Celcuity Inc. (CELC)
NASDAQ:CELC
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Earnings Data
Report Date
Aug 06, 2026After Close (Confirmed)
Period Ending
2026 (Q2)Consensus EPS Forecast
-1.11Last Year’s EPS
-1.04Same Quarter Last Year
Strong Buy
Based on 9 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Positive
The call was clinically very positive: robust Phase III efficacy signals in both wild-type and mutant cohorts, expansion into first-line studies, promising prostate cancer combo data, IP and formulation work for a subcutaneous version, and a staffed commercial organization targeting a large (~$5B+) second-line market and potential peak revenues up to $2.5B. Offsetting these achievements are materially higher losses and cash burn (net loss up ≈43%, non-GAAP loss up ≈35%, operating cash use up ≈54%), a large increase in SG&A (≈176%), runway that extends through 2027 only with debt drawdowns, and regulatory/clinical timelines (notably first-line data by 2028–2030 and potential additional studies for subcutaneous formulation) that delay broader commercialization. On balance, strong clinical progress and commercial preparations outweigh the near-term financial and timing challenges, but the company will need to manage cash and regulatory requirements closely.Company Guidance
Positive Phase III VIKTORIA-1 Mutant Cohort Top-line Results
Gedatolisib triplet (gedatolisib + fulvestrant + palbociclib) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus alpelisib + fulvestrant in the PIK3CA mutant cohort; the gedatolisib doublet (gedatolisib + fulvestrant) also showed a statistically significant PFS improvement. Both regimens were generally well tolerated with no new safety signals. Detailed results to be presented at ASCO (June 2).
Record Benchmarking in PIK3CA Wild-Type Cohort
Previously reported VIKTORIA-1 wild-type results set new benchmarks: a 7.3-month incremental improvement in median PFS for the gedatolisib triplet over fulvestrant (noted as higher than any Phase III in this setting), 17.5 months median duration of response for the triplet, and a 31 percentage-point incremental increase in objective response rate for the triplet vs control. Low adverse event-related discontinuation rates (2% triplet, 3% doublet) and rapid improvement in stomatitis (median 12 days for Grade 2, 14 days for Grade 3) were reported.
VIKTORIA-2 Expansion to First-Line Endocrine-Sensitive Patients
VIKTORIA-2 amended to include two studies: Study 1 (endocrine-resistant) and Study 2 (endocrine-sensitive). Study 1 sample size reduced from 638 to 440 (≈31% reduction) while preserving power; Study 2 expected to enroll ~740 endocrine-sensitive patients. Primary endpoints are BICR-assessed PFS. Top-line expectations: Study 1 by end of 2028, Study 2 by 2030.
Subcutaneous Gedatolisib Program and IP
Company advancing development of a subcutaneous formulation to support long-duration treatments, submitted first U.S. patent application for an injectable formulation, progressing formulation optimization, stability and animal studies with multiple candidates, and targeting functional volume requirements to make the dose injectable. Aim is to demonstrate clinical equivalence to IV formulation and align subcu availability with potential approvals.
Promising Prostate Cancer Combo Data (Phase Ib)
Gedatolisib + darolutamide in metastatic castration-resistant prostate cancer (Phase Ib): 6-month radiographic PFS rate of 67% (vs historical ~40%), median radiographic PFS 9.1 months. Combination generally well tolerated with no dose-limiting toxicities and no discontinuations due to adverse events.
Commercial Preparations and Market Opportunity
Commercial organization substantially built; oncology sales specialists fully hired and onboarded with average experience of 24 years in pharma and 16 years in oncology. Extensive payer and account outreach underway. Estimated U.S. second-line total addressable market >$5 billion annually; company estimates potential peak second-line revenue up to $2.5 billion.
Cash Position and Runway (Near-Term)
Cash, cash equivalents and short-term investments of $387.1 million at March 31, 2026. Company expects cash, investments and drawdowns on its debt facility to finance operations through 2027.
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 |
|---|---|---|---|
May 14, 2026 | $134.72 | $137.68 | +2.20% |
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% |
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 Aug 06, 2026, After Close (Confirmed).
What is Celcuity Inc. (CELC) earnings time?
Celcuity Inc. (CELC) earnings time is at Aug 06, 2026, After Close (Confirmed).
Where can I see when companies are reporting earnings?
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What is CELC EPS forecast?
CELC EPS forecast for the fiscal quarter 2026 (Q2) is -1.11.