Investor Webinar Presentation
Released
Released
Announcement PDF
Investor Webinar Presentation
Melbourne, Australia, February 8, 2024: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based
and globally integrated biopharmaceutical company is pleased to advise our Chief Executive Officer, Steven
Lydeamore will be presenting at the Monsoon Communications Investor function on Thursday, 8th
February in Sydney, Australia.
A copy of the presentation being made is included below.
Authorised for release by the Board of Immuron Limited.
COMPANY CONTACT:
Steven Lydeamore
Chief Executive Officer
Ph: +61 (0)3 9824 5254
info@immuron.com
- - - END - - -
About Travelan®
Travelan® is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting traveller’s
diarrhoea, a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce. Travelan® is a
highly purified tabletised preparation of hyperimmune bovine antibodies and other factors, which when taken with meals bind to
diarrhoea-causing bacteria and prevent colonisation and the pathology associated with traveller’s diarrhoea. In Australia,
Travelan® is a listed medicine on the Australian Register for Therapeutic Goods (AUST L 106709) and is indicated to reduce the risk
of Traveller’s Diarrhoea, reduce the risk of minor gastrointestinal disorders and is antimicrobial. In Canada, Travelan® is a licensed
natural health product (NPN 80046016) and is indicated to reduce the risk of Traveller’s Diarrhoea. In the U.S., Travelan® is sold as
a dietary supplement for digestive tract protection.
About Traveller’s Diarrhoea
Traveller’s Diarrhoea is a gastrointestinal infection with symptoms that include loose, watery (and occasionally bloody) stools,
abdominal cramping, bloating, and fever, Enteropathogenic bacteria are responsible for most cases, with enterotoxigenic
Escherichia coli (ETEC) playing a dominant causative role. Campylobacter spp. are also responsible for a significant proportion of
cases. The more serious infections with Salmonella spp. the bacillary dysentery organisms belonging to Shigella spp. and Vibrio
spp. (the causative agent of cholera) are often confused with Traveller’s Diarrhoea as they may be contracted while travelling and
initial symptoms are often indistinguishable.
About Immuron
Immuron Limited (ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical company focused on developing and
commercialising orally delivered targeted polyclonal antibodies for the treatment of infectious diseases.
For more information visit: http://www.immuron.com
FORWARD-LOOKING STATEMENTS:
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development
programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to
risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to
differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and
strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing
clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key
personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property
matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on
which any such statement is based, except as required by law.
INVESTOR
PRESENTATION
M O N S O O N C O M M U N I C AT I O N S
8 FEBRUARY, 2024
S t e v e n Ly d e a m o r e - C E O
NASDAQ: IMRN
ASX: IMC
1
SAFE HARBOR STATEMENT
C e r ta i n state m e n t s m a d e i n t h i s p re s e nta t i o n a re fo r wa rd - l o o k i n g state m e n t s a n d a re
b a s e d o n I m m u ro n ’s c u r re nt ex p e c tat i o n s , e st i m ate s a n d p ro j e c t i o n s . Wo rd s s u c h a s
“a nt i c i p a t e s ,” “ex p e c t s ,” “ i nte n d s ,” “ p l a n s ,” “ b e l i e ve s ,” “s e e ks ,” “e st i m a te s ,” “g u i d a n c e ”
a n d s i m i l a r ex p re s s i o n s a re i nte n d e d to i d e nt i f y fo r wa rd - l o o k i n g state m e n t s .
A l t h o u g h I m m u ro n b e l i e v e s t h e fo r wa rd - l o o k i n g state m e n t s a re b a s e d o n
re a s o n a b l e a s s u m p t i o n s , t h ey a re s u b j e c t to c e r ta i n r i s ks a n d u n c e r ta i n t i e s ,
s o m e o f w h i c h a re b eyo n d I m m u ro n ’s c o nt ro l , i n c l u d i n g t h o s e r i s ks o r
u n c e r ta i n t i e s i n h e re n t i n t h e p ro c e s s o f b o t h d e ve l o p i n g a n d c o m m e rc i a l i z i n g
te c h n o l o g y. A s a re s u l t , a c t u a l re s u l t s c o u l d m ate r i a l l y d i ffe r f ro m t h o s e
ex p re s s e d o r fo re ca ste d i n t h e fo r wa rd - l o o k i n g state m e n t s .
