Immuron Ltd 6-K, filed Jun 19, 2020
Immuron Ltd (IMRN)
About this 6-K
Immuron Ltd filed this 6-K on June 19, 2020.
UNITEDSTATES
SECURITIESAND EXCHANGE COMMISSION
Washington,D.C. 20549
Form6-K
REPORTOF FOREIGN PRIVATE ISSUER
PURSUANTTO RULE 13a-16 OR 15d-16 UNDER
THESECURITIES EXCHANGE ACT OF 1934
For the Month of June 2020
Commission File Number: 001-38104
IMMURONLIMITED
(Name of Registrant)
Level3, 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-
IMMURONLIMITED
EXPLANATORYNOTE
Immuron Limited (the “Company”) published three announcements (the “Public Notices”) to the Australian Securities Exchange on June 19, 2020 titled:
| - | “IMC<br> & CSIRO to produce oral therapeutic for DoD evaluation” |
|---|---|
| - | “Change<br> of Director’s Interest Notice PA” |
| --- | --- |
| - | “Change<br> in substantial holding (GL)” |
| --- | --- |
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
| Exhibit<br><br> Number | Description |
|---|---|
| 99.1 | IMC & CSIRO to produce oral therapeutic for DoD evaluation |
| 99.2 | Change of Director’s Interest Notice PA |
| 99.3 | Change in substantial holding (GL) |
1
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: June<br> 19, 2020 | By: | /s/<br> Phillip Hains |
| Phillip<br> Hains | ||
| Company<br> Secretary |
2
Exhibit 99.1

Immuronand CSIRO to produce a new oral therapeutic for clinical evaluation by the US Department of Defense
KeyPoints
| ● | Immuron executes a Research Agreement with The Henry M. Jackson Foundation for Advancement of Military Medicine Inc. |
|---|---|
| ● | Immuron executes a Research Agreement with CSIRO to develop a new oral therapeutic targeting Campylobacter and ETEC for clinical evaluation |
| --- | --- |
| ● | Vaccination program initiated |
| --- | --- |
| ● | NMRC submits Pre-Investigational New Drug (IND) information package to FDA |
| --- | --- |
| ● | NMRC plans to file an IND application with FDA |
| --- | --- |
| ● | Two human phase II clinical trials to be conducted in 2021 |
| --- | --- |
| ● | One trial will focus on the ability of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis |
| --- | --- |
| ● | The second trial will focus on ETEC infections |
| --- | --- |
Melbourne, Australia, June 19, 2020: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercialising oral immunotherapeutics for the prevention and treatment of gut mediated pathogens, today is pleased to provide shareholders with an update on the progress made to date on the company’s research collaboration with the Naval Medical Research Center (NMRC) previously announced in October 2019.
Immuron has now executed a research agreement with Australia’s national science agency, CSIRO. to produce the new therapeutic against Campylobacter and Entero-Toxigenic Escherichia coli(ETEC) for clinical evaluation by the US Department of Defense. Under the terms of the research agreement CSIRO has been engaged to produce a hyper-immune bovine colostrum product using vaccines developed by the NMRC. The work will be conducted at the Department of Agriculture and Water Resources Biosecurity Approved Arrangement facilities located in Armidale NSW.
“Thisis the second R&D program CSIRO has been engaged to undertaken recently with Immuron” said CSIRO’s Dr Peter Hunt, principal research scientist.
“Weare pleased to once again offer the services, expertise and facilities of CSIRO to produce this new therapeutic product for clinicalassessment by the Naval Medical Research Center (NMRC). Approval was obtained fromBiosecurity Australia early this year to import the NMRC vaccines and they have been in storage since the COVID-19 pandemic hitthe world. I am pleased to report the vaccination campaign has been finally initiated and the finished product should be availableby the end of this year.”
| Level<br> 3, 62 Lygon Street,<br><br> <br>Carlton<br> South, Victoria<br><br> <br>AUSTRALIA<br> 3053 | www.immuron.com<br><br> <br><br><br> <br>ABN:<br> 80 063 114 045 | Phone:<br> + 61 (0)3 9824 5254<br><br> <br>Facsimile:<br> + 61 (0)3 9822 7735 |
|---|

Immuron is also pleased to inform shareholders that the NMRC submitted the Pre-IND information package as planned on the 10^th^ of June 2020 and expects to receive written comments on the non-clinical information from the U.S. Food and Drug Administration (FDA) within 30-days regarding its planned investigational new drug application to treat moderate to severe campylobacteriosis and ETEC infections. The company has also recently fully executed the Research Subaward Agreement with The Henry M. Jackson Foundation for Advancement of Military Medicine Inc. the Pass-Through Entity managing the Federal Award.
