Immuron Presentation

39
COMPANY PRESENTATION November 2015

Transcript of Immuron Presentation

Page 1: Immuron Presentation

COMPANY PRESENTATION

November 2015

Page 2: Immuron Presentation

Forward-­Looking Statement

Certain statements made in this presentation are forward-­looking statements and are based onImmuron’s current expectations, estimates and projections. Words such as “anticipates,” “expects,”“intends,” “plans,” “believes,” “seeks,” “estimates,” “guidance” and similar expressions are intended toidentify 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 commercializingtechnology. As a result, actual results could materially differ from those expressed or forecasted inthe forward-­looking statements.

The forward-­looking statements made in this presentation relate only to events as of the date onwhich the statements are made. Immuron will not undertake any obligation to release publicly anyrevisions or updates to these forward-­looking statements to reflect events, circumstances orunanticipated events occurring after the date of this presentation except as required by law or by anyappropriate regulatoryauthority.

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Immuron LimitedCompany Overview

• Proven Platform – IP protected; Wide therapeutic possibilities

• In-Market OTC Product – Generating growing revenues with large worldwide distribution upside

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

• Unique Safety Profile – No significant side effects; GRAS rated

• Market Cap Comparables for NASDAQ Companies Is Over US$100M – One phase two

• Large Valuation Upside – Company currently valued at ~AUS$35M3

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Causing:- Impaired gut epithelial integrity- Increased gut permeability- Increased LPS serum levels

NASH – Pathogenesis

Unique PropertiesGut flora imbalance

Overgrowth of intestinal bacteriaincl. gram-negative bacteria

Drives:- Increased BT from lumen into liver through portal vein (70% of blood flow to liver)

- Increased hepatic / systemic inflammatory response (e.g., TNF)

- Induction of systemic inflammation by innate immune cells in the gut

- Increased concentration of immunoglobulin (mainly IgG)

- Strong anti-LPS properties, Cross reactive- Immuno-active adjuvants that promote regulatory T-Cells; suppress systemic inflammation

- Not absorbed in the blood- Immune modulation without immune suppression

Prevents bacteria spread:

Binds and neutralizes wide

range of LPS

Allows lumen to rebuild integrity

Decreasing BT / LPS levels

resulting in decreased liver inflammation

Decreases liver inflammation - Improves liver function

promotes regulatory T cells systemically that suppress

inflammation at site

Alter the function of innate immune

cells in the gut

Obesity is associated with

a chronic inflammatory

state

IMM-124E – MOA

1

2

Decrease systemic and local inflammation

Liver damage contributing to progression of steatosis then NASH then onto fibrosis and eventually cirrhosis

Systemic inflammation: Inflammatory cells and cytokines secreted systemically

IMM-­124ECompelling MOA in NASH

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Immuron LimitedInvestment Highlights

Significant and Growing OTCBusiness

- Travelan: Only clinically proven preventive product for Traveler’s Diarrhea

- Early success: $1M+ sales in AUS/CAN; USA launch (2Q2015) with strong sales commitment; Reg in China

- Worldwide market estimated at $600M+

Strong Pipeline with Blockbuster Potential

- 2 Phase IIs in Fatty-Liver Disease (NASH) and ASH – No approved therapies; $35-$40B market by 2030; ASH study completed funded by NIH

- Pre-Clinical C-Difficile – Targeting toxin B, spores and vegetative cells; $Multi-billion indication

Significant Near Term Inflexion Points

- Travelan growth in US and other territories; NASDAQ listing; NASH progress; Results of C-Difficile pre-clinical program

Valuation Gap- Average PHII NASH Peer Companies: $260M- Average C-Diff Peer Companies: $362M

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PipelineStrong Asset Portfolio Mix

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Pre-Clinical Phase 1 Phase 2 Phase 3 On Market

Launched in multiple geographies

Fatty-Liver Disease (NASH) IMM-124E

Alcoholic Steatohepatitis(ASH) (Funded by the NIH)IMM-124E

C-DifficileIMM-529

IMM-124E

IMM-124E

Diabetes

Colitis

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FY2015 Year in Review

• US: Launch; 4 distribution partners signed• Canada: Launch by Paladin (Endo)• China: Distribution and registration agreement signed• Protectyn: Launch of Liver Health brand in Australia• WW: Multiple partnership discussions ongoing

