![]() ![]() ![]() Developing Unique Products for Autoimmune
Diseases and Cancer (NASDAQ: CNDO)
September 2013
Harlan F. Weisman, MD
Chairman and CEO
Exhibit 99.1 |
![]() ![]() ![]() ![]() ![]() ![]() Statements
in
this
presentation
that
are
not
descriptions
of
historical
facts
are
forward-looking
statements
within
the
meaning
of
the
safe
harbor
provisions
of
the
Private
Securities
Litigation
Reform
Act
of
1995.
We
have
attempted
to
identify
forward-looking
statements
by
terminology
including
anticipates,
believes,
can,
continue,
could,
estimates,
expects,
intends,
may,
plans,
potential,
predicts,
should,
or
will
or
the
negative
of
these
terms
or
other
comparable
terminology.
Forward-looking
statements
are
based
on
managements
current
expectations
and
are
subject
to
risks
and
uncertainties
that
could
negatively
affect
our
business,
operating
results,
financial
condition
and
stock
price.
Factors
that
could
cause
actual
results
to
differ
materially
from
those
currently
anticipated
risks
include
those
set
forth
in
our
SEC
filings
including,
in
particular,
risks
relating
to:
our
ability
to
attract,
integrate
and
retain
key
personnel;
the
results
of
research
and
development
activities;
uncertainties
relating
to
preclinical
and
clinical
testing,
financing
and
strategic
agreements
and
relationships;
the
early
stage
of
products
under
development;
our
need
for
substantial
additional
funds;
government
regulation;
patent
and
intellectual
property
matters;
our
ability
to
successfully
manufacture
TSO
in
the
US;
dependence
on
third
party
manufacturers;
and
competition.
We
expressly
disclaim
any
obligation
or
undertaking
to
update
or
revise
any
statements
contained
herein
to
reflect
any
change
in
our
expectations
or
any
changes
in
events,
conditions
or
circumstances
after
the
date
of
this
presentation.
Forward-Looking Statements
Forward-Looking Statements
2 |
![]() ![]() ![]() ![]() ![]() ![]() »
Two biologic product candidates in clinical
stage development -
Focused on autoimmune diseases and cancer immunotherapy
-
Strong proprietary position
»
Novel treatments with broad therapeutic applications
addressing multi-billion dollar markets
»
Four efficacy clinical trials completed and multiple additional trials
ongoing
-
TSO:
Trichuris suis
ova
(CNDO-201) in Crohns Disease, Ulcerative
Colitis (UC) and Multiple Sclerosis (MS)
-
CNDO-109:
Tumor Activated NK Cells
in relapsed Acute Myeloid
Leukemia (AML)
»
Experienced management team and board of directors
Value Proposition
Value Proposition
3 |
![]() ![]() ![]() ![]() ![]() ![]() TSO (Trichuris
suis ova or CNDO-201) Indication
Pre-Clinical
Phase 1
Phase 2a*
Phase 2
Phase 3
Crohns Disease
Ulcerative Colitis
Multiple Sclerosis
Autism
Psoriasis
Type-1 Diabetes
Psoriatic Arthritis
Rheumatoid Arthritis
CNDO-109 (Tumor-Activated Natural Killer Cells)
Acute Myeloid Leukemia
Multiple Myeloma
4
Coronado Pipeline Overview
Coronado Pipeline Overview
2H2013
* TSO Phase 2a studies being conducted as Investigator-Initiated
Studies; CNDO-109 Phase 2a AML study is a Phase 1/2 study Planned
2H2013
2H2013
2014
2H2013 |
![]() ![]() ![]() ![]() ![]() ![]() »
Porcine whipworm ova
-
Represents a novel approach to treating autoimmune diseases
the
Hygiene Hypothesis
-
Natural immunomodulator -
regulates T-Reg cells and inflammatory
cytokines
»
Clinical proof of principle established in Inflammatory Bowel
Disease and Multiple Sclerosis
»
Phase 2 studies ongoing in Crohns disease
»
Planned and ongoing studies in multiple additional autoimmune
indications
»
