01 Nov 2021

Investor Presentation Imugene Eureka Therapeutics

A S X : I M U IMUGENE 01 November 2021 1. 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. 2. 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. 3. 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. 4. 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. 5. Any opinions expressed reflect the Company’s position at the date of this presentation and are subject to change 6. 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. Disclaimer 2 Introduction to Imugene 3 2 0 1 7 HER-Vaxx, our HER-2 targeted B Cell Immunotherapy entered the clinic 2 0 1 8 Licensed extensive B cell portfolio and platform from OSU and Mayo Clinic comprising of PD1, HER1, HER2, HER3, VEGF, IGF-1R, CD28 Imugene is a biotech company headquartered in Australia and publicly traded on the Australian Securities Exchange (ASX:IMU) 2 0 1 3 Paul Hopper built Imugene around a technology that originated from the Medical University of Vienna M A Y 2 0 2 1 Licensed onCARlytics from City of Hope invented by Dr Y Fong, Dr S Priceman & Dr A Park 2 0 1 5 Leslie Chong from Genentech joined Imugene A U G 2 0 2 1 Strategic Partnership with Celularity 2 0 1 9 Completed the acquisition of a prolific oncolytic virus from City of Hope invented by Dr Yuman Fong S E P 2 0 2 1 Entered the S&P/ASX 300 Index N O V 2 0 2 1 Strategic Partnership with Eureka Partnership Highlights 4 • Strategic Research Partnership Eureka Therapeutics, Inc. for the Treatment of Solid Tumours • Collaboration will explore the therapeutic potential of a combination of Imugene’s CD19 oncolytic virus onCARlytics in combination with Eureka’s anti-CD19 ARTEMIS ® T-cell therapy for the treatment of solid tumours. • In head-to-head pre-clinical studies against CAR-T cells, ARTEMIS ® T-cells demonstrated superior efficacy, enhanced tumour infiltration, and less T-cell exhaustion. • In the clinic, ARTEMIS ® T-cells have demonstrated reduced cytokine release syndrome (CRS) and other cytokine- related toxicities compared to CAR-T cells, potentially improving the efficacy and safety of a combination approach • Imugene’s novel strategy to treat solid tumors uses onCARlytics to prime the tumor cells for destruction by eliciting the expression of a validated tumor marker, CD19, then used as a target for CD19 cellular therapy • Nonclinical in vitro and in vivo combination studies with ARTEMIS ® and onCARlytic to commence Developing Safer and More Effective T-cell Therapies for Solid Tumors Dr. Cheng Liu President and CEO Leader in Solid Tumor T-cell Therapy Headquartered in San Francisco Bay Area Proprietary ARTEMIS ® technology empowering T-cells to infiltrate solid tumors Lead clinical assets to treat liver cancer (HCC) in Phase I/II trials Multiple near-term clinical milestones Multiple partnerships/collaborations ARTEMIS is a registered trademark owned by Eureka Therapeutics, Inc. 6 Eureka Ranks in Top 10 CAR-T Patent Assignees Worldwide 9 (No. 4 Among Industries) Top CAR-T Cell Patent Assignee Worldwide 2020 7 Eureka ARTEMIS ® Technology Platform 8 ARTEMIS Superiority to CAR • ARTEMIS T-cell therapy is clinically validated in patients • ARTEMIS vs. CAR-T • Superior efficacy • Enhanced tumor infiltration • Less T cell exhaustion • Reduced Cytokine Release Syndrome (CRS) and cytokine related toxicities ARTEMIS receptor is primarily localized in microvilli. (Collaboration: Alice Liang, Ph.D. Director of Microscopy Laboratory, NYU Langone Health NYU School of Medicine) Xu et al., Cell Discovery , 2018 Preclinical Data Demonstrates Superior Safety/Efficacy Profile Compared to CAR T CD19 ARTEMIS ® T cells release less CRS-related cytokines than CAR-T, including IL-6 CD19 ARTEMIS ® T cells shows matching efficacy in mouse model (Raji) Mock CD19-CAR CD19 ARTEMIS ® 9 ARTEMIS CAR-T Tumor Infiltration - ARTEMIS vs. CAR - T cells Mock