Appendix 4E and Annual Report

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Stock Imugene Ltd (IMU.ASX)
Release Time 26 Aug 2025, 9:20 a.m.
Price Sensitive Yes
 Imugene Ltd reports FY2025 results
Key Points
  • Azer-cel CAR T therapy shows 79% overall response rate in DLBCL patients
  • Expanded azer-cel trial to include additional rare blood cancers
  • Completed $42 million in funding rounds from new and existing investors
  • Received $17 million in R&D tax incentives and refunds
Full Summary

Imugene Ltd, a clinical-stage immuno-oncology company, reported its financial results for the year ended 30 June 2025. The company made significant progress across its pipeline, particularly with the azer-cel (azercabtagene zapreleucel) program, an allogeneic CD19 CAR T-cell therapy for blood cancers. The Phase 1b trial of azer-cel in diffuse large B-cell lymphoma (DLBCL) patients reported an impressive 79% overall response rate, with six complete and five partial responses. The durability of these responses, with some extending beyond 15 months, is particularly promising given the heavily pre-treated and often unresponsive nature of this patient population. The U.S. FDA granted Fast Track Designation to azer-cel, recognizing its potential to address critical treatment gaps. Imugene also expanded the scope of the azer-cel trial to include additional rare blood cancers, such as primary central nervous system lymphoma, chronic lymphocytic leukemia, and marginal zone lymphoma, which currently lack effective treatment options. Patient recruitment has continued across multiple clinical sites in the U.S. and Australia. Imugene also advanced its onCARlytics program, a novel combination immunotherapy using an oncolytic virus to make solid tumors express the CD19 antigen, allowing them to be targeted by existing CD19-directed therapies. The first dose level in the intravenous combination arm of the Phase 1 OASIS trial was cleared, allowing the study to progress to the next dose level. During and subsequent to the end of the financial year, Imugene completed two funding rounds totaling approximately $42 million, supported by both new and existing institutional investors. The company also received ~$17 million in R&D tax incentives and refunds, providing valuable non-dilutive funding for its pipeline. Imugene strengthened its executive leadership with the appointments of Darren Keamy as CFO and Dr. John Byon as CMO, who bring deep industry expertise to support the company's continued growth and advancement of its programs.

Outlook

Imugene remains committed to seeing its data mature and advancing its therapies toward further milestones. With a robust clinical program, experienced leadership, and a stronger capital base, the company is poised to deliver another important year of progress.