What Celcuity (CELC) Said on Its Q3 Earnings Call

Key Points

• REVTORPYK’s launch showed early traction: 78% of Celcuity’s 36 strategic accounts had ordered the drug, health plans covering 91% of U.S. commercial and Medicare lives covered it, and it was added to three of four major provider pathways. No product revenue was recorded in Q3 because shipments began on the quarter’s final day and had not yet reached treatment sites.
• Higher launch-related costs widened the loss: Celcuity reported a Q3 net loss of $73.3 million, up from $43.8 million a year earlier, as operating expenses rose to $77.3 million. The company ended the quarter with $642.7 million in cash and investments and expects that balance to fund operations through 2029.
• Clinical and regulatory programs advanced: Celcuity submitted an FDA application based on the PIK3CA-mutant VIKTORIA-1 cohort and expects further regulatory submissions and trial updates. Overall-survival data from VIKTORIA-1 are anticipated in the first half of 2027, though timing is event-driven.

Celcuity NASDAQ: CELC reported a wider third-quarter loss as it prepared to commercialize its breast cancer treatment REVTORPYK, while executives said early orders and insurance coverage pointed to an encouraging launch.

The company recorded no product revenue in the quarter ended Sept. 30, 2026. Shipments began on the final day of the quarter, but none reached treatment locations until afterward, Chief Financial Officer Vicky Hahne said on the earnings call.

Chief Executive Officer and Co-Founder Brian Sullivan said Celcuity expects to provide a preliminary report on fourth-quarter sales in mid-January. The company’s net loss for the third quarter widened to $73.3 million, or $1.33 per share, from $43.8 million, or $0.92 per share, a year earlier.

Early launch and market access

REVTORPYK is available in the U.S. in combination with fulvestrant, with or without palbociclib, for certain patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation after progression on or following endocrine therapy in the metastatic setting.

Sullivan said 78% of Celcuity’s top 36 strategic accounts had ordered REVTORPYK since it became commercially available on Sept. 30. Those accounts treat roughly half of the addressable patient population, he said. More than 3,400 sites had engaged directly with the company’s oncology sales specialists, while more than 1,100 health care providers had attended educational programs.

Health plans covering 91% of U.S. commercial and Medicare lives cover the treatment, Sullivan said. He also said REVTORPYK had been incorporated into three of the four largest health care provider pathways within 30 days of commercial availability.

Shipments began at a wholesale acquisition cost of $10,000 per vial, or $30,000 per 28-day treatment cycle. Sullivan estimated a roughly $9 billion annual U.S. market for second-line treatment, including patients with and without PIK3CA mutations, based in part on an assumed net receipt of 80% of the list price. The drug is not currently approved for patients with PIK3CA mutations.

Because most providers are expected to order the infused drug through specialty distributors using a buy-and-bill system, Celcuity does not receive detailed data on the number of prescribers or patients, Sullivan said. He described reports that physicians favor the three-drug regimen as anecdotal.

Sullivan said the company has sufficient production to meet planned or higher-than-planned demand. A second manufacturing site is not expected to be approved until around the middle of 2027, he said.

Clinical and regulatory updates

Celcuity submitted a supplemental new drug application to the Food and Drug Administration in the third quarter based on results from the PIK3CA-mutant cohort of the Phase 3 VIKTORIA-1 study, Sullivan said. The company expects to submit data from both the mutant and wild-type cohorts to global regulators later this year or early next year.

At the European Society for Medical Oncology meeting in October, the company presented updated results from the mutant cohort. Among patients without liver metastases, median progression-free survival was 21.5 months for the gedatolisib triplet and 11.5 months for the doublet, compared with 9.1 months for alpelisib plus fulvestrant, Sullivan said.

He added that the rate of discontinuation of gedatolisib because of adverse events was 5% for the triplet and 4% for the doublet, compared with a 19% discontinuation rate for alpelisib plus fulvestrant. Sullivan said Celcuity expects to provide further VIKTORIA-1 updates at the San Antonio Breast Cancer Symposium later this year.

The company expects overall survival data from VIKTORIA-1 in the first half of 2027, although the timing is event-driven, Sullivan said. He cautioned that crossover in the wild-type cohort could complicate interpretation of the results.

Celcuity is also conducting the Phase 3 VIKTORIA-2 trial in first-line advanced breast cancer and developing a subcutaneous formulation of gedatolisib. A randomized Phase 2 study of gedatolisib with darolutamide in metastatic castration-resistant prostate cancer is expected to begin in the first half of 2027, following completion of the Phase 1b portion of the current study.

Commercial spending drives expenses higher

Third-quarter operating expenses rose to $77.3 million from $42.8 million a year earlier. Research and development expenses increased to $37.5 million from $30.4 million, while selling, general and administrative expenses rose to $39.8 million from $12.4 million.

Hahne said $25.3 million of the increase in selling, general and administrative expenses related to commercial hiring and other activities supporting the REVTORPYK launch. The company also made a $50 million payment to Pfizer triggered by FDA approval under its gedatolisib license agreement.

Celcuity ended the quarter with $642.7 million in cash, cash equivalents and short-term investments, compared with $441.5 million at the end of 2025. Hahne said the balance reflected proceeds from a convertible note offering completed in June, offset partly by operating cash use, repayment of a term loan and the Pfizer payment. The company expects its cash and investments to fund operations through 2029.

About Celcuity (NASDAQ:CELC)

Celcuity, Inc is a clinical-stage biotechnology company developing functional diagnostic tests designed to help identify cancer treatments that may be most effective for individual patients. Its technology analyzes living tumor cells taken from patients to measure how signaling pathways respond to different therapies, with the goal of supporting more personalized treatment decisions.

The company's CELsignia platform is designed to assess the activity of cancer-related signaling pathways in patient-derived cells.

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