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6-K 1 ea0205217-6k_immuron.htm REPORT OF FOREIGN PRIVATE ISSUER

 

 

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 May 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 (the “Company”) published two announcements (the “Public Notices”) to the Australian Securities Exchange on May 3, 2024 titled:

 

 

 

 


 

IMMURON LIMITED

 

EXPLANATORY NOTE

 

 

- “Board Change”
- “Final Director’s Interest Notice (SA)”

 

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.

 

1


 

EXHIBITS

 

Exhibit
Number
  Description
99.1   Board Change
99.2   Final Director’s Interest Notice (SA)

 

2


 

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: May 3, 2024 By: /s/ Phillip Hains
    Phillip Hains
    Company Secretary

 

3

 

EX-99.1 2 ea020521701ex99-1_immuron.htm BOARD CHANGE

Exhibit 99.1

 

 

Board Change

 

Melbourne, Australia, May 3, 2024: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company, advises that Stephen Anastasiou has resigned from his position as Non- Executive Director effective today to focus on his other business interests.

 

Stephen has served as a Director since 2013 and has provided valued contributions and experienced counsel to the Company. During Stephen’s tenure, Immuron launched Travelan® into the USA and Canadian markets and dual listed the Company on NASDAQ (IMRN).

 

In making this decision to retire, he cited a desire to focus on a restructure of his business commitments in order to dedicate more time to his family and pursue other personal interests. Stephen Anastasiou said, “It has been a great privilege to have served on the Board of Immuron and with a professional and dedicated Chairman, and outstanding Board members. The company enters a period of exciting opportunity and growth, based on unique products and platform technology. I wish all Board members and Immuron staff every success in the future.”

 

Immuron’s Chairman Paul Brennan said, “Stephen has made significant contributions to IMC with his strength in marketing and clinical applications for our immunotherapy product. We wish Stephen all the best in his new ventures. I would like to thank him for his support and active contributions.”

 

This release has been authorised by the directors of Immuron Limited.

 

- - - END - - -

 

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.

 

 

 


 

 

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

 

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®.

 

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.

 

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.

 

 

2


 

 

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.

 

 

 

 

3

 

 

EX-99.2 3 ea020521701ex99-2_immuron.htm FINAL DIRECTOR'S INTEREST NOTICE (SA)

Exhibit 99.2

 

Appendix 3Z
Final Director’s Interest Notice

 

Rule 3.19A.3

Appendix 3Z

 

Final Director’s Interest Notice

 

Information or documents not available now must be given to ASX as soon as available. Information and documents given to ASX become ASX’s property and may be made public.

 

Introduced 30/9/2001.

 

Name of entity Immuron Limited
ABN 80 063 114 045

 

We (the entity) give ASX the following information under listing rule 3.19A.3 and as agent for the director for the purposes of section 205G of the Corporations Act.

 

Name of director Stephen Anastasiou
Date of last notice 15 June 2022
Date that director ceased to be director 3 May 2024

 

Part 1 – Director’s relevant interests in securities of which the director is the registered holder

 

In the case of a trust, this includes interests in the trust made available by the responsible entity of the trust

 

Note: In the case of a company, interests which come within paragraph (i) of the definition of “notifiable interest of a director” should be disclosed in this part.

 

Number & class of securities


1,800,000 Unlisted Options








 

+ See chapter 19 for defined terms.

 

11/3/2002 Appendix 3Z Page 1

 

 


 

Appendix 3Z
Final Director’s Interest Notice

 

Part 2 – Director’s relevant interests in securities of which the director is not the registered holder

 

Note: In the case of a company, interests which come within paragraph (ii) of the definition of “notifiable interest of a director” should be disclosed in this part.

 

In the case of a trust, this includes interests in the trust made available by the responsible entity of the trust

 

Name of holder & nature of interest

Note: Provide details of the circumstances giving rise to the relevant interest

 

Director related entity

Number & class of securities

 

 

 

Shares 4,882,388

 

 

 

 

 

 

 

 

Part 3 – Director’s interests in contracts

 

Detail of contract N/A
Nature of interest N/A
Name of registered holder (if issued securities) N/A
No. and class of securities to which interest relates N/A

 

+ See chapter 19 for defined terms.

 

Appendix 3Z Page 2   11/3/2002