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IMUGENE LIMITED — AGM Information 2024
Nov 13, 2024
65124_rns_2024-11-13_b1cf70d3-ebf7-4a94-a203-b72db605c285.pdf
AGM Information
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Leading Innovation in Cancer Treatment
AGM, November 2024
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Disclaimer
The information in this presentation does not constitute personal investment advice. The presentation is not intended to be comprehensive or provide all information required by investors to make an informed decision on any investment in Imugene Limited (Company). In preparing this presentation, the Company did not take into account the investment objectives, financial situation and particular needs of any particular investor.
Further advice should be obtained from a professional investment adviser before taking any action on any information dealt with in the presentation. Those acting upon any information without advice do so entirely at their own risk.
Whilst this presentation is based on information from sources which are considered reliable, no representation or warranty, express or implied, is made or given by or on behalf of the Company, any of its directors, or any other person about the accuracy, completeness or fairness of the information or opinions contained in this presentation. No responsibility or liability is accepted by any of them for that information or those opinions or for any errors, omissions, misstatements (negligent or otherwise) or for any communication written or otherwise, contained or referred to in this presentation.
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Neither the Company nor any of its directors, officers, employees, advisers, associated persons or subsidiaries are liable for any direct, indirect or
consequential loss or damage suffered by any person as a result of relying upon any statement in this presentation or any document supplied with this presentation, or by any future communications in connection with those documents and all of those losses and damages are expressly disclaimed.
Any opinions expressed reflect the Company’s position at the date of this presentation and are subject to change
International offer restrictions - This document does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States or any other jurisdiction in which it would be unlawful. In particular, the New Shares have not been, and will not be, registered under the US Securities Act of 1933 and may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements of the US Securities Act and applicable US state securities laws. The distribution of this presentation in jurisdictions outside Australia may be restricted by law and any such restrictions should be observed.
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Imugene is a clinical stage cancer company developing three drug products in CAR T cell therapy and oncolytic viruses.
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Seasoned and Highly Engaged Board Of Directors
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Diverse expertise, market sector leadership and catalysts for value creation
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Paul Hopper
Executive Chairman and Founder
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Dr. Jakob Dupont, MD
Non-Executive Director
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Leslie Chong
Kim Drapkin
CEO & Managing Non-Executive Director Director and Chair of the Audit & Risk Committee
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Dr. Lesley Russell
Non-Executive Director
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Dr. Jens Eckstein
Non- Executive Director and Chair of the Remuneration & Nomination Committee
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Experienced Leadership Team has brought > 17 FDA Approved Drugs to Market
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Leslie Chong
Dr. Paul Woodard, MD
Dr. Bradley Glover, PhD MBA
Ursula McCurry
Dr. John Byon, MD, PhD Senior VP of Clinical Development
Chief Executive Officer & Managing Director
Chief Medical Officer
Chief Clinical Chief Operating Officer Operations Officer
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Dr. Monil Shah
Head of Business Development (consultant)
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Investment Highlights
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Market Capitalisation A$342M Cash Position As of 13 November 2024 PLATFORM LONGTECHNOLOGIES 4 LIFE PATENT PORTFOLIO azer-cel Ph1b DLBCL (FDA IND) CLINICAL VAXINIA: Ph1 Solid Tumours (FDA IND) 4 STUDIES onCARlytics: Ph1 Solid Tumours (FDA IND) > 200 cancer patients dosed PD1-Vaxx: Ph2 neoPOLEM
Cash Position As of 30 September 2024
A$54.3M (Pro-forma) DISEASE AREAS
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Blood cancers Breast (TNBC) Lung (NSCLC) Gastric Gastroesophageal Colorectal (CRC) Melanoma Head and Neck Cholangiocarcinoma Pancreatic Bladder
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Three Novel Cancer Technologies In Clinical Trials
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onCARlytics CD19 targeting virus OASIS Trial
CF33 Oncolytic Virus azer-cel CD19 CAR T VAXINIA MAST Trial Phase 1b Phase 1
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 cancers Targeting a range of late-stage solid Targeting blood cancers cancers Makes solid cancers visible to CD19 drugs Positive Phase 1 data in 84 patients Phase 1 trial with >40 patients enrolled Currently in Phase 1 in combination with Blinatumomab (Approved CD19 drug in blood cancers) in solid cancers Encouraging results in bile tract cancer Currently in Phase 1b FDA IND FDA IND FDA IND
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What is Autologous CAR T Therapy?
