Ann: Chair's Address and CEO Presentation, page-7

Phase 3 trial of TPM/CBD in the treatment of insomnia

1700 prospective trial participants screened to date.

Of these, 150 have passed first stage screening and been referred to clinical trial sites to undergo final testing and commence dosing.

First patient dosed in April.

519 participants planned for recruitment; interim analysis planned after 219 participants have completed treatment.

Five trial sites – Brisbane, Sydney, Central Coast, Melbourne, Perth.

8 week, 3-arm trial – placebo/75mg CBD/150mg CBD.

Currently estimating interim analysis by end of Q1 2025, but a more accurate picture should emerge within a few months as recruitment and drop-out rates are more clearly established.

If interim analysis is positive, intention is to sign commercial partner/s following.

It was confirmed that the Company has worked on strategies to move forward in the event that interim analysis indicates that continuation of the trial would be futile.

Significant interest has been expressed in partnering Avecho’s CBD capsule. This includes interest from a couple of major international pharma. It was said that such a licensing partner would likely choose to launch the product as a prescription pharmaceutical rather than OTC product. TGA approval would allow either option.



TPM in US Recreational Cannabis/THC Gummies

Ongoing BD discussions. Hoping to secure a cornerstone TPM-supply deal this calendar year.



Lambert Initiative

Although progressing slowly, it was said that work with Lambert Initiative was still ongoing.



New Director

Newly-appointed NED, Kathy Connell, briefly addressed the meeting and I also spoke with her after. Ms Connell’s CV speaks for itself - she is a highly experienced and respected leader in lifesciences who has served in senior executive positions at major pharmas. During her 12 years at Johnson & Johnson as Senior Director, New Ventures ANZ, Kathy was personally responsible for executing almost 100 deals across Australia.

Kathy said she was excited to bring her expertise to one of the few Australian biotechs currently executing a Phase 3 trial. She described the Board as “a highly focused team”. She said that she knows that might sound trite but that her enthusiasm is genuine.


Other

I note that SAS-B applications for medicinal cannabis (the only current legal way to access medicinal cannabis in Australia) are continuing to show strong growth. From ~25,000 applications in 2019, the current trend suggests the possibility of ~200,000 applications for access to medicinal cannabis this year.

One of my siblings, a doctor (who happens to be unaware of my biotech investments), was complaining to me yesterday that seemingly “every second patient” was either on, or seeking medicinal cannabis for either sleep or anxiety. Certainly seems that patient demand is there!

Paul mentioned at the AGM that psychiatrists were keenly interested in new products they could prescribe for sleep. Lack of sleep worsens depression; improving sleep improves depression. However prescription of currently-available medications to aid sleep is not advised because of the risk of suicide by overdose.