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

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

Group A: Group B: Naïve
Control anti LPS
Group C: Group D:
Treated Treated
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----- Start of picture text -----

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
----- End of picture text -----*

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

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

1
2
3
----- End of picture text -----

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
----- End of picture text -----

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All studies statistically significant

Potentially only therapeutic (approved or in development) that can treat all phases of the disease:

  1. Prophylaxis

  2. Treatment

  3. 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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----- Start of picture text -----

2Q
2017
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  • Clinical supplies manufacturing

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

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-529IMM-124EIMM-124EIMM-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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