Celcuity Reports $78.9 Million Net Loss and FDA Approval for REVTORPYK

Celcuity Inc. reported significant financial developments in its latest 10-Q filing for the quarter ending June 30, 2026. The company recorded a net loss of $78.9 million for the quarter, compared to a loss of $45.3 million in the same period last year, marking a 74% increase in losses. For the first half of 2026, the net loss was $131.7 million, up from $82.3 million in the prior year, reflecting a 60% increase. Operating expenses totaled $66.1 million for the quarter, a 50% increase from $44.0 million in the previous year, driven primarily by a substantial rise in selling, general, and administrative expenses, which surged to $35.0 million from $7.6 million.

The company’s financial position showed a notable increase in total assets, which rose to $828.2 million as of June 30, 2026, compared to $466.6 million at the end of 2025. This increase was largely attributed to a significant rise in cash and cash equivalents, which reached $182.0 million, and investments totaling $572.0 million. Celcuity's accumulated deficit also grew to $580.6 million, reflecting ongoing investments in research and development, particularly for its lead product, REVTORPYK (gedatolisib), which received FDA approval in July 2026.

Strategically, Celcuity has made substantial progress in its clinical development pipeline. The FDA approved REVTORPYK for the treatment of HR+/HER2- advanced breast cancer, and the company has initiated commercialization activities. The National Comprehensive Cancer Network (NCCN) has recommended REVTORPYK as a preferred treatment option, which is expected to enhance market adoption. The company has also opened an Expanded Access Program to provide the drug to eligible patients prior to its commercial launch, which is anticipated to begin in late Q3 2026.

Operationally, Celcuity has been expanding its clinical trials, with ongoing studies such as the VIKTORIA-2 Phase 3 trial and the CELC-G-201 Phase 1b/2 trial. As of June 30, 2026, over 1,130 patients have participated in various trials involving gedatolisib. The company is also exploring a subcutaneous formulation of gedatolisib to potentially extend treatment durations. The workforce has expanded to support these initiatives, with increased hiring in commercial functions to prepare for the drug's launch.

Looking ahead, Celcuity anticipates continued growth in both research and development and selling, general, and administrative expenses as it prepares for the commercial launch of REVTORPYK and advances its clinical trials. The company believes its current cash reserves and investments will be sufficient to fund operations for at least the next year, although it may seek additional capital to support its growth strategy and operational needs.