BIOTRON LIMITED — AGM Information 2016

Nov 21, 2016

==> picture [224 x 34] intentionally omitted <==

Level 2, 66 Hunter Street Sydney NSW 2000 Tel: (61-2) 9300 3344 Fax: (61-2) 9221 6333 E-mail: pnightingale@biotron.com.au Website: www.biotron.com.au

22 November 2016

The Manager Companies ASX Limited 20 Bridge Street SYDNEY NSW 2000

(22 pages by email)

Dear Madam,

PRESENTATION TO ANNUAL GENERAL MEETING

I attach an address by the Chairman and a PowerPoint presentation which are to be delivered to the shareholders present at today’s Annual General Meeting which is convened to be held at 11.30 am.

Yours faithfully

==> picture [107 x 69] intentionally omitted <==

Peter J. Nightingale Company Secretary

pjn8684

==> picture [224 x 34] intentionally omitted <==

Level 2, 66 Hunter Street Sydney NSW 2000 Tel: (61-2) 9300 3344 Fax: (61-2) 9221 6333 E-mail: info@biotron.com.au Website: www.biotron.com.au

22 November 2016

My Fellow Shareholders

CHAIRMAN’S ADDRESS TO THE AGM

While the last 12 months have been challenging, I’m pleased to report Biotron has made significant progress in the Company’s aim of building resilience across its platform.

One thing we of which we can all remain confident of is that there is an unceasing, growing, demand for health solutions worldwide, particularly for the treatment of infectious diseases. We can also be confident that Biotron’s portfolio of quality assets is well placed to benefit patients and, importantly in the context of this meeting, shareholders.

Today there is no doubt about the need for reservoir treatments to eradicate HIV-1. In fact ‘eradicate’ has become the sector mantra, most of ‘Big Pharma’ have discovery programs in place to attempt to identify therapeutics that will ‘cure’ HIV-1. While existing drugs may help control the virus, they can’t kill it.

There is equally no doubt that the struggle against Hepatitis C, no matter what claims are made publicly, is far from over.

There is no doubt that Biotron’s anti-viral library is particularly important clinically and commercially. This is perhaps borne out by the unsolicited approach the Company received from the National Institute of Allergy, Immunology and Infectious Diseases, a division of the USA National Institute of Health, with an offer to provide research support to further the Company’s Zika virus program.

Biotech – our field – is an exciting sector but also an easy target for overstatement and ill-informed rumor.

Inarguable facts are:

• An estimated 2.4 million patients in the USA and Europe are infected with HIV-1, with 91,000 new cases each year.

• Globally, 130 - 150 million people have chronic hepatitis C infection. That number also continues to grow daily.

Biotron’s lead molecule, BIT225, just one in the Company’s library of hundreds of compounds, has demonstrated in pre-clinical and clinical studies to date, to have an impact on both HIV and HCV.

Our work continually expands our knowledge of these diseases - and how to combat them.

Drug development is inherently risky. Drugs fail in development, encounter unforeseen issues or are met by surprise claims or breakthroughs from competitors. Biotech companies need to be adaptable, prepared to change direction, remain patient, adept with technology and vigilant with financial resources.

Biotron is now well advanced in its clinical programs and results to date have been very encouraging. A commercial outcome based on the Company’s current and anticipated results is our mutually expected objective.

My thanks to my fellow directors and Biotron staff for their commitment and contributions over the past 12 months.

I would now like to invite our CEO, Michelle Miller, to address the meeting.

==> picture [166 x 74] intentionally omitted <==

Michael Hoy Chairman

Annual General Mee+ng 22 November, 2016

Forward Looking Statements

condi,on, results and business achievements/performance of Biotron Limited (ACN 086 399 144) and certain of the plans and objec,ves of its management. These statements are statements that are not historical facts. Words such as “should”, “expects”, “an,cipates”, “es,mates”, “believes” or similar expressions, as they relate to Biotron Limited, are intended to iden,fy forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect Biotron’s current expecta,ons and assump,ons as to future events and circumstances that may not prove accurate. There is no guarantee that the expected events, trends or results will actually occur. Any changes in such assump,ons or expecta,ons could cause actual results to differ materially from current expecta,ons.

