Celcuity Inc. (CELC) Q3 FY2025 Earnings Call Transcript & Summary

Good afternoon, ladies and gentlemen, and welcome to the Celcuity's Third Quarter 2025 Financial Results Webcast and Conference Call. [Operator Instructions] I would now like to turn the conference over to Apoorva Chaloori with ICR Healthcare. Please go ahead.

Thank you, operator, and good afternoon to everyone. Thank you for joining us to review Celcuity's Third Quarter 2025 Financial Results and Business Update. Earlier today, Celcuity Inc. released financial results for the third quarter ended September 30, 2025. The press release can be found on the Investors section of Celcuity's website. Joining me on the call today are Brian Sullivan, Celcuity's Chief Executive Officer and Co-Founder; Vicky Hahne, Chief Financial Officer; as well as Igor Gorbatchevsky, Chief Medical Officer, who will be available during Q&A. Before we begin, I would like to remind listeners that our comments today will include some forward-looking statements. These statements involve a number of risks and uncertainties, which are outlined in today's press release and in our reports and filings with the SEC. Actual events or results may differ materially from those projected in the forward-looking statements. Such forward-looking statements and their implications involve known and unknown risks, uncertainties and other factors that may cause actual results or performance to differ materially from those projected. On this call, we will also refer to non-GAAP financial measures. These non-GAAP measures are used by management to make strategic decisions, forecast future results and evaluate the company's current performance. Management believes the presentation of these non-GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future. You can find the table reconciling the non-GAAP financial measures to GAAP measures in today's press release. And with that, I would now like to turn the call over to Brian Sullivan, CEO of Celcuity. Please go ahead.

