Celcuity Stifel 2026 Healthcare Conference

Well, I think it's helpful maybe just to look back on the past 18 months for us, because it's been a transformative period.

We reported our first phase III data, middle of 2025 for PIK3CA wild-type patients in the second-line setting of breast cancer. It was very, very positive, unprecedented data. We've subsequently gotten an approval for that indication, so that's a big deal, and launched our first indication, and so we're in the process of that. We also announced data, positive data for a second phase III trial in patients who have PIK3CA mutations. Again, very positive. Certain components of that were unprecedented data. We've submitted an sNDA there. We did get a PDUFA date, so that'll be end of Q2. We're laying the groundwork. The launch itself is, and I'm sure we'll talk about that in detail, gotten off, in our view, to a good start. In that same period of time, we started two phase III studies in the first-line patient population.

in two different populations. We're separately evaluating each of those patients in a single study. Market potential for that segment is very, very significant. 90,000 patients would potentially be indicated for gedatolisib if those trials read out positively. We have very favorable preliminary data in those populations, so we think the probability of success is high in those studies. We've also reported recently data in the metastatic castration-resistant prostate cancer population. Again, very encouraging, not surprising in our view, given the similar biology that underlies prostate cancer and HR-positive breast cancer. More to come. I mean, we're at an earlier stage, but that data was what we were hoping to see. Certainly then warrants further investigation. We'll be initiating additional work to further prosecute that.

Sure. Well, one of the challenges when you are launching a drug is that there are a lot of gatekeepers that you need to work with to lift the gate.

For instance, insurers would be an example of that, right? If they do not incorporate our drug on their policies and patients cannot get reimbursed, that would be a huge barrier. So we were successful, and that just reflects the work done prior to launch, not just since launch, but prior to launch, to get incorporated in those policies, to get NCCN level 1 recommendation, so that now 90%-plus of patients have policies that will reimburse them for treatment with REVTORPYK. That is an important gate to get lifted. Another important gate is with what we label strategic accounts, okay? These are accounts that when you look at the total population that they collectively treat, represent 50% or treat 50% of breast cancer patients. Now, these accounts have multiple sites, so it is 36 accounts, but ultimately they represent well over 1,000 different treatment locations.

Because of the way they are organized, think of them as they have a corporate approach to saying, "Okay, we want to have this drug on formulary. We want it to be incorporated in the pathway. We need to have order sets built. We need various committees within our organization to approve usage of this drug." That is a process. It is a lot of constituents, a lot of infrastructure that needs to get built. Until that is built or those approvals are received, that is a gate. If you have an account that has 1,000 or rather 400 treating sites, you need to get that gate lifted so that your reps can effectively engage with physicians who treat patients at those sites.

We were successful there in getting roughly 80% of these key 36 strategic accounts to order, which essentially an order reflects that all of this pre-work- was successfully accomplished.