BIT 0.00% 2.0¢ biotron limited

Ann: Chairman's Address and Presentation to AGM, page-2

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    Key Achievements 2020/2021 FY
    Key milestone for HIV-1 program:
    Commenced two clinical trials of BIT225
    Trials designed in consultation with international experts with key links to pharma
    Designed specifically to solidify understanding of what BIT225 is doing and how it is doing
    it with focus on partner requirements
    There is no roadmap to follow for HIV cure/eradication
    Trials are being done to generate data to support future regulatory filings/use labels
    Completed a new manufacturing of BIT225 clinical-grade (cGMP) drug for future trials
    Progressed identification of next-generation HIV-1 drug candidate –candidates are currently
    undergoing preliminary safety testing
    Key Achievements 2020/2021 FY (cont)

    Expanded the SARS-CoV-2 program
    Testing in relevant, robust animal model of COVID in USA laboratory
    Results are imminent
    Hepatitis B Virus (HBV) program
    Progressed identification of potential lead to move into animal model(s)
    Unique approach to tackling virus infections
    Combining direct antiviral and immunomodulatory activities to knock down virus levels and boost
    the body’s immune system to fight the infection
    Focus is on partnering

    HIV-1 Unmet Need
    Safe, effective antiretroviral drugs (ART) have been central to successfully keeping virus levels down in HIV+
    people; Profound reductions in mortality, morbidly and transmission
    BUT
    ART is not curative, latent viral reservoirs remain
    and reactivate
    Immune reconstitution is only partial and
    accompanied by a state of chronic inflammation
    A significant excess of chronic diseases,
    malignancy and neurocognitive deficits result in
    individual and societal burdens
    Global treatment costs are not remotely
    sustainable


    SARS-CoV-2 Program
    Vaccines remain central to control of the pandemic but there is an urgent need for effective drugs to treat COVID in at-risk
    populations
    Designed and synthesised >100 new compounds to target the SARS-CoV-2 E protein (oral drugs)
    Screened for ability to inhibit replication of SARS-CoV-2 in a range of cell culture models
    Lead series identified based on these studies
    Several compounds with good antiviral activity in these in vitro studies
    IN PROGRESS:
    Testing key compounds in an animal model of SARS-CoV-2 in the USA
    Assessing immunomodulatory activity in parallel with antiviral activity
    Running preliminary preclinical safety studies in parallel
    Data expected before end 2021
 
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