Celcuity Inc. (NASDAQ:CELC) Q1 2024 Earnings Call Transcript

Celcuity Inc. (NASDAQ:CELC) Q1 2024 Earnings Call Transcript May 15, 2024

Celcuity Inc. beats earnings expectations. Reported EPS is $-0.59, expectations were $-0.71.

Operator: Good afternoon, ladies and gentlemen. And welcome the Celcuity First Quarter 2024 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. Instructions will be provided at that time for you to queue up for a question. [Operator Instructions] I would now like to turn the conference over to Maria Yonkoski with ICR Westwicke. Please go ahead.

Maria Yonkoski: Thank you, Operator, and good afternoon to everyone on the call. Thank you for joining us to review Celcuity’s first quarter 2024 financial results and business updates. Earlier today, Celcuity released financial results for the first quarter ending March 31, 2024. 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; Vicky Hahne, Chief Financial Officer; as well as Igor Gorbatchevsky, Chief Medical Officer, who will be available during Q&A. Before I 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 the 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.

Brian Sullivan: Thank you, Maria, and good afternoon, everyone. We appreciate your interest in Celcuity. Our Phase 3 trial, VIKTORIA-1, remains on track to report topline data for the PIK3CA wild type patient sub-group in the second half of 2024. Enrollment continues to proceed well. During the first quarter, in conjunction with an update related to our debt facility, we reported that the wild type subgroup was more than 50% enrolled. Achieving this enrollment threshold during the first quarter gave us the right to draw down an additional $10 million tranche from our current debt facility. The patients we’re evaluating in this study have HR-positive HER2-negative advanced breast cancer, whose disease progressed while receiving treatment with a CDK4/6 inhibitor and an aromatase inhibitor.

And patients are eligible for enrollment if they’ve received up to two prior lines of endocrine treatment. But we anticipate that most of those enrolled will be receiving second-line treatment. And these patients typically remain on their first-line CDK4/6 inhibitor plus letrozole regimen for a median of 18 months to 22 months, depending on the CDK4/6 inhibitor. And this compares to the 13-month medium duration of prior treatment reported for patients enrolled in the comparable arm of our Phase 1b breast cancer study that evaluated gedatolisib combined with palbociclib and fulvestrant. Patients who received prior chemo in the advanced setting are not eligible for our Phase 3 study, unlike the comparable arm of our Phase 1b study. And this is relevant since the prognosis tends to be worse for individuals who have previously undergone chemotherapy for advanced breast cancer, compared to those who are chemo naive.

Another difference in the Phase 3 eligibility criteria relative to our Phase 1b study is the allowance of patients with bone-only disease. Based on data from other Phase 3 trials, we expect that roughly 20% of the patients enrolled in our Phase 3 study will have bone-only disease. Our Phase 1b study did not allow bone-only patients. Only those with visceral disease were enrolled. And this is relevant since patients with non-bone-only disease generally have worse prognosis than those with bone-only disease. By not allowing patients who have received prior chemotherapy in the advanced setting, and by including those with bone-only disease, we’re eliminating two factors in our Phase 3 study that correlate with worse outcomes. As we begin preparing for gedatolisib’s potential position in a future treatment landscape, we’ll take into account the criteria oncologists use to select a cancer therapy.

We think these criteria, in order of importance, are efficacy, then safety, then mode of administration. And this is consistent with guideline recommendations, which are based on efficacy and safety considerations, not mode of administration preference, especially in advanced breast cancer. The current second-line treatment paradigm for ER-positive, HER2-negative patients with advanced breast cancer are selective estrogen receptor degraders or SERDs, like fulvestrant or elacestrant, as single agents, or one of three approved PAM inhibitors combined with fulvestrant. However, each of the PAM inhibitors only targets a single PAM node, such as PI3K-alpha, AKT, or mTORC1, which is suboptimal because the uninhibited PAM nodes can induce compensatory resistance.

In patients who have received prior treatment with a CDK and 4/6 inhibitor, none of these drugs have demonstrated efficacy in patients who have PIK3CA wild type tumors, while only the PI3K-alpha and AKT inhibitor have reported benefit in patients with PIK3CA mutations. And these results are consistent with the non-clinical data that shows these single node inhibitors are 3 times to 4 times less potent in breast cancer cells without PIK3CA mutations than in those with them. This is in sharp contrast to the non-clinical and preliminary efficacy data we’ve reported for gedatolisib. In studies evaluating breast cancer and prostate cancer cell lines, gedatolisib was found to be equally potent and efficacious in cell lines with and without PIK3CA mutations, and at least 300 times more potent, on average, in breast cancer cells than the improved single-node PAM inhibitors.

