10-K: NovAccess Global Reports Deep Losses, Faces Liquidity Crisis

NovAccess Global Inc., a biopharmaceutical company, reported a significant net loss and a growing working capital deficit for fiscal year 2024, highlighting severe liquidity challenges despite progress in immunotherapy development.

Summary

• NovAccess Global Inc. is a biopharmaceutical company focused on developing novel immunotherapies for brain tumor patients, particularly glioblastoma.
• The company acquired StemVax, LLC in September 2020, which holds an exclusive patent license for StemVax Glioblast (SVX-GB/TLR-AD1).
• TLR-AD1 received Orphan Drug Designation from the FDA in October 2022 for aggressive brain cancers, offering benefits like tax credits and potential seven-year marketing exclusivity.
• A provisional patent for new intellectual property related to the IDH1 protein was submitted in May 2024, and a non-provisional patent in May 2025, effectively doubling the company's patent portfolio.
• The company plans to submit an Investigational New Drug (IND) application to the FDA in 2026 to begin human clinical trials for TLR-AD1 and co-develop IDH1 as a biomarker.
• NovAccess Global reported no revenue for the fiscal years ended September 30, 2024, and 2023.
• The net loss for fiscal year 2024 was $2,657,889, a decrease from $4,724,946 in fiscal year 2023.
• Selling, General and Administrative (SG&A) expenses decreased to $747,776 in fiscal 2024 from $2,312,399 in fiscal 2023, primarily due to lower stock compensation and warrant expenses.
• Research and development expenses remained stable at approximately $153,898 in fiscal 2024.
• The company had a working capital deficit of $10,023,523 as of September 30, 2024, an increase from $7,798,484 in 2023.
• Cash flow used by operating activities decreased to $215,402 in fiscal 2024 from $624,636 in fiscal 2023, primarily due to lower cash expenses from lack of funding.
• NovAccess Global is in default on multiple loans, with outstanding debt of approximately $2.3 million, and does not have the funds to repay these obligations.
• The company's independent auditors issued a 'going concern' audit opinion, indicating substantial doubt about its ability to continue operations.
• The market value of common stock held by non-affiliates was $337,901 based on a $0.010 closing price on March 31, 2024.
• There were 61,652,385 shares of common stock outstanding on January 14, 2026.
• The company's stock is considered a 'penny stock' and is only eligible to trade on the OTC Expert Market for unsolicited customer orders due to delinquent SEC filings.

Sentiment

Score: 2

Explanation: The company is in severe financial distress with no revenue, substantial losses, a growing working capital deficit, and defaults on multiple loans, leading to a 'going concern' audit opinion. While there is promising early-stage R&D and patent activity in a high-demand area, the immediate financial viability and ability to fund future development are highly questionable. The failed capital raise and limited operational resources further exacerbate the negative sentiment.

Positives

• Orphan Drug Designation for TLR-AD1 provides significant benefits, including assistance in drug development, financial incentives, tax credits, exemptions from certain FDA fees, and potential seven years of post-approval marketing exclusivity.
• The filing of a provisional patent in May 2024 and a non-provisional patent in May 2025 for the IDH1 protein effectively doubled the company's patent portfolio, enhancing its intellectual property.
• IDH1 research shows promise in discerning long-term from short-term survivors after vaccine therapy in brain tumor patients, potentially allowing for targeted delivery of TLR-AD1 to patients most likely to benefit.
• Net loss decreased by $2,067,057 in fiscal year 2024 compared to fiscal year 2023, primarily due to reduced SG&A and other expenses.
• The company has a highly experienced advisory board with expertise in biopharmaceutical R&D and commercialization.

Negatives

• The company currently generates no revenue and has a history of substantial losses, with a net loss of $2,657,889 for fiscal year 2024.
• A significant working capital deficit of $10,023,523 as of September 30, 2024, indicates severe financial distress.
• The company is in default under multiple loans, with approximately $2.3 million in outstanding debt, and lacks the funds to repay these obligations.
• Independent auditors issued a 'going concern' audit opinion, raising substantial doubt about the company's ability to continue operations.
• The company has been forced to suspend operations due to a lack of funds.
• The stock is considered a 'penny stock' and is only eligible for unsolicited customer orders on the OTC Expert Market due to delinquent SEC filings, limiting liquidity and market access.
• The failed capital raise transaction with Sumner Global LLC for $3.63 million in equity and a $7.05 million loan indicates difficulty in securing significant funding.
• The company has limited staff, with only one full-time employee (the CEO) as of September 30, 2024, and relies heavily on consultants.
• Internal control deficiencies were identified as material weaknesses in prior years, and while remediated in 2023, the small size and limited resources pose ongoing risks for financial reporting mistakes.
• The CEO, Dwain K. Irvin, controls 30% of the voting power, which could deter unsolicited takeovers and make it difficult for other shareholders to influence governance.

