Arovella Therapeutics Limited · ASX:ALA
Arovella Therapeutics — Investor Presentation (March 2024)
41 slides from Arovella Therapeutics's investor presentation, Mar 26, 2024
Slide 1: Completion of $12.5m Placement
ASX:ALA For personal use only Completion of $12.5m Placement March 2024
Slide 2: Disclaimer
Disclaimer IMPORTANT INFORMATION Purpose of presentation: This presentation is dated 26 March 2024, and contains summary information 902(k)(2)(i) under the U.S . Securities Act and (B) agree that it will not forward or deliver this about Arovella and its activities which is current only as at the da
Slide 3: Disclaimer (cont.)
Disclaimer (cont.) IMPORTANT INFORMATION Past performance: Past performance and pro forma historical financial information in this presentation Financial information: In this presentation, unless otherwise stated or the context requires otherwise, is given for illustrative purposes only and should n
Slide 4: Arovella Summary
Summary TOPIC DISCUSSION • Arovella is now funded to see data from its Phase 1 Clinical Trial • Developing unique, proprietary, allogeneic cell therapy treatments for cancers using novel iNKT cell platform (CAR-iNKT) For personal use only • Lead product is ALA-101 (CAR19-iNKT), a potential new treat
Slide 5: Arovella's strengths
Arovella’s strengths Off-the-Shelf iNKT Funded to take Addressing Key Strong For personal use only Cell Platform ALA-101 into Phase 1 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
Slide 6: Financial overview
Financial overview Financial Snapshot ALA Price and Volume - 12 Months1 ASX CODE ALA $0.20 For personal use only Market capitalisation1 $120.3 million 40,000,000 $0.18 Shares on issue 925.16 million $0.16 52-week low / high1 $0.033 / $0.185 $0.14 30,000,000 Cash Balance (Dec 31 2023) $4.76 million $
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) Dec-23 Acquisition T Cell Phase 1b $1,000 $200 $1,200 Collaboration and $70-220 per For personal use only Nov-23 Not specified Platform $25 i
Slide 8: About CAR-T cells
For personal use only About CAR-T cells 8
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: 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 11: 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 11
Slide 12: Autologous CAR-T pose challenges
Autologous CAR-T pose challenges Allogeneic The current manufacturing costs and time are limiting A single healthy donor Manufacturing & supply batch = treatment for For personal use only T cell chain costs are high multiple patients T cell Each T cells can be manufacturing compromised T cell batch
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 1. Via the CAR • Specific target depending
Slide 15: 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 15
Slide 16: 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 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 17
Slide 18: 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 19: 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 20: 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 21: 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 clinical trial Demonstrated efficacy of ALA-101 against CD19+ iNKT cells have been show
Slide 22: 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 23: 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 24: 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 Antigen specificity iNKT cells: and uniformity Home to tissues and infiltrate tumours Tumour microenvironment Modify the TME to block or kill cells tha
Slide 25: Add additional CARs for novel targets
STRATEGY 1 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 C
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" CAR-iNKT cells
STRATEGY 2 “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 28: 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 29: 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 CAR-iNKT IL-12-TM is not Enhances Integrates with For personal use only cell numbers released from CAR- CAR-iNKT cell existing manufacturing iNKT cells antitumour activity process IL
Slide 30: Arovella's expanding pipeline
Arovella’s expanding pipeline For personal use only ASX:ALA 30
Slide 31: Upcoming milestones for 2024
Upcoming milestones for 2024 January July December 2024 2024 2024 For personal use only Complete cGMP manufacture for Phase 1 clinical trials Commence Phase 1 for ALA-101 targeting CD19+ ALA-101 Complete preparatory activities for Phase 1 study, lymphoma and leukemia (CD19) including preparati
Slide 32: Strong Leadership
Strong Leadership Leadership For personal use only Dr. Michael Baker Dr. Nicole van der Weerden Dr. Robson Dossa Dr. Simon Poon CEO & MANAGING DIRECTOR CHIEF OPERATING OFFICER VP MANUFACTURING & QUALITY DIRECTOR PROJECT MANAGEMENT Board of Directors Dr. Tom Duthy Dr. Elizabeth Stoner Dr. Debora Bart
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: Source and use of funds
Source and use of funds Comments For personal use only $12.5M PLACEMENT $12.5 million Placement Source of funds $ (millions) With the proceeds of the capital raising, Arovella Capital raised under the Offer 12.5 expects to have sufficient capital to: Expected Use of funds $ (millions) % of total
Slide 35: Offer timetable
Offer timetable EVENT DATE For personal use only Trading Halt Friday 22 March Placement bookbuild commenced Friday 22 March Firm Bids Due 2:00PM (AEDT) Monday 25 March Acceptances Due 5:00PM (AEDT) Monday 25 March ASX Announcement - Transaction, Investor Presentation, Trading Halt Lifted Tuesday 26
Slide 36: Key Risks
Key Risks The Company considers that the following summary, which is not exhaustive, represents some of the major risk factors which investors ought to be aware of in evaluating the Company’s business and risks: Company and industry risks The risks outlined below are specific to the Company's operat
Slide 37: Key Risks (cont.)
Key Risks (cont.) Product manufacturing risk Cell therapies, like Arovella’s CAR-iNKT cell products, are complex therapeutics that relay on the use of a viral vector and human immune cells. The use of human immune cells as a raw material and the generation of a living therapeutic introduces the risk
Slide 38: Key Risks (cont.)
Key Risks (cont.) General Risks The future prospects of the Company’s business may be affected by circumstances and external factors beyond the Company’s control. Financial performance of the Company may be affected by a number of business risks that apply to companies generally and may include econ
Slide 39: Key Risks (cont.)
Key Risks (cont.) Insurance risk The Company intends to insure its operations in accordance with industry practice. However, in certain circumstances, the Company's insurance may not be of a nature or level to provide adequate insurance cover. The occurrence of an event that is not covered or fully
Slide 40: 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 41: Cell therapy deal references
Cell therapy deal references 1. https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-to-acquire-gracell-furthering-cell-therapy-ambition-across-oncology-and- autoimmune-diseases.html 2. https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-cell-and-gene-therapy
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