BIOTRON LIMITED — AGM Information 2014

Nov 12, 2014

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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

13 November 2014

The Manager Companies ASX Limited 20 Bridge Street SYDNEY NSW 2000

(22 pages by email)

Dear Madam,

PRESENTATION TO ANNUAL GENERAL MEETING

I attach an address by the Chairman and a PowerPoint presentation which are to be delivered to the shareholders present at today’s Annual General Meeting which is convened to be held at 11.00 am.

Yours faithfully

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Peter J. Nightingale Company Secretary

pjn7928

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

13 NOVEMBER 2014

MY FELLOW SHAREHOLDERS

CHAIRMAN’S ADDRESS TO THE AGM

IN A YEAR OF MIXED FORTUNES FOR AUSTRALIA’S LIFE SCIENCES SECTOR, BIOTRON HAS CONTINUED TO PERFORM STRONGLY.

I AM HAPPY TO REPORT THAT SIGNIFICANT PROGRESS HAS BEEN MADE WITH THE COMPANY’S CLINICAL PROGRAMS.

A PHASE II CLINICAL TRIAL IN CO-INFECTED HIV/HEPATITIS C PATIENTS WAS COMPLETED SUCCESSFULLY.

A PARTICULARLY EXCITING STANDOUT RESULT FROM THE TRIAL WAS THE FACT ALL GENOTYPE 3 PATIENTS – A NOTABLY CHALLENGING PATIENT POPULATION – HAD UNDETECTABLE LEVELS OF HCV 12 WEEKS AFTER COMPLETING ALL TREATMENT, INDICATIVE OF A CURE.

A LONGER TERM PHASE II HCV TRIAL WAS UNDERTAKEN, WITH PARTICULAR FOCUS ON GENOTYPES 1 AND 3. THE 60 PATIENT 12 WEEK DOSING TRIAL IS PIVOTAL FOR THE COMPANY. THE TRIAL, NOW IN ITS FINAL STAGES OF RECRUITMENT, HAS PROGRESSED WELL TO DATE.

A SUCCESSFUL HUMAN TRIAL, EARLIER THIS YEAR, DEMONSTRATED THAT THE COMPANY’S NEWLY DEVELOPED CAPSULE FORMULATION SIGNIFICANTLY IMPROVED DELIVERY OF BIT225 IN A MORE USER-FRIENDLY FORMAT, SUITABLE FOR LARGER SCALE CLINICAL TRIALS.

BIOTRON’S ALREADY STRONG PATENT POSITION WAS FURTHER STRENGTHENED IN KEY MARKETS, PARTICULARLY THE USA.

AND A RECENT $4 MILLION CAPITAL RAISING WAS SUBSTANTIALLY OVERSUBSCRIBED; INDICATIVE, PERHAPS, OF THE POTENTIAL AND OPPORTUNITY BIOTRON OFFERS INVESTORS.

THE HEPATITIS C ARENA HAS BEEN THE SUBJECT OF MUCH RECENT MEDIA ATTENTION. WITH A MARKET EXPECTED TO TOP $20 BILLION IN THE NEXT 5 YEARS, IT IS NOT SURPRISING THAT MAJOR PHARMACEUTICAL COMPANIES ARE STAKING CLAIMS TO NEW, AND EXPENSIVE, CLINICAL OUTCOMES.

BIOTRON’S MANAGEMENT AND BOARD BELIEVE THE COMPANY IS STRATEGICALLY WELL POSITIONED, PARTICULARLY IN HARD TO TREAT POPULATIONS OF THE VIRUS, INCLUDING GENOTYPE 3 AND CO-INFECTED HCV/HIV PATIENTS.

BIOTRON’S FOCUS FOR THE NEXT 12 MONTHS NOW SHIFTS TO AN INVESTIGATIONAL NEW DRUG (IND) TRIAL. THE SUCCESSFUL OUTCOME OF SUCH A TRIAL IS LIKELY TO BE TRANSFORMATIONAL FOR THE COMPANY. PLANNING FOR THE TRIAL IS WELL UNDERWAY. THE COMPANY HAS ENTERED INTO PRELIMINARY DISCUSSIONS WITH THE USA FOOD AND DRUG ADMINISTRATION TO ENSURE ALL POSSIBLE OBJECTIVES ARE ADDRESSED.

