immuron ltd. (asx: imc) investor presentation

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COMPANY UPDATE July 2016

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Page 1: Immuron Ltd. (ASX: IMC) Investor Presentation

COMPANY UPDATE

July 2016

Page 2: Immuron Ltd. (ASX: IMC) Investor Presentation

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.

2

Page 3: Immuron Ltd. (ASX: IMC) Investor Presentation

Immuron Limited1H 2016 Developments

3

Company Overview and Pipeline

1H 2016 Developments

Upcoming Milestones

Summary

Page 4: Immuron Ltd. (ASX: IMC) Investor Presentation

Immuron LimitedIntroduction

4

• Clinical stage biopharmaceutical company focused on oral immunotherapies for

the treatment of inflammatory and gut mediated diseases

• Strong platform technology (dairy-derived antibodies); wide applicability/low cost

- Validations: Product approved and launched; US NIH fully funding Phase II studies (ASH)

• Lead asset IMM-124E targeting fatty liver diseases (NASH / ASH)

- Targeting LPS endotoxins, a key disease mediator, and up-regulation of suppressor T-Cells

- Early studies have shown evidence of anti-inflammatory effects + prevention of fibrosis

- Potential exist to expand the use of IMM-124E in other indications such as diabetes

• NASH represents a blockbuster opportunity. Large and growing market ($35B-$40B by 2030) driven by obesity epidemic. No approved drugs. High BD activity

• Second key asset is IMM-529 which is targeting C-Difficile. This is a bacterial infection for which Immuron could get orphan drug designation from the FDA

• Generating growing revenues from OTC products (FY2015: $1.1M)

• Experienced management team and strong support from KOLs

Page 5: Immuron Ltd. (ASX: IMC) Investor Presentation

5

Platform OverviewOral Immunotherapy - A Disruptive Technology

Disease

Specific

Antibodies

Induction

of

regulatory

T-cells

- Reduces systemic

inflammation

- Lowers organ injury

- Not associated with general

immune suppression

- No risks of severe infection

or malignancy

- Easily tolerated by patients

Vaccines Are

Developed

Antibodies Are

Harvested from

Colostrum

Bovine

adjuvants

IgG (IgG1)

Broad Therapeutic Effect

Clearance of

Targeted

Pathogens

1 2 3

++

Can create therapeutics targeting any microbiome signature(s)

Clinical supplies for new therapeutics can be ready for trials in as little as 6 months

Extended market protection (regulated as biologics)

Page 6: Immuron Ltd. (ASX: IMC) Investor Presentation

PipelineClinical Assets Targeting Blockbuster Indications

6New trials since last update (Nov. 2015)

Pre-Clin Phase1 Phase2 Phase3 Market

NASH

ASH

PediatricNASH

IMM-529 Anti-Infective C-Difficile(Orphan)

IMM-124EAnti-

InflammatoryColitis

TBD Anti-Infective USArmy/Shigella

IMM-124E/

TBDMicrobiota Autism

Travelan/

ProtectynOTC

Traveler'sDiarrhea

/GutDysbiosis

IMM-124EImmuno-

Modulation(NIH Trial)

(NIH Trial)

Page 7: Immuron Ltd. (ASX: IMC) Investor Presentation

Dr Arun Sanyal (MD) – University of Virginia. Professor of Medicine and Former Chairman of the Division of

Gastroenterology, Hepatology and Nutrition, VCU Medical Center. Dr Sanyal is an internationally renowned expert in liver

diseases. He is a former President of the AASLD (American Association for the Study of Liver Diseases) and is the current

Chair of the Liver Study Section at the NIH.

Dr Stephen Harrison (MD) – Professor of Medicine, Uniformed Services University of the Health Sciences, Bethesda,

Maryland; Physician, San Antonio Military Medical Center, Fort Sam Houston, San Antonio, Texas. Chief of Residents, Internal

Medicine, Brooke US Army Medical Center. Dr. Harrison is an internationally renowned expert in NASH and his group has

published seminal work on many aspects in the field. Dr Harrison is the Principal Investigator of Galectin’s GR-MD-02’s Phase

II trial and hold's key roles in other leading clinical NASH studies.

