Celcuity Q1 2026 Earnings Report

Celcuity EPS Results

• Actual EPS: -$0.97
• Consensus EPS: -$1.07
• Beat/Miss: Beat by +$0.10
• One Year Ago EPS: N/A

Celcuity Revenue Results

• Actual Revenue: N/A
• Expected Revenue: $2.94 million
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Celcuity Announcement Details

• Quarter: Q1 2026
• Date: 5/14/2026
• Time: After Market Closes
• Conference Call Date: Thursday, May 14, 2026
• Conference Call Time: 4:30PM ET

Celcuity (NASDAQ:CELC) is a clinical-stage biotechnology company specializing in precision oncology diagnostics. The company develops and commercializes predictive biomarker assays designed to identify which patients are most likely to benefit from targeted cancer therapies. By integrating functional profiling of tumor cells with molecular analyses, Celcuity seeks to optimize treatment selection and improve outcomes for patients with solid tumors.

Celcuity’s proprietary platform evaluates tumor cell sensitivity to various therapeutic agents using ex vivo assays that measure DNA damage response and other critical pathways. These assays are intended to serve as companion diagnostics, guiding the use of therapies such as PARP inhibitors and other targeted molecules in oncology. In addition to its core diagnostic offerings, Celcuity collaborates with pharmaceutical companies to co-develop new companion tests alongside emerging drug candidates, aiming to streamline clinical development and regulatory approval.

Headquartered in Malvern, Pennsylvania, Celcuity was founded in the mid-2000s by a team of scientists and clinicians with extensive experience in cancer biology and diagnostic innovation. The company’s operations are primarily focused on the North American market, where it provides testing services through its CAP-accredited and CLIA-registered laboratory. Celcuity’s leadership team brings together expertise in biopharma partnerships, clinical diagnostics, and regulatory affairs to advance its pipeline of precision oncology solutions.

Celcuity Q1 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Celcuity reported positive top-line Phase III VIKTORIA-1 results in the PIK3CA mutant cohort, with both the triplet and doublet gedatolisib regimens showing statistically significant and clinically meaningful PFS improvements versus alpelisib plus fulvestrant.
• Positive Sentiment: Management said gedatolisib regimens were generally well tolerated with manageable safety profiles and no new safety signals, supporting the company’s view that the drug could be a differentiated option in advanced breast cancer.
• Positive Sentiment: The company expanded VIKTORIA-2 to include a new first-line study in endocrine-sensitive HR-positive, HER2-negative advanced breast cancer, broadening the potential patient population beyond the original endocrine-resistant design.
• Positive Sentiment: Celcuity said it is advancing a subcutaneous formulation of gedatolisib and has filed its first patent application, aiming to support longer-term use and potentially improve convenience versus infusion.
• Neutral Sentiment: Financial results showed a larger quarterly loss and higher spending, driven mainly by increased R&D, commercial buildout, and launch preparations, while the company ended the quarter with $387.1 million in cash and expects funding to last through 2027.

Presentation

[Operator]

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

[Jodi Sievers, Corporate Communications and Investor Relations at Celcuity]

Thank you, Matthew, good afternoon, everyone. Thank you for joining us to review Celcuity's first quarter 2026 financial results and business update. Earlier today, Celcuity released financial results for the first quarter ended March 31st, 2026. 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 also 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.

[Jodi Sievers, Corporate Communications and Investor Relations at Celcuity]

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 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. With that, I will turn the call over to Brian Sullivan, CEO of Celcuity. Please go ahead, Brian.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Thank you, Jodi, and good afternoon, everyone. Thank you for joining our first quarter 2026 operating and financial update conference call. We continue to make great progress as we prepare for the potential approval and commercial launch of gedatolisib in the third quarter. Achieving these milestones would be a pivotal moment for the women with advanced breast cancer who need new therapeutic options. With the groundbreaking data we have previously reported from the wild-type cohort and the recent announcement of positive data from the mutant cohort of our VIKTORIA-1 study, we believe gedatolisib is well-positioned to become a new standard of care second-line therapy for patients with HR-positive, HER2-negative advanced breast cancer. It's been an eventful past few months for Celcuity.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Last week, we reported positive top-line results for the PIK3CA mutant cohort of the phase III VIKTORIA-1 clinical trial. We look forward to presenting detailed results at a late-breaking abstract oral session at the 2026 ASCO meeting on June 2nd. Given the timing of our ASCO presentation, we will not be answering questions regarding these results during the Q&A portion of our call. Second, this morning, we announced two important updates to our clinical development plan. First, we announced the expansion of our phase III VIKTORIA-2 trial to include a second study evaluating gedatolisib as first-line treatment in patients with endocrine-sensitive HR-positive, HER2-negative advanced breast cancer. We are now positioned to evaluate nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIK3CA status.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