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OTC

Rx

Corporate

• NASH: Start of Phase II; Added new US and Israel sites; 36 patients enrolled; 10 in screening

• ASH: Start of Phase II; 22 patients recruited; Funded by NIH• NASH/ASH: No significant AEs reported to date• C-Difficile: Start of pre-clinical program

• Capital Consolidation Completed• Hiring of key management staff (Head of Medical / NASH;

COO/CSO)

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FY2015 Share Performance

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Share Price Performance (July 1, 2014 – Nov 24, 2015)

RedChip Research Report Released

Travelan US Launch

Travelan China Agreement Signed

NASH Recruitment Update

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FY2016 Major Goals and Objectives

• US: Accelerate market penetration• China: CFDA approval; Push products through more

creative channels (Travelan/Protectyn)• Protectyn: Launch in other territories• Expand Geographic partners: Korea, EU, Japan, etc.

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OTC

Rx

Corporate

• NASH: Completion of recruitment• C-Difficile: Start of Phase 1/2 • Diabetes: Start of Phase 1/2 • Colitis: Start of pre-clinical studies

• NASDAQ Listing

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FY2016 SummaryFocus on Three Key Valuation Levers to Rerate Valuation

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Expand and Maximize OTC Business

Execute Prioritized Rx Program

NASDAQ Listing and Careful Capital

Allocation

Dataroom Open for Scientific Due Diligence

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FinancialsStrong Financial Position

• Ticker: ASX (Australia): IMC

• Share price (11/14/15): $0.46

• Liquidity: $700,000 – $800,000/month

• Shares outstanding: 75M

• Market Cap: $35M

• Cash (as of 30/06/2015): $3.1M

• Debt: $011

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PEER COMPARISONNASH and C-­Diff Comparables

C-Difficile Peer Comparables

NASH Peer ComparablesCompany Ticker Share

Price Share Price (52w

High/Low) Asset Stage Cash Debt Market Cap EV

Intercept ICPT $167.64 $128.50 -­‐ $314.88 Phase III $700M $0 $4.1B $3.4BTobira TBRA $10.17 $7.20 -­‐ $24.31 Phase II $69M $15M $111M $57MGalectin GALT $2.40 $1.68 -­‐ $4.68 Phase II $21M $0 $57M $36MGalmed GLMD $8.22 $4.58 -­‐ $13.50 Phase II $23M $1M $95M $71MGenfit GNFT $37.99 $24.61 -­‐ $70.64 Phase II $67M $4M $978M $915MConatus CNAT $3.18 $2.70 -­‐ $11.74 Phase II $15M $1M $62M $48MGilead GILD $106.61 $85.95 -­‐ $108.05 Phase II $15B $22B $155B $162B

Average (not including Gilead) $901M $754MAverage (Phase IIs, not including Gilead) $260M $225M

Company Ticker Share Price

Share Price (52w High/Low) Asset Stage Cash Debt Market

Cap EV

Seres Therapeutics MCRB $33.00 $25 -­‐ $52 Phase II $222 $5 $1.26B $1.04BAssembly Biosciences ASMB $9.14 $6.51 -­‐ $20.50 Pre-­‐Clinical $66 $12 $154M $100MSynthetic Biologics SYN $2.81 $1.39 -­‐ $4.32 Phase II $32 $10 $230M $208MSummit Therapeutics SUMM.L $10.73 $8.84 -­‐ $14.78 Phase II $41 $0 $131M $90MAmpliPhi Biosciences APHBD $5.86 $2.75 -­‐ $16.75 Lead Opt. $12 $3 $33M $24M

Average $362M $292M

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OTC BUSINESS

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Travelan®A Unique Preventative Product

Without Travelan®: Bacteria attach to gut wall

and infect

With Travelan®: Bacteria neutralized by Travelan®

antibodies

The only therapy that prevents Travelers’ Diarrhea by up to

90%

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• Marketed in the US, Australia by Immuronand by Paladin/Endo in Canada

• Global market estimate: US$ 600M -­ 1.2B

• All-­natural product;;

• Clinically proven

• SAFE

• OTC

• Strong brand loyalty

• Multiple life-­cycle opportunities

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Travelan®A Growing Global Brand

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Regional Brand:–Launched: US, CA, US– In registration: China

and South Korea

Markets

Products

CustomersConsumer Focused:

–Travel Clinics–Pharmacies–Retail

One Brand:–Travelan

Today Future

Global Brand:–Expand to: Europe, Russia, Rest

of Asia,–Own marketing and/or Licensing

All Relevant Channels:–Consumer + –Corporate, institutions,

schools, military, etc.

