Arovella Therapeutics Limited · ASX:ALA
Arovella Therapeutics — Non-Deal Roadshow (September 2023)
34 slides from Arovella Therapeutics's roadshow presentation, Sep 6, 2023
Slide 1: ASX Release: Investor Presentation
ASX: ALA Arovella Therapeutics Limited ACN 090 987 250 ASX Release 6 September 2023 INVESTOR PRESENTATION MELBOURNE, AUSTRALIA 6 September 2023: Arovella Therapeutics Ltd (ASX: ALA), a biotechnology company focused on developing its invariant Natural Killer T (iNKT) cell platform to treat cancer, is
Slide 2: Glossary and forward-looking statements
ASX: ALA Arovella Therapeutics Limited ACN 090 987 250 Glossary: iNKT cell – invariant Natural Killer T cells; CAR – Chimeric Antigen Receptor that can be introduced into immune cells to target cancer cells; TCR – T cell receptors are a group of proteins found on immune cells that recognise fragment
Slide 3: Investor Presentation, Non-deal Roadshow, September 2023
For personal use only ASX:ALA Investor Presentation Non-deal Roadshow September 2023
Slide 4: Disclaimer
Disclaimer 1. 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 Arovella Therapeutics Limited (Company). In prepa
Slide 5: Arovella Therapeutics Highlights
Arovella Therapeutics Highlights For personal use only Off-the-Shelf iNKT Cell Platform Lead Product Advancing to Clinic Addressing Key Unmet Need Arovella is developing off-the-shelf iNKT cell ALA-101, a potential treatment for CD19-expressing Arovella’s iNKT cell platform is well therapies to targ
Slide 6: Arovella Financial Overview
Arovella Financial Overview Financial Snapshot ALA Price and Volume - 12 Months ASX CODE ALA For personal use only Market capitalisation1 $55.9 million 40,000,000 $0.10 Shares on issue 901.96 million $0.08 52-week low / high1 $0.020 / $0.105 30,000,000 $0.06 Pro Forma Cash (June 30 2023 + SPP)2 $7.3
Slide 7: Recent Cell Therapy Transactions
Recent Cell Therapy Transactions Upfront Milestones Total deal Date Type of deal Acquirer/Licensee Target/Licensor Cell Type Stage ($M) ($M) value ($M) Aug-23 License1 T Cell Phase 1b $21 $206 $227 Strategic Investment For personal use only Aug-23 T Cell Phase 1 $25 $0 $25 (ROFR) 2 May-23 License T
Slide 8: Arovella is in a Differentiated Sector of Cell Therapy
Arovella is in a Differentiated Sector of Cell Therapy For personal use only 6 Companies with T cell, NK cell, or iNKT cell therapy programs. Source: Company analysis based on public information
Slide 9: CAR-T Cell Therapy is Personalised Medicine
CAR-T Cell Therapy is Personalised Medicine ▪ T cells are a common type of immune cell that fight infections and can help fight cancer For personal use only ▪ To generate autologous CAR-T cells, T cells are taken from a patient with blood cancer and ‘reprogrammed’ to produce a Chimeric Antigen Recep
Slide 10: CAR-T Has Revolutionized Blood Cancer Treatment
CAR-T Has Revolutionized Blood Cancer Treatment ▪ CAR-T cells have demonstrated ability to cure haematological cancers and have generated strong sales ▪ The Cell Therapy market is expected to reach $61.2 billion by 20301 ▪ 40-60% of patients relapse post-CAR-T therapy2 For personal use only Approval
Slide 11: CAR-T Cell Therapies Pose Major Supply Challenges
CAR-T Cell Therapies Pose Major Supply Challenges ▪ T cells must originate from the patient to be treated so each manufacturing batch is patient-specific Arovella’s off-the-shelf CAR-iNKT For personal use only ▪ High manufacturing and supply chain costs lead to high drug cell platform has the potent
