TECX

TX45 APEX Phase 2 patient enrollment in PH-HFpEF is nearing completion with topline results anticipated in late Q4 2026 or early Q1 2027 TX2100 advanced into Phase 1a healthy volunteer clinical trial in February 2026 as a potential treatment for Hereditary Hemorrhagic Telangiectasia (“HHT”), and as of April 2026, four cohorts have been dosed with topline results expected by the end of Q3 2026 TX45 ALPINE Phase 2 clinical trial initiated in Pulmonary Hypertension in Heart Failure associated with Interstitial Lung Disease (“PH-ILD,” Group 3 PH), with first site activated in February 2026 and screening initiated in March 2026, expanding TX45 into a second pulmonary hypertension indication Strengthened leadership with the appointment of François Nader, M.D., as Chair of the Board and Jessica Chutter, as independent board director, enhancing governance and strategic oversight as the Company advances its pipeline Cash and cash equivalents were $236.9 million as of March 31, 2026, expected to provide cash runway into Q4 2028 WATERTOWN, Mass., May 07, 2026 (GLOBE NEWSWIRE) -- Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic” or the “Company”), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (GPCRs), today announced financial results for the first quarter ended March 31, 2026, and provided an overview of recent business highlights. "During Q1 2026, we made meaningful progress advancing both TX45 and TX2100 across key clinical milestones, including dosing the first subjects in our Phase 1a trial of TX2100 in HHT, continued dosing of patients in the TX45 APEX Phase 2 trial and initiating our TX45 ALPINE Phase 2 trial in PH-ILD ," said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic Therapeutic. "We believe TX2100 represents a novel, first-in-class approach in a disease with significant unmet need. Looking ahead, we remain focused on executing our ongoing clinical trials and advancing both programs toward important topline readouts.” Recent Business Highlights Initiated Phase 1a Clinical Trial of TX2100 in HHT: In February 2026, the Company initiated dosing in its Phase 1a clinical trial of TX2100 in healthy volunteers. The randomized, placebo-controlled, double-blind, ascending-dose trial is intended to characterize...

Announced positive topline results from TX45 Phase 1b acute hemodynamic clinical trial in patients with Group 2 Pulmonary Hypertension in Heart Failure with reduced Ejection Fraction (“PH-HFrEF”) in October 2025. Topline results showed TX45 was well tolerated and improved both left heart function and pulmonary hemodynamics in patients with Group 2 PH-HFrEF TX2100 advanced into Phase 1a healthy volunteer clinical trial, randomizing the first subject in February 2026, as a potential treatment for Hereditary Hemorrhagic Telangiectasia (“HHT”) TX45 advanced into Phase 2 clinical trial in February 2026 with first site activated and opened for screening patients with Pulmonary Hypertension associated with Interstitial Lung Disease (“PH-ILD”, Group 3 PH) to potentially broaden the therapeutic scope of TX45 Announced the appointment of François Nader, M.D., MBA, as an independent director to Board of Directors, effective April 1, 2026, at which time he will also assume the role of Chair of the Board TX45 APEX Phase 2 clinical trial topline results expected in 2026 in patients with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction (“PH-HFpEF”) Cash and cash equivalents were approximately $253.8 million as of December 31, 2025, expected to provide cash runway into Q4 2028 WATERTOWN, Mass., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic”), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (GPCRs), today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided an overview of recent business highlights. “Over the last 12 months, we have made significant progress expanding our clinical pipeline. In February 2026 we advanced our second program, TX2100, a potential novel treatment for patients with HHT, and dosed the first patient in a Phase 1a clinical trial in normal healthy volunteers. This marks an important milestone for Tectonic which now has two programs in clinical development to address patient populations with high unmet need and no approved therapy,” said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic Therapeutic. “We continued to advance TX45 through a series of important clinical and operational mil...

