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BIOTRON LIMITED — Investor Presentation 2018
Jan 9, 2018
64528_rns_2018-01-09_579c2d3a-04d3-416b-85e1-974b15d00ce0.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
10 January 2018
The Mana g er Compa n ies ASX Limi t ed 20 Bridge S treet Sydney N S W 2000
(23 pages by email)
Dear Mad a m
BIOTRON LIMITED PRESENTS AT BIOTECH SHOWCASE[TM] 2018
Biotron Li m ited advises that Dr M ichelle Miller, Mana g ing Direc t or, gave th e attached p resentatio n this morni n g at the B i otech Sho w case[TM] 2 0 18 Confer e nce being held this w eek in Sa n Francisco , California, USA.
In addition , Dr Miller will give b r iefings to U SA institu t ional inve s tors and p h armaceutical compan y representat i ves as par t of activiti e s surround i ng the an n ual JP Morgan Health c are Confe r ence. Thi s is one of the most important annual he a lthcare in v estor con f erences, a t tracting t h ousands o f healthcare a nd life sci e nce business executiv e s, as well a s investors and analy s ts, to San F rancisco.
The Biotec h Showcas e TM feature s corporate p resentatio n s by inno v ative life s c ience com p anies to a n audience o f public an d private in v estors, bu s iness deve l opment ex e cutives an d professio n al advisor s who are in t erested in i nvestment opportunit i es and collaborations. Now in it s tenth yea r , it expect s to attract u p wards of 3,500 atten d ees.
Yours sinc e rely
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Peter J. Ni g htingale Company S ecretary
pjn9233
BIOTRON LIMITED (ASX:BIT)
Biotech Showcase 2018
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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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Biotron Limited
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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 of viral infec,ons
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Pipeline of programs in high value, high need markets
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Progress in clinical lead program (BIT225) provides strong valida,on for en,re plaUorm
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Biotron Limited – Snap Shot
BROAD PLATFORM WITH NEW CLASS OF ANTIVIRAL DRUGS
| HIV-1 ERADICATION | HEPATITIS C VIRUS (HCV) | HBV & EARLY STAGE PROGRAMS | |||
|---|---|---|---|---|---|
| - | Targe,ng HIV-1 in long- | - New class of HCV drug |
- Pipeline of early stage |
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| lived reservoirs | - Phase 2 completed |
programs, including: | |||
| - | Phase 2 trial in progress | - Seeking partnerships in |
- Hepa,,s B virus |
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| during 2017; dosing | China | - Respiratory viruses |
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| complete | |||||
| - Flaviviruses (Dengue) |
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| ROBUST CLINICAL | VALIDATION – COMPLETED 8 | CLINICAL TRIALS WITH | |||
| STRONG SAFETY & EFFICACY OUTCOMES |
Key Achievements 2017
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Commenced Phase 2 HIV-1 clinical trial of BIT225 and Combina,on An,retroviral Therapy (cART) in Feb’17
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Dosing with BIT225/placebo completed; data pending (an,cipated 1Q18)
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humanised mouse model of HIV-1 infec,on in Feb ‘17
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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
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Appointed a Corporate Advisor for China – assis,ng with execu,ng HCV regional partnering strategy in June ‘17
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Raised $1.56 million via rights issue in June ‘17
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Received $1.6 million R&D tax refund in Nov ‘17
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HIV-1 EradicaTon
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Current drugs do not eradicate HIV-1 virus
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HIV-1 remains hidden in reservoirs, leading to chronic, life-long infec,on
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Invisible to body’s immune defenses
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Not sensi,ve to an,-HIV-1 drugs
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New mode of ac,ons drugs are needed to eradicate or cure HIV-1 infec,on
Why is HIV-1 eradicaTon necessary?
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Long-term health implica,ons e.g. HAND, immune ac,va,on, drug-drug interac,ons
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Cost of treatment
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~ $20 billion p.a. world wide
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Major burden on healthcare systems
BIT225 has potenTal to be used in combinaTon with other drugs to eradicate HIV-1 reservoirs Mario Stevenson Scien.fic American 299 , 78 - 83 (2008)
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299 , 78 - 83 (2008)
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Current Drugs Do Not Eradicate HIV-1
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Macrophages are Key HIV-1 Reservoirs
Study published in Nature Medicine in April 2017 confirmed that macrophages are key viral reservoirs
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BIT225 Targets HIV-1 in Reservoir Cells
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BIT225 inhibits assembly and budding of new virus in macrophage reservoirs
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Phase 1b/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)
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Phase 2 trial (009) in progress (BIT225 in combina,on with ART) during 2017
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A
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B
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- (A) Untreated Controls (B) BIT225 treated cells
BIT225 – Proven Clinical AcTvity Against HIV-1
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BIT225-004: Phase 1b/2a randomised, placebo controlled, doubleblind trial
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21 pa,ents, HIV-1 posi,ve, treatment-naïve ; 10 days dosing with BIT225 (monotherapy)
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Results demonstrated that BIT225:
1. reduces virus in these cells
2. Crosses the blood-brain barrier, opening up the possibility of treatment of AIDS-related demenTa
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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PotenTal role for BIT225:
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AddiTon to current ART to eradicate key reservoirs, impacTng immune acTvaTon
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Key component of cure/eradicaTon strategies
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HIV-1 EradicaTon: BIT225-009 Trial
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BIT225 or placebo
added to ART
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36 HIV-1[+ve] , treatment-naïve subjects commencing ART
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Randomised 2:1 (drug:placebo)
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Read-out
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Impact on virus levels; reduc,on of immune ac,va,on markers
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Fully recruited; completed dosing with BIT225/placebo. AnTcipate data in 1Q18
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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
