Celcuity Q1 Earnings Call Highlights

Key Points

• Celcuity is preparing for a potential FDA approval of gedatolisib, with a possible U.S. launch in the third quarter and the company saying it remains optimistic the July 17 PDUFA date is still on track.
• Top-line Phase 3 VIKTORIA-1 results showed statistically significant and clinically meaningful progression-free survival benefits for both the gedatolisib triplet and doublet versus the comparator, with no new safety signals and manageable tolerability.
• Celcuity is expanding its first-line VIKTORIA-2 program to study gedatolisib in both endocrine-resistant and endocrine-sensitive HR-positive, HER2-negative advanced breast cancer, while continuing to build out commercial infrastructure and a subcutaneous formulation program.

Celcuity NASDAQ: CELC reported a wider first-quarter loss as the biotechnology company increased spending tied to commercial launch preparations and continued development of gedatolisib, its investigational therapy for hormone receptor-positive, HER2-negative advanced breast cancer.

On the company’s first-quarter 2026 earnings call, Chief Executive Officer and Co-Founder Brian Sullivan said Celcuity is preparing for a potential U.S. Food and Drug Administration approval and commercial launch of gedatolisib in the third quarter. He said the company remains “optimistic” about the FDA’s review of its new drug application and noted that Celcuity does not believe recent interactions with regulators suggest the July 17 PDUFA decision date is off track.

“We continue to make great progress as we prepare for the potential approval and commercial launch of gedatolisib in the third quarter,” Sullivan said. He added that approval would be “a pivotal moment” for women with advanced breast cancer who need additional treatment options.

Celcuity Highlights VIKTORIA-1 Data Ahead of ASCO

Sullivan said Celcuity recently reported positive top-line results from the PIK3CA mutant cohort of its Phase 3 VIKTORIA-1 trial. The company plans to present detailed findings in a late-breaking oral session at the 2026 American Society of Clinical Oncology meeting on June 2. Celcuity said it would not take questions on those data during the call ahead of the ASCO presentation.

According to Sullivan, the primary efficacy analysis showed that gedatolisib combined with fulvestrant and palbociclib — referred to by the company as the gedatolisib triplet — produced a statistically significant and clinically meaningful improvement in progression-free survival compared with alpelisib and fulvestrant. He said a secondary endpoint evaluating gedatolisib with fulvestrant, called the gedatolisib doublet, also showed a statistically significant and clinically meaningful improvement in progression-free survival versus alpelisib and fulvestrant.

Sullivan said both gedatolisib regimens were generally well tolerated, with manageable safety profiles and no new safety signals. He said the findings, when considered alongside previously presented data from the PIK3CA wild-type cohort, suggest gedatolisib regimens could improve second-line treatment regardless of a patient’s PIK3CA mutation status.

The company has previously reported that in the PIK3CA wild-type cohort, the gedatolisib triplet produced a 7.3-month incremental improvement in median progression-free survival over fulvestrant. Sullivan also cited a 17.5-month median duration of response and a 31% incremental increase in objective response rate relative to the control arm for the triplet. He said adverse event-related discontinuation rates were 2% for the triplet and 3% for the doublet.

First-Line Breast Cancer Trial Expanded

Celcuity also announced changes to its Phase 3 VIKTORIA-2 program, expanding the trial to include a second study evaluating gedatolisib as a first-line treatment in endocrine-sensitive HR-positive, HER2-negative advanced breast cancer. The trial had previously been focused on endocrine-resistant disease.

Sullivan said the revised design positions Celcuity to evaluate gedatolisib in “nearly all patients in the first-line setting,” regardless of endocrine sensitivity or PIK3CA status. He said approximately 90,000 women in the U.S. are newly diagnosed each year with HR-positive, HER2-negative advanced breast cancer, including about 60,000 with endocrine-sensitive disease.

