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Immuron Ltd — Investor Presentation 2014
Jan 21, 2014
35121_rns_2014-01-21_e942be9f-373a-4bf3-999c-f21d91a8f5d1.pdf
Investor Presentation
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Investor Presentation January 2014
Chief Executive Officer - Amos Meltzer
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ORAL IMMUNOTHERAPY
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Certain statements made in this presentation are forward-looking statements and are based on Immuron’s current estimates and Words such as expectations, projections. "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 to release any obligation publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or events after the date of this as unanticipated occurring presentation except required by law or by any appropriate regulatory authority.
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Safe and proven technology platform
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Rich product pipeline
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Travelan[®] approved and already in market generating sales
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Revenues growing and set to accelerate.
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2[nd] product: Fatty liver / NASH
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an expected off-label use $3.2B market by 2016 in the US alone with no current treatment
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Very positive Phase I/IIa results
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FDA granted IND for Phase IIB trials for NASH
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Red hot focus on companies developing NASH after Intercept Pharmaceuticals recently leapt from $1.5B to $8.5B on positive NASH trial.
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3[rd] product: Preventative treatment for C. diff bowel infections.
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Section 1
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Company Overview
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New Cornerstone investors
| ASX Code | IMC | |||||||||||||||||
| Shares on Issue | 1,053,679,310 | |||||||||||||||||
| Current Share price | 1.0 c | |||||||||||||||||
| Top | 20 holders | 55.4% | ||||||||||||||||
| **Rank ** | Name | Units (m) | % of Units | |||||||||||||||
| 1. | GRANDLODGE PTY LTD | 101.6 | 9.8 | |||||||||||||||
| 2. | MR PETER ANASTASIOU + | MRS KRISTINE PATRICIA ANASTASIOU | 66.7 | 6.4 | ||||||||||||||
| 3. | CHIMAERACAPITAL LIMITED | 65.0 | 6.3 | |||||||||||||||
| 4. | HADASIT MEDICAL RESEARCH SERVICES & DEVELOPMENT LTD | 59.2 | 5.7 | |||||||||||||||
| 5. | FIFTY-FIFTH LEPRECHAUN PTY LTD | 50. 0 | 4.8 | |||||||||||||||
| 6. | CAPITAL CONCERNS PTY LIMITED | 34.9 | 3.37 | |||||||||||||||
| 7. | MR DAVID ANTHONY PLUSH | + MRS ANN LOUISE PLUSH | 33.4 | 3.22 | ||||||||||||||
| 8. | G & N LORD SUPERANNUATION PTY LTD | 20.4 | 1.97 | |||||||||||||||
| 9. | INSYNCINVESTMENTSPTY | LTD <WEEKLEYSUPER FUND | NO1 A/C> | 19.0 | 1.83 | |||||||||||||
| 10. | MR HAMISH SALMON + MRS BRIGETTE MCGUIRE | 16.0 | 1.55 | |||||||||||||||
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Board and Management
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- Chairman - Dr Roger Aston
Founding CEO of Mayne Pharma Group; experience with FDA and EU product registration, clinical trials, global licensing agreements & fundraising
- Non-executive Director – Daniel Pollock
Internationally experienced lawyer with significant commercial expertise in new market entries into overseas markets, distribution agreements and corporate start-ups.
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Non-executive Director – Stephen Anastasiou Extensive experience in general management, marketing and strategic planning in the healthcare industry, formerly with KPMG.
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Chief Executive Officer – Amos Meltzer
Technology commercialisation specialist with over 18 years experience in a diverse range of life science and other businesses.
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The Platform
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Points of Difference
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Product Other roducts p Natural product � Synthetic product
-
Natural product
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Powerful systemic immuno-modulatory � Immune modulation can be achieved
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effect
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� Does not suppress immunity � Can suppress immunity
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Proven: no side effects or toxicity
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Easily tolerated by patients
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Some side effects or toxicity
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Not easily tolerated by patients
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Polyclonal Abs combat infectious diseases � Monoclonal Abs are strain specific
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effectivel y
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Oral administration
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Oral administration
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Longer and substantially more costly
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� Rapid Development Cycle development
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HIC: multiple regulatory pathways, multiple � Ordinarily: one regulatory pathway
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revenue streams
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| Indication | Research | Pre-Clinical | Phase I | Phase II | Phase III | Market | |
|---|---|---|---|---|---|---|---|
| Traveller’s | |||||||
| Diarrhea | |||||||
| NASH | |||||||
| (IMM-124E) | |||||||
| ASH | |||||||
| (IMM-124E) | |||||||
| Clostridium difficile | |||||||
| infection | |||||||
| Other Projects: | |||||||
| Related to Liver | |||||||
| Related to IMM-124E | |||||||
| And other indications |
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Section 2
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TRAVELAN
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TRAVELAN
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The last 3 years
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- Unique: Prevents travellers’ diarrhoea
All other products are treatments and typically start to provide benefits only 48-72 hours after the onset of an attack
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All Natural
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Accessible: over-the-counter.
