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Immuron Ltd — Investor Presentation 2023
Apr 18, 2023
35121_rns_2023-04-18_1f7063b3-99fa-4c9b-89c7-83a4561e7d96.pdf
Investor Presentation
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Q3 FY23 Business Update Presentation
Melbourne, Australia, April 19, 2023: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases, ) is pleased to provide the Q3 FY23 Investor Presentation for the business update webinar to be held today at 11:00 am (AEST) .
The Investor Presentation includes the following material information (unaudited):
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Worldwide sales for the two weeks 1 to 14 April 2023 were A$320,000. This represents 37% of sales for the whole of Q3 FY23 of A$875,000.
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Sales FY23 YTD to 14 April 2023 of A$1,779,000 represents a 233% increase over the corresponding prior period YTD to 14 April 2022 of $534,000.
Investors are invited to join the webcast and Q&A hosted by Immuron CEO Steven Lydeamore.
To register for the webinar, please click on this link:
https://us02web.zoom.us/webinar/register/WN_TpvaXZZ1QDG1FnZdXdtSGA
After registering, you will receive a confirmation email containing information to join the webinar.
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Approved for release by the CEO.
COMPANY CONTACT:
Steven Lydeamore Chief Executive Officer Ph: +61 (0)3 9824 5254 [email protected]
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About Travelan®
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.
About Travelers’ 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.
About Immuron
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.
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 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.
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INVESTOR PRESENTATION BUSINESS UPDATE
19 APRIL, 2023
Steven Lydeamore - CEO
NASDAQ: IMRN ASX: IMC
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SAFE HARBOR STATEMENT
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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.
Immuron believes the statements are based on reasonable are Although forward-looking assumptions, they 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. YTD FY2023 results in this presentation are subject to audit review.
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EXECUTIVE SUMMARY
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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
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Two commercially available oral immunotherapeutic products – Travelan® and Protectyn®
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Company • 4 clinical programs – IMM-124E, CampETEC, IMM-529, Travelan®
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Overview • Market capitalisation of A$17.08m as of 17 April 2023 with cash & cash equivalates balance of A$18.5m as of 31 Dec 2022
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CampETEC – toxicology study report completed and submitted to FDA
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• Travelan® Uniformed Health Services University P2TD IMM-124E field clinical trial recruitment reaches 300
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Business • 35% of target 868 participants recruited •
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Update Immuron’s own shopfront on amazon.com set up for USA market • Launch pending establishing necessary safety stock level
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• Working towards relaunch into Canadian retail pharmacy in FY24 • Submitted for range review to major pharmacy chain
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FY23 YTD 14 April 2023 revenue of A$1.78m, up 233% on pcp – Australian sales contributing A$1.18m
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Results & Outlook • Evaluating options to enter Asian and European markets through distributors • Evaluating options to add to marketed products portfolio in FY24
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a ASX Release link in appendix. YTD FY2023 results in this presentation are subject to audit review.
SALES | YEAR TO DATE | 14[TH] APRIL 2023
| A$000s | |||
|---|---|---|---|
| Profit & Loss | FY23 YTD 14 April 2023 |
FY22YTD 14 April 2022 |
Var % |
| Australian Sales | $ 1,184 | $ 137 | 764% |
| Rest of World Sales | $ 595 | $ 397 | 50% |
| Total Revenue | $ 1,779 | $ 534 | 233% |
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Key Commentary
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Strong start to Q4 2023 (to 14 April 2023)
- $320k Net Sales; up 233% YTD on pcp
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Supply chain capacity addressed by contracting another packaging supplier
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Australian wholesalers and retail pharmacies now fully stocked
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Building stock to allow accelerated growth in international markets
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*YTD FY2023 results in this presentation are subject to audit review.
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KEY MILESTONES ANTICIPATED TO DRIVE VALUE
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||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|2H|1H|2H|1H|
|2022|2023|2023|2024|
|•|FDA IND|[1]|approved for|•|IRB Approval|[4]|•|Topline results for IMM-|•|Clinical Study Report|
|Travelan®|single daily dose IMM-124E|•|Initiate IMM-124E ETEC|124E ETEC CHIM clinical|
|ETEC|[2]|CHIM|[3]|clinical trial|[a]|CHIM clinical trial|trial|
|•|Submitted Response Letter|•|Toxicology Study Report|•|Initiate NMRC|[5]|CampETEC|•|Topline results for NMRC|
|to FDA Clinical Hold|[e]|•|FDA feedback to clinical|ETEC CHIM clinical trial|CampETEC ETEC CHIM|
|•|Immuron sponsored|hold response letter|•|Initiate NMRC CampETEC|clinical trial|
|CampETEC|
|Toxicology study -|Campylobacter CHIM|•|Topline results for NMRC|
|completed|clinical trial|CampETEC Campylobacter|
|CHIM clinical trial|
|•|600 mg solid dose active|•|Project strategic planning|•|IMM-529 cGMP|•|IMM-529 IND submission|[6]|
|formulation development|and budget development|manufacture|[6]|•|Initiate IMM-529 phase 2|
|IMM-529|
|•|IMM-529 IND Pre-IND|CDI clinical trial|[6]|
|submission|[6]|
|•|USU|[7]|P2TD IMM-124E field|•|35% of 868 participants|•|Primary Study Completion|•|Study Completion|
|clinical trial recruitment|recruited|
|Travelan®|
|commencement|[d]|
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Completed; 1. Investigational New Drug; 2. Enterotoxigenic E.coli ; 3. controlled human infection model; 4. Institutional Review Board; 5. Naval Medical Research Center; 6. Project strategy and budget to be approved by the Immuron Board; 7. Uniformed Health Services University of the Health Sciences;[a,h,g] ASX Release links in appendix
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Steven Lydeamore Chief Executive Officer Immuron Limited 19 April 2023 Contact Information: Phone: Australia: +613 8892 4854 Email: [email protected]
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TECHNOLOGY PLATFORM
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.
