BIOTRON LIMITED — Investor Presentation 2017

Jan 12, 2017

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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

13 January 2017

The Manager Companies ASX Limited 20 Bridge Street Sydney NSW 2000

(26 pages by email)

Dear Madam

BIOTRON LIMITED PRESENTS AT BIOTECH SHOWCASE[TM] 2017

CORRECTED PRESENTATION

Biotron Limited advises that Dr Michelle Miller, Managing Director, will be giving the attached presentation to the Biotech Showcase[TM] 2017 Conference being held this week in San Francisco, California, USA.

In addition, Dr Miller will give briefings to USA institutional investors and pharmaceutical company representatives as part of activities surrounding the annual JP Morgan Healthcare Conference. This is one of the most important annual healthcare investor conferences, attracting thousands of healthcare and life science business executives, as well as investors and analysts, to San Francisco.

The Biotech Showcase[TM] features corporate presentations by innovative life science companies to an audience of public and private investors, business development executives and professional advisors who are interested in investment opportunities and collaborations. Now in its ninth year, it expects to attract upwards of 2,800 attendees.

Yours sincerely

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Peter J. Nightingale Company Secretary

pjn8740

BIOTRON LIMITED (ASX:BIT)

Biotech Showcase 2017

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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.

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• Developing new class of an,viral drugs

• Lead programs: BIT225 targe,ng HIV-1 eradica,on and Hepa,,s C virus (HCV)

• mul,-billion dollar markets

• Phase 1 / 2a trials completed in over 200 subjects – safety and efficacy validated

• Several near term, value-adding milestones driven by two key HIV-1 studies in 2017:

• BIT225 treatment interrup,on study and BIT225 Phase 2 HIV-1 human trial

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Corporate Snapshot

Key Financial Metrics

Brief Biotron Overview

Ticker Code ASX: BIT

Share Price (09 Jan 17) A $0.04 Market capitalisa,on A $12.24 million 12 Month Trading A $0.040 – 0.105 Range Shares Outstanding 313 million Cash Posi,on (09/2016) A $2.29 million

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• Spun out from John Cur,n School of Medical Research at the Australian Na,onal University in 1999

• Listed on ASX in Jan 2001 (ASX:BIT)

• Headquartered in Sydney, Australia

Board

Michael Hoy Non-execu,ve Chairman Michelle Miller Managing Director Susan Pond Non-execu,ve Director Rob Thomas Non-execu,ve Director Denis Wade Non-execu,ve Director

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• Core exper,se is design and development of a new class of an,viral drugs targe,ng viral-encoded viroporin proteins

• Dengue and West Nile (M protein), SARS (E protein) and others

• Broad plalorm:

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

• Focused library of compounds that target these viral proteins

• for key markets

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• Small hydrophobic proteins with ion channel ac,vity

• Form hydrophilic pores in host cell ~~membranes~~

~~Key stages of the viral cycle such a~~ s virus ~~uncoa,ng, transport and matura,o~~ n are - ion infuenced processes in many viral species

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ion
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• Crucial for viral pathogenicity due to involvement in various steps of virus life cycles

• Ideal therapeuPc targets

Nature Reviews Microbiology 10 , 563-574

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Compound Discovery Process

		1				Design of compounds to explore 3D space and determine SAR of target proteins; expansion of compound library to increase ac,vity against target
	Addi,onal chemistry to refne hits			2		Compounds screened in proprietary assay set up for each virus target e.g. HIV-1 Vpu; HCV p7; Infuenza M2; Dengue M; Coronavirus E.
				3		Hits tested against virus in cell cultures; Secondary screening of hits against other key viruses e.g. Hep B, infuenza, Zika
		4				Lead op,misa,on and selec,on. Current lead: BIT225 (HIV-1 and HCV). BIT314 (HCV) is next generaPon

Library of compounds designed to target viroporins:

Ini,ally >250 compounds designed and synthesised; library now ~350

OTHER “HITS” IN LIBRARY include:

• Coronaviruses (Including SARS)

• Epstein-Barr virus (EBV)

• Hepa,,s B virus (HBV)

X-axis: compound ID Y-axis: virus Z-axis: strength of hit

• Zika virus

• others

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		Biotron - Advanced Pipeline	Biotron - Advanced Pipeline	Biotron - Advanced Pipeline	Biotron - Advanced Pipeline
INDICATION	COMPOUND	DISCOVERY	PRECLINICAL	PHASE 1	PHASE 2	PHASE 3
HCV	BIT225
HIV-1	BIT225
Next
generaPon -	BIT314
HCV
Dengue	Leads

HIV-1 Reservoirs

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Mario Stevenson Scien6fic American 299 , 78 - 83 (2008)

• 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

HIV-1: Towards a Cure

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• Over 1.1 million people living with HIV-1 in the USA, with 1 in 6 unaware of diagnosis

• US$11.9 bn sales in US, Europe and Japan in 2013; expected to grow to US$16.8 bn by 2020

• HIV-1 pa,ents need to stay on an,retroviral drugs (ART) to keep virus levels under control

• 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 eradicate or cure HIV-1 infec,on

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BIT225 Targets HIV-1 in Reservoir Cells

• BIT225 inhibits assembly and budding of new virus in macrophages

• Phase 2a trial (004) demonstrated that BIT225 can reduce HIV-1 levels in macrophage cells in vivo , paralleling in vitro studies (Wilkinson et al , J An,microb Chemother. 2015 Nov 29. pii: dkv389. [Epub ahead of print])

• Poten,al for use in future virus eradica,on treatment

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A B
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BIT225 Stops HIV-1 Replica7on in
Human Macrophage Cells
200
150
100 +BIT225
50
16 17 19 21 22 23 24 25 26 27 28
+HIV-1 Time (days)
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(A) Untreated Controls (B) BIT225 treated cells

BIT225 – Proven Clinical AcPvity Against HIV-1

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

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

• Results demonstrated that BIT225:

1. (reservoir) cells

2. Crosses the blood-brain barrier, opening up the possibility of treatment of AIDS-related demenPa

2. trial

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16
Placebo
14 BIT225
12
10
8
6
4
2
5 10 15 20 25
Time in Co-culture (days)
HIV-1 Replica,on (pg/200uL)
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PotenPal role for BIT225:

• AddiPon to current ART to eradicate key reservoirs, impacPng immune acPvaPon

• Key component of cure/eradicaPon strategies

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HIV-1 Viral Dynamics

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BIT225-009 Hu-Mouse ATI
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• Ini,ate Phase 2 HIV-1 Clinical Trial - 3 month trial in combina,on with ART (BIT225-009); Expect trial

• commencement early 2017 – Data expected in 3Q17

  • Expected outcome(s) – Impact on kine7cs of viral load decay in combina7on with ART indica7ng impact on underlying viral reservoir, also impact on immune ac7va7on

• Analy,cal Treatment Interrup,on (ATI) Study – Currently underway evalua,ng BIT225 in HIV-1 Infected Humanised Mice - Data expected Q1 2017

  • Expected outcome(s) – impact on viral kine7cs in combina7on with ART, plus poten7al impact on rebound once ART is stopped

• pa,ent trials.

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BIT225 – First of a New Class of HCV DAA Drugs

• Novel, oral, small molecule compound

• Only one of its class (p7 inhibitor) in clinical trials

• Inhibits viral assembly and infec,vity

• Pan-genotype ac,vity:

• Ac,ve in vitro against all main genotypes

• Clinically ac,ve against HCV GT 1 (1a and 1b) and GT 3

• Seeking partnerships for further development, in par,cular, in Asia

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POLYMERASE/PROTEASE
INHIBITORS e.g.
Sofosbuvir/Simeprevir
BIT225 - ASSEMBLY/
BUDDING INHIBITOR
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• • Prepared based on above azer the August Board mee,ng Four clinical trials I HCV-infected subjects completed (including one HIV-1/HCV coinfected - Guided the wording of the prospectus draz and the use of proceeds trial)
• • Pr ~~omising clinical efcacy against HCV~~ of work will be largely dictated by available capital