Consistent with these non-clinical results, the preliminary efficacy we reported in our Phase 1b breast cancer study that evaluated gedatolisib combined with palbociclib and letrozole or fulvestrant was comparable in both treatment-naive and second-third-line patients with and without PIK3CA mutations. And we think these results demonstrate that along with the estrogen receptor and CDK4/6 pathways, the PAM pathway plays an intrinsic role as a disease driver in HR-positive HER2-negative advanced breast cancer that’s independent of the presence of an activating mutation like PIK3CA. And that’s why we believe development of an optimized PAM inhibitor like gedatolisib that targets all Class I PI3K isoforms and mTORC1 and 2 represents one of the most important opportunities to improve the standard of care in HR-positive HER2-negative advanced breast cancer.

Now, obviously, the foundation of gedatolisib’s potential future positioning will require that gadatelicib report a clinically meaningful MPFS benefit. The current median PFS benchmarks for patients pretreated with a CDK4/6 inhibitor are modest. Published reports of median PFS for the SERD range from 2 months to 3.8 months, and in patients with PIK3CA mutations, 5.5 months to 7.3 months for the AKT and PI3K-alpha inhibitors, respectively. The two most recently approved therapies for this patient population reported 2 months to 3.5 months of incremental PFS benefit, the threshold KOLs generally consider to be clinically meaningful. In addition, we’ve consistently heard from oncologists that they’d lately prefer to delay use of chemotherapy or ADCs until the benefit from endocrine backbone regimens is exhausted.

And this perspective was actually recently echoed by senior management from an ADC sponsor that characterized ADCs as creating a third pillar in the treatment landscape for HR-positive HER2-negative breast cancer that sits between endocrine therapy-based regimens and classical chemotherapy. And these comments are consistent with the sponsor’s drug development strategy in breast cancer, which includes development of an oral SERD and AKT inhibitor. We also think gedatolisib’s safety profile may favor its potential positioning in a future treatment landscape. Gedatolisib’s treatment-related discontinuation rate was only 4% in the Phase 1b arm with the Phase 3 intermittent dose schedule, which is comparable to the 6% to 8% discontinuation rates for CDK4/6 plus fulvestrant regimens.

And these results compare favorably to the treatment-related discontinuation rates reported in the Phase 3 studies for alpelisib plus fulvestrant, where 26% of patients discontinued, and everolimus plus exemestane, where 24% of patients discontinued. The results for gedatolisib are especially encouraging given that patients in the Phase 1b study did not receive prophylactic treatment for stomatitis. Since we’re prescribing stomatitis prophylaxis in our Phase 3 trial, we would expect fewer stomatitis-related adverse events, which would further enhance gedatolisib’s already promising safety profile. And finally, in-office administered therapies, such as an infused therapy like gedatolisib, have several key advantages relative to orally or self-administered drugs.

In a real-world setting, convenience is only a meaningful consideration when the efficacy and safety profile of the alternative drugs are comparable or when a patient lives a significant distance from the treatment site. Otherwise, a well-tolerated therapy that offers a clinically meaningful PFS benefit will be overwhelmingly preferred by oncologists relative to one that offers less efficacy but is more convenient. In-office administered therapies, such as gedatolisib, fall into the medical benefit category, which has a far more streamlined reimbursement process than orally administered drugs, which fall into the pharmacy benefit category. And this has several implications. First, oncologists can recover additional costs associated with treating their patients.

Second, oncologists have more autonomy to select therapies and the payer management process is much less burdensome. And third, payer contracting is less frequent, which results in fewer price discounts for this pharmaceutical company. And fourth, patients typically incur lower out-of-pocket costs with an infused therapy, which is an important consideration for most patients. Beyond our breast cancer program, we’re excited about the opportunity to develop gedatolisib for patients with metastatic castration resistant prostate cancer or CRPC. This past February, we dosed our first patient in a Phase 1b/2 trial evaluating gedatolisib in combination with darolutamide, an androgen receptor inhibitor, in CRPC patients previously treated with an AR inhibitor.

