rodman & renshaw - immuron.com.au

34
Immuron Limited January 2018 Oral Immunoglobulins Changing the Paradigms of Care www.immuron.com ASX:IMC NASDAQ:IMRN

Upload: others

Post on 02-Apr-2022

26 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Rodman & Renshaw - immuron.com.au

Immuron Limited

January 2018

Oral Immunoglobulins

Changing the Paradigms

of Care

www.immuron.com

ASX:IMC NASDAQ:IMRN

Page 2: Rodman & Renshaw - immuron.com.au

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 forward-

looking 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.

Page 3: Rodman & Renshaw - immuron.com.au

Company Highlights

3

• Clinical stage biopharmaceutical company targeting inflammatory-mediated and infectious diseases with oral immunotherapies

• Validated technology platform – with one registered asset generating revenue

• 2 Lead clinical assets in Phase 2 development for the treatment of multiple high value indications, Fat Liver Disease and CDI.

• Excellent safety profile, GRAS by FDA, expedited regulatory review and approval process

• Well positioned to address high unmet medical need in multiple blockbuster markets

• High-value peer licensing deals and M&A underscore potential upside

• Company listed on NASDAQ in 2Q 2017

• Experienced Management Team and strong support from leading KOLs and institutions (NIH, DoD)

Page 4: Rodman & Renshaw - immuron.com.au

Platform Overview: Oral Immunoglobulins

4

1

Vaccines Are

Developed

2

Antibodies Are Harvested

from Colostrum

Antigen Specific

Antibodies

(IgG and IgG1)

Adjuvants+

3

Broad Therapeutic Effect

+

• Reduced gut and blood pathogens

responsible for initiating

inflammation

• Reduces systemic inflammation

• Lowers organ injury

• Strong anti-toxin properties

• Decrease toxin levels results in

decrease gut damage

• Generally Regarded as Safe

(GRAS)

Induction of

regulatory

T-cells

Clearance of

Targeted GUT

Pathogens

Competitive

Advantage

• Platform capable of producing multiple drug candidates Long-term value creation

• Bovine IgG possesses a unique ability to remain active in the human GI tract

delivering its full benefits to the bacteria found there

• Bovine IgG is capable of withstanding the acidic environment of the stomach and is

resistant to proteolysis by the digestive enzymes in the GI tract

• Safety established Not absorbed into the blood

Page 5: Rodman & Renshaw - immuron.com.au

Immunotherapy Targeting Pathogenic Bacteria

Technology Platform Capable of Producing High Levels of Antibodies

against specific pathogenic and antigenic determinants

5

Targeting Virulence Factors;

• Spores

• Lipopolyscaccarride

Endotoxins

• Exotoxins

• Fimbrae & Molecules which

facilitate adhesion

• Surface Layer Proteins which

contribute to Colonisation

• Flagella (Flagellin)

Antigens Important For;

• Outer Membrane Stability

• Host Immune Evasion

• Motility

• Host Cell Adherence

• Colonization

• Cellular Invasion

Page 6: Rodman & Renshaw - immuron.com.au

6

Immunotherapy Targeting Pathogenic Bacteria

Proprietary Technology to “Weed” Harmful Bacteria

Direct Protective MOA

• Toxin Neutralization

• Suppression of Germination

• Suppression of Adhesion

• Suppression of Motility

• Suppression of Colonization

Indirect Protective MOA

• Inhibition of Toxin Induced

Inflammatory Signal Cascades

• Anti-Inflammatory Effect via

Stimulation of the Innate

Immune Response

• Enhancement of Gut Barrier

Function

• Inhibition of Epithelial Cell

Apoptosis

Page 7: Rodman & Renshaw - immuron.com.au

Immuron’s Clinical Programs

Multiple Near-Term Inflection Points

7

Program IndicationsDevelopment Stage

Program HighlightsPre-Clinical Phase 1 Phase 2 Phase 3

Anti-Inflammatory Programs

IMM-124E NASH- Interim data reported 2Q 2017- Topline results expected 1Q 2018

IMM-124E ASH- NIH Funded; UVA- Topline results expected 2019

IMM-124E Pediatric NAFLD- NIH Funded; Emory University- Topline results expected 4Q 2018

IMM-124E ColitisCollaboration with Dr. Rogler, Zurich University

IMM-124E AutismMurdoch Childrens Research Institue, La Trobe & RMIT Universities

Anti-Infective Programs

IMM-529 C. difficile- Phase 1/2 initiated 4Q 2017- Topline results expected Q4 2018

