Shareholder Email 19 December 2023, page-4

Tue 12/19/2023 11:36 AMView this email in your browser2023 Year in Review
Good morning,
As 2023 draws to a close, I would like to extend my gratitude to our valued shareholders and supporters for backing Avecho's mission. Despite local industry and global economic headwinds presenting some challenges, this year has been a testament to our resilience as we enter the final stages of planning for our pivotal Phase III clinical trial. We have laid strong foundations for a transformative 2024. We are set up for success and hope to emerge as a leading innovator in the insomnia treatment space, and much more.Phase III Clinical TrialThis time last year, we announced a green light from the Human Research Ethics Committee (HRECS) to conduct a Phase III clinical trial of our TPM®-enhanced oral CBD product in the treatment of insomnia. Since then, our team has been working diligently to coordinate every aspect of the trial, including manufacturing, clinical site selection, IT infrastructure and more.This study is built to succeed. Recruitment and dosing are on track for Q1 next year. We have, from the beginning, set ourselves ahead of our peers with the right expertise in pharmaceutical clinical trial design and execution to meet essential TGA requirements in this market. As a reminder, we shared quite pointed predictions about this in 2021.Today - as the sole remaining player in the Australian market for this particular indication - we are ready to become the first Australian pharmaceutical company to successfully register an over-the-counter pharmaceutical CBD product.Avecho's progress has not gone unnoticed. Earlier this year Avecho was featured on Channel 7 News, which explored the need for effective insomnia treatments and consumer demand for this product on successful completion of the trial. We can expect an increase in awareness for the Company next year as the trial commences, and we are working closely with leading key opinion leaders (KOLs) to support this market engagement program.Take another look at the Channel 7 story.Business Development This year we announced the development of our own edible dosage formulation, a TPM gummy, which combines TPM with cannabinoids, such as CBD and THC. Absorption from gummies is typically slow, but we have demonstrated the ability of TPM to enhance buccal drug absorption, which supports faster absorption into the bloodstream. Our cannabinoid portfolio now contains four different dosage forms; oral oils, oral soft-gel capsules, oral edibles, and topical gels, all of which show increased absorption through the inclusion of TPM. As part of our business development program we are continuing to explore large commercial opportunities within the North American consumer market. I travelled to the US earlier in the year to initiate discussions with several companies related to our TPM cannabinoid products. Feedback has been positive and testing of TPM-enhanced cannabinoid products is currently underway at a number of North American facilities, with the aim of entering subsequent licensing and supply agreements. Our non-CBD licensing deals exploiting the unique properties of TPM continue to advance. Our topical Ibuprofen gel under investigation by Perrigo continued through the manufacturing phase of product development in anticipation of clinical studies in a pain indications. Additionally, the Arthur Group commenced formulation development of TPM enhanced oncology, using TPM to replace adverse excipients included in existing products that have known safety concerns. Further business development activities will kick off early in 2024 as members of our team fly to San Francisco to attend the Biotech Showcase and meet companies attending the J.P. Morgan 42nd Annual Healthcare Conference.Key highlights in 2023The first batch of oral TPM®-enhanced CBD softgel capsule product passed a pivotal two-year milestone in ongoing stability trials. Manufacturing is now underway for use in the clinical trial, as well as formal registration batches that will be submitted to the TGA/FDA. Completed the development of our first edible gummies combining TPM with cannabinoids, placing the Company in a strong position to enter discussions around the use of the gummy in the medicinal market. New patent covering an optimised manufacturing method for TPM granted by the US Patent and Trade Marks Office. Expanded our collaboration with the Lambert Initiative to examine novel indications that may be treatable using lower doses of cannabidiol therapeutics. Signed a licensing and development agreement with the Arthur Group LLC, for the development of a series of leading cancer drugs with TPM. Raised $8M in capital to advance our Phase III clinical trial.2024 will be a watershed year for Avecho. We have done the hard work and we are moving quickly towards registration of a highly lucrative and scalable new treatment.On behalf of the Avecho team, I thank you for your ongoing support, and I wish you a safe and relaxing time with your family and friends.With thanks,Dr Paul GavinAvecho Chief Executive Officer