This offers the potential to advance the standard of care for the approximately 90,000 women each year who are newly diagnosed in the U.S. with HR-positive, HER2-negative advanced breast cancer. Secondly, we also announced this morning that we are advancing the development of a gedatolisib formulation for subcutaneous injection and that we have submitted our first patent application to the United States Patent and Trademark Office. The subcutaneous formulation is aimed at supporting potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years. Finally, we remain optimistic about the outcome of the FDA's review of our NDA.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Assuming our NDA is approved, we intend to submit the FDA a supplemental new drug application based on the results of the PIK3CA mutant cohort VIKTORIA-1 and to submit VIKTORIA-1 data for both the mutant and wild-type cohorts to other global regulatory authorities following the sNDA submission. Turning now to the top-line results for the PIK3CA mutant cohort. The primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib, which we refer to as the gedatolisib triplet, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to alpelisib, which is a PI3K alpha inhibitor, and fulvestrant. The secondary endpoint of gedatolisib combined with fulvestrant, which we refer to as the gedatolisib doublet, which was not part of the primary efficacy analysis in a hierarchical order, demonstrated a statistically significant and clinically meaningful improvement in PFS compared to alpelisib and fulvestrant.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Both gedatolisib regimens were generally well-tolerated with manageable safety profiles and no new safety signals. When considered alongside previously presented data from the VIKTORIA-1 PIK3CA wild-type cohort, the gedatolisib regimens have now demonstrated the potential to improve the standard of care in a second-line setting regardless of the PIK3CA status of a patient's tumor. We believe the results from the VIKTORIA-1 study validate our pioneering approach to targeting cancers involving the PI3K, AKT, mTOR or PAM pathway. Researchers have sought for nearly 20 years to develop a drug that blockades this pathway comprehensively without inducing unacceptable levels of toxicity. VIKTORIA-1 represents the first phase III study that demonstrate that comprehensively blocking the PAM pathway can significantly improve outcomes for patients with PIK3CA mutations compared to therapies only targeting a single component of this pathway.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

As we've previously reported, the VIKTORIA-1 PIK3CA wild-type cohort set several new benchmarks for clinical trials evaluating patients with HR-positive, HER2-negative advanced breast cancer. The hazard ratios for the gedatolisib triplet and doublet were more favorable than has ever been reported by any phase III trial for patients with HR-positive, HER2-negative advanced breast cancer. 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 endocrine therapy. The 17.5 months of median duration of response for the gedatolisib triplet and 31% incremental increase in the objective response rate relative to the control for the gedatolisib triplet are the highest reported for an endocrine therapy-based regimen in the second-line setting.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Both regimens were found to have a manageable safety profile that was well-tolerated by patients as evidenced by the 2% and 3% adverse event-related discontinuation rates for the triplet and doublet respectively. We've also previously reported safety and tolerability-related analyses. In particular, for patients who experienced dermatitis, 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 grade 3 stomatitis who received the gedatolisib triplet was 12 and 14 days respectively. To characterize the overall tolerability of the gedatolisib regimens, we reported results from patient-reported outcomes that capture a patient's perception of their overall well-being. Of particular note was the stability of the patient's assessment of their well-being relative to their well-being prior to starting treatment with gedatolisib.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Over the first eight cycles of treatment with gedatolisib, patients reported no degradation in their sense of well-being, which we believe provides meaningful evidence that patients treated with gedatolisib tolerate it well. Let's talk about our VIKTORIA-2 study. Results from the PIK3CA wild type and mutation cohort of our VIKTORIA-1 study demonstrated the benefit of gedatolisib combination treatment in the 2nd line setting of HR-positive, HER2-negative advanced breast cancer. These results confirm the role the PAM pathway plays in patients with or without PIK3CA mutations and the importance of multi-target inhibition of this pathway. Additionally, results from our phase I-B clinical trial provided strong evidence that the PAM pathway is also an important disease driver in treatment-naive patients with advanced breast cancer.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