Dr Manal Abdelmalek (MD) – Duke University Medical Center. Dr Abdelmalek is Associate Professor of Medicine at

Duke Medical University Medical Center, Division of Gastroenterology & Hepatology, Section of Hepatobiliary Diseases & Liver

Transplantation. Dr Abdelmalek is a leading investigator in the field of NASH.

Dr Gerhard Rogler (MD, PhD) – Zurich University. Dr Rogler is the Chairman of the Scientific Advisory Board of the

University of Zurich and Professor of Gastroenterology and Hepatology and Consultant Gastroenterologist at the Division of

Gastroenterology & Hepatology, Department of Medicine, Zürich University Hospital, Switzerland. Prof. Rogler is a leader in

the field of Colitis and has authored approximately 200 original peer-reviewed articles.

Dr Miriam Vos (MD) – Emory University. Dr Vos is an associate professor of pediatrics at the Emory University School of

Medicine, and an attending Hepatologist at Children’s Healthcare of Atlanta. She specializes in the treatment of

gastrointestinal disease in children as well as fatty liver disease and obesity. Dr. Vos is also the author of The No-Diet Obesity

Solution for Kids.

Dr. Dena Lyras (PhD) – Monash University. Dr Lyras is associate professor at Monash University, is one of the world’s

leading expert in C-Dfficile. Dr Lyras has spent her research career developing world-leading knowledge of C-Difficile. She

was the lead author of a seminal study published in Nature in 2009, which shed new light on the essential role specific toxins

play in causing disease, a discovery that disproved prevailing opinion.

Stellar KOL SupportPrincipal Investigators & Scientific Advisory Board

7

Page 8: Immuron Ltd. (ASX: IMC) Investor Presentation

Immuron Limited1H 2016 Developments

8

Company Overview and Pipeline

1H 2016 Developments

Upcoming Milestones

Summary

Page 9: Immuron Ltd. (ASX: IMC) Investor Presentation

9

1H2016 DevelopmentsClinical Assets – Fatty Liver Programs

NASH 50% recruitment milestones met in

NASH Phase 2 (May 2016)1

Pediatric NASHInitiation of Pediatric NASH study (3Q

2016)2

Immuron’s NASH Portfolio:(1) Phase 2 in NASH; (2) Phase in ASH and now (3) Phase 2 in

Pediatric NASH

Page 10: Immuron Ltd. (ASX: IMC) Investor Presentation

10

1H2016 DevelopmentsClinical Assets – C-Difficile

C-Difficile IMM-529 reports highly successful

pre-clinical data (January 2016)3

Strongly differentiated and unique triple action mechanism

Page 11: Immuron Ltd. (ASX: IMC) Investor Presentation

11

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In fe c te d + S O C

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

IMM-529Results of Pre-Clinical Study

All studies

statistically

significant

Demonstrated 80%

efficacy without use

of antibiotics

Demonstrated ~90%

survival rate vs. 22%

survival rate in control

group

Potentially only

therapeutic

(approved or in

development) that

can treat all phases

of the disease:

(1) Prophylaxis

(2) Treatment

(3) Recurrence

Demonstrated 80%

efficacy without use

of antibiotics

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Page 12: Immuron Ltd. (ASX: IMC) Investor Presentation

12

IMM-529Unique MOA in CDI

Heat, ethanol & UV

resistant. Survive gastric

acid, adhere to cells in the

colon & germinate

Spores – Infectious Particles

IMM-529 antibodies bind to

surface antigens on spores

& prevent adheres to host

cells & limit germination.

Vegetative Cells

Fimbriae & other surface

layer proteins (SLP)

contribute to bacterial

colonization. Fimbriae are

used to adhere to other

bacteria & to host cells

and isone of the primary

mechanisms of virulence

IMM-529 antibodies bind

to SLP on vegetative cells

& limit colonization.

