Presentation to Coffee Microcaps Conference
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Released
Announcement PDF
Immuron CEO, Steven Lydeamore presentation to Coffee
Microcaps Conference
Melbourne, Australia, July 25, 2025: Immuron Limited (ASX: IMC; NASDAQ: IMRN) is pleased to advise our
Chief Executive Officer, Steven Lydeamore will be presenting virtually at the Coffee Microcaps Conference
on Friday 25th July 2025 (11am Australian Eastern time).
Link to the conference:
https://us02web.zoom.us/webinar/register/WN_iO4boPLuRgiQFyGbQT7YVA#/registration
A copy of the presentation being made is included below.
This release has been authorised by the directors of Immuron Limited.
COMPANY CONTACT:
Steven Lydeamore
Chief Executive Officer
steve@immuron.com
- - - END - - -
About Immuron
Immuron Limited (ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical company focused on developing and
commercializing orally delivered targeted polyclonal antibodies for the treatment of infectious diseases.
About Travelan®
Travelan® is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting
travelers’ diarrhea, a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce.
Travelan® is a highly purified tabletized preparation of hyper immune bovine antibodies and other factors, which when taken
with meals bind to diarrhea-causing bacteria and prevent colonization and the pathology associated with travelers’ diarrhea.
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 Travelers’ Diarrhea, reduce the risk of minor gastro-intestinal disorders and is antimicrobial. In Canada,
Travelan® is a licensed natural health product (NPN 80046016) and is indicated to reduce the risk of Travelers’ Diarrhea. In the
U.S., Travelan® is sold as a dietary supplement for digestive tract protection.
Travelers’ diarrhea (TD)
TD is generally defined as the passage of ≥ 3 unformed stools per 24 hours plus at least one additional symptom (such as nausea,
vomiting, abdominal cramps, fever, blood/mucus in the stools, or fecal urgency) that develop while abroad or within 10 days of
returning from any resource-limited destinations (Leung et al., 2006). Diarrhea continues to be the most frequent health problem
among travelers to destinations in lower- and middle-income regions (Steffen, 2017). Deployed US military personnel, essentially
representing a long-term traveller population, are particularly affected given their population dynamics and the context in which
they seek care and treatment (Connor et al., 2012). Diarrhea is the leading infectious disease threat to the overall health and
preparedness of deployed US armed forces, with diarrheagenic E. coli, Campylobacter spp., and Shigella spp. among the most
commonly reported etiologies (Riddle et al., 2006).
Immuron Platform Technology
Immuron’s proprietary technology is based on polyclonal immunoglobulins (IgG) derived from engineered hyper-immune bovine
colostrum. Immuron has the capability of producing highly specific immunoglobulins to any enteric pathogen and our products
are orally active. Bovine IgG can withstand the acidic environment of the stomach and is resistant to proteolysis by the digestive
enzymes found in the Gastrointestinal (GI) tract. Bovine IgG also possesses this unique ability to remain active in the human GI
tract delivering its full benefits directly to the bacteria found there. The underlying nature of Immuron’s platform technology
enables the development of medicines across a large range of infectious diseases. The platform can be used to block viruses or
bacteria at mucosal surfaces such as the Gastrointestinal tract and neutralize the toxins they produce.
IMM-124E (Travelan®)
IMM-124E was developed using Immuron’s platform technology. IMM-124E is produced from the colostrum of birthing cattle
that have been immunised during pregnancy with a vaccine containing the outer antigens of multiple human derived ETEC. A total
of 13 ETEC strains are used in the vaccine to produce high levels of antibodies against selected surface antigens from the most
common strains of ETEC. (Otto et al., 2011)
The resultant hyperimmune colostrum IMM-124E from ETEC vaccinated cows contains significant levels of polyclonal antibodies
specific for ETEC antigens LPS, CFA-I and Flagellin (Sears et al., 2017).
The antibodies produced in IMM-124E have been found to have a stronger binding and neutralizing activity (than the antibodies
of unvaccinated cattle) against a wide range of LPS antigens including both the variable O-polysaccharide region and the preserved
oligosaccharide core ‘R’ region of LPS from the 13 serotypes used in the ETEC vaccine.
IMM-124E is manufactured into a tablet form referred to as Travelan®.
IMM-529
Immuron is developing IMM-529 as an adjunctive therapy in combination with standard of care antibiotics for the prevention
and/or treatment of recurrent Clostridioides difficile infection (CDI). IMM-529 antibodies targeting Clostridioides difficile (C.
diff) may help to clear CDI infection and promote a quicker re-establishment of normal gut flora, providing an attractive oral
preventative for recurrent CDI.
