Arovella Therapeutics Limited · ASX:ALA
Arovella Therapeutics — Shareholder Meeting (November 2024)
29 slides from Arovella Therapeutics's shareholder meeting presentation, Nov 15, 2024
Slide 1: Chairman's Address and CEO Presentation to Annual General Meeting
ASX: ALA Arovella Therapeutics Limited ACN 090 987 250 ASX Release 15 November 2024 CHAIRMAN’S ADDRESS AND CEO PRESENTATION TO ANNUAL GENERAL MEETING MELBOURNE, AUSTRALIA 15 November 2024: Arovella Therapeutics Ltd (ASX: ALA), a biotechnology company focused on developing its invariant Natural Kille
Slide 2: Notes to Editors: About Arovella Therapeutics
ASX: ALA Arovella Therapeutics Limited ACN 090 987 250 NOTES TO EDITORS: About Arovella Therapeutics Ltd Arovella Therapeutics Ltd (ASX: ALA) is a biotechnology company focused on developing its invariant natural killer T (iNKT) cell therapy platform from Imperial College London to treat blood cance
Slide 3: Chairman's Address
ASX: ALA Arovella Therapeutics Limited ACN 090 987 250 Chairman’s Address The order of events for today’s Meeting will be as follows: • I will firstly provide an overview of Arovella’s performance during the 2024 financial year (FY24) • We will then proceed with the formal business and the resolutions
Slide 4: Chairman's Address (continued)
ASX: ALA Arovella Therapeutics Limited ACN 090 987 250 strategy, leaving us optimistic about an IND filing in the first quarter of the 2025 calendar year. Having an IND secured is a critical step, enabling Arovella to commence our Phase 1 clinical trial for ALA-101. In preparation of our first-in-hu
Slide 5: Chairman's Address closing
ASX: ALA Arovella Therapeutics Limited ACN 090 987 250 Thank you again to all our shareholders for their continued support and faith in the company. We look forward to striving to create additional shareholder value over the next twelve months and the years to come. Dr Thomas Duthy Non-Executive Cha
Slide 6: Annual General Meeting November 2024
ASX:ALA For personal use only Annual General Meeting November 2024
Slide 7: Arovella's Board of Directors
Arovella’s Board of Directors Dr. Tom Duthy Dr. Michael Baker Dr. Debora Barton CHAIRMAN CEO & MANAGING DIRECTOR DIRECTOR Dr Duthy has over 18 years of direct Over 15 years experience in scientific Dr. Barton has over 20 years of oncology For personal use only financial markets experience and is the
Slide 8: CEO & MD address
For personal use only CEO & MD address 3
Slide 9: Disclaimer
Disclaimer 1. The information in this presentation does not constitute personal investment 4. Whilst this presentation is based on information from sources which are advice. The presentation is not intended to be comprehensive or provide all considered reliable, no representation or warranty, expres
Slide 10: Key achievements for FY2024
Key achievements for FY2024 FY24 was a transformative year for Arovella and its proprietary iNKT cell platform For personal use only Completed key manufacturing Completed regulatory steps Continued to enhance activities for ALA-101 in and initiated clinical readiness the iNKT cell platform and prepa
Slide 11: Financial overview
Financial overview Financial Snapshot ALA Price and Volume - 12 Months1 ASX CODE ALA For personal use only Market capitalisation1 $211.51 million 40,000,000 Shares on issue 1,057.6 million $0.18 52-week low / high1 $0.080 / $0.210 30,000,000 Pro-forma Cash Balance (30 Sep, 2024)2 $13.2 million 20,00
Slide 12: Recent cell therapy transactions
Recent cell therapy transactions1 Upfront Milestones Total deal Date Type of deal Acquirer/Licensee Target/Licensor Cell Type Stage (US$M) (US$M) value (US$M) Research May-24 T cell TBD $50 $550 $600 collaboration For personal use only Dec-23 Acquisition T Cell Phase 1b $1,000 $200 $1,200 Collaborat
Slide 13: A differentiated position
A differentiated position T cell and NK cell sectors are competitive For personal use only T cell iNKT cell NK cell Companies with T cell, NK cell, or iNKT cell therapy programs. Source: Company analysis based on public information ASX:ALA 8
Slide 14: Arovella's expanding pipeline
Arovella’s expanding pipeline For personal use only ASX:ALA 9
Slide 15: Clinic-ready manufacturing process developed for ALA-101
Clinic-ready manufacturing process developed for ALA-101 Semi-automated process suitable for large-scale and late-phase clinical development TECHNOLOGY PRE-CLINICAL LENTIVIRUS MANUFACTURING FDA (IND) / PHASE 1 CLINICAL PHASE 2 CLINICAL PLATFORM For personal use only ACQUISITION CONFIRMATION MANUFACT
