Annuncio • Jun 11
Tectonic Therapeutic, Inc. Completes Enrollment in TX45 APEX Phase 2 Clinical Trial in PH-HFpEF Patients Tectonic Therapeutic, Inc. announced the completion of enrollment for the APEX trial, a 24-week Phase 2 clinical trial evaluating the safety and efficacy of TX45 in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (“PH-HFpEF”). The trial was designed to include an enriched population of a more severe disease subtype of combined pre- and post-capillary pulmonary hypertension (“CpcPH”) patients with a pulmonary vascular resistance (“PVR”)>3 Wood Units (“WU”) at baseline. The APEX Phase 2 clinical trial enrolled a total of 191 patients across 14 countries of which 137 patients were enrolled with CpcPH and PVR>3 WU at baseline, consistent with the goal for this patient population to represent approximately 70% of the overall patients enrolled in APEX. In the APEX clinical trial, the mean baseline PVR in the overall patient population and the subset of patients with CpcPH and PVR>3 WU was 4.2 WU¹ and 5.2 WU¹, respectively. Tectonic expects topline results from the APEX clinical trial in early First Quarter 2027. The APEX Phase 2 clinical trial is a global, randomized, double-blind, placebo-controlled, proof-of-concept trial designed to evaluate the safety and efficacy of two dose regimens of TX45 administered subcutaneously (“SC”) in patients with PH-HFpEF, enriched for patients with CpcPH. Patients were randomized to receive 300 mg SC (2 ml injection) once monthly of TX45, 300 mg SC every other week of TX45, or a placebo. Change from baseline in PVR in the PVR>3 WU population is the primary endpoint of the trial. The World Health Organization has defined 5 groups of pulmonary hypertension (“PH”). Tectonic is focused on the Group 2 subtype, a condition that develops due to left-sided heart disease, specifically PH-HFpEF. In patients with PH-HFpEF, chronic heart failure leads to increased blood pressure in the pulmonary arteries, exerting severe strain on the right side of the heart, which adapts poorly to the increased pressure. This increased pulmonary pressure gradually causes worsening exercise capacity, shortness of breath and right-sided heart failure, which can lead to death. PH-HFpEF is further segmented based on pulmonary hemodynamics into Isolated, post-capillary PH (“IpcPH”) and CpcPH. CpcPH is more severe, accounts for about one third to one half of the 1.4 million PH-HFpEF patients in the U.S. and is characterized by additional, abnormal changes to the pulmonary vasculature, leading to an increase in PVR. Although several Group 1 PH (Pulmonary Arterial Hypertension, “PAH”) medications have been explored in Group 2 PH, to date, no medications have been approved for its treatment. TX45 is an Fc-relaxin fusion protein with optimized pharmacokinetics and biophysical properties that activates the RXFP1 receptor, the G-protein coupled receptor target of the hormone relaxin. Relaxin is an endogenous protein, expressed at low levels in both men and women that is a pulmonary and systemic vasodilator with lusitropic, anti-fibrotic and anti-inflammatory activity. In normal human physiology, relaxin is upregulated during pregnancy where it exerts vasodilative effects, reduces systemic and pulmonary vascular resistance and increases cardiac output to accommodate the increased demand for oxygen and nutrients from the developing fetus. Relaxin also exerts anti-fibrotic effects on pelvic ligaments to facilitate delivery of the baby. Annuncio • Apr 27
Tectonic Therapeutic, Inc., Annual General Meeting, Jun 08, 2026 Tectonic Therapeutic, Inc., Annual General Meeting, Jun 08, 2026. Annuncio • Apr 26
Tectonic Therapeutic, Inc. Appoints Jessica Chutter to Board of Directors, Effective June 8, 2026 Tectonic Therapeutic, Inc. announced it has appointed Jessica Chutter to its Board of Directors, effective June 8, 2026. Ms. Chutter brings more than four decades of experience in global healthcare investment banking, with deep expertise advising biotechnology and pharmaceutical companies on strategic positioning, mergers and acquisitions, and capital markets execution. She is widely recognized as a pioneer in investment banking in the biotechnology sector and has served as a trusted advisor to CEOs and boards across the industry. Ms. Chutter spent her career at Morgan Stanley, where she served as Managing Director from 