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 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
two announcements (the “Public Notices”) to the Australian Securities Exchange on November 21, 2023 titled:
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“Presentation to Annual General Meeting” |
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“Results of Annual General Meeting” |
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: November 21, 2023 |
By: |
/s/ Phillip Hains |
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Phillip Hains |
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Company Secretary |
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Exhibit 99.1
1 1 AGM PRESENTATION 21 NOVEMBER , 2023 NASDAQ: IMRN ASX: IMC Steven Lydeamore - CEO
2 2 Certain statements made in this presentation are forward - looking statements and are based on Immuron’s current expectations, estimates and projections. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “guidance” and similar expressions are intended to identify forward - looking statements. Although Immuron believes the forward - looking statements are based on reasonable assumptions, they are subject to certain risks and uncertainties, some of which are beyond Immuron’s control, including those risks or uncertainties inherent in the process of both developing and commercializing technology. As a result, actual results could materially differ from those expressed or forecasted in the forward - looking statements. The forward - looking statements made in this presentation relate only to events as of the date on which the statements are made. Immuron will not undertake any obligation to release publicly any revisions or updates to these forward - looking statements to reflect events, circumstances or unanticipated events occurring after the date of this presentation except as required by law or by any appropriate regulatory authority. SAFE HARBOR STATEMENT FY2024 results in this presentation are subject to audit review.
3 3 EXECUTIVE SUMMARY Immuron Ltd (ASX:IMC) (NASDAQ:IMRN) is a globally integrated biopharmaceutical company focused on developing, and commercialising, oral immunotherapeutics for the treatment of gut mediated diseases Company Overview • Platform Technology: capable of producing highly specific orally active immunoglobulins to any enteric pathogen • Two commercially available oral immunotherapeutic products – Travelan® and Protectyn® • Three pipeline assets in four clinical programs • Market capitalisation of $ 16.86 million as of 17 November 2023 with cash and cash equivalates balance of $17.2 million as of 30 June 2023 • G lobal sales increased 136% in FY23 to $1.80 million; Travelan® sales of $1.74 million • Record quarterly Travelan® sales of $1.55 million in Q1, FY2024 • Travelan® is now the #2 SKU and fastest growing in the Antidiarrheal category across all pharmacy in Australia 1 • Australian sales YTD FY24 have exceeded full year FY23 sales • Pursuing growth strategies to expand commercial product sales within existing and new geographies and to increase product off eri ng • Launched on Amazon in USA in July 2023 • Status of investment in leading gut health biotech, Ateria Health • Launched ground - breaking Juvia Ρ for irritable bowel syndrome (IBS) in UK (August 2022), Australia (July 2023) • September 2023: annualised revenue run rate >A$1.2 million with 40%+ growth trajectory since April 2023 • Achieved milestones in all clinical programs (Travelan® IND, Travelan® USU study, CampETEC and IMM - 529) ; near - term milestones anticipated Business Update 1. IQVIA Australia Pharmacy Scan – Antidiarrheal segment, value sales 13 weeks to 21 October 2023
4 4 COMPANY HIGHLIGHTS Strong Sales Growth o Global sales increased by 136% in the 2023 fiscal year to A$1.80 million compared to A$0.77 million in FY22 o Record quarterly global sales in Q1, FY24 of $1.57 million o Australia Net Sales o FY23: A$1.16 million o Q1, FY24 : A$1.35 million o 229% higher than pre - pandemic period Q1, FY20 o 12 months to July 2023 short term resident returns 77% of those in 2019 1 o Travelan® is now the #2 SKU and fastest growing in the Antidiarrheal category across all pharmacy in Australia 2 o Australian sales YTD FY24 have exceeded full year FY23 sales o USA Net Sales o FY23: A$0.64 million o Q1, FY24: A$0.21 million o 9% lower than pre - pandemic period Q1, FY20 o Total departures June 2023 99.4% of June 2019 3 1. https://www.abs.gov.au/statistics/industry/tourism - and - transport/overseas - arrivals - and - departures - australia/latest - release 2. IQVIA Australia Pharmacy Scan – Antidiarrheal segment, value sales 13 weeks to 21 October 2023 3. https://www.trade.gov/sites/default/files/2023 - 09/US - Outbound - to - World - Regions.xlsx
5 5 STRONG PIPELINE WITH NEAR TERM MILESTONES 5 5 Market Phase III Phase II Phase I Partner Compound or brand name Travelan® CampETEC Market Phase III Phase II Phase I Indication Compound or brand name Traveler’s Diarrhea ETEC challenge IMM - 124E Travelan® Clostridioides difficile Infection & Recurrence IMM - 529 Uniformed Services University Naval Medical Research Command Immuron’s Clinical Programs Our Partners’ Clinical Programs