Risks

• Lack of funds to continue operations or repay past due debt, with a substantial doubt about the company's ability to continue as a going concern.
• Need to raise substantial additional funds on an ongoing basis for clinical trials, commercialization, patent maintenance, and general corporate purposes, with no assurance of obtaining such funds on acceptable terms.
• Dependence on the success of TLR-AD1 platform technology and IDH1 biomarkers; if these core assets are ineffective, toxic, or not commercially viable, the business could fail.
• Likelihood of continuing to incur substantial losses and may never achieve profitability.
• Difficulty in evaluating business and prospects due to novel technology, unproven personalized treatment business strategy, and limited scale of operations.
• Inability to recruit and retain necessary management and technical personnel as operations progress.
• Reliance on third-party contract manufacturers, posing risks related to manufacturing agreements, capacity limitations, supply disruptions, and product equivalency issues.
• Challenges in scaling up manufacturing for commercialization, especially for living cell, personalized immune therapies, which is a fundamentally new category of product.
• Uncertainty of technology effectiveness, as immune therapies have a history of failures, and animal study results may not translate to human clinical trials.
• Clinical trials are expensive, time-consuming, and their outcome is uncertain, with late-stage trials for glioblastoma costing tens or hundreds of millions of dollars and taking years.
• Limited experience in conducting and managing clinical trials and relying on third parties, which may result in delays or failures.
• Potential failure to comply with regulatory requirements, leading to fines, injunctions, suspension of approvals, or product recalls.
• Regulatory approval of product candidates may be withdrawn at any time, and post-approval obligations may be imposed.
• Difficulty in negotiating reimbursement from health insurance and national health systems, especially for expensive, personalized products with atypical cost structures.
• Intense competition in the biotechnology and biopharmaceutical industry from companies with substantially greater resources and expertise.
• Exposure to potential product liability claims, with insurance potentially being unavailable or inadequate.
• Potential adverse effects from new legislation, regulatory policy changes, or animal rights activist activities.
• Requirement for multiple late-stage clinical trials for TLR-AD1 and IDH1, which may not be feasible due to funding, competing products, or changes in standard of care.
• Changes in manufacturing methods for TLR-AD1 could require additional equivalency studies or clinical trials.
• Uncertainty in obtaining or delays in receiving regulatory approvals for product candidates.
• Risk of not maintaining the benefits associated with orphan drug status, including market exclusivity, if a competing product reaches the market first.
• Intellectual property rights may be overturned, narrowed, blocked, or infringed upon by third parties, and patent protection may not be sufficient.
• Exposure to claims or lawsuits that products infringe patents or proprietary rights of other parties, leading to significant expenses, delays, or cessation of operations.
• Significant dilution of ownership interests due to future issuance of additional shares for capital raising, employee compensation, acquisitions, and conversion of outstanding debt, preferred shares, options, and warrants.
• The CEO's ability to significantly influence the election of directors and shareholder matters due to 30% voting control.
• Board's ability to create new series of preferred stock without shareholder approval, potentially adversely affecting common stock rights.
• Provisions in articles of incorporation and bylaws that could discourage, delay, or prevent a change in control.
• Volatility of the common stock market price, which can be adversely affected by numerous factors.
• The requirements of the Sarbanes-Oxley Act of 2002 and other U.S. securities laws impose substantial costs and may drain resources and distract management.
• No intention to pay cash dividends in the foreseeable future, meaning any return on investment must come from stock price increases.

Future Outlook

The company anticipates submitting an Investigational New Drug (IND) application to the FDA in 2026 for its TLR-AD1 immunotherapy, with an estimated 12-18 months to generate FDA-requested data. Following successful clinical trials proving safety and efficacy, NovAccess plans to commercialize the product, potentially through licensing to larger biopharmaceutical companies. The company also intends to co-develop the IDH1 protein as a biomarker to identify patients most likely to benefit from TLR-AD1. Additional treatment candidates are expected to be developed as the patent portfolio expands. However, the company acknowledges the need to raise substantial additional funds to finance ongoing operations and clinical trials.

