2. 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.
3. 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
• High-value peer licensing deals and M&A underscore potential upside
• Experienced Management Team and strong support from leading KOLs and
institutions (NIH, DoD)
• Company listed on NASDAQ in 2Q 2017
4. 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
5. Immuron’s Clinical Programs
Multiple Near-Term Inflection Points
5
Program Indications
Development Stage
Program Highlights
Pre-Clinical Phase 1 Phase 2 Phase 3
Anti-Inflammatory Programs
IMM-124E NASH - Topline results Available
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 Colitis
Collaboration with Dr. Rogler, Zurich
University
IMM-124E Autism
Murdoch Childrens Research
Institue,
La Trobe & RMIT Universities
Anti-Infective Programs
IMM-529 C. difficile
- Phase 1/2 initiated 4Q 2017
- Topline results expected Q1 2019
IMM-124E /
Shigella Vaccine
Shigella
Infections
Collaboration with US Army
IMM-124E
Campylobacter;
ETEC Infections
Collaboration with US Navy
6. • Hyperimmune bovine IgG powder 200mg
(30 caplets, 24 month shelf life)
• Reduces the risk of TD, reduces the
symptoms of minor GI disorders
TRAVELAN
6
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
7. Prominent immune-reactive bands of
Campylobacter, ETEC and Shigella isolates
from Bhutan, Cambodia, Nepal and Thailand
7
Travelan immunoreactivity study:
• Armed Forces Research Institute of Medical Sciences (AFRIMS)
• Walter Reed Army Institute of Research (WRAIR)
• US Naval Medical Research Centre (NMRC)
11. STUDY POPULATIONS
11
Patients Screened: N = 237
Patients Randomized: N = 133
Study Analysis Sets:
ITT: 133FAS: 133PP: 102
Screening Failure n =
104
Early Discont. n = 21
Non-compliance n=8
Major deviations n=2
Definitions:
ITT = Intention to Treat
FAS = Full analysis set
PP = Per Protocol
12. SUMMARY: IMM-124E Clinical Trial Results
12
• First-In Class Anti-LPS Mechanism of Action
confirmed for IMM-124E
• Results demonstrate excellent safety and tolerability
• Statistically significant reduction in serum endotoxin/
Lipopolysaccharide (LPS) levels compared to
placebo
• Statistically significant reduction in mean serum ALT
in patients with elevated pre-treatment ALT
• Statistically significant Reduction of additional serum
NASH biomarkers associated with liver damage – AST
and CK-18
• IMM-124E retained within the GI tract and not
absorbed into the bloodstream, contributing to
favourable safety profile
• No effect on liver steatosis
13. FIRST IN CLASS MoA
LPS ANTAGONISM
13
• Hyperglycemia drives intestinal barrier dysfunction and risk for enteric infection. Thaiss CA et al. Science, 2018
• Non-alcoholic fatty liver and the gut microbiota. Stavros B et al. Molecular Metabolism, 2016
• Age-Associated Microbial Dysbiosis Promotes Intestinal Permeability, Systemic Inflammation, and Macrophage Dysfunction.
Thevaranjan N1, et al. Cell Host Microbe 2017.
• Hepatic TLR4 signaling in obese NAFLD. Sharifnia T, et al. Am J Physiol Gastrointest Liver Physiol 2015
• Obesity, Diet, Alcohol and
liver disease
• Dysbiosis
• “leaky gut” (LPS)
• Endotoxemia
• LPS engages TLR4
• lipogenesis,
inflammation, hepatocyte
apoptosis and fibrosis
NASH
18. SERUM LPS
OVERALL RESPONSE TO TREATMENT
TERTILE ANALYSIS
18
• Analysis aimed at
looking at the entire
population
• Shows an overall
beneficial effect across
all patients
• Minimizes risk of cut-off
selection bias
• p=0.0715 (1200mg vs.