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STEP 1
STEP 2
STEP 3
FINAL PRODUCT
Development of Highly Specific Vaccines
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Isolation of Hyperimmune antibody-rich bovine colostrum
Oral Antimicrobial therapeutics without drawbacks of antibiotics
Toxin Neutralization + Clearance of targeted gut pathogens
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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
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Enhance/promote health liver function
Australian Permitted indications; these statements have not been evaluated by the Food and Drug Administration (FDA)
ADDRESSABLE MARKET & INDUSTRY OVERVIEW
Immuron’s products are a subset of the global digestive health market, which a multi-billion-dollar market*
~$15b+
Travelers diarrhea treatment market is large and growing at a ~7% CAGR CAGR of ~7% over 2019-2022*
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Travelan® has large market potential given that acute diarrhea affects millions of travelers each year
Based on US annual travel numbers and a penetration rate of $83m 15%, the market potential is estimated at $83m**
Based on EU travel numbers and a penetration rate of 15%, the $50m market potential is estimated at $50m**
Clostridioides difficile infections (CDIs) to grow to almost $1.7 $1.7b billion by 2026, according to GlobalData
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IQVIA Consumer Health Category QuickView MAT Q1 2019
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** IMC Company Report - Travelan Market Analysis 2019
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*** Centers for Disease Control and Prevention Yellow Book
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Billion Dollar Market
Travelers diarrhea treatment market is large and growing at a CAGR of ~7%
Industry tailwinds
Travel picking up significantly following COVID lockdowns
Frequent Symptom
30% - 70% of travelers experience traveler’s diarrhea***
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IMMURON’S CLINICAL PROGRAMS – OPPORTUNITY ASSESSMENT
Lumanity* Opportunity Assessment for IMM-124E[b]
Lumanity Opportunity Assessment for IMM-529[c]
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Immuron’s development of IMM-124E (hyperimmune bovine colostrum) as a prescription medication has the potential to address this unmet need
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Infectious disease experts reacted favorably to the IMM-529 MOA, and its unique ability to target three elements of the rCDI infection – the spores, vegetative cells, and Toxin B
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Primary care physicians (PCP)s impressed with clinical efficacy endpoint targets demonstrating > 80% protection against the development of diarrhea.
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If base case efficacy targets are reached, IMM-124E would mostly be used by travelers going to the highest risk areas (e.g., rural Central America/Asia/Africa).
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Based on the estimated market size and pricing, the base case yearly revenue in USA for IMM-124E is projected at US$102M.
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Reaching higher efficacy goals could broaden use.
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Non-microbiome approaches (such as IMM-529) are still appealing to experts, who noted that clinical trial efficacy (reduction in relapse rate) and cost/access will be the key drivers of clinical use in recurrent patients, not mechanism of action
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Based on the estimated market size, anticipated payer restrictions, pricing, and competition, base case yearly revenue in USA for IMM529 is conservatively projected at $93M for the target patient population (limited to 2[nd] recurrence and later based on trial design and payer coverage)
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Positioning IMM-529 at the point of second relapse and/or efficacy targets could lead to higher uptake.
| Compound or brand name | Indication | Phase I | Phase II | Phase III | Market |
|---|---|---|---|---|---|
| IMM-124E - Travelan® | Traveler’s Diarrhea ETEC challenge | ||||
| IMM-529 | _Clostridioides difficile_Infection & Recurrence | ||||
• Lumanity, a leading lifescience consulting company: https://lumanity.com/company/our-story/
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SCIENTIFIC REFERENCES
| 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 |
| 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 |
US Department of Defense, Armed Forces Research Institute of Medical Sciences (AFRIM), 4 September, 2019 |
| 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), 5 September, 2018 |
| Travelan® able to bind and was reactive to 60 clinical isolates of each bacteria, Campylobacter, ETEC, and Shigella |
US Department of Defense, Armed Forces Research Institute of Medical Sciences (AFRIM), 30 January, 2017 |
| Efficacy of hyperimmune bovine colostrum against shigellosis in rhesus macaque (Macaca mulatta), and bioactivity of HBC against common enteric pathogens |
Islam et al., 2020. Submitted to mSphere, American Society for Microbiology |
| 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 effect on gut microbial communities in unchallenged mice |
Rachele Gore, Mitra Mohsenipour, Jennifer L Wood, Gayathri K Balasuriya, Elisa L Hill-Yardin, Ashley E Franks |
| 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 |
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ASX RELEASES REFERENCED
| Ref | Slide statement | ASX Release |
|---|---|---|
| a | Travelan® (IMM-124E) IND filed with and approved by FDA | Immuron Receives FDA Approval for Travelan IND Application |
| b | Market evaluation by Lumanity confirms the Traveler’s Diarrhea market opportunity for IMM-124E (Travelan®) |
AGM Presentation |
| c | Market evaluation by Lumanity confirms the Clostridioides difficile market opportunity for IMM-529 |
AGM Presentation |
| d | Travelan® - Uniformed Services University has recruited more than 20% of participants in a randomized clinical trial with Travelan® to evaluate the effectiveness for prophylaxis during deployment or travel to a high traveler’s diarrhea risk region |
US DOD Travelan Clinical Recruitment Milestone |
| e | Naval Medical Research Center Clinical Trials of CampETEC in campylobacter and enterotoxigenic E.coli (ETEC) |
Immuron and US NMRC respond to CampETEC FDA Clinical Hold |
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