IMUGENE LIMITED — Capital/Financing Update 2025

Dec 7, 2025

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ASX Announcement

FDA Supports Strategy Toward Registration for Imugene’s Azer-cel

• The FDA confirmed data from the current Phase 1b study with azer-cel +IL-2 dosing regimen (including lymphodepletion conditioning) along with the safety profile supporting moving towards a Phase 3 Registrational study

• 3[rd] line and later DLBCL including patients who relapsed after autologous CAR-T was accepted as the registrational study population in a major high-need setting

• The FDA confirmed support of a single, randomized study using Overall Response Rate (ORR) with durability for accelerated approval and Progression Free Survival (PFS) for full approval.

• The FDA agreed with Imugene’s approach to Chemistry Manufacturing Controls (CMC) readiness for a registrational study

• Recent company ASX releases with updated clinical results showing 82% ORR in CAR-T relapsed DLBCL and 83% response rate in CAR-T naïve niche indications highlighted the expanding opportunity for azer-cel across multiple CD19-positive cancers.

Sydney, Australia, 8 December 2025: Imugene Limited (ASX: IMU), a clinical-stage immune-oncology company, has received written minutes from the US Food and Drug Administration (FDA) following its recent Type C meeting regarding the registrational pathway for azercabtagene zapreleucel (azer-cel).

The minutes from the meeting with the FDA held on 21[st] of November 2025 provide clear alignment across the key elements required to advance azer-cel into a pivotal study and further validate the program’s growing clinical and commercial potential.

Following a productive Type C meeting with the U.S. FDA, we received directional confirmation that Imugene’s proposed regimen for the pivotal program which includes augmented lymphodepletion followed by a flat 500 million cell dose of azer-cel with 14

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days subcutaneous low dose IL-2 is appropriate. The Agency also endorsed 3[rd] line and later DLBCL including patients who have relapsed after autologous CAR-T as an acceptable registrational population. This represents a significant opportunity in a setting where treatment options are extremely limited and real-world outcomes remain poor.

The FDA endorsed Imugene’s dual end point strategy with Overall Response Rate (ORR) and durability for accelerated approval and Progression Free Survival (PFS) for full approval and confirmed that one randomised study can support both endpoints with adequate follow-up. The Agency also asked that the control arm include several investigator choice therapies, and they provided routine statistical guidance that will be incorporated into the final protocol and analysis plan.

The FDA also agreed that Imugene’s Chemistry Manufacturing Controls (CMC) program is suitable for initiating a registrational study with only a few standard late-stage refinements recommended for analytical methods. This feedback further supports the readiness of the program to advance into late-stage development.

The clinical activity for azer-cel continues to strengthen and now includes an 82% ORR in CAR-T relapsed DLBCL and an 83% ORR in CAR-T naïve indications across multiple CD19-positive cancers. Durability continues to develop and additional patients maintain meaningful responses.

These results continue to reinforce azer-cel as a differentiated and scalable opportunity in both the CAR-T relapsed and naïve settings. Continued enrolment in the CAR T naïve niche cohort of the Phase 1b trial is proceeding at a remarkable pace, which may position us to explore additional registrational opportunities through future planned meetings with the FDA.

Imugene Chief Executive Officer Leslie Chong said the FDA feedback provided important clarity as the Company advances toward a pivotal study “The alignment across dosing regimen, patient population selection, accelerated approval end point strategy and CMC

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readiness gives us confidence as we continue to design our pivotal study plans. Combined with our growing clinical data set, we believe azer-cel is well positioned to address highneed patient populations.”

Imugene will compile the positive feedback received from the FDA to inform the potential pivotal study protocol, operational plans, and additional clinical program data. This will be done in alignment with the FDA’s supportive minutes as we prepare for future meetings to seek further guidance on the pivotal programs and statistical analysis plan. Additional updates will be provided as the program advances.

About the Phase 1b azer-cel trial

The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for CAR T relapsed patients with DLBCL. The study has recently expanded to include and treat CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including primary central nervous system lymphoma (PCNSL), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM) and follicular lymphoma (FL). Treatment with azer-cel, lymphodepletion (LD) and IL-2 is showing promising results with evidence of meaningful clinical activity, and durability of response. Additionally, the safety profile is manageable and generally well tolerated.

