Breaking Down Orgenesis Inc. (ORGS) Financial Health: Key Insights for Investors

You're looking at Orgenesis Inc. (ORGS) and trying to map the risk to the potential reward, and honestly, the numbers paint a stark picture you need to understand right now. This is a micro-cap biotech stock, trading around $0.750 as of mid-November 2025, with a tiny market capitalization of just $3.878 million, which means volatility is defintely the name of the game. For the trailing twelve months leading up to mid-2025, the company reported a net loss of approximately $34.4 million against a TTM revenue of only about $0.90 million, a massive disconnect that highlights a significant cash burn and a rough financial health profile. Still, insiders have shown confidence, purchasing $302.6K in high-impact open-market transactions over the last year, so the question isn't just about the deep red ink, but whether their Point-of-Care (POCare) platform can finally convert its promise into meaningful revenue growth.

Revenue Analysis

You're looking at Orgenesis Inc. (ORGS) and seeing a biotech company with a high-risk, high-reward revenue profile. The direct takeaway? The revenue base is currently minimal, reflecting a major strategic shift and a tough market, so you need to focus on platform adoption, not product sales, for near-term growth.

The company's trailing twelve months (TTM) revenue as of mid-2025 stood at just $899.00K. That's a tiny number for a biotech, and it tells a story of significant volatility, which is common when a company pivots toward a platform model in the cell and gene therapy space.

Where the Revenue Comes From

Orgenesis Inc. (ORGS) has two primary business segments, and the revenue you see is largely from the support side of their technology platform, not from commercialized therapies yet. This is a critical distinction for your valuation model.

• Octomera (Point of Care - POCare): This segment focuses on their proprietary system for decentralized cell therapy manufacturing. Revenue here comes from licensing and service fees for the POCare systems, plus development and regulatory support provided to hospitals and research partners. This is the long-term strategic bet.
• Therapies: This segment includes the pipeline of autologous (from-your-own-cells) treatments for metabolic and antiviral diseases, like the promising ORG-101 CAR-T therapy. While this holds the massive future potential, it generates little to no revenue today.

The recent acquisition of Neurocords LLC in March 2025 is a significant change, designed to expand their regenerative medicine portfolio with spinal cord injury therapies and is expected to contribute to the Therapies segment, but its commercialization impact is still on the horizon.

The Steep Drop in Growth Rate

The year-over-year revenue trend is defintely a shocker, but it's crucial to understand the context. The company's revenue peaked in 2022 at $36.025 million. The following year, 2023, saw a collapse to only $530,000, representing a staggering -98.53% decrease.

Here's the quick math on the near-term trend: The TTM revenue of $899.00K (as of September 2024) still represents a year-over-year TTM decline of about -93.57%. This massive drop is a direct result of the company divesting or winding down its legacy contract development and manufacturing organization (CDMO) business, MaSTherCell, to focus entirely on the capital-intensive POCare platform.

The current revenue is a floor, not a ceiling. What this estimate hides is the potential for exponential growth if the POCare model gains traction with hospitals. You can read more about the long-term vision in their Mission Statement, Vision, & Core Values of Orgenesis Inc. (ORGS).

Your action here is to watch for Q3 2025 earnings, expected around mid-November 2025, which should provide a clearer view of any revenue ramp-up from new POCare licensing or the Neurocords integration.

Profitability Metrics

You need to understand Orgenesis Inc.'s core profitability to gauge its financial viability, especially in the volatile biotech space. The direct takeaway is that the company's margins are deeply negative, reflecting a high-burn, pre-commercialization, or financially distressed operational model, which is a major red flag for near-term investors.

Based on the most recent Trailing Twelve Months (TTM) data available, which ended September 30, 2024, Orgenesis Inc. is operating at a significant loss across all key metrics. This TTM period provides the most current picture of the company's financial health as of late 2025, despite the company's recent challenges with timely financial filings. Honestly, the numbers show a company struggling to cover even its direct costs.

