Celcuity Inc. Q3 FY2025 Earnings Call

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 trial during Q2 2026. 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 with 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 Celcuity 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 for HR-positive HER2-negative advanced breast cancer. But to recap, median progression-free survival, or PFS, for the getetelicib triplet which is gadotolitinib, palbociclib, and fulvestrant was 9.3 months, compared to only 2 months for fulvestrant. This represents a 7.3-month incremental improvement in median PFS. The hazard ratio was 0.24. For the getetelicib doublet, which is gaditalisib and fulvestrant, the median PFS was 7.4 months versus 2.0 months with fulvestrant, a 5.4-month incremental improvement in median PFS, with a hazard ratio of 0.33. These results set several new benchmarks in HR-positive HER2-negative advanced breast cancer. The hazard ratios for both the triplet and doublet are more favorable than have ever been reported by any Phase III trial for patients with HR-positive HER2-negative advanced breast cancer. The 7.3 and 5.4-month incremental improvements in median PFS with the gadotilitinib triplet and doublet over fulvestrant, respectively, are higher than have ever been reported by any Phase III trial in this context. Furthermore, getetelicib is the first inhibitor that targets the PI3K AKT mTOR pathway to demonstrate positive Phase III results in patients with wild-type breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor. As a follow-up, additional data were released at a late-breaking oral presentation in October at ESMO. In this presentation, the objective response rate of the getetelicib triplet was 32% compared to 1% with fulvestrant, and the median duration of response was 17.5 months, while for the getetelicib doublet, the objective response rate was 28%, and the median duration of response was 12.0 months. Median duration of response for fulvestrant was not determinable due to only one objective response. These results established new benchmarks, reflecting the highest reported duration of response for an endocrine therapy-based regimen in second-line, HR-positive HER2-negative advanced breast cancer. Furthermore, we noted strong consistency in the clinical benefit of the getetelicib regimens across patient subgroups, with a significant improvement in median PFS observed in patients enrolled in the United States and Canada achieving 19.3 months with the getetelicib triplet and 14.9 months with the getetelicib doublet. The ESMO presentation also provided detailed safety results demonstrating that the getetelicib triplet and doublet were generally well tolerated with mostly low-grade treatment-related adverse events. Treatment discontinuation due to treatment-related adverse events was reported in 2.3% of patients treated with the triplet, and 3.1% of patients with the doublet. As we approach what we hope will be an FDA approval for getetelicib in 2026, our efforts to prepare for the potential launch have ramped up per our strategic launch plan. Key to these efforts was the additional cash raised and the enhanced financial flexibility from our $500 million term loan facility. We began laying the groundwork for a potential getetelicib launch 18 months ago, and we have since made significant progress in building the organization and internal systems required to operate as a commercial entity. With the exception of the field sales force, we've mostly completed hiring the individuals needed for the launch. We are fortunate to have attracted an incredibly talented group of individuals with a strong track record in launching novel oncology therapeutics. Our sales management and operations teams have defined our sales territories and go-to-market strategies. Medical science liaison and KOL engagement teams have effectively conveyed scientific information with key opinion leaders and community practice leaders and have gained valuable insights from them. Our current focus includes extensive outreach to payers and decision-makers in various treatment settings, including healthcare systems, integrated delivery networks, and community oncology practices, which will be pivotal in making oncologists aware of getetelicib. We are encouraged by the positive feedback and responses from our efforts. Additionally, we are optimistic based on research regarding the willingness of community and academic oncologists to prescribe getetelicib, should it gain approval. In light of this feedback, we believe capturing a significant market share in the second-line setting is not only achievable but potentially underestimating. Our analysis of published epidemiological data estimates 37,000 patients in the US with HR-positive HER2-negative advanced breast cancer who have progressed after treatment with a CDK4/6 inhibitor. Based on internal treatment duration estimates and price assumptions aligned with currently available therapies for breast cancer, we estimate that the total addressable market for getetelicib in the second-line setting could be $5 billion to $6 billion. Given the high penetration suggested by our research, we believe it is reasonable to estimate peak revenues of $2.5 billion to $3 billion for a second-line wild-type indication. The progress to date is encouraging and exciting; we look forward to providing updates in the coming quarters. We believe the resources we have raised will enable us to advance multiple potential blockbuster indications in breast and prostate cancer while also aggressively preparing for the commercial launch of getatolizumab upon FDA approval. Getatolizumab is well positioned to address significant needs in the second-line space due to 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 a net loss of $29.8 million 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 a 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 costs, $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 trials. 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 was related to increased employee and consulting expenses. Of this increase, $4 million was related to non-cash 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 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 PIC3CA wild-type cohort of the VICTORIA-one phase three clinical trial, Celcuity achieved the term D milestone and was then eligible to draw an additional $30 million under the term loan facility. Following 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 for commercial launch preparations of getatolizumab and other strategic initiatives. Additionally, the release of positive top-line data also triggered a 75-day expiration date for warrants issued in a private placement that closed on December 9, 2022. Exercising those warrants generated cash proceeds of $12.8 million. We expect our cash resources, 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 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. 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. Enrollment's on track. I mean, certainly, investigators who are participating in the VICTORIA-two study were very excited about the results. 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, we have a long-term life cycle development plan, and 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 trying to figure out if 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. We've had specific conversations about the approach we're taking with this NDA and the RTOR submission, which the FDA ultimately approved, reflected that we'll just be submitting and seeking an NDA for the wild-type population. 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. Real-time reviews are typically only granted when the data is very clear and the potential for a new standard of care is possible. 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, there are a couple of ways to think about that. We found variation in outcomes according to region. In the US, we reported that PFS was 19.3 months, which was significantly longer than the intent to treat. We have an internal estimate of what we believe is reasonable, but we will perform further analysis before sharing that externally. As for assumptions regarding pricing, several novel therapeutics targeting the PFK pathway are priced in the range of $25,000 plus or minus. You must also factor in potential discounts associated with the drug’s distribution. Oral drugs typically have a gross to net discount of about 30%, while medical benefit drugs like getetelicib might have a gross to net discount of around 20%. Research is ongoing, and we haven't finalized our pricing strategy yet, but for estimating the addressable market, we think it makes sense to reference the numbers I mentioned.

