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BIOTRON LIMITED Investor Presentation 2018

Oct 24, 2018

64528_rns_2018-10-24_75866dd8-4625-4764-a8e4-4f335bd14154.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

25 Octobe r 2018

The Mana g er Compa n ies ASX Limi t ed 20 Bridge S treet Sydney NSW 2000 (17 pages by email)

Dear Mad a m

PRESENTATION TO INVESTORS

I attach a PowerPoi n t presenta t ion as pr e sented by Biotron L imited's M anaging D irector, D r Michelle M iller, to in v estors.

Yours sinc e rely

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Peter J. Ni g htingale Company S ecretary

pjn9647

BIOTRON LIMITED (ASX:BIT)

Investor Update October 2018

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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 (ACN 086 399 144) 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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Key Financial Metrics Key Financial Metrics 6 Month Share Price Performance 6 Month Share Price Performance
Ticker Code ASX: BIT
Share Price (24 Oct 18) A $0.16 Ticker Code ASX: BIT
Market cap A $83 million
12 Month Trading Range A $0.014 - $0.445 Share Price (15 Sept 2014) A $0.115
Shares Outstanding 503 million Market cap A $26.3 million
A $1.5 million*
*Excludes R&D Tax of $1.07 million 12 Month Trading Range A $0.075 – 0.315
Cash Position (June ‘18) received in Oct; and also Nov 18
$0.06 BITOA underwritten for $4.7
~~million~~
Shares Outstanding 228 million
Board Cash Position (06/14) A $1.76mn
Michael Hoy Non-executive Chairman
Michelle Miller Managing Director
Susan Pond Non-executive Director
Rob Thomas Non-executive Director
Stephen Locarnini Non-executive Director
  • Clinical stage drug development company

  • Robust pipeline of drugs targeting serious virus infections

  • Lead candidate BIT225 is a novel, first-in-class, oral small molecule drug

  • In development for treatment of HIV-1 and Hepatitis C virus (HCV)

    • Positive data in trials to date

    • Recently reported positive news from the HIV-1 Phase 2 trial

  • Provides clinical validation of Biotron’s approach to treating serious virus infections

  • Headquartered in Sydney, Australia

  • Experienced Board and management team with pharma, financial and VC backgrounds

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Key Achievements 2018

  • Completed Phase 2 HIV-1 clinical trial of BIT225

  • Reported positive outcomes from the Phase 2 HIV-1 clinical trial in Sept ’18

  • Receipt of $1.07 million R&D Tax Incentive refund in Oct ‘18

  • Secured $4.7 million underwriting agreement for 30 Nov ‘18 $0.06 options

  • Places the company in a sound financial position as it focuses on commercial outcomes

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Biotron – Antiviral-Focused Pipeline

PROGRAM MECHANISM OF
ACTION
INDICATION PRECLINICAL PHASE 1/2a PHASE 2 MARKET OPPORTUNITY
BIT225 Targets HIV-1 Vpu
viroporin protein
HIV-1 Ph 2 data -
~$20 bn p.a.
-
>36 m living with HIV-1 ww
-
1.1 m in USA
Recently reported positive
Targets HCV p7
viroporin protein
Hepatitis C
virus
ships in China -
~$20 bn p.a.
-
Estimated 30 – 50 m
infected in China
Ph 2 comple te; seeking partner
BIT314 Targets HCV p7
viroporin protein
(next generation)
Hepatitis C
virus
Dengue Targets Dengue M
viroporin protein
Dengue -
2.5 bn live in at risk areas
-
~100 m infections p.a.
-
No drug treatment
HBV,
Respiratory &
others
Target specific virus
virporin proteins
HBV,
Respiratory &
others
-
Growing billion dollar
markets
  • Focused on the design and development of a new class of antiviral drugs targeting viralencoded viroporin proteins

  • Viroporins are present in wide range of viruses: Influenza (M2), HIV-1 (Vpu), HCV (p7), Dengue and West Nile (M protein), SARS (E protein) and others

  • Broad platform:

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

  • Focused library of compounds that target these viral proteins

  • Pipeline of internally-generated, first-in-class small molecule viroporin inhibitors for key markets

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HIV-1 Eradication

Current antiretroviral drugs to not cure HIV-1 infection

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

  • Invisible to body’s immune defenses

  • Not sensitive to current anti-HIV-1 drugs

  • New mode of actions drugs are needed to eradicate or cure HIV-1 infection

Why is HIV-1 eradication necessary?

