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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
GlobeNewswire· 2025-05-17 14:40
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]
Tectonic Therapeutic (TECX) 2025 Conference Transcript
2025-05-15 17:20
Tectonic Therapeutic (TECX) 2025 Conference May 15, 2025 12:20 PM ET Speaker0 Hey, everyone. Good morning, and welcome to day three of the twenty twenty five Bank of America Healthcare Conference. And thanks for joining this session with Tectonic Therapeutics. My name is Alex Stranahan. I'm senior biotech analyst at Bank of America. And I'm pleased to introduce Elise Raisin, president and CEO of Tectonic. She'll be running through some slides and going over the company. So with that, Elise, over to you. Spe ...
Wall Street Analysts See a 258.52% Upside in Tectonic Therapeutic, Inc. (TECX): Can the Stock Really Move This High?
ZACKS· 2025-05-13 15:00
Tectonic Therapeutic, Inc. (TECX) closed the last trading session at $20.71, gaining 15.9% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $74.25 indicates a 258.5% upside potential.The mean estimate comprises four short-term price targets with a standard deviation of $20.71. While the lowest estimate of $51 indicates a 146.3% increase from the current price level, the most optimis ...
Tectonic Therapeutic, Inc.(TECX) - 2025 Q1 - Quarterly Report
2025-05-08 20:20
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number: 001-38537 TECTONIC THERAPEUTIC, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 81 ...
Tectonic Therapeutic, Inc.(TECX) - 2025 Q1 - Quarterly Results
2025-05-08 20:07
Exhibit 99.1 • Full Data from Phase 1b Part A Trial to be Presented at the ESC Congress: Full results from the TX45 Phase 1b trial in the Group 2 PH-HFpEF cohort will be presented as an oral late-breaking presentation at the European Society of Cardiology (ESC) Heart Failure 2025 Congress. The data set includes a total of 19 patients with PH-HFpEF. The presentation is scheduled for May 17, 2025, at 10:40 a.m. ET. • Ongoing Phase 1b Part B Results Expected 2H 2025: Part B of the TX45 Phase 1b hemodynamic cli ...
Tectonic Therapeutic Announces First Quarter 2025 Financial Results and Recent Business Highlights
GlobeNewswire News Room· 2025-05-08 20:01
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, SerbiaPart B of the TX45 Phase 1b trial initiated in March with topline results expected in t ...
Tectonic Therapeutic To Present on May 15th, 2025 at the Bank of America Securities Health Care Conference
GlobeNewswire· 2025-05-07 12:00
The live webcast can also be accessed under "Events & Presentations" on the Investors section of the Tectonic website at www.tectonictx.com. Once the conference has concluded, a replay of the webcast will be available on the Company's website for approximately 90 days. WATERTOWN, Mass., May 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 th ...
Tectonic Therapeutic to Present Phase 1b Data for TX45 at European Society of Cardiology Heart Failure 2025
Newsfilter· 2025-04-15 12:00
WATERTOWN, Mass., April 15, 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 that it will make a late-breaking oral presentation at the European Society of Cardiology (ESC) Heart Failure 2025 Congress. The presentation will highlight Phase 1b data for TX45, Tectonic's lead ass ...
Tectonic Therapeutic, Inc.(TECX) - 2024 Q4 - Annual Report
2025-03-20 20:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _________________ Commission File Number: 001-38537 TECTONIC THERAPEUTIC, INC. (Exact name of Registrant as specified in its Charter) Delaware ...
Tectonic Therapeutic, Inc.(TECX) - 2024 Q4 - Annual Results
2025-03-20 20:02
Financial Performance - Tectonic experienced a net loss of $12.4 million for Q4 2024, compared to a net loss of $7.9 million for the same period in 2023[11]. - Net loss for Q4 2024 was $12,373,000, compared to a net loss of $7,869,000 in Q4 2023, reflecting a 57.5% increase in losses[18]. - Comprehensive loss for the year ended December 31, 2024, was $57,973,000, compared to $42,834,000 in 2023[18]. - Net loss per share for Q4 2024 was $0.84, compared to $5.01 in Q4 2023[18]. Cash and Assets - Tectonic reported cash and cash equivalents of $141.2 million as of December 31, 2024, with an additional $185.0 million raised in a private placement in February 2025, providing a cash runway into Q4 2028[6]. - Cash and cash equivalents increased significantly to $141,239,000 in 2024 from $28,769,000 in 2023[20]. - Total assets grew to $152,905,000 in 2024, up from $39,399,000 in 2023[20]. - Working capital improved to $135,247,000 in 2024, compared to a negative working capital of $(10,004,000) in 2023[20]. - Total stockholders' equity improved to $140,776,000 in 2024, compared to a deficit of $84,636,000 in 2023[20]. Expenses - Research and development expenses increased to $9.2 million for Q4 2024, up from $7.1 million in Q4 2023, primarily due to higher costs associated with clinical trials[11]. - General and administrative expenses rose to $4.8 million in Q4 2024, compared to $2.3 million in Q4 2023, driven by increased audit, legal, and professional service costs[11]. - Total operating expenses for Q4 2024 were $13,989,000, a 49.5% increase from $9,372,000 in Q4 2023[18]. - Research and development expenses rose to $9,155,000 in Q4 2024, up 29.3% from $7,081,000 in Q4 2023[18]. - Interest income for Q4 2024 was $1,735,000, a significant increase from $132,000 in Q4 2023[18]. Clinical Trials and Research - The TX45 Phase 1b trial interim analysis showed a 17.9% reduction in Pulmonary Capillary Wedge Pressure (PCWP) and over 30% reduction in Pulmonary Vascular Resistance (PVR) in patients with Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF)[7]. - The APEX Phase 2 trial for TX45 is ongoing, with topline results expected in 2026[6]. - The first patient for the TX45 Phase 1b Part B trial was enrolled in March 2025, with results anticipated in the second half of 2025[11]. - Tectonic plans to initiate a Phase 1 clinical trial for TX2100, a GPCR-targeting biotherapeutic for Hereditary Hemorrhagic Telangiectasia (HHT), in Q4 2025 or Q1 2026[11]. - Tectonic presented positive TX45 Phase 1a results at the AHA 2024 Scientific Sessions in November 2024[7]. Events and Engagement - The company hosted a Key Opinion Leader webinar in December 2024 discussing the treatment landscape for patients with Group 2 PH-HFpEF[7].