Immuron - New Investor Corporate Presentation (May 2017)
Released
Released
Announcement PDF
www.immuron.com
Immuron Limited
Developing Unique Oral Immunotherapies
that Fundamentally Change the Paradigms
of Care
May 2017
ASX:IMC
Forward Looking Statement
Certain statements made in this presentation are forward-looking statements
and are based on Immuron’s current expectations, estimates and projections.
Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,”
“estimates,” “guidance” and similar expressions are intended to identify
forward-looking statements.
Although Immuron believes the forward-looking statements are based on
reasonable assumptions, they are subject to certain risks and uncertainties,
some of which are beyond Immuron’s control, including those risks or
uncertainties inherent in the process of both developing and commercializing
technology. As a result, actual results could materially differ from those
expressed or forecasted in the forward-looking statements.
The forward-looking statements made in this presentation relate only to events
as of the date on which the statements are made. Immuron will not undertake
any obligation to release publicly any revisions or updates to these forwardlooking statements to reflect events, circumstances or unanticipated events
occurring after the date of this presentation except as required by law or by
any appropriate regulatory authority.
Free Writing Prospectus Statements
Immuron Limited (ASX:IMC)
This presentation contains a “free writing prospectus,” or a portion thereof, required to be
filed by us with the Commission or retained by us pursuant to Rule 433 under the
Securities Act of 1933, as amended, or the Act.
This presentation highlights basic information about us and the offering. Because it is a
summary, it does not contain all the information you should consider before investing.
We have filed a registration statement (including a prospectus) with the SEC for the
offering to which this presentation relates. The registration statement has not yet become
effective. Before you invest, you should read the prospectus in the registration statement
(including the risk factors described therein) and other documents we have filed with the
SEC for more complete information about us and the offering. You may get these
documents for free by visiting EDGAR on the SEC website at http://www.sec.gov. The
preliminary prospectus, dated May 5, 2017, is available on the SEC website at
http://www.sec.gov. Alternatively, we or any underwriter participating in the offering will
arrange to send you the prospectus if you contact Joseph Gunnar & Co., LLC. Attention:
Prospectus Department, 30 Broad Street, 11th Floor, New York, NY 10004. Telephone:
888-248-6627, E-mail: prospectus@jgunnar.com.
3
Offering Summary
Immuron Limited (ASX:IMC)
Offering
Size
US$8,750,000
o f
American
Depository
Shares
(ADSs)
and
Warrants
Ordinary
Shares
are
listed
o n
the
ASX
u nder
the
symbol
IMC
Exchange/Ticker
Applied
to
list
the
ADSs
and
Warrants
o n
the
NASDAQ
Capital
Market
u nder
the
s ymbols
“IMRN”
and
“IMRNW”,
respectively
Warrants
Offered
50%
Warrant
coverage.
Each
Warrant
will
have
an
estimated
p er
ADS
exercise
price
o f
125%
of
the
p er
ADS
p ublic
o ffering
p rice,
will
be
exercisable
immediately
and
will
expire
five
years
from
the
d ate
o f
issuance.
Use
of
P roceeds
Clinical
development
o f
IMM-‐124E
(fatty
liver),
IMM-‐529
(C.
difficile)
and
o ther
general
corporate
p urposes
Joint
Book-‐Runners
Joseph
Gunnar
&
Co.
and
Rodman
&
Renshaw,
a
u nit
o f
H.C.
Wainwright
&
Co.
Co-‐Manager
WallachBeth Capital,
LLC
4
Investment Highlights
• Clinical
stage
biopharmaceutical
company
targeting
inflammatory-‐mediated
and
infectious
diseases
with
oral
immunotherapies
• Lead
program,
IMM-‐124E,
in
Phase
2
development
for
the
treatment
of
multiple
high
value
indications,
including
NASH,
ASH
and
Pediatric NAFLD
- NASH
Phase
2
interim
data
expected
3Q
2017
with
topline
results
expected
4Q
2017
- National
Institutes
of
Health
(NIH)
funding
Phase
2
studies
in
ASH
and
pediatric NAFLD
• IMM-‐529,
biologic
with
unique
triple
mechanism
of
action
for
treatment
of
C.
