Celcuity Inc. (CELC) 2025 Q4 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the Celcuity fourth-quarter and full year 2025 financial call. (Operator Instructions)

I would now like to turn the conference over to Jodi Sievers, Corporate Communications and Investor Relations at Celcuity. Please go ahead.

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; Vicki 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.

Thank you, Jodi. Good afternoon, everyone, and thank you for joining our fourth-quarter and full year 2025 operating and financial update conference call.

The past year has laid the groundwork for what we expect to be a transformative year for Celcuity as we prepare for the potential approval and commercialization of gedatolisib. In 2025, we made remarkable progress, achieving a number of clinical and regulatory milestones while also significantly bolstering our balance sheet. These achievements and the groundbreaking data reported to date are foundational to our goal of establishing gedatolisib as a new standard of care therapy for patients with HR-positive PER2 negative advanced breast cancer.

Among the key clinical and regulatory milestones achieved recently, include: first, the FDA accepted our new drug application, or NDA, granted it priority review with a Prescription Drug User Fee Act, or PDUFA, goal date of July 17, 2026.

The NDA was submitted under the FDA's real-time oncology review program, which is utilized for drugs offering substantial improvements over available therapies in light of the unprecedented efficacy data from the PIK3CA wild-type cohort of the Phase 3 VICTORIA-1 clinical trial. We're optimistic about the outcome of the FDA's review of our NDA.

Second, 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. More recently, these data were published a few weeks ago in a peer-reviewed manuscript in the Journal of Clinical Oncology.

And third, we completed enrollment of the PIK3CA mutant cohort of our Phase 3 VICTORIA-I trial late last year, reporting results from this cohort of this Phase 3 trial will be another incredibly important milestone for Celcuity. We expect to announce these results in our top-line press release in the second quarter and to present full results at a medical conference in 2026, where we also intend to host an investor call.

Given how close we are to this disclosure, we will not be answering questions about trial progress or offering additional guidance on expectations for the results of the PIK3CA mutant cohort during the Q&A portion of our call. We've discussed previously the historic nature of the results from the PIK3CA wild-type cohort of the VICTORIA-1 trial and the new milestones they achieved in HR+ HER2-negative advanced breast cancer.

And just to recap, median progression-free survival, or PFS, for the gedatolisb triplet, palbociclib and fulvestrant was 9.3 months compared to only two months for fulvestrant and hazard ratio was 0.24. Overall, these results set several new benchmarks for clinical trials evaluating patients in this disease setting.

First, the hazard ratio for the gedatolisb triplet is more favorable than has ever been reported by any Phase 3 trial for patients with HR-positive HER2-negative advanced breast cancer.

And second, the 7.3 months incremental improvement in median PFS for the gedatolisb over fulvestrant is higher than has ever been reported by any Phase 3 trial for patients with HR-positive, HER2-negative advanced breast cancer, receiving at least their second line of a regimen, including an androgen therapy.

And third, gedatolisb is the first inhibitor targeting the PI3K-AKT-mTOR pathway to demonstrate positive Phase 3 results in patients with HER2-positive HER2-negative, PIK3CA wild-type advanced breast cancer, which disease progressed on or after treatment with a CDK4/6 inhibitor.

And fourth, the 17.5 months of median duration of response and the 31% incremental increase in the objective response rate relative to control for the fulvestrant triplet or the gedatolisb triplet are the highest reported for an endocrine therapy-based regimen in second-line HR-positive, HER2-negative advanced breast cancer.

Additionally, the results demonstrated that the clinical benefit of the gedatolisb triplet was consistent across all patient subgroups. One patient subgroup of note, patients enrolled in the United States or Canada achieved median PFS of 19.3 months to gedatolisb triplet versus 2 months for fulvestrant, which resulted in a hazard ratio of 0.13.

Further analysis that included patients enrolled in the US, Canada, Western Europe and Asia Pacific, representing nearly 60% of those enrolled found that median PFS was 16.6 months, with a gedatolisb triplet versus 1.9 months for fulvestrant, which resulted in a hazard ratio relative to fulvestrant of 0.14.

Safety results showed that gedatolisib triplet is generally well tolerated in the trial with mostly low-grade adverse events. Study treatment discontinuation due to treatment-related adverse events was reported to 2.3 of patients treated with gedatolisib triple.