YOUR COMPANY HAS COME FAR WITH A DETERMINED FOCUS ON PROGRESSING THE CLINICAL DEVELOPMENT OF ITS LEAD ANTIVIRAL DRUG, BIT 225, WHILE MAINTAINING TIGHT COST CONTROL.

BIOTRON OFFERS A NOVEL APPROACH TO THE TREATMENT OF HCV AND HIV. THE COMPANY’S PHASE II TRIALS, TO DATE, HAVE DEMONSTRATED PROOF OF CONCEPT AND EFFICACY. THE COMPANY’S BOARD AND MANAGEMENT HAVE EVERY CONFIDENCE THE MOMENTUM CAN, AND WILL BE, MAINTAINED.

I AM NOW VERY HAPPY TO INTRODUCE BIOTRON’S MANAGING DIRECTOR DR MICHELLE MILLER.

MICHAEL HOY CHAIRMAN

BIOTRON
LIMITED (ASX:BIT)

AGM 13
November
2014

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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.

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**Significant

Progress
During
Last
12
Months**

ACTIVITY		STATUS/OUTCOME
~~Phase~~ ~~2~~ ~~HIV/HCV~~ ~~co-infected~~ ~~trial~~		~~100%~~ ~~SVR12~~ ~~data~~ ~~reported~~ ~~for~~ ~~HIV/HCV~~ ~~G3~~
Phase 2a HIV trial		Impact on immune ac,va,on reported
Phase 2, three-month dosing HCV G1 & G3 t~~rial~~		Close to fully recruited; preliminary interim data an,cipated ~~1Q15~~
Development of BIT225 capsules		Improves delivery of BIT225, in a user friendly format suitable ~~for~~ ~~larger~~ ~~scale~~ ~~trials~~
Patent posi,on strengthened		Key patents for BIT225 and other compounds issued in the USA and other jurisdic,ons
Comple,on of $4 million capital raising		Fully underwrigen rights issue closed over-subscribed with no shorhall

**In

the
Media**

Biotron
shares
jump
on
trial
result

AAP
-­‐
March
2014

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Biotron’s
drug
eradicates
Hepa66s
C
in
coinfected
HIV
pa6ents
at
24
weeks ~~Proac,ve Investors – March 20~~ 14 Bi Biotron
in
HIV
success g
Biotron
Boost Northern
Territory
News Adver,ser
(Adelaide) Bi ~~otron Ltd BIT225 Reverses HIV-Induced the Immune~~ em ~~Impairment of Syst~~ BioSpace
/
ThePharmaLeger
/
Australian
Life
Scien,st
–
July
2014 Breakthrough
drives
Biotron
shares
surge Biotron
HIV
breakthrough Gold
Coast
Bulle,n
–
March
2014 Burnie
Advocate
–
July
2014 Biotron
shares
soar
on
HIV
drug
data

Slide
2

**In

the
Media**

Hep
C
pioneers
seeking
billions “…
Biotron
is
looking
for
a
major
partner
…” Hepa66s
C
cure
hope Biotron
shares
up
on
hep
C
cure
drug Weekend
Post
–
October
2014 Courier
Mail
–
October
2014 ~~C cure rate Biotron Biotron’s C cure Hep helps hope for hep~~ D ~~aily Telegraph – October 2014 Adver,ser (Adelaide) – October 2014~~ He p
C
Success
–
Drug
trial
results
send
Biotron
shares
soaring ~~Herlad Sun (Melbourne) – October 2014~~ ‘Cure’
boosts
Biotron Biotron
gets
boost
in
trial
on
hepaSSs Illawarra
Mercury
–
October
2014 Weekend
Gold
Coast
Bulle,n
–
October
20 Biotron
shares
soar
on
back
of
hepaSSs
C
trial
results

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Slide
3

• -­‐-­‐ First
  in
  class
  drug
  and
  new
  drug
  target
  for
  treatment
  of
  HIV
  and
  Hepa,,s
  C
  virus
  (HCV)
  Prepared
  based
  on
  above
  aner
  the
  August
  Board
  mee,ng - Seven
  clinical trials
  completed;
  one
  in
  progress
  Guided
  the
  wording
  of
  the
  prospectus
  dran
  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
4

