Celcuity Inc. Fourth Quarter and Full Year 2025 Earnings Call - NDA accepted, VIKTORIA-1 wild-type results position gedatolisib for approval and commercial launch

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.0: I would now like to turn the conference over to Jodi Severs, Corporate Communications and Investor Relations at Celcuity. Please go ahead.

Jodi Severs, Corporate Communications and Investor Relations, Celcuity Inc.: 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 investor 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 presentations 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. With that, I would like to turn the call over to Brian Sullivan, the CEO of Celcuity. Please go ahead.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: 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, HER2-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 III VIKTORIA-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. Third, we completed enrollment of the PIK3CA mutant cohort of our phase III VIKTORIA-1 trial late last year. Reporting results from this cohort of this phase III trial will be another incredibly important milestone for Celcuity.

We expect to announce these results in a 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. Now, 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 VIKTORIA-1 trial and the new milestones they achieved in HR-positive, HER2-negative advanced breast cancer. Just to recap, median progression-free survival or PFS for the gedatolisib triplet, which is gedatolisib, abemaciclib, and fulvestrant, was 9.3 months compared to only 2 months for fulvestrant, and the 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 gedatolisib triplet is more favorable than has ever been reported by any phase III trial for patients with HR-positive, HER2-negative advanced breast cancer. Second, the 7.3 months incremental improvement in median PFS for the gedatolisib triplet over fulvestrant is higher than has ever been reported by any phase III trial for patients with HR-positive, HER2-negative advanced breast cancer receiving at least their second line of a regimen including an endocrine therapy. Third, gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR pathway to demonstrate positive phase III results in patients with HR-positive, HER2-negative PIK3CA wild-type advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor.

Fourth, the 17.5 months median duration of response and the 31% incremental increase in the objective response rate relative to control for the gedatolisib 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 gedatolisib 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 with the gedatolisib triplet versus 2 months for fulvestrant, which resulted in a hazard ratio of 0.13.

Further analysis that included patients enrolled in the U.S., Canada, Western Europe, and Asia-Pacific, representing nearly 60% of those enrolled, found that median PFS was 16.6 months with the gedatolisib 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 was generally well-tolerated in the trial with mostly low-grade adverse events. Study treatment discontinuation due to treatment-related adverse events was reported in 2.3% of patients treated with the gedatolisib triplet. In December, we presented additional safety analyses in an oral presentation at the San Antonio Breast Cancer Symposium. For patients who experienced stomatitis, we reported that measures to mitigate it were generally effective.

The 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 gedatolisib did not induce meaningful changes in patient glucose levels. Unlike other approved drugs targeting PI3K alpha, gedatolisib 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 that capture a patient’s perception of their overall well-being. 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 reported prior to the patient starting treatment on the trial. For the gedatolisib triplet, the median time to definitive deterioration was 23.7 months versus 4 months for fulvestrant, with a hazard ratio of 0.39. Additionally, for the first 8 cycles of treatment, patients’ assessment of their well-being remained stable relative to their assessment prior to starting treatment with gedatolisib. Based on these assessments, we believe this provides meaningful evidence that patients treated with gedatolisib tolerated it well. Let’s turn now to our VIKTORIA-2 study, which is a phase III clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor in fulvestrant as first-line treatment for patients with HR-positive, HER2-negative advanced breast cancer who are endocrine therapy-resistant.

We’re wrapping up the safety run-in, and we expect to provide an update on our final phase III study design in the second quarter. We believe the positive results from the PIK3CA wild-type cohort of our VIKTORIA-1 study augurs well for the potential efficacy our gedatolisib triplet may induce in this patient population. Now let’s turn now to our phase Ib/II clinical trial that is evaluating gedatolisib in combination with darolutamide, an androgen receptor inhibitor. We’re evaluating this in men with metastatic castration-resistant prostate cancer. We presented detailed data for the phase Ib portion of the study at a poster presentation at ESMO. In this portion of the phase Ib/II 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 rate was 67%, and the median RPFS for patients was 9.1 months in both arms combined. 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 as 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 II 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 per 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 who have 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. These results make us optimistic about the possibility of establishing gedatolisib as the new standard of care in the second-line setting for HR-positive, HER2-negative advanced breast cancer in the wild-type patient population. Should 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 their PIK3CA mutation status.