Positive topline data from Part B of the TX45 Phase 1b trial demonstrated improvements in both left heart function and pulmonary hemodynamics in patients with Group 2 Pulmonary Hypertension in Heart Failure with reduced Ejection Fraction (“PH-HFrEF”) Expect to initiate TX2100 Phase 1 clinical trial in healthy volunteers in Q1’2026 as a potential treatment for Hereditary Hemorrhagic Telangiectasia (“HHT”) TX45 PH-ILD Phase 2 clinical trial is planned to initiate in 2026 to evaluate TX45’s safety and hemodynamic effects in patients with Pulmonary Hypertension associated with Interstitial Lung Disease (“PH-ILD”, Group 3 PH) to expand the therapeutic breadth of TX45 Ongoing TX45 APEX Phase 2 clinical trial in patients with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction (“PH-HFpEF”) continues to enroll; topline results expected in 2026 Cash and cash equivalents were $268.4 million as of September 30, 2025, expected to provide cash runway into Q4’2028 WATERTOWN, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic”), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (GPCRs), today announced financial results for the third quarter ended September 30, 2025, and provided an overview of recent business highlights. “Our team continued to advance our lead asset TX45 with the positive topline data from Part B of our Phase 1b study in patients with HFrEF. Following our recent presentation of the full Part A data set at the ESC Heart Failure 2025 Congress, the improvements demonstrated in both left heart function and pulmonary hemodynamics across both PH-HFrEF and PH-HFpEF populations suggest TX45 has the potential to be effective in a broad patient population,” said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic. “Enrollment continues in our global APEX Phase 2 trial in PH-HFpEF, and we expect to report topline results from that study in 2026.” Recent Business Highlights Positive Topline Results from Part B of the TX45 Phase 1b Clinical Trial: In October 2025, positive topline results from Part B of the TX45 Phase 1b clinical trial in 14 patients with PH-HFrEF were announced. TX45 was well tolerated in the overall study population and demonstrated a 2...

TX45 PH-ILD Phase 2 clinical trial is planned to initiate in 2026 to evaluate TX45’s safety and hemodynamic effects in subjects with Pulmonary Hypertension associated with Interstitial Lung Disease (“PH-ILD”, Group 3 PH) to expand the therapeutic breadth of TX45 Complete results from Part A of the TX45 Phase 1b clinical trial presented at ESC Heart Failure 2025 confirmed TX45’s tolerability profile and improvements in left ventricular function and pulmonary hemodynamics in subjects with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction (“PH-HFpEF”) Part B of the TX45 Phase 1b clinical trial in subjects with Group 2 Pulmonary Hypertension in Heart Failure with reduced Ejection Fraction (“PH-HFrEF”) completed enrollment; topline results are expected in early Q4’2025 Ongoing TX45 APEX Phase 2 clinical trial continues to enroll; topline results expected in 2026 TX2100 is expected to initiate a Phase 1 clinical trial in healthy volunteers in Q1’2026 Cash and cash equivalents were $287.4 million as of June 30, 2025, including the private placement net proceeds raised in February 2025, expected to provide cash runway into Q4’2028 WATERTOWN, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic”), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (GPCRs), today announced financial results for the second quarter ended June 30, 2025, and provided an overview of recent business highlights. “Today our team is excited to announce PH-ILD as an additional indication for TX45 that we plan to explore in a Phase 2, proof of concept trial. PH-ILD is a devastating disease with high mortality, significant unmet medical need and limited therapeutic alternatives. TX45’s preclinical and hemodynamic data from Part A of the Phase 1b trial in Group 2 PH-HFpEF supports expanding into PH-ILD,” said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic. “Additionally, we have completed enrollment in Part B of our TX45 Phase 1b trial in subjects with PH-HFrEF, with topline results expected in early Q4’2025. In parallel, enrollment continues in our global TX45 APEX Phase 2 trial in PH-HFpEF, with topline results expected in 2026.” Recent Business Highlights Positive Complete Resu...

Data confirmed TX45’s tolerability profile and improvements in left ventricular function and pulmonary hemodynamics in patients with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction (“PH-HFpEF”) In new echocardiographic analysis, TX45 treatment resulted in sustained hemodynamic effects for 29 days TX45 improved cardiac and pulmonary hemodynamics in PH-HFpEF patients across a range of left ventricular ejection fractions (“LVEF”), including LVEF≥50% and LVEF 41-49% WATERTOWN, Mass., May 17, 2025 (GLOBE NEWSWIRE) -- Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic”) today 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. Interim data for 16 patients in the Phase 1b trial was previously reported in a press release on January 30, 2025. The complete data from Part A of the Phase 1b clinical trial confirmed the tolerability and hemodynamic effects of TX45 in patients with PH-HFpEF previously reported in the interim data. Based on the complete dataset in PH-HFpEF, a single intravenous dose of TX45 was well tolerated, with no serious or severe adverse events. In the overall study population, TX45 achieved a 19.0% 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 this patient population. The Phase 1b trial enrolled a patient population and evaluated hemodynamic endpoints which are similar to the ongoing APEX Phase 2 clinical trial (ClinicalTrials.gov NCT06616974). APEX is a 24-week clinical trial in PH-HFpEF with topline results expected in 2026. New hemodynamic data reported today f...

