Celcuity Inc. (CELC)
NASDAQ:CELC
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Celcuity
(NASDAQ:CELC)
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Rating:61Neutral
Price Target:
$145.00
▲(18.41% Upside)
Action:Reiterated
Date:05/19/26
The score is held down primarily by weak financial performance (pre-revenue, widening losses, heavy cash burn, and higher leverage). Offsetting this are strong technical momentum and a highly positive earnings call centered on compelling Phase 3 results and a defined near-term FDA catalyst (July 2026), while valuation support remains limited due to negative earnings and no dividend.
Positive Factors
Phase III efficacy & regulatory catalyst
Statistically significant PFS improvements in both mutant and doublet cohorts with manageable safety establish a durable clinical foundation for regulatory filings. A mid‑July 2026 PDUFA decision is a concrete near‑term structural catalyst that could convert a development program into a commercial-stage franchise, materially shifting the company's cash generation profile if approved.
Negative Factors
Pre‑revenue with widening losses
The company remains pre‑commercial with deeply negative earnings and cash flow. Widening losses and persistently negative free cash flow are structural until commercial sales begin, meaning the business will continue to consume capital and remain vulnerable to prolonged development or approval delays, raising dilution and financing risk over the medium term.
Read all positive and negative factors
Positive Factors
Negative Factors
Phase III efficacy & regulatory catalyst
Statistically significant PFS improvements in both mutant and doublet cohorts with manageable safety establish a durable clinical foundation for regulatory filings. A mid‑July 2026 PDUFA decision is a concrete near‑term structural catalyst that could convert a development program into a commercial-stage franchise, materially shifting the company's cash generation profile if approved.
Read all positive factors
Celcuity (CELC) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$6.71B
Dividend YieldN/A
Average Volume (3M)1.08M
Price to Earnings (P/E)―
Beta (1Y)0.39
Revenue GrowthN/A
EPS Growth-28.74%
CountryUS
Employees87
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-3.89
Shares Outstanding48,766,290
10 Day Avg. Volume1,580,707
30 Day Avg. Volume1,082,970
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 Cap0.97
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-50.75K
Enterprise Value/Ebitda-38.65
Forecast
1Y Price Target
$171.13Price Target Upside39.74% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering9
EPS Forecast (FY)-3.99
Revenue Forecast (FY)$57.21M
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 biotech and does not have publicly disclosed product sales revenue from commercialized drugs. Its cash inflows are typically driven by financing activities (e.g., public or private equity offerings) and, where applicab...
Celcuity Earnings Call Summary
Earnings Call Date:May 14, 2026
(Q1-2026)
| % Change Since: |
Next Earnings Date:Aug 06, 2026
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.Positive Updates
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).
Negative Updates
Increased Net Losses and Higher Non-GAAP Loss
GAAP net loss for Q1 2026 was $52.8 million ($0.97 per share) vs $37.0 million ($0.86) in Q1 2025 — an increase of $15.8 million (≈43%). Non-GAAP adjusted net loss was $46.8 million ($0.86) vs $34.7 million ($0.81) a year earlier — an increase of $12.1 million (≈35%).
Read all updates
Q1-2026 Updates
Positive
Negative
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).