Natural properties suggest strong potential for a safe profile
»
North and South America and Japanese rights for all indications
TSO: Trichuris suis ova (CNDO-201)
TSO: Trichuris suis ova (CNDO-201)
5 |
![]() ![]() ![]() ![]() ![]() ![]() (adapted from Bach, NEJM, 2002)
6
Rapid Emergence of Autoimmune
Rapid Emergence of Autoimmune
and Immune Mediated Diseases
and Immune Mediated Diseases
»
There are >100 immune-
mediated diseases affecting
50 million Americans
»
Second highest cause of
chronic disease in United
States and number one
cause of morbidity in women
»
In contrast, most of these
diseases are rare in less
developed countries
Walsh SJ, Rau LM. Am J Public Health 2000
Faustman, D. Institute of Medicine Report, Womens Health Research:
Progress, Pitfalls, and Promise, 2010 |
![]() ![]() ![]() ![]() ![]() ![]() Epidemiological data demonstrate:
»
Various immunological and autoimmune diseases are much less common in
the developing world than the industrialized world
»
Immigrants to the industrialized world from the developing world
increasingly
develop immunological disorders in relation to the length of time since arrival
in the industrialized world
Distribution of Autoimmune Disorders
Distribution of Autoimmune Disorders
and Helminths
and Helminths
7
Autoimmune disorders incidence
Helminths infestation incidence |
![]() ![]() ![]() ![]() ![]() ![]() 8
Elliott & Weinstock, Ann NY AcadSci, 2012
The Biology Supporting the Hygiene
The Biology Supporting the Hygiene
Hypothesis
Hypothesis |
![]() ![]() ![]() ![]() ![]() ![]() »
Does not multiply in human host
»
Colonization is self-limited in
humans
»
No systemic phase
»
No direct transmission
»
Ova stable
»
Oral dosing; 1 tbsp solution
taken once every 2 weeks
-
Clear, odorless, tasteless
-
Ova are Microscopic
Benefits of Trichuris suis ova (TSO)
Benefits of Trichuris suis ova (TSO)
9 |
![]() ![]() ![]() ![]() ![]() ![]() Effect
of TSO in Crohns Disease Effect of TSO in Crohns Disease
10
75.9
62.1
79.3
72.4
Patients
and
Methods
29 CD patients with
CDAI>220 (mean=294)
Median duration of the
disease : 4 yrs
Baseline meds
5ASA, low
dose steroids, 6-MP or Aza,
washout of TNF
inhibitors
2500 TSO every 3 weeks for
24 weeks
Remission defined as a
CDAI of < 150 points
Response defined as a
CDAI > 100 point drop from
baseline
Summers, et.al., GUT2004 |
![]() ![]() ![]() ![]() ![]() ![]() Effect
of TSO in Ulcerative Colitis Effect of TSO in Ulcerative Colitis
11
50
40
30
20
10
0
p=0.04
16.7%
43.3%
Placebo
T. suis
Summers, et.al., Gastroenterology 2005
Patients
and
Methods
n = 54 UC patients with a
UCDAI score > 4 points
Average score 8.7-8.8
Duration of disease
averaged 8 years
2500 TSO every 2 weeks
for 3 months
Most patients refractory to
previous therapy
Response was defined as
> 4 point drop |
![]() ![]() ![]() ![]() ![]() ![]() »
12 week, dose ranging study
-
Double-blind, randomized,
placebo controlled
-
TSO 250, 2500, 7500 or placebo
-
N=240 (2
nd
interim)
-
Crohns patients
CDAI = 220-350
CRP 2X ULN or Calprotectin 1X
ULN
»
Outcome
Remission rates
»
2
nd
Interim
4Q 2013
TSO Phase 2 Crohns Disease Studies
TSO Phase 2 Crohns Disease Studies
12
TRUST -
I
TRUST -
II
»
12 week study
-
Double-blind, randomized,
placebo controlled
-
TSO 7500 or placebo
-
N=250
-
Crohns patients
CDAI = 220-450
Endoscopic evidence of
inflammation
»
Outcome
Response rates
»
Topline data
4Q 2013 |
![]() ![]() ![]() ![]() ![]() ![]() Impact
of Parasitic Infections on the Impact of Parasitic Infections on the
Course of Multiple Sclerosis
Course of Multiple Sclerosis
Correale J, Farez MF.
