Full Press Release Details
report - 30 June 2021
| Corporate directory | 1 |
| Chairman's letter | 4 |
| Review of operations and activities | 7 |
| Directors' report | 12 |
| Directors and company secretary | 12 |
| Principal activities | 12 |
| Dividends - Immuron Limited | 12 |
| Review of operations | 12 |
| Significant changes in the state of affairs | 12 |
| Events occurring after the reporting period | 13 |
| COVID-19 | 13 |
| Likely developments and expected results of operations | 13 |
| Environmental regulation | 13 |
| Information on directors | 14 |
| Company secretary | 17 |
| Meetings of directors | 18 |
| Remuneration report (audited) | 19 |
| Shares under option | 27 |
| Insurance of officers and indemnities | 28 |
| Proceedings on behalf of the company | 28 |
| Non-audit services | 28 |
| Auditor's independence declaration | 28 |
| Rounding of amounts | 28 |
| Corporate governance statement | 31 |
| Financial statements | 33 |
| Independent auditor's report to the members | 74 |
| Shareholder information | 78 |
| Directors | Dr Roger Aston |
| Independent Non-Executive Chairman | |
| Mr Peter Anastasiou (resigned 24 September 2021) | |
| Executive Vice Chairman | |
| Mr Daniel Pollock | |
| Independent Non-Executive Director | |
| Mr Stephen Anastasiou | |
| Independent Non-Executive Director | |
| Prof. Ravi Savarirayan | |
| Independent Non-Executive Director | |
| Secretary | Mr Phillip Hains |
| Registered office | Level 3, 62 Lygon Street Carlton VIC 3053 Australia |
| Telephone: +61 (0)3 9824 5254 | |
| Facsimile: +61 (0)3 9822 7735 | |
| Principal place of business | Unit 10, 25-37 Chapman Street Blackburn North VIC 3130 Australia |
| Telephone: +61 (0)3 9824 5254 | |
| Facsimile: +61 (0)3 9822 7735 | |
| Share register | Automic Pty Ltd |
| Level 5, 126 Phillip Street | |
| Sydney NSW 2000 Australia | |
| Telephone: +61 (0)2 9698 5414 | |
| Bank of New York 225 Liberty Street New York NY 102286 United States | |
| Telephone: +1 212 495 1784 | |
| Auditor | Grant Thornton Audit Pty Ltd |
| Collins Square | |
| Tower 5, 727 Collins Street | |
| Melbourne VIC 3008 Australia | |
| Telephone: +61 (0)3 8320 2222 |
| Solicitors | Francis Abourizk Lightowlers (FAL) |
| Level 14, 144 William Street | |
| Melbourne VIC 3000 Australia | |
| Telephone: +61 (0)3 9642 2252 | |
| Sichenzia Ross Ference LLP 1185 Avenue of the America's New York NY 10036 | |
| United States | |
| Telephone: +1 212 930 9700 |
| Bankers | National Australia Bank |
| 330 Collins Street | |
| Melbourne VIC 3000 Australia | |
| Stock exchange listings | Immuron Limited shares are listed on the Australian Securities Exchange (ASX: IMC) and the National Association of Securities Dealers Automated Quotations (NASDAQ: IMRN). |
| Our American Depositary Shares (each, an "ADS" and, collectively the "ADSs") and warrants (each, a "Warrant" and collectively, the "Warrants") are listed on NASDAQ under the symbols "IMRN" and "IMRNW", respectively. Each ADS represents 40 of our ordinary shares (IMC), no par value. | |
| Website | www.immuron.com.au |
On behalf of the Immuron Board I am pleased to present the
2020-2021 annual report.
As announced to the Market on the 24th of September 2021,
the company received the resignation of Mr. Peter Anastasiou. Mr. Anastasiou joined the Board in May 2015 after becoming a major shareholder
in 2013 and was appointed Vice Executive Chairman in August 2015. The Board is enormously grateful to Peter for all his hard work, energy,
and expertise over the last few years. He has made a significant contribution in securing Immuron's long term future and leaves the Company
in a substantially significantly stronger position than when he joined the Board.
