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IMUGENE LIMITED — Capital/Financing Update 2021
Jul 28, 2021
65124_rns_2021-07-28_a04f544c-2dd9-4209-95db-74fc89f44ad5.pdf
Capital/Financing Update
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A SX : I M U
IMUGENE
Capital Raising Presentation 29 July 2021
Disclaimer
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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.
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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.
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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.
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Any opinions expressed reflect the Company’s position at the date of this presentation and are subject to change
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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.
2
Introduction to Imugene
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2 0 1 8
Licensed extensive B cell portfolio and platform from OSU and Mayo Clinic comprising of PD1, HER1, HER2, HER3, VEGF, IGF-1R, CD28
Imugene is a biotech company headquartered in Australia and publicly traded on the Australian Securities Exchange (ASX:IMU)
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2 0 1 5
Leslie Chong from Genentech 2 0 1 7 joined Imugene HER-Vaxx, our HER-2 targeted B Cell Immunotherapy entered the clinic
2 0 1 3
Paul Hopper built Imugene around a technology that originated from the Medical University of Vienna
2 0 1 9
Completed the acquisition of a prolific oncolytic virus from City of Hope invented by Dr Yuman Fong
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M A Y 2 0 2 1
Licensed onCARlytics from City of Hope invented by Dr Y Fong, Dr S Priceman & Dr A Park
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3
Capital Raising and Use of Funds
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Raising A$95m via a $90m Placement and $5m Share Purchase Plan at A$0.30
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Well capitalised post transaction with pro forma funding position of A$202.3m
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A$95m raised will fund all programs until end of 2025. Potential partnering or licensing deals + R&D rebates have the potential to extend that runway further
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CF33 (oncolytic virus) manufacturing can be brought in house via third party CRO
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Significant capacity to add multiple new assets to the pipeline via acquisition / licensing
Use Of Funds
| HER-Vaxx Clinical Trials | A$9m |
|---|---|
| PD-1-Vaxx Clinical Trials | A$11m |
| CHECKvacc Clinical Trials | A$11m |
| Vaxinia Clinical Trials | A$8m |
| OnCarlytic Clinical Trials | A$26m |
| CMC/CDMO/Manufacturing | A$17m |
| Regulatory | A$3m |
| Working Capital & Costs | A$10m |
| Total | A$95.0m |
Pro Forma Funding Position
| Cash (@ 30 June 2021) | A$29.5m |
|---|---|
| Capital Raising Proceeds1 | A$89.3m |
| IMUOB option proceeds2 | ~A$6.9m |
| IMUOC option proceeds2 | ~A$9.1m |
| IMUOD options proceeds3 | ~A$67.5m |
| Total | A$202.3m |
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1) Assumes full subscription of the offer and net of offer costs 2) Assumes options are fully exercised
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3) Assumes options to be issued with this capital raising are fully exercised
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Investment Highlights
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Three novel technology platforms: Oncolytic virotherapies, onCARlytics in cellular therapy and B-Cell activating immunotherapies
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Highly experienced team in immunotherapy, oncolytic virus and cellular therapies
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3 Programs currently in the Clinic
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Robust IP
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Significant news flow with multiple near & medium term value inflections
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Fully funded to 2025 with significant capacity for further asset acquisitions
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Three Novel Technology
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Platforms
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onCARlytics
CF33 Oncolytic Virus B Cell Immunotherapy
CHECKvacc VAXINIA
CF33-CD19 CAR T Combination Therapy HER-Vaxx PD1-Vaxx
“Armed” Virus Parental Virus
B-Vaxx, PDL1-Vaxx, LAG3-Vaxx,
TIM3-Vaxx, VEGF-Vaxx, CTLA4-Vaxx etc
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Imugene’s Deep Pipeline
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| Pre-clinical | Clinical development Phase 1 |
Clinical development Phase 1 |
Clinical development Phase 1 |
Clinical development Phase 2 |
Clinical development Phase 2 |
Key Data / Results | Intellectual Property |
