Celcuity Q2 Earnings Call Highlights

Key Points

• REVTORPYK launch remains on track: Celcuity expects commercial shipments of its FDA-approved gedatolisib therapy for certain advanced breast cancer patients to begin in late Q3 2026. The treatment has a $30,000 per-cycle wholesale acquisition cost, and the company estimates a U.S. addressable market exceeding $6 billion annually.
• Clinical expansion continues: Celcuity plans a supplemental filing for the PIK3CA-mutant VIKTORIA-1 cohort after results showed roughly 11 months of median progression-free survival and fewer treatment discontinuations than alpelisib. The company is also expanding first-line breast cancer studies and advancing a prostate cancer trial.
• Higher losses reflect launch preparations: Q2 net loss widened to $78.9 million as selling, general and administrative expenses increased substantially for commercial hiring and pre-launch activities. Celcuity ended June with $754 million in cash and investments, expected to fund operations into at least 2029.

Celcuity NASDAQ: CELC said it remains on track to begin commercial shipments of REVTORPYK, its gedatolisib therapy for certain patients with advanced breast cancer, late in the third quarter of 2026 following its recent FDA approval.

The FDA approved REVTORPYK in July in combination with fulvestrant, with or without palbociclib, for patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation who progressed on or after at least one line of endocrine therapy in the metastatic setting. Shortly afterward, the National Comprehensive Cancer Network recommended both the triplet and doublet regimens as preferred Category 1 options for second-line or subsequent treatment in tumors without a PIK3CA mutation, Chief Executive Officer and Co-founder Brian Sullivan said during the company’s second-quarter call.

Clinical and Regulatory Plans

Sullivan said Celcuity plans to submit a supplemental new drug application in the third quarter seeking to include data from the PIK3CA-mutant cohort of its Phase III VIKTORIA-1 trial. The company also expects to submit VIKTORIA-1 data from both the wild-type and mutant cohorts to global regulators after the U.S. filing.

At the ASCO annual meeting in June, Celcuity presented results from the PIK3CA-mutant cohort. In the primary analysis, the gedatolisib triplet produced median progression-free survival of 11.1 months, compared with 5.6 months for alpelisib plus fulvestrant, with a hazard ratio of 0.50. The gedatolisib doublet showed median progression-free survival of 11.3 months, compared with 5.6 months for alpelisib plus fulvestrant, with a hazard ratio of 0.51.

Celcuity updated its adverse-event discontinuation analysis using the methodology used for the wild-type cohort in the REVTORPYK label. The company said 5.2% of patients receiving the gedatolisib triplet and 3.8% receiving the doublet discontinued gedatolisib because of an adverse event in the mutant cohort, compared with 19% who discontinued alpelisib due to an adverse event.

The company is also expanding its VIKTORIA-2 first-line breast cancer program. A second study will evaluate gedatolisib with palbociclib and letrozole in treatment-naive, endocrine-sensitive HR-positive, HER2-negative advanced breast cancer. The ongoing first study is evaluating gedatolisib, palbociclib and fulvestrant in treatment-naive endocrine-resistant disease.

Sullivan cited an earlier Phase Ib trial of gedatolisib, palbociclib and letrozole in 41 endocrine-sensitive patients, in which median progression-free survival was 48.6 months and the objective response rate was 79%. He said Celcuity is also continuing work on a subcutaneous formulation intended to demonstrate clinical equivalence with the current intravenous formulation.

Launch Preparation and Supply

Celcuity said its commercial infrastructure is in place, including 88 oncology sales specialists. The company has engaged key opinion leaders, community breast cancer experts, accounts, oncology organizations and patient advocacy groups as part of its launch preparation, Sullivan said.

REVTORPYK will carry a wholesale acquisition cost of $10,000 per vial, or $30,000 per treatment cycle. Celcuity estimated a combined wild-type and mutant second-line U.S. addressable market of more than $6 billion annually, based on an estimated 37,000 patients receiving second-line treatment and approximately 10 treatment cycles per patient.

The company opened an expanded-access program before commercial availability and said it has already begun shipping drug to participating sites. Patients in the program are expected to transition to commercial supply after launch, with the timing dependent on patient and site circumstances to avoid interruptions in treatment.

During the question-and-answer session, Sullivan said Celcuity submitted validation information for a second manufacturing site shortly after FDA approval. The company cannot ship product from that site until it receives FDA clearance, but Sullivan said management remains confident in its ability to begin shipments late in the third quarter. He noted that the review process can take about two to four months, depending on the FDA’s review and any issues that arise.

Prostate Cancer Program

Celcuity is also advancing a Phase Ib/II trial of gedatolisib with darolutamide in metastatic castration-resistant prostate cancer. The company completed evaluation of a 240-milligram gedatolisib dose in the dose-finding portion of the study, with no adverse events leading to gedatolisib discontinuation and no dose-limiting toxicity criteria for dose reduction met.

Evaluation of a 300-milligram dose is underway. Celcuity expects to provide additional clinical data and discuss its prostate cancer development strategy during the fourth quarter. Sullivan said possible updates could include PSA50 response data, progression-free survival data and subgroup analyses, though data from the 300-milligram dose may not yet be mature.

Second-Quarter Financial Results

Celcuity reported a second-quarter net loss of $78.9 million, or $1.44 per share, compared with a net loss of $45.3 million, or $1.04 per share, in the prior-year period. Non-GAAP adjusted net loss was $58.7 million, or $1.07 per share, compared with $40.5 million, or $0.93 per share, a year earlier.

• Research and development expense declined to $31.1 million from $36.4 million, primarily reflecting lower VIKTORIA-1 clinical trial costs.
• Selling, general and administrative expense rose to $35 million from $7.6 million, driven largely by commercial hiring and pre-launch activities for REVTORPYK.
• Cash used in operating activities was $55.4 million, compared with $36.2 million in the prior-year quarter.
• Cash, cash equivalents and short-term investments totaled $754 million as of June 30, up from $441.5 million at year-end 2025.

Chief Financial Officer Vicky Hahne said the increase in cash was primarily driven by a June convertible note offering that generated $557.2 million in net proceeds. The company used a portion of the proceeds to repay $137 million of term-loan debt. Celcuity said it expects its cash, cash equivalents and investments to fund operations at least into 2029.

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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