Celcuity Inc. (CELC) Earnings Call Transcript & Summary

Good morning, everyone, and welcome to Citi's Back-to-School Biopharma Summit. I'm Eric Joseph, senior biotech analyst with the firm. And one of our first fireside sessions this morning is with Celcuity, and it's my pleasure to be joined by company's CEO, Brian Sullivan, to discuss the company. So Brian, thanks for joining us.

Welcome. Thanks for having me.

Maybe for anyone less familiar with the company, Brian, it would be -- we could perhaps to have you start out by just providing some high-level remarks, and then we'll hop into Q&A.

Sure. So our lead candidate is actually now an approved drug, REVTORPYK, which is a pan-PI3K/mTORC1/2 inhibitor. And 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 2 Phase III studies in the first-line setting in HR-positive breast cancer, one in -- for patients who are endocrine-sensitive than another one for patients who are endocrine resistant. And we have an additional study ongoing in prostate cancer that is in the early stage Phase Ib/II, and we expect to provide updated results towards the end of this year on that study.

Okay. Okay. Great. Well, so let's pick up on the REVTORPYK launch. We're kind of in this interim period before product shipments start to go out. Can you just frame where things are with respect to -- just from a product awareness standpoint among oncology providers and just sort of the groundwork that's been put in place to support access?

Sure. So we began preparing for this launch 2.5 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. And so they began big profiling accounts, working with doctors prior to having approval. They couldn't educate doctors on the data, but they could get an understanding of the physicians' tendencies towards how they -- what they used to treat patients. They could kind of 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. And then similarly, with strategic accounts, these are the Dana-Farber's, U.S. Oncologies 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. So with these strategic accounts, they have outweighed a very significant influence beyond just the group of patients they may be treating at their facilities. And so now we have our sales force has been meeting with doctors with the data. Now we've had 2 Phase III data releases. We released our wild-type data on July '24. 25 rather. And then we released our mutant data, this is PIK3CA mutant data at ASCO. And so with those 2 data releases, because the data was -- we believe, was unprecedented in terms of the level of results that we were able to report, it got a lot of attention. And so prior to the launch, we conducted an unbranded campaign to educate doctors, physicians about the importance of the PAM pathway, PI3K/AKTMTR pathway as well as the importance of comprehensively inhibiting it. So we can't promote the drug. We can't mention our drug, but we can educate them about the pathway and the relevance, in particular, of our mechanism of action. And so now that we have approval, we have our sales force meeting with doctors, -- we have -- each of these oncology sales specialists has a business plan. They have a target number of doctors within their territory. They understand and priority doctors and accounts to work with, and that's been going very well. So -- and then 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. And so we think we have created 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.

Okay. Great. I know that having clarity on a second manufacturing site is a key step that you want to have in place before beginning shipments later this quarter. What's the approval status of that second site today? And how should we be thinking about the scale of market reach, right? How much of the market you can serve once you start shipping commercial product?

Sure. So 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 method. 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 will follow a normal course.

Can you say more about how that line of sight has provided, I guess, the interaction there?

Interaction with the FDA. And once you submit, you'll typically get information requests and those interactions essentially provide a perspective on -- that we'll assess. I mean we've been interacting with the agency for 5 years on this particular drug and a lot of familiarity with the individuals involved. And so again, we just are somewhat being cautious. We're confident about the data. We just don't want to be blindsided.

Okay. Okay. Got it. And I know that they -- expanded access program is already open. Can you discuss the pull-through that you're seeing into that program currently and then sort of how patient eligibility is determined?

Sure. So we just put that in place a couple of weeks ago, and it's targeting or it's limited to patients who would be otherwise indicated for the drug, essentially the patients who would be consistent with the label population. And one of the challenges of any EAP, which is essentially considered a clinical trial. It's an expanded access protocol. And because it falls into that category of approach, each site needs to approve that protocol. And for larger sites that may have their own IRBs, institutional review boards, that process can be quite extended. And because the window of time that we won't be having product available. And it's very difficult for some of these larger sites to actually take advantage of it. Whereas the community sites or smaller sites that essentially are willing to rely on a central IRB approval, which we have, the process is much easier. So we've gotten a lot of interest. Patients are on the drug through this. And more importantly, I think it signaled to the community that we want to do everything we can to make sure product is available for their patients, and we'll work with them if we -- if it's possible for their institution to take advantage of the program.

Okay. Okay. But I guess from a -- for all the folks who are tracking estimates and so forth like that, from a reporting standpoint, I'm just curious whether EAP demand or any volumes get reflected in sales and whether you'd expect that to be a meaningful.

So no, they won't get reflected in sales. We're offering this drug. It's considered a clinical trial. We're providing this drug in the context of that clinical trial. It's in effect, free of charge. And once the drug is commercially available, those patients will be transitioned to commercially available product.