CAR Scans of tumor tissue stained with T - cell marker CD3 show ARTEMIS T cells armed with tumor infiltration technology went deeper into the solid tumor than control and CAR - T cells. Intravenous (IV) T - cell infusion Subcutaneous Tumor ARTEMIS M o c k G P C 3 - C A R G P C 3 - A R T E M I S 0 5 0 1 0 0 C D 3 + C e l l P e r c e n t a g e ( % ) 10 ARTEMIS Construct Validated by Independent Researchers Stephan A. Grupp, MD, PhD • Delivered CAR T-cell therapy to the first pediatric patient in the world (Emily Whitehead). • Led the first multicenter global study of Kymriah ® , which became the first CAR-T therapy to receive approval by the FDA. Published work with Grupp’s team Xu et al. Cell Discovery (2018) 4:62 ARTEMIS vs. CAR-T cells • Potent anti-tumor activity • Better safety profile • Longer durability with less exhausted phenotype 0 5 10 15 20 25 30 35 10 5 10 6 10 7 10 8 10 9 10 10 10 11 Days post implantation Total Flux (p/s) mean +/- SEM Mock CAR ARTEMIS Ô Dose **** IL-2 IL-10 IFN- g TNF- a 0 100 200 300 400 500 600 700 Serum Cytokines (pg/mL) Mock CAR ARTEMIS Ô ** *** * D1 D9 D15 0 1000 2000 3000 4000 Days (D) Post T cell infusion PD-1 MFI CAR ARTEMIS™ *** * 11 Eureka Pipeline Wholly-owned program. Collaboration program. 12 PROGRAM (TARGET)/INDICATION ET140203 (AFP) Adult HCC/Liver Cancer (ARYA-1) ET140203 (AFP) Pediatric Liver Cancers (ARYA-2) ECT204 (GPC3) HCC/Liver Cancer (ARYA-3) Undisclosed Target Mesothelioma, Ovarian & Pancreatic Cancers Undisclosed Target Lung, Breast & Ovarian Cancers Partnered Asset (BCMA) Multiple Myeloma Partnered Asset (GPRC5D) Multiple Myeloma Partnered Asset (MUC16) Ovarian Cancer Partnered Asset (WT1) Ovarian Cancer Partnered Asset (GPRC5D), non-CAR use Multiple Myeloma Partnered Asset (AFP) Adult HCC, Greater China and ASEAN Partnered Asset (GPC3) Adult HCC, Greater China and ASEAN Partnered Asset (CD19), Oncolytic Virus Solid tumors DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PARTNERS / / / The CAR T Solid Tumour Challenge & Imugene’s Solution Chimeric Antigen Receptor (CAR) T cell therapy has had limited activity in solid tumours, largely due to a lack of selectively and highly expressed surface antigens, such as the blood B cell antigen CD19. CD19 Targeting domain OV generated CD19 CD19 CAR T Cells Solid Tumour N E W C O N C E P T Utilise OV’s as a delivery vector to deliver CD19 antigen to solid tumour cells Engineer Imugene’s CF33 to infect solid tumour cells and insert CD19 transgene to enable presentation of CD19 over the tumour cells during tumour cell infection, onCARlytics (CF33-CD19) Combination use of autologous or allogeneic CD19 CAR Ts with onCARlytics (CF33-CD19) presents CD19 targets on solid tumours 13 1 2 3 4 onCARlytics makes solid tumours “seen” by CD19 directed CAR T Mechanism of Action: How does it work? 14 1. OnCARlytics infects tumour cells 2. Virus replication and production of CF33-CD19 on the cell surface enabling CD19 CAR T cell targeting 3. Tumour cell lysis leads to viral particle release and the combination promotes endogenous immune cell recruitment to tumours 4. Released viral particles re-initiate virus infection of surrounding tumour cells. onCARlytics delivers CAR Targets to “ targetless ” solid tumours 21 Fig. 1. OV effectively deliver CD19t to solid tumors in vitro. A) Schematic of vaccinia OV [CF33- (SE)hCD19t], showing incorporation of human truncated CD19 (CD19t) under the control of the synthetic early promoter (P SE ) inserted into the J2R locus replacing the thymidine kinase gene. B) Immunofluorescence microscopy of MDA-MB-468 cells infected for 24 h with OV19t at MOI 0.025 (left) and MOI 1 (middle), untransduced (MOI 0), or cells transduced with lentivirus to stably express CD19t (right). Images are at 10x magnification, and insets are at 40x magnification. C) FACS plots displaying the cell surface expression of CD19t