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:

 

  - “Presentation to Annual General Meeting”

 

  - “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.

 

1

 

 

EXHIBITS

 

Exhibit
Number
  Description
99.1   Presentation to Annual General Meeting
99.2   Results of Annual General Meeting

 

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: November 21, 2023 By: /s/ Phillip Hains
    Phillip Hains
    Company Secretary

 

 

3

 

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    
Immuron Limited   GPO Box 5193, Sydney, NSW 2001

Annual General Meeting

Tuesday, 21 November 2023
  P 1300 288 664 (aus) or +61 (0)2 9698 5414 (world)
    F +61 (0)2 8583 3040 E hello@automic.com.au
    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.

 

   Decided by
Show of
  Total Number of Proxy Votes exercisable
by proxies
   Proxy Votes     Poll Results (if applicable)  Results 
Resolution  Hands (S)
or Poll (P)
  validly
appointed
   FOR    AGAINST     ABSTAIN   PROXY’S DISCRETION     FOR     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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