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BIOTRON LIMITED — Investor Presentation 2013
Jun 4, 2013
64528_rns_2013-06-04_cb68c820-86f7-4e36-8c9f-3f01058f599f.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
5 June 2013
The Manager Companies ASX Limited 20 Bridge Street Sydney NSW 2000
(10 pages by email)
Dear Madam
BIOTRON TO PRESENT AT ASIA BIOTECH INVEST 2013 - HONG KONG
Biotron Limited's CEO and Managing Director Dr Michelle Miller will make a presentation this morning at the Asia Biotech Invest 2013 conference in Hong Kong.
Dr Miller will present an overview of the Company’s clinical program for its first in class drug candidate BIT225, which is currently in development for the treatment of both Hepatitis C (HCV) and HIV.
Dr Miller commented: "The Company is accelerating its clinical and commercialisation activities and this conference is a timely opportunity to update our programs to a global investor audience."
A copy of the presentation is attached.
Enquiries
Dr Michelle Miller Rudi Michelson Managing Director Monsoon Communications Biotron Limited +61-3 9620 3333 +61-2 9805 0488 +61-(0)412313329
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.
Yours sincerely
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Peter J. Nightingale Company Secretary
pjn7261
**BIOTRON
LIMITED
(ASX:BIT)**
**Clinical
Stage
An;viral Drug
Development
Company**
Michelle
Miller CEO
&
Managing
Director +61
(0)
412
313
329 [email protected]
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This
presenta,on
may
contain
forward-‐looking
statements
with
respect
to
the
financial
condi,on, results
and
business
achievements/performance
of
Biotron
Limited
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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-
Clinical stage antiviral drug development company
-
Focus on developing novel small molecule drugs
-
Clinical programs for Hepatitis C virus (HCV) and HIV
-
Earlier stage programs include Dengue and others
-
Headquartered in Sydney, Australia
-
Key recent highlights
-
Mar 2013 – Announced positive preliminary headline results from Phase 2a HIV reservoir trial
-
Nov 2012 – Commenced Phase 2 HIV/HCV co-infection trial
-
Nov 2012 – Announced positive 48-week follow-up data from Phase 2a HCV trial
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**Biotron
-‐
Advanced
Pipeline
of
Clinical
Programs**
| INDICATION | VIRAL TARGET |
DISCOVERY | PRE-CLINICAL | PHASE 1a | PHASE 1b | PHASE 2a | PHASE 2b | STATUS |
|---|---|---|---|---|---|---|---|---|
| Hepa;;s C | p7 | • Ph 2a complete; • Ph 2b (3 mth dosing) scheduled for 4Q13 |
||||||
| HIV | Vpu | • Ph 2a complete |
||||||
| Hepa;;s C/ HIV |
Vpu/p7 | • Ph 2 in progress |
||||||
| Dengue | M | |||||||
| Next genera;on for Hepa;;s C |
p7 | • Ready for IND- enabling (formal preclinical) studies |
||||||
-
~~New investigational oral drug for treating HCV infection~~
-
First in class; targets p7 protein – essential for virus assembly and release
-
Synergistic with IFN/RBV (current treatment) and polymerase inhibitors
-
Three completed trials:
-
§ Phase Ia –Single dose, dose-escalating safety study in healthy volunteers (n=48)
-
§ Phase Ib - 7-day multiple dose study in patients with HCV (n=18)
-
§ Phase 2a – 28-day multiple dose study in patients with HCV (gen 1) in combination with IFN/RBV (n=24)
-
§ 12-week data presented at HepDART, Dec 2011
-
§ 48-week headline data presented at AASLD, Nov 2012
-
§ Additional PK and resistance data presented at EASL, April 2013
Michelle Miller, CEO; +61 412 313329; [email protected]
**BIT225
HCV
Phase
2
Clinical
Informa;on**
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----- Start of picture text -----
%
with
End
of
%
with
Early
Treatment
Viroogical
Median
log
Virological
Response
Treatment
reduc;on
at
Response
35
days
(<50IU/ml
at
12
Treatment window (<50IU/ml
at
48
weeks)
weeks)
400
mg
BIT225
+
-‐4.957
86
100
IFN/RBV
200
mg
BIT225
+
-‐4.351
88
88
IFN/RBV
Placebo
+
IFN/
-‐3.649
63
75
RBV
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- Clear demonstration that this first in class, direct-acting antiviral drug has good antiviral activity in hard-to-treat, treatment-naïve genotype 1 patients
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**BIT225
and
HIV**
-
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 2a trial of BIT225 in HIV-infected subjects recently completed
-
+BIT225
-
10 days dosing (treatment-naïve, high viral load, CD4 >350)
-
Headline results show that BIT225 can significantly reduce HIV levels in these reservoir cells in HIV-infected subjects
-
Results support a potential role for BIT225 in cure/eradication strategies
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Control
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**Biotron
Opportunity**
• Documented need for new antiviral drugs
-
Licensing space is very active (Gilead/Pharmasset US$11b deal)
-
HCV worldwide market ~US$2.8 billion; predicted to reach >US$10 billion
-
BIT225 - good clinical efficacy against both HCV and HIV
-
Potential use with new (DAA) or existing classes of HCV drugs
- Phase 2b, 3 month study in combination with IFN/RBV anticipated to commence 4Q13
-
Potential for use in HIV/HCV co-infected population
-
Major unmet medical need
-
No other drugs target both HIV and HCV; Ph 2 trial in HIV/HCV patients in progress
-
-
Potential role for BIT225 in elimination/cure strategies for HIV
-
Promising early stage drug discovery program for Dengue
Michelle Miller, CEO; +61 412 313329; [email protected]
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| Key Financials and Facts | Key Financials and Facts | Key Financials and Facts | |||
|---|---|---|---|---|---|
| ~~BIOTRON LIMITED price history~~ KEY FINANCIALS ASX Code BIT |
~~chart~~ Mr Michael Hoy |
BOARD AND MANAGEMENT Chairman |
|||
| Recent Share Price (30 May 2013) | A$0.10 | Dr Michelle Miller | CEO & Managing Director | ||
| 52 Wee~~k~~ ~~High~~ | ~~A$0.185~~ | Dr Denis Wade | Non-Execu;ve Director | ||
| 52 Week Low | A$0.08 | Dr Susan Pond | Non-Execu;ve Director | ||
| Shares on Issue | 228 million | Mr Robert Thomas | Non-Execu;ve Director | ||
| Market Capitaliza;on | A$23 m | Mr Bruce Hundertmark | Non-Execu;ve Director | ||
| Net Cas~~h~~ ~~(31~~ ~~Mar~~ ~~‘13)~~ |
~~A$5.05~~ ~~m~~ |
Mr Peter Nigh;ngale | CFO & Company Secretary |