Immuron CEO, Dr Jerry Kanellos commented.
“Weare grateful that the CSIRO is such a strong supporter of the Australian Biotechnology Industry. The current program is now backon track and we will have the hyper-immune bovine colostrum harvested in September 2020. The drug substance and drug product willbe manufactured by the end of this year and will be available for the clinical development program to prevent acute infectiousdiarrhea which the NMRC plans to initiate early next year.”
This release has been authorised by the directors of Immuron Limited.
-
-
- END - - -
| COMPANY CONTACT:<br><br> <br>****<br><br> <br>Dr Jerry Kanellos, Ph.D.<br><br> <br>Chief<br> Executive Officer<br><br> <br>Ph:<br> +61 (0)3 9824 5254<br><br> <br>info@immuron.com |
|---|
AboutTravelers’ 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.
AboutImmuron
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).
Page 2 of 3

AboutTravelan®
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.
For more information visit: http://www.immuron.com
FORWARD-LOOKINGSTATEMENTS:
Thispress release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of1933 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 historicalfacts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertaintiesthat could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actualresults 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 anddevelopment activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinicaland clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; theearly stage of products under development; our need for substantial additional funds; government regulation; patent and intellectualproperty matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertakingto release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectationsor any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Page 3 of 3
Exhibit 99.2
Appendix3Y
Changeof Director’s Interest Notice
Rule3.19A.2
Appendix3Y
Changeof Director’s Interest Notice
Informationor documents not available now must be given to ASX as soon as available. Information and documents given to ASX become ASX’sproperty and may be made public.
Introduced30/9/2001. Amended 01/01/11
| Name of Entity: | Immuron<br> Limited (ASX:IMC) |
|---|---|
| ABN: | 80<br> 063 114 045 |
We (the entity) give ASX the following information under listing rule 3.19A.2 and as agent for the director for the purposes of section 205G of the Corporations Act.
| Name of Director: | Mr<br>Peter Anastasiou |
|---|---|
| Date of Last Notice: | 13<br>November 2019 |
Part1 - Change of director’s relevant interests in securities
Inthe 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.
| Direct or Indirect Interest | Indirect | ||
|---|---|---|---|
| Nature of indirect interest<br><br> <br>(including registered holder)<br><br> <br>Note:<br> Provide details of the circumstances giving rise to the relevant interest. | Director<br>Related Entity | ||
| Dateof change<br><br> <br>**** | 17^th^June 2020 | ||
| No. of securities held prior to change | Shares | Options | |
| --- | --- | --- | --- |
| Direct | - | - | |
| Indirect | 18,273,644* | 5,158,409* | |
| Total | 18,273,644 | 5,158,409 | |
| * Securities include American Depository Securities (ADSs) and Warrants. | |||
| Class<br><br> <br>**** | a)<br> Fully paid ordinary shares<br><br> b) NASDAQ ADS<br><br> c) NASDAQ Warrants | ||
| --- | --- | ||
| Number acquired | Shares | Options | |
| --- | --- | --- | --- |
| Direct | - | - | |
| Indirect | - | - | |
| Total | - | - | |
| Number disposed | Shares | Options | |
| --- | --- | --- | --- |
| Direct | - | - | |
| Indirect | a) 4,184,808<br>b) 1,345,880* | b) 1,725,880* | |
| Total | 5,530,688 | 1,725,880 | |
| * Securities include American Depository Securities (ADSs) and Warrants. |
+ See chapter 19 for defined terms.
