Celcuity Inc. Common Stock Wells Fargo 21st Annual Healthcare Conference

You're welcome. My pleasure. Cool.

Sure. Our lead candidate, the lead drug, is now actually an approved drug, REVTORPYK. It's a pan PI3K/mTORC1/2 inhibitor. We recently received approval to treat patients who have progressed on their first line of endocrine treatment for metastatic disease. It's a second-line therapeutic option for patients who have no PIK3CA mutation detected. We have two regimens that were approved, gedatolisib or REVTORPYK with palbociclib and fulvestrant, or REVTORPYK with fulvestrant. We're in the midst of preparing for our launch. We expect to have commercially available drug by the end of this quarter. We've also initiated and are enrolling patients in two phase III studies for patients who are treatment-naive in the advanced breast cancer setting. There are two different groups of patient population of patients, one that is considered endocrine sensitive, one endocrine resistant.

Total number of patients that potentially could be eligible over time would be roughly 90,000 annually, so a very significant patient population. We expect to have data from the endocrine-resistant population sometime late 2028, early 2029, and for the sensitive population, probably late 2029 or 2030. We have a phase I/II study underway, ongoing in prostate cancer, prosecuting a similar underlying biological hypothesis as we've done in breast cancer, which is that it's a hormonally driven disease, in this case, the androgen receptor pathway, that involves the PAM pathway, PI3K/AKT/mTOR pathway. We've reported initial data that, in our view, was favorable. We'll be providing an update with that data later this year at a medical conference. There you go. That's an overview.

A lot of stuff. Oh, and we have another data set. We announced data for patients who have a PIK3CA mutation. We presented that data at ASCO. We submitted a supplemental NDA last month, and so we expect things go the way we hope that that supplement, that sNDA, would be approved sometime in the second quarter next year.

Sure. Well, we had always projected third quarter, so essentially we just provided more detail when we got the approval. As far as the timing of the launch and when the product will be commercially available, basically we are waiting to get initial feedback from the FDA on a post-approval supplement for our second manufacturer. The first manufacturer we have has relatively low capacity, and to support the launch, we want to have visibility and to confirm that we will have two manufacturers able to support the volume of what we anticipate the demand. This post-approval supplement was provided to the FDA or submitted to the FDA within a week after approval. So we expect to get some feedback before the end of this month. The process we have is very robust. The review and the NDA of our first manufacturer was very straightforward, really no meaningful information requests.

We are very confident about the quality of the data that we submitted, the robustness of the process overall, and the capability of this manufacturer. It is just a matter of, to be frank, being cautious on my part to minimize the risk of potentially having a drug shortage in the midst of a launch, which obviously would not be a good thing.

We just want line of sight on when that manufacturer would be approved, and so we just want to make sure there is no obstacle in that. Again, process is very robust, using the same process at the second manufacturer. The data generated in that process, there are probably 50 analytical methods that are used to assess, and in fact to determine adherence to the various specifications, to measure adherence to these specifications. All those metrics essentially line up. We are very confident, but again, it is the FDA, we are not in charge, and you do not know what you do not know. So we are just being extra cautious on that front.