Earnings Call Transcript - CELC Q4 2025

Operator, Operator

Good afternoon, ladies and gentlemen, and welcome to the Celcuity Fourth Quarter and Full Year 2025 Financial Call. I would now like to turn the conference over to Jodi Sievers, Corporate Communications and Investor Relations at Celcuity. Please go ahead.

Jodi Sievers, Corporate Communications and Investor Relations

Thank you, John, and good afternoon, everyone. Thank you for joining us to review Celcuity's Fourth Quarter and Full Year 2025 Financial Results and Business Update. Earlier today, Celcuity Inc. released financial results for the fourth quarter and full year ended December 31, 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; and Eldon Mayer, Chief Commercial 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 may 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 financial measures in today's press release. And with that, I would like to turn the call over to Brian Sullivan, CEO of Celcuity. Please go ahead.

Brian Sullivan, CEO

Thank you, Jodi, and good afternoon, everyone. I appreciate you joining our fourth quarter and full year 2025 operating and financial update conference call. The past year has set the stage for what we anticipate will be a transformative year for Celcuity as we prepare for the potential approval and commercialization of gedatolisib. In 2025, we made significant strides, reaching multiple clinical and regulatory milestones while enhancing our balance sheet. These accomplishments and the groundbreaking data reported thus far are crucial to our objective of establishing gedatolisib as a new standard of care therapy for patients with HR-positive/HER2-negative advanced breast cancer. Recent key clinical and regulatory milestones include the FDA's acceptance of our new drug application, or NDA, which has been granted priority review with a PDUFA goal date of July 17, 2026. This NDA was submitted under the FDA's real-time oncology review program for drugs that provide substantial improvements over existing therapies. Given the unprecedented efficacy data from the PIK3CA wild-type cohort of the Phase III VIKTORIA-1 trial, we are optimistic about the FDA's review outcome. Additionally, these data were presented at a late-breaking oral presentation at the European Society for Medical Oncology and San Antonio Breast Cancer Symposium in December, and they were more recently published in a peer-reviewed manuscript in the Journal of Clinical Oncology. Furthermore, we successfully completed enrollment of the PIK3CA mutant cohort of our Phase III VIKTORIA-1 trial late last year. Reporting results from this cohort of the Phase III trial represents another crucial milestone for Celcuity, with an expectation to announce results in a top-line press release in the second quarter and present full results at a medical conference in 2026, at which we plan to host an investor call. Due to the proximity of this disclosure, we will refrain from answering questions about trial progress or providing additional guidance on expectations for the PIK3CA mutant cohort results during the Q&A portion of our call. We've previously highlighted the historic nature of the results from the PIK3CA wild-type cohort of the VIKTORIA-1 trial and their achievement of new milestones in HR-positive/HER2-negative advanced breast cancer. To summarize, the median progression-free survival, or PFS, for the gedatolisib triplet—consisting of gedatolisib, palbociclib, and fulvestrant—was 9.3 months compared to only 2 months for fulvestrant, with a hazard ratio of 0.24. Overall, these results set new benchmarks for clinical trials in this disease setting. Notably, the hazard ratio for the gedatolisib triplet is more favorable than any previously reported in Phase III trials for HR-positive/HER2-negative advanced breast cancer patients. Additionally, the 7.3 months improvement in median PFS for the gedatolisib triplet over fulvestrant surpasses any reported Phase III trial for patients with HR-positive/HER2-negative advanced breast cancer receiving at least their second line of treatment, including endocrine therapy. Gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR pathway to show positive Phase III results in HER2-positive, HER2-negative PIK3CA wild-type advanced breast cancer patients whose disease progressed after treatment with a CDK4/6 inhibitor. Furthermore, the 17.5 months median duration of response and 31% increase in the objective response rate relative to the control for the gedatolisib triplet are the highest reported for an endocrine therapy regimen in second-line HR-positive HER2-negative advanced breast cancer. The results also indicated that the clinical benefit of the gedatolisib triplet was consistent across all patient subgroups. Notably, patients enrolled in the U.S. or Canada achieved a median PFS of 19.3 months for the gedatolisib triplet compared to 2 months for fulvestrant, resulting in a hazard ratio of 0.13. A further analysis including patients from the U.S., Canada, Western Europe, and Asia Pacific—representing nearly 60% of those enrolled—showed a median PFS of 16.6 months with the gedatolisib triplet versus 1.9 months for fulvestrant, leading to a hazard ratio of 0.14. Safety results indicated that the gedatolisib triplet was generally well tolerated, with mostly low-grade adverse events