BIOTRON LIMITED — Investor Presentation 2013

Apr 25, 2013

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Level 2, 66 Hunter Street Sydney NSW 2000 Tel: (61-2) 9300 3344 Fax: (61-2) 9221 6333 E-mail: pnightingale@biotron.com.au Website: www.biotron.com.au

26 April 2013

The Manager Companies ASX Limited 20 Bridge Street Sydney NSW 2000

(12 pages by email)

Dear Madam

CEO PRESENTATION AT THE 2013 BIO INTERNATIONAL CONVENTION

26 April 2013, Sydney, Australia – Biotron Limited’s (ASX:BIT) Managing Director, Dr Michelle Miller, presented the attached update of the Company’s activities this week to an international audience at the 2013 BIO International Convention. Hosted by the Biotechnology Industry Organization Biotechnology Industry Organization (BIO), this year’s global event for biotechnology has been underway this week at the McCormick Place in Chicago, Illinois, USA.

The BIO International Convention is the largest global event for the biotechnology industry and attracts the biggest names in biotech, offers key networking and partnering opportunities. A key feature of BIO is the Business Forum which provides a unique platform for biotechnology and pharmaceutical companies, academic research institutions, and investors from around the world to gather and discuss strategic opportunities in one-on-one meetings and corporate presentations.

The Company recently announced positive headline date from its Phase 1b/2a trial of BIT225 in HIV-infected subjects. BIT225 targets HIV in long-lived virus reservoir cells, and may be useful in future elimination strategies.

In addition, in another Phase 1b/2a trial, 100% of patients infected with Hepatitis C virus, who received BIT225 (400 mg) in combination with interferon and ribavirin, had undetectable HCV after 48 weeks.

A Phase 2 trial of BIT225 in HIV/HCV co-infected patients is currently in progress.

For further information please contact Dr Michelle Miller, Managing Director, on 61 (0)412 313 329.

Yours sincerely

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Peter J. Nightingale Company Secretary

pjn7194

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.

2

**BIOTRON

LIMITED
(ASX:BIT)**

**Clinical

Stage
An;viral Drug
Development
Company**

Michelle
Miller CEO
&
Managing
Director +61
(0)
412
313
329 mmiller@biotron.com.au

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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
  an,viral
  drug
  development
  company

• Focus
  on
  developing
  novel
  small
  molecule
  drugs

• Clinical
  programs
  for
  Hepa,,s
  C
  virus
  (HCV)
  and
  HIV

• Earlier
  stage
  programs
  include
  Dengue
  and
  others

• Headquartered
  in
  Sydney,
  Australia

• Key
  recent
  highlights

• Mar
  2013
  –
  Announced
  posi:ve
  preliminary
  headline
  results
  from
  Phase
  2a
  HIV
  reservoir
  trial

• Nov
  2012
  –
  Commenced
  Phase
  2
  HIV/HCV
  co-­‐infec:on
  trial

• Nov
  2012
  –
  Announced
  posi:ve
  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
HEP C	p7							Ph 2a complete; Ph 2b (3 mth dosing) scheduled for 4Q13
HIV	Vpu							Ph 1b/2a complete
Hep C/HIV	Vpu/p7							Ph 2 In progress
Dengue	M
Next genera;on for HCV	p7							Ready for IND- enabling (formal preclinical) studies

• New
  inves,ga,onal
  oral
  drug
  for
  trea,ng
  HCV
  infec,on

• First
  in
  class;
  targets
  p7
  protein
  –
  essen,al
  for
  virus
  assembly
  and
  release

• Preclinical
  studies
  –
  synergism
  with
  IFN/RBV
  and
  polymerase
  inhibitors

• • Three
  completed
  trials:

• § Phase
  Ia –Single
  dose,
  dose-­‐escala,ng
  safety
  study
  in
  healthy
  volunteers
  (n=48)

• § Phase
  Ib -­‐ 7-­‐day
  mul,ple
  dose
  study
  in
  pa,ents
  with
  HCV
  (n=18)

§ Phase
2a –
28-­‐day
mul,ple
dose
study
in
pa,ents
with
HCV
(gen
1)
in
combina,on
with
IFN/RBV
(n=24) § 12-­‐week
data
presented
at
HepDART,
Dec
2011

• § 48-­‐week
  headline
  data
  presented
  at
  AASLD,
  Nov
  2012

• § Addi,onal
  PK
  and
  resistance
  data
  to
  be
  presented
  at
  EASL,
  April
  2013

