Summary of Conference Call on Sagimet's Acne Treatment Development Company and Industry Overview - **Company**: Sagimet - **Industry**: Dermatology, specifically focusing on acne treatment - **Key Product**: Denifenstat, a novel fasten inhibitor for moderate to severe acne Core Points and Arguments 1. **Development Program**: Sagimet is advancing TVB3567, a new fasten inhibitor for treating moderate to severe acne, following successful Phase III results of denifenstat by partner Asclitis [3][4][6] 2. **Market Opportunity**: The global acne market is projected to reach approximately $17 billion in the next decade, with the U.S. expected to account for about 50% of this growth [8][9] 3. **Patient Demographics**: In the U.S., around 50 million people suffer from acne, with 5.1 million seeking professional treatment annually. Approximately 70% of these patients have moderate to severe acne, which is the target indication for Sagimet's oral fasten inhibitor [9][10] 4. **Current Treatment Limitations**: Existing treatments often have limited efficacy, high irritation potential, or risk of antibiotic resistance. Isotretinoin, while effective, has strict prescription limitations due to the FDA's iPLEDGE REMS program [10][11] 5. **Clinical Data**: Denifenstat has shown significant efficacy in reducing sebum production and inflammation in clinical trials, with a Phase III trial in China meeting all primary and secondary endpoints [6][25][26] 6. **Safety Profile**: Denifenstat was generally well tolerated in trials, with adverse events similar to placebo. Notably, there were no significant cases of hair thinning reported [27][63] 7. **Comparative Efficacy**: Denifenstat demonstrated an 18.6% placebo-adjusted treatment differential in the Phase III trial, outperforming other recently approved treatments [30][31] 8. **Future Development Plans**: Sagimet has initiated a Phase I trial for TVB3567 and anticipates starting Phase II trials in 2026, contingent on Phase I results [34][37] Additional Important Insights 1. **Potential for Combination Therapy**: Fasten inhibitors like denifenstat may serve as effective monotherapy or complement existing treatments, addressing the root causes of acne [38][46] 2. **Regulatory Pathway**: Discussions with regulatory authorities will guide the size and scope of future clinical trials for both denifenstat and TVB3567 [50][94] 3. **Commercial Strategy**: Sagimet aims to target the significant moderate to severe acne population, leveraging the expertise of approximately 12,000 dermatologists in the U.S. [72] 4. **Long-term Treatment Considerations**: The treatment duration in real-world settings may vary, with potential for chronic use or combination with topical treatments [85] 5. **Exploration of Other Indications**: There is interest in investigating the use of fasten inhibitors for other dermatological conditions, such as hidradenitis suppurativa, based on similar underlying mechanisms [88][89] This summary encapsulates the key points discussed during the conference call regarding Sagimet's development of acne treatments and the broader market context.

Denifanstat/Resmetirom Combination Development Program May 29, 2025 Forward-Looking Statements and Disclaimer This presentation contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this document, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding possible or assum ...

Company Overview - Sagimet Biosciences Inc. (SGMT) currently holds a Momentum Style Score of B, indicating a favorable momentum outlook [3] - The company has a Zacks Rank of 2 (Buy), suggesting strong potential for outperformance in the market [4] Price Performance - SGMT shares have increased by 56.62% over the past week, significantly outperforming the Zacks Medical - Biomedical and Genetics industry, which rose by 5.43% during the same period [6] - Over the past month, SGMT's price change is 86.79%, compared to the industry's 8.65% [6] - In the last three months, SGMT shares have risen by 54.29%, and they are up 19.76% over the past year, while the S&P 500 has only moved 7.87% and 14.01%, respectively [7] Trading Volume - SGMT's average 20-day trading volume is 1,939,129 shares, which serves as a bullish indicator when combined with rising stock prices [8] Earnings Outlook - In the past two months, four earnings estimates for SGMT have been revised upwards, while none have been lowered, leading to an increase in the consensus estimate from -$3.68 to -$2.49 [10] - For the next fiscal year, three estimates have moved upwards, with one downward revision noted [10] Conclusion - Considering the positive momentum indicators and earnings outlook, SGMT is positioned as a 2 (Buy) stock with a Momentum Score of B, making it a potential candidate for near-term investment [12]

Core Viewpoint - Sagimet Biosciences Inc. (SGMT) shares have increased by 70.6% in the past four weeks, closing at $5.56, with a mean price target of $29.86 indicating a potential upside of 437.1% according to Wall Street analysts [1] Group 1: Price Targets and Analyst Estimates - The mean estimate consists of seven short-term price targets with a standard deviation of $20.44, indicating variability among analysts; the lowest estimate suggests a 10.1% decline, while the highest predicts a surge of 1105% to $67 [2] - Analysts' consensus on price targets is often questioned, as they may not accurately reflect the stock's future price movements [3][7] - A low standard deviation in price targets suggests a high degree of agreement among analysts regarding the stock's price direction, which can serve as a starting point for further research [9] Group 2: Earnings Estimates and Market Sentiment - Analysts are optimistic about SGMT's earnings prospects, as indicated by a strong agreement in revising EPS estimates higher, which correlates with potential stock price increases [11] - The Zacks Consensus Estimate for the current year has risen by 26.4% over the past month, with four estimates increasing and no negative revisions [12] - SGMT holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, suggesting a strong potential upside [13]