reported. Only 2.3% of patients on the gedatolisib triplet discontinued treatment due to treatment-related adverse events. In December, we shared additional safety analyses during an oral presentation at the San Antonio Breast Cancer Symposium. For patients who experienced stomatitis, our measures to mitigate it were generally effective, with median improvement times reported for Grade 2 or 3 stomatitis. We also found that gedatolisib did not lead to substantial changes in patient glucose levels, unlike other approved drugs targeting PI3K-alpha, and did not cause clinically relevant hypoglycemia, requiring no dose reductions or withdrawals for this reason. Patient-reported outcomes that capture overall well-being were also assessed, revealing that for the gedatolisib triplet, the median time to definitive deterioration was 23.7 months compared to 4 months for fulvestrant, with a hazard ratio of 0.39. Throughout the first eight cycles of treatment, patient assessments of their well-being remained stable compared to their assessments before starting treatment. Based on these findings, we believe there is meaningful evidence that patients treated with gedatolisib tolerated it well. Now, regarding our VIKTORIA-2 study, a Phase III clinical trial evaluating gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR-positive/HER2-negative advanced breast cancer patients who are resistant to endocrine therapy, we are finalizing the safety run-in and expect to share an update on our final Phase III study design in the second quarter. We are optimistic that the positive results from the PIK3CA wild-type cohort of our VIKTORIA-1 study bode well for the potential efficacy of the gedatolisib triplet in this patient population. Additionally, we are conducting a Phase Ib/II clinical trial evaluating gedatolisib together with darolutamide, an androgen receptor inhibitor, in men with metastatic castration-resistant prostate cancer. Detailed data from the Phase Ib portion of this study were presented at ESMO. In this segment of the trial, 38 patients received standard doses of darolutamide alongside either 120 milligrams of gedatolisib or 180 milligrams of gedatolisib. The combined 6-month radiographic PFS rate was 67%, with a median rPFS of 9.1 months across both arms, which compares favorably to historical results showing a 40% 6-month rPFS survival rate for similar patients treated with second-line androgen receptor inhibitors. The combination of gedatolisib and darolutamide was generally well tolerated, with primarily low-grade treatment-related adverse events. There were no dose-limiting toxicities and no discontinuations due to adverse events. We are continuing to enroll patients in the dose escalation portion of the trial to assess higher doses of gedatolisib and determine the recommended Phase II dose. As we approach a hopeful FDA approval for gedatolisib in 2026, we are enhancing our preparations for a potential launch according to our strategic launch plan. We began laying the groundwork for this launch nearly 2 years ago and have made considerable progress in building the organization, including our sales force and the necessary internal systems to function as a commercial-stage company. We are fortunate to have attracted a talented team with strong experience in successfully launching novel oncology therapeutics. Our current efforts include extensive outreach to payers, strategic accounts, and population health decision-makers across various treatment settings, including health systems, integrated delivery networks, and community oncology practices. Each of these groups is expected to play a critical role in ensuring oncologists can access gedatolisib for their patients. We are encouraged by our progress in engaging decision-makers and the positive feedback we have received. Additionally, we are buoyed by research indicating the willingness of community and academic oncologists to prescribe gedatolisib upon approval. These results give us hope for 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. Should we report positive results for patients with PIK3CA mutations, the gedatolisib triplet will be uniquely positioned to provide second-line therapy regardless of PIK3CA mutation status. Based on published epidemiological data, we estimate around 37,000 patients in the U.S. with HR-positive/HER2-negative advanced breast cancer have progressed after treatment with a CDK4/6 inhibitor. Internal analyses of treatment duration estimates and pricing assumptions suggest the total addressable market for gedatolisib in the second-line setting is over $5 billion. Given the strong penetration we anticipate achieving, we believe it is reasonable to estimate that a second-line indication for gedatolisib could potentially generate peak revenue of up to $2.5 billion annually. We are excited about the opportunities approaching a potential launch and the prospects for multiple potentially blockbuster indications in breast and prostate cancer, all while aggressively preparing for the commercial launch of gedatolisib should we secure FDA approval. Gedatolisib is poised to meet critical needs in the second-line space with its unique mechanism of action and promising safety and efficacy profile. Now, I will turn the call over to Vicky for a review of our finances.

Operator, Operator

It seems like we lost Vicky.