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|---|---|---|---|---|---|---|---|---|---|---|
| onCARlytics (CF33-CD19) |
• Compelling pre-clinical activity in multiple cancers when combining onCARlytics (CF33-CD19) with CD19 CAR T • Combination of onCARlytics and CD19 CAR T cells promotes endogenous memory T cell responses • No infection in normal cells |
Expiring 2038 | ||||||||
| VAXINIA (CF33-hNIS) Metastatic Advanced solid tumours |
• CF33 has shown strong anti tumour responses in preclinical studies • Inhibition of tumour growth in nearly all NCI60 models in TNBC, Lung, Pancreatic etc. • Signs of increased tumour growth inhibition with CF33 + anti PD-L1 |
Expiring 2037 | ||||||||
| CHECKvacc (CF33-hNIS- aPD-L1) Triple negative breast cancer |
• Pre-clinical studies showed cancer growth inhibition was better than compared to Amgen or • Genelux oncolytic virus • Potentially solves the industry problem of additive toxicity of combined checkpoint inhibitors if safety of CF33 is maintained in combination |
Expiring 2037 | ||||||||
| HER-Vaxx (HER-2) Gastric |
• Successful completion of Phase 1b trials, published in AACR, ASCO GI, ASCO, ESMO GI, ESMO, ESMO Asia 2019 • Strong trial results with no safety or toxicity issues, all patients had increased antibody response, 11/14 evaluable patients with encouraging clinical responses • Phase 2 Interim data: 0.418 HR (80% 2-sided CI: 0.186, 0.942); 14.2 months HER-Vaxx + chemo compared to 8.8 months chemo alone |
Expiring 2036 | ||||||||
| PD1-Vaxx (PD-1) Lung |
• PD1-Vaxx has shown encouraging response in preclinical studies • Strong inhibition of tumour growth in mouse models of colorectal cancer (outperformed industry standard mouse PD-1 mAb) • Signs of increased tumour growth inhibition when co-administered with B-Vaxx • FDA IND approval • First NSCLC patient dosed December 2020 |
Expiring 2037 7 |
International Leadership Team with Extensive Commercialisation Expertise in the Sector
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Imugene has a team with oncology drug development experience
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Leslie Chong
Paul Hopper
SYDNEY, AU
SYDNEY, AU
Managing Director & CEO
Executive Chairman
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Founder and Chairman of Imugene
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23+ years of oncology experience across Phase I – • Founder & Chairman of Chimeric III clinical development Therapeutics programs
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Chairman of SUDA Pharmaceutical
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Ex Senior Clinical Program • Former Chairman of Viralytics Lead at Genentech, one of the world’s most successful • Founder of Prescient & Former biotech businesses which Director sold the best selling breast • Extensive international & ASX cancer drug Herceptin
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Extensive international & ASX
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cancer drug Herceptin biotech capital markets experience
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• Also worked at global majors particularly in immuno-oncology & GSK and Exelixis vaccines
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Non-Executive Director of Cure Brain Cancer Foundation (CBCF) & Chimeric Therapeutics
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Dr Jens Eckstein
CAMBRIDGE, USA
Non-Executive Director
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Managing Partner of Apollo Ventures
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Former president of SR One Ltd., the VC arm of GSK
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15+ years in VC experience funding early to clinical stage biopharmaceutical companies
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Extensive experience as chairman, board director and founder of several biotechnology and venture capital companies.
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Creator of OneStart, the world’s
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largest life science accelerator
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Dr Lesley Russell
PHILADELPHIA, USA
Non-Executive Director
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25+ years of senior international operational and leadership experience having worked at Amgen, Eli Lilly, Teva, and Cephalon
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Extensive knowledge and experience with new drug development
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Non-Executive Director of Enanta Pharmaceuticals.
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Dr Axel Hoos
PHILADELPHIA, USA
Non-Executive Director
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CEO of Scorpion Therapeutics
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Former Senior Vice President and Head of Oncology at GSK
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Former Medical Lead for Yervoy, the first immunooncology treatment to improve first survival .
