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Immuron Ltd — Investor Presentation 2023
Sep 10, 2023
35121_rns_2023-09-10_07b188fa-ef36-4636-92d5-51ee43dde309.pdf
Investor Presentation
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Immuron CEO, Steven Lydeamore to present at H.C. Wainwright
Melbourne, Australia, September 11, 2023: 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 virtually at the H.C. Wainwright 25[th] Annual Global Investment Conference on September 11[th] .
The webcast to this presentation will be available here at 7am Eastern Standard Time / 9pm Australian Eastern Standard time on September 11th.
A copy of the presentation being made at the H.C. Wainwright 25th Annual Global Investment Conference is included below.
This release has been authorised by the directors of Immuron Limited.
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COMPANY CONTACT:
Steven Lydeamore Chief Executive Officer Ph: +61 (0)3 9824 5254 [email protected]
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.
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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.
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H.C. WAINWRIGHT & CO. VIRTUAL PRESENTATION 11 SEPTEMBER, 2023 - Steven Lydeamore CEO NASDAQ: IMRN ASX: IMC
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SAFE HARBOR STATEMENT
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.
YTD FY2023 results in this presentation are subject to audit review.
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EXECUTIVE SUMMARY
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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
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Financial Snapshot
• Two commercially available oral immunotherapeutic products – Travelan® Shares on Issue 227,798,346
and Protectyn®
Total Options 14,568,559
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Company 4 clinical programs: Travelan®(NMRC: Phase 2 CHIM trial), Travelan®(USU: Last Traded Price IMC: A$0.075
Phase 4 field study), CampETEC (Phase 2 CHIM trial), IMM-529 (Protocol
Overview 52 week High/Low IMC: A$0.105/0.067
development phase, Phase 2 trial)
IMRN: $3.21/1.39
Market Cap IMC: A$17.085m
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Flagship product Travelan® growing strongly as overseas travel rebounds Cash & Cash Equivalents (as at A$18.5m
• Travelan® (IMM-124E) IND filed with and approved by FDA 31 Dec 22)
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Travelan® (IMM-124E) Phase 2 clinical trial initiated
Business
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Travelan® Uniformed Health Services University (USU) P2TD IMM-124E field
Update
clinical trial recruited 347 (~40% of target 868) Major Shareholders
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CampETEC IND approved (released from Clinical Hold)
Holder Units % of CSO
• FY23 sales of A$1.80 million up 136% on FY22 (subject to audit review) BNY Mellon Asset Management 78,973,505 34.7 %
• Evaluating options to enter international markets through distributors Management & Board 6,904,554 3.0 %
Results & • Evaluating options to add to marketed products portfolio in FY24
Authentics Australia Pty. Ltd. 6,000,000 2.6 %
Outlook
Grandlodge 3,846,712 1.7 %
as of 21 August 2023
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ADDRESSABLE MARKET & INDUSTRY OVERVIEW
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Billion Dollar Market
Traveller’s diarrhoea treatment market is large and growing at a CAGR of ~7%
Industry tailwinds
Travel picking up significantly following COVID lockdowns
Frequent Symptom
30% - 70% of travelers experience traveller’s diarrhoea**
$83m $50m $1.7b USA Market Chief Commercial Based on US annual Based on EU travel Clostridioides difficile Evaluating options: Officer has 20+ year’s • travel numbers and a numbers and a infections (CDIs) to for entry into amazon.com shopfront experience with local international penetration rate of penetration rate of grow to almost $1.7 launched 1QFY24 and global (Asia, UK) markets 15%, the market 15%, the market billion by 2026, Re-entry into retail commercial leadership • to add marketed potential is estimated potential is estimated according to pharmacies will be roles with GSK and at $83m at $50m GlobalData products to explored in FY24 P&G portfolio in FY24
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* IMC Company Report - Travelan Market Analysis 2019
** Centers for Disease Control and Prevention Yellow Book
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TECHNOLOGY PLATFORM
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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.
