Earnings call transcript: Celcuity Q1 2025 reports wider loss, stable stock

Celcuity LLC reported a larger-than-expected loss for Q1 2025, with earnings per share (EPS) of -$0.86, missing the forecast of -$0.72. Despite the earnings miss, the stock remained stable in aftermarket trading, closing at $10.86, a slight 0.37% increase from its previous close. According to InvestingPro data, the company’s stock currently trades below its Fair Value, suggesting potential upside opportunity. InvestingPro analysis reveals 8 key investment tips for Celcuity, including insights about its cash position and financial health - unlock these valuable insights with an InvestingPro subscription.

Key Takeaways

• Celcuity’s Q1 2025 EPS of -$0.86 missed forecasts by $0.14.
• Stock remained stable post-earnings, closing at $10.86 in aftermarket.
• Strong cash reserves projected to support operations through 2026.
• Ongoing clinical trials with potential significant market impact.

Company Performance

Celcuity’s performance in Q1 2025 showed increased financial strain, with a net loss of $37 million compared to $21.6 million in Q1 2024. The company is investing heavily in research and development, with expenses rising from $20.6 million to $32.2 million year-over-year. InvestingPro analysis indicates the company is quickly burning through cash, though it maintains more cash than debt on its balance sheet. Despite these challenges, Celcuity remains focused on advancing its clinical trials, which are crucial for future growth. Get detailed insights into Celcuity’s financial health and growth prospects with InvestingPro’s comprehensive research report.

Financial Highlights

• Revenue: Not provided for Q1 2025.
• Earnings per share: -$0.86, down from -$0.64 in Q1 2024.
• Cash and investments: $205.7 million, expected to fund operations through 2026.

Earnings vs. Forecast

Celcuity’s EPS for Q1 2025 was -$0.86, missing the forecast of -$0.72 by $0.14. This represents a significant deviation from expectations, highlighting the impact of increased R&D expenditures on the company’s financial results.

Market Reaction

Despite the earnings miss, Celcuity’s stock price saw a slight increase of 0.37% in aftermarket trading, closing at $10.86. The stock’s stability suggests that investors may be focusing on the company’s long-term potential rather than short-term financial performance.

Outlook & Guidance

Celcuity anticipates top-line data from its PIK3CA wild-type and mutant cohorts in Q3 and Q4 2025, respectively. Additionally, results from its prostate cancer trial are expected in late Q2 2025. The company maintains a strong cash position to support these initiatives.

Executive Commentary

CEO Brian Sullivan highlighted the potential of gadotelisib, stating, "If proven effective, gadotelisib in combination with fulvestrant and palbociclib could offer a new standard of care." CFO Vicki Hahn emphasized financial stability, noting, "We expect this cash, cash equivalents, and short-term investments to fund current clinical development program activities through 2026."

Risks and Challenges

• Increased R&D expenses could continue to pressure financial performance.
• Delays in clinical trial data readouts may affect revenue timelines.
• Competitive pressures in the cancer treatment market could impact market share.

Celcuity’s Q1 2025 results highlight a challenging financial landscape, balanced by promising clinical developments and a strong cash position. The company’s ability to navigate these challenges will be crucial in determining its future trajectory.

Full transcript - Celcuity LLC (CELC) Q1 2025:

Conference Operator: would now like to turn the conference over to Apoorva Chiluri with ICR Healthcare. Please go ahead.

Apoorva Chiluri, IR Representative, ICR Healthcare: Thank you, operator, and good afternoon to everyone. Thank you for joining us to review Celcuity’s first quarter twenty twenty five financial results and business update. Earlier today, Celcuity, Inc. Released financial results for the first quarter ended 03/31/2025. 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 Hahn, Chief Financial Officer as well as Igor Gorbachevsky, Chief Medical Officer, who will be available during Q and 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 Cellcuity.

Please go ahead.

Brian Sullivan, CEO and Co-Founder, Celcuity: Thank you, Oparova. Good afternoon, everyone, and thank you for joining our first quarter financial results conference call. We have an exciting year ahead of us with multiple upcoming clinical data readouts. We expect to report top line data from the PIK3CA wild type patient cohort of our Phase III VICTORIA-one trial in Q3 twenty twenty five and from the PIK3CA mutated patient cohort in Q4 twenty twenty five. We also anticipate reporting preliminary top line data for the phase 1B portion of our phase 1B2 trial in prostate cancer in late second quarter.

