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BIOTRON LIMITED Investor Presentation 2012

Feb 14, 2012

64528_rns_2012-02-14_7b5f916e-52d1-41a2-aa41-e1df979620a9.pdf

Investor Presentation

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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

15 February 2012

The Manager Companies ASX Limited 20 Bridge Street Sydney NSW 2000

(18 pages by email)

Dear Madam

CEO PRESENTATION AT INTERNATIONAL INVESTOR CONFERENCE

Sydney, Australia: 15 February 2012: Australian drug development company Biotron Limited (ASX: BIT) has presented at a prominent investor forum held in New York this week.

CEO Dr Michelle Miller outlined the Company's strategy to institutional investors, industry analysts and senior biotechnology executives at the BIO CEO and Investor Conference held on 13 and 14 February 2012.

She indicated that the New York showcase was a solid opportunity to highlight the company’s ongoing commercialisation program.

"Recent US deals in the HCV space demonstrate that American investors are keenly aware of the opportunities presented by new HCV antiviral drug targets," she said.

"Our partnership discussions with potential partners are ongoing."

A recent phase 2a trial of the Company's lead Hepatitis C drug candidate BIT225 demonstrated it had good antiviral activity against HCV.

The Company has previously reported that 87% of patients receiving BIT225 in combination with Interferon and Ribavarin (the current standard of care treatment for treating HCV) were virus-free at the 3 month time point in the trial, compared to 63% of patients receiving standard of care treatment alone.

About Biotron

Biotron Limited is engaged in the research, development, and commercialisation of drugs targeting significant viral diseases with unmet medical need, with a major focus on HIV and HCV. The Company has BIT225 in clinical development for both HIV and HCV, and also has several earlier stage preclinical and research programs for several other viral infections including Dengue, influenza, and others.

Enquiries

Dr Michelle Miller Managing Director Biotron Limited +61-2 9805 0488

Rudi Michelson Monsoon Communications +61-3 9620 3333

Yours sincerely

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Peter J. Nightingale Company Secretary

pjn6525

BIOTRON LIMITED

ASX:BIT

BIO CEO and Investor Conference, New York February 2012

Michelle Miller CEO & Managing Director

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‐ This presentation may contain forward looking statements with respect to the financial condition, results and business achievements/performance of Biotron Limited and certain of the plans and objectives of its management. These statements are statements that are not historical facts. Words such as “should”, “expects”, “anticipates”, “estimates”, “believes” or similar expressions, as they ‐ relate to Biotron Limited, are intended to identify forward looking statements. By ‐ their nature, forward looking statements involve risk and uncertainty because they reflect Biotron’s current expectations and assumptions 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 assumptions or expectations could cause actual results to differ materially from current expectations.

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  • Clinical stage drug development company

  • Focus on developing novel small molecule antiviral drugs

  • Hepatitis C virus (HCV), HIV, Dengue and others

  • Established in 1999

  • Spun out from the Australian National University, Canberra, Australia;

  • Headquartered in Sydney, Australia

  • IPO on ASX in Jan 2001 (ASX:BIT)

  • Key highlights

  • Dec 2011 – Presentation of positive data from Phase 2a trial of BIT225 against Hepatitis C

  • Jan 2012 – Raised A$8 m via exercise of listed options (~80% exercised)

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KEY FINANCIALS BOARD AND MANAGEMENT ASX Code BIT Mr Michael Hoy Chairman Current Share Price (13 Feb ‘12) A$0.135 Dr Michelle Miller CEO & Managing 52 Week High A$0.19 Director 52 Week Low A$0.089 Dr Denis Wade Non-Executive Director Shar ~~es on Issue 228 million~~ Mark ~~et Capitalization A$31 m~~ Mr Bruce Hundertmark Non-Executive Director Net Cash (31 Dec ‘11) A$9.15 m Mr Peter Nightingale CFO & Company Secretary

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  • Anti-viral drug market is very attractive

  • Ongoing need for new drugs to overcome viral resistance;

  • Patients are treated with cocktails i.e. combinations of different anti-viral drugs

  • Developing first-in-class drugs against a number of targets

  • Identified of new class of viral proteins called viroporins

  • Present in broad range of viruses including HIV, Hep C, Dengue virus , influenza, SARS (E) and others

  • Designed and made a library of new drugs (~350 compounds) to target these viral proteins

  • Developed rapid screening assays for the targets

  • Generated first-in-class drugs to treat diseases with high unmet medical need

  • Initial focus on HIV and Hep C

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Pipeline
INDICATION
VIRAL
TARGET
DISCOVERY
PRE-
CLINICAL
PHASE 1a
PHASE 1b
PHASE 2a
PHASE 2b
STATUS
HEP C
p7
Ph 2a
complete
HIV
Vpu
Ph 1b
In
Progress
Dengue
M
Influenza
M2
Others
various
  • Leading cause of chronic liver disease and transplants

  • 180 m people infected worldwide (3% world population); 130 m are chronically infected

  • 4 m patients in US (2.7 m chronically infected)

  • 70% will develop liver diseases including cirrhosis and liver cancer

  • Currently only 2.6% are treated each year

  • Standard of care is interferon and ribavirin

  • Up to 50% patients don’t respond to current treatment

  • Significant side effect profile – high drop out rate

  • Documented need for new, safer drugs

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Only small percentage currently receive treatment.

