Analyst Summary
- Oragenics Inc. is a development-stage biopharmaceutical company focused on nasal delivery pharmaceutical medications in neurology and fighting infectious diseases, primarily ONP-002 for mild traumatic brain injury (mTBI).
- The company faces significant financial challenges, including recurring losses and the need for additional capital.
- Auditor’s expression of substantial doubt about the company’s ability to continue as a going concern.
- Net Loss: $10.6 million (2024) vs. $20.7 million (2023) – Improvement, but still significant.
- Accumulated Deficit: $217 million – High and concerning.
- Cash and Cash Equivalents: $0.8 million (2024) – Critically low.
- Current ratio decreased from 2.15 to 0.87, indicating a weaker ability to meet short-term obligations.
- Debt-to-assets ratio increased from 0.36 to 1.14, indicating a higher proportion of assets are financed by debt.
- Revenue decreased by 100%.
Opportunities and Risks
- Risk: Financial Instability: Recurring losses, high accumulated deficit, and dependence on future financing.
- Risk: Going Concern Uncertainty: Auditor’s opinion indicates a high risk of business failure.
- Risk: Product Development Risk: Reliance on a single product candidate, ONP-002, which is still in clinical development.
- Risk: Competition: Intense competition from larger pharmaceutical companies with greater resources.
- Risk: Regulatory Risk: Dependence on FDA approvals and potential for delays or rejections.
- Risk: Supply Chain Risk: Reliance on a single manufacturer for ONP-002.
- Risk: Personnel Risk: Dependence on key personnel and potential impact of legal proceedings involving Dr. VanLandingham.
- Opportunity: Market Opportunity: Significant unmet need for concussion treatment.
- Opportunity: Nasal Delivery Advantages: Potential for faster onset of action and reduced side effects.
- Opportunity: Strategic Partnerships: Potential for collaborations and licensing agreements to fund development.
Potential Implications
Company Performance
- The company’s ability to continue operations is highly uncertain due to its precarious financial position.
- Success depends heavily on securing additional funding and successfully developing and commercializing ONP-002.
- The company’s high debt-to-asset ratio and negative equity raise concerns about its long-term solvency.
Stock Price
- The company’s stock is likely to be highly volatile due to the company’s financial instability and dependence on a single product candidate.
- Negative news regarding clinical trials, regulatory approvals, or funding could significantly impact the stock price.
- Investors should exercise extreme caution due to the high risk associated with the company’s financial position.
Oragenics Inc. (OGEN) – 10-K Filing Report – December 31, 2024
Executive Summary
This report analyzes Oragenics Inc.’s 10-K filing for the fiscal year ended December 31, 2024. The company is a development-stage biopharmaceutical company focused on nasal delivery pharmaceutical medications in neurology and fighting infectious diseases, with a primary focus on ONP-002 for mild traumatic brain injury (mTBI) treatment. The company faces significant financial challenges, including recurring losses and the need for additional capital. While ONP-002 shows promise, the company’s ability to continue as a going concern is uncertain. The overall assessment is SELL due to the high risk associated with the company’s financial position and reliance on a single product candidate.
Key Findings:
- Significant operating losses and accumulated deficit.
- Need for additional capital to fund operations and clinical trials.
- Auditor’s expression of substantial doubt about the company’s ability to continue as a going concern.
- Reliance on a single product candidate, ONP-002.
- Potential competition from larger pharmaceutical companies.
Recommendations:
- Investors should exercise extreme caution due to the company’s precarious financial situation.
- Monitor the company’s ability to secure additional funding and progress ONP-002 through clinical trials.
- Consider alternative investments with lower risk profiles.
Company Overview
Oragenics, Inc. is a development-stage company focused on developing ONP-002, a neurosteroid for the treatment of mild traumatic brain injury (mTBI). The company acquired the Neurology Assets from Odyssey Health, Inc. in December 2023. The company’s strategy involves nasal drug delivery for neurological disorders. The company faces intense competition and requires regulatory approvals for its products.
Detailed Analysis
Management’s Discussion and Analysis (MD&A)
Management acknowledges significant net losses and negative cash flow. They state the need to raise additional capital to fund operations and clinical trials. The MD&A highlights the focus on ONP-002 and the expected timeline for clinical trials. A red flag is the auditor’s expression of substantial doubt about the company’s ability to continue as a going concern.
Financial Statement Analysis
Key Ratios and Trends:
- Net Loss: $10.6 million (2024) vs. $20.7 million (2023) – Improvement, but still significant.
- Accumulated Deficit: $217 million – High and concerning.
- Cash and Cash Equivalents: $0.8 million (2024) – Critically low.
- Research and Development Expenses: Decreased significantly due to focus on ONP-002 and pausing other programs.
- Going Concern: Auditor’s opinion raises serious concerns about the company’s viability.
