Arovella Therapeutics Limited · ASX:ALA
Arovella Therapeutics — Euroz Hartleys Healthcare Forum 2025
33 slides from Arovella Therapeutics's conference presentation, Feb 4, 2025
Slide 1: ALA presents at the Euroz Hartleys 2025 Healthcare Forum
ASX: ALA Arovella Therapeutics Limited ACN 090 987 250 ASX Release 04 February 2025 ALA PRESENTS AT THE EUROZ HARTLEYS 2025 HEALTHCARE FORUM Highlights: • Arovella presents at Euroz Hartleys 2025 Healthcare Forum MELBOURNE, AUSTRALIA 04 February 2025: Arovella Therapeutics Ltd (ASX: ALA), a biotechn
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: Unlocking the potential of iNKT cells to treat cancer
ASX:ALA For personal use only Unlocking the potential of iNKT cells to treat cancer Euroz Hartleys Healthcare Forum February 2025
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, potential treatment Our iNKT cell platform is Leadership team and Board cell therapies to target blood
Slide 6: Financial overview
Financial overview Financial Snapshot ALA Price and Volume - 12 Months1 ASX CODE ALA For personal use only Market capitalisation1 $201.54 million 40,000,000 Shares on issue 1,060.7 million $0.18 52-week low / high1 $0.105 / $0.210 30,000,000 Pro-forma Cash Balance (31 Dec, 2024)2 $30.6 million Major
Slide 7: Recent cell therapy transactions
Recent cell therapy transactions1 Upfront Milestones Total deal Date Type of deal Acquirer/Licensee Target/Licensor Cell Type Stage (US$M) (US$M) value (US$M) Nov-24 Acquisition Allo T cell Phase 1 ~$1,038 ~$462 $1,500 Research For personal use only May-24 T cell TBD $50 $550 $600 collaboration Dec-
Slide 8: About CAR-T cells
For personal use only About CAR-T cells 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: 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 8
Slide 11: Current CAR-T technology challenges and ALA's solution
Current CAR-T technology challenges ALA’s solution: One CAR-T product only treats the patient who supplied the T cells One CAR-iNKT batch from Manufacturing & supply a healthy donor treats For personal use only T cell chain costs are high multiple patients T cell Each T cells can be manufacturing co
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 iNKT cell 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 response
Slide 14: 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. ASX:ALA Source: Company analysis based on public information 12
Slide 15: Arovella's path to patient
Arovella’s path to patient TECHNOLOGY PRE-CLINICAL LENTIVIRUS MANUFACTURING FDA (IND) / PHASE 1 PHASE 2 PRODUCT ACQUISITION CONFIRMATION MANUFACTURING PLATFORM TGA (CTA) CLINICAL TRIAL CLINICAL TRIAL For personal use only CD19-iNKT Blood Cancer FY2025 ALA-101 CLDN18.2-iNKT Gastric Cancer ALA-105 CAR
Slide 16: ALA-101 (CAR19-iNKT cells)
For personal use only ALA-101 (CAR19-iNKT cells) A next generation off-the-shelf cell therapy for CD19 expressing cancers 14
Slide 17: 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: PBS (saline) Day 0 Unmodified T cells (T) Dor
Slide 18: 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 positive for CD19 and CD1d For personal use only were intravenously delivered into mice Mice were treated with: P <0.01 PBS (saline) Unmodified T cells (T)
Slide 19: 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 20: Clinic-ready manufacturing process developed
Clinic-ready manufacturing process developed 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 MANUFACTURING TGA (C
Slide 21: 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 22: 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 23: 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 24: 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 22
Slide 25: 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 26: 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 27: 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 28: 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 29: Arovella's expanding pipeline
Arovella’s expanding pipeline For personal use only ASX:ALA 27
Slide 30: Upcoming milestones for CY2025
Upcoming milestones for CY2025 Jan Dec 2025 2025 For personal use only Complete cGMP manufacture and file an IND application with US ALA-101 FDA for phase 1 Arovella is funded to dose (CD19) Commence phase 1 dose escalation study for ALA-101 in patients patients with ALA-101 during with CD19+ NH
Slide 31: 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 32: 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 33: Cell therapy deal references
Cell therapy deal references 1. https://www.reuters.com/business/healthcare-pharmaceuticals/roche-acquire-us-based-poseida-therapeutics-2024-11-26/ 2. https://www.astellas.com/en/news/29166 3. https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-to-acquire-gracell-furthering-cell
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