CELC - NASDAQ

Good afternoon, ladies and gentlemen, and welcome to the Celcuity Third Quarter 2025 Financial Results Webcast and Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press 0 for the operator. 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 F. Sullivan, Celcuity's Chief Executive Officer and Co-Founder, Vicky Hahne, Chief Financial Officer, as well as Igor Gorbachevsky, 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 F. 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. The 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 Get It Solicit 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 VICTORIA-one 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 one portion of a clinical trial evaluating getetelicib in combination with darolutamide and then with metastatic castration-resistant prostate cancer. And third, we completed enrollment of the '6 or during Q2 'twenty-six. And fourth, the FDA accepted our request to submit our new drug application or NDA under their real-time oncology review program. Brigadatilissa based on the results from the PIK3CA wild-type cohort of the VICTORIA-one 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 within Novartis 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 Cuity was, of course, the release of positive data from the PIK3CA wild-type cohort of the VICTORIA-one trial. And we've discussed previously the historic nature of the results and the new milestones they achieved HR-positive HER2-negative advanced breast cancer. But to recap, median progression-free survival, or PFS, for the gadgets elicit triplet which is gadgetolitinib, 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 gadgetolitinib doublet, is gaditalisib 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 again, if those are triplet and doublet are more favorable than have ever been reported by any Phase III trial patients with HR-positive HER2-negative ABC. The 7.3 and 5.4 months incremental improvements in median PFS with the gonadotilus and 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 gaditalisib is the first inhibitor that targets the PI3K AKT mTOR pathway to demonstrate positive Phase III results in patients with its HR-positive HER2-negative PIK3CA wild-type breast cancer whose disease progressed on or after treatment with a CDK4six inhibitor. As a follow-up, reported among other things, 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, that the objective response rate of the genitilus 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 gadgetolitinib doublet was 28% and the median duration of response was 12.0 months. 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 the getetelicit 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 gantalizumab 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 a gadathilicit triplet and 14.9 months with the gadatholizumab doublet. The ESMO presentation also provided detailed safety results that showed the gadathalisib triplet N 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 again, least a triplet, and 3.1 months of patients with the gadatholicit doublet. Now in the presentation of results from the PIK3CA wild-type cohort, of the VICTORIA-one study at ESMO, additional data from a Phase 1b clinical trial that evaluated gabatolizumab patients with HR-positive HER2-negative advanced breast cancer was included. And the analyses reported efficacy data from patients who were treated with the same drug regimen evaluated in the VICTORIA-one study. Ganatolizumab 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 1B study. Median PFS and the Objective Response Rate, or ORR, 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 valuable patients was 48%. For the 60 patients with PIK3CA wild-type tumors, median PFS was 9 months, and the ORR in response to viable patients was 41%. Now let's turn over to our VICTORIA-two study, which is a phase three clinical trial evaluating genitelisib plus a CDK4six 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 VICTORIA-one study are as well for the potential efficacy of gadathalicit triplet they induce in this patient population. Now let's turn to our Phase III clinical trial that is evaluating getasilisib in combination with darolutamide in men with metastatic castration-resistant prostate cancer. We presented detailed data the Phase I portion of the study at a poster presentation at ESMO. And in this portion of the Phase III study, 38 patients were randomly assigned to receive standard doses of genafilisib in either 120 milligrams of genifilisib in arm one or 180 milligrams of genifilisib in arm two. Among the 38 patients enrolled, 61% had received one line of prior systemic therapy, 39% had received at least two or more lines of prior therapy. The Phase I data set utilized in August 15, 2025, data cutoff and median duration follow-up was 9 months. The six-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 getitalisib, the six-month RPFS rate was 74%, and the median RPFS was 9.5 months. For patients treated with 180 milligrams of genitulisib, the six-month PFS rate was 61% and the medium RPFS 7.4 months. And these results compare favorably to historic results for patients with MCR PC who were treated with an androgen receptor inhibitor as second-line treatment. The combination of geta 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 III 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 three hyperglycemia was reported. Additionally, though patients discontinued the study treatment due to an adverse event, Now as we near what we hope is an FDA approval for get 2026, our efforts to prepare for the potential launch of have ramped up per our strategic launch plan. Foundational to these efforts was the additional cash we raised and the enhanced financial flexibility of $500 million term loan facility provides us. We began laying the groundwork for a potential Get Us With Sub launch 18 months ago, and we've since made significant progress building the organization internal systems required to operate as a commercial states company. As planned, once the VICTORIA-one 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 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. 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 together to listen to 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 Ganaxlica should it get approved. And these results make us optimistic about the possibility of establishing geditsilicit as the new standard of care. 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 on the setting is not only achievable but potentially too conservative. Based on analysis of published epidemiological data, estimate there are 37,000 patients in The US with HR-positive HER2-negative advanced breast cancer who've progressed after treatment with a CDK4six inhibitor. Now using internal duration of treatment estimates and pricing assumptions can consistent with currently available novel therapeutics for breast cancer, we estimate the total addressable market for Ogedegylus 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 get us to listen 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 and potentially launching gabapalizumab commercially should we receive FDA approval. Gadasolizumab 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 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 2024. Our non-GAAP adjusted net loss was $37.2 million or $0.78 per share, for 2025 compared to non-GAAP adjusted net loss of $27.6 million or $0.65 per share for 2024. Research and development expenses were $34.9 million for 2025 compared to $27.6 million for 2024. Of the approximately $7.3 million increase in R&D expenses, $5.6 million was related to increased employee and consulting, $3.2 million of which related to commercial headcount additions and other launch activities. The remaining $1.7 million increase was primarily related to supporting our ongoing clinical trial. General and administrative expenses were $7.9 million for 2025, compared to $2.5 million for 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 $500,000 of the $5.4 million increase primarily related to professional fees, expanding infrastructure, and other administrative expenses. Net cash used in operating activities for 2025 was $44.8 million compared to $20.6 million for 2024. We ended the quarter with approximately $455 million of cash, cash equivalents, and short-term investments. As Brian mentioned earlier, in July 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 $2.287 billion after deducting underwriting discounts, commissions, and the company's offering 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 PIC three CA wild-type cohort of the VICTORIA-one phase three 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 getatolizumab and other strategic initiatives. Also triggered by the release of the positive top-line data was the seventy-five-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?

