Arovella Therapeutics (ALA) Q1 2026 TU earnings summary

Executive summary

• Advanced IND application for ALA-101, including a successful Type D meeting with the FDA, de-risking the regulatory path for first-in-human trials in early CY26.

• Selected SAPRO as CRO for the upcoming phase 1 trial of ALA-101, targeting CD19-positive non-Hodgkin's lymphoma and leukemia.

• Demonstrated potent in vitro activity of CLDN18.2-targeting CAR for the ALA-105 program against pancreatic cancer cells.

• Received Notice of Allowance for a US patent covering the core CAR-iNKT cell therapy platform, extending IP protection to at least 2039.

• Maintained a strong cash position, ending the quarter with $21.9 million, bolstered by a $3.2 million R&D tax incentive rebate.

Financial highlights

• Cash and cash equivalents at 30 September 2025 were $21.9 million.

• Received $3.2 million R&D tax incentive refund during the quarter.

• Net cash from operating activities was $0.83 million for the quarter.

• Cash outflows from operating activities totaled $2.7 million, with R&D and staff costs comprising 81% of outflows.

• Payments to related parties for the quarter were $269,206, covering director fees and executive compensation.

Outlook and guidance

• Phase 1 clinical trial for ALA-101 expected to commence in early CY26, with funding secured to complete patient enrollment and initial data reporting.

• IND submission for ALA-101 anticipated before the end of CY25.

• Continued progress expected in solid tumour programs, including CLDN18.2 CAR-iNKT and IL-12-TM armouring.

• Ongoing review of new technologies for acquisition to enhance or expand the CAR-iNKT platform.