6 6 COMPANY HIGHLIGHTS Collaborations with U.S. DoD – Remain Strong o Travelan® IND Approval – December 2022 o Study Initiation – May 2023 o First cohort recruitment completed – July 2023 o Presentations at Military Health System Research Symposium – August 2023 o Second cohort recruitment completed – October 2023 o Completion of In - patient phase – October 2023 o Anticipated Top Line Results and Clinical Study Report – 1H 2024 US Uniformed Services University Traveller’s Diarrhoea Clinical Field Trial o USU’s Infectious Diseases Clinical Research Program (IDCRP), the UK Ministry of Defence and the New York City Travel Clinic are jointly planning to conduct the randomized clinical trial to evaluate the efficacy of Travelan® against placebo for Traveller’s Diarrhoea o Florastor ® removed from active study arms – February 2023 o Now 868 study participants (434 per arm) o 50% recruitment milestone – October 2023 o Anticipated completion of recruitment – March 2024 o Anticipated completion of In - patient phase – June 2024
7 7 COMPANY HIGHLIGHTS US Naval Medical Research Command – Campylobacter & ETEC PROJECT o New Therapeutic in Clinical Development for Treatment of moderate to severe Campylobacteriosis and Infectious diarrhea caused by ETEC pathogens o Toxicology study completed – December 2022 o FDA removed IND Clinical Hold – May 2023 o Institutional Review Board Approval – October 2023 o Anticipated Initiation of Campylobacter Controlled Human Infection Model (CHIM) clinical trial – 1H2024 o Anticipated completion of In - patient phase – 1H2024
8 8 COMPANY HIGHLIGHTS IMM - 529 Clinical Development for Treatment of C. difficile Infections o Opportunity Assessment Completed o C. difficile infection (CDI) affects just over ~400,000 people in the US annually o S izable number of patients who experience at least one recurrence (~20 - 25%), o M any patients experience multiple recurrences, creating persistent unmet need for novel therapies to address recurrences o Infectious disease experts reacted favorably to the IMM - 529 MOA, and its ability to target three elements of the rCDI infection – the spores, vegetative cells, and Toxin B. o Non - antibiotic treatments (such as IMM - 529) are appealing to experts o 600mg solid dose active formulation development – February 2023 o Anticipated cGMP manufacture – December 2023 o Anticipated FDA pre - IND submission – 1H 2024
9 9 EMAIL: STEVE@IMMURON.COM PHONE: AUSTRALIA: +613 8892 4854 STEVEN LYDEAMORE CHIEF EXECUTIVE OFFICER IMMURON LIMITED CONTACT INFORMATION:
10 10 SCIENTIFIC REFERENCES Travelan® (IMM - 124E) Scandinavian Journal of Gastroenterology, 46:7 - 8, 862 - 868, DOI: 10.3109/00365521.2011.574726 Travelan® has been shown to reduce both the incidence and severity of ETEC - induced diarrhea in up to 90% of volunteers Military Health System Research Symposium 14 - 17 Aug 2023_Abstract 1 Clinical Evaluation of Travelan® an Oral Prophylactic for Prevention of Travelers’ Diarrhea in Active Duty Military Service Assigned Abroad. Immuron Limited, 29 April, 2011 Travelan as a broad Spectrum anti - bacterial US Department of Defense, Armed Forces Research Institute of Medical Sciences (AFRIM), 4 September, 2019 Travelan® demonstrates broad reactivity to Vibrio cholera strains from Southeast Asia indicating broad potential for prevention of traveler’s diarrhea US Department of Defense, Armed Forces Research Institute of Medical Sciences (AFRIM), 5 September, 2018 Travelan® prevented clinical shigellosis (bacillary dysentery) in 75% of Travelan® treated animals compared to placebo and demonstrated a significant clinical benefit US Department of Defense, Armed Forces Research Institute of Medical Sciences (AFRIM), 30 January, 2017 Travelan® able to bind and was reactive to 60 clinical isolates of each bacteria, Campylobacter, ETEC, and Shigella Islam et al., 2020. Submitted to mSphere, American Society for Microbiology Efficacy of hyperimmune bovine colostrum against shigellosis in rhesus macaque (Macaca mulatta), and bioactivity of HBC against common enteric pathogens Clin Vaccine Immunol 24:e00186 - 16. https://doi.org/10.1128/CVI.00186 - 16 Bioactive Immune Components of Travelan® Rachele Gore, Mitra Mohsenipour, Jennifer L Wood, Gayathri K Balasuriya, Elisa L Hill - Yardin, Ashley E Franks Hyperimmune bovine colostrum containing lipopolysaccharide antibodies (IMM - 124E) has a non - detrimental effect on gut microbial communities in unchallenged mice Journal of Crohn's and Colitis, Volume 13, Issue 6, June 2019, Pages 785 – 797, https://doi.org/10.1093/ecco - jcc/jjy213 Administration of the Hyper - immune Bovine Colostrum Extract IMM - 124E Ameliorates Experimental Murine Colitis IMM - 529 Sci Rep 7, 3665 (2017). https://doi.org/10.1038/s41598 - 017 - 03982 - 5 Bovine antibodies targeting primary and recurrent Clostridium difficile disease are a potent antibiotic alternative
Exhibit 99.2
Results
of Annual General Meeting
Melbourne, Australia, November 21, 2023:
Immuron Limited (ASX: IMC, NASDAQ: IMRN) advises that resolutions 1, 2, 4, 5 and 6 considered at the Annual General Meeting held earlier
today were carried by a poll. Resolution 3, Approval of increased placement capacity, was not passed.