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Board of Director of TCR[2 ] Therapeutics in Boston
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Chairman of the Sabin Vaccine Institute
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Co-Chair of the Cancer Immunotherapy Consortium Think-Tank
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Charles Walker
BRISBANE, AU
Non-Executive Director
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Experienced listed biotech CEO and CFO (ASX:ACL and ASX:IMU)
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Extensive financial markets experience having executed 50+ cross border transactions
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Clinical experience includes managing pipeline of drugs in all stages from discovery, through to Phase III to product launch
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CEO, Founder and NED of RedEarth Energy Storage
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B-Cell Immunotherapies
B Cell Based Antibodies have Distinct Advantages to Existing Treatments
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| B cell Vaccines offer a unique opportunity to intervene at multiple points in the immune system and create immune memory which enhances durability of response. |
N A T U R A L B C E L L D E R I V E D A N T I B O D I E S |
M O N O C L O N A L A N T I B O D I E S Synthetic Ab, with side effects (including ventricular dysfunction, CHF, anaphylaxis, immune mediation) Monoclonal Ab – may develop anti-drug antibodies Half life necessitates recurrent dosing |
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| Safety | Stimulates the immune system to produce Abs, which may be potentially safer |
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| Efficacy | Polyclonal Ab response reduces risk of resistance and potentially increases efficacy |
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| Durability Usability |
Antibodies continuously produced with lasting immune response to potentially inhibit tumor recurrence |
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| Potentially low numbers of vaccinations required per year |
Requires regular infusion Expensive course of treatment >US$100K per year 1 |
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| Cost | Low cost of production enables greater pricing flexibility facilitating combination |
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Her-Vaxx Phase 2 Recruitment Complete
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Trial
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Phase 2
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Open label
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Asia
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Eastern Europe
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India
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Patients
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HER-2+++
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HER-2++ FISH/CISH +ve
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Advance or metastatic Gastric Cancer
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Stage IIIb/IV
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36 patients in two arms
Study
Randomised
HER-Vaxx in combination
with standard of care chemotherapy Or
Standard of care chemo: Cisplatin and 5FU or capecitabine or oxaliplatin
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Primary Endpoints
- Overall survival
Secondary Endpoints
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Progression-free survival
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Safety and Tolerability
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Immune response
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First patient dosed March 2019/Last patient enrolled Jan 2021
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126 140
Days -21 0 14 21 35 42 63 77 84 105
+42 +63
IMU-131
administration
Chemotherapy
1 2 3 4 5 6
Cycle
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Max 6 cycles SOC chemo with progression assessment every 42 days
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AACR 2021 Presentation Poster
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AACR Presentation
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Highlights
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PFS Endpoint Events met on 21st April 2021
Treatment with HER-Vaxx clearly demonstrates that all patients develop high levels of HER2-specific antibodies early in the treatment protocol.
The constant and high HER2 antibody levels correlate with the early separation of the Kaplan Meier (KM) Curves for overall survival (OS) and progression free survival (PFS) clinical trial endpoints. The Kaplan Meier Curve provides a recognised statistical estimation of the survival function which visually represents the probability of an event occurring for each treatment arm at a respective time interval.
Analysis of the antibody data reveals high levels are maintained during the treatment and maintenance phases, with only minimal booster injections of HER-Vaxx required to maintain the high levels.
Overall, this interim data is suggestive that the treatment is effective and well tolerated with an overall survival benefit that is superior to chemotherapy alone.
Final tumour response, correlation of antibodies with tumour response, and final PFS and OS data is expected to read out in 2021.
