Sagimet Biosciences Q2 2024 Financial Results and Corporate Updates

Sagimet Biosciences Inc., a clinical-stage biopharmaceutical company specializing in novel therapeutics for metabolic diseases, has announced its financial results for the second quarter ending June 30, 2024, along with several significant corporate updates.

During the European Association for the Study of the Liver (EASL) Congress in June 2024, the company presented the 52-week biopsy results from its Phase 2b FASCINATE-2 clinical trial. The trial demonstrated denifanstat's efficacy in reducing fibrosis in patients with advanced stages of metabolic dysfunction-associated steatohepatitis (MASH). Key data showed a statistically significant reduction in liver fibrosis and a delay in the progression to cirrhosis, differentiating denifanstat from other treatments currently available.

David Happel, Sagimet's Chief Executive Officer, highlighted that these results underscore denifanstat's unique mechanism as a fat synthesis inhibitor targeting three primary drivers of MASH: fat accumulation, inflammation, and fibrosis. This positions denifanstat as a potentially leading therapeutic option in the treatment of MASH, a condition affecting millions globally. The company plans to commence a Phase 3 clinical development program for denifanstat in the latter half of 2024.

The company also welcomed two new members to its Board of Directors, effective August 1, 2024: Anne Phillips and Jennifer Jarrett. Both bring extensive experience in clinical development, regulatory strategy, operations, and finance, further strengthening the company's leadership team.

Financially, Sagimet reported $188.5 million in cash, cash equivalents, and marketable securities as of June 30, 2024. This financial position is expected to support the company's operations through 2025. For the three months ending June 30, 2024, the company reported research and development expenses of $6.3 million, an increase from $4.7 million in the same period the previous year. General and administrative expenses also rose, amounting to $4.3 million compared to $2.4 million in 2023. The net loss for the quarter was $8.1 million, up from $6.8 million in the second quarter of 2023.

Regarding ongoing and future developments, the company's End-of-Phase 2 meeting with the FDA in May 2024 has led to ongoing discussions concerning the Phase 3 development plans for denifanstat in MASH. A contract with a Contract Research Organization (CRO) for the global Phase 3 program has been executed, and operational activities are in progress to start the study in the second half of 2024, pending FDA feedback.

In addition to its MASH program, Sagimet's license partner, Ascletis Pharmaceuticals, is recruiting participants for a Phase 3 study of denifanstat in acne in China. This follows positive Phase 2 data reported in Q2 2023 and is anticipated to be fully enrolled by the end of 2024.

Sagimet's lead drug candidate, denifanstat, is an oral, once-daily pill and a selective fatty acid synthase (FASN) inhibitor. It targets dysfunctional metabolic pathways associated with diseases like MASH, caused by the overproduction of the fatty acid palmitate. The successful Phase 2b trial of denifanstat, which involved liver biopsy-based primary endpoints, demonstrated positive outcomes, justifying the progression to Phase 3 trials.

MASH, recently renamed from nonalcoholic steatohepatitis (NASH), is a severe liver disease affecting over 115 million people globally. Despite its widespread impact, there is currently only one approved treatment in the United States and none in Europe. This underscores the critical need for effective therapeutic options like denifanstat.

In summary, Sagimet Biosciences is making significant strides in its clinical development programs, particularly with denifanstat, amid robust financial support and strategic leadership enhancements. The company’s focus on addressing metabolic diseases such as MASH continues to drive its research and development initiatives forward.