Alzheimer's Therapeutics company Ceretas (CTS: $0.925) listed on the ASX at the end of July at $0.25 a share. It has been a very successful listing, with the stock up 270% to date. The company raised $8 million in the process. Its Executive Director is Tony Keating, former CEO of ResApp Health which was sold to Pfizer in 2022 for $179 million.
Two Approaches
Ceretas is commercializing an ultrasound system to reduce the behavioural symptoms of Alzheimer's disease. The technology has been developed over the last decade at The University of Queensland and the Queensland Brain Institute. There are two approaches the company is taking.
The first is to use directed ultrasound agitation of brain tissue and neuronal activity to help reset neural circuit function and synaptic connectivity. The first positive results with this approach were achieved in mice in 2021, with improved memory-related brain activity and neural circuit function. However in 2024, in a Phase I study in 12 patients with Alzheimer's disease, a statistically significant effect was recorded in behaviour improvements and psychological metrics (noting that these are subjective measures to assess). These results were published in the journal Brain Communications.
The second approach being taken by Ceretas is to incorporate 'microbubbles' with the ultrasound stimulation to accelerate the clearance of tau and beta amyloid proteins from the brain. In 2015, the results from a study using this approach in an Alzheimer's disease mouse model showed that memory function could be 'restored' and beta-amyloid plaques were cleared. The results were published in the journal Science Translational Medicine.
Clinical Studies Underway
Ceretas is now commencing a Phase II study with directed ultrasound therapy alone in Australia. Three sites have been approved to commence. These are at St Vincent's Hospital in Sydney, John Hunter Medical Research Institute, and at Cognivus Research.
The study will recruit a minimum of 60 subjects with probable Alzheimer's disease with dementia. The trial will include a placebo arm, with the primary endpoint being improvements in neuropsychiatric symptom burden over six weeks. Participants will receive weekly treatment over four weeks. This study is expected to finish in the first half of 2028.
A second similar study is being conducted by The University of Queensland and is funded by Queensland Health. It will focus on changes in the level of agitation in participants. It is expected to be a similar sized study with similar timelines.
The second approach, to open the blood-brain-barrier with microbubbles and ultrasound stimulation, is expected to enter clinical studies in 2028, with data to emerge from preclinical studies. It is expected to be trialed patients with Alzheimer's disease and other neurodegenerative diseases.
Ceretas is capitalized at $66 million.
Bioshares recommendation: Speculative Hold Class B
