BIOTRON LIMITED - Investor Presentation 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: [email protected] Website: www.biotron.com.au

13 January 2017

The Manager Companies ASX Limited 20 Bridge Street Sydney NSW 2000

(22 pages by email)

Dear Madam

BIOTRON LIMITED PRESENTS AT BIOTECH SHOWCASE[TM] 2017

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)

Update – January 2017

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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.

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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
Directors
Michael Hoy Chairman
Michelle Miller CEO & Managing Director; ex-Johnson & Johnson Research; ex-Start-up Australia biotech fund
Denis Wade Independent non-execu,ve director; ex-J&J (Chairman and MD Johnson & Johnson Research); Director of Heartware Inc (NASDAQ:HTWR)
Susan Pond Independent non-execu,ve director; ex-J&J (Chairman and MD Johnson & Johnson Research)
Rob Thomas Independent non-execu,ve director; Director of Heartware Inc (NASDAQ:HTWR); Starpharma (ASX:SPL), REVA Medical Limited (ASX:RVA); Virgin Australia Limited (ASX:VAH)

Slide 2

Biotron’s core exper,se is based on design and development of a new class of an,viral drugs targe,ng viral ion channel proteins (viroporins)
Viroporins are present in broad range of viruses:
- protein) and others
Broad plakorm:
Rapid, proprietary primary bacterial cell-based screening assays for target proteins
Targeted library of compounds that target these viral proteins
markets

•

Small hydrophobic proteins with ion channel ac,vity
Form hydrophilic pores in host cell membranes
as
Key stages of the viral cycle such virus uncoa,ng, transport and -
matura,on are ion infuenced processes in many viral species
Crucial for viral pathogenicity due to involvement in various steps of virus life cycles
Ideal therapeu,c targets