Here's the quick math on the TTM profitability ratios:

• Gross Profit Margin: -97.66%
• Operating Margin: -2,196% (Q3 2024)
• Net Profit Margin: -3,827.81%

The negative gross profit margin of -97.66% means the cost of goods sold (COGS) is nearly double the revenue, indicating a fundamental problem with the pricing, production, or cost structure of their products and services. The operating margin of -2,196% is a stark indicator of operational inefficiency, where operating expenses-like research and development (R&D) and general and administrative costs-vastly outstrip revenue.

Operational Efficiency and Cost Management

The trend in profitability over the last few years has been erratic and concerning. Revenue plummeted from $36.03 million in 2022 to just $530,000 in 2023, a massive drop of over 98%. This steep decline is the primary driver of the current negative margins. The TTM revenue is only slightly higher at US$899.00k.

The gross margin trend is the most telling sign of operational efficiency (or lack thereof). A negative gross margin means Orgenesis Inc. is losing money on every sale before accounting for overhead. This suggests a few near-term risks:

• Pricing Model Failure: Products are priced too low to cover direct costs.
• Cost Overruns: Production costs are out of control, defintely in the Octomera segment.
• Low Utilization: High fixed costs in their Point of Care (POCare) platform are spread over minimal revenue.

The TTM net loss stands at -US$34.41 million. This consistent cash burn necessitates a continuous need for fresh capital, increasing the risk of shareholder dilution.

Industry Comparison: A Sobering View

To put Orgenesis Inc.'s numbers in context, we compare them to the US Biotechnology industry average as of November 2025. The gap is enormous, but also reveals a nuanced reality for development-stage biotech firms.

While the industry average net profit margin is also negative at -169.5%, reflecting the high R&D costs and long timelines of drug development, the industry's average gross margin is a very healthy 86.7%. This shows that while most biotech firms lose money overall, they do generate significant profit on the actual sale of their products or services once they reach commercialization. Orgenesis Inc.'s negative gross margin is the critical difference, suggesting its core business model or current operational execution is fundamentally flawed, unlike the average biotech firm.

You need to see a clear, credible path to a positive gross margin before even considering the long-term potential of their therapies segment. For a deeper look at the valuation and strategy, check out the full analysis: Breaking Down Orgenesis Inc. (ORGS) Financial Health: Key Insights for Investors.

Debt vs. Equity Structure

You're looking at Orgenesis Inc. (ORGS) and immediately, the debt-to-equity picture tells you this is a high-risk, high-burn biotech model. The company's financing structure is currently defined by a significant imbalance: a negative shareholder equity position, which is a much bigger red flag than just a high debt load.

As of the most recent data, Orgenesis Inc. carries a total debt of approximately $15.1 million against a total shareholder equity of about $-23.9 million. Here's the quick math: the resulting Debt-to-Equity (D/E) ratio is a negative -63.2%. A negative D/E ratio means the company's total liabilities, which are around $53.6 million, exceed its total assets, wiping out shareholder equity. It's a sign of deep financial distress.

Compare that to the Biotechnology industry average D/E ratio of roughly 0.17. Orgenesis Inc. isn't just leveraged; it's financing its operations almost entirely through debt and liabilities, a common but dangerous path for pre-commercial biotech firms with high cash burn. This is a classic case of chasing a breakthrough while running on fumes.

The company has been actively managing its capital structure in 2025, balancing debt and equity to keep the lights on:

• New Debt: In September 2025, a subsidiary secured a Convertible Loan Agreement for an initial $1,000,000, part of a larger facility up to $10,000,000, at a 10% annual interest rate.
• Debt-to-Equity Swap Risk: The loan includes a critical clause: the lender has the option to convert the outstanding amount into equity, potentially holding up to 80% of the outstanding share capital. This conversion is a massive dilution risk for existing shareholders.
• Equity Funding: Earlier in the year, in January 2025, Orgenesis Inc. secured a $5 million equity investment from Williamsburg Venture, providing a temporary cash infusion.

The recent financing activity shows a reliance on convertible debt-a hybrid instrument that pushes the funding decision down the road. It's a short-term fix, but the conversion feature means the company is essentially trading future equity for current liquidity. Plus, the current ratio of just 0.07 tells you the immediate liquidity situation is defintely concerning, as current assets barely cover a fraction of current liabilities.