Based on analysis of published epidemiological data, we estimate there are approximately 37,000 patients in the U.S. with HR-positive, HER2-negative advanced breast cancer who’ve progressed after treatment with a CDK4/6 inhibitor. Using internal duration of treatment estimates and pricing assumptions consistent with currently available novel therapeutics for breast cancer, we estimate the total addressable market for gedatolisib in the second-line setting is more than $5 billion. 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 a potential launch to advance multiple potential blockbuster indications over the years in breast and prostate cancer, while also aggressively preparing for potentially launching 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. It seems like we lost Vicky. 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?

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.0: Yes. She’s reconnecting right now.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: Well, why don’t I continue, so we don’t delay everyone.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.2: Brian, I apologize. I think I’m back on.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: Okay. Why don’t you get going?

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.2: 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 Severs, Corporate Communications and Investor Relations, Celcuity Inc.: 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?

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.0: Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press star followed by 1 on your touch tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by 2. If you’re using a speakerphone, please lift the handset before pressing any keys. One moment please for your first question. Our first question comes from the line of Maury Raycroft from Jefferies. Your line is now open.

Maury Raycroft, Analyst, Jefferies: Hi, congrats on the progress, and thanks for taking my questions. Not sure if this fits within your criteria or not for on status update, but wondering if for the mutant data, if you could say if the database lock is already in place. If that’s something you can comment on.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: No, I can’t comment on that.

Maury Raycroft, Analyst, Jefferies: Okay. Understood. I know you’ve already commented on this in the past too, but if you could just recap how the disclosure is gonna take place and what exactly you’ll share in the readout?

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: 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.

Maury Raycroft, Analyst, Jefferies: Got it. Okay. When thinking about when we could see more details at a medical conference, can you say if that’s gonna be, like, relatively soon, or is it more likely gonna be a second half update?

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: I think you’ll just have to wait and see, Maury. Sorry, I can’t provide any more details.

Maury Raycroft, Analyst, Jefferies: Understood. Okay. Those were the questions I’ll ask. I’ll hop back in queue.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: Okay.

Maury Raycroft, Analyst, Jefferies: Thank you.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: All right. Thank you, Maury.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.0: Your next question comes from the line of Tara Bancroft from TD Cowen. Your line is now open.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.1: Hi. Good afternoon. 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, you know, 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. Thanks.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: Well, thanks. Now, as we launch, we aren’t gonna be targeting or narrowcasting 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. We would expect our sales force, you know, upon approval, that assuming that occurs, you know, to reach out generally to doctors and essentially help them understand how gedatolisib and the data, you know, can offer, again, what we believe is an improvement in the alternatives that are currently available.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.1: Okay. Great. Thanks. 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, Chief Executive Officer and Co-founder, Celcuity Inc.: Yeah. Yeah. That, that’s just not something that we have any conversations with doctors about.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.1: Okay. All right. Thank you.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: Thank you.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.0: As a reminder, please ask one question and one follow-up. Your next question comes from the line of Stephen Willey from Stifel. Your line is now open.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.2: Yeah, good afternoon. Thanks for taking the questions, and sorry to badger you, Brian, on the top-line release of the median data. 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, Chief Executive Officer and Co-founder, Celcuity Inc.: It’ll be the latter. I mean, we’re mindful of embargo requirements, you know, that we need to adhere to in order to be in a position to have a podium presentation at one of these medical conferences.

