Celcuity (CELC) Q1 2026 Earnings Transcript

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DATE

Thursday, May 14, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

• Chief Executive Officer and Co-Founder — Brian F. Sullivan
• Chief Financial Officer — Vicky Hahne
• Chief Medical Officer — Igor Gorbachevsky
• Chief Commercial Officer — Eldon C. Mayer
• Vice President of Investor Relations — Jodi Sievers

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TAKEAWAYS

• PIK3CA Mutant Cohort Top-Line Results -- Gedatolisib triplet showed a statistically significant and clinically meaningful improvement in progression-free survival compared to alpelisib plus fulvestrant.
• Gedatolisib Doublet Results -- Gedatolisib plus fulvestrant demonstrated significant and clinically meaningful improvement in progression-free survival versus alpelisib plus fulvestrant, though it was not part of the primary efficacy hierarchy.
• Safety Profile -- Both gedatolisib regimens reported manageable safety with no new safety signals and low discontinuation rates of 2% (triplet) and 3% (doublet) due to adverse events.
• PFS and ORR in Wild-Type Cohort -- The gedatolisib triplet provided a 7.3-month incremental median progression-free survival improvement over fulvestrant and a 31% objective response rate increase, both highest among reported phase III trials in this disease context.
• Patient-Reported Outcomes -- Stability in patients' perceived well-being over the first eight cycles of gedatolisib treatment indicated no degradation from baseline.
• Stomatitis Management -- Median improvement time from onset to lower grade was 12 days for grade 2 and 14 days for grade 3 for triplet-treated patients.
• Phase III VICTORIA-2 Expansion -- The study was amended to include a new first-line evaluation for endocrine sensitive HR-positive/HER2-negative advanced breast cancer, broadening clinical application.
• Phase IIb First-Line Data -- Early-phase results for gedatolisib plus letrozole showed a median progression-free survival of 48.6 months and a 79% objective response rate, both superior to historical benchmarks for ribociclib plus letrozole (25 months and 53%, respectively).
• ON-TRACC (Prostate Cancer) Interim Data -- Gedatolisib plus darolutamide combination resulted in a 67% six-month radiographic progression-free survival rate and 9.1 months median radiographic PFS, exceeding historic 40% benchmarks for androgen receptor inhibitor monotherapy in this setting.
• Subcutaneous Formulation Update -- Development of a gedatolisib subcutaneous formulation advanced, with a patent application submitted to the U.S. Patent and Trademark Office.
• Peak Revenue Estimate -- Management estimates potential for up to $2.5 billion in annual peak revenue for gedatolisib’s second-line indication, based on current epidemiology and internal market research.
• Commercial Readiness -- Hiring of all oncology sales specialists completed, with average sales experience of 24 years and 16 years in oncology, in preparation for anticipated launch.
• Net Loss -- Reported net loss was $52.8 million ($0.97 per share), compared to $37 million ($0.86 per share) in the prior year period.
• Non-GAAP Adjusted Net Loss -- Management disclosed a non-GAAP adjusted net loss of $46.8 million ($0.86 per share), an increase from $34.7 million ($0.81 per share) previously.
• R&D Expenses -- Research and development expenses rose to $33.1 million, up from $29.8 million, driven by higher employee and consulting costs, increased manufacturing, partially offset by reduced VICTORIA-1 trial spending.
• SG&A Expenses -- Selling, general, and administrative expenses totaled $17.4 million versus $6.3 million, with $6.6 million of the $8.7 million personnel cost increase attributed to commercial headcount additions.
• Cash Position -- Cash, cash equivalents, and short-term investments stood at $290.4 million at quarter-end.
• Cash Runway Guidance -- Management expects available cash resources and debt facility drawdowns to fund operations through 2027.

SUMMARY

Celcuity (NASDAQ:CELC) announced pivotal clinical data positioning gedatolisib as a potentially new standard for both wild-type and PIK3CA-mutant HR-positive/HER2-negative advanced breast cancer, supported by statistically significant progression-free survival outcomes and exceptional objective response rates. The company broadened the target population for gedatolisib by expanding the VICTORIA-2 first-line trial design to include both endocrine sensitive and resistant patients, aiming for broader clinical adoption. Subcutaneous formulation development is progressing, with intellectual property protection underway, to support long-duration treatment needs and commercialization flexibility. Commercial infrastructure build-out is complete, with experienced oncology specialists ready for an anticipated launch pending regulatory decisions. Financially, the company noted increased operating losses as it ramps clinical and commercial activity, with a stated cash runway expected to last through 2027.

• Management intends to seek global approvals after U.S. regulatory submission, using wild-type and mutant cohort data from VICTORIA-1.
• FDA feedback has been obtained and incorporated into the revised VICTORIA-2 clinical trial design; top-line data for endocrine-resistant and endocrine-sensitive studies are targeted for 2028 and 2030, respectively.
• For metastatic castration-resistant prostate cancer, management highlighted favorable early-phase ON-TRACC efficacy and safety signals compared to historical controls, supporting diversification beyond breast cancer.
• Cost structure increases included significant personnel, commercial infrastructure, and manufacturing investments related to the planned product launch, as outlined in management's commentary.

