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Celcuity (CELC)
NASDAQ:CELC
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Celcuity
(NASDAQ:CELC)
Rating:44Neutral
Price Target:―
Positive Factors
Clinical Trials
Early-phase clinical trials evaluating gedatolisib in prostate cancer and HER2+ breast cancer have shown promising results.
Market Opportunity
Gedatolisib is seen as a uniquely differentiated asset that could become a standard-of-care treatment option in the competitive 2L+ HR+/HER2- metastatic breast cancer landscape.
Safety Profile
The safety profile from the Ph 1 trial indicates that prophylactic measures can effectively manage side effects, as shown by the absence of dose reductions or discontinuations.
Negative Factors
Financial Performance
For 2025, projections indicate no revenues and a net loss of $3.92 per diluted share.
Short Interest
Short interest in Celcuity is 11.7% of the float.
Celcuity (CELC) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$511.57M
Dividend YieldN/A
Average Volume (3M)183.55K
Price to Earnings (P/E)―
Beta (1Y)1.36
Revenue GrowthN/A
EPS Growth-4.14%
CountryUS
Employees87
SectorHealthcare
Sector Strength39
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.86
Shares Outstanding37,866,360
10 Day Avg. Volume256,253
30 Day Avg. Volume183,553
Financial Highlights & Ratios
PEG Ratio-0.30
Price to Book (P/B)1.61
Price to Sales (P/S)0.00
P/FCF Ratio-5.97
Enterprise Value/Market Cap0.44
Enterprise Value/Revenue493.54
Enterprise Value/Gross Profit-7.29K
Enterprise Value/Ebitda-0.60
Forecast
1Y Price Target
$28.25Price Target Upside107.42% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering7
Celcuity Business Overview & Revenue Model
Company DescriptionCelcuity Inc. is a biotechnology company focused on discovering new cancer sub-types and developing diagnostic tests designed to significantly improve the clinical outcomes of cancer patients treated with targeted therapies. Operating primarily within the healthcare sector, Celcuity’s core product, CELsignia, is a platform that identifies the dynamic cellular activity in a patient's cancerous cells, helping to determine the most effective targeted therapy for their treatment.
How the Company Makes MoneyCelcuity generates revenue primarily through the commercialization of its CELsignia platform. The company's revenue model is based on partnerships with pharmaceutical companies and healthcare providers who utilize its diagnostic tests to optimize cancer treatment strategies. Celcuity collaborates with pharmaceutical firms to enhance the efficacy of their targeted therapies, potentially sharing in the economic benefits of improved treatment outcomes. Additionally, the company may receive payments for conducting clinical trials and providing diagnostic services to institutions focused on personalized cancer treatment.
Celcuity Earnings Call Summary
Earnings Call Date:May 14, 2025
(Q1-2025)
| % Change Since: 25.41%|
Next Earnings Date:Aug 07, 2025
Earnings Call Sentiment Neutral
The earnings call reflects a mix of positive developments in clinical trials and potential market opportunities, contrasted by increased financial losses and operational cash burn. The anticipation for upcoming data readouts is high, but there are concerns about financial sustainability.Q1-2025 Updates
Positive Updates
Upcoming Clinical Data Readouts
Celcuity expects to report topline data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial in Q3 2025 and from the PIK3CA mutated patient cohort in Q4 2025, indicating significant progress in their clinical trials.
Potential Revenue from Gedatolisib
If gedatolisib receives FDA approval for both PIK3CA wild-type and mutant populations, the estimated peak revenue potential for the second-line indication could exceed $2 billion with 40% market penetration.
Advancements in VIKTORIA-2 Trial
Significant progress in activating trial sites for the Phase 3 first-line VIKTORIA-2 trial, with nearly 200 sites qualified across multiple regions.
Endometrial Cancer Collaboration
Celcuity announced a collaboration with Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole in patients with endometrial cancer.
Negative Updates
Increased Financial Losses
Celcuity reported a net loss of $37 million for Q1 2025, compared to $21.6 million for Q1 2024, with a notable increase in research and development expenses.
Significant Operational Cash Burn
Net cash used in operating activities for Q1 2025 was $35.9 million, up from $17.1 million in Q1 2024, signaling increased cash consumption.
Delay in Data Readout Timeline
The timeline for the data readout of the PIK3CA wild-type cohort was slightly adjusted, now expected in Q3 2025, reflecting potential delays in the trial process.