Under the amended design, patients will be assigned to one of two studies based on endocrine sensitivity and then randomized to treatment arms. Study 1 will enroll treatment-naive patients with endocrine-resistant advanced breast cancer and compare gedatolisib with palbociclib and fulvestrant against ribociclib with fulvestrant. Celcuity expects top-line data from Study 1 by the end of 2028.

Study 2 is expected to enroll about 740 patients with treatment-naive endocrine-sensitive advanced breast cancer. It will compare gedatolisib with palbociclib and letrozole against ribociclib with letrozole. Celcuity expects top-line data from Study 2 by 2030. Sullivan said the company conducted a Type B meeting with the FDA before finalizing the amended trial design.

Subcutaneous Formulation Program Advances

Celcuity said it is advancing development of a subcutaneous formulation of gedatolisib and has filed its first patent application with the U.S. Patent and Trademark Office for an injectable formulation. The current formulation is administered intravenously.

Sullivan said the company began the program with future indications in mind that could involve treatment durations of several years. The goal is to develop an injection that demonstrates clinical equivalence to the intravenous formulation.

During the question-and-answer session, Sullivan said Celcuity is working with multiple formulation candidates and conducting stability and nonclinical studies, including animal studies. He said the process is expected to include optimization of the formulation, transfer to manufacturing, scaling, stability work and pharmacokinetic studies before clinical equivalence is evaluated. He said Celcuity expects the subcutaneous formulation to be available on a timeline aligned with a potential approval in the endocrine-sensitive population.

Commercial Preparations Continue

Sullivan said Celcuity has completed hiring and onboarding its oncology sales specialists ahead of a potential U.S. launch. He said the sales specialists have an average of 24 years of pharmaceutical sales experience and 16 years of oncology experience.

The company is also engaging with payers, health systems, integrated delivery networks and community oncology practices. Sullivan said Celcuity has been encouraged by research assessing oncologists’ willingness to prescribe gedatolisib if approved.

Based on its analysis of published epidemiological data, Celcuity estimates there are 37,000 U.S. patients receiving second-line treatment for HR-positive, HER2-negative advanced breast cancer. Sullivan said Celcuity estimates the total addressable market for gedatolisib in the second-line setting is more than $5 billion annually and that a second-line indication could potentially generate peak revenue of up to $2.5 billion annually.

Celcuity is also evaluating gedatolisib with darolutamide in metastatic castration-resistant prostate cancer. Sullivan said Phase 1b data presented last year included 38 patients and showed the combination was generally well tolerated, with no dose-limiting toxicities and no discontinuations due to adverse events. He said the six-month radiographic progression-free survival rate was 67% and median radiographic progression-free survival was 9.1 months. Enrollment in the dose-escalation portion is ongoing, with a data update expected at a future medical conference.

Quarterly Loss Widens as Launch Spending Rises

Chief Financial Officer Vicky Hahne said Celcuity’s first-quarter net loss was $52.8 million, or $0.97 per share, compared with a net loss of $37 million, or $0.86 per share, in the first quarter of 2025. The non-GAAP adjusted net loss was $46.8 million, or $0.86 per share, compared with $34.7 million, or $0.81 per share, a year earlier.

Research and development expenses rose to $33.1 million from $29.8 million in the prior-year period. Hahne said the increase was primarily due to higher employee-related and consulting expenses and increased manufacturing and other costs, partially offset by lower clinical trial costs tied mainly to VIKTORIA-1.

Selling, general and administrative expenses increased to $17.4 million from $6.3 million. Hahne said the increase was driven primarily by employee-related and consulting expenses, including commercial headcount additions and other launch-related activities.

Net cash used in operating activities was $55.1 million for the quarter, compared with $35.9 million a year earlier. Celcuity ended the quarter with $387.1 million in cash, cash equivalents and short-term investments. Hahne said the company expects its cash, investments and drawdowns on its debt facility to finance operations through 2027.

About Celcuity NASDAQ: CELC

Celcuity, Inc 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.

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