Management Comments

• "We are filing an Investigational New Drug Application (IND) and working closely with the Food and Drug Administration (FDA) to obtain approval for human clinical trials to determine the safety and efficacy of our drug product for brain cancer patients."
• "We anticipate that it will take roughly twelve to eighteen months to generate the FDA requested data to submit the IND application."
• "Once we have successfully completed the clinical trials and proven that the new therapy is safe and efficacious, we plan to commercialize the product."
• "We plan to submit an IND application in 2026."
• "The Company will now approach the US Food and Drug Administration to determine how best to co-develop IDH1 and TLR-AD1."
• "In order to finance our operations, including clinical trials development and execution, we intend to raise capital through financial institutions that invest in cancer therapeutics, including VSI."
• "As we achieve milestones during the process of R&D, we expect our overall value to increase."
• "We intend to commercialize our products immediately after successful completion of clinical trials."
• "We plan to license our products to larger biopharmaceutical companies to deliver our product to as many patients as possible once we have obtained the required FDA approvals."
• "We expect to have other treatment candidates outside of our lead candidate moving forward as we build our patent portfolio of other therapeutics to improve patient outcomes and overall quality of health."
• "Management believes the existing shareholders, prospective new investors and lenders will provide the additional cash needed to meet the Companys obligations as they become due and will allow the development of its business."

Industry Context

NovAccess Global operates in the highly competitive and rapidly advancing biopharmaceutical industry, specifically targeting brain cancer immunotherapy. Glioblastoma, their primary focus, has seen no significant survival improvement in over 50 years despite advances in chemotherapy and radiation, creating a high demand for novel therapies. The industry is actively promoting immunotherapies, with significant R&D by numerous large and small companies in checkpoint inhibitors, T-cell therapies, and monoclonal antibodies. NovAccess's personalized, living cell-based immunotherapy (TLR-AD1) and companion diagnostic (IDH1) represent a novel approach, but also face challenges in manufacturing scale-up and reimbursement compared to conventional drugs. The company competes with established players like Roche, Merck, AstraZeneca, and innovative companies like Adaptimmune and NovoCure, many of whom have substantially greater resources.

Comparison to Industry Standards

• NovAccess Global's focus on personalized, dendritic cell-based immunotherapy for glioblastoma is a novel approach, contrasting with more established checkpoint inhibitor drugs (e.g., Keytruda by Merck & Co., Opdivo by Bristol Myers Squibb) and CAR-T cell therapies (e.g., Kymriah by Novartis, Yescarta by Gilead/Kite Pharma) that have seen FDA approvals for other cancers but have been largely ineffective in glioblastoma.
• The company's strategy to co-develop IDH1 as a companion diagnostic biomarker to predict treatment success aligns with a growing industry trend towards precision medicine and patient stratification, similar to how certain genetic markers guide therapies in other cancers.
• Unlike many pharmaceutical companies that have several products in development, NovAccess is currently dependent on the success of its TLR-AD1 platform technology and IDH1 biomarkers, which is a higher-risk profile compared to diversified pipelines of larger competitors.
• The challenge of scaling up manufacturing for living cell products like TLR-AD1 is a known industry hurdle, exemplified by Dendreon Corporation's difficulties with its Provenge product for prostate cancer, and even CAR-T products have only scaled to moderate volumes so far.
• The company's lack of revenue and significant accumulated deficit are typical for early-stage biopharmaceutical companies in the pre-clinical or early clinical development phase, but the magnitude of its working capital deficit and loan defaults are indicative of more severe financial distress than many peers at a similar stage.

Management Changes

Corporate Governance

Legal Proceedings

• On October 7, 2024, 13 Paul Lending LLC filed a complaint against NovAccess in the Circuit Court of Fairfax County, Virginia, alleging breach of a convertible promissory note and seeking default damages of approximately $510,000.
• NovAccess believes the damages sought by 13 Paul are excessive, having repaid a portion of the loan.
• On October 22, 2025, the court dismissed the case because NovAccess had not been served within a year of the complaint filing.
• On October 31, 2025, 13 Paul filed a motion for reconsideration, arguing NovAccess had agreed to accept service.
• In November 2025, NovAccess made a payment of $10,000 to 13 Paul.
• Ongoing discussions are taking place with 13 Paul's counsel to settle the case, but a settlement on acceptable terms is not guaranteed.