PLB)
21. SUMMARY
21
• IMM-124E targets inflammation a major disease driver
• Inflammation drives disease progression from NAFLD to
NASH to NASH fibrosis to NASH Hepatocellular
carcinoma and NASH Cirrhosis
• Our Medical Advisory Board was particularly interested in
further evaluating the compound in NASH cirrhosis
• Huge potential to treating patients exhibiting endotoxemia
and elevated gut permeability e.g. cirrhotics either NASH or
of any cause (evaluating on de-/compensated near
compensation
• “The potential clinical applications for this drug candidate
are numerous and very exciting indeed” – Immuron MAB
23. IMM-529 in Clostridium difficile Infection (CDI)
23
• 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)
24. IMM-529 for the Treatment of CDI
24
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
25. Triple Action MOA
Neutralizing C. difficile; Sparing the Microbiome
25
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
26. Results of Pre-Clinical Studies
Hutton et al; Scientific Reports June 2017 | 7: 3665 | DOI:10.1038/s41598-017-03982-5
26
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 rv iv a l
h o u rs p o s t in fe c tio n
Percentsurvival
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
PreventionStudies
Demonstrated ~70%
survival rate without
use of antibiotics vs.
0% for control group
(P<0.0001)
All studies
statistically
significant
TreatmentStudies
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
Percentsurvival
S u rv 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 fec te d , V a n c o m y c in trea tm e n t
U n in fe c te d , N o tre a tm e n t
RelapseStudies
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 0
S u rv 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
Percentsurvival
In fe c te d + S O C
In fe c te d + S O C + IM M -5 2 9**
p=0.0027
27. Phase 1/2 Study Design
27
• 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
28. NASH and C. difficile Comps Indicate
Potential for Substantial Growth
28
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
29. Capital Profile Immuron Limited (ASX:IMC NASDAQ:IMRN)
29
Current Unmerged
Top 10 Shareholders
Current Company
Market Capitalization
AUD$47.83M ≈ USD$37.13M
At Current Share Price = AUD$0.335 (18th April 2018)
Rank Holder Name Current Qty %
1 HSBC CUSTODY NOMINEES (Incl. US ADR Program) 14,427,779 10.11%
2 CITICORP NOMINEES PTY LIMITED (Incl. Empery US) 14,250,941 9.98%
3 * GRANDLODGE PTY LTD 9,556,682 6.69%
4 AUTHENTICS AUSTRALIA PTY LTD 8,624,999 6.04%
5 * MR PETER ANASTASIOU 2,907,236 2.04%
6 INVERAREY PTY LTD 2,731,632 1.91%
7 INSYNC INVESTMENTS PTY LTD 2,500,000 1.75%
8 * ADVANCE CLINICAL SYSTEMS 2,296,874 1.61%
9 * MR STEPHEN ANASTASIOU & 2,035,371 1.43%
10 MR WILLIAM DAVID FRANK BIRD 2,006,000 1.40%
TOTAL TOP 20 SHAREHOLDERS 61,337,514 42.96%
BALANCE OF SHARES 81,440,692 57.04%
TOTAL SHARE ON ISSUE 142,778,206 100.00%
* Denotes a Director Related Entity
30. Key Milestones Expected to Drive Value
30
• IMM-124E
- NASH Phase 2 study
closed
• IMM-529
- Initiation of Phase
1/2 Trial in CDI
• IMM-124E
- NASH Phase 2
topline results
• IMM-124E
- NASH centric
transaction
- Pediatric NAFLD
Phase 2 topline
results
• IMM-124E
- ASH Phase 2 topline
results
• IMM-529
- Topline results expected
from Phase 1/2 study in
CDI
4Q
2017
1Q
2018
2018 2019
Results from colitis preclinical studies and US
Army and US Navy trials expected 2018
Hello everyone and thank you for taking the time to meet with IMMURON today stock symbol IMRN on the NASDAQ and IMC on the ASX
My name is JK CEO and I would like to walk you through some of the key company milestones we have achieved to date
First of all I would like to thank Dave Genry and the RedChip team for the invitation to present at this conference it is a great opportunity for me to provide you all with a corporate update on the progress the company has made
I first started doing the Investor Road shows with RedChip in August last year and at the time our Market Capitilization was under 20 million AUD
Today our MC is just under 50 million AUD and I have a brief presentation which covers some of the major milestones achieved to date which have been the driving force behind the increase in our SP and I will also highlight some near term inflection points which are due in the next 12 months which we believe will drive value in our stock
Slide 2 covers the forward looking statements which we are required by law to make sure all investors are aware of and you should take the necessary time to review before making any investment decisions
SLIDE 3 – Provides an Overview of the Company for you who are new to IMMURON
IMRN is a clinical stage biotechnology company – Biologics
We have 2 lead clinical assets targeting high value inflammation and infectious diseases
The company listed on the NASDAQ in June 2017 raising 6 million USD and we have just completed a Capital Raise of 4 million USD on the back of our phase 2 NASH data which we reported in March this year. We have enough money in the bank to drive our development programs forward well into 2019.