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 getetelicib to patients outside the US? Thanks.

Sure. We've discussed in other calls, and at least we've mentioned that we expect to commercialize in the US and find partners to commercialize the drug outside the US. We are holding off on finalizing intense discussions until we have our mutant data available. Coinciding with the submission of the sNDA for the mutant population, should things go 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’re working with the Japanese Health Authority to determine their submission requirements, and we believe we are aligned on an approach. We will move forward on this regulatory path to ensure rapid commercialization. We expect to start engaging in discussions around this mid next year, once our data is available, and regulatory submissions are underway.

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 getetelicib for endocrine-resistant frontline before the VICTORIA-one readout. I'm curious if your thinking around the frontline population to be enrolled has changed at all now that you have phase three data from the wild-type population, and assuming you have KOL feedback and investor feedback. What is your philosophical view around the need to conduct endocrine-sensitive trials in the frontline setting? Thank you.

Thank you for the question. We believe there is an important opportunity to help patients delay their progression for longer than is possible with the current CDK4/6 letrozole regimens. We base that view on the data we obtained in our phase Ib study in treatment-naive, endocrine-sensitive patients where standard of care CDK4/6, letrozole regimens provide approximately 25 months of median PFS, while in our Phase Ib study we reported about 48 months of median PFS. This suggests compelling preliminary evidence that this pathway is a significant driver in treatment-naive hormone receptor-positive breast cancer. This aligns with our hypothesis and demonstrates that the PAM pathway is one of three essential driver pathways promoting breast cancer. We believe there is a strong rationale to develop this drug for that population, although it may involve a long study length given potential progression-free survival for both the control and study arms. We are keen on being thoughtful about how to design the study moving forward, especially in light of current results from wild-type patients. Endocrine-resistant patients represent about two-thirds of women who are treatment-naive in the metastatic setting, making it an important population for our development efforts. We will provide updates as we continue to formulate our approach.

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

Thanks for taking my question. I'm curious if you can speak to the potential impact of a favorable overall survival trend in the second and third-line setting. Additionally, if you can discuss the interim OS data so far, what role might these data play in the regulatory process?

Sure. In conjunction with the primary analysis, our statistics plan typically includes an interim OS analysis to determine any potential impact on overall survival for these patients. The regulatory requirement is that we do not demonstrate a reduction in a patient's likelihood of survival, meaning we need a hazard ratio below one. For our study's interim analysis, we achieved a hazard ratio of about 0.69 for the triplet and a similar value for the doublet, which we believe suggests a favorable trend and supports our submission for drug approval. The impact of a positive overall survival readout is certainly substantial, but it's a high bar to meet—especially given the heterogeneous nature of patients and downstream therapies received. Our study size has a relatively small number of events that characterize what can be only a specific effect size, so it's something we look forward to reporting, but it will be challenging.

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 provides flexibility in manufacturing locations. We have not announced where the drug is specifically being manufactured, but we are taking steps to ensure that our supply chain is as robust as possible.

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.

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