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Celcuity Inc. (CELC)
:CELC
US Market

Celcuity (CELC) AI Stock Analysis

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Celcuity

(NASDAQ:CELC)

44Neutral
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
Clinical Trials
Celcuity's Phase 3 VIKTORIA-1 trial for ER+ breast cancer patients shows promise with a pan-PI3K/mTOR inhibitor, gedatolisib, in combination with other treatments.
Financial Position
Celcuity's strong financial position with $206M in cash supports operations through 2026.
Negative Factors
Clinical Trial Concerns
Concerns have been raised around the EMBER-3 dataset, including a high proportion of 1L and bone-only disease patients, and no 3L patients identified.
Market Sentiment
Short interest is high at 10.2% of the float, indicating a significant portion of investors may be betting against the stock.

Celcuity (CELC) vs. S&P 500 (SPY)

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 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
10
Very Negative
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.
Balance Sheet
40
Negative
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.
Cash Flow
30
Negative
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.
Breakdown
TTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
0.000.000.000.000.000.00
Gross Profit
-31.11K0.00-142.77K-210.92K-303.24K-385.59K
EBIT
-126.91M-113.27M-66.23M-39.39M-28.36M-9.56M
EBITDA
-117.32M-113.27M-58.31M-39.18M-28.05M-9.17M
Net Income Common Stockholders
-127.16M-111.78M-63.78M-41.35M-30.56M-9.09M
Balance SheetCash, Cash Equivalents and Short-Term Investments
24.20M235.10M180.58M168.59M84.29M11.64M
Total Assets
31.97M245.12M191.22M175.70M85.91M12.96M
Total Debt
0.0097.95M37.45M35.24M14.89M262.49K
Net Debt
-2.64M75.44M6.78M10.67M-69.40M-11.38M
Total Liabilities
578.05K129.50M51.45M41.93M17.20M1.25M
Stockholders Equity
31.39M115.62M139.77M133.77M68.71M11.70M
Cash FlowFree 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
129.86M138.39M64.91M120.33M93.04M137.97K

Celcuity Technical Analysis

Technical Analysis Sentiment
Negative
Last Price10.61
Price Trends
50DMA
10.24
Positive
100DMA
11.04
Negative
200DMA
13.00
Negative
Market Momentum
MACD
0.10
Positive
RSI
51.66
Neutral
STOCH
59.35
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For CELC, the sentiment is Negative. The current price of 10.61 is below the 20-day moving average (MA) of 10.75, above the 50-day MA of 10.24, and below the 200-day MA of 13.00, indicating a neutral trend. The MACD of 0.10 indicates Positive momentum. The RSI at 51.66 is Neutral, neither overbought nor oversold. The STOCH value of 59.35 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative 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
52
Neutral
$5.15B3.02-44.64%2.83%16.44%-0.47%
ALALT
52
Neutral
$452.58M-57.28%-95.12%21.09%
46
Neutral
$380.93M-147.48%18.47%
45
Neutral
$353.97M-49.97%-14.16%25.80%
44
Neutral
$363.52M-33.14%
44
Neutral
$401.76M-115.39%-4.14%
43
Neutral
$336.25M-48.45%7.15%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
CELC
Celcuity
10.61
-6.19
-36.85%
ALT
Altimmune
5.58
-2.46
-30.60%
AUTL
Autolus Therapeutics
1.33
-2.69
-66.92%
ORIC
Oric Pharmaceuticals
4.73
-4.35
-47.91%
ABVX
Abivax SA Sponsored ADR
6.01
-7.84
-56.61%
RAPP
Rapport Therapeutics, Inc.
9.96
-16.23
-61.97%

Celcuity Earnings Call Summary

Earnings Call Date:May 14, 2025
(Q1-2025)
|
% Change Since: -2.30%|
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.
Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.

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.