T h e fo r wa rd - l o o k i n g state m e n t s m a d e i n t h i s p re s e n ta t i o n re l ate o n l y to
e ve nt s a s o f t h e d ate o n w h i c h t h e state m e n t s a re m a d e . I m m u ro n w i l l n o t
u n d e r ta ke a ny o b l i gat i o n to re l e a s e p u b l i c l y a ny re v i s i o n s o r u p d ate s to
t h e s e fo r wa rd - l o o k i n g state m e n t s to ref l e c t e ve nt s , c i rc u m sta n c e s o r
u n a nt i c i p a te d e ve nt s o c c u r r i n g a f te r t h e d ate o f t h i s p re s e nta t i o n exc e p t a s
re q u i re d b y l aw o r b y a ny a p p ro p r i a te re g u l ato r y a u t h o r i t y.
F Y 2 0 2 4 re s u l t s i n t h i s p re s e nta t i o n a re s u b j e c t to a u d i t re v i e w.
2
REVENUE GENERATING WITH STRONG PIPELINE
Immuron Ltd (NASDAQ:IMRN) (ASX:IMC) is a globally integrated biopharmaceutical company focused on developing, and
commercialising, oral immunotherapeutics for the treatment of gut mediated diseases
Financial Snapshot
Shares on Issue
Total Options
Last Traded Price
Market Cap.
Cash & Cash
Equivalents
Sales Revenue
30-Jun-23
31-Dec-23
227,798,346
12,879,720
IMC: A$0.075
IMC: A$17.1m
227,798,346
15,568,559
IMC: A$0.077
IMC: A$17.5m
A$17.2m
A$1.8m
H1, FY24 A$2.4m
3
REVENUE GENERATING WITH STRONG PIPELINE
Immuron Ltd (NASDAQ:IMRN) (ASX:IMC) is a globally integrated biopharmaceutical company focused on developing, and
commercialising, oral immunotherapeutics for the treatment of gut mediated diseases
Pipeline Snapshot
30-Jun-23
31-Dec-23
Travelan (IMM-124E) Phase 2
Traveller’s Diarrhoea
Travelan® (IMM-124E) –
Phase 4
Traveller’s Diarrhoea
Initiated IMM-124E ETEC2 CHIM3 clinical
trial
Completion of In-patient phase ETEC2
CHIM3 clinical trial
USU4 P2TD IMM-124E field clinical trial
recruited 35% of 868 participants
Recruited 50% of 868 participants
CampETEC – Phase 2
Campylobacteriosis
FDA IND1 approved (Clinical Hold
released)
Completion of In-patient phase
Campylobacter CHIM3 clinical trial
IMM-529 – Phase 2
Clostridioides Difficile
Completed 600 mg solid dose active
formulation development
Completion of IMM-529 drug substance
manufacture by CSIRO
1. Investigational New Drug; 2. Enterotoxigenic E.coli; 3. controlled human infection model; 4. Uniformed Health Services University of the Health Sciences
4
DISTRIBUTION CAPABILITY
Australia
USA
Shandex
Canada
Ontario, Canada
Distributes to all
provinces of Canada
Retail Pharmacy
B2B
Established
E-commerce
Developing
Immuron Limited
Vancouver, BC, Canada
Key Commentary
Australia
• Retail network includes over 3,500 pharmacies
• Online sales of both Travelan® and Protectyn®
• Protectyn® is distributed by Osborne Health Supplies
USA
• Travelan® is sold to travel medicine clinics and on our own amazon.com
shopfront (launched July 2023)
• Re-entry into retail pharmacies in USA being explored in FY24
Canada
• We are relaunching 1Q2024
International
• We are evaluating options to enter international markets through
distributors
RJW Logistics
Immuron Inc.
