Celcuity Reports $73.3 Million Third-Quarter Loss, No Product Revenue

The Tip Desk · November 7, 2026 · 3 min read

For the third quarter of 2026, Celcuity reported a $73.3 million net loss, or $1.33 a share, and no product revenue. Gedatolisib shipments began September 30, but providers and pharmacies received the product after quarter-end.

Celcuity Inc. (CELC), a commercial-stage biotechnology company focused on targeted therapies for solid tumors, reported a $73.3 million net loss, or $1.33 a share, and no product revenue for the third quarter ended September 30, 2026. REVTORPYK (gedatolisib) became commercially available on September 30 after U.S. Food and Drug Administration approval on July 14. Shipments began that day, but healthcare providers and pharmacies did not receive product until after quarter-end.

The launch followed FDA clearance of REVTORPYK in combination with fulvestrant, with or without palbociclib, for HR+/HER2- locally advanced or metastatic breast cancer without a PIK3CA mutation after progression on at least one line of endocrine therapy. NCCN listed the regimen as a preferred Category 1 option on July 30. Chief Executive Brian Sullivan said physicians were interested in treating eligible patients in the initial weeks.

The company said 91% of U.S. commercial and Medicare lives are in health plans that cover REVTORPYK. Seventy-eight percent of the top 36 strategic accounts, which it said represent about half of the total addressable patient population, have prescribed the drug. More than 3,400 sites have engaged with Celcuity oncology sales specialists, and REVTORPYK has been incorporated in three of the four largest health care provider pathways.

Net loss for the third quarter ended September 30, 2026, was $73.3 million, or $1.33 a share, compared with $43.8 million, or $0.92 a share, a year earlier. Non-GAAP adjusted net loss was $66.8 million, or $1.21 a share.

Total operating expenses were $77.3 million, versus $42.8 million a year earlier. Selling, general and administrative expenses were $39.8 million, up $27.4 million from $12.4 million. Celcuity said $25.3 million of that SG&A increase related to commercial headcount and other activities to support REVTORPYK commercialization. Research and development expenses were $37.5 million.

Net cash used in operating activities was $66.2 million. The company also made a $50.0 million payment to Pfizer triggered by FDA approval under its exclusive global license for gedatolisib. Cash, cash equivalents and short-term investments were $642.7 million at quarter-end. Celcuity said that cash position is expected to finance operations through 2029.

Convertible notes on the balance sheet were $753.96 million at September 30, 2026, after a $575.0 million convertible note offering completed in the second quarter. A $126.53 million note payable outstanding at year-end 2025 had been repaid.

On the mutant-cohort path, Celcuity submitted a supplemental New Drug Application to the FDA in the third quarter. Updated VIKTORIA-1 results were presented at ESMO 2026 in October. In patients without liver metastases, median progression-free survival was 21.5 months with the gedatolisib triplet and 11.5 months with the doublet versus 9.1 months with alpelisib plus fulvestrant. The company said it expects to submit VIKTORIA-1 data for both wild-type and mutant cohorts to global regulatory authorities later this year or early next year.

Enrollment continues in Phase 3 VIKTORIA-2 for first-line HR+/HER2- advanced breast cancer. In metastatic castration-resistant prostate cancer, Phase 1b/2 data for gedatolisib plus darolutamide showed median radiographic progression-free survival of 15.7 months in patients with prior abiraterone and 9.1 months with prior enzalutamide. A randomized Phase 2 study of that combination is expected to begin in the first half of 2027.