Slide 1: Imugene Investor Presentation
For personal use only ASX: IMU IMUGENE Investor Presentation November 2020
Slide 2: Disclaimer
DISCLAIMER 1. The information in this presentation does not constitute personal investment advice. The presentation is not intended to be comprehensive or For personal use only provide all information required by investors to make an informed decision on any investment in Imugene Limited (Company).
Slide 3: Investment Highlights
INVESTMENT HIGHLIGHTS For personal use only Two novel technologies: B-Cell activating immunotherapies and CF33 oncolytic virotherapy B-Cell Technologies: HER-Vaxx Positive Interim Data read out for Phase 2 trial in gastric cancer B-Cell Technologies: PD1-Vaxx screening patients in Phase 1 for
Slide 4: Two Novel Technology Platforms
TWO NOVEL TECHNOLOGY PLATFORMS For personal use only CF33 B-Cell Oncolytic Vaccines Virus CHECKvacc VAXINIA HER-Vaxx PD1-Vaxx “Armed” Parental Virus Virus November 2020 4
Slide 5: Imugene's Deep Pipeline
IMUGENE’S DEEP PIPELINE For personal use only Clinical Clinical Pre- Intellectual development development Key Data / Results Clinical Property Phase 1 Phase 2 • CF33 has shown strong anti tumour responses in preclinical studies Expiring 2037 VAXINIA Mixed Advanced • Inhibition of tumour growth in ne
Slide 6: International Leadership Team with Extensive Commercialization Expertise in the Sector
International Leadership Team with Extensive Commercialization Expertise in the Sector For personal use only Leslie Chong Paul Hopper Dr Jens Eckstein Dr Lesley Russell Dr Axel Hoos Mr Charles Walker SYDNEY, AU SYDNEY, AU CAMBRIDGE, USA PHILADELPHIA, USA PHILADELPHIA, USA BRISBANE, AU Managing Direc
Slide 7: Experienced management team with significant clinical development expertise
Experienced management team which have significant clinical development expertise For personal use only Dr Rita Laeufle Dr Nick Ede SAN DIEGO, USA MELBOURNE, AU Chief Medical Officer Chief Technology Officer • 27+ years of oncology experience • 25+ years peptide vaccine in academia and industry and
Slide 8: B-Cell Immunotherapy
For personal use only B-Cell Immunotherapy
Slide 9: 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 NATURAL B CELL D ERIVED MONOCLONAL enhances durability of response. ANTIBODIES
Slide 10: B-Cell Immunotherapy Vaccine Against HER-2
B-CELL IMMUNOTHERAPY VACCINE AGAINST HER-2 • HER-Vaxx is a B-cell immunotherapy designed to For personal use only treat tumours that over-express the HER2/neu receptor, including gastric and breast cancer HER-Vaxx stimulates the patients B cells to produce antibodies that target only • The immunothe
Slide 11: HER-Vaxx Phase 1b/2 Study Design
HER-Vaxx PHASE 1B/2 STUDY DESIGN For personal use only PHASE 1B PHASE 2 Cohort 3 R IMU-131 + SOC chemo 3-6 A Advanced N Adenocarcinoma D TREAT Cohort 2 Primary endpoint – OS FOLLOW 3-6 RP2D of the Stomach O 1:1 Secondary endpoint PFS UNTIL M FOR OS n=68 PD I Cohort 1 3-6 Z SOC: Cisplatin + 5FU or E
Slide 12: HER-Vaxx Phase 1b: Design & Results
HER-Vaxx PHASE 1B: DESIGN & RESULTS For personal use only Trial Patients Study Endpoints Study Results • HER2 Gastric • Advanced stage IIIb • 14 patients • Recommended • No safety or toxicity issues or GEJ cancer or IV in 3 cohorts (10µg (3), Phase 2 Dose of • All patients had increased • Phase 1b •
Slide 13: HER-Vaxx Phase 2: Recruiting
HER-Vaxx PHASE 2: RECRUITING For personal use only Trial Patients Study Primary Endpoints • Phase 2 • HER-2+++ Randomized • Overall survival • Open label • HER-2++ FISH/CISH +ve HER-Vaxx in combination • Eastern Europe • Advance or metastatic with standard of care Secondary Endpoints • India Gastric
Slide 14: HER-Vaxx Phase 2: Interim Analysis
HER-Vaxx PHASE 2: INTERIM ANALYSIS Efficacy Outcome Overview For personal use only OS ITT * Endpoint (Primary) Chemo+ Treatment Chemo HER-Vaxx All Patients n=27 (at data cut off) 13 14 Events** 8 4 Hazard Ratio (HR) 0.418 2-sided 80%CI (0.186,0.942) Log-rank Test (1-sided p-value)*** .083+ *Overall
Slide 15: HER-Vaxx Phase 2: Interim Analysis Safety Overview
HER-Vaxx PHASE 2: INTERIM ANALYSIS Safety Overview - Patients with at least one TEAE* For personal use only Chemo + HER-Vaxx Chemo alone Total at data cut off % % Grade 3 42.9% 30.8% Grade 4 0% 15.4% Grade 5 0% 7.7% *Treatment Emergent Adverse Events showed no added Toxicity to HER-Vaxx and Chemo ar
Slide 16: HER-Vaxx Phase 2: Interim Analysis
HER-Vaxx PHASE 2: INTERIM ANALYSIS Interim analysis showed statistically significant overall survival Hazard Ratio (HR) of 0.418 (80% 2- For personal use only sided CI: 0.186, 0.942); HER-Vaxx showed a reduced risk of death of 58.2% in the HER-Vaxx plus chemotherapy group as compared to chemothera
Slide 17: How Does PD1-Vaxx Work?
