UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the Month of August 2024
Commission File Number: 001-38104
IMMURON LIMITED
(Name of Registrant)
Level 3, 62 Lygon Street, Carlton South,
Victoria, 3053, Australia
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form
40-F ☐
Indicate by check mark whether by furnishing the information contained
in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes ☐ No
☒
If “Yes” is marked, indicate below the file number assigned
to the registrant in connection with Rule 12g3-2(b): 82-
IMMURON LIMITED
EXPLANATORY NOTE
Immuron Limited (the “Company”) published
one announcement (the “Public Notices”) to the Australian Securities Exchange on August 7, 2024 titled:
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“Immuron CEO to host webinar on MarketOpen Direct Connect” |
A copy of the Public Notice is attached as an exhibit to this report
on Form 6-K.
This report on Form 6-K (including the exhibit
hereto) shall not be deemed to be “filed” for purposes of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”) and shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be
expressly set forth by specific reference in such filing.
EXHIBITS
SIGNATURE
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
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IMMURON LIMITED |
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Date: August 7, 2024 |
By: |
/s/ Phillip Hains |
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Phillip Hains |
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Company Secretary |
3
Exhibit 99.1
![](https://www.sec.gov/Archives/edgar/data/1660046/000121390024065899/ex99-1_001.jpg)
Immuron CEO, Steven Lydeamore to host webinar
on MarketOpen Direct Connect
Melbourne, Australia, August 7, 2024: Immuron
Limited (ASX: IMC; NASDAQ: IMRN) is pleased to invite shareholders to attend an investor webinar on MarketOpen Direct Connect to be held
on
Thursday 8th August 2024, 11:00am AEST
(9:00am AWST).
Chief Executive Officer, Steven Lydeamore will
provide an update on additional data analysis of IMM-124E (Travelan®) Phase 2 trial and next steps.
Following the presentation, attendees will have the opportunity to
ask questions directly to Mr. Lydeamore during a moderated Q & A session.
This webinar can be viewed live via zoom & you register for FREE
via the link below.
https://us06web.zoom.us/webinar/register/WN_QV-yMVvGRQuYq698XMTQxA
A recorded copy of the webinar will be made available following the
event.
This release has been authorised by the directors
of Immuron Limited.
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COMPANY CONTACT:
Steven Lydeamore
Chief Executive Officer
steve@immuron.com
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.
![](https://www.sec.gov/Archives/edgar/data/1660046/000121390024065899/ex99-1_003.jpg)
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.
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).
![](https://www.sec.gov/Archives/edgar/data/1660046/000121390024065899/ex99-1_003.jpg)
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.
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