Immuron CEO, Steven Lydeamore to present at AusBioInvest
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Immuron CEO, Steven Lydeamore to present at AusBioInvest
Melbourne, Australia, October 30, 2023: 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 AusBioInvest 2023 on Monday, October 30th in the
9.40am – 10.35am session (AEST) at the Park Hyatt, Melbourne, Australia.
A copy of the presentation being made at AusBioInvest 2023 is included below.
This release has been authorised by the directors of Immuron Limited.
- - - END - - COMPANY CONTACT:
Steven Lydeamore
Chief Executive Officer
Ph: +61 (0)3 9824 5254
info@immuron.com
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 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.
AUSBIOINVEST
PRESENTATION
30 OCTOBER, 2023
S t e v e n Ly d e a m o r e - C E O
NASDAQ: IMRN
ASX: IMC
1
SAFE HARBOR STATEMENT
C e r t a i n s t a t e m e nt s m a d e i n t h i s p re s e nt a t i o n a re fo r wa rd - l o o k i n g s t a t e m e nt s a n d a re
b a s e d o n I m m u ro n ’s c u r re nt ex p e c t a t i o n s , e s t i m a t e s a n d p ro j e c t i o n s . Wo rd s s u c h a s
“a nt i c i p a t e s ,” “ex p e c t s ,” “ i nt e n d s ,” “ p l a n s ,” “ b e l i e v e s ,” “s e e k s ,” “e s t i m at e s ,” “g u i d a n c e ”
a n d s i m i l a r ex p re s s i o n s a re i nt e n d e d t o i d e nt i f y fo r wa rd - l o ok i n g s t a t e m e nt s .
A l t h o u g h I m m u ro n b e l i e v e s t h e fo r wa rd - l o o k i n g s t a t e m e nt s a re b a s e d o n
re a s o n a b l e a s s u m p t i o n s , t h e y a re s u b j e c t t o c e r t a i n r i s k s a n d u n c e r t a i nt i e s ,
s o m e o f w h i c h a re b e y o n d I m m u ro n ’s co nt ro l , i n c l u d i n g t h o s e r i s k s o r
u n c e r t a i nt i e s i n h e re nt i n t h e p ro c e s s o f b o t h d e v e l o p i n g a n d co m m e rc i a l i z i n g
t e c h n o l o g y. A s a re s u l t , a c t u a l re s u l t s co u l d m a t e r i a l l y d i f fe r f ro m t h o s e
ex p re s s e d o r fo re ca st e d i n t h e fo r wa rd - l o o k i n g s t a t e m e nt s .
T h e fo r wa rd - l o ok i n g s t a t e m e nt s m a d e i n t h i s p re s e nt a t i o n re l a t e o n l y t o
e v e nt s a s o f t h e d a t e o n w h i c h t h e s t a t e m e nt s a re m a d e . I m m u ro n w i l l n o t
u n d e r t a ke a ny o b l i ga t i o n t o re l e a s e p u b l i c l y a ny re v i s i o n s o r u p d a t e s t o
t h e s e fo r wa rd- l o o k i n g s t a t e m e nt s t o re f l e c t e v e nt s , c i rc u m sta n c e s o r
u n a nt i c i p a t e d e v e nt s o c c u r r i n g a f t e r t h e d a t e o f t h i s p re s e nt a t i o n exc e p t a s
re q u i re d by l a w o r by a ny a p p ro p r i at e re g u l a t o r y a u t h o r i t y.
F Y 2 0 2 4 re s u l t s i n t h i s p re s e nt a t i o n a re s u b j e c t t o a u d i t re v i e w.
2
REVENUE GENERATING WITH STRONG PIPELINE
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
Major Shareholders
Financial Snapshot
Units
% of CSO
Shares on Issue
227,798,346
Holder
Total Options
14,568,559
BNY Mellon Asset Management 78,704,665
34.6 %
Last Traded Price
IMC: A$0.075
Management & Board
6,904,554
3.0 %
52 week High/Low
IMC: A$0.105 / 0.067
IMRN: $3.21 / 1.39
Authentics Australia Pty. Ltd.
6,000,000
2.6 %
Grandlodge
3,846,712
1.7 %
Market Cap
IMC: A$17.08m
Cash & Cash Equivalents
(30 June 2023)
A$17.2m
3
TECHNOLOGY PLATFORM FOR GUT MEDIATED DISEASES
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.
