Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]
2023年8月9日 - 7:01PM
Edgar (US Regulatory)
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 August 2023
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
EXPLANATORY NOTE
Immuron Limited (the “Company”) published
one announcement (the “Public Notices”) to the Australian Securities Exchange on August 9, 2023 titled:
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“Immuron Receives TGA GMP Clearance” |
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.
EXHIBITS
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.
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IMMURON LIMITED |
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Date: August 9, 2023 |
By: |
/s/ Phillip Hains |
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Phillip Hains |
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Company Secretary |
3
Exhibit 99.1
Immuron Receives TGA GMP Clearance
Highlights:
| ● | Immuron Receives TGA GMP Clearance |
| ● | Immuron to release and dispatch Travelan®
to customers this week |
Melbourne, Australia, August 9, 2023: Immuron
Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce that
the Therapeutic Goods Administration (TGA) has given GMP Clearance for Immuron’s packaging supplier allowing Travelan® to be
released for sale in Australia to retail pharmacy wholesalers and other customers.
On July 5, 2023, Immuron announced FY23 sales increase of 136% on FY22
sales and at the same time advised that until the TGA provided GMP Clearance for a new packaging supplier, Travelan® would be out
of stock in wholesalers and pharmacies. If Immuron was able to supply product to wholesalers in June, FY23 sales would have been even
higher. Immuron plans to release and dispatch Travelan® to customers this week.
Immuron’s resolution of supply and stock outages will allow continuation
of anticipated growth in sales in Australia and also USA where Immuron recently launched on its own Amazon.com shopfront.
Immuron is focused on growing sales of its commercial
products, expanding its portfolio of products and has a strong existing pipeline.
This release has been authorised by the directors
of Immuron Limited.
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COMPANY CONTACT: |
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Steven Lydeamore |
Chief Executive Officer |
Ph: +61 (0)3 9824 5254 |
info@immuron.com |
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.
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.
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.
Immuron (NASDAQ:IMRN)
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