BIOTRON LIMITED — AGM Information 2015

Nov 23, 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

24 November 2015

The Manager Companies ASX Limited 20 Bridge Street SYDNEY NSW 2000

(16 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 11.30 am.

Yours faithfully

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Peter J. Nightingale Company Secretary

pjn8300

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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

24 November 2015

My Fellow Shareholders

CHAIRMAN’S ADDRESS TO THE AGM

As you are aware, Biotron’s clinical programs focus on HIV, Hepatitis C and HIV/Hepatitis C in co-infected patients - very large, competitive and compelling markets.

I am happy to report that since the last time we met, Biotron has continued to make significant progress. The Company has completed a Phase II clinical trial for HIV/Hepatitis C co-infected patients. It was our sixth successful clinical trial, convincingly demonstrating the efficacy and safety of our lead compound, BIT225.

The Company has also completed the enrolment of a long term Phase II clinical Hepatitis C trial for Genotype 1 and Genotype 3 patients. It is this trial to which I would like to turn my full attention this morning.

The trial is yet to be completed. As you are no doubt aware, preliminary data on one part of the trial were recently made public. Let me, as plainly as possible, clear up a few misconceptions.

• Data to hand give us sound cause for optimism.

• At no time was any consideration given to stopping the trial.

• Any safety issue which has arisen with patients during the trial, in fact across all of the Company’s clinical trials, has shown, on subsequent analysis, to be unremarkable.

• Hepatitis C patients, for the first time, received the drug in capsule form, not powder. This delivered greater impact than was planned. Not totally unexpected but, in fact, a positive, in that it provides even more confidence that BIT225 is acceptably safe and tolerable. In future, patients may need to take the drug only once daily, not twice.

• Some patients were withdrawn during the trial. For various reasons, largely inexplicable, this caused concern to some stock market commentators. The simple fact is, it happens. Clinical trials do not provide perfect outcomes for all patients at all times. The patients are, by necessity, very sick. Every effort is made to ensure a patient’s well-being and the safety of a drug is the prime consideration in any trial. We are, after all, making a serious effort to save lives.

The Company’s CEO, Dr Michelle Miller, will deal with technical details but, be assured, detailed analyses to date have indicated no significant safety concern across any of the clinical trials.

• The crucial benefit, widely overlooked, is the importance of successful long term dosing to furthering the Company’s Hepatitis C and HIV programs. This has been achieved.

• The trial is expected to end early in the New Year. At this stage, I should say, we have no reason to believe the outcome will be other than positive.

• Most importantly, Biotron’s strategy is unchanged.

The markets on which we’re focused are massive. Hepatitis C treatment costs are tipped to reach $19 billion a year by the end of the decade. The HIV market has already reached $12 billion a year and, despite claims to the contrary, is growing.

Biotron Directors understand the requirements of all stakeholders.

We operate in a complex, competitive and confusing arena where simple explanations are not always easy to provide. This is not a sprint; more a conservative, careful, consistent commitment to delivering long term results.

Our strategy is clearly defined and your Directors remain confident that the Company is on the right pathway towards a positive medical and commercial outcome.

I sincerely thank my fellow Directors and all members of Biotron management and staff for their commitment, dedication and performance over the past 12 months.

I would now like to invite our CEO, Michelle Miller, to address the meeting.

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Michael Hoy Chairman

BIOTRON
LIMITED (ASX:BIT)

AGM 24
November,
2015

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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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• Leader
  in
  developing
  viroporin
  inhibitors
  for
  the
  treatment
  of
  viral
  infec,ons

• Viroporin
  targets
  include
  influenza
  (M2),
  HIV-­‐1
  (Vpu),
  Hep
  C
  (p7),
  Dengue
  (M
  ),
  SARS
  (E),
  RSV
  (SH) and
  others

  • Crucial
    for
    viral
    pathogenesis

• Rapid
  proprietary
  primary
  bacterial
  cell-­‐based
  screening
  assays

• • Designed
  library
  of
  compounds
  to
  target
  these
  viroporins

• Pipeline
  of
  internally-­‐generated,
  first-­‐in-­‐class
  small
  molecule
  viroporin
  inhibitors
  for
  key
  markets • BIT225
  derived
  from
  Biotron’s
  compound
  library

• Demonstrated
  clinical
  ac,vity
  against
  HIV-­‐1,
  and
  HCV
  G1
  and
  GT3

• • Focused
  on
  clinical
  development
  of
  BIT225,
  but
  next
  genera,on
  inhibitor
  is
  ready
  to
  progress
  to
  IND-­‐ enabling
  studies

BIT225
demonstrates
that
Biotron’s
viroporin-­‐targeJng
approach
to
drug
development
works

CONFIDENTIAL

**Biotron’s

Core
Technology
&
Pipeline**

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Designed
library
of
compounds
to Compounds
screened
in target viroporins : proprietary
assay
set
up
for OTHER
“HITS”
IN
LIBRARY
include: each
virus
target
e.g.
HIV-­‐1 **IniJally

