Arovella Therapeutics Limited · ASX:ALA
Arovella Therapeutics — Non-Deal Roadshow (July 2024)
35 slides from Arovella Therapeutics's roadshow presentation, Jul 3, 2024
Slide 1: Investor Presentation ASX Release
ASX: ALA Arovella Therapeutics Limited ACN 090 987 250 ASX Release 03 July 2024 INVESTOR PRESENTATION MELBOURNE, AUSTRALIA 3 July 2024: Arovella Therapeutics Ltd (ASX: ALA), a biotechnology company focused on developing its invariant Natural Killer T (iNKT) cell therapy platform, is pleased to provi
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: Non-deal roadshow July 2024
ASX:ALA For personal use only Non-deal roadshow July 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 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: 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 moieties strategy Process-specific transduce iNKT cells Complementary for targeting 12-year ma
Slide 7: Arovella's path to patient
Arovella’s path to patient Taking Arovella’s first CAR-iNKT therapeutic to human trials in FY2025 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-iN
Slide 8: Financial overview
Financial overview Financial Snapshot ALA Price and Volume - 12 Months1 ASX CODE ALA $0.20 For personal use only Market capitalisation1 $147.1 million 40,000,000 $0.18 Shares on issue 1,050.2 million $0.16 52-week low / high1 $0.042 / $0.185 $0.14 30,000,000 Cash Balance (Mar 31, 2024)2 $15.31 milli
Slide 9: Recent cell therapy transactions
Recent cell therapy transactions1 Upfront Milestones Total deal Date Type of deal Acquirer/Licensee Target/Licensor Cell Type Stage (US$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 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 10
Slide 12: iNKT cells represent a next-generation cell therapy
iNKT cells represent a next-generation cell therapy Innate 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
Slide 13: A differentiated position
A differentiated position T cell and NK cell sectors are competitive, iNKT cells remain untapped 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: 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: 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 For personal use only Clinical trial design and IND-enabling studies and Regulatory approval and KOL engagement regulatory submission site startup Engagement with key opinion ALA is conducting IND-enab
Slide 16: 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 17: Arovella's expanding pipeline
Arovella’s expanding pipeline For personal use only ASX:ALA 15
Slide 18: 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 Arovella is funded to dose ALA-101 of regulatory dossier, engagement with clinical sites and KOLs patients
Slide 19: 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 20: 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 18
Slide 21: 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 22: 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 For personal use only were intravenously delivered into mice Mice were treated with: P <0.01 PBS (saline) Unmodified T cells (T)
Slide 23: 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 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: Solid tumours pose challenges to cell therapies
Solid tumours pose challenges to cell therapies 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 and infiltrate tumours Tumour microenvironment Modify the TME to block or kill c
Slide 27: 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 28: ALA-105 (CLDN18.2-iNKT cells)
For personal use only ALA-105 (CLDN18.2-iNKT cells) A next generation off-the-shelf cell therapy for CLDN18.2+ solid tumours 26
Slide 29: Claudin 18.2 (CLDN18.2)
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 CLDN18.2-targeting monoclonal antibody types of cancers approved in Japan in March 2024 gastric cancer (GC) gastroesophageal junction cance
Slide 30: iNKT cell armouring (IL-12-TM)
For personal use only iNKT cell armouring (IL-12-TM) Armouring strategy to enhance activity of CAR-iNKT cells against solid tumours 28
Slide 31: 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 32: Key benefits of IL-12-TM for CAR-iNKT cells
Key benefits of IL-12-TM for CAR-iNKT cells IL-12-TM enhances antitumor activity of CAR-iNKT cells Tumour cells expressing GD2 and were For personal use only intravenously delivered into mice before treatment with CAR-iNKT cells Mice were treated with: PBS (saline) GD2-CAR PBS (n=4) GD2-CA
Slide 33: Key benefits of IL-12-TM for CAR-iNKT cells
Key benefits of IL-12-TM for CAR-iNKT cells We expect IL-12-TM to enhance Arovella’s CAR-iNKT cell platform Increases IL-12-TM is not Enhances For personal use only CAR-iNKT cell released from CAR-iNKT cell numbers CAR-iNKT cells antitumour activity IL-12-TM prolongs IL-12-TM is not IL-12-TM enhance
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.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
Arovella Therapeutics — Non-Deal Roadshow (July 2024) on 6ix