difficile
expected
to
commence
Phase
1/2
study
in
2Q
2017
• Well
positioned
to
address
high
unmet
medical
need
in
multiple
blockbuster
markets
• High-‐value
peer
licensing
deals
and
M&A
underscore
potential
upside
• Company
plans
to
uplist
to
NASDAQ
in
2Q
2017
• Experienced Management
Team
and
strong
support
from
leading
KOLs
and
institutions
(NIH,
DoD)
5
Experienced Management Team
Thomas Liquard
Chief Executive Officer
Dan Peres, MD
Chief Medical Officer
Mr. Liquard spent the majority of his career at
Pfizer in New York in various commercial
leadership positions, and was also COO,
then CEO, of Alchemia Limited, an oncology
ASX biotech company.
Dr. Peres, a surgeon by training, has deep
experience in liver diseases and clinical
development, including NASH, having
worked for leading Medical Devices and
Pharma companies since 2008.
Jerry Kanellos, PhD
COO & Scientific Officer
Reza Moussakhani
Manufacturing Quality Director
Dr. Kanellos has over 20 years of experience
in the pharmaceutical and biotech industries
including CMC, operations and BD. He has
held senior roles at CSL and Transbio
Limited.
Mr. Moussakhani has extensive experience
in implementation of project/quality and
process improvements, including with
Hospira and Sigma Pharmaceuticals.
6
Prominent Scientific Advisory Board and
Leading Research Partners
Advisory Board
Dr. Arun Sanyal (MD)
University of Virginia
Dr. Stephen Harrison (MD)
San Antonio Military Medical Center
Brooke US Army Medical Center
Former President of the
AASLD. Current Chair of the
Liver Study Section at the NIH.
IMM-124E lead PI.
Internationally renowned expert
in NASH. Lead PI of Galectin’s
GR-MD-02’s Phase 2 trial.
Dr. Gerhard Rogler (MD, PhD)
Zurich University
Dr. Miriam Vos (MD)
Emory University
Dr. Dena Lyras (PhD)
Monash University
Professor Rogler is a leader in
the field of colitis and has
authored more than 200
original peer-reviewed articles.
Dr. Vos specializes in the
treatment of gastrointestinal
disease in children, as well as
fatty liver disease and obesity.
Dr. Lyras is one of the world’s
leading experts in C. difficile.
Organizations
7
Dr. Manal Abdelmalek (MD)
Duke University Medical Center
Dr. Abdelmalek is a leading
investigator in the field of
NASH.
Oral Immunotherapy: Scalable, Disruptive
Technology
1
2
3
Vaccines Are
Developed
Antibodies Are Harvested
from Colostrum
Broad Therapeutic Effect
Antigen Specific
Antibodies
(IgG and IgG1)
+
Induction of
regulatory
T-cells
•
Reduced gut and blood pathogens
responsible for initiating
inflammation
+
•
Reduces systemic inflammation
•
Lowers organ injury
Clearance of
Targeted GUT
Pathogens
•
Not associated with general
immune suppression
•
Generally Regarded as Safe
(GRAS)
Adjuvants
• Platform capable of spawning multiple drugs à Long-term value creation
Competitive
Advantage
• Regulated as biologics by the FDA à 12 years exclusivity in the US for each approval
• Significant hurdles to generic biosimilar entry à No pharmacokinetic baseline; Mixture
(e.g., Copaxone)
• Safety established à Generally Regarded As Safe (GRAS)
8
Immuron’s Clinical Programs
Multiple Near-Term Inflection Points
Program
Indications
Development
Stage
Pre-‐Clinical
Phase
1
Phase
2
Phase
3
Program
H ighlights
Anti-‐Inflammatory
Programs
IMM-‐124E
NASH
-‐ Interim
data
expected
3Q
2017
-‐ Topline
results
expected
4Q
2017
IMM-‐124E
ASH
-‐ NIH
F unded;
UVA
-‐ Topline
results
expected
2018
IMM-‐124E
Pediatric
NAFLD
-‐ NIH
F unded;
Emory
University
-‐ Topline
results
expected
1H
2018
IMM-‐124E
Colitis
Collaboration
Univ. of
Zurich;
Pre-‐
clinical
acute
studies
positive
(04/17)
IMM-‐124E
Autism
Childrens Research
Institute,
La
Trobe
&
RMIT
Universities
Anti-‐Infective
Programs
IMM-‐529
C.