And finally, we made great progress activating trial sites for our phase three first line Victoria two trial, over the past few months. In our view, each of our three programs has the potential to generate significant levels of revenue. If these programs ultimately result in regulatory approvals, we estimate that nearly two hundred thousand late stage cancer patients globally, would be eligible to be treated with gadotelisib. Let’s turn now to our VICTORIA-one trial. Our Phase three VICTORIA-one trial, is designed to evaluate gadotelisib in combination with fulvestrant with and without palbociclib.

In patients with hormone receptor positive HER2 negative advanced breast cancer whose disease has progressed on or after treatment with a CDK foursix inhibitor. The Victoria one trial includes two patient cohorts with independent statistical analysis plans and primary endpoints. The primary endpoints for VICTORIA-one are progression free survival or PFS as assessed by blinded independent central review. Study is designed to independently evaluate a PIK3CA wild type cohort and a PIK3CA mutant cohort. For the PIK3CA wild type cohort, there are two primary endpoints that will be tested hierarchically, whereas the PIK3CA mutant patient cohort has a single primary endpoint.

The primary analysis for each patient cohort is triggered upon reaching a predefined number of progression events. And based on the current blinded event rates, we anticipate the primary completion of the PIK3CA wild type patient cohort will occur in June, which would allow us to announce in a press release, top line data in the third quarter, and to present full results from this patient cohort at a medical conference later in 2025. If positive, we expect the data will support our first new drug application and if approved, our transition to a commercial stage company. If proven effective, gatatolizumab in combination with fulvestrant and palbociclib could offer a new standard of care for patients with HR positive, HER2 negative advanced breast cancer, whose disease progressed on or after treatment with a CDK foursix inhibitor. For the PIK3CA mutant patient cohort, we anticipate reporting top line data in the fourth quarter of twenty twenty five.

The current second line treatment paradigm for HR positive HER2 negative patients with advanced breast cancer includes selective estrogen receptor degraders or SERDs like fulvestrant or elacitrant as single agents, or one of three approved PAM inhibitors combined with endocrine therapy. However, each of the PAM inhibitors only targets a single PAM nodes such as PI3K alpha, AKT or mTORC1, which is suboptimal because the uninhibited PAM nodes can induce compensatory resistance. In patients who’ve received prior treatment with a CDK foursix inhibitor, none of these single node PAM inhibitors have demonstrated efficacy in patients who have PIK3CA wild type tumors. While only the PIK3CA 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 three to four times less potent than breast cancer cells without PIK3CA mutations than in those with them.

Of course, we recognize the foundation of gadathalisib’s role in this treatment landscape will require that gadathalisib be well tolerated and report a clinically meaningful result measured in terms of the incremental improvement in both PFS and the hazard ratio relative to standard of care. Breast cancer KOLs and regulators generally consider an incremental improvement in PFS of three months relative to its control to be clinically meaningful. Current MPFS or medium progression free survival benchmarks for patients pretreated with a CDK foursix inhibitor patient population we are evaluating are modest. Only two non chemo related therapies have been evaluated in this patient population and received approval. One reported a one point nine month incremental median PFS improvement relative to its comparator in patients with ESR1 mutations.

The other did not report median progression free survival improvement relative to current standard of care, but it did report a more favorable safety profile in patients with PIK3CA mutations. Despite the modest or no efficacy improvements on this benchmark, both of these recently approved drugs has experienced rapid market adoption and penetration. Each drug reached revenue run rates within the first twelve months of launch estimated to be, nearly half a billion dollars despite approvals that only address thirty to forty percent of the eligible second line patient population. We believe this demonstrates the significant interest amongst oncologists for new treatment options for these patients and the relatively low bar required to obtain adoption and market penetration. Potentially more important data point than incremental PFS benefit to consider in advanced breast cancer when assessing the clinical benefit of therapeutic regimen relative to another is the hazard ratio.

And this is because recent randomized studies evaluating therapies for patients with HR positive, HER2 negative advanced breast cancer have enrolled widely heterogeneous patient populations. Since physicians make different treatment decisions for patients depending on among other factors, how many lines of therapy, how well they responded to prior therapy and which type of therapy they may have received, results from these studies can be hard to interpret using absolute median PFS or incremental PFS benefit alone. As a result, top line and PFS results from these studies don’t provide sufficient clarity about the actual benefit the particular patient population may receive. The hazard ratio essentially factors out the differences in study populations and thus provides physicians with a more objective benchmark. We must not only hope to report a hazard ratio that is statistically significant, but one that compares favorably to the hazard ratio reported for other therapies available for second line patients whose disease progressed while receiving a CDK4six inhibitor.