1998 to February 2026 and helped build its biotechnology investment banking practice. Most recently, she was Vice Chair of Healthcare Investment Banking from 2020 to February 2026 and Chair of Biotechnology Investment Banking from 2010 to February 2026. Earlier in her tenure, she served as Co-Head of Biotechnology Investment Banking and held various roles in healthcare investment banking. Over the course of her career, Ms. Chutter advised biotechnology and pharmaceutical companies on strategic and capital markets initiatives and was involved in approximately $80 billion in capital raising transactions and $85 billion in strategic transactions. Ms. Chutter currently serves on the Board of Directors of PTC Therapeutics. She is also on the Board of The Hospital for Sick Children and the Toronto Innovation Acceleration Partners, a not-for-profit organization focused on translating health science research into commercial opportunities. She holds an M.B.A. from Harvard Business School and a Bachelor of Arts in Commerce and Honors Economics from McGill University. Annuncio • Feb 24
Tectonic Therapeutic, Inc. Announces Board and Committees Changes Tectonic Therapeutic, Inc. announced it has appointed François Nader, M.D., MBA, as an independent director to its Board of Directors, and as a member of the Nominating and Corporate Governance Committee, effective April 1, 2026, at which time he will also assume the role of Chair of the Board. Dr. Nader brings more than 30 years of leadership experience across the biotechnology and pharmaceutical industry and currently serves as an Independent Director of Moderna, Inc. . Upon Dr. Nader assuming the role as independent director to the Board of Directors, Terrance McGuire on February 23, 2026, notified the Board of his intent to (i) resign as Chair of the Board, effective as of April 1, 2026 and (ii) resign from the Board, including its committees, effective as of the Company’s 2026 annual stockholder meeting. In order to provide for a smooth leadership transition, Mr. McGuire will remain a member of the Board of Directors until Tectonic’s 2026 Annual Meeting of Stockholders, which is anticipated to be in June 2026. Dr. Nader was appointed as an Independent Director of Moderna in 2019, where he chairs both the Talent & Compensation Committee and the Nominating & Governance Committee. He has served as Chairman, Executive Chairman, and/or Independent Director of numerous biotechnology companies which culminated in significant strategic transactions, including Acceleron Pharma (acquired by Merck), Alexion Pharmaceuticals (acquired by AstraZeneca), Prevail Therapeutics (acquired by Eli Lilly), Clementia Pharmaceuticals (acquired by Ipsen), Advanced Accelerator Applications (acquired by Novartis), Baxalta (acquired by Shire), NPS Pharmaceuticals (acquired by Shire), and Noven Pharmaceuticals (acquired by Hisamitsu). He also previously served as President and Chief Executive Officer of NPS Pharmaceuticals, where he led the company’s transformation into a global rare disease leader. Earlier in his career, he held senior leadership roles spanning medical, regulatory, and commercial functions at Aventis and its predecessor companies. Dr. Nader earned his French Doctorate in Medicine from St. Joseph University in Lebanon and a Physician Executive MBA from the University of Tennessee. Annuncio • Oct 30
Tectonic Therapeutic, Inc. Announces Positive Topline Data from Phase 1B Part B Clinical Trial for Tx45 in Patients with Group 2 Pulmonary Hypertension in Hfref Tectonic Therapeutic, Inc. announced positive topline results from the Phase 1b Part B acute hemodynamic clinical trial of TX45, a long-acting, Fc-relaxin fusion protein, in patients with Group 2 PH-HFrEF. Highlights from Phase 1b Part B Topline Results and Clinical Trial Overview The topline results from the phase 1b Part B open label clinical trial are based on 14 enrolled patients with PH-HFrEF. The topline results from The Phase 1b part B open label clinical trial arebased on 14 enrolled patients withPH-HFrEF. Highlights of Phase 1b Part B Top line results and Clinical Trial Overview The to pline results from the Phase 1ss Part B open label clinical trial were based on 14 enrolled patients withPH - combined post- and pre-capillary pulmonary hypertension. Highlights from Phase 1b part B Topline results and Clinical Trial Overview: the topline results from thePhase 1b Part B open label patients with PH-HFrF. Highlights from Phase 1b Topline Results and Clinical Trial overview: The topline results from of the Phase 1b Part B openlabel clinical trial are based on 14 enrollment patients with PH-HFr EF. Highlights from Phase 1bPart B Topline Results and Clinical trial Overview: The topline results of the Phase 1b PartB open label clinical trial are based On 14 enrolled patients with PH-HFpEF. Highlights from Phase 1ss Part B Topline Results and clinical Trial Overview: The topline Results from the Phase 1b part B open labels are based on 14 enrolled patients With PH-HFrEF. Annuncio • Jul 08