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STEP 1
Development of Highly Specific Vaccines
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STEP 2
STEP 3
Isolation of Hyperimmune Oral Antimicrobial antibody-rich therapeutics bovine colostrum without drawbacks of antibiotics
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FINAL PRODUCT
Toxin Neutralization +
Clearance of targeted gut pathogens
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✓ Reduce occurrence and reduce/relieve diarrhoea
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✓ Reduce/relieve abdominal cramping
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✓ Reduce/relieve gastrointestinal pain
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✓ Assists repair of
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gastrointestinal/gut wall lining
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✓ Enhance/promote immune defence
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✓ Enhance/promote health liver function
Australian Permitted indications; these statements have not been evaluated by the Food and Drug Administration (FDA)
* Gomes et. al., NFS Journal, Volume 25, November 2021, pages 1- 11, https://doi.org/10.1016/j.nfs.2021.10.001
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STATUS OF PRODUCT PORTFOLIO AND KEY MILESTONES
US Department of Defense grant of US$4.45 million to examine a dosing regimen for Travelan® more suited for use by the military[b]
Immuron’s Clinical Programs Compound or Indication Phase Phase Phase Market brand name I II III Traveler’s IMM-124E Diarrhea ETEC Travelan® challenge Clostridioides difficile IMM-529 Infection & Recurrence Our Partners’ Clinical Programs Compound or Partner Phase Phase Phase Market brand name I II III Travelan® Uniformed Services University CampETEC Naval Medical Research Center
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Market evaluation by Lumanity confirms the Traveler’s Diarrhea market opportunity for IMM-124E (Travelan®)[c]
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IMM-124E (Travelan®) IND was approved by the FDA in 2H2022[a]
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Clinical trial initiated May 2023[g]
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First patients enrolled in July 2023[I]
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Anticipated clinical study report – 1H 2024
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Market evaluation by Lumanity confirms the Clostridioides difficile market opportunity for IMM-529[d]
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600mg solid dose active formulation development completed
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Anticipated manufacture of cGMP IMM-529 – 31 December 2023[h]
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Anticipated pre-IND submission to the FDA – 30 June 2024[h]
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Travelan® - Uniformed Services University has recruited ~40% of participants in a randomized clinical trial with Travelan® to evaluate the effectiveness for prophylaxis during deployment or travel to a high traveler’s diarrhea risk region[e, i]
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Anticipated completion of enrollment – 31 March 2024
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Anticipated completion of in-patient phase – 30 June 2024
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Naval Medical Research Center Clinical Trials of CampETEC in campylobacter and enterotoxigenic E.coli (ETEC)
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Animal ethics approval for Toxicology study – 22 November 2022
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Immuron sponsored Toxicology study - completed 20 December 2022
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- FDA Removed Clinical Hold on Campylobacter ETEC – 8 May 2023[f]
a ,b,c,d,e,f g,h,i ASX Release links in appendix
*Further information on the clinical programs can be found on slide 7
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KEY MILESTONES ANTICIPATED TO DRIVE VALUE
2H 2022 1H 2023 2H 2023 1H 2024
• FDA IND [1] approved for single • IRB Approval [4] • First patients enrolled [i] • Topline results for IMM-124E
Travelan® daily dose IMM-124E ETEC [2] • Initiated IMM-124E ETEC [2] • Completion of In-patient ETEC [2] clinical trial
CHIM [3] clinical trial [a] CHIM [3] clinical trial [g] phase ETEC [2] CHIM [3] clinical trial • Clinical Study Report
• Submitted Response Letter to • Toxicology Study Report • Initiate NMRC [5] CampETEC
FDA Clinical Hold • FDA IND [1] approved (Clinical Campylobacter CHIM [3] clinical
• Immuron sponsored Toxicology Hold released) [f] trial
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CampETEC study - completed Completion of In-patient
phase CampETEC
Campylobacter CHIM [3] clinical
trial
• 600 mg solid dose active • Project strategic planning and • IMM-529 cGMP manufacture • IMM-529 (CDI) [7] Pre-IND [1]
formulation development budget development submission
IMM-529
• USU [6] P2TD IMM-124E field • ~40% of 868 participants • Completion of enrollment
Travelan® clinical trial recruitment recruited • Completion of in-patient phase
commencement [e,i]
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Completed; 1. Investigational New Drug; 2. Enterotoxigenic E.coli ; 3. controlled human infection model; 4. Institutional Review Board; 5. Naval Medical Research Command;
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- Uniformed Health Services University of the Health Sciences; 7. Clostridioides Difficile;[a,e,f,g, i] ASX Release links in appendix
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IMMURON’S CLINICAL PROGRAMS – OPPORTUNITY ASSESSMENT
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› 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
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› Non-microbiome approaches (such as IMM-529) are still appealing to experts, who noted that clinical trial efficacy (reduction in relapse rate) and cost/access will be the key drivers of clinical use in recurrent patients, not mechanism of action
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› Immuron’s development of IMM-124E (hyperimmune bovine colostrum) as a prescription medication has the potential to address this unmet need
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› Primary care physicians (PCP)s impressed with clinical efficacy endpoint targets demonstrating > 80% protection against the development of diarrhea.
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› 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, anticipated payer restrictions, pricing, and competition, base case yearly revenue in USA for IMM-529 is conservatively projected at US$93M for the target patient population (limited to 2nd recurrence and later based on trial design and payer coverage)
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› Based on the estimated market size and pricing, the base case yearly revenue in USA for IMM-124E is projected at US$102M .
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› Reaching higher efficacy goals could broaden use.
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› Positioning IMM-529 earlier than second recurrence and/or efficacy targets could lead to higher uptake.