Like HR-positive breast cancer, prostate cancer involves both the hormonal pathway and the PAM pathway. The role the PAM pathway plays in prostate cancer has been well-characterized non-clinically and in two synscis [ph] continued PAM inhibitors, which showed compelling proof-of-concept clinical trial data in two randomized studies. In each of the clinical trials for these other PAM inhibitors, a clinically meaningful treatment benefit was reported relative to the androgen receptor inhibitor control arm in patients with CRPC. This is especially encouraging since gedatolisib is significantly more potent and efficacious than these PAM inhibitors in vitro. Primary objectives of the Phase 1b portion of the trial include assessment of the safety and tolerability of gedatolisib in combination with darolutamide, and determination of the recommended Phase 2 dose of gedatolisib.

We anticipate reporting initial preliminary data in the first half of 2025. And with that, I’ll turn the call over now to Vicky Hahne, our Chief Financial Officer, to review our financial results.

Vicky Hahne: Thank you, Brian, and good afternoon, everyone. I’ll provide a brief overview of our financial results for the first quarter 2024. Our first quarter net loss was $21.6 million or $0.64 net loss per share, compared to $11.9 million net loss or $0.55 per share for the first quarter of 2023. Because these quarterly net loss includes significant non-cash items, including stock-based compensation and interest, we also included in our press release non-GAAP-adjusted net loss for the quarter ending March 31, 2024. Our non-GAAP-adjusted net loss was $19.9 million or $0.59 per share for the first quarter of 2024, compared to non-GAAP-adjusted net loss of $11.9 million or $0.55 per share for the first quarter of 2023. Research and development expenses were $20.7 million for the first quarter of 2024, compared to $11.3 million for the first quarter of 2023.

Of the approximately $9.4 million increase in R&D expenses, $7.9 million primarily related to activities supporting the VIKTORIA-1 Phase 3 trial and the initiation of the prostate Phase 1b/2 clinical trial and $1.5 million was related to increased employee and consulting expenses. General and administrative expenses were $1.8 million for the first quarter of 2024, that compared to $1.3 million for the first quarter of 2023. Employee-related expenses accounted for $0.3 million of the increase. The remaining increase of approximately $0.2 million resulted from professional fees and other administrative expenses. Net cash used in operating activities for the first quarter of 2024 was $17.1 million, compared to $12.9 million for the first quarter of 2023.

We ended the quarter with approximately $177.7 million of cash, cash equivalents and short-term investments, compared to cash and cash equivalents of $180.6 million at December 31, 2023. The decrease in cash quarter-over-quarter of $2.9 million is primarily the result of non-GAAP adjusted net loss of approximately $19.9 million, offset by a warrant exercise yielding $14 million in proceeds and working capital adjustments of approximately $3 million. I will now hand the call back to Brian.

Brian Sullivan: Thank you, Vicky. Operator, could you please open the call for questions?

Q&A Session

Operator: Thank you. [Operator Instructions] Your first question is from Maury Raycroft from Jefferies. Please ask your question.

Unidentified Analyst: Hi. Good afternoon. This is Yao [ph] on for Maury. Thanks for taking our questions. So, for the Phase 3 study, can you remind us how the primary analysis is going to be triggered in terms of events and maturity? And what were the PFS assumptions for treatment and control that went into the guidance of second half 2024 topline data?

Brian Sullivan: Sure. Well, the study primary analysis will be triggered by hitting an event threshold number of events and that’s independent of follow-up, although there are assumptions made about the follow-up period to derive an estimate of the timing when we would expect those events to occur and which informs the sample size assumptions. We haven’t published the assumptions we used to do that analysis, but we have presented data and there’s publicly available data, particularly for fulvestrant, that suggests that 2 months to 3.5 months would be the most likely in that range, probably centering around 2.7 months for fulvestrant.

Unidentified Analyst: Maybe a quick follow-up. You recently said some KOLs think the bar for well-type patients is 8-month PFS or 5-month delta versus fulvestrant. And there is one everolimus study in post-CDK4/6 patients that showed PFS in that ballpark. So how does the current trial compare to the everolimus trial and what in the current trial gave you confidence that you should show better PFS? Thanks. I’ll hop back in the queue.