Tectonic Therapeutic, Inc. has filed a Follow-on Equity Offering in the amount of $100 million. Tectonic Therapeutic, Inc. has filed a Follow-on Equity Offering in the amount of $100 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Annuncio • May 17
Tectonic Therapeutic Presents Complete Results for Positive Phase 1B Clinical Trial of Tx45 in Patients with Group 2 Pulmonary Hypertension in Hfpef in Late-Breaking Presentation At Esc Heart Failure 2025 Tectonic Therapeutic, Inc. announced the complete results from Part A of the Phase 1b clinical trial of TX45 in patients with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction ("PH-HFpEF"), which are being presented in a late-breaking, oral session at the European Society of Cardiology (ESC) Heart Failure 2025 Congress being held in Belgrade, Serbia. The results include the full cohort of 19 patients in part A of the Phase 1b trial of TX45, Tectonic's lead asset and a long-acting relaxin therapy. The complete data from Part A of the Phase1b clinical trial confirmed the tolerability and hemodynamic effects of TX45 in patients with PH-HFpEF previously reported in the interim data. The Phase 1b trial enrolled a patient population and evaluated hemodynamic endpoints which are similar to the ongoing APEX Phase 2 clinical trial (ClinicalTrials.govNCT06616974). APEX is a 24-week clinical trial in PH-HFpEF with topline results expected in 2026. New hemodynamic data reported from the Phase 1b clinical trial include the following: Echocardiograms were evaluated at baseline and at Days 2, 15 and 29. In the clinical trial, hemodynamics were analyzed across a range of left ventricular ejection fractions ("LVEF"), including LVEF50% and LVEF 41-49%. Cardiac output increased numerically more in response to TX45 in patients with higher baseline PVR, with 16.8% improvement in patients with baseline PVR. Highlights from complete Phase 1b Part A results: Within the cohort of 19 patients with PH-HFp EF enrolled in the Phase 1b open label clinical trial of TX45, 9 patients had CpcPH, as measured by PVR>2 Wood units. The Phase 1b open label clinical trials is designed to evaluate the safety and hemodynamic effect of single doses of TX45 in patients with group 2 pulmonary hypertension. The design of the clinical trial is as follows: after obtaining informed consent, a right heart catheter, which is the gold standard for the measurement of cardiopulmonary hemodynamics, is inserted and baseline measurements are obtained, an intravenous dose of TX45 is administered, and hemodynamic effects are evaluated over 8 hours post dose. Leveraging its proprietary technology platform called GEODe™? (GPCRs Engineered for Optimal Discovery), Tectonic is focused on developing biologic medicines that overcome the existing challenges of GPCR-targeted drug discovery and harness the human body to modify the course of disease. Annuncio • Apr 28
Tectonic Therapeutic, Inc., Annual General Meeting, Jun 06, 2025 Tectonic Therapeutic, Inc., Annual General Meeting, Jun 06, 2025. Annuncio • Feb 04
Tectonic Therapeutic, Inc. announced that it expects to receive $185 million in funding from a group of investors Tectonic Therapeutic, Inc. announced that it has entered into a securities purchase agreement with accredited investors to issue aggregate of 3,689,465 shares at a price of $50 per Share to fund investors and $54.14 per Share to individual investors that are either an officer or director of the Company for gross proceeds of $185,000,000 on February 3, 2025. The Private Placement is expected to close on or about February 5, 2025. The Company has agreed to pay the placement agents customary placement fees in their capacity as placement agents for the sale of the Shares to the Purchasers. The PIPE financing included participation from new and existing investors, including Adage Capital Partners LP, Ally Bridge Group, Deep Track Capital, EcoR1 Capital, funds managed by Farallon Capital Management, L.L.C., Soleus Capital, StemPoint Capital LP, TAS Partners, Woodline Partners LP, a major mutual fund, a life-sciences focused institutional investor and other investors. Annuncio • Jan 30