Read all positive updates
Company Guidance
Management said they remain on track for the FDA PDUFA decision by July 17, 2026 and will pursue an sNDA if approved; cash, cash equivalents and short‑term investments were $387.1M at March 31, 2026 and, together with drawdowns on the debt facility, are expected to fund operations through 2027. Q1 results: GAAP net loss $52.8M ($0.97/share), non‑GAAP adjusted net loss $46.8M ($0.86/share), R&D $33.1M, SG&A $17.4M and net cash used in operations $55.1M. They amended VIKTORIA‑2 (Study 1 sample size cut from 638 to 440; topline data expected by end‑2028; Study 2 ~740 patients with topline by 2030) to enroll endocrine‑resistant and endocrine‑sensitive patients (the latter ≈60,000 of ~90,000 U.S. annual HR+/HER2‑ advanced breast cancer cases); they estimate ~37,000 U.S. patients are on second‑line therapy, a >$5B second‑line TAM and potential peak revenue up to $2.5B. Clinical highlights/guidance cited: first‑line Phase Ib median PFS 48.6 months (vs ~25 months historical) and ORR 79% (vs 53%); VIKTORIA‑1 wild‑type triplet showed +7.3 months incremental median PFS, 17.5‑month median DOR and +31% ORR vs control, with AE‑related discontinuation rates of 2% (triplet) and 3% (doublet), stomatitis median time to improvement 12/14 days and stable patient‑reported well‑being over 8 cycles; prostate Phase Ib 6‑month rPFS 67% and median rPFS 9.1 months (vs historical 40% 6‑month). They also reported a subcutaneous formulation program (first patent filed) with PK/bridging and equivalence studies planned to align with the endocrine‑sensitive approval timeline and a fully onboarded oncology sales team averaging 24 years in pharma and 16 years in oncology.Celcuity Financial Statement Overview
Summary
Income Statement
12
Very Negative
Balance Sheet
28
Negative
Cash Flow
16
Very Negative
| Breakdown | TTM | Dec 2025 | Mar 2025 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | -128.00K | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| EBITDA | -168.08M | -159.73M | -101.37M | -58.31M | -39.18M | -28.04M |
| Net Income | -192.89M | -177.04M | -111.78M | -63.78M | -40.37M | -29.61M |
Balance Sheet | ||||||
| Total Assets | 410.16M | 466.56M | 245.12M | 191.22M | 175.70M | 85.91M |
| Cash, Cash Equivalents and Short-Term Investments | 145.19M | 441.50M | 235.10M | 180.58M | 168.59M | 84.29M |
| Total Debt | 195.58M | 195.38M | 97.95M | 37.45M | 35.24M | 14.89M |
| Total Liabilities | 356.64M | 366.00M | 129.50M | 51.45M | 41.93M | 17.20M |
| Stockholders Equity | 53.52M | 100.56M | 115.62M | 139.77M | 133.77M | 68.71M |
Cash Flow | ||||||
| Free Cash Flow | -172.93M | -153.53M | -83.72M | -53.91M | -36.17M | -20.39M |
| Operating Cash Flow | -172.49M | -153.28M | -83.47M | -53.81M | -36.01M | -20.31M |
| Investing Cash Flow | -53.83M | -64.08M | -63.07M | -5.01M | -144.03M | -81.40K |
| Financing Cash Flow | 355.03M | 360.55M | 138.39M | 64.91M | 120.33M | 93.04M |
Celcuity Technical Analysis
Positive
122.46
Price Trends
120.05
Positive
113.69
Positive
90.92
Positive
Market Momentum
3.71
Positive
54.78
Neutral
52.39
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 122.46 is below the 20-day moving average (MA) of 128.10, above the 50-day MA of 120.05, and above the 200-day MA of 90.92, indicating a bullish trend. The MACD of 3.71 indicates Positive momentum. The RSI at 54.78 is Neutral, neither overbought nor oversold. The STOCH value of 52.39 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 | $5.72B | -52.96 | -22.95% | ― | ― | -94.37% | |
61 Neutral | $6.71B | -29.41 | -244.61% | ― | ― | -28.74% | |
59 Neutral | $6.11B | -19.78 | -32.64% | ― | ― | -22.17% | |
58 Neutral | $2.69B | -108.13 | -14.19% | ― | 128.99% | 58.46% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
51 Neutral | $2.48B | -7.50 | -13.96% | ― | 3118.14% | 55.95% |
* Healthcare Sector Average
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Celcuity Corporate Events
Business Operations and StrategyExecutive/Board ChangesShareholder Meetings
Celcuity Shareholders Approve New 2026 Equity Incentive Plans
Positive
May 18, 2026
At its May 14, 2026 annual meeting, Celcuity’s shareholders approved a new 2026 Stock Incentive Plan authorizing up to 3,000,000 shares for equity awards to employees, consultants and non-employee directors, replacing the prior 2017 plan and...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Celcuity Reports Positive Phase 3 Results for Gedatolisib
Positive
May 1, 2026
On May 1, 2026, Celcuity announced positive topline Phase 3 VIKTORIA-1 results in patients with PIK3CA mutant HR+/HER2- advanced or metastatic breast cancer whose disease had progressed on or after CDK4/6 inhibitor and aromatase inhibitor therapy....
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.