IMM-124E / Shigella Vaccine

Shigella Infections

Collaboration with US Army

IMM-124ECampylobacter; ETEC Infections

Collaboration with US Navy

Page 8: Rodman & Renshaw - immuron.com.au

• Hyperimmune bovine colostrum powder

200mg (30 caplets, 24 month shelf life)

• Reduces the risk of TD, reduces the

symptoms of minor GI disorders

TRAVELAN

8

Regulatory

Authority

Regulatory Pathway Indications

TGA Listed Medicine • Reduces the risk of travellers’ diarrhoea

• Reduces the symptoms of minor gastro-intestinal disorders

• Antimicrobial

Medsafe (New

Zealand)

Not marketed in New Zealand Not marketed in New Zealand

FDA (USA) Self-affirmed generally

regarded as safe (GRAS)

Dietary supplement. FDA does

not review dietary supplements

for safety and effectiveness

Hyperimmune colostrum dietary supplement

Health Canada Natural Health Product Travelan helps reduce the risk of traveller’s diarrhea.

EMA (Europe) Not marketed in Europe Not marketed in Europe

ARTG Listing for Travelan

http://www.travelanusa.com/

Australian Packaging

US Packaging

Page 9: Rodman & Renshaw - immuron.com.au

Novel Approaches Targeting Pathogenic Gut

Bacteria

9

• Travelan contains high levels of specific antibodies which have been generated

against 13 strains of Enterotoxigenic E.coli bacteria, the most common cause of

Travellers’ Diarrhea.

• The active pharmaceutical ingredient is bovine colostrum powder enriched with

anti-ETEC antibodies (> 35% w/w) scientifically proven to bind and remove LPS

Bacteria and their LPS Toxin from the Digestive System.

• Travelan directly targets the pathogens in the gut that are implicated in

Travellers’ Diarrhea and prevents the infection and its resulting symptoms from

occurring in the first place.

• Travelan is a biological product which is intended to prevent Travellers’ Diarrhea

without destroying the microbiome like antibiotics do, allowing the microbiome to

return to a healthy state.

Page 10: Rodman & Renshaw - immuron.com.au

Formulated with 13 Strains of

E-Coli

• ETEC strain M452C1 [serotype O20:H-] • ETEC strain T0225-C4 [O75:H4]• ETEC strain 83-552 [O126:H-] • ETEC strain G33 [O126:H12] • ETEC strain M145C2 [O128:H(NT)] • ETEC strain E23477/0/A [O139:H25] • ETEC strain ND782 [O141:H4] • ETEC strain ND748 [O149:H10] • ETEC strain E11881A [O25:H42] • Enterobacter aerogenes strain ATCC 13048 • Enteropathogenic Escherichia coli strain E2348/69 • Klebsiella pneumoniae strain ATCC 26• Pseudomonas aeruginosa strain ATCC 27853 • Salmonella typhimurium strain ATCC 14028• Vibrio cholerae strain 6239 • Yersinia enterocolitica strain 67R • Citrobacter rodentium strain DSB100• Shigella flexnerii LPS 2a (CVD Lot # 2457T)• Shigella sonnei LPS 53G (CVD Lot # 95-WRAIR), • Shigella dysenterii LPS (CVD #1251), • Salmonella enterica Serovar Typhi LPS (Difco # 3946-25), • Salmonella enterica Serovar Typhimurium LPS (Sigma # L6511)• Salmonella enterica Serovar Enteriditis LPS (Sigma # L2012)

Proven to Be Cross-Reactive (binds) to Other E-Coli

Strains and Gram-Negative Bacteria

Novel Approaches Targeting Pathogenic Gut

Bacteria

Serotype Strains#

ETEC O6: H16 B2C

ETEC O8: H19 C55 3/3c3

ETEC O15: H4 PE 595

ETEC O25: H42 E11881A

ETEC O27: HR C1067-77

ETEC O63: H- PE 673

ETEC O78: H11 H10407

ETEC O114: H21 E20738/0

ETEC O115: H- PE 724

ETEC O128: H21 EI 37-2

ETEC O148: H28 B7A

ETEC O153: H12 E8772/0

ETEC O159: H- PE 768

Page 11: Rodman & Renshaw - immuron.com.au

Novel Approaches Targeting Pathogenic Gut

Bacteria

11

Pre-Clinical

Studies

• Significantly reduces adherence of CFA/I producing ETEC strains to a

cell-line that mimics the human small intestinal epithelium

• Significantly reduces the motility of ETEC strains through soft agar

• Binds to both the bacterial surface and flagella

• Has substantially greater reactivity against purified ETEC flagella

antigen than IgG purified from non-immune colostrum powder

Without Travelan®:

