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Immuron Ltd — Investor Presentation 2017
May 8, 2017
35121_rns_2017-05-08_ea7749f0-1e44-444a-a318-730e221db378.pdf
Investor Presentation
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www.immuron.com
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Unique Oral Immunotherapies
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of Care
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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)
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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 SecuritiesAct 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: [email protected].
3
Offering Summary Immuron Limited (ASX:IMC)
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Offering
Size
US$8,750,000
of
American
Depository
Shares
(ADSs)
and
Warrants
Exchange/Ticker
Ordinary
Shares
are
listed
on
the
ASX
under
the
symbol
IMC Applied
to
list
the
ADSs
and
Warrants
on
the
NASDAQ
Capital
Market
under the
symbols
“IMRN”
and
“IMRNW”,
respectively
Warrants
Offered Use
of
Proceeds
50%
Warrant
coverage.
Each
Warrant
will
have
an
estimated
per
ADS
exercise price
of
125%
of
the
per
ADS
public
offering
price,
will
be
exercisable immediately
and
will
expire
five
years
from
the
date
of
issuance.
Clinical
development
of
IMM-‐124E
(fatty
liver),
IMM-‐529
(C. difficile )
and
other general
corporate
purposes
Joint
Book-‐Runners
Joseph
Gunnar
&
Co.
and
Rodman
&
Renshaw,
a
unit
of
H.C.
Wainwright
&
Co.
Co-‐Manager
WallachBeth Capital,
LLC
4
Investment Highlights
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-
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 Pediatric NAFLD -
value
indications,
including NASH,
ASH and -
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
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Thomas Liquard Chief Executive 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.
Dan Peres, MD Chief Medical Officer
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 Leadin Research Partners g
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Advisory Board
Dr. Arun Sanyal (MD) University of Virginia
Former President of the AASLD. Current Chair of the Liver Study Section at the NIH. IMM-124E lead PI.
Dr. Gerhard Rogler (MD, PhD) Zurich University
Professor Rogler is a leader in the field of colitis and has authored more than 200 original peer-reviewed articles.
Dr. Stephen Harrison (MD) San Antonio Military Medical Center Brooke US Army Medical Center
Internationally renowned expert in NASH. Lead PI of Galectin’s GR-MD-02’s Phase 2 trial.
Dr. Miriam Vos (MD) Emory University
Dr. Vos specializes in the treatment of gastrointestinal disease in children, as well as fatty liver disease and obesity.
Dr. Manal Abdelmalek (MD) Duke University Medical Center
Dr. Abdelmalek is a leading investigator in the field of NASH.
Dr. Dena Lyras (PhD) Monash University
Dr. Lyras is one of the world’s leading experts in C. difficile .
Organizations
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7
Oral Immunotherapy: Scalable, Disruptive Technolo gy
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1 2 3
Vaccines Are Antibodies Are Harvested Broad Therapeutic Effect
Developed from Colostrum
Induction of • Reduced gut and blood pathogens
regulatory responsible for initiating
inflammation
T-cells
• Reduces systemic inflammation
+ • Lowers organ injury
Clearance of • Not associated with general
Targeted GUT immune suppression
Antigen Specific Antibodies + Adjuvants Pathogens • Generally Regarded as Safe
(GRAS)
(IgG and IgG1)
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- 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 Multi le Near-Term Inflection Points p
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| Program | Indications | Development Stage | Development Stage | Development Stage | Development Stage | Program Highlights |
|---|---|---|---|---|---|---|
| Pre - Clinical |
Phase 1 | Phase 2 | Phase 3 |
|||
| Anti - Inflammatory Programs |
||||||
| IMM-124E | NASH | - Interim data expected 3Q 2017 - Topline results expected 4Q 2017 |
||||
| IMM-124E | ASH | - NIH Funded; UVA - Topline results expected 2018 |
||||
| IMM-124E | Pediatric NAFLD | - NIH Funded; 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
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NASH (Non-Alcoholic Fatty Liver) Pathophysiology
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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)
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-
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)
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-
NASH Cirrhosis
-
NAFLD 25M People 1.2M people
-
Up to 145M People F0 F1 F2 F3 F4
-
• 17M People 8M People No regulatory pathway currently exists for NAFLD
-
• Intercept (OCA) Drug would need to Tobira (CCR2/CCR5)
-
be extremely safe to Galmed (Aramchol)
-
be considered for Genfit (Elafibranor)
-
trial / approval
-
• NAFLD not Galectin (GR-MD-02)
-
available to current competitors due to IMM-124E safety profile •
-
• Only asset in development that, due to its safety profile: Up to 50% of the -
-
US population are Can potentially target all spectrum of the disease including mild/moderate patients -
-
thought to have Likely can be used in combination with any other agents currently in development NAFLD - No safety concerns to date that could limit chronic / long-term use
