Celcuity Inc. (CELC)
NASDAQ:CELC
Earnings Data
Report Date
May 18, 2026After Close (Confirmed)
Period Ending
2026 (Q1)Consensus EPS Forecast
-1.04Last Year’s EPS
-0.86Same Quarter Last Year
Strong Buy
Based on 8 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Positive
The call conveyed strong clinical and regulatory momentum centered on potentially practice-changing Phase III data for the wild-type cohort, an accepted NDA with Priority Review and supporting peer-reviewed publication, plus active commercial preparation and a solid cash runway. These positives are balanced against materially higher operating losses, rising R&D and G&A spend tied to the commercial launch, increased operating cash burn, and limited near-term disclosure around the mutant cohort readout. On balance, the transformative clinical/regulatory progress and commercial positioning materially outweigh the financial burn and execution risks, which appear expected for a company transitioning to potential commercialization.Company Guidance
Regulatory Milestone – NDA Accepted with Priority Review
FDA accepted Celcuity's NDA for gedatolisib under the Real-Time Oncology Review program and granted Priority Review with a PDUFA date of July 17, 2026, positioning the company for potential approval and commercialization in 2026.
Outstanding Phase III VIKTORIA-1 Wild-Type Results
PIK3CA wild-type cohort: median PFS for the gedatolisib triplet was 9.3 months versus 2.0 months for fulvestrant (incremental improvement 7.3 months) with a hazard ratio of 0.24. Subgroup analyses: U.S./Canada median PFS 19.3 vs 2.0 months (HR 0.13); broader region (~60% of patients) median PFS 16.6 vs 1.9 months (HR 0.14). Median duration of response was 17.5 months and the objective response rate improved by 31 percentage points versus control.
Safety and Tolerability Profile
Gedatolisib triplet was generally well tolerated with mostly low-grade adverse events, treatment discontinuation due to treatment-related AEs at ~2.3% (reported), effective mitigation of stomatitis (median time to improvement 12 days for Grade 2 and 14 days for Grade 3), and no clinically relevant hypoglycemia or glucose-driven dose reductions/withdrawals.
Clinical Impact on Patient-Reported Outcomes
Patient-reported outcomes showed median time to definitive deterioration of 23.7 months for the gedatolisib triplet versus 4.0 months for fulvestrant (HR 0.39), and patient well-being remained stable for the first eight cycles versus baseline.
Publication and Scientific Dissemination
Key VIKTORIA-1 wild-type data were presented in late-breaking oral presentations at ESMO and San Antonio Breast Cancer Symposium and were recently published in the Journal of Clinical Oncology, supporting scientific validation and visibility.
Completed Enrollment in PIK3CA Mutant Cohort and Imminent Readout
Enrollment of the PIK3CA mutant cohort of VIKTORIA-1 was completed late last year; top-line results are expected in Q2 2026 with a detailed conference presentation to follow.
Promising Prostate Cancer Combination Data (Phase Ib)
In the Phase Ib portion evaluating gedatolisib plus darolutamide in metastatic castration-resistant prostate cancer (38 patients), the 6-month rPFS rate was 67% and median rPFS was 9.1 months (combined arms), comparing favorably to historical 6-month rPFS ~40%. No dose-limiting toxicities and no discontinuations due to AEs were observed.
Commercial Preparation and Market Opportunity
Company reports the commercial organization and systems largely built (sales force, payer outreach). Estimated U.S. addressable population ~37,000 second-line HR+/HER2- patients post-CDK4/6 inhibitor; estimated second-line TAM >$5 billion and potential peak revenue up to ~$2.5 billion annually (using illustrative 10-month duration assumption).
Strong Cash Position and Runway
Cash, cash equivalents and short-term investments of $441.5 million at FY2025 year-end, which management expects will finance operations through 2027, providing runway into and through planned regulatory and initial commercial activities.
CELC Earnings History
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
CELC Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
Mar 25, 2026 | $110.22 | $114.81 | +4.16% |
Nov 12, 2025 | $85.15 | $86.00 | +1.00% |
Aug 14, 2025 | $51.89 | $51.79 | -0.19% |
May 14, 2025 | $10.86 | $10.52 | -3.13% |
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
FAQ
When does Celcuity Inc. (CELC) report earnings?
Celcuity Inc. (CELC) is schdueled to report earning on May 18, 2026, After Close (Confirmed).
What is Celcuity Inc. (CELC) earnings time?
Celcuity Inc. (CELC) earnings time is at May 18, 2026, After Close (Confirmed).
Where can I see when companies are reporting earnings?
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What companies are reporting earnings today?
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What is CELC EPS forecast?
CELC EPS forecast for the fiscal quarter 2026 (Q1) is -1.04.