Thank you, Apoorva. Good afternoon, everyone, and thank you for joining our third quarter operating and financial update conference call. Past few months were busy and fruitful ones for Celcuity. We made significant progress achieving a number of clinical and regulatory milestones while also significantly bolstering our balance sheet. These achievements lay the groundwork for us to potentially establish gedatolisib as a new standard of care second-line therapy for patients with HR-positive, HER2-negative advanced breast cancer. Amongst the key clinical and regulatory milestones achieved, first, we released top line data results from the PIK3CA wild-type cohort of the Phase III VIKTORIA-1 study and then subsequently presented detailed efficacy and safety results for this study at a late-breaking oral presentation at the European Society for Medical Oncology, or ESMO Congress. We also presented at this ESMO Congress updated clinical results from the Phase I portion of a clinical trial evaluating gedatolisib in combination with darolutamide in men with metastatic castration-resistant prostate cancer. And third, we completed enrollment of the PIK3CA mutant cohort of the Phase III VIKTORIA-1 trial, and we now expect top line data in late Q1 '26 or during Q2 '26. And fourth, the FDA accepted our request to submit our New Drug Application, or NDA, under their real-time oncology review program for gedatolisib based on the results from the PIK3CA wild-type cohort of the VIKTORIA-1 trial, and we expect to complete the submission this quarter. And then fifth, to strengthen our balance sheet, we completed concurrent offerings of convertible notes, common stock and prefunded warrants, which resulted in net proceeds of approximately $287 million. We also amended our term loan facility with Innovatus Capital Partners and Oxford Finance to increase the total term loan facility size to $500 million, including $350 million in committed capital and up to $150 million at the mutual discretion of Celcuity and its lenders. Future draws of committed capital under the facility are subject to the achievement of certain milestones. The most consequential milestone of the quarter for Celcuity was, of course, the release of positive data from the PIK3CA wild-type cohort of the VIKTORIA-1 trial. And we've discussed previously the historic nature of the results and the new milestones they achieved in HR-positive, HER2-negative advanced breast cancer. But to recap, median progression-free survival, or PFS, for the gedatolisib triplet, which is gedatolisib, palbociclib and fulvestrant was 9.3 months compared to only 2 months for fulvestrant, which is a 7.3-month incremental improvement in median PFS. The hazard ratio was 0.24. For the gedatolisib doublet, which is gedatolisib and fulvestrant, median PFS was 7.4 months versus 2.0 months with fulvestrant, a 5.4-month incremental improvement in median PFS. And the hazard ratio was 0.33. These results set several new benchmarks in HR-positive, HER2-negative advanced breast cancer. The hazard ratios for both the gedatolisib triplet and doublet are more favorable than have ever been reported by any Phase III trial for patients with HR-positive, HER2-negative ABC. The 7.3 and 5.4 months incremental improvements in median PFS with the gedatolisib triplet and doublet over fulvestrant, respectively, are higher than have ever been reported by any Phase III trial for patients with HR-positive, HER2-negative advanced breast cancer receiving at least their second line of endocrine therapy. And gedatolisib is the first inhibitor that targets the PI3K/AKT/mTOR pathway to demonstrate positive Phase III results in patients with HR-positive, HER2-negative PIK3CA wild-type breast cancer, whose disease progressed on or after treatment with a CDK4/6 inhibitor. Now as a follow-up to the release of the top line data in July, additional data were released at a late-breaking oral presentation in October at ESMO. Now in this presentation, we reported, among other things, that the objective response rate of the gedatolisib triplet was 32% compared to 1% with fulvestrant and the median duration of response was 17.5 months and that the objective response rate of the gedatolisib doublet was 28% and the median duration of response was 12.0 months. The median duration of response for fulvestrant was not determinable because there was only one objective response. And these results also established new benchmarks. The median duration of response and the incremental improvement in the objective response rate relative to control for the gedatolisib triplet and doublet are the highest reported for an endocrine therapy-based regimen in second-line HR-positive, HER2-negative advanced breast cancer. Additionally, the results demonstrated the clinical benefit of the gedatolisib regimens was consistent across patient subgroups. And one patient subgroup of note, patients enrolled in the United States and Canada, achieved median PFS of 19.3 months with the gedatolisib triplet and 14.9 months with the gedatolisib doublet. The ESMO presentation also provided detailed safety results that showed the gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events. Study treatment discontinuation due to treatment-related adverse events was reported in 2.3% of patients treated with the gedatolisib triplet and 3.1 months of patients with the gedatolisib doublet. Now in the presentation of results from the PIK3CA wild-type cohort of the VIKTORIA-1 study at ESMO, additional data from a Phase Ib clinical trial that evaluated gedatolisib in patients with HR-positive, HER2-negative advanced breast cancer was included. And the analyses reported efficacy data from patients who are treated with the same drug regimen evaluated in the VIKTORIA-1 study, gedatolisib combined with fulvestrant and palbociclib. Now these patients were included from the escalation Arm B and expansion arms B, C and D of the Phase Ib study. Median PFS and the objective response rate, or ORR, were assessed in subgroups of patients according to their PIK3CA status. For the 30 analyzed patients with PIK3CA mutant tumors, median PFS was 14.6 months and the ORR in response of evaluable patients was 48%. For the 60 patients with PIK3CA wild-type tumors, median PFS was 9 months and the ORR in response evaluable patients was 41%. Now let's turn over to our VIKTORIA-2 study, which is a Phase III clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR-positive, HER2-negative advanced breast cancer who are endocrine therapy resistant. We dosed the first patient for this study in late July and enrollment is ongoing. We believe the positive results from the PIK3CA wild-type cohort of our VIKTORIA-1 study augurs well for the potential efficacy of gedatolisib triplet may induce in this patient population. Now let's turn to our Phase I/II clinical trial that is evaluating gedatolisib in combination with darolutamide in men with metastatic castration-resistant prostate cancer. We presented detailed data for the Phase I portion of the study at a poster presentation at ESMO. And in this portion of the Phase I/II study, 38 patients were randomly assigned to receive standard doses of gedatolisib in either 120 milligrams of gedatolisib in Arm 1 or 180 milligrams of gedatolisib in Arm 2. Among the 38 patients enrolled, 61% had received 1 line of prior systemic therapy and 39% had received at least 2 or more lines of prior therapy. The Phase I data set utilized in August 15, 2025 data cutoff and median duration of follow-up was 9 months. The 6-month radiographic PFS, or rPFS rate was 67% and the median radiographic progression-free survival for patients was 9.1 months from both arms combined. For patients treated with 120 milligrams of gedatolisib, the 6-month rPFS rate was 74% and the median rPFS was 9.5 months. For patients treated with 180 milligrams of gedatolisib, the 6-month PFS rate was 61% and the median rPFS was 7.4 months. And these results compare favorably to historical results for patients with mCRPC who were treated with an androgen receptor inhibitor as second-line treatment. The combination of geda and darolutamide were generally well tolerated in the trial with mostly low-grade treatment-related adverse events. No dose-limiting toxicities were observed in either arm. The only Grade 3 treatment-related adverse events for patients from both arms combined included rash in about 5.3% of patients, stomatitis in 2.6% of patients and pruritus in 2.6% of patients as well. No Grade 3 hypoglycemia was reported. Additionally, no patients discontinued the study treatment due to an adverse event. Now as we near what we hope is an FDA approval for gedatolisib in 2026, our efforts to prepare for the potential launch of gedatolisib have ramped up per our strategic launch plan. Foundational to these efforts was the additional cash we raised and the enhanced financial flexibility, our $500 million term loan facility provides us. We began laying the groundwork for a potential gedatolisib launch 18 months ago, and we've since made significant progress building the organization and internal systems required to operate as a commercial stage company. Now as planned, once the VIKTORIA-1 wild-type data was in hand, our commercial launch preparation efforts significantly accelerated. Except for the field sales force, we've mostly completed hiring of the individuals needed to execute the launch, and we're very fortunate to have attracted an incredibly talented group of individuals who have a strong track record of successfully launching novel oncology therapeutics. Our sales management and customer operations groups have defined our regional and sales territories and our go-to-market objectives for each one. The medical science liaison and KOL engagement teams have done a great job of exchanging scientific information with key opinion leaders and community practice leaders and obtaining important insights and feedback from them. Now key efforts today include extensive outreach across the country to the payers and population health decision-makers in various treatment settings, including health systems, integrated delivery networks and community oncology practices that will play a key role in providing oncologists access to gedatolisib for their patients. We've made strong progress engaging with these decision-makers, and we're very pleased with the feedback and enthusiastic response these efforts have yielded. We're also very encouraged by the results of research we have fielded to gauge the willingness of community and academic oncologists to prescribe gedatolisib should it get approved. And these results make us optimistic about the possibility of establishing gedatolisib as the new standard of care in the second-line setting for HR-positive, HER2-negative advanced breast cancer in the wild-type patient population. Now in light of this feedback, we believe obtaining majority market share in this setting appears not only achievable, but potentially too conservative. Based on analysis of published epidemiological data, we estimate there are 37,000 patients in the U.S. with HR-positive, HER2-negative advanced breast cancer who've progressed after treatment with a CDK4/6 inhibitor. Using internal duration of treatment estimates and pricing assumptions consistent with currently available novel therapeutics for breast cancer, we estimate the total addressable market for gedatolisib in the second-line setting is $5 billion to $6 billion. And given the significant penetration our research is suggesting we can achieve, we believe it's reasonable to estimate that a second-line wild-type indication or second-line indication in general for gedatolisib can potentially generate peak revenues of $2.5 billion to $3 billion. The progress we've made to date is encouraging and exciting. We look forward to providing you updates over the next few quarters. We believe the resources we've raised will enable us to advance multiple potential blockbuster indications in breast and prostate cancer while also aggressively preparing for and potentially launching gedatolisib commercially should we receive FDA approval. Gedatolisib is well positioned to address critical needs in the second-line space with its unique mechanism of action and potential first-in-class and best-in-class safety and efficacy profile. I'd like to now hand the call over to Vicky to review our finances.

Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the third quarter of 2025. Our third quarter net loss was $43.8 million or $0.92 per share compared to $29.8 million net loss or $0.70 per share for the third quarter of 2024. Our non-GAAP adjusted net loss was $37.2 million or $0.78 per share for the third quarter of 2025 compared to non-GAAP adjusted net loss of $27.6 million or $0.65 per share for the third quarter of 2024. Research and development expenses were $34.9 million for the third quarter of 2025 compared to $27.6 million for the third quarter of 2024. Of the approximately $7.3 million increase in R&D expenses, $5.6 million was related to increased employee and consulting expenses, $3.2 million of which related to commercial headcount additions and other launch activities. The remaining $1.7 million increase was primarily related to activities supporting our ongoing clinical trials. General and administrative expenses were $7.9 million for the third quarter of 2025 compared to $2.5 million for the third quarter of 2024. Of the approximately $5.4 million increase in G&A expenses, $4.9 million increase was related to increased employee and consulting expenses. Of this increase, $4 million was related to noncash stock-based compensation. The remaining $0.5 million of the $5.4 million increase primarily related to professional fees, expanding infrastructure and other administrative expenses. Net cash used in operating activities for the third quarter of 2025 was $44.8 million compared to $20.6 million for the third quarter of 2024. We ended the quarter with approximately $455 million of cash, cash equivalents and short-term investments. As Brian mentioned earlier, in July of 2025, we conducted a concurrent public offering of 2.75% convertible senior notes due in 2031 common stock and a prefunded warrant offering. The net proceeds from the combined offerings were $287 million after deducting underwriting discounts, commissions and the company's operating expenses. In September 2025, the company entered into an amendment to its existing senior secured term loan facility with an affiliate of Innovatus Capital Partners and Oxford Finance and certain of its affiliates. The amendment increases the total term loan facility size to $500 million, including $350 million in committed capital and up to $150 million at the mutual discretion of Celcuity and its lenders. In connection with the release of the positive top line data from the PIK3CA wild-type cohort of the VIKTORIA-1 Phase III clinical trial, Celcuity achieved the Term D milestone and was eligible to draw an additional $30 million under the term loan facility. In connection with the amendment to the term loan facility, the Term D loan was disbursed and Celcuity received net proceeds of $27.8 million. The upsized facility strengthens Celcuity's ability to manage its capital structure efficiently while providing additional funding to support commercial launch preparations for gedatolisib and other strategic initiatives. Also triggered by the release of the positive top line data was the 75-day expiration date for warrants that were issued pursuant to a private placement that closed on December 9, 2022. Warrants that were exercised generated cash proceeds of $12.8 million. We expect cash, cash equivalents, investments and drawdowns on our current debt facility to fund operations through 2027. I will now hand the call back to Brian.