| 01/01/2011 | Appendix 3Y Page 1 |
|---|
Appendix 3Y
Change of Director’s Interest Notice
| Value/Consideration<br><br> <br>Note: If consideration is non-cash, provide details<br>and estimated valuation | a)<br> AUD 1,306,326<br><br>b) USD 429,240 | |||
|---|---|---|---|---|
| No. of securities held after change | Shares | Options | ||
| --- | --- | --- | --- | --- |
| Direct | - | - | ||
| Indirect | 12,742,956^1^ | 14,400^2^ | ||
| Total | 12,742,956 | 14,400 | ||
| ^1.^ Securities<br> include American Depository Securities (ADSs).<br><br> <br>^2.^ 14,400<br> Options (360 Warrants) exercisable on or before 13 June 2022.<br><br> <br>(Note: 3,418,129 options lapsed in November 2019) | ||||
| Nature of change<br><br> <br>Example: On-market trade, off-market trade, exercise<br>of options, issue of securities under dividend reinvestment plan, participation in buy-back | On-Market Trade. | |||
| --- | --- |
Part 2 – Change of director’s interests in contracts
| Note: | In the case of a company, interests which come within<br>paragraph (ii) of the definition of “notifiable interest of a director” should be disclosed in this part. |
|---|---|
| Detail of contract<br><br> <br>**** | N/A |
| --- | --- |
| Nature of interest | N/A |
| Name of registered holder (if issued securities) | N/A |
| Date of change | N/A |
| No. and class of securities to which interest related prior to change<br><br> <br>Note: Details are only required for a contract in relation to<br> which the interest has changed | N/A |
| Interest acquired | N/A |
| Interest disposed | N/A |
| Value/Consideration<br><br> <br>Note: If consideration is non-cash, provide details and an estimated<br> valuation | N/A |
| Interest after change | N/A |
Part 3 – +Closed period
| Were the interests in the securities or contracts detailed above traded during a +closed period where prior written clearance was required? | No |
|---|---|
| If so, was prior written clearance provided to allowthe trade to proceed during this period? | N/A |
| If prior written clearance was provided, on whatdate was this provided? | N/A |
19th June, 2020
| The CFO Solution |
|---|
- See chapter 19 for defined terms.
| 01/01/2011 | Appendix 3Y Page 2 |
|---|
Exhibit 99.3
604 Page 1 of 3 15 July 2001
Form 604
Corporations Act 2001
Section 671B
Noticeof change of interests of substantial holder
| To Company Name/Scheme | Immuron Limited |
|---|---|
| ACN/ARSN | 063 114 045 |
1. Details of substantial holder (1)
| Name | Peter Anastasiou |
|---|---|
| ACN/ARSN (if applicable) | N/A |
| There was a change in the interests of the substantial holder on | 17/June/2020 |
| --- | --- |
| The previous notice was given to the company on | 12/November/2019 |
| The previous notice was dated | 13/November/2019 |
2. Previous and present voting power
The total number of votes attached to all the voting shares in the company or voting interests in the scheme that the substantial holder or an associate (2) had a relevant interest (3) in when last required, and when now required, to give a substantial holding notice to the company or scheme, are as follows:
| Class of securities (4) | Previous notice | Present notice | ||
|---|---|---|---|---|
| Person’s votes | Voting power (5) | Person’s votes | Voting power (5) | |
| Ordinary Shares | 18,273,644 | 10.31% | 12,742,956 | 7.15% |
3. Changes in relevant interests
Particulars of each change in, or change in the nature of, a relevant interest of the substantial holder or an associate in voting securities of the company or scheme, since the substantial holder was last required to give a substantial holding notice to the company or scheme are as follows:
| Date of change | Person whose relevant interest changed | Nature of change (6) | Consideration given in relation to change (7) | Class and number of securities affected | Person’s votes affected |
|---|---|---|---|---|---|
| 16 June 2020 | Grandlodge Pty Ltd<br><br> <br>**** | On-Market Trade | AUD 416,556 | Ordinary Shares 1,277,572 | Ordinary Shares 1,277,572 |
| from 15 to 16 June 2020 | Mr Peter Anastasiou & Mrs Kristine Patricia Anastasiou (Anastasiou Super Fund A/C)<br><br> <br>**** | On-Market Trade | AUD 889,770 | Ordinary Shares 2,907,236 | Ordinary Shares 2,907,236 |
| 17 June 2020 | Wattle Laboratory Pty Ltd | On-Market Trade | USD 355,894 | Ordinary Shares 1,345,880 | Ordinary Shares 1,345,880 |
604 Page 2 of 3 15 July 2001