difficile
Phase
1/2
Expected
to
start
2Q
2017
IMM-‐124E
/
Shigella
Vaccine
Shigella
Infections
Collaboration
with
US
Army
IMM-‐124E
Campylobacter;
ETEC
Infections
Collaboration
with
US
Navy
9
IMM-124E
Revolutionary Treatment for NASH
NASH (Non-Alcoholic Fatty Liver)
Pathophysiology
NASH – Pathophysiology
• Blood derived antigens
(including circulating
LPS) determines
tolerance vs.
inflammation
• Kupffer cells play a key
role in liver inflammation
and fibrosis
• Tregs hold a key role in
tolerance (homeostasis)
• Much like hepatic
tolerance the gut
immune system can
promote antiinflammatory effect
Source: Adapted from Cohen-Naftaly; Scott L. Friedman, 2011
11
IMM-124E in NASH (Non-Alcoholic Fatty Liver)
• Broad anti-inflammatory mechanism of action
- Targeted LPS antibodies
- Upstream Effect: LPS-TLR4 pathway
- Downstream: Anti-inflammatory through both innate and adaptive immune
systems (e.g., the induction of regulatory T-cells to control and inhibit excess
inflammation)
• Strong anti-fibrotic effect demonstrated with CCl4 model
• Unique competitive profile due to safety/MOA:
- Addresses multi-factorial nature of NASH
- Potential for broad combination use
- Safety profile supporting of long-term chronic use
- Potential to expand to mild/moderate populations
• Market exclusivity (biologics; high barriers to generic biosimilar entry)
12
IMM-124E – Uniquely Positioned to Address
Large Unmet Need of $35B Market (2030)
NAFLD
Up to 145M People
F0
• No regulatory
pathway currently
exists for NAFLD
NASH
Cirrhosis
25M People
1.2M people
F1
F2
17M People
• Up to 50% of the
US population are
thought to have
NAFLD
F4
8M People
Intercept (OCA)
Tobira (CCR2/CCR5)
Galmed (Aramchol)
Genfit (Elafibranor)
• Drug would need to
be extremely safe to
be considered for
trial / approval
• NAFLD not
available to current
competitors due to
safety profile
F3
Galectin (GR-MD-02)
IMM-124E
• Only asset in development that, due to its safety profile:
- Can potentially target all spectrum of the disease including mild/moderate patients
- Likely can be used in combination with any other agents currently in development
- No safety concerns to date that could limit chronic / long-term use
13
IMM-124E: Fatty-Liver Portfolio – 3 Phase 2
Trials
Three Ongoing Phase 2 Programs: NASH, ASH and Pediatric NAFLD
• Lead Principal Investigator: Arun Sanyal; Former President of AASLD (American Association for the Study
of Liver Diseases) and current Chair of the Liver Study Section at the NIH (National Institute of Health)
• Multi-center, double-blinded, placebo controlled trial; 25 sites running in US, Australia and Israel
NASH
• Fully recruited: 134 patients with biopsy proven NASH
• Primary endpoint: changes in liver fat content confirmed by MRI; changes in ALT (liver enzymes)
• 3 arms: placebo, high dose and low dose
• Timing: topline results expected by 4Q 2017
• NIH funded; sponsored by University of Virginia
ASH
• Expected enrollment: 66 patients
• Endpoint: ALT
• Timing: topline results expected in 2018
• NIH funded; sponsored by Emory University
Pediatric
NAFLD
• Expected enrollment: 40 patients
• Endpoint: ALT; 3 months treatment
• Timing: topline results expected in 1H 2018
14
IMM-124E – Summary of Data
Prevention of Fibrosis and Improvement in Metabolic/Inflammatory Markers
CCl4 Fibrosis
Studies
Ob-Ob Mice
Phase 1/2
Clinical Studies
• Carbon-Tetrachloride (CCl4) a non-disease related fibrosis model
• Aim: To demonstrate effects of IMM-124E on Fibrosis caused by Intraperitoneal CCl4
• Results:
- Marked reduction in Liver Fibrosis and Inflammation on Histology
- Marked reduction on Liver Damage markers (i.e. ALT, Bilirubin etc.)
