Imugene’s Funding and Trial Progress Highlight Risks and Opportunities Ahead

Clinical Milestones Mark Progress

Imugene Limited (ASX:IMU) has delivered a compelling update for the quarter ended 31 December 2024, showcasing significant clinical progress alongside a strengthened financial footing. The highlight is a bile tract cancer patient in the Phase 1 MAST trial who has maintained a complete response for over two years, underscoring the potential durability of Imugene's oncolytic virotherapy, CF33-hNIS (VAXINIA).

The bile tract cancer expansion cohort has now opened, enrolling up to 10 patients after successfully clearing an initial group of three without dose-limiting toxicities. This development not only validates the safety profile but also signals growing momentum for this novel treatment approach.

Advancing Oncolytic and CAR T-cell Therapies

Further clinical progress was marked by dosing the first patient in the intratumoural combination arm of the Phase 1 onCARlytics (CF33-CD19) trial, known as OASIS. This trial, conducted across eight leading U.S. oncology centers, explores a unique mechanism where solid tumors are induced to express CD19, enabling targeting by established CD19 therapies like blinatumomab. This innovation could redefine treatment options for otherwise “targetless” solid tumors.

On the cellular therapy front, Imugene opened its first Australian site for the Phase 1b azer-cel trial, targeting relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The Royal Prince Alfred Hospital in Sydney began patient recruitment in November 2024, with the first Australian patient enrolled in January 2025. Early results from U.S. sites are promising, with three complete responses reported, including durable responses beyond 90 and 120 days in patients receiving azer-cel combined with lymphodepletion and low-dose interleukin-2.

Intellectual Property and Scientific Recognition

Imugene also secured a patent extension in the U.S. for CF33’s method of composition and use, extending protection until 2040. This patent strengthens the intellectual property underpinning VAXINIA and related therapies, providing a solid foundation for future development and commercialization.

Adding to its scientific credentials, Imugene’s azer-cel research was accepted for presentation at the 2025 ASTCT Tandem Meetings in Hawaii. The poster highlights how low-dose subcutaneous interleukin-2 enhances the pharmacokinetic profile of azer-cel without compromising safety, reinforcing the therapy’s potential in treating relapsed DLBCL patients.

Financial Strength and Corporate Updates

On the financial front, Imugene entered a funding agreement with CVI Investments, Inc., raising $20 million through convertible notes with the potential to raise an additional $26 million via warrants. This financing extends the company’s cash runway to the end of 2025, excluding further warrant exercises, and supports ongoing clinical programs including azer-cel, onCARlytics, and VAXINIA.

Additionally, the company received an $11.7 million R&D tax refund for FY23 in January 2025, further bolstering its cash position. At quarter-end, Imugene held $33.7 million in cash, with pro-forma cash including recent receipts at $65.4 million.

On the corporate side, Non-Executive Director Jens Eckstein retired following the November AGM, concluding over five years of service on the board.

Strategic Focus and Outlook

Imugene continues to prioritize its azer-cel and oncolytic virus programs, having deprioritized its B-cell immunotherapy candidates to focus resources on these promising platforms. The company is actively pursuing out-licensing opportunities for its B-cell immunotherapies, aiming to maximize value while concentrating on advancing its lead clinical assets.

With multiple clinical milestones achieved and a robust financial foundation, Imugene is well positioned to sustain momentum in 2025 as it progresses toward pivotal data readouts and potential commercial partnerships.