Brian Sullivan, CEO

Well if Vicky is having trouble connecting, I can review the remarks that she was prepared to give. Operator, is she no longer on the line?

Operator, Operator

Yes. She's reconnecting right now.

Brian Sullivan, CEO

Well, why don't I continue...

Vicky Hahne, CFO

Yes. Well, good afternoon, everyone. I will provide a brief overview of our financial results for the fourth quarter and full year 2025. Our fourth quarter net loss was $51 million or $0.97 per share compared to $36.7 million net loss, or $0.85 per share, for the fourth quarter of 2024. Net loss for the full year was $177 million, or $3.79 per share, compared to $111.8 million, or $2.83 per share, compared to the same period in 2024. Our non-GAAP adjusted net loss was $38.4 million, or $0.73 per share for the fourth quarter of 2025 compared to non-GAAP adjusted net loss of $32.3 million, or $0.75 per share, for the fourth quarter of 2024. Non-GAAP adjusted net loss for the full year of 2025 was $150.8 million, or $3.22 per share, compared to non-GAAP adjusted net loss of $101.9 million or $2.58 per share for 2024. Research and development expenses were $37.6 million for the fourth quarter of 2025, compared to $33.5 million for the prior year period. Of the $4.1 million increase in R&D expenses, $8.6 million was related to increased employee and consulting expenses, of which $5.3 million related to commercial headcount additions and other launch-related activities. These amounts were partially offset by a $4.5 million decrease primarily related to costs supporting ongoing activities for the VIKTORIA-1 Phase III trial. R&D expenses for the full year 2025 were $145 million compared to $104.2 million for the prior year. Of the approximately $40.8 million increase in R&D expenses, $26.7 million was related to increased employee and consulting expenses, of which $13.1 million related to commercial headcount additions and other launch-related activities. The remaining $14.1 million increase was primarily related to activities supporting our ongoing clinical trials, a development milestone payment under the license agreement with Pfizer and other commercial launch-related activities. General and administrative expenses were $11.6 million for the fourth quarter of 2025 compared to $3 million for the prior year period. Of the approximately $8.6 million increase in G&A expenses, $6.9 million was related to increased employee and consulting expenses, of which $5.4 million related to non-cash stock-based compensation. The remaining $1.7 million increase was primarily related to professional fees, expanding infrastructure costs and other administrative expenses. G&A expenses for the full year 2025 were $27.2 million compared to $9.1 million for the prior year. Of the $18.1 million increase in G&A expenses, $14.9 million was related to increased employee-related and consulting expenses, of which $10.4 million related to non-cash stock-based compensation. The remaining $3.2 million increase was primarily related to professional fees, expanding infrastructure costs and other administrative expenses. Net cash used in operating activities for the fourth quarter of 2025 was $36.4 million compared to $27.8 million for the fourth quarter of 2024. Net cash used in operating activities for the full year 2025 was $153.3 million compared to $83.5 million for the full year 2024. Cash, cash equivalents and short-term investments were $441.5 million at the end of fiscal year 2025 and are expected to finance our operations through 2027. I will now hand the call back to Jodi.

Jodi Sievers, Corporate Communications and Investor Relations

Thanks, Vicky. Before we turn the call over to the operator for questions, I'll remind you, we will not be answering questions related to the progress or status of the mutant cohort of the VIKTORIA-1 study or providing any additional guidance on our expectations for data at this time. John, could you please open the call for questions?

Operator, Operator

Our first question comes from Maury Raycroft from Jefferies.

Maurice Raycroft, Analyst

Congratulations on the progress. I’m curious if you can provide an update on whether the database lock for the mutant data is already in place.

Brian Sullivan, CEO

No, I can't comment on that.

Maurice Raycroft, Analyst

Okay. Understood. And I know you've already commented on this in the past, too, but if you could just recap how the disclosure is going to take place and what exactly you'll share in the readout?

Brian Sullivan, CEO

Well, as I indicated, we'll provide top line data in a press release, and then we will provide details at an upcoming medical conference.

Maurice Raycroft, Analyst

Got it. Okay. And then when thinking about when we could see more details at a medical conference, can you say if that's going to be like relatively soon? Or is it more likely going to be a second half update?

Brian Sullivan, CEO

I think you'll just have to wait and see, Maury. Sorry, I can't provide any more details.

Operator, Operator

Your next question comes from the line of Tara Bancroft from TD Cowen.