have already reported to our shareholders, the sales of Travelan remain severely impaired due to COVID-19 restrictions and the
associated reduction in long-haul travel, in particular to Asian destinations. The sales of Travelan are likely to remain suppressed
until the impact of COVID-19 on travel restrictions and lockdowns by government bodies are reduced. The company is pleased to report
albeit a small uplift of sales in the United States as domestic and international travel resumes on the back of over 380 million
total vaccine doses administered in the country to date. Despite the impact of the COVID-19 pandemic, we remain fully engaged in
developing our proprietary antibody technology further for specialized indications. The US Department of Defence (US DoD), Naval
Medical Research Centre (NMRC) projects on Campylobacter and E-Coli, aimed at benefiting US military personnel based in countries
with endemic levels of gastrointestinal disease are progressing well. The company initiated the second vaccination campaign in March
2021 and utilized the bispecific vaccine developed by the NMRC. The second vaccination campaign was successfully completed in May
2021 and the hyper-immune colostrum was harvested in July 2021. Serum and colostrum samples were shipped to the NMRC for
immunological evaluation. The NMRC have confirmed that the new hyper-immune therapeutic preparations contain high levels of
antibodies which specifically target structural regions of Campylobacter jejuni capsule as well as Enterotoxigenic Escherichia coli
(ETEC) colonization factor antigen 1 (CFA/1). These are key antigenic targets predicted to be protective against diarrhea induced by
both pathogens. The NMRC plans to file an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA)
to initiate two planned clinical development programs in placebo-controlled trials in human subjects.
Executive management has also been actively engaged in several
strategic planning meetings with our US DoD associates to advance the development of Travelan with the FDA and the investigational new
drug (IND) application in Travelers Diarrhea. The proposed company sponsored phase III clinical trial protocol has been reviewed and the
key questions identified by the FDA clinical reviewers have been addressed. The meetings also focused on funding opportunities available
to support the Biologics License Application (BLA) and the associated approval process, as well as to provide some additional insights
on the processes the company would need to navigate to advance Travelan with FDA licensure and DoD acquisition. The company also received
a purchase order and in May 2021 supplied Travelan drug substance to support the Uniformed Services University (USU) planned clinical
trial program to evaluate the efficacy of Travelan and two other non-antibiotic OTC products in Travelers' Diarrhea.
The company has continued its clinical development effort
to focus resources on IMM-529 to treat Clostridiodes difficle Infections (CDI) in patients subject to recurrent disease and has established
an expert Medical Advisor Committee to review the clinical development plans and establish a clinical protocol for IMM-529 in recurrent
During this year Immuron has also expanded its COVID-19 research
program to try and identify the SARS-CoV-2 inhibitory molecules in IMM-124E. Work completed to date has identified several Ig-like protein
sequences as major components that appear to be enriched in the colostrum samples which were not present in the milk powder control samples.
Earlier this year, Immuron identified a transformational COVID-19
asset, for which it entered a binding contract to acquire. The company's securities were placed in suspension by the Australian
Securities Exchange (ASX) until the company met the requirements set out by the Exchange. Unfortunately, after filing an ASX In-Principal
Advice Application and subsequent lengthy discussions and exchanges with the ASX, Immuron was unable to satisfy the ASX that the combined
group, following the proposed acquisition, would meet the requirements of the Listing Rules. Ultimately the ASX has an absolute discretion
whether to approve such a major acquisition. Immuron is now unable to satisfy the pre-conditions for this proposed acquisition due to
the expiration of the existing contractual timetable and will not proceed with the proposed acquisition in its present form.
Immuron's financial position remains strong with $25
million in the bank as of 30 June 2021.
On behalf of the Board, I would like to thank our Chief
Executive Officer, Dr Jerry Kanellos, and my fellow Board members. They have worked tirelessly in recent months to protect Immuron's
position in a threatening health and economic climate and maintained the development of our pipeline.
