On October 31, 2025 Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, reported its Quarterly Cash Flow report (Appendix 4C) for the quarter ended 30 September 2025.
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CLINICAL UPDATES
Azer-cel Phase 1b clinical trial records overall response rate of 81% in relapsed/refractory DLBCL
Late in the quarter, the Company reported an overall response rate (ORR) of 81% in its ongoing Phase 1b clinical trial of azer-cel (azercabtagene zapreleucel), an allogeneic, offthe-shelf CD19 CAR T-cell therapy being developed for patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Of the sixteen patients treated so far, thirteen have responded to therapy, including seven complete responses (CRs) and six partial responses (PRs). This marks an increase from the previously reported 79% ORR in August 2025, following two new patients achieving partial responses and one transitioning from partial to complete response at the Day 90 scan. Importantly, responses have been both rapid and durable, with the average time to best response occurring within one to three months, and ongoing durability data continuing to strengthen.
The first patient dosed with azer-cel and IL-2 in 2024 remains cancer-free for more than eighteen months, while additional responders are maintaining outcomes beyond five, five, six, and fifteen months, highlighting the long-lasting clinical activity of azer-cel. Patients enrolled in this trial represent a heavily pre-treated population, having typically failed at least three prior lines of therapy, and in many cases up to four to six, including autologous CAR T-cell treatments. These results reinforce the potential of azer-cel to provide a new therapeutic option for patients who have exhausted existing avenues.
Two patients who achieved a complete (CR) or partial response (PR) following azer-cel treatment became eligible for allogeneic stem cell transplant (allo-SCT). This approach using azer-cel as a bridge to allo-SCT has the potential to consolidate response and deliver long-term disease control. The sequence of azer-cel followed by allo-SCT may yield durable remission rates that exceed those typically observed with conventional salvage regimens.
Azer-cel is being administered in combination with interleukin-2 (IL-2), a cytokine known to enhance the survival and cancer-killing function of CAR T-cells, with the combination appearing to be contributing to both the depth and durability of responses.
Azer-cel aims to address key limitations of autologous CAR T therapies, including long manufacturing times, logistical constraints, and limited accessibility to treatment centres, by offering a readily available, on-demand cell therapy manufactured from healthy donor T-cells. Imugene continues to enrol patients at ten US and five Australian sites.
During the period the study also 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), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM), follicular lymphoma (FL) and leukemias such as chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL).
Following quarter end, the company also provided a positive update to the market on the CAR T naïve patient expansion:
• 83% Overall Response Rate (ORR) in six evaluable heavily pretreated, CAR T naïve patients (no prior CAR T treatment). 5/6 responders, with results from the sixth patient pending
• 50% Complete Response (CR) rate, 3/6 patients
• Ten patients treated to date across multiple CD19+ B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM) and primary CNS lymphoma (PCNSL)
• Enrolment progressing significantly faster than the CAR T-relapsed DLBCL cohort, supporting a potential expedited clinical path
Following an internal portfolio review, Imugene is refining its investment focus toward programs with near-term clinical and commercial milestones.
In light of the recent encouraging azer-cel results and broader capital considerations, the Company is exploring alternative development pathways for the CF33 programs, including potential collaborations with external partners who are encouraged by its potential.
As part of this approach, Imugene will moderate internal funding for CF33 and onCARlytics, while assessing partnership, out-licensing, or joint venture opportunities to support continued advancement of these programs.
FINANCIAL
$24.9 million institutional Placement and Share Purchase Plan
During the quarter, the Company successfully completed a $22.5 million institutional Placement and a $2.42 million Share Purchase Plan (SPP) for eligible shareholders, both priced at $0.33 per share. The Placement was strongly supported by new Australian and international institutional and sophisticated investors.
Participants in both the Placement and SPP received three free, attaching listed options for every four new shares subscribed, exercisable at $0.43 by 30 March 2026. Upon exercising these options, investors will receive one additional "piggyback" option per option exercised, with an exercise price of $0.86 and expiry on 30 June 2028.
Proceeds from the capital raising will primarily fund Imugene’s azer-cel (azercabtagene zapreleucel) program through initiation of a pivotal clinical trial in calendar year 2026, while also extending the company’s funding runway into mid-2027 and supporting general working capital needs.
(Press release, Imugene, OCT 31, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/7ce28d9c-c2ac-c33f-0f13-955286db572b/03017251.pdf [SID1234657171])