Who's Buying, page-52

Paul Gavin presented at the Bell Potter Healthcare Conference today. Focus was on the current Phase 3 trial of TPM/CBD in Insomnia.

To date, there are 70 patients on the trial. There has been a very high rate of attrition from the potential patient pool due to the trial’s strict eligibility criteria and controls for placebo response.

The company is finalizing a number of planned strategies to increase the rate of recruitment and these will be announced shortly.

When questioned on the likely timing for interim readout, Paul said that there were hopes to reach that point by the end of H1 next year.

The interim readout will serve two purposes – a futility analysis for a Go/No Go decision and to provide a repowering calculation to estimate how many more patients would be required to successfully complete the trial.

The trial has two primary endpoints. The first is improvement on the Insomnia Severity Index, a 28 point scale. The second is improvement in sleep efficiency which measures time asleep as a percentage of time in bed. Only one of the primary endpoints needs to be met in order for the trial to succeed.

The formulation is patent protected through until 2040.

Currently in discussion with a range of companies that might assist with further financing. Believes there is adequate funding to get through to completion of those discussions.

There are multiple levels of partnering interest if interim readout is successful. The four levels of interest are large pharmacy chains, large Australian generic companies, global pharma in the OTC space with interest in a cannabinoid product and large global pharma with interest in a cannabinoid product for the global prescription market.

Suggestion that we will hear more within the next couple of weeks.