Full Press Release Details
| Name of entity: | Immuron Limited |
| ABN: | 80 063 114 045 |
| Half-year ended: | 31 December 2023 |
| Previous period: | 31 December 2022 |
for announcement to the market
| $ | ||||||||||||
| Revenue from ordinary activities | Up | 303.6% to | 2,355,580 | |||||||||
| Net loss after tax (from ordinary activities) for the period attributable to members | Up | (4.8)% to | (2,073,182 | ) | ||||||||
| Net loss after tax for the period attributable to members | Up | (4.8)% to | (2,073,182 | ) | ||||||||
| Net tangible assets per security |
| 31 December | 31 December | |||||||
| 2023 Cents | 2022 Cents | |||||||
| Net tangible asset backing (per share) | 7.62 | 9.25 |
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 financial
in controlled entities
have been no changes in controlled entities during the half-year ended 31 December 2023.
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: |
| Ownership interest held by the group | ||||||||||
| Place of business/ | 31 December 2023 | 31 December 2022 | ||||||||
| Name of entity | country of incorporation | % | % | |||||||
| Ateria Health Limited | United Kingdom | 17.5 | 17.1 |
financial statements have been reviewed by the group's independent auditor without any modified opinion, disclaimer or emphasis of matters.
the half-year 31 December 2023
report - 31 December 2023
| Contents | Page | |
| Review of operations and activities | 2 | |
| Directors' report | 4 | |
| Auditor's Independence Declaration | 6 | |
| Interim financial report | 7 | |
| Consolidated statement of profit or loss and other comprehensive income | 8 | |
| Consolidated statement of financial position | 9 | |
| Consolidated statement of changes in equity | 10 | |
| Consolidated statement of cash flows | 11 | |
| Notes to the consolidated financial statements | 12 | |
| Directors' declaration | 24 | |
| Independent Auditor's Review Report | 25 |
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 2023 and any public announcements made by Immuron
Limited during the interim reporting period in accordance with the continuous disclosure requirements of the Corporations Act 2001.
of operations and activities
Limited has reported a loss for the half-year ended 31 December 2023 of A$2,073,182 (31 December 2022: A$1,978,383). The group's net
assets decreased to A$17,526,515 compared with A$19,616,836 at 30 June 2023, including cash reserves of A$15,213,462 (30 June 2023: A$17,159,764).
Revenue from ordinary activities for the half-year ended 31 December 2023 was A$2,355,580 (31 December 2022: A$583,646) generating, for
Hyperimmune products, Gross profit of A$1,580,348 (31 December 2022: A$427,920) and Operating profit of A$854,715 (31 December 2022:
sales of A$2.4 million for H1, FY24 up A$1.8 million on H1, FY23
Sales of Travelan increased to AUD $1,853,048 in H1, FY24, compared to AUD $260,205 in H1, FY23. Sales increased by $1,054,164
(132%) on the pre-pandemic peak period (H1, FY20). This increase partially reflects 3 months (May, June, July) of backorders accrued
while awaiting GMP Clearance from the TGA. TGA GMP clearance was obtained in August 2023.
Bureau of Statistics: short term resident returns in October 2023 were 47% higher than October 2022 and approaching pre-pandemic levels
(93% of October 2019)1.
Sales of Travelan increased to AUD $481,920 in H1, FY24, compared to AUD $295,410 in H1, FY23. Sales were lower by $31,633
(-6%) on the pre-pandemic peak period (H1, FY20).
Trade Administration Total U.S. citizen international visitor departures from the United States in September 2023 were 17% higher than
in September 2022.2 Immuron's target departure markets 3, July - September 2023 departures were 1% higher
than the pre-pandemic period July - September 2019.2
| 1. | https://www.abs.gov.au/statistics/industry/tourism-and-transport/overseas-arrivals-and-departuresaustralia/latest- release |
| 2. | https://www.trade.gov/sites/default/files/2023-12/US-Outbound-to-World-Regions.xlsx |
| 3. | Caribbean, Asia, South America, Central America, Africa, Mexico |
completes in-patient phase of IMM-124E Phase 2 clinical trial
inpatient challenge phase of the Travelan clinical study led by Principal Investigator Dr Mohamed Al- Ibrahim at the Pharmaron CPC
FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US, has been completed. The double-blind study
was separated into two cohorts of approx. 30 subjects (60 in total) dosed with Travelan or placebo for two days prior to challenge continuing
for a total of 7 days. All study participants were challenged with Escherichia coli, monitored for symptoms, and treated with antibiotics.
Safety data at two weeks and 4 weeks post challenge has been collected and the final 6 month follow up interviews will be initiated in
January 2024 and are expected to be completed in April 2024. Headline results from the clinical trial are anticipated to be reported
in June 2024. The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of Travelan compared to a placebo
in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea.
ClinicalTrials.gov Identifier: NCT05933525.
completes in-patient phase of CampETEC Phase 2 clinical trial
NMRC has recently completed the in-patient stage of the campylobacter challenge clinical study. The clinical study is being led by
Principal Investigator Dr Kawsar Talaat, MD at the Johns Hopkins University (JHU) Center for Immunization Research (CIR) Inpatient
Unit, located at the JHU Bayview Medical Campus, Baltimore, Maryland. U.S. A total of 30 participants were enrolled in the study, of
which 27 participants were dosed with either the Investigational Medical Product or placebo and all subjects were challenged with
Campylobacter. All study volunteers have now been treated with antibiotics and discharged from the clinic. The study participants
will return as outpatients for several follow-up visits, with the last patient last visit scheduled to be completed in June 2024.
Headline results from the clinical trial are anticipated to be reported in H2 2024. The Phase 2 clinical trial is designed to
evaluate the safety and protective efficacy of the new product manufactured by Immuron compared to a placebo in a controlled human
infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea.
ClinicalTrials.gov Identifier: NCT06122870.
Services University Travelan clinical field trial reaches 50% recruitment
Infectious Diseases Clinical Research Program (IDCRP), the UK Ministry of Defence and the New York City Travel Clinic are jointly conducting
the randomized clinical trial to evaluate the efficacy of Travelan in Travelers' Diarrhea. The P2TD study is a randomized,
double-blind, placebo controlled multicenter clinical trial designed to evaluate the effectiveness of IMM-124E (Travelan ) passive
immunoprophylaxis verses a placebo, during deployment or travel to a high-TD risk region (ClinicalTrials.gov Identifier: NCT04605783).
All study participants (868 in total) will be randomized to Travelan or placebo (434 per arm).
Problem: Travelers' diarrhea (TD) remains a highly prevalent disease that impacts operational readiness of military personnel
and is also debilitating civilian travel. In addition to its acute morbidity, TD is associated with acquisition of antimicrobial resistance
genes and long-term sequelae. Current mitigation strategies including pre-travel counseling and antibiotics for prevention and treatment
have important limitations, and there are currently no licensed, pathogen-specific vaccines for TD prevention.
Approach: Passive immunotherapy may offer safe and relatively inexpensive preventive strategies by promoting gut resistance to enteropathogens,
and potentially lessening the use of antibiotics. USU's Infectious Diseases Clinical Research Program (IDCRP), the UK Ministry
of Defence and the New York City Travel Clinic are jointly conducting a randomized clinical trial to evaluate the efficacy of these nutraceutical
products for TD prevention and inform strategies for Force Health Protection.
of IMM-529 drug substance manufacture by CSIRO
's manufacturing campaign for a new therapeutic product which targets the Clostridioides Difficile (C. Diff) bacteria, IMM-529
drug substance was completed in December 2023 by CSIRO Agriculture and Food. IMM-529 is the second therapeutic drug candidate the company
is planning to take into the clinic and has been specifically developed to target (i) toxin B, (ii) spores and (iii) vegetative cells
of Clostridioides Difficile (C. Diff) which are thought to be the primary cause of C. Diff disease recurrences. A research services agreement
has recently been executed with Monash University to assist with vaccine manufacture and stability testing of the Investigational Medical
Product to support the pre-IND information package. A research services agreement has also been executed with VivoPharm Global Preclinical
Services to conduct a GLP compliant toxicity study in rodents. The study protocol has been submitted and approved by the Animal Ethics
Committee and the study is planned to commence in Q1 2024. The company is working towards submitting a Pre-IND information package to
the U.S. Food and Drug Administration (FDA) in H1 2024.
to present at The Military Health System Research Symposium (MHSRS)
MHSRS is the U.S. Department of Defense's premier scientific meeting that focuses specifically on the unique medical needs of the
Warfighter. This annual symposium brings together 3,000 healthcare professionals, researchers, U.S DoD leaders and decision markers as
well as various funding bodies. The company attended the meeting as an Exhibitor and presented two posters at the event. One entitled
Clinical Evaluation of an Oral prophylactic for prevention of Travelers diarrhea in active-duty military assigned abroad.'
The company was also invited by the Medical Technology Enterprise Consortium (MTEC) to showcase Immuron and its collaborative work with
the U.S. Department of Defense including an overview of the current MTEC award entitled Biologics license application of a bovine
immunoglobulin supplement that prevents travelers' diarrhea caused by enterotoxigenic Escherichia coli (ETEC).' The Naval
Medical Research Command (NMRC) also presented a poster at the symposium on the new oral therapeutic targeting Campylobacter and Enterotoxigenic
Escherichia coli (ETEC) developed in collaboration with Immuron. The NMRC poster is entitled Research and Development of Hyperimmune
Bovine Colostrum Products for the Prevention of Travelers' Diarrhea.' Copies of the presentations are available on the Company's
Your 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 2023.
The following persons were directors of Immuron Limited
during the whole of the half-year and up to the date of this report:
Paul Brennan, Independent Non-Executive Chairman
Roger Aston, Independent Non-Executive Director