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Immuron Limited Appendix 4D Half-year 31 December 2019 Name of entity: Immuron Limited ABN: Half-year ended: Previous period: 80 063 114 045 31 December 2019 31 December 2018 Results for announcement to the market $ Reve

Key Takeaway: Name of entity: Immuron Limited ABN: Half-year ended: Previous period: 80 063 114 045 31 December 2019 31 December 2018 for announcement to the market $ Revenue from ordinary activities Up 59.1% to 1,556,623 Net loss after tax (from ordinary activities) for the peri

Full Press Release Details

Name of entity: Immuron Limited
ABN: Half-year ended: Previous period: 80 063 114 045 31 December 2019 31 December 2018
for announcement to the market
$
Revenue from ordinary activities Up 59.1% to 1,556,623
Net loss after tax (from ordinary activities) for the period attributable to members Down 5.8% to (1,490,249 )
Net loss after tax for the period attributable to members Down 5.8% to (1,490,249 )
Net tangible assets per security
31 December 31 December
2019 2018
Cents Cents
Net tangible asset backing (per share) 3.82 5.01
calculation of net tangible assets excludes right-of-use assets arising from AASB 16 Leases.
explanation of the key financial elements contributing to the revenue and result above can be found in the review of operations
included within the directors' report.
dividends have been paid or declared by the company for the current financial period. No dividends were paid for the previous
in controlled entities
have been no changes in controlled entities during the half-year ended 31 December 2019.
information required by Listing Rule 4.2A
a. Details of individual and total dividends or distributions and dividend or distribution payments: N/A
b. Details of any dividend or distribution reinvestment plans: N/A
c. Details of associates and joint venture entities: N/A
d. Other information N/A
financial statements have been reviewed by the group's independent auditor without any modified opinion, disclaimer or emphasis
report - 31 December 2019
Contents Page
Directors' report 2
Interim financial report
Condensed consolidated statement of profit or loss and comprehensive income 9
Condensed consolidated balance sheet 10
Condensed consolidated statement of changes in equity 11
Condensed consolidated statement of cash flows 12
Notes to the condensed consolidated financial statements 13
Directors' declaration 23
Independent auditor's report to the members 24
interim financial report does not include all the notes of the type normally included in an annual financial report. Accordingly,
this report should be read in conjunction with the annual report for the year ended 30 June 2019 and any public announcements
made by Immuron Limited during the interim reporting period in accordance with the continuous disclosure requirements of the Corporations
directors present their report on the consolidated entity consisting of Immuron Limited and the entities it controlled at the
end of, or during, the half-year ended 31 December 2019.
following persons held office as directors of Immuron Limited during the financial period:
Prof. Ravi Savarirayan
Richard Berman (resigned 17 October 2019)
Limited has reported a loss for the half-year ended 31 December 2019 of AUD $1,490,249 (31 December 2018: AUD $1,581,899).
The group's net assets decreased to AUD $6,850,009 compared with AUD $7,351,136 at 30 June 2019, including cash
reserves of AUD $4,839,868 (2018: AUD $5,119,887).
enjoys continued high growth in all markets
experienced robust gross sales growth in the US, Canada and Australia throughout the first half of FY20, with global unaudited
sales reaching AU $1.68M during the 6-month period.
America sales of Travelan were up 98% YoY for the first half of FY20, 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% within the Passport Health
network of clinics. A series of podcasts on the "Not old, better" network assisted in raising consumer awareness of
Australia, Immuron unaudited sales reached AU $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
Review of operations (continued)
registration for clinical development of IMM-124E/Travelan to prevent travelers' diarrhea underway
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 was 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 Agency, and successful FDA approval of IMM-124E
to specifically prevent travelers' diarrhea could lead to substantial increases in the marketing of an FDA-approved drug
to treat travelers' diarrhea.
shown to work, and successfully approved, 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.
Medical Research Center (NMRC) grant funded to develop and clinically evaluate new therapeutic against Campylobacter
October 02, 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.
results for U.S. DoD study on Travelan and Vibrio cholera
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' diarrhoea caused by these pathogens.
depository shares (ADS) capital raise completed
July 2019, the company successfully completed an AU$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.
a division of Fordham Financial Management, were the underwriters for the financing.
Review of operations (continued)
trial in SAH patients leads to decision to discontinue further development of IMM-124E in this and similar indications
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.
trial in patients with C. difficile infection (CDI)
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.
Department of Defense's Travelan Shigellosis animal study results reported
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.
Evaluation of three new Shigella drug products
the same June 2019 announcement, we reported the completed 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
Last updated: Feb 26, 2020