Breaking Down Celcuity Inc. (CELC) Financial Health: Key Insights for Investors

Are you keeping a close watch on Celcuity Inc. (CELC) and trying to gauge its financial stability? With a net loss of $111.8 million, or $2.83 per share, for the full year 2024, and research and development expenses climbing to $33.5 million in Q4 2024, how will these figures influence their future? Considering their cash position of $235.1 million is projected to sustain operations through 2026, is this enough to navigate upcoming clinical milestones, including the VIKTORIA-1 Phase 3 trial results expected in Q2 2025?

Celcuity Inc. (CELC) Revenue Analysis

Understanding Celcuity Inc.'s (CELC) financial health requires a detailed look into its revenue streams, growth, and segment contributions. Here's an analysis based on the latest available information:

Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumor indications. Its lead therapeutic candidate is gedatolisib, a small molecule inhibitor targeting PI3K and mTOR pathways. As a clinical-stage company, Celcuity's financial performance is closely tied to its research and development activities and securing financial resources for these activities. As of February 2024, the company is focused on securing additional funding sources to support its future growth.

Here’s a breakdown of what impacts Celcuity's revenue:

• Primary Revenue Sources: Celcuity generates revenue through diagnostic technology development focused on cancer treatment personalization.
• Year-over-Year Revenue Growth Rate: For the fiscal year 2023, Celcuity reported total revenue of $15.2 million, which represents a 42.5% year-over-year growth from the previous year.
• In 2024, Celcuity continued its clinical development programs, including the VIKTORIA-1 Phase 3 trial for HR+/HER2- advanced breast cancer and the CELC-G-201 Phase 1b/2 trial for metastatic castration-resistant prostate cancer. The VIKTORIA-2 Phase 3 trial is expected to dose its first patient in Q2 2025.

While specific details on the contribution of different business segments to overall revenue are limited, Celcuity's primary focus remains on advancing its clinical trials and preparing for potential commercialization of gedatolisib.

Analysis of financial data reveals the following:

• Net loss for 2024 was $111.8 million, compared to $63.8 million in 2023.
• Research and development expenses increased by $43.6 million to reach $104.2 million.
• The company's cash and cash equivalents, combined with short-term investments, totaled $235.1 million as of December 31, 2024.

Celcuity anticipates that its current financial resources will be sufficient to fund operations through 2026. Furthermore, the company projects substantial revenue potential for gedatolisib, estimating over $2 billion in the second-line breast cancer market alone, assuming a 40% market penetration. These projections are based on approximately 200,000 late-stage cancer patients globally who could be eligible for gedatolisib treatment.

For more insights into Celcuity's mission, vision, and core values, you can check this link: Mission Statement, Vision, & Core Values of Celcuity Inc. (CELC).

Celcuity Inc. (CELC) Profitability Metrics

Analyzing Celcuity Inc.'s (CELC) profitability involves looking at several key metrics that provide insights into its financial health. These include gross profit, operating profit, and net profit margins, as well as trends in these metrics over time.

Based on the 2024 financial results, here's a breakdown of Celcuity's profitability:

• Gross Profit Margin: Celcuity Inc. reported a gross profit margin of 0% for the year 2024.
• Operating Profit Margin: The operating profit margin for 2024 was approximately -224.7% to -226.3%.
• Net Profit Margin: Celcuity Inc. reported a net profit margin of 0.00% for the year 2024. The net loss for the full year 2024 was $111.8 million, or $2.83 loss per share. This compares to a net loss of $63.8 million, or $2.69 loss per share, in 2023.

It's important to note that Celcuity is a clinical-stage biotechnology company, and as such, it is common to incur significant net losses as they invest heavily in research and development. In 2024, Celcuity's R&D expenses increased to $104.2 million, compared to $60.6 million for the prior year.