- Marked reduction in Liver Activated Macrophages (F4/80 high)
• Model represents the Metabolic syndrome
• Aim: To demonstrate the effect of IMM-124E or anti-LPS IgG (derived from IMM-124E)
• Results:
- Anti-LPS IgG considerable reduces ALT level
- Improved metabolic status for IG and IMM-124E treated mice (i.e. TG, Fasting
Glucose and OGTT)
- Anti-inflammatory shift: Decreased TNF-α and increase splenic NKT cells
• Aim: To show safety and efficacy of IMM-124E Biopsy Proven NASH Patients
• Population: 10 subjects with biopsy proven NASH and Type 2 Diabetes
• Results:
- Improved Metabolic status (e.g. HbA1c, HOMA OGTT) GLP1 and Adiponectin
- Improved Liver status (e.g. ALT)
- Proof of concept: increase in Circulatory Regulatory T-Cell
15
IMM-124E in NASH (Non-Alcoholic Fatty Liver)
Liver:
• Activated Kupffer cells ↓
(F4/80 macrophages)
IMM-124E
• Fibrosis and inflammation ↓
Gut:
Serum:
• Insulin resistance ↓
• Intestinal LPS ↓
• Circulating LPS ↓
• Intestinal permeability ↓
• TGF-β ↑
• Tolerance – Activation of
innate system to suppress
inflammation (NKT, DC,
macrophages)
• TNF-α ↓
• IL-2, IL-6, IL-10, IL-12
• Treg ↑ (CD4, CD25, FoxP3)
16
Animal Models: IMM-124E Improves Fibrosis
and Inflammatory Markers
Decrease Portal Inflammation
Improved Metavir Fibrosis Score
Group A:
Control
Group B: Naïve
anti LPS
Group A:
Control
Group B: Naïve
anti LPS
Group C:
Treated
Group D:
Treated
Group C:
Treated
Group D:
Treated
3
4
*p<0.02
^^ p<0.01
2.4
2.5
3.5
3.4
*p<0.0009
^^ p<0.0003
3
2
2.5
1.4
1.33
1.5
1.8
2
0.66
1
1.5
1
1
0.5
0.5
0
0
0
A
B
Mizrahi M. 2013, AASLD; Hepatology 751A
C
D
A
17
B
C
D
Animal Models: Macroscopy – Prevents Fibrosis
IMM-124E Treated
Liver
Fibrotic Liver
CCl4 (carbon tetrachloride)
CCl4 (carbon tetrachloride)
IMM-124E
Treatment with IMM-124E Prevents Fibrosis and Inflammation
Mizrahi M. 2013, AASLD; Hepatology 751A
18
Suppression of F4/80High Macrophages
Marked Reduction in Liver Activated Macrophages (F4/80 high)
19
Phase 1/2: Improves Liver Function and
Reduces Insulin Resistance
Results of a Phase 1/2a clinical trial; N=10
30 Days Treatment Endpoint Met; NO SAFETY ISSUES REPORTED
Improved Liver Enzymes
Improved HBA1C, OGTT and HOMA
Improved Metabolic Status (e.g. HbA1c,
HOMA OGTT) GLP1, and Adiponectin
and Liver Function (e.g. ALT)
Mizrahi M, J Inflamm Res. 2012;5:141-50
20
Phase 1/2: Improves Inflammatory Biomarkers
Increased CD4+CD25+FOXP3+ TREGS
Day 1
Increased GLP1 and Adiponectin
Day 30
Proof of Concept:
Increase in Circulatory
Regulatory T-Cell
Mizrahi M. J Inflamm Res. 2012
21
IMM-124E Key Milestones
3Q
2017
4Q
2017
2018
• NASH Phase 2 interim
analysis
• NASH Phase 2 Topline
Results
• NASH-centric transaction
after NASH Phase 2
• Results of MOA studies:
• Results of MOA studies:
• Pediatric NAFLD Phase 2
topline results
- SanyalBio
- Duke
• ASH Phase 2 topline results
• Results of colitis pre-clinical studies:
2017/2018
22
IMM-529
Neutralizing Clostridium difficile, but Sparing the
Microbiome
IMM-529 in Clostridium difficile Infection (CDI)
• Biologic with unique triple mechanism of action
- Antibodies neutralize the toxin B, the spores and the vegetative cells