Okay. Great. Great. So I guess, in the wild-type PI3-kinase setting where REVTORPYK is approved today, you're talking about a market here that's roughly the same size as HR-positive/HER2-negative breast cancer with PI3-kinase alpha mutation, if you are excluding patients with ESR1 mutation, if I have that kind of rough math correct. From a benchmarking standpoint, is it useful to look at sort of the launch trajectories of other PI3K-alpha products here? I'm thinking of TruCap, for example, can we think about sort of demand as a comp here for REVTORPYK?

So I think there are 2 profiles of companies that end up launching drugs these days. One is the major pharmaceutical companies or ones that are already in the market and maybe already in the indication that they're launching a new drug. And those companies will have an advantage and we'll be able to reach peak sales probably within 24 months. I think that would be the typical result. And we've tracked that. Whereas companies like ours, launching their first drug into a new space, the time to peak based on the analogs that we've found is closer to 36 to 42 months and 36 months is probably more realistic. And so I think when you think of it that way and you reflect on the importance of the time to peak on the actual early sales, then the analogs of, let's say, a TruCap aren't quite applicable.

Okay. That's helpful. And just you're approved with 2 regimens here, a doublet with fulvestrant and then a triplet with fulvestrant and palbociclib. What's your sense of which combo regimen docs are more likely to treat with here? And do you anticipate any payer pushback, payer limitations with respect to the use of a triplet regimen in any sense, perhaps putting GE and palbociclib in a little bit of tension.

Sure. So 2 things. One is that by having 2 regimens, we've actually, I think, increased our ability to optimize the penetration of usage of GEDA. -- because it's a very heterogeneous population in breast cancer, 30-year-old women, in some cases, up to 75 or 80-year-old women. And so giving doctors 2 options that they can use to essentially optimize for their patient depending on their characteristics will be very helpful. And that's the feedback we've received. However, for the triplet, the research that we've done to date has shown suggested at least that we would expect roughly an 80-20 split between the triplet and the doublet. And part of that may be informed by the fact that some doctors have indicated they'll start with a triplet. They always have the option if they're concerned about the neutropenia from palbociclib to back off the palbociclib. Alternatively, we've had some doctors tell us that, well, they'll start with the doublet and then allow the patient to see how the patient is doing and then potentially add palbociclib once that patient has received a cycle of therapy or so. And so I think that flexibility will be very helpful to the doctors because they -- again, they can select what they think might be best depending on the patient's profile. And that's always a challenge with any regimen, especially in breast cancer where you have such a wide range of patient subtypes.

From your discussions with docs, do you anticipate use of REVTORPYK in patients with an ESR1 mutation? I guess -- yes. And I guess if they were to do that, would they use the doublet combination as per label? Or would they kind of seek to perhaps do a novel combination with an oral SERD?

So I think it would be helpful just to step back and think about these segments. There's roughly 40% of patients that lack a PIK3CA mutation or an ESR1 mutation. They're double wild type. There's about 40% of patients that have a PIK3CA mutation, and they may have or have not an ESR1 mutation. And then there's 20% of patients that are PIK3CA wild-type that have an ESR1 mutation. So I think in the 2 groups of patients, PIK3CA wild-type, ESR1 wild-type and the PIK3CA mutant, the GEDA regimens will be very, very competitive. They're highly differentiated in efficacy and safety profile, and we think that will be a significant -- comprise a significant proportion of the regimens that doctors are prescribing. -- in that subgroup, that 20% portion that are PIK3CA wild-type ESR1 mutant, it will be more competitive. I think there's a very strong rationale to use the GEDA regimens when you look -- especially when you dig into some of the subgroups that we reported on in terms of the duration of response, patients with or without visceral mets, characteristics like that allow you to see some fairly significant differentiation from the regimens that include an oral SERD.

Okay. Okay. When we look at the results from Study 1 of VIKTORIA-1, there's a little bit of discord in the PFS duration on the triplet regimen versus the doublet. And I'm wondering whether -- and I know there were some regional differences in that this quarter. I'm wondering whether there are any implications from that signal as we think about the real-world duration on therapy with REVTORPYK where in the U.S.

Sure. I actually think the population that we enrolled was a tougher population than the population you would see in the real world. Even our eligibility criteria, we require patients to have measurable disease. And in the real world, you'd find roughly 20% to 30% of patients with nonmeasurable disease, bone-only disease. And interestingly, when we look at the subgroups and look at patients who, for instance, don't have visceral disease or don't have measurable disease, the median PFS, the duration on therapy is significantly longer than those with measurable disease. And that's consistent across the mutant and wild-type subgroups. And so we actually think there's limited downside to the duration of treatment that we reported for the VIKTORIA-1 study, roughly 10 months duration of treatment average. And in fact, if anything, there could be upside given the nature of the population that exists in the real world.

Okay. Okay. Great. So let's turn to the PI3K mutant opportunity here. You're expecting to file an sNDA this quarter.

We actually already filed. excuse me, that...