Imugene sharpens focus on Azer-Cel as costs fall and clinical progress builds

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Imugene (ASX:IMU) has reported a half-year shaped by tighter spending, renewed strategic focus and advancing clinical progress, as the company works to position its lead cell therapy program for the next stage of development.

For the six months to 31 December 2025, the company recorded a net loss of $37.8 million, an improvement on the $48.3 million loss in the prior corresponding period, reflecting a deliberate reduction in operating costs and a leaner organisational structure.

Management cut headcount to around fifteen staff supported by a small group of consultants, less than half the previous level, while also reducing research and clinical spending across most pipeline programs. These savings were partly offset by milestone payments tied to the Azer-Cel program and by higher non-cash amortisation charges. At period end, cash reserves stood at $14.1 million, down from $21.9 million six months earlier, underlining the importance of capital management and funding initiatives undertaken during the period.

The company’s strategic centre of gravity continues to shift toward Azer-Cel, its allogeneic CD19 CAR T therapy being developed for patients with relapsed or refractory diffuse large B-cell lymphoma. Clinical data from the Phase 1b study have remained encouraging, with an overall response rate of 82 per cent among evaluable patients, including both complete and partial responses. The first patient dosed in 2024 has remained cancer-free for more than twenty-two months, reinforcing the therapy’s potential durability. The treatment is being trialled across sites in the United States and Australia and includes interleukin-2 to improve T cell persistence and activity.

Imugene said it has expanded recruitment to include patients who have not previously received CAR T therapy. Early data from this group have also been promising, with five of six evaluable patients responding to treatment. The company believes targeting niche lymphoma indications within this population may allow smaller studies and faster regulatory pathways, potentially lowering development costs while accelerating timelines.

Feedback from the Food and Drug Administration supported key elements of the company’s clinical and manufacturing strategy, including dosing, endpoints and study design, providing a clearer path toward a registrational trial. Additional regulatory engagement is expected later in the year.

While Azer-Cel remains the primary focus, Imugene said it has also repositioned its onCARlytics program through a new collaboration with China-based JW Therapeutics. The partnership aims to explore a combination approach in which an oncolytic virus induces CD19 expression on solid tumours, enabling them to be targeted by CAR T cells. Initial work will begin with preclinical studies, followed by a Phase 1 investigator-initiated trial in China. By pursuing this partnership rather than continuing standalone development, the company said it expects to reduce capital requirements and free resources for its lead program.

The company also strengthened its financial position during the half year through a capital raising that brought in roughly $25 million via an institutional placement and share purchase plan. Proceeds have been directed primarily toward advancing Azer-Cel, extending the company’s funding runway, and supporting working capital needs.

Additional support came from a research and development tax refund of nearly $5.9 million received in July 2025,

Operationally, the period also included leadership changes, with the chief operating officer stepping down. The company said the transition would not affect ongoing programs. Looking ahead, directors acknowledge that continued funding will be required to sustain development, but believe recent cost reductions, capital initiatives and clinical progress provide a basis for meeting obligations over the coming year.