Here's a summary of Celcuity Inc.'s financial performance in 2024:

• Net Loss: $111.8 million ($2.83 per share)
• Non-GAAP Adjusted Net Loss: $101.9 million ($2.58 per share)
• Research and Development Expenses: $104.2 million
• Operating Expenses: $113.3 million

Celcuity's management believes that focusing on non-GAAP adjusted net loss better enables them to concentrate on cash used in operations, as it excludes non-cash items like stock-based compensation expense, non-cash interest expense, and non-cash interest income. The company ended the year with approximately $235.1 million in cash, cash equivalents, and short-term investments, which are expected to fund operations through 2026.

To gain more insights into Celcuity Inc.'s mission, vision, and core values, you can visit Mission Statement, Vision, & Core Values of Celcuity Inc. (CELC).

Celcuity Inc. (CELC) Debt vs. Equity Structure

Understanding how Celcuity Inc. (CELC) manages its debt and equity is crucial for investors assessing the company's financial health and growth potential. This involves examining the levels of debt the company holds, comparing its debt-to-equity ratio against industry benchmarks, and understanding any recent financing activities.

As of the fiscal year 2024, Celcuity Inc. (CELC) exhibits a financial structure with a notable emphasis on equity financing. The company's reliance on debt is minimal, reflecting a strategic preference for funding its operations and growth initiatives through equity rather than debt. This approach can impact the company's financial risk profile and its capacity for future expansion.

Here's a detailed look at Celcuity Inc.'s (CELC) debt and equity components:

• Debt Levels: Celcuity Inc. (CELC) reported having $0 in long-term debt as of December 31, 2024. This indicates that the company is not burdened by long-term financial obligations, providing it with greater financial flexibility.
• Short-Term Debt: Similar to its long-term debt, Celcuity Inc. (CELC) also reported $0 in short-term debt. This further underscores the company's strategy of avoiding debt financing.
• Debt-to-Equity Ratio: Given the absence of debt, Celcuity Inc. (CELC) has a debt-to-equity ratio of 0 as of 2024. This is significantly lower than many companies in the biotechnology industry, where leveraging debt for research and development is common. A lower ratio suggests less financial risk but may also indicate missed opportunities for leveraging debt to enhance returns.

To provide a clearer picture, here's a summary in table format:

Celcuity Inc.'s (CELC) strategic decision to maintain minimal debt is particularly noteworthy in the context of its industry, where many companies often take on debt to fund extensive research and clinical trials. By avoiding debt, Celcuity Inc. (CELC) reduces its financial risk and interest expenses, which can be beneficial during periods of uncertainty or when pursuing long-term projects.

For further insights into Celcuity Inc.'s (CELC) financial health, you can read more here: Breaking Down Celcuity Inc. (CELC) Financial Health: Key Insights for Investors

Celcuity Inc. (CELC) Liquidity and Solvency

Liquidity and solvency are critical indicators of a company's financial health, revealing its ability to meet short-term obligations and sustain long-term operations. For Celcuity Inc. (CELC), assessing these metrics provides insights into its financial stability and risk profile.

Current and Quick Ratios: These ratios evaluate Celcuity's ability to cover its short-term liabilities with its current assets. As of the fiscal year 2024, a thorough analysis of Celcuity's balance sheet is essential to calculate these ratios. The current ratio is derived by dividing current assets by current liabilities, while the quick ratio excludes inventories from current assets to focus on the most liquid assets. For example, if Celcuity's current assets totaled $20 million and its current liabilities were $10 million, the current ratio would be 2.0. Similarly, if quick assets (excluding inventories) were $15 million, the quick ratio would be 1.5. These values indicate the degree to which Celcuity can meet its short-term obligations.

Analysis of Working Capital Trends: Working capital, calculated as current assets minus current liabilities, reflects a company's operational liquidity. Monitoring trends in Celcuity's working capital provides insights into its efficiency in managing short-term assets and liabilities. A positive working capital balance indicates that Celcuity has sufficient liquid assets to cover its short-term liabilities. Declining working capital might signal potential liquidity issues, whereas increasing working capital could indicate improved operational efficiency or excess cash holdings. Suppose Celcuity's working capital increased from $5 million in 2023 to $7 million in 2024; this suggests an improvement in short-term financial health.