• Potential to redefine the standard-of-care (SOC) therapy for CDI
- Current antibiotic treatments exacerbate recurrence
- IMM-529 stops virulence, without impacting the microbiome
- Compelling data in all three phases of the disease including (1) prevention of primary
disease, (2) treatment of primary disease and (3) prevention of recurrence
- Orally administrated, safe
• >70% survival rate in CDI mice treated with IMM-529 vs. <7% survival rate
in control groups
• Potential orphan disease designation; potential breakthrough / fast track
designations
• Market exclusivity (biologics; high barriers to generic biosimilar entry)
24
IMM-529 for the Treatment of CDI
Market
Opportunity
• Therapeutic market is expected to grow from $356.3 million in 2014 to over $1.5 billion
by 2024 – CAGR 15%
• Nearly 30,000 patients die each year from C. difficile infections (US)
• Potential orphan disease (7 years market exclusivity and premium pricing)
• Vancomycin and metronidazole are the current standard of care, accounting for 80% of
patient share (US)
Unmet Need
• However, therapies are plagued by significant CDI recurrences (1st relapse: 25%; 2nd:
40%; 3rd: 50%) underscoring need for new treatments
• There is also growing resistance to vancomycin treatment
• Highly differentiated – Neutralizes C. difficile but does not impact microbiome
IMM-529
Positioning
• Only asset that targets not only toxin B but also the spores and the vegetative cells
responsible for recurrence
• Can be used in combination with standard of care
• Targets many isolates
Sources: GlobalData, Decision Resources, CDC
25
Triple Action MOA
Neutralizing C. difficile; Sparing the Microbiome
Spores – Infectious Particles
IMM-529 antibodies bind to
multiple epitopes on surface
antigens on spores and
prevent adherence to host
cells and limit germination.
Heat, ethanol and UV
resistant. Survive gastric acid,
adhere to cells in the colon
and germinate.
1
Vegetative Cells
IMM-529 antibodies bind to
multiple epitopes on the
surface layer proteins (SLP)
on vegetative cells and limit
colonization.
Fimbriae and other surface
layer proteins (SLP) contribute
to bacterial colonization.
Fimbriae are used to adhere to
other bacteria and to host cells
and is one of the primary
mechanisms of virulence
Toxin B
IMM-529 antibodies bind to
multiple epitopes effectively
neutralize toxin B, inhibiting toxin
mediated epithelial cell apoptosis
and limit toxin translocation into
the systemic circulation and
inflammatory cascades.
Toxin B is essential for
virulence. Toxin B disrupt the
cytoskeleton and tight
junctions of intestinal epithelial
cells.
26
2
3
S u r v iv a l
100
Demonstrated ~70%
survival rate without
use of antibiotics vs.
0% for control group
P e r c e n t s u r v iv a l
U n in f e c t e d , N o t r e a t m e n t
In f e c t e d , N o t r e a t m e n t
80
In fe c t e d , N o n - im m u n e Ig G t r e a t m e n t
60
In f e c t e d , IM M - 5 2 9 t r e a t m e n t
In f e c te d , V a n c o m y c in tr e a tm e n t
40
20
(P<0.0001)
0
0 .0
0 .5
1 .0
1 .5
2 .0
2 .5
3 .0
3 .5
4 .0
h o u r s p o s t in f e c t io n
S u r v iv a l
100
Demonstrated ~80%
survival rate without
use of antibiotics vs.