Interim analysis from the TX45 Phase 1b Part A trial demonstrated 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”) Full results from the Phase 1b Part A trial will be presented on May 17, 2025 at the European Society of Cardiology (ESC) Heart Failure Congress in Belgrade, Serbia Part B of the TX45 Phase 1b trial initiated in March with topline results expected in the second half of 2025 Ongoing TX45 APEX Phase 2 trial continues to enroll with topline results expected in 2026 Cash and cash equivalents were $306.2 million as of March 31, 2025, including the private placement net proceeds raised in February 2025, expected to provide cash runway into Q4 2028 WATERTOWN, Mass., May 08, 2025 (GLOBE NEWSWIRE) -- Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic”), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (GPCRs), today announced financial results for the first quarter ended March 31, 2025, and provided an overview of recent business highlights. “During the first quarter, we continued to make meaningful progress across our proprietary pipeline and fortified our cash position with over 3 years of cash runway,” said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic. “We will be sharing the complete data set from the 19 patients with PH-HFpEF enrolled in Part A of our Phase 1b trial of TX45 at the ESC Heart Failure 2025 Congress. Looking ahead, we expect to present topline results from Part B of the Phase 1b trial in the second half of 2025. We are also advancing our APEX Phase 2 trial and believe the Phase 1b data support both our selected endpoints and patient population, and provided a strong proof-of-principle for the TX45 program.” Recent Business Highlights Positive Interim TX45 Phase 1b Part A Trial Results: In January 2025, Tectonic announced positive interim results from Part A of the TX45 Phase 1b trial in patients with Group 2 pulmonary hypertension in HFpEF (n=16). Results demonstrated that TX45 achieved 17.9% reduction in Pulmonary Capillary Wedge Pressure (“PCWP”) in the total study population of PH-HFpEF and >30% reduction in Pulmonary Vascular Resistance...

TX45 Phase 1b trial interim analysis demonstrated 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”) Positive TX45 Phase 1b interim results support endpoints and patient population in ongoing APEX Phase 2 trial, with topline results expected in 2026 TX45 Phase 1b Part B trial enrolled its first subject with Heart Failure with reduced Ejection Fraction (“HFrEF”) in March 2025 Cash and cash equivalents of $141.2 million as of December 31, 2024 and February 2025 private placement gross proceeds of approximately $185.0 million, together expected to provide a cash runway into Q4’28 WATERTOWN, Mass., March 20, 2025 (GLOBE NEWSWIRE) -- Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic”), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (“GPCRs”), today announced financial results for the fourth quarter and full year ended December 31, 2024, and provided an overview of recent business highlights. “2024 was an important year for Tectonic as we transitioned to a public company, and 2025 is already off to an excellent start,” said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic. “We are very pleased to have recently reported positive interim results from our ongoing Phase 1b trial of TX45, which we believe supports the endpoints and patient population included in our ongoing APEX Phase 2 trial. We look forward to presenting detailed results at an upcoming medical meeting as well as continuing to advance both the APEX Phase 2 trial and Part B of the Phase 1b trial.” Recent Business Highlights Positive TX45 Phase 1b Part A Interim Trial Results: In January 2025, Tectonic announced positive interim results from Part A of the Phase 1b trial of TX45 in patients with Group 2 pulmonary hypertension in HFpEF. Results demonstrated that TX45 achieved 17.9% reduction in Pulmonary Capillary Wedge Pressure (“PCWP”) in the total study population of PH-HFpEF and >30% reduction in Pulmonary Vascular Resistance (“PVR”) in Combined pre- and post-capillary PH (“CpcPH”), a subpopulation with more severe disease. In addition, results demonstrated that TX45 achieved 17.4% improvement in Cardiac Out...