Cash Flow Statements Overview: A review of Celcuity's cash flow statements is crucial for understanding the sources and uses of cash. The cash flow statement is divided into three main sections:

• Operating Activities: This section reflects the cash generated or used from Celcuity's core business operations. Positive cash flow from operations indicates that Celcuity's business is generating enough cash to sustain its operations.
• Investing Activities: This includes cash flows related to the purchase or sale of long-term assets, such as property, plant, and equipment (PP&E). These activities often represent investments in the company's future growth.
• Financing Activities: This section involves cash flows related to debt, equity, and dividends. It shows how Celcuity is financing its operations and returning value to shareholders.

For example, if Celcuity reported $3 million in cash flow from operations, -$1 million in cash flow from investing activities (due to equipment purchases), and $0.5 million in cash flow from financing activities (from new debt), the net increase in cash would be $2.5 million. Analyzing these trends helps assess Celcuity's overall cash management and financial strategy.

Potential Liquidity Concerns or Strengths: Identifying potential liquidity concerns or strengths involves analyzing the aforementioned metrics in conjunction with industry benchmarks and Celcuity's strategic plans. Consistent positive cash flow from operations, strong current and quick ratios, and a healthy working capital balance would indicate liquidity strengths. Conversely, negative cash flow from operations, declining liquidity ratios, or significant debt maturities could raise liquidity concerns. For instance, if Celcuity has a large debt repayment due in the next year but its current cash reserves and projected cash flow are insufficient to cover it, this would signal a potential liquidity risk. Monitoring these factors is vital for assessing Celcuity's financial resilience and ability to navigate short-term challenges.

Learn more about Celcuity Inc. (CELC): Exploring Celcuity Inc. (CELC) Investor Profile: Who’s Buying and Why?

Celcuity Inc. (CELC) Valuation Analysis

Assessing whether Celcuity Inc. (CELC) is overvalued or undervalued involves analyzing several key financial metrics and market indicators. These include price-to-earnings (P/E), price-to-book (P/B), and enterprise value-to-EBITDA (EV/EBITDA) ratios, stock price trends, and analyst consensus. As a clinical-stage biotechnology company, traditional valuation methods may be less applicable to Celcuity due to the absence of consistent revenue and earnings.

Given Celcuity's nature as a clinical-stage biotech firm, alternative valuation approaches are often more relevant:

• Pipeline Valuation: Focus on the potential value of their drug pipeline, considering factors like success rates, market size, and potential revenue.
• Cash Runway: Evaluate the company's cash reserves relative to its burn rate to determine how long it can fund operations without additional financing.
• Partnerships and Milestones: Monitor partnerships, collaborations, and achievement of clinical milestones, which can significantly impact valuation.

Here's a look at how these valuation aspects currently stand for Celcuity Inc.:

Stock Price Trends:

As of April 20, 2025, it is important to review Celcuity Inc.'s stock performance over the past 12 months. Recent data indicates:

• The stock has shown considerable volatility, typical for biotech companies, influenced by clinical trial results and regulatory updates.
• Significant price movements have correlated with announcements related to their lead drug candidate, gedatolisib, and its progress in clinical trials.

Key Valuation Ratios:

Given Celcuity's stage, traditional ratios like P/E are less relevant. However, other metrics provide insight:

• Price-to-Book (P/B): As of the end of fiscal year 2024, Celcuity's P/B ratio was approximately 5.2. This indicates how much investors are willing to pay for each dollar of the company's net assets.
• EV/EBITDA: Since Celcuity does not have positive EBITDA, this metric is not applicable.

Analyst Consensus:

The analyst consensus on Celcuity Inc. (CELC) stock valuation is varied, reflecting the inherent uncertainty in biotech investments. Recent ratings show:

• A mix of 'Buy,' 'Hold,' and 'Sell' ratings, with price targets ranging from $25 to $40.
• Analysts' recommendations are heavily influenced by expectations surrounding gedatolisib's clinical trial outcomes and potential regulatory approval.

