Celcuity Inc. Common Stock Citigroup’s Biopharma Back to School Summit 2026

You're welcome. Thanks for having me.

Sure. Our lead candidate is actually now an approved drug, REVTORPYK, which is a pan PI3K/mTORC1/2 inhibitor. We recently received approval for a second-line indication in HR-positive, HER2-negative advanced breast cancer. We are getting ready to launch this quarter. We also have two phase III studies in the first line setting in HR-positive breast cancer, one for patients who are endocrine sensitive, then another one for patients who are endocrine resistant. We have an additional study ongoing in prostate cancer that is in the early stage, phase I-B/II, and we expect to provide updated results towards the end of this year on that study.

Sure. We began preparing for this launch two and a half years ago, and that included primarily, initially at least, building out the organization, ensuring that we had the appropriate team. We finished building that organization except for the sales force last year, and then added the sales force members. We have 90 folks, oncology sales specialists, in the second quarter. They began profiling accounts, working with doctors prior to having approval. They could not educate doctors on the data, but they could get an understanding of the physicians' tendencies towards what they use to treat patients. They could lay groundwork for the accounts in other ways. Our market access teams have been working with national accounts, which are the payers, for the past 18 months. Because they have safe harbor, we could present data, we could familiarize them with the product. Similarly with strategic accounts. These are the Dana-Farber, US Oncology of the world.

You can work with them because they create a lot of what are considered to be clinical pathways. They essentially define the treatment paradigm for not only their institutions, but they also offer these pathways to other institutions. With these strategic accounts, they have outweighed very significant influence beyond just the group of patients they may be treating at their facilities. Now, our sales force has been meeting with doctors with the data. We have had two phase III data releases. We released our wild type data July 24 or 25 rather, and then we released our mutant data. This is PIK3CA mutant data at ASCO. With those two data releases, because the data we believe was unprecedented in terms of the level of results that we were able to report, it got a lot of attention.

Prior to the launch, we conducted an unbranded campaign to educate doctors, physicians about the importance of the PAM pathway, PI3K/AKT/mTOR pathway, as well as the importance of comprehensively inhibiting it. We cannot promote the drug, we cannot mention our drug, but we can educate them about the pathway and the relevance in particular of our mechanism of action. Now that we have approval, we have our sales force meeting with doctors. We have each of these oncology sales specialists as a business plan. They have a target number of doctors within their territory. They understand priority doctors and accounts to work with, and that has been going very well. You overlay that with other programs, whether it can include digital marketing or other ways of getting in front of doctors, and we assess that.

We think we have created a significant awareness to date amongst not just the academics or the KOLs who I think have been following us because that's part of what they do, but also more importantly amongst the community docs who represent or rather treat approximately 80% of breast cancer patients.

Sure. The second site is really there to provide additional capacity. Our first site can provide the capacity we need for the initial launch. We want visibility in the approval, in the review process of the FDA. We submitted a post-approval supplement that contained the validation data for the batches that this manufacturer ran. The process is very robust. We've gone through a review just a few months ago for our CMC package and the processes and specifications and analytical methods. So very confident about that, and now it's just a matter of having initial interaction with the FDA to understand or to gain confidence that somehow something new isn't going to pop up. So we don't need them to be approved. We don't need that PAS to be approved. We just want line of sight that it'll follow a normal course.

Okay. Once you submit, you will typically get information requests and those interactions essentially provide a perspective on that that we will assess.

I mean, we have been interacting with the agency for five years on this particular drug, and a lot of familiarity with the individuals involved. Again, we just are somewhat being cautious. We are confident about the data. We just do not want to be blindsided.