J Neuroimmunol. 2011;233:6
13 |
![]() ![]() ![]() ![]() ![]() ![]() Effect
of TSO in Multiple Sclerosis Effect of TSO in Multiple Sclerosis
Fleming, et.al., Multiple Sclerosis Journal 2011
14 |
![]() ![]() ![]() ![]() ![]() ![]() Indication
Pre-Clinical
Phase 1
Phase 2a*
Phase 2
Phase 3
Design
Crohns Disease
~500pts, DB, PC
Ulcerative Colitis
120 pt, DB, PC
Ulcerative Colitis (MOA)
18 pt, DB, PC
Multiple Sclerosis (US)
15 pt, SB
Multiple Sclerosis (EU)
50 pt, DB, PC
Autism
10 pt, DB, Cross
Autism
60 pt, DB, PC
Psoriasis
20 pt, OL
Type-1 Diabetes
36 pt, DB, PC
Early Intervention
Type-1 Diabetes
100 pt, DB, PC
Early intervention
Type-1 Diabetes
150 pt, DB, PC
Prevention
Psoriatic Arthritis
24 pt, DB, PC
Rheumatoid Arthritis
50 pt, DB, PC
15
TSO Pipeline
TSO Pipeline
* TSO Phase 2a studies being conducted
as Investigator-Initiated Studies
Planned
OL = Open-Label DB = Double-Blind
SB= Single-Blind PC = Placebo-Controlled
2H2013
Two phase 2 studies
2H2013
2H2013
2H2013
2H2013
2H2013
2H2013 |
![]() ![]() ![]() ![]() ![]() ![]() TSO
Manufacturing Process TSO Manufacturing Process
Certified specific pathogen-free minipigs
Observation and pathogen testing
Oral Inoculation with OVA from master bank
Development of infection
Harvest OVA from pigs
Isolation and purification
Processing and pathogen inactivation
API
Quality and pathogen testing
Incubation and sterilization
Formulation process
Fill/finish
DRUG Product
Quality and microbiological testing
16 |
![]() ![]() ![]() ![]() ![]() ![]() »
Three issued US patents entitled Use of Parasitic Biological Agents for
Prevention and Control of Autoimmune Disease
directed to compositions,
methods of producing compositions, and methods of autoimmune disease with
helminths
exp. 12/2018
»
Five additional pending patents
-
Use
of
Parasitic
Biological
Agents
for
Disease
Prevention
and
Control
-
directed
to
the
treatment
of
animals/man
with
a
Th1
or
Th2
mediated
autoimmune
disease
exp.
11/2023
-
Production
of
a
Viable,
Storable
Worm
Egg
Suspension
-
directed
to
a
process
for
preparation
of
TSO
using
an
acid
wash
-
exp.
3/2028
-
Method
for
Characterizing
the
Biological
Activity
of
Helminth
Eggs,
in
particular
Trichuris
Eggs
exp.
5/2029
-
Treatment
with
Helminths
directed
to
methods
of
treating
obesity
and
IBS
-
exp.
10/2029
-
Compositions
and
Methods
for
Treating
IBD
-
directed
to
a
method
of
treating
IBD
by
contacting
an
isolated
dendritic/macrophage
cell
with
a
helminth
exp.
