Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-2

Financial Status:

• Pro-forma cash and equivalents: $4.76 million as of December 31, 2023.

Q2 FY24 Achievements:

1. Solid Tumor Strategy:

• Signed an exclusive license with Sparx Group to develop a world-first CAR-iNKT cell therapy targeting Claudin 18.2 (CLDN18.2), expressed in gastric cancers (GC), gastroesophageal junction cancers (GEJC), and pancreatic cancer (PC).

Manufacturing and Development:

• Completed GMP manufacturing and release of ALA-101 lentiviral vector for the lead CD-19-targeting iNKT cell product.
• Advanced manufacturing process development and scale-up.

Financial Strengthening:

• Received a $1.92 million R&D Tax Incentive refund.

Executive Appointment:

• Appointed Tim Luscombe as Chief Financial Officer (CFO) and Company Secretary.

Upcoming 12-Month Milestones:

1. Proof-of-Concept Data:

• Present initial proof-of-concept data for CLDN18.2-iNKT cells in H1 CY24.

Clinical Batches and IND Studies:

• Manufacture clinical batches of ALA-101 for phase I clinical trials (H1 CY24).
• Complete IND-enabling non-clinical safety and efficacy studies (H1 CY24).

Regulatory Approvals and Clinical Trials:

• Secure IND application with the FDA and/or regulatory filing with TGA for a phase I clinical trial in non-Hodgkin’s lymphoma (H2 CY24).
• Commence a phase I clinical trial in non-Hodgkin’s lymphoma (H2 CY24).

Technology In-Licensing:

• In-license additional technologies to enhance the iNKT cell therapy platform.

Solid Tumor Targeting:

• Arovella's iNKT cell therapy platform aims to target solid tumors and has advantages over existing CAR-T treatments.

Specifics of iNKT Cells:

• Can be sourced from healthy donors without causing graft versus host disease (GvHD).
• Contain an invariant T cell receptor (iTCR) targeting lipid-bound CD1d on various tumor types.
• Can be modified to produce a chimeric antigen receptor (CAR) for dual-targeting of specific tumors.
• Can be expanded significantly from a single manufacturing batch.
• Exhibit natural efficacy against solid tumors, influencing the tumor microenvironment and targeting pro-tumor cells.

Novel Monoclonal Antibody (mAb) Sequence:

• Secured a global, exclusive license for a novel mAb sequence (SPX-101) targeting Claudin 18.2 (CLDN18.2) in cell therapies.
• SPX-101 has completed preclinical studies and is set for a phase I trial to treat gastric cancers.

Clinical Landscape:

• CLDN18.2 is a validated target, with products like zolbetuximab in clinical development. Zolbetuximab has Priority Review for treating GC and GEJC by the FDA, with an expected decision in 2024.