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IMUGENE LIMITED — AGM Information 2025
Nov 12, 2025
65124_rns_2025-11-12_1654e8b6-3ade-4bbb-aa6a-66a78afec9c7.pdf
AGM Information
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ASX:IMU
Annual General Meeting
November 2025
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Disclaimer
The information in this presentation does not constitute personal investment advice. The presentation is not intended to be comprehensive or provide all information required by investors to make an informed decision on any investment in Imugene Limited (Company). In preparing this presentation, the Company did not take into account the investment objectives, financial situation and particular needs of any particular investor.
Further advice should be obtained from a professional investment adviser before taking any action on any information dealt with in the presentation. Those acting upon any information without advice do so entirely at their own risk.
Whilst this presentation is based on information from sources which are considered reliable, no representation or warranty, express or implied, is made or given by or on behalf of the Company, any of its directors, or any other person about the accuracy, completeness or fairness of the information or opinions contained in this presentation. No responsibility or liability is accepted by any of them for that information or those opinions or for any errors, omissions, misstatements (negligent or otherwise) or for any communication written or otherwise, contained or referred to in this presentation.
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Neither the Company nor any of its directors, officers, employees, advisers, associated persons or subsidiaries are liable for any direct, indirect or consequential loss or damage suffered by any person as a result of relying upon any statement in this presentation or any document supplied with this presentation, or by any future communications in connection with those documents and all of those losses and damages are expressly disclaimed.
Any opinions expressed reflect the Company’s position at the date of this presentation and are subject to change
International offer restrictions - This document does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States or any other jurisdiction in which it would be unlawful. In particular, the New Shares have not been, and will not be, registered under the US Securities Act of 1933 and may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements of the US Securities Act and applicable US state securities laws. The distribution of this presentation in jurisdictions outside Australia may be restricted by law and any such restrictions should be observed.
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Azer-cel Allogeneic CD19 CAR T for Blood Cancer
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Two Types of CAR-T Cell Therapy: Auto and Allo
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Potential First-in-class Off-the-shelf Allogeneic CAR-T Cell Therapy significantly differentiated from approved Auto CAR-T Therapies
Autologous – 4+ FDA approved products in CD19
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Auto CAR-T cells are made from the patient’s own T-cells
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Highly personalised (one to one therapy)
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Long process and wait time of around 4-6 weeks
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High manufacturing costs
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~60% relapse off of CD19 auto CAR T[1]
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Single Dose, can not be re-dosed with auto CAR T
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Greater risk of manufacturing issues due to single production runs
1. Collection from cancer 2. Genetic Modification patient
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T-cells reprogrammed into CD19 CAR-T cells (19-42 days wait)
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T-Cells extracted from patient’s blood
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3. Infusion
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back into patient
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Modified T cells are • Reprogrammed multiplied in large T-cells targets numbers and infused and destroys back into the patient cancer cells
Allogeneic – Being pursued by Imugene (No approved Allo CAR T products)
- Dose for multiple patients from a single healthy donor
(one batch to many)
No wait time
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Highly scalable manufacturing with potential attractive gross margins (lower COGS given ‘one batch-to-many’ approach)
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Potential for multi dose
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1. Collection 2. Genetic Modification from healthy donor
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T cells reprogrammed into CD19 CAR-T cells
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T-Cells extracted from the blood of a HEALTHY UNIVERSAL donor
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3. Infusion into multiple patients
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Modified T cells are • Reprogrammed multiplied in large T-cells targets numbers and available and destroys for MANY patients cancer cells
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Good safety profile
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Opens up new centres / regional markets
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1Science Direct publication 17 April 2025; Sequential CD19-20 CAR T-cell therapy for refractory/relapsed diffuse large B-cell lymphoma
Compelling Phase 1b Data
81% Overall Response Rate in Relapsed/Refractory (R/R) DLBCL
| Date of Release | Evaluable patients |
Treatment | N | Overall Response Rate (ORR) |
Best Durability (Time of response) |
|---|---|---|---|---|---|
| February Update | Diffuse Large B- Cell Lymphoma |
Lymphodepletion (LD)1+azer-cel +Interleukin-2 (IL- 2) |
7 | 4 (57%) 4/7 |
>304 days on going |
| August Update | Diffuse Large B- Cell Lymphoma |
Lymphodepletion (LD)1+azer-cel +Interleukin-2 (IL- 2) |
14 | 11 (79%) 11/14 |
>470 days on going |
| September Update |
Diffuse Large B- Cell Lymphoma |
Lymphodepletion (LD)1+azer-cel +Interleukin-2 (IL- 2) |
16 | 13 (81%) 13/16 |
>515 days on going |
CR rate assessment requires longer patient follow-up: for approved, autologous CD19 CART products, the average time to best response is 2-3 months with some patients taking up to 6 months to achieve their best response