Chicago, USA
Distributes to all
states of USA
New York, USA
Immuron Limited
Melbourne, Australia
Distributes to all states of Australia and to distributors in USA
and Canada
5
Traveller’s Diarrhoea (TD)
STRONG SALES GROWTH IN
A BILLION DOLLAR MARKET 3
Market is large and growing ~7% 3 CAGR
Industry tailwinds
Travel picking up significantly following COVID
lockdowns
Frequent
30% - 70% of travelers experience TD 4
Net Sales
FY23: A$1.16 million
1HFY24: A$1.85 million
132% higher than prepandemic period
1HFY20
Net Sales
FY23: A$0.64 million
1HFY24: A$0.48 million
6% lower than prepandemic period
1HFY20
Australia
Short term resident
returns in Oct 23 were
47% higher than Oct
22 1
USA
Total departures
Sep 23 were 17%
higher than Sep 22 2
Chief Commercial
Officer has 20+ year’s
experience with local
and global (Asia, UK)
commercial leadership
roles with GSK and
P&G
$83m
$50m
Based on US annual
travel numbers and a
penetration rate of
15%, the market
potential is estimated
at $83m 5
Based on EU travel
numbers and a
penetration rate of
15%, the market
potential is estimated
at $50m 5
1. https://www.abs.gov.au/statistics/industry/tourism-and-transport/overseas-arrivals-and-departures-australia/latest-release
2. https://www.trade.gov/sites/default/files/2023-09/US-Outbound-to-World-Regions.xlsx
3. https://www.transparencymarketresearch.com/travelers-diarrhea-market.html
4. Centers for Disease Control and Prevention Yellow Book
5. IMC Company Report - Travelan Market Analysis 2019
6
TECHNOLOGY PLATFORM FOR GUT MEDIATED DISEASES
Bovine colostrum is the first milk of cows after calving. It is rich in immunoglobulins, lactoferrin, lysozyme, lactoperoxidase,
growth factors and bioactive peptides. Colostrum has higher levels of protein, fat, vitamins, and minerals when compared to
milk. This enables full development of the newborn calf in addition to immunity against several pathogens.*
Immuron’s proprietary technology platform combines the natural human nutrition & health benefits of bovine colostrum with
a novel class of specifically targeted oral polyclonal antibodies that offer delivery within the gastrointestinal (“GI”) tract and
can be used to target viruses or bacteria and neutralize the toxins they produce at mucosal surfaces.
STEP 1
Development of Highly
Specific Vaccines
STEP 2
Isolation of Hyperimmune
antibody-rich
bovine colostrum
* Gomes et. al., NFS Journal, Volume 25, November 2021, pages 111, https://doi.org/10.1016/j.nfs.2021.10.001
STEP 3
Oral Antimicrobial
therapeutics
without drawbacks
of antibiotics
FINAL PRODUCT
Toxin Neutralization +
Clearance of targeted gut
pathogens
✓ Reduce occurrence and
reduce/relieve diarrhoea
✓ Reduce/relieve abdominal
cramping
✓ Reduce/relieve gastrointestinal
pain
✓ Assists repair of
gastrointestinal/gut wall lining
✓ Enhance/promote immune
defence
✓ Enhance/promote health liver
function
Australian Permitted indications;
these statements have not been
evaluated by the Food and Drug
Administration (FDA)
7
STRONG PIPELINE WITH NEAR TERM MILESTONES
Immuron’s Clinical Programs
Compound or
brand name
Indication
IMM-124E
Travelan®
Traveler’s
Diarrhea ETEC
challenge
IMM-529
Clostridioides
difficile
Infection &
Recurrence
Phase
I
Phase
II
Phase
III
Market
Our Partners’ Clinical Programs
Compound or
brand name
Travelan®
CampETEC
Partner
Phase
I
Phase
II
Phase
III
Market
Uniformed Services University
Naval Medical
Research Command
Further information on the clinical programs can be found on slide 8
8
NEAR TERM MILESTONES ANTICIPATED TO DRIVE VALUE
2H 2022
1H 2023
2H 2023
FDA IND1 approved for
•
single daily dose IMM•
124E ETEC2 CHIM3 clinical
trial
IRB Approval4
•
Initiated IMM-124E ETEC2 •
CHIM3 clinical trial
100% of patients enrolled •
Completion of In-patient
phase ETEC2 CHIM3
