Immuron Ltd 6-K, filed Nov 15, 2021
Immuron Ltd (IMRN)
About this 6-K
Immuron Ltd filed this 6-K on November 15, 2021.
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 November 2021
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 if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
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 November 15, 2021 titled:
| - | “US DoD Travelan Clinical Update” |
|---|
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.
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EXHIBITS
| Exhibit<br><br>Number | Description |
|---|---|
| 99.1 | US DoD Travelan Clinical Update |
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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.
| IMMURON LIMITED | ||
|---|---|---|
| Date: November 15, 2021 | By: | /s/ Phillip Hains |
| Phillip Hains | ||
| Company Secretary |
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Exhibit 99.1
US DoD Uniformed Services University Travelers’ Diarrhea Clinical Update
Key Points
| ● | Manufacture of investigational medical products to support the Uniformed ServicesUniversity (USU) clinical program to evaluate the efficacy of Travelan® and two other non- antibiotic OTC products in Travelers’Diarrhea initiated |
|---|---|
| ● | USU are anticipating an enrolment start date of April 2022 and plan to enrol1336 participants in total |
Melbourne, Australia, November 15, 2021: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercializing oral immunotherapeutic products for the prevention and treatment of gut pathogens, today is pleased to provide shareholders and the market with an update on the planned clinical trial program to evaluate the efficacy of Travelan® and two other non-antibiotic OTC products in Travelers’ Diarrhea sponsored by the Uniformed Services University of the Health Sciences (USU).
USU have initiated the manufacturing campaign to produce the first batches of investigational medical products in November 2021 to support the planned clinical trial program to evaluate the efficacy of Travelan® and two other dietary supplement products in Travelers’ Diarrhea. USU are anticipating an enrollment start date of April 2022 for the planned clinical trial and are hoping to complete enrollment in approximately 18 months. USU’s Infectious Diseases Clinical Research Program (IDCRP), the UK Ministry of Defense and the New York City Travel Clinic are jointly planning to conduct the randomized clinical trial to evaluate the efficacy of three nutraceutical products for TD and inform strategies for Defense Force Health Protection. The P4TD study is a randomized, double-blind, placebo controlled multicenter clinical trial designed to evaluate the effectiveness of 3 commercially available nutraceuticals: A prebiotic (Bimuno®), a probiotic (Florastor®) and IMM- 124E (Travelan®) passive immunoprophylaxis verses a placebo, for prophylaxis during deployment or travel to a high-TD risk region (ClinicalTrials.gov Identifier: NCT04605783).
All study participants (1336 in total) will be randomized to one of the three active products or placebo (334 per arm).
This release has been authorised by the directors of Immuron Limited.
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| Level 3, 62 Lygon Street, | www.immuron.com | Phone: + 61 (0)3 9824 5254 |
|---|---|---|
| Carlton South, Victoria | Facsimile: + 61 (0)3 9822 7735 | |
| AUSTRALIA 3053 | ABN: 80 063 114 045 |
COMPANY CONTACT:
Dr Jerry Kanellos, Ph.D.
Chief Executive Officer
Ph: +61 (0)3 9824 5254
info@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 inflammatory mediated and infectious diseases. Immuron has a novel and safe technology platform with one commercial asset generating revenue. In Australia, Travelan® is a listed medicine on the Australian Register of Therapeutic Goods (AUST L 106709) and is indicated to reduce the risk of Travellers’ Diarrhea, reduce the risk of minor gastro-intestinal disorders and is antimicrobial. In Canada, Travelan® is a licenced natural health product (NPN 80046016) and is indicated to reduce the risk of Travellers’ Diarrhea. In the U.S., Travelan® is sold as a dietary supplement for digestive tract protection in accordance with section 403 (r)(6) of the Federal Drug Administration (FDA).
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.
About Travelers’ diarrhea
Travelers’ diarrhea 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 travelers’ diarrhea as they may be contracted while travelling and initial symptoms are often indistinguishable.
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 SecuritiesExchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategyand product development programs and any other statements that are not historical facts. Forward- looking statements are based on management’scurrent expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financialcondition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risksrelating 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 clinicaltrials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrateand 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 anyobligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect anychange in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as requiredby law.
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