Compound or brand name
Indication
Phase I
Phase II
Phase III Market
IMM-124E - Travelan®
IMM-529
Traveler’s Diarrhea ETEC challenge
Clostridioides difficile Infection & Recurrence
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Lumanity, a leading lifescience consulting company: https://lumanity.com/company/our-story/
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DISTRIBUTION CAPABILITY
Australia USA Canada Retail Pharmacy Established B2B E-commerce Developing
Key Commentary
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The Australian retail network includes over 3,500 pharmacies
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In the USA, the key B2B customer is Passport Health - the largest network of travel medicine clinics
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Immuron launched its own US shopfront on amazon.com in July 23
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Re-entry into retail pharmacies in USA will be explored in FY24
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In Canada, we are working towards a relaunch into retail pharmacy in late FY24
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We are exploring options to expand B2B business in airlines, cruise ships, health & wellness segments
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We are evaluating options to enter international markets through distributors
ANB Canada Ontario, Canada Distributes to all provinces of Canada
Immuron Limited Vancouver, BC, Canada
RJW Logistics Chicago, USA Distributes to all states of USA
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Immuron Limited
Melbourne, Australia Distributes to all states of Australia and to distributors in USA and Canada
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Immuron Inc. New York, USA
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BUSINESS POSITIONED FOR ORGANIC GROWTH AND NEW M&A STRATEGY
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Organic Growth Strategy
Focus on commercialised products and near-term development extensions, including:
01 Travelan®:
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Sales expansion across target geographies
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Growth in distribution network and sales & marketing initiatives
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Product development (new formulations including once daily dosing) e.g. FDA approval
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02 Protectyn®:
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Sales expansion across target geographies
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• Growth in distribution network and sales & marketing initiatives
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• Product development and broader applications
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M&A Strategy
By pursuing growth through M&A of a fragmented market, IMC believes that it will be able to increase market geographies, sales channels and penetration driving revenue growth and ultimately shareholder value
Our M&A Key Criteria focusses on:
01 Expand market verticals & product offering 02 Expand existing customer base
03 Cost & Earnings Synergies
04 Strength of IP and Management
05 Distribution network and sales & marketing by each product
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STEVEN LYDEAMORE CHIEF EXECUTIVE OFFICER IMMURON LIMITED CONTACT INFORMATION:
EMAIL: [email protected] PHONE: AUSTRALIA: +613 8892 4854
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|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|Scandinavian Journal of Gastroenterology, 46:7-8, 862-868, DOI:|
|volunteers|10.3109/00365521.2011.574726|
|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|US Department of Defense, Armed Forces Research Institute of Medical|
|for prevention of traveler’s diarrhea|Sciences (AFRIM), 4 September, 2019|
|Travelan® prevented clinical shigellosis (bacillary dysentery) in 75% of Travelan® treated animals compared to|US Department of Defense, Armed Forces Research Institute of Medical|
|placebo and demonstrated a significant clinical benefit|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|
|Efficacy of hyperimmune bovine colostrum against shigellosis in rhesus macaque (Macaca mulatta), and|Islam et al., 2020. Submitted to mSphere, American Society for Microbiology|
|bioactivity of HBC against common enteric pathogens|
|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|Rachele Gore, Mitra Mohsenipour, Jennifer L Wood, Gayathri K Balasuriya,|
|effect on gut microbial communities in unchallenged mice|Elisa L Hill-Yardin, Ashley E Franks|
|Administration of the Hyper-immune Bovine Colostrum Extract IMM-124E Ameliorates Experimental Murine|Journal of Crohn's and Colitis, Volume 13, Issue 6, June 2019, Pages 785–797,|
|Colitis|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|
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| ASX | RELEASES REFERENCED Ref Slide statement ASX Release a Travelan® (IMM-124E) IND filed with and approved by FDA Immuron Receives FDA Approval for Travelan IND Application b US Department of Defense grant of US$4.45 million to examine a dosing regimen for Travelan® more suited for use by the military Immuron awarded A$6.2 million US DoD funding for Travelan c Market evaluation by Lumanity confirms the Traveler’s Diarrhea market opportunity for IMM-124E (Travelan®) AGM Presentation d Market evaluation by Lumanity confirms the Clostridioides difficile market opportunity for IMM-529 AGM Presentation e Travelan® - Uniformed Services University has recruited more than 20% of participants in a randomized clinical trial with Travelan® to evaluate the effectiveness for prophylaxis during deployment or travel to a high traveler’s diarrhea risk region US DOD Travelan Clinical Recruitment Milestone f Immuron Announces FDA Removed Clinical Hold on New Campylobacter FDA Removed Clinical Hold on |
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| ETEC Therapeutic Paves Way for Clinical Trial Initiation Campylobacter ETEC Therapeutic g Immuron Initiates Recruitment of Travelan® Clinical Study Immuron Initiates Recruitment of Travelan Clinical Study h Immuron Board approves IMM-529 cGMP manufacturing and FDA pre-IND submission Letter to Shareholders i Immuron Announces First Patients Enrolled in Travelan® Clinical Study Immuron enrols patients in Travelan clinical study |
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