-­‐ Over
180
pa,ents
and
healthy
volunteers
dosed
with
BIT225
to
date -­‐ Posi,ve
data
recorded
in
all
trials -­‐ 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
infecSon

-­‐ BIT225
increases
the
rate
at
which
HCV
is
cleared
(especially
for
GT3)

Slide
5

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

• Forecast
to
grow
to
over
$19bn
by
2016

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

• Es,mated
  3
  to
  5
  million
  pa,ents
  in
  US
  &
  30
  million
  pa,ents
  in
  China

• New
  drugs
  have
  demonstrated
  significant
  pricing
  power

• Gilead’s
  Sovaldi
  (Sofosbuvir)
  at
  US$84,000
  for
  a
  12
  week
  course

• Q1
  2014
  sales
  US$2.3
  bn;
  Q2
  2014
  sales
  US$3.5
  bn

• Recent
  new
  HCV
  drug
  combina,ons
  not
  op,mal

• 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
  acSvity
  against
  HCV
  G3

• Partnering
  s,ll
  ac,ve

• Merck
  bought
  Idenix
  for
  US$3.8
  bn
  in
  June
  14

Slide
7

**BIT225

–
First
of
a
New
Class
of
HCV
Drugs**

ü Novel,
oral,
small
molecule

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

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 Shown
  to
  be
  clinically
  ac,ve
  against
  hard-­‐to-­‐ treat
  HCV
  Gen
  1
  (1a
  and
  1b)
  and
  Gen
  3

• ü Poten,al
  to
  fill
  the
  gaps
  len
  by
  other
  HCV
  drugs, e.g.
  HCV
  G3

Slide
8

• :

• BIT225-­‐001

Phase
1a,
single
dose,
dose
escala,ng
study
in
healthy
volunteers
(48
subjects;
Aust)

• BIT225-­‐003:

Phase
1b,
7-­‐day,
repeat
dose
study
in
HCV+
pa,ents
(35
and
200
mg
BID;
18
subjects;
Aust)

• B ~~IT225-004:~~

• B ~~IT225-005 :~~

• B ~~IT225-006:~~

• B ~~IT225-007:~~

• BIT225-­‐008:

• ~~Phase 2a, 10-day, repeat dose study in HIV+ pa,ents (400 mg BID; 21 subjects; Thailand) Phase 2a, 28-day, repeat dose study in HCV G1 pa,ents in combina,on with PEG/RBV (20~~ 0
  and ~~400 mg BID; 24 pa,ents; Thailand)~~

~~Phase 2, 28-day, repeat dose, open label study in HIV/HCV G1 and 3 co-infected pa,ents~~ in ~~combina,on with PEG/RBV (300 mg BID; 12 pa,ents; Thailand)~~

~~Phase 1, BE/PK study in healthy volunteers, cross-over, single dose comparing capsule formula,on with exis,ng powder (400 mg BID; 12 subjects; Aust)~~

Phase
2,
3
month,
repeat
dose
study
in
HCV+
pa,ents
(G1
&
3)
in
combina,on
with
PEG/RBV ~~(200 mg BID; 60 subjects; Thailand) IN PROGRESS~~

NB
BIT225-­‐002
was
an ex
vivo study
of
BIT225
on
HIV-­‐infected
cells
isolated
from
HIV-­‐posiEve
paEents

**BIT225

-­‐
Clinical
AcSvity
in
HCV
and
HIV/HCV
PaSents**

BIT225-­‐005 (HCV G1) BIT225-­‐006 (HIV/HCV)

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

NB
All
paEents
were
stable
on
ART
before
BIT225
300
mg
BID
+
n=8
Placebo
+
IFN/RBV
IFN/RBV
IFN/RBV
IFN/RBV
–
n=4
and
throughout
the
study;
HIV
remained
HCV
Genotype
1
undetectable
during
the
treatment
period
BIT225
200
mg
BID
E ETVR
IFN/ No
n=8
+
IFN/RBV
V RBV
IFN/RBV
drug
IFN/RBV
R
IFN/RBV
BIT225
300
mg
BID
n=8
BIT225
400
mg
BID
+
IFN/RBV
HCV
Genotype
3
+
IFN/RBV
–
n=8
ETVR
SVR12
Week
4
12
48
Week
1
5
24
48
60
Median
log
%
Complete
EVR
%
ETVR
(<50
IU/
Treatment
reducSon
at
35
(<50
IU/ml
at
12
days
weeks)
ml
at
48
weeks)
Week
60
All
GT3
pa,ent
who
400
mg
BIT225
+
SOC
-­‐4.957
86
100
completed
treatment
are
200
mg
BIT225
+
SOC
-­‐4.351
88
88
HCV-­‐free
Placebo
+
SOC
-­‐3.649
63
75
(SVR12)
----- End of picture text -----