Immuron is collaborating with Dr. Dena Lyras and her team at Monash University, Australia to develop vaccines to produce
bovine colostrum-derived antibodies. Dairy cows were immunised to generate hyperimmune bovine colostrum (HBC) that
contains antibodies targeting three essential C. diff virulence components. IMM-529 targets Toxin B (TcB), the spores and the
surface layer proteins of the vegetative cells.
This unique 3-target approach has yielded promising results in pre-clinical infection and relapse models, including (1) Prevention
of primary disease (80% P =0.0052); (2) Protection of disease recurrence (67%, P <0.01) and (3) Treatment of primary disease
(78.6%, P<0.0001; TcB HBC). Importantly IMM-529 antibodies cross-react with whole cell lysates of many different human
strains of C. diff including hypervirulent strains.
To our knowledge, IMM-529 is, to date, the only investigational drug that has shown therapeutic potential in all three phases of
the disease (Hutton et al., 2017).
ProIBS®
Immuron has an exclusive distribution agreement with Calmino goup AB for the territories of Australia and New Zealand for
ProIBS®. ProIBS® - to help patients treat IBS symptoms ProIBS® is a certified medical device for the treatment of IBS symptoms
such as abdominal pain, bloating and unsettled bowel movements (diarrhoea and/or constipation). ProIBS® contains AVH200®,
derived from the plant Aloe barbadensis. Mill. AVH200® has gel forming components which support the intestinal mucosal
barrier. As IBS is known to affect individuals for a long period of time, it is essential to have a treatment appropriate for longterm use –as ProIBS® is. The product is safe, and no interactions with other medications are known. Science-driven innovative
Calmino group AB, the developer of ProIBS®, conducted a usability study among 1,003 users. PROIBS® was helpful for 94% of
them. 91% of the users experienced an improvement in daily life and 98% would recommend PROIBS® to someone else. To
learn more please check: www.proibs.eu.
Irritable bowel syndrome (IBS) is a common condition where you experience symptoms related to your digestive system. This is
sometimes linked to certain foods, lifestyle habits and stress levels or mood. IBS affects around 3 out of every 10 people.
Females are more likely than males to be affected. Some key symptoms of IBS include: abdominal pain or discomfort; stomach
bloating and wind; chronic diarrhoea or constipation, or alternating between the two.(healthdirect.gov.au) According to
available data, the IBS treatment market in Australia is estimated to be a part of the broader "Digestives & Intestinal Remedies"
market, generating a revenue of around AU$221.14 million in 2025, with a projected annual growth rate of 3.28%.(Statista)
References
Connor P, Porter CK, Swierczewski B and Riddle MS. Diarrhea during military deployment: current concepts and future directions. Curr Opin
Infect Dis. 25(5): 546-54; 2012.
Hutton, M.L., Cunningham, B.A., Mackin, K.E. et al. 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
Leung AK, Robson WL, Davies HD. Travelers’ diarrhea. Adv Ther. Jul-Aug; 23(4): 519-27; 2006
Otto W, Najnigier B, Stelmasiak T and Robins-Browne RM. Randomized control trials using a tablet formulation of hyperimmune bovine
colostrum to prevent diarrhea caused by enterotoxigenic Escherichia coli in volunteers Scandinavian Journal of Gastroenterology 46: 862– 868;
2011.
Riddle MS, Sanders JW, Putnam SD, and Tribble DR. Incidence, etiology, and impact of diarrhea among long-term travelers’ (US military and
similar populations): A systematic review. American Journal of Tropical Medicine and Hygiene. 74(5): 891-900; 2006.
Sears KT, Tennant SM, Reymann MK, Simon R, Konstantopolos N, Blackwelder WC, Barry EM and Pasetti MF. Bioactive Immune Components of
Anti-Diarrheagenic Enterotoxigenic Escherichia coli Hyperimmune Bovine Colostrum products. Clinical and Vaccine Immunology. 24 (8) 1-14;
2017.
Steffen R. Epidemiology of travelers' diarrhea. J Travel Med. 24(suppl_1): S2-S5; 2017.
For more information visit: https://www.immuron.com.au/ and https://www.travelan.com
Subscribe for Immuron News: Here
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.
NASDAQ: IMRN
ASX: IMC
Coffee Microcaps
Steven Lydeamore
Chief Executive Officer
25 July 2025
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 5 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.