Tara Bancroft, Analyst

So I guess I'll shift to maybe a question on the launch. I was hoping maybe you could give us some feedback of what you're hearing from physicians on which segments may be treated immediately upon the wild-type approval and which ones may be more gradual? Just to get an idea of how you're planning ahead for cadence once you receive approval?

Brian Sullivan, CEO

Thanks. No. So as we launch, we aren't going to be targeting or narrow casting our approach to doctors or patient segments. We believe gedatolisib regimens offer an opportunity to get the best option relative to what's available today. And so we would expect our sales force upon approval, assuming that occurs, to reach out generally to doctors and essentially help them understand how gedatolisib and the data can offer, again, what we believe is an improvement in the alternatives that are currently available.

Tara Bancroft, Analyst

Okay. Great. And I guess in that feedback that you are hearing in these discussions with physicians, do you think or have any inkling whether they would be willing to potentially use it off-label in mutants ahead of a potential mutant approval if the data are positive?

Brian Sullivan, CEO

Yes. That's just not something that we have any conversations with doctors about.

Operator, Operator

Your next question comes from the line of Stephen Willey from Stifel.

Stephen Willey, Analyst

Sorry to badger you, Brian, on the top line release of the mean data. But just curious if that will include any details just with respect to headline PFS numbers and risk reduction? Or would this just simply be a statement regarding the achievement of stat sig?

Brian Sullivan, CEO

It will be the latter. We're mindful of the embargo requirements that we need to follow in order to be able to present at one of these medical conferences.

Stephen Willey, Analyst

Okay. Regarding prostate, I'm curious how high you believe you can increase the dose beyond the 180 mg used in the VIKTORIA trial. Also, what safety and tolerability considerations will you take into account when determining a recommended Phase II dose? Are there any efficacy metrics that will be prioritized? You've shared the radiographic PFS data, but I'd like to know how factors like PSA response and RECIST response for patients with measurable lesions will influence dose nomination.

Brian Sullivan, CEO

Sure. Well, just to recap relative to what we announced previously, we were pleasantly surprised by the safety profile that the 180-milligram dose reported. No dose-limiting toxicities, very limited Grade 3 adverse events. Hypoglycemia was consistent with our breast cancer. Stomatitis was significantly less frequent at that dose in these men. And so that's what led us to decide to increase the dose or rather to evaluate higher doses. And essentially, we're using some standard methodology to stepwise increase the dose and basically depending on achievement or levels of dose-limiting toxicities, we'll keep going. But we're in the midst of that. So I can't really comment on where we'll end up. But again, it's always a balance. We can't sacrifice tolerability to such an extent that it's self-defeating. But to the extent that we believe there's a dose response that would lead to improved response at higher doses, we want to explore where that might take us. And so we would expect to have some look at that data by the end of this year, sometime early next year.

Stephen Willey, Analyst

Okay. That's helpful. And then maybe just lastly, with respect to breast, I appreciate some of the color around kind of peak revenue opportunity here in the second-line setting. I think you mentioned just kind of using historical pricing and duration of therapy. Obviously, the pricing is kind of readily available. But what's the duration of therapy estimate that you're using to inform the peak numbers that you mentioned?

Brian Sullivan, CEO

If you take a round number of 10 months, that is not a projection but an assumption to guide an estimate, which aligns with how we are modeling the market.

Operator, Operator

Our next question comes from the line of Josh Boen from Guggenheim.

Josh Boen, Analyst

This is Josh on for Brad. Just wanted to know, with most of the commercial build complete for second line, what is the key gating factor in getting the frontline endocrine-sensitive trial up and running?

Brian Sullivan, CEO

Key gating factor is just completing the safety run-in. And just to look back a little bit, we were evaluating gedatolisib in combination with ribociclib as a potential CDK4/6 option for doctors to use in the treatment arm. And because we haven't evaluated gedatolisib with ribociclib before, we needed to evaluate it in a sufficient number of patients to make a decision about dosing and how to move forward. And so that's wrapping up. And based on those results, we'll update the study design accordingly, and we expect to kind of provide an update on the study design in the second quarter and proceed apace to begin enrolling for the Phase III study.

Operator, Operator

Our next question comes from the line of Gil Blum from Needham & Company.

Gil Blum, Analyst

I'll try to keep this brief. So a commercial question that we've gotten a couple of times is surrounding potential challenges in getting patients to come in for infusions. Can you discuss a bit how you plan to avoid these kinds of challenges? Or are they actually challenges?