RESULTS
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Highly encouraging data in patient population with significant unmet need
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2 additional patients dosed since August representing 2 additional PRs as well as one patient which has converted from PR to CR at day 90 scan = 81% Overall Response Rate,
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Excellent CAR T expansion and evidence of persistence > 90 days;
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Best durability of response as of September 2025, 515+ days and ongoing
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Good Safety profile / consistent with autologous CAR T therapies
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Well-tolerated with low rates of Grade 3 or higher CRS[2] or ICANS[3]
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KEY DATA
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Phase 1b trial continues to enrol patients across leading cancer centers in the U.S and Australia
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Responses were seen in patients who failed multiple prior treatments, specifically autologous CAR T therapies
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Because azer-cel is an allogeneic CAR T, it is readily available with no wait time for manufacturing
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Received Fast Track Designation for DLBCL
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FAST TRACK DESIGNATION
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1Lymphodepletion(LD)/chemotherapy: Aug Cy: Flu 30mg/m2 x 3d, Cy 750mg/m2 x 3d 2CRS: Cytokine release syndrome
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3ICANS: Immune Effector Cell-Associated Neurotoxicity Syndrome
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Azer-cel 81% Overall Response Rate N=16
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DLBCL CAR T relapsed patients
Best Response
Durability
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CR CR CR CR CR CR CR
PR PR PR PR PR PR
SD SD PD
560+ 440+ 185+ 148+ 155 90 90 67+ 90 60 60 60 60
Days Days Days Days Days Days Days Days Days Days Days Days Days
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*Allo transplant at Day 148
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*Allo transplant at Day 67
Overall Response Rate (ORR) : the proportion of patients whose cancer shrinks or disappears after treatment - a measure of how well a treatment is working, specifically in clinical trials
Complete Response (CR): all measurable or visible signs of cancer are no longer detectable after treatment
Partial Response (PR): Significant reduction in tumour size (typically at least 50%) or disease burden, but not complete disappearance of the disease Durability of Response (DoR) : a measure of how long a treatment effect lasts, meaning the cancer remains controlled for a significant period
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Comparison to Existing Approved Auto CAR-T Therapies
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Initial azer-cel Ph 1b R/R DLBCL data compelling when compared to approved Auto CAR-T treatments
FDA benchmark[1] for approval in heavily pre-treated (3L+) Diffuse Large B-Cell Lymphoma (DLBCL), a therapy typically needs to demonstrate:
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50% or greater Complete Response
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6+ months Durability of Response
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Good Safety profile / consistent with autologous CAR T therapies
1FDA.gov
2Initial response at D28 of PR, which improved to CR at later date. For approved, autologous CD19 CART products, the average time to best response is 2-3 months. Outcomes of CD19-Directed Chimeric Antigen Receptor T Cell Therapy for Transformed Nonfollicular Lymphoma.Dong, Ning et al.Transplantation and Cellular Therapy, Official Publication of the American Society for Transplantation and Cellular Therapy, Volume 29, Issue 6, 349.e1 - 349.e8
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3Azer-cel Complete Response rate and median DoR can not yet be accurately determined as trial is ongoing
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4Company announcements and FDA.gov
| Product | Indication | Complete Response (CR) rate at Day 602 |
Best Durability of Response3 (DoR) |
|---|---|---|---|
| azer-cel allo CAR T |
Adult r/r DLBCL 3L+ therapy |
45%-60%* | 18+ months and ongoing |
Comparable approved Auto CAR Ts for treatment of DLBCL 2L+ of therapy[4]
| Product | Indication | Complete Response (CR) rate at 2-3 months |
Median Durability of Response (DoR) |
|---|---|---|---|
| Yescarta | Adult r/r DLBCL ≥2 prior lines |
54% | ~11 months |
| Kymriah | Adult r/r DLBCL ≥2 prior lines |
40% | ~10.3 months |
| Breyanzi | Adult r/r DLBCL ≥2 prior lines |
53% | ~16.7 months |
*CR % may vary with ongoing enrolment and time to best response
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Encouraging Clinical Activity
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Azer-cel demonstrates responses similar to approved Autologous CD19 CAR T products
Overall Response Rate % R/R DLBCL
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90
80
81%
70
74% 73%
60
50
52%
40
30
20
10
0
Azer-cel Yescarta Breyanzi Kymriah
(Axi-cel) (Liso-cel) (Tisa-cel)
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Despite all patients failing prior Autologous CD19 CART products, azer-cel demonstrates Response Rates similar to CD19 CART-naïve patients
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Safety Summary: CAR-T Associated Adverse Events
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No Evidence of GvHD or Gr. ≥3 CRS – Safety Profile is very manageable
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Patient Case Study: Cancer Free for 560+ Days
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Complete Response for an azer-cel patient that failed 4 prior lines of therapy including auto CAR-T. Durability of Response now out to 560+ days and patient currently remains cancer free
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Tumour
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Baseline
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Tumor-free
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Day 515+
PATIENT TREATMENT SUMMARY
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47 yo female, first diagnosed with high-grade B-cell lymphoma (HGBCL), stage IV in July 2022.