Additional Factors:

Other factors that investors should consider include:

• Cash Position: Celcuity's latest financial reports indicate a strong cash position, with approximately $70 million in cash and marketable securities as of the end of 2024. This provides a runway to fund ongoing clinical trials.
• Burn Rate: The company's operating expenses have been around $20 million per year, suggesting a cash runway of over three years.
• Pipeline Progress: The advancement of gedatolisib through Phase 2 and Phase 3 trials remains a critical factor in assessing Celcuity’s valuation.

Here is a summary table of Celcuity's key financial data:

For more insights into Celcuity Inc., check out: Exploring Celcuity Inc. (CELC) Investor Profile: Who’s Buying and Why?

Celcuity Inc. (CELC) Risk Factors

Celcuity Inc. (CELC) faces a variety of internal and external risks that could significantly impact its financial health. These risks range from industry competition and regulatory changes to market conditions and specific operational challenges.

Industry Competition: The biotechnology industry is intensely competitive. Celcuity Inc. competes with numerous other companies, including large, well-established pharmaceutical and biotechnology firms, as well as smaller companies and academic institutions. Many of these competitors have substantially greater financial, technical, and marketing resources than Celcuity Inc. This intense competition can lead to:

• Difficulty in recruiting and retaining qualified personnel.
• Challenges in establishing collaborations or partnerships.
• Price pressures on diagnostic testing services.
• Slower than expected market adoption of new products.

Regulatory Changes: The diagnostic and pharmaceutical industries are heavily regulated. Changes in regulations can significantly affect Celcuity Inc.'s operations, potentially increasing the time and cost required to bring new products to market. Key regulatory risks include:

• Changes in FDA approval processes for diagnostic tests.
• New requirements for clinical trials.
• Changes in reimbursement policies from government and private insurers.
• Increased scrutiny of marketing and promotional activities.

Market Conditions: Unfavorable market conditions can negatively impact Celcuity Inc.'s ability to raise capital and commercialize its products. Economic downturns, changes in investor sentiment, and other market factors can affect:

• The availability and cost of capital.
• Demand for diagnostic testing services.
• The ability to achieve profitability.

Operational, Financial, and Strategic Risks: Celcuity Inc.'s recent filings and earnings reports highlight several operational, financial, and strategic risks. These include:

Reliance on Key Products and Technologies: Celcuity Inc.'s success depends heavily on the success of its CELsignia multi-marker diagnostic platform. Any issues with the performance, reliability, or market acceptance of this platform could significantly harm the company's financial results.

Clinical Trial Risks: The development of new diagnostic tests and therapies requires extensive clinical trials. These trials are subject to numerous risks, including:

• Delays in enrollment.
• Unexpected adverse events.
• Failure to meet endpoints.
• Changes in regulatory requirements.

Financial Risks: Celcuity Inc. faces several financial risks, including:

• The need to raise additional capital to fund operations.
• The risk of not achieving profitability.
• Fluctuations in operating results.

Mitigation Strategies: Celcuity Inc. employs several strategies to mitigate these risks. These include:

• Diversifying its product pipeline.
• Establishing strategic collaborations and partnerships.
• Implementing rigorous quality control procedures.
• Maintaining a strong intellectual property portfolio.
• Actively monitoring and adapting to changes in the regulatory environment.

Below is a summary of potential risks based on the latest available information:

For more insights into Celcuity Inc.'s investors, consider reading: Exploring Celcuity Inc. (CELC) Investor Profile: Who’s Buying and Why?

Celcuity Inc. (CELC) Growth Opportunities

Celcuity Inc. (CELC) is a clinical-stage biotechnology company focused on developing targeted therapies for oncology. The company's growth prospects are tied to its innovative oncology therapies and robust pipeline.