What makes us different?
We believe we have transformative therapies to that can be the standard of care
Phase IIs in NASH; Use for all treatments
C. difficile – Potential to displace all current therapies
Great progress in last ~2 years of so
Growing body of evidence to support this view – Why our stock has been doing so well
What it matters? Where is the value for our investors? Near-term and long-term
Opportunity to be Tobira, bought by $500M by Allergan (5x market cap) or Intercept/Genfit which are $1B companies
Well established M&A/BD playbook – we are not reinventing the well
Plenty of milestones to drive the upside
Lead inflammatory program expected to report interim data in Q3 and topline results before year end
Lead infectious disease program to commence Phase 1/2 study in Q3
HOW MUCH are you prepared to Invest in IMRN?
Keep on driving value for the long-term
Have an impact – not only on patients but on value for shareholders
Slide 4 provides an overview of our technology platform which is based on orally active immunoglobulins derived from engineered hyper-immune bovine colostrum
This technology platform has the capability to produce highly specific immunoglobulins to any pathogenic bacteria we choose to target and
Has the capability of delivering multiple new drug candidates for clinical evaluation which will drive long term value creation for the company
The products are designed to work in the gut targeting pathogenic bacteria there and have been clinical proven NOT to be absorbed into the blood stream hence the excellent safety profile
Why bovine IgG
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 making them ideal candidates for oral drug delivery
Slide 5 provides you with an overview of our Research and Development pipeline
We currently have 4 phase II clinical trials on going
3 of our trials are focused on Fatty Liver Diseases (NASH, we also have two NIH funded studies in Pediatric NAFLD and ASH
we have just initiated a clinical study in Clostridium difficle infection which is one of the hospital super bugs
We also have a robust preclinical portfolio focused on Infectious diseases with the US DoD (Campylobacter, ETEC and Shigella) and have programs targeting IBD such as Colitis and we have a program focused on Autism Spectrum Disorder
Driving Multiple ongoing therapeutic programs to late-stage clinical development with multiple key millstones over the next 6 to 9 months
Our flagship product Travelan® was first approved in 2004 as a listed medicine on the Australian Register of Therapeutic Goods (AUST L 106709)
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
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
The product achieved 1.3 million AUD in Sales last year on track to reach 2 million AUD this year
Significant growth in USA major customer – Passport Health ~ 200 travel medicine clinics
The product has gained the attention of the U.S. Department of Defense (DoD) who have been investing in the development of an effective vaccine against enteric diseases for over for over 20 years
The findings of the recent research program conducted by the Department of Enteric Diseases, Armed Forces Research Institute of Medical Sciences in Bangkok, Thailand an overseas laboratory of the Walter Reed Army Institute of Research (WRAIR) was reported in January
The primary goal of this program was to investigate Travelan® immunological reactivity with pathogenic bacteria including Campylobacter, Enterotoxigenic E-coli and Shigella. The tested bacterial isolates originated from the AFRIMS’s library of infectious diseases
The pathogenic bacteria were retrieved from infected personnel deployed in Bhutan, Cambodia, Nepal and Thailand over a 20 year period
Results reported demonstrated that the antibodies in Travelan® were able to bind and reactive to ALL 180 strains of bacteria tested by Western blot analysis demonstrating the broad spectrum antimicrobial properties of the product
Travelan® showed particularly strong reactivity to 60 clinical isolates of personnel infected with ETEC and 60 personnel infected with Shigella
I would like to go over the top line results of our phase 2 NASH clinical study
