Arovella Therapeutics Limited · ASX:ALA
Arovella Therapeutics — Monsoon Twilight Investor Briefing (November 2023)
35 slides from Arovella Therapeutics's conference presentation, Nov 21, 2023
Slide 1: Monsoon Twilight Investor Briefing Presentation (ASX Release)
ASX: ALA Arovella Therapeutics Limited ACN 090 987 250 ASX Release 21 November 2023 MONSOON TWILIGHT INVESTOR BRIEFING PRESENTATION Highlights: • Arovella to present at the Monsoon Twilight Investor Briefing MELBOURNE, AUSTRALIA 21 November 2023: Arovella Therapeutics Ltd (ASX: ALA), a biotechnology
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: Monsoon Twilight Briefing November 2023
ASX:ALA For personal use only Monsoon Twilight Briefing November 2023
Slide 4: 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 5: Arovella's strengths
Arovella’s strengths Off-the-Shelf iNKT Lead Product Addressing Key Strong For personal use only Cell Platform Advancing to Clinic Unmet Need Leadership Group Developing off-the-shelf iNKT ALA-101, a potential treatment Our iNKT cell platform is Leadership team and Board cell therapies to target blo
Slide 6: About Cell Therapy
For personal use only About Cell Therapy 4
Slide 7: Cell Therapy has revolutionised blood cancer treatment
Cell Therapy has revolutionised blood cancer treatment CAR-T cells have demonstrated their curative potential in blood cancers For personal use only Approval 2022 Product Year Revenue Cure CAR-T cells have 2017 US$1160m3 demonstrated ability to cure haematological 2017 US$536m4 cancers 2021 US$388
Slide 8: Emily Whitehead - Celebrating years of CAR-T cell therapy
For personal use only Emily Whitehead - Celebrating 10 years of CAR-T cell therapy https://emilywhiteheadfoundation.org/10-years-of-car-t/ ASX:ALA 6
Slide 9: How original CAR-T cell therapies work
How original CAR-T cell therapies work CAR-T cell therapy is personalised medicine T cells = immune cell For personal use only - T cells are a common type of immune cell that fight infections and can help fight cancer. T cells from patient ‘reprogrammed’ - - To generate autologous CAR-T cells, T cel
Slide 10: CAR-T challenges: supply chain costs and pricing
CAR-T cell therapies pose challenges Arovella’s off-the-shelf CAR-iNKT cell platform The current supply chain results in very high costs with potential for improved efficacy T cell For personal use only Manufacturing High drug pricing T cell & supply chain (>US$500k per costs are high patient) T cel
Slide 11: CAR-T challenges: manufacturing time blocks patient access
CAR-T cell therapies pose challenges Arovella’s off-the-shelf CAR-iNKT cell platform The manufacturing time can block patient access with potential for improved efficacy For personal use only Patient may Time is an issue die waiting for for patients with treatment aggressive disease 4-6 weeks manufa
Slide 12: Introducing invariant Natural Killer T (iNKT) cells
Introducing invariant Natural Killer T (iNKT) cells Bridging the innate and adaptive immune system For personal use only Innate Immunity Adaptive Immunity ASX:ALA 10
Slide 13: iNKT cells represent a next-generation cell therapy
iNKT cells represent a next-generation cell therapy Properties make them ideal for use in cell therapy Strong safety profile For personal use only Don’t cause graft versus host disease (GvHD) Innate Front line of the human Immunity immune system Bridge innate & adaptive immune responses Contai
Slide 14: CAR-iNKT cells have multiple ways to kill cancer cells
CAR-iNKT cells have multiple ways to kill cancer cells Also recruit ‘good’ immune cells and block ‘bad’ immune cells For personal use only TAM Tumour Associated Macrophage MDSC Myeloid Derived Suppressor Cell CAR Chimeric Antigen Receptor NK Natural Killer ASX:ALA 12
Slide 15: CAR-iNKT cell therapy production advantages
CAR-iNKT cell therapy production advantages Off-the-shelf manufacturing advantages MANUFACTURING For personal use only Isolate iNKT cells Expand to grow billions of CAR-iNKT cells Collect Healthy Engineer iNKT cells Vial and freeze Donor Blood to produce a CAR CAR-iNKT cells TREATMENT Thaw CAR-iNKT
Slide 16: 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 14
Slide 17: About ALA-101 (CAR19-iNKT cells)
For personal use only About ALA-101 (CAR19-iNKT cells) A next generation off-the-shelf cell therapy for CD19+ cancers 15
Slide 18: CD19+ hematological malignancies