About diffuse large B cell lymphoma (DLBCL)

DLBCL is an aggressive and fast-growing type of non-Hodgkin’s lymphoma (NHL), a type of blood cancer. DLBCL is the most common type of NHL, with approximately 160,000[1] global cases per year and approximately 30,000 new cases per year in the U.S. Relapsed/refractory DLBCL has a high unmet medical need; ~60% of patients treated with approved autologous CD19 CAR T relapse.

1Science Direct Volume 60, Issue 5, November 2023

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About primary central nervous system lymphoma (PCNSL)

PCNSL is a rare and aggressive form of non-Hodgkin lymphoma (NHL), a type of blood cancer that originates in the brain, spinal cord, leptomeninges, or eyes, usually without evidence of systemic disease. In the U.S., there are approximately 1,500 to 1,800 new cases per year with limited approved treatment options and is a high unmet need. Currently, there are no CAR T-cell products approved for the treatment of PCNSL providing a unique opportunity for azer-cel to treat CART naïve patients.

About other types of B Cell Lymphoma

Other subtypes of non-Hodgkin lymphoma (NHL) include chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), the most common slow growing leukemia that can become resistant to therapy; marginal zone lymphoma (MZL), a slow-growing B-cell lymphoma that arises in lymphoid tissues associated with mucosal sites like the stomach and lung; Waldenström macroglobulinemia (WM), a rare slow-growing lymphoma characterized by excess IgM production, which can cause multiple complications ; and follicular lymphoma (FL), a common slow-growing NHL that can become more aggressive. While several targeted therapies and monoclonal antibodies are available for these types of B Cell Lymphoma, relapsed or refractory disease remains an ongoing challenge, highlighting the ongoing need for continued innovation and new and better treatments.

About Interleukin 2 (IL-2)

IL-2 is a cytokine (a protein that affects what happens between cells in the immune system) that helps T-cells (which are part of the immune system that help fight cancer) grow and survive. IL-2 has been shown to help T cells live longer and to enhance the cancer killing functions of CAR T cells, making them more effective at targeting and killing cancer cells.

Glossary

3[rd] line: The third course of therapy a patient receives for a disease Augmented Lymphodepletion: Crucial preconditioning step using chemotherapy making the body more receptive for the cancer-fighting cells to expand and work effectively

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CAR-T relapsed: When a patient's cancer worsens after CAR T cell therapy

CD19-Positive: Cells with the CD19 protein on their surface, a significant target in diagnosing and treating B-cell cancers like lymphoma

Chemistry Manufacturing Controls (CMC): critical regulatory and scientific aspects of drug development, covering the entire lifecycle to ensure a pharmaceutical product's quality, safety, and efficacy by defining its composition, manufacturing process, controls and stability

Overall Response Rate: defined for blood cancers as either Complete Response, (the disappearance of signs of cancer in response to treatment) or Partial Response, (defined as cancer reduction by at least 50%)

Progression Free Survival (PFS): Involves patients with complete response, partial response or stable disease; the time the disease remains stable or does not get worse

For more information please contact:

Leslie Chong

Managing Director and Chief Executive Officer

info@imugene.com

General Investor Enquiries

shareholderenquiries@imugene.com

Media Enquiries

communications@imugene.com

Connect with us on LinkedIn @Imugene Limited

Follow us on Twitter @TeamImugene

Watch us on YouTube @ImugeneLimited

About Imugene (ASX:IMU)

Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours. Our unique platform technologies seek to harness the body’s immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. Our pipeline includes an off-the-shelf (allogeneic) cell therapy CAR T drug azer-cel (azercabtagene zapreleucel) which targets CD19 to treat blood cancers. Our pipeline also includes oncolytic virotherapy (CF33) aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies such as CAR T’s

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for solid tumours. We are supported by a leading team of international cancer experts with extensive experience in developing novel cancer therapies that are currently marketed globally.

Our vision is to help transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments. This vision is backed by a growing body of clinical evidence and peer-reviewed research. Together with leading specialists and medical professionals, we believe Imugene’s immuno-oncology therapies may become foundation treatments for cancer. Our goal is to ensure that Imugene and its shareholders are at the forefront of this rapidly growing global market.

Release authorised by the Managing Director and Chief Executive Officer Imugene Limited.

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