In December, we presented additional safety analysis in an oral presentation at the San Antonio Breast Cancer Symposium. For patients who experience stomatitis, we reported that measures to mitigate it were generally effective in median time to improvement from first onset to a lower grade of stomatitis for patients with Grade 2 or 3 stomatitis who received the gedatolisib triplet was 12 and 14 days, respectively.

We also reported that gedatolisb did not induce meaningful changes in patient glucose levels, unlike other approved drugs targeting PI3K alpha, Gedatolisb, did not induce clinically relevant hypoglycemia and required no dose reductions or withdrawals due to hypoglycemia. To characterize the tolerability of the gedatolisib regimens, we also reported results from patient-reported outcomes to capture a patient's perception of their overall well-being.

And these measures include a patient's assessment of their mobility, ability to care for themselves, ability to conduct their usual activities, their pain or discomfort and anxiety depression. The result of these assessments is then summarized as the patient's time to definitive deterioration and changes in well-being relative to the measures we reported prior to the patients starting treatment on the trial.

For the gedatolisib triplet, the median time to definitive deterioration was 23.7 months versus four months of fulvestrant with a hazard ratio of 0.39.

Additionally, for the first eight cycles of treatment, patient's assessment of their well-being remained stable relative to their assessment prior to starting treatment with gedatolisib. And based on these assessments, we believe this provides meaningful evidence that patients treated with gedatolisib tolerated it well.

And let's turn now to our VICTORIA-2 study, which is a Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor, fulvestrant as first-line treatment for patients with HR+ HER2-negative advanced breast cancer or endocrine therapy resistant. We're wrapping up the safety run-in, and we expect to provide an update on our final Phase 3 study design in the second quarter. We believe the positive results from the PIK3CA wild type cohort of our VICTORIA-1 study augurs well for the potential efficacy of gedatolisib triplet may induce in this patient population.

Now let's turn now to our Phase 2b/2 clinical trial that is evaluating gedatolisib in combination with darolutamide in androgen -- receptor inhibitor we're evaluating this in men with metastatic castration-resistant prostate cancer. We present a detailed data for the Phase 1b portion of the study at a poster presentation at ESMO.

And in this portion of the Phase 1b/2 study, 38 patients were randomly assigned to receive standard doses of darolutamide twice daily in either 120 milligrams of gedatolisib in Arm 1 or 180 milligrams of gedatolisib in Arm 2. The six-month radiographic PFS or rPFS raised was 67% and the median rPFS for patients was 9.1 months both arms combined.

And these results compare favorably to historical results of a 40% six-month rPFS survival rate for patients with metastatic, castration-resistant prostate cancer who were treated with an androgen receptor inhibitor of second-line treatment. The combination of gedatolisib and darolutamide was generally well tolerated in the trial with mostly low-grade treatment-related adverse events. No dose-limiting toxicities were observed in either arm and no patients discontinued study treatment due to an adverse event.

We're continuing to enroll patients in the dose escalation portion of the trial to evaluate higher doses of gedatolisib to determine the recommended Phase 2 dose.

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 continue to ramp up for our strategic launch plan. we began laying the groundwork for a potential gedatolisib launch nearly two years ago. And we've since largely completed building the organization, including our sales force and internal systems required to operate as a commercial stage company.

We're very fortunate to have attracted an incredibly talented group of individuals with strong track records of successfully launching novel oncology therapeutics. Key efforts today include extensive outreach across the country to payers strategic accounts and population health decision-makers in various treatment settings, including health systems, integrated delivery networks and community oncology practices.

Each of these groups are expected to 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 the enthusiastic response. These efforts have yielded.

We're also very encouraged by the results of research we 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 a 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.

In February, we report positive results from our study with patients whose tumors have PIK3CA mutations. The gedatolisib triplet will be uniquely positioned to provide second-line therapy for patients regardless of the PIK3CA mutation status. Based on analysis of published epidemiological data, we estimate there are approximately 37,000 patients in the US with HR-positive HER2-negative advanced breast cancer.

We've progressed after treatment as a CDK4/6 inhibitor and using internal duration of treatment estimates and pricing assumptions consistent with currently available novel therapeutic for breast cancer, we estimate the total addressable market for gedatolisib in the second-line setting is more than $5 billion. And given the significant penetration, our research is suggesting we can achieve, we believe it is reasonable to estimate that a second-line indication for gedatolisib can potentially generate peak revenue of up to $2.5 billion annually.