Nature Reviews Microbiology 10 , 563-574

Slide 4

Biotron’s Core Technology

Designed library of compounds to target viroporins: IniHally >250 compounds design~~ed and synthesised;~~ librarynow~350 BIT314 (HCV) Compounds screened in proprietary assay set up for each virus target e.g. HIV-1 Vpu; HCV p7; Infuenza M2; Dengue M; Coronavirus E. Hits tested against ~~virus in cell~~ cultures Lead op,misa,on and selec,on OTHER “HITS” IN LIBRARY include: - Infuenza A and B - Coronaviruses - Including SARS - Epstein-Barr virus (EBV) ~~-~~ ~~HepaHHs B virus (HBV)~~ ~~-~~ ~~Zika virus~~ - others ~~BIT225:~~ - RepresentaHon of the value that resides within Biotron’s core experHse; - Valuable, Phase 2 clinical asset DENGUE – ~~Several~~ compounds with promising anHviral acHvity OTHER VIRUSES– Secondary ~~screening of hits~~ against key viruses e.g. Hep B, infuenza, Zika	Designed library of compounds to target viroporins: IniHally >250 compounds design~~ed and synthesised;~~ librarynow~350 BIT314 (HCV) Compounds screened in proprietary assay set up for each virus target e.g. HIV-1 Vpu; HCV p7; Infuenza M2; Dengue M; Coronavirus E. Hits tested against ~~virus in cell~~ cultures Lead op,misa,on and selec,on OTHER “HITS” IN LIBRARY include: - Infuenza A and B - Coronaviruses - Including SARS - Epstein-Barr virus (EBV) ~~-~~ ~~HepaHHs B virus (HBV)~~ ~~-~~ ~~Zika virus~~ - others ~~BIT225:~~ - RepresentaHon of the value that resides within Biotron’s core experHse; - Valuable, Phase 2 clinical asset DENGUE – ~~Several~~ compounds with promising anHviral acHvity OTHER VIRUSES– Secondary ~~screening of hits~~ against key viruses e.g. Hep B, infuenza, Zika	Designed library of compounds to target viroporins: IniHally >250 compounds design~~ed and synthesised;~~ librarynow~350 BIT314 (HCV) Compounds screened in proprietary assay set up for each virus target e.g. HIV-1 Vpu; HCV p7; Infuenza M2; Dengue M; Coronavirus E. Hits tested against ~~virus in cell~~ cultures Lead op,misa,on and selec,on OTHER “HITS” IN LIBRARY include: - Infuenza A and B - Coronaviruses - Including SARS - Epstein-Barr virus (EBV) ~~-~~ ~~HepaHHs B virus (HBV)~~ ~~-~~ ~~Zika virus~~ - others ~~BIT225:~~ - RepresentaHon of the value that resides within Biotron’s core experHse; - Valuable, Phase 2 clinical asset DENGUE – ~~Several~~ compounds with promising anHviral acHvity OTHER VIRUSES– Secondary ~~screening of hits~~ against key viruses e.g. Hep B, infuenza, Zika	Designed library of compounds to target viroporins: IniHally >250 compounds design~~ed and synthesised;~~ librarynow~350 BIT314 (HCV) Compounds screened in proprietary assay set up for each virus target e.g. HIV-1 Vpu; HCV p7; Infuenza M2; Dengue M; Coronavirus E. Hits tested against ~~virus in cell~~ cultures Lead op,misa,on and selec,on OTHER “HITS” IN LIBRARY include: - Infuenza A and B - Coronaviruses - Including SARS - Epstein-Barr virus (EBV) ~~-~~ ~~HepaHHs B virus (HBV)~~ ~~-~~ ~~Zika virus~~ - others ~~BIT225:~~ - RepresentaHon of the value that resides within Biotron’s core experHse; - Valuable, Phase 2 clinical asset DENGUE – ~~Several~~ compounds with promising anHviral acHvity OTHER VIRUSES– Secondary ~~screening of hits~~ against key viruses e.g. Hep B, infuenza, Zika	Designed library of compounds to target viroporins: IniHally >250 compounds design~~ed and synthesised;~~ librarynow~350 BIT314 (HCV) Compounds screened in proprietary assay set up for each virus target e.g. HIV-1 Vpu; HCV p7; Infuenza M2; Dengue M; Coronavirus E. Hits tested against ~~virus in cell~~ cultures Lead op,misa,on and selec,on OTHER “HITS” IN LIBRARY include: - Infuenza A and B - Coronaviruses - Including SARS - Epstein-Barr virus (EBV) ~~-~~ ~~HepaHHs B virus (HBV)~~ ~~-~~ ~~Zika virus~~ - others ~~BIT225:~~ - RepresentaHon of the value that resides within Biotron’s core experHse; - Valuable, Phase 2 clinical asset DENGUE – ~~Several~~ compounds with promising anHviral acHvity OTHER VIRUSES– Secondary ~~screening of hits~~ against key viruses e.g. Hep B, infuenza, Zika	Designed library of compounds to target viroporins: IniHally >250 compounds design~~ed and synthesised;~~ librarynow~350 BIT314 (HCV) Compounds screened in proprietary assay set up for each virus target e.g. HIV-1 Vpu; HCV p7; Infuenza M2; Dengue M; Coronavirus E. Hits tested against ~~virus in cell~~ cultures Lead op,misa,on and selec,on OTHER “HITS” IN LIBRARY include: - Infuenza A and B - Coronaviruses - Including SARS - Epstein-Barr virus (EBV) ~~-~~ ~~HepaHHs B virus (HBV)~~ ~~-~~ ~~Zika virus~~ - others ~~BIT225:~~ - RepresentaHon of the value that resides within Biotron’s core experHse; - Valuable, Phase 2 clinical asset DENGUE – ~~Several~~ compounds with promising anHviral acHvity OTHER VIRUSES– Secondary ~~screening of hits~~ against key viruses e.g. Hep B, infuenza, Zika	Designed library of compounds to target viroporins: IniHally >250 compounds design~~ed and synthesised;~~ librarynow~350 BIT314 (HCV) Compounds screened in proprietary assay set up for each virus target e.g. HIV-1 Vpu; HCV p7; Infuenza M2; Dengue M; Coronavirus E. Hits tested against ~~virus in cell~~ cultures Lead op,misa,on and selec,on OTHER “HITS” IN LIBRARY include: - Infuenza A and B - Coronaviruses - Including SARS - Epstein-Barr virus (EBV) ~~-~~ ~~HepaHHs B virus (HBV)~~ ~~-~~ ~~Zika virus~~ - others ~~BIT225:~~ - RepresentaHon of the value that resides within Biotron’s core experHse; - Valuable, Phase 2 clinical asset DENGUE – ~~Several~~ compounds with promising anHviral acHvity OTHER VIRUSES– Secondary ~~screening of hits~~ against key viruses e.g. Hep B, infuenza, Zika	OTHER “HITS” IN LIBRARY include: - Infuenza A and B - Coronaviruses - Including SARS - Epstein-Barr virus (EBV) ~~-~~ ~~HepaHHs B virus (HBV)~~ ~~-~~ ~~Zika virus~~ - others
Designed library of compounds to target viroporins: IniHally >250 compounds design~~ed and synthesised;~~ librarynow~350
	~~d and synthesised;~~ ow~350						~~-~~ ~~HepaHHs B virus (HBV)~~ ~~-~~ ~~Zika virus~~
			its tested against				- others
		DENGUE – ~~Sl~~	~~virus in cell~~ cultures OTHER VIRUSES–
				OTHER VIRUSES–
		~~evera~~ compounds		Secondary	~~BIT225:~~
						~~BIT225:~~
		with promising anHviral acHvity		~~screening of hits~~ against key viruses e.g. Hep B, infuenza, Zika

