Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

Immuron Ltd Investor Presentation 2024

Feb 7, 2024

35121_rns_2024-02-07_11139d33-4cbf-4a52-9da9-44c0ec9c72dd.pdf

Investor Presentation

Open in viewer

Opens in your device viewer

==> picture [202 x 56] intentionally omitted <==

Investor Webinar Presentation

Melbourne, Australia, February 8, 2024: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to advise our Chief Executive Officer, Steven Lydeamore will be presenting at the Monsoon Communications Investor function on Thursday, 8[th] February in Sydney, Australia.

A copy of the presentation being made is included below.

Authorised for release by the Board of Immuron Limited.

      • END - - -

COMPANY CONTACT: Steven Lydeamore Chief Executive Officer Ph: +61 (0)3 9824 5254 [email protected]

About Travelan®

Travelan® is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting traveller’s diarrhoea, a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce. Travelan® is a highly purified tabletised preparation of hyperimmune bovine antibodies and other factors, which when taken with meals bind to diarrhoea-causing bacteria and prevent colonisation and the pathology associated with traveller’s diarrhoea. 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 Traveller’s Diarrhoea, reduce the risk of minor gastrointestinal disorders and is antimicrobial. In Canada, Travelan® is a licensed natural health product (NPN 80046016) and is indicated to reduce the risk of Traveller’s Diarrhoea. In the U.S., Travelan® is sold as a dietary supplement for digestive tract protection.

About Traveller’s Diarrhoea

Traveller’s Diarrhoea 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 Traveller’s Diarrhoea 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 commercialising orally delivered targeted polyclonal antibodies for the treatment of 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

==> picture [556 x 64] intentionally omitted <==

==> picture [138 x 38] intentionally omitted <==

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.

==> picture [556 x 65] intentionally omitted <==

==> picture [419 x 419] intentionally omitted <==

==> picture [197 x 48] intentionally omitted <==

INVESTOR PRESENTATION MONSOON COMMUNICATIONS 8 FEBRUARY, 2024 - Steven Lydeamore CEO NASDAQ: IMRN ASX: IMC

1

SAFE HARBOR STATEMENT

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.

FY2024 results in this presentation are subject to audit review.

==> picture [143 x 35] intentionally omitted <==

2

REVENUE GENERATING WITH STRONG PIPELINE

==> picture [55 x 53] intentionally omitted <==

Immuron Ltd (NASDAQ:IMRN) (ASX:IMC) is a globally integrated biopharmaceutical company focused on developing, and commercialising, oral immunotherapeutics for the treatment of gut mediated diseases

==> picture [688 x 286] intentionally omitted <==

----- Start of picture text -----

Financial Snapshot
30-Jun-23 31-Dec-23
Shares on Issue 227,798,346 227,798,346
Total Options 12,879,720 15,568,559
Last Traded Price IMC: A$0.075 IMC: A$0.077
Market Cap. IMC: A$17.1m IMC: A$17.5m
Cash & Cash
A$17.2m
Equivalents
Sales Revenue A$1.8m H1, FY24 A$2.4m
----- End of picture text -----

==> picture [143 x 35] intentionally omitted <==

3

REVENUE GENERATING WITH STRONG PIPELINE

==> picture [55 x 53] intentionally omitted <==

Immuron Ltd (NASDAQ:IMRN) (ASX:IMC) is a globally integrated biopharmaceutical company focused on developing, and commercialising, oral immunotherapeutics for the treatment of gut mediated diseases

Pipeline Snapshot

30-Jun-23 31-Dec-23
Travelan (IMM-124E) -
Phase 2
Traveller’sDiarrhoea
Initiated IMM-124E ETEC2 CHIM3 clinical
trial
Completion of In-patient phase ETEC2
CHIM3 clinical trial
Travelan® (IMM-124E) –
Phase 4
Traveller’sDiarrhoea
USU4 P2TD IMM-124E field clinical trial
recruited 35% of 868 participants
Recruited 50% of 868 participants
CampETEC – Phase 2
Campylobacteriosis
FDA IND1 approved (Clinical Hold
released)
Completion of In-patient phase
Campylobacter CHIM3 clinical trial
IMM-529 – Phase 2
Clostridioides Difficile
Completed 600 mg solid dose active
formulation development
Completion of IMM-529 drug substance
manufacture by CSIRO

==> picture [143 x 35] intentionally omitted <==

  1. Investigational New Drug; 2. Enterotoxigenic E.coli ; 3. controlled human infection model; 4. Uniformed Health Services University of the Health Sciences

4

DISTRIBUTION CAPABILITY

Australia USA Canada Retail Pharmacy Established B2B E-commerce Developing

Key Commentary

Shandex

Ontario, Canada Distributes to all provinces of Canada

Immuron Limited Vancouver, BC, Canada

==> picture [55 x 53] intentionally omitted <==

Australia

  • Retail network includes over 3,500 pharmacies

  • Online sales of both Travelan® and Protectyn®

  • Protectyn® is distributed by Osborne Health Supplies

USA

  • Travelan® is sold to travel medicine clinics and on our own amazon.com shopfront (launched July 2023)