Financial Statement Highlights:
| Financial Metric |
2024 |
2023 |
Change |
| Grant Revenue |
$0 |
$37,653 |
-$37,653 |
| Research and Development Expenses |
$4,114,434 |
$15,490,604 |
-$11,376,170 |
| General and Administrative Expenses |
$6,444,381 |
$5,451,952 |
$992,429 |
| Net Loss |
-$10,567,918 |
-$20,655,737 |
$10,087,819 |
| Cash and Cash Equivalents |
$864,840 |
$3,483,501 |
-$2,618,661 |
Uncommon Metrics:
- Reliance on a Single Supplier: The company depends on one manufacturer for ONP-002, creating a supply chain risk.
- Potential Conflict of Interest: Involvement of Dr. VanLandingham in legal proceedings related to prior company.
Risk and Opportunity Assessment
Risks:
- Financial Instability: Recurring losses, high accumulated deficit, and dependence on future financing.
- Going Concern Uncertainty: Auditor’s opinion indicates a high risk of business failure.
- Product Development Risk: Reliance on a single product candidate, ONP-002, which is still in clinical development.
- Competition: Intense competition from larger pharmaceutical companies with greater resources.
- Regulatory Risk: Dependence on FDA approvals and potential for delays or rejections.
- Supply Chain Risk: Reliance on a single manufacturer for ONP-002.
- Personnel Risk: Dependence on key personnel and potential impact of legal proceedings involving Dr. VanLandingham.
Opportunities:
- Market Opportunity: Significant unmet need for concussion treatment.
- Nasal Delivery Advantages: Potential for faster onset of action and reduced side effects.
- Strategic Partnerships: Potential for collaborations and licensing agreements to fund development.
Conclusion and Actionable Insights
Oragenics faces significant financial and operational risks. While ONP-002 represents a potential opportunity, the company’s ability to successfully develop and commercialize the product is highly uncertain. The company’s financial position is precarious, and the auditor’s going concern opinion is a major red flag.
Overall Assessment: SELL
Recommendations:
- Investors should exercise extreme caution and consider alternative investments with lower risk profiles.
- Closely monitor the company’s ability to secure additional funding and progress ONP-002 through clinical trials.
- Evaluate the competitive landscape and the potential for alternative treatments.
Financial Analysis of Oragenics, Inc. (OGEN) – 10-K Filing for Year Ended December 31, 2024
1. Commentary
Oragenics, Inc. is a development-stage pharmaceutical company with a history of operating losses and no revenue generation in 2024. The company’s net loss decreased by 49% from 2023 to 2024, primarily due to a significant reduction in research and development expenses. However, the company’s auditor has expressed substantial doubt about its ability to continue as a going concern, and it needs to raise additional capital to fund its operations. The company is pursuing a reverse stock split and an increase in authorized shares, indicating potential future financing activities.
2. Financial Ratio and Metric Analysis
Profitability
Gross Profit Margin
- Metric: Not applicable, as the company has no revenue.
Operating Profit Margin
- Metric:
- 2024: Loss from operations / Total revenue = (-$10,504,437) / $0 = N/A
- 2023: Loss from operations / Total revenue = (-$20,904,903) / $37,653 = N/A
Net Profit Margin
- Metric:
- 2024: Net loss / Total revenue = (-$10,567,918) / $0 = N/A
- 2023: Net loss / Total revenue = (-$20,655,737) / $37,653 = N/A
Return on Assets (ROA)
- Metric:
- 2024: Net loss / Total assets = (-$10,567,918) / $1,472,510 = -7.18
- 2023: Net loss / Total assets = (-$20,655,737) / $4,966,335 = -4.16
- Trend: ROA decreased from -4.16 to -7.18, indicating a less efficient use of assets to generate earnings.
Return on Equity (ROE)
- Metric:
- 2024: Net loss / Total shareholders’ equity = (-$10,567,918) / (-$211,885) = 49.88
- 2023: Net loss / Total shareholders’ equity = (-$20,655,737) / ($3,168,154) = -6.52
- Trend: ROE increased from -6.52 to 49.88, but this is due to the negative equity in 2024.
Earnings Per Share (EPS) – Basic and Diluted
- Metric:
- 2024: ($1.60)
- 2023: ($9.18)
- Trend: EPS increased from ($9.18) to ($1.60), indicating a smaller loss per share.
Liquidity
Current Ratio
- Metric:
- 2024: Total current assets / Total current liabilities = $1,472,510 / $1,684,395 = 0.87
- 2023: Total current assets / Total current liabilities = $3,865,774 / $1,798,181 = 2.15
- Trend: Current ratio decreased from 2.15 to 0.87, indicating a weaker ability to meet short-term obligations.
Quick Ratio (Acid-Test Ratio)
- Metric:
- 2024: (Total current assets – Inventory) / Total current liabilities = $1,472,510 / $1,684,395 = 0.87 (Assuming no inventory)
- 2023: (Total current assets – Inventory) / Total current liabilities = $3,865,774 / $1,798,181 = 2.15 (Assuming no inventory)
- Trend: Quick ratio decreased from 2.15 to 0.87, indicating a weaker ability to meet short-term obligations without relying on inventory.
