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Celcuity (CELC)
NASDAQ:CELC
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Celcuity
(NASDAQ:CELC)
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Rating:44Neutral
Price Target:―
Celcuity's stock score of 43.73 reflects the challenges faced by early-stage biotech firms. The company's financial performance is weak due to lack of revenue and high expenses. Technical analysis shows a neutral to slightly negative outlook, while valuation metrics are poor due to negative earnings. Despite these challenges, the earnings call provided a positive outlook with potential future revenue and strong financial positioning. The overall score indicates significant risks but potential for future growth if clinical and financial milestones are achieved.
Positive Factors
FDA Application Acceptance
The FDA's acceptance of the NDA for gedatolisib under the Real-Time Oncology Review program is a significant milestone. It suggests regulatory confidence in the drug's potential, which could expedite market entry, enhancing Celcuity's competitive position and revenue prospects.
Strong Financial Position
A robust cash position provides Celcuity with the financial flexibility to fund ongoing R&D and clinical trials without immediate pressure to raise additional capital. This stability supports long-term strategic initiatives and potential growth opportunities.
Potential Blockbuster Revenue
The potential market size for gedatolisib, if approved, represents a significant revenue opportunity. This aligns with Celcuity's strategy to leverage its diagnostic platform for high-impact treatments, potentially transforming its financial outlook and market position.
Negative Factors
Consistent Losses
The increasing net loss highlights ongoing financial challenges, primarily due to high R&D and operational expenses. This trend underscores the risk of prolonged unprofitability, which could strain resources and delay breakeven, impacting long-term financial health.
High R&D Expenses
Rising R&D costs reflect the intensive investment required for clinical trials and product development. While necessary for innovation, these expenses can pressure margins and cash flow, posing a risk if not offset by future revenue growth.
Lack of Revenue
The absence of revenue generation is a critical concern, as it limits Celcuity's ability to self-fund operations. This reliance on external financing increases vulnerability to market conditions and investor sentiment, potentially affecting long-term viability.
Celcuity (CELC) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$4.29B
Dividend YieldN/A
Average Volume (3M)1.26M
Price to Earnings (P/E)―
Beta (1Y)0.41
Revenue GrowthN/A
EPS Growth-40.75%
CountryUS
Employees87
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.92
Shares Outstanding46,271,260
10 Day Avg. Volume812,578
30 Day Avg. Volume1,264,162
Financial Highlights & Ratios
PEG Ratio-0.89
Price to Book (P/B)4.47
Price to Sales (P/S)0.00
P/FCF Ratio-6.17
Enterprise Value/Market Cap0.52
Enterprise Value/Revenue8.05K
Enterprise Value/Gross Profit1.27M
Enterprise Value/Ebitda-16.34
Forecast
1Y Price Target
$99.63Price Target Upside7.50% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering9
EPS Forecast (FY)N/A
Revenue Forecast (FY)N/A
Celcuity Business Overview & Revenue Model
Company DescriptionCelcuity 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 identify the specific abnormal cellular process driving a patient's cancer and the related targeted therapy for the treatment. Its drug candidate includes Gedatolisib, which selectively targets various class I isoforms of PI3K and mammalian target of rapamycin and focus on the treatment of patients with hormone receptor positive, HER2-negative, and advanced or metastatic breast cancer. The company is also developing CELsignia MP test, a qualitative laboratory developed test that measures HER2, c-Met, and PI3K signaling activity in breast and ovarian tumor cells. It had a license agreement with Pfizer, Inc. for the development and commercialization rights to Gedatolisib. Celcuity Inc. was founded in 2011 and is headquartered in Minneapolis, Minnesota.
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:Nov 12, 2025
(Q3-2025)
| % Change Since: |
Next Earnings Date:Mar 19, 2026
Earnings Call Sentiment Positive
The earnings call reflects a strong position for Celcuity, with significant clinical and regulatory progress, a solid financial foundation, and promising market potential. However, the increased financial loss and regulatory uncertainties present challenges that need to be addressed.Q3-2025 Updates
Positive Updates
Progress in Clinical and Regulatory Milestones
Significant achievements in clinical trials, including presenting positive data from the PIK3CA wild-type cohort of the VICTORIA-one trial, and FDA's acceptance of the NDA under the real-time oncology review program.
Strong Financial Position
Completion of concurrent offerings resulting in net proceeds of approximately $287 million and an increase in the term loan facility to $500 million, providing substantial financial flexibility.
Positive Clinical Trial Results
In the VICTORIA-one trial, the triplet therapy showed a 7.3-month incremental improvement in median PFS, with hazard ratios more favorable than previously reported.
