Arovella Therapeutics Limited · ASX:ALA

Arovella Therapeutics — Investor Presentation (June 2023)

43 slides from Arovella Therapeutics's investor presentation, Jun 7, 2023

  1. Slide 1: Capital Raise Investor Presentation

    For personal use only ASX:ALA Capital Raise Investor Presentation 7 June 2023

  2. Slide 2: Disclaimer

    Disclaimer IMPORTANT INFORMATION Purpose of presentation: This presentation (including this document, any related video or oral presentation, Failure to comply with these restrictions may constitute a violation of applicable securities laws. any question and answer session and any written or oral ma

  3. Slide 3: Disclaimer (cont.)

    Disclaimer (cont.) IMPORTANT INFORMATION Disclaimer: While the information in this presentation has been prepared in good faith with reasonable care, neither Arovella nor its officers, employees, contractors or advisers make any representation or For personal use only warranty (express or implied) a

  4. Slide 4: 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

  5. Slide 5: Arovella Financial Overview

    Arovella Financial Overview Financial Snapshot ALA Price and Volume - 12 Months ASX CODE ALA For personal use only Market capitalisation1 $37.1 million 40,000,000 $0.10 Shares on issue 758.8 million $0.08 30,000,000 52-week low / high $0.020 / $0.105 $0.06 Cash (31 March 2023) $3.2 million 20,000,00

  6. Slide 6: Recent Cell Therapy Transactions

    Recent Cell Therapy Transactions Milestones Total deal Date Type of deal Acquirer/Licensee Target/Licensor Stage Upfront ($M) ($M) value May-23 License Phase Ib $245 undisclosed For personal use only Jan-23 Acquisition Phase I $200 $120 $320 Development Oct-22 Phase II $225* undisclosed collaboratio

  7. Slide 7: What are "CAR-T Cells"?

    What are “CAR-T Cells”?  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 Receptor (CAR) o The CAR

  8. Slide 8: Cell Therapy Has Revolutionized Blood Cancer Treatment

    Cell Therapy 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 $12.3 billion by 20301 For personal use only February 2022 May 2022 Product Approval 2022 Year

  9. Slide 9: But…Manufacturing and Logistics Pose Major Challenges

    But…Manufacturing and Logistics Pose Major Challenges  T cells must originate from the patient to be treated so each manufacturing batch is patient-specific Arovella’s allogeneic CAR-iNKT For personal use only cell platform has the potential to  High manufacturing and supply chain costs lead to hi

  10. Slide 10: Advantages of iNKT Cells

    Advantages of iNKT Cells Cells from a healthy donor can be used to treat patients (no GvHD) iNKT cells Modify the tumour microenvironment and For personal use only kill cells that promote tumour growth Naturally target tumour cells through subpopulation of T cells with properties of invariant TCR (C

  11. Slide 11: The Potential of CAR-iNKT Cells is Untapped

    The Potential of CAR-iNKT Cells is Untapped For personal use only 11 © Copyright Arovella Therapeutics Ltd 2023 Companies with T cell, NK cell, or iNKT cell therapy programs. Source: Company analysis based on public information

  12. Slide 12: 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 Allogeneic Manufacturing Advantag

  13. Slide 13: Arovella's Potential Cancer Targets

    Arovella’s Potential Cancer Targets CD19-CAR CD19-CAR DKK1-CAR For personal use only ALA-101 ALA-101 + onCARlytics ALA-104 Triple Non- Head and Prostate Brain Negative Pancreatic Multiple Hodgkin’s Lung Cancer Neck Cancer Cancer Metastases Breast Cancer Myeloma Lymphoma Cancer  Additional CARs can

  14. Slide 14: CAR19-iNKT (ALA-101)

    CAR19-iNKT (ALA-101) For personal use only An off-the-shelf cell therapy for CD19-expressing cancers © Copyright Arovella Therapeutics Ltd 2023

  15. Slide 15: CD19-expressing Blood Cancers

    CD19-expressing Blood Cancers Incidence Current Treatments ALA-101 solution For personal use only CD19 is commonly expressed on Two 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-expressing cancer cells B

  16. Slide 16: ALA-101: Superior Activity Over CAR-T Cells

    ALA-101: Superior Activity Over CAR-T Cells ALA-101 significantly increased PBS T iNKT CAR19-T ALA-101 survival in mice versus treatment Ventral For personal use only with CAR19-T cells 3 Days  Tumour cells expressing CD19 and CD1d were after intravenously delivered into mice treatment Dorsal  Mic