• HCV GT1 (BIT225-005) – 100% receiving 400mg BID for 28 days in combina,on with 48 - weeks IFN/RBV (per protocol) were virus free at 48 weeks

• on ~~HIV-1/HCV GT3 (BIT225-006) – 100% receiving 300mg BID for 28 days in combina,~~ with 48 weeks IFN/RBV (per protocol) achieved SVR12 i.e. cured of HCV infecPon

• BIT225 increases the rate at which HCV is cleared in combinaPon with other drugs

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• Emerging evidence that Interferon sparing therapies may cause reac,va,on of Hepa,,s B (HBV)

• Evidence of reac,va,on of hepa,,s B in co-infected pa,ents (HBV & HCV) presented at AASLD

• 30 – 50 million HCV-infected subjects in China

  • High HCV/HBV co-infec,on rate in China

• Poten,al for another class of DAA such as BIT225 to shorten treatment and reduce costs, in par,cular in markets ex-USA/Europe

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• Renewed industry interest in targe,ng viral diseases including

• Hepa,,s B virus

• Tropical diseases including Dengue

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

• BIT225 has demonstrated the robustness of Biotron’s approach with targePng viroporin proteins

• progress, with the aim of iden,fying poten,al candidates to progress into IND-enabling studies

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

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Dengue Virus Program

• 2.5 billion people (40% world popula,on) live in areas at risk

• of Dengue

• ~100 million people infected yearly

• A leading cause of illness and death in tropics and subtropics

• Transmission is by mosquito; most preven,on programs target the vector

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• Vaccine trials have had disappoin,ng results

• Biotron is targe,ng Dengue M protein – Similar target to HIV-1/Vpu and HCV/p7

• Several compounds with promising ac,vity have been generated; tests are on-going

• Poten,al for pan-Flavivirus therapeu,c

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www.sciencenews.org
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HepaPPs B Virus

• Limited screening of Biotron compound library has generated interes,ng data

• • Seeking collabora,on to explore hits and develop program

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CommercialisaPon and Partnering

• ~~HIV-1 Program - Signifcant value infec,on points around HIV-1 program data expected~~ in 2017

• HCV Program - BIT225 par,cularly well suited to Asia, with high numbers of HCVinfected pa,ents including a high propor,on of HCV/HBV co-infected pa,ents

• Early stage collabora,on opportuni,es for pre-clinical targets, such as:

• Dengue

• Hepa,,s B

• Addi,onal development collabora,on poten,al for “other” pharma targets

• Seeking partners for individual targets or en,re plalorm

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• Complete Analy,cal Treatment Interrup,on (ATI) Study in HIV-1 Infected Humanised Mice

• Data expected Q2 2017

  • Expected outcome(s) – Impact on kine7cs of viral load decay in combina7on with ART indica7ng impact on underlying viral reservoir

• Complete Phase 2 HIV-1 Trial - Data expected in 3Q17

  • Expected outcome(s) – impact on viral kine7cs in combina7on with ART, plus poten7al impact on rebound once ART is stopped

• Finalise a regional partnering agreement for BIT225 for HCV

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Investment Highlights

NOVEL ANTIVIRAL PLATFORM

TargePng viroporin proteins with a rapid screening proprietary primary bacterial cell-based plaform - a library of over 350 compounds with acPvity against a range of viruses.

Clinical and Preclinical programs in indicaPons with high unmet clinical need BROAD ANTIVIRAL or large paPent populaPons such as HIV-1, HCV & Dengue, HBV, Zika & PIPELINE

ROBUST CLINICAL VALIDATION

outcomes

STRONG INTELLECTUAL Porfolio of patents and patent applicaPons directed to the Company’s anPPROPERTY POSITION viral drug porfolio

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

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