BriaCell Partners with Uneedle for Scalable Microneedle Administration of Bria-IMT(TM)

Executive Summary

• BriaCell Therapeutics entered into a non-binding Memorandum of Understanding (MoU) with Uneedle to support the commercial readiness and scaling of Uneedle’s proprietary microneedle technology for the intradermal administration of Bria-IMT.
• The microneedle delivery system is already being utilized in BriaCell’s ongoing pivotal Phase 3 clinical trial for advanced metastatic breast cancer.
• The collaboration aims to establish a production scaling plan for commercial quantities, with all activities and projections strictly contingent upon successful regulatory approval of Bria-IMT.

Key Details

• Agreement Type: Non-binding Memorandum of Understanding (MoU)
• Parties: BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL; TSX: BCT) and Uneedle (Netherlands-based microneedle drug-delivery device company)
• Technology: Uneedle’s proprietary silicon microneedle platform designed for precise intradermal and suprachoroidal drug delivery
• Clinical Application: Administration of BriaCell’s lead Phase 3 clinical candidate, Bria-IMT (a cell-based immunotherapy for advanced metastatic breast cancer)
• Current Trial Status: Technology is actively used in BriaCell’s pivotal Phase 3 study (ClinicalTrials.gov identifier: NCT06072612)
• Commercial Objective: Establish a plan to scale microneedle device manufacturing for commercial quantities to enable faster, more convenient administration and improve the patient/provider experience
• Regulatory Contingency: All collaboration activities, projections, and commercial scaling plans are contingent upon successful regulatory approval of Bria-IMT in relevant jurisdictions

Notable Quotes

• William V. Williams, MD, President and CEO of BriaCell: “Efficient and reliable drug administration is integral to treating cancer patients... Uneedle’s microneedle technology is already being used in our pivotal Phase 3 study, and we believe this approach may support faster, more convenient administration and a more patient-friendly treatment experience.”
• Jeroen Wissink, Chief Executive Officer of Uneedle: “Precision and consistency in intradermal drug delivery are important attributes for therapies administered into the skin... We are excited to work with BriaCell to support the use of our proprietary microneedle technology for Bria-IMT and to help advance delivery readiness ahead of potential commercialization.”