==> picture [840 x 66] intentionally omitted <==

Biotron Snap Shot

• Biotron’s core exper,se is design and development of new an,viral drugs targe,ng viral ion channel proteins (viroporins)

  • Viroporins are present in broad range of viruses:

    • (E protein) and others

• Broad plaborm:

  • Rapid, proprietary primary bacterial cell-based screening assays for target proteins

  • Focused library of compounds that target these viral proteins

• BIT225 clinical program con%nues to demonstrate that Biotron’s viroporintarge+ng approach to drug development works

==> picture [840 x 66] intentionally omitted <==

Strategy Update

• Con,nue to posi,on Biotron as Clinical Stage An,-viral Development Company with:

o Clinical programs for HIV-1 and Hepa,,s C virus (HCV)

o A lead program, BIT225, as “First in Class” therapy for HIV-1 eradica,on

o Valuable HCV clinical program, with a new class of direct-ac,ng an,viral agent

o Early stage collabora,on opportuni,es for preclinical targets such as:

• § Dengue

• § Zika

• § Hepa,,s B virus

o Addi,onal development collabora,on poten,al for “other” Pharma target(s)

==> picture [840 x 66] intentionally omitted <==

BIT225 – Phase 2 Asset for Two Indica+ons

• Demonstrates robustness of Biotron’s approach

• BIT225 is a valuable Phase 2 asset with two indica,ons – HIV-1 and HCV

• Both are mul,-billion dollar markets

• Over 200 individuals dosed (healthy, HCV, HIV-1 and HIV-1/HCV co-infected) in trials

• 7 clinical trials completed - posi+ve data recorded in all trials

• Demonstrated clinical ac,vity against HCV GT1 and GT3

  • Posi,ve data readout from BIT225-008 GT1 data earlier in year

• efficacy, dosage, etc)

• To support combina,on studies with poten,al partners” HCV drugs

Data generated in HCV trials is also applicable to HIV-1 program

==> picture [840 x 66] intentionally omitted <==

HIV-1 Eradica+on – Towards a “Cure”

==> picture [360 x 373] intentionally omitted <==

• need

•

• E.g. BIT225 @ US$100,000 per dose with 25% market penetra,on:

• Poten,al US$60 billion current infected market

• Poten,al US$2.25 billion new infec,ons

• Long-term health implica,ons even in pa,ents on an,retroviral drugs e.g. HAND, immune ac,va,on, etc

•

New mode of ac,ons drugs are needed:

•

• To improve health outcomes in pa,ents

• To eradicate or cure HIV-1 infec,on

• Area of real interest to interna,onal pharmaceu,cal industry

==> picture [840 x 66] intentionally omitted <==

HIV-1 Reservoirs

==> picture [331 x 438] intentionally omitted <==

• HIV-1 remains hidden in reservoirs, leading to chronic, life-long infec,on

• Invisible to body’s immune defenses

• Not sensi,ve to an,-HIV-1 drugs

• Eradica,on will require mul,ple approaches; approaches include:

• An,-latency agents for latently-infected T cells

• Drugs to modify immune response

• Drugs targe,ng HIV-1 in macrophage lineage cells

BIT225 has poten+al to impact immune response AND reduce HIV-1 in macrophage reservoir cells

299 , 78 - 83 (2008)

BIT225 – Proven Clinical Ac+vity Against HIV-1

16 Placebo 14 BIT225 12 10 8 6 4 5 10 15 20 25 Time in Co-culture (days)

• BIT225-004 : Phase 1b/2a randomised, placebo controlled, double-blind trial

• 21 pa,ents, HIV-1 posi,ve, treatment-naïve ; 10 days dosing with BIT225 (monotherapy)

Results demonstrated that:

1. macrophage (reservoir) cells; BIT225 crossed blood-brain barrier, possibility of treatment of AIDS-related demen+a

2. markers during trial

• Results support a poten+al role for BIT225 in cure/eradica+on strategies

==> picture [840 x 66] intentionally omitted <==

Combina+on with ART

==> picture [681 x 405] intentionally omitted <==

----- Start of picture text -----

1 - BIT225-009 2 - Treatment Interrup+on
----- End of picture text -----

Slide 13

HIV-1 Program Trials - I

• BIT225-009 Overview

• Phase 2 human clinical trial

  • 12 weeks BIT225 in combina,on with current an,retroviral treatment (ART)

  • Double blind, placebo controlled study

  • Measuring BIT225 impact on:

    • HIV-1 second phase of decay

    • Immune ac,va,on

    • Intracellular HIV-1 in reservoir lineage cells

==> picture [840 x 66] intentionally omitted <==

HIV-1 Program Trials - II

• Treatment Interrup%on Study (ATI)

• To look at impact on viral reservoir:

  • Treat with current ART drugs, with and without BIT225

  • Take away drugs

  • Measure impact on viral rebound

    • Delay, change in dynamics, etc

• BUT Recent advances in models of HIV-1 infec,on allow us to do this in a new animal model:

  • Directly mimics human ATI

  • Validated in discussions with poten,al partners

==> picture [840 x 66] intentionally omitted <==

Human Treatment Interrup+on Model

• Mice with human immune system

• Can be infected with HIV-1 and treated with human drugs

• Mimic Treatment Interrup,on trial in humans

ADVANTAGES:

• Less cost, risk, %me

• Provide data to:

• Guide for poten%al clinical use

• • Support outcome of 009 trial

• Handle on %me to rebound

• • Data is key to bedding down partnership

==> picture [295 x 23] intentionally omitted <==

----- Start of picture text -----

POTENTIAL Effect of addi+on of BIT225
----- End of picture text -----

==> picture [840 x 66] intentionally omitted <==

in HIV-1 Program

• Studies very carefully designed in conjunc,on with Key Opinion Leaders with industry feedback

• current ART

• Phase 2 HIV-1 Trial ( BIT225-009) -

• Expect trial commencement shortly – Headline data expected in 3Q17

• Expected outcome(s) – change of viral load in blood indica%ng impact on underlying viral reservoir, also impact on immune ac%va%on

• –

• Analy,cal Treatment Interrup,on (ATI) Study

• Trial is underway evalua,ng BIT225 in HIV-1 Infected Humanised Mice - Data expected Q1/17

• Expected outcome(s) – impact on viral rebound once ART is stopped

Both study approaches validated in discussions with poten+al partners

==> picture [840 x 66] intentionally omitted <==

HCV Program Update

• Partner-ready for combina,on studies with other HCV drugs

• BIT225 is pan-genotypic, new class of HCV drug

• 30 – 50 million people infected (compared to 3 – 5 million in USA)

• with interest in licensing BIT225 (for HCV)

• Pricing of latest HCV drugs from the USA is strong incen,ve for China to commercialise therapies for its domes,c market

• Licensee would undertake development, regulatory, manufacturing & marke,ng in China for its domes,c market

==> picture [840 x 66] intentionally omitted <==

Unlocking Value in Compound Library

• Renewed industry interest in targe,ng viral diseases including

• Respiratory syncy,al virus (RSV)

• Hepa,,s B virus

• Tropical diseases including Dengue

• Ebola, MERS-CoV and Zika outbreaks have caused public health issues worldwide

• BIT225 has demonstrated the robustness of Biotron’s approach with targe+ng viroporin proteins

• Main focus remains on commercialising the Company’s HIV-1 and HCV programs, but essen,al that other opportuni,es are developed

==> picture [840 x 66] intentionally omitted <==

Compound Library is Rich Source of Hits

X-axis: BIT compound ID Y-axis: Virus class Z-axis: Strength of hit

Library is valuable to Biotron and poten+al partners as it is a new chemical space that has not been exploited in drug development to date

Preclinical – Early Stage Opportuni+es

• Technology core is an an,viral plaborm with new class of small molecules with broad range of ac,vity against different viruses

  • Extending earlier stage programs for other key viruses:

    • Iden,fying hits for other viruses including RSV, Zika, BK, and others

    • Developing leads for programs including Dengue and HBV

      • Dengue virus – Applying for non-equity funding from US organisa,ons

      • Hepa,,s B Virus (HBV) - Early stage, but key target of interest to poten,al partners

• Screening ac+vi+es are KEY to demonstra+ng value of our pladorm

• Seeking collabora,ons for individual programs or en,re plaborm

==> picture [840 x 66] intentionally omitted <==

Summary

Biotron well posi,oned for value growth in 2017:

• Strong clinical program in HIV-1

• BIT225-009 trial and ATI Study making Biotron “Partner Ready”

• Regional HCV licensing strategy enabling addi,onal value op,misa,on

• Extensive safety, etc data package for BIT225 suppor,ng both HIV-1 and HCV programs

• Mul,ple preclinical collabora,on opportuni,es including high value HBV approach

• Commercialisa,on of drugs and plaborm remains the key focus and aim of the company, and basis of all ac,vi,es

==> picture [840 x 66] intentionally omitted <==

Contact

Dr Michelle Miller CEO & Managing Director +61 412 313329 mmiller@biotron.com.au ~~www.biotron.com.au~~

==> picture [840 x 66] intentionally omitted <==