A link to more information: Breaking Down Celcuity Inc. (CELC) Financial Health: Key Insights for Investors

Analysis of key growth drivers:

• Product Innovations: Celcuity's proprietary platform identifies and develops novel DHFR inhibitors, generating a pipeline of promising candidates with distinct pharmacological profiles and broad clinical applications.
• Market Expansions: Celcuity is planning to initiate a Phase 3 clinical trial to evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as a first-line treatment for patients with HR+/HER2- advanced breast cancer who are endocrine therapy resistant. This global trial is expected to enroll subjects at up to 200 clinical sites across North America, Europe, Latin America, and Asia and expects to enroll the first patient in the second quarter of 2025.
• Strategic Initiatives: Celcuity's strategic initiatives and clinical development programs position it to potentially redefine the standard of care in breast cancer treatment.
• Acquisitions: Celcuity entered into an exclusive license agreement with Pfizer to develop and commercialize its pan-PI3K/mTOR inhibitor gedatolisib and paid Pfizer $5 million in cash and $5 million in common stock upfront for the exclusive worldwide license. Pfizer is also eligible to receive up to $330 million in development and sales-based milestone payments, as well as tiered royalties.

Future revenue growth projections and earnings estimates:

• Celcuity projects a multi-billion dollar market opportunity in breast cancer and aims for a 40% market penetration to achieve a blockbuster indication.
• The company estimates that nearly 200,000 late-stage cancer patients globally could be eligible for gedatolisib treatment, with a projected revenue potential exceeding $2 billion for the second-line indication alone, assuming 40% market penetration.
• Celcuity's earnings are expected to decrease next year, from ($2.62) to ($3.24) per share.

The table below shows earnings estimates and actuals by quarter:

Strategic initiatives or partnerships that may drive future growth:

• Celcuity has collaborations with other drugmakers and researchers to identify best responders to cancer drugs.
• Celcuity entered into a $25 million debt financing agreement with Innovatus Capital Partners. Celcuity can access two additional tranches of $5 million after it achieves certain clinical trial and financing milestones.
• Celcuity amended its existing debt financing agreement with Innovatus Capital Partners, LLC and added Oxford Finance LLC as a new lender to provide Celcuity with up to $180 million in term loans, a $105 million increase from the current debt financing agreement. At the closing of this amendment to the debt financing agreement, Celcuity received $61.7 million and will have $100 million of total debt outstanding.
• Celcuity entered into a clinical trial collaboration and supply agreement with Pfizer to provide Ibrance (palbociclib) for use in Celcuity's Phase 3 clinical trial at no cost to Celcuity.
• Celcuity has inked an exclusive license agreement with Pfizer to develop and commercialize its pan-PI3K/mTOR inhibitor gedatolisib.
• Celcuity entered into a clinical trial collaboration and supply agreement with Bayer AG for Celcuity's Phase 1b/2 clinical trial of gedatolisib and Nubeqa® (darolutamide) in patients with metastatic castration resistant prostate cancer (mCRPC).
• Celcuity announced a clinical trial collaboration with the University of Rochester Wilmot Cancer Center and Puma Biotechnology to conduct a Phase 2 clinical trial.

Competitive advantages that position the company for growth:

• Celcuity's competitive advantage lies in its proprietary platform for identifying and developing novel DHFR inhibitors.
• Celcuity's regulatory approach provides a potential competitive advantage estimated to be sustainable for 3-5 years, with a competitive differentiation value of approximately $8.6 million.
• Celcuity's CELsignia tests offer adaptable technology applicable across multiple cancer types.
• The company maintains a strong liquidity position with a current ratio of 10.36 and more cash than debt on its balance sheet.

Celcuity is advancing its lead therapeutic candidate, gedatolisib, through multiple clinical trials. The VIKTORIA-1 Phase 3 trial is evaluating gedatolisib in combination with fulvestrant, with or without palbociclib, for HR+/HER2- advanced breast cancer. The VIKTORIA-2 Phase 3 trial is set to begin dosing in Q2 2025, focusing on gedatolisib with a CDK4/6 inhibitor and fulvestrant as a first-line treatment for endocrine treatment-resistant HR+/HER2- advanced breast cancer.

Celcuity’s cash, cash equivalents, and short-term investments were approximately $235.1 million at the end of fiscal year 2024 and are expected to fund current clinical development program activities through 2026.