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Dengue and West Nile (M protein), SARS (E protein) and others
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Broad plaUorm:
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Rapid, proprietary primary bacterial cell-based screening assays for target proteins
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Focused library of compounds that target these viral proteins
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for key markets
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Small hydrophobic proteins with ion channel ac,vity
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Form hydrophilic pores in host cell membranes
• Key stages of the viral cycle such as virus ~~uncoa,ng, transport and matura,o~~ n are ~~ion-infuenced processes in many v~~ iral ~~species • Crucial for viral pathogenicity due t~~ o involvement in various steps of virus life cycles
- Biotron’s HIV-1 program (BIT225)
Nature Reviews Microbiology 10 , 563-574
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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 :
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Hepa,,s B virus (HBV)
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Coronaviruses (Including SARS)
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Epstein-Barr virus (EBV)
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Zika virus
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Dengue virus
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Herpes viruses
X-axis: compound ID Y-axis: virus Z-axis: strength of hit
- BK virus
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Unlocking Value for Other Virus Targets
Biotron’s Viroporin approach enables the targe,ng of a wide range of viral diseases; examples include:
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cause of “common cold”)
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Flaviviruses such as Zika Virus and Dengue
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Transplant viruses such as BK virus
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Epstein Barr virus (EBV) - par,cular interest in Asia where it is causa,ve agent of Nasopharyngeal Carcinoma
Biotron’s Viroporin-targeTng plahorm has the potenTal to become an important tool in the development of anTviral therapies
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HepaTTs B Virus Program
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companies
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against HBV
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Screening in Hep G2 and AD38 cell lines, as well as studies in primary human hepatocytes (PHH)
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In vitro data includes evidence of reducTon of industry recognised markers, including cccDNA
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Biotron compounds appear to have a novel mechanism of ac,on
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Poten,al for use in combina,on approaches to treatment of HBV
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Expands Biotron’s partnering opportuni,es – poten,al for early stage co-development / collabora,on agreement
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Dengue Virus Program
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2.5 billion people (40% world popula,on) live in areas at risk
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of Dengue
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~100 million people infected yearly
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A leading cause of illness and death in tropics and subtropics
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Transmission is by mosquito; most preven,on programs target the vector
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Vaccine trials have had disappoin,ng results
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Biotron is targe,ng Dengue M protein – Similar target to HIV-1/Vpu and HCV/p7
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Several compounds with promising ac,vity have been generated; tests are on-going
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Poten,al for pan-Flavivirus therapeu,c
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www.sciencenews.org
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The new HCV drugs may cause reac,va,on of HBV in HCV/HBV coinfected pa,ents
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Resulted in US FDA “Black Box” Warning on new HCV drugs
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30 million HCV-infected people in China, compared to 3-5 million in USA
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93 million chronically infected with HBV in China, compared to 2.2 million in USA
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High HCV/HBV co-infec,on rate in China (es,mated to be 10 million)
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Reac,va,on of HBV has poten,al to be a major health & economic issue in China
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pa,ents in combina,on with Interferon & Ribavirin (IFN/RBV)
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IFN/RBV have several poten,al advantages over new HCV drugs in some seyngs
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HBV reac,va,on is less common and less severe in HCV/HBV co-infected pa,ents with IFN/RBV
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Seeking partnerships for Biotron’s HCV program in China
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CommercialisaTon and Partnering
~~•~~ ~~HIV-1 Program - Signifcant value infec,on points around HIV-1 program data expected~~ in 2018
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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
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Early stage collabora,on opportuni,es for pre-clinical targets, such as:
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Hepa,,s B
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Dengue
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Addi,onal development collabora,on poten,al for “other” pharma targets
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Seeking partners for individual targets or en,re plaUorm
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Corporate Snapshot
Key Financial Metrics
Brief Biotron Overview
Ticker Code ASX: BIT Share Price (09 Jan 18) A $0.03 Market capitalisa,on A $11.4 million 12 Month Trading A $0.016 – 0.046 Range Shares Outstanding 392 million Cash Posi,on (09/2017) A $0.83 million Excludes A$1.6 m R&D tax rebate received in Nov ‘17
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Spun out from John Cur,n School of Medical Research at the Australian Na,onal University in 1999
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Listed on ASX in Jan 2001 (ASX:BIT)
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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
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Investment Highlights
NOVEL ANTIVIRAL PLATFORM
TargeTng viroporin proteins with a rapid screening proprietary primary bacterial cell-based plahorm - a library of over 350 compounds with acTvity against a range of viruses.
Clinical and Preclinical programs in indicaTons with high unmet clinical need BROAD ANTIVIRAL or large paTent populaTons such as HIV-1, HCV & Dengue, HBV, Zika & PIPELINE
ROBUST CLINICAL VALIDATION
outcomes
STRONG INTELLECTUAL Porholio of patents and patent applicaTons directed to the Company’s anTPROPERTY POSITION viral drug porholio
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Dr Michelle Miller Managing Director +61 412 313329 [email protected] www.biotron.com.au
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