Core Insights - Sagimet Biosciences Inc. is hosting a virtual key opinion leader event on June 16, 2025, to discuss the efficacy and tolerability results of denifanstat for treating moderate to severe acne vulgaris in China [1][2] - Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor that met all primary and secondary endpoints in a Phase 3 clinical trial, demonstrating its potential as a novel treatment for acne, which affects over 50 million people in the U.S. annually [3][7] - The company has initiated a Phase 1 first-in-human study for its second oral FASN inhibitor, TVB-3567, aimed at treating acne in the U.S. [3][6] Company Overview - Sagimet is a clinical-stage biopharmaceutical company focused on developing FASN inhibitors to target metabolic and fibrotic diseases caused by excessive palmitate production [6] - The lead drug candidate, denifanstat, has received Breakthrough Therapy designation from the FDA for treating non-cirrhotic metabolic dysfunction associated steatohepatitis (MASH) with moderate to advanced liver fibrosis [6] - The company successfully completed a Phase 2b clinical trial of denifanstat in MASH, achieving positive results [6] Industry Context - The U.S. acne market includes over 50 million individuals, with 5.1 million patients treated by dermatologists annually [7] - Acne management often requires chronic treatment, as there is currently no cure, and adherence to topical therapies is lower compared to oral medications, with 30% to 40% of patients not adhering to topical treatments [7]

4 June 2025 | 12:29PM EDT Sagimet Biosciences (SGMT): Ph3 Ascletis-partnered trial confirms denifanstat's therapeutic profile in acne SGMT's partner Ascletis (covered by Ziyi Chen) announced positive topline results from its Ph3 trial of denifanstat in patients with moderate to severe acne. Part of a joint-development program between SGMT/Ascletis, the study evaluated denifanstat's efficacy and safety in 480 patients treated with either denifanstat 50mg (QD, oral) or matching placebo for 12 weeks and found ...

Group 1 - The article is authored by Terry Chrisomalis, who operates the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace, offering a two-week free trial for new subscribers [1] - Biotech Analysis Central includes a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and various analysis and news reports to assist healthcare investors [2] - The service is priced at $49 per month, with a yearly plan available at a discounted rate of $399, reflecting a 33.50% discount [1] Group 2 - The article does not provide any specific investment recommendations or advice regarding the suitability of investments for particular investors [4] - The author has no current stock or derivative positions in any mentioned companies and does not plan to initiate any within the next 72 hours [3] - The views expressed in the article may not represent those of Seeking Alpha as a whole, as the platform includes contributions from various authors, both professional and individual investors [4]

Denifanstat met all primary and secondary endpoints versus placebo Denifanstat was well tolerated Oral FASN inhibitors offer a novel mechanism of action for the potential treatment of moderate to severe acne Sagimet initiated first-in-human Phase 1 clinical trial of a second FASN inhibitor, TVB-3567, that is planned to be developed for acne in the U.S. SAN MATEO, Calif., June 04, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel the ...

Sagimet Biosciences (SGMT) Update / Briefing May 29, 2025 01:00 PM ET Speaker0 Greetings, and welcome to the Sagimet Biosciences Post EASL Key Opinion Leader Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentations. As a reminder, this conference is being recorded. Before we begin, I would like to remind our listeners that our comments today will include some forward looking statements. These statements include statements regarding th ...

Core Viewpoint - Sagimet Biosciences Inc. is advancing its clinical-stage biopharmaceutical development, focusing on novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) through a combination therapy approach involving denifanstat and resmetirom [1][2][3] Company Overview - Sagimet Biosciences is a clinical-stage biopharmaceutical company developing fatty acid synthase (FASN) inhibitors targeting metabolic and fibrotic pathways [6][7] - The lead product candidate, denifanstat, is an oral, once-daily selective FASN inhibitor aimed at treating MASH, which has received Breakthrough Therapy designation from the FDA for non-cirrhotic MASH with moderate to advanced liver fibrosis [7] Upcoming Event - A virtual key opinion leader (KOL) event is scheduled for May 29, 2025, featuring Dr. Rohit Loomba, who will discuss the potential of combining denifanstat with resmetirom for treating advanced MASH [1][2] - The event will include an overview of the planned Phase 1 pharmacokinetic clinical trial for the combination therapy and a live Q&A session [3][4] Clinical Development - The development program builds on positive results from the Phase 2b FASCINATE-2 clinical trial of denifanstat in MASH F2-F3 patients, particularly those at the advanced F3 stage [2][3] - Preclinical data indicate a synergistic effect of combining a FASN inhibitor with resmetirom on liver disease markers, showing improved NAS and hepatic collagen content compared to single agents [3] Disease Context - MASH is a severe liver disease affecting over 115 million people globally, with limited treatment options available [8] - The renaming of non-alcoholic fatty liver disease (NAFLD) to MASH aims to provide a more affirmative diagnosis and reduce stigma associated with the disease [8]