Brian Sullivan: So all the numbers for PFS should be on a relative basis, because obviously, it’s relative to the control. And I think generally KOLs think or would consider a clinically meaningful benefit to be about 3 months. Certainly more is better. But that’s the threshold. If you’re referring to, I’m not sure which everolimus study you’re referring to, could you tell me which study you’re referring to?

Unidentified Analyst: I think you recently said one of the everolimus study in the post-CDK4/6 patients that showed PFS in the, I think, maybe 6 months to 8 months.

Brian Sullivan: No. Okay. That’s why I asked. That’s not correct. So there’s been some retrospective analyses of everolimus that doesn’t break out what their activity is between PIK3CA wild type and mutant patients. But those retrospective analyses, there are three of them and if you aggregate the data and weight it for the number of patients in each study, the median PFS was 4.2 months. But again, given the non-clinical data which suggests everolimus is more likely to be more effective in patients with mutations than not with mutations, I think there’s an open question about how effective everolimus is in the wild type — PIK3CA wild type patients. And as I mentioned, there’s been no randomized data that provides any informed information or credible data about the activity of the drug in patients who’ve received prior CDK4/6s.

Unidentified Analyst: Oh! I see. Thanks for the clarification. That was really helpful and thanks so much for taking our questions again.

Brian Sullivan: You’re welcome.

Operator: Thank you. Your next question is from Tara Bancroft from TD Cowen. Please ask your question.

Tara Bancroft: Hi. Good afternoon. I have one clarifying question. Can you explain the reasoning that you have behind stratifying patients by six months on prior therapy versus 12 months, as these are chemo-naive patients, and that essentially implies that many will have a longer time on prior therapy? And do you expect that the prior therapy will be almost entirely all prior CDK4/6, or will it be including others like everolimus or SERD, too, if it’s appropriate, as you know, the time on prior CDK4/6 specifically is important for outcomes? So it’ll be helpful to know. Thank you.

Brian Sullivan: Sure. So the stratification factor for prior treatment duration was based on ESMO guidelines, which define endocrine resistance in the advanced setting as less than — patients receiving less than six months PFS in endocrine therapy. So we felt that was a validated way of defining a patient population. There’s a clear demarcation in responsiveness, the subsequent round of chemotherapy, which is why the benchmark or that guideline identified six months as the threshold. To the extent that people want to look at more than 12 months, I would say, the bulk of the differentiation in outcomes probably occurs in six months. And so what you’ll see is a bit of an upward-sloping curve, that correlates highly with prior treatment that is much more gradual than the curve for patients who have progressed on less than six months.

And what you’ll see when you’re looking at some data for therapies under development, particularly the SERDs, it appears the strategy or the patient population they’re going after really sets who they’re enrolling in some of their studies are patients who have — they’re only enrolling patients who’ve had more than six months of benefit PFS on their prior endocrine therapy. So essentially, they’re selecting out the patients who are endocrine resistant. In our study, since we set the meaningful and important group of patients to treat, we are including those patients. Stratification variable factor, though, allows us to do an analysis and make sure that the arms of the study are well-balanced.

Tara Bancroft: Okay. Thank you so much. Perfect.

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

Brad Canino: Thank you and good to see the reiteration of the second half 2024 topline guidance. Brian, maybe another timing question to layer on top of that. I’m just wondering, how important is it for your strategy to be able to report the full data for the wild type cohort at the San Antonio Breast Cancer meeting in December?

Brian Sullivan: Yeah. Again, what’s going to be most important is what the data says. And it’d certainly be nice if the data was available, we could present it. I don’t think it’s essential, to be frank. I think it’s a very secondary consideration and we don’t control the timing of that and there’s other complicating factors that you have to weigh. So we’ll see, basically. But I don’t think it’s a nice-to-have, not a need-to-have, and certainly, what’s more important is the data itself.

Brad Canino: Okay. And then you also mentioned in your comments about the prior chemo and bone-only patient factors between your Phase 2 and Phase 3. Could you point us to any data that might help quantify the degree of impact these factors can have on durability and PFS or any other comments on how you think about the potential directional impact? Thank you.

Brian Sullivan: Sure. So there’s data across many tumor types that will show patients who’ve received chemo and then are subsequently treated on targeted therapy will have a worse outcome than patients who hadn’t had prior chemo. In the breast cancer space, I guess, the data that’s probably most meaningful was reported out of the BYLieve study. Cohort A enrolled kind of a first-line, second-line population, no chemo, chemo-naive patients. And then Cohort C of that study enrolled or allowed patients who had prior chemo to enroll. And so it was more of a second-, third-line study. The Cohort A, which is more similar to the patient population we’re enrolling, reported 7.3 months. Cohort B, about 5.5 months or 5.6 months.

