Avecho Biotechnology (AVE) Q4 2025 TU earnings summary

Executive summary

• Phase III CBD insomnia trial nearing completion of interim analysis recruitment, with 190 of 210 patients dosed as of December 2025; interim analysis expected in H1 2026.

• $2.5 million raised in October 2025 to accelerate commercial manufacturing and support regulatory submissions for the CBD insomnia product.

• US and European patent applications for the CBD TPM® soft-gel capsule have been allowed, with formal grants expected by end of FY26, providing protection until at least 2040.

Financial highlights

• Cash balance at 31 December 2025 was $4.7 million, with an estimated $1.8 million in R&D tax credits forecast for Q2 2026.

• $1,846K invested in R&D during the quarter (YTD: $4,293K), primarily for the Phase III trial and manufacturing activities.

• Net cash used in operating activities for the quarter was $(2,214)K.

• $2.5 million raised via equity placement; net cash from financing activities was $2,291K for the quarter.

• Payments to related parties totaled $67K for the quarter.

Outlook and guidance

• Interim analysis of the Phase III trial is targeted for completion in the first half of 2026, representing a major clinical and commercial milestone.

• Accelerated manufacturing program aims to enable rapid TGA submission and commercial supply following successful trial results.

• Quarterly operating costs are expected to decrease in coming months as significant trial and support costs were concentrated in the December quarter.