If gaditalisib ultimately does receive FDA approval for both the PIK3CA wild type and mutant populations, we estimate the peak revenue potential for this second line indication could exceed $2,000,000,000 with just 40% market penetration. I’d like now to turn to our first line breast cancer program in our VICTORIA-two trial. The VICTORIA-two study is a global phase three open label randomized clinical trial evaluating the efficacy and safety of gaditalisib in combination with fulvestrant plus investigators choice of either rivociclib or palbociclib as a first line treatment for patients with HR positive, HER2 negative advanced breast cancer and these patients are endocrine therapy resistant. Approximately six thirty eight subjects will be assigned to a cohort based on their PIK3CA mutation status. The primary PFS endpoint for each of the cohorts will be evaluated independently.

Prior to initiation of the phase three portion of the trial, a safety run-in study will be conducted in 12 to 36 participants to assess the safety profile of gatatulisib in combination with rivociclib and fulvestrant. And during the first quarter, we completed our site qualification activities and we’re now focused on activating the nearly 200 sites we’ve qualified across North America, Europe, Latin America, and Asia Pacific. We’ve also begun screening patients and expect to dose our first patient during the second quarter. Current standard of care first line treatment for most endocrine therapy resistant patients includes any of the three approved CDK4six inhibitors combined with fulvestrant. Results from a recent trial suggest that the median PFS period for patients receiving one of these three regimens is only seven to eight months and these results compare poorly to the median PFS of twenty five to twenty seven months reported for patients who are sensitive to endocrine therapy and who receive a similar regimen, highlighting the significant need for more effective therapies for patients with advanced breast cancer that are resistant to endocrine therapy.

Now I’d like to turn to our Phase 1btwo trial that’s evaluating the safety and efficacy of gadgetalisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer whose disease progressed while receiving a next generation androgen receptor inhibitor. The Phase 1btwo study evaluates gatatulisib in combination with darolutamide, which is an androgen receptor signaling inhibitor in patients with metastatic castration resistant prostate cancer. We’ve completed enrollment of the phase 1b dose escalation portion of the study and anticipate reporting top line data by the end of the second quarter of this year. Since we’re at an earlier phase in this program, our focus is optimizing the dose and schedule for this tumor type and drug combination. This data set will include approximately thirty six patients, half of whom will have received a one hundred and twenty mg dose of gaditalisib, the other half a one hundred and eighty milligram dose.

Each are administered on a three week on, one week off schedule. We’re comparing both the landmark PFS at six months and safety profile of these two arms to each other and to historical control data for second line metastatic castration resistant prostate cancer patients who were retreated with an androgen receptor inhibitor. And finally, we’re excited about the opportunity we announced today to collaborate with the Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate getatolizumab in combination with bemacyclib and letrozole in patients with endometrial cancer. The rationale to initiate this study is based on compelling historical clinical data that indicates women with ER positive or type one endometrial cancer may benefit from treatment with a PI3KAKT mTOR inhibitor like getatolizumab in combination with endocrine therapy. Additionally, results from a prior phase two clinical study evaluated gaditalisib as a monotherapy in patients with either type one or type two endometrial cancer and these results were encouraging.

So I’d like now to turn the call over to Vicki to review our finances.

Vicki Hahn, Chief Financial Officer, Celcuity: Thank you, Brian, and good afternoon, everyone. I’ll provide a brief overview of our financial results for the first quarter of twenty twenty five. Our first quarter net loss was $37,000,000 or $0.86 per share, compared to $21,600,000 net loss, or $0.64 per share for the first quarter of twenty twenty four. Our non GAAP adjusted net loss was $34,700,000 or $0.81 per share for the first quarter of twenty twenty five, compared to non GAAP adjusted net loss of $19,900,000 or $0.59 per share for the first quarter of twenty twenty four. Research and development expenses were $32,200,000 for the first quarter of twenty twenty five, compared to $20,600,000 for the first quarter of twenty twenty four.

Of the approximately $11,600,000 increase in R and D expenses, dollars 5,900,000.0 was related to increased employee and consulting expenses, and $5,700,000 primarily related to activities supporting our ongoing clinical trials. General and administrative expenses were $3,900,000 for the first quarter of ’twenty five, compared to $1,800,000 for the first quarter of twenty twenty four. Increased employee and consulting related expenses accounted for $1,600,000 of the increase. Professional fees, expanding infrastructure, and other administrative expenses accounted for the remaining increase of approximately $500,000 Net cash used in operating activities for the first quarter of twenty twenty five was $35,900,000 compared to $17,100,000 for the first quarter of twenty twenty four. We ended the quarter with approximately $205,700,000 of cash, cash equivalents, and short term investments.

