Celcuity Inc. (CELC) Earnings Call Transcripts

Celcuity Inc.'s Latest Earnings Call - June 10, 2026

Celcuity Inc. reported its earnings for Q2 2026, highlighting significant advancements in its lead candidate, gedatolisib, targeting the PAM pathway in oncology. The company did not provide specific revenue or earnings figures in the call, but emphasized the FDA's priority review and an upcoming PDUFA date as potential stock movers. Management confirmed the completion of their commercial organization in anticipation of approval, signaling readiness for market entry. Guidance was notably extended, with a financial runway now projected through 2029 following a recent $575 million capital raise.

Reported metrics

Guidance from management

Celcuity maintained its guidance for a financial runway through 2029, supported by a recent $575 million capital raise. Management expressed confidence in achieving FDA approval for gedatolisib and emphasized readiness for commercial launch.

What management said

Sure. So you're referring to our Phase III study in second-line breast cancer where essentially we evaluated patients who HER2, HR+ R2 negative advanced breast cancer, LACT mutations, but fantastic results, really unprecedented results. And we've anticipated success in this business, you have to plan for success. So we began building our commercial organization over 2 years ago. We've since completed the build out of...

Well, we actually just raised some additional money. We raised about $575 million recently. And so combined with the current cash, we think that takes us through '29 and at least through '29. So we think we have a long runway. I think that funds, obviously, our commercial launch, but also funds some 2 additional Phase III studies that we have, and we can talk about those in the advanced breast cancer space. .

What analysts pressed on

Analysts expressed concerns about regional variability in PFS outcomes and the potential impact on commercial strategy. There were also questions about the competitive landscape, particularly regarding emerging therapies and combination strategies.

Main topics on the call

• FDA Priority Review and PDUFA Date — Celcuity's lead candidate, gedatolisib, has been granted FDA priority review with a PDUFA date approaching, indicating potential near-term approval. Management stated, 'We're kind of a few weeks away from what we think w...
• Commercial Readiness — Celcuity has completed the build-out of its commercial organization, including hiring and training a sales force, in preparation for gedatolisib's potential market launch. Brian Sullivan noted, 'Sales force has been hire...
• Phase III Study Results — The VIKTORIA-1 study showed promising results in both wild-type and mutant populations, with median PFS of 17 months in certain regions. However, mixed results were noted in Latin America and Eastern Europe due to less f...
• Financial Runway Extension — Celcuity extended its financial runway through 2029 after raising $575 million. This funding supports commercial launch and additional Phase III studies. Sullivan stated, 'We think that takes us through '29 and at least ...

Read the full Celcuity Inc. transcript (June 10, 2026) → Summary generated from the call transcript; every figure above is stated by management on the record.

Earnings Call History

EarningsCalls.dev has 34 Celcuity Inc. earnings call transcripts on record, spanning March 12, 2020 to July 14, 2026. Based on this history, Celcuity Inc. reports quarterly. The most recent call on file is dated July 14, 2026. The full list is below — each row opens the complete, free-to-read transcript.

Ticker

CELC

Exchange

NasdaqCM

Country

US

Sector

Health Care

Industry

Biotechnology

Calls on record

34

First call

March 12, 2020

Most recent

July 14, 2026

Reporting cadence

quarterly