NovAccess Global Inc.

Overview

NovAccess Global Inc. is a biopharmaceutical company developing immunotherapies for brain tumors, with an initial focus on glioblastoma in the United States and plans to expand globally. The company specializes in autologous, dendritic cell–based vaccine approaches and in developing biomarkers to predict or enhance immunotherapy response.

Lead product candidates and platform

• TLR-AD1: A dendritic cell–based immunotherapy that uses Toll-like receptor adjuvants to stimulate an anti-tumor immune response. The approach uses patient tumor antigens and autologous dendritic cells ex vivo and then re-administers the cell product to the patient.
• IDH1 biomarker program: Co-development of IDH1-based biomarkers with the TLR-AD1 platform to help select patients more likely to benefit. IDH1 status is used to distinguish responders (high non-mutated IDH1) from non-responders (mutated IDH1) in tumor tissue. Provisional and non-provisional patent filings were submitted in May 2024 and May 2025, respectively.
• Regulatory designation: The FDA granted orphan drug designation for TLR-AD1 targeting aggressive brain cancers (glioblastoma and high-grade gliomas) in October 2022.

Intellectual property

• StemVax, LLC (acquired September 2020) holds an exclusive license from Cedars-Sinai Medical Center for StemVax Glioblast (SVX-GB/TLR-AD1) technology.
• Cedars-Sinai patents related to TLR-based brain tumor immunotherapy were issued in 2017 (patents 9764014 and 8728465) and were licensed to StemVax in 2018.
• NovAccess filed a provisional patent in May 2024 and a non-provisional patent in May 2025 for IDH1-related innovations to support the immunotherapy platform.

Development timeline and regulatory posture

• IND submission is planned for 2026 after completing required FDA data generation; estimated preparation time from the current filing state to IND readiness is 12–18 months.
• The company has ongoing engagement with the FDA on IND strategy and Phase I/IIa pathway discussions; StemVax founder Dr. Christopher Wheeler has led interactions, including pre-IND engagements in 2021.
• The company monitors EMA opportunities for potential development outside the U.S.

Manufacturing and product delivery

• TLR-AD1 production requires fresh tumor tissue and personalized cell manufacturing for each patient, with products frozen for distribution. This creates time- and logistics-related challenges.
• The company relies on third-party contract manufacturers and specialized GMP facilities for cell therapy production and IDH1 biomarker analysis, exposing operations to supply disruptions, capacity limits, and regulatory changes.
• Scale-up to commercial volumes is expected to be a major challenge given the personalized, living-cell nature of the product.

Commercialization model

• The company intends to commercialize following successful clinical development and plans to license products to larger biopharmaceutical firms for broader distribution.
• Marketing and sales resources are not yet established; distribution will likely require substantial partner training and process adaptation because of the living-cell, personalized product format.
• Reimbursement for novel immunotherapies and companion diagnostics in the U.S. and internationally remains uncertain and will be a key consideration.

Financial condition and liquidity

• The company has not generated product revenue to date and requires substantial funding to continue operations, including clinical development and patent work.
• Substantial debt outstanding: approximately $2.3 million as of September 30, 2024, largely in default and past due, with repayment extensions through November 1, 2025 in place.
• A December 29, 2023 securities purchase agreement with Sumner Global LLC proposed 33.0 million shares at $0.11 per share ($3.63 million) and a $7.05 million loan; the transaction did not close as expected.
• On August 21, 2025, VSI founder Dr. David Alessi guaranteed a portion of a $250,000 loan from AJB Capital Investments LLC.
• The company faces dilution risk from potential conversion of debt, warrants, and other convertible securities, including approximately 511 million shares issuable from convertible debt, 6.0 million from preferred stock, 5.5 million from stock options, and 20.3 million from warrants, plus 2.8 million shares issued as loan commitment fees.
• Auditors have expressed substantial doubt about the company’s ability to continue as a going concern without additional financing.
• The company’s common stock trades on the OTC market and is classified as a penny stock.

Ownership and governance

• As of September 30, 2024, CEO Dwain K. Irvin held substantial voting control through ownership of common and preferred shares, able to cast about 30% of the voting power on shareholder matters.
• The company has authorized a large pool of unissued common stock (approximately 1.9 billion shares) and board authority to create additional series of preferred stock without shareholder approval.
• Board provisions include denial of cumulative voting, restrictions on director removal, and authority for remaining directors to fill board vacancies.

Corporate footprint and operations

• The company does not maintain a centralized biopharma headquarters and uses third-party office facilities; mailing address is 459 Columbus Ave #607, New York, NY 10025.
• StemVax operates using third-party laboratory and research space in California (Pasadena and Santa Cruz) as needed.
• Operations rely on consultants and a small internal team; as of September 30, 2024, the company reported one full-time employee (the CEO).

Legal and other risks

• Ongoing litigation with 13 Paul Lending LLC related to an alleged breach of a note/purchase agreement; damages asserted around $510,000. The case was dismissed for lack of service and subsequently refiled, with settlement discussions ongoing.
• Other principal risks include regulatory changes, manufacturing scale-up, third-party dependency, potential patent disputes, and market volatility that could affect development and commercialization.