iX Biopharma Secures US\$41 Million U.S. Department of Defense Contract for Non-Opioid Pain Treatment: A Potential Game-Changer for Shareholders

Key Highlights

• iX Biopharma Ltd (SGX: 42C), a Singapore-listed specialty pharmaceutical company, has been awarded a significant US\$40.95 million development contract by the United States Department of Defense (DoD).
• The contract will fund the Phase 3 clinical development of Wafermine®, the world’s first patented sublingual racemic ketamine wafer, for treating acute moderate to severe pain.
• The contract includes funding for activities required to obtain a U.S. FDA Emergency Use Authorization (EUA) for Department of Defense deployment for a 36-month period.
• Sole-source procurement means iX Biopharma was uniquely chosen, reflecting the U.S. government’s confidence in its proprietary WaferiX® drug delivery platform and advanced development status.
• This is a substantial international validation of Singapore-developed pharmaceutical innovation, potentially establishing iX Biopharma as a global leader in non-opioid pain management.

Details for Investors and Shareholders

The awarded program represents a major milestone and is likely to be price-sensitive news for shareholders. The U.S. DoD’s award not only provides substantial non-dilutive funding, but also significantly de-risks the company’s flagship asset, Wafermine®, by advancing it through pivotal late-stage clinical development.

• Wafermine® is uniquely suited for emergency, battlefield, and remote care settings, offering rapid pain relief without the need for injections or intravenous access. This supports both military and civilian markets for non-opioid pain treatment.
• The contract covers both the near-term EUA pathway (enabling military deployment before full FDA approval) and the Phase 3 trials required for a full New Drug Application with the FDA, accelerating market access and revenue potential.
• Wafermine® has already demonstrated efficacy and safety in a Phase 2b post-operative pain study and is currently supplied to Australian hospitals under regulatory exemption, further establishing its credibility.
• The company’s proprietary WaferiX® technology enables precise, fast-dissolving sublingual delivery of drugs, improving speed, safety, and ease of administration—key advantages in both military and civilian healthcare settings.
• The DoD contract will fund iX Biopharma’s labor and project costs using a mix of fixed monthly payments and actual cost reimbursements, ensuring ongoing operational funding for the next three years.
• This agreement is a major international validation of iX Biopharma’s R&D and manufacturing capabilities, and positions Singapore as a hub for advanced pharmaceutical innovation.
• Beyond Wafermine®, iX Biopharma is scaling its wellness portfolio (e.g., SL-NAD+ wafer for longevity and healthy aging) and leveraging its platform for additional pharmaceutical and nutraceutical applications, including expansion into the U.S. compounding pharmacy market.

Potential Impact on Share Value

The award of this contract is likely to be a highly positive catalyst for iX Biopharma’s share price due to several factors:

• Non-dilutive funding of nearly US\$41 million significantly strengthens the company’s balance sheet and reduces reliance on equity fundraising.
• Acceleration of late-stage clinical development for Wafermine® and potential expedited path to U.S. market entry via EUA and FDA approval.
• Increased international recognition and validation from a major U.S. government agency, enhancing credibility and potential for future collaborations or licensing deals.
• Expansion into high-value non-opioid pain market segments, both military and civilian, with a differentiated, patented technology.

Additional Company Information

• iX Biopharma operates a fully integrated business model, with R&D and manufacturing in Australia and is listed on the Catalist board of the Singapore Exchange.
• The company’s proprietary platforms (WaferiX™ and WaferlogiX™) are designed for rapid, predictable sublingual delivery of both small molecules and biologics, opening additional licensing and compounding opportunities, especially in areas like diabetes and weight loss.

Contact Information

For further media enquiries, please contact:
Sunita Kanapathy
Regional Vice President, PRecious Communications Ltd
T: +65 81931080
E: [email protected]

Disclaimer

This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own due diligence and consult with professional advisors before making any investment decisions. The information contained herein is based on company announcements and may be subject to change or further clarification.

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