For a deeper dive into who is betting on this high-risk strategy, you can read more here: Exploring Orgenesis Inc. (ORGS) Investor Profile: Who's Buying and Why?

Here is a snapshot of the core balance sheet metrics as of the latest reporting to frame the debt discussion:

What this estimate hides is the true cost of that convertible debt. If the company hits a clinical milestone, the conversion will be less painful, but without a clear path to profitability (trailing twelve months net loss was $34.4 million), the debt-for-equity swap is a likely and highly dilutive outcome.

Liquidity and Solvency

You're looking at Orgenesis Inc. (ORGS) and wondering if the company can cover its near-term bills. The direct takeaway is that Orgenesis Inc.'s liquidity position is extremely weak, with current assets barely covering a fraction of its current liabilities, signaling significant financial stress and a high dependency on outside financing to keep operations running.

Assessing Orgenesis Inc.'s Liquidity Ratios

The company's most recent liquidity ratios are a flashing red light. The Current Ratio, which measures current assets against current liabilities, is sitting at a mere 0.07 for the 2025 fiscal year (TTM data). A healthy business needs a ratio of 1.0 or higher; anything below 1.0 means current debts outweigh current assets. For a biotech company, you'd prefer to see a much higher buffer, closer to 2.0, to fund R&D and clinical trials without immediate stress.

The Quick Ratio (Acid-Test Ratio), which is even stricter as it excludes less liquid assets like inventory, is even lower at just 0.01. This tells you that if all short-term creditors demanded payment today, Orgenesis Inc. would only have about one cent in readily available, non-inventory assets for every dollar of debt. Honestly, that's defintely a tough spot.

Working Capital and Cash Flow Trends

The working capital trend is deeply negative. Based on the latest available data, current liabilities have ballooned to approximately $36 million. Here's the quick math: with a 0.07 Current Ratio, current assets are only around $2.52 million. This leaves a working capital deficit of roughly $33.48 million. This deficit means the company is technically insolvent in the near term, relying heavily on the forbearance of creditors or a fresh capital infusion.

The cash flow statements confirm the severe cash burn. The Trailing Twelve Months (TTM) net loss was approximately $34.4 million, and free cash flow remains negative. Let's break down the cash flow overview:

• Operating Cash Flow: Consistently negative, driven by significant operating losses and high R&D expenses. This is the core cash burn.
• Investing Cash Flow: Likely minimal or negative, as the company needs to fund its POCare platform and other strategic acquisitions, like the Neurocords assets in March 2025.
• Financing Cash Flow: This is the lifeline. To cover the operating cash deficit, Orgenesis Inc. is forced to pursue strategies like raising additional capital, which often means diluting existing shareholders.

What this estimate hides is the speed of the cash burn. Cash and cash equivalents dropped from $837,000 at the end of 2023 to just $204,000 in Q3 2024. That's a massive drop, and it shows the company is running on fumes, making the need for a successful capital raise immediate and critical.

Potential Liquidity Concerns and Action

The primary liquidity concern is the company's ability to generate enough cash from operations to sustain itself, which it currently cannot. The substantial increase in current liabilities from $16.4 million to $36 million in the nine months leading up to Q3 2024 is a major red flag, indicating a rapid build-up of short-term obligations the company is struggling to meet. The risk of a complete financial restructuring or even bankruptcy is real without a significant, non-dilutive event, like a major licensing deal or a large, successful capital raise.

For investors, the clear action is to monitor the SEC filings-specifically the 8-Ks-for any material definitive agreements related to new financing or asset sales. You can read more about the company's full financial picture here: Breaking Down Orgenesis Inc. (ORGS) Financial Health: Key Insights for Investors.

Valuation Analysis

You're looking at Orgenesis Inc. (ORGS) and trying to figure out if the price reflects the underlying value, which is tough with a clinical-stage biotech. The direct takeaway is that traditional valuation metrics paint a stark picture of a company facing significant financial headwinds, suggesting the stock is highly speculative and likely overvalued relative to its current financial metrics, despite its low share price.