Thank you, Vicky. Operator, could you please open the call for questions.

[Operator Instructions] Your first question comes from the line of Maury Raycroft from Jefferies.

Congrats on the progress. You're planning on having additional data at the San Antonio Breast Cancer Symposium Conference. Maybe talk about what the main focus of the presentation is going to be? And do you anticipate sharing more detailed subpopulation data related to ESR1 wild-type and mutant in the near future?

Thanks, Maury. We'll present the data when it's presented. Typically, these presentations that follow the detailed initial presentation include additional subgroup analyses for efficacy, additional data that might relate to certain safety or quality of life aspects of the study. And we expect to follow that approach with the data we released in San Antonio.

Okay. Understood. And maybe a question just related to the frontline setting. Wondering if you can comment on whether enrollment in VIKTORIA-2 has been positively impacted by the second-line data? And is there anything additional you can say on time lines? And also wondering if you're considering expanding to first-line endocrine-sensitive patients with the current formulation.

Thanks for the question. No, enrollment is on track. I mean, certainly, investigators who are participating in the VIKTORIA-2 study were very excited about the results. And I think that, of course, would impact the visibility for their patients and the credibility of the study itself. So we think it will have a favorable effect. As far as additional Phase III studies, I mean, certainly, we have a long-term life cycle development plan. And over time, as we make progress fleshing that out or making some decisions about timing and approach, we'll announce those, but we're not ready to do that yet.