We expect this cash, cash equivalents, and short term investments, and drawdowns on our debt facility to fund current clinical development program activities through 2026. I will now hand the call back to Brian.

Brian Sullivan, CEO and Co-Founder, Celcuity: We’re now ready, to turn the call over for questions.

Conference Operator: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number one 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 the star followed by the number two.

If you are using a speakerphone, please lift the headset before pressing any keys. One moment, please, for your first question. Your first question comes from the line of Maury Raycroft from Jefferies. Your line is now open. Please go ahead.

Maury Raycroft, Analyst, Jefferies: Hi. Congrats on the progress, thanks for taking my questions. I was going to ask one on Victoria one, you’re using the blind independent central review analysis which can take longer, can take a longer amount of time to analyze versus investigator assessed And so just wondering if you can provide more perspective on how long you think it will take to lock the data set sometime in June and then to get to the actual results in 3Q. Just wondering if you can give more perspective on the amount of time there.

Brian Sullivan, CEO and Co-Founder, Celcuity: Sure, the primary completion date, essentially is referencing the data cutoff date, when you stop collecting data. And that’s typically done, in our case will be done, when you’ve achieved the prescribed event threshold. And so from there, you are engaged in the data cleaning process and ultimately, at that point, you lock the database. So we expect that in Q3 and if we achieve what we are very confident about achieving with completing primary completion date, we think that Q3 is absolutely certain time when we would have the data available. And, you know, we’re not going to get into more specificity in terms of month.

But again, I think there’s no further risk of delay at this point in the trial of being able to report these results.

Maury Raycroft, Analyst, Jefferies: Understood. But I guess for that amount of time from locking the database to reporting the data, any general estimate on how long that could take?

Brian Sullivan, CEO and Co-Founder, Celcuity: I mean, typically you would see no more than three months, typically less than that.

Andrew Berens/Ethan, Analyst, Leerink: Okay. Got

Maury Raycroft, Analyst, Jefferies: it, okay. And then understanding that overall survival might not be fully mature at the top line, do you think you would be able to provide some sort of an update on just the directionality of survival trend that you’re seeing between the three arms at the data readout?

Brian Sullivan, CEO and Co-Founder, Celcuity: The data readout that we expect to make in a press release will only include the median PFS and the hazard ratios for the two primary analyses. The subsequent data will be analyzed, or rather presented, at the medical conference later in the year.

Maury Raycroft, Analyst, Jefferies: Got it, okay. I’ll stop there and hop back in the queue. Thanks for taking my questions.

Brian Sullivan, CEO and Co-Founder, Celcuity: Okay, thanks.

Conference Operator: Your next question comes from the line of Andrew Berens from Leerink. Your line is now open, please go ahead.

Andrew Berens/Ethan, Analyst, Leerink: Hi, good afternoon. This is Ethan on for Andy. Thanks for taking our question. I wanted to get your thoughts on the potential impact of SERNA6 on the second line setting for HR positive patients. Just curious, what could broad adoption from this mean for get a wild type population and also kind of a similar question, what could the potential impact be together in the mutant patient population as well?

Thank you.

Brian Sullivan, CEO and Co-Founder, Celcuity: Sure. Well, we don’t think that would affect us at all. These are still essentially first line CDK foursix patients. It’s actually current practice amongst many doctors, depending on the profile of their patients to transition them off letrozole to fulvestrant depending on how they believe their patients are progressing. So this trial essentially identified a more precise way of determining the timing and what appears to be a very effective way of doing But the patients in our trial are essentially consistent with the patients that this trial evaluated, which were patients who received CDK4six and eventually progressed.

And so if our data is favorable, we would expect physicians to then seek to continue treatment with a CDK4six inhibitor with one that includes gaditalicit. And I don’t think the practice will vary between those patients who lack PIK3CA mutations versus those who do have PIK3CA mutations. I think the primary effect may be on how other CDK foursix plus oral SIRD combinations get used. Operator?

Conference Operator: Yes. Your next question comes from the line of Tara Bancroft from TD Cowen. Your line is now open. Please go ahead.

Tara Bancroft, Analyst, TD Cowen: So, was wondering if you could provide any updated thoughts on what minimum HR you would consider to be good data in the wild type update, not just for hitting stats, but in relation to other data sets in medication like Serena six that was just mentioned and other marketed products. And what do KOLs want to see in order to use it? Thanks so much.

