Full Press Release Details
Steven Lydeamore presentation at
Melbourne, Australia,
August 21 2024: Immuron Limited (ASX: IMC; NASDAQ: IMRN) is pleased to advise our Chief Executive Officer, Steven Lydeamore will be presenting
at Peak Biotech Showcase on Wednesday 21st August
2024 at Work Club Olderfleet, 477 Collins Street, Melbourne, Australia.
A copy of the presentation being made is included below.
This release has been authorised by the directors of Immuron Limited.
Chief Executive Officer
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.
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.
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
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 .
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).
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
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):
For more information visit: https://www.immuron.com.au/
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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.
21 August 2024 Steven Lydeamore Chief Executive Officer Biotech Showcase NASDAQ: IMRN ASX: IMC
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 s imilar 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 r i sks and uncertainties, some of which are beyond Immuron's control, including those r i sks or uncertainties inherent in the process of both developing and commercializing technology. As a result, actual results could materially differ f rom 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, c i rcumstances or unanticipated events occurring after the date of this presentation except as required by law or by any appropriate regulatory authority. YTD FY 2024 results in this presentation are subject to audit review. SAFE HARBOR STATEMENT
3 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 3 as of 18 August 2024 CampETEC Phase 2 clinical trial completed inpatient phase IMM - 529 pre - IND filed with FDA U.S. Department of Defense Research Award for NMRC and WRAIR to develop an enhanced formulation of Travelan Major Shareholders Financial Snapshot 227,998,346 Shares on Issue 15,078,839 Total Options IMC: A$0.10 Last Traded Price IMC: A$0.17/0.065 IMRN: $5.96/1.481 52 week High/Low IMC: A$22.8m Market Cap A$15.2m Cash & Cash Equivalents (as at 31 Dec 23) % of CSO Units Holder 34.1 % 77,828,104 BNY Mellon Asset Management 2.4 % 5,500,000 Authentics Australia Pty. Ltd. 1.7 % 3,846,712 Grandlodge 0.9 % 1,954,070 Management & Board Company Overview Two commercially available oral immunotherapeutic products - Travelan and Protectyn 4 clinical programs: Travelan (IMC: Phase 2 CHIM trial), Travelan (USU: Phase 4 field study), CampETEC (NMRC: Phase 2 CHIM trial), IMM - 529 (IMC: Protocol development phase, Phase 2 trial) Business Update Flagship product Travelan growing strongly as overseas travel rebounds Travelan (IMM - 124E) Phase 2 CHIM trial topline results Travelan (IMM - 124E) Travelan Uniformed Services University IMM - 124E Phase 4 trial recruited ~77% of 866 Results & Outlook Sales 1 Jul 23 to 30 June 24 of A$4.9 million up 174% on pcp (unaudited) Evaluating options to enter international markets Evaluating options to add to marketed products portfolio