BIOTRON LIMITED — Investor Presentation 2016

Jan 11, 2016

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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

12 January 2016

The Manager Companies ASX Limited 20 Bridge Street Sydney NSW 2000

(22 pages by email)

Dear Madam

BIOTRON LIMITED PRESENTS AT BIOTECH SHOWCASE[TM] 2016

Biotron Limited advises that Dr Michelle Miller, Managing Director, will be giving the attached presentation to the Biotech Showcase[TM] 2016 Conference being held this week in San Francisco, California, USA.

In addition, Dr Miller will give briefings to USA institutional investors and pharmaceutical company representatives as part of activities surrounding the annual JP Morgan Healthcare Conference. This is one of the most important annual healthcare investor conferences, attracting thousands of healthcare and life science business executives, as well as investors and analysts, to San Francisco.

The Biotech Showcase[TM] features corporate presentations by innovative life science companies to an audience of public and private investors, business development executives and professional advisors who are interested in investment opportunities and collaborations. Now in its eighth year, it expects to attract upwards of 1,700 attendees.

Yours sincerely

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Peter J. Nightingale Company Secretary

pjn8359

BIOTRON
LIMITED (ASX:BIT)

Biotech
Showcase
2016

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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
(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.

==> picture [720 x 50] intentionally omitted <==

**Key

Financial
Metrics**

Key Financial Metrics	Key Financial Metrics	Key Financial Metrics
Ticker Code		ASX: BIT
Share Price (8 Jan 2016)		A $0.05
Market cap		A $16 million
12 Month Trading Range		A $0.041 – 0.165
Shares Outstanding		313 million
Op,ons (BITO)		50.7 million $0.12 expiry 30/09/16
Cash Posi,on (09/2015)		A $4.7 million Board
~~Mihl~~ ~~H~~	~~N~~	~~,~~ ~~Chi~~
~~cae~~ ~~oy~~	~~on-execuve~~ ~~arman~~
Michelle Miller	Managing Director
Susan Pond	Non-execu,ve Director
Rob Thomas	Non-execu,ve Director
Denis Wade	Non-execu,ve Director

**12

Month
Share
Price
Performance**

12 Month Share Price Performance	12 Month Share Price Performance
Ticker Code	ASX: BIT
Share Price (15 Sept 2014)	A $0.115
Market cap	A $26.3 million
12 Month Trading Range	A $0.075 – 0.315
Shares Outstanding	228 million
Cash Posi,on (06/14)	A $1.76mn

Slide
1

• Spun
  out
  from
  John
  Cur,n
  School
  of
  Medical
  Research
  at
  the
  Australian
  Na,onal
  University
  in
  1999

• Listed
  on
  ASX
  in
  Jan
  2001
  (ASX:BIT)

• Headquartered
  in
  Sydney,
  Australia

• Directors

• Michael
  Hoy

Chairman

• Michelle
  Miller

CEO
&
Managing
Director;
ex-­‐Johnson
&
Johnson
Research;
ex-­‐Start-­‐up
Australia
biotech
fund

• Denis
  Wade

Independent
non-­‐execu,ve
director;
ex-­‐J&J
(Chairman
and
MD
Johnson
&
Johnson
Research); Director
of
Heartware
Inc
(NASDAQ:HTWR)

• Susan
  Pond

Independent
non-­‐execu,ve
director;
ex-­‐J&J
(Chairman
and
MD
Johnson
&
Johnson
Research)

• Rob
  Thomas

Independent
non-­‐execu,ve
director;
Director
of
Heartware
Inc
(NASDAQ:HTWR);
Starpharma (ASX:SPL),
REVA
Medical
Limited
(ASX:RVA);
Virgin
Australia
Limited
(ASX:VAH)

Slide
2

• Viroporin
  proteins
  are
  present
  in
  influenza
  (M2),
  HIV-­‐1
  (Vpu),
  Hep
  C
  (p7),
  Dengue
  and
  West
  Nile
  (M protein),
  SARS
  (E
  protein)
  and
  others

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

• Designed
  library
  of
  compounds
  to
  target
  these
  viral
  targets

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

• Focused
  on
  clinical
  development
  of
  lead
  drug
  BIT225
  (HIV-­‐1
  and
  HCV)

• Next
  genera,on
  inhibitor
  ready
  to
  progress
  to
  IND-­‐enabling
  studies

• • Promising
  earlier
  stage
  drug
  discovery
  programs
  for
  other
  viruses
  including
  Dengue,
  Hepa,,s
  B and
  others

Slide
3

INDICATION	COMPOUND	DISCOVERY	PRECLINICAL	PHASE 1	PHASE 2	PHASE 3
Hep C	BIT225
HIV-1/Hep C	BIT225
HIV-1	BIT225
Next generaEon - HCV	BIT314
Dengue	Leads

