Arovella Therapeutics Limited · ASX:ALA

Arovella Therapeutics — Investor Presentation (June 2021)

41 slides from Arovella Therapeutics's investor presentation, Jun 18, 2021

Slide 1: Licence for a Therapeutic CAR-iNKT Cell Therapy Platform to Treat Cancer
Licence for a Therapeutic CAR-iNKT Cell Therapy Platform to Treat Cancer June 2021 © Copyright SUDA Pharmaceuticals Ltd 2021
Slide 2: 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 Suda Pharmaceuticals Limited (Company). In prepar
Slide 3: Significant Transaction Highlights
Significant Transaction Highlights SUDA Pharmaceuticals acquires “supercharged” invariant Natural Killer T (iNKT) cell therapy platform placing SUDA at the forefront of immuno-oncology drug development and expands the Company’s development pipeline and potential. ▪ A new dual-target cell therapy pla
Slide 4: The Inventor – Imperial College London, UK
The Inventor – Imperial College London, UK Imperial College London: ▪ Consistently ranked one of the top 10 Universities in the world ▪ Voted 10th most innovative University by Reuters1 ▪ Since its foundation, application of its work to industry, commerce and healthcare is central to its mission ▪ T
Slide 5: CAR-iNKT Platform Highlights
CAR-iNKT Platform Highlights CAR-iNKT cell therapy Additional CARs ▪ Chimeric Antigen Receptor (CAR) invariant Natural Killer T (iNKT) cell therapy – CAR-iNKT – has been developed for the treatment of cancer ▪ CD19 ▪ iNKT cells naturally target cancer cells and by introducing a CAR, they are dual ta
Slide 6: How does the CAR-iNKT Cell Platform Work?
How does the CAR-iNKT Cell Platform Work? 1. iNKT cells contain an iTCR 2. We introduce a chimeric 3. CAR-iNKT cells are activated 4. The cancer cell is killed that naturally assists to antigen receptor (CAR) to after they attach to the cancer recognise and kill cancer target cancer cells, making ce
Slide 7: CAR19-iNKT Cells: Enhanced Tumour Killing In Vivo
CAR19-iNKT Cells: Enhanced Tumour Killing In Vivo CAR19- In vivo anti-tumour activity of CAR19-iNKT PBS T iNKT CAR19-T iNKT after three days ▪ Tumour cells expressing CD1d were intravenously delivered into mice ▪ Mice were treated with: Day 0 ▪ Nothing (PBS) ▪ Unmodified T cells (T) ▪ Unmodified iNK
Slide 8: CAR19-iNKT Cells: Superior Animal Survival
CAR19-iNKT Cells: Superior Animal Survival In vivo anti-tumour activity of CAR19-iNKT cells ▪ Tumour cells expressing CD1d were intravenously delivered into mice ▪ Mice were treated with, Nothing (tumour only), Unmodified T cells (T) Unmodified iNKT cells (iNKT) CAR19 T cells or CAR19-iNKT cells ▪ A
Slide 9: CAR19-iNKT Cells Demonstrate Spontaneous Remission
CAR19-iNKT Cells Demonstrate Spontaneous Remission In vivo anti-tumour activity of CAR19- iNKT cells following relapse ▪ Tumour cells expressing CD1d were intravenously delivered into mice ▪ Four mice treated with CAR19-iNKT cells had the cancer return to the brain ▪ In all four mice, the cancer was
Slide 10: The Benefits of “Off-the-shelf” Cell Therapy
The Benefits of “Off-the-shelf” Cell Therapy SUDA’s technology Current technology Traditional CAR-T cell therapy manufacturing processes are complicated and expensive, requiring every patient’s immune cells to be collected, frozen, genetically modified, expanded to sufficient numbers and frozen agai
Slide 11: CAR-iNKT Cells are Engineered to Enhance Activity
CAR-iNKT Cells are Engineered to Enhance Activity APPROVED ALLOGENIC CAR-iNKT CAR-T CAR-T CELLS THERAPIES THERAPIES Intrinsic anti-cancer receptor (dual targeting) Persistence TBD Minimal Genetic Engineering Low Risk of GVHD TBD Low Risk of CRS or Neurotoxicity Allogenic, ‘Off-the-shelf’ Manufacturi
Slide 12: Technology Highlights