<7% in control group
U n in f e c t e d , N o t r e a t m e n t
P e r c e n t s u r v iv a l
In f e c t e d , N o t r e a t m e n t
80
In fe c t e d , N o n - im m u n e Ig G t r e a t m e n t
In f e c t e d , IM M - 5 2 9 t r e a t m e n t
60
In f e c te d , V a n c o m y c in tr e a tm e n t
40
20
(P<0.0001)
0
0
1
2
3
4
D a y s p o s t in f e c tio n
In f e c t e d + S O C
100
90
**
80
p = 0 .0 0 27
Demonstrated ~80%
survival rate vs.
~11% survival rate
in control group
In f e c t e d + S O C + IM M - 5 2 9
70
60
50
40
30
20
10
(P<0.0027)
0
0
2
4
6
8
10
12
All studies
statistically
significant
Potentially only
therapeutic
(approved or in
development) that
can treat all
phases of the
disease:
1. Prophylaxis
S u r v iv a l
110
P e r c e n t s u r v iv a l
Relapse Studies
Treatment Studies
Prevention Studies
Results of Pre-Clinical Studies
14
16
18
20
D a y s a f te r v a n c o m y c in tr e a t m e n t c e a s e d
27
2. Treatment
3. Recurrence
Phase 1/2 Study Design
Phase 1/2 Study in CDI Expected to Commence 2Q 2017
•
Phase 1/2, randomized, double blind, placebo-controlled clinical study of IMM-529
for the treatment of CDI
•
60 subjects to be enrolled up to 3 weeks of definitive diagnosis of CDI (at least 20
subjects to be enrolled within the first 72 hours)
•
Subjects randomized to IMM-529 or placebo in a 2:1 ratio
•
Treatment duration: 28 days on top of SOC (vancomycin / metronidazole)
•
Follow-up: 3 months
•
Primary objective: To evaluate the safety and tolerability of IMM-529 together with
standard of care (SOC) in patients with CDI
•
Secondary objective: To evaluate the effectiveness of IMM-529 together with SOC to
treat patients with CDI
28
IMM-529 Key Milestones
2Q
2017
• Clinical supplies manufacturing
2018
• Topline results expected from
Phase 1/2 study in CDI
• Initiation of Phase 1/2 Trial in CDI
29
Corporate and Financial Overview
Robust IP and Extended Market Protection
• 6 patent families offering composition and/or method of treatment claims
Strong Patent
Portfolio
Extended
Market
Exclusivity
Generic
Protection
• Approved / pending in major geographies including US, Europe, Japan and
China
• Granted patent terms ending between 2024 and 2030 with possible
extensions
• Immuron’s drugs are considered “biologics” by the FDA
• In the US, this is expected to confer Immuron’s new drugs 12 years of
market exclusivity, offering investors a long revenue tail
• Immuron’s drug not absorbed in the blood
• No baseline for PK studies
• This results in lengthy process for biosimilar manufacturers
31
Recent High-Value NASH LM&A Highlights
Potential for Significant Upside
• Focused on advancing IMM-124E and IMM-529 through key clinical inflection points while
pursuing partnering opportunities
• Recent licensing and M&A partnerships in NASH underscores potential of IMM-124E
• 2016:
Licensed
preclinical
NASH
asset
• 2015:
Acquired
Phenex
• ~$50M
upfront
+
other
undisclosed
m ilestones
• NASH
asset
in
Phase
2
• 2016:
Acquired
Tobira
• 2014:
Acquired
Nimbus
• ~$530M
(5x
m arket
cap
at
time
of
announcement),
in
a
deal
valued
at
up
to
$1.7B
• $400M upfront
in
a
deal
valued
at
$1.2B
• Total
deal
value
$470M
• 2015:
Acquired
Pharmaxis
• 2014:
Acquired
Lumena
• NASH
asset
in
Phase
1
• 2
Phase
2
assets
for
NASH
and
cholestatic
liver
disease
• $39M
upfront
– Total
deal
value
$600M
• Preclinical
assets
and
platform
32
• Total
deal
value
$260M
NASH and C. difficile Comps Indicate
Potential for Substantial Growth
Company
Ticker
Program
Development
Stage
Market
Cap*
Program
in
NASH
ICPT
Obeticholic
acid
Phase
3
US$2.9B
GNFT
Elafibranor
Phase
3
US$1.1B
CNAT
ENCORE-‐LF
Phase
2
US$195M
Program
in
C.
