Avecho Biotechnology has confirmed that an interim analysis of a pivotal insomnia clinical trial — one that could lead to Australia's first over-the-counter CBD product — is anticipated before the end of June.
Chief executive Dr Paul Gavin said the company was getting "close to a defining moment".
In its December quarter financial update, the company reported that $2.5 million raised during the period is being directed toward accelerating production of its CBD insomnia capsule.
Patient recruitment for the interim analysis cohort was ongoing, with 190 participants dosed as of mid-December — the majority of the 210 needed to proceed.
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 positive trial outcome would underpin a submission to the Therapeutic Goods Administration (TGA) as Avecho pursues its goal of becoming the first Australian company to offer over-the-counter CBD products through pharmacies.
The company held $4.7m in cash at the close of December and flagged anticipated R&D tax incentives of approximately $1.8m in the first half of 2026.
InhaleRx
InhaleRx has completed formal registration of its new name, Nexalis Therapeutics Limited, with the Australian Securities and Investments Commission (ASIC), after shareholders approved the rebrand at a general meeting.
An updated ASX name and ticker have yet to be announced, though the name change follows plans the clinical-stage biotech first outlined last year.
The company also disclosed a net operating cash outflow of $628,000 for the December quarter as it advanced several drug development programs.
Its current pipeline includes cannabinoid-based treatments IRX-211 for breakthrough cancer pain and IRX-616a for panic disorder, as well as SRX-25, an oral ketamine-based therapy targeting treatment-resistant depression.
Neurotech International
Neurotech International ended the December quarter in a considerably stronger cash position, with approximately $6.3 million on hand compared to $1.7m at the close of the previous quarter.
The improvement was driven by a $4.73m R&D tax incentive refund for FY25 and a $4m placement completed during the period.
In a separate ASX filing, Neurotech announced it had received ethics approval to begin a Phase 3 clinical study of NTI164 for autism spectrum disorder.
The approval follows the publication of Phase I/II clinical data from the study in a peer-reviewed scientific journal.
Peak Processing
The ASX has directed Peak Processing, formerly known as Althea Group Holdings, to clarify its funding position after the company's December quarterly cash flow report revealed less than six weeks of available funding, with $685,000 in cash at period end.
ASX listing rules require companies with less than six months of cash to explain whether current spending levels will persist, what measures are being taken to secure additional funds, and whether they can sustain operations.
Peak attributed the elevated December quarter cash outflows — totalling $1.5 million — largely to "one-off items including debt repayment, restructuring costs and elevated professional and audit fees", which it said were not expected to recur.
The company said it expects operating cash flows to improve from the March quarter onward and confirmed it is working on a capital raise to meet "operational requirements", stating it expects to continue trading on that basis.
The business rebranded as Peak after withdrawing from Australia to concentrate on its North American THC-beverage operations.
Zelira Therapeutics
Zelira posted a net operating cash inflow of $529,000 for the December quarter, supported by a $1.07 million R&D tax incentive refund, and finished the period with $52,000 in cash.
The quarter also saw the company lock in commitments to raise close to US$33 million (A$49.5 million) to back HOPE 1, its special purpose vehicle (SPV).
Argent BioPharma
Argent recorded a net operating cash outflow of $1.55 million for the December quarter, closing the period with $1.53m in cash.
Over the quarter, the company secured access to up to $11m from US-based institutional investors, including an immediate $3m drawdown to fund the AusCann asset acquisition.
The transaction is expected to be finalised in Q1 2026.