  • Long-term health implications e.g. HAND, immune activation, drug-drug interactions

  • Compliance issues/drug holidays can lead to viral rebound

  • Cost of treatment

  • ~ $20 billion p.a. world wide

  • Major burden on healthcare systems

BIT225 has potential to be used in combination with other antiretroviral drugs to eradicate HIV-1 reservoirs

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HIV-1 Eradication

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BIT225 targets and kills HIV-1 in macrophage cells – these are a key reservoir of infection, even in people taking antiretroviral drugs

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

BIT225-009 Phase 2 HIV-1 Trial

36 HIV +ve, treatment-naïve subjects commencing standard antiretroviral
Subjects treatment (ART). Two arms:
1.
n=9 : 100 mg daily for detailed pharmacokinetic analyses
2.
2. n=27; 200 mg daily for efficacy
-
Double-blind, placebo-controlled, randomised, multi-centre study
Protocol -
12 weeks, once daily, oral treatment with BIT225 or placebo in combination
with ART
Headline Results BIT225 is having a unique effect in patients, over and above what is seen with
current antiretroviral drugs used to treat HIV-1 infection.
The data from the trial are consistent with targeting and eradication of virus from
macrophage reservoir cells by BIT225.
What’s Next Detailed data is expected to be presented at scientific conferences in late
2018/early 2019

BIT225 Clears Virus from Macrophage Reservoirs

  • Cell culture studies showed that BIT225 targets formation of new virus in macrophage cells (Figs A and B)

  • Immunological data from the Phase 2 clinical trial showed a significant immune response in BIT225-treated patients that is triggered by this non-infectious, dead virus

  • This response is consistent with BIT225 targeting and clearing virus from these reservoir cells

Infectious HIV-1 Non-infectious HIV-1

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A B
(A) Untreated Controls (B) BIT225 treated cells
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  • Statistically significant reduction in cCD163 also found in BIT225-treated subjects; this marker is linked to positive clinical benefits

This is a major advance towards eradicating HIV-1 infection

Unlocking Value for Other Virus Targets

Biotron’s approach enables the targeting of a wide range of viral diseases; examples include:

  • Respiratory Viruses such as Respiratory Syncytial Virus (RSV), Influenza, & Coronaviruses (leading cause of “common cold”)

  • Flaviviruses such as Dengue and Zika Virus

  • Transplant viruses such as BK virus

  • Epstein Barr virus (EBV) - particular interest in Asia where it is causative agent of Nasopharyngeal Carcinoma

Biotron’s Viroporin-targeting platform has the potential to become an important tool in the development of antiviral therapies

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Hepatitis B Virus Program

  • Hepatitis B virus (HBV) therapeutic space has generated significant interest from pharma & biotech companies

  • Oct 18 – J&J and Arrowhead in deal worth up to US$3.7 billion

  • Screening of Biotron’s compound library has identified several compounds with activity against HBV

  • Expands Biotron’s partnering opportunities – potential for early stage co-development /collaboration agreement

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  • Aim is to achieve commercial outcomes for the company’s programs

  • Prime focus is partnering the HIV-1 program

    • Data from the Phase 2 HIV-1 trial to be presented at key conferences, and also shared with potential partners, during late 2018/early 2019

    • The successful results from this study are expected to facilitate commercialisation negotiations with these parties

  • Continuing to explore regional partnering opportunities in China for the BIT225 Hepatitis C (HCV) program. China has one of the world’s largest populations of people infected with HCV and there may be key benefits in this particular population for treatment of HCV with BIT225

  • Hepatitis B (HBV) remains a promising early stage program. Additional resources are being committed to progress this to partner-ready status

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  • BIT drugs target high growth, multi-billion dollar markets with defined treatment gaps

  • HIV-1 Program

  • Significant value created through positive results from the Phase 2 clinical trial

  • (share price up from $0.019 on 27 Sept to $0.16 at close on 24 Oct)

  • Results also provide validation of Biotron’s approach to treating viral infections

  • Focus is on achieving a commercial transaction for this program

  • HCV Program

  • Particularly well suited to China, with high numbers of HCV-infected patients including a high proportion of HCV/HBV co-infected patients

  • Early stage commercial collaboration opportunities for pre-clinical targets, such as: • Hepatitis B, respiratory viruses and others

  • Multiple partnering opportunities across Biotron’s portfolio

  • Stock has shown that it moves significantly on the back of good news

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BIOTRON LIMITED (ASX:BIT)

Michelle Miller Managing Director [email protected] www.biotron.com.au

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