Imugene Ltd · ASX:IMU
Imugene — Investor Presentation (May 2024)
30 slides from Imugene's investor presentation, May 2024
Slide 1: Developing Cancer Immunotherapies
ASX: IMU DEVELOPING CANCER IMMUNOTHERAPIES May, 2024
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, comprehensive or pro
Slide 3: Investment Highlights
INVESTMENT HIGHLIGHTS MARKET CAPITALISATION AS OF CASH AS OF A$114.1M A$593M 29 APRIL 2024 31 MARCH 2024 4 DISEASE AREAS PLATFORM Blood cancers (DLBCL) Breast (TNBC) TECHNOLOGIES Lung (NSCLC) Gastric Gastroesophageal Colorectal (CRC) Melanoma Head and Neck Hepatocellular Pancreatic Azer-Cel Research
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 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 Operating Snr VP of Clin
Slide 5: Azer-cel CD19 Allogeneic CAR T Cell Therapy
AZER-CEL CD19 ALLOGENEIC CAR T CELL THERAPY 5 5
Slide 6: 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 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 access (highly personaliz
Slide 7: Azer-cel Has Meaningful Clinical Activity in B Cell Malignancies
AZER-CEL HAS MEANINGFUL CLINICAL ACTIVITY IN B CELL MALIGNANCIES 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 Response Rate 2. CR – Compl
Slide 8: 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 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 NHL Patients 83% Over
Slide 9: 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 • 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/refractory DLBCL has a hig
Slide 10: How Is DLBCL Treated Today?
HOW IS DLBCL TREATED TODAY? ~30,000 New Cases in the U.S. Annually (2020 – SEER) 1st line 2nd line 3rd line R-CHOP (Combination High dose chemo w/ stem No standard of care – for Chemotherapy1) cell transplant or standard auto CAR T relapse chemo. Auto CD19 CAR T patients2 cell therapies: Yescarta (G
Slide 11: CD19 Autologous CAR T Relapse Market Is Large and Growing
CD19 AUTOLOGOUS CAR T RELAPSE MARKET IS LARGE AND GROWING ~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 autologous CAR T drugs become
Slide 12: Phase 2 Trial Assumptions (Potential Registrational/To Market)
PHASE 2 TRIAL ASSUMPTIONS (POTENTIAL REGISTRATIONAL/TO MARKET) Potential registrational trial (FDA approval) to start upon completion of the Phase 1B trial. Dependent on acceptable CR rate and durability of CR Population: Relapse after auto-CART in DLBCL patients Positive FDA guidance on the potenti
Slide 13: Imugene and Kincell Bio Partnership
IMUGENE AND KINCELL BIO PARTNERSHIP Kincell Bio acquired Imugene’s North Carolina manufacturing facility • Imugene retains rights to azer-cel • Imugene will receive up to $6M USD in upfront and milestone-driven payments over 3 years • Imugene will recognize $32M USD in staff cost reductions, manufac
Slide 14: CF33 Oncolytic Virus
CF33 ONCOLYTIC VIRUS 14 14
Slide 15: CF33 Can Infect and Selectively Kill Tumor Cells
CF33 CAN INFECT AND SELECTIVELY KILL TUMOR CELLS 1 2 3 Virus enters Virus Cell explodes, tumour 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 cancer cells • Direct kill
Slide 16: Our Phase 1 MAST Study Has Enrolled Well
OUR PHASE 1 MAST STUDY HAS ENROLLED WELL Dose Administration (Parallel Groups) VAXINIA VAXINIA + Pembrolizumab Monotherapy Dose Escalation Combination Dose Escalation Cohort Expansion n=52-100 patients IT IV IT IV IT COHORT COHORT Intratumoural (IT) 3-6 PATIENTS 3-6 PATIENTS Administration 3x108 COH
Slide 17: Phase 1 MAST Trial - Encouraging Early Signals
PHASE 1 MAST (METASTATIC ADVANCED SOLID TUMOURS) TRIAL - ENCOURAGING EARLY SIGNALS • The Phase I trial treats advanced cancer patients intravenously (IV) or intratumourally (IT) with CF33-hNIS (VAXINIA) alone, or in combination with pembrolizumab in multiple solid cancers • 47 heavily pre-treated pa
Slide 18: Turning Cold Tumours Hot
TURNING COLD TUMOURS HOT Complete Remission after Pseudoprogression (immune activity) in a Monotherapy patient with a cold tumour (bile tract cancer) Baseline scan Second scan Third scan Fourth scan Start of the Trial Pseudoprogression Decreased size Complete Remission (Tumour looks to have grown du
Slide 19: onCARlytics for Solid Tumors
ONCARLYTICS FOR SOLID TUMORS 19 19
Slide 20: Variety of Approved CD19 Drugs Only for Blood Cancers
VARIETY OF APPROVED CD19 DRUGS ONLY FOR BLOOD CANCERS • 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 cell surface • When you
Slide 21: Mechanism of Action: How Does It Work?
MECHANISM OF ACTION: HOW DOES IT WORK? onCARlytics makes solid tumours “seen” by CD19 targeting therapies 1. OnCARlytics infects Tumour cells 2. Virus replication and production of CF33-CD19 on the cell surface enabling CD19 cell targeting 3. Tumour cell lysis leads to viral particle release and the
Slide 22: Phase 1 OASIS Trial
PHASE 1 OASIS TRIAL • Phase 1 trial designed to treat with onCARlytics (CF33-CD19) alone, or in combination with Blinatumomab (bispecific antibody targeting CD19) and either dosed IV or IT in metastatic advanced patients across multiple solid Combination treatment for tumours solid tumours • First I
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 CD19 therapies in solid tumours (~90% of cancer market) FIRST FDA APPROVED COMPANY TARGET APPROVAL CANCERS B-ALL, 2017 CD19 Auto CAR T DLBCL Combination Opportunities 2017 CD19 A
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 •Azer-cel in combination with onCARlytics demonstrated sustained, robust activity against multiple tumour types Combination treatment for solid •100% killing of Triple Negative Breast Cancer (468P) and Gastric (SNU16) tum
Slide 25: B-Cell Immunotherapies
B-CELL IMMUNOTHERAPIES 25 25
Slide 26: 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) 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 • Objective Response C
Slide 27: Key Catalysts for the Next 12-18 Months
KEY CATALYSTS FOR THE NEXT 12-18 MONTHS 2025 • AZER-CEL: DLBCL Phase 1b data updates • AZER-CEL: Target regulatory meeting with FDA • ONCARLYTICS + AZER-CEL FDA IND and FPI in H2 2024 solid tumours H1 2024 • AZER-CEL: expansion into additional blood • VAXINIA: IT Expansion Open other cancers (Phase
Slide 28: Why Imugene?
WHY IMUGENE? Value Proposition for Investors 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 tumours protect and conserve Le
Slide 29: Investment Highlights
INVESTMENT HIGHLIGHTS MARKET CAPITALISATION AS OF CASH AS OF A$114.1M A$593M 29 APRIL 2024 31 MARCH 2024 4 DISEASE AREAS PLATFORM Blood cancers (DLBCL) Breast (TNBC) TECHNOLOGIES Lung (NSCLC) Gastric Gastroesophageal Colorectal (CRC) Melanoma Head and Neck Hepatocellular Pancreatic Azer-Cel Research
Slide 30: shareholderenquiries@imugene.com imugene.com
ASX:IMU shareholderenquiries@imugene.com imugene.com 30