Ladies and gentlemen, we will now begin the question and answer session. You will hear a prompt that your hand has been raised. If you would like to withdraw from the polling process, please press star then the number two. If you are using a speakerphone, please make sure to lift your handset before pressing any keys. Your first question comes from the line of Maury Raycroft from Jefferies. Please go ahead.

Hi, congrats on the progress and thanks for taking my questions. You're welcome. 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. You know, 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 Victoria two has been positively impacted by the second line data. And is there anything additional you could say on timelines? And also wondering if you're considering expanding to first-line endocrine-sensitive patients with the current formulation.

Well, thanks for the question. No. Enrollment's on track. I mean, certainly, investigators who are participating in the VICTORIA-two 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, you know, over time as we make progress, in fleshing that out or making some decisions about timing and approach, we'll announce those, but we're not ready to do that yet.

Got it. Okay. Thanks for taking my questions.

You're welcome.

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

Hi, everyone. This is Amanda on for Andy. Thanks for taking our question. So for the real-time oncology review submission to the FDA, you're guiding to completing that in the fourth quarter. We're just kinda trying to figure out the wild-type submission will be completely separate from the mutant submission. Are there any implications to this, Do you also expect the mutant submission to be real-time oncology review? Any color would be helpful. Thanks.

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. You know, these real-time reviews are typically only granted when, you know, 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.

Got it. Thank you.

You're welcome. Next question is from the line of Tara Bancroft from TD Cowen.

Hi, good afternoon. Thanks for taking the questions. 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? Thanks.