  • Re-entry into retail pharmacies in USA being explored in FY24

Canada

  • We are relaunching 1Q2024

International

  • We are evaluating options to enter international markets through distributors

RJW Logistics Chicago, USA Distributes to all states of USA

==> picture [93 x 78] intentionally omitted <==

Immuron Limited

Melbourne, Australia Distributes to all states of Australia and to distributors in USA and Canada

Immuron Inc. New York, USA

==> picture [143 x 35] intentionally omitted <==

5

STRONG SALES GROWTH IN A BILLION DOLLAR MARKET[3]

==> picture [37 x 36] intentionally omitted <==

Traveller’s Diarrhoea (TD)

Market is large and growing ~7%[3 ] CAGR

Industry tailwinds Travel picking up significantly following COVID lockdowns

Frequent

30% - 70% of travelers experience TD[4]

Australia

Short term resident $83m $50m returns in Oct 23 were Chief Commercial Net Sales Net Sales Based on US annual Based on EU travel 47% higher than Oct Officer has 20+ year’s FY23: A$1.16 million FY23: A$0.64 million travel numbers and a numbers and a 22[1] experience with local 1HFY24: A$1.85 million 1HFY24: A$0.48 million USA and global (Asia, UK) penetration rate of penetration rate of 132% higher than pre- 6% lower than pre15%, the market 15%, the market Total departures commercial leadership pandemic period pandemic period Sep 23 were 17% roles with GSK and potential is estimated potential is estimated 1HFY20 1HFY20 at $83m[5] at $50m[5] higher than Sep 22[2] P&G

1. https://www.abs.gov.au/statistics/industry/tourism-and-transport/overseas-arrivals-and-departures-australia/latest-release

==> picture [143 x 35] intentionally omitted <==

2. https://www.trade.gov/sites/default/files/2023-09/US-Outbound-to-World-Regions.xlsx

3. https://www.transparencymarketresearch.com/travelers-diarrhea-market.html

4. Centers for Disease Control and Prevention Yellow Book

5. IMC Company Report - Travelan Market Analysis 2019

6

TECHNOLOGY PLATFORM FOR GUT MEDIATED DISEASES

==> picture [55 x 53] intentionally omitted <==

Bovine colostrum is the first milk of cows after calving. It is rich in immunoglobulins, lactoferrin, lysozyme, lactoperoxidase, growth factors and bioactive peptides. Colostrum has higher levels of protein, fat, vitamins, and minerals when compared to milk. This enables full development of the newborn calf in addition to immunity against several pathogens.[*]

Immuron’s proprietary technology platform combines the natural human nutrition & health benefits of bovine colostrum with a novel class of specifically targeted oral polyclonal antibodies that offer delivery within the gastrointestinal (“GI”) tract and can be used to target viruses or bacteria and neutralize the toxins they produce at mucosal surfaces.

==> picture [145 x 146] intentionally omitted <==

STEP 1

Development of Highly Specific Vaccines

==> picture [143 x 35] intentionally omitted <==

==> picture [145 x 146] intentionally omitted <==

==> picture [145 x 146] intentionally omitted <==

STEP 2

STEP 3

Isolation of Hyperimmune Oral Antimicrobial antibody-rich therapeutics bovine colostrum without drawbacks of antibiotics

==> picture [145 x 146] intentionally omitted <==

FINAL PRODUCT

Toxin Neutralization +

Clearance of targeted gut pathogens

  • Reduce occurrence and reduce/relieve diarrhoea

  • Reduce/relieve abdominal cramping

  • Reduce/relieve gastrointestinal pain

  • Assists repair of gastrointestinal/gut wall lining

  • Enhance/promote immune defence

  • Enhance/promote health liver function

Australian Permitted indications; these statements have not been evaluated by the Food and Drug Administration (FDA)

* Gomes et. al., NFS Journal, Volume 25, November 2021, pages 1- 11, https://doi.org/10.1016/j.nfs.2021.10.001

7

STRONG PIPELINE WITH NEAR TERM MILESTONES

==> picture [960 x 435] intentionally omitted <==

----- Start of picture text -----

Immuron’s Clinical Programs
Compound or Indication Phase Phase Phase Market
brand name I II III
Traveler’s
IMM-124E
Diarrhea ETEC
Travelan®
challenge
Clostridioides
difficile
IMM-529
Infection &
Recurrence
Our Partners’ Clinical Programs
Compound or Partner Phase Phase Phase Market
brand name I II III
Travelan®
Uniformed Services University
CampETEC
Naval Medical
Research Command
----- End of picture text -----