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PD1-Vaxx Phase 1: Recruiting Current Status
1st Patient Dosed 1st Patient Dosed Cohort 3 Cleared,
Cohort 1 Cleared Cohort 2 Cleared 1st Patient Dosed
Cohort 1 Cohort 2 RP2D & Expansion
Jan 2021 April 2021 Cohort 3
30 Nov 2020 Feb 2021 Opened
Part 1: Monotherapy Dose Escalation Part 2: Combination Escalation & Expansion (Planned)
Indication Non-small cell lung cancer expressing PD-L1
Objectives Safety & Tolerability, Immunogenicity, OBD Monotherapy
No. of Patients Approx. 12-22 Approx. 12-30
Site Location Australia & USA
M I L E S T O N E S
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Oncolytic Virus CF33
CF33 Mechanism of Action
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Step 1:
Virus enters cell
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Step 2: Step 3:
Virus duplicates itself Cell explodes,
releasing thousands of
brand new virus particles
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HOW A VIRUS KILLS A CELL
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Direct infection, replication within and cancer cell killing
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Viral infection increases local check point targets (PD-1, PD-L1, CTLA4 etc)
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Cell death is immunogenic [surface expression of calreticulin, release of adenosine triphosphate (ATP) and release of high mobility group box 1 (HMGB1)]
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Local anti-PD-L1 expression may allow enhancement of anti-cancer immunotherapy
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Human sodium iodine symporter (hNIS) expression allows additional use of[131] Iodine or[188] Rhenium killing of infected cells and adjacent cells
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CHECKvacc: CF33+hNIS+aPD-L1 (“Armed” Virus)
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Phase 1: Triple Negative Breast Cancer Study – FDA IND cleared
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COHORT | 3-6 PATIENTS
Identify:
COHORT | 3-6 PATIENTS
Recommended Phase 2
Dose (RP2D)
RP2D Expansion
Metastatic Triple Negative COHORT | 3-6 PATIENTS
Based on:
Breast Cancer 12 Patients
COHORT | 3-6 PATIENTS • Safety
• Immunogenicity
• Tumour Response
COHORT | 3-6 PATIENTS
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Disease of need
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Potential target for immunotherapy
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8-13 month survival for metastatic disease • Expresses PD1, with few treatments PD-L1
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Treatment responses to Atezolizumab (JAMA Oncology, 5:74, 2019)
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1st line: 24%; 2nd line: 6%
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Approved by FDA 8 March 2019
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Potential for registration in well-designed, randomised P2 study
Indication TNBC FDA IND CHECKvacc: CF33-hNIS-aPDL1 N Part 1=18-24 ; Part 2=12 Location Single Center: COH Admin Route Intratumoral (IT)
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VAXINIA Phase 1 Mast Study (Metastatic Advanced Solid Tumours)
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Dose Admin Part 1: VAXINIA Monotherapy Part 2: VAXINIA + SOC IO []
Dose Escalation Combination Dose Escalation
IT
IT IV Identify IT IV Identify
IT Administration
Monotherapy Combination
Head & Neck,
Advanced COHORT COHORT Maximum Feasible COHORT COHORT DLT [#] cleared VAXINIA
Melanoma, TNBC 3-6 PATIENTS 3-6 PATIENTS Dose (MFD), 3-6 PATIENTS 3-6 PATIENTS monotherapy dose
based on: combined with IO [] in
IV COHORT COHORT • Safety COHORT COHORT dose escalation cohorts.
3-6 PATIENTS 3-6 PATIENTS • Immunogenicity 3-6 PATIENTS 3-6 PATIENTS Select IO [ ] Combination
IV Administration • Tumour Response for recommended phase
Head & Neck, COHORT COHORT COHORT COHORT 2 dose (RP2D) based on:
Advanced Melanoma, 3-6 PATIENTS 3-6 PATIENTS 3-6 PATIENTS 3-6 PATIENTS • Safety
TNBC, NSCLC, •
Immunogenicity
Bladder, Gastric, •
COHORT COHORT Tumour Response
Colorectal, RCC 3-6 PATIENTS 3-6 PATIENTS
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No. of Patients: Approx. 60-120 Site Location: USA
*IO: Immunotherapy
#DLT: Dose Limiting Toxicity
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onCARlytics CF33-CD19 Cellular Therapy
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N E W C O N C E P T
Utilise OV’s as a delivery vector to deliver CD19 antigen to solid tumour cells
CD19 Targeting domain
Solid Tumour
CD19 CAR T Cells
Engineer Imugene’s CF33 to infect solid tumour cells and insert CD19 transgene to enable presentation of CD19 over the tumour cells during tumour cell infection, onCARlytics (CF33-CD19)
Combination use of autologous or allogeneic CD19 CAR Ts (eg. Novartis KYMRIAH®) with onCARlytics (CF33CD19) presents CD19 targets on solid tumours
OV generated CD19
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How Does the CD19 Oncolytic Virus Work?
