Avecho Biotechnology Limited (ASX: AVE) Reports Q4 Activities

Phase III Clinical Trial Progress

Avecho Biotechnology Limited (ASX: AVE) has made significant strides in its Phase III clinical trial for its TPM®-enhanced CBD capsule aimed at treating insomnia. The Company is on track to reach its interim analysis in 2025, a crucial milestone. By December 2024, approximately 70 participants had received the study medication. Recruitment has been steady, albeit slower than expected, leading to planned adjustments for 2025 to increase enrolment.

Revisions to the inclusion and exclusion criteria were submitted and approved, broadening eligibility. New trial sites in Gold Coast and Sydney are set to commence operations in early 2025.

Commentary from the CEO

Dr. Paul Gavin, CEO of Avecho, stated, “As we move into 2025, Avecho is strategically positioned to potentially achieve a significant industry milestone—becoming the first company to report positive results in a Phase III clinical trial with a CBD product for insomnia indications.” He emphasised that the approaching interim analysis is a significant inflection point that may create numerous partnership and licensing opportunities globally.

Business Development and Manufacturing Achievements

During the quarter, Dr. Gavin presented at the 7th Annual CB1, CB2 & Cannabinoid Drug Development Summit in Boston, outlining the advancements in cannabinoid absorption mechanisms.

Additionally, Avecho successfully completed a manufacturing campaign of 6.4 tonnes of its Vital-ET® product for partner Ashland, contributing to a total of 11 tonnes produced in 2024. A subsequent campaign of 5.4 tonnes occurred in January 2025, with more planned for the year.

Financial Overview

In Q4 2024, Avecho invested approximately A$1,196K in research and development and incurred administration costs of about A$248K. The received R&D loan from Endpoints Capital amounted to around A$301K. As of December 31, 2024, the Company’s cash position stood at approximately A$2.375M, positioning it to continue its operations while pursuing licensing opportunities.

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Motley Fool contributor Lianne Eastty has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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