Technology Highlights CAR-iNKT cell therapy There are a number of All-trans retinoic acid By introducing one or is a novel haematological (ATRA) can stimulate two CARs, iNKT cells immunotherapy malignancies and cancer cells to have two or three platform developed to solid tumours that increase the a
Slide 13: Robust Intellectual Property Position
Robust Intellectual Property Position FOUNDATION PATENT ▪ PCT: GB2019/050570 ▪ Method of manufacture, cell population claims ▪ Title: Transduction and Expansion of Cells ▪ Applicant: Imperial College of Science Technology and Medicine ▪ Patent applications have been filed in the US, Canada, China, E
Slide 14: Recent Commercial Activity for iNKT Cell Therapies
Recent Commercial Activity for iNKT Cell Therapies Acquisition Capital Raise May 2021 May 2021 US$70m upfront US$52m US$115m milestone payments Series A Early Phase 1 Pre-clinical ▪ The CAR-T Cell Therapy market is expected to reach ~US$13.6 billion by 2026 growing at a CAGR of 56.2% from 2018 to 20
Slide 15: Valuation of Early-Stage Cell Therapy Companies
Valuation of Early-Stage Cell Therapy Companies Company Exchange Valuation (AU$m)1 Number of Cell Stage of Lead Cell Therapy Products2 Therapy NASDAQ $1072 5 Phase 1 NASDAQ $1456 1 Phase 1 NASDAQ $820 5 Phase 1 NASDAQ $582 4 Phase 1 ASX $99 1 Phase 1 ASX $99 3 Preclinical 1.As of June 16th, 2021 2.
Slide 16: CAR-iNKT Cell Therapy News Flow
CAR-iNKT Cell Therapy News Flow 12 – 24 months ▪ Recruit cell therapy manufacturing expert ▪ Select GMP manufacturer ▪ GMP manufacturing of CAR19-iNKT cells for phase 1 clinical trial ▪ FDA pre-IND meeting ▪ FDA IND clearance ▪ Dose first patient in Phase 1 clinical trial for non-Hodgkin’s lymphoma
Slide 17: Expanding our Drug Development Portfolio
Expanding our Drug Development Portfolio Regulatory Sales Drug Feasibility Preclinical Clinical trials Approved Submissions (Royalties) CAR19-iNKT cells Second CAR-iNKT target iNKT cell platform (blood cancers) Additional Targets Additional Diseases Anagrelide (solid tumours) ZolpiMist (insomnia)* S
Slide 18: Board & Senior Management
Board & Senior Management Chairman CEO & Managing Director Executive Director Director Paul Hopper Dr. Michael Baker David Phillips David Simmonds Over 25 years experience in the Over 15 years experience in scientific Senior Business Development Executive David was a senior audit partner with medica
Slide 19: Summary
Summary Exclusive global rights - iNKT cell therapy platform Potential to produce an ‘off-the-shelf’ product SUDA Pharmaceuticals Ltd has secured the iNKT cells have been shown to be protective exclusive, global rights to the iNKT cell therapy against acute graft-versus host disease (GVHD). platform
Slide 20: Contact
CONTACT Dr Michael Baker The CFO Solution CEO & Managing Director Level 3, 62 Lygon Street Email: mbaker@sudapharma.com Carlton VIC 3053 Mobile: +61 403 468 187 (T) +61 8 6142 5555 (F) +61 8 9443 8858 © Copyright SUDA Pharmaceuticals Ltd 2021
Slide 23: What is CAR-iNKT Cell Therapy?
What is CAR-iNKT Cell Therapy? Licensed to Kill ▪ Modification of immune cells by introducing CARs has revolutionized cancer treatment ▪ There are 5 CAR-T cell products that have been approved by the FDA ▪ CAR-iNKT cell therapies use CARs to drive the iNKT cells to target and destroy cancer cells. T
Slide 24: CAR-iNKT Cells for the Treatment of Cancer
CAR-iNKT Cells for the Treatment of Cancer ▪ iNKT cells have been studied extensively and are a subset of immune cells that are typically found in very low abundance ▪ iNKT cells have a T Cell Receptor (TCR) that enables them to recognize specific cancer cells that have glycolipid-bound CD1d on thei
Slide 25: CAR19-iNKT Cells to Treat Blood Cancers
CAR19-iNKT Cells to Treat Blood Cancers ▪ In the US in 2021, it is anticipated that more than 81,000 people will be diagnosed with Non-Hodgkin’s Lymphoma (NHL; a type of blood cancer) and more than 20,000 people will die from the disease1 ▪ CAR19-iNKT cells have two ways to attach to cancer cells du