The goal is to show the main outcomes of the study while further analyses are still being ran
The IMM-124E NASH clinical study
The study Design consisted of a 3 arm, randomized double blind , placebo vs. 2 doses of IMM-124E
The major aim of the study was to recruit 120 patients with a histologically proven positive NASH liver biopsy and HbA1c
Allocation was done at a 1:1:1 ratio
Stratification performed according to country, HbA1c and HFF at baseline
Eclusion attepted to remove any confounding factors such as other liver diseases
The Study primary endpoint included safety of IMM-124 compared to the placebo group
HFF was another primary and will be discussed separately
The Secondary endpoints were the most commonly used endpoints which examine liver damage, metabolism and pharmacokinetics – which is unique to our product
Additional endpoints were put in plalce to better define liver injury and the MoA
Immuron screened a total of 237 patients
Enrolling a total of 133 found eligible according to the study criteria
31 subjects were removed from the Per Protocol final analysis if they did not reach the 24 weeks visit or a major protocol violation was identified
102 patients successfully completed the 24 week treatment as per the clinical protocol
Slide 12 summarize our topline results reported in March 2018
It is important to remember that Our drug candidate IMM-124E has been developed to target the endotoxin LPS in the gut and prevent it translocating into the portal circulation.
The major study hypothesis was if you decrease the reservoir of endotoxin in the gut you reduce the source and supply of the major driver of inflammation in the disease
The endotoxin LPS has been widely reported in the literature to be a major mediator of inflammation and a major driver of NASH
A literature search of LPS and NASH produces over 800,000 scientific articles
The study results we reported in March clearly demonstrate a statistically significant reduction of serum LPS levels in the treatment groups when compared to placebo and provides us with a proof of concept that metabolic endotoxemia can indeed be decreased using this drug candidate (IMM-124E) which targets the endotoxin LPS.
A few words on IMM-124E MoA
The Gut microbiota is the normal microbe population living in our intestine. Our gut microbiota contains tens of trillions of microorganisms, including at least 1000 different species of known bacteria
Dysbiosis is a term used to refer to a microbial imbalance inside the body, in an impaired microbiota - good bacteria get over run by pathogenic bad bacteria
The Gut liver axis refers to imbalances of normal microbes in the gut which can directly impact the health of our livers
LPS Antagonist could potentially target Autism, IBD (Colitis), NASH Liver Cirrhosis, etc
The same anlysis was done for all patients showing a statistical trend
* = outlier sites excluded (site recruiting <3 patients) - as commonly practiced in clinical trails
Same as with ALT, AST is showing a statistical trend to reduce AST by 30% or more
This accumulates to a significant overall drug effect
And now to the results …
we’ve managed to show that more than twice as many subjects treated by 1200 mg demonstrated a 30% or greater reduction in serum ALT
ALT is widely used in all NASH studies and is associated with liver necro-inflammation
a recent scientific review prof. Ratziu, one of the world leading KOL on NASH presented the most accepted endpoint for NASH studied
ALT was ranked the highest amongst serum markers though non specific it is important to show improvement fot he diseased liver
Prof. Ratziu further detemened that a significant reduction in ALT would be 30-40%
Lipopolysaccharide, endotoxin, are fragments of gram negative bacteria
Various factors change the bacterial composition within the gut leading to increase in intraluminal LPS which in-turn translocate into the blood stream
To show effect across the entire population
Another serum marker showing the level of liver cell death (apoptosis) is CK-18
Though sample size is relatively small and variability is high we’ve been able to demonstrate a statistically significant decrease when comparing 1200mg to placebo