CD19+ hematological malignancies Targeting CD19+ blood cancers For personal use only >140k inin the 2023 US 1,2 >40k inin the 2023 US CD19+ cases deaths1,2 lymphomas and CD19+ No approved to CAR-T are moving leukemias to second products line therapy allogeneic date for cell therapy blood cancers ASX
Slide 19: ALA-101: enhanced tumour killing in vivo
ALA-101: enhanced tumour killing in vivo ALA-101 rapidly eradicates tumour cells in mice Tumour cells expressing CD19 and PBS T iNKT CAR19-T ALA-101 For personal use only CD1d were intravenously delivered into mice Ventral Mice were treated with: Day 0 PBS (saline) Unmodified T cells (T) Dor
Slide 20: ALA-101: next generation cell therapy
ALA-101: next generation cell therapy ALA-101 significantly increased survival in mice versus treatment with CAR19-T cells Tumour cells expressing CD19 and CD1d were intravenously delivered into mice For personal use only Mice were treated with: P <0.01 PBS (saline) Unmodified T cells (T)
Slide 21: ALA-101: spontaneous secondary remission
ALA-101: spontaneous secondary remission ALA-101 activity may persist to eradicate tumour cells following relapse For personal use only Four mice treated with ALA-101 Ventral had the cancer return to the brain In all four mice, the cancer was eliminated a second time with no Dorsal additional do
Slide 22: Progress towards first-in-human clinical trials
Progress towards first-in-human clinical trials ALA-101 data confirms activity and off-the-shelf capability For personal use only Potent Antitumour Expected to Multiple Dose Activity be Safe Manufacturing Phase 1 Demonstrated efficacy of iNKT cells have been shown ALA has demonstrated that its Clini
Slide 23: 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 21
Slide 24: 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 25: Manufacturing CLDN18.2-iNKT cells
STRATEGY 1 Manufacturing CLDN18.2-iNKT cells Generation of CLDN18.2-iNKT cells will leverage existing manufacturing process MANUFACTURING For personal use only Isolate iNKT cells Expand to grow billions of CAR-iNKT cells Engineer iNKT cells Collect Healthy to produce a Vial and freeze Donor Blood CL
Slide 26: 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 expected to be approved in types of cancers 2024 gastric cancer (GC) gastroesophageal junction cancer (GEJC
Slide 27: "Armouring" iNKT cells
STRATEGY 2 “Armouring” iNKT cells Cytokine technology enhances activity of iNKT cells in solid tumours For personal use only Cytokine technology iNKT cells cytokine technology Adding specialised cytokines to iNKT cells can Expand more 10x more Superior increase persistence of the cells and survive c
Slide 28: ALA-101 & Imugene's onCARlytics
STRATEGY 3 ALA-101 & Imugene’s onCARlytics Imugene’s onCARlytics platform may make solid tumours sensitive to ALA-101 For personal use only Expecting in vivo data in H2 2023 ASX:ALA 26
Slide 29: Arovella's expanding pipeline
Arovella’s expanding pipeline CD19-CAR CD19-CAR Novel Targets Introduction of CLDN18.2 For personal use only ALA-101 ALA-101 + onCARlytics CLDN18.2 Cytokine Technology Non-Hodgkin’s Head and Prostate Brain Triple negative Pancreatic Gastric Lung Cancer Lymphoma Neck Cancer Cancer Metastases breast c
Slide 30: Milestones for FY2024
Milestones for FY2024 June December June 2023 2023 2024 For personal use only Complete process optimisation and scale-up in Complete cGMP manufacture for Phase 1 ALA-101 preparation for cGMP manufacture clinical trials Complete production of cGMP lentiviral vector Complete preparatory activi
Slide 31: Financial overview
Financial overview Financial Snapshot ASX CODE ALA ALA Price and Volume - 12 Months1 For personal use only Market capitalisation1 $81.5 million Shares on issue 906.31 million 40,000,000 $0.10 52-week low / high1 $0.020 / $0.105 $0.08 Cash Balance (September 30 2023) $5.32 million 30,000,000 R&D tax
Slide 32: Recent cell therapy transactions
Recent cell therapy transactions1 Upfront Milestones Total deal Date Type of deal Acquirer/Licensee Target/Licensor Cell Type Stage (US$M) (US$M) value (US$M) Collaboration and $70-220 per Nov-23 Not specified Platform $25 investment product For personal use only Aug-23 Licence2 T Cell Phase 1b $21
Slide 33: 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-expressing blood cancers, is cell therapies to treat cancer b
Slide 34: 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 35: 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 For personal use only 3. https://www.jnj.com/janssen-enters-worldwide-collabor
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