Bod Australia Limited advised that the company's planned phase IIB clinical trial to be undertaken at the Woolcock Institute of Medical Research has received ethics approval from Bellberry Limited. The trial will investigate the efficacy of a new unique Schedule 3 (pharmacist only) CBD formulation on symptoms associated with insomnia. This is a major milestone for the Company allowing the immediate commencement of participant recruitment for the study.

The Woolcock Institute of Medical Research is Australia's leading sleep and respiratory research organisation. The trial will be a double blind, randomised and placebo-controlled investigation of the effect of administering a 50mg and 100mg oral CBD product per day, versus a placebo, over a 8-week period with over 200 participants. The clinical trial is one of the first registered in Australia for a Schedule 3 CBD product.

Following completion of the study, Bod expects to have sufficient data to commence product registration for a Schedule 3 low dose CBD product with the Therapeutic Goods Administration (TGA) and for the product to be included on the Australian Register of Therapeutic Goods (ARTG). It is anticipated that completion of this process will provide Bod with a low dose CBD product that can be sold over-the-counter by a pharmacist to Australian consumers without a prescription. This unlocks another channel to market for the Company and has the potential to significantly increase domestic sales, underpinning additional revenue growth.

Insomnia provides a large opportunity for Bod. In an estimated global market of $5.4 Billion by 2023, current pharmacological interventions for the treatment of insomnia have major limitations including abuse and dependence, questionable or uncertain efficacy and hangover effects. The successful development of Bod's product will provide it with a defined pathway to market and an opportunity to grow its market share.

Ethics approval underpins Bod's strong momentum bringing its Schedule 3 products to market. Participant recruitment will commence shortly and Bod is also in advanced discussions with a number of potential partners for its Schedule 3 CBD products and expects to provide additional updates on these over the coming months.