Slide 1: An Emerging Leader in Cancer Immuno-Oncology
For personal use only AN EMERGING LEADER IN CANCER IMMUNO-ONCOLOGY Investor Presentation April 2019
Slide 2: Notice: Forward Looking Statements
N O T I C E : F O R W A R D L O O K I N G S TAT E M E N T S For personal use only Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events a
Slide 3: Key investment highlights
Key investment highlights • Promising Phase 1 clinical trial results across lead candidate B cell vaccines For personal use only Strong preliminary results from • Currently have two therapies (HER-Vaxx and B-Vaxx) in Phase 2 studies with a pipeline of other ongoing clinical trials therapies and comb
Slide 4: Experienced management team with clinical development and commercialisation expertise
Lead by an experienced management team which have significant clinical development commercialisation expertise in the sector Leslie Chong Paul Hopper Dr Axel Hoos Mr Charles Walker For personal use only SYDNEY, AU SYDNEY, AU PHILADELPHIA, USA BRISBANE, AU Managing Director & CEO Executive Chairman N
Slide 5: Scientific Advisory Board of world leading oncologists, researchers and developers
Imugene‘s Scientific Advisory Board consists of world leading oncologist, researchers and developers For personal use only Prof. Josep Tabernero Prof Pravin Kaumaya Dr. Michael Galigiuri VALL D’HEBRON, BARCELONA, Prof Tanios BekaiI Saab OHIO STATE UNIVERSITY, USA CITY OF HOPE, USA SPAIN MAYO CLINIC,
Slide 6: Immuno-oncology: A high-value therapeutic approach
Immuno–oncology: A high-value therapeutic approach For personal use only Immuno-oncology - A rapidly B cell peptide vaccines provide A pioneer and leader in the B growing market potential benefits cell peptide cancer vaccine space • Immuno-oncology allows for a ü Potentially leading to a better • Im
Slide 7: B cell based antibodies have distinct advantages to existing treatments
B cell based antibodies have distinct advantages to existing treatments B cell Vaccines offer a unique For personal use only opportunity to intervene at multiple points in the immune system and create immune memory which N ATU R A L B C EL L DER I V ED MONOCLONAL enhances durability of response. ANT
Slide 8: What is Imugene's B cell vaccine (HER-Vaxx) trying to solve?
What is Imugene’s B cell vaccine (HER-Vaxx) trying to solve? For personal use only HER-2 is a • HER-2 (Human Epidermal clinically and Growth Factor Receptor) HER-2 commercially stimulates cancer cells to grow validated target for cancer treatment • 10 - 30% of gastric, breast, ovarian and pancreatic
Slide 9: How does HER-Vaxx work?
How does HER-Vaxx work? 3 Peptides “mimic” the epitope For personal use only (antibody binding site) HER-Vaxx stimulates the patients B cells to produce antibodies that target only those cancer cells with HER-2 on their surface B cells attack the cancer cell CANCER HER-VAXX B CELL IMMUNOTHERAPY AC T
Slide 10: A significant market opportunity across key Imugene vaccines
For personal use only A significant market opportunity across key Imugene vaccines GASTRIC CANCER LUNG CANCER (HER - VAXX) (KEY- VAXX) Newly diagnosed 1m cases per year, globally Incidence 1.8m cases per year, globally cases 19% relate to HER2+ cancers 5 year relative < 25% ~18% survival rate Progno
Slide 11: Imugene has a developing pipeline of cancer vaccines
Imugene has a developing pipeline of cancer vaccines Clinical Clinical For personal use only development development Pre-Clinical Phase 1 Phase 2 Key Data / Results • Successful completion of Phase 1b trials • Strong trial results with no safety or toxicity issues HER-Vaxx (HER-2) • All patients had
Slide 12: Imugene discovery pipeline
Imugene discovery pipeline For personal use only Program Pre-clinical ID of candidate Her-1 (EGFR) Her-3 IGF-1R VEGF Combination (numerous) PD-L1 12
Slide 13: HER-Vaxx: Successfully completed Phase 1B study
HER-Vaxx: Successfully completed Phase 1B study… For personal use only Phase 1b – Complete Trial Patients Study Endpoints Study Results • Phase 1b • Gastric Cancer HER-Vaxx in • Recommended Phase • 50 µg selected as the • Open label • Up to 18 patients combination 2 Dose of HER-Vaxx RP2D in 3 cohort
Slide 14: Positive results for HER-Vaxx Vaccine Phase 1b trial
Positive results for HER-Vaxx Vaccine Phase 1b trial For personal use only Key Findings Change from baseline (%) in tumor size 40 ü 11 out of 14 were evaluable for vaccine-specific immune 20 responses and tumour response assessment 0 * ü Those patients that were dosed with 50 micrograms showed Chang
Slide 15: …and commenced Phase 2
…and commenced Phase 2 For personal use only Phase 2 commenced - First patient dosed March 2019 Trial Patients Study Primary Endpoints • Phase 2 • Gastric Cancer Randomized • Overall survival • Open label • Up to 70 patients HER-Vaxx in combination • Progression-free • Asia with standard of care sur
Slide 16: KEY-Vaxx: A new entrant in the checkpoint inhibitor market
KEY-Vaxx: A new entrant in the checkpoint inhibitor market For personal use only — KEY-Vaxx is a PD-1 B cell vaccine, How PD-1 targeted Limitations of current aimed to induce the body to treatments work treatments produce polyclonal antibodies while • Current checkpoint inhibiting existing commercia
Slide 17: How does KEY-Vaxx work?