HOW DOES PD1-Vaxx WORK? HOW CANCER STAYS UNDETECTED PD1-VAXX STOPS THE CANCER CELL FROM For personal use only BY THE IMMUNE SYSTEM AVOIDING T-CELL RECOGNITION AND KILLING PD-L1 PROTEIN Gives T-cells the ability to recognise the cancer cell and ANTI PD-1 CANCER pAb BINDS CELL mount an immune response
Slide 18: PD1-Vaxx Phase 1: Study Design
PD1-Vaxx PHASE 1: STUDY DESIGN Part 1: Monotherapy Dose Escalation Part 2: Combination Escalation & Dose Expansion For personal use only (Planned) PD1-Vaxx Monotherapy (MTD/OBD evaluation) Cohort 1 Cohort 2 Cohort 3 Combination OBD 10 µg 50 µg 100 µg IMU-201 IMU-201 IMU-201 n = 3-6 n = 3-6 n = 3-6 I
Slide 19: PD1-Vaxx Phase 1: Recruiting
PD1-Vaxx PHASE 1: RECRUITING Current status For personal use only PRE-CLINICAL Successful MILSTONES CMC pre-clinical 1st HREC Approval Australian Sites FDA/IND manufacturing FDA de-briefing 1st Patient Dosed Granted in Australia Open to Recruitment Granted Complete meeting in Q1, 2019 Phase 2 – Expa
Slide 20: 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 are driving value • Combining drugs for better immuno-oncology PD-1 vaccine plus Her-2 vaccine 90% outcome is drivin
Slide 21: Imugene's Discovery Pipeline
IMUGENE’S DISCOVERY PIPELINE Imugene has the ability to advance these programs at any point For personal use only Program Pre-clinical ID of candidate Her-1 (EGFR) Her-3 IGF-1R VEGF PD-L1 Combination (numerous) November 2020 21
Slide 22: CF33: Oncolytic Virus
For personal use only CF33: Oncolytic Virus
Slide 23: CF33 Mechanism of Action
CF33 MECHANISM OF ACTION For personal use only HOW A VIRUS KILLS A CELL Step 1: Step 2: Step 3: Virus enters cell Virus duplicates itself Cell explodes, releasing thousands of brand new virus particles • Direct infection, replication within and cancer cell killing • Viral infection increases local c
Slide 24: CF33 Outperforms Amgen & Genelux Viruses
CF33 OUTPERFORMS AMGEN & GENELUX VIRUSES For personal use only MICE BEARING THE A549 XENOGRAFTS WERE TREATED WITH INDICATED VIRUSES AT A DOSE OF 103 V0 V PFU/MOUSE PERCENT CELL SURVIVAL FOR INJECTED TUMORS NON-INJECTED TUMORS BXPC-3 PANCREATIC CANCER 2800 2400 PBS 100 2400 2000 PBS CF33 V0 V 80 Tumo
Slide 25: CF33 Shrinks Triple-Negative Breast Cancer
CF33 SHRINKS TRIPLE-NEGATIVE BREAST CANCER 130 Mice treated with both For personal use only PBS intratumoral virus and IV 110 #33, 10^3 pfu 90 #33, 10^4 pfu The viral dose used was 2-5 % change in tumor volume 70 orders of magnitude lower than doses used for oncolytic viruses 50 under clinical testi
Slide 26: CHECKvacc: CF33+hNIS+aPD-L1 (Armed Virus)
CHECKvacc: CF33+hNIS+aPD-L1 (“Armed” Virus) Phase 1 Triple Negative Breast Cancer Study – GMP Manufacturing Complete For personal use only COHORT | 3-6 PATIENTS IDENTIFY COHORT | 3-6 PATIENTS Recommended Metastatic Triple Phase 2 Dose Negative Breast COHORT | 3-6 PATIENTS (RP2D) RP2D EXPANSION Cance
Slide 27: VAXINIA Phase MAST Study (Metastatic Advanced Solid Tumours)
VAXINIA PHASE 1 MAST STUDY (Metastatic Advanced Solid Tumours) Part 2: VAXINIA + SOC IO* For personal use only Part 1: VAXINIA Monotherapy Dose Escalation Combination Dose Escalation Dose IDENTIFY Admin IT AND IV COMBINATION IT Administration Dose COHORT | 3-6 COHORT | 3-6 Head & Neck, Admin IT AND
Slide 28: Landscape: Recent Oncolytic Virus Transactions
LANDSCAPE: RECENT ONCOLYTIC VIRUS TRANSACTIONS For personal use only ~$3.7 billion USD in total value) with 3 Deals Done in Preclinical Stage November 2020 28
Slide 29: Multiple Near & Medium Term Value Inflection Points
MULTIPLE NEAR & MEDIUM TERM VALUE INFLECTION POINTS For personal use only PD1-Vaxx VAXINIA HER-Vaxx VAXINIA 1st Patient Dosed CHECKvacc CHECKvacc TNBC IST 1st Patient Dosed VAXINIA FDA IND Clearance PD1-Vaxx Maximum Feasible Dose Identified PD1-Vaxx 3rd cohort escalation HER-Vaxx Phase 2 Final Analy
Slide 30: Financial Summary
FINANCIAL SUMMARY Public Market Overview Share Price Performance (last 6 months) For personal use only Share Price 1 A$0.115 Market Capitalisation 2 A$528.4M Cash equivalents (30 Sep 20) A$26.6M Enterprise Value A$501.8M Top 5 Shareholders (as at November 2020) Richard Mann and Assoc. 5.66% Paul Hop
Slide 31: Leslie Chong, Managing Director & CEO
For personal use only Leslie Chong Managing Director & CEO leslie.chong@imugene.com +61 458 040 433