Related Party Transactions

• As of September 30, 2024, the company owed Innovest Global, Inc. $86,217 for advanced operating funds. Daniel Martin, former Chairman, was CEO of Innovest.
• As of September 30, 2024, the company owed TN3, LLC (owned by former Chairman Daniel G. Martin) $95,000 of a preferred stock redemption price and was in default.
• On July 28, 2022, Jason M. Anderson, an independent director, provided a $12,500 interest-free short-term loan to fund operations.
• On February 9, 2023, Jason M. Anderson provided a second interest-free loan of $8,500.
• On January 26, 2024, Jason Anderson loaned the company a further $2,000.
• On July 22, 2024, Jason Anderson loaned the company a further $1,000.
• On December 21, 2023, Chairman John A. Cassarini loaned the company $10,000.
• On May 31, 2024, Chairman John A. Cassarini loaned the company $9,000 via an interest-free unsecured promissory note.
• Our Chief Financial Officer, Neil J. Laird, loaned the Company $1,000 on December 21, 2023.
• Dwain K. Irvin, CEO, guaranteed repayment of a $265,000 loan (February 2023 Letter Agreement) and a $75,000 loan (June 19, 2023 Letter Agreement).
• Dwain K. Irvin, CEO, deferred payment of $231,400 in salary in fiscal 2024 and $231,400 in fiscal 2023 to conserve cash.
• Irvin Consulting LLC, owned by Dwain K. Irvin, holds 600 shares of Series B Preferred Stock, entitling 40,000 votes per share and convertible into 10,000 common shares per share.

Stakeholder Impact

• **Shareholders:** Face significant dilution risk from potential future equity issuances and conversion of existing debt, warrants, and preferred stock. The 'going concern' opinion and penny stock status indicate high investment risk and limited liquidity. The CEO's significant voting control (30%) limits influence of other shareholders.
• **Employees/Consultants:** The company's limited staff and reliance on consultants, coupled with financial instability, suggest potential challenges in attracting and retaining talent. Compensation for the CEO and some service providers has been deferred or paid in equity to conserve cash.
• **Creditors:** Many loans are in default, and the company lacks funds for repayment, leading to extensions and legal proceedings. This poses a high risk of non-recovery or delayed recovery for creditors.
• **Patients/Medical Community:** The development of novel immunotherapies for glioblastoma addresses a critical unmet medical need. However, the company's financial instability and operational challenges could delay or halt the progress of these potentially life-saving treatments.
• **Regulatory Bodies (FDA):** The company is actively engaging with the FDA for IND submission and orphan drug designation, but its financial and operational weaknesses could impact its ability to meet regulatory requirements and timelines for clinical trials and approvals.

Next Steps

• Generate FDA requested data to submit an Investigational New Drug (IND) application for human clinical trials (anticipated 12-18 months).
• Submit an IND application to the FDA in 2026 for TLR-AD1.
• Approach the US Food and Drug Administration to determine how best to co-develop IDH1 and TLR-AD1.
• Conduct human clinical trials to prove safety and efficacy of TLR-AD1 and IDH1.
• Commercialize products after successful completion of clinical trials, potentially through licensing to larger biopharmaceutical companies.
• Raise additional funds through equity issuance and debt to finance ongoing operations and clinical trials.
• Continue discussions with 13 Paul Lending LLC to settle the legal case.
• Conduct a search for a new Chief Financial Officer (CFO) following Neil Laird's resignation.
• Monitor regulatory agencies outside the United States, such as the European Medicines Agency (EMA), for government-sponsored opportunities.

Key Dates

Recommendation

NovAccess Global Inc. presents an extremely high-risk investment profile. The company has no revenue, a history of substantial losses, and a rapidly increasing working capital deficit. It is in default on multiple loans, and its auditors have issued a 'going concern' opinion, indicating severe doubt about its ability to continue operations. The failure of a significant capital raise and the 'penny stock' status with limited trading further underscore its precarious financial position. While its biopharmaceutical research into glioblastoma immunotherapy (TLR-AD1 and IDH1) holds long-term potential and has received Orphan Drug Designation, the company's immediate and overwhelming financial distress, coupled with the inherent risks of early-stage drug development, make it an unsustainable investment in the short to medium term. The high potential for significant shareholder dilution from outstanding convertible instruments and the urgent need for capital further compound the risks. Investors should avoid this stock due to the severe financial instability and operational challenges.

Keywords

Biopharmaceutical, Immunotherapy, Brain Cancer, Glioblastoma, TLR-AD1, IDH1, Orphan Drug Designation, FDA Approval, Clinical Trials, SEC Filing, 10-K, Liquidity Crisis, Going Concern, Convertible Debt, Patent, Biomarker, Oncology, Drug Development, Financial Reporting, Corporate Governance