Executive summary
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
Company Overview
Two commercially available oral immunotherapeutic products – Travelan® and Protectyn®
3 clinical programs:
Shares on Issue
268,219,973
Travelan®: IMC: Phase 2 CHIM trial (n=60)
Total Options
18,561,973
Travelan®: USU: Field Study (n=866)
Last Traded Price
IMC: A$0.07
IMM-529: IMC: preparing IND for Phase 2 trial (n=60)
52 week High/Low
IMC: A$0.11/0.054
IMRN: $2.87/1.50
Market Cap
IMC: A$18.77m
Cash & Cash Equivalents (as at 31
December 2024)
A$7.7m
Business Update
Travelan® (IMM-124E) Travelan® Uniformed Services University
IMM-124E trial 100% of 866 participants have been randomized
and deployed
Investigational New Drug (IND) by end of September 2025
IMM-986 (VRE): Colostrum manufactured for preclinical studies;
In Vitro assay development in progress.
Major Shareholders
Travelan® (IMM-124E) Travelan® Uniformed Services University
IMM-124E trial topline results anticipated in October 2025
IMM-529 (CDI): Immuron anticipates submission of
Results & Outlook
Full Year sales to 30 June 2025 of A$7.3 million up 49% on prior year (unaudited)
Units
% of CSO
BNY Mellon Asset Management
114,718,464
42.77 %
Authentics Australia Pty. Ltd.
5,500,000
2.05 %
Grandlodge
3,846,712
1.43 %
Management & Board
3,234,153
1.21 %
Holder
North American Travelan® sales A$2.0 million up 76% on prior year (unaudited)
Evaluating options to enter international markets
Evaluating options to add to marketed products portfolio
3
as of 23 July 2025
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
7 March 2025
25 July 2025
December 2024 Half Yearly revenue of A$4.0 million, up 70% on prior year
(unaudited)
December 2024 Half Yearly North American revenue of A$1.1 million, up
130% on prior year (unaudited)
June 2025 Yearly revenue of A$7.3 million, up 49% on prior year (unaudited)
June 2025 Yearly North American revenue of A$2.0 million, up 76% on prior year
(unaudited)
Travelan® (IMM-124E) Phase 2 Clinical Study Report submitted to the FDA
Awaiting Travelan® Uniformed Services University clinical trial topline results before
requesting end of Phase 2 meeting
Travelan® Uniformed Services University clinical trial reaches 100%
recruitment of 866 patients
Travelan® Uniformed Services University clinical trial 100% of 866 participants have been
randomized and deployed
Quality review of study data initiated
October 2025 anticipated top line results
IMM-529: Immuron completes pre-IND meeting with the FDA on
development
Planning IMM-529 FDA IND submission by end of September 2025
Anticipated IMM-529 FDA approval December 2025
New project (IMM-986) initiation of pre-clinical research collaboration with
Monash University targeting Vancomycin Resistant Enterococci (VRE)
Colostrum manufactured for preclinical studies. In Vitro method development initiated.
New distribution agreement to launch ProIBS in Australia
Purchase order placed with anticipated delivery in 3Q2025. Anticipated product launch in
1Q2026.
Opportunity to Convert Billion Dollar Traveller’s Diarrhoea
Market from Relief to Prevention by Travelan®
Billion Dollar Market
Traveller’s diarrhoea treatment market is large and growing at a CAGR of ~7%1
Industry tailwinds
International travel continues to grow
Travel to high-risk destinations from Australia exceeds pre-pandemic levels and
still growing
Frequent Symptom
30% - 70% of travelers experience traveller’s diarrhoea2
Proprietary Vaccine
No White Label Threat
Dairy cows inoculated with proprietary vaccines covering 13 strains of
enterotoxigenic E.coli (ETEC)
•Colostrum has some antibacterial and immune modulatory properties.
•However, Travelan® has in addition to the colostrum-derived compounds very
high concentration of anti-E.coli antibodies.
•Travelan® utilises specific antibodies to bind the bacteria and the toxins they
produce effectively neutralising them and inhibiting their attachment to the
gastrointestinal tract reducing LPS-related inflammation and bacterial.
•These antibodies target the major bacteria which cause Traveller’s Diarrhoea.
•Travelan® has a unique synergistic effect between the colostrum-derived
products and the high concentration antibodies for suppressing the inflammation
and targeting the bacteria which cause Traveller’s Diarrhoea in the gastrointestinal
system.
Bind and Neutralise to Prevent
According to the Centers for Disease Control and Prevention Traveller’s
Diarrhoea is a clinical syndrome resulting from microbial contamination of
ingested food and water.