• Small
  hydrophobic
  proteins
  with
  ion channel
  ac,vity

• • Form
  hydrophilic
  pores
  in
  host
  cell membranes

• • Key stages of the viral cycle such
  as virus uncoa,ng, transport and matura,on are ion infuenced -­‐

• in viral

• processes many species

Nature
Reviews
Microbiology 10 ,
563-­‐574

•

•

Crucial
for
viral
pathogenicity
due
to involvement
in
various
steps
of
virus life
cycles Ideal
therapeu,c
targets

**Biotron’s

Core
Technology**

OTHER
“HITS”
IN
LIBRARY
include: Designed
library
of Compounds
screened
in compounds
to
target proprietary
assay
set
up
for viroporins : each
virus
target
e.g.
HIV-­‐1 -­‐ Influenza
A
and
B Vpu;
HCV
p7;
Influenza
M2; -­‐ **Coronaviruses IniEally

250
compounds design ~~ed and synthesised;~~ Dengue M; Coronavirus E. ~~-~~ ~~Including SARS~~ library
now
~350 -­‐ Epstein-­‐Barr
virus
(EBV) -­‐ HepaEEs
B
virus
(HBV) Hits
tested
against DENGUE
– ~~virus in cell~~ ~~Several~~ cultures OTHER VIRUSES
– compounds Secondary with Lead ~~screening of hits~~ promising op,misa,on against
key BIT225
is
a
representaEon
of and
selec,on viruses
e.g.
Hep anEviral B,
influenza the
value
that
resides
within acEvity Biotron’s
core
experEse BIT314
(HCV)**

BIT225
(HIV-­‐1
and
HCV)

Slide
6

-­‐ First
in
class
drug
and
new
drug
target
for
treatment
of
HIV-­‐1
and
Hepa,,s
C
virus
(HCV) -­‐ Prepared
based
on
above
aper
the
August
Board
mee,ng -­‐ Seven
clinical
trials
completed;
another
is
fully
recruited
with
data
expected
1Q16 -­‐ Guided
the
wording
of
the
prospectus
drap
and
the
use
of
proceeds -­‐ Over
200
subjects
dosed
in
trials
to
date -­‐ While
capital
requirements
are
determined
based
on
proposed
plan,
the
final
schedule -­‐ Pro ~~mising clinical efcacy against HIV-1 and HCV~~ of work will be largely dictated by available capital -­‐ HCV
GT1
(BIT225-­‐005)
–
100%
receiving
400mg
BID
for
28
days
in
combina,on
with
48
weeks
IFN/ RBV
(per
protocol)
were
virus-­‐free
at
48
weeks

-­‐ ~~HIV-1/HCV GT3 (BIT225-006) – 100% receiving 300mg BID for 28 days in combina,on with 48~~ weeks
IFN/RBV
(per
protocol)
achieved
SVR12
i.e.
cured
of
HCV
infec,on -­‐ BIT225
increases
the
rate
at
which
HCV
is
cleared -­‐ BIT225
efficiently
inhibits
HIV-­‐1
replica,on
in
macrophage
reservoir
cells in
vitro and in
vivo (BIT225-­‐004)

Slide
7

**BIT225

–
First
of
a
New
Class
of
HCV
DAA
Drugs**

POLYMERASE/PROTEASE INHIBITORS
e.g. Sofosbuvir/Simeprevir BIT225
-­‐
ASSEMBLY/ BUDDING
INHIBITOR

ü Novel,
oral,
small
molecule
compound

ü Only
one
of
its
class
(p7
inhibitor)
in
clinical
trials

ü Inhibits
viral
assembly
and
infec,vity

ü Pan-­‐genotype
ac,vity:

ü Ac,ve in
vitro against
all
main
genotypes

• ü Clinically
  ac,ve
  against
  hard-­‐to-­‐treat
  HCV
  GT 1
  (1a
  and
  1b)
  and
  GT
  3

Slide
8

**BIT225-­‐008:

Phase
2
HCV
Three-­‐Month
Dosing
Trial**

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----- Start of picture text -----

Placebo
+
IFN/RBV
n=20
(HCV
Genotype
1
or
3)
IFN/RBV
ETVR
n=20
BIT225 200 mg BID + IFN/RBV HCV Genotype 1 IFN/RBV
ETVR
BIT225
200
mg
BID
+
IFN/RBV
HCV
Genotype
3
IFN/RBV
n=20
Week
12
24
48
----- End of picture text -----

Design:

• -­‐ Randomised,
  placebo-­‐controlled,
  double-­‐blind
  trial
  (n=60)

• -­‐ Treatment
  naïve,
  HCV
  GT
  1
  and
  3

• -­‐ 3
  months
  dosing
  with
  BIT225
  in
  combina,on
  with
  IFN/RBV

• -­‐ Using
  new
  capsule
  formula,on

Aims:

