Q1 2026 Celcuity Inc Earnings Call Transcript

May 14, 2026 / 08:30 PM GMT

Release Date Price: $134.72 (+8.23%)

Transcript 10-Q8-K

Key Points

Positve

Celcuity Inc (CELC) reported positive top-line results for the PIK3CA mutant cohort of the Phase III Victoria I clinical trial, indicating a significant improvement in progression-free survival.
The company is preparing for the potential approval and commercial launch of Gedit-Silisib in the third quarter, which could become a new standard-of-care for HR-positive HER2-negative advanced breast cancer.
Celcuity Inc (CELC) announced the expansion of their Phase III Victoria II trial to include a study evaluating gadotilisib as a first-line treatment, potentially advancing the standard of care for newly diagnosed patients.
The company is developing a subcutaneous formulation of gadotilisib, which could support future indications and improve patient convenience.
Celcuity Inc (CELC) has completed building their commercial organization and hired experienced oncology sales specialists in preparation for the potential launch of gadotilisib.

Negative

Celcuity Inc (CELC) reported a net loss of $52.8 million for the first quarter of 2026, an increase from the previous year's loss of $37 million.
Research and development expenses increased to $33.1 million, driven by higher employee-related and consulting expenses.
Selling, general, and administrative expenses rose significantly to $17.4 million, primarily due to commercial headcount additions and launch-related activities.
The company used $55.1 million in net cash for operating activities in the first quarter, up from $35.9 million in the prior year period.
There is uncertainty regarding the FDA's review timeline and potential approval of the NDA for gadotilisib, which could impact the company's strategic plans.

Refinitiv StreetEvents Event Transcript
E D I T E D V E R S I O N

CELC.OQ - Celcuity Inc
Q1 2026 Celcuity Inc Earnings Call
May 14, 2026 / 08:30PM GMT

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Presentation
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Unidentified_1 [1]
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Good afternoon, ladies and gentlemen, and welcome to the Security First Quarter 2026 Financial Results Call Webcast.

At this time, all lines are in listen-only mode.

Following the presentation, we will conduct a question-and-answer session.

If at any time during this call you require immediate assistance, please press *0 for the operator.

I would now like to turn the conference over to Jodi Seavers. Corporate Communications and Investor Relations at Celcuity. Please go ahead.

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Unidentified_2 [2]
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Thank you, Matthew, and good

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