BIT225 (HIV-1 and HCV)

Slide 5

First in class drug and new drug target for treatment of HIV-1 and Hepa,,s C virus (HCV) - Prepared based on above aoer the August Board mee,ng
- Seven clinical trials completed; another is fully recruited with data expected 1Q16 - Guided the wording of the prospectus drao and the use of proceeds
- - Over 200 subjects dosed in trials to date While capital requirements are determined based on proposed plan, the final schedule
Pro ~~mising clinical efcacy against HIV-1 and 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
~~HIV-1/HCV GT3 (BIT225-006) – 100% receiving 300mg BID for 28 days in combina,on with 48~~ weeks IFN/RBV (per protocol) achieved SVR12 i.e. cured of HCV infec,on
BIT225 increases the rate at which HCV is cleared
in vitro and in vivo
(BIT225-004)

Slide 7

BIT225 – First of a New Class of HCV DAA Drugs

ü Novel, oral, small molecule compound

POLYMERASE/PROTEASE INHIBITORS e.g. Sofosbuvir/Simeprevir

ü Only one of its class (p7 inhibitor) in clinical trials
ü Inhibits viral assembly and infec,vity

BIT225 - ASSEMBLY/ BUDDING INHIBITOR

ü Pan-genotype ac,vity:
ü Ac,ve in vitro against all main genotypes
ü Clinically ac,ve against hard-to-treat HCV GT 1 (1a and 1b) and GT 3
ü Seeking partnerships for further development, in par,cular in Asia

Slide 8

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

Slide 9

HIV-1 Reservoirs

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Mario Stevenson Scien@fic 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

Slide 10

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
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

Slide 11

BIT225 – Proven Clinical AcHvity Against HIV-1

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16
• Placebo
BIT225-004: Phase 1b/2a randomised, placebo controlled, double-blind trial
14 BIT225
– 21 pa,ents, HIV-1 posi,ve, treatment-naïve ; 10 days dosing with BIT225
12
(monotherapy)
10
• Results demonstrated that:
8
1.
BIT225 significantly reduces HIV-1 levels in the macrophage (reservoir)
6
cells BIT225 can cross the blood-brain barrier, opening up the
4
possibility of treatment of AIDS-related demenHa
2
2.
BIT225 reduced myeloid-specific immune acHvaHon markers during trial
5 10 15 20 25
Results support a potenHal role for BIT225 in cure/eradicaHon strategies Time in Co-culture (days)
HIV-1 Replica,on (pg/200uL)
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2. Results support a potenHal role for BIT225 in cure/eradicaHon strategies

