Imugene Ltd · ASX:IMU
Imugene — Investor Presentation (September 2024)
32 slides from Imugene's investor presentation, September 2024
Slide 1: Leading Innovation in Cancer Treatment
ASX:IMU Leading Innovation in Cancer Treatment September 2024 Release authorised by the Managing Director and Chief Executive Officer, Imugene Limited.
Slide 2: Disclaimer
Disclaimer The information in this presentation does not constitute personal Neither the Company nor any of its directors, officers, employees, investment advice. The presentation is not intended to be comprehensive advisers, associated persons or subsidiaries are liable for any direct, or provide a
Slide 3: Investment Highlights
Investment Highlights Market Capitalisation A$500M Cash Position A$93.1M (Pro-forma) As of 2 September 2024 As of 30 June 2024 4 PLATFORM DISEASE AREAS LONG- TECHNOLOGIES Blood cancers LIFE Breast (TNBC) Lung (NSCLC) PATENT Gastric PORTFOLIO Gastroesophageal Colorectal (CRC) Melanoma 4 Head and Neck
Slide 4: Three Novel Cancer Technologies In Clinical Trials
Three Novel Cancer Technologies In Clinical Trials CF33 Oncolytic Virus onCARlytics CD19 targeting virus azer-cel CD19 CAR T VAXINIA MAST Trial OASIS Trial Phase 1b Phase 1 Phase 1 Novel virus which acts as a CD19 target in Off-the-shelf drug, aka “Allo”geneic Novel cancer killing virus solid cancer
Slide 5: Azer-cel CD19 CAR T for Blood Cancer
AZER-CEL CD19 CAR T FOR BLOOD CANCER 5 5
Slide 6: The Future of Cell Therapy is Off-the-Shelf Treatments
The Future of Cell Therapy is Off-the-Shelf Treatments Patients shouldn't have to wait for treatment AUTOLOGOUS ALLOGENEIC INFUSION INFUSIONS REAL TIME T CELLS IN ADVANCE T CELLS Limited patient access Broad patient access Long and complex manufacturing process Available on demand and off-the-shelf
Slide 7: What is Imugene's azer-cel CAR T?
What is Imugene’s azer-cel CAR T? Azer-cel is an Azer-cel is currently Approximately ‘off-the-shelf’ enrolling patients with a 30,000 CAR T drug, rare form of blood cancer cases (US) per aka allogeneic, which is made known as diffuse large B year of DLBCL from healthy donor T-cells cell lymphoma (DL
Slide 8: Large Phase 1 Blood Cancer Trial Completed in 84 Patients with Encouraging Results
Large Phase 1 Blood Cancer Trial Completed in 84 Patients with Encouraging Results % 83% ORR ORR Overall Response Rate: 61 18 the percentage of patients who have a partial response or Non-Hodgkin complete response to the drug CAR T Relapse 61% within a certain period of time Lymphoma (NHL) Patients
Slide 9: DLBCL is an Aggressive Type of Non-Hodgkin Lymphoma with Improving Options for Patients
DLBCL is an Aggressive Type of Non-Hodgkin Lymphoma (NHL) with Improving Options for Patients ~30,000 New Cases in the U.S. Annually (2020 – SEER) 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 relaps
Slide 10: CD19 Autologous CAR T Failure Market is Large and Growing
CD19 Autologous CAR T Failure Market is Large and Growing Potential blockbuster sales of ~$2.5B3 per 60-65% By 2025 annum in DLBCL (Blood cancer) CAR T of patients currently treated Global CAR T relapse patient with autologous CD19 CAR T pool is expected to grow ~4x as relapsed patients will relapse
Slide 11: 67% Complete Response Rates Observed in Phase 1b Cohort B
67% Complete Response Rates Observed in Phase 1b Cohort B Evaluable patients: Evaluable Evaluable Cohort A+B patients: patients: (N=9) Cohort A (N=6) Cohort B (N=3)* Cohort A Overall 6 Response Rate % 4 (44%) 2 (33%) 2 (67%) Patients Complete 3 (33%) 1 (17%) 2 (67%) Lymphodepletion(LD)1 Response % +
Slide 12: Azer-cel has a Manageable Safety Profile
Azer-cel has a Manageable Safety Profile No evidence of GVHD or GR. >3 CRS CRS ICANS Infections Safety Profile • Manageable CRS occurs within first week but resolves quickly • In Cohort B, no ICANS has been observed to date • While infections have Cohort A Cohort B azer-cel azer-cel + IL-2 occurred,
Slide 13: Addition of IL-2 to Dosing Regimen Enhances CAR-T Expansion
Addition of IL-2 to Dosing Regimen Enhances CAR-T Expansion and Possibly Efficacy In Vivo IL-2 effect on azer-cel persistence Cohort A Median, DL4b/AugCy (no IL-2) n=12 • Limited expansion seen in vivo in the Cohort B Median, DL4b/AugCy (plus IL-2) n=4 absence of IL-2 • Higher C-Max in patients with
Slide 14: Representative PET Scans of Complete Responses
Representative PET Scans of Complete Responses Subject Treatment Summary Tumour • 60 yo female, first diagnosed with DLBCL Tumour-free (GCB, w/o c-Myc/BCL-2 rearrangements), stage IV in Apr 2012. Treated at University of Minnesota (UMN). • Prior to azer-cel, patient failed 5 prior lines of therapy;
Slide 15: Azer-cel Clinical Development Strategy
Azer-cel Clinical Development Strategy Phase 1 Open label Seek FDA Randomised completed clearance 1 2023 2 Phase 1b trial ongoing 3 for Phase 2/3 4 Phase 2/3 registration n=84 registration n=10-20 trial trial 2020-2023 2024-2025 2025 2025-2026 Milestones: • Preliminary early DLBCL Phase 1b data upda