Stephen Willey, Analyst, Stifel: Okay. Maybe just a question on prostate, and then maybe just a quick one on the second line breast opportunity that you spoke to. In prostate, just curious how high you think you can push dose kinda north of the 180 mg that is used in the VIKTORIA trial. And then just curious, you know, what metrics. I mean, obviously, there’s a balance of safety and tolerability you need to consider in terms of nominating a recommended phase II dose. But are there any efficacy metrics that you’re gonna be prioritizing? I know you’ve shown us the radiographic PFS data, but just curious how things like PSA response, maybe even a RECIST response for those patients with measurable lesions, how that kind of factors into dose nomination.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: Sure. Well, just to recap, relative to what we announced previously, we were pleasantly surprised by the safety profile of that, the 180 mg dose, reported. No dose-limiting toxicities, very limited grade 3 adverse events. Hyperglycemia was, you know, consistent with our breast cancer. Stomatitis was significantly less frequent at that dose in these men. That’s what led us to decide to increase the dose or rather to evaluate higher doses. Essentially, we’re using some standard methodology to, you know, stepwise increase the dose and basically, depending on, you know, achievement or levels of dose-limiting toxicities, you know, we’ll keep going.

You know, we’re in the midst of that, so I can’t really comment on where we’ll end up. Again, it’s always a balance. We can’t sacrifice tolerability to such an extent that it’s self-defeating. To the extent that we believe there’s a dose response that would, you know, lead to improved response at higher doses, we wanna explore where that might take us. We would expect to have some look at that data, you know, by the end of this year or sometime early next year.

Stephen Willey, Analyst, Stifel: Okay, that’s helpful. Maybe just lastly, with respect to breast, I appreciate some of the color and kind of the peak revenue opportunity here in the second-line setting. I think you mentioned just kinda using you know historical pricing and duration of therapy. Obviously, the pricing is kinda readily available. What’s the duration of therapy estimate that you’re using to inform the peak numbers that you mentioned? Thanks.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: Well, you know, if you know, just use a round number, that, you know, of 10 months, and again, that’s not a projection, that’s just an assumption to drive an estimate, you would, you know, be consistent with how we’re modeling the market.

Stephen Willey, Analyst, Stifel: All right. Much appreciated. Thanks.

Operator: Our next question comes from the line of Josh Bowen from Guggenheim. Your line is now open.

Josh Bowen, Analyst, Guggenheim: Hey, guys. 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? Thanks.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: Sure. Key gating factor is just completing the safety run-in. Just to, you know, look back a little bit, we’re evaluating data in combination with ribociclib as a potential CDK4/6 option for doctors to use in the treatment arm. Because we haven’t evaluated data with ribociclib before, we needed to evaluate it in a sufficient number of patients to make a decision about, you know, dosing and how to move forward. That’s wrapping up, and you know, based on those results, we’ll update the study design accordingly. You know, we expect to provide an update on the study design in the second quarter. Proceed apace to begin enrolling the phase III study.

Operator: Our next question comes from the line of Gil Blum from Needham & Company. Your line is now open.

Stephen Willey, Analyst, Stifel: Thanks for taking our questions. I’ll try to keep this brief. 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?

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: No, thanks for the question. You know, we have heard this question from investors. 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 you know, have a back and forth, but also in a quantitative setting where it’s non-interactive and doctors are essentially going stepwise through information prompts that we provide. You know, they both allow us to gauge you know, how they interpret the data, how they think about that data relative to other regimens that are currently available, what factors they like, dislike, you know, how strong a factor that is. Are they neutral on different factors?

One thing that’s very clear when we review 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 shows up as a negative factor and meaningfully less than 10% of the responses we have in this research. Secondly, we also, you know, do research with patients, and again, that’s primarily qualitative. Again, except in cases where we believe there’s a geographic limitation for a patient, simply clinic’s too far or if there’s some other considerations, you know, their mobility, we do not expect that there’ll be significant patient pushback on the IV.

I mean, we have some interesting anecdotes, you know, from these conversations that suggest that women take very seriously their obligation for their family to do everything they can to, you know, 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. 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 gonna guide selection of therapy by both the physician and then the preference for the patient is gonna be related to the efficacy that the regimen can induce and then also to how well-tolerated the regimen is.

The feedback we’ve received, again, is very positive on that front as well. You know, finally, you know, as it relates to the administration route, again, we think that’s gonna be an exigent issue for only a small number of patients, you know, for the reasons I mentioned, and we don’t believe that it is going to restrict preference for physicians to prescribe the therapy.

