Announcement PDF ABN 80 063 114 045 ANNUAL REPORT 20 24 Annual Report 2024 Corporate Governance Immuron Limited and its Board of Directors are committed to implementing and achieving an effective corporate governance framework. Our Corporate Governance Statement can be found on our website at www.immuron.com.au. Annual Report 2024 Form 20-F Annual 2024 AnnualReport Report 2023 Immuron Limited 0 7 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report Commission file number 000-38104 IMMURON LIMITED (Exact name of Registrant as specified in its charter and translation of Registrant’s name into English) Australia (Jurisdiction of incorporation or organization) Level 3, 62 Lygon Street, Carlton South, Victoria, 3053, Australia (Address of principal executive offices) Mr. Steven Lydeamore, Chief Executive Officer Level 3, 62 Lygon Street, Carlton South, Victoria, 3053, Australia Telephone: +61 (0)3 9824 5254 Fax: +61 (0)3 9822 7735 (Name, telephone, e-mail and/or facsimile number and address of company contact person) Securities registered or to be registered pursuant to Section 12(b) of the Act: Title of each class American Depositary Shares, each representing 40 Ordinary Shares Annual Report 2024 Trading Symbol IMRN Name of each exchange on which registered The NASDAQ Stock Market LLC Securities registered or to be registered pursuant to Section 12(g) of the Act: None Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None The number of outstanding ordinary shares, as of June 30, 2024, was 227,998,346 ordinary shares. Annual Report 2024 Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒ If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934. Yes ☐ No ☒ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§2232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer ☐ Emerging growth company ☐ Accelerated filer ☐ Non-accelerated filer ☒ If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. ☐ † The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012. Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐ Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing: Annual Report 2024 U.S. GAAP ☐ International Financial Reporting Standards as issued by the International Accounting Standards Board ☒ Other ☐ If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow: Item 17 ☐ Item 18 ☐ If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒ Annual Report 2024 INTRODUCTION We are a commercial and clinical-stage biopharmaceutical company with a proprietary technology platform focused on the development and commercialization of a novel class of specifically targeted polyclonal antibodies that we believe can address significant unmet medical needs. This is a large addressable market which continues to grow as we seek to increase sales of our existing commercial products and to expand our product portfolio and distribution capability. We currently market our flagship commercial products Travelan® and Protectyn® in Australia, where both products are listed medicines on the Australian Register for Therapeutic Goods. Travelan® (AUST L 106709) is an over-the-counter product indicated to reduce the risk of travelers’ diarrhea, reduce the risk of minor gastro-intestinal disorders and is antimicrobial and is sold in pharmacies throughout Australia. Protectyn® (AUST L 231001) is currently sold online and in health practitioner clinics and is marketed as an immune supplement to help maintain a healthy digestive function and liver. We also market Travelan® (NPN 80046016) in Canada where it is licensed as a natural health product indicated to reduce the risk of travelers’ diarrhea, and presently market Travelan® in the U.S. as a dietary supplement for digestive tract protection. Our polyclonal antibodies offer delivery within the gastrointestinal (“GI”) tract and do not cross into the bloodstream, potentially leading to improved safety and tolerability, without sacrificing efficacy. Our technology platform can be used to target viruses or bacteria and neutralize the toxins they produce at mucosal surfaces. We believe that our lead drug candidates currently entering the clinical development phase have the potential to transform the existing treatment paradigms for moderate to severe campylobacteriosis, Enterotoxigenic Escherichia coli (ETEC) infections, travelers’ diarrhea and for Clostridioides difficile (C.difficle) infections. Our American Depositary Shares (each, an “ADS” and, collectively the “ADSs”) are listed on The NASDAQ Capital Market under the symbols “IMRN” Each ADS represents 40 of our ordinary shares, no par value. Our ordinary shares are also listed on the Australian Securities Exchange under the symbol “IMC.” Our consolidated financial statements appearing in this annual report are prepared in Australian dollars and in accordance with the International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. Our consolidated financial statements appearing