Tectonic Therapeutic Announces Positive Interim Data from Phase 1b Trial for TX45 in Patients with Group 2 Pulmonary Hypertension in HFpEF Tectonic Therapeutic, Inc. announced positive interim data from the Phase 1b acute hemodynamic clinical trial of its lead product candidate, TX45, a long-acting, Fc-relaxin fusion protein. The interim data showed that a single intravenous dose of TX45 resulted in meaningful improvements in both left ventricular function and pulmonary hemodynamics in patients with Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (“PH-HFpEF”). In the trial, TX45 was well tolerated in patients with PH-HFpEF with no serious or severe adverse events. In the overall study population, TX45 achieved a 17.9% reduction in pulmonary capillary wedge pressure (“PCWP”), an endpoint known to correlate with exercise capacity, morbidity and mortality in patients with heart failure. In the subpopulation with combined pre- and post-capillary pulmonary hypertension (“CpcPH”) who have an elevated Pulmonary Vascular Resistance (“PVR”) and more severe disease, TX45 demonstrated >30% reduction in PVR, which along with PCWP is correlated to exercise capacity and mortality in these patients. The Phase 1b trial enrolled a patient population and evaluated hemodynamic endpoints which are similar to the ongoing APEX Phase 2 clinical trial. APEX is a 24-week clinical trial in PH-HFpEF with topline results expected in 2026. Highlights from interim Phase 1b results and overview of the Phase 1b trial: The interim results from the Phase 1b open label clinical trial are based on 16 of 19 enrolled patients with PH-HFpEF, with the remaining 3 patients currently completing Part A of the protocol. Within the 16 patients in the interim analysis, 9 patients had CpcPH, as measured by PVR>2 Wood units. Hemodynamic measures evaluating left ventricular function included PCWP, Cardiac Output (“CO”) and Stroke Volume (“SV”). Hemodynamic measures evaluating the pulmonary vasculature included PVR, Total Pulmonary Resistance (“TPR”) and mean Pulmonary Artery Pressure (“mPAP”). Safety Results: TX45 was well tolerated with no serious or severe adverse events, discontinuations, infusion reactions or drug-related adverse events. There were no clinically significant changes in vital signs, physical exam or safety laboratory values. Transient asymptomatic decreases in blood pressure were observed over the first 24 hours after TX45 dosing. Hemodynamic Results: TX45 administration resulted in meaningful improvement in both left ventricular function and pulmonary hemodynamics, representing a differentiated profile for TX45 compared to other PAH drugs that are pulmonary vasodilators but have not shown improvement in left ventricular function and have not shown efficacy in PH-HFpEF. Improvement in left ventricular function: In the overall population, TX45 achieved 17.9% [95% CI, -9.8% to -26.1%] reduction in PCWP and 17.4% [95% CI, 8.9% to 25.9%] increase in CO. Improvement in pulmonary hemodynamics: TX45 achieved 32.0% [95% CI, -28.1% to -35.9%] reduction in PVR in the subgroup of patients with CpcPH who have elevated PVR at baseline, a 26.3% [95% CI, -20.1% to -32.5%] reduction in TPR and a 15.9% [95% CI, -11.2% to -20.6%] reduction in mean pulmonary artery pressure in the overall population. As a relaxin therapeutic, the unique mechanism of TX45 improves both left ventricular function and pulmonary hemodynamics, which most strongly matches the more severe pathophysiology of patients with CpcPH. The Phase 1b open label clinical trial is designed to evaluate the safety and hemodynamic effect of single doses of TX45 in patients with Group 2 pulmonary hypertension. Part A is examining the effect of TX45 in PH-HFpEF and Part B will evaluate effects of TX45 in Pulmonary Hypertension in Heart Failure with reduced Ejection Fraction (“PH-HFrEF”). The design of the clinical trial is as follows: after obtaining informed consent, a right heart catheter, which is the gold standard for the measurement of cardiopulmonary hemodynamics, is inserted and baseline measurements are obtained, an intravenous dose of TX45 is administered, and hemodynamic effects are evaluated over 8 hours post dose. Participants are then followed for 45 days post dose for safety and exploratory biomarker endpoints. Part A enrollment has completed. Part B enrollment will start in February with topline data expected in the second half of 2025. The complete Phase 1b clinical trial results in PH-HFpEF and PH-HFrEF patient populations are planned to be presented at future medical meetings. Annuncio • Nov 11