Inflammation is the major driver of disease
NAFLD to NASH fibrosis to NASH Hepatocellular carcinoma and NASH Cirrhosis
Targeting inflammation is the key to an effective NASH therapeutic
We believe this to be a huge unmet medical need and the regulatory path has been previously established by the FDA. The additional data expected to be generated from our Alcoholic Steatohepatitis study in Q1 next year should support this as well as our pediatric NAFLD
A LPS Antagonist could potentially target a wide range of diseases from Autism, IBD (Colitis), NASH, Liver Cirrhosis, endotoxemia
There are over 3 million scientific articles on LPS associated diseases
Medical Advisory Board
The primary objective of the study was to evaluate the safety and efficacy of IMM-124E, at two oral dosage levels as compared with a placebo and provide proof of concept in human subjects for its unique Mechanism of Action
Significant reduction of liver Transaminases (ALT and AST) markers of liver injury
Moving to our second Clinical stage asset – IMM-529
Our second clinical asset targets the Gram positive, spore forming toxin producing anaerobe C. difficile
Pathogenic C. difficile strains produce toxins that cause diarrhoea and mediate gut damage
The bacteria is resistant to most clinical antibiotics
It is the leading cause of infectious antibiotic-associated diarrhoea in hospitals and healthcare facilities worldwide
C. difficile only colonises the gut if the normal microbiota is disrupted
People at greatest risk include those on antibiotics, the elderly and immunocompromised patients
The current Standard of Care treatment is antibiotics Vancomycin and metronidazole
Our product targets the three infectious phases of the diseases, the highly infectious spores, the germinating cells that colonize the gut and produce toxins which damage the gut
WE have produced 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
Some background
Gut overgrowth of a bacteria named Clostridium difficile
rising concern with increasing incidence
attributed to Antibiotic therapy
SOC is effective but doesn’t make sense - search for alternative therapies
IMM-529 based on the same platform hence safety
unique combination of 3 types of antibodies creating a tri-component MOA
Anti Toxin B Ig the current leading target fro therapy
polyclonal antibodies to bacteria
polyclonal antibodies to spores
Does not affect the Microbiome as SOC
As before uniquely positioned to be the therapy of choice per safety and MOA
Slide 24 shows that CDI represents
a significant market opportunity and
an unmet need due to the rising incidence as well as limited efficacy in preventing recurrence
current SOC therapies are plagued by significant disease recurrences once you are infected with the bacteria you have a 25% chance of being reinfected once reinfected the chances of being reinfected again increase to 40% and then 50% (1st relapse: 25%; 2nd: 40%; 3rd: 50%) underscoring need for new treatments
Let move to slide 27
EFFICACY
comprehensive preclinical program in
prevention,
treatment and
prevention of recurrence
makes IMM-529 applicable to all indication of CDI with a massive unmet need and huge potential market in each one
rolling out our phase 1/2 clinical study
Enrolling 60 subjects
To demonstrate
safety within the acute and post acute disease to
Efficacy - affect disease parameters and rate of recurrence
With results expected in 2018 it should generate massive value moving into our next clinical development phase
As an investor this is an exciting time for Immuron. The competitive landscape truly underscores our the potential for significant upside
I know you are busy / your time is precious.
We love what we are doing at Immuron because we believe that we are developing very high value assets, that will change who diseases are treated.
So I will walk through the story in a minute, but first a bit of grounding
Slide 30 covers our report card for the next 12 months Why Immuron….Why now…The next 12-18 months will be transformative for Immuron with multiple value driving milestones
I would like to thank you once again for your time and look forward to addressing any questions in the Q&A session