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Dec 30, 2024
Sagimet Biosciences Q4 2024 Earnings Report
Sagimet Biosciences reported its financial results for the fourth quarter and full year ended December 31, 2024, highlighting the initiation of its Phase 3 MASH program and the clearance of an IND application for TVB-3567.
Key Takeaways
Sagimet Biosciences had a productive 2024, initiating its Phase 3 denifanstat program for MASH and receiving Breakthrough Therapy designation from the FDA. The company also advanced its second FASN inhibitor, TVB-3567, into clinical trials for acne. Financially, Sagimet reported a net loss of $16.2 million for Q4 2024, with increased research and development expenses.
Sagimet initiated its Phase 3 denifanstat program for MASH in Q4 2024, with patient screening expected to begin in 1H 2025.
Denifanstat received Breakthrough Therapy designation from the FDA for MASH, supported by positive Phase 2b FASCINATE-2 results.
The company announced the clearance of an Investigational New Drug (IND) application for TVB-3567, a second FASN inhibitor, for the treatment of acne, with Phase 1 trial initiation planned for 2025.
Sagimet reported a net loss of $16.2 million for the three months ended December 31, 2024, compared to $8.2 million for the same period in 2023.
Sagimet Biosciences
Sagimet Biosciences
Forward Guidance
Sagimet Biosciences anticipates significant progress in its clinical programs in 2025, with key milestones including the initiation of patient screening for the Phase 3 MASH program and the start of a first-in-human Phase 1 trial for TVB-3567. The company expects its cash and cash equivalents to fund operations for at least the next 12 months.
Positive Outlook
- Patient screening for the Phase 3 denifanstat program in MASH is expected to start in the first half of 2025.
- The Phase 3 program for denifanstat in MASH will include two registrational trials: FASCINATE-3 (F2/F3 MASH) and FASCINIT (MASLD/MASH).
- FASCINATE-3 aims for accelerated approval in the US and Europe based on 52-week liver biopsy assessments.
- A first-in-human Phase 1 trial of TVB-3567 for acne is anticipated to initiate in 2025.
- The company's cash and cash equivalents of $158.7 million as of December 31, 2024, are expected to fund operations for at least the next 12 months.
Challenges Ahead
- The FASCINATE-3 trial will continue for an estimated 3.5 years after the week 52 timepoint to reach the required number of clinical outcomes.
- The Phase 3 program is designed to comprise a minimum of 1,800 patients exposed to denifanstat, indicating a large and potentially lengthy trial.
- The FASCINIT trial, while not requiring liver biopsy, focuses on safety and tolerability as its primary endpoint, with non-invasive biomarkers as secondary endpoints.
- Topline results for Ascletis BioScience Co. Ltd.'s Phase 3 clinical trial of denifanstat for acne in China are expected in Q2 2025, which could impact future plans.
- The company's operations are dependent on the successful progression and outcomes of its clinical trials, which inherently carry risks and uncertainties.