Arovella Therapeutics Limited · ASX:ALA
Arovella Therapeutics — Investor Presentation (April 2025)
36 slides from Arovella Therapeutics's investor presentation, Apr 29, 2025
Slide 1: Investor Webinar Presentation ASX Release
ASX: ALA Arovella Therapeutics Limited ACN 090 987 250 ASX Release 29 April 2025 INVESTOR WEBINAR PRESENTATION MELBOURNE, AUSTRALIA 29 April 2025: Arovella Therapeutics Ltd (ASX: ALA), a biotechnology company focused on developing its invariant Natural Killer T (iNKT) cell therapy platform, will tod
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: Investor Webinar April 2025
ASX:ALA For personal use only Investor Webinar April 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 Addressing Key Strategic Strong Cell Platform Unmet Need Acquisitions Leadership Group For personal use only Developing off-the-shelf iNKT Our iNKT cell platform is Focused on acquiring Leadership team and Board cell therapies to target blood well positioned t
Slide 6: About CAR-T cells
For personal use only About CAR-T cells 4
Slide 7: 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 8: 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 Product Approval Year 2024 Revenue Cure CAR-T cells have 2017 US$1570m3 demonstrated ability to cure haematological 2017 US$442m4 cancers 2021 US$242
Slide 9: 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 10: 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 8
Slide 11: 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 12: 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 1. Via the CAR • Specific target depending on tumour type 2. Via the NKG2D pathway • NKG2D ligands are upregulated in cancer cells TAM Tumour Associated Macropha
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. ASX:ALA Source: Company analysis based on public information 11
Slide 14: Arovella's iNKT cell strategy
Arovella’s iNKT cell strategy Incorporating world class IP to target a range of tumour types For personal use only Foundation IP Armouring Novel CARs Regulatory Know-How Unique process to technology Unique CARs strategy Process-specific transduce iNKT cells Complementary for targeting 12-year market
Slide 15: Arovella's path to patient
Arovella’s path to patient TECHNOLOGY PRE-CLINICAL LENTIVIRUS MANUFACTURING PHASE 1 PHASE 2 PRODUCT FDA (IND) ACQUISITION CONFIRMATION MANUFACTURING PLATFORM CLINICAL TRIAL CLINICAL TRIAL For personal use only CD19-iNKT Blood Cancer 2025 ALA-101 CLDN18.2-iNKT Gastric Cancer ALA-105 CAR-iNKT Other Ca
Slide 16: Highlights for Q3 FY25
Highlights for Q3 FY25 For personal use only Completed $15 million placement to fully fund enrolment and report initial safety and efficacy data for the phase 1 trial for ALA-101 Cash and cash equivalents at 31 March, 2025 of Successfully transferred ALA-101 manufacturing process into cGMP environme
Slide 17: 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 15
Slide 18: 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 KOL engagement and For personal use only IND-enabling studies and Regulatory approval and clinical trial design regulatory submission site startup Engagement with key opinion ALA is conducting
Slide 19: 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 PHASE 1 CLINICAL PHASE 2 CLINICAL For personal use only FDA (IND) ACQUISITION CONFIRMATION MANUFACTURING PLATFORM TRIAL TR
Slide 20: IND enabling studies – in vivo killing
IND enabling studies – in vivo killing ALA-101 significantly increased survival of tumour-bearing mice relative to controls For personal use only ALA-101 was generated using Arovella’s clinic-ready 3 x 105 Raji-luc cells Treatment administered IV to NSG mice administered IV manufacturing process (
Slide 21: Building our clinical capabilities
Building our clinical capabilities Preparing for phase 1 first-in-human clinical trial in 2025 For personal use only Recently appointed Jacqueline Cumming as Senior Director of Clinical Development • Strong background in clinical development and clinical operations • Over 20 years experience with se
Slide 22: Arovella has a world class Clinical Advisory Board
Arovella has a world class 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 A
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: 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 KOL engagement and For personal use only IND-enabling studies and Regulatory approval and Clinical trial design regulatory submission site startup Engagement with key opinion ALA is conducting
Slide 25: 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 23
Slide 26: 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 27: Solid tumours pose challenges to cell therapies
Solid tumours pose challenges to cell therapies iNKT cells have features that may make them useful for treating solid tumours For personal use only Solid tumours are more difficult to treat with cell therapies Access to tumour Lack of antigen iNKT cells: specificity and uniformity Home to tissues an
Slide 28: New CARs: add additional CARs for novel targets
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 Vial and freeze Donor Blood to produce a CAR
Slide 29: 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 30: Targeting tumours of high unmet need
Targeting tumours of high unmet need CLDN18.2 is found in a high proportion of gastric and pancreatic cancers For personal use only Regional Gastric >1,000k per annum 770k per annum ~6-33% and distant 5-year 4th cause of cancer death cases globally1 deaths globally1 highest annually1 Cancer survival
Slide 31: Leverage the mAb to create a CLDN18.2-CAR
Leverage the mAb to create a CLDN18.2-CAR The sequence of SPX-101 was used to create CAR sequences For personal use only Test the Chimeric Incorporate the CAR Antigen Receptor into Arovella’s SPX-101 (CAR) in T cells platform The CLDN18.2-binding domains of SPX-101 were used to create a CAR, which c
Slide 32: Creation of a CLDN18.2 targeting CAR
Creation of a CLDN18.2 targeting CAR The SPX-101 sequence was used to create a CLDN18.2 –targeting CAR For personal use only The activity of Arovella’s newly created CLDN18.2 CAR 80 Specific Cytotoxicity (%) and a control CAR expected to display robust killing were compared with T cells lacking a
Slide 33: Arovella's pipeline
Arovella’s pipeline For personal use only ASX:ALA 31
Slide 34: Upcoming milestones for CY2025
Upcoming milestones for CY2025 Jan Dec 2025 2025 For personal use only Complete cGMP manufacture, IND enabling studies and file an Arovella is funded to obtain ALA-101 IND application with US FDA for phase 1 preliminary safety and efficacy (CD19) Commence phase 1 first-in-human study for ALA-101
Slide 35: 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 36: 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
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