Arovella Therapeutics (ALA) investor relations material

FY26 progress and platform

• FY26 milestones included FDA acceptance of the ALA-101 IND, GMP drug product release and first patient dose in Phase 1.

• ALA-105 generated potent proof-of-concept data for CLDN18.2 CAR-INKT cells, with demonstrated benefit from IL-12-TM armouring.

• Donor-derived, off-the-shelf CAR-INKT manufacturing is designed for multiple patient doses per batch; the approach does not require gene editing.

• The platform is intended to support multiple therapies, with CAR-INKT cells designed to attack tumours through multiple mechanisms and modulate the tumour microenvironment.

ALA-101 clinical program

• First-in-human Phase 1 study targets adults with relapsed or refractory CD19-positive B-cell cancers; dose escalation, backfill and expansion aim to identify a recommended Phase 2 dose.

• Study assessments include safety, pharmacology, cell expansion and persistence, and preliminary efficacy; follow-up includes safety, response and biology through Month 24.

• If Phase 1 supports B-cell depletion, ALA-101 could be evaluated in autoimmune diseases including lupus, myositis and systemic sclerosis.

• Trial data are intended to inform future blood-cancer, solid-tumour and autoimmune programs, including persistence, trafficking, immune activation and B-cell depletion.

ALA-105 and pipeline expansion

• In an advanced gastric cancer mouse model, 5 of 7 animals treated with CLDN18.2 CAR-INKT cells survived with no tumours at 60 days; an IL-12-TM armoured subgroup cleared tumours in all treated animals.

• ALA-105 development steps include IND-enabling studies, GMP manufacturing process development, FDA meetings and clinical trial protocol work.

• Pipeline strategy spans CD19-positive blood cancers and autoimmune disease with ALA-101, and CLDN18.2-positive solid tumours with ALA-105; gastric cancer is first, with pancreatic cancer later.

• Upcoming priorities include ALA-101 Phase 1 safety and efficacy data, regulatory filings for autoimmune expansion, ALA-105 manufacturing scale-up and selection of another solid-tumour target.