In the early phase study that we performed, we evaluated gedatolisib plus palbociclib and letrozole as first-line treatment in patients with endocrine-sensitive HR-positive, HER2-negative advanced breast cancer. Median progression-free survival, or PFS, was 48.6 months, which compares favorably to historical data of approximately 25 months for ribociclib plus letrozole. The objective response rate was 79%, which again compares favorably to historical data of 53% for ribociclib plus letrozole. In light of the positive results for the PIK3CA wild type and mutant cohorts of VIKTORIA-1 and the promising preliminary data for our gedatolisib triplet as first-line treatment, we have high confidence that we can successfully develop the gedatolisib triplet for nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIK3CA status.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Successful development in the first-line setting would offer the potential to advance the standard of care for the approximately 90,000 women each year who are diagnosed with late-stage HR-positive, HER2-negative advanced breast cancer in the U.S. To achieve this goal, we amended several important elements of the VIKTORIA-2 study design. First, VIKTORIA-2 will now evaluate the safety and efficacy of patients with endocrine-sensitive HR-positive, HER2-negative advanced breast cancer in addition to those with endocrine-resistant disease, which was the original study. Endocrine-sensitive patients represent approximately two-thirds or 60,000 of the 90,000 women in the U.S. newly diagnosed with advanced breast cancer each year. Current standard of care therapies for these patients provide median PFS of approximately 25 months.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Patients will be assigned manually according to their endocrine sensitivity status to either Study 1 if they are endocrine resistant, or Study 2 if they are endocrine sensitive, and subsequently be randomized to a treatment arm. Each study will have independent statistical analysis plans that will include separate primary endpoints. The primary efficacy analyses for both Study 1 and Study 2 of VIKTORIA-2 will evaluate the entire intent to treat population enrolled in their respective study. Primary endpoints for patient cohorts based on their PIK3CA status are no longer included. This revision of the primary analyses allowed us to reduce the sample size for Study 1, the endocrine-resistant study, from 638 patients to 440 patients without affecting the power of the analysis.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Third, the control arms for Study 1 and Study 2 will evaluate ribociclib combined with either fulvestrant for Study 1 or letrozole for Study 2. Study 1 will enroll patients with treatment-naive endocrine-resistant advanced breast cancer, and these are women whose breast cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. It's a more aggressive disease. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and fulvestrant in arm A and compare that to ribociclib combined with fulvestrant in arm B. We expect to have top-line data by the end of 2028 for this study. Study 2 is expected to enroll approximately 740 subjects with treatment-naive endocrine-sensitive advanced breast cancer.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

These are women whose cancer relapsed or progressed 12 months or more after completion of adjuvant endocrine therapy, or those with de novo metastatic disease who've had no prior endocrine therapy exposure. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and letrozole and compare itself to ribociclib combined with letrozole. The clinical trial primary endpoints for the VIKTORIA-2 clinical trial are progression-free survival per RECIST 1.1 criteria as assessed by blinded independent central review. We expect top-line data for the Study 2 in the endocrine-sensitive patients to be available by 2030. Prior to finalizing this amended phase III trial design, we conducted a Type B meeting with the FDA to obtain their feedback and to gain alignment on these planned amendments.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Knowing that our lifecycle plan would eventually include indications that may offer several years of progression-free survival benefit, we initiated a program to develop a subcutaneous formulation of gedatolisib that would enable a patient to receive gedatolisib as an injection, as an alternative to an infusion. This program is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. This work has resulted in a submission to the United States Patent and Trademark Office of our first patent application for an injectable formulation of gedatolisib. Let's turn to our phase I-B/II trial that's evaluating gedatolisib in combination with darolutamide in men with metastatic castration-resistant prostate cancer. We presented data for the phase I-B portion of the study at a poster presentation at ESMO last year.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

In this portion of the trial, 38 patients were randomly assigned to receive standard doses of darolutamide twice daily and either 120 milligrams of gedatolisib in arm one or 180 milligrams of gedatolisib in arm two. The combination of gedatolisib and darolutamide was generally well-tolerated in the trial and 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. For all patients treated, the six month radiographic PFS rate was 67%, and the median radiographic PFS was 9.1 months. These results compare favorably to historical results of a 40% six-month radiographic PFS rate for patients with metastatic castration-resistant prostate cancer who are treated with an androgen receptor inhibitor as second-line treatment.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Enrollment of patients in the dose escalation portion of the trial is ongoing. We expect to provide a data update at an upcoming medical conference. 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 over 24 months ago. Last call, we mentioned that we had largely completed building the commercial organization, except for the sales force. I'm excited to report now that we have since hired and onboarded all of our oncology sales specialists. They're a very experienced crew. On average, these individuals have 24 years of experience selling pharmaceuticals and 16 years of experience in oncology.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

