Level 2, 6 66 Hunter Str reet Syd dney NSW 2 2000 Tel: - - PDF document

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Level 2, 6 66 Hunter Str reet Syd dney NSW 2 2000 Tel: - - PDF document

Level 2, 6 66 Hunter Str reet Syd dney NSW 2 2000 Tel: (61-2) 9300 3 344 Fax: (61-2) 9221 6 6333 E-mail: p pnightingale@ @biotron.com m.au W Website: www w.biotron.com m.au 20 Novemb ber 2017 The Manag ger Compan nies ASX


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SLIDE 1

20 Novemb The Manag ASX Limit 20 Bridge S SYDNEY Dear Mada I attach an shareholder Yours faith Peter J. Nig Company S pjn9169 ber 2017 ger Compan ted Street NSW 2000 am, n address by rs present at hfully ghtingale Secretary nies PRESENT y the Chair t today’s An TATION TO rman and a nnual Gener O ANNUAL a PowerPoin ral Meeting L GENERA nt presentat which is co

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AL MEETI tion which

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Level 2, 6 Syd Tel: Fax: pnightingale@ Website: www

(19 p ING are to be d be held at 1

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pages by em delivered to 1.30 am.

reet 2000 344 6333 m.au m.au

mail)

  • the
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SLIDE 2

20 Novemb My Fellow In recent w The 36th a designed to current ant choice but

  • f patients

Company m This is the stepping st determinati significanc desired by Much has b Looking ah

  • pportuniti

portfolio of Importantly now suppo beneficial a A disciplin priority is t product. I would lik productive equally ded ber 2017 w Shareholde weeks, Biotro and final pa

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ti-HIV treat to impatien destined to maybe, just 9th clinical tones along ion to dem e of the Co shareholder been achiev head, we ha

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f possibilitie y, BIT225 i

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against addi ned and focu to retain fle ke to take th efforts dur dicated parti ers CH

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atient in th ate the Com

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ntly await fi

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maybe, ther trial condu g the clinic monstrate so

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rs is by patie ed during th ave every re n should no es capable o is only one ef that many itional viral used approa exibility in t his opportun ring the pas icipation an HAIRMAN’ n a giant ste he Company mpany's lea alysis of tria nal results. his disease, re is light at ucted by Bio cal developm

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y opportuni targets. ach to capit the developm nity to than st12 months nd support. S ADDRES ep towards d y's Phase 2 ad compoun al data is, b Neverthele there is ho t the end of

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SS TO THE demonstratin 2 HIV trial nd, BIT225, by necessity ess, we rem

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Level 2, 6 Syd Tel: Fax: E-mail: info@ Website: www

dication of H treatment. atients abov gly slow so

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66 Hunter Str dney NSW 2 (61-2) 9300 3 (61-2) 9221 6 @biotron.com w.biotron.com

HIV is possi The trial w ve and bey

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many milli eholders of provided sou al caps off r belief in comes that

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reet 2000 344 6333 m.au m.au

ible. was

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Our lead and heir

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SLIDE 3

In particular, I should single out Denis Wade for his enduring contribution and dedication to the Company since he joined the Board in 2010. For personal reasons, Denis steps down from the Board today. Denis' advice and insight have been of enormous value to me personally and to the entire Board. He departs with a mix of our regret and

  • gratitude. I am relieved to report he won't be going far. Denis will retain an ongoing advisory role with

the Company. I would now like to invite our CEO, Michelle Miller, to address the meeting. Michael J. Hoy Chairman

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SLIDE 4

Slide 'tle

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SLIDE 5

Forward Looking Statements

This presenta'on may contain forward looking statements with respect to the financial 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.

