Imugene’s Path to Profitability Hinges on Azer-cel’s Pivotal Trial Success

Financial Performance and Cost Management

Imugene Limited has reported a substantial 54% improvement in its net loss for the financial year ended 30 June 2025, narrowing the loss to $69 million from $149.7 million in the prior year. This improvement was underpinned by a disciplined approach to cost management, including headcount reductions, out-licensing of manufacturing assets, and trimming administrative expenses. Research and development expenses also declined by 46%, reflecting a strategic focus on prioritised clinical programs.

Clinical Progress – Azer-cel Leads the Way

The company’s lead immuno-oncology asset, azer-cel, an allogeneic CD19 CAR T cell therapy targeting blood cancers, delivered compelling clinical data during FY25. In its ongoing Phase 1b trial involving patients with diffuse large B-cell lymphoma (DLBCL) who had relapsed after autologous CAR T therapy, azer-cel achieved an impressive 79% overall response rate, including six complete and five partial responses. Notably, some responses have shown durability extending beyond 15 months, a promising outcome in a heavily pre-treated patient population.

Recognising its potential to address significant unmet medical needs, the U.S. Food and Drug Administration granted azer-cel Fast Track designation during the year. Imugene has also expanded the trial to include additional rare B-cell lymphomas, such as primary central nervous system lymphoma and chronic lymphocytic leukemia, broadening the therapy’s potential impact. Recruitment efforts are ongoing across multiple sites in the U.S. and Australia, with the first Australian patient dosed at Royal Prince Alfred Hospital in Sydney.

Pipeline and Regulatory Outlook

Beyond azer-cel, Imugene continues to advance its oncolytic virus programs, including onCARlytics and VAXINIA, as well as the PD1-Vaxx cancer vaccine, which recently entered Phase II trials targeting colorectal cancer. The company is preparing for pivotal discussions with the FDA in the fourth quarter of calendar year 2025 to define the pathway for registrational Phase 2 trials of azer-cel, anticipated to commence in 2026, subject to data and regulatory approvals.

Capital Raising and Leadership Strengthening

Imugene successfully raised approximately $42 million through two funding rounds during and after the financial year, supported by both new and existing institutional investors. These funds, alongside $17 million received in R&D tax incentives, bolster the company’s financial position to support ongoing clinical development and operational needs. The company also enhanced its executive team with the appointments of Darren Keamy as Chief Financial Officer and Dr John Byon as Chief Medical Officer, bringing extensive industry experience to guide Imugene through its next growth phase.

Shareholder Returns and Outlook

No dividends were declared or paid during FY25, consistent with the company’s focus on reinvesting capital into clinical development. Imugene’s cash reserves stood at $21.9 million as of 30 June 2025, prior to receiving additional funds from recent placements and government incentives. Looking ahead, the company is positioned to deliver key clinical readouts and regulatory milestones, with significant newsflow expected around azer-cel’s Phase 1b data expansion, FDA meetings, and the initiation of pivotal trials in 2026.