13
IMM-124E: Fatty-Liver Portfolio – 3 Phase 2 Trials
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Three Ongoing Phase 2 Programs: NASH, ASH and Pediatric NAFLD
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||||
|---|---|---|
|•|
|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|
|•|Expected enrollment: 66 patients|
|ASH|
|•|Endpoint: ALT|
|•|Timing: topline results expected in 2018|
|•|
|NIH funded; sponsored by Emory University|
|Pediatric|•|Expected enrollment: 40 patients|
|NAFLD|•|Endpoint: ALT; 3 months treatment|
|•|Timing: topline results expected in 1H 2018|
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14
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IMM-124E – Summary of Data Prevention of Fibrosis and Improvement in Metabolic/Inflammatory Markers
- Carbon-Tetrachloride (CCl4) a non-disease related fibrosis model
CCl4 Fibrosis Studies
-
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:
Ob-Ob Mice Phase 1/2 Clinical Studies
-
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)
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Liver:
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•
Activated Kupffer cells ↓
IMM-124E (F4/80 macrophages)
•
Fibrosis and inflammation ↓
Gut:
Serum:
• Insulin resistance ↓
•
Intestinal LPS ↓
•
Circulating LPS ↓
• Intestinal permeability ↓
•
TGF-β ↑
• Tolerance – Activation of
innate system to suppress • TNF-α ↓
inflammation (NKT, DC, • IL-2, IL-6, IL-10, IL-12
macrophages)
•
Treg ↑ (CD4, CD25, FoxP3)
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16
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Animal Models: IMM-124E Improves Fibrosis and Inflammatory Markers
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Decrease Portal Inflammation
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Group A: Group B: Naïve
Control anti LPS
Group C: Group D:
Treated Treated
3
2.4 p<0.02
2.5 ^^ p<0.01
2
1.4 1.33
1.5
0.66
1
0.5
0
A B C D
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Improved Metavir Fibrosis Score
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Group A: Group B: Naïve
Control anti LPS
Group C: Group D:
Treated Treated
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4
3.4
3.5 p<0.0009
^^ p<0.0003
3
2.5
1.8
2
1.5 1
1
0.5
0
0
A B C D
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Mizrahi M. 2013, AASLD; Hepatology 751A
17
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Animal Models: Macroscopy – Prevents Fibrosis
Fibrotic Liver CCl4 (carbon tetrachloride)
IMM 124E Treated Liver 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
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Marked Reduction in Liver Activated Macrophages (F4/80 high)
19
Phase 1/2: Improves Liver Function and Reduces Insulin Resistance
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Results of a Phase 1/2a clinical trial; N=10
30 Days Treatment Endpoint Met; NO SAFETY ISSUES REPORTED
Improved HBA1C, OGTT and HOMA
Improved Liver Enzymes
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
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Increased CD4+CD25+FOXP3+ TREGS
Increased GLP1 and Adiponectin
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Day 1 Day 30
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Proof of Concept: Increase in Circulatory Regulatory T-Cell
Mizrahi M. J Inflamm Res. 2012
21
IMM-124E Key Milestones
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3Q 4Q
2018
2017 2017
• • •
NASH Phase 2 interim NASH Phase 2 Topline NASH-centric transaction
analysis Results 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
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- Results of colitis pre-clinical studies: ~~2017/2018~~
22
IMM-529
Neutralizing Clostridium difficile , but Sparing the Microbiome
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IMM-529 in Clostridium difficile Infection (CDI)
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-
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
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-
Therapeutic market is expected to grow from $356.3 million in 2014 to over $1.5 billion
-
Market by 2024 – CAGR 15%
-
Opportunity • 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 • Only asset that targets not only toxin B but also the spores and the vegetative cells
-
IMM-529 responsible for recurrence
-
Positioning • Can be used in combination with standard of care • Targets many isolates
Sources: GlobalData, Decision Resources, CDC
25
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Triple Action MOA Neutralizing C. difficile; Sparing the Microbiome
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1
2
3
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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.
Vegetative Cells
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
IMM-529 antibodies bind to multiple epitopes on the surface layer proteins (SLP) on vegetative cells and limit colonization.
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
Results of Pre-Clinical Studies
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S u rv iv a l
1 0 0
U n in fe c te d , N o tre a tm e n t Demonstrated ~70%
8 0 In fe c te d , N o tre a tm e n t
In fe c te d , N o n -im m u n e Ig G tre a tm e n t survival rate without
6 0 In fe c te d , IM M -5 2 9 tre a tm e n t
In fe c te d , V a n c o m y c in tre a tm e n t
4 0 use of antibiotics vs.