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SLIDE 6

Investment Highlights

  • Biotron is designing, developing and commercialising a plaUorm of

an'viral drugs with a novel mode of ac'on – able to target a wide variety

  • f viral infec'ons
  • Pipeline of programs in high value, high need markets
  • Progress in clinical lead program (BIT225) provides strong valida'on for

en're plaUorm

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SLIDE 7

Biotron Limited – Snap Shot

BROAD PLATFORM WITH NEW CLASS OF ANTIVIRAL DRUGS

HIV-1 ERADICATION HBV & EARLY STAGE PROGRAMS HEPATITIS C VIRUS (HCV)

  • Targe'ng HIV-1 in long-lived

reservoirs

  • Phase 2 trial in progress

during 2017; dosing complete

  • New class of HCV drug
  • Phase 2 completed
  • Seeking partnerships in

China

  • Pipeline of early stage

programs, including:

  • Hepa''s B virus
  • Respiratory viruses
  • Flaviviruses (e.g. Dengue)

ROBUST CLINICAL VALIDATION – COMPLETED 8 CLINICAL TRIALS WITH STRONG SAFETY & EFFICACY OUTCOMES

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SLIDE 8

Key Achievements FY 2017

  • Commenced Phase 2 clinical trial of BIT225 and Combina'on An'retroviral Therapy (cART) in Feb’17
  • Fully recruited in July ‘17; Dosing with BIT225/placebo completed; data pending
  • Demonstrated significant and accelerated reduc'on in HIV-1 viral load following addi'on of BIT225 in

humanised mouse study in Feb ‘17

  • Independent Nature publica'on validated Biotron’s approach of targe'ng HIV-1 in macrophages as a key

step in HIV-1 eradica'on in May ’17

  • Appointed Lynx Financial as Corporate Advisor for China – assis'ng with execu'ng HCV regional partnering

strategy in June ‘17

  • Raised $1.56 million via rights issue in June ‘17
  • Received $1.6 million R&D tax refund in Nov ‘17 (post-end of FY)
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SLIDE 9

CommercialisaUon – Key Focus

  • Three tac'cal priori'es:
  • Partnering lead clinical program - BIT225 for HIV-1 eradica'on
  • Partnering one or more preclinical programs – e.g. HBV
  • Execute a regional licensing deal in China - HCV program remains a

great opportunity

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SLIDE 10

HIV-1 EradicaUon

Mario Stevenson Scien.fic American 299, 78 - 83 (2008)

Current drugs do not eradicate HIV-1 virus Why is HIV-1 eradicaUon necessary?

  • Long-term health implica'ons e.g. HAND, immune ac'va'on, etc
  • Cost of treatment
  • ~ $20 billion p.a. world wide
  • Major burden on healthcare systems

BIT225 has potenUal to be used in combinaUon with other drugs to eradicate HIV-1 reservoirs

  • 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
  • New mode of ac'ons drugs are needed to eradicate or cure HIV-1 infec'on
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SLIDE 11

HIV-1 EradicaUon: BIT225-009 Trial

  • 36 HIV-1+ve, treatment-naïve subjects commencing ART
  • Randomised 2:1 (drug:placebo)

BIT225 or placebo added to ART

  • BIT225 or placebo added to ART for first 12 weeks of treatment
  • Read-out
  • Impact on virus levels; reduc'on of immune ac'va'on markers
  • Fully recruited; completed dosing with BIT225/placebo; in follow-up period (ART alone)
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SLIDE 12

HIV-1 EradicaUon: BIT225-009 Trial

  • Fully recruited July; last pa'ent, last dose in mid-October
  • Three month follow-up period post-dosing with BIT225/placebo
  • Addi'onal samples collected from pa'ents throughout this next 3 month period
  • Post-trial laboratory analyses on samples from treatment period are in progress:
  • Virological Outcomes
  • Immunological Outcomes
  • Post-dosing sample data also required to complete the analyses
  • E.g. Any rebound or change in parameters once drug ceased?
  • All data is necessary to determine outcome of the trial
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SLIDE 13

CommercialisaUon: BIT225 HIV-1 EradicaUon

  • Several pharmaceu'cal companies have ac've HIV-1 “Cure” Programs
  • Iden'fied and qualified poten'al partners
  • Posi've outcomes – BIT225 clinical trial - key to progressing commercialisa'on

discussions

  • Poten'al partners have defined their success criteria – we are aligned!
  • Communica'ng trial data as soon as available
  • Follow up mee'ngs with poten'al partners con'nue
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SLIDE 14

