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Immuron Ltd — Investor Presentation 2023
Feb 27, 2023
35121_rns_2023-02-27_8724a2fb-7166-4df9-b4b6-f5be91986459.pdf
Investor Presentation
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INVESTOR PRESENTATION BUSINESS UPDATE
28 FEBRUARY, 2023
Steven Lydeamore - CEO
NASDAQ: IMRN ASX: IMC
1
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.
HY and YTD FY2023 results in this presentation are subject to audit review. The final 2023 Half Year Report will be issued on 28 February 2023.
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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 Overview • Incorporated in Australia in 1994 and has been listed on the ASX since 1999 and NASDAQ since 2017 • Market capitalisation of $16.6m as of 24 Feb 2023 with cash & cash equivalates balance of $18.5 million as of 31 Dec 2022
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• Refreshed corporate structure including key hire – Flavio Palumbo as Chief Commercial Officer • Flagship product Travelan® demand surged faster than current supply capability
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Business • Supply chain capacity addressed by contracting another packaging supplier
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Update • Capable of producing highly specific orally active immunoglobulins to any enteric pathogen • Travelan® (IMM-124E) IND filed with and approved by FDA[a]
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• FY23 H1 revenue of $584k, up 153% on pcp – Australian sales contributing $287k
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• FY23 YTD 24 Feb 2023 revenue of $1.23m, up 234% on pcp – Australian sales contributing $776k
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Results & •
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Outlook Evaluating launch of Travelan® via distributors in international markets (Asia, Europe) • Extremely strong balance sheet that will be supporting its refreshed organic growth strategy and new M&A strategy • Set to initiate a clinical trial for Travelan® (IMM-124E) this financial year
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a ASX Release link in appendix. YTD FY2023 results in this presentation are subject to audit review. The final 2023 Half Year Report will be issued on 28 February 2023.
YEAR TO DATE SALES – 24[TH] FEBRUARY 2023
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Key Commentary
| $000s | |||||
|---|---|---|---|---|---|
| FY23 YTD | FY22YTD | ||||
| Profit & Loss | 24 | Feb 23 | 24 | Feb 22 | Var % |
| Australian Sales | $ | 776 |
$ | 67 |
1058% |
| Rest of World Sales | $ | 457 |
$ | 302 |
51% |
| Total Revenue | $ | 1,233 |
$ | 369 |
234% |
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$649k sales during January and to 24 February boosting sales YTD
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Up 234% on pcp
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Up 111% on FY23 half year
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Australian sales contributing 63% (up from 18% in 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
*YTD FY2023 results in this presentation are subject to audit review. The final 2023 Half Year Report will be issued on 28 February 2023.
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CEO UPDATE & CORPORATE SNAPSHOT
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Continued strengthening executive team, bringing on Flavio Palumbo as Chief Commercial Officer
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Flavio brings over 20 year’s experience with local and global (Asia, UK) commercial leadership roles with GSK and P&G.
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Travelan® is now widely available again following supply challenges in January which have been resolved through the qualification of a new packaging company.
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USA Market:
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Immuron’s own shopfront on amazon.com will be introduced during FY23
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Re-entry into retail pharmacies will be explored in FY23
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Canadian Market:
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Working towards relaunch into retail pharmacy in FY24
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Market Expansion:
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Evaluating options to enter Asian and European markets through distributors
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Evaluating options to add to marketed products portfolio in FY24
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Shareholder Base:
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| Financial Snapshot | Financial Snapshot |
|---|---|
| Shares on Issue | 227,798,346 |
| Total Options | 21,303,877 |
| Last Traded Price | $0.078 |
| 52 week High/Low | 0.125/0.07 |
| Market Cap | $16.6m |
| Cash & Cash Equivalents (as at 31 Dec 22) | $18.5m |
*As at 24 February 2023
| Substantial Shareholders | Substantial Shareholders | Substantial Shareholders |
|---|---|---|
| Holder | Units | % of CSO |
| BNY Mellon Asset Management | 77,903,505 | 34.2 % |
| Management & Board | 6,904,554 | 3.0 % |
| Authentics Australia Pty. Ltd. | 6,000,000 | 2.6 % |
| Grandlodge | 3,846,712 | 1.7 % |
*As at 24 February 2023
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Large retail shareholder base in US and Australia
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BNY Mellon Asset Management (American Depository Shares) holds 34% stake
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Board and management aligned with shareholders, holding 3% stake
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STATUS OF PRODUCT PORTFOLIO AND KEY MILESTONES
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US Department of Defense grant of US$4.45 million to examine a dosing regimen for Travelan® more suited for use by the military[d]
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Market evaluation by Lumanity confirms the Traveler’s Diarrhea market opportunity for IMM- ~~124E (Trav~~ elan®)[e]
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IMM-124E (Travelan®) IND was approved by the FDA in 2H2022[a]
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Clinical trials anticipated to commence in 1H2023
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Market evaluation by Lumanity confirms the Clostridioides difficile market opportunity for IMM-529[f]
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600mg solid dose active formulation development completed
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Project strategy and budget to be approved by the Immuron Board before initiating clinical trials
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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[g]
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Estimated Study Primary Completion Date – 30 July 2023
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Estimated Study Completion Date – 31 December 2023
