Imugene Ltd · ASX:IMU
Imugene — JP Morgan Healthcare Conference 2024
35 slides from Imugene's conference presentation, Jan 10, 2024
Slide 1: Developing Cancer Immunotherapies
For personal use only ASX: IMU DEVELOPING CANCER IMMUNOTHERAPIES January, 2024 JP Morgan Release authorized by the Managing Director and Chief Executive Officer Imugene Limited
Slide 2: Disclaimer
DISCLAIMER 1. The information in this presentation does not constitute personal 4. Neither the Company nor any of its directors, officers, employees, investment advice. The presentation is not intended to be advisers, associated persons or subsidiaries are liable for any direct, For personal use onl
Slide 3: Investment Highlights
INVESTMENT HIGHLIGHTS MARKET CAPITALISATION A$860M CASH AS OF A$163M 5 January 2024 US$576M 30 September 2023 US$109M For personal use only IN-HOUSE GMP 4 DISEASE AREAS PLATFORM CELL THERAPY Blood cancers (DLBCL) Breast (TNBC) TECHNOLOGIES MANUFACTURING Lung (NSCLC) FACILITIES Gastric Gastroesophage
Slide 4: Imugene Clinical Executive Team
IMUGENE CLINICAL EXECUTIVE TEAM Over 150 years of combined experience in Clinical Development 13 FDA Approved Drugs to market For personal use only Leslie Chong Dr. Paul Woodard, MD Dr Bradley Glover Ursula McCurry Dr. John Byon, MD, PhD Dr Monil Shah Chief Executive Chief Medical Officer Chief Oper
Slide 5: Cell Therapy and Oncolytic Virus Platforms Deliver Innovative and Potent Therapies
CELL THERAPY AND ONCOLYTIC VIRUS PLATFORMS DELIVER INNOVATIVE AND POTENT THERAPIES TO PATIENTS For personal use only Allogeneic CF33 OnCARlytics B Cell CAR T Oncolytic Virus CF33-CD19 Immunotherapy Cell Therapy (OV) Therapy OV Therapy azer-cel VAXINIA onCARlytics HER-Vaxx & PD1-Vaxx 5
Slide 6: Azer-cel CD19 Allogeneic CAR T Cell Therapy
For personal use only AZER-CEL CD19 ALLOGENEIC CAR T CELL THERAPY 6
Slide 7: The Future of Cell Therapy Is Off the Shelf (Allogeneic) CAR T
THE FUTURE OF CELL THERAPY IS OFF THE SHELF (ALLOGENEIC) CAR T Patients shouldn't have to wait for treatment For personal use only AUTOLOGOUS (AUTO) ALLOGENEIC (ALLO) • Auto CAR Ts are made from the patient’s own T-cells • Allo CAR Ts are made from a universal donor. Broad cells. Limited patient acc
Slide 8: Azer-cel Has Meaningful Clinical Activity in B Cell Malignancies
AZER-CEL HAS MEANINGFUL CLINICAL ACTIVITY IN B CELL MALIGNANCIES For personal use only 84 patients treated with azer-cel 61 Non-Hodgkin lymphoma (NHL) 23 B-Cell lymphoblastic Patients leukaemia (B-ALL) Patients 58% ORR 41% CR 61% ORR 61% CR/CRi 1 2 All Doses / All LD* Regimens 1. ORR – Overall Respo
Slide 9: Azer-cel Has the Potential to Be a New Standard of Care
Azer-cel AZER-CEL HAS THE POTENTIAL TO BE A NEW STANDARD OF CARE High response rates and durability For personal use only 84 blood cancer patients treated with azer-cel : 61 patients with Non-Hodgkin lymphoma (NHL); 23 patients with B-Cell acute lymphoblastic leukaemia (B-ALL) Across All 61 Subjects
Slide 10: Diffuse Large B-Cell Lymphoma Is an Aggressive Type of Non-Hodgkin Lymphoma
DIFFUSE LARGE B-CELL LYMPHOMA IS AN AGGRESSIVE TYPE OF NON-HODGKIN LYMPHOMA For personal use only • B-cells become cancerous and grow uncontrollably • Most common type of non-Hodgkin lymphoma (80,500 cases/year) • Most common in people over 50 • Fast growing and needs rapid treatment • Relapsed/refr
Slide 11: How Is DLBCL Treated Today?
