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Ann: Chairman's Address and Presentation to AGM, page-53

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29/11/21

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Post #: 57940526
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Originally posted by moosey: ↑

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

Expand

In the part of Covid19 Study progress, have we seen any indication of immunomodulatory analysis or result in last Thursday ann?

If not, we could expect a followup soon by end of 2821? Once immunity study result is also presented, we could see a bigger reaction of market.
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