They're an incredibly talented group of individuals who have a strong track record of successfully launching novel oncology therapeutics. Key efforts today include continuing our extensive outreach across the country to payers, strategic accounts, which include health systems, integrated delivery networks, and community oncology practices. We're also very encouraged by the results of research we've continued to field 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. Now, with positive results from our study with patients whose tumors have PIK3CA mutations, we expect the gedatolisib combination regimens to be uniquely positioned to provide second-line therapy for patients regardless of their PIK3CA mutation status.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Based on the analysis of published epidemiological data, we estimate there are 37,000 patients in the U.S. receiving second-line treatment for HR-positive, HER2-negative advanced breast cancer. 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 annually. Given the significant penetration our research is suggesting we can achieve, we believe it's reasonable to estimate that a second-line indication for gedatolisib can potentially generate peak revenue of up to $2.5 billion annually. The progress we've made today is encouraging, and we look forward to providing with updates over the next few quarters.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Gedatolisib is well-positioned to address critical needs in the second-line space with its unique mechanism of action and potential first-in-class best-in-class safety and efficacy profile. This gives us an exciting opportunity to advance potential blockbuster indications in breast cancer and prostate cancer, while also aggressively preparing for and potentially launching gedatolisib commercially should we receive FDA approval. Now I'd like to hand the call over to Vicky to review our finances.

[Vicky Hahne, CFO at Celcuity]

Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the first quarter 2026. Our first quarter net loss was $52.8 million or $0.97 per share, compared to a net loss of $37 million or $0.86 per share for the first quarter of 2025. Our non-GAAP adjusted net loss was $46.8 million or $0.86 per share for the first quarter of 2026, compared to non-GAAP adjusted net loss of $34.7 million or $0.81 per share for the first quarter of 2025.

[Vicky Hahne, CFO at Celcuity]

Research and development expenses were $33.1 million for the first quarter of 2026, compared to $29.8 million for the prior year period. The $3.3 million increase was primarily due to a $3 million increase in employee-related and consulting expenses. The remaining increase was primarily due to a $5.4 million increase in manufacturing and other costs, partially offset by a $5.1 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VIKTORIA-1 phase III clinical trial. Selling, general, and administrative expenses were $17.4 million for the 1st quarter of 2026, compared to $6.3 million for the prior year period.

[Vicky Hahne, CFO at Celcuity]

The $11.1 million increase was primarily due to an $8.7 million increase in employee-related and consulting expenses, of which $6.6 million was due to commercial headcount additions and other launch-related activities. The remaining $2.4 million increase was primarily due to software costs, professional fees, and other administrative costs. Net cash used in operating activities for the first quarter of 2026 was $55.1 million, compared to $35.9 million for the prior year period. The additional cash in operating activities quarter-over-quarter of $19.2 million was primarily due to non-GAAP adjusted net loss of $12.1 million and working capital adjustments of $7.1 million. Cash, cash equivalents, and short-term investments were $387.1 million at the end of first quarter 2026.

[Vicky Hahne, CFO at Celcuity]

We expect cash equivalents, and investments and drawdowns on our debt facility to finance our operations through 2027. I will now hand the call back to Jodi.

[Jodi Sievers, Corporate Communications and Investor Relations at Celcuity]

Thanks, Vicky. Before we turn the call to the operator for questions, I'll remind you, we will not be answering questions related to the VIKTORIA-1 mutant cohort data being presented at ASCO on June 2nd or providing additional guidance on our expectations for data at this time. Matthew, could you please open the call for questions?

[Operator]

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press 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 star followed by the number two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment please for your first question. Your first question comes from Maury Raycroft of Jefferies. Please go ahead. Your line is open.

[Maury Raycroft, Biotech Analyst at Jefferies]

Hi. Congrats on the progress, and thanks for taking my questions.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

You're welcome.

[Maury Raycroft, Biotech Analyst at Jefferies]

Maybe starting off, just wondering if you can provide any perspective into the nature of questions and interactions with FDA that you're getting ahead of the PDUFA date. Have you submitted a draft label, and are you in labeling discussions at this point?

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Yeah, we're not going to provide that level of detail about the interactions other than to say that there's nothing about the interactions to date that suggests that we will be off track for the PDUFA decision by July 17th.

[Maury Raycroft, Biotech Analyst at Jefferies]

Got it. Okay. Then wanted to ask about the subQ formulation as well. Wondering if there's anything more you could say about what you're seeing with preclinical data in respect to comparability on PK/PD and dosing frequency. Can you talk more about timeline to move this version into the clinic and whether there could be any bridging efforts as it relates to the VIKTORIA-2 study?

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Sure. As far as the internal work, I mean, we're not gonna be providing a play-by-play of the internal work. I can speak to the timeline and the steps. I mean, obviously the first step is optimizing the formulation itself. It's required and you work with multiple candidates to ensure you've optimized it. You have to transfer that to manufacturing, scale it, ensure you have stability, et cetera. Ultimately you end up with PK studies, you know, phase I, to confirm the PK profile and map its equivalence to the IV formulation. Finally, we expect the FDA to probably require equivalent study, phase III study.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

They've laid out some guidance on that front. The goal is to have an subQ form available, basically along the same timeline that we would expect to get an approval or hope to get an approval for the endocrine sensitive population.