Bacteria attach to gut wall

and infect

With Travelan®: Bacteria

neutralized by Travelan®

antibodies

Page 12: Rodman & Renshaw - immuron.com.au

Novel Approaches Targeting Pathogenic Gut

Bacteria

12

Clinical

Studies

• Travelan has undergone clinical testing in two patient randomised,

double-blind, placebo-controlled clinical trials (90 healthy volunteers)

• Methodology: Study 1: 30 participants in total, 15 randomised to

treatment and 15 to placebo

– Active treatment with Travelan 400mg with buffer tds against placebo

– Oral challenge with O78 ETEC strain (H10407), treatment 5 days after challenge with

ciprofloxacin 500mg bd for 5 days

– Diarrhea was defined as passage of two or more unformed stools during 48 hour period

within 72 hours of the challenge

Otto et al. 2011 RCTs using a tablet formulation of hyperimmune bovine colostrum to prevent diarrhea caused by ETEC in volunteers. Scandinavian

Journal of Gastroenterology, 2011; 46: 862–868

Clinical protocols were approved by Bioethics Committee of the Warsaw Chamber of Physicians.

Procedures in accordance with Declaration of Helsinki.

Results: Travelan provided 90.9% prophylactic efficacy against diarrhea

(due to infection by the major strain of E.coli that causes TD)

In addition these trials showed a significant reduction in abdominal cramps

and stomach pain compared to those who did not receive Travelan.

There were no reported treatment-related side effects.

Page 13: Rodman & Renshaw - immuron.com.au

IMM-124E

Revolutionary Treatment for Fatty Liver

Disease

Page 14: Rodman & Renshaw - immuron.com.au

NASH (Non-Alcoholic Fatty Liver)

Pathophysiology

14

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 anti-

inflammatory effect

Source: Adapted from Cohen-Naftaly; Scott L. Friedman, 2011

Page 15: Rodman & Renshaw - immuron.com.au

IMM-124E in NASH (Non-Alcoholic Fatty Liver)

15

Liver:

Serum:

• Intestinal LPS ↓

• Intestinal Permeability ↓

• Tolerance – Activation of

Innate system to suppress

inflammation (NKT, DC,

macrophages)

Gut:

• Insulin resistance ↓

• Circulating LPS ↓

• TGF-β ↑

• TNF-α ↓

• IL-2, IL-6, IL-10, IL-12

• Treg ↑ (CD4, CD25, FoxP3)

• Activated Kupffer Cells ↓

(F4/80 macrophages)

• Fibrosis and Inflammation ↓IMM-124E

Page 16: Rodman & Renshaw - immuron.com.au

IMM-124E: Fatty-Liver Portfolio – 3 Phase II

Trials

16

Three Ongoing Phase 2 Programs: NASH, ASH and Pediatric NAFLD

NASH

• 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

• Fully recruited: 133 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 by 1Q 2018

ASH

• NIH funded; sponsored by University of Virginia

• Expected enrollment: 66 patients

• Endpoint: ALT

• Timing: topline results in 2019

Pediatric

NAFLD

• NIH funded; sponsored by Emory University

• Expected enrollment: 40 patients

• Endpoint: ALT; 3 months treatment

• Timing: topline results in 4Q 2018

Page 17: Rodman & Renshaw - immuron.com.au

IMM-124E Interim analysis

17

• Goal: Validate Safety and test for futility

• Analysis was not powered for efficacy due to sample size

• Design: interim analysis initiated when 80 patients reached 24W and have 2 MRI

• Execution: Performed by an independent Committee to keep Company Blinded

• Results:

• Excellent Safety

• Treatment well tolerated at both doses

• No Futility

• Significant change in ALT and AST at 24W

• Significant reduction in ALT and AST over time compared to placebo

• Dose response

• Non-absorbable

Page 18: Rodman & Renshaw - immuron.com.au

Phase II: Interim Analysis Report - Improves

Liver Function

18

Results of a Phase IIa clinical trial; N=13324 Week Treatment; NO SAFETY ISSUES REPORTED

Box plot for predicted ALT AUC from ANCOVA (FAS population)

Improved Liver Enzymes

• Using logarithmic regression

the predicted value was used

• Both 1200 mg and 600 mg

arms demonstrated

significant change over

placebo (p=0.0036 and

p=0.0075)

• but were not different from

one another (p=0.3589)