and intracellular expression of vaccinia virus in MDA- MB-468 tumor cells determined by flow cytometry after 24 h of OV19t infection at increasing MOIs. D) Quantification of CD19t (left), vaccinia (middle), and viability (right) of MDA-MB-468 tumor cells following 24, 48, and 72 h co-culture with indicated MOIs of OV19t. E) Quantification of CD19t (left), Figure 1 A B C D CD19 Vaccinia Virus MOI 0 0.00625 0.0125 0.025 0.05 0.1 1 22.2% 37.8% 6.8% 11.5% <1% 63.8% 98.0% MOI 0 CD19t MOI 0.025 Vaccinia Virus CD19 DAPI MOI 1 J2R hCD19t P SE Vaccinia Oncolytic Virus CF33-(SE)hCD19t 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection CD19t (%) 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection Vaccinia (%) 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection Viability (%) 24h 48h 72h 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection CD19t (%) 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection Vaccinia (%) 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection Viability (%) Capan-1 (pancreas) Panc-1 (pancreas) DU145 (prostate) OV90 (ovarian) UM-SCC-1 (head and neck) UM-SCC-47 (head and neck) U251T (glioma) E 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection Viability (%) 24h 48h 72h not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. The copyright holder for this preprint (which was this version posted November 16, 2019. ; https://doi.org/10.1101/843052 doi: bioRxiv preprint 21 Fig. 1. OV effectively deliver CD19t to solid tumors in vitro. A) Schematic of vaccinia OV [CF33- (SE)hCD19t], showing incorporation of human truncated CD19 (CD19t) under the control of the synthetic early promoter (P SE ) inserted into the J2R locus replacing the thymidine kinase gene. B) Immunofluorescence microscopy of MDA-MB-468 cells infected for 24 h with OV19t at MOI 0.025 (left) and MOI 1 (middle), untransduced (MOI 0), or cells transduced with lentivirus to stably express CD19t (right). Images are at 10x magnification, and insets are at 40x magnification. C) FACS plots displaying the cell surface expression of CD19t and intracellular expression of vaccinia virus in MDA- MB-468 tumor cells determined by flow cytometry after 24 h of OV19t infection at increasing MOIs. D) Quantification of CD19t (left), vaccinia (middle), and viability (right) of MDA-MB-468 tumor cells following 24, 48, and 72 h co-culture with indicated MOIs of OV19t. E) Quantification of CD19t (left), Figure 1 A B C D CD19 Vaccinia Virus MOI 0 0.00625 0.0125 0.025 0.05 0.1 1 22.2% 37.8% 6.8% 11.5% <1% 63.8% 98.0% MOI 0 CD19t MOI 0.025 Vaccinia Virus CD19 DAPI MOI 1 J2R hCD19t P SE Vaccinia Oncolytic Virus CF33-(SE)hCD19t 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection CD19t (%) 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection Vaccinia (%) 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection Viability (%) 24h 48h 72h 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection CD19t (%) 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection Vaccinia (%) 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection Viability (%) Capan-1 (pancreas) Panc-1 (pancreas) DU145 (prostate) OV90 (ovarian) UM-SCC-1 (head and neck) UM-SCC-47 (head and neck) U251T (glioma) E 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection Viability (%) 24h 48h 72h not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. The copyright holder for this preprint (which was this version posted November 16, 2019. ; https://doi.org/10.1101/843052 doi: bioRxiv preprint 21 Fig. 1. OV effectively deliver CD19t to solid tumors in vitro. A) Schematic of vaccinia OV [CF33- (SE)hCD19t], showing incorporation of human truncated CD19 (CD19t) under the control of the synthetic early promoter (P SE ) inserted into the J2R locus replacing the thymidine kinase gene. B) Immunofluorescence microscopy of MDA-MB-468 cells