  17. Slide 17: ALA-101: Spontaneous Secondary Remission

    ALA-101: Spontaneous Secondary Remission ALA-101 activity may persist to For personal use only eradicate tumour cells Ventral following 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

  18. Slide 18: New Data Presented at AACR 2023

    New Data Presented at AACR 2023 Key Highlights: For personal use only  iNKT cells could be well expanded  Following expansion, ALA-101 cells retained the ability to multiply further when exposed to tumour cells that express CD19  Once stimulated, ALA-101 cells express anti-cancer cytokines  ALA-

  19. Slide 19: Summary

    Summary  Arovella’s proprietary manufacturing process allows for efficient expansion of iNKT cells while retaining functionality For personal use only o Essential to produce multiple doses from a single batch and address the manufacturing costs and logistical challenges of current autologous therap

  20. Slide 20: ALA-101 + CF33-CD19

    ALA-101 + CF33-CD19 For personal use only An off-the-shelf cell therapy and oncolytic virus combination to mark and destroy solid tumours © Copyright Arovella Therapeutics Ltd 2023

  21. Slide 21: Combining ALA-101 and CF33-CD19 (onCARlytics)

    Combining ALA-101 and CF33-CD19 (onCARlytics)  ALA-101 is very potent and is rapidly  CF33 is an oncolytic virus that targets activated to kill CD19 expressing cancers1 tumour cells2 For personal use only  The product is being developed as an off-  CF33 has been engineered to induce CD19 the-she

  22. Slide 22: ALA-101 + onCARlytics Mechanism of Action

    ALA-101 + onCARlytics Mechanism of Action For personal use only The research collaboration progressed to in vivo testing based on promising in vitro results 22 © Copyright Arovella Therapeutics Ltd 2023

  23. Slide 23: DKK1-CAR-iNKT Cells (ALA-104)

    DKK1-CAR-iNKT Cells (ALA-104) For personal use only An off-the-shelf cell therapy for multiple myeloma and potentially solid tumours © Copyright Arovella Therapeutics Ltd 2023

  24. Slide 24: DKK1 is a Novel Cancer Target

    DKK1 is a Novel Cancer Target  DKK1 is a secreted protein that functions as a negative regulator of the WNT signaling pathway For personal use only  DKK1 is overexpressed in numerous cancer types and DKK1 peptides are loaded onto immune complexes and presented at the surface of cancer cells  Arov

  25. Slide 25: Milestones FY2024

    Milestones FY2024  Arovella expects to advance ALA-101 into a phase I first-in-human clinical trial during 2024  Arovella also continues to assess novel complimentary technologies to expand the use of the iNKT platform to treat solid tumours For personal use only June December June 2023 2023 2024

  26. Slide 26: 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 Ana Radeljevic CEO & MANAGING DIRECTOR CHIEF OPERATING OFFICER SENIOR VP DEVELOPMENT & SENIOR DIRECTOR BUSINESS DEVELOPMENT TRANSLATIONAL MEDICINE M

  27. Slide 27: 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

  28. Slide 28: Key Risks

    Key Risks The Company considers that the following summary, which is not exhaustive, represents some of the major risk factors which investors ought to be aware of in evaluating the Company’s business and risks: Dependency upon licence agreements Access to the intellectual property rights to develop

  29. Slide 29: Key Risks

    Key Risks Dependence upon key personnel Arovella depends on the talent and experience of its personnel, and it may be difficult to replace them, or to do so in a timely manner or at comparable expense. The loss of services of one or more senior executives may have an adverse effect on the Company’s

  30. Slide 30: Key Risks

    Key Risks Litigation risk In the ordinary course of business, Arovella may be involved in litigation disputes from time to time. These disputes could be brought by third parties including customers, suppliers, business partners and employees, and may adversely impact the financial performance and in

  31. Slide 31: International Offer Restrictions

    International Offer Restrictions ***NOT FOR DISTRIBUTION IN THE UNITED STATES*** International Offer Restrictions For personal use only No action has been taken to register the securities or otherwise permit a public offering of securities in any jurisdiction. The distribution of this document outsi

