Sagimet Biosciences Inc.

Current report

Our business may be materially adversely affected by the imposition of tariffs and other trade barriers and retaliatory countermeasures implemented by the United States and other governments.

Current report

There is currently significant uncertainty about the future relationship between the United States and certain other countries, including China, including potential changes with respect to trade policies, treaties, tariffs, taxes, and other limitations on cross-border operations. In April 2025, the United States imposed broad tariffs on imports from virtually all countries, with particularly high tariffs on imports from China. Since this announcement and as of the date of this Quarterly Report, most tariffs for countries other than China have been suspended temporarily. We have previously utilized CMOs outside the United States, including in the UK, EU and China, for the supply of raw materials, API and finished product, and may do so in the future. The recently announced tariffs may lead to higher manufacturing costs, which would have an adverse effect on our business, financial condition and operating results, the extent of which cannot be predicted with certainty at this time.

Previous report

Although we have received Breakthrough Therapy designation for denifanstat, this may not lead to a faster development, regulatory review or approval process, and it does not increase the likelihood of receiving marketing approval in the United States.

Previous report

In October 2024, the FDA granted Breakthrough Therapy designation to denifanstat for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). A Breakthrough Therapy is defined as a therapy that is intended, alone or in combination with one or more other therapies, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For therapies that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Therapies designated as breakthrough therapies by the FDA may also be eligible for priority review and accelerated approval.

Previous report

The Breakthrough Therapy designation we have obtained for denifanstat may not result in faster development processes, reviews or approvals compared to therapies considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, the FDA may later decide that our denifanstat development program no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened. In addition, the FDA may later decide that denifanstat no longer meets the conditions for qualification.