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It works: Clinically proven, >90% efficacy
Traveller’s diarrhoea market estimated between $600M and 1.2B globally
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TRAVELAN
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In Market, the last 3 years
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Takeda shed its License
License with Takeda
pharmacy sales force Termination
6,000
5,000
4,000
3,000
2,000
1,000
0
TRAVELAN
Jan-10 Feb-10 Mar-10 Apr-10 May-10 Jun-10 Jul-10 Aug-10 Sep-10 Oct-10 Nov-10 Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Sep-11 Oct-11 Nov-11 Dec-11 Jan-12 Feb-12 Mar-12 Apr-12 May-12 Jun-12 Jul-12 Aug-12 Sep-12 Oct-12 Nov-12 Dec-12 Jan-13 Feb-13 Mar-13
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TRAVELAN
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Australia
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Previous arrangement:
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Immuron is commanding substantially higher margin
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TRAVELAN
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Going Forward
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Approved
In Discussion
In Discussion
Variousstages of<br>regulatory<br>
process<br>Licensed In Discussion<br>
In Revenue `
Proceeding through
13
regulatory process
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Section 3
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IMM-124E for NASH
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NASH
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How big is the opportunity?
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Intercept Pharmaceuticals (NASDAQ: ICPT) $1.5B before more than quadrupling overnight on NASH trial results
What this mean for Immuron:
Market cap: $8.5B
Scientifically
- NASH is addressable
Commercially
January 9, 2014: Announces successful results in NASH clinical trials
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There is a huge, unmet opportunity.
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• NASH on the radar.
Comparison:
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Intercept’s drug increases bad cholesterol, reduces good cholesterol
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Immuron’s drug has shown to do the opposite.
Market cap: $1.5B
Immuron may still be best in class
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NASH
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The Epidemic
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NASH – An Epidemic of
NCID : >25M AMERICANS WILL HAVE NASH BY 2025
THERE IS NO APPROVED DRUG
ESTIMATE: OFF-LABEL MARKET ~$2B
Fatty liver: one of most common liver diseases in the industrialized world
Non-Alcoholic Steatohepatitis (NASH): the most severe form of liver injury in the spectrum of non-alcoholic fatty liver disease
Chronic Inflammatory Disease, associated with Obesity, Type II Diabetes (insulin resistance), Hyperlipidemia
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1 in 5 NASH patients develop liver cirrhosis Leads to liver cancer
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IMM-124E for NASH
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Ready to go: Phase 2B trial
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Based on existing technology:
-
Mature manufacturing process
-
High Safety profile
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IND cleared by the FDA: Immuron set to commence clinical trials Preparations under way
Investigators identified
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IMM-124E has been independently validated: selected as only 1 of 3 products to be studied for alcoholic steatohepatitis (ASH) under a fully funded NIH TREAT study
NASH remains a very large unmet medical need of significant interest to the medical profession and the pharmaceutical industry
17
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IMM-124E for NASH
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Mechanism of Action
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Oral Immunotherapy: An approach to treating autoimmune, infectious and inflammatory disease through the oral delivery of antibodies
Scientific support for Immuron’s approach continues to grow
Immuron has the right product at the right time
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Clinically Proven
120.0 120.0
INTRODUCTION 100.0 100.0
9.0 Day Day
• disorder associated with insulin resistance and hepatic steatosis. Metabolic syndrome is a chronic inflammatory 80.060.040.0 80.060.040.0 8.07.06.05.0 101054 49.01% CD4 1 5.66% 30
• Anti LPS colostrum ( Imm124-E) is a bovine 20.00.0 20.00.0 4.03.0 103
colostrum raised against LPS from an E.coli Day 1 Day 30 Day 1 Day 30 2.0 102
extract. Administration of Imm122-E improved cholestatic liver enzymes levels (7/10 Pt. p<0.002) 1.0 -101 44.94% 0.39%
0.0
• Imm124-E was shown to exert an 10.0 Day 1 Day 30 -102100102 CD25 - PE103 104 105
immunomodulatory effect and to alleviate Increased N. of CD4+CD25+ cells (7/10 Pt. p<0.001)
target organ damage in animal models. 10.0 8.0 3.5 Day 1 Day 30
• Aim: To determine the safety and efficacy of 8.0 6.0 3.0
oral administration of anti LPS colostrum to 6.0 4.0 2.5
patients with insulin resistance and NASH. 4.0 2.0
2.0 2.0 1.5
0.0 0.0 1.0
0.5
METHODS Day 1 Day 30 Day 1 Day 30 0.0
• In an open-label trial, 10 subjects with biopsy proven NASH and insulin resistance or Improvement in HBA1C levels (9/10 Pt. p<0.001) 8.0 Improvement in FGT levels (6/10 Pt. p<0.06) Increased N. of CD4+CD25+FOXp3 cells (7/10 Pt. p<0.001) Day 1 Day 30
diabetes type II were orally treated for 30 days with Imm124-E (600 mg a day). 1000 7.06.05.0 5.04.0 Day 1 Day 30
• Subjects were monitored for serum levels of 500 4.03.0 3.0
insulin, adiponectin, and GLP-1 and for the 2.0
0
changes of expression in peripheral 1.0 2.0
regulatory T cells (Tregs). Day 1 Day 30 0.0
Day 1 Day 30 1.0
• Clinical effect was evaluated by: OGTT, liver Improvement in early insulin secretion (6/10 Pt. Improvement in cholesterol levels 9/10 Pt.