Toxin B

IMM-529 antibodies

neutralise toxin B, inhibiting

toxin mediated epithelial

cell apoptosis & limit toxin

translocation into the

systemic circulation &

inflammatory cascades

Toxin B is essential for

virulence. Toxin B disrupt

the cytoskeleton and tight

junctions of intestinal

epithelial cells

Page 13: Immuron Ltd. (ASX: IMC) Investor Presentation

13

1H2016 DevelopmentsClinical Assets – Other

ColitisStart of Pre-Clinical Programs

(February 2016)4

Expansion and validation of Immuron’s Technology

Shigella

Vaccine

Collaboration with the US Army

(June 2016)5

AutismIn collaboration with leading

Australian institutions (July 2016)6

Page 14: Immuron Ltd. (ASX: IMC) Investor Presentation

14

1H2016 DevelopmentsOTC Products

US Additions of multiple customers1

Expansion of retail and distribution footprint

Page 15: Immuron Ltd. (ASX: IMC) Investor Presentation

15

1H2016 DevelopmentsOTC Products (continued)

USMultiple PR Exposure (FOX, ABC,

NBC, etc.) 2

PR driving growing brand recognition in the US

Page 16: Immuron Ltd. (ASX: IMC) Investor Presentation

16

1H2016 DevelopmentsOTC Products (continued)

ChinaLaunch of Travelan and Protectyn in

China (June 2016)3

Partnership with JD.com/QBID opens up direct-to-consumer e-

commerce channels

Page 17: Immuron Ltd. (ASX: IMC) Investor Presentation

Immuron Limited1H 2016 Developments

17

Company Overview and Pipeline

1H 2016 Developments

Upcoming Milestones

Summary

Page 18: Immuron Ltd. (ASX: IMC) Investor Presentation

Key MilestonesNear Term and Long Term Milestones

18

Milestones Timing

OTCProducts-ContinuedExpansion(NewTerritoryandSalesGrowth) Ongoing

C-DIFFICILE-OrphanIndicationFilling 3Q2016

PediatricNASH-StudyInitiation 3Q2016

C-DIFFICILE-ManufacturingofClinicalSuppliesCompleted 3Q2016

C-DIFFICILE-InitiationofPhase1 4Q2016

NASH-InterimResults 4Q2016

NASH-Endofrecruitment 4Q2016

C-DIFFICILE-OrphanIndicationGranted 4Q2016

NASH-TopLinePhaseII Mid-2017

COLITIS-ResultsofPre-clinicalStudies 2Q2017

C-DIFFICILE-Phase1Results 4Q2017

ASH-TopLinePhase2 1H2018

Page 19: Immuron Ltd. (ASX: IMC) Investor Presentation

Immuron Limited1H 2016 Developments

19

Company Overview and Pipeline

1H 2016 Developments

Upcoming Milestones

Summary

Page 20: Immuron Ltd. (ASX: IMC) Investor Presentation

Immuron LimitedInvestment Highlights

• Strong Platform – Product already launched; NIH sponsored trials; Support from leading KOLs

• Strong Pipeline with Significant Upside – Two Phase II clinical trials with differentiated profiles in multi-billion market (Fatty liver disease - NASH/ASH)

- NASH: Phase II results - Mid-2017- ASH: Phase II results - 2018; 100% funded by NIH- Pediatric NASH- C-difficile: Phase 1 results – Mid-2017- US Army Collaboration

• Generating Growing Revenues from Marketed OTC Products – Targeting WW $1.8M+ in 2016E; $3M-5M in 2017E; $30M/year peak revenues

• De-Risked Value Proposition – Significant upside from clinical assets, coupled with growing revenues from OTC business

• Strong newsflow expected over the next 6-12 months

• Success in clinic could create licensing/M&A opportunity 20

Page 21: Immuron Ltd. (ASX: IMC) Investor Presentation

THANK YOU