2 0
0% for control group
0 (P<0.0001)
0 .0 0 .5 1 .0 1 .5 2 .0 2 .5 3 .0 3 .5 4 .0
h o u rs p o s t in fe c tio n
S u rv iv a l
1 0 0 U n in fe c te d , N o tre a tm e n tIn fe c te d , N o tre a tm e n t Demonstrated ~80%
8 0 In fe c te d , N o n -im m u n e Ig G tre a tm e n tIn fe c te d , IM M -5 2 9 tre a tm e n t survival rate without
6 0
In fec te d , V a n c o m y c in trea tm e n t use of antibiotics vs.
4 0
2 0 <7% in control group
0 (P<0.0001)
0 1 2 3 4
D a y s p o s t in fe c tio n
1 1 0 S u rv iv a l
1 0 0 In fe c te d + S O C
9 0 ** In fe c te d + S O C + IM M -5 2 9 Demonstrated ~80%
8 0 p=0.0027
7 0 survival rate vs.
6 0
5 04 0 ~11% survival rate
3 0
2 0 in control group
1 0
0 (P<0.0027)
0 2 4 6 8 1 0 1 2 1 4 1 6 1 8 2 0
D a y s a fte r v a n c o m y c in tre a tm e n t c e a s e d
P e rc e n t s u rv iv a l
Prevention Studies
P e rc e n t s u rv iv a l
Treatment Studies
P e rc e n t s u rv iv a l
Relapse Studies
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All studies statistically significant
Potentially only therapeutic (approved or in development) that can treat all phases of the disease:
-
Prophylaxis
-
Treatment
-
Recurrence
27
Phase 1/2 Study Design
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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
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2Q
2017
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- Clinical supplies manufacturing
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2018
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- Topline results expected from Phase 1/2 study in CDI
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- Initiation of Phase 1/2 Trial in CDI
29
Corporate and Financial Overview
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Robust IP and Extended Market Protection
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-
6 patent families offering composition and/or method of treatment claims
-
• Approved / pending in major geographies including US, Europe, Japan and
-
Strong Patent China
-
Portfolio • Granted patent terms ending between 2024 and 2030 with possible extensions
-
•
-
Extended Immuron’s drugs are considered “biologics” by the FDA Market • In the US, this is expected to confer Immuron’s new drugs 12 years of
-
Exclusivity market exclusivity, offering investors a long revenue tail • Immuron’s drug not absorbed in the blood
-
Generic • No baseline for PK studies
-
Protection • This results in lengthy process for biosimilar manufacturers
31
Recent High-Value NASH LM&A Highlights Potential for Si nificant U side g p
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-
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
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-
2016:
Licensed
preclinical • 2015:
Acquired
Phenex -
NASH
asset • -
• NASH
asset
in
Phase
2 ~$50M upfront -
other •
-
undisclosed
milestones Total
deal
value $470M
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-
2014:
Acquired
Nimbus -
• Preclinical
assets
and
platform -
• $400M upfront
in
a
deal valued
at $1.2B -
2016:
Acquired
Tobira -
~ $530M (5x
market
cap
at -
time
of
announcement),
in
a deal
valued
at
up
to $1.7B
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-
•
-
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 Total
deal
value $260M
32
NASH and C. difficile Comps Indicate Potential for Substantial Growth
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| 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
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----- Start of picture text -----
Pre-‐Offering Pre-‐Offering
Immuron Limited
Ordinary Shares “ADSs Equivalent” [1]
Shares 103,641,417 2,591,035
Options [2] 33,177,523 829,438
Warrants 0 0
Total
136,818,940 3,420,473
1.
Each
ADS
is
equal
to
40
ordinary
shares
2.
Options
-‐ Weighted
average
exercise
price:
AUD$0.544
----- End of picture text -----
34
Use of Funds – Net of Raise Fees
Programs
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
IMM-‐529 – Advance
development
of
IMM-‐529
and
complete
our Phase
1/
2
in
patients
suffering
from
recurrent
CDI
Other Clinical
– Support
other
programs
including
colitis
pre-‐clinical program
and
collaboration
with
the
US
Army
and
US
Navy
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
• Total
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Use
of
Funds $3,000,000
$1,100,000
$1,000,000
$2,138,000
• $7,238,000 (net of fees)
35
Travelan OTC/Business
A unique Preventative Treatment for Traveler’s Diarrhea
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-
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
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-
Geographic expansions
-
New products / new formulations (e.g., shigella)
36
Key Milestones Expected to Drive Value
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-
2Q 3Q 4Q ~~2018~~
-
2017 2017 2017
-
• IMM-529 • IMM-124E • IMM-124E • IMM-124E - Clinical supplies - NASH Phase 2 - NASH Phase 2 - NASH centric transaction manufacturing interim analyses topline results - Pediatric NAFLD Phase 2
-
- Initiation of Phase - SanyalBio – NASH - Duke – NASH MOA topline results 1/2 Trial in CDI MOA - ASH Phase 2 topline results
-
Uplist to NASDAQ
-
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
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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
Thank You
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