How does KEY-Vaxx work? HOW CANCER STAYS UNDETECTED BY KEY-VAXX STOPS THE CANCER CELL FROM AVOIDING For personal use only THE IMMUNE SYSTEM T-CELL RECOGNITION AND KILLING PD-L1 PROTEIN L C EL T- Gives T-cells the ability to RE PD- recognise the cancer cell and ANTI PD-1 CANCER CE 1 PT O mount an imm
Slide 18: PD-1/HER-2 Combination: Potential to increase response rates in HER-2+ cancers
PD-1/HER-2 Combination: Potential to increase response rates in HER-2+ cancers For personal use only % CANCER GROWTH INHIBITION IN COLORECTAL CANCER MODEL Immuno-oncology combinations driving value • Combining drugs for better immuno-oncology PD-1 vaccine plus Her-2 vaccine 90% outcome is driving va
Slide 19: KEY-Vaxx: Vaccine in Phase 1 development path
KEY-Vaxx: Vaccine in Phase 1 development path Current status For personal use only PRE-CLINICAL MILSTONES PD-1 Formal Finalise Q4, 2019: candidate CMC pre-clinical regulatory IND FDA/IND Commence vaccine manufacturing FDA de-briefing submissions Granted by Q4, 2019 Phase 1 identified meeting in Q1,
Slide 20: B-Vaxx: Phase 1 trial results leading into Phase 2
B- Vaxx: Phase 1 trial results leading into Phase 2 For personal use only Similar to HER-Vaxx, B-Vaxx is a B cell Broad tumor types treated in Phase 1; peptide cancer vaccine designed to now in Phase 21 treat tumours that over-express the HER-2 receptor by binding to the same regions as Herceptin® a
Slide 21: The immuno-oncology market is experiencing robust growth
For personal use only The immuno-oncology market is experiencing robust growth Strong deal activity involving big pharma with Strong sales for leading immuno-oncology a number of M&A and licensing transactions treatments Oncolytic A$500m Jun 2018 immunotherapy US$7.2bn in 2018 sales Acquired US$2bn
Slide 22: Robust cash position with supportive institutional shareholder base
For personal use only Robust cash position with supportive institutional shareholder base Public Market Overview Share Price Performance (last 6 months) Share Price 1 A$0.017 Price (A$) IMU releases Volume (k) 0.030 appendix 4C results 90,000 Market Capitalisation 2 A$61.4M (Sept quarter) IMU advanc
Slide 23: Clinical development and milestones
Clinical development and milestones Phase 2 clinical trials for key indications underway – trials underpinned by For personal use only additional value-adding studies and an exciting pipeline With a proactive approach to business development and brand awareness through participation in key STUDIES 1
Slide 24: Appendix
For personal use only Appendix 24
Slide 25: The global immuno-oncology sector rapidly growing
The global immuno-oncology sector rapidly growing For personal use only With strong interest in the sector, Imugene‘s Significant growth in global immuno-oncology products have the potential to outperform pipelines of 2017 and 2018 exsiting treatments T-cell targetted 2018 419 86 49 immunomodulator
Slide 26: HER-Vaxx uses a polyclonal response to target HER-2
HER-Vaxx uses a polyclonal response to target HER-2 B cell vaccines offer a unique opportunity to For personal use only HER-Vaxx address the targets of intervene at multiple Herceptin and Perjeta combined as well points in the immune system and create as an additional site immune memory HER- Vaxx st
Slide 27: Leslie Chong, Managing Director & CEO
For personal use only Leslie Chong Managing Director & CEO leslie.chong@imugene.com +61 458 040 433