Tectonic Therapeutic, Inc. - TECX STOCK NEWS

Tectonic Therapeutic (NASDAQ: TECX), a clinical stage biotech company specializing in G-protein coupled receptors (GPCRs), has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The event will take place in New York from December 3-5, 2024. Alise Reicin, MD, President and CEO, will deliver a presentation on Tuesday, December 3rd, 2024, at 12:30 PM ET.

The presentation will include one-on-one meetings and will be accessible via webcast. Interested parties can access the live webcast through the Investors section of Tectonic's website, where a replay will remain available for approximately 90 days after the conference.

Tectonic Therapeutic announced positive Phase 1a results for TX45, its long-acting Fc-relaxin fusion protein. The trial, involving 55 healthy volunteers, demonstrated favorable safety profile with no severe adverse events or anti-drug antibodies. TX45 showed a half-life of 14-20 days and approximately 50% subcutaneous bioavailability. The drug increased renal plasma flow across all doses, with mean cohort effects up to 42%. Based on these results, two doses (300mg Q2W and Q4W) were selected for the ongoing APEX Phase 2 trial in PH-HFpEF patients. Topline results are expected in late 1Q or early 2Q'2025 for Phase 1b, and in 2026 for Phase 2.

Tectonic Therapeutic (NASDAQ: TECX) reported Q3 2024 financial results and business updates. Patient enrollment in Phase 1b hemodynamic trial is ahead of schedule, with topline results expected in late Q1'2025 or early Q2'2025. The company dosed its first subject in the APEX Phase 2 trial for TX45 in October, with results expected in 2026. Cash position stands at $159.1 million, providing runway into mid-2027. Q3 net loss increased to $17.7 million from $10.1 million year-over-year. The company selected TX002100 as its development candidate for treating Hereditary Hemorrhagic Telangiectasia, with Phase 1 trials expected to begin in Q4'2025 or Q1'2026.

Tectonic Therapeutic (NASDAQ: TECX) announced favorable Phase 1a topline data for its lead asset TX45, a long-acting relaxin being developed for Group 2 PH-HFpEF treatment. The trial demonstrated TX45's safety, tolerability, and favorable PK/PD profile with no observed immunogenicity. Doses of 0.3, 1, and 3 mg/kg (IV) and 150, 300, and 600 mg (SC) were tested. Based on these results, Tectonic has selected doses for its global Phase 2 randomized clinical trial.

The company also reported progress in its Phase 1b single-dose hemodynamic proof-of-concept trial, which has escalated to the highest dose of TX45 (3 mg/kg). Topline results for this trial are expected in Q2 2025. Tectonic has initiated screening for the Phase 2 APEX clinical trial, with topline results anticipated in 2026.

Tectonic Therapeutic (NASDAQ: TECX), a clinical stage biotech company focused on G-protein coupled receptors (GPCRs), has announced its participation in two major investor conferences in September 2024. The company will present at the 2024 Wells Fargo Healthcare Conference in Boston on September 4, featuring a fireside chat with CEO Alise Reicin at 3:45 PM ET. Additionally, Tectonic will participate in the Morgan Stanley 22nd Annual Global Healthcare Conference in New York on September 6, engaging in one-on-one investor meetings.

A live webcast of the Wells Fargo conference presentation will be available on Tectonic's website, with a replay accessible for approximately 90 days. These conferences provide Tectonic with opportunities to showcase its progress in developing therapeutic proteins and antibodies that modulate GPCR activity to potential investors and industry professionals.

Tectonic Therapeutic (NASDAQ: TECX) reported Q2 2024 financial results and business highlights. Key developments include:

1. Advancement of TX45 into Phase 2 clinical trial for Group 2 PH-HFpEF, with first site activated in August 2024.
2. U.S. IND clearance for TX45 in July 2024.
3. Completion of reverse merger with AVROBIO and concurrent private placement of $130.7 million in June 2024.
4. Cash position of $185.1 million as of June 30, 2024, expected to provide runway into mid-2027.

Financials: R&D expenses decreased to $7.1 million, while G&A expenses increased to $4.3 million. Net loss was $12.7 million for Q2 2024. Upcoming milestones include Phase 1a trial results and first subject dosing in Phase 2 trial, both expected in September 2024.

Tectonic Therapeutic (NASDAQ: TECX) announced FDA clearance for its Investigational New Drug application for TX45, an Fc-relaxin fusion protein targeting Group 2 Pulmonary Hypertension due to Heart Failure with Preserved Ejection Fraction (PH-HFpEF). This condition affects over 600,000 people in the U.S. with no approved therapies. The company plans to initiate a global, 24-week Phase 2 clinical trial in Q3 2024, with topline results expected in 2026.

Key updates include:

• Phase 1a topline results in healthy volunteers expected in September 2024
• Ongoing Phase 1b hemodynamic trial in PH-HFpEF subjects, with topline results expected mid-2025
• Phase 2 trial to enroll up to 180 subjects, evaluating two dose regimens of TX45 vs placebo
• Primary and secondary endpoints include changes in pulmonary vascular resistance and other hemodynamic measures

Tectonic Therapeutic has completed a merger with AVROBIO and a $130.7 million private placement. The company now operates as Tectonic Therapeutic, trading on Nasdaq under ticker symbol 'TECX' starting June 21, 2024. The merger gives Tectonic approximately $181 million in cash and investments to fund operations until mid-2027. Tectonic's lead program, TX45, is in Phase 1 trials for treating Group 2 Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction, with Phase 2 trials expected in 2026. Another program targets Hereditary Hemorrhagic Telangiectasia. AVROBIO shareholders received a contingent value right for certain cash payments related to AVROBIO’s legacy assets.