Sagimet Biosciences Inc. Series A Common Stock Canaccord Genuity's 46th Annual Growth Conference
Review the key takeaways and the transcript of this earnings call.
Transcript
Preview the first fifteen paragraphs, organized by speaker.
Good afternoon, everyone. My name is Edward Nash, senior biotech analyst here at Canaccord Genuity. I am joined here by the management team of Sagimet Biosciences. With us from Sagimet, we have David Happel, who is the CEO, and Andreas Grauer, Chief Medical Officer. We actively cover Sagimet with a buy rating. Welcome to you both. Thanks for joining us.
Thank you for the Thank you.
invitation. To kick off the conversation, could you just give us a little bit of background to our audience on Sagimet as a company and what your clinical programs are really encompassing from a therapeutic standpoint?
Sure. Sagimet is a clinical stage biopharmaceutical company, and our focus really is on understanding how fatty acid synthase or FASN, or I should say overexpression or overactivity of FASN, plays such a critical role in the development of a number of underserved conditions, with our lead program being in acne. We also have obviously really positive data in the liver and in some tumors as well that are dependent on FASN for progression of disease. To solve for this overexpression of FASN, we have developed a portfolio of FASN inhibitors led by our lead program, denifanstat, that really target an underlying cause that is common to all of these conditions. That underlying cause is de novo lipogenesis or fat accumulation. That manifests itself in different diseases.
In acne, where we have spent and focused our attention most recently, it results in increased sebum production, inflammation, increased bacterial load for these patients and hyperkeratinization or skin plugging. Our molecule, denifanstat, really targets the two primary drivers of the condition in acne, and that is sebum and inflammation. By doing so, you reduce obviously the bacterial load and the hyperkeratinization. Where our programs are at this stage, we're getting ready to launch into a phase III study with denifanstat in moderate to severe acne patients, and that will take place in the next couple of months, where we will dose our first patient. We expect to have last patient, last dose by roughly this time next year, and top-line data shortly thereafter.
We have an open IND with denifanstat to begin treatment in phase III and the FDA has been great to work with. We have a study may proceed. We're really excited to get that off the ground. We also have a second oral FASN inhibitor that will start phase II at the end of this year. We're wrapping up phase I as we speak. We'll have phase II data from our second oral FASN inhibitor next year, at the end of next year, at roughly the same time we have phase III data with denifanstat. Thirdly, we have a topical FASN inhibitor that is in formulation development, which will allow us to branch out and reach more mild acne patients in the population that we're pursuing development. We'll begin first in human studies with the topical in the beginning of 2028.
We raised a significant sum of money in April. The market has kindly received our transition and really excited to get going.
You guys obviously had very positive value. You were originally going after MASH as an indication, and you had really strong phase II-A and II-B data.
Yes In that indication, and then acne really kind of presented itself.
Yes. Which was given, for those who don't know, there's just the world of new drug development acne has been pretty much nonexistent, I think, especially when it comes to orals that are not antibiotics.
For 45 years. Yeah. I mean, it's a major medical need there.
Yes and a huge market.
For us to better understand it, this obviously starts in part of the whole, I think underlying, interesting part about the story is that we really feel is that denifanstat in acne is de-risked for the reasons of what we see with the Ascletis phase III trial in China. Maybe you could just walk us through the results of that phase III before we jump into what your design's going to look like or my next question specifically on how that design would look. Just talk about that data and what was so compelling that made you decide to choose this.
Sure. Andreas, you want to tackle that?
Yeah. The phase III study that our partners in China have performed, Ascletis, is a study. They randomized 480 patients one to one. These patients had moderate to severe acne. Moderate to severe means the IGA score, the investigator global assessment was 3 to 4, which is pretty severe. If you turn that into lesion counts, it means they had 30 to 75 inflammatory lesions and 30 to 100 non-inflammatory lesions. So very significant acne. And in order to be called successfully treated, IGA success, they had to arrive at an IGA score of 0 to 1. 0 to 1 means clear, like really clear or almost clear skin. So really the bar is very high for success.
FULL TRANSCRIPT
Continue the full translated transcript in StockNow.
Access every statement, the English original, and speaker-by-speaker history with StockNow Pro.
View the full transcript with ProCall participants
3 people spoke on this call — only 2 are shown here.
PARTICIPANT LIST
View participant details in StockNow.
Log in to see executives and analysts, their roles, and complete speaking history.
Log in to view all participantsKeep exploring