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- CD19 ONCOLYTIC VIRUS CD19 ONCOLYTIC VIRUS CD19 CAR T CELLS CANCER CELLS DIE INFECTS SOLID CANCER CAUSES THE SOLID RECOGNISE THE “CD19 CELLS CANCER CELLS TO GROW FLAGS” AND ATTACK THE “CD19 FLAGS” CANCER CELL
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CF33 CD19 Front Cover of Science Translational Medicine Journal in 2020
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solid tumours
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Park AK, Fong Y, Kim SI, Yang J, Murad JP, Lu J, Jeang B, Chang WC, Chen NG, Thomas SH, Forman SJ, Priceman SJ. Sci Transl Med. 2020 Sep 2;12(559): eaaz1863. doi: 10.1126/scitranslmed.aaz18 63.PMID: 32878978
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Four FDA Approved CD19 CAR T’s
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Approved and in-development autologous or allogeneic CD19 CAR Ts can be partnered with Imugene’s onCARlylics for treating solid tumours:
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Milestones
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Technology Milestone onCARlytics 1[st] Patient Dosed Monotherapy ~~Next 12~~ -24 months onCARlytics FDA IND Clearance PD1-Vaxx Combination RP2D onCARlytics GLP Toxicology Study VAXINIA 1st Patient Dosed PD1-Vaxx Expansion combination study FPI HER-Vaxx Phase 2 Final Analysis VAXINIA FDA IND Clearance onCARlytics FDA Pre-IND Meeting PD1-Vaxx Maximum Feasible Dose Identified HER-Vaxx OS Endpoint Met onCARlytics GMP manufacturing for pre-clinical toxicology & Phase 1 study CHECKvacc TNBC IST 1st Patient Dosed CHECKvacc FDA IND Clearance (achieved June, 2021)
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Financial Summary
| Financial Summary | |
|---|---|
| Public Market Overview | |
| Share Price1 | A$0.35 |
| Market Capitalisation2 | A$1,746m |
| Pro Forma Cash equivalents (30 Jun 21)3 |
A$202m |
| Enterprise Value | A$1,544m |
| Top 5 Shareholders(as of May 2021) | |
| Mann Family | 5.93% |
| Paul Hopper | 4.09% |
| Dr Nicholas Smith | 2.40% |
| Ms Leslie Chong | 1.56% |
| Private Portfolio Management | 1.35% |
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Share Price Performance (last 6 months)
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Note:
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As of 22 July 2021
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Market capitalization calculations based on ordinary shares (4.988 bn) only and excludes the dilutive impact of options outstanding (537m) as of 22 July 2021
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Assumes fully subscribed capital raising
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Capital Raising Overview
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Imugene is conducting a capital raising of up to A$95 million via an institutional placement and share purchase plan
| • Placement to raise approximately A$90 million (“Placement”) | |
|---|---|
| Placement | • Approximately 300m new Shares under the Company’s existing placement capacity under ASX |
| Listing Rules 7.1 | |
| • The offer price of A$0.30 per share (“Offer Price”) represents: | |
| Placement Pricing | • A discount of 9.1% to the last close of A$0.33 on 26 July 2021 |
| • A discount of 13.3% to the 30-day VWAP of A$0.346 up to and including 26 July 2021 | |
| • Imugene intends to offer eligible shareholders an opportunity to subscribe for up to A$15,000 of new | |
| Share Purchase Plan | Shares under a Share Purchase Plan (SPP) at a price per Share equal to the Offer Price |
| • It is intended the SPP will be capped at approximately A$5 million | |
| • Participants will receive one free attaching option for every two Placement or SPP shares | |
| Attaching Option | • The option is intended to be listed on the ASX with an exercise price of A$0.45 and expiry date of 31 |
| August 2024 | |
| Ranking | • New Shares issued under the Placement will rank pari passu with existing Shares from their date of issue |
| Lead Manager | • Bell Potter Securities Limited |
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Offer Timetable
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| Event | AEST |
|---|---|
| Trading halt | Tuesday, 27 July 2021 |
| Record Date for SPP | Wednesday, 28 July 2021 |
| Placement announced & Shares resume trading on ASX | Thursday, 29 July 2021 |
| Placement settlement of new Shares | Wednesday, 4 August 2021 |
| Placement issue of new Shares | Wednesday, 4 August 2021 |
| SPP opens | Wednesday, 4 August 2021 |
| SPP closes | Wednesday, 18 August 2021 |
| Issue of new Shares under SPP | Friday, 20 August 2021 |
The timetable is indicative only and subject to change by the Company and Lead Manager
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Leslie Chong Managing Director & CEO [email protected] +61 458 040 433
Release authorised by the Managing Director and CEO