• Clinical stage immuno-oncology company developing novel cancer technologies in clinical trials
• Lead program azer-cel is an 'off-the-shelf' allogeneic CAR T therapy with promising Phase 1b data in Diffuse Large B-Cell Lymphoma
• Pursuing registrational trial pathway with FDA for azer-cel in rare lymphomas

Imugene is a clinical stage immuno-oncology company developing three novel cancer technologies in clinical trials: azer-cel CD19 allo CAR T, onCARlytics CD19 expressing virus, and CF33 Oncolytic Virus. The company's lead program is azer-cel, an 'off-the-shelf' allogeneic CAR T therapy that is currently in a Phase 1b clinical trial for Diffuse Large B-Cell Lymphoma (DLBCL). The Phase 1b data has shown a 75% Overall Response Rate and 55% Complete Response rate in patients who have failed 3-5 prior treatments, including autologous CAR T therapy. Imugene now intends to pursue indications with large unmet needs, including rare lymphomas and the relapsed/failed auto CAR T therapy setting, which represents a US$2 billion market opportunity in the US alone. Azer-cel is highly differentiated from approved autologous CAR T therapies, as it is a scalable, 'off-the-shelf' product that can be used to treat multiple patients from a single healthy donor. Imugene is undertaking a capital raising of up to A$37.5 million to fund the development of azer-cel, including preparation for a pivotal Phase 2 registrational trial in rare lymphomas, which is expected to commence in 2026 subject to data and regulatory approvals.

The company's pro-forma cash of A$64 million will fund the company into the second half of 2026 and the initiation of the pivotal clinical trial for azer-cel. Potential proceeds from the exercise of options (A$36.7 million) will fund the company into mid-2027.

Imugene expects significant newsflow over the next 12 months, including the release of additional data from the Phase 1b azer-cel trial, potential FDA Fast Track and/or Orphan Designation, an FDA Type B End-of-Phase meeting, and preparation for the azer-cel pivotal Phase 2 registrational trial in rare lymphomas.