Good afternoon, ladies and gentlemen, and welcome to the Celcuity Fourth Quarter and Year-End Financial Results Conference Call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. [Operator Instructions] I would now like to turn the conference over to Maria Yonkoski with ICR Westwicke. Please go ahead.

Thank you, Operator, and good afternoon to everyone on the call. Thank you for joining us to review Celcuity's fourth quarter and full-year 2023 financial results and business update. Earlier today, Celcuity released financial results for the fourth quarter and full-year ending December 31, 2023. The press release can be found on the Investors section of the 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, who will be available during Q&A. Before we begin, I would like to remind listeners that our comments today will include some forward-looking statements. These statements involve a number of risks and uncertainties, which are outlined in today's press release and in our reports and filings with the SEC. Actual events or results may differ materially from those projected in the forward-looking statements. Such forward-looking statements and their implications involve known and unknown risks, uncertainties and other factors that may cause actual results or performance to differ materially from those projected. On this call, we will also refer to non-GAAP financial measures. These non-GAAP measures are used by management to make strategic decisions, forecast future results and evaluate the company's current performance. Management believes the presentation of these non-GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future. You can find the table reconciling the non-GAAP financial measures to GAAP measures in today's press release. And with that, I would now like to turn the call over to Brian Sullivan, CEO of Celcuity. Please go ahead.

Thank you, Maria, and good afternoon, everyone. In 2023, we made significant progress advancing development of gedatolisib, while strengthening our balance sheet and adding to our leadership team. Our Phase 3 VIKTORIA-1 trial remains on track to report top line data from the PIK3CA wild-type patient subgroup in the second-half of this year and top line data for the PIK3CA mutated patient subgroup in the first-half of 2025. We were also excited to begin development of gedatolisib for patients with metastatic castration resistant prostate cancer this past year. Enrollment has begun in our Phase 1b/2 trial evaluating gedatolisib in combination with darolutamide, and we look forward to sharing preliminary data from this trial in the first-half of 2025. Our VIKTORIA-1 Phase 3 clinical trial is designed to evaluate gedatolisib in combination with fulvestrant with and without palbociclib in patients with advanced hormone receptor positive HER2 negative breast cancer, whose disease has progressed after treatment with a CDK4/6 inhibitor. We're seeking to improve outcomes for this patient population, which today receives only limited benefit from current second-line standard-of-care therapies. We estimate that this initial potential target population represents over 100,000 breast cancer patients globally on an annual basis. Current standard-of-care for these patients includes endocrine therapies, such as fulvestrant and regimens that combine fulvestrant with an mTOR-specific or PI3K-alpha specific targeted therapy. These therapies only offer modest progression free survival periods, and in the case of the approved PI3K-alpha inhibitor, a very challenging safety profile. Significant unmet need for these breast cancer patients has led to development and subsequent investigation of a significant number of new therapies, an oral SERD for patients with an ESR1 mutation, an AKT inhibitor for patients with a PIK3CA or AKT mutation was recently approved. Median Progression Free Survival or PFS for these two new therapies…

Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the fourth quarter and full-year '23, and I invite you to review our 10-K, which will be filed later today for a more detailed discussion. Our fourth quarter net loss was $18.8 million, or $0.69 per share, compared to $11.6 million net loss or $0.69 per share for the fourth quarter of 2022. Net loss for the full-year of 2023 was $63.8 million, or $2.69 per share, compared to $40.4 million net loss, or $2.64 per share for the same period in 2022. Because these quarterly and full-year net losses include significant non-cash items, including stock-based compensation and non-cash interest, we also include in our press release non-GAAP adjusted net loss for the quarter and full-year ending December 31, 2023. Our non-GAAP adjusted net loss was $17.6 million or $0.61 per share for the fourth quarter of 2023 compared to non-GAAP-adjusted net loss of $10.3 million or $0.61 per share for the fourth quarter of 2022. Non-GAAP-adjusted net loss for the full-year 2023 was $57.8 million or $2.44 per share compared to non-GAAP-adjusted net loss of $35 million, or $2.27 per share for the full-year 2022. Research and development expenses were $18.1 million for the fourth quarter of 2023, compared to $10.6 million for the fourth quarter of 2022. R&D expenses for the full-year 2023 were $60.6 million, compared to $35.3 million for the prior year. Of the approximately $25.3 million increase in R&D expenses year-over-year, $22.9 million was related to activities supporting the VIKTORIA-1 Phase 3 trial and the initiation of the Phase 1b/2 clinical trial. The remaining $2.4 million increase in R&D expense is related to increased employee and consulting expenses. General and administrative expenses were $1.6 million for the fourth…

Thank you, Vicky. Operator, could you please open the call for questions.

Yes, thank you. Ladies and gentlemen, we will now begin the question-and-answer session. [Operator Instructions] Your first question is from Tara Bancroft from TD Cowen. Please ask your question.