Company Guidance
During the Celcuity First Quarter 2025 Financial Results Webcast Conference Call, the company provided guidance on several key metrics. Celcuity expects to report topline data from the PIK3CA wild-type cohort of their Phase 3 VIKTORIA-1 trial by Q3 2025, with data from the PIK3CA mutated cohort anticipated in Q4 2025. The company also plans to release preliminary data from a Phase 1b prostate cancer trial by the end of Q2 2025. They foresee significant revenue potential if their programs receive regulatory approval, estimating a $2 billion peak revenue potential for their second-line indication with gedatolisib if they achieve 40% market penetration. Financially, Celcuity reported a Q1 2025 net loss of $37 million, noting a 49% increase in R&D expenses compared to Q1 2024, and closed the quarter with $205.7 million in cash and equivalents, projecting funding through 2026.Celcuity Financial Statement Overview
Summary
Celcuity's financial performance reflects the challenges of early-stage biotech firms. The income statement shows consistent losses with no revenue, leading to a score of 10. Despite a stable balance sheet with low debt and strong liquidity, the declining equity is a concern, resulting in a score of 40. Persistent negative free cash flow due to high cash burn further impacts the score, with cash flow scoring 30. Overall, financial stability is challenged by high operational expenses and no revenue generation.Income Statement
Celcuity's income statement shows consistent losses with no revenue generation over multiple years, which is common in biotech firms during early stages. The company has high negative EBIT and net income, reflecting significant R&D and operational expenses without revenue offset. The lack of revenue growth and profitability margins poses a challenge to financial stability.10
Very Negative
Balance Sheet
The balance sheet indicates a stable equity base and low debt levels, with a debt-to-equity ratio of 0.002 in 2024. The company has substantial cash reserves compared to its liabilities, indicating a strong liquidity position. However, the declining equity and increasing liabilities over time can be a concern if the trend continues without revenue growth.40
Negative
Cash Flow
The cash flow statement reveals persistent negative free cash flow, indicating high cash burn due to operational activities. However, the company has managed to secure financing, as shown by strong positive financing cash flows, which provide necessary liquidity. The free cash flow to net income ratio remains negative, highlighting inefficiencies in cash generation relative to net losses.30
Negative
| Breakdown | TTM | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | -31.11K | 0.00 | -142.77K | -210.92K | -303.24K | -385.59K |
| EBITDA | -117.32M | -113.27M | -58.31M | -39.18M | -28.05M | -9.17M |
| Net Income | -127.16M | -111.78M | -63.78M | -41.35M | -30.56M | -9.09M |
Balance Sheet | ||||||
| Total Assets | 218.13M | 245.12M | 191.22M | 175.70M | 85.91M | 12.96M |
| Cash, Cash Equivalents and Short-Term Investments | 16.48M | 235.10M | 180.58M | 168.59M | 84.29M | 11.64M |
| Total Debt | 182.00K | 97.95M | 37.45M | 35.24M | 14.89M | 262.49K |
| Total Liabilities | 131.46M | 129.50M | 51.45M | 41.93M | 17.20M | 1.25M |
| Stockholders Equity | 86.67M | 115.62M | 139.77M | 133.77M | 68.71M | 11.70M |
Cash Flow | ||||||
| Free Cash Flow | -66.62M | -83.72M | -53.91M | -36.17M | -20.39M | -7.24M |
| Operating Cash Flow | -66.40M | -83.47M | -53.81M | -36.01M | -20.31M | -7.15M |
| Investing Cash Flow | -42.34M | -63.07M | -5.01M | -144.03M | -81.40K | -89.37K |
| Financing Cash Flow | 129.86M | 138.39M | 64.91M | 120.33M | 93.04M | 137.97K |
Celcuity Technical Analysis
Positive
13.62
Price Trends
11.65
Positive
10.99
Positive
12.26
Positive
Market Momentum
0.54
Negative
62.30
Neutral
77.73
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 13.62 is above the 20-day moving average (MA) of 12.57, above the 50-day MA of 11.65, and above the 200-day MA of 12.26, indicating a bullish trend. The MACD of 0.54 indicates Negative momentum. The RSI at 62.30 is Neutral, neither overbought nor oversold. The STOCH value of 77.73 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
Overall Rating
UnderperformOutperform
Sector (52)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
53 Neutral | $657.37M | ― | -49.91% | ― | -14.16% | 25.88% | |
52 Neutral | $500.10M | ― | -147.48% | ― | ― | 18.47% | |
52 Neutral | kr5.55B | 11.43 | -72.81% | 7.82% | 28.10% | 22.23% | |
50 Neutral | $371.47M | ― | -57.28% | ― | -95.12% | 21.09% | |
44 Neutral | $460.60M | ― | -33.14% | ― | ― | ― | |
44 Neutral | $511.57M | ― | -115.39% | ― | ― | -4.14% | |
43 Neutral | $888.89M | ― | -48.45% | ― | ― | 7.15% |
* Healthcare Sector Average
Performance Comparison
CELC
Celcuity
13.62
-4.15
-23.35%
ALT
Altimmune
4.40
-3.50
-44.30%
AUTL
Autolus Therapeutics
2.48
-1.77
-41.65%
ORIC
Oric Pharmaceuticals
11.45
1.39
13.82%
ABVX
Abivax SA Sponsored ADR
8.30
-5.33
-39.10%
RAPP
Rapport Therapeutics, Inc.
15.38
-10.29
-40.09%
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.