Biotron Limited has again demonstrated substantial and clinically meaningful efficacy against SARS-CoV-2 in a series of animal studies performed at The SCRIPPS Research Institute, La Jolla, CA, USA. BIT225 protected against severe disease, indicated by the significant prevention of body weight loss and absence of death in SARS-CoV-2-infected animals treated with BIT225 compared to non-treated controls. BIT225 administered orally significantly reduced virus levels in the lungs of animals challenged with SARS-CoV-2. The results show statistically and clinically significant efficacy of BIT225 in this model of COVID-19.

Experimental details of this repeat study (`Study 2'), set out in the Addendum below, are the same as for the first 300mg dosage study (`Study 1') announced on 25 November 2021 with the exception that, due to the good health of the mice receiving BIT225 at the end of Study 1, the treatment period was extended from 7 days for Study 1 to 12 days for Study 2. In both studies, BIT225 was tested in a 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. In Study 2, shown below in the Addendum, body weights of the mice throughout the studies show a pronounced downward trend in SARS-CoV-2-infected mice treated with vehicle control (i.e. drug-free control) from about Day 4, which is not observed in SARS-CoV-2- infected mice treated with BIT225. No mice receiving daily BIT225 by oral gavage developed any signs of disease, and all continued to gain weight as per age expectations through to Day 12 when the study was terminated.

In contrast, all mice in the control, drug-free group died by Day 8 post-infection with SARS- CoV-2 from severe COVID. As in the previous study announced in November 2021, BIT225-treated mice in Study 2 had significantly lower viral loads of SARS-CoV-2 in lung compared to vehicle (drug-free) controls.