INDUSTRY GLOSSARY

• PIK3CA: A gene encoding the p110α catalytic subunit of PI3K; mutations in this gene are associated with various cancers and impact therapy response in breast cancer trials.
• PAM Pathway: Refers to the integrated PI3K/AKT/mTOR signaling cascade, a critical regulator of cell growth and survival targeted by compounds such as gedatolisib.
• Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with disease but without it worsening, a key efficacy endpoint in oncology studies.
• Objective Response Rate (ORR): The proportion of patients with a significant reduction in tumor size (partial or complete response) during a given treatment period.
• Subcutaneous Formulation: A drug formulation designed for injection under the skin, enabling outpatient or at-home administration.
• RECIST 1.1: Standardized criteria for evaluating tumor response to treatment in solid tumors used in clinical trials.

Full Conference Call Transcript

Jodi Sievers: Thank you, Matthew, and good afternoon, everyone. Thank you for joining us to review Celcuity's first quarter 26 financial results and business update. Earlier today, Celcuity released for the first quarter ended 03/31/2026. The press release can be found on the Investors section of Celcuity's website. Joining me on the call today are Brian F. Sullivan, Celcuity's chief executive officer and co-founder; Vicky Hahne, chief financial officer; as well as Igor Gorbachevsky, chief medical officer; and Eldon C. 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. 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. And with that, I will turn the call over to Brian F. Sullivan, CEO of Celcuity. Please go ahead, Brian.

Brian F. Sullivan: Thank you, Jodi, and good afternoon, everyone. Thank you for joining our first quarter 26 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, the recent announcement of positive data from the mutant cohort of our VICTORIA-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 is been an eventful past few months for Celcuity. Last week, we reported positive top line results for the PIK3CA mutant cohort of the Phase III VICTORIA-1 clinical trial, and we look forward to presenting detailed results at a late breaking abstract oral session at the 26 ASCO meeting on June 2. 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 2 important updates to our clinical development plan.

First, we announced the expansion of our Phase III VICTORIA-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. And this offers the potential to advance the standard of care for the approximately 90 thousand women each year who are newly diagnosed in the US with HR-positive, HER2-negative advanced breast cancer.

And 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 US Patent and Trademark Office. Subcutaneous formulation is aimed at supporting potential future for gedatolisib regimens that may result in duration of treatment periods greater than several years. And finally, we remain optimistic about the outcome of the FDA's review of our NDA.

Assuming our NDA is approved, we intend to submit to the FDA a supplemental new drug application based on the results of the PIK3CA mutant cohort of VICTORIA-1 and to submit VICTORIA-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, fulvestrant.

The secondary endpoint of gadatolitinib combined with fulvestrant, which we refer to as the gedatolisib doublet, which was not part of the primary efficacy analysis in the hierarchical order. Demonstrated a statistically significant and clinically meaningful improvement in PFS compared to alpelisib and fulvestrant. Both gedatolisib regimens were generally well tolerated with manageable safety profiles, and no new safety signals. When considered alongside previously presented data from the VICTORIA-1, PIK3CA wild type cohort, the gedatolisib regimens have now demonstrated the potential to improve the standard of care in the second-line setting regardless of the PIK3CA status of a patient's tumor.

And we believe the results from the VICTORIA-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. VICTORIA-1 represents the first phase 3 study that demonstrated that comprehensively blocking the pan pathway can significantly improve outcomes for patients with PIK3CA mutations compared to therapies only targeting a single component. of this pathway. Now as we have previously reported, the VICTORIA-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. 7.3 months incremental improvement in median PFS for the gedatolisib triplet over fulvestrant is higher than has ever been reported by any phase 3 trial for patients with HR-positive/HER2-negative advanced breast cancer receiving at least their second line of endocrine therapy. And 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.

Both regimens were found to have a manageable safety profile and was well tolerated by patients, as evidenced by the 2% and 3% adverse event related discontinuation rates for the triplet and doublet, respectively. We have also previously reported safety and tolerability related analyses. In particular, for patients who experience stomatitis, we reported that measures to mitigate it were generally effective, The median time to improvement from first onset to a lower grade of stomatitis for patients with grade 2 or grade 3 stomatitis who receive the gedatolisib triplet. Was 12 and 14 days, respectively.

Now to characterize the overall tolerability of the gedatolisib regimens, we reported results from patient reported outcomes, the capture of patients' 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. Over the first 8 cycles of treatment with gedatolitinib, patients reported no degradation in their sense of well-being, which we believe provides meaningful evidence that patients treated with gedatolisib tolerated well. Now let's talk about our VICTORIA-2 study. Results from the PIK3CA wild type mutation cohort of our VICTORIA-1 study demonstrated the benefit of gedatolisib combination treatment in the second 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 Ib clinical trial provided strong evidence that the PAM pathway is also an important disease driver in treatment naive patients with advanced breast cancer. In the early phase study that we performed, we evaluated gedatolisib plus 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, This compares favorably to historical data of approximately 25 months for ribociclib plus letrozole, And 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 VICTORIA-1, and the promising preliminary data for our gedatolisib triplet in this first line treatment, we have high confidence that we can successfully develop a gedatolisib triplet for nearly all patients in the first line setting irrespective of their endocrine sensitivity or PIK3CA status. Successful development in the first line setting would offer the potential to advance the standard of care for the approximately 90 thousand women each year who are diagnosed with late stage HR-positive/HER2-negative advanced breast cancer in the United States.

