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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
$3.01B
Dividend YieldN/A
Average Volume (3M)1.35M
Price to Earnings (P/E)―
Beta (1Y)0.44
Revenue GrowthN/A
EPS Growth-25.61%
CountryUS
Employees87
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.04
Shares Outstanding42,426,712
10 Day Avg. Volume1,991,890
30 Day Avg. Volume1,345,215
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)N/A
P/FCF RatioN/A
Enterprise Value/Market Cap0.17
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-16.52K
Enterprise Value/Ebitda-4.38
Forecast
1Y Price Target
$82.50Price Target Upside10.83% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering9
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:Aug 14, 2025
(Q2-2025)
| % Change Since: |
Next Earnings Date:Nov 17, 2025
Earnings Call Sentiment Neutral
The earnings call presented a strong set of highlights with significant clinical trial progress, patent extension, and financial fortification, although it was balanced by increased losses and expenses.Q2-2025 Updates
Positive Updates
Significant Milestones Achieved
Celcuity reported positive top line data from the PIK3CA wild-type cohort of the Phase III VIKTORIA-1 clinical trial, showing significant improvements in progression-free survival (PFS) for HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer patients. Median PFS for the gedatolisib triplet was 9.3 months with a hazard ratio of 0.24, and 7.4 months for the gedatolisib doublet with a hazard ratio of 0.33.
Phase III VIKTORIA-2 Clinical Trial Progress
The first patient was dosed in the Phase III VIKTORIA-2 trial, evaluating gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR-positive, HER2-negative advanced breast cancer.
Favorable Preliminary Results from Early-Phase Trials
Preliminary top line results from trials evaluating gedatolisib with darolutamide in prostate cancer and with trastuzumab biosimilar in HER2-positive breast cancer were favorable. The prostate cancer trial showed a 66% 6-month radiographic PFS rate.
Patent Extension for Gedatolisib
Celcuity extended patent exclusivity for gedatolisib into 2042 with a new dosing regimen patent.
Strong Financial Position
Celcuity raised approximately $287 million through public offerings, bringing cash, cash equivalents, and investments to $455 million on a pro forma basis, ensuring funding through 2027.
Negative Updates
Increased Net Loss
The net loss for Q2 2025 was $45.3 million, a significant increase from $23.7 million in Q2 2024, primarily due to increased R&D expenses and anticipated milestone payments.
Increased R&D and Administrative Expenses
R&D expenses increased to $40.2 million from $22.5 million YoY, and general administrative expenses rose to $3.8 million from $1.8 million, driven by higher employee, consulting, and development costs.
Company Guidance
During the Celcuity Second Quarter 2025 Financial Results Webcast and Conference Call, the company provided extensive guidance on their progress and future directions. Key highlights included the positive top-line data from the Phase III VIKTORIA-1 clinical trial for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, where the gedatolisib triplet and doublet showed unprecedented improvements in progression-free survival (PFS) with hazard ratios of 0.24 and 0.33, respectively. The company also dosed the first patient in the VIKTORIA-2 trial, aiming to evaluate gedatolisib as a first-line treatment. Financially, Celcuity reported a second-quarter 2025 net loss of $45.3 million and ended the quarter with $168.4 million in cash, with pro forma cash totaling approximately $455 million post-financing activities. The company is gearing up for a potential FDA approval and market launch of gedatolisib, estimating an addressable market of $5 billion and projecting sufficient resources 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 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | -31.11K | -129.95K | -142.77K | -210.92K | -303.24K | -385.59K |
| EBITDA | -117.32M | -101.37M | -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 | 205.69M | 235.10M | 180.58M | 168.59M | 84.29M | 11.64M |
| Total Debt | 98.71M | 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
74.44
Price Trends
54.65
Positive
38.94
Positive
24.86
Positive
Market Momentum
6.20
Negative
68.96
Neutral
75.83
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 74.44 is above the 20-day moving average (MA) of 56.75, above the 50-day MA of 54.65, and above the 200-day MA of 24.86, indicating a bullish trend. The MACD of 6.20 indicates Negative momentum. The RSI at 68.96 is Neutral, neither overbought nor oversold. The STOCH value of 75.83 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 |
|---|---|---|---|---|---|---|---|
| ― | $2.79B | ― | -31.46% | ― | 254.45% | 48.06% | |
| ― | $2.56B | ― | -35.09% | ― | -41.48% | -73.55% | |
| ― | $2.36B | ― | -37.05% | ― | -100.00% | 55.31% | |
| ― | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
| ― | $3.75B | ― | -34.12% | ― | ― | -79.09% | |
| ― | $3.01B | ― | -134.54% | ― | ― | -25.61% | |
| ― | $2.86B | ― | -37.34% | ― | ― | -26.26% |
* Healthcare Sector Average
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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.