  32. Slide 32: International Offer Restrictions

    International Offer Restrictions ***NOT FOR DISTRIBUTION IN THE UNITED STATES*** Singapore For personal use only This document and any other materials relating to the New Shares have not been, and will not be, lodged or registered as a prospectus in Singapore with the Monetary Authority of Singapore

  33. Slide 33: Thank You

    Thank You For personal use only Dr. Michael Baker CEO & Managing Director Email: investor@arovella.com Mobile: +61 403 468 187 © Copyright Arovella Therapeutics Ltd 2023

  34. Slide 34: Appendix

    Appendix For personal use only Dr. Michael Baker CEO & Managing Director Email: investor@arovella.com Mobile: +61 403 468 187 © Copyright Arovella Therapeutics Ltd 2023

  35. Slide 35: Development of ALA-101 (CAR19-iNKT Cells)

    Development of ALA-101 (CAR19-iNKT Cells)  Arovella’s lead product is ALA-101, a CD19-targeting CAR-iNKT cell therapy iTCR CD19-CAR For personal use only Targets CD1d Targets CD19  The lentivirus for ALA-101 is manufactured using a third-generation lentiviral vector system  ALA-101 is being devel

  36. Slide 36: CAR19-iNKT Cells Enhanced Primary Tumor Cell Killing

    CAR19-iNKT Cells Enhanced Primary Tumor Cell Killing A. Mantle Cell Lymphoma C. Chronic Lymphocytic Leukemia Cytotoxic activity (%) Patient 1; Donor A Patient 1; Donor B For personal use only DMSO ATRA B. Marginal Zone Lymphoma Patient 1; Donor A Patient 2; Donor B Cytotoxic activity (%) DMSO – dime

  37. Slide 37: CAR19-iNKT (ALA-101) Cells Can Be Expanded

    CAR19-iNKT (ALA-101) Cells Can Be Expanded 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 6000 4000  iNKT cells from a healthy donor were modified to produce a Fold Ex

  38. Slide 38: Expanded iNKT Cells Retain the Ability to Proliferate

    Expanded iNKT Cells Retain the Ability to Proliferate  ALA-101 cells that had been expanded ~5,000 fold were labeled with a fluorescent dye (CTV) With IL-15 Without IL-15 For personal use only  Cells were then exposed to SEM tumour cells that were either positive (CD19+) or negative (CD19-) for CD

  39. Slide 39: ALA-101 Releases Anti-Tumour Cytokines

    ALA-101 Releases Anti-Tumour Cytokines  When stimulated by tumour cells expressing CD19, ALA-101 cells dramatically up-regulated the anti-tumour cytokines Granzyme B, TNF-α and Perforin For personal use only Granzyme B TNF-α Perforin Control Stimulated by CD19+ tumour cells AACR Poster Fig 4(A) 39

  40. Slide 40: ALA-101 Kills Tumour Cells That Express CD19

    ALA-101 Kills Tumour Cells That Express CD19  SEM cells originate from a patient with an aggressive form of B-cell Acute Lymphoblastic Leukemia and express CD19, but not CD1d For personal use only  ALA-101 cells efficiently kill multiple leukemia cells lines, including SEM  ALA-101 eradicated >90

  41. Slide 41: ALA-101 is Effective in an Aggressive Leukemia Model

    ALA-101 is Effective in an Aggressive Leukemia Model For personal use only  ALA-101 was tested in mouse model of B-Cell SEM-luc cells ALA-101 0.5x106 i.v Acute Lymphoblastic Leukemia (B-ALL) model 5x106 cells i.v  Mice were transplanted with SEM cells originating from a patient with an aggressive

  42. Slide 42: ALA-101 Dramatically Reduced Tumour Burden

    ALA-101 Dramatically Reduced Tumour Burden  After 26 days, tumour burden in ALA-101-treated mice was ~90% lower than control animals For personal use only  Bioluminescent imaging reveals substantially lower tumour burden in ALA-101-treated animals on Day 8 ALA-101 #2 NT iNKT #5 Vehicle #3 1.5×10 1

  43. Slide 43: ALA-101 Significantly Increased Animal Survival

    ALA-101 Significantly Increased Animal Survival  ALA-101 significantly enhanced the survival of the mice over untreated controls (p<0.005) For personal use only Vehicle NT iNKT Cells ALA-101 100 Probability of Survival 50 ** P<0.005 0 0 4 8 12 16 20 24 28 32 36 40 Days AACR Poster Fig 5(C) 43 © Cop

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