HOW IS DLBCL TREATED TODAY? ~30,000 New Cases in the U.S. Annually (2020 – SEER) For personal use only 1st line 2nd line 3rd line R-CHOP (Combination High dose chemotherapy No standard of care – for Chemotherapy*) w/ stem cell transplant. auto CAR T relapse Auto CD19 CAR T cell patients therapies: Y
Slide 12: CD19 Autologous CAR T Relapse Market Is Large and Growing
CD19 AUTOLOGOUS CAR T RELAPSE MARKET IS LARGE AND GROWING For personal use only ~85% 60-65% By 2025 of patients continue to of patients currently treated Global CAR T relapse patient express CD19 the target of with autologous CD19 CAR T pool is expected to grow ~4x azer-cel will relapse2 as autologo
Slide 13: Phase Trial Assumptions (Potential Registrational/To Market)
PHASE 2 TRIAL ASSUMPTIONS (POTENTIAL REGISTRATIONAL/TO MARKET) For personal use only Potential registrational study (FDA approval) to start upon completion of the Phase 1B study H2 2024. Dependent on acceptable CR rate and durability of CR Population: Relapse after auto-CART in DLBCL patients Positi
Slide 14: CF33 Oncolytic Virus
For personal use only CF33 ONCOLYTIC VIRUS 14
Slide 15: CF33 Can Infect and Selectively Kill Tumor Cells
CF33 CAN INFECT AND SELECTIVELY KILL TUMOR CELLS For personal use only 1 2 3 Virus enters Virus Cell explodes, tumor cell duplicates itself releasing thousands of brand new virus particles Engineering enhancements Multiple ways to kill cancer cells Precedent for approval • Infect and kill only cance
Slide 16: Our Phase MAST Study Has Enrolled Well
OUR PHASE 1 MAST STUDY HAS ENROLLED WELL Dose Administration For personal use only (Parallel Groups) VAXINIA VAXINIA + Pembrolizumab Monotherapy Dose Escalation Combination Dose Escalation Cohort Expansion n=52-100 patients IT IV IT IV IT COHORT COHORT 3-6 PATIENTS 3-6 PATIENTS IT Administration 3x1
Slide 17: CF33 MAST Study Show Durable Responses in Heavily Pre-Treated Population
CF33 MAST STUDY SHOW DURABLE RESPONSES IN HEAVILY PRE-TREATED POPULATION US02-001 iCR3 On Study Best Change in Tumor Response For personal use only US09-001 SD2 US05-007 SD 20 PD PD1PD PD1SD SD2 PD PD SD1 Off Treatment US03-008 SD US03-007 SD SD2SD IV Admin. Without Pembrolizumab US15-001 SD (Sum of
Slide 18: Turning Cold Tumors Hot
TURNING COLD TUMORS HOT Complete Remission after Pseudoprogression (immune activity) in a Monotherapy patient with a cold tumor (bile duct cancer) For personal use only Baseline scan Second scan Third scan Fourth scan Start of the Study Pseudoprogression Decreased size Complete Remission (Tumour loo
Slide 19: onCARlytics for Solid Tumors
For personal use only ONCARLYTICS FOR SOLID TUMORS 19
Slide 20: Variety of Approved CD19 Drugs Only for Blood Cancers
VARIETY OF APPROVED CD19 DRUGS ONLY FOR BLOOD CANCERS For personal use only • Many blood cancers such as leukemia and lymphoma have a • Solid cancers like breast, lung, gastric, colon, etc. don’t have a common protein, called CD19, on the surface of their cells common target such as CD19, on their c
Slide 21: Mechanism of Action: How Does It Work?