[Maury Raycroft, Biotech Analyst at Jefferies]

Got it. Okay. That's helpful. Thanks for taking my questions. I'll hop back in the queue.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

You're welcome. Okay.

[Operator]

Thank you. Your next question comes from Tara Bancroft of TD Cowen. Please go ahead. Your line is open.

[Tara Bancroft, Vice President and Senior Biotech Analyst at TD Cowen]

Hi. Good afternoon. My question is, you know, not about the mutant data, more about some educational historical background. Because in thinking about, you know, the range for alpelisib and fulvestrant in a five to seven months, can you just, from your view of historical trials, some context around the bookends of that range from BYLieve cohort C to then cohort A and EPIK-B5 in terms of patient characteristics that you think most contributed to the difference there, just to help us understand?

[Brian Sullivan, CEO and Co-Founder at Celcuity]

I don't want to speak directly other than to say that, you know, there is always a certain amount of heterogeneity between trials, the patient populations that get enrolled. Anytime you are looking at potential results for a particular therapy, we think it is best to look at the range and not get overly fixated on trying to calculate a probability. It is just not practically possible. The data that has been reported is, you know, really the only we think data that can be assessed to understand, you know, what the performance of a drug like (uncertain) can do.

[Tara Bancroft, Vice President and Senior Biotech Analyst at TD Cowen]

Okay, great. Thanks.

[Operator]

Thank you. Your next question comes from Andrew Berens of Leerink Partners. Please go ahead. Your line is open.

[Andrew Berens, Senior Research Analyst at Leerink Partners]

Hi. Thanks for taking the questions, and congrats on the progress, Brian. Looking forward to seeing the data at ASCO in Chicago.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Thank you.

[Andrew Berens, Senior Research Analyst at Leerink Partners]

My questions are about the subQ announcement today. We've been trying to think of an analog of a small molecule that was given IV and then was changed to subcutaneous. You know, most of them are antibiotics, and there's not really a benefit going subQ there. Is there one that you could point us to to get an idea of the process, the regulatory process? Then also, would you expect that the, you know, the PK and the Cmax would change when you go from intravenous to subQ? We've heard some speculation about, you know, the mucositis maybe being related to Cmax. Just wondering if you think that would come down with a subQ version.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Yeah, thanks for the question. As far as the regulatory process, I think there's a general process that FDA requires to assess drugs that are injected in some form or other, injected or infused. We expect our program will follow those requirements. I outlined those in one of the prior questions, you know, essentially where you have to characterize the PK profile for a variety of reasons, but then also then characterize the equivalence from an efficacy standpoint.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

To date, it appears that when you are introducing a new formulation, that has a different route, you know, even if it's, you know, still being systemically administered directly, you do need to demonstrate clinical equivalence. Based on some recent guidance, it appears that the FDA's position is that if you demonstrate equivalence in one indication, that that data will then, and that approval will allow that new formulation to be used for any other indications that may exist. So we expect that to be the path forward for us, and, you know, we'll take it from there.

[Andrew Berens, Senior Research Analyst at Leerink Partners]

Okay. What about the PK and the Cmax? Any insights on how it's different?

[Brian Sullivan, CEO and Co-Founder at Celcuity]

No, I mean, obviously from a development standpoint, I mean, the perfect world is you match PK profile as, as closely as you can, or at least you kind of focus on certain ranges. As far as speculating about the stomatitis effect like that, it's just too premature to get into that. It's certainly, we think a function of a Cmax. The fact that, you know, the concentration settles in after a few hours at a much lower concentration and basically remains stable. We think that's one of the reasons why patients have reported the drug to be very well tolerated, not affecting their quality of life.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

You know, certainly there's ways of thinking about administering the drug or formulating it that would allow you to try to optimize that. Those are all will be elements of the development program that we'll be evaluating.

[Andrew Berens, Senior Research Analyst at Leerink Partners]

Okay. Well, congrats again on continuing to move the needle.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Thank you.

[Operator]

Thank you. Your next question comes from Stephen Willey of Stifel. Please go ahead. Your line is open.