Difficile
MCRB
SER-‐109;
SER-‐262
Phase
2
US$423M
SMMT
SMT19969
Phase
1
US$143M
ASMB
ABI-‐M101
Preclinical
US$419M
*As of May 4, 2017
33
Company Capitalization – Pre-Offering
Pre-‐Offering
Ordinary Shares
Pre-‐Offering
“ADSs Equivalent”1
Shares
103,641,417
2,591,035
Options2
33,177,523
829,438
Warrants
0
0
136,818,940
3,420,473
Immuron Limited
Total
1.
2.
Each
ADS
is
equal
to
40
ordinary
shares
Options
-‐ Weighted
average
exercise
p rice:
AUD$0.544
34
Use of Funds – Net of Raise Fees
Programs
Use
of
Funds
IMM-‐124E
– Advance
the
clinical
development
of
IMM-‐124E
for
the
treatment
of
fatty-‐liver
diseases.
Funds
sufficient
to
complete
our
Phase
2
clinical
programs
in
NASH,
ASH
and
Pediatric
NASH
$3,000,000
IMM-‐529 – Advance
development
of
IMM-‐529
and
complete
our
Phase
1/
2
in
patients
suffering
from
recurrent
CDI
$1,100,000
Other Clinical
– Support
other
programs
including
colitis
pre-‐clinical
program
and
collaboration
with
the
US
Army
and
US
Navy
$1,000,000
Corporate
Activities – Fund
manufacturing
costs
of
clinical
supplies
and
Travelan,
current
and
feature
R&D
activities,
Business
Development
activities,
marketing
initiatives
for
Travelan
in
the
United
States
and
Australia, for
working
capital
and
other
general
corporate
purposes
$2,138,000
• Total
35
• $7,238,000 (net of fees)
Travelan OTC/Business
A unique Preventative Treatment for Traveler’s Diarrhea
• Travelan/OTC: unique value proposition that is valued by consumers and customers
- Up to 90% effective in preventing traveler’s diarrhea
- Significantly reduces the motility of ETEC strains
- Binds to multiple epitopes and antigens on both the bacterial surface and flagella
- Has substantially greater reactivity against purified ETEC flagella antigen than IgG purified from nonimmune colostrum powder
• Annual Revenues of AU$1M+; Cash flow positive
- Net revenues: 1H2017 +41% vs 1H2016
- Pursuing new geographies
- Potential WW peak sales: $20M+
- Global traveler’s diarrhea market estimated at $600M
• Multiple ways to keep growing OTC business:
- Continued penetration of current markets
- Geographic expansions
- New products / new formulations (e.g., shigella)
36
Key Milestones Expected to Drive Value
2Q
2017
3Q
2017
4Q
2017
• IMM-529
- Clinical supplies
manufacturing
- Initiation of Phase
1/2 Trial in CDI
• IMM-124E
- NASH Phase 2
interim analyses
- SanyalBio – NASH
MOA
• IMM-124E
- NASH Phase 2
topline results
- Duke – NASH MOA
• Uplist to NASDAQ
2018
• IMM-124E
- NASH centric transaction
- Pediatric NAFLD Phase 2
topline results
- ASH Phase 2 topline
results
• IMM-529
- Topline results expected
from Phase 1/2 study in
CDI
Results from colitis preclinical studies and Army
and US Navy trials expected 2017/2018
37
Investment Highlights
ü Targeting
inflammatory-‐mediated
and
infectious
diseases
with
oral
immunotherapies
ü Lead
program,
IMM-‐124E,
in
Phase
2
with
key
data
readouts
before
year
end
ü Phase
1/2
study
IMM-‐529
for
treatment
of
CDI
expected
to
commence
2Q
2017
ü Well
positioned
to
address
high
unmet
medical
need
in
multiple
blockbuster
markets
ü High-‐value
peer
licensing
deals
and
M&A
underscore
potential
upside
ü Plans
to
uplist
to
NASDAQ
in
2Q
2017
ü Experienced
Management
Team
with
strong
support
from
leading
KOLs
and
institutions
38
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