Brian Sullivan, CEO

Thank you for the question. We've received inquiries about this from investors. We have conducted several rounds of market research where we engage with doctors both qualitatively through conversations and quantitatively with a structured approach where doctors review information we provide. This allows us to understand how they interpret the data, compare it to other available treatments, identify factors they view positively or negatively, and assess their levels of neutrality on various factors. One key finding from this research is that efficacy is the most crucial factor for doctors when assessing treatment options. Additionally, concerns about IV administration appear in fewer than 10% of our research responses. We also conduct research with patients, mainly through qualitative methods. In cases where geographical limitations may affect patients' ability to access treatment, we may see some pushback, but overall we do not expect significant resistance to IV administration. Conversations with patients suggest that many women prioritize their responsibility to their families, valuing the opportunity to use the best possible treatments. Overall, this reinforces our belief that in serious conditions like metastatic breast cancer, efficacy and tolerability will guide both physician and patient preferences for therapy. Feedback on these aspects has been very positive. Regarding the route of administration, we believe it will only be a significant concern for a small number of patients, and we do not anticipate it will hinder physicians' willingness to prescribe the therapy.

Gil Blum, Analyst

And maybe as a follow-up, can you help us understand the commercial advantages of having gedatolisib label across metastatic breast cancer subtypes?

Brian Sullivan, CEO

Sure. Well, as anybody that's followed this space knows one word that gets used to describe the landscape is it's very complex, a lot of activity. And so what we hope to be able to provide and the way we expect to position the drug is that we can simplify the decision-making process for these physicians by giving them an option that we believe for any patient subgroup that they may be treating the best potential risk/benefit relative to the alternatives. Now it doesn't mean there aren't available options that some doctors may select or prefer in certain patient segments. But we think overall, we'll be in a very strong position by being able to offer essentially a biomarker-agnostic alternative that doesn't require them to evaluate some complex decision-making around biomarker subgroups. And we think ultimately, that hitting the easy button, which isn't to diminish the importance of the decision for the doctors. But particularly in the community setting, the challenges of keeping up with the alternatives can make it difficult for them to make the right decisions in some cases. And so to the extent we can leverage the data that we a, have now and we hope to have with the mutant setting, we think that will be a very significant advantage.

Operator, Operator

Our next question comes from Oliver McCammon from LifeSci Capital.

Oliver McCammon, Analyst

So switching gears a little bit. We're roughly 1.5 years into the launch of inavolisib for the PIK3CA mutant endocrine therapy resistant setting. I'm curious if there are any learnings from the launch, label and/or KOL feedback that you think are supportive of the positioning of gedatolisib in the VIKTORIA-2 trial.

Brian Sullivan, CEO

Thank you. So they reported very good data. And unfortunately, though, the patient population that really is appropriate to treat with that drug is fairly limited. The study only enrolled patients who essentially were metabolically healthy, patients who had an HbA1C level below 6 and essentially ruling out patients that were either prediabetic or diabetic type 2 diabetes. And there's since been several dear doctor letters for very significant adverse events that have been reported. And the label requires fairly extensive glucose monitoring, both by the physician as well as the patient while they're at home. And so overall, just based on our assessment of the claims data, it appears those restrictions are having an impact on the usage in the clinic to date. So from a learning standpoint for us, I mean, it essentially highlights just how unique a drug gedatolisib is, a, we're addressing this pathway. But more importantly or rather very importantly, we're not inducing the levels of glycemic system disruption that can lead to hypoglycemia that requires significant management or any management at all actually. And we do not believe that patients who are prediabetic or type 2 diabetes will be restricted in their ability to receive treatment with gedatolisib. And so it really goes back to the drug and the overall safety profile. And when you don't have a safety profile like gedatolisib when you hit this pathway, you run into challenges and really being able to treat a broad group of patients or to treat patients in a way that does create some potentially significant adverse event risks.

Oliver McCammon, Analyst

Very helpful. And just one sort of frontline follow-up. Given the persevERA results we saw recently, your prior Phase Ib data that you've shared in frontline patients as well as the number of oral PI3K inhibitors looking at the frontline setting, I'm curious what your level of interest is in a frontline endocrine-sensitive study.

Brian Sullivan, CEO

Well, it would be very logical given the very favorable data that we've reported in that setting in our Phase Ib study. And just as a reminder to folks, in that study, sample size of 41 we reported median PFS of over 48 months and an objective response rate of 79% with gedatolisib combined with palbociclib and letrozole. So those really compare very favorably to what's been published to date for the currently approved therapies. So I think there's a very strong case to be made for us in conducting a study in that space, and we will keep people posted on our thinking.

