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1 Annual General Meeting November 2025 ASX:IMU For personal use only
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2 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. 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. For personal use only
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3 3 Azer-cel Allogeneic CD19 CAR T for Blood Cancer For personal use only
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4 Two Types of CAR-T Cell Therapy: Auto and Allo Potential First-in-class Off-the-shelf Allogeneic CAR-T Cell Therapy significantly differentiated from approved Auto CAR-T Therapies 1Science Direct publication 17 April 2025; Sequential CD19-20 CAR T-cell therapy for refractory/relapsed diffuse large B-cell lymphoma Autologous – 4+ FDA approved products in CD19 • Auto CAR-T cells are made from the patient’s own T-cells • Highly personalised (one to one therapy) • Long process and wait time of around 4-6 weeks • High manufacturing costs • ~60% relapse off of CD19 auto CAR T1 • Single Dose, can not be re-dosed with auto CAR T • Greater risk of manufacturing issues due to single production runs • T-Cells extracted from patient’s blood • T-cells reprogrammed into CD19 CAR-T cells (19-42 days wait) • Modified T cells are multiplied in large numbers and infused back into the patient • Reprogrammed T-cells targets and destroys 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 Highly scalable manufacturing with potential attractive gross margins (lower COGS given ‘one batch-to-many’ approach) Potential for multi dose Good safety profile Opens up new centres / regional markets 1. Collection from healthy donor 3. Infusion into multiple patients • T-Cells extracted from the blood of a HEALTHY UNIVERSAL donor 2. Genetic Modification • T cells reprogrammed into CD19 CAR-T cells • Modified T cells are multiplied in large numbers and available for MANY patients • Reprogrammed T-cells targets and destroys cancer cells 1. Collection from cancer patient 3. Infusion back into patient2. Genetic Modification 4 For personal use only
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5 KEY DATA • Phase 1b trial continues to enrol patients across leading cancer centers in the U.S and Australia • Responses were seen in patients who failed multiple prior treatments, specifically autologous CAR T therapies • Because azer-cel is an allogeneic CAR T, it is readily available with no wait time for manufacturing • Received Fast Track Designation for DLBCL Compelling Phase 1b Data 81% Overall Response Rate in Relapsed/Refractory (R/R) DLBCL FAST TRACK DESIGNATION 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 RESULTS • Highly encouraging data in patient population with significant unmet need o 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, o Excellent CAR T expansion and evidence of persistence > 90 days; o Best durability of response as of September 2025, 515+ days and ongoing • Good Safety profile / consistent with autologous CAR T therapies o Well-tolerated with low rates of Grade 3 or higher CRS2 or ICANS3 1Lymphodepletion(LD)/chemotherapy: Aug Cy: Flu 30mg/m2 x 3d, Cy 750mg/m2 x 3d 2CRS: Cytokine release syndrome 3ICANS: Immune Effector Cell-Associated Neurotoxicity Syndrome 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 For personal use only
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6 Durability CR CRCRCRCR CR CR PR 560+ Days 440+ Days *148+ Days 185+ Days 155 Days 90 Days SD SD PD 90 Days 90 Days 60 Days Best Response *Allo transplant at Day 148 *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 PRPR 60 Days 60 Days PR PR 60 Days PR *67+ Days Azer-cel 81% Overall Response Rate N=16 DLBCL CAR T relapsed patients For personal use only
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7 Comparison to Existing Approved Auto CAR-T Therapies Initial azer-cel Ph 1b R/R DLBCL data compelling when compared to approved Auto CAR-T treatments FDA benchmark1 for approval in heavily pre-treated (3L+) Diffuse Large B-Cell Lymphoma (DLBCL), a therapy typically needs to demonstrate: • 50% or greater Complete Response • 6+ months Durability of Response • 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 3Azer-cel Complete Response rate and median DoR can not yet be accurately determined as trial is ongoing 4Company announcements and FDA.gov 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 Product Indication Complete Response (CR) rate at Day 60 2 Best Durability of Response 3 (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 *CR % may vary with ongoing enrolment and time to best response For personal use only
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8 Encouraging Clinical Activity Azer-cel demonstrates responses similar to approved Autologous CD19 CAR T products 0 10 20 30 40 50 60 70 80 90 Azer-cel Yescarta (Axi-cel) Breyanzi (Liso-cel) Kymriah (Tisa-cel) 81% 74% 73% 52% Despite all patients failing prior Autologous CD19 CART products, azer-cel demonstrates Response Rates similar to CD19 CART-naïve patients Overall Response Rate % R/R DLBCL For personal use only
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9 Safety Summary: CAR-T Associated Adverse Events No Evidence of GvHD or Gr. ≥3 CRS – Safety Profile is very manageable For personal use only
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10 Patient Case Study: Cancer Free for 560+ Days 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 Baseline Tumour Tumor-free PATIENT TREATMENT SUMMARY • 47 yo female, first diagnosed with high-grade B-cell lymphoma (HGBCL), stage IV in July 2022. • 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 • Good initial response to Yescarta (CR) but short duration of response (relapsed ~7 months later) • Response: CR @ D28. Remains in CR at greater than 560+ days and ongoing Day 515+ For personal use only