250
compounds
designed Vpu;
HCV
p7;
Influenza
M2; and
synthesised;
library
now
~350 Dengue M; Coronavirus E. -­‐ Influenza
A
and
B -­‐ Coronaviruses ~~-~~ ~~Including SARS~~ VIROPORINS Hits
tested
against ~~-~~ ~~Epstein-Barr virus (EBV)~~ -­‐
New
class
of
viral
proteins ~~virus~~ cultures ~~in cell~~ DENGUE
– -­‐ HepaJJs
B
virus
(HBV) -­‐
Key ~~roles in produc,on and~~ ~~Several~~ release of infec,ous virus compounds Lead ~~with~~ op,misa,on promising BIT225
is
a
representaJon
of and
selec,on anJviral acJvity the
value
that
resides
within Biotron’s
core
experJse 10,
563-­‐574
(2012) BIT314
(HCV)**

BIT225
(HIV-­‐1
and
HCV)

Slide
2

-­‐ Over
200
pa,ents
and
healthy
volunteers
dosed
with
BIT225
to
date

-­‐ Promising
clinical
efficacy
against
HIV-­‐1
and
HCV -­‐ 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 w~~ ith ~~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)

-­‐ Patent
posi,on
over
compound
and
its
uses -­‐ Compound
is
rela,vely
easy
to
make
and
very
stable

Slide
3

• Aim
  has
  been
  to
  generate
  data
  for
  posi,oning
  of
  BIT225
  for
  partnerships

• Focus
  has
  been
  on:

• Defining
  genotype
  ac,vity in
  vitro and in
  vivo

• Genera,ng
  pharmacokine,c
  (PK)
  data
  on
  BIT225

• Genera,ng
  suppor,ng
  toxicology
  and
  non-­‐clinical
  data
  package

• GeneraJng
  safety
  data
  to
  support
  combinaJon
  trials
  with
  other
  HCV
  drugs

• As
  a
  result,
  a
  solid,
  IND-­‐suppor,ng
  data
  package
  for
  BIT225
  has
  been
  generated

The
BIT225-­‐008
(3-­‐month
dosing
trial)
was
central
to
providing
essenJal
safety
and
PK
data Focus
is
on
partnering
the
HCV
program
for
combinaJon
trials

Slide
4

• Preliminary
  data
  from
  HCV
  GT3
  cohort:

• Response
  to
  IFN/RBV
  was
  much
  higher
  than
  historical
  controls
  had
  indicated

  • Rates
    influenced
    by
    age,
    gender,
    liver
    damage,
    gene,cs,
    etc

  • High
    SVR12
    rate
    in
    control
    arm
    means
    cannot
    show
    a
    BIT225
    effect

• BUT
  we
  have
  data
  demonstra,ng
  pan-­‐genotypic in
  vitro ac,vity
  plus
  005
  and
  006
  trial
  data

• GT1
  SVR12
  data
  is
  due
  in
  1Q16

• Prime
  aim
  of
  the
  trial:

  • Now
    have
    safety
    data
    with
    the
    new
    capsule
    formulaJon
    out
    to
    12
    week
    dosing

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

BIT225
remains
a
promising
new
anJviral
drug
for
HIV
and
HCV
infecJons

Slide
5

**HIV-­‐1

–
Towards
a
Cure**

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

• 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
  (cART)
  to
  keep
  virus
  levels
  under
  control

• Despite
  reducing
  viral
  loads,
  cART
  does
  not
  fully restore
  health

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

Slide
6

**BIT225

Targets
HIV-­‐1
in
Reservoir
Cells**

• BIT225
  inhibits
  assembly
  and
  budding
  of
  new
  virus

• Phase
  2a
  trial
  (BIT225-­‐004)
  showed
  that
  BIT225
  can
  reduce
  HIV-­‐1
  levels
  in
  macrophage
  cells in
  vivo ,
  paralleling in vitro studies

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

• PotenJal
  for
  use
  in
  future
  virus
  eradicaJon
  treatment

• Progressing
  to
  pivotal
  Phase
  2
  HIV
  trial
  in
  2016

• Aim
  is
  to
  demonstrate
  clinical
  benefit
  to
  ajract
  a
  partner

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A
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B
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The
non-­‐clinical
and
clinical safety/PK
package
generated
in the
HCV
program
supports
the HIV
program
for
BIT225

(A)
Untreated
Controls (B)
BIT225
treated
cells

Slide
7

• Renewed
  interest
  in
  targe,ng
  viral
  diseases
  including

• Respiratory
  syncy,al
  virus
  (RSV)

• • Influenza
    (in
    par,cular
    drug
    resistant
    strains)

• Hepa,,s
  B
  virus

• Tropical
  diseases
  including
  Dengue

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

• Aim
  -­‐
  demonstrate
  u,lity
  of
  Biotron’s
  drug
  development
  approach

• Genera,ng
  ac,vity
  “heat
  map”
  of
  compound
  library

• Characterising
  ac,vity
  against
  key
  viruses
  of
  interest

• Fund
  as
  much
  as
  possible
  with
  non-­‐equity
  capital

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

Slide
8

**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

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• No
  approved
  Dengue-­‐specific
  therapeu,c

• Vaccine
  trials
  have
  had
  disappoin,ng
  results

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

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

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www.sciencenews.org
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Slide
9

• 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

  • Main
    focus
    is
    HCV
    Genotype
    3

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

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

• Unique
  core
  exper,se
  against
  novel
  viral
  targets

• Poten,al
  within
  compound
  library
  for
  significant
  other
  viral
  infec,ons

Slide
10

• ~~Complete BIT225-008 HCV trial currently in progress~~

• 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
  trial
  to
  commence
  in
  1H16

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

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

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

Slide
11