Presentation to Annual General Meeting
Released
Released
Announcement PDF
AGM
PRESENTATION
21 NOVEMBER, 2023
S t e v e n Ly d e a m o r e - C E O
NASDAQ: IMRN
ASX: IMC
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SAFE HARBOR STATEMENT
C e rta in state m e nts ma de in this pre s e nta t io n a re fo rwa rd- lo o k i n g state m e nt s a nd a re
ba s e d o n I mmuro n’s c urre nt ex pe c ta tio n s , e stimate s a nd pro j e c tio ns . Wo rds s uc h a s
“a ntic ip a te s ,” “ex pe c ts ,” “inte n ds ,” “pla ns ,” “be lie ve s ,” “s e e ks ,” “e stima te s ,” “guida nc e ”
a nd s imila r ex pre s s io ns a re inte n de d to ide nt if y fo rwa rd- lo o ki n g state me nt s .
A ltho ug h I mmuro n be lie ve s the fo rwa rd- lo o k i n g state m e nts a re ba s e d o n
re a s o na ble a s s umptio n s , the y a re s ubj e c t to c e rta in ris ks a nd unc e rta i nt ie s ,
s o me o f whic h a re be yo nd I mmuro n’s c o ntro l, inc ludi n g tho s e ris ks o r
unc e rta i n ti e s inhe re nt in the pro c e s s o f bo th de ve lo pi n g a nd c o mme rc ia liz i n g
te c hno lo g y. A s a re s ult, a c tua l re s ults c o uld mate ria l l y diffe r f ro m tho s e
ex pre s s e d o r fo re c a ste d in the fo rwa rd- lo o k in g state me n ts .
The fo rwa rd- lo o k i n g state m e nts ma de in this pre s e nta t io n re late o nly to
e ve nts a s o f the date o n whic h the state m e nts a re ma de . I mmuro n will no t
unde rta ke a ny o bligat io n to re le a s e public l y a ny re vis io ns o r upda te s to
the s e fo rwa rd- lo o k i ng state me n ts to ref le c t e ve nts , c irc umsta nc e s o r
una nt ic i p a te d e ve nts o c c urring a f te r the date o f this pre s e nta t io n exc e pt a s
re quire d by la w o r by a ny a ppro pri a te re gula to r y a utho ri t y.
F Y2024 re s ults in this pre s e nta t io n a re s ubj e c t to a udit re vie w.
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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
Business
Update
•
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
•
Global 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 Australia1
•
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 offering
•
Launched on Amazon in USA in July 2023
•
Status of investment in leading gut health biotech, Ateria Health
•
•
Launched ground-breaking Juvia™ 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
1. IQVIA Australia Pharmacy Scan – Antidiarrheal segment, value sales 13 weeks to 21 October 2023
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COMPANY HIGHLIGHTS
Strong Sales Growth
o
o
Global sales increased by 136% in the 2023 fiscal year to A$1.80 million compared to A$0.77 million in FY22
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 20191
o Travelan® is now the #2 SKU and fastest growing in the Antidiarrheal category across all pharmacy in
Australia2
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 20193
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
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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
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COMPANY HIGHLIGHTS
Collaborations with U.S. DoD – Remain Strong
o
o
o
o
o
o
o
Travelan® IND Approval – December 2022
Study Initiation – May 2023
First cohort recruitment completed – July 2023
Presentations at Military Health System Research Symposium – August 2023
Second cohort recruitment completed – October 2023
Completion of In-patient phase – October 2023
Anticipated Top Line Results and Clinical Study Report – 1H 2024
US Uniformed Services University Traveller’s Diarrhoea Clinical Field Trial
o
o
o
o
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
Florastor® removed from active study arms – February 2023
o Now 868 study participants (434 per arm)
50% recruitment milestone – October 2023
Anticipated completion of recruitment – March 2024
Anticipated completion of In-patient phase – June 2024
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COMPANY HIGHLIGHTS
US Naval Medical Research Command – Campylobacter & ETEC PROJECT
o
o
o
o
o
o
New Therapeutic in Clinical Development for Treatment of moderate to severe
Campylobacteriosis and Infectious diarrhea caused by ETEC pathogens
Toxicology study completed – December 2022
FDA removed IND Clinical Hold – May 2023
Institutional Review Board Approval – October 2023
Anticipated Initiation of Campylobacter Controlled Human Infection Model
(CHIM) clinical trial – 1H2024
Anticipated completion of In-patient phase – 1H2024
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COMPANY HIGHLIGHTS
IMM-529 Clinical Development for Treatment of C. difficile Infections
o
o
o
o
o
o
o
o
o
Opportunity Assessment Completed
C. difficile infection (CDI) affects just over ~400,000 people in the US annually
Sizable number of patients who experience at least one recurrence (~20-25%),
Many patients experience multiple recurrences, creating persistent unmet need for novel therapies
to address recurrences
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.
Non-antibiotic treatments (such as IMM-529) are appealing to experts
600mg solid dose active formulation development – February 2023
Anticipated cGMP manufacture – December 2023
Anticipated FDA pre-IND submission – 1H 2024
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STEVEN LYDEAMORE
CHIEF EXECUTIVE OFFICER
IMMURON LIMITED
CONTACT INFORMATION:
EMAIL: STEVE@IMMURON.COM
PHONE: AUSTRALIA: +613 8892 4854
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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
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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