So to achieve this goal, we amended several important elements of the VICTORIA-2 study design. First, VICTORIA-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 represented approximately 2/3, or 60 thousand of the 90 thousand women in the US newly diagnosed with advanced breast cancer each year. Current standard of care therapies for these patients provide a median PFS of approximately 25 months. 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. Second, the primary efficacy analyses for both study 1 and study 2 of VICTORIA-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. And this revision of the primary analyses allowed us to reduce the sample size for Study 1, endocrine resistant study, from 38 patients to 44 patients without affecting the power of the analysis.

And 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 is 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 2028 for this study.

Study 2 is expected to enroll approximately 740 subjects with treatment naive, endocrine sensitive advanced breast cancer. And 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 have had no prior endocrine therapy exposure. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and letrozole, and compare that to ribociclib combined with letrozole. The clinical trial primary endpoints for the VICTORIA-2 clinical trial is progression-free survival per RECIST 1.1 criteria. As assessed by blinded independent central review. And we expect top line data for the study 2 in the endocrine-sensitive patients. To be available by 2030.

And prior to finalizing this amended phase 3 trial design, we conducted a Type B meeting with the FDA to obtain their feedback and to gain alignment on these planned amendments. Now knowing that our life cycle 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. And this program is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation.

And 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. Now let's turn to our ON-TRACC 1b/2 trial, that is evaluating gedatolisib in combination with darolutamide. Men with metastatic castration resistant prostate cancer. We presented data for the Phase Ib portion of the study at a poster presentation at ESMO last year. In this portion of the trial, 38 patients were randomly assigned to receive standard doses of darolutamide twice daily, and other 120 milligrams of gedatolisib in arm 1 or 180 milligrams of gedatolisib in arm 2.

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, No patients discontinued study treatment due to an adverse event. For all patients treated, the 6-month radiographic PFS rate was 67%, and the median radiographic PFS was 9.1 months. And these results compare favorably to historical results of a 40% 6-month radiographic PFS rate for patients with metastatic castration resistant prostate cancer who were treated with an androgen receptor inhibitor as second line treatment. Now 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.

Now as we near what we hope is an FDA approval, for gedatolisib in 2026, our efforts to prepare for the potential launch of gedatolisib continue to ramp up per our strategic launch plan. And 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 am excited to report now that we have since hired and onboarded all of our oncology sales specialists. They are a very experienced crew. On average, these individuals have 24 years of experience selling pharmaceuticals, and 16 years of experience in oncology.

They are an incredibly talented group of individuals who have a strong track record of successfully launching novel oncology therapeutics. And key efforts to date include continuing our extensive outreach across the country to payers, strategic accounts which include health systems, integrated delivery networks, and community oncology practices. We are also very encouraged by the results of research we have continued to field to gauge the willingness of community and academic oncologists to prescribe gedatolisib should it get approved. And 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 tumor 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. Based on the analysis of published epidemiological data, we estimate there are 37 thousand patients in the US receiving second line treatment for HR-positive/HER2-negative advanced breast cancer, and 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 is 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 have made today is encouraging, and we look forward to providing you with updates over the next few quarters. Gedatolisib is well positioned to address critical needs in the second line space with its unique mechanism of action and potential first in class and best in class safety and efficacy profile. And 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 would like to hand the call over to Vicky to review our finances.

Vicky Hahne: Thank you, Brian, and good afternoon, everyone. I will provide a brief overview of our financial results for the first quarter 26. 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 2025. Our non GAAP adjusted net loss was $46.8 million or $0.86 per share for the 2026 compared to non GAAP adjusted net loss of $34.7 million or $0.81 per share for 2025. Research and development expenses were $33.1 million for the 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 VICTORIA-1 phase 3 clinical trial. Selling, general, and administrative expenses were $17.4 million for the 2026, compared to $6.3 million for the prior year period. 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 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 totaled $290.4 million as of the end of the first quarter of 2026. We expect cash, 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: Thanks, Vicky. Before we turn the call to the operator for questions, I will remind you that we will not be answering questions related to the VICTORIA-1 mutant cohort data being presented at ASCO on June 2 or providing additional guidance on our expectations for data at this time.

Operator: Matthew, could you please open the call for questions?. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press star followed by the #1 on your touch tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press * followed by the #2. If you are using a speakerphone, please remove your handset before pressing any keys. 1 moment, please, for your first question. And your first question comes from Maury Raycroft of Jefferies.

Analyst (Maury Raycroft): Your line is open.

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