In accordance with Listing Rule 3.13.2
and Section 251AA of the Corporations Act 2001, details of the resolutions and the proxies received in respect of each resolution are
attached.
Phillip Hains
Company Secretary
About Immuron
Immuron Limited (ASX: IMC, NASDAQ: IMRN), is an Australian
biopharmaceutical company focused on developing and commercialising orally delivered targeted polyclonal antibodies for the treatment
of infectious diseases.
For more information visit: http://www.immuron.com
Disclosure of Proxy Votes |
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Immuron Limited |
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GPO Box 5193, Sydney, NSW 2001 |
Annual General Meeting
Tuesday, 21 November 2023 |
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P 1300 288 664 (aus) or +61 (0)2 9698 5414 (world) |
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F +61 (0)2 8583 3040 E hello@automic.com.au |
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ABN 27 152 260 814 |
In accordance with section 251AA of the Corporations Act
2001, the following information is provided in relation to resolutions put to members at the meeting.
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Decided by
Show of | |
Total Number of Proxy Votes exercisable
by proxies | | |
Proxy
Votes |
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Poll
Results (if applicable) | |
Results | |
Resolution | |
Hands
(S) or Poll (P) | |
validly
appointed | | |
FOR |
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AGAINST |
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ABSTAIN | | |
PROXY’S DISCRETION |
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FOR |
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AGAINST | | |
ABSTAIN | | |
OUTCOME | |
1
Adoption of Remuneration Report | |
P | |
| 27,081,372 | | |
21,217,240 78.35 |
% | |
| 5,831,361 21.53 |
% | | |
| 1,565,693 | | |
32,771 0.12 |
% | | |
28,582,198 78.49 |
% | | |
| 7,831,361 21.51 |
% | |
| 1,565,693 | | |
- | |
2 Re-election
of Dr Roger Aston | |
P | |
| 32,351,601 | | |
29,364,340 90.77 |
% | |
| 2,939,490 9.09 |
% | | |
| 2,338,378 | | |
47,771 0.15 |
% | | |
38,744,298 92.95 |
% | | |
| 2,939,490 7.05 |
% | |
| 2,338,378 | | |
Passed | |
3 Approval
of increased placement capacity | |
P | |
| 34,284,689 | | |
22,757,363 66.38 |
% | |
| 11,479,555 33.48 |
% | | |
| 405,290 | | |
47,771 0.14 |
% | | |
32,137,321 73.68 |
% | | |
| 11,479,555 26.32 |
% | |
| 405,290 | | |
Not Passed | |
4 Approval
to Amend Constitution - Employee share scheme provisions | |
P | |
| 33,902,049 | | |
28,831,941 85.04 |
% | |
| 5,012,337 14.78 |
% | | |
| 766,730 | | |
57,771 0.17 |
% | | |
38,221,899 88.41 |
% | | |
| 5,012,337 11.59 |
% | |
| 766,730 | | |
Passed | |
5 Approval
of Omnibus Incentive Plan | |
P | |
| 26,025,967 | | |
21,210,445 81.50 |
% | |
| 4,782,751 18.38 |
% | | |
| 2,621,098 | | |
32,771 0.13 |
% | | |
28,575,403 85.66 |
% | | |
| 4,782,751 14.34 |
% | |
| 4,621,098 | | |
Passed | |
6 Approval
of the Issue of Options to Mr Paul Brennan | |
P | |
| 25,761,232 | | |
19,390,967 75.27 |
% | |
| 6,322,494 24.54 |
% | | |
| 2,907,033 | | |
47,771 0.19 |
% | | |
28,770,925 81.98 |
% | | |
| 6,322,494 18.02 |
% | |
| 2,907,033 | | |
Passed | |
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