Celcuity Inc.

Celcuity did not give revenue for the quarter in the prepared remarks. Net loss was $78.9 million, or $1.44 per share, versus 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, versus $40.5 million, or $0.93 per share a year ago. R&D expense was $31.1 million, down from $36.4 million, while SG&A was $35.0 million, up from $7.6 million. Cash, cash equivalents, and short-term investments were $754 million at 6/30/2026, up from $441.5 million at 12/31/2025, driven by gross proceeds of $575 million and net proceeds of $557.2 million from a June 2026 convertible note offering; the company also repaid $137 million of term debt. Net cash used in operating activities was $55.4 million versus $36.2 million in the prior-year period. Forward, management said Revtopik shipments should start late in Q3 2026, the mutant-cohort sNDA is planned for Q3 2026, and cash is expected to finance operations at least into 2029.

Brian Sullivan framed the quarter as a major inflection point, citing FDA approval of Revtopik, positive mutant-cohort data, and NCCN category 1 preferred recommendations as validation of gedatolisib’s potential in HR-positive/HER2-negative breast cancer. He emphasized that the company is positioned for both a second-line launch and broader first-line development, including VICTORIA-2 expansion into endocrine-sensitive disease. His tone was confident and upbeat, but he repeatedly stressed that launch timing still depends on the FDA review of the second manufacturing site.

Vicky Hahne highlighted the widening loss profile tied to commercialization buildout and capital structure changes. R&D fell to $31.1 million from $36.4 million mainly on lower VICTORIA-1 clinical trial costs, while SG&A jumped to $35.0 million from $7.6 million due largely to commercial hiring and pre-launch spending, with $23.4 million of the increase linked to launch-related activities. She said the company ended the quarter with $754 million in cash, cash equivalents, and short-term investments after raising $575 million gross in convertible debt, repaying $137 million of term debt, and using $110.5 million in operating cash, and she reiterated a runway through at least 2029.

Analysts focused first on the Revtopik launch and whether the company can begin shipping in late Q3 without delay, especially around FDA review of the second manufacturing site and whether inspection or additional sign-off is needed. Management said validation data were submitted almost immediately after approval, the review is underway, and they remain confident in late-Q3 shipping, while acknowledging that they cannot control the FDA’s exact process. Questions also centered on the expanded access program, gross-to-net expectations, launch metrics, and how quickly EAP patients will transition to commercial supply; management said gross-to-net should be about 80%, EAP-to-commercial transition will be site- and patient-specific but intended to be seamless, and launch tracking will rely mainly on vial shipments and survey data rather than prescription-level visibility.