Tectonic Therapeutic Announces Third Quarter 2024 Financial Results and Recent Business Highlights

In This Article:

Tectonic Therapeutic
Tectonic Therapeutic
  • Patient enrollment in the Phase 1b hemodynamic trial remains ahead of expectation, with topline results now expected in late Q1’2025 or early Q2’2025

  • First subject dosed with TX000045 (“TX45”) in APEX Phase 2 clinical trial in early October, with topline results expected in 2026

  • Development Candidate TX002100 (“TX2100”) selected for second program targeting patients with Hereditary Hemorrhagic Telangiectasia (HHT)

  • Cash and cash equivalents were $159.1 million as of September 30, 2024, expected to provide cash runway into mid-2027

WATERTOWN, Mass., Nov. 07, 2024 (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 its financial results for the third quarter ending September 30, 2024, and provided an overview of recent business highlights.

“During the third quarter we continued to make excellent progress advancing our novel pipeline. We initiated the APEX Phase 2 clinical trial and continued better than expected enrollment in our Phase 1b hemodynamic, proof of concept clinical trial for TX45,” commented Alise Reicin, M.D., President and Chief Executive Officer of Tectonic. “Additionally, today we are announcing the selection of TX2100 as our development candidate for Tectonic’s second program targeting HHT, and we are looking forward to discussing our Phase 1a trial results for TX45 this month at the American Heart Association followed by topline results for the Phase 1b trial expected in late Q1’2025 or early Q2’2025.”

Recent Business Highlights

  • First Subject Dosed TX45 in APEX Phase 2 Trial in Early October 2024: Tectonic dosed its first subject in its global, 24-week APEX Phase 2 clinical trial in early October. The trial is a placebo-controlled study designed to evaluate the safety and efficacy of Tectonic’s lead program, TX45 administered subcutaneously (SC) in subjects with PH-HFpEF. Subjects will be randomized to 300 mg SC (2 ml injection) once monthly of TX45, 300 mg SC once every other week of TX45, or placebo. Topline trial results from the APEX trial are expected in 2026.

  • Favorable Phase 1a Topline Trial Results for TX45 Announced in September 2024: In September, Tectonic announced favorable Phase 1a safety, tolerability and pharmacokinetic (PK) and pharmacodynamic (PD) results for TX45. TX45 was well-tolerated with no observed immunogenicity and demonstrated a favorable PK/PD relationship which was used to identify doses for the ongoing APEX Phase 2 clinical trial.

  • Development Candidate TX2100 Selected for HHT Program: Tectonic has identified TX2100 as its development candidate for the treatment of HHT, the second most common genetic bleeding disorder with no approved therapy. TX2100 is a VHH-Fc fusion antagonist antibody that binds to an undisclosed GPCR target (“GPCR3”) which plays a key role in pathogenic angiogenesis. A rodent surrogate of TX2100 demonstrated reduced arteriovenous malformation development and bleeding in an animal model of HHT. A 4-week non-human primate dose-range study with a functionally equivalent precursor to TX2100 showed no treatment-related toxicity observed at doses up to 100 mg/kg. Tectonic expects to initiate a Phase 1 clinical trial for TX2100 in Q4’2025 or Q1’2026 following the conclusion of favorable IND enabling studies. 

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