Hi, good afternoon. I was wondering if you could tell us more about the overlap of ESR1 and PIK3A mutations, and if the FDA still considers Arm C or fulvestrant alone the best comparator for Arms A and B, now a year into the launch of elacestrant. So, I'm just basically trying to gauge your level of confidence in the Arm B versus C endpoint or even the chances that you might go for an ESR1 wild-type labeling for that subset or what? Thank you.

Thanks for the question, Tara. We have not seen any variation in outcomes for patients associated with ESR1 mutation with the combination of therapy that we're evaluating in this study. And so, we don't anticipate a challenge on that front. We closely collaborated with the FDA when we were developing the design of our study. We reviewed the study with them on an ongoing basis through a series of Type B meetings, where we are collaborating with them, and in close contact to review not only the clinical development, but also work associated with what we hope is a future NDA. As far as changing the control, there's no discussion or consideration of that. Drug was recently approved, capivasertib that used fulvestrant as a control just this past few months. And so, we'll certainly have data available to us to report potential outcomes in patients according to their mutational status, but we don't anticipate, as I said earlier, to find any differences or meet clinically meaningful differences.

Great. Thanks. Have you said which HR you're powering to for the B versus C endpoint, you commented on that?

We haven't commented on that. But again, we're powering the study sufficiently to support regulatory approval.

Okay. Thanks so much.

Thank you.

Thank you. Your next question is from Maury Raycroft from Jefferies. Please ask your question.

Hi, thanks for taking my questions. It seems like the data timing is intact and on track. Is there anything else you're saying about enrollment rate? I think at one point you mentioned, you aim to enroll 50% of the wild-type patients by the end of the first quarter. Wondering if you've achieved that milestone and is that something that you could announce for the wild-type cohort?

Yes, that milestone is associated with one of the terms of our debt facility, and we did achieve that milestone during this quarter. And so, we remain on track. That is consistent with the guidance we provided about having data in the second-half of this year.

Okay, great. And for the Phase 3 readout, can you provide an estimate for how much follow-up you think you will have by the time of the data readout?

That's not a number that we'll disclose at this point. We anticipate obviously reporting the top line data and the data readout will be triggered by achieving sufficient events, and that factors in follow-up period necessary to get a fulsome mature set of data.

Okay. Yes, it makes sense. And lastly, another question on mutations, when you analyze the Phase 1b data, you reported similar efficacy in patients with or without PI3K mutations. But can you remind me if you looked at other mutations in the pathway, including AKT, mTOR and PTEN loss? And for the Phase 3, have you had discussions with FDA on how you would evaluate patients with other non-PI3K mutations?

We've done analysis of patients with these other mutations, but the numbers are small. And so, we didn't feel that reporting those results would be scientifically rigorous enough to really discuss. But we have evaluated them and based on at least our interpretation of the small sample sizes, we haven't seen anything that is concerning or inconsistent with the comparable results we saw with wild-type PIK3CA versus mutated PIK3CA. And as far as other mutations and how that might interact with the FDA, essentially when you design a clinical trial, Phase 3 clinical trial, you have a very detailed protocol with statistical analysis that's well prescribed. And you essentially interact with the agency quite a bit or at least we did to get their feedback and to ensure that our assumptions and the statistical analysis plan would be satisfactory, subject to review to support an NDA and nothing on that front has changed. And the primary biomarker that we're using is primarily to assign patients to a study that's focusing on PIK3CA mutated patients and a study that's associated with or randomizing patients who lack a PIK3CA mutation. And we're using what the PIK3CA mutations that have supported approval of PIK3CA-alpha inhibitor. So, again, we're relying on an approved PIK3CA test and have confidence that that test will support subject to review by the FDA and NDA submission.

Got it. That's helpful. Thanks for taking my questions.

You're welcome.

Thank you. Your next question is from Gil Blum from Needham. Please ask your question.

Gil, I think that was for you.

I think my name was butchered pretty severely there. Sorry, so, okay. Quick question on the prostate cancer, so just to understand, I mean you're not the first patients that are a little far from this, what kind of signs of early efficacy would the company be looking for in that study? I mean, talking responses here or PSA activity? Thank you.

Sure. While the study is primary endpoint is PFS, the PFS rate at after six months of treatment. And then, there are a number of secondary endpoints which include PFS at 9 and 12 months as well as evaluating PSA change. We think the most important milestone, or rather, endpoint is related to radiographic progress to free survival, since that's the regulatory endpoint that we would use for evaluation in a registrational study. And so we will be, I think, consistently reporting that number and as that number matures with the number of patients who've achieved that whether it's a six-month milestone, nine-month or 12-month milestone that will conduct the -- well, that will be a rhythm that we'll have for reporting data.

That's very helpful. Maybe another detail on the enrollment here, so it sounds like the wild-type cohort is enrolling well, any thoughts on the mutant cohort? Thank you.

Well, they enroll in tandem. Essentially we're enrolling screening patients who have had prior CDK4/6. If they meet criteria, screening criteria, that includes assessment of their PIK3CA status, they then get randomized. So, essentially, the enrollment of wild-type and mutant are occurring concurrently. And so, if our wild-type is on track, then our mutant population is on track, just because of the way the trial enrollment is designed.