Slide
10

**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
  gen
  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
gen
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

• -­‐ IN
  PROGRESS
  (Thailand);
  Preliminary
  interim
  data
  expected
  1Q15

Slide
11

**HIV

–
Towards
a
Cure**

==> picture [309 x 254] intentionally omitted <==

• Infec,on
  rates
  in
  Australia
  are
  at
  20
  year
  high

Over
1.1
million
people
living
with
HIV
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
  pa,ents
  need
  to
  stay
  on
  an,retroviral
  drugs (ART)
  to
  keep
  virus
  levels
  under
  control

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

Slide
12

**BIT225

Targets
HIV
in
Reservoir
Cells**

• BIT225
  inhibits
  assembly
  and
  budding
  of
  new
  virus

• Phase
  2a
  trial
  (004)
  showed
  that
  BIT225
  can
  reduce
  HIV
  levels
  in
  macrophage
  cells in
  vivo , paralleling in
  vitro studies

• 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
Replica6on
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

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

• Treatment
  gaps
  remain

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

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

• Poten,al
  to
  fill
  significant
  HCV
  treatment
  gaps

  • HCV
    Genotype
    3

  • HIV/HCV
    co-­‐infected
    pa,ents

  • • Cirrho,c
    pa,ents

• Poten,al
  to
  eradicate
  important
  HIV
  reservoirs,
  plus
  may
  impact
  on
  HIV-­‐associated
  demen,a

• Flexibility
  to
  combine
  with
  any
  other
  HCV
  and
  HIV
  drug
  combina,ons

• • Significantly
  undervalued
  in
  comparison
  with
  other
  HCV
  companies

Slide
14

• Complete
  BIT225-­‐008
  HCV
  trial
  currently
  in
  progress

• ~~Preliminary interim data expected 1Q14~~

• Inves,ga,onal
  New
  Drug
  applica,on(s)
  (INDs)

• Engaged
  with
  FDA
  -­‐
  pre-­‐IND
  consulta,on
  HCV
  combina,on
  trial
  with
  DAA

• • Complete
  IND-­‐related
  ac,vi,es

  • Modeling
    of
    pharmacokine,c
    data
    from
    previous
    trials
    to
    determine
    op,mal
    BIT225 dose
    and
    frequency
    in
    IND
    trials

  • Addi,onal
    IND-­‐suppor,ng in
    vitro laboratory
    studies
    with
    BIT225

  • Drug-­‐drug
    interac,on
    studies

• File
  IND
  applica,on(s)

• Expand
  earlier
  stage
  drug
  programs
  e.g.
  Dengue
  virus
  when
  funding
  available

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

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

Slide
15

**BIT225

–
Progression
to
CommercialisaSon**

• ~~Strategy is guided by:~~

• Advisory
  panels
  of
  US-­‐based
  KOLs
  who
  are
  leaders
  of
  the
  field

• Interac,on
  and
  feedback
  from
  US
  healthcare
  analysts
  who
  specialise
  in
  an,viral
  space

• Interac,on
  and
  feedback
  from
  poten,al
  partners

• Biotron
  con,nues
  to
  engage
  with
  industry
  at
  different
  levels

• One-­‐on-­‐one
  mee,ngs

• Presenta,ons
  at
  US
  corporate
  healthcare
  events

• Presenta,on
  of
  key
  data
  at
  major
  medical/scien,fic
  conferences,
  including
  pres,gious late-­‐breaking
  sessions

• Expansion
  of
  commercialisa,on
  ac,vi,es
  an,cipated
  through
  2015
  on
  back
  of
  data
  from
  008 trial
  and
  IND
  filings

Slide
16

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ASX:BIT

Dr
Michelle
Miller Managing
Director +61
2
9805
0488 +61
412
313329 mmiller@biotron.com.au www.biotron.com.au

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