infected for 24 h with OV19t at MOI 0.025 (left) and MOI 1 (middle), untransduced (MOI 0), or cells transduced with lentivirus to stably express CD19t (right). Images are at 10x magnification, and insets are at 40x magnification. C) FACS plots displaying the cell surface expression of CD19t and intracellular expression of vaccinia virus in MDA- MB-468 tumor cells determined by flow cytometry after 24 h of OV19t infection at increasing MOIs. D) Quantification of CD19t (left), vaccinia (middle), and viability (right) of MDA-MB-468 tumor cells following 24, 48, and 72 h co-culture with indicated MOIs of OV19t. E) Quantification of CD19t (left), Figure 1 A B C D CD19 Vaccinia Virus MOI 0 0.00625 0.0125 0.025 0.05 0.1 1 22.2% 37.8% 6.8% 11.5% <1% 63.8% 98.0% MOI 0 CD19t MOI 0.025 Vaccinia Virus CD19 DAPI MOI 1 J2R hCD19t P SE Vaccinia Oncolytic Virus CF33-(SE)hCD19t 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection CD19t (%) 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection Vaccinia (%) 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection Viability (%) 24h 48h 72h 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection CD19t (%) 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection Vaccinia (%) 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection Viability (%) Capan-1 (pancreas) Panc-1 (pancreas) DU145 (prostate) OV90 (ovarian) UM-SCC-1 (head and neck) UM-SCC-47 (head and neck) U251T (glioma) E 0.001 0.01 0.1 1 10 0 20 40 60 80 100 Multiplicity of Infection Viability (%) 24h 48h 72h not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. The copyright holder for this preprint (which was this version posted November 16, 2019. ; https://doi.org/10.1101/843052 doi: bioRxiv preprint 0 20 40 60 80 0 200 400 600 Days post tumor injection Tumor Volume (mm 3 ) No treatment Mock alone CAR alone OV19t alone OV19t + Mock OV19t + CAR OV T cells p < 0.05 Combination of onCARlytics (CF33-CD19) and CD19-CAR T cells promotes tumour regression in xenograft model of TNBC Park et al. Science Translational Medicine 2020 Multiplicity if infection 0 20 40 60 80 0 200 400 600 Days post tumor injection Tumor Volume (mm 3 ) No treatment Mock alone CAR alone OV19t alone OV19t + Mock OV19t + CAR OV T cells p < 0.05 i.t.10M pfu OV19t i.t. 5M Mock or CD19-CAR T cells s.c. MDA-MB-468 onCARlytics (CF33-CD19) infects a wide array of solid tumour cell lines, with dose-dependent CD19 cell surface expression 15 Technology Milestone onCARlytics 1 st Patient Dosed onCARlytics FDA IND Clearance PD1 -Vaxx Combination RP2D onCARlytics GLP Toxicology Study VAXINIA 1st Patient Dosed onCARlytics FDA Pre -IND Meeting onCARlytics GMP manufacturing for pre -clinical toxicology & Phase 1 study VAXINIA FDA IND Clearance HER -Vaxx Neo and Next HERIZON studies PD1 -Vaxx Maximum Feasible Dose Identified HER -Vaxx OS Primary Endpoint onCARlytics Strategic Partnership with Eureka on autologous CD19 CART CHECKvacc TNBC IST 1st Patient Dosed HER -Vaxx PFS analysis data onCARlytics Strategic partnership with Celularity on allogenic CD19 CART CHECKvacc FDA IND Clearance Milestones 16 Next 12-24 months Financial Summary 17 Public Market Overview Share Price 1 A$0.485 52 week range 0.052 - 0.515 Market Capitalisation 2 A$2.73B Cash equivalents (30 Sept 21) A$112.2M Enterprise Value A$2.617B Top 5 Shareholders (as at September 2021) Paul Hopper 6.96% HSBC Custody Nominees (Australia) 5.98% Richard Mann and Assoc. 5.35% JP Morgan Nominees Australia Pty Limited 4.57% Citicorp Nominees Pty Limited 3.67% Note: 1. As of 29 Oct 2021 2. Market capitalisation calculations based on ordinary shares (5.46 bn) only and excludes the dilutive impact of options outstanding (0.64 bn) Share Price Performance (last 3 months) I M U G E N E L I M I T E D www.imugene.com info@imugene.com A S X : I M U
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