Multiple Brands:–Pathogen(s) specific (e.g.,

Cholera; regional variances)–Customized (e.g., Military)–Combinations (e.g.:+probiotics)

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NASH

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• 25% of the US population has NAFLD

• 5% of the population will develop NASH

• No treatments approved

• All major pharma looking to get into the game

• Most treatments ‒ Do not capture the entire disease population ‒ Limited efficacy‒ Severe / unknown side effect profile

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Estimated Market Size: $35B - $40B USD by 2025 (Deutsche Bank)

NASHA $35B-­$40B Global Opportunity

IMM-124E Can Potentially Treat All Spectrum of Fatty-Liver Disease

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Bile Acid Shire -­ LUM-­002Intercept -­ Obeticholic acid, modified bile acid

Galmed -­ Aramchol, Conjugate of Fatty acid and Fatty bile acid

Anti-­fibrotic

Gilead -­ Simtuzumab, anti-­fibrotic

Galectin -­ galectin proteins

Anti-­Inflammatory + (anti-­inflammatory, anti-­diabetic, cholesterol control, FFA)

Immuron – Oral enriched with Anti-­LPS Abs

Tobira -­ CCR2 / CCR5 inhibitorGenfit -­ Peroxisome proliferator activated receptor alpha

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NASH – Competitive LandscapeRoom Exist for Many Therapies, and Combinations

IMM-124E DifferentiationCompetition

• Shuts down the underlying cause of NASH, not just one pathway

• Superior safety profile

• No safety concerns limiting chronic / long term use

• Can be used across the spectrum of NASH / NAFLD

• Can be used in combination with other agents

• Oral vs. IV/SubQ

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NASHMULTI-­CENTER, MULTI NATIONAL DOUBLE BLIND 2-­DOSE PLACEBO CONTROLLED

PRIMARYENDPOINTS: CHANGES IN LIVER FAT CONFIRMED BY MRI and CHANGES IN ALT

LEAD PRINCIPALINVESTIGATOR: ARUN SANYAL

22 SITES RUNNING(USA, Australia and Israel) & 3 MORE COMING

RECRUITING 120 SUBJECTS

35 PATIENTS ALREADY RANDOMIZED

NASH Phase IIDesign and Recruitment

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C-­DIFFICILE

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Center for Disease Control (CDC)Antibiotic Resistance Threats in the United States, 2013

C-­DifficileA Significant Unmet Need

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-­ IMM-­529 is combination vaccine that targets: Toxin B, C-­Diff spores and C-­Diff vegetative cells

-­ Murine studies performed at Monash University, Australia:-­ Prophylaxis – Demonstrating effectiveness in 80% of cases-­ Treatment – Prevented death in 80% of cases

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TreatmentProphylaxis

IMM-­529Toxin B Vaccine Developed to Defeat C-­Diff

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SUMMARY

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Newsflow12 – 18 Months

• OTC Business– Expansion of Travelan in the US

– Approval and launch in China

– Expansion / Launch into EU

– Product line extensions

• Therapeutics– NASH: Meeting recruitment target (June 2016);; PHII results (1H2017)

– C-­Difficile: Results of pre-­clinical studies;; Phase 1/2 start of results

– Diabetes: Start and results of Phase 1/2

– Colitis: Results of pre-­clinical studies

• Corporate– NASDAQ listing

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Immuron LimitedInvestment Highlights

Significant and Growing OTCBusiness

- Travelan: Only clinically proven preventive product for Traveler’s Diarrhea

- Early success: $1M+ sales in AUS/CAN; USA launch (2Q2015) with strong sales commitment; Reg in China

- Worldwide market estimated at $600M+

Strong Pipeline with Blockbuster Potential

- 2 Phase IIs in Fatty-Liver Disease (NASH) and ASH – No approved therapies; $35-$40B market by 2030; ASH study completed funded by NIH

- Pre-Clinical C-Difficile – Targeting toxin B, spores and vegetative cells; $Multi-billion indication

