BIOTRON LIMITED — Investor Presentation 2015

Oct 5, 2015

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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

6 October 2015

The Manager Companies ASX Limited 20 Bridge Street Sydney NSW 2000

(10 pages by email)

Dear Madam

PRESENTATION TO INVESTORS

I attach a PowerPoint presentation as presented by Biotron Limited's Managing Director, Dr Michelle Miller, to investors.

Yours sincerely

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Peter J. Nightingale Company Secretary pjn8235

BIOTRON
LIMITED (ASX:BIT) Australia
Biotech
Invest October
2015

Michelle
Miller 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
(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 <==

• -­‐-­‐ First
  in
  class
  drug
  and
  new
  drug
  target
  for
  treatment
  of
  HIV
  and
  Hepa,,s
  C
  virus
  (HCV)
  Prepared
  based
  on
  above
  aVer
  the
  August
  Board
  mee,ng - Seven
  clinical trials
  completed;
  one
  in
  progress
  (HCV
  G3
  interim data
  reported;
  G1
  due
  1Q16)
  Guided
  the
  wording
  of
  the
  prospectus
  draV
  and
  the
  use
  of
  proceeds

• -­‐-­‐ Demonstrated
  clinical
  ac,vity
  against
  HCV
  G1
  and
  G3
  While
  capital
  requirements
  are
  determined
  based
  on
  proposed
  plan,
  the
  final
  schedule -­‐ of ~~Independently~~ work will be ~~shown~~ largely ~~to have~~ dictated ~~HCV pan-~~ by available ~~genotype~~ capital ~~ac,vity~~ ~~in vitro~~

-­‐ Efficiently
inhibits
HIV
replica,on
in
monocyte/macrophage
reservoir
cells in
vitro and in
vivo -­‐ ~~Patent posi,on over compound and its uses~~ -­‐ Compound
is
rela,vely
easy
to
make
and
formulate;
very
stable
at
room
temperature
–
important for
supply
chains

-­‐ Significantly
undervalued
compared
to
other
HCV
drugs
=
poten,al
for
considerable
upside

Slide
1

**Key

Financial
Metrics**

Ticker
Code ASX:
BIT Share
Price
(5
Oct
2015) A
$0.54 Market
cap A
$15
million 12
Month
Trading
Range A
$0.041
–
0.183 Shares
Outstanding 313
million Op,ons
(BITO) 50.7
million
$0.12
expiry
30/09/16 Cash
Posi,on
(06/2015) A
$6.5
million

Board

**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

Michael
Hoy Non-­‐execu,ve
Chairman Michelle
Miller Managing
Director Susan
Pond Non-­‐execu,ve
Director Rob
Thomas Non-­‐execu,ve
Director Denis
Wade Non-­‐execu,ve
Director

Slide
2

-­‐ Independently
shown
to
work
against
all
HCV
genotypes in
vitro -­‐ Over
200
pa,ents
and
healthy
volunteers
dosed
with
BIT225
to
date -­‐ BIT225
has
consistently
shown
posi,ve
data:

-­‐ HCV
G1
(BIT225-­‐005)
–
100%
receiving
400mg (28
days
in
combina,on
with
48
weeks IFN/RBV)
were virus-­‐free at
48
weeks ~~Co-infected HIV/HCV GT3 (BIT225-006) – 100% comple,ng course of 300mg (28 days in~~ combina,on with 48 weeks IFN/RBV) were HCV-­‐free 12 weeks post-­‐treatment (SVR12) i.e. cured
of
HCV
infecPon -­‐ Trials
of
BIT225
to
date
in
combina,on
with
IFN/RBV
as
cannot
test
HCV
drugs
on
their
own -­‐ BIT225
posi,oned
to
fill
poten,al
gaps
leV
by
other
HCV
drugs
– only
one
of
its
class

Slide
3

**BIT225

–
First
of
a
New
Class
of
HCV
Drugs**

ü Novel,
oral,
small
molecule
compound

POLYMERASE/PROTEASE INHIBITORS
e.g. Sofosbuvir/Simeprevir

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

ü Inhibits
viral
assembly
and
infec,vity

• ü Pan-­‐genotype
  ac,vity:

BIT225
-­‐
ASSEMBLY/ BUDDING
INHIBITOR

ü Ac,ve in
vitro against
all
main
genotypes

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

• ü Also
  ac,ve
  against
  HIV
  hiding
  in
  reservoir
  cells

Slide
4

• New
  HCV
  drug
  combina,ons
  not
  op,mal

• Cost
  of
  new
  treatments
  is
  excessive:

  • Sovaldi
    US$84,000
    for
    12
    weeks;
    Harvoni
    US$94,500
    for
    12
    weeks

• Lengthy
  treatment
  –
  12
  weeks
  or
  more

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

• Not
  as
  effec,ve
  against
  HCV
  G3
  – BIT225
  has
  good
  acPvity
  against
  HCV
  G3
  (and
  G1)

• More
  treatment
  failures
  than
  an,cipated –
  need
  for
  new
  classes
  of
  drugs
  like
  BIT225

• Resistance
  may
  become
  more
  of
  an
  issue
  with
  new
  HCV
  classes
  –
  need
  for
  new
  classes
  as
  for
  HIV

Slide
5

• ~~Interim data from BIT225-008 (3 month dosing study in HCV gen 1 and gen 3):~~

• We
  now
  have
  safety
  data
  with
  the
  new
  capsule
  formula,on
  out
  to
  12
  week
  dosing

  • i.e.
    sufficient
    for
    dosing
    studies
    with
    new
    HCV
    drugs

  • Prime
    aim
    of
    the
    trial

• The
  gen
  3
  cohort
  responded
  beqer
  than
  expected
  to
  IFN/RBV

  • Rates
    depend
    on
    age,
    gender,
    liver
    damage,
    gene,cs,
    etc

  • SVR12
    rates
    excellent
    in
    BIT225/IFN/RBV
    and
    placebo/IFN/RBV
    arms
    (88%
    and
    90%)

• Withdrawals
  higher
  than
  expected
  but
  retrospec,ve
  analysis
  shows
  majority
  NOT
  due
  to
  BIT225

• • BIT225
  did
  not
  fail
  in
  this
  study

  • BIT225
    is
    sPll
    a
    very
    promising
    new
    anPviral
    drug
    for
    HIV
    and
    HCV
    infecPons

Slide
6

• Complete
  BIT225-­‐008
  HCV
  trial

• ~~HCV Gen 1 due 1Q16~~

• Inves,ga,onal
  New
  Drug
  applica,on

• Complete
  IND-­‐related
  ac,vi,es
  required
  by
  the
  FDA

  • Modeling
    of
    pharmacokine,c
    data
    from
    all
    trials
    to
    determine
    op,mal
    BIT225
    dose and
    frequency
    in
    IND
    trials;
    Exposure/AE
    analysis
    ( 008
    trial
    data
    is
    KEY )

  • • Drug-­‐drug
    interac,on
    studies
    ( in
    vitro and in
    vivo )

• File
  IND
  applica,on
  1Q16

• Phase
  2
  HIV
  trial
  to
  commence
  1H16

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

• Con,nue
  commercialisa,on
  ac,vi,es
  aimed
  at
  aqrac,ng
  partners

• Con,nue
  to
  promote
  company
  to
  local
  and
  interna,onal
  investment
  community

Slide
7