USA and Europe represent major markets but other, larger markets are emerging. Worldwide market ~US$2 billion; predicted to expand to >US$10 - 20 billion as new, safer drugs enter the market.

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Smith Nature Reviews Drug Discovery 5, 715–716 (September 2006)

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Nov 2011 – Gilead (GILD) acquires Pharmasset (VRUS) for US$11 billion

- PSI-7977 recently advanced into Phase 3

Jan 2012 – BMS acquires Inhibitex (INHX) for US$2.5 billion - INX-189 currently in Phase 2

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p7 – a New Target for Direct Acting HCV Drugs

p7 plays a critical role in production of infectious HCV in infected cells

BIT225 acts as a viral assembly inhibitor

Potential to combine BIT225 with other classes of directacting antivirals

PSI-7977, INX-189

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48

 – Phase Ia 48 patient, single dose safety study in healthy volunteers  Phase Ib - 18 patient, 7-day multiple dose study in patients with HCV

  • Phase 2a – 24 patient, 28-day multiple dose study in patients with HCV (genotype 1)

 Combination trial with peg-IFN and Ribavirin (Standard of Care, SOC).  Trial completed Sept 2011; data presented at HepDART in Dec 2011

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

0 2 4 Weeks
400 mg BIT225
IFN/RBV
8 pts + IFN/RBV
200 mg BIT225 IFN/RBV
8 pts + IFN/RBV
Placebo
IFN/RBV
8 pts + IFN/RBV
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BIT225 + SOC Leads to 87% Virus-Free at 3 Months
Median log reduction Median log reduction
Treatment % Complete EVR
at 28 days at 35 days
(<50IU/ml at 12 weeks)
400 mg BIT225 + SOC -4.077 -4.957 86
200 mg BIT225 + SOC -3.871 -4.351 88
Placebo + SOC -3.013 -3.649 63
HCV RNA Change from Baseline (Log10)
- Non-Compliers Removed - Median at timepoint -
0.000
-1.000
-2.000
400 mg
200 mg
-3.000
Placebo
-4.000
-5.000
DOSING PERIOD
-6.000
0 7 14 21 28 35 42 49 56 63 70 77 84 91
Time point (Days)
Baseline
Log10 Change from
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  • Industry moving to all oral DAA (direct acting antiviral) combinations

  • Current focus on NS5B+NS3/4 (+ribavirin)

  • Expect first combo approvals 2014/15 (if no hiccoughs)

  • BUT viral resistance is a potential issue for these new fast-acting drugs

  • Remember HIV….

  • Addition of a third drug such as BIT225 to these DAA combos could potentially retard development of resistance

  • IFN/Ribavirin likely to remain the backbone of treatments in various countries due to costs

  • BIT225 improves outcome in hard-to-treat genotype 1 patients; likely to be active in other genotypes (p7 conserved)

  • Result is multiple market opportunities for BIT225 - potential to be used with IFN/Ribavirin treatment or in combination with new DAAs

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BIT225 - HIV / HCV Co-Infected Population

  • BIT225 also has potent anti-HIV activity

  • Unique mode of action targets HIV “hiding” in long-lived reservoir cells

    • Reservoirs are last of the holy grail in HIV; No existing drugs target this source of HIV in the body
  • Phase 1b/2a trial of BIT225 in HIV+ patients is currently in progress

  • Up to 30% of HIV-infected patients are also HCV-infected

  • significantly worse prognosis than mono-infected patients

  • US and European regulatory agencies have stated the need for new treatment strategies for this difficult-to-treat population

  • BIT225 is uniquely placed due to dual anti-HIV and anti–HCV activity

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  • World-class portfolio of anti-viral, first-in-class drugs

  • BIT225 has demonstrated potent anti-HCV activity

  • Market opportunity with new and existing classes of HCV drugs

  • Phase 1b/2a trial of novel approach to eliminating HIV underway

  • Anticipated to complete 1Q2012

  • Unique opportunity to target HIV / HCV co-infected population

  • Biotron has back-up drugs and proprietary assays to facilitate development of 2[nd] generation drugs

  • Additional early stage drug discovery projects for Dengue and others

  • Strong patent protection – 5 patent families filed worldwide

  • Well positioned with significant value inflection points anticipated over next 12 months

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Michelle Miller Managing Director +61 2 9805 0488 +61 412 313329 [email protected]

www.biotron.com.au

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