Arovella Therapeutics Limited · ASX:ALA
Arovella Therapeutics — Investor Presentation (September 2024)
33 slides from Arovella Therapeutics's investor presentation, Sep 18, 2024
Slide 1: Investor Webinar Presentation ASX Release
ASX: ALA Arovella Therapeutics Limited ACN 090 987 250 ASX Release 18 September 2024 INVESTOR WEBINAR PRESENTATION MELBOURNE, AUSTRALIA 18 September 2024: Arovella Therapeutics Ltd (ASX: ALA), a biotechnology company focused on developing its invariant Natural Killer T (iNKT) cell therapy platform,
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: ALA-101 clinical development
ASX:ALA For personal use only Investor Webinar ALA-101 clinical development September 2024
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 Proprietary manufacturing ALA-101, potential treatment Our iNKT cell platform is Leadership team and Board process that can be used for for C
Slide 6: Arovella's path to patient
Arovella’s path to patient For personal use only TECHNOLOGY PRE-CLINICAL LENTIVIRUS MANUFACTURING FDA (IND) / PHASE 1 PHASE 2 PRODUCT ACQUISITION CONFIRMATION MANUFACTURING PLATFORM TGA (CTA) CLINICAL TRIAL CLINICAL TRIAL CD19-iNKT Blood Cancer FY2025 CLDN18.2-iNKT Gastric Cancer CAR-iNKT Other Canc
Slide 7: About CAR-T cells
For personal use only About CAR-T cells 5
Slide 8: 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 9: 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 2023 Revenue Cure CAR-T cells have 2017 US$1498m3 demonstrated ability to cure haematological 2017 US$509m4 cancers 2021 US$472
Slide 10: 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 11: 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 9
Slide 12: 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 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 11
Slide 14: 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 15: 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 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-positive 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 positive for 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) D
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: Successful preIND meeting with FDA
Successful preIND 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, Manufacturi
Slide 21: 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 22: 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 Part 1: Dose Escalation lymphoma (NHL, including DLBCL, FL, MCL, MZL) and CD19+ leukemias (including
Slide 23: ALA-101-001: anticipated study design
ALA-101-001: phase 1 first-in-human study Anticipated study design For personal use only Inclusion of a broad range Refinement of indications of CD19+ lymphomas and for inclusion in Part 2 based leukemias in Part 1 on safety and efficacy data SCREENING ENROLMENT DOSING RESPONSE ASSESSMENT DAY 28 (+
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: 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 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: Arovella's expanding pipeline
Arovella’s expanding pipeline For personal use only ASX:ALA 25
Slide 28: Upcoming milestones for FY2025
Upcoming milestones for FY2025 July July 2024 2025 For personal use only Complete cGMP manufacture for phase 1 clinical trials Complete preparatory activities for phase 1 study, preparation of regulatory dossier, assembly of clinical advisory board, finalise clinical Arovella is funded to dose A
Slide 29: 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 Dec-23 Acquisition T Cell Phase 1b $1,000 $200 $1,200 For personal use only Collaborat
Slide 30: Financial overview
Financial overview Financial Snapshot ALA Price and Volume - 12 Months1 ASX CODE ALA $0.20 For personal use only Market capitalisation1 $168.3 million 40,000,000 $0.18 Shares on issue 1,051.7 million $0.16 52-week low / high1 $0.062 / $0.185 $0.14 30,000,000 Cash Balance (Jun 30 2024) $12.7 million
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.astellas.com/en/news/28271 2. https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-to-acquire-gracell-furthering-cell-therapy-ambition-across-oncology-and- autoimmune-diseases.html For personal use only 3. https://www.astrazeneca.com/me
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