFCompany to host webcast today, October 29th at 4:30 p.m. ET WATE ...

Summary of Tectonic Therapeutics FY Conference Call Company Overview - **Company**: Tectonic Therapeutics (NasdaqGM: TECX) - **Focus**: Development of novel therapeutics targeting heart failure and pulmonary hypertension Key Molecule: TX-45 - **Description**: TX-45 is a long-acting relaxin mimetic with potential applications in heart failure and pulmonary hypertension [3][4] - **Mechanisms of Action**: - Acts as a vasodilator for both peripheral and pulmonary circulation [4] - Functions as a leisotropic agent, relaxing heart muscle during diastole [4] - Exhibits antifibrotic properties by increasing metalloproteinases and inhibiting the TGF beta pathway [5] Target Patient Population - **Heart Failure with Preserved Ejection Fraction (HFpEF)**: Estimated 3.5 to 4 million patients in the U.S. [9] - **Specific Subset**: Approximately 1.4 million patients with Class II and III heart failure and elevated pulmonary pressures, with around 700,000 to 1 million having combined pre- and post-capillary pulmonary hypertension (CPCPH) [10] Competitive Landscape - **Lilly's Program**: Competes with a long-acting relaxin designed differently, leading to fluid retention issues in decompensated heart failure patients [12][13] - **AstraZeneca**: Conducting studies in similar patient populations, focusing on pulmonary vascular resistance [24] - **Merck**: Investigating treatments for pulmonary hypertension, with potential data release expected [29] Clinical Trial Updates - **Phase Ib Study**: Showed a 32% to 35% reduction in pulmonary vascular resistance and an 18% to 19% reduction in pulmonary capillary wedge pressure [38] - **Phase II APeX Trial**: Over 30% enrollment, focusing on patients with high pulmonary vascular resistance [42] - **Future Trials**: Plans to initiate a trial for pulmonary hypertension associated with interstitial lung disease (PHILD) in 2026 [50] Additional Program: Hereditary Hemorrhagic Telangiectasia (HHT) - **Target Population**: 70,000 to 75,000 patients in the U.S., focusing on moderate to severe cases with no approved therapies [61] - **Study Timeline**: Phase I study expected to start in Q1 2026 [62] Platform Technology - **G Protein-Coupled Receptors (GPCRs)**: Tectonic's platform enables the development of antibodies against GPCRs, a significant target for drug development [66] Upcoming Milestones - **Data Releases**: Anticipated data from reduced ejection fraction Phase Ib study in October and further updates on clinical trials throughout 2026 [71][72] Conclusion - Tectonic Therapeutics is positioned to address significant unmet needs in heart failure and pulmonary hypertension with innovative therapies and a robust pipeline, while navigating a competitive landscape with ongoing clinical trials and strategic patient targeting.

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]