-8000

-6000

-4000

-2000

0

2000

Pre

dic

ted v

alu

e f

or

AL

T A

UC

Placebo600mg1200mgGroup

Predicted value adjusted for Baseline ALT

Page 19: Rodman & Renshaw - immuron.com.au

• NASH Phase 2 interim

analysis

• NASH Phase 2 Closed

• Results of MOA studies:

- Duke

- Sanyal Biotechnology

• NASH Phase 2 Topline

Results

• Pediatric NAFLD Phase 2

topline results

• ASH Phase 2 topline results

IMM-124E Key Milestones

19

3Q

2017

4Q

2017

• Results of colitis & US DoD pre-clinical

studies: 2017/2018

2018

Page 20: Rodman & Renshaw - immuron.com.au

IMM-529

Neutralizing Clostridium difficile, while Sparing the

Microbiome

Page 21: Rodman & Renshaw - immuron.com.au

IMM-529 in Clostridium difficile Infection (CDI)

21

• Biologic with unique triple mechanism of action

- Targets and neutralizes the toxin B, the spores and the vegetative cells

• Potential to redefine the standard-of-care (SOC) therapy for CDI

- 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)

Page 22: Rodman & Renshaw - immuron.com.au

IMM-529 for the Treatment of CDI

22

Market

Opportunity

• Therapeutic market is expected to grow from US$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)

Unmet Need

• Vancomycin and metronidazole are the current standard of care, accounting for 80% of

patient share (US)

• 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

IMM-529

Positioning

• 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

responsible for recurrence

• Can be used in combination with standard of care

• Targets many isolates

Sources: GlobalData, Decision Resources, CDC

Page 23: Rodman & Renshaw - immuron.com.au

Triple Action MOA

Neutralizing C. difficile; Sparing the Microbiome

23

Spores – Infectious Particles

IMM-529 antibodies bind to

multiple epitopes on surface

antigens on spores and

prevent adheres to host cells

and limit germination.

Heat, ethanol and UV

resistant. Survive gastric acid,

adhere to cells in the colon

and germinate.

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.

3

1

2

Page 24: Rodman & Renshaw - immuron.com.au

IMM-529 antibodies are cross-reactivewith the exosporium layer from C. difficile spores

exosporium

250 kDa

250 kDa

Non-immune

250 kDa

IMM-529 #1

IMM-529 #2

1 2 3 4 5 6 7 8

1 KI (A+B+)2 M7404 (A+B+)3 VPI10463 (A+B+)4 GE (A+B+)5 MDU2992 (A-B+)6 JGS6133 (A+B+)7 AI35 (A-B+)8-1470 (A-B+)

IMM-529 contains antibodiesthat are cross-reactive with the exosporiumlayer of spores from a variety of isolates (human and animal)

Strain used to generate product

Page 25: Rodman & Renshaw - immuron.com.au

IMM-529 antibodies are cross-

reactive with Toxin B from differentC. difficile strains

IMM-529 contains antibodies specific to Toxin B from a variety ofhuman and animal isolates

1 2 3 4 5 6 7 8 9 10 11

Non-immune

IMM-529 #1

250 kDa

IMM-529 #2

250 kDa

1 KI (A+B+)2 M7404 (A+B+)3 VPI10463 (A+B+)4 GE (A+B+)5 MDU2992 (A-B+)6 JGS6133 (A+B+)7 AI35 (A-B+)8-1470 (A-B+)9CD37 (A-B-)10Purified Toxin B (commercial)

250 kDa

Page 26: Rodman & Renshaw - immuron.com.au

N o N o n -im m u n e IM M -5 2 9 B 1

0

2 5

5 0

7 5

1 0 0

A n tib o d y

%

ce

ll d

ea

th

****

C o m m e r c ia l p u r if ie d T o x in B

(s t ra in V P I1 0 4 6 3 )

****

N o N o n -im m u n e IM M -5 2 9 B 1

0

2 5

5 0

7 5

1 0 0

A n tib o d y

%

ce

ll d

ea

th

***

H is to r ic a l T o x in B

(s t ra in 6 3 0 )

***

N o N o n -im m u n e IM M -5 2 9 B 1

0

2 5

5 0

7 5

1 0 0

A n tib o d y

%

ce

ll d

ea

th

****

H y p e r v ir u le n t T o x in B

(s t ra in K I)

****

IMM-529 antibodies neutralize Toxin B from

historical and hypervirulent strains

Page 27: Rodman & Renshaw - immuron.com.au

Results of Pre-Clinical Studies

27

0 .0 0 .5 1 .0 1 .5 2 .0 2 .5 3 .0 3 .5 4 .0

0

2 0

4 0

6 0

8 0

1 0 0

S u r v iv a l

h o u rs p o s t in fe c t io n

Pe

rc

en

t s

urv

iva

l

U n in fe c te d , N o tre a tm e n t

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

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

Pre

ve

nti

on

Stu

die

s

Demonstrated ~70%

survival rate without

use of antibiotics vs.