CommercialisaUon: Preclinical Programs – HBV

  • Hepa''s B virus (HBV) therapeu'c space has significant interest from pharma & biotech

companies

  • Biotron’s HBV program is elici'ng early interest from poten'al partners
  • In vitro data on several candidate compounds includes evidence of reduc'on of

industry recognised markers

  • Novel mechanism is very asrac've in combina'on approaches to treatment of HBV
  • Expands Biotron’s partnering opportuni'es – poten'al for early stage co-development /

collabora'on agreement

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SLIDE 15

CommercialisaUon: Regional Licensing – China, HCV Program

  • The new HCV drugs (e.g. Solvadi) may cause reac'va'on of HBV in HCV/HBV coinfected pa'ents
  • Resulted in US FDA “Black Box” Warning on new HCV drugs
  • 30 million HCV-infected people in China, compared to 3-5 million in USA
  • 93 million chronically infected with HBV in China, compared to 2.2 million in USA
  • High HCV/HBV co-infec'on rate in China (es'mated to be 10 million)
  • Reac'va'on of HBV in people undergoing HCV treatment with these new HCV drugs has poten'al to be a

major health & economic issue in China

  • BIT225 has been shown in clinical trials to significantly improve clinical outcome in HCV GT1-infected pa'ents

in combina'on with Interferon & Ribavirin (IFN/RBV)

  • IFN/RBV have several poten'al advantages over new HCV drugs in some sevngs
  • IFN/RBV is significantly cheaper than the new HCV drugs
  • HBV reac'va'on is less common and less severe in HCV/HBV co-infected pa'ents with IFN/RBV
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SLIDE 16
  • Seeking partnerships for commercialisa'on of BIT225 for the treatment of HCV in China
  • Appointed a Shanghai-based corporate advisor with extensive experience in cross-border

transac'ons in the healthcare space

  • Developed a well qualified prospect list
  • Presented to poten'al licensees – all with capacity to finalise commercial development and

launch of BIT225 in China

  • Discussions are on-going

CommercialisaUon: Regional Licensing – China, HCV Program

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SLIDE 17

Unlocking Value for Other Virus Targets

Library of compounds designed to target viroporins found in some viruses:

Ini'ally >250 compounds designed and synthesised; library now ~350 OTHER “HITS” IN LIBRARY include:

  • Influenza A and B
  • Hepa''s B virus (HBV)
  • Coronaviruses (Including SARS)
  • Epstein-Barr virus (EBV)
  • Zika virus
  • thers

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

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SLIDE 18

Unlocking Value for Other Virus Targets

Biotron’s Viroporin approach enables the targe'ng of a wide range of viral diseases; examples include:

  • Respiratory Viruses such as Respiratory Syncy'al Virus (RSV), Influenza, & Coronaviruses (leading cause of

“common cold”)

  • Flaviviruses such as Zika Virus and Dengue
  • Transplant viruses such as BK virus
  • Epstein Barr virus (EBV) - par'cular interest in Asia where it is causa've agent of Nasopharyngeal

Carcinoma

Biotron’s Viroporin placorm has the potenUal to become an important tool in the development of anUviral therapies

PotenUal for establishing early stage collaboraUons with pharmaceuUcal companies uUlising

Biotron’s approach

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SLIDE 19

Summary

  • HIV EradicaUon
  • Engaged with the right poten'al partners
  • Wai'ng for data from trial but con'nue to engage with pharma
  • Preclinical Programs
  • HBV has promise as a preclinical candidate for joint development. HBV therapeu'c space is very hot.
  • BIT225 results validate the plaUorm; poten'al to facilitate funded developments by partners for

“other” viral diseases

  • Regional Licensing
  • HCV in China remains a significant development opportunity – “cost-conscious” market combined

with the high rate of co-infec'on HCV & HBV requires different approach than used in the USA

Success in any or all of these strategies will be a “company maker” increasing the value for Biotron stakeholders