Travelan® utilises specific antibodies to bind the bacteria and the toxins they
produce effectively neutralising them and inhibiting their attachment to the
gastrointestinal tract reducing LPS-related inflammation and bacterial
colonisation.
5
1 https://www.transparencymarketresearch.com/travelers-diarrhea-market.html;Centers for Disease Control and Prevention CDC.gov 2024
Travelan® continued strong sales growth
Global
+ FY2026 AUD$7.3 million up 49% on prior year
Global Year to Date Net Sales ($AUD)
$8,000,000
$7,000,000
Australia
$6,000,000
+ FY2026 AUD$5.2 million up 40% on prior year
$4,000,000
+ Secured core ranging in additional nine pharmacy banner
groups
$5,000,000
$3,000,000
$2,000,000
$1,000,000
$Jul - Sep
North America
+ FY2026 AUD$2.0 million up 76% on prior year
+ Strongest sales growth on amazon.com
+ Secured distribution in ten pharmacy/grocery retailers in
Canada
6
Oct - Dec
FY24
Jan - Mar
FY25
Apr - Jun
EXPANSION OF TRAVELAN® DISTRIBUTION
CONSUMER MARKETING ACTIVITY DRIVING TRAVELAN®
SALES GROWTH
We continue to drive awareness,
consideration and engagement
o Ranging across major retailers
(Australia, Canada)
o In-store positioning and
promotion
o Retailer catalogues
o Search and social media
marketing
o Social competitions
o User generated content
o Influencer program
o HCP user generated activity
o Amazon Prime sales promotions
o Amazon sponsored brand ads
STATUS OF PRODUCT PORTFOLIO AND KEY
MILESTONES
Indication
Traveller's Diarrhoea
Compound
Travelan®
Peak U.S.
sales
US$ 102 m
IMM-124E
Clostridioides Difficile
IMM-529
Vancomycin Resistant
Enterococci
IMM-986
US$ 400 m
Preclinical
Phase 1
Phase 2
Phase 3
Registration
Current
Status
2H 2025
Uniformed
Services
University
100% of 866
participants
recruited
Topline Data
Naval Medical Research
Command
Completed
Collaborator
End of Phase 2
FDA meeting
Pre-IND
IND
submission to submission to
FDA
FDA
Manufacturig
completed
1H 2026
Preclinical
activities
IND FDA
approval (31
December
2025)
In Vitro and In
Vivo
Preclinical
data
IMMURON’S CLINICAL PROGRAMS – OPPORTUNITY ASSESSMENT
Lumanity*
Opportunity
Corporate
Assessment for IMM-124E
›
›
›
›
Immuron’s development of IMM-124E (hyperimmune
bovine colostrum) as a prescription medication has
the potential to address this unmet need
Primary care physicians (PCP)s impressed with clinical
efficacy endpoint targets demonstrating > 80%
protection against the development of diarrhea.
If base case efficacy targets are reached, IMM-124E
would mostly be used by travelers going to the
highest risk areas (e.g., rural Central
America/Asia/Africa).
Based on the estimated market size and pricing, the
base case yearly revenue in USA for IMM-124E is
projected at US$102M.
Reaching higher efficacy goals could broaden use.
Compound or brand name
Indication
IMM-124E - Travelan®
Traveler’s Diarrhea ETEC challenge
IMM-529
Clostridioides difficile Infection (CDI) &
Recurrence
›
›
Lumanity
Opportunity
Corporate
Assessment for IMM-529
›
›
›
Infectious disease experts reacted favorably to the IMM-529
MOA, and its unique ability to target three elements of the
rCDI infection – the spores, vegetative cells, and Toxin B
If IMM-529 can achieve a significant reduction in
recurrences among patients with CDI, it can reach peak
revenues of ~US$400 million in USA
Based on new information about the overall CDI market and
IMM-529’s potential to be used earlier in the treatment
algorithm (based on approvals for treatment and prevention
of recurrence)
Derived wholly from secondary research, price target
increased to Vowst level, as a second mover IMM-529 is
projected to reach a 30% share of the advanced treatment
market
Phase I
Phase II
Lumanity, a leading lifescience consulting company: https://lumanity.com/company/our-story/
Phase III
Market
10
WORLD FIRST TRIPLE MECHANISM OF ACTION FOR CDI
IMM-529: pre-IND filed with FDA July 2024; successful pre-IND meeting
Indication / Target
Population
IMM-529 will be indicated for the treatment of recurrent C. difficile
infection
Product
Description /
Mechanism of
Action
• Novel antibody-containing therapeutic which neutralizes C. difficile
but does not impact the microbiome
• Targets not only toxin B but also spores and vegetative cells
responsible for recurrence
• Potential for use in combination with standard of care (e.g.