Michelle Miller, CEO; +61 412 313329; mmiller@biotron.com.au

**BIT225

HCV
Phase
2
Clinical
Informa;on**

Treatment	Treatment			% ETVR (<50IU/ml at 48 weeks)	% ETVR (<50IU/ml at 48 weeks)
	Treatment	Median log reduc;on at 35 days	% Complete EVR (<50IU/ml at 12 weeks)	% ETVR (<50IU/ml at 48 weeks)
	400 mg BIT225 + IFN/RBV	-4.957	86	100
	200 mg BIT225 + IFN/RBV	-4.351	88	88
Placebo + IFN/RBV	Placebo + IFN/RBV	-3.649	63	75

• Clear
  demonstra,on
  that
  this
  first
  in
  class,
  direct-­‐ac,ng
  an,viral
  drug
  has
  good
  an,viral ac,vity
  in
  treatment-­‐naïve
  genotype
  1
  pa,ents

• Generally
  well
  tolerated
  at
  the
  doses
  selected
  in
  trial

• Confirmed
  preclinical
  efficacy
  studies
  that
  demonstrated
  synergism
  with
  IFN
  and
  RBV

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**BIT225

and
HIV**

• BIT225
  also
  has
  potent
  an,-­‐HIV
  ac,vity

– Unique
mode
of
ac,on
targets
HIV
“hiding”
in
long-­‐lived
reservoir
cells

• Reservoirs
  are
  last
  of
  the
  holy
  grail
  in
  HIV

• No
  exis,ng
  drugs
  target
  this
  source
  of
  HIV
  in
  the
  body

• Phase
  2a
  trial
  of
  BIT225
  in
  HIV-­‐infected
  subjects
  recently
  completed – 10
  days
  dosing
  (treatment-­‐naïve,
  high
  viral
  load,
  CD4

  350)

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+BIT225

Headline
results
show
that
BIT225
can
significantly
reduce
HIV
levels
in these
reservoir
cells
in
HIV-­‐infected
subjects

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Results
support
a
poten:al
role
for
BIT225
in
eradica:on
strategies

Control

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**BIT225

-­‐
HIV
/
HCV
Co-­‐Infected
Popula;on**

• 25
  –
  40%
  of
  HIV-­‐infected
  people
  in
  the
  USA
  are
  also
  HCV-­‐infected

– Significantly
worse
prognosis
than
mono-­‐infected
pa,ents

– US
and
European
regulatory
agencies
have
stated
the
need
for
new
treatment
strategies
for
this difficult-­‐to-­‐treat
popula,on

• Phase
  2
  HIV/HCV
  trial
  in
  progress

• Treatment-­‐naïve
  to
  HCV
  treatment
  with
  RBV
  and/or
  IFN;
  virologically
  suppressed
  on
  ART

–

Genotypes
1
and
3

– 28
day
dosing
in
combina,on
with
IFN/RBV

– Recruitment
and
clinical
phase
an,cipated
to
be
complete
by
mid-­‐2013

BIT225
is
uniquely
placed
due
to
dual
an;-­‐HIV
and
an;–HCV
ac;vity

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**Biotron

Programs
Summary**

• Documented
  need
  for
  new
  an,viral
  drugs

• Licensing
  space
  is
  very
  ac,ve

• BIT225
  has
  shown
  good
  clinical
  efficacy
  against
  both
  HCV
  and
  HIV

• Poten;al
  to
  be
  used
  with
  new
  (DAA)
  or
  exis;ng
  classes
  of
  HCV
  drugs

  • Phase
    2b,
    3
    month
    study
    in
    combina,on
    with
    IFN/RBV
    an,cipated
    to
    commence
    4Q13

• Poten;al
  for
  use
  in
  HIV/HCV
  co-­‐infected
  popula;on

  • Major
    unmet
    medical
    need

  • No
    other
    drugs
    target
    both
    HIV
    and
    HCV

• Poten;al
  role
  for
  BIT225
  in
  elimina;on/cure
  strategies
  for
  HIV

• Currently
  progressing
  development
  of
  next-­‐genera,on
  inhibitors

• Promising
  early
  stage
  drug
  discovery
  program
  for
  Dengue

• Seeking
  partner(s)
  for
  further
  development
  of
  BIT225
  and
  development
  of
  next
  genera,on
  of inhibitors

Michelle Miller, CEO; +61 412 313329; mmiller@biotron.com.au

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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 (23 April 2013)		A$0.11	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$25 m	Mr Bruce Hundertmark		Non-Execu;ve Director
Net Cas~~h~~ ~~(31~~ ~~Dec~~ ~~‘12)~~		~~A$6.3~~ ~~m~~	Mr Peter Nigh;ngale		CFO & Company Secretary