Slide 16: Successful pre-IND meeting with FDA
Successful pre-IND meeting with FDA ALA is progressing towards its phase 1 study for ALA-101 For personal use only First formal interaction with FDA Positive feedback and clear path forward to submitting an IND for a Included a review of: phase 1 first-in-human clinical trial • Chemistry, Manufactur
Slide 17: Taking ALA-101 into first-in-human trials
Taking ALA-101 into first-in-human trials ALA is progressing towards its ALA-101-001 phase 1 study Ongoing Clinical trial design and For personal use only IND-enabling studies and Regulatory approval and KOL engagement regulatory submission site startup Engagement with key opinion ALA is conducting
Slide 18: Introducing Arovella's Clinical Advisory Board (CAB)
Introducing Arovella’s Clinical Advisory Board (CAB) World class medical oncologists with early phase clinical trial expertise For personal use only Dr Salvatore (Sam) Fiorenza Dr Debora Barton Professor Sattva Neelapu Epworth HealthCare, Melbourne ANIM8 LLC The University of Texas MD Anderson Austr
Slide 19: ALA-101-001: phase 1 first-in-human study
ALA-101-001: phase 1 first-in-human study Dose escalation and dose expansion study in patients with CD19+ blood cancers Patients with relapsed or refractory CD19+ non-Hodgkin’s For personal use only lymphoma (NHL, including DLBCL, FL, MCL, MZL) and Part 1: Dose Escalation CD19+ leukemias (including
Slide 20: iNKT cells to target solid tumours
iNKT cells to target solid tumours For personal use only Arovella is implementing its strategy to target and kill solid tumours – 90% of newly diagnosed cancer cases1 1. https://www.cancer.gov/types/common-cancers 15
Slide 21: Arovella's strategies to combat solid tumours
Arovella’s strategies to combat solid tumours Arovella is using three approaches to expand the iNKT cell platform into solid tumours For personal use only License novel Armour Create unique cancer targets iNKT cells partnerships Identify and license Enhance the Create partnerships new targets that a
Slide 22: New CARs
New CARs Add additional CARs for novel targets Arovella’s manufacturing process can be leveraged for multiple cancer types MANUFACTURING For personal use only Isolate iNKT cells Expand to grow billions of CAR-iNKT cells Collect Healthy Engineer iNKT cells to Vial and freeze Donor Blood produce CARs
Slide 23: Introducing Claudin 18.2 (CLDN18.2)
Introducing Claudin 18.2 (CLDN18.2) A promising solid tumour target For personal use only CLDN18.2 overexpression has been Validated target identified in several with first monoclonal antibody approved in Japan and the types of cancers US in 2024 gastric cancer (GC) gastroesophageal junction cancer
Slide 24: Armouring CAR-iNKT cells
Armouring “Armouring” CAR-iNKT cells IL-12-TM (cytokine technology) enhances CAR-iNKT cell activity in solid tumours For personal use only iNKT cells IL-12-TM IL-12-TM Expand more 10x more Superior and survive circulating anti-tumour for longer CAR-iNKT cells activity IL-12-TM is a modified version
Slide 25: Upcoming milestones for FY2025
Upcoming milestones for FY2025 July July 2024 2025 For personal use only Complete cGMP manufacture for phase 1 and IND-enabling studies Complete preparatory activities for phase 1 study, preparation of Arovella is funded to dose ALA-101 regulatory dossier, engagement with clinical sites and KOLs
Slide 26: Summary
Summary Novel allogeneic Lead product progressing CAR-iNKT cell platform to clinical trials For personal use only iNKT cells serve as an excellent platform ALA-101, a potential treatment for to develop allogeneic, or “off-the-shelf”, CD19+ blood cancers, is being cell therapies to treat cancer progr
Slide 27: Thank You
ASX:ALA For personal use only Thank You Dr. Michael Baker CEO & Managing Director Email: investor@arovella.com Mobile: +61 403 468 187
Slide 28: Cell therapy deal references
Cell therapy deal references 1. https://www.reuters.com/business/healthcare-pharmaceuticals/astrazeneca-signs-drug-development-deal-with-biotech-cellectis-2023-11-01/ 2. https://www.businesswire.com/news/home/20230815091930/en/Precision-BioSciences-Completes-Strategic-Transaction-with-Imugene-for-Az
Slide 29: Thank You
ASX:ALA For personal use only Thank You Email: investor@arovella.com Mobile: +61 403 468 187
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