Significant Near Term Inflexion Points

- Travelan growth in US and other territories; NASDAQ listing; NASH progress; Results of C-Difficile pre-clinical program

Valuation Gap- Average PHII NASH Peer Companies: $900M- Average C-Diff Peer Companies: $362M

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Dr Roger AstonChairman

Daniel PollockNon-­executive Director

Stephen AnastasiouNon-­executive Director

Peter AnastasiouExecutive Vice-­Chairman

Thomas LiquardChief Executive Officer

Dan Peres, MDHead of Medical

Jerry Kanellos, PhD COO & Scientific Officer

Reza MoussakhaniManufacturing Quality Director

Dr. Yaron IlanMedical and Scientific Advisor

Roger has more than 20 years of experience in the pharmaceutical and biotech industries. He was the Founding Chief Executive Officer and a Director of Mayne PharmaGroup Limited.

Daniel is an internationally experienced lawyer admitted in both Scotland and Australia, with significant commercial expertise in overseas new market entries, distribution agreements and corporate start-­ups.

Stephen has extensive experience in general management, marketing and strategic planning in the healthcare industry, formerly with KPMG.

Peter is the founder of major shareholder Grandlodge. He has had 20 years of successful investment across many sectors. He started his first Biotech at age 23, and has a strong philanthropic portfolio.

Thomas spent the majority of his career at Pfizer in New York in various commercial positions and was COO then CEO of Alchemia Limited, an oncology ASX biotech company.

Dan had been leading Medical Device and Pharma companies in their clinical stage since 2008. a Physician in origin has years of experience in management and medical development.

Dr Jerry Kanellos has over 20 years of experience in the pharmaceutical and biotech industries including CMC, operations and business development. He has held senior roles at CSL and Transbio Limited.

A professional Operations manager with extensive experience in implementation of project / quality and process improvements including with Hospiraand Sigma Pharmaceuticals.

Dr. Yaron Ilan, MD, is a Director-­Inpatient Medicine Department at Hadassah Medical Center. He holds more than 50 patents and co-­authored more than 240 articles.

Corporate StructureThe Board and Management

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THANK YOU

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APPENDICES

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Extended Market ProtectionPatent Portfolio and Biologic Pathway Confers Extended Protection

Patent Portfolio Biologics Protection

• Immuron’s drugs are considered “biologics” by the FDA and as such will be reviewed under the Biologics License Application (BLA)

• In the US, this will confer Immuron’s new drugs 12 years of market exclusivity, offering investors a long revenue tail

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Platform OverviewDeveloping Customized Vaccines Targeted at Diseases

Vaccine is Developed Targeting Specific

Pathogens

Cows Are Immunized, Creating

HyperImmuneColostrum

HyperImmuneColostrum Is Collected

1

2

3

Proprietary methods to significantly increase levels of antibodies of choice

Cows are immunized with select antigens in the last trimester of pregnancy to produce

‘HyperImmunecolostrum’ (HIC)

HIC contains antibodies to all the pathogens and antigens to which the cows have been exposed to, including the antibodies against the antigens used to immunize the cows;

Product is also high in adjuvants

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Oral ImmunotherapyA differentiated Approach

An approach to treat autoimmune, infectious and inflammatory disease through the oral delivery of antibodies and adjuvantsAn active process that uses the inherent ability of the GI tract's immune system to control unwanted systemic immune responses, by inducing systemic regulatory T cells to suppress inflammation

Disease Specific Antibodies+

Colostrum Adjuvants Induction of regulatory T-

cells

Target organs• Liver• Pancreas• Adipose Tissue• Brain

Presented in the Bowel

Oral Immunotherapy• No side effects or toxicity• Not associated with general

immune suppression• No risks of severe infection

or malignancy• Easily tolerated by patients • Platform for a wide range of

diseases

1

2

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Travelan®Cross-­Reactive Antibodies to Gram-­Negative Bacteria

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Traveler’s Diarrhea - Pathogens

Shah, Dupont, Ramsey; Am. J. Trop. Med. Hyg., 80(4), 2009, pp. 609–614Global Etiology of Travelers’ Diarrhea: Systematic Review from 1973 to the Present

• Studies conducted with the University of Maryland demonstrated that Travelanis cross-reactive to other gram-negative bacteria

