Celcuity Inc. (CELC)
NASDAQ:CELC
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Celcuity
(NASDAQ:CELC)
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Rating:62Neutral
Price Target:
$122.00
▲(6.81% Upside)
Action:ReiteratedDate:03/27/26
Score is held back primarily by weak financial performance (pre-revenue, escalating losses/cash burn, and sharply higher leverage). This is partially offset by very strong earnings-call catalysts (Priority Review NDA and robust Phase III data) and supportive technical trend, while valuation is difficult to justify on earnings due to negative profitability and no dividend support.
Positive Factors
Phase III efficacy
Robust, practice‑level Phase III efficacy and durable responses materially de‑risk the lead program versus competitors. Sustained PFS and response improvements support clinical differentiation, stronger physician adoption potential, and a clearer path to meaningful commercial uptake if approved.
Negative Factors
Pre-revenue and widening losses
Remaining pre‑revenue while losses accelerate creates sustained funding needs and heightens dilution risk. Continued negative operating cash flow means the company must convert clinical success into stable commercial revenue to achieve breakeven, a multi‑period transition that carries execution and timing risk.
Read all positive and negative factors
Positive Factors
Negative Factors
Phase III efficacy
Robust, practice‑level Phase III efficacy and durable responses materially de‑risk the lead program versus competitors. Sustained PFS and response improvements support clinical differentiation, stronger physician adoption potential, and a clearer path to meaningful commercial uptake if approved.
Read all positive factors
Celcuity (CELC) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$5.52B
Dividend YieldN/A
Average Volume (3M)688.41K
Price to Earnings (P/E)―
Beta (1Y)0.43
Revenue GrowthN/A
EPS Growth-40.75%
CountryUS
Employees87
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.97
Shares Outstanding48,336,674
10 Day Avg. Volume858,360
30 Day Avg. Volume688,414
Financial Highlights & Ratios
PEG Ratio-0.88
Price to Book (P/B)52.11
Price to Sales (P/S)0.00
P/FCF Ratio-34.13
Enterprise Value/Market Cap1.02
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-69.33K
Enterprise Value/Ebitda-37.09
Forecast
1Y Price Target
$121.17Price Target Upside6.08% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering8
EPS Forecast (FY)-4
Revenue Forecast (FY)$55.30M
Celcuity Business Overview & Revenue Model
Company Description
Celcuity Inc., a clinical stage biotechnology company, focuses on the development of molecularly targeted therapies for cancer patients in the United States. The company's CELsignia diagnostic platform uses a patient's living tumor cells to identi...
How the Company Makes Money
Celcuity is a clinical-stage biotechnology company and, based on publicly available information, it has not established a recurring product-revenue business. Its ability to generate revenue is therefore primarily tied to external financing (e.g., ...
Celcuity Earnings Call Summary
Earnings Call Date:Mar 25, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:May 18, 2026
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.Positive Updates
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.
Negative Updates
Widening GAAP Net Losses
Q4 2025 GAAP net loss was $51.0 million ($0.97/share) versus $36.7 million ($0.85/share) in Q4 2024, an increase of ~$14.3 million (~39%). Full-year 2025 GAAP net loss was $177.0 million ($3.79/share) versus $111.8 million ($2.83/share) in 2024, an increase of ~$65.2 million (~58%).
Read all updates
Q4-2025 Updates
Positive
Negative
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.