Slide 12: Introducing invariant Natural Killer T (iNKT) Cells
Introducing invariant Natural Killer T (iNKT) Cells For personal use only 10
Slide 13: iNKT Cells Represent a Next-Gen Cell Therapy
iNKT Cells Represent a Next-Gen Cell Therapy Front line of the human immune system ▪ Bridge innate and adaptive immune responses For personal use only ▪ Contain both T cell and NK cell killing mechanisms ▪ Naturally target and kill cancers that express CD1d Strong safety profile ▪ They do not cause
Slide 14: CAR-iNKT Cells Have Multiple Ways to Kill Cancer Cells
CAR-iNKT Cells Have Multiple Ways to Kill Cancer Cells For personal use only TAM = Tumour Associated Macrophage; MDSC = Myeloid Derived Suppressor Cell; CAR = Chimeric Antigen Receptor; NK = Natural Killer 12
Slide 15: CAR-iNKT Cell Therapy Production Advantages
CAR-iNKT Cell Therapy Production Advantages MANUFACTURING Collect Healthy Isolate iNKT cells Engineer iNKT cells to Expand to grow billions of Vial and freeze Donor Blood produce a CAR CAR-iNKT cells CAR-iNKT cells For personal use only TREATMENT Thaw CAR-iNKT cells Off-the-shelf Manufacturing Advan
Slide 16: CAR19-iNKT (ALA-101)
CAR19-iNKT (ALA-101) For personal use only A next generation off-the-shelf cell therapy for CD19 expressing cancers
Slide 17: ALA-101: Targeting CD19-expressing Blood Cancers
ALA-101: Targeting CD19-expressing Blood Cancers Incidence Current Treatments ALA-101 solution For personal use only ▪ CD19 is commonly expressed on ▪ Four approved autologous CAR-T ▪ ALA-101 is an off-the-shelf iNKT B cell blood cells, including: products target CD19 cell therapy that targets CD19-
Slide 18: ALA-101: Enhanced Tumour Killing In Vivo
ALA-101: Enhanced Tumour Killing In Vivo ALA-101 rapidly eradicates tumour PBS T iNKT CAR19-T ALA-101 cells in mice For personal use only ▪ Tumour cells expressing CD19 and CD1d were intravenously delivered into mice Ventral ▪ Mice were treated with: Day 0 ▪ PBS (saline) Dorsal ▪ Unmodified T cells
Slide 19: ALA-101: Next Generation Cell Therapy
ALA-101: Next Generation Cell Therapy ALA-101 significantly increased survival in For personal use only mice versus treatment with CAR19-T cells ▪ Tumour cells expressing CD19 and CD1d were intravenously delivered into mice ▪ Mice were treated with: ▪ PBS (saline) ▪ Unmodified T cells (T) ▪ Unmodifi
Slide 20: ALA-101: Spontaneous Secondary Remission
ALA-101: Spontaneous Secondary Remission ALA-101 activity may persist to For personal use only eradicate tumour cells following Ventral relapse ▪ Four mice treated with ALA-101 had the cancer return to the brain Dorsal ▪ In all four mice, the cancer was eliminated a second time with no additional do
Slide 21: ALA-101 Data Confirms Activity and Off-the-shelf Capability
ALA-101 Data Confirms Activity and Off-the-shelf Capability ▪ Arovella’s proprietary manufacturing process facilitates the production of large numbers of potent CAR-iNKT cells For personal use only o Essential to produce multiple doses from a single batch and address the manufacturing costs and logi
Slide 22: iNKT Cells to Target Solid Tumours
iNKT Cells to Target Solid Tumours For personal use only Arovella’s strategy to target and kill solid tumours – 90% of newly diagnosed cancer cases1 1. https://www.cancer.gov/types/common-cancers
Slide 23: iNKT Cell Platform to Target Solid Tumours
iNKT Cell Platform to Target Solid Tumours ALA is actively building the iNKT cell platform to expand into treatment of For personal use only solid tumours ▪ We expect ALA-101 to be effective against blood cancers that naturally express CD19 21