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A cancer treatment in which a patient’s T-cells are reprogramed in a laboratory so that they become like a guided missile to attack certain proteins (ie CD19) on the cancer cells − CAR T stands for chimeric antigen receptor T-cell. Currently many CD19 targeted auto CAR Ts are approved and only in blood cancers.
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blood
Patient’s T-cells
cancer cell
reprogrammed CAR T CD19
into CD 19
T-cells taken from targeted CAR T
patient’s blood
Two types of CAR Ts
CD19
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Personalised aka Off the shelf aka allogeneic /allo
autologous /auto. Made from healthy donor T-cells
Made from the patient’s own T- that provide CAR T drug that
cells and only works for them works for many patients
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What is Imugene’s azer-cel Allogeneic CAR T?
Azer-cel is currently enrolling patients with a rare form of blood cancer known as diffuse large B cell lymphoma (DLBCL) for patients who have failed approved treatments
Approximately 30,000 cases (US) per year of DLBCL blood cancer[1]
Azer-cel is an
‘off-the-shelf’ CAR T drug,
aka allogeneic, which is made from healthy donor T-cells that provide CAR T drug that works for many patients
CAR T drugs have revolutionised treatments for blood cancer
The large Phase 1 trial demonstrated safety and encouraging signs of efficacy
Currently in a Phase 1b trial in leading US and Australian centres
A Phase 1 clinical trial in 84 patients was completed across twelve leading cancer centres in the US
The technology was acquired in September 2023
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Hold space for Paul
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1https://ascopost.com/news/november-2023/novel-strategy-may-improve-outcomes-in-patients-with-treatment-resistant-dlbcl/
67% Complete Response Rates Observed in Phase 1b Cohort B
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Evaluable patients: Evaluable Evaluable Cohort A+B patients: patients: (N=9) Cohort A (N=6) Cohort B (N=3) Overall Response 4 (44%) 2 (33%) 2 (67%) Rate % Complete 3 (33%) 1 (17%) 2 (67%) Response % Best Durability >120 days on (Time of <60 days going response)
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Cohort B Results
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The first 2 patients treated achieved a complete response (CR), 1 patient had stable disease (SD), 1 patient yet to be evaluated
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Responses were seen in patients who failed multiple prior treatments, including autologous CAR T therapies
1Lymphodepletion(LD)/chemotherapy: Aug Cy: Flu 30mg/m2 x 3d, Cy 750mg/m2 x 3d
- Phase 1b trial continues to enrol patients into Cohort B across leading cancer centres in the U.S. and Australia including, Columbia University, University of Minnesota, Emory and Moffitt Cancer Centres and Royal Price Alfred Hospital
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Representative PET Scans Of Complete Responses
Subject Treatment Summary
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47 yo female, first diagnosed with High-grade B- cell lymphoma (HGBCL), stage IV in Jul 2022. Treated at Emory University.
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Prior to azer-cel, patient failed 4 prior lines of therapy; R-CHOP; R-DHAP, Yescarta , and Prednisone
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Pathologist report revealed neoplastic cells were positive (90%) for CD19 by flow
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Azer-cel treatment regimen
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Augmented Cy conditioning regimen (750 mg/m2/d (3d) Cyclophosphamide i.v. + 30 mg/m2/d (3d) fludarabine iv) + low dose SC IL-2
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DL4b (500 x 106 CAR T cells )
Tumour-free
Tumour
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Baseline
Day 28
Day 60
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Day 90
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Notable Safety Events–No CRS/ICANS
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Response – CR @ D28, D60 & D90
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CF33 VAXINIA Can Infect and Kill Cancer Cells
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Cell explodes, releasing thousands of brand new virus particles
Virus duplicates itself
Virus enters tumour cell
Engineering enhancements
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Infect and kill only cancer cells
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Carry payloads to increase killing
Multiple ways to kill cancer cells
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Direct killing
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Activation of immune cells to kill cancer cells
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Priming the tumour environment to enhance immune response[1]
Precedent for approval
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Tvec approved in the United States for skin cancer (2015)
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Oncorine approved in China for head and neck cancer (2005)
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Delytact approved in Japan for brain cancer (2021)
TME: tumour microenvironment 1. Ribas et al., Cell 170:1109, 2017
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Phase 1 MAST Trial − Encouraging Early Signals
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Patients[1]
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40 patients have been dosed and evaluated (at least their first scan at day 42)
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Disease Control So Far
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Nearly half of the evaluable patients (48%) have remained on treatment for >3 months
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3 patients have remained on treatment for >200 days
Responses
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Patient with bile tract cancer who had a complete response (CR); ongoing remission for >2 years
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2 patients with melanoma had partial responses (PRs); 17 patients achieved stable disease (SD)
Bile Tract Trial
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Bile tract cancer expansion trial opened based on positive response
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First cohort cleared, establishing safety
Fast Track and Orphan Drug Designation
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US FDA Fast Track Designation for bile tract cancer, which allows for faster review
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US FDA Orphan Drug Designation for bile tract cancer, which allows for further efficiencies
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FAST TRACK Orphan Drug Designation Designation
1Preliminary study update as of June 2024; data and number of evaluable patients subject to change with full statistical analysis
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What is Imugene’s onCARlytics CD19 virus?