Read all positive updates
Company Guidance
The company guided that the gedatolisib NDA has been accepted for priority review under the FDA’s RTOR program with a PDUFA date of July 17, 2026; the PIK3CA‑mutant cohort of VIKTORIA‑1 is fully enrolled with topline results expected in Q2 2026 (press release) and full data at a medical conference, VIKTORIA‑2’s safety run‑in is wrapping up with a final Phase III design update expected in Q2, and the Phase Ib prostate program (n=38 in the Phase Ib portion) reported a 6‑month rPFS of 67% and median rPFS of 9.1 months across 120 mg/180 mg arms with no DLTs and dose escalation ongoing. Key clinical metrics cited for the PIK3CA wild‑type VIKTORIA‑1 cohort: median PFS 9.3 vs 2.0 months (Δ 7.3 months), hazard ratio 0.24; median duration of response 17.5 months; incremental ORR +31%; U.S./Canada subgroup median PFS 19.3 vs 2.0 months (HR 0.13); U.S./Canada/Western Europe/Asia‑Pacific (~60% of enrollment) median PFS 16.6 vs 1.9 months (HR 0.14); median time to definitive deterioration 23.7 vs 4.0 months (HR 0.39); stomatitis median time to improvement 12 days (Grade 2) and 14 days (Grade 3); treatment discontinuation for treatment‑related AEs ~2.3%; and no clinically relevant hypoglycemia observed. Financial metrics and runway: Q4 net loss $51.0M ($0.97/share) and FY net loss $177.0M ($3.79/share); Q4 non‑GAAP adjusted net loss $38.4M ($0.73) and FY non‑GAAP $150.8M ($3.22); Q4 R&D $37.6M and FY R&D $145M; Q4 G&A $11.6M and FY G&A $27.2M; net cash used in operations Q4 $36.4M and FY $153.3M; cash, cash equivalents and short‑term investments $441.5M, expected to fund operations through 2027. Commercial/market assumptions noted: ~37,000 U.S. second‑line patients, total addressable market >$5B, potential peak revenue up to $2.5B using a ~10‑month treatment duration assumption.Celcuity Financial Statement Overview
Summary
Income Statement
12
Very Negative
Balance Sheet
28
Negative
Cash Flow
14
Very Negative
| Breakdown | Dec 2025 | Mar 2025 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | -167.00K | 0.00 | 0.00 | 0.00 | 0.00 |
| EBITDA | -172.19M | -101.37M | -58.31M | -39.18M | -28.04M |
| Net Income | -177.04M | -111.78M | -63.78M | -40.37M | -29.61M |
Balance Sheet | |||||
| Total Assets | 466.56M | 245.12M | 191.22M | 175.70M | 85.91M |
| Cash, Cash Equivalents and Short-Term Investments | 441.50M | 235.10M | 180.58M | 168.59M | 84.29M |
| Total Debt | 195.38M | 97.95M | 37.45M | 35.24M | 14.89M |
| Total Liabilities | 366.00M | 129.50M | 51.45M | 41.93M | 17.20M |
| Stockholders Equity | 100.56M | 115.62M | 139.77M | 133.77M | 68.71M |
Cash Flow | |||||
| Free Cash Flow | -153.53M | -83.72M | -53.91M | -36.17M | -20.39M |
| Operating Cash Flow | -153.28M | -83.47M | -53.81M | -36.01M | -20.31M |
| Investing Cash Flow | -64.08M | -63.07M | -5.01M | -144.03M | -81.40K |
| Financing Cash Flow | 360.55M | 138.39M | 64.91M | 120.33M | 93.04M |
Celcuity Technical Analysis
Positive
114.22
Price Trends
110.03
Positive
105.16
Positive
74.55
Positive
Market Momentum
0.67
Negative
54.44
Neutral
69.88
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CELC, the sentiment is Positive. The current price of 114.22 is above the 20-day moving average (MA) of 111.69, above the 50-day MA of 110.03, and above the 200-day MA of 74.55, indicating a bullish trend. The MACD of 0.67 indicates Negative momentum. The RSI at 54.44 is Neutral, neither overbought nor oversold. The STOCH value of 69.88 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for CELC.
Celcuity Risk Analysis
Celcuity disclosed 47 risk factors in its most recent earnings report. Celcuity reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Celcuity Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
67 Neutral | $6.73B | -69.12 | -34.29% | ― | ― | -73.27% | |
62 Neutral | $5.52B | ― | -203.17% | ― | ― | -40.75% | |
62 Neutral | $2.99B | ― | -19.63% | ― | 182.44% | 47.21% | |
61 Neutral | $5.84B | -17.91 | -36.77% | ― | ― | -58.35% | |
52 Neutral | $2.84B | ― | -11.10% | ― | 5376.27% | 20.97% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% |
* Healthcare Sector Average
CELC
Celcuity
114.22
106.01
1291.23%
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84.01
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191.80%
Celcuity Corporate Events
Business Operations and StrategyExecutive/Board Changes
Celcuity Adds Veteran Director to Strengthen Oncology Strategy
Positive
Feb 12, 2026
On February 11, 2026, Celcuity’s board expanded from seven to eight members and appointed pharmaceutical industry veteran Charles (Chip) R. Romp as an independent director for a term running through the 2026 annual meeting. He will receive s...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.