p=0.07) p<0.05)
enzyme, and lipid profile. The comparison 8.0 14 0.0
was done between day 1 and day 30 for each patient. 6.0 1210 Increased N. of CD4+CD25+HLA-DR Day 1 Day 30 cells (8/10 Pt.p<0.001)
4.0 8
• 6
Data analysis was carried out on responders. CONCLUSION
2.0 4
2
RESULTS 0.0 0 • Oral administration of Imm124-E exerts an
immunomodulatory effect in subjects with insulin
100.0 70.0 Day 1 Day 30 Day 1 Day 30 resistance or type 2 diabetes, hyperlipidemia and
80.0 60.0 Improvement in LDL levels (8/10 Pt.p=0.07) Improvement in GLP1 secretion (6/10 Pt. NASH.
50.0 10000 p=0.07)
60.0 40.0 8000 60.0 • The anti-inflammatory effect and promotion of
40.0 30.0 50.0 peripheral Tregs, were in some of the responders
20.0 6000 40.0 associated with alleviation of insulin resistance and
20.0
10.0 4000 30.0 NASH in these subjects.
0.0 0.0 2000 20.0
Day 1 Day 30 Day 1 Day 30 0 10.00.0 DISCLOSURE
Administration of Imm124-E improved hepatocellular liver Day 1 Day 30 Day 1 Day 30 * Medical Director of Immuron.
enzymes levels p<0.04. Increased Adiponestin secretion (8/10 Pt.p=0.08) Increased N. of CD4+CD62+ cells (6/10 Pt. The study was supported by Immuron Ltd, Australia
p<0.002)
AP levels (u/L) GGT levels (u/L)
C D 4 - F IT C
ga te d c e lls (% )
C
1
b A
H FPG (mmol/L)
gated cells (%)
l ) M/dL) µ
a fte r i n (p g / m )
Cholesterol levels (
I n s u l i n l e v e l s 3 0 m
g a te d c e lls (%
M/dL) µ 3(pM, X10)
Serum GLP-1
Serum LDL (
L T le v e ls (u /L )
A A S T le v e ls (u/L)
gated cells (%)
Adiponectin (ng/ml)
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Section 4
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R&D PIPE LINE
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Clostridium difficile (C.diff): a bacteria normally found in people’s intestines.
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Certain circumstances C.diff can multiply and its toxin causes illness such as diarrhoea & severe inflammation of the bowel.
C.diff infection accounts for:
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considerable increases in length of hospital stays.
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more than US$3.2 billion in health care costs each year in the United States.
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IMM-529 for Clostridium Difficile
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Very encouraging results to date
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IMM-529 under collaboration with Monash University
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All data owned by Immuron
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IMM-529 demonstrated positive pre-clinical results:
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Encouraging preventative data
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Treatment effect currently being investigated
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Proprietary vaccine given to cows being improved
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Section 5
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LOOKING AHEAD
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2013: THE ACHIEVEMENTS
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April rights issue: high net worth investors who provide a lot of
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New Shareholders support
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Direct-to-wholesale model in Australia, increase revenues
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� Regulatory approval in Canada
Travelan: continue commercialization
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Regulatory progress in licensed territories
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� Discussions in various territories progressing
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Continue preparation for Phase IIb Clinical trial
Fatty Liver / NASH
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ASH trial cleared by FDA
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� Industry (potential partner) interest
Clostridium difficile and other projects
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Very encouraging preventative result. Treatment studies ongoing.
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� A number of promising applications, including for orphan conditions
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----- Start of picture text -----
LOOKING AHEAD
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----- Start of picture text -----
What we are seeking to achieve
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Financial Strength � Improve balance sheet
Travelan: continue commercialization
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More licenses
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More revenue
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- Commence Phase IIb Clinical trial
Fatty Liver / NASH
-
Partner
-
Progress to the clinic with another product
Progress R&D
- A number of promising applications, including for orphan conditions
We continue to nurture and benefit from strong partnerships with our R&D collaborators and with our commercial partners.
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Section 6
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SUMMARY
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THE OPPORTUNITY
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Immuron presents a unique opportunity:
The present:
The near term future:
The rich pipe line:
Current market cap of ~$10M can be justified based on the company’s in-revenue Travelan business alone.
Revenues are
growing and set to accelerate.
Addressing large unmet medical need in red hot area: NASH / fatty liver .
Positive Clinical results
Potential: Orders of magnitude greater than the value of the Travelan business.
Substantial support for this therapeutic from clinical results, key opinion leaders and the NIH.
Immuron’s technology supports a rich pipeline of products.
The time to market for Immuron’s products is accelerated on account of the high safety profile and the various . regulatory options
The infrastructure:
Experienced Management Team Supportive shareholders Immuron’s retains control of its production.
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THE OPPORTUNITY
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Thank you
Contact Amos Meltzer – Chief Executive Officer Ph: 0437 587 680
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