Ecofibre expects to complete its phase 3 clinical study into sleep-related issues by the end of September as it progresses plans to register an over-the-counter product with the Therapeutic Goods Administration (TGA).
Recruitment for the double-blind, randomised, placebo-controlled trial is ongoing, the company said, with 1,500 patients having applied to take part.
In a separate move, the company said it has acquired hemp food brand Soul Seed in a A$300,000 deal.
The developments came as Ecofibre reported revenues of $7.4 million in the January to March quarter, 8% more than the same period last year, but down 3% on the previous quarter.
Its US-headquartered CBD division, Ananda Health, generated $2.9m, down from $3.1m on the previous corresponding period, with the closure of its original Ananda Hemp brand blamed for the drop.
The brand was axed “to focus its assets on the Ananda Professional brand and pharmacy segment”, the firm said.
Pharmacy sales in the US climbed 37% from last year as the effects of Covid continued to recede.
Meanwhile, its Australia-based Ananda Food operation contributed revenue of $800,000, down from $1.2m in the previous quarter — a period which included $500,000 from the seasonal sale of planting seed to US fibre customers.
The underlying performance of the division remained strong, Ecofibre said.
Hemp Black, the firm’s sustainable industrial division, generated $3.6m, up from $3.3m.
Schedule 3 trial on track
Chief executive Eric Wang told an investor briefing the S3 study should be completed by September 30, ahead of lodging a product registration dossier with the TGA before the end of the year.
“With 2.1 million Australians having a sleep-related issue, it is a very attractive market and we are looking to make access a lot simpler,” he said, adding that the over-the-counter move in Australia will replicate how Ecofibre already operates in the US.
“We will be leveraging and lifting everything we do in the US and moving it to Australia,” he said.
Ecofibre continues to distribute S4 and S8 medicines under the Ananda Professional brand in Australia.
Meanwhile, the company, which suffered a turbulent FY21 with profits tumbling from $13m to a loss of $7m, has expanded its food division with the acquisition of Soul Seed.
Ecofibre already manufactured and packaged the products for Soul Seed, which is sold in Coles supermarkets, but now has ownership of the brand, Wang said.
“It gives us a true retail brand,” he told investors. “Until now we have been focused on wholesale, bulk and processing, but using the Soul Seed brand, we can enter the retail part of the market.”
Wang said it will look to distribute Soul Seed to other supermarkets, expand into health food stores, develop new products and export to international markets.
“We are very excited to have the retail margins and have a little more control over where we distribute our products,” he said.
Ecofibre shares, which have lost 61% of their value over the past year, climbed 1.23% to $0.41c.
