Odyssey Therapeutics, Inc. Common Stock Morgan Stanley 24th Annual Global Healthcare Conference

Well first, good morning and thank you for the introduction. Good to see you again. I've been working in inflammation and autoimmunity I think since 1990 when I started my faculty position and over the course of a number of different companies, and I've watched the sort of the space evolve over I guess close to 40 years now. Despite the fact that there's been, I think, advances across the field in making immunomodulators for a variety of different conditions, one of the things that really is still standing out for patients is the ability to treat large numbers of patients, put patients into deep, long-lasting remission, and to do so in a very durable way.

Odyssey was set up to capitalize on novel insights in biology I think that's emerged over the last 15 or 20 years that has significant potential to achieve all of those goals.

It's true that seven of my last companies were all sold to large pharma. Most of those organizations were one asset or two asset companies. One of the things that I wanted to be able to do different at Odyssey was to be able to work across a larger portfolio of medicines and to work in different modalities. There's exciting things in small molecules. There's very exciting developments in biologics. I think the ability to work on both of those in one organization is one of the visions that we had for Odyssey when it was established. Really the only way to finance an organization like that is in the public markets.

Yeah. Maybe let's start with the overlying medical question because that's really important in how we think of everything at Odyssey. I'll start with a personal story and maybe go into a little bit broader. My son, who's now 31, was diagnosed with Crohn's disease when he was 13. I watched him go from REMICADE to HUMIRA to SKYRIZI, and now he's looking for his fourth medicine. I think the journey, his name is Jeremy, that Jeremy has sort of gone on over the last 17 or so years is characteristic of many patients with inflammatory bowel disease. Medicines may put them into symptomatic remission. That remission is usually short-lived, and then they have to go onto another medicine, and that second medicine is usually much harder to put them into remission.

Oftentimes they'll lose response there and go onto a third and sort of a fourth. That is really kind of the big picture we're trying to address. RIPK2 is a target in the innate immune system. It recognizes bacteria that translocate when the epithelial barrier is breached, and it really starts the inflammatory process in inflammatory bowel disease. It has the chance to block, if you will, the root cause of inflammation and turn off multiple downstream cytokines and effector molecules rather than target any one specific inflammatory pathway. That's important because we know that inflammatory bowel disease is caused by multiple cytokines, multiple chemokines, multiple inflammatory mediators. If you could kind of turn all of them off at once, you have the potential for a broader therapeutic response, deeper remission, and more long-lasting remission.

Good question. The target was discovered in the early 2000s at the University of Michigan where I actually was on the faculty and I knew the inventor of the molecule or the inventor of the target. His name is Gabriel Nuñez in the pathology department. It took a better part of 18 years to actually understand the biology that led from RIPK2 activation to the production of inflammatory cytokines. We now understand that in order for that to occur, there needs to be binding to RIPK2 of a second protein known as XIAP. When XIAP binds to RIPK2, it activates the protein, leading to the production of things like TL1A, TNF, and IL-23. That discovery really only was made and published around 2018, and in pharma years, that's yesterday. It takes time to understand that biology and translate that into a small molecule understanding.

The ability to block two proteins coming together is among the harder problems in medicinal chemistry and drug development, and we're very fortunate at Odyssey to really have an outstanding team of chemists and biologists that were able to put together the right set of assays and the right chemical matter to do that, and do so in a very safe and effective manner.

So just to take a step back for a second, we conducted an open-label phase IIa study, where 41 patients completed a higher dose, and now 15 patients have completed a lower dose. We reported top-line results of a 27% clinical remission. One of the interesting things about the trial was not only are the remission rates we are seeing for induction very similar to what one sees in today's advanced therapies, but all of the data across the board is completely concordant. So we are seeing good reductions in inflammation histologically, endoscopically, and perhaps most important, we do not see a diminution of activity when looking at patients that have seen prior advanced therapies. This is really a big problem in inflammatory bowel disease.