in this annual report comply with the IFRS. In this annual report, all references to “U.S. dollars” or “US$” are to the currency of the United States, and all references to “Australian dollars”, “A$” or “$” are to the currency of Australia. Unless otherwise indicated or the context implies otherwise, items included in the financial statements of each of the group’s entities are measured using the currency of the primary economic environment in which the entity operates (‘the functional currency’). The consolidated financial statements are presented in Australian dollar (“A$” or “$”), which is Immuron Limited’s functional and presentation currency. Unless otherwise indicated or the context implies otherwise all references to “we,” “us,” or “our” refers to Immuron Limited, an Australian corporation. Statements made in this annual report concerning the contents of any contract, agreement or other document are summaries of such contracts, agreements or documents and are not complete descriptions of all of their terms. If we filed any of these documents as an exhibit to this annual report or to any registration statement or annual report that we previously filed, you may read the document itself for a complete description of its terms. Except for the historical information contained in this annual report, the statements contained in this annual report are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and the Private Securities Litigation Reform Act of 1995, as amended, with respect to our business, financial condition and results of operations. Such forward-looking statements reflect our current view with respect to future events and financial results. We urge you to consider that statements which use the terms “anticipate,” “believe,” “expect,” “plan,” “intend,” “estimate,” or the negative of these terms or other comparable terminology. are intended to identify forward-looking statements. We Annual Report 2024 remind readers that forward-looking statements are merely predictions and therefore inherently subject to uncertainties and other factors and involve known and unknown risks that could cause the actual results, performance, levels of activity, or our achievements, or industry results, to be materially different from any future results, performance, levels of activity, or our achievements expressed or implied by such forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, including the securities laws of the United States, we undertake no obligation to publicly release any update or revision to any forward-looking statements to reflect new information, future events or circumstances, or otherwise after the date hereof. We have attempted to identify significant uncertainties and other factors affecting forward-looking statements in the Risk Factors section that appears in Item 3.D. “Key Information-Risk Factors.” Australian Disclosure Requirements Our ordinary shares are primarily quoted on the Australian Securities Exchange (“ASX”) in addition to our listing of our ADSs on the NASDAQ Global Select Market. As part of our ASX listing, we are required to comply with various disclosure requirements as set out under the Australian Corporations Act 2001 and the ASX Listing Rules. Information furnished under the sub-heading “Australian Disclosure Requirements” is intended to comply with ASX listing and Corporations Act 2001 disclosure requirements and is not intended to fulfill information required by this annual report on Form 20F. Annual Report 2024 TABLE OF CONTENTS Page 1 PART I ITEM 1. ITEM 2. ITEM 3. ITEM 4. ITEM 4A. ITEM 5. ITEM 6. ITEM 7. ITEM 8. ITEM 9. ITEM 10. A. B. C. D. A. B. C. D. A. B. C. D. E A. B. C. D. E. F. A. B. C. A. B. A. B. C. D. E. F. A. B. C. D. E. F. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS OFFER STATISTICS AND EXPECTED TIMETABLE KEY INFORMATION [RESERVED] Capitalization and Indebtedness Reasons for the Offer and Use of Proceeds Risk Factors INFORMATION ON THE COMPANY History and Development of the Company Business Overview Organizational Structure Property, Plant and Equipment UNRESOLVED STAFF COMMENTS OPERATING AND FINANCIAL REVIEW AND PROSPECTS Operating Results Liquidity and Capital Resources Research and Development, Patents and Licenses Trend Information Critical Accounting Estimates DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES Directors and Senior Management Compensation Board Practices Employees Share Ownership Disclosure of a Registrant’s Action to Recover Erroneously Awarded Compensation MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS Major Shareholders Related Party Transactions Interests of Experts and Counsel FINANCIAL INFORMATION Financial Statements and Other Financial Information Significant Changes THE OFFER AND LISTING Offer and Listing Details Plan of Distribution Markets Selling Shareholders Dilution Expenses of the Issue ADDITIONAL INFORMATION Share Capital Memorandum and Articles