• -­‐ Demonstrate
  safety
  of
  BIT225
  with
  3
  months
  dosing

• -­‐ Extend
  HCV
  GT
  1&3
  efficacy
  data

• -­‐ Provide
  key
  data
  to
  assist
  with
  determining
  future
  dosing
  with BIT225
  capsules

• -­‐ 1.6
  fold
  higher
  blood
  levels
  than
  previous
  formula,on

• -­‐ Fully
  recruited
  (Thailand);
  data
  expected
  1Q16

Slide
9

• HCV market forecast to grow to over $19bn by 2016

• 180
  million
  infected
  worldwide
  (3%
  world
  popula,on)

• ~3
  to
  5
  million
  in
  US

• The
  race
  to
  cure
  pa,ents
  faster
  (and
  cheaper)
  is
  s,ll
  on

• Recent
  new
  HCV
  drug
  combina,ons
  are
  good,
  but
  not
  op,mal

• Lengthy
  treatment
  –
  12
  weeks
  or
  more

• Not
  pan-­‐genotypic
  – BIT225
  is
  pan-­‐genotypic in
  vitro

• EXPENSIVE!!!

• Very
  large
  markets
  currently
  untapped
  ex-­‐USA/Europe

• 30
  million
  in
  China

• Poten,al
  for
  another
  class
  of
  DAA
  such
  as
  BIT225
  to
  shorten
  treatment
  and
  reduce
  costs,
  and in
  other
  markets
  as
  well
  as
  US/Europe

Slide
10

**HIV-­‐1:

Towards
a
Cure**

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• Over
  1.1
  million
  people
  living
  with
  HIV-­‐1
  in
  the
  USA, with
  1
  in
  6
  unaware
  of
  diagnosis

• US$11.9
  bn
  sales
  in
  US,
  Europe
  and
  Japan
  in
  2013; expected
  to
  grow
  to
  US$16.8
  bn
  by
  2020

• HIV-­‐1
  pa,ents
  need
  to
  stay
  on
  an,retroviral
  drugs (ART)
  to
  keep
  virus
  levels
  under
  control

• Long-­‐term
  health
  implica,ons
  even
  in
  pa,ents
  on an,retroviral
  drugs
  e.g.
  HAND,
  immune
  ac,va,on, etc

• New
  mode
  of
  ac,ons
  drugs
  are
  needed
  to
  eradicate or
  cure
  HIV-­‐1
  infec,on

Slide
11

**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

• Eradica,on
  will
  require
  mul,ple
  approaches; approaches
  include:

• An,-­‐latency
  agents
  for
  latently-­‐infected
  T
  cells

• Drugs
  to
  modify
  immune
  response

• Drugs
  targe,ng
  HIV-­‐1
  in
  macrophage
  lineage cells

Mario
Stevenson ScienAfic
American 299 ,
78
-­‐
83
(2008)

Slide
12

**BIT225

Targets
HIV-­‐1
in
Reservoir
Cells**

• BIT225
  inhibits
  assembly
  and
  budding
  of
  new
  virus
  in
  macrophages

• Phase
  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
  Nov

• pii:
  dkv389.
  [Epub
  ahead
  of
  print])

• Poten,al
  benefits
  on
  immune
  aging
  and
  HIV-­‐associated
  demen,a

• Poten,al
  for
  use
  in
  future
  virus
  eradica,on
  treatment

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----- Start of picture text -----

A
B
----- End of picture text -----

(A)
Untreated
Controls (B)
BIT225
treated
cells

==> picture [303 x 175] intentionally omitted <==

----- Start of picture text -----

BIT225
Stops
HIV-­‐1
Replica:on
200
150
100 +BIT225
50
16 17 19 21 22 23 24 25 26 27 28
Time
(days)
+HIV-­‐1
----- End of picture text -----

Slide
13

**BIT225

–
Proven
Clinical
AcEvity
Against
HIV-­‐1**

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----- Start of picture text -----

16
• Placebo
BIT225-­‐004:
Phase
1b/2a
randomised,
placebo
controlled,
double-­‐blind
trial
14 BIT225
–
21
pa,ents,
HIV-­‐1
posi,ve,
treatment-­‐naïve ;
10
days
dosing
with
BIT225
12
(monotherapy)
10
•
Results
demonstrated
that:
8
1.
BIT225
significantly
reduces
HIV-­‐1
levels
in
the
macrophage
(reservoir)
6
cells
BIT225
can
cross
the
blood-­‐brain
barrier,
opening
up
the

possibility
of
treatment
of
AIDS-­‐related
demenEa
4
2
2.
BIT225
reduced
myeloid-­‐specific
immune
acEvaEon
markers
during
trial
5 10 15 20 25
Results
support
a
potenEal
role
for
BIT225
in
cure/eradicaEon
strategies
Time
in
Co-­‐culture
(days)
HIV-­‐1
Replica,on
(pg/200uL)
----- End of picture text -----

