Immuron Limited (ASX: IMC; NASDQ: IMRN), an Australian
biopharmaceutical company focused on developing and commercializing
oral immunotherapeutics for the treatment of gut mediated diseases,
today announced an update of its results for the first half of
fiscal year 2020 ended on December 31, 2019.
Travelan® enjoys continued high growth
in all markets
Immuron experienced robust gross sales growth in
the US, Canada and Australia throughout the first half of FY20,
with global sales reaching USD $1.1M* (AUD $1.68M*) during the
6-month period.
North America sales of Travelan® were up 98% YoY
for the first half of FY20 from the first half of FY 2019, spurred
on by the launch of Travelan® in Canadian pharmacies in June 2019
and also by robust growth in online Amazon sales within the US.
Passport Health, the USA’s largest travel medicine provider, also
contributed to the strong result, with Travelan® sales rising by
27% from first half FY 2019 within the Passport Health network of
clinics. A series of podcasts on the “Not old, better” network
assisted in raising consumer awareness of Travelan® in the US.
In Australia, Immuron sales reached USD $622K*
(AUD $954K*) for the first half FY20, displaying a 33% YoY growth
rate. Travelan® strengthened its presence in Australian pharmacies
with in-store promotional material and TV advertising with Chemist
Warehouse. Immuron’s participation in Medical Practitioner
conferences also contributed to increased awareness of Travelan®
within the medical community.
FDA registration for clinical development of
IMM-124E/Travelan® to prevent travelers’ diarrhea
underway
In April 2019, Immuron announced plans to pursue clinical
development of IMM-124E through a formal FDA registration pathway
as a drug to prevent travelers’ diarrhea (TD). This is an important
strategic initiative towards enhancing commercialisation of the
IMM-124E/Travelan® franchise. On November 21, 2019, the company
announced that it had completed a Pre-IND meeting with the U.S.
Food and Drug Administration (FDA) regarding its investigational
drug IMM-124E to treat travelers’ diarrhea (TD). Following the
FDA’s guidance and feedback, the company announced plans to file an
investigational new drug (IND) application for IMM-124E, and to
conduct a Phase 3 trial of IMM-124E to prevent TD in individuals
traveling to areas endemic for TD. Immuron believes that success
with the clinical trial, followed by a BLA filing with the FDA, and
successful FDA approval of IMM-124E to specifically prevent
travelers’ diarrhea could lead to substantial increases in sales of
an FDA-approved drug to treat travelers’ diarrhea.
Once shown to work, and successfully approved, we believe
IMM-124E would be the first and only FDA approved prophylactic
effective against acute infectious diarrhea. Overall, diarrhea
leads to an estimated 1.5 billion episodes a year globally, killing
about 2.2 million people, mostly children in developing
countries.
Naval Medical Research Center (NMRC)
grant funded to develop and clinically evaluate new therapeutic
against Campylobacter
On October 2, 2019, Immuron announced funding by
the U.S. Department of Defense (DoD) of a new research agreement
with America’s Naval Medical Research Centre (NMRC), a research arm
of the DoD, located in Silver Spring, Maryland, to develop a
combined Campylobacter and enterotoxigenic E. coli (ETEC)-specific
drug candidate for clinical evaluation. Under this agreement,
Immuron and NMRC will be collaborating on the manufacture and
evaluation of the new product candidate designed to protect against
travelers’ diarrhea caused by Campylobacter and ETEC pathogens. The
protective efficacy of the candidate product will be evaluated
utilizing two controlled human infection-model clinical trials,
with one trial focusing on the ability of the hyperimmune product
to protect volunteers against moderate to severe
campylobacteriosis, and the second trial focusing on preventing
ETEC-specific diarrhea.
Positive results for U.S. DoD study on
Travelan® and Vibrio cholera
A prior study conducted during the previous year
showed Travelan’s immuno-reactivity to infectious Vibrio cholera
strains from Southeast Asia. The U.S. Department of Defense
sponsored the project conducted at the Bangkok laboratory of the
Walter Reed Army Institute of Research. Clinical isolates were
collected from infected U.S. personnel stationed in Bangladesh,
Cambodia, and Thailand. The new study found Travelan’s polyclonal
antibodies were reactive to all 71 clinical isolates from infected
participants. The 71 add on to the 180 isolates of Campylobacter
spp, ETEC, and Shigella spp from the earlier 2018 study. The
results, along with findings from primate shigellosis studies,
point towards Travelan as a potentially effective
immuno-prophylactic for travelers’ diarrhea caused by these
pathogens.
American depository shares (ADS) capital raise
completed
In July 2019, the company successfully completed a USD $1.24
million (AUD $1.9 million) public offering of American Depository
Shares (ADS). Immuron issued 339,130 ADSs, equivalent to 13,565,200
fully paid ordinary shares. The proceeds will go towards clinical
development of our therapeutic drug candidates, as well as for
working capital.
ThinkEquity, a division of Fordham Financial Management, were
the underwriters for the financing.