Thank you. That's a very helpful clarification. Thanks for taking our questions.

You're welcome.

Thank you. Your next question is from Brad Canino from Stifel. Please ask your question.

Hi. Good afternoon. I want to ask is there any way you've been able to track adherence with the prophylactic mouthwash for stomatitis mitigation in VIKTORIA-1?

Well, we do. One of the primary advantages we have in managing that and monitoring compliance is when the patients come in for their three-week on, one-week off infusion. And so, the treating physicians or the associated nurses are evaluating and including compliance with that prophylactic and standard questionnaire. And so, we have a high degree of confidence based on that, that if patients aren't compliant, we'll find out, but also we reinforce the value of that prophylaxis. And just as a reminder, that prophylaxis is only used and prescribed for the first two cycles of treatment. The data is fairly clear that for patients who may be prone to development of mucositis, it's in almost all cases likely to occur in the first two cycles of treatment. And so, that if you are able to provide that prophylaxis for that first two cycles, that the manifestation of mucositis is much, much lower after that period. So, it's not a requirement then for patients to remain on that prophylaxis beyond those first two cycles.

Okay. And then, I'll try to ask another enrollment question, maybe in a slightly different way. Because I think the continued reiteration of top-line guidance for VIKTORIA-1 is going to be important for investors. I think based on the enrollment pace you see, is there anything you can share about a time point that could be passed this year where you would reach that sufficient enrollment to fully secure the second-half guidance for the wild-type using the rate assumption you got for events?

I think, again, we provided the guidance for the second-half of this year. Obviously, as we get closer to that, we can get more granular. And I think we'll update that each quarter. And so, the closer we get, I think, the more descriptive we can be. But so far, again, we're monitoring enrollment, we're monitoring the event rate, and you make certain assumptions about the event rate, and we're tracking to what our assumptions are so far.

Thanks for the question.

You're welcome.

Thank you. Your next question is from Swayampakula Ramakanth from H.C. Wainwright. Please ask your question.

Thank you. This is RK from H.C. Wainwright. Good afternoon, Brad.

Good afternoon.

Most of my questions have been answered. So, when the data -- when you are ready to publish the data from the wild-type in the second-half. I'm just trying to figure out how would you disseminate that information? Would that be a medical meeting or do a press release and then follow up with a medical meeting at the appropriate time?

It's somewhat situational depending on the timing of meetings and when the data will be cleaned and able to be released publicly. And so, when the event threshold is triggered, we'll understand whether what the gross or not gross, but what the data is telling us. And we would finish up data cleaning at that point. Obviously that's going on an ongoing basis. But it would be our expectation that we would announce the top-line results, meaning whether or not we met statistical significance, whether the trial was positive, and probably characterize how clinically relevant those results are. But I think it's typical that you present these results of a Phase 3 study at a medical meeting. That would be our current desire, but again, depending on the timing of when the data's available, we may reconsider. But we'll follow, I think, practice that's been used with other drugs, but I think it's fairly typical that if a major meeting isn't scheduled coincident with the availability of data that people will provide that top line and then wait until a medical meeting to provide the more fulsome description of the results.

Thank you. Thanks for taking my question.

You're welcome.

Thank you. [Operator Instructions] Your next question is from Alex Nowak from Craig-Hallum Capital. Please ask your question.

Hey, great. Good afternoon, everyone. As we're getting close to the first VIKTORIA readout here, you brought on your Chief Commercial Officer. That's great. Just what other additional investment in the commercial talent, commercial resources do you need to plan for here over this year?

Sure. You start to build out the team underneath Eldon, which I think typically includes a person who would head up your market access, a person who would head up your marketing, and a person who would head up commercial operations. And with that team, you can do the planning that's necessary to lay the groundwork for obviously a lot more significant efforts once the data reads out and you're really marching towards a specific date for launch. And so, we factored that into the assumptions in our budget for this year. We've incorporated that in our forecast of cash requirements and they're not extraordinary, they are appropriate relative to what needs to be done and when.

Okay. No, it makes sense. And then, can you remind us the IEP position of Geda within breast cancer and then the potential to expand that length within breast or potentially other cancer indications?

Right. So, we have 11 different patents that have been approved for Geda. We have several that are pending. The active pharmaceutical ingredient patent is-would provide an exclusivity period through December 34. But because Geda is formulated and because the formulation actually is critical to being able to deliver the drug, administer the drug, we think that patent will be very relevant. And that patent would have an expiration date of December 39. And so, we think we'll have extended exclusive period that would potentially carry for more than 15 years post-launch. That's our plan.

Excellent. I appreciate the update. Thank you.

You're welcome.

Thank you. There are no further questions at this time. Please proceed.

Well, we appreciate your attendance to the call, and we look forward to updating you in the future.

Thank you. Ladies and gentlemen, the conference has now ended. Thank you all for joining. You may all disconnect.