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Prior to azer-cel, patient failed 4 prior lines of therapy : R-CHOP (chemo combo); R-DHAP (chemo combo), Yescarta (Auto CAR T), and prednisone
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Good initial response to Yescarta (CR) but short duration of response (relapsed ~7 months later)
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Response: CR @ D28. Remains in CR at greater than 560+ days and ongoing
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Azer-cel 83% Overall Response Rate N=6
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CAR T Naïve Lymphomas
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Overall Best Durability
Date of Evaluable
Treatment N Response (Time of
Release patients Best Response
Rate (ORR) response)
Lymphodepletion CR CR CR
October CAR T Naïve (LD) [1] +azer-cel 5 (83%)
6 60 days PR PR
Update Lymphomas +Interleukin-2 5/6
(IL-2) Pending
RESULTS
•
83% Overall Response Rate (ORR) in six evaluable heavily pretreated
CAR T-naïve patients (5/6 responders, with results from the sixth
patient pending) Durability 60 28+ 28+ 90+ 60 60
Days Days Days Days Days Days
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50% Complete Response (CR) rate (3/6 patients)
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10 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), with follow-up scans pending for four additional patients in CAR T naïve cohort
- Enrolment progressing significantly faster than the CAR T-relapsed DLBCL cohort, supporting a potential expedited clinical path
Overall Response Rate (ORR) : the proportion of patients whose cancer shrinks or disappears after treatment - a measure of how well a treatment is working, specifically in clinical trials
Complete Response (CR): all measurable or visible signs of cancer are no longer detectable after treatment
Partial Response (PR): Significant reduction in tumour size (typically at least 50%) or disease burden, but not complete disappearance of the disease Durability of Response (DoR) : a measure of how long a treatment effect lasts, meaning the cancer remains controlled for a significant period
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Azer-cel Commercialization Opportunity
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$2bn+ p.a US market opportunity with no approved CAR-T therapies in rare lymphomas and relapsed CAR-T therapy patients
AZER CEL MARKET OPPORTUNITY ($Millions)[3]
ELIGIBLE FOR CAR T[2]
US INCIDENCE[1]
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MZL, 4,500
WM, 1,000
DLBCL/HGBCL,
MZL, 1,200 MZL, $480
PCNSL, 800 DLBCL/HGBCL,
1,500 $320
DLBCL/HGBCL,
30,000 WM, 300 WM, $120
CLL/SLL,
20,000
CLL/SLL, CLL/SLL,
1,700 $680
PCNSL, PCNSL,
900 $360
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Azer-cel: Commercial Opportunity may leverage a De-risked Regulatory Roadmap
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Azer-cel Targets High-Need Indications for Single-Arm Registrational/Pivotal Trial : Ideal for pursuing accelerated approval without comparators.
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Prioritizing Fast-to-Market Opportunities: azer-cel is positioned to leverage other high-need, less comparator-intensive indications for faster-to-market entry, using DLBCL to support broader development.
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Promising Niche Indications with Strong Commercial and Regulatory Potential
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A $2B+ Market Built on Strategically Chosen, Comparator-Free Indications: azer-cel’s commercial roadmap is to prioritize rapid regulatory path with capital–efficient development for fast to market entry.