Sure. Okay. As far as the duration of therapy, I mean, there are a couple of ways to think about that. Because there we did find variation in the outcomes, according to region. And, you know, in The US, for instance, we reported that PFS was 19.3 months, you know, which was, you know, 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'll 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, you know, targeting, in this case, the PFK 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, you know, that's a reasonable benchmark. You also have to factor in potential discounts that would be associated with the distribution of the drug. Oral drugs typically will have probably closer to a 30% discount, you know, gross to net of 70%. Discount. And then medical benefit drugs like Gheta 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. 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.

Great. Thank you. That's very helpful.

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

Just one question for me. What is the plan to bring gedotolitinib to patients outside The US? Thanks.

Sure. I think we've discussed in other calls, or at least we've mentioned that we expect to commercialize in The US and as I discussed on the call and then find a partner or partners to commercialize the drug ex-US. 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 submission that makes sense to us. We think we're aligned with them, on an approach. 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 a regular or rather a marketing partner. And we would expect to start engaging those discussions once, you know, I would say the middle of next year once our data was available and regulatory submissions were on their way.

You're welcome. Next question is from the line of Stephen Douglas Willey from Stifel. Please go ahead.

Hey. Can you hear me?

We can.

Hey. This is Dara Azar on for Steve. Brian, you announced plans to develop Geratolosib for endocrine-resistant frontline well before the Victoria one readout. I'm curious as you're thinking around the type of frontline population to be enrolled change at all now that you have phase three data from the wild-type population, you have this interesting signal from phase one b 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. Thank you.

No, thank you for the question. Well, I mean, we believe that there's an important opportunity to help patients delay their progression for even longer than is possible with the current CDK foursix letrozole regimens. And we base that view on the data that we obtained in our phase 1b study in treatment-naive, underconsensitive patients. Now standard of care CDK4six, liposome regimens, the three of them, offer patients, at least as reported in this in their phase three studies, about 25 months plus or minus median PFS. In our Phase Ib study, which again, 41 patients, single-arm study, so you have to caveat it, but meaningful enough population that it's probably not a random result. But we reported, about 48 months medium TFS. So that we think, helps establish or certainly provide preliminary, evidence. That this pathway is important, an important driver in treatment-naive hormone receptor-positive breast cancer. And in effect, kinda confirms our hypothesis and certainly helps demonstrate that this pathway, the PAM pathway, is really one of three driver pathways promoting breast cancer. The PAM pathway CDK4six 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. We really saw a profound, effect in wild-type patients. And, and be, you know, very thoughtful about how we would design that study and in light of the current study. Endocrine-resistant patients. So yes, we believe it's an important opportunity to help patients further. Represents probably two-thirds of women who are treatment-naive in the metastatic setting. And so, you know, it, 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, you know, we will provide updates on our thoughts on that.

Hello? Next question comes from the line of Oliver McCammon from LifeSci. Please go ahead.

Thanks for taking my question. 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. And also curious if you can speak to caveating that, we've seen interim OS data so far. essentially what role these data could play in the regulatory process as well. Thanks again.

Sure. And so, in conjunction with the primary analysis, our stats plan 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 a patient's likelihood of survival, i.e. you have to have a hazard ratio that's below one. And in the case of interim analysis, for our study, you know, 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 you know, supports our submission for drug approval. Supportive of that. As far as the impact of an overall survival positive readout, certainly we think impactful. But that's a it it tends it has been a very high bar to beat. In a second-line setting. There hasn't been a drug yet the second-line setting that has shown an OS advantage. And that's 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.

Thanks, Ken. Your last question comes from the line of Chase Richard Knickerbocker from Craig Hallum. Please go ahead.

Hi, guys. Thanks for taking the questions. This is Jake on for Chase. In light of this administration's focus on domestic manufacturing, could you just remind us where data 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 of finding second sources, you know, we're basically in taking the steps necessary to make sure our supply chain is as bulletproof as you can make it.

Great. Thank you. There are no further questions at this time. I would like to turn the call back to Brian F. 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.