Full Press Release Details
Melbourne, Australia, November 18, 2024: Immuron
Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to release its AGM
Presentation ahead of today's Annual General Meeting which is being held at the office of K&L Gates, Level 25, Rialto South
Tower, 525 Collins Street Melbourne, Victoria, Australia at 11am Australian EST and virtually at https://bit.ly/IMCAGM2024.
This release has been authorised by the directors of Immuron Limited.
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.
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.
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 .
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):
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.
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
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.
1 1 AGM PRESENTATION 18 NOVEMBER, 2024 NASDAQ: IMRN ASX: IMC Steven Lydeamore - CEO
2 2 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. SAFE HARBOR STATEMENT FY2025 results in this presentation are subject to audit review.
3 3 EXECUTIVE SUMMARY Immuron Ltd (ASX:IMC) (NASDAQ:IMRN) is a globally integrated biopharmaceutical company focused on developing, and commercialising, oral immunotherapeutics for the treatment of gut mediated diseases Company Overview Platform Technology: capable of producing highly specific orally active immunoglobulins to any enteric pathogen Two commercially available oral immunotherapeutic products - Travelan and Protectyn Two pipeline assets in three clinical programs Market capitalisation of $ 17.6 million as of 25 October 2024 with cash and cash equivalents balance of $11.7 million as of 30 June 2024 The FY24 sales and marketing strategy of distribution, awareness, education and visibility via consumer media and the trade i s working Travel continues its momentum and Travelan is increasing market share of the antidiarrheal category G lobal sales increased 172% in FY24 to $4.90 million; Record Travelan sales of $4.86 million Travelan was the #1 SKU in the Antidiarrheal category across Chemist Warehouse pharmacy in Australia 1 Record monthly sales in October 2024 of $1.49 million Completed and reported topline results for Travelan Phase 2 and NMRC's Campylobacter clinical trial; planning 2H2025 Phase 3 initiation for Travelan Positive feedback from the FDA to IMM - 529 pre - IND filing; planning 2H2025 Phase 2 initiation Business Update 1. IQVIA Australia Pharmacy Scan - Antidiarrheal segment, value sales 4 weeks to 28 September 2024
4 4 NAVAL MEDICAL RESEARCH COMMAND TRIAL NMRC experimental campylobacter/ETEC vaccine o The trial was funded by the Naval Medical Research Command (NMRC). Immuron's produced a hyperimmune bovine colostrum (HBC) trial product using the NMRC vaccine which was tested in a controlled human infection model study. The results of this clinic al trial are unrelated to Travelan and do not impact Immuron's plans to hold an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA). Nor does this NMRC trial impact on Immuron's commercialization strategy for Travelan . o Trial Conclusions: o CampETEC was well - tolerated o No moderate or severe adverse events were reported o CampETEC did not significantly prevent campylobacteriosis o Regimen dose of CampETEC not enough / too many bacteria in the inoculum o Targeting the polysaccharide capsule may not prevent epithelial cell invasion o Future Direction: o NMRC to evaluate: o New vaccine candidates which target Campylobacter (e.g. whole cells and Surface layer proteins of the flagellum, a whip - like appendage that enables bacterial motility) for the development of HBC o USD $2.3 million funding for NMRC and Walter Reed Army Institute of Research (WRAIR) approved by the U.S. Department of Defense o This work will utilize the extensive experience of the US Department of Defense human infectious disease vaccine programs, and one part of this program will target key protective antigens of the enteric bacterial pathogen campylobacter
5 5 STRONG PIPELINE WITH NEAR TERM MILESTONES 5 5 Market Phase III Phase II Phase I Partner Compound or brand name Travelan Market Phase III Phase II Phase I Indication Compound or brand name Traveler's Diarrhea ETEC challenge IMM - 124E Travelan Clostridioides difficile Infection & Recurrence IMM - 529 Uniformed Services University Immuron's Clinical Programs Our Partners' Clinical Programs
6 6 TRAVELAN PROGRESSES TOWARDS PHASE 3 Travelan (IMM - 124E) Phase 2 o Travelan IND Approval - December 2022 o Study Initiation - May 2023 o First cohort recruitment completed - July 2023 o Presentations at Military Health System Research Symposium - August 2023 o Second cohort recruitment completed - October 2023 o Completion of In - patient phase - October 2023 o Topline Results - March 2024 o Anticipated Clinical Study Report - December 2024 o Anticipated End of Phase 2 FDA meeting - 1H 2025 o Anticipated initiation of Phase 3 clinical study - 2H 2025 US Uniformed Services University Traveller's Diarrhoea Clinical Field Trial o USU's Infectious Diseases Clinical Research Program (IDCRP) are conducting a randomized clinical trial to evaluate the efficacy of Travelan against placebo for Traveller's Diarrhoea o 866 study participants (433 per arm) o 50% recruitment milestone - October 2023 o 85% recruitment milestone - September 2024 o Anticipated completion of recruitment - December 2024 o Anticipated topline results - April 2025