iX Biopharma Awarded US\$41 Million U.S. Defense Contract to Advance Wafermine® for Acute Pain Treatment

Key Highlights

• iX Biopharma Ltd has secured a significant US\$40,954,914 (approximately US\$41 million) contract from the U.S. Government, specifically the Defense Health Agency Contracting Activity (DHACA) under the Program Executive Office Operational Medical Systems (PEO OPMED).
• The funding will support the development and regulatory approval of Wafermine®, iX Biopharma’s patented sublingual ketamine wafer for treating acute moderate to severe pain.
• The grant will accelerate Wafermine® towards battlefield deployment and operational use by the U.S. Department of Defense (DoD), potentially making it a standard issue in Joint Force medical kits.
• The contract was awarded via a sole-source procurement process, indicating that iX Biopharma has unique capabilities required by the U.S. military.
• Contract duration: 36 months, with structured monthly payments and cost reimbursements.
• Key deliverables: Completion of Phase 3 clinical trials and FDA Emergency Use Authorization (EUA) for DoD use, allowing military deployment prior to full FDA approval.

Detailed Analysis

Strategic Importance

The contract is designed to address both immediate and long-term needs of the U.S. military. In the near term, it will fund Wafermine®’s pathway to an FDA Emergency Use Authorization (EUA), which is a significant regulatory milestone allowing the U.S. DoD to access and use the drug in military settings before full FDA approval. In the long term, the program supports Phase 3 clinical development and an eventual New Drug Application (NDA) with the FDA, with the broader goal of integrating Wafermine® into military medical kits for Joint Force deployment.

Why Wafermine® Was Selected

The U.S. Government’s selection of iX Biopharma was based on its proprietary WaferiX® sublingual drug delivery technology, advanced clinical development status, and manufacturing capabilities. Wafermine® can deliver ketamine rapidly into the bloodstream without the need for injections or special training, making it ideal for battlefield, emergency, and remote care environments.

Details of the Funding and Agreement

• Total contract value: US\$40,954,914
• Duration: 36 months
• Payment structure: Fixed monthly payments for labor and monthly reimbursement of other project costs.
• Major deliverables:
  • Completion of Phase 3 clinical trials for Wafermine®
  • Securing FDA EUA for DoD use (precedes full FDA NDA approval)

Potential Impact on Shareholders

• The contract is a major validation of iX Biopharma’s technology, providing non-dilutive funding and a clear development pathway for Wafermine® in the world’s largest pharmaceutical market and with the prestigious U.S. Department of Defense as a partner.
• The program could accelerate Wafermine®’s commercial and military deployment, opening up significant new revenue streams if successfully developed and approved.
• The contract’s sole-source award underscores iX Biopharma’s unique position in the non-opioid pain management space, especially relevant amidst the global opioid crisis.
• Wafermine® may provide an alternative or complement to opioid painkillers, as ketamine does not cause respiratory depression at low doses—a safety advantage that could drive adoption.
• Although the agreement is not expected to have a material impact on the current financial year ending 30 June 2026, the successful achievement of milestones (FDA EUA, Phase 3 results) could be highly price sensitive and have a significant positive impact on future share value.
• There are no conflicts of interest with directors or controlling shareholders in relation to this contract.

Background on Wafermine®

Wafermine® is the world’s first patented sublingual racemic ketamine wafer for acute moderate to severe pain. Ketamine has a long history of safe use as an intravenous anesthetic and pain treatment. Wafermine® delivers ketamine rapidly without injections, enhancing its suitability for military and emergency medical use.
Development milestones include:

• Strong efficacy and safety results in Phase 2b post-operative pain studies
• Supplied to Australian hospitals since 2014 under special regulatory exemption
• Successful End-of-Phase 2 meeting with the U.S. FDA confirming the Phase 3 clinical development pathway

The Defense Health Agency (DHA), part of the U.S. DoD, supports innovative medical technologies that address critical operational needs. If Wafermine® meets development and regulatory milestones, it may progress to further military deployment and procurement.

Forward-Looking Statements

The company cautions that this announcement contains forward-looking statements. Actual results may differ materially due to regulatory, clinical, operational, or market factors. Investors should not place undue reliance on these statements, which reflect management’s current view as of the announcement date.

Disclaimer: This article is for information purposes only and does not constitute investment advice. Investors are advised to conduct their own due diligence and consult their professional advisors before making any investment decisions. The information presented herein is based on publicly available documents as of the date of publication.

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