0% for control group(P<0.0001)

All studies

statistically

significant

Tre

atm

en

t S

tud

ies

Demonstrated ~80%

survival rate without

use of antibiotics vs.

<7% in control group(P<0.0001)

0 1 2 3 4

0

2 0

4 0

6 0

8 0

1 0 0

D a y s p o s t in fe c tio n

Pe

rc

en

t s

urv

iva

l

S u r v iv a l

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

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

U n in fe c te d , N o tre a tm e n t

Re

lap

se

Stu

die

s

Demonstrated ~20%

relapse rate vs.

~89% relapse rate in

control group(P<0.0027)

Potentially only

therapeutic

(approved or in

development) that

can treat all

phases of the

disease:

1. Prophylaxis

2. Treatment

3. Recurrence

0 2 4 6 8 1 0 1 2 1 4 1 6 1 8 2 0

0

1 0

2 0

3 0

4 0

5 0

6 0

7 0

8 0

9 0

1 0 0

1 1 0S u r v iv a l

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

Pe

rc

en

t s

urv

iva

l

In fe c te d + S O C

In fe c te d + S O C + IM M -5 2 9**p=0.0027

Page 28: Rodman & Renshaw - immuron.com.au

Phase 1/2 Study Design

28

• 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 overall

• 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

Phase 1/2 Study in CDI Initiated 4Q 2017

Page 29: Rodman & Renshaw - immuron.com.au

• Clinical supplies manufacturing

• Initiation of Phase 1/2 Trial in CDI

• Topline results expected from

Phase 1/2 study in CDI

IMM-529 Key Milestones

29

3Q/4Q

20172018

Page 30: Rodman & Renshaw - immuron.com.au

NASH and C. difficile Comps Indicate

Potential for Substantial Growth

30

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

Page 31: Rodman & Renshaw - immuron.com.au

Capital Profile Immuron Limited (ASX:IMC NASDAQ:IMRN)

31

Current Top 10 Shareholders

Current Company

Market CapitalizationAUD$22.3M ≈ USD$19.1M (21st Dec 2017)

Rank Holder Name Current Qty %

1 HSBC CUSTODY NOM AUST LTD (ADR Program) 19,531,706 14.97%

2 * GRANDLODGE PL 9,056,682 6.94%

3 AUTHENTICS AUST PL 8,624,999 6.61%

4 RETZOS EXECUTIVE PL 3,800,000 2.91%

5 * ANASTASIOU PETER + K P 2,907,236 2.23%

6 INVERAREY PL 2,731,632 2.09%

7 * FIFTY-FIFTH LEPRECHAUN PL 2,645,983 2.03%

8 INSYNC INV PL 2,500,000 1.92%

9 SBI INV PR LLC 2,000,000 1.53%

10 ADVANCE PUBLICITY PL 2,000,000 1.53%

TOTAL TOP 20 SHAREHOLDERS 55,798,238 42.76%

BALANCE OF SHARES 74,642,224 57.24%

TOTAL SHARE ON ISSUE 130,440,462 100.00%

* Denotes a Director Related Entity

Page 32: Rodman & Renshaw - immuron.com.au

Travelan OTC/BusinessA unique OTC targeting Traveler’s Diarrhea

• Travelan/OTC: Unique value proposition that is valued by consumers and customers

- 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 non-

immune colostrum powder

• Multiple ways to keep growing OTC business:

- Continued penetration of current markets

- Geographic expansions

- New products / New formulations (e.g., shigella)

• Annual Revenues of AU$1M+; Cash flow positive

- Net revenues: 1H2017 +41% vs 1H2016

- Pursuing new geographies

- Potential WW peak sales: $20M+

32

Page 33: Rodman & Renshaw - immuron.com.au

Key Milestones Expected to Drive Value

33

• IMM-529

- Clinical supplies

manufacturing

• IMM-124E

- NASH Phase 2

interim analyses

• IMM-124E

- NASH Phase 2 study

closed

- NASH MOA

• IMM-529

- Initiation of Phase

1/2 Trial in CDI

• IMM-124E

- NASH Phase 2 topline

results

- 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

2Q

2017

3Q

20174Q

20172018

Results from colitis preclinical studies and US

Army and US Navy trials expected 2017/2018

Page 34: Rodman & Renshaw - immuron.com.au

Thank You