Slide 24: Solid Tumours Pose Challenges to CAR-T
Solid Tumours Pose Challenges to CAR-T ▪ Access to tumour ▪ Antigen specificity and uniformity ▪ Tumour microenvironment contains pro-tumour cells For personal use only TAM = Tumour Associated Macrophage; MDSC = Myeloid Derived Suppressor Cell; CAR = Chimeric Antigen Receptor 22
Slide 25: CAR-iNKT Cells Have Multiple Ways to Kill Solid Tumours
CAR-iNKT Cells Have Multiple Ways to Kill Solid Tumours For personal use only Modification of the tumour microenvironment will be essential for success in solid tumours ▪ iNKT cells: ▪ Home to tissues and infiltrate tumours1,2 ▪ Block or kills cells that promote tumour growth3 ▪ Recruit other immune
Slide 26: Strategy 1: ALA-101 & Imugene's onCARlytics
Strategy 1: ALA-101 & Imugene’s onCARlytics For personal use only Expecting in vivo data in H2 2023 24
Slide 27: Strategy 2: Add Additional CARs for Novel Targets
Strategy 2: Add Additional CARs for Novel Targets MANUFACTURING Collect Healthy Donor Isolate iNKT cells Engineer iNKT cells to produce Expand to grow billions of CAR- Vial and freeze CAR- Blood a CAR iNKT cells iNKT cells For personal use only CARs targeting novel antigens specific for solid tumour
Slide 28: Strategy 3: "Armouring" iNKT cells
Strategy 3: “Armouring” iNKT cells ▪ Adding specialised cytokines to iNKT cells can increase persistence of the cells (how long they last in the body) and increase anti-tumour activity For personal use only ▪ Exclusive Option with University of North Carolina for cytokine technology developed by Pro
Slide 29: Arovella's Expanding Pipeline
Arovella’s Expanding Pipeline CD19-CAR CD19-CAR Novel Targets New CARs can be used to target For personal use only different solid tumour cancers: ▪ E.g. mesothelin, EGFRvIII, IL13α32, GPC3, HEPG2, GD2 ALA-101 1. ALA-101 + onCARlytics 2. Novel Targets 3. Cytokine Technology Non- Head and Prostate Br
Slide 30: Milestones for FY2024
Milestones for FY2024 ▪ Arovella expects to advance ALA-101 into a phase I first-in-human clinical trial during 2024 o Non-Hodgkin’s lymphoma patients, dose escalation, primary end point – DLTs, secondary endpoint – efficacy signals ▪ Arovella also continues to assess novel complimentary technologie
Slide 31: Arovella Has a Strong Leadership Team
Arovella Has a Strong Leadership Team LEADERSHIP For personal use only Dr. Michael Baker Dr. Nicole van der Weerden Dr. Mini Bharathan Dr. Robson Dossa Dr. Simon Poon CEO & MANAGING DIRECTOR CHIEF OPERATING OFFICER SENIOR VP DEVELOPMENT & VP MANUFACTURING & QUALITY DIRECTOR PROJECT TRANSLATIONAL MED
Slide 32: Summary – Arovella's CAR-iNKT Cell Platform
Summary – Arovella’s CAR-iNKT Cell Platform A novel allogeneic CAR-iNKT cell platform Lead product progressing to clinical trials iNKT cells serve as an excellent platform to ALA-101, a potential treatment for CD19-expressing For personal use only develop allogeneic, or “off-the-shelf”, cell blood c
Slide 33: Cell Therapy Deal References
Cell Therapy Deal References 1. https://www.businesswire.com/news/home/20230815091930/en/Precision-BioSciences-Completes-Strategic-Transaction-with-Imugene-for-Azer- Cel-in-Cancer 2. https://www.astellas.com/en/news/28271 3. https://www.jnj.com/janssen-enters-worldwide-collaboration-and-license-agre
Slide 34: Thank You
Thank You For personal use only Dr. Michael Baker CEO & Managing Director Email: investor@arovella.com Mobile: +61 403 468 187
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