Sagimet Biosciences Q1 2024 Financial Results and Corporate Updates

Sagimet Biosciences Inc., headquartered in San Mateo, California, is a clinical-stage biopharmaceutical company focused on the development of novel fatty acid synthase (FASN) inhibitors. Their lead drug candidate is denifanstat, an oral, once-daily pill aimed at treating metabolic dysfunction-associated steatohepatitis (MASH). The company recently reported its financial results for the quarter ending March 31, 2024, and shared significant corporate developments.

In the first quarter of 2024, Sagimet revealed that their Phase 2b FASCINATE-2 clinical trial for denifanstat met primary efficacy endpoints. This trial demonstrated a significant reduction in fibrosis among MASH patients. Additionally, Sagimet successfully completed a follow-on offering, raising net proceeds of $104.7 million, which will support further development of their pipeline and other corporate purposes.

One of the highlights of Sagimet's recent achievements includes the successful outcomes from the Phase 2b FASCINATE-2 trial. Announced in January 2024, the trial evaluated denifanstat in MASH patients with stage F2 or F3 fibrosis. The study concluded at week 52 and met its primary efficacy endpoints, showing that 36% of denifanstat-treated patients achieved MASH resolution without worsening fibrosis, compared to 13% with placebo. Additionally, 52% of treated patients experienced a ≥2-point reduction in NAS (NAFLD Activity Score) without fibrosis worsening, compared to 20% with placebo. Secondary endpoints were also achieved, notably with 41% of denifanstat-treated patients showing fibrosis improvement by ≥1 stage, versus 18% with placebo.

In terms of corporate updates, Sagimet conducted a public offering in January 2024, selling 9,000,000 shares of its Series A common stock, resulting in $104.7 million in net proceeds. These funds, combined with existing cash, equivalents, and marketable securities, will support ongoing developments and corporate operations.

In March 2024, Sagimet announced the completion of a Phase 1 hepatic impairment trial for denifanstat. This trial, essential for MASH development programs, aimed to assess the safety and pharmacokinetics of denifanstat in subjects with hepatic impairment. The drug was well-tolerated with no reported safety signals, and the pharmacokinetic results further support the planned Phase 3 clinical trial.

Sagimet also announced the appointment of two new members to its board of directors, effective April 1, 2024: Tim Walbert and Paul Hoelscher, both leaders in the biotechnology industry.

Looking ahead, Sagimet anticipates an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in the second quarter of 2024. Following this, the company plans to initiate a pivotal Phase 3 clinical trial for denifanstat in MASH in the latter half of 2024. They also expect their current cash reserves to sustain operations through 2025.

For the quarter ending March 31, 2024, Sagimet reported $193.7 million in cash, cash equivalents, and marketable securities, inclusive of the proceeds from the January offering. Research and development expenses for the quarter were $5.3 million, up from $4.5 million in the same period in 2023. General and administrative expenses also increased to $3.5 million from $2.3 million in the prior year. The net loss for the quarter was $6.6 million, consistent with the loss reported for the same period in 2023.

Sagimet continues to move forward in its mission to develop innovative treatments targeting metabolic and fibrotic diseases. With significant progress in clinical trials, strategic financial maneuvers, and strong leadership, the company is well-positioned to advance denifanstat to the next phase of clinical development and potentially offer a new treatment option for patients with MASH.