Gil Blum, Analyst, Needham & Company: Thank you for all that. Maybe as a follow-up, can you help us understand the commercial advantages of having a label across metastatic breast cancer subtypes? Thank you.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: Sure. Well, yeah, 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. 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 you know they may be treating the best potential risk-benefit relative to the alternatives. Now, doesn’t mean there aren’t you know available options that some doctors may select or prefer in certain patient segments.

We think overall, you know, we’ll be in a very strong position by being able to offer essentially a biomarker-agnostic alternative that doesn’t require them to you know, evaluate you know, some complex decision-making around you know, biomarker subgroups. We think ultimately you know, that you know, hitting the easy button with which isn’t to diminish the importance of the decision for the doctors. Particularly in the community setting, you know, the challenges of keeping up with the alternatives you know, can make it difficult for them to make the right decisions in some cases. To the extent we can leverage the data that we have now and we hope to have with the mutant setting, we think that’ll be a very significant advantage.

Gil Blum, Analyst, Needham & Company: Our next question comes from the line of Oliver McCammon from LifeSci Capital. Your line is now open.

Oliver McCammon, Analyst, LifeSci Capital: Thanks for taking my questions. Switching gears a little bit, you know, 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, the label and/or KOL feedback that you think are supportive of the positioning of gedatolisib in the VIKTORIA-2 trial. Thanks.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: Well, thank you. So you know, they’ve reported very good data and unfortunately though, the patient population that really is appropriate to treat with that drug is fairly limited. You know, the study only enrolled patients who essentially were metabolically healthy, you know, patients who had an HbA1c level below 6 and essentially, you know, ruling out patients that were either pre-diabetic or diabetic, you know, type 2 diabetes. There’s since been several Dear Doctor letters for very significant adverse events that have been reported. You know, the label requires fairly extensive glucose monitoring, both by the physician as well as the patient while they’re at home.

Overall, this is based on our assessment of the claims data. It appears those restrictions are having an impact on the usage in the clinic to date. From a learning standpoint for us, I mean, essentially, highlights just how unique a drug Geda is. 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. We do not believe that patients who are pre-diabetic or type 2 diabetes will be restricted in their ability to receive treatment with gedatolisib.

It really goes back to the drug and the overall safety profile. When you don’t have a safety profile like gedatolisib, when you hit this pathway, you’ll run into challenges, and really being able to treat a broad group of patients or to treat patients in a way that doesn’t create some potentially significant adverse event risk.

Oliver McCammon, Analyst, LifeSci Capital: Very helpful. Just one sort of frontline follow-up. Given the PERSEVERE results we saw recently, your prior phase I/B 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, Chief Executive Officer and Co-founder, Celcuity Inc.: Well, it would be very logical given the very favorable data that we’ve reported in that setting in our phase I-B study. Just as a reminder to folks, in that study, sample size of 41, we reported median PFS of, you know, over 48 months and an objective response rate of 79%. With gedatolisib combined with palbociclib and letrozole. Those really compare very favorably to what’s been published to date for currently approved therapies. I think there’s a very strong case to be made for us in conducting a study in that space. You know, we will keep people posted on our thinking.

Oliver McCammon, Analyst, LifeSci Capital: Thank you for taking my questions.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.0: Our next question comes from the line of Eva Forte from Wells Fargo. Your line is now open.

Eva Forte, Analyst, Wells Fargo: Good afternoon. Thanks for taking our question. 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 you expect EU to sequence versus the US?

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: Sure. So our current plan, if our grand plan comes to fruition, is that if we have as we hope and expect, a positive readout with our mutant cohort, we would then follow up with a supplemental NDA, assuming we get the initial approval for gedatolisib. Once that NDA is complete or that 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 datasets, and the NDA modules overall, to create an NDA submission in the fourth quarter this year. That’s roughly a 13-month process to potentially get it accelerated, but 13 months with a regular review.