Phase 2 HIV-1 trial of BIT225 in combinaHon with current anH-HIV-1 drugs scheduled to commence early 2017

Slide 12

HIV-1 Viral Dynamics

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BIT225-009 Hu-Mouse ATI
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Slide 13

Phase 2 trial an,cipated to commence early 2017
12 weeks BIT225 in combina,on with cART
- 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
Headline data 3Q17
Humanised Mouse Study
Modelling treatment interrup,on (ATI)
In progress
- Expected outcome(s) – impact on viral kine7cs in combina7on with ART, plus poten7al impact on rebound once ART is stopped
Data 1Q17

Slide 14

Renewed industry interest in targe,ng viral diseases including
Respiratory syncy,al virus (RSV)
Hepa,,s B virus
Tropical diseases including Dengue
Ebola and MERS-CoV outbreaks have caused public health issues worldwide
BIT225 has demonstrated the robustness of Biotron’s approach with targeHng 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

Slide 15

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

Slide 16

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-Flavi therapeu,c

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www.sciencenews.org
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Slide 17

HepaHHs 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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Slide 18

Unique core exper,se against novel viral targets
Demonstrated proof of concept of successful targe,ng of viroporins with BIT225
HCV and HIV-1 are high growth, mul,-billion dollar markets
Treatment gaps remain
Represents a new class of direct-ac,ng HCV drugs
Poten,al to eradicate important HIV-1 reservoirs, plus may impact on immune ac,va,on
Robust data package has been generated to support combina,on studies with poten,al partners
~~Technology core is an an,viral plakorm with new class of small molecules with broad range of~~ ac,vi,es
Extending earlier stage programs for other key viruses:
- Developing leads for programs including Dengue and HBV
- Iden,fying hits for other viruses including RSV, Zika, BK, and others
- Dengue virus – applying for non-equity funding from US organisa,ons
- Poten,al to expand to areas of poten,al partner interest
Seeking collabora,ons for individual programs or en,re plakorm

Slide 20

Dr Michelle Miller Managing Director +61 412 313329 [email protected] www.biotron.com.au

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AI assistant

BIOTRON LIMITED Investor Presentation 2017

64528_rns_2017-01-12_b7c34ec8-8e9e-4277-8ee2-f0f957f9c638.pdf

BIOTRON LIMITED PRESENTS AT BIOTECH SHOWCASE[TM] 2017

BIOTRON LIMITED (ASX:BIT)

Biotron’s Core Technology

BIT225 – First of a New Class of HCV DAA Drugs

HIV-1: Towards a Cure

HIV-1 Reservoirs

BIT225 Targets HIV-1 in Reservoir Cells

BIT225 – Proven Clinical AcHvity Against HIV-1

HIV-1 Viral Dynamics

Dengue Virus Program

HepaHHs B Virus

AI assistant

BIOTRON LIMITED — Investor Presentation 2017

64528_rns_2017-01-12_b7c34ec8-8e9e-4277-8ee2-f0f957f9c638.pdf

BIOTRON LIMITED PRESENTS AT BIOTECH SHOWCASE[TM] 2017

BIOTRON LIMITED (ASX:BIT)

Biotron’s Core Technology

BIT225 – First of a New Class of HCV DAA Drugs

HIV-1: Towards a Cure

HIV-1 Reservoirs

BIT225 Targets HIV-1 in Reservoir Cells

BIT225 – Proven Clinical AcHvity Against HIV-1

HIV-1 Viral Dynamics

Dengue Virus Program

HepaHHs B Virus

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BIOTRON LIMITED Investor Presentation 2017