Your next question is from the line of Andrew Berens from Leerink Partners.

This is [ Samantha ] on for Andy. So for the real-time oncology review submission process to the FDA, you're guiding to completing that in fourth quarter. We're just kind of trying to figure out the wild-type submission will be complete from the -- completely separate from the mutant submission. Are there any implications to this? Do you also expect the mutant submission to be a real-time oncology review? Any color would be helpful.

Sure. So we're on track, as I indicated, with the submission for the wild-type cohort completed by the end of this quarter. And we've had specific conversations about the approach that we're taking with this NDA and the RTOR submission and that was ultimately approved by the FDA, reflected that we'll just be submitting and seeking an NDA for the wild-type population. So we're in sync with the FDA on that front. We would, depending on the data, request a real-time oncology review for the mutant data, but it's always a function of the data. These real-time reviews are typically only granted when the data is very, very clear and the potential for a new standard of care is possible. And so, we hope that's the case. But until we have the data, we can't necessarily commit to that.

Next question is from the line of Tara Bancroft from TD Cowen.

So I'm hoping you can maybe expand a bit more on what you believe the eventual duration of therapy will be, especially in the commercial setting for the triplet based on the data that you've seen so far? And then separately, I'm wondering if you could tell us what assumptions would go into your pricing strategy and what are some good comps to look for there?

Okay. As far as the duration of therapy, I mean, there's a couple of ways to think about that because there -- we did find variation in the outcomes according to region. And in the U.S., for instance, we reported that PFS was 19.3 months, which was significantly longer than the intent to treat. And so, we have an internal estimate of what we think is reasonable yet. We will do some further analysis before we might share that externally, and that will be a function of providing additional subgroup analyses over the coming months. As far as assumptions for pricing, there have been drugs launched recently that are novel therapeutics targeting, in this case, the PI3K pathway. I think the wholesale acquisition cost for one therapeutic or several therapeutics that are in this HR-positive, HER2-negative space are in the range of, let's call it, $25,000, plus or minus. And so, that's a reasonable benchmark. You also have to factor in potential discounts that would be associated with distribution of the drug. Oral drugs typically will have probably closer to a 30% discount, gross to net of 70% discount. And then medical benefit drugs like geda would probably only have a 20% discount. So you could potentially get a better price in this market just by virtue of being a medical benefit on a net basis with the same wholesale acquisition cost price. Now we're doing research in this area now. We haven't made a final decision on our pricing approach. But for purposes of trying to estimate what the addressable market value is, we think it's reasonable to use the numbers that I just shared.

Your next question comes from the line of Brad Canino from Guggenheim.

Just one question for me. What is the plan to bring gedatolisib to patients outside the U.S.?

Sure. I think we've discussed in other calls or at least we've mentioned that we expect to commercialize in the U.S. and as I discussed on the call, and then find a partner or partners to commercialize the drug ex U.S. And we are holding off finalizing or really moving forward with intense discussions on that until we have our mutant data available and until we've submitted what we hope is an sNDA for the mutant population. And coincident with the submission of the sNDA for the mutant population, if all goes according to plan, we would soon after expect to file an MAA to the European medical authorities that would comprise both mutant and wild-type patient data. Additionally, we've also been working with the Japanese health authority to identify their requirements for a submission. We think we're aligned with them on an approach that makes sense to us. And so, we're moving forward on a regulatory path that will allow us to stay on track with as rapid commercialization as possible, even without the -- rather a marketing partner. And we would expect to start engaging those discussions once, I would say, the middle of next year once our data was available and the regulatory submissions were on their way.

Next question is from the line of Stephen Willey from Stifel.

Can you hear me?

We can.

This is Dara Azar on for Steve. Brian, you announced plans to develop gedatolisib for endocrine-resistant frontline well before the VIKTORIA-1 readout. I'm curious, has your thinking around the type of frontline population to be enrolled changed at all now that you have Phase III data from the wild-type population, you have this interesting signal from Phase Ib subgroup analysis. And I'm assuming you have KOL feedback, investor feedback. So what is your philosophical view around the need to conduct endocrine-sensitive trial in the frontline setting?