[Stephen Willey, Managing Director at Stifel]

Yeah, good afternoon. Thanks for taking the questions. Congrats on the announcement today. I know that we've seen frontline market share in the endocrine-sensitive setting, kind of largely influenced by longer-term OS data. Just curious as you were thinking about the sizing of VIKTORIA-2, kind of how this factored into the design and whether you might be able to provide just any preliminary powering assumptions on either OS or PFS in the primary. Thanks.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Well, OS becomes, in effect, the way to break the tie when you have three regimens that offer almost equivalent progression-free survival. That was, you know, the case with the CDK 4/6 drugs. Ribociclib then subsequently demonstrated that it offered a survival benefit. We'll be comparing ourselves to ribociclib, and if we offer a progression-free survival period that's superior to ribociclib, and we show that there's no decrement in overall survival, that would, in effect, achieve the goal of demonstrating that there's a clinical benefit for these patients. Certainly, for any study you do, you'd like to show that there's a survival advantage relative to what you're comparing to.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

If we achieve PFS and show no decrement in OS, we'll have essentially satisfied, you know, certainly the regulatory requirements, and we think we'll satisfy the clinical expectations for a drug. Certainly, the drug has to offer a meaningful increase in incremental PFS. You know, three months on top of 10 is different than three months on top of 25. We're mindful of that and then design the study to reflect the expectations that you need more than three months to demonstrate a clinically meaningful benefit.

[Stephen Willey, Managing Director at Stifel]

All right. Thanks for taking the question.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

You're welcome.

[Operator]

Thank you. Your next question comes from Bradley Canino of Guggenheim Securities. Please go ahead. Your line is open.

[Bradley Canino, Managing Director and Biotechnology Equity Research Analyst at Guggenheim Securities]

Hey, Brian and team. Great to see the strong progress on my end as well.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

You're welcome.

[Bradley Canino, Managing Director and Biotechnology Equity Research Analyst at Guggenheim Securities]

For the subQ, sorry if I missed this on the call. I missed some of the prepared remarks. Is the formulation completed, and have you conducted animal models with it yet, or is this still in process?

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Well, I mean, again, we're not gonna give play-by-play on each stage of the program other than to say that we have multiple candidates that we're advancing and we're, you know, in the middle of doing a variety of both stability studies to confirm and to characterize the formulation itself, as well as evaluating, you know, the other nonclinical parameters, including, you know, animal studies and work like that.

[Bradley Canino, Managing Director and Biotechnology Equity Research Analyst at Guggenheim Securities]

Okay. Maybe it'd be helpful, are there any certain properties about gedatolisib that support its translation to a subQ formulation that could give investors confidence?

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Well, we're confident we'll be able to develop it. You know, every drug has its own challenges when it comes to, you know, converting it to a more concentrated form. I think part of the advance that we've made is that it requires invention, and which is good because it's not an obvious approach, and it's one that we think will certainly enhance our intellectual property position significantly. As far as, you know, signaling, you know, how to interpret the likelihood that we'll be successful, I would say we're very confident.

[Bradley Canino, Managing Director and Biotechnology Equity Research Analyst at Guggenheim Securities]

Just anything you can say about what you're seeing so far about predicted dose, not so much disclosure of the dose, but how that might shape the specific device that you can use for the patient and the administration time.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

I think you're referring to the volume. You know, the dose itself will be the same, and it's just a matter of translating that dose into a smaller volume so it's injectable. We have targets internally. We have functional requirements that we're targeting. You know, so far, we fully expect to meet the functional requirements that would allow it to be an injectable form.

[Bradley Canino, Managing Director and Biotechnology Equity Research Analyst at Guggenheim Securities]

Okay, great. Thanks for taking the questions and look forward to seeing you at ASCO.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Great. Thank you.

[Operator]

Thank you. Your next question comes from Oliver McCammon of LifeSci Capital. Please go ahead. Your line is open.

[Oliver McCammon, VP and Research Analyst at LifeSci Capital]

Hi, Brian. Thanks for taking my questions. I'm just thinking about the endocrine sensitive study. I'm wondering if there are any learnings to take from the PALOMA trials experience in terms of being thoughtful about patient follow-up and powering for OS. Thanks again.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

There's a lot of learnings from the PALOMA-2 and also from the MONALEESA-2 rival study. Believe me, we've taken in the learnings from the rival study more than the PALOMA study. We think, you know, there's certainly a way to design the study in a way that maximizes your opportunity to potentially demonstrate an overall survival advantage.

[Oliver McCammon, VP and Research Analyst at LifeSci Capital]

Thanks again.

[Operator]

Thank you. Your next question comes from Eva Fortea-Verdejo of Wells Fargo. Please go ahead. Your line is open.

[Eva Fortea-Verdejo, Vice President and Equity Research Analyst at Wells Fargo]

Hey, good afternoon. Congrats on the progress and thanks for taking.