Slide 16: CF33 VAXINIA Oncolytic Virus
CF33 VAXINIA ONCOLYTIC VIRUS 16
Slide 17: CF33 VAXINIA Can Infect and Kill Cancer Cells
CF33 VAXINIA Can Infect and Kill Cancer Cells 1 2 3 Virus enters Virus Cell explodes, releasing tumour cell duplicates thousands of brand new itself virus particles Engineering enhancements Multiple ways to kill cancer cells Precedent for approval • Infect and kill only cancer • Direct killing • Tve
Slide 18: Phase 1 VAXINIA MAST Trial
Phase 1 VAXINIA Metastatic Advanced Solid Tumour (MAST) Trial Dose Administration VAXINIA VAXINIA + Pembrolizumab Cohort Expansion (Parallel Groups) Monotherapy Dose Escalation Combination Dose Escalation n=52-100 patients IT IV IT IV IT COHORT COHORT 3-6 PATIENTS 3-6 PATIENTS Intratumoural (IT) 3x1
Slide 19: Phase 1 MAST Trial − Encouraging Early Signals
Phase 1 MAST Trial − Encouraging Early Signals Patients1 • >40 patients have been dosed and evaluated (at least their first scan at day 42) Disease Control So Far • Nearly half of the evaluable patients (48%) have remained on treatment for >3 months • 3 patients have remained on treatment for >200 d
Slide 20: 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 21: MAST CF33 Clinical Development Strategy
MAST CF33 Clinical Development Strategy Establish 1 Open Label Phase 1 2 Recommended 3 Phase 2 Trial Phase 2 Dose 2023-2024 2025 2025 - 2026 Milestones: • Intratumoural (IT) Second Indication Trial open • Preliminary early Bile Tract expansion trial update • Optimal Biological Dose Established for I
Slide 22: onCARlytics CD19 Virus for Solid Cancers
ONCARLYTICS CD19 VIRUS FOR SOLID CANCERS 22
Slide 23: Mechanism of Action: How Does it Work?
Mechanism of Action: How Does it Work? OnCARlytics makes solid tumors “seen” by CD19 targeting therapies 1 OnCARlytics infects Tumour cells Virus replication and 2 production of CF33-CD19 on the cell surface enabling CD19 cell targeting Tumour cell lysis leads to viral 3 particle release and the com
Slide 24: Imugene has Initiated The OASIS Phase 1 Open Label Trial
Imugene has Initiated The OASIS Phase 1 Open Label Trial with CD19 Virus and Blinatumomab Combination treatment for solid cancers + onCARlytics CD19 Bispecific CD19 virus antibody Recruiting 40-45 patients First patient dosed July 2023 at City of Hope Multiple trial sites including; University of Ci
Slide 25: Variety of Approved Therapies Available for Combination with OnCARlytics
Variety of Approved Therapies Available for Combination with OnCARlytics Combination Opportunities OnCARlytics can become the preferred partner for CD19 therapies in solid tumours (~90% of cancer market) First FDA Approved Company Approval Target Cancers B-ALL, Blood 2017 CD19 Auto CAR T DLBCL cance
Slide 26: CD19 Virus Clinical Development Strategy
CD19 Virus Clinical Development Strategy Establish 1 Open Label Phase 1 2 Recommended 3 Phase 2 Phase 2 Dose 2024 2025 2025-2026 Milestones • FPI IT Combo Cohort 1 • Early IT and/or IV Combo data • Optimal Biological Dose (OBD) Established • Phase 2 FPI • OnCARlytics + azer-cel FDA IND and FPI in so
Slide 27: Expected Upcoming Key Catalysts
Expected Upcoming Key Catalysts H2 2024 2025-2026 • azer-cel: Preliminary early DLBCL • azer-cel: DLBCL Phase 1b interim data update Phase 1b data update • azer-cel: Target regulatory meeting with FDA • onCARlytics: FPI IT Combo Cohort 1 • azer-cel: FPI in registration Phase 2/3 study • onCARlytics:
Slide 28: Investment Highlights
Investment Highlights Robust platform technologies supporting 4 clinical trials with >200 patients treated to date in US and Australia, all under FDA INDs Novel platforms in Strong cash Clinical data Deeply Robust and immuno- position of $93 readouts over experienced broad patent oncology, cell mill
Slide 29: Experienced Leadership Team has brought >17 FDA Approved Drugs to Market
Experienced Leadership Team has brought > 17 FDA Approved Drugs to Market Leslie Chong Dr. Paul Woodard, MD Dr. Bradley Glover, PhD Ursula McCurry Dr. John Byon, MD, PhD Dr. Monil Shah Chief Executive Officer Chief Medical Officer MBA Chief Clinical Senior VP of Clinical Head of Business & Managing
Slide 30: Seasoned and Highly Engaged Board Of Directors
Seasoned and Highly Engaged Board Of Directors Diverse expertise, market sector leadership and catalysts for value creation Paul Hopper Dr. Jakob Dupont, MD Leslie Chong Kim Drapkin Dr. Lesley Russell Dr. Jens Eckstein Executive Chairman Board Director CEO & Managing Board Director Non-Executive Boa
Slide 31: Corporate Snapshot
Corporate Snapshot Stock Code ASX IMU Top 15 Shareholders 12 Month Trading Range 3.9-15 cents Paul Hopper 409,071,906 5.50% Market Capitalisation (2 September 2024) $500 million Vanguard 315,683,712 4.24% Shares on Issue 7.4 B Mann Family 265,582,609 3.57% Average Monthly Trading Volume 583 million
Slide 32: ASX : IMU shareholderenquiries@imugene.com imugene.com
ASX : IMU shareholderenquiries@imugene.com imugene.com 32