Operator, Operator

Our next question comes from the line of Eva Fortea from Wells Fargo.

Eva Fortea-Verdejo, Analyst

A quick one from us. Do you have any updated thoughts on the European commercial strategy for gedatolisib in terms of like timing for a potential update or approach to partnering? Or how do you expect EU to sequence versus the U.S.

Brian Sullivan, CEO

Sure. Our current plan, if everything goes well, is that if we receive a positive result with our mutant cohort, we will proceed with a supplemental NDA after getting initial approval for gedatolisib. Once that sNDA package is completed, we will use the documentation, mostly from both the wild-type and mutant data sets, along with the NDA modules, to create an MAA submission in the fourth quarter of this year. This process will take about 13 months for a standard review, but we may look for acceleration. During this time, after our submission, we will have the opportunity to explore partnerships for launching not only in Europe but potentially worldwide. We are also in discussions with regulators in Japan to establish the regulatory path for submission there, and we believe we are reaching an understanding on that front. Even though we have not yet secured a partner, we are actively moving forward with regulatory preparations in the major five European countries and Japan. This timeline will allow us to find the right partner while ensuring that we can effectively launch gedatolisib in these markets.

Operator, Operator

Our next question comes from the line of Kalpit Patel from Wolfe Research.

Kalpit Patel, Analyst

One from us on the mutant update. Do you need to hit both the doublet and triplet arms to file later in the year? Or can you file on a successful hit on triplet alone?

Brian Sullivan, CEO

Well, without getting into any more detail, just limit it to the study design. The study design primary endpoint is a comparison of the triplet to alpelisib. And so that is the primary endpoint and that would form the basis for any potential regulatory submission. The analysis comparing the doublet to alpelisib is an exploratory analysis or secondary analysis.

Operator, Operator

Our next question comes from the line of Chase Knickerbocker from Craig-Hallum.

Chase Knickerbocker, Analyst

We'll be curious what you and your market access team have heard in your early prelaunch discussions with payers on a number of items around the profile of gedatolisib in wild type. Maybe kind of foremost amongst them, how that's solidified or altered any of your thoughts around potential pricing?

Brian Sullivan, CEO

I guess just the overall reception to information that we've shared with payers and strategic accounts, which we're able to do on a safe harbor basis since they're not health care providers has been very, very positive. I think it's interesting to get the feedback they provide. They're in the business of helping ensure the individuals who they are insuring have access to therapies or ultimately responsible for treating and have access to the right therapies. And so we've been very pleased with how they've reacted to the data and their collaboration is how I would say it, in working with us to lay the groundwork to ensure that as early as practically possible geda rather patients would have access to this drug and the regimen.

Chase Knickerbocker, Analyst

Maybe just as a follow-up around the competitive environment. And we saw recently another acquisition of a mutant selective PI3K alpha inhibitor. Can you just refresh us on your thoughts on the potential future competition for you from that angle? And then just kind of generally on kind of the next-generation assets coming up in competition here?

Brian Sullivan, CEO

Thank you for the question. Since alpelisib was approved about seven years ago, several companies have attempted to develop alternatives that could be safer than alpelisib, which is an important endeavor. However, we believe the biological assumptions driving those projects may not be accurate. Our approach with gedatolisib, which inhibits all Class I PI3K isoforms along with mTORC1 and 2, is essential for maximizing antitumor control. We believe there is a biological limit to the benefits a single-target inhibitor, like a PI3K-alpha inhibitor, can achieve. More options, as we have seen with SERDs, do not necessarily lead to different outcomes, as demonstrated by five Phase III trials yielding very similar results. In this context, it is reasonable to expect that the new drugs targeting the mutant and wild-type forms of PI3K alpha may improve the safety profile compared to alpelisib. However, we anticipate a limited biological capacity to achieve optimal efficacy. The results we have seen so far from gedatolisib underscore the significance of comprehensive pathway inhibition over selective inhibition. Regarding the impact on us, we believe our targeting approach may become obsolete if the forthcoming data aligns with our expectations.

Operator, Operator

There are no further questions at this time. I will now turn the call over to Brian Sullivan, Celcuity's Chief Executive Officer, for closing remarks. Sir, please go ahead.

Brian Sullivan, CEO

Well, thank you for participating in our call today, for your ongoing support and look forward to reporting back to you soon. Take care.

Operator, Operator

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