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Naval Medical Research Center Clinical Trials of CampETEC in campylobacter and enterotoxigenic E.coli (ETEC)[h]
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Animal ethics approval for Toxicology study – 22 November 2022
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Immuron sponsored Toxicology study - completed 20 December 2022
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Meeting with FDA to discuss clinical hold – 2 December 2022
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Written Guidance received from FDA – 20 December 2022
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Response letter submitted – 25 January 2022
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Anticipate FDA feedback in March 2023
Immuron’s Clinical Programs
| Compound or brand name |
Indication | Phase I |
Phase I |
Phase II |
Phase III |
Market |
|---|---|---|---|---|---|---|
| IMM-124E Travelan® |
Traveler’s Diarrhea ETEC challenge |
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| IMM-529 | Clostridioides difficile Infection & Recurrence |
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Our Partners’ Clinical Programs
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Compound or Partner Phase Phase Phase Market
brand name I II III
Travelan® Uniformed Services
University
CampETEC Naval Medical
Research Center
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*Further information on the clinical programs can be found on slide 11
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a ,b,c,d,e,f ASX Release links in appendix
DISTRIBUTION CAPABILITY
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Australia USA Canada
Retail Pharmacy
B2B
E-commerce
Established Developing
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Key Commentary
- The Australian retail network includes over 3,500 pharmacies
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Immuron Limited ANB Canada Vancouver, BC, Canada Ontario, Canada Distributes to all provinces of Canada
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RJW Logistics Immuron Inc. Chicago, USA New York, USA Distributes to all states of USA
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In the USA, the key B2B customer is Passport Health - the largest network of travel medicine clinics
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We have transitioned to new sales management service and third party logistics providers in the USA
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Immuron’s own shopfront on amazon.com will be introduced in the USA during FY23
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Re-entry into retail pharmacies in USA will be explored in FY23
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In Canada, we are working towards a relaunch into retail pharmacy in FY24
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We are exploring options to expand B2B business in airlines, cruise ships, health & wellness segments
Immuron Limited
Melbourne, Australia
Distributes to all states of Australia and to distributors in USA and Canada
- We are evaluating options to enter Asian and European markets through distributors
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BUSINESS POSITIONED FOR ORGANIC GROWTH AND NEW M&A STRATEGY
Organic Growth Strategy
M&A Strategy
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Focus on commercialised products and nearterm development extensions, including:
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1 Travelan®:
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By pursuing growth through M&A of a fragmented market, IMC believes that it will be able to increase market geographies, sales channels and penetration driving revenue growth and ultimately shareholder value
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Sales expansion across target geographies
- Our M&A Key Criteria focusses on:
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Growth in distribution network and sales & marketing initiatives
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Product development (new formulations including once daily dosing) e.g. FDA approval
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2 Protectyn®:
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Sales expansion across target geographies
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Growth in distribution network and sales & marketing initiatives
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Product development and broader applications
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Expand market verticals & product offering
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1 2 • Expand existing customer base
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3 • Cost & Earnings Synergies 4 • Strength of IP and Management
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Distribution network and sales & marketing by each
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5 product
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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|[h]|•|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|•|Recruitment Updates|•|Primary Study Completion|•|Study Completion|
|clinical trial recruitment|
|Travelan®|
|commencement|[g]|
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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 28 February 2023 Contact Information: Phone: Australia: +613 8892 4854 Email: [email protected]
10
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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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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 |
| Hyperimmune bovine colostrum reduces gastrointestinal carriage of uropathogenic Escherichia coli | Human Vaccines & Immunotherapeutics, 15:2, 508-513, DOI: 10.1080/21645515.2018.1528836 |
| 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 | Strategic investment in leading UK based health biotech Ateria Health Limited; an initial 17.5% equity stake; Value of option for further investment in Ateria Health of £1.47m, expiring on 31 July 2023 |
Immuron completes strategic investment in Ateria Health |
| c | Strategic investment in leading UK based health biotech Ateria Health Limited; an initial 17.5% equity stake; Value of option for further investment in Ateria Health of £1.47m, expiring on 31 July 2023 |
IMC investment in leading gut health biotech Ateria Health |
| d | US Department of Defense grant of US$4.45 million to examine a dosing regimen for Travelan® more suited for use by the military |
Immuron awarded A$6.2 million US DoD funding for Travelan |
| e | Market evaluation by Lumanity confirms the Traveler’s Diarrhea market opportunity for IMM-124E (Travelan®) |
AGM Presentation |
| f | Market evaluation by Lumanity confirms the Clostridioides difficile market opportunity for IMM-529 |
AGM Presentation |
| g | 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 |
| h | 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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