[Eva Fortea-Verdejo, Vice President and Equity Research Analyst at Wells Fargo]

Our questions. Do you have any updated thoughts on the competitive positioning for gedatolisib versus other PI3K inhibitors in development, and how do you see this evolving with a subcutaneous formulation coming online? Thanks.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Well, I think, you know, details to follow, we did report that gedatolisib doublet, just in a head-to-head, a replacement for an existing PIK3CA approved drug, was, you know, statistically significantly and clinically meaningfully differentiated from a single target inhibitor. Ultimately, what we think we've been saying has been confirmed, which is that multi-target inhibition of this pathway is required to optimize antitumor control and that single target inhibitors are going to be limited. If you look at the data for alpelisib and capivasertib, you'd see that the hazard ratios that they have reported in patients who've had prior CDK treatment are very similar. You know, roughly 0.5 compared to fulvestrant.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

We've demonstrated that we're superior to that. What we think that means is that, you know, the approach will be at a, you know, a disadvantage going forward, just from a benefit standpoint. That approach we do not believe offers the potential to provide comparable efficacy.

[Eva Fortea-Verdejo, Vice President and Equity Research Analyst at Wells Fargo]

Got it. Thanks.

[Operator]

Thank you. Your next question comes from Gil Blum of Needham & Company. Please go ahead.

[Gil Blum, Senior Analyst at Needham & Company]

Good afternoon, everyone, congrats on the progress and the impressive results, Brian.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Thanks.

[Gil Blum, Senior Analyst at Needham & Company]

Just a couple of quick points from us. One, as it relates again to the potential for a subQ formulation, is there any chance that would change kind of the. You currently have a very specific schedule of dosing. Would there could be any changes to that, or how do you view this? I have a follow-on.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Sure. Those are factors that, you know, go beyond, you know, simply the formulation, because it gets to the overall PK profile of gedatolisib and what's required to, you know, sustain sufficient target engagement. I think that question is broader than simply subQ. I think it's, you know, relates more generally to how to administer, or rather how frequently, gedatolisib needs to be administered. You know, how we answer that question, if it's different over time, you know, will be the byproduct of, you know, studies probably involving the infused form because we have that now, and we can evaluate that.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

You know, to the extent that we find ways to potentially alter the administration schedule, you know, that would be applied if that were to happen to a potential subcutaneous formulation.

[Gil Blum, Senior Analyst at Needham & Company]

Yeah, that makes sense. Just interesting to hear your thoughts of recent news from one of your competitors, OnKure Pharma, decided to move away from a PI3K selective mutant to an alpha specific, if you have any thoughts on that? Thank you.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Well, I, you know, I think, again, there's only so much biological potential that targeting, you know, the alpha, you know, PI3K alpha gives you. I think that's less a function maybe of the targeting and more a function of, you know, increasing the potential patient population that they're hoping to treat. You know, they had a more selective approach that essentially meant that they would have a smaller patient population, I would imagine they found some results that indicated they didn't need to be that specific. alpelisib is generally targets, and their indications include, you know, the 12 or 13 most common mutations. There's been some evidence of variation in response to those patients depending on their mutations.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

You know, I'm not sure that that is dispositive in how you think about developing for that population. You know, they, you know, they've got data, I'm sure, that is guiding their decisions and again, but it is in the context of, you know, what we think is limited biological potential to induce a treatment effect when you limit targeting to the alpha isoform.

[Gil Blum, Senior Analyst at Needham & Company]

Thank you for all that, Brian.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

You're welcome.

[Operator]

Thank you. Your next question comes from Kalpit Patel of Wolfe Research. Please go ahead. Your line is open.

[Kalpit Patel, Director and Senior Research Analyst at Wolfe Research]

Yeah. Hey, good afternoon, and thanks for taking my question. One from us, another one on this subQ formulation. You know, would you characterize gedatolisib's antitumor effect as being Cmax driven or AUC driven? How does that inform your confidence on the subQ formulation that it can achieve clinical equivalence to an IV?

[Brian Sullivan, CEO and Co-Founder at Celcuity]

You know, I mean, those are great questions, and I think every drug company tries to tease that out. There's been a lot of work that people have done to try to kind of determine whether a drug is more Cmax versus total volume, total exposure. You know, I think an argument could be made that it's both, that you get a benefit, the high Cmax in the gedatolisib case and then, you know, the sustained target engagement. You know, again, your roadmap is gonna factor in what we've seen to date. That's the best approach to take is see how close you can match that curve, knowing that it won't be exact, but there are other ways you can affect that.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

You know, we're taking those other factors into account.

[Kalpit Patel, Director and Senior Research Analyst at Wolfe Research]

Okay. Got it. Thank you.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

You're welcome.

[Operator]

Your next question comes from Silvan Tuerkcan of Citizens JMP. Please go ahead. Your line is open.