==> picture [143 x 35] intentionally omitted <==

Further information on the clinical programs can be found on slide 8

8

==> picture [960 x 482] intentionally omitted <==

----- Start of picture text -----

NEAR TERM MILESTONES ANTICIPATED TO DRIVE VALUE
2H 2022 1H 2023 2H 2023 1H 2024 2H 2024
• FDA IND [1] approved for • IRB Approval [4] • 100% of patients enrolled • Topline results for IMM- • Clinical Study Report
single daily dose IMM- • Initiated IMM-124E ETEC [2] • Completion of In-patient 124E ETEC [2] clinical trial
Travelan® 124E ETEC [2] CHIM [3] clinical CHIM [3] clinical trial phase ETEC [2] CHIM [3]
trial clinical trial
• Submitted Response • Toxicology Study Report • Institutional Review • Completion of In- • Topline results for
Letter to FDA Clinical Hold • FDA IND [1] approved Board approval of NMRC [5] patient phase CampETEC

Immuron sponsored (Clinical Hold released) CampETEC CampETEC Campylobacter CHIM [3]
Toxicology study - Campylobacter CHIM [3] Campylobacter CHIM [3] clinical trial
CampETEC
completed clinical trial protocol clinical trial
• Initiated IMM-124E
Campylobacter CHIM [3]
clinical trial
• 600 mg solid dose active • IMM-529 cGMP • IMM-529 (CDI) [7] Pre- • FDA meeting
IMM-529
formulation development manufacture IND [1] submission
• USU [6] P2TD IMM-124E • ~50% of 868 participants • Completion of • Topline results
field clinical trial recruited enrollment
Travelan® recruitment • Completion of in-
commencement patient phase
----- End of picture text -----

==> picture [143 x 35] intentionally omitted <==

Completed; 1. Investigational New Drug; 2. Enterotoxigenic E.coli ; 3. controlled human infection model; 4. Institutional Review Board; 5. Naval Medical Research Command; 6. Uniformed Health Services University of the Health Sciences; 7. Clostridioides Difficile

9

SCIENTIFIC REFERENCES

==> picture [55 x 53] intentionally omitted <==

Travelan® (IMM-124E)

Travelan® has been shown to reduce both the incidence and severity of ETEC-induced diarrhea in up to 90% of volunteers

Scandinavian Journal of Gastroenterology, 46:7-8, 862-868, DOI: 10.3109/00365521.2011.574726

Clinical Evaluation of Travelan® an Oral Prophylactic for Prevention of Travelers’ Diarrhea in Active Duty Military Service Assigned Abroad.

Military Health System Research Symposium 14-17 Aug 2023_Abstract 1

Travelan as a broad Spectrum anti-bacterial

Immuron Limited, 29 April, 2011

Travelan® demonstrates broad reactivity to Vibrio cholera strains from Southeast Asia indicating broad potential for prevention of traveler’s diarrhea

Travelan® demonstrates broad reactivity to Vibrio cholera strains from Southeast Asia indicating broad US Department of Defense, Armed Forces Research Institute of Medical Sciences potential for prevention of traveler’s diarrhea (AFRIM), 4 September, 2019 Travelan® prevented clinical shigellosis (bacillary dysentery) in 75% of Travelan® treated animals compared US Department of Defense, Armed Forces Research Institute of Medical Sciences to placebo and demonstrated a significant clinical benefit (AFRIM), 5 September, 2018 Travelan® able to bind and was reactive to 60 clinical isolates of each bacteria, Campylobacter, ETEC, and US Department of Defense, Armed Forces Research Institute of Medical Sciences Shigella (AFRIM), 30 January, 2017 Bioactivity and efficacy of a hyperimmune bovine colostrum product- Travelan, against shigellosis in a nonIslam D, Ruamsap N, Imerbsin R, Khanijou P, Gonwong S, Wegner MD, et al. (2023) Human primate model (Macaca mulatta) Bioactivity and efficacy of a hyperimmune bovine colostrum product- Travelan, against shigellosis in a non-Human primate model (Macaca mulatta). PLoS ONE 18(12): e0294021. Bioactive Immune Components of Travelan® Clin Vaccine Immunol 24:e00186-16. https://doi.org/10.1128/CVI.00186-16 Hyperimmune bovine colostrum containing lipopolysaccharide antibodies (IMM-124E) has a non-detrimental Infect Immun. 2023 Nov; 91(11): e00097-23.

Hyperimmune bovine colostrum containing lipopolysaccharide antibodies (IMM-124E) has a non-detrimental effect on gut microbial communities in unchallenged mice

Administration of the Hyper-immune Bovine Colostrum Extract IMM-124E Ameliorates Experimental Murine Colitis

Journal of Crohn's and Colitis, Volume 13, Issue 6, June 2019, Pages 785–797, https://doi.org/10.1093/ecco-jcc/jjy213

IMM-529

Bovine antibodies targeting primary and recurrent Clostridium difficile disease are a potent antibiotic alternative

Sci Rep 7, 3665 (2017). https://doi.org/10.1038/s41598-017-03982-5

10

==> picture [419 x 419] intentionally omitted <==

==> picture [175 x 43] intentionally omitted <==

STEVEN LYDEAMORE CHIEF EXECUTIVE OFFICER IMMURON LIMITED CONTACT INFORMATION:

EMAIL: [email protected] PHONE: AUSTRALIA: +61 438 027 172

==> picture [55 x 53] intentionally omitted <==

11