STEP 1
Development of Highly
Specific Vaccines
STEP 2
Isolation of Hyperimmune
antibody-rich
bovine colostrum
* Gomes et. al., NFS Journal, Volume 25, November 2021, pages 111, https://doi.org/10.1016/j.nfs.2021.10.001
STEP 3
Oral Antimicrobial
therapeutics
without drawbacks
of antibiotics
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)
4
STRONG PIPELINE WITH NEAR TERM MILESTONES
Immuron’s Clinical Programs
Compound or
brand name
Indication
IMM-124E
Travelan®
Traveler’s
Diarrhea ETEC
challenge
IMM-529
Clostridioides
difficile
Infection &
Recurrence
Phase
I
Phase
II
Phase
III
Market
Our Partners’ Clinical Programs
Compound or
brand name
Travelan®
CampETEC
Partner
Phase
I
Phase
II
Phase
III
Market
Uniformed Services University
Naval Medical
Research Command
Further information on the clinical programs can be found on slide 8
5
Traveller’s Diarrhoea (TD)
STRONG SALES GROWTH
IN AT TRACTIVE MARKET
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
Net Sales
FY23: A$1.16 million
1QFY24: A$1.35 million
229% higher than prepandemic period
1QFY20
Net Sales
FY23: A$0.64 million
1QFY24: A$0.21 million
9% lower than prepandemic period
1QFY20
Australia
12 months to July 2023
short term resident
returns 77% of those
in 2019 1
USA
Total departures
June 2023 99.4%
of June 2019 2
Chief Commercial
Officer has 20+ year’s
experience with local
and global (Asia, UK)
commercial leadership
roles with GSK and
P&G
$83m
Based on US annual
travel numbers and a
penetration rate of
15%, the market
potential is estimated
at $83m 5
1. https://www.abs.gov.au/statistics/industry/tourism-and-transport/overseas-arrivals-and-departures-australia/latest-release
2. https://www.trade.gov/sites/default/files/2023-09/US-Outbound-to-World-Regions.xlsx
3. Research Reports World, 28 May 2021: Global Traveler’s Diarrhea Therapeutics Industry Research Report, Growth Trends and Competitive Analysis 2021-2027
4. Centers for Disease Control and Prevention Yellow Book
5. IMC Company Report - Travelan Market Analysis 2019
$50m
Based on EU travel
numbers and a
penetration rate of
15%, the market
potential is estimated
at $50m 5
6
VALUABLE SALES POTENTIAL FOR PIPELINE PRODUCTS
Lumanity*
CorporateOpportunity
Assessment for IMM-124E
›
›
›
›
Immuron’s development of IMM-124E (hyperimmune
bovine colostrum) as a prescription medication has
the potential to address this unmet need
Primary care physicians (PCP)s impressed with clinical
efficacy endpoint targets demonstrating > 80%
protection against the development of diarrhea.
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).
Based on the estimated market size and pricing, the
base case yearly revenue in USA for IMM-124E is
projected at US$102M.
Reaching higher efficacy goals could broaden use.
Compound or brand name
Indication
IMM-124E - Travelan®
Traveler’s Diarrhea ETEC challenge
IMM-529
Clostridioides difficile Infection & Recurrence
›
›
Lumanity
Opportunity
Corporate
Assessment for IMM-529
›
›
›
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
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
Based on the estimated market size, anticipated payer
restrictions, pricing, and competition, base case yearly
revenue in USA for IMM-529 is conservatively projected at
US$93M for the target patient population (limited to 2nd
recurrence and later based on trial design and payer
coverage)
Positioning IMM-529 earlier than second recurrence and/or
efficacy targets could lead to higher uptake.
Phase I
Phase II
Phase III
Lumanity, a leading lifescience consulting company: https://lumanity.com/company/our-story/
Clostridioides difficile infections (CDI) to grow to almost $1.7 billion by 2026, according to GlobalData
Market
7
NEAR TERM MILESTONES ANTICIPATED TO DRIVE VALUE
2H 2022
•
Travelan®
•
•
CampETEC
IMM-529
•
•
Travelan®
1H 2023
2H 2023
1H 2024
•
FDA IND1 approved for single
daily dose IMM-124E ETEC2
CHIM3 clinical trial
•
•
•
IRB Approval4
Initiated IMM-124E ETEC2 CHIM3 •
clinical trial
100% of patients enrolled
Completion of In-patient phase
ETEC2 CHIM3 clinical trial
Submitted Response Letter to
FDA Clinical Hold
Immuron sponsored Toxicology
study - completed
•
•
•
Toxicology Study Report
FDA IND1 approved (Clinical Hold
released)
Institutional Review Board
approval of NMRC5 CampETEC
Campylobacter CHIM3 clinical
trial protocol
FDA approval of IND
amendment for change to
protocol
•
•
IMM-529 cGMP manufacture
•
•
~50% of 868 participants
recruited
•
•
600 mg solid dose active
formulation development
USU6 P2TD IMM-124E field
clinical trial recruitment
commencement
•
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
•
•
Topline results for IMM-124E
ETEC2 clinical trial
Clinical Study Report
Initiate NMRC5 CampETEC
Campylobacter CHIM3 clinical
trial
Completion of In-patient phase
CampETEC Campylobacter
CHIM3 clinical trial
IMM-529 (CDI)7 Pre-IND1
submission
Completion of enrollment
Completion of in-patient phase
8
STEVEN LYDEAMORE
CHIEF EXECUTIVE OFFICER
IMMURON LIMITED
CONTACT INFORMATION:
EMAIL: STEVE@IMMURON.COM
PHONE: AUSTRALIA: +613 8892 4854
9
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
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
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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