• Travelan therefore offers protection against other pathogenic bacteria such as Shigella and Salmonella that cause Traveler’s Diarrhea

• Ability to broaden appeal and find new customers (e.g., military)

Travelan: Beyond E-Coli

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Causing:- Impaired gut epithelial integrity- Increased gut permeability- Increased LPS serum levels

NASH – Pathogenesis

Unique PropertiesGut flora imbalance

Overgrowth of intestinal bacteriaincl. gram-negative bacteria

Drives:- Increased BT from lumen into liver through portal vein (70% of blood flow to liver)

- Increased hepatic / systemic inflammatory response (e.g., TNF)

- Induction of systemic inflammation by innate immune cells in the gut

- Increased concentration of immunoglobulin (mainly IgG)

- Strong anti-LPS properties, Cross reactive- Immuno-active adjuvants that promote regulatory T-Cells; suppress systemic inflammation

- Not absorbed in the blood- Immune modulation without immune suppression

Prevents bacteria spread:

Binds and neutralizes wide

range of LPS

Allows lumen to rebuild integrity

Decreasing BT / LPS levels

resulting in decreased liver inflammation

Decreases liver inflammation - Improves liver function

promotes regulatory T cells systemically that suppress

inflammation at site

Alter the function of innate immune

cells in the gut

Obesity is associated with

a chronic inflammatory

state

IMM-124E – MOA

1

2

Decrease systemic and local inflammation

Liver damage contributing to progression of steatosis then NASH then onto fibrosis and eventually cirrhosis

Systemic inflammation: Inflammatory cells and cytokines secreted systemically

IMM-­124ECompelling MOA in NASH

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NKT

Macrophage

DCDC

DCM cell

B cell folliculeInterfollicular T cell area

Perifollicular area

Lamina Propria

Alteration of the GI immune system

Systemic immune imbalance

Systemic chronic inflammation

Bacterial antigens / Endotoxin

Based on: Ilan Y, World J Gastro, 2012 Hand TW. Science 2012;337.34

The “Leaky Gut”Fueling Inflammation

The “Leaky Gut” Translocation

• Translocation is not purely passive

• It occurs via transcellular pathways activated in enterocytes by inflammatory or metabolic stresses

• Endotoxin/bacterial antigens play a role in activation of inflammatory pathways

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Down regulation of inflammation in liver and other organs (pancreas, Bowel)

Modified from: Ilan Y, PNAS, 2010

IMM-­124EAttacking Inflammation in Multiple Ways

Oral Anti-LPS + Adjuvants (Glycolipids)

Activates gut innate immune cellsShut down bacterial translocation

DCMacrophage

Promotes Treg

Antibodies presentation at

the gut

T Cells

T Regs

TGF-βIL10

NKT Cells

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Mizrahi M. 2013, AASLD; Hepatology751A36

Fibrotic LiverCCl4 (carbon tetrachloride)

IMM-124E LiverCCl4 (carbon tetrachloride)

IMM-124E

IMM-­124EPre-­Clinical: Significant Impact on Liver Fibrosis

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Group A: Control

Group D: Treated

Group B: Naïve anti LPS

Group C: Treated

0

1

1.8

3.4

0

0.5

1

1.5

2

2.5

3

3.5

4

A B C D

*p<0.0009^ p<0.0003

Group A: Control

Group D: Treated

Group B: Naïve anti LPS

Group C: Treated

2.4

0.66

1.4 1.33

0

0.5

1

1.5

2

2.5

3

A B C D

*p<0.02^ p<0.01

Decreased Portal Inflammation

Mizrahi M. 2013, AASLD; Hepatology751A

Improved Metavir Fibrosis Score

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IMM-­124EPre-­Clinical: Improves Inflammation and Fibrosis Markers

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IMM-­124EPhase I/IIa: Inflammatory Biomarkers

Mizrahi M. J Inflamm Res. 2012

Day 1 Day 30Increased GLP1 and Adiponectin

Increased CD4+CD25+FOXP3+ TREGS

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Mizrahi M, J Inflamm Res. 2012;5:141-­‐50 39

Improved Liver Enzymes Improved HBA1C, OGTT and HOMA

IMM-­124EPhase I/IIa: Improves Liver Function and Insulin Resistance

Results of a Phase I/IIA clinical trial; N=10 30 Days Treatment: NO SAFETY ISSUES REPORTED