So essentially a 30% delta in favor of the patients who are chemo-naive and that’s probably a relevant benchmark just because they’re hitting a similar pathway. As far as bone-only impact, and essentially when you say bone-only, there’s one qualification. Patients who are enrolling are bone-only, but they have to have a measurable lytic lesion so you can measure PFS. But in the PALOMA-2 study for palbociclib, they did a follow-up analysis and found that patients with bone-only disease had 38 months or 50% greater PFS than patients who had only vis — that had visceral disease, not bone-only disease, which suggests, obviously, there’s a much better — mush more favorable prognosis for bone-only patients who are more likely to get a favorable response to targeted therapy, at least one that includes a CDK4/6 inhibitor.

Brad Canino: Thank you.

Operator: Thank you. Your next question is from Chase Knickerbocker from Craig-Hallum. Please ask your question.

Unidentified Analyst: Good afternoon, everyone. This is Connor [ph] on for Chase. Thanks for taking my question. I just have one here today. Last quarter, you brought on Eldon Mayer to prepare for a commercial launch of data. Since then, what initiatives has he implemented or plan on implementing to prepare for the launch on your own?

Brian Sullivan: Thanks for the question. I’m very happy to have Eldon on board. As folks who’ve invested in the space know, the preparation time for a launch is quite long. And I think launch preparation takes place in two time buckets. I would say there’s the T minus 12, launch minus 12 months’ bucket, which is the most intense and expensive time. And that time can be gated or really be gone once you have your Phase 3 data, essentially when you can really fully flesh out your product profile and be much more specific when you’re doing research and characterize your positioning and your overall messaging in the marketplace and you able to put together dossiers, et cetera, for payers. So we’re in the T minus 24 timeframe, right?

We’re in between month 12, T minus 12, and let’s say, T minus 20 or so. And so the work that we’re focused on now is, A, building the initial team. You need to bring on people who can lead the marketing effort, business operations effort, the manage market effort and that we are on track with identifying and getting those people on board. And that — those are individuals. Those are not teams. And then you start to do research which — and lay out the overall plan. So, I would say, the main focus for us by the end of this quarter was to essentially develop a preliminary plan, which would identify organizational structure. That will be required, in particular, by month over the next, let’s say, 20 months or so. The budget that’s associated with that during that timeline, as well as post-launch, the first year of commercialization.

We’ve identified the cross-departmental dependencies or that will require support of the launch, whether it’s IT or administrative support or clinical operations support, medical affairs support, et cetera. And so — and then making sure that all that work is aligned with the landscape as we see it today or as we see it evolving down the road.

Unidentified Analyst: Awesome. Thanks for the question.

Brian Sullivan: You’re welcome. Thank you.

Operator: Thank you. [Operator Instructions] Your next question is from Gil Blum from Needham & Company. Please ask your question.

Gil Blum: Hi, everyone, and thanks for taking our question. So, maybe a bit of a rewording on a couple of previous ones here. So, given you’re enrolling patients with better-expected outcomes, shouldn’t this overall extend timelines for study readout? I mean, increased benefits should be evenly spread across the treatment arms. But I’m assuming this went into your calculations? Thank you.

Brian Sullivan: It did. But I would say, though, there’s a cap on the potential for fulvestrant. If you look at the data, I don’t think there’s any data that has been reported in this patient population that suggests, excuse me, that fulvestrant can do more than 3.7 months. If you aggregate the data that’s been reported, you’d see it’s about 2.7 months. If you look at the error bars on the data that has been reported, the upper bound, the 95% confidence interval is around 3.8 months. You can nudge that up and round it to 4 months. But just given the mechanism and those results, we think that there’s much less upside, I guess, due to a more favorable patient population than there is by treating untreated disease mechanism, which is what we’re doing with gedatolisib.

Gil Blum: All right. Thank you. That’s very helpful.

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

Brian Sullivan: Well, great. Well, thank you again for participating in our call today and for your ongoing support and interest in our company. We’re participating in a number of conferences in the coming months and look forward to interacting with many of you soon. I hope you have a great evening. Good-bye.

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