Imugene’s novel onCARlytics CD19 virus, makes a solid cancer “resemble” a CD19 blood cancer cell, and lures FDA approved anti-CD19 CAR T drugs, to attack them
Solid cancers do not have the CD19 molecule on their cell surface
IMU’s CD19 virus causes solid cancers to display (create a target) the CD19 molecule on their cell surface
This makes them a killing target for anti-CD19 CAR T blood cancer drugs
Insert CD19 CD19 virus CD19 displayed on virus infects cell cell surface
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Cancer cell appears as a
CD19 target
CD19
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CD19 drug “sees” solid
cancer cell and
attacks & kills
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Solid Cancer Cell
Solid Cancer Cell
Solid Cancer Cell
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Solid Cancer Cell
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E.g. Breast, Melanoma, Lung, Gastric etc.
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2024 Highlights
azer-cel : Three Complete Responses in azer-cel Phase 1B DLBCL trial
azer-cel : First Australian site open for Phase 1b Clinical Trial
VAXINIA : Positive early trial update; 1 CR (in remission for over 2 years), 2 PRs, All treatments determined to be safe and tolerable
VAXINIA : Orphan Drug Designation for treatment of Bile Tract Cancer, giving 7 years of market exclusivity
VAXINIA : Bile Tract cancer trial open and first cohort cleared
VAXINIA : Oncolytic Virotherapy CF33 patent granted in China and CF33 patent extension to 2040 in US
onCARlytics : OASIS IV and IT Monotherapy cohort cleared
onCARlytics : OASIS Combination arm open, FPI in IV and IT Combo
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Key
DLBCL : Diffuse Large B-Cell Lymphoma (Blood Cancer)
CR: Complete Response PR: Partial Response FPI: First Patient In Combo : Combination Therapy Mono : Monotherapy
IT : Intratumoural, IV : Intravenous
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Expected Upcoming Key Catalysts H2 2024/2025
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azer-cel : DLBCL Phase 1b interim data update
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azer-cel : Target regulatory meeting with FDA
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azer-cel : FPI in Phase 2 study
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azer-cel : Expansion into additional blood cancers (Phase 1b Expansion Cohort)
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onCARlytics : IT and/or IV Combo status
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onCARlytics : Data update and trial expansion
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onCARlytics: Optimal Biological Dose (OBD) Established
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onCARlytics + azer-cel FDA IND and FPI in solid tumours
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onCARlytics: Phase 2 Start-up
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VAXINIA : Second indication trial open
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- VAXINIA: Optimal Biological Dose Established for IT and/or IV monotherapy
Key
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VAXINIA: Phase 2 Study Open
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VAXINIA : Phase 2 FPI
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VAXINIA : IP & IA Phase 1 FPIs
FPI: First Patient In
Combo : Combination Therapy Mono : Monotherapy
DLBCL : Diffuse Large B-Cell Lymphoma (Blood Cancer)
IT : Intratumoural, IV : Intravenous
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Imugene Commercialisation Strategy Multiple Value Realisation Pathways
They often manage more COMPANY ACQUISITION money than hedge funds or mutual funds
Due to the network effect, each financial advisor represents hundreds of potential shareholders DEVELOP /
PARTNER WITH BIG These investors have the They make decisions quickly LICENSE ability to purchase stock PHARMA without the bureaucracy of TECHNOLOGIES immediately traditional investment firms SEPARATELY
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The global model for biotech commercialisation is to out-license the technology to Big Pharma in Phase 1b/2 trials
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Conducting Phase 3 trials, obtaining FDA approval for the product not within the remit of biotech
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Out-licensing is highly dependent upon demonstrating safety in Phase 1 and convincing signals of efficacy in Phase 1b/2
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Licensing deals are generally structured with an up-front cash payment, payments upon reaching certain development milestones such as entering Phase 3 trials, payment on FDA approval of the drug, and royalties on net sales when the drug is on the market
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ASX : IMU
[email protected] imugene.com
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