Immuron details -529 IND submission to FDA

Immuron Limited furnished a Form 6-K for October 2025 to provide U.S. investors with information it released in Australia.

Rhea-AI Filing Summary

Immuron Limited furnished a Form 6-K for October 2025 to provide U.S. investors with information it released in Australia. The company explains that it published public notices to the Australian Securities Exchange on October 10, 2025 and is attaching one of these as an exhibit.

The attached Exhibit 99.1 is titled “Immuron Submits -529 IND to FDA,” indicating that Immuron has submitted a -529 IND to the U.S. Food and Drug Administration. The company also clarifies that this Form 6-K, including the exhibit, is being furnished rather than filed and will only be incorporated into other U.S. securities filings if specifically referenced.

Insights

Biotech regulatory analyst

Immuron reports submitting a -529 IND to the FDA via an attached ASX announcement.

Immuron Limited is using a Form 6-K to make a prior Australian Securities Exchange announcement available to U.S. markets. Exhibit 99.1 is titled “Immuron Submits -529 IND to FDA,” which signals that the company has taken a regulatory step by submitting a -529 IND to the U.S. Food and Drug Administration.

This sort of disclosure highlights a development in the company’s pipeline but does not provide financial figures or describe clinical details in the excerpt. The impact for investors depends on future regulatory feedback and any subsequent development milestones, which are not discussed here. Overall, this looks like an informative regulatory update rather than a thesis-changing event.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What does Immuron Limited (IMRN) report in this October 2025 Form 6-K?

Immuron Limited reports that it furnished to U.S. investors an announcement it made to the Australian Securities Exchange, attaching it as an exhibit to the Form 6-K.

What is included as Exhibit 99.1 in Immuron Limited's Form 6-K?

Exhibit 99.1 is titled “Immuron Submits -529 IND to FDA,” indicating that the company has submitted a -529 IND to the U.S. Food and Drug Administration.

When were the related announcements published to the Australian Securities Exchange by Immuron (IMRN)?

The company states that it published the related announcements to the Australian Securities Exchange on October 10, 2025.

Does Immuron treat this Form 6-K as filed or furnished under U.S. securities laws?

Immuron states that the Form 6-K, including its exhibit, is being furnished, not filed, for purposes of the Securities Exchange Act of 1934.

Will this Immuron (IMRN) Form 6-K automatically be incorporated into other U.S. securities filings?

The company states that the Form 6-K will not be incorporated by reference into other U.S. securities filings unless expressly set forth by specific reference.

Who signed the October 2025 Form 6-K for Immuron Limited (IMRN)?

The Form 6-K was signed on behalf of Immuron Limited by Phillip Hains, who is identified as the Company Secretary.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 10/07/2025 - 07:29 PM Learn about SEC filing dates

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 October 2025

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 two announcements (the “Public Notices”) to the Australian Securities Exchange on October 10, 2025 titled:

- Immuron Submits IMM-529 IND to FDA

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 Number		Description
99.1		Immuron Submits IMM-529 IND to FDA

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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: October 8, 2025	By:	/s/ Phillip Hains
		Phillip Hains
		Company Secretary

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