Brian Sullivan, CEO and Co-Founder, Celcuity: No, I appreciate the question. At this time, with the data fairly imminent, we’re not gonna comment specificity about those types of projections. We’ve commented, because the analysis is easier to do, that an incremental three months, would, be considered clinically meaningful. Certainly, any statistically significant hazard ratio that’s consistent with three months would also be considered clinically meaningful. How the regimen and the results specifically stack up against other regimens, you know, will just be a function of how those two sets of data compare.

Vicki Hahn, Chief Financial Officer, Celcuity: Okay, great. Thanks.

Conference Operator: Your next question comes from the line of Gil Blum from Needham and Company. Your line is now open. Please go ahead.

Andrew Berens/Ethan, Analyst, Leerink: Good afternoon, and thanks for taking our question. So, to fully clarify this, what exactly drove the slight change in timing for the wild type readout? And should we expect to see no change in the PIK3CA timeline? And

Brian Sullivan, CEO and Co-Founder, Celcuity: as

Andrew Berens/Ethan, Analyst, Leerink: a follow on, what investment, if any, would you need to do to support the endometrial cancer collaboration? Thank you.

Brian Sullivan, CEO and Co-Founder, Celcuity: Sure. As far as what drove it, again, I think we’ve indicated on prior calls that because this is a three arm trial and the primary analysis is driven by reaching an event threshold in each of two different analyses, it’s imprecise for us to estimate the timing. Think there’s this variance in how those results are distributed within the three, the aggregate total of events for all three arms. And we’re now at a point where, you know, the potential for variability is de minimis and so that’s why we have confidence about being able to establish a data cutoff in June. And as far as Q4 for the PIK3CA mutant, you know, confident about that.

It’s a less complicated tracking of event threshold because even though they’re three arms, you know, the third arm comprises only about 15% of the total. So the primary analysis event threshold is much more closely aligned to the aggregate of the three arms. And as far as the endometrial study that we announced, we are supplying drug product and providing clinical support to that study. So we don’t think we’ll have any incremental financial effect on the company.

Maury Raycroft, Analyst, Jefferies: Operator?

Conference Operator: Next question comes from the line of Oliver McCammon from LightSide Capital. Your line is now open. Please go ahead.

Maury Raycroft, Analyst, Jefferies: Hi. Thanks for the update and taking my question. Maybe we’ll take a break from Victoria one for a moment. I’m curious if you can just remind us on some of the prior proof of concept data for targeting the PI3KAKT mTOR pathway in prostate cancer, and more specifically, you think the potential is for multi node inhibition versus single node inhibitors like capivacertib? And then I’m also curious if you plan to share PSA data at the time of the update late in the second quarter.

Thanks again for the question.

Brian Sullivan, CEO and Co-Founder, Celcuity: Sure. And so the data that’s been reported with either in particular AKT inhibitors, those have been the inhibitors from this general class of drugs that have been evaluated in patients with metastatic castration resistant prostate cancer. Now capivacitor reported positive data with patients who have hormone sensitive prostate cancer that was favorable in patients who have P10 mutations, and so a subgroup of the total population. You know, the non clinical data that we’ve reported and published indicates AGet is equally active independent of the status of P10, which is the primary mutation in prostate cancer. And know, caprovastarib hasn’t demonstrated activity or it’s significantly less active in tumor cells, prostate tumor cells that lack P10 mutations.

And so we think that data is encouraging because it demonstrates the role of the pathway plays. And similar to breast cancer, gadotelisib in non clinical models has shown to be significantly more potent and cytotoxic than let’s say an AKT inhibitor like capivaciturb or the other drugs that have been approved that address the PAM pathway. And so that was a major part of the rationale for evaluating get a in this setting that A) the pathway has been demonstrated to be approved and B) the drugs that have demonstrated activity are at least non clinically, less active than Geta, which we think creates a very strong rationale for the trial. As far as the update, you know, the update will really just focus on the primary analysis and safety data And then the rest of the data we would expect to report at a medical meeting in 2025.

Maury Raycroft, Analyst, Jefferies: Super helpful. Thank you again.

Brian Sullivan, CEO and Co-Founder, Celcuity: You’re welcome.

Conference Operator: There are no further questions at this time. Please continue, Mr. Brian Sullivan.

Brian Sullivan, CEO and Co-Founder, Celcuity: Well, thank you. We appreciate your interest in CellCuity, and we’ll be attending and presenting at several investor conferences over the next few weeks. So I look forward to seeing some of you there. Goodbye.

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

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