~9/2032
* Expiration dates do not include any patent term extension
TSO Intellectual Property
TSO Intellectual Property
17 |
![]() ![]() ![]() ![]() ![]() ![]() Potential TSO Target
Indications
U.S./Japan
Prevalence
U.S./Japan Annual
Market Sales
(USD Mil)
Ulcerative Colitis
669,000
$1,300
Crohns Disease
534,000
$2,600
Multiple Sclerosis
485,000
$6,400
Sources:
Decision Resources 2012
The
mechanism
of
action
of
TSO
should,
if
approved,
allow
it
to
be
positioned
in
a
variety
of
autoimmune
disorders,
including
inflammatory
bowel
diseases
and
multiple
sclerosis
as
well
as
other
potential
disorders
such
as
rheumatoid
arthritis
and
psoriasis.
18
TSO Market Opportunity
TSO Market Opportunity |
![]() ![]() ![]() ![]() ![]() ![]() »
NK cells represent the key component of the bodys innate immune
surveillance system
»
Proof of principle established in patients with high-risk refractory or
relapsed acute myeloid leukemia (AML)
»
Activation with CNDO-109 does not require toxic cytokines or long-
term culture/expansion, and does not change NK cell phenotypes
»
Preclinical activity demonstrated in multiple myeloma, breast
cancer, prostate cancer and ovarian cancer
CNDO-109: Activated Natural Killer Cells
CNDO-109: Activated Natural Killer Cells
19 |
![]() ![]() ![]() ![]() ![]() ![]() »
Activated ex vivo by tumor cell
lysate (CNDO-109)
»
Effective from autologous or
allogeneic NK cell source
»
Uniquely positioned in patients
with minimal residual disease
»
Remains active after
freeze/thaw
CNDO-109 Mechanism of Action
CNDO-109 Mechanism of Action
20
Trigger
receptor
Trigger
receptor
Priming
receptor
Priming
receptor
Trigger
receptor
Priming
receptor
Resting
Donor NK
Primed
Donor NK
Priming
signal
CNDO-109
Trigger
ligand
Patients
tumor
Priming
Signal 1
Triggering
Signal 2
Primed
Donor NK
Serial Killer
Tumor lysis |
![]() ![]() ![]() ![]() ![]() ![]() »
Phase 1 investigator sponsored open-label trial
»
To determine the safety of infusion of allogeneic Tumor-activated
NK (TaNK) cells after low dose radiotherapy plus chemotherapy
in high-risk relapse or refractory AML patients
»
Enrolled 8 AML patients
-
5 in Complete Remission 2 or 3 (CR2 or CR3)
-
1 patient in partial relapse (PR)
»
3/5 experienced a longer CR than their previous CR, in addition
PR patient achieved CR
21
Kottaridis, et al., ASH 2011
CNDO-109 Phase 1 Study in AML
CNDO-109 Phase 1 Study in AML |
![]() ![]() ![]() ![]() ![]() ![]() »
Initiated Phase 1/2 allogeneic clinical trial for the treatment of
relapsed AML
»
Once the dose is selected, plan to initiate a randomized Phase 2
trial
-
Potential for regulatory approval with single randomized, controlled
clinical trial if data are clinically meaningful and statistically
persuasive »
Future autologous studies planned in other tumor types (including
multiple myeloma, breast, ovarian and prostate)
22
CNDO-109 Clinical Development
CNDO-109 Clinical Development |
![]() ![]() ![]() ![]() ![]() ![]() »
Core patent -
Method for activating natural killer cells by tumor
cell preparation in vitro
-
Issued in U.S. -
exp. 1/2029
-
Issued in Australia
exp. 3/2026
-
Pending in Europe, Canada, Japan and India
»
Patent pending -
Preserved Compositions of Activated NK Cells
and Methods of Using the Same
exp. 7/2030
»
Provisional application pending in the U.S. -
Compositions and
Methods for Treating Viral Infections
* Expiration dates do not include any patent term extension
CNDO-109 Intellectual Property
CNDO-109 Intellectual Property
23 |
![]() ![]() ![]() ![]() ![]() ![]() Potential CNDO-109
Target Indications
G7 Drug
Treatable
Population
G7 Market
Sales
(USD Mil)
Mortality
AML
43,500
$165
5 year mortality rate is 85-90% but varies by age
Multiple Myeloma
44,000
$2,870
Stage III: median survival of 29 months
Breast Cancer
494,000
$10,100
Stage IV: 5 year mortality rate is 76%
Ovarian
57,110
$424
Overall 5 year survival rate of 45%
Prostate
500,000
$4,000
Overall 5-year survival rate of +99%, but 2
leading cause of cancer deaths in men
G7 = U.S., U.K., Germany, France, Italy, Spain, Japan
Sources:
Decision Resources 2011/2012
If Coronado establishes the efficacy of CNDO-109 activated NK cells in the treatment of
AML, Coronado believes the market opportunity for CNDO-109 activated NK cell therapy
is large due to the fact that many types of tumors are sensitive
to killing by activated NK
cells.