vancomycin, fidaxomicin)
• Targets many isolates
Dosage and ROA
• Oral administration, 3 x daily
• Trial to test safety 7-day treatment course on top of standard of care
(vancomycin, fidaxomicin)
Efficacy
1. Prevention of primary disease (80% P =0.0052)
2. Protection of disease recurrence (67%, P <0.01) and
3. Treatment of primary disease (78.6%, P<0.0001; TcB HBC).
Safety / Tolerability
• To be evaluated in Phase 2 study
• Equivalent or better than current standard of care
Positive results support Travelan®
progress to phase 3
IMM-124E Phase 2
+ Healthy volunteers were recruited and randomized to receive a single daily oral
dose of 1200 mg of Travelan® or placebo. Dosing commenced 2 days prior to
challenge with ETEC strain H10407 and continued for 7 days.
+ 60 subjects completed the inpatient challenge component of this current clinical
study.
+ 36.4% protective efficacy against Enterotoxigenic Escherichia coli (ETEC) induced
moderate to severe diarrhea was observed in the Travelan® group compared to
the Placebo group (primary endpoint) even though the attack rate for this study
was 37%, much lower than the planned 70%.
+ The attack rates on previous Phase 2 (Otto et al. 2011) were 73% and 86% with
protective efficacy of 90.9% and 76.7%.
+ 43.8% reduction in diarrhea of any severity in the Travelan® group compared to
the Placebo group during the 5-day period post challenge which is approaching
statistical significance; p=0.066
+ The number of cumulative adverse events per participant in the Travelan® group
(58) was statistically significantly lower than the Placebo group (109); p<0.05.
+ Phase 2 clinical study data supports the excellent safety and tolerability profile of
Travelan®.
12
Travelan® topline clinical
trial results demonstrate
protective efficacy with
single daily dose.
IMM-124E Phase 3 strategy
Pre
2024
2025
2026
Post
Phase 1 clinical study
(Baltimore, 1996)
Phase 2 clinical study
(Baltimore)
Clinical Study Report
January 2025
End of Phase 2 FDA meeting
Initiate Phase 3
Phase 2 clinical study
(Poland, 2000)
Additional topline data
analysis August 2024
FDA1 IND2 approval
(December 2022)
+ The pivotal registration studies is anticipated to involve two
randomized, double-blind, parallel-group, placebo-controlled Phase 3
clinical studies (drug substance IMM-124E) to assess the efficacy and
safety of Travelan® for prevention of traveler’s diarrhea (TD)
+ Anticipated enrolment of approximately 1200 healthy adult subjects
(600 subjects in two studies) traveling to regions with high TD risk.
13
1. U.S. Food and Drug Administration; 2. Investigational New Drug; 3. Biologics License Application
Trial duration ~ 2 years
End of Phase 3 FDA meeting
BLA3 submission
+ Subjects anticipated to be randomized 1:1 to receive Travelan® or
placebo.
+ Dosing anticipated to begin 3 days prior to arrival in country and for at
least 14 days in country.
+ The primary endpoint requested will be traveler’s diarrhea.
Upcoming Milestones
Revenue
+ Continued quarter on quarter growth of Travelan® from growth drivers
+ Australian launch of ProIBS
Clinical
IMM-124E (Travelan®): Traveller’s Diarrhoea
+ IMM-124E: completed 100% recruitment, randomization and deployment
(Phase 4; n=866)
+ IMM-124E: October 2025: Topline data (Phase 4; n=866)
+ IMM-124E: 1H 2026: End of Phase 2 FDA meeting (Phase 2; n=60)
IMM-529: Clostridioides difficile infection (C.diff, CDI)
+ IMM-529: 2H 2025: FDA IND Submission
+ IMM-529: 31 December: FDA IND Approval
14
Scientific references
Travelan® (IMM-124E)
Travelan® has been shown to reduce both the incidence and severity of ETECinduced 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 non-Human 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 (IMM124E) 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
15
Sci Rep 7, 3665 (2017). https://doi.org/10.1038/s41598-017-03982-5
STEVEN LYDEAMORE
CHIEF EXECUTIVE OFFICER
IMMURON LIMITED
CONTACT INFORMATION:
EMAIL: STEVE@IMMURON.COM
PHONE: AUSTRALIA: +61 438 027 172
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