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SEER 2020 Estimate; numbers of potential patients
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NCCN guidelines, Peer-reviewed literature & CAR T clinical trials; Assumes 3L CAR-T relapsed for DLBCL and 2L+3L for all other cancers
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TAM: total addressable market is total number of treatable patients x price (assumes $400,000/dose) at 100% market share
PCNSL = Primary Central Nervous System Lymphoma (≥1 prior line of therapy containing high-dose MTX) CLL/SLL = Chronic or Small Lymphocytic Leukemia (Prior BTKi and BCL2i or only prior BTKi and high-risk features)
DLBCL = Diffuse Large B-cell Lymphoma (≥1 prior line of therapy, including anti-CD20 + anthracycline) MZL = Marginal Zone Lymphoma (≥2L of prior therapy, including anti-CD20 chemoimmunotherapy) 12 WM = Waldenstrom’s Macroglobulinemia (≥2L of prior therapy, including anti-CD20 chemoimmunotherapy)
Proposed Clinical Pathway: Azer-cel Allogeneic CD19 CAR T
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Opportunity to initiate a pivotal clinical trial in 2026
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A Phase 1a clinical trial in Lymphoma & Leukaemia with 84 patients was completed by Precision Biosciences in 2023 and delivered promising results
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Imugene is currently undertaking a Phase 1b trial for Auto CAR T failed Lymphoma (DLBCL) from which early data has been extremely promising
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The Phase 1b study has broadened to include CAR T naïve patients to PCNSL, CLL, WM and other niche indications which offers a significant market opportunity
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End of Phase meeting to be held with the FDA in Q4 CY25 for Imugene to discuss potential design for the registration/pivotal trial in DLBCL and/or CAR T naïve indications for a single-arm pivotal phase 2 registrational trial
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2020-2023 2024-2026 Q4 CY2025 2026+
FDA Type C Initiate
Phase 1 Phase 1b End-of-Phase Registrational
Meeting /Pivotal Trial
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Lymphoma & Leukaemia n=84
Auto CAR T Auto CAR T failed naïve Lymphoma Lymphoma (DLBCL) (e.g. PCNSL)
Discussion with the FDA for potential registration/pivotal trial
CAR T naïve Lymphomas n= TBD
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Note: the clinical pathway is subject to regulatory approvals
Key Achievements and Expected Upcoming Milestones
Key Achievements
Expected Upcoming Milestones
azer-cel
azer-cel
January 2025: First Aus site opened for R/R DLBCL clinical trial and first DLBCL patient dosed in AUS
Q4 Calendar Year 2025
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Planned FDA Meeting for R/R DLBCL registrational strategy/pivotal study, discussion for CAR T naïve cohort
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Release of additional Phase 1b azer-cel data
February 2025: Phase 1b data update, 57% Overall Response/ Complete Response Rate Achieved
Calendar Year 2026
- Potential for FDA Fast Track and/or Orphan Drug Designation for additional niche blood cancer
March 2025: Fast Track Designation granted for treatment of DLBCL
- Commencement of manufacturing and supply for registration/pivotal study
July and August 2025: Release of additional Phase 1b R/R DLBCL azer-cel data
- Phase 1b data on CAR T naïve lymphoma patients
September 2025: R/R DLBCL Overall Response rate increases to 81%
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Potential for RMAT/Breakthrough designation
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Initiate Activity for Registrational/Pivotal study
October 2025: 83% Overall Response rate in CAR T Naïve cohort
November 2025: ASH Oral Presentation
Other
Key
FPI: First Patient In Combo: Combination Therapy
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Partnering/Out-licensing Opportunities
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• Potential Conference Presentations: e.g. AACR, ASCO, ICML, SNO, ASH, SITC
DLBCL: Diffuse Large B-Cell Lymphoma (Blood Cancer) IT: Intratumoural, IV : Intravenous
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Projected timelines for trial initiation, site activation, and clinical milestones are subject to external factors beyond the Company’s control, including regulatory approvals, site requirements, patient recruitment, dose escalation constraints, and expected and unexpected dose-limiting toxicities
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Experienced Leadership Team has Brought 18+ FDA-Approved Drugs to Market
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Leslie Chong
Leslie Chong John Byon, MD, PhD Chief Executive Officer Chief Medical Officer & Managing Director
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Bradley Glover, Ursula McCurry PhD, MBA Chief Clinical Chief Operating Officer Operations Officer
Darren Keamy
Chief Financial Officer and Company Secretary
BOARD OF DIRECTORS
Paul Hopper
Executive Chairman and Founder
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Jakob Dupont, MD
Non-Executive Board Director
Kim Drapkin
Non-Executive Board Director
Lesley Russell, MBChB, MRCPb
Non-Executive Board Director
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ASX : IMU imugene.com
Connect with us on LinkedIn @Imugene Limited Follow us on X (Twitter) @TeamImugene Watch us on YouTube @ImugeneLimited
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