MECHANISM OF ACTION: HOW DOES IT WORK? onCARlytics makes solid tumors “seen” For personal use only by CD19 targeting therapies 1. OnCARlytics infects Tumor cells 2. Virus replication and production of CF33-CD19 on the cell surface enabling CD19 cell targeting 3. Tumor cell lysis leads to viral parti
Slide 22: Phase OASIS Study
PHASE 1 OASIS STUDY Combination treatment for For personal use only • The Phase 1 study is designed to treat with onCARlytics solid tumors (CF33-CD19) alone, or in combination with Blinatumomab (bispecific antibody targeting CD19) and either dosed intravenously (IV) or intratumorally (IT) in metasta
Slide 23: Variety of Approved Therapies Available for Combination with onCARlytics
VARIETY OF APPROVED THERAPIES AVAILABLE FOR COMBINATION WITH ONCARLYTICS onCARlytics can become the preferred partner for For personal use only CD19 therapies in solid tumors (~90% of cancer market) FIRST FDA APPROVED COMPANY TARGET APPROVAL CANCERS B-ALL, 2017 CD19 Auto CAR T DLBCL Combination Oppo
Slide 24: Azer-cel Offers onCARlytics an In-House Combination Approach for Solid Tumours
AZER-CEL OFFERS ONCARLYTICS AN IN-HOUSE COMBINATION APPROACH FOR SOLID TUMOURS For personal use only •Azer-cel in combination with onCARlytics demonstrated sustained, robust activity against multiple tumor types •100% killing of Triple Negative Breast Cancer (468P) and Gastric Combination treatment
Slide 25: B-Cell Immunotherapies
For personal use only B-CELL IMMUNOTHERAPIES 25
Slide 26: HER-Vaxx HERIZON Study Shows Continued Overall Survival Benefit
HER-VAXX HERIZON STUDY SHOWS CONTINUED OVERALL SURVIVAL BENEFIT WITH AN ADDITIONAL FOLLOW UP For personal use only 26
Slide 27: HER-Vaxx Re-Focus Phase (nextHERIZON)
HER-VAXX RE-FOCUS PHASE 2 (NEXTHERIZON) Focus on a Chemotherapy Combination in Gastric Cancer that progressed after Trastuzumab For personal use only TRIAL PATIENTS STUDY • Phase 2 • 2L+ • Non-Randomised • Open label • Advanced or metastatic GJ/GEJ • Arm 1: HER-Vaxx + ramucirumab • USA, Australia, T
Slide 28: Imprinter: PD1-Vaxx NSCLC Phase Study Design
IMPRINTER: PD1-VAXX NSCLC PHASE 1 STUDY DESIGN Phase 1: PD1-Vaxx Monotherapy Dose Escalation & Expansion For personal use only 2L+ NSCLC Progressed on/after ICI • CR (3 years +), PRs and SD have been noted MONOTHERAPY Cohort 1 Cohort 2 Cohort 3 Expansion • With encouraging data in NSCLC, Imugene 10
Slide 29: PD1-Vaxx Ph2 neoPOLEM Neoadjuvant IST in MSI-High Colorectal Cancer
PD1-VAXX PH2 NEOPOLEM NEOADJUVANT (PRE-SURGERY) IST IN MSI-HIGH COLORECTAL CANCER (CRC) For personal use only Neoadjuvant Treatment Surgery Follow Up Site Locations: AUS & UK Within 3 weeks of last dose Outcomes: Days 1 - 29 Patient: n= 44 • Safety • Major Pathological Inoperable, Response MSI-High
Slide 30: Four Unique Technology Platforms Prioritizing Opportunities in Blood & Solid Cancers
FOUR UNIQUE TECHNOLOGY PLATFORMS PRIORTIZING OPPORTUNITIES IN BLOOD & SOLID CANCERS For personal use only Therapeutic approaches with combination potential with existing standards of care PLATFORM CF33-CD19 CAR T Allogeneic CD19 CAR T VAXINIA HER-Vaxx PD1-Vaxx Combination Therapy CLINICAL TRIALS SOL
Slide 31: Key Catalysts for the Next 12-24 Months
KEY CATALYSTS FOR THE NEXT 12-24 MONTHS 2025 For personal use only • AZER-CEL: DLBCL Phase 2 Pivotal Study FPI • ONCARLYTICS + AZER-CEL; Q4 2024 Study Start Up • AZER-CEL: Target • IND filing Q3 2024 regulatory meeting with FDA ONCARLYTICS + AZER-CEL in Q2 2024 • AZER-CEL: Phase 1b • ONCARLYTICS: IT
Slide 32: Financial Summary
FINANCIAL SUMMARY PUBLIC MARKET OVERVIEW (January 5, 2024) SHARE PRICE PERFORMANCE Share Price A$0.12 For personal use only 52 week range A$0.039 - A$0.175 Market Capitalisation1 A$860.3M Cash equivalents (30 Sept ‘23) A$163.4M Enterprise Value A$696.9M TOP 10 SHAREHOLDERS (November 30, 2023) Mr Pau
Slide 33: Why Imugene?
WHY IMUGENE? Value Proposition for Investors For personal use only Advanced Portfolio Experienced management Ongoing clinical trials Robust cash runway; with multiple team with over 150 years in blood cancer and prudent use of funds to shots on goal. of combined experience in diverse solid tumors pr
Slide 34: Investment Highlights
INVESTMENT HIGHLIGHTS MARKET CAPITALISATION A$860M CASH AS OF A$163M 5 January 2024 US$576M 30 September 2023 US$109M For personal use only IN-HOUSE GMP 4 DISEASE AREAS PLATFORM CELL THERAPY Blood cancers (DLBCL) Breast (TNBC) TECHNOLOGIES MANUFACTURING Lung (NSCLC) FACILITIES Gastric Gastroesophage
Slide 35: For personal use only
ASX:IMU For personal use only shareholderenquiries@imugene.com imugene.com 35