Cash Ratio
- Metric:
- 2024: Cash and cash equivalents / Total current liabilities = $864,840 / $1,684,395 = 0.51
- 2023: Cash and cash equivalents / Total current liabilities = $3,483,501 / $1,798,181 = 1.94
- Trend: Cash ratio decreased from 1.94 to 0.51, indicating a significantly reduced ability to cover current liabilities with available cash.
Solvency/Leverage
Debt-to-Equity Ratio
- Metric:
- 2024: Total liabilities / Total shareholders’ equity = $1,684,395 / (-$211,885) = -7.95
- 2023: Total liabilities / Total shareholders’ equity = $1,798,181 / $3,168,154 = 0.57
- Trend: The debt-to-equity ratio changed from 0.57 to -7.95 due to the negative equity in 2024.
Debt-to-Assets Ratio
- Metric:
- 2024: Total liabilities / Total assets = $1,684,395 / $1,472,510 = 1.14
- 2023: Total liabilities / Total assets = $1,798,181 / $4,966,335 = 0.36
- Trend: Debt-to-assets ratio increased from 0.36 to 1.14, indicating a higher proportion of assets are financed by debt.
Interest Coverage Ratio (Times Interest Earned)
- Metric:
- 2024: Earnings before interest and taxes / Interest expense = (-$10,504,437) / (-$29,828) = 352.16
- 2023: Earnings before interest and taxes / Interest expense = (-$20,655,737) / (-$30,591) = 675.22
- Trend: Interest coverage ratio decreased from 675.22 to 352.16, indicating a reduced ability to cover interest expenses.
Activity/Efficiency
Note: Inventory Turnover, DSO, and DPO are not applicable as the company is not a retail or manufacturing business.
Asset Turnover
- Metric:
- 2024: Total revenue / Total assets = $0 / $1,472,510 = 0
- 2023: Total revenue / Total assets = $37,653 / $4,966,335 = 0.0076
- Trend: Asset turnover decreased from 0.0076 to 0, indicating a less efficient use of assets to generate revenue.
Valuation
Note: Stock price at the time of reporting (OGEN – 2025-03-14 – $0.28)
Note: Market Cap is calculated using the shares outstanding as of March 10, 2025 (21,475,289) and the stock price of $0.28.
- Market Cap: 21,475,289 * $0.28 = $6,013,081
Price-to-Earnings Ratio (P/E)
- Metric:
- 2024: Market cap / Net Income = $6,013,081 / (-$10,567,918) = -0.57
- 2023: Market cap / Net Income = $6,013,081 / (-$20,655,737) = -0.29
Price-to-Book Ratio (P/B)
- Metric:
- 2024: Market cap / Book Value = $6,013,081 / (-$211,885) = -28.38
- 2023: Market cap / Book Value = $6,013,081 / $3,168,154 = 1.90
Price-to-Sales Ratio (P/S)
- Metric:
- 2024: Market cap / Total revenue = $6,013,081 / $0 = N/A
- 2023: Market cap / Total revenue = $6,013,081 / $37,653 = 159.69
Enterprise Value to EBITDA (EV/EBITDA)
- Metric:
- 2024: EV = Market Cap + Total Debt – Cash = $6,013,081 + $328,528 – $864,840 = $5,476,769
EBITDA = Net Income + Interest + Taxes + Depreciation and Amortization = -$10,567,918 + (-$29,828) + $0 + $0 = -$10,597,746
EV/EBITDA = $5,476,769 / (-$10,597,746) = -0.52
- 2023: EV = Market Cap + Total Debt – Cash = $6,013,081 + $312,703 – $3,483,501 = $2,842,283
EBITDA = Net Income + Interest + Taxes + Depreciation and Amortization = -$20,655,737 + (-$30,591) + $0 + $27,391 = -$20,658,937
EV/EBITDA = $2,842,283 / (-$20,658,937) = -0.14
Growth Rates
Revenue Growth
- Metric:
- 2024: ($0 – $37,653) / $37,653 = -100%
- Trend: Revenue decreased by 100%.
Net Income Growth
- Metric:
- 2024: (-$10,567,918 – (-$20,655,737)) / (-$20,655,737) = -49%
- Trend: Net loss decreased by 49%.
EPS Growth
- Metric:
- 2024: (-$1.60 – (-$9.18)) / (-$9.18) = -83%
- Trend: EPS increased by 83%.
Other Relevant Metrics
The company did not present any company-specific key performance indicators (KPIs) or non-GAAP metrics in this filing.
⚠️ This is an experimental project and this report is for informational purposes only and should not be considered investment advice. Conduct your own thorough research and consult with a qualified financial advisor before making any investment decisions. ⚠️