No, thank you for the question. Well, I mean, certainly, we believe that there's an important opportunity to help patients delay their progression for even longer than is possible with the current CDK4/6 letrozole regimens. And we base that view on the data that we obtained in our Phase Ib study in treatment-naive endocrine-sensitive patients. Now the standard of care CDK4/6 letrozole regimens, the 3 of them offer patients, at least as reported in their Phase III studies, about 25 months, plus or minus median PFS. In our Phase Ib study, which, again, only 41 patients, single-arm study, so you have to caveat it, but a meaningful enough population that is probably not a random result. But we reported about 48 months median PFS. So that we think helps establish or certainly provide preliminary evidence that this pathway is an important driver in treatment-naive hormone receptor positive breast cancer. And in effect, it kind of confirms our hypothesis certainly helps demonstrate that this pathway, the PAM pathway is really 1 of 3 driver pathways promoting breast cancer, the PAM pathway, CDK4/6 and endocrine therapy, or ER pathway. And so, we think there's a very, very strong rationale to develop this drug for that population. It's a long study, given the potential progression-free survival of both the control and study arm and probably a fairly sizable number of patients as well. And so, again, we are wanting to step back, as you suggested, given the results we have here where we really saw a profound effect in wild-type patients and be very thoughtful about how we would design that study in light of the current study in endocrine-resistant patients. So yes, we believe it's an important opportunity to help patients further. It represents probably 2/3 of women who are treatment-naive in the metastatic setting. And so, we think would be an important thing for us to do. And we think there's a lot of strong rationale to do it. And over time, we will provide updates on our thoughts on that.

Your next question comes from the line of Oliver McCammon from LifeSci.

I'm just curious if you can speak to the potential impact of a favorable overall survival trend in the second- and third-line setting, caveating that we've seen interim OS data so far. And also curious if you can speak to potentially what role these data could play in the regulatory process as well.

Sure. And so, in conjunction with the primary analysis, our stats plan and typically is required, but our stats plan performed an interim OS analysis to demonstrate or hopefully to reveal what, if any, effect you might have on overall survival for these patients. The requirement from a regulatory standpoint is that, you don't show any evidence that you're reducing patients' likelihood of survival, i.e., you have to have a hazard ratio that's below 1. And in the case of the interim analysis for our study, the hazard ratio was, I think, 0.69 for the triplet and about the same for the doublet, which, again, we believe is a favorable trend. And we think that, that supports our submission for drug approval and supportive of that. As far as the impact of an overall survival positive readout, certainly, we think, impactful. But that's -- it has been a very high bar to beat in second-line setting. There hasn't been a drug yet in the second-line setting that has showed an OS advantage. And that's just because of the nature and heterogeneous nature of the patients and the subsequent drugs they receive. But we'll see. I mean, certainly, we look forward to reporting out those numbers. But when you have a study of our size with the sample size, you have a relatively small number of events that you're using to characterize what is only a certain effect size. And so, it's a high bar to beat with a small sample size, but we'll see. And certainly, if successful, it will be very impactful.

Your last question comes from the line of Chase Knickerbocker from Craig-Hallum.

This is Jake on for Chase. In light of this administration's focus on domestic manufacturing, could you just remind us where geda is manufactured?

Sure. We have several sites for manufacturing, and we have an approach that we think allows us to have flexibility in how we manufacture, where we manufacture the drug. We haven't really announced where we're manufacturing the drug. But based on our kind of inventory approach and also our approach to finding second sources, we're basically taking the steps necessary to make sure our supply chain is as bulletproof as you can make it.

There are no further questions at this time. I would like to turn the call back to Brian Sullivan for closing comments. Sir, please go ahead.

Well, thank you for attending our call, and I look forward to providing further updates in the future. Goodbye.

Ladies and gentlemen, this concludes today's conference call. Thank you very much for your participation. You may now disconnect.