Alumis Inc. Common Stock Morgan Stanley 24th Annual Global Healthcare Conference

Well, Terence, thanks for having us, and happy to go a little bit into psoriasis. So yes, envudeucitinib is a TYK2 inhibitor. We believe that actually in TYK2 inhibition, one of the most critical things in psoriasis is that you maximally inhibit the target. I think our data has been actually extremely consistent. I think that's actually the one piece that we feel we're very proud of. What we see with envudeucitinib is that we consistently see basically PASI 100 rates in 40% or more at week 24. We actually do believe that the predictability of the molecule and the consistency of the data is an important aspect.

The fact that actually fundamentally we put about 40% of patients into a state of clinical cure at week 24, then in our ONWARD3 trial where people were able to choose to go into, we see that rate actually going up in the ONWARD3 section overall to about 54%. If you actually take a complete ITT analysis from the very beginning of our ONWARD program all the way through the end at week 48, you're actually getting close to 50% as well of patients getting PASI 100. So almost half of the patients actually with this drug basically get clinical cure. The other aspect that we feel is very important is actually when you ask patient what their most important symptom is that they want to take care of, they will actually tell you it's itch.

Physicians don't always agree with them, because itch in psoriasis is actually a matter of disrupting the plaque. But for patients, that's a very important symptom, and we've shown consistently in our data set that for itch, we have a very strong onset. That means it resolves very fast, a lot faster than the plaque, which is where physicians thought the resolution of itch comes from. But not only does it resolve very fast, but we actually use the NRS scale to measure it, which is what other people have used in itch trials for atopic dermatitis. And the FDA perceives the 4-point or more improvement as really clinically very meaningful and improvable. And we've actually seen the 4-point improvement in a very large number of patients, over 70%.

We are guided to filing in the fourth quarter. We are on track to do that. One of the things that we can now publicly say also is that the FDA asks you to contribute safety from all ongoing trials. So one of the pieces that actually we were looking to get was the safety from the LUMUS trial, and we could have done that as just a cutoff point. But we felt actually understanding the LUMUS safety data, including the placebo responses, was helpful. And we've shared that one of the key outcomes for us for LUMUS, which was a lupus trial, which is normally a sicker patient population, also on other concomitant meds, basically showed us that it was again, very well tolerated. We saw no new safety signals. We have publicly disclosed. We saw no MACE, we saw no malignancies, no blood chemistry elevations that would lead to a potential risk of monitoring or anything.

So we actually do believe the LUMUS safety data makes the case for envudeucitinib even stronger. And that was the last piece that we needed to finalize the NDA.

At this point, we should assume a standard review timeline.

Yeah. Jörn, you want to start?

Yeah. I think SOTYKTU still had some carryover language from JAK inhibitors. I think both us and Takeda as well have consistently shown that with selective inhibition, you really do not have any JAK inhibition. Possible side effects of JAK inhibitors would be blood cell abnormalities. There would be lipid elevations, this type of thing. Consistently across both molecules, Takeda's and ours, we have not seen any evidence of that. We have had extensive early clinical development where we also have carefully tested whether there is any evidence of JAK inhibition. There is none. It is fundamentally a different pathway, so we will certainly make the case that we should have a label that reflects our actual data. There is no hint of anything related to JAK inhibition in our data set.

The other one is the TB issue. I think what we have now seen is two really interesting data points. First, neither us nor Takeda have shown any TB reactivation in any of our trials to date. The other one is Repatha, which is a tigecycline, basically just got a labeling where it is very similar to ICOTYDE, where the label actually is not a requirement for TB testing, but rather just a recommendation. We believe that is actually a good surrogate for us to look at, that we believe we have a good chance to also get that kind of labeling.