Interim analysis of a pivotal insomnia clinical trial that could pave the way for Australia’s first over-the-counter CBD product is expected before the end of June, Avecho Biotechnology has confirmed.
Chief executive Dr Paul Gavin said the company was getting “close to a defining moment”.
Reporting its December quarter financials, the firm said $2.5 million worth of funds raised during the period was being used to accelerate manufacture of its CBD insomnia capsule.
It said recruitment continued for the interim analysis cohort, with 190 patients dosed at mid-December, representing the majority of the 210 participants required.
Gavin said: “The end of recruitment is in sight and the significance of this milestone is tangible across the organisation. The interim analysis represents a major clinical and commercial catalyst for Avecho, and a compelling opportunity to create value for our shareholders.
“After years of disciplined development we are close to a defining moment for the company.”
A successful trial would support a dossier to the Therapeutic Goods Administration (TGA) as it looks to become the first Australian business to sell over-the-counter CBD products through pharmacies.
Avecho had $4.7m cash on hand at the end of December and flagged an estimated $1.8m in R&D tax incentives expected in the first half of 2026.
InhaleRx
InhaleRx has formally registered its new company name, Nexalis Therapeutics Limited, with the Australian Securities and Investments Commission (ASIC), following shareholder approval for its rebranding at a general meeting.
While an ASX name and ticker change has yet to be announced, confirmation of the rebrand follows plans first outlined by the clinical-stage biotech last year.
The firm separately reported a net operating cash outflow of $628,000 for the December quarter, as it continued to progress multiple drug development programs.
It is currently working on cannabinoid-based therapies IRX-211 for breakthrough cancer pain and IRX-616a for panic disorder, alongside SRX-25, a ketamine-based oral therapy for treatment-resistant depression.
Neurotech International
Neurotech International reported a stronger cash position at the end of the December quarter, closing with approximately $6.3 million, up from $1.7m at the end of the prior three-month period.
The increase followed a $4.73m research and development tax incentive refund for FY25, and a $4m placement completed during the period.
In a separate announcement to the ASX, Neurotech said it had received ethics approval to commence a Phase 3 clinical study of NTI164 in treating autism spectrum disorder.
It follows the publication of Phase I/II clinical data for the study in a peer-reviewed scientific journal.
Peak Processing
The ASX has required Peak Processing, formerly Althea Group Holdings, to address its funding position after the firm’s December quarterly cash flow report showed it had less than six weeks of available funding after closing the period with $685,000 in cash.
Under ASX listing rules, firms with less than six months of cash must explain whether current cash outflows will continue, what steps are being taken to raise funds, and whether operations can continue.
Peak said elevated cash outflows during the December quarter – $1.5 million – were driven largely by “one-off items including debt repayment, restructuring costs and elevated professional and audit fees”, which were not expected to recur.
The firm said it expected operating cash flows to improve from the March quarter and confirmed it was progressing a capital raise to support “operational requirements”, adding it expected to continue operating on that basis.
The company rebranded as Peak after exiting Australia to focus on its North American THC-beverage business.
Zelira Therapeutics
Zelira reported a net operating cash inflow of $529,000 for the December quarter, driven by the receipt of a $1.07 million R&D tax incentive refund, and closed the period with $52,000 in cash.
The quarter was also marked by the firm securing commitments to raise almost US$33 million (A$49.5 million) to support HOPE 1, its special purpose vehicle (SPV).
Argent BioPharma
Argent reported a net operating cash outflow of $1.55 million for the December quarter, closing the period with $1.53m in cash.
During the quarter, Argent secured access to up to $11m in funding from US-based institutional investors, including an immediate $3m drawdown to complete the AusCann asset acquisition.
The transaction is expected to complete in Q1 2026.