Biotron's Phenomenal Success ..., page-105

Hi TGMax

It has been frustrating not getting any updates.

The last update was on the 25th November 2021(1 day after the AGM).

Looking at what they actually achieved was very exciting.

The point is things are happening, it is just that the shareholders are not told of these achievements.

If the AGM was not held, when would we have found out about these achievements/progress.

This is extremely frustrating. There needs to be more communication.

Essentially we could get information at any time, and then this share price will be in a much better place than it is now.

Clinical stage company developing small molecule drugs targeting viral diseases with major health problems:

• HIV-1, COVID-19, Hepatitis B virus and others

• Unique approach to tackling virus infections

• Combining direct antiviral and immunomodulatory activities to knockdown virus levels and boost the body’s immune system to fight the infection

• Experienced Board and management team with pharma, financial and VC backgrounds

• Headquartered in Sydney, Australia

• portfolio of clinical and preclinical antiviral drugs

Since the start of the pandemic Biotron’s focus has been on designing and testing new compounds to target the SARS-CoV-2 E protein (oral drugs) based on SARS-1 program active compounds

• Lead series of new compounds identified based on these studies

• Included BIT225, Biotron’s clinical-stage anti-viral (HIV-1 and Hepatitis C virus) drug in vitro cell-based and and in vivo animal studies of SARS-CoV-2 infection.

• Studies were undertaken in laboratory of collaborators at The SCRIPPS Research Institute, La Jolla, CA

BIT225 is a small molecule, an antiviral drug that is in capsule form for oral dosing

• Suitable for once-daily dosing

• BIT225 is in development for HIV-1 eradication and improving health outcomes associated with immune dysfunction

• Two Phase 2 trials are currently recruiting in ART-treatment naïve (Thailand sites)and ART-treatment experienced (Australian sites) populations

• Over 200 people have been dosed in clinical trials to date, with up to 12 weeks of dosing. Current trial approvals are for dosing out to 24 weeks.

• Completed 9 clinical trials involving healthy volunteers, patients with HIV-1 infection, patients co-infected with Hepatitis C virus (HCV) and HIV-1 and patients with HCV (as monotherapy and in combination with pegylated interferon-alfa and ribavirin).

• Well characterised safety and PK profile

• Completed formal preclinical studies including chronic (i.e.24 weeks) safety studies

• Recently completed another cGMP manufacturing campaign of BIT225 - 8KG for HIV-1 More than enough

• BIT225 is very stable over extended periods, including at room temperatures

In discussions with international advisors to design clinical study(s) to assess efficacy against COVID

• Engaging with relevant regulators (FDA/CTAP) to facilitate fast assessment

• Aim is to progress BIT225 into trials to assess efficacy as therapeutic for COVID-19 as quickly as possible

Summary

BIT225 demonstrated substantial and clinically meaningful efficacy against SARS-CoV-2 infection in an animal model of COVID-19

• It is active against the highly infectious delta strain in cell cultures

• BIT225 is a clinical-stage drug in development for the treatment of HIV-1, with over 200 people dosed in trials to date.

• BIT225 is an oral drug, suitable for once-a-day dosing and has a well-characterised safety profile.

• BIT225 has a unique mode of action that differentiates it from other COVID drugs in development

• It belongs to a new class of antiviral drugs known as viroporin inhibitors

• Existing HIV-1 data has demonstrated that BIT225 uniquely combines direct-acting antiviral activity with immunomodulatory activity in clinical studies.

• Biotron Limited is now seeking to accelerate BIT225 into clinical trials in SARS-CoV-2-infected people.