IMM-124E trial in SAH patients leads to decision to
discontinue further development of IMM-124E in this and similar
indications
In August 2019, the results from a Phase II clinical study in
patients with severe alcoholic hepatitis (SAH), conducted under FDA
IND #015675 and funded by the National Institute of Alcohol Abuse
and Alcoholism (NIAAA), were released. The primary objective of the
study was to evaluate the safety and efficacy of IMM-124E at two
oral dosage levels as compared with a placebo in patients with SAH
and with all patients also being treated with steroids. The data
showed that IMM-124E did not reduce circulating lipopolysaccharide
levels, mortality or have an impact on MELD score in the study
population. Further clinical development of IMM-124E to treat SAH
and similar indications has been discontinued.
IMM-529 trial in patients with C. difficile infection
(CDI)
In March 2019, Immuron provided an update regarding the status
of the IMM-529 clinical trial in patients with CDI, along with a
refocusing of its efforts to develop IMM-529. The Phase I/IIa
clinical trial of IMM-529 in patients with CDI initiated at the end
of 2017 at two clinics in Israel exhibited poor patient enrollment,
with only nine patients being randomized into a study planned to
enroll 60 patients. Immuron decided to close these sites and to
focus further development of IMM-529 to treat CDI patients through
a formal filing of an IND with FDA, and to develop a new plan for
development of the drug candidate to treat patients subject to
recurrent disease, a major unmet medical need in the treatment of
patients suffering with C. difficile infections. The company plans
to file a Type B meeting request with FDA to explore further
development of IMM-529.
U.S. Department of Defense’s Travelan Shigellosis animal
study results reported
In June 2019, we updated the market on the Shigella research
program with the Walter Reed Army Institute of Research (WRAIR).
Shigella is the bacterium responsible for the onset of bacillary
dysentery, and a major concern for armed forces personnel located
in high risk areas for this disease throughout the world. The study
results demonstrated that animals with severe inflammation in the
gastrointestinal tract and high inflammatory cytokines in fecal
samples were associated with severe bacillary dysentery, and that
those animals treated with prophylactic administration of Travelan
significantly reduced the inflammatory response.
Preclinical Evaluation of three new Shigella drug
products
In the same June 2019 announcement, we reported the completion
of the manufacture of three new Shigella-specific therapeutic
products using proprietary vaccines developed by WRAIR. The immune
reactivity of the three hyper-immune Shigella-specific bovine
colostrum products have been assessed by WRAIR using ELISA and
Western Blot analysis. The antibodies in these products were shown
to react with the specific antigens present in the vaccines and
were also reactive to four different clinical isolates of Shigella
(S. flexneri 2a, S. flexneri 3a, S. flexneri 6, and S. sonnei).
These three Immuron Shigella-specific therapeutic products are now
undergoing further evaluation in WRAIR’s preclinical models of
shigellosis, with results expected to be reported throughout this
year.
Research and development tax concession refund
paid
The Australian government has paid Immuron a cash refund of USD
$345,560 (AUD $530,000) as part of its Research and Development
Income Tax Concession program.
Immuron CEO, Dr. Gary S. Jacob, said “We are pleased to report
continued sales momentum globally for Travelan® as consumer
awareness continues to grow. Our work toward FDA registration
remains ongoing and we believe it provides a further boost to our
long-term sales potential. Cash flow from increasing Travelan®
sales, combined with our successful ADS offering and non-dilutive
tax concession R&D refund, provide a solid foundation to move
our development programs with IMM-529 and IMM-124E forward. We will
provide further updates as these and other in-house programs
progress.”
*Unaudited gross revenue
COMPANY CONTACT:
Gary S. Jacob, Ph.D.Chief Executive OfficerPh: +61
(0)3 9824 5254info@immuron.com |
AUS INVESTOR RELATIONS:
Peter TaylorNWR CommunicationsPh: +61 (0)4 1203
6231peter@nwrcommunications.com.au |
USA INVESTOR RELATIONS:
Dave Gentry - CEO RedChip Companies, Inc. US Ph:
+1 (407) 491 4498 dave@redchip.com |
About Travelan®
Travelan® is an orally administered passive
immunotherapy that prophylactically reduces the likelihood of
contracting travelers’ diarrhea. 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 ImmuronImmuron 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. Immuron has a novel and safe
technology platform with one commercial asset generating revenue.
In Australia, Travelan® is a listed medicine on the Australian
Register of Therapeutic Goods (AUST L 106709) and is indicated to
reduce the risk of Travellers’ Diarrhea, reduce the risk of minor
gastro-intestinal disorders and is antimicrobial. In Canada,
Travelan® is a licenced natural health product (NPN 80046016) and
is indicated to reduce the risk of Travellers’ Diarrhea. In the
U.S., Travelan® is sold as a dietary supplement for digestive tract
protection in accordance with section 403 (r)(6) of the Federal
Drug Administration (FDA). Immuron’s lead clinical candidate,
IMM-124E, is presently in Phase II trials in Severe Alcoholic
Hepatitis (SAH) and Pediatric Nonalcoholic Fatty Liver Disease
(NAFLD). The company now has plans to develop a U.S. registration
dossier for IMM-124E for Travellers’ Diarrhea. Immuron’s second
clinical-stage asset, IMM-529, targets Clostridium difficile
Infections (CDI), and is in clinical trial development in CDI
patients. These products together with the Company’s other
preclinical immunotherapy pipeline products currently under
development targeting immune-related and infectious diseases are
anticipated to meet pressing needs in the global immunotherapy
market. 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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