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Immuron Ltd — AGM Information 2016
Nov 28, 2016
35121_rns_2016-11-28_34cc0733-ce97-45d7-90d1-46fe6fb8489b.pdf
AGM Information
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2016 AGM PRESENTATION
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November 2016
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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
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FY2016
Strong execution of priority pipeline programs (NASH Phase II, C. Difficile, Travelan, & Other New Programs) through the strategic use of capital resources has placed Immuron in strong position to achieve major inflection milestones in CY2017
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Key Events 2016
Immuron’s Value Proposition
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1 Acceleration of NASH Phase II
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2 World-class results for IMM-529 in C.
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3 Expansion of our programs /
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4• Continued growth of Travelan in our
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5• Oversubscription of $6M rights issue
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- 6• Strong LM&A market NASH activities
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1
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Cumulative Randomization
120
104
100
Major Amendment to 95
Phase II clinical trial 89
80 80
68
60 61 [64]
53
48
40 39 [41] [44]
31 [34] [35]
23
20 19
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9
7
0 0 0 1 2
Dec-14 Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15 Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16 Jul-16 Aug-16 Sep-16 Oct-16 Nov-16 Dec-16
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Drivers
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2
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2
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Spores – Infectious Particles
IMM-529 antibodies bind to Heat, ethanol & UV surface antigens on spores resistant. Survive gastric & prevent adheres to host acid, adhere to cells in the cells & limit germination. colon & germinate
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
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3
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Dosing Development Status
Program MOA Indication Notes
Form Pre-Clinical Phase 1 Phase 2 Phase 3
IMM-124E Anti-LPS Oral NASH Top line results in mid-2017
IMM-124E Anti-LPS Oral ASH NIH Funded; UVA
1 IMM-124E Anti-LPS Oral Pediatric NASH NIH Funded; Emory University
IMM-529 ToxinB antagonist Oral C. difficile Start of Phase 1 in 2017
2 Several Shigella vaccine Oral Shigella infections In collaboration with US Army
3 Several Campylobacter; ETEC Vaccines Oral Campy/ETEC infections In collaboration with US Navy
4 TBD Anti-LPS Oral Colitis In collaboration with Dr Rogler
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Building one of the most compelling fatty-liver portfolio in the industry Deepening our anti-infective portfolio
Supported by world-class collaborations with minimal capital investment
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Travelan Growth Continues
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WW Growth
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FY2016 Sales total $1.2M (up 3% from FY2015)
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July 2016 – October 2016, sales are outpacing last year’s sales (same
period)
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New marketing strategies developed for Australia and the US. Added
marketing team with mixed skills set (traditional media; social media)
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WW sales up +62%; +34% when smoothing out Canada’s order
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5
June 2016 Rights Issue
NASDAQ Listing Rationale
✔
✔
NASDAQ Listing Progress
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6
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(2010) Acquired Arresto for US$225m + potential for future payments. Phase I asset (LoxL2 antibody) targeting NASH, IPF
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(2012) Regulus: Preclinical. AZN paid US$125m per compound
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(2014) Acquired Lumena for US$260m. Company had two
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(2015) Pharmaxis: Acquired NASH asset in Phase I. A$39m
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value US$470m. Undisclosed upfront and milestones
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(2016) Acquired Tobira for ~US$330M upfront (8.2x market
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(2016) Akarna: Licensed Preclinical NASH asset for ~US$50M
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NASH: The most severe form of liver injury in the spectrum of nonalcoholic fatty liver disease (NAFLD)
Market Estimated to top $35B-$40B WW by 2030 driven by Size obesity epidemic (Deutche Bank – 2014)
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NAFLD Up to 145M People
NASH Cirrhosis 25M People 1.2M people F0 F1 F2 F3 F4
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Only asset in development that due to its safety profile can potentially target all spectrum of the disease including the mild/moderate patients and also be used
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IMM-124E in combination with other agents currently in development
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No safety concerns to date to limit chronic / long term use
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July 1 2015 to 25 Nov 2016
Share Performance
Share Price Performance: 1 July 2015 to 25 Nov 2016
Travelan US Sales C-Diff Pre-
US OTCQB Partnerships Signed Clinical Results
Listing
NASH Update
US CVS and McKesson 100 Patients
Travelan Partnerships
Rights Issue Closed
Over-subscribed
NASH Recruitment
Update
C-Diff Pre-
Clinical Results
RedChip Research
Report Released
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| Key Milestones | |
|---|---|
| Near-Term and Medium-Term Milestones | |
| Major Milestones | Timing |
| OTC Products - Continued Expansion (New Territory and Sales Growth) | Ongoing |
| NASH Phase II - 120 Patients Randomized | Dec 2016/Jan 2017 |
| NASDAQ Listing and US Capital Raise | 1Q2017 |
| NASH Phase II - Interim Results (minimum of 60 patients) | Late 1Q2017 |
| C-DIFFICILE - Manufacturing of Clinical Supplies Completed | 2Q2017 |
| C-DIFFICILE - Initiation of Phase 1/2 | 2Q2017 |
| NASH - Top Line Phase II | 2H2017 |
| C-DIFFICILE - Orphan Indication Granted | 2017 |
| ASH - Top Line Phase 2 | 2018 |
| C-DIFFICILE - Phase 1/2 Results | 2018 |
| Other Major Milestones (Timing TBD) | |
| Results of Phase II Pediatric NASH | Expected 2017 |
| Results of IMM-124E Mechanism of Action Studies | Expected 2017 |
| Publication of C. Difficile Preclinical Results in Major Publication | Expected 2017 |
| Results of US Army and US Navy Trials | Expected 2017 |
| Results of Colitis Preclinical Studies | Expected 2017 |
| Other Major Initiatives (Timing and Level of Activity TBD) | |
| Results of LM&A Activities | TBD |
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Major Company Inflexion Points
Demand for Potentially + NASH Assets Transformative FY2017
Completion of NASH Phase II Recruitment
NASH Phase II Interim Analysis
NASH Phase II Results
NASDAQ Listing/ Access to US Capital Markets and US Capital Raise
Advancement of Anti-Infective Portfolio
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THANK YOU
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