For the 2025 fiscal year, Orgenesis Inc.'s valuation ratios are largely non-meaningful or negative, which is a massive red flag. Since the company reported a trailing twelve-month (TTM) loss of -$34.41 million, the Price-to-Earnings (P/E) ratio is negative and therefore not a useful metric for comparison. Honestly, a negative P/E just means the company is losing money. The Enterprise Value (EV) is approximately $18.44 million, but the Enterprise Value-to-EBITDA (EV/EBITDA) is not a calculable, positive number because of the negative profitability. Here's the quick math on the Price-to-Book (P/B) ratio: it sits at a negative -0.06. A negative P/B means the company's liabilities exceed its assets, meaning shareholders' equity is negative. That's defintely something to pay attention to.

The stock price trend over the last year has been brutal. As of November 2025, the stock has seen a -83.20% decrease over the last 52 weeks, with a 52-week range swinging wildly from a low of $0.022 to a high of $5.89. The recent stock price is around $0.750, but the volatility is extreme. This kind of price action shows a massive erosion of investor confidence, plus the low market capitalization of around $1.38 million indicates it's a micro-cap stock with high risk.

• P/E Ratio: Not applicable (negative earnings).
• P/B Ratio: -0.06 (negative shareholder equity).
• EV/EBITDA: Not applicable (negative profitability).

What this estimate hides is the potential of their Point-of-Care (POCare) platform, which is what investors are really betting on. Still, you can't ignore the financial health. Orgenesis Inc. does not pay a dividend, so the dividend yield is 0.00%, and the payout ratio is not applicable. This is standard for a biotech focused on R&D and burning cash to fund clinical trials.

The analyst consensus is not encouraging. Wall Street analysts currently rate the stock with a 'Strong Sell' sentiment, and some view Orgenesis Inc. as 'Overvalued' based on its current price and financial situation. This is a clear signal that the market is skeptical of the company's ability to turn its technology into profitable revenue in the near term. This is a classic high-risk, high-reward scenario where the risk is clearly winning right now. For a deeper dive into who is holding this risk, check out Exploring Orgenesis Inc. (ORGS) Investor Profile: Who's Buying and Why?

Next Step: Finance: draft a scenario analysis that models a 50% probability of a successful Phase 3 trial and its impact on a five-year discounted cash flow (DCF) valuation by the end of the month.

Risk Factors

You need to look past the innovative cell therapy platform at Orgenesis Inc. (ORGS) and confront the stark financial reality: the company is in a high-risk, cash-intensive stage, which translates to immediate solvency concerns and heavy reliance on capital markets. Its financial health is defintely rough.

The core internal risk is a severe cash burn and a balance sheet that is underwater. For the trailing twelve months (TTM) leading up to mid-2025, Orgenesis Inc. reported a net loss of approximately $34.4 million on TTM revenue of only about $0.90 million. This massive disconnect results in a gross margin of nearly -97.7% and an operating margin of roughly -2,196% as of Q3 2024, signaling that the core business is not yet covering its costs, let alone generating profit.

Here's the quick math on the balance sheet: Orgenesis Inc. has negative shareholder equity of approximately $-23.9 million, which is a more serious situation than simply having high debt. While total debt is around $15.1 million, the negative equity means the company's total liabilities of $53.6 million currently exceed its total assets of $29.7 million. This is a major financial risk that puts the company's long-term viability in question, especially since analysts have insufficient data to determine a stable cash runway.

• Funding Risk: Constant need for new capital, often through painful stock dilution.
• Liquidity Risk: Insufficient cash runway based on current negative free cash flow.
• Compliance Risk: Delays in filing key financial reports (like the 10-Q and 10-K) in 2025, which raises red flags about financial controls.

On the external front, Orgenesis Inc. faces fierce competition in the cell and gene therapy space from giants like Novartis (Kite), Lonza, and Thermo Fisher. These companies have the deep pockets to replicate or surpass Orgenesis Inc.'s decentralized Point of Care (POCare) model, which is its main strategic differentiator. Also, the regulatory environment is a major hurdle; getting new, decentralized manufacturing technology approved by regulators is tough and expensive.