Tectonic Therapeutic Announces Positive Phase 1a Results in AHA 2024 Presentation for TX45, a Long-Acting, Fc-Relaxin Fusion Protein Tectonic Therapeutic, Inc. announced detailed results from the Phase 1a clinical trial of its lead asset, TX45, a long-acting, Fc-relaxin fusion protein. The poster will be presented at the American Heart Association (AHA) Scientific Sessions on November 16, 2024 from 3-4pm EST in Chicago, Illinois. Favorable topline results from the TX45 Phase 1a clinical trial were announced on September 19, 2024, along with the dose selection for the TX45 APEX Phase 2 trial that is currently underway in patients with PH-HFpEF. The Phase 1a single ascending dose (“SAD”) clinical trial assessed the safety and tolerability of TX45 in 55 healthy volunteers. Additionally, the Phase 1a clinical trial evaluated pharmacokinetic (“PK”) and pharmacodynamic (“PD”) measures of TX45 based on relaxin’s known ability to increase RPF in order to create an exposure-response model for Phase 2 dose selection. Phase 1a Highlights: Safety Results: TX45 was well tolerated with no drug-related severe adverse events, no evidence of immune-mediated clearance, and no antidrug antibodies or injection site reactions. The most common Treatment Emergent Adverse Event was orthostatic tachycardia (increase in heart rate while standing), which was transient and not associated with decreases in blood pressure. No clinically meaningful changes in laboratory values, ECG intervals or blood pressure were observed. Pharmacokinetic Results: TX45 demonstrated a potential best-in-class half-life for a long-acting relaxin therapy. Final analysis showed that a single dose of TX45 had approximately 50% subcutaneous bioavailability with a half-life (t1/2) of two to three weeks (14-20 days). Pharmacodynamic Results and Exposure Response-Modeling: TX45 administration resulted in increased RPF across all doses. Comparing TX45 blood levels to RPF allowed for the development of a robust exposure-response model for Phase 2 dose selection. The exposure-response model is a nonlinear, mixed-effects Emax model that included repeated measurements of RPF for each subject in the study (>200 data points), resulting in a modeled Emax (maximum effect) of 33% (SE 3.3%, p < 0.0001). The magnitude of effect of TX45 on RPF was consistent with other relaxin therapeutics. Mean dose cohort effects (n=6 per cohort) demonstrated increased RPF of up to 42%. The model also demonstrated that the two doses selected for the APEX Phase 2 study, 300 mg every two weeks (Q2W) and 300 mg every four weeks (Q4W), yield maximal or near-maximal PD effects on human RPF at steady state trough. TX45 is being evaluated in the APEX Phase 2 clinical trial (NCT06616974) in patients with Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (“PH-HFpEF”). The trial is designed to evaluate efficacy in the broad PH-HFpEF population and enrich for the subset of Group 2 PH patients with a more severe form of disease. The trial plans to enroll up to 180 subjects who will be randomized to one of two dose regimens of TX45 or placebo. TX45 will be administered by subcutaneous injection over 24-weeks followed by an 8-week follow-up period. The primary and secondary endpoints of the trial include change from baseline in pulmonary vascular resistance (PVR) as well as other relevant hemodynamic changes. It will also explore TX45’s effect on change in six-minute walk distance. TX45 aims to address the physiological abnormalities of PH-HFpEF through its effects on both pulmonary and systemic vasodilation, cardiac diastolic dysfunction and potential remodeling in both the pulmonary vessels and cardiac muscle, which could translate into a clinically meaningful improvement in exercise capacity in these patients.