Sagimet Biosciences Inc. Series A Common Stock 12th Annual Cantor Fitzgerald Global Healthcare Conference

Yeah, sure. Thanks, Yanni, for the invitation. Sagimet Biosciences is a clinical stage biopharmaceutical company. Our approach really begins with trying to understand how overactivity of fatty acid synthase, or FASN, plays such a critical role in the development of a number of underserved conditions, such as acne, MASH, and in certain tumors where the overactive FASN plays a role in contributing to disease progression. To solve for this overactivity, we have developed a portfolio of novel FASN inhibitors led by our lead program, denifanstat, or as we call it, DENNY, that really targets the underlying cause of all of these conditions, and that underlying cause is de novo lipogenesis, which is fat accumulation, and that elevated fat accumulation is present in all those conditions that makes it sometimes challenging to treat.

We announced, most recently in April, we have great data and industry-leading data in the liver and MASH. Our partner in China, Ascletis, ran a couple of clinical studies, a phase II and a phase III study in acne that showed virtually identical results, statistically significant 20% placebo-adjusted improvements in IGA, which is the Investigator Global Assessment Score for the treatment of acne, and also 20% lesion count reductions, placebo adjusted. We had industry-leading data in the liver and industry-leading data in acne. We chose acne for a couple of reasons. The market is huge. There hasn't been an innovative treatment in acne in over 40 years now. Accutane was really the last molecule to really come to the market. It was approved in 1982. While it can be very effective, it also has pretty significant limitations as well due to its safety tolerability profile.

This molecule in this phase, treating moderate to severe acne patients, is really a game changer. It's going to be a game changer. As part of the market, we have 50 million patients in the U.S. that suffer from acne. 20% of those have moderate to severe acne. That's roughly 10 to 15 million. Only 5 million of those, roughly half or less, are actually being treated right now because there aren't many options for them. They are on oral antibiotics and topicals, but none are particularly effective. We approached the FDA last year with the Ascletis phase III data, to understand what their receptivity to that data set would be. They were quite enamored. We took it to the dermatology division, and we had a pre-IND meeting with them in December of last year in which a couple of really important things came out.

One, they recognized the disease is absolutely agnostic to demographic or ethnic background. Working in China in a Han Chinese patient population is expected to be no different than any other non-Han Chinese population. The FDA aligned on conducting a single phase III study, which was very important. It is within their guidance, and they also indicated that they will be looking at the Ascletis phase III data set as well. I think finally, and perhaps most importantly, they indicated and recommended that we evaluate 12 to 17-year-old patients. All of the Ascletis, the acne data studies that were conducted in China were all in 18 year old and above, but the dermatology division had cross-referenced our discussions, the end of phase II discussions that we had with the hepatology division and recognized that the molecule is extremely well characterized.

It carries a very favorable safety tolerability profile and therefore, from their perspective, it should go into a younger population. We were going to ask anyway, but it was just nice that the FDA offered that up from the outset. You combine the market size with the clinical data and the opportunity that is there, and also the rapidness in which we can take this program forward directly into phase III. It became quite an easy decision, and certainly one that the scientific community as well as the financial community rallied behind. We raised a significant amount of cash in April of this year to support our three programs in dermatology. The first being denifanstat to start a phase III, which we will do, as I indicated, shortly in October.

We will take that through the phase III readout next year, and we will have enough to do commercial preparation and an NDA. We also garnered support from our investors to take, excuse me, our second-generation FASN inhibitor, an oral FASN inhibitor that is a bit more potent than denifanstat. We are about to launch that into a phase II at the end of this year, and we will have phase II dose-ranging data from that program by the end of next year. So we will have phase III data from denifanstat in moderate to severe acne, and we will have phase II data from our second oral FASN inhibitor next year. Then we also have a topical FASN inhibitor that we are, that is in formulation development right now.

This molecule as a topical formulation will allow us to branch out into more mild acne patients, and we anticipate that that will be extremely well-received. So we have a lot going on and we are really excited by the path forward and- Understood.

Yeah, no, it's going to be a game changer for sure. It really is. If you're looking for a surrogate market and how this molecule could change the treatment paradigm, I would encourage you to look at the atopic derm and the psoriasis markets, both of which were really littered with low-cost alternative products, topical corticosteroids, oral steroids, immunosuppressants. Immunosuppressants in many ways in psoriasis and atopic derm functions like Accutane. It's sort of a nuclear bomb. It can be very effective, but also pretty toxic. You can't take it long term. I think we've seen the effect of the new molecules that have come into this space, the IL-4/13s, the DUPIXENTs of the world, the IL-23s in the psoriasis, the JAK inhibitors, the PDE4s.

All of them have had really a robust effect in treating those conditions, and I think we're about to see the same thing in acne. As you pointed out, there hasn't been anything novel in many, many years. The treatment regimens that patients have at their disposal are pretty limiting, particularly outside of Accutane. Accutane is generally reserved for the most severe form of acne. That's nodular inflammatory acne. But now I think these patients are frankly going to have an option even before they get to Accutane. I think we'll see more data from the phase III study from Ascletis that is about to be presented later this month at the European Academy of Dermatology and Venereology Congress, in which they will share the totality of the 52-week data. That 52-week extension was really designed for safety first to support the NDA, which it did beautifully.

The safety tolerability was rock solid through the entire 52 weeks. In fact, it improved a little bit even over the last 40, once the patients rolled over from the phase III randomized part of the study. I think what's going to be a bit eye-opening is the continuing improvement in the IGA score, as well as the reductions in lesion count, both on a non-inflammatory and probably more importantly on the inflammatory. When we look at the inflammatory lesion counts, that's the one that most derms really focus on, because that can lead to scarring, and that's really what they're trying to prevent. In this situation, I think we're about to see that denifanstat performs exceptionally well and starts to tread awfully close to what Accutane has demonstrated in their clinical trials.