AnEcipated
that
a
Phase
2
HIV-­‐1
trial
of
BIT225
in
combinaEon
with
current anE-­‐HIV-­‐1
drugs
will
commence
mid-­‐2016

Slide
14

• Renewed
  industry
  interest
  in
  targe,ng
  viral
  diseases
  including

• Respiratory
  syncy,al
  virus
  (RSV)

• Hepa,,s
  B
  virus

• Tropical
  diseases
  including
  Dengue

• Influenza
  (in
  par,cular
  drug
  resistant
  strains)

• Ebola
  and
  MERS-­‐CoV
  outbreaks
  have
  caused
  public
  health
  issues
  worldwide

• BIT225
  has
  demonstrated
  the
  robustness
  of
  Biotron’s
  approach
  with
  targeEng
  viroporin
  proteins

• Compounds
  with
  ac,vity
  against
  other
  key
  viruses
  have
  been
  iden,fied;
  secondary
  screening
  is
  in progress,
  with
  the
  aim
  of
  iden,fying
  poten,al
  candidates
  to
  progress
  into
  IND-­‐enabling
  studies

• Main
  focus
  remains
  on
  commercialising
  the
  Company’s
  HIV-­‐1
  and
  HCV
  programs,
  but
  essen,al
  that other
  opportuni,es
  are
  developed

Slide
15

**Dengue

Virus
Program**

• 2.5 billion people (40% world popula,on) live in areas at risk of
  Dengue

• ~100
  million
  people
  infected
  yearly

• A
  leading
  cause
  of
  illness
  and
  death
  in
  tropics
  and
  subtropics

• Transmission
  is
  by
  mosquito;
  most
  preven,on
  programs target
  the
  vector

==> picture [255 x 125] intentionally omitted <==

• No
  approved
  Dengue-­‐specific
  therapeu,c
  drug

• Vaccine
  trials
  have
  had
  disappoin,ng
  results

• Biotron
  is
  targe,ng
  Dengue
  M
  protein
  –
  Similar
  target
  to HIV-­‐1/Vpu
  and
  HCV/p7

• Several
  compounds
  with
  promising
  ac,vity
  have
  been generated;
  tests
  are
  on-­‐going

==> picture [255 x 141] intentionally omitted <==

----- Start of picture text -----

www.sciencenews.org
----- End of picture text -----

Slide
16

• Unique
  core
  exper,se
  against
  novel
  viral
  targets

• Demonstrated
  proof
  of
  concept
  of
  successful
  targe,ng
  of
  viroporins
  with
  BIT225

• Poten,al
  within
  compound
  library
  for
  significant
  other
  viral
  infec,ons
  e.g.
  Dengue,
  RSV,
  Hep
  B

• BIT225
  is
  a
  novel
  approach
  with
  demonstrated
  promising
  efficacy
  in
  Phase
  2a/2
  clinical
  trials

• HCV
  and
  HIV-­‐1
  are
  high
  growth,
  mul,-­‐billion
  dollar
  markets

• Treatment
  gaps
  remain

• Represents
  a
  new
  class
  of
  direct-­‐ac,ng
  HCV
  drugs

• Poten,al
  to
  fill
  significant
  HCV
  treatment
  gaps,
  shorten
  treatment
  and
  reduce
  costs

• Poten,al
  to
  eradicate
  important
  HIV-­‐1
  reservoirs,
  plus
  may
  impact
  on
  immune
  ac,va,on

• • Robust
  data
  package
  has
  been
  generated
  to
  support
  combina,on
  studies
  with
  poten,al partners

Slide
17

• ~~Report data from BIT225-008 HCV trial~~

• SVR12
  for
  G1
  due 1Q16

• Inves,ga,onal
  New
  Drug
  applica,on
  (IND)

• Finalise
  regulatory
  documenta,on
  containing
  an
  extensive
  data
  package

• Partner
  for
  HCV
  combina,on
  studies

• Progress
  protocol
  and
  regulatory
  documenta,on
  for
  key
  Phase
  2
  HIV-­‐1
  trial
  to
  commence
  in
  1H16

• Expand
  earlier
  stage
  drug
  programs
  e.g.
  Dengue
  virus

• Iden,fy
  leads
  for
  other
  viruses
  including
  RSV
  and
  Hep
  B

Slide
18

Dr
Michelle
Miller Managing
Director +61
412
313329 mmiller@biotron.com.au www.biotron.com.au

==> picture [420 x 60] intentionally omitted <==

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