Slide 27: iNKT Cells Protect Against Graft Versus Host Disease
iNKT Cells Protect Against Graft Versus Host Disease 2017 2017 2016 2015 2015 Front Immunol Leukemia Blood Blood Blood 2017 July 31;8:900 2017 Apr;31(4):903-912 2016 Apr 7;127(14):1828-35 2015 May 28;125(22):3374-3375 2015 May 28;125(22):3491-3500 Invariant Natural Killer T Cells As Pre-transplant d
Slide 28: Use of iNKT Cells in Clinical Trials
Use of iNKT Cells in Clinical Trials 2020 2017 2013 2012 2011 2011 2011 Nat Med Clin Cancer Res. Blood J Clin Immunol. Clin Cancer Res. Clin Immunol. Cancer Immunol Immunother. 2020 Nov;26(11):1686-1690. 2017 Jul 15;23(14):3510-3519 2013 Jan 17;121(3):423-430 2012 Apr 26;32(5):1071-81 2011 Aug 1; 17
Slide 29: In Vivo Safety Evaluation – No Reduction in Body Weight
In Vivo Safety Evaluation – No Reduction in Body Weight CAR19-iNKT cells do not elicit adverse effects in preclinical mouse tumour models Mice Body Weight ▪ No body weight loss ▪ Data in mouse models did not show off target effects ▪ No histological changes in normal tissues ▪ Beside the profound an
Slide 31: CAR19-iNKT Cells Kill non-CD1d Expressing Cancer Cells
CAR19-iNKT Cells Kill non-CD1d Expressing Cancer Cells Tumour cells that express CD19 but not CD1d were treated with CAR19-T cells or CAR19-iNKT cells. CAR19-iNKT cells (pink line) performed as well as CAR19-T cells (black line) at killing tumour cells that lack CD1d on their surface Rotolo et al.,
Slide 32: CAR19-iNKT Cells Show Superior Killing Activity to CAR-T Cells
CAR19-iNKT Cells Show Superior Killing Activity to CAR-T Cells Mantle Cell Lymphoma (MCL) and Marginal Zone Lymphoma (MZL) cells were isolated from cancer patients and subjected to treatment with CAR19-iNKT cells or CAR19-T cells. CAR19-iNKT cells (red line) outperformed CAR19-T cells (blue line) in
Slide 34: CAR-iNKT Cell Therapy Development Plan
CAR-iNKT Cell Therapy Development Plan Lead Product ▪ Construct: CAR19-iNKT cells to treat blood cancers (non-Hodgkin’s lymphoma) ▪ Stage: Robust activity in animal models (published in Cancer Cell), manufacturing pathway identified ▪ Remaining Activities: Select the best performing construct and de
Slide 36: Chimeric Antigen Receptor (CAR) Cell Therapy Revolution
Chimeric Antigen Receptor (CAR) Cell Therapy Revolution CAR-T Revolution Product Approval Year 2020 Revenue Due to their impressive cure rates, CAR-T cell therapies have revolutionised the treatment of cancer. As of June 2021, there are five approved CAR-T products to 2017 US$474m1 treat a number of
Slide 37: Recent Preclinical Cell Therapy Transactions
Recent Preclinical Cell Therapy Transactions Date Party 1 Party 2 Upfront Payment Milestone Payments US$185m per Jun 2014 US$80m product Feb 2016 US$105m US$1.6b Dec 2017 US$175m US$322m Jan 2020 US$50m US$847m Dec 2020 US$71m US$610m Feb 2021 US$40m US$300m 37 © Copyright SUDA Pharmaceuticals Ltd 2
Slide 39: Major Cell Therapy Capital Raises
Major Cell Therapy Capital Raises Company Date Amount (US$m) ▪ Over US$4 billion has been Appia Bio May-21 $52 raised for cell therapy products since 2014 Century Therapeutics Apr-21 $160 ▪ Immuno-oncology continues Artiva Biotherapeutics Feb-21 $120 to be a very commercially relevant area with cont
Slide 40: Multiple Value Realisation Pathways
Multiple Value Realisation Pathways $ Sale of the Company Strategic Partnership Develop Independently with Big Pharma 40 © Copyright SUDA Pharmaceuticals Ltd 2021
Slide 41: Glossary
Glossary ▪ Antigen = Any substance that induces the immune system to produce antibodies against it is called an antigen. Any foreign invaders, such as pathogens (bacteria and viruses), chemicals, toxins, and pollens, can be antigens. ▪ alpha-galactosylceramide (aGalCer) = is a specific ligand for hu