4. Present relevant interests
Particulars of each relevant interest of the substantial holder in voting securities after the change are as follows:
| Holder of relevant interest | Registered holder of securities | Person entitled to be registered as holder (8) | Nature of relevant interest (6) | Class and number of securities | Person’s votes |
|---|---|---|---|---|---|
| Peter Anastasiou<br><br> <br>**** | Grandlodge Pty Ltd<br><br> <br>**** | Grandlodge Pty Ltd<br><br> <br>**** | Shareholder<br><br> <br><br><br> <br>**** | Ordinary Shares<br><br> <br>10,431,682 | 10,431,682<br><br> <br><br><br> <br>**** |
| Peter Anastasiou | Advanced Clinical Systems International Pty Ltd | Advanced Clinical Systems International Pty Ltd | Shareholder<br><br> <br><br><br> <br>**** | Ordinary Shares<br><br> <br>2,296,874 | 2,296,874<br><br> <br>**** |
| Peter Anastasiou | Wattle Laboratory Pty Ltd | Wattle Laboratory Pty Ltd | Shareholder<br><br> <br>**** | Ordinary Shares 14,400<br><br> <br>**** | 14,400<br><br> <br>**** |
5. Changes in association
The persons who have become associates (2) of, ceased to be associates of, or have changed the nature of their association (9) with, the substantial holder in relation to voting interests in the company or scheme are as follows:
| Name and ACN/ARSN (if applicable) | Nature of association |
|---|---|
| N/A | N/A |
6. Addresses
The addresses of persons named in this form are as follows:
| Name | Address | |||
|---|---|---|---|---|
| All | Unit 10, 25-37 Chapman Street, Blackburn North, VIC. 3130 | |||
| Signature | ||||
| --- | --- | --- | --- | --- |
| print name | Mr. Peter Anastasiou | capacity | Director | |
| sign here | ![]() |
date | 19/June/2020 |
604 Page 3 of 3 15 July 2001
DIRECTIONS
| (1) | If there are a number of substantial holders with similar or related relevant interests (eg. a corporation and its related corporations, or the manager and trustee of an equity trust), the names could be included in an annexure to the form. If the relevant interests of a group of persons are essentially similar, they may be referred to throughout the form as a specifically named group if the membership of each group, with the names and addresses of members is clearly set out in paragraph 6 of the form. | |
|---|---|---|
| (2) | See the definition of “associate” in section 9 of the Corporations Act 2001. | |
| (3) | See the definition of “relevant interest” in sections 608 and 671B(7) of the Corporations Act 2001. | |
| (4) | The voting shares of a company constitute one class unless divided into separate classes. | |
| (5) | The person’s votes divided by the total votes in the body corporate or scheme multiplied by 100. | |
| (6) | Include details of: | |
| (a) | any relevant agreement or other circumstances because of which the change in relevant interest occurred. If subsection 671B(4) applies, a copy of any document setting out the terms of any relevant agreement, and a statement by the person giving full and accurate details of any contract, scheme or arrangement, must accompany this form, together with a written statement certifying this contract, scheme or arrangement; and | |
| (b) | any qualification of the power of a person to exercise, control the exercise of, or influence the exercise of, the voting powers or disposal of the securities to which the relevant interest relates (indicating clearly the particular securities to which the qualification applies). | |
| See the definition of “relevant agreement” in section 9 of the Corporations Act 2001. | ||
| (7) | Details of the consideration must include any and all benefits, money and other, that any person from whom a relevant interest was acquired has, or may, become entitled to receive in relation to that acquisition. Details must be included even if the benefit is conditional on the happening or not of a contingency. Details must be included of any benefit paid on behalf of the substantial holder or its associate in relation to the acquisitions, even if they are not paid directly to the person from whom the relevant interest was acquired. | |
| (8) | If the substantial holder is unable to determine the identity of the person (eg. if the relevant interest arises because of an option) write “unknown”. | |
| (9) | Give details, if appropriate, of the present association and any change in that association since the last substantial holding notice. |