We're excited about the opportunity now that we're approaching potential launch to advance multiple potential blockbuster indications over the years in breast and prostate cancer, while also aggressively preparing for potentially launch of gedatolisib commercially, should we receive an 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 now to hand the call over to Vicky to review our finances.

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

Yes. She's reconnecting right now.

Well, why don't I continue?

Brian, I apologize, I think I'm back on.

Okay.

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 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 VICTORIA-1 Phase 3 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 noncash 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 noncash 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 Jody.

Thanks, Vicki. 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 VICTORIA-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 Instructions) Maury Raycroft, Jefferies.

Congrats on the progress. Not sure if this fits within your criteria or not for a status update. But wondering if for the immune data, if you could say if the database lock is already in place, that's something you can comment on?

No, I can't comment on that.

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?

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.

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?

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

Understood. Okay. Those were the questions.

Tara Bancroft, TD Cowen.

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.

So as we launch, we aren't going to be targeting or narrow casting our approach to doctors or patient segments. We believe gedatolisib regiments 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 retail 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.

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

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

(Operator Instructions) Stephen Willey, Stifel.

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

It will be the latter. I mean, we're mindful of embargo requirements to -- that we need to adhere to in order to be in a position to have podium presentation at one of these medical conferences.

Okay. And then maybe just a question on prostate and then maybe just a quick one on on the second-line breast opportunity that you spoke to. So in prostate, just curious how high you think you can push dose kind of north of the 180 mg that is used in the VICTORIA trial.

And then just curious, what metrics -- I mean, obviously, there's a balance of safety and tolerability you need to consider in terms of nominating a recommended Phase 2 dose. But are there any efficacy metrics that you're going to be prioritizing? I know you've shown us the radiographic PFS data, but just curious how things like PSA response maybe even a (inaudible) response for those patients with measurable lesions, how that kind of factors into [dose denomination].

Sure. Well, just to recap relative to what we announced previously, we were pleasantly surprised by the safety profile of 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 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 or sometime early next year.

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?

If you just use a round number that of 10 months, and again, that's not a projection, that's just an assumption to drive an estimate. You would be consistent with how we're modeling the market.

Josh Bowen, Guggenheim.

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 front-line endocrine-sensitive trial up and running.

Key gating factor is just completing the safety run and just to look back a little bit, we were evaluating, geda in combination with ravaciclib as a potential CDK4/6 option for doctors to use in the treatment arm. And because we haven't evaluated with geda with revaciclib 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, that we'll update study design accordingly, and we expect to kind of provide an update on the study design in the second quarter and proceed a pace to begin enrolling the Phase 3 study.

Gil Blum, Needham & Company.

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 kind of challenges? Or are they actually challenges?

No, thanks for the question. We heard this question from investors. We do -- we've done a number of rounds of market research where we not only engage with doctors on a qualitative basis where we're able to have conversations and have it back and forth, but also quantitative setting where it's noninteractive and doctors are essentially going stepwise through information prompts that we provide.

And they both allow us to gauge probably interpret the data, how they think about that data relative to other regimens are currently available. What factors they like, dislike how strong a factor that is on a neutral on different factors.

And one thing that's very clear when we reviewed the results of that research is that, a, the efficacy is clearly the most important factor for them as they're evaluating the regimen; and b, the IV administration, it shows up as a negative factor and meaningfully less than 10% of the responses we have in this research.

Secondly, we also do research with patients. And again, that's primarily qualitative. And again, except in cases where we believe there's a geographic limitation for a patient simply clinics too far, or if there are some other considerations in their mobility, we do not expect that there will be significant patient pushback on the IV.

I mean, we have some interesting anecdotes from these conversations that suggest that women take very seriously their obligation for their family to do everything they can to maximize the time that they can be with their family and to use what they believe are the best drugs that they may have an option to take.

So we think all in, it just reinforces what we believe, which is in certainly a terminal disease like metastatic breast cancer, the most important criteria that's going to guide selection of therapy by both the physician and then the preference for the patient is going to be related to the efficacy that the regimen can induce. And then also to how well tolerated the regimen is and the feedback we've received again is very positive on that front as well.

And so finally, as it relates to the administration route, again, we think that's going to be an (inaudible) issue for only a small number of patients for the reason I mentioned. And we don't believe that is going to restrict preference for physicians to prescribe the therapy.

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

Sure. Well, has anybody that's followed this space, no 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.