clinical trial
Topline results for IMM- •
124E ETEC2 clinical trial
Clinical Study Report
•
Submitted Response
•
Letter to FDA Clinical Hold •
Immuron sponsored
Toxicology study completed
Toxicology Study Report
FDA IND1 approved
(Clinical Hold released)
•
Institutional Review
•
5
Board approval of NMRC
CampETEC
Campylobacter CHIM3
clinical trial protocol
Initiated IMM-124E
Campylobacter CHIM3
clinical trial
IMM-529 cGMP
•
manufacture
~50% of 868 participants •
recruited
•
Completion of Inpatient phase
CampETEC
Campylobacter CHIM3
clinical trial
•
Topline results for
CampETEC
Campylobacter CHIM3
clinical trial
IMM-529 (CDI)7 PreIND1 submission
Completion of
enrollment
Completion of inpatient phase
•
FDA meeting
•
Topline results
•
CampETEC
•
•
•
Travelan®
2H 2024
•
Travelan®
IMM-529
1H 2024
600 mg solid dose active
formulation development
USU6 P2TD IMM-124E
field clinical trial
recruitment
commencement
•
•
Completed; 1. Investigational New Drug; 2. Enterotoxigenic E.coli; 3. controlled human infection model; 4. Institutional Review Board; 5. Naval Medical Research Command;
6. Uniformed Health Services University of the Health Sciences; 7. Clostridioides Difficile
9
SCIENTIFIC REFERENCES
Travelan® (IMM-124E)
Travelan® has been shown to reduce both the incidence and severity of ETEC-induced diarrhea in up to 90%
of volunteers
Scandinavian Journal of Gastroenterology, 46:7-8, 862-868, DOI:
10.3109/00365521.2011.574726
Clinical Evaluation of Travelan® an Oral Prophylactic for Prevention of Travelers’ Diarrhea in Active Duty
Military Service Assigned Abroad.
Military Health System Research Symposium 14-17 Aug 2023_Abstract 1
Travelan as a broad Spectrum anti-bacterial
Immuron Limited, 29 April, 2011
Travelan® demonstrates broad reactivity to Vibrio cholera strains from Southeast Asia indicating broad
potential for prevention of traveler’s diarrhea
US Department of Defense, Armed Forces Research Institute of Medical Sciences
(AFRIM), 4 September, 2019
Travelan® prevented clinical shigellosis (bacillary dysentery) in 75% of Travelan® treated animals compared
to placebo and demonstrated a significant clinical benefit
US Department of Defense, Armed Forces Research Institute of Medical Sciences
(AFRIM), 5 September, 2018
Travelan® able to bind and was reactive to 60 clinical isolates of each bacteria, Campylobacter, ETEC, and
Shigella
US Department of Defense, Armed Forces Research Institute of Medical Sciences
(AFRIM), 30 January, 2017
Bioactivity and efficacy of a hyperimmune bovine colostrum product- Travelan, against shigellosis in a nonHuman primate model (Macaca mulatta)
Islam D, Ruamsap N, Imerbsin R, Khanijou P, Gonwong S, Wegner MD, et al. (2023)
Bioactivity and efficacy of a hyperimmune bovine colostrum product- Travelan, against
shigellosis in a non-Human primate model (Macaca mulatta). PLoS ONE 18(12):
e0294021.
Bioactive Immune Components of Travelan®
Clin Vaccine Immunol 24:e00186-16. https://doi.org/10.1128/CVI.00186-16
Hyperimmune bovine colostrum containing lipopolysaccharide antibodies (IMM-124E) has a non-detrimental
effect on gut microbial communities in unchallenged mice
Infect Immun. 2023 Nov; 91(11): e00097-23.
Administration of the Hyper-immune Bovine Colostrum Extract IMM-124E Ameliorates Experimental Murine
Colitis
Journal of Crohn's and Colitis, Volume 13, Issue 6, June 2019, Pages 785–797,
https://doi.org/10.1093/ecco-jcc/jjy213
IMM-529
Bovine antibodies targeting primary and recurrent Clostridium difficile disease are a potent antibiotic
alternative
Sci Rep 7, 3665 (2017). https://doi.org/10.1038/s41598-017-03982-5
10
STEVEN LYDEAMORE
CHIEF EXECUTIVE OFFICER
IMMURON LIMITED
CONTACT INFORMATION:
EMAIL: STEVE@IMMURON.COM
PHONE: AUSTRALIA: +61 438 027 172
11
Share your feedback
Discover