Solid Market Potential
With a total addressable market estimated at $5 billion to $6 billion, potential peak revenues for Get It Solicit are projected at $2.5 billion to $3 billion.
Progress in Commercial Launch Preparations
Significant progress in building the organization and systems required for a potential launch, alongside positive feedback from key opinion leaders and decision-makers.
Negative Updates
Increased Financial Loss
Net loss increased to $43.8 million for Q3 2025 compared to $29.8 million in 2024, with a rise in research and development expenses and general and administrative expenses.
Regulatory and Market Uncertainties
Pending FDA approval and the need for further data, particularly concerning the mutant population and potential challenges in the regulatory submission process.
Company Guidance
During the Celcuity Third Quarter 2025 Financial Results Webcast, the company provided guidance on several key metrics. They highlighted significant clinical and regulatory milestones, including top-line data results from the PIK3CA wild-type cohort of the Phase III VICTORIA-one study and detailed efficacy and safety results presented at the European Society for Medical Oncology (ESMO) Congress. The median progression-free survival (PFS) for the triplet therapy was 9.3 months, with a hazard ratio of 0.24, while the doublet therapy showed a median PFS of 7.4 months with a hazard ratio of 0.33. Additionally, Celcuity completed a concurrent offering resulting in net proceeds of $287 million and increased their term loan facility to $500 million. The company also discussed their strategic plans for the potential launch of Get It Solicit, citing a total addressable market in the U.S. for the second-line setting estimated at $5 billion to $6 billion, and potential peak revenues of $2.5 billion to $3 billion. They expect cash and investments to fund operations through 2027.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 | 275.34K | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | 1.75K | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| EBITDA | -135.66M | -101.37M | -58.31M | -39.18M | -28.04M | -9.17M |
| Net Income | -162.72M | -111.78M | -63.78M | -40.37M | -29.61M | -9.47M |
Balance Sheet | ||||||
| Total Assets | 476.00M | 245.12M | 191.22M | 175.70M | 85.91M | 12.96M |
| Cash, Cash Equivalents and Short-Term Investments | 454.98M | 235.10M | 180.58M | 168.59M | 84.29M | 11.66M |
| Total Debt | 320.35M | 97.95M | 37.45M | 35.24M | 14.89M | 262.49K |
| Total Liabilities | 359.04M | 129.50M | 51.45M | 41.93M | 17.20M | 1.25M |
| Stockholders Equity | 116.96M | 115.62M | 139.77M | 133.77M | 68.71M | 11.70M |
Cash Flow | ||||||
| Free Cash Flow | -99.98M | -83.72M | -53.91M | -36.17M | -20.39M | -7.24M |
| Operating Cash Flow | -99.83M | -83.47M | -53.81M | -36.01M | -20.31M | -7.15M |
| Investing Cash Flow | 127.68M | -63.07M | -5.01M | -144.03M | -81.40K | -89.37K |
| Financing Cash Flow | 5.91M | 138.39M | 64.91M | 120.33M | 93.04M | 137.97K |
Celcuity Technical Analysis
Positive
92.68
Price Trends
61.61
Positive
47.56
Positive
29.24
Positive
Market Momentum
7.44
Negative
78.09
Negative
94.33
Negative
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 92.68 is above the 20-day moving average (MA) of 76.05, above the 50-day MA of 61.61, and above the 200-day MA of 29.24, indicating a bullish trend. The MACD of 7.44 indicates Negative momentum. The RSI at 78.09 is Negative, neither overbought nor oversold. The STOCH value of 94.33 is Negative, 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 |
|---|---|---|---|---|---|---|---|
60 Neutral | $3.10B | ― | -28.35% | ― | 182.44% | 47.21% | |
57 Neutral | $6.84B | ― | -68.70% | ― | -100.00% | 53.89% | |
53 Neutral | $2.82B | ― | -14.15% | ― | 5376.27% | 20.97% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
49 Neutral | $4.47B | ― | -38.41% | ― | ― | -58.35% | |
44 Neutral | $4.29B | ― | -122.04% | ― | ― | -40.75% | |
43 Neutral | $3.62B | -71.67 | -32.30% | ― | ― | -73.27% |
* Healthcare Sector Average
CELC
Celcuity
92.68
80.22
643.82%
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217.71
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IDEAYA Biosciences
32.14
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TARS
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72.92
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63.39%
BLTE
Belite Bio, Inc. ADR
116.72
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41.03%
APGE
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65.50
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44.50%
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.