24
CNDO-109 Market Opportunity
CNDO-109 Market Opportunity
nd |
![]() ![]() ![]() ![]() ![]() ![]() Harlan
F. Weisman, MD Chairman and Chief Executive Officer
»
Company Group Chairman, Research & Development for
Pharmaceuticals at JNJ
»
President of Research & Development at Centocor
»
Over 20 years of pharmaceutical/biotechnology experience
Noah D. Beerman
EVP & Chief Operating Officer
»
President & CEO of RXi Pharmaceuticals
»
Over 25 years of pharmaceutical/biotechnology experience
Karin Hehenberger, MD, PhD
EVP of Scientific Affairs
»
Senior positions at private and public investment firms and as an
executive at Eyetech, JNJ and JDRF
»
MD and PhD from Karolinska, postdoc at Harvard medical school
Key Management and Board Members
Key Management and Board Members
25
Lucy Lu, MD
EVP & Chief Financial Officer
»
Senior Analyst at Citi Investment Research
»
Over 10 years of biotech equity research experience
George C. Avgerinos, PhD
Sr. VP, Biologics Operations
»
Divisional VP, Global Process and Manufacturing Sciences, Abbvie
»
Over 30 years experience in biopharmaceutical process development
including Humira
process and manufacturing
Eric K. Rowinsky, MD
Vice Chairman
»
World renown oncologist, former CMO at ImClone, board of
Biogen/Idec
»
Over 25 years of healthcare experience
Lindsay Rosenwald, MD
Director and Founder
»
A
prolific
and
successful
investor
in
the
life
sciences
industry
for
over
20
years |
![]() ![]() ![]() ![]() ![]() ![]() Financials
Financials
26
Listed on NASDAQ: CNDO
Market Cap as of 8/28/2013
~$275M
Shares Outstanding
33.9M
-
Additional 5.2M options and warrants
Cash Position as of 6/30/2013
$67.9M
-
Additional $35.9M from ATM through 8/28/13 |
![]() ![]() ![]() ![]() ![]() ![]() TSO
Initiate Multiple Investigator Initiated Studies
2H 2013
TRUST-II (Falk) Crohns study 2nd Interim Results
4Q 2013
TRUST-I (CNDO) Crohns study Topline Results
4Q 2013
CNDO-109
Initiate Multiple Myeloma Study
2014
Anticipated Upcoming Milestones
Anticipated Upcoming Milestones
27 |
![]() ![]() ![]() ![]() ![]() ![]() »
Two biologic product candidates in clinical
stage development -
Focused on autoimmune diseases and cancer immunotherapy
-
Strong proprietary position
»
Novel treatments with broad therapeutic applications
addressing multi-billion dollar markets
»
Four efficacy clinical trials completed and multiple additional trials
ongoing
-
TSO:
Trichuris suis
ova (CNDO-201) in Crohns Disease, Ulcerative
Colitis (UC) and Multiple Sclerosis (MS)
-
CNDO-109:
Tumor Activated NK Cells in relapsed Acute Myeloid
Leukemia (AML)
»
Experienced management team and board of directors
Investment Highlights
Investment Highlights
28 |