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11 Durability CR CRCR 60 Days 28+ Days 28+ Days Pending Best Response 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 PRPR 60 Days 90+ Days 60 Days Azer-cel 83% Overall Response Rate N=6 CAR T Naïve Lymphomas Date of Release Evaluable patients Treatment N Overall Response Rate (ORR) Best Durability (Time of response) October Update CAR T Naïve Lymphomas Lymphodepletion (LD)1 +azer-cel +Interleukin-2 (IL-2) 6 5 (83%) 5/6 60 days 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) • 50% Complete Response (CR) rate (3/6 patients) • 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 For personal use only
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12 1. SEER 2020 Estimate; numbers of potential patients 2. NCCN guidelines, Peer-reviewed literature & CAR T clinical trials; Assumes 3L CAR-T relapsed for DLBCL and 2L+3L for all other cancers 3. TAM: total addressable market is total number of treatable patients x price (assumes $400,000/dose) at 100% market share Azer-cel: Commercial Opportunity may leverage a De-risked Regulatory Roadmap • Azer-cel Targets High-Need Indications for Single-Arm Registrational/Pivotal Trial : Ideal for pursuing accelerated approval without comparators. • 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. • Promising Niche Indications with Strong Commercial and Regulatory Potential • 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. 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) WM = Waldenstrom’s Macroglobulinemia (≥2L of prior therapy, including anti-CD20 chemoimmunotherapy) DLBCL/HGBCL, 30,000 CLL/SLL, 20,000 PCNSL, 1,500 WM, 1,000 MZL, 4,500 DLBCL/HGBCL, 800 CLL/SLL, 1,700 PCNSL, 900 WM, 300 MZL, 1,200 DLBCL/HGBCL, $320 CLL/SLL, $680 PCNSL, $360 WM, $120 MZL, $480 US INCIDENCE 1 ELIGIBLE FOR CAR T 2 AZER CEL MARKET OPPORTUNITY ($Millions) 3 Azer-cel Commercialization Opportunity $2bn+ p.a US market opportunity with no approved CAR-T therapies in rare lymphomas and relapsed CAR-T therapy patients For personal use only
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13 Opportunity to initiate a pivotal clinical trial in 2026 Proposed Clinical Pathway: Azer-cel Allogeneic CD19 CAR T Phase 1b 2024-2026 • A Phase 1a clinical trial in Lymphoma & Leukaemia with 84 patients was completed by Precision Biosciences in 2023 and delivered promising results • Imugene is currently undertaking a Phase 1b trial for Auto CAR T failed Lymphoma (DLBCL) from which early data has been extremely promising • 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 • 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 Phase 1 2020-2023 FDA Type C End-of-Phase Meeting Q4 CY2025 Initiate Registrational /Pivotal Trial 2026+ Lymphoma & Leukaemia n=84 Auto CAR T failed Lymphoma (DLBCL) Auto CAR T naïve Lymphoma (e.g. PCNSL) Discussion with the FDA for potential registration/pivotal trial CAR T naïve Lymphomas n= TBD Note: the clinical pathway is subject to regulatory approvals For personal use only
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14 Key Achievements and Expected Upcoming Milestones Key Achievements Key FPI: First Patient In Combo: Combination Therapy DLBCL: Diffuse Large B-Cell Lymphoma (Blood Cancer) IT: Intratumoural, IV: Intravenous Expected Upcoming Milestones 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 January 2025: First Aus site opened for R/R DLBCL clinical trial and first DLBCL patient dosed in AUS February 2025: Phase 1b data update, 57% Overall Response/ Complete Response Rate Achieved March 2025: Fast Track Designation granted for treatment of DLBCL July and August 2025: Release of additional Phase 1b R/R DLBCL azer-cel data September 2025: R/R DLBCL Overall Response rate increases to 81% October 2025: 83% Overall Response rate in CAR T Naïve cohort November 2025: ASH Oral Presentation azer-cel Q4 Calendar Year 2025 • Planned FDA Meeting for R/R DLBCL registrational strategy/pivotal study, discussion for CAR T naïve cohort • Release of additional Phase 1b azer-cel data Calendar Year 2026 • Potential for FDA Fast Track and/or Orphan Drug Designation for additional niche blood cancer • Commencement of manufacturing and supply for registration/pivotal study • Phase 1b data on CAR T naïve lymphoma patients • Potential for RMAT/Breakthrough designation • Initiate Activity for Registrational/Pivotal study azer-cel • Partnering/Out-licensing Opportunities • Potential Conference Presentations: e.g. AACR, ASCO, ICML, SNO, ASH, SITC Other For personal use only
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15 Experienced Leadership Team has Brought 18+ FDA-Approved Drugs to Market Leslie Chong Chief Executive Officer & Managing Director Ursula McCurry Chief Clinical Operations Officer John Byon, MD, PhD Chief Medical Officer Bradley Glover, PhD, MBA Chief Operating Officer Darren Keamy Chief Financial Officer and Company Secretary BOARD OF DIRECTORS Paul Hopper Executive Chairman and Founder Jakob Dupont, MD Non-Executive Board Director Kim Drapkin Non-Executive Board Director Lesley Russell, MBChB, MRCPb Non-Executive Board Director For personal use only
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16 16 ASX : IMU imugene.com Connect with us on LinkedIn @Imugene Limited Follow us on X (Twitter) @TeamImugene Watch us on YouTube @ImugeneLimited For personal use only