In the meantime, after we submit, you know, that would be the window of time that we would use to explore finding partners to collaborate with launching, you know, not only in Europe but potentially globally. You know, simultaneously, we’ve also been engaging with the regulators in Japan, and to identify the regulatory path forward for submission in Japan. We think we’ve kind of gained alignment so far on that front. You know, even though we haven’t identified a partner at this time, 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.

We will, you know, in this window have ample time to, you know, find the right partner without delaying at all our ability to have geda launched in those markets.

Eva Forte, Analyst, Wells Fargo: Got it. Thanks.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.0: Our next question comes from the line of Kalpit Patel from Wolfe Research. Your line is now open.

Kalpit Patel, Analyst, Wolfe Research: Yeah. Hey, thanks for taking the question. 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, Chief Executive Officer and Co-founder, Celcuity Inc.: Well, without getting into any more detail, just limit it to you know the study design. The study design has as a primary endpoint a comparison of the triplet to alpelisib. That is the primary endpoint and that would form the basis for any potential regulatory submission. The analysis comparing

Kalpit Patel, Analyst, Wolfe Research: Okay. Thank you.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: The doublet to alpelisib is an exploratory analysis or secondary analysis.

Kalpit Patel, Analyst, Wolfe Research: Got it. Thank you.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: You’re welcome.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.0: Our next question comes from the line of Chase Knickerbocker from Craig-Hallum. Your line is now open.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.3: Good afternoon. Thanks for the questions. We’ll be curious what you and your, you know, market access team, have heard in your early pre-launch discussions with payers, on a number of items around the profile of geda and wild-type. Maybe kind of foremost among them, you know, how that’s solidified or altered any of your thoughts around potential pricing.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: I guess you know just the overall reception to the information that we’ve shared with you know payers and strategic accounts, which we’re able to do on a safe harbor basis since they’re not healthcare providers, has been very positive. I think it’s interesting to get the feedback they provide. You know, they’re in the business of helping ensure you know the individuals who they are insuring have access to therapies or ultimately responsible for treating and have access to the right therapies.

We’ve been very pleased with how they’ve reacted to the data and their you know collaboration is how I would say it in working with us to lay the you know groundwork to ensure that as early as practically possible patients would have access to this drug and the regimen.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.3: 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, you know, potential future competition for you from that angle? Just kinda generally on kind of the next generation assets coming up in competition here.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: Sure. No. Thank you. Again, I think there’s been, you know, since alpelisib received its approval, you know, I guess seven years ago, there have been other, you know, the number of companies that have, you know, sought to potentially provide an alternative that would be safer than alpelisib. That’s a worthy project. You know, the underlying biological assumption that’s really driving those projects, we think is not necessarily current. We think gedatolisib and the approach we’ve taken of inhibiting all class I PI3K isoforms as well as mTOR 1 and 2 is the approach that’s required to optimize antitumor control, you know, to provide maximum antitumor control.

We just think there’s a biological limit on the benefit that a single-target inhibitor like a PI3K-alpha inhibitor can induce. You know, having more, as we’ve seen with SERDs, doesn’t necessarily yield different results. I think, you know, five phase III reports later, I think we’ve seen very similar results. Now, in this case, you know, 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, that they can improve upon safety profile relative to alpelisib. I think that seems pretty reasonable.

Ultimately, I think there’s gonna be a limited biological potential to induce an optimal outcome for efficacy. I think the results today for gedatolisib certainly we think demonstrate the value and importance of providing comprehensive inhibition of this pathway as opposed to selective inhibition of this pathway. As far as you know, impact on us, we actually think again that targeting approach will be obsoleted if the data we hope to report out soon is what we hope and expect.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.3: Got it. Thanks, Brian.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: You’re welcome.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.0: There are no further questions at this time. I’ll now turn the call over to Brian Sullivan, Celcuity’s Chief Executive Officer, for closing remarks. Sir, please go ahead.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.: Well, thank you for participating in our call today for your ongoing support. Look forward to reporting back to you soon. Take care.

Brian Sullivan, Chief Executive Officer and Co-founder, Celcuity Inc.0: Ladies and gentlemen, this concludes today’s conference call. Thank you for your participation. You may now disconnect.