The Directors are advised that the Biotron Limited's lead clinical drug, BIT225, has demonstrated effective protection from severe disease in mice with established SARS-CoV-2 infection in a new animal study performed at The SCRIPPS Research Institute, La Jolla, CA, USA. In previously reported studies (17 March 2022 and 25 November 2021), animals were dosed with BIT225 12 hours before infection with SARS-CoV-2. In this new study, the animals were infected with SARS-CoV-2 up to 48 hours before starting treatment with BIT225. This is a more challenging model and creates a high hurdle to demonstrate efficacy of the drug.

In all studies, BIT225 was tested in a human-adapted COVID-19 mouse model (K18-hACE2) that is routinely used to assess the ability of drugs to target SARS-CoV-2 and treat COVID-19 disease. The experimental details, set out in the Addendum below, show that BIT225 can both prevent and treat SARS-CoV-2 disease ­ necessary requirements for successful product development in this therapeutic area. All BIT225 pre-dosed mice (n=5) and 24-hour post-dose mice (n=5) remained healthy and continued to gain weight as per age expectations through to Day 12 when the study was terminated.

One of the five animals in the 48-hour post-dosing cohort died on Day 11 of the study. As in previous studies all vehicle-control mice showed an inexorable downward trend in body weight, and all control mice (n=5) died by Day 8. Group mean body weights of BIT225-treated mice throughout the studies (a reflection of COVID-19 disease) were statistically different to vehicle control mice throughout the study. While there appears to be a trend for less weight gain if initiation of BIT225 dosing is delayed, the trend lines are statistically the same regardless of whether drug treatment was initiated pre-infection or post-infection.

In March 2022 the Company submitted a proposal to the USA Food and Drug Administration (FDA) to conduct a human clinical trial to assess the efficacy of BIT225 for the treatment of COVID-19 under the Coronavirus Treatment Acceleration Program, a special emergency program for potential coronavirus therapies. A response is expected shortly and, once received, the Company will be in a position to determine its capital requirements for the human clinical program funding which will be sought from potential partners and non-equity funding sources.