Arovella Therapeutics — Investor Presentation (June 2021) on 6ix

Arovella Therapeutics — Investor Presentation (June 2021)

Slide 1: Licence for a Therapeutic CAR-iNKT Cell Therapy Platform to Treat Cancer

Slide 2: Disclaimer

Slide 3: Significant Transaction Highlights

Slide 4: The Inventor – Imperial College London, UK

Slide 5: CAR-iNKT Platform Highlights

Slide 6: How does the CAR-iNKT Cell Platform Work?

Slide 7: CAR19-iNKT Cells: Enhanced Tumour Killing In Vivo

Slide 8: CAR19-iNKT Cells: Superior Animal Survival

Slide 9: CAR19-iNKT Cells Demonstrate Spontaneous Remission

Slide 10: The Benefits of “Off-the-shelf” Cell Therapy

Slide 11: CAR-iNKT Cells are Engineered to Enhance Activity

Slide 12: Technology Highlights

Slide 13: Robust Intellectual Property Position

Slide 14: Recent Commercial Activity for iNKT Cell Therapies

Slide 15: Valuation of Early-Stage Cell Therapy Companies

Slide 16: CAR-iNKT Cell Therapy News Flow

Slide 17: Expanding our Drug Development Portfolio

Slide 18: Board & Senior Management

Slide 19: Summary

Slide 20: Contact

Slide 21: Appendix

Slide 22: CAR-iNKT Cell Therapy

Slide 23: What is CAR-iNKT Cell Therapy?

Slide 24: CAR-iNKT Cells for the Treatment of Cancer

Slide 25: CAR19-iNKT Cells to Treat Blood Cancers

Slide 26: Evidence of Safety

Slide 27: iNKT Cells Protect Against Graft Versus Host Disease

Slide 28: Use of iNKT Cells in Clinical Trials

Slide 29: In Vivo Safety Evaluation – No Reduction in Body Weight

Slide 30: Evidence of Activity Against Cancer Cells

Slide 31: CAR19-iNKT Cells Kill non-CD1d Expressing Cancer Cells

Slide 32: CAR19-iNKT Cells Show Superior Killing Activity to CAR-T Cells

Slide 33: iNKT Cell Therapy Development Plan

Slide 34: CAR-iNKT Cell Therapy Development Plan

Slide 35: Commercial Opportunity

Slide 36: Chimeric Antigen Receptor (CAR) Cell Therapy Revolution

Slide 37: Recent Preclinical Cell Therapy Transactions

Slide 38: Notable CAR-T Transactions

Slide 39: Major Cell Therapy Capital Raises

Slide 40: Multiple Value Realisation Pathways

Slide 41: Glossary