[Silvan Tuerkcan, Managing Director and Senior Research Analyst at Citizens JMP]

Thank you for taking my question, and congrats on all the progress. I'm looking forward to ASCO. Maybe if I can ask around ASCO, not about the data, but in general, it seems it's a very important venue for you, especially with the PDUFA in the, in the wildtype patients ahead. What's your strategy there to interact with doctors? What sort of events do you have planned, and what is your messaging on the wildtype population here ahead of the approval? Thank you.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

You're welcome. Well, we'll have an army of folks at ASCO, with that are, you know, mostly, there to, you know, medical professionals to be able to engage with doctors and exchange information. There's a lot of other work that can be done as well. Certainly, it's a big venue. A lot of doctors will have a good opportunity to communicate the results. No, we view it as a great staging ground to lay the groundwork for what we hope is a future launch over the summer. No, we're Very excited about the timing of ASCO and its alignment with the schedule we're on, we hope to get an approval.

[Silvan Tuerkcan, Managing Director and Senior Research Analyst at Citizens JMP]

Great. Thank you. Have you done already some payer feedback discussions and kind of around coverage? Do you have any comments around that?

[Brian Sullivan, CEO and Co-Founder at Celcuity]

We've had a lot of discussions. You know, we built our payer team, which includes, you know, a team focused on strategic accounts and then a team focused on payers, national accounts. We've been engaging at great depth and length with them, you know, for almost a year. Been very encouraged by the feedback we've gotten. Their formal review really doesn't take place until you have an approval and you submit a dossier. Along the way, you can certainly get their input about their expectations.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

You can learn about the system and exactly what their requirements are and ensure that when it comes time to make decisions that everybody on these various committees is well informed and feels comfortable with getting and from their perspective, the proposition that it offers to their patients and and to the, you know, and relative reimbursement expectations. No, we've made a lot of we're, I would say, very, very well along in laying that groundwork and being in a great position, you know, once the approval comes to really move expeditiously with the various accounts I described.

[Silvan Tuerkcan, Managing Director and Senior Research Analyst at Citizens JMP]

Great. Well, thanks, yeah, so much for the color.

[Operator]

Thank you. Your next question comes from Chase Knickerbocker of Craig-Hallum. Please go ahead, your line is open.

[Chase Knickerbocker, Senior Equity Research Analyst at Craig-Hallum]

Good afternoon. Thanks for taking the questions. Just wanted to maybe just assess kinda your current kinda commercial readiness. You know, in the past couple of months, there's been a couple of early oncology approvals relative to PDUFA date. Brian, I just wanna get your thoughts on kind of where you, where you think you sit from an innings perspective as kinda having your team ready for a potential launch in wild type. Thanks.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Sure. Again, there's all of these situations with some of these early approvals are, I would say, situationally based. You know, there was an approval recently for a drug that had a regular review, and it came in a few weeks early. You know, we have a priority review for a new drug, six-month review period. Historically, our priority reviews of drugs with priority designation occur pretty much in line with the PDUFA date. That's, that's been our governing assumption. Internally, you know, we've, you know, identified a launch-ready date that's before PDUFA, so we're make sure that we are ready to roll when we hope the approval decision comes.

[Chase Knickerbocker, Senior Equity Research Analyst at Craig-Hallum]

Helpful. Thank you.

[Operator]

Thank you. There are no further questions at this time. I'd now like to turn the call back over to Brian Sullivan, Chief Executive Officer and Co-Founder, for closing comments.

[Brian Sullivan, CEO and Co-Founder at Celcuity]

Great. Well, thank you very much for your participation in our call. We appreciate the questions, and we look forward to seeing some of you at ASCO. Take care. Goodbye.

[Operator]

Ladies and gentlemen, this concludes today's conference. We thank you for participating and ask that you please disconnect your line.

Participants

Executives

• Brian Sullivan, CEO and Co-Founder
• Jodi Sievers, Corporate Communications and Investor Relations
• Vicky Hahne, CFO

Analysts

• Andrew Berens, Senior Research Analyst at Leerink Partners
• Bradley Canino, Managing Director and Biotechnology Equity Research Analyst at Guggenheim Securities
• Chase Knickerbocker, Senior Equity Research Analyst at Craig-Hallum
• Eva Fortea-Verdejo, Vice President and Equity Research Analyst at Wells Fargo
• Gil Blum, Senior Analyst at Needham & Company
• Kalpit Patel, Director and Senior Research Analyst at Wolfe Research
• Maury Raycroft, Biotech Analyst at Jefferies
• Oliver McCammon, VP and Research Analyst at LifeSci Capital
• Silvan Tuerkcan, Managing Director and Senior Research Analyst at Citizens JMP
• Stephen Willey, Managing Director at Stifel
• Tara Bancroft, Vice President and Senior Biotech Analyst at TD Cowen