Arovella Therapeutics (ALA) investor relations material

Platform and differentiation

• CAR-INKT uses healthy-donor cells for off-the-shelf treatment without gene editing; each batch can supply multiple doses, addressing patient-specific manufacturing and T-cell fitness constraints.

• iNKT cells combine CAR targeting with natural tumor recognition, tumor infiltration and immune-microenvironment modulation, with potential to reduce antigen escape and support solid-tumor activity.

• FDA accepted the ALA-101 IND; Phase 1 was expected to start in October 2026, with preliminary data expected in early CY27.

ALA-101 clinical program

• Phase 1 targets adults with relapsed/refractory CD19-positive B-cell cancers; planned enrollment is up to 46 participants, with dose escalation and backfill/expansion.

• Study design includes up to four dose levels and ~13–21 participants in escalation, followed by up to 25 additional participants for backfill/expansion.

• A single infusion is followed by safety, response and biology monitoring through Month 24, then long-term follow-up; the goal is to identify a recommended Phase 2 dose.

• Potential readouts include safety, CAR-INKT expansion and persistence, preliminary efficacy and B-cell depletion; results may inform blood-cancer, solid-tumor and autoimmune programs.

Pipeline expansion

• ALA-101 is positioned for CD19-positive blood cancers, with potential autoimmune expansion if Phase 1 supports B-cell depletion; indications are to be prioritized using emerging CAR-T clinical data.

• ALA-105 targets CLDN18.2, with gastric cancer first and pancreatic cancer later; other stated target settings include esophageal, GEJC and ovarian cancers.

• The three workstreams are blood-cancer validation, solid-tumor expansion and autoimmune expansion, built on healthy-donor iNKT cells, a modular CAR backbone and scalable manufacturing.