The company's stock has also been highly volatile, underperforming the broader US Biotechs industry, which returned 17.8% over the past year, and the US Market, which returned 11.9%. The move to the OTCQX market after a Nasdaq delisting decision also limits its access to mainstream investors.

Still, management is taking clear actions to mitigate these existential risks. They've been actively raising capital, securing a $5 million equity investment in January 2025 and a convertible loan agreement in September 2025. Strategically, the focus is on achieving pipeline milestones, like the anticipated Q4 2025 readout for the ORG-101 trial, and integrating the newly acquired Neurocords assets, both of which could be major inflection points for future revenue. You can read more about the capital structure and investor base here: Exploring Orgenesis Inc. (ORGS) Investor Profile: Who's Buying and Why?

Growth Opportunities

You are looking for clear growth signals in a high-risk biotech like Orgenesis Inc. (ORGS), and the core takeaway is this: near-term revenue is tiny, but the company's strategic pivot to decentralized manufacturing creates a potential for a major revenue inflection point. The company's growth hinges entirely on the adoption of its proprietary Point of Care (POCare) platform, which is its competitive edge against the centralized manufacturing model.

The financial reality is that formal analyst consensus for 2025 revenue and earnings per share (EPS) is not available, reflecting the company's early-stage commercialization and high volatility. For the trailing twelve months (TTM) ending mid-2025, Orgenesis Inc.'s revenue was only around $0.90 million. But here's the quick math: the company has signed POCare Network contracts that could generate more than $40 million in revenue over the next three years if fully realized, which is the number to watch.

Key Growth Drivers: Decentralization and Pipeline

Orgenesis Inc.'s future growth is driven by two segments: Octomera, the technology platform, and Therapies, the clinical pipeline. The biggest innovation is the shift to decentralized cell and gene therapy (CGT) production using the Octomera Mobile Processing Units and Labs (OMPULs), which are essentially mobile, closed-system cleanrooms. This model is designed to drastically lower the cost and complexity of CGTs, a major hurdle for the entire industry.

The Therapies segment is advancing its pipeline, with a key near-term catalyst being the ORG-101 CAR-T therapy. This is an autologous (using the patient's own cells) treatment for CD19+ Acute Lymphoblastic Leukemia (B-cell ALL), and a critical Phase 1/2 trial readout from Greece is slated for Q4 2025. A positive readout here could radically improve expectations for future licensing and service fee revenues.

• Decentralized Manufacturing: POCare Network and OMPULs lower CGT costs.
• ORG-101 CAR-T: Phase 1/2 data readout expected in Q4 2025.
• Neurocords LLC: Acquired assets in March 2025 for spinal cord injury (SCI) therapies.

Strategic Partnerships and Financial Runway

The company is using strategic partnerships to expand its global footprint and secure a financial runway. In January 2025, Orgenesis Inc. secured an equity line of credit of up to $5 million from Williamsburg Venture Holdings, which provides flexibility to draw on funding to accelerate the rollout of the POCare platform. Also, the March 2025 acquisition of certain Neurocords LLC assets, which focuses on regenerative medicine for spinal cord injuries, expands the therapeutic portfolio into a market projected to reach $11.2 billion by 2031.

Partnerships with major institutions add credibility and market access. For example, the July 2025 partnership with Johns Hopkins University to establish a cell and gene therapy manufacturing center in Baltimore is a key public-private collaboration that validates the decentralized approach. Plus, a partnership with Harley Street Healthcare Group (HSHG) includes an investment commitment of up to $10 million over 3 years for a Longevity & Wellness Initiative, diversifying revenue streams.

The company is defintely a high-risk, high-reward play, betting on its unique decentralized model to disrupt the traditional cell therapy contract development and manufacturing organization (CDMO) space. You need to monitor the Q4 2025 clinical data and commercialization updates for the Neurocords assets closely. For further analysis on the market sentiment, you should check out Exploring Orgenesis Inc. (ORGS) Investor Profile: Who's Buying and Why?