Anything ultimately that hitting the easy button 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 have now, and we hope to have with the mutant setting, we think that will be a very significant advantage.

Oliver McCammon, LifeSci Capital.

So switching gears a little bit. We're roughly 1.5 years into the launch of enavalisib for the PIK3Ca mutant endocrine therapy resistant setting. I'm curious if there are any learnings from the launch, the label and/or KOL feedback that you think are supportive of the positioning of geda in the VICTORIA-2 trial?

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 (inaudible) level below 6 and essentially ruling out patients that were either prediabetic or diabetic type 2 diabetes.

And there has 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, essentially, highlights just how unique a drug geda is, a, we're addressing this pathway. But more importantly or rather very importantly, we're not inducing the levels of 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 have -- were 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 geda when you hit this pathway, you run challenges and really being to able to treat a broad group of patients or to treat patients in a way that does create some potentially significant adverse event risk.

Very helpful. And just one sort of frontline follow-up. Given the Percepta results we saw recently, your prior Phase 1b 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.

Well, it would be very logical given the very favorable data that we've reported in that setting in our Phase 1b 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 effective response rate of 79% with gedatolisib combined with palbociclib in that result.

So those those really compare very favorably to what's been published to date for 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.

Eva Verdejo, Wells Fargo.

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 US?

So our current plan, if our grand plan comes to fruition is that if we have as we hope and expect a positive readout in our mutant cohort, we would then follow up with a supplemental NDA, assuming we get the initial approval for gedatolisib.

And then once that NDA is complete -- the sNDA package is completed, we would then utilize the documents and essentially most of the documentation will translate, but essentially use the information from both the wild-type and mutant data sets and the NDA modules overall to create an [MAA] submission in the fourth quarter this year. That's roughly a three-month process to potentially get it accelerated, but 13 months with a regular review.

And so in the meantime, after we submit, that would be the window of time that we would use to explore finding partners to collaborate with launching not only in Europe but potentially globally. Simultaneously, we've also been engaging with the regulators in Japan to identify the regulatory path forward for submission in Japan.

We think we've got gained alignment so far on that front. And so even though we haven't identified a partner at this time, we are not -- we're proceeding at pace with regulatory activities in the most significant markets, which would include the major five European countries as well as Japan. And so we will in this window have ample time to find the right partner without delaying at all our ability to have get a launch in those markets.

Kalpit Patel, Wolfe Research.

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?

Well, without getting into any more detail, I'll 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.

Chase Knickerbocker, Craig-Hallum.

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 geda in wild type. Maybe kind of foremost amongst them, how that's solidified or altered any of your thoughts around potential pricing?

I guess, just the overall reception to the information that we've shared with payers and strategic accounts, which you're able to do on a safe harbor basis 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 ensuring have access to therapies are 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 they're collaboration to how I would say it and working with us to lay the groundwork to ensure that as early as practically possible, get a rather patients would have access to this -- to this drug and the resident.

Maybe just as a follow-up around the competitive environment, we saw recently another acquisition of a mutant selective PI3K alpha inhibitor. Can you just refresh us on your thoughts on 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.

sure, Thank you. Again, I think there's been -- since alpelisib received its approval, I guess, seven years ago, there have been a number of companies that have sought to potentially provide an alternative that would be safer than alpelisib. And that's a worthy project.

But the underlying biological assumption that's really driving those projects, we think is not necessarily current. (inaudible) and the approach we've taken of inhibiting all Class 1 (inaudible) isoforms as well as Mtor 1 and 2 is the approach that's required to optimize anti-tumor control to provide maximum antitumor control.

And so we just think there's a biological limit on the benefit that a single target inhibitor like a PI3K inhibitor can induce. And having more, as we've seen with SERDs, doesn't necessarily yield different results. I think five Phase 3 reports later. I think we've seen very, very similar results.

Now in this case, with this in this setting, I think it's reasonable to expect that based on the way these drugs are distinguishing their targeting between the mutant form of PI3K alpha and the wild-type form, they can improve upon safety profile relative to alplisib, but I think that seems pretty reasonable. But ultimately, I think there's going to be limited biological potential to induce an optimal outcome for efficacy.

And I think the results today for geda certainly, we think, demonstrate the value and importance of providing comprehensive inhibition of this pathway as opposed to selective inhibition of this pathway. So as far as impacting us, we actually -- we think, again, that targeting approach will be obsolete. If the data we hope to report out soon is what we hope and expect.

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.

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

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