| Dr Roger Aston | |
| Independent Non-Executive Chairman |
Review of operations
| Immuron Director Resignation. | |
| Major M&A target identified. | |
| U.S. Department of Defense Naval Medical Research Center Campylobacter and ETEC project aimed at benefiting travelers and military personnel based in countries with endemic diseases. |
| NMRC plans to file an IND application with the FDA to initiate the clinical development program and the efficacy of the new therapeutic will be evaluated in two human placebo controlled clinical trials. | |
| Immuron's Hyper-immune Bovine Colostrum used to manufacture Travelan and Protectyn demonstrates antiviral activity against the COVID-19 virus. | |
| Travelers' Diarrhea Market Update - Travelan US registration strategy recommencement of CMC program. | |
| Medical Advisor Committee Established for the clinical development of IMM-529 in Clostridial Infections. |
Limited has reported an accounting loss for the financial year ended 30 June 2021 of $8,384,465 (30 June 2020: $2,927,206) of which
$3,458,306 related to non cash expense items comprising of $582,528 net foreign exchange (losses)/gains, $759,765 net impairment
(losses) relating to inventory and $2,116,013 in share-based payment expenses. The group's net assets increased to $25,895,057
compared with $5,643,913 at 30 June 2020, including cash reserves of $25,047,281 (30 June 2020: $3,250,468).
Immuron Director Resignation
The company announced to the market on 24 September 2021 that
Mr. Peter Anastasiou had resigned from the Board of Immuron. Mr Anastasiou joined the Board in May 2015 after becoming a major shareholder
in 2013 and was appointed Vice Executive Chairman in August 2015.
Major M&A Target Identified
2021 the company identified a major potential acquisition target and executed a legally binding Term Sheet to exclusively negotiate
the sale and purchase of all issued shares in the proposed target. The securities of Immuron Limited were placed in trading halt at
the request of the company on the 27 May 2021 and were suspended from quotation on the 31 May 2021 under ASX listing 17.2 to allow
the company to complete the due diligence process and allow the ASX time to consider a submission prepared by the company in
relation to ASX Listing rule 11.1 and 11.2 and Guidance Note 12. Further to our market announcements of 8 June 2021 and 7 July 2021,
while Immuron remained in suspension - it pursued ASX approval for the proposed purchase of a private biotechnology company with a
phase III ready asset in clinical development to be used as a vaccine for COVID-19 and an extensive research & development
project pipeline with multiple clinical assets. The Immuron Board of Directors considered that this acquisition opportunity would
have added significant value to the Company and shareholders potentially delivering a much-needed Australian developed COVID-19
vaccine candidate for commercialization and would also significantly expand the company's current research and development
project portfolio. After filing an ASX In-Principal Advice Application and subsequent lengthy discussions and exchanges with the ASX
Immuron is currently unable to satisfy the ASX that the combined group after the proposed acquisition would meet the requirements of
the Listing Rules. Ultimately the ASX has an absolute discretion whether to approve such a major acquisition. Immuron is now unable
to satisfy the pre-conditions for this proposed acquisition due to the expiration of the existing contractual timetable and will not
proceed with the proposed acquisition in its present form.
Review of operations
Naval Medical Research Center (NMRC) project to
develop and clinically evaluate new therapeutic against Campylobacter and ETEC
The COVID-19 pandemic has disrupted clinical trials globally
and following over a 12-month hiatus the NMRC has reported that most of the inpatient clinical trial sites in the USA are slowly coming
off COVID-19 based restrictions and the Company looks forward to the recommencement of the planned NMRC clinical development programs.
In July 2020, Immuron announced that the NMRC received written guidance from the U.S. Food and Drug administration (FDA) in relation to
the clinical development pathway of a new investigational drug which the company is developing to treat moderate to severe campylobacteriosis
and Enterotoxigenic Escherichia coli (ETEC) infections. The Type B meeting with the FDA discussed the Chemistry, Manufacturing and Controls
including the proposed release testing specifications of the product as well as the planned clinical studies evaluating the safety and
efficacy of the product. The NMRC has addressed the FDA questions posed in the briefing documentation and is in the process of finalizing
the IND application.
The company initiated the second vaccination campaign in March
2021 and utilized the bispecific vaccine developed by the NMRC which is made up of the capsule of C. jejuni chemically conjugated
to the CFA/I pilin of ETEC. The second vaccination campaign was successfully completed in May 2021 and each animal in the second herd
received three doses of the vaccine. The hyper-immune colostrum was harvested in July 2021 and samples were shipped to the NMRC for immunological
evaluation. The NMRC confirmed that the conjugated vaccine produced a robust immunological response and reported that the new Hyper-immune
therapeutic contains high levels of antibodies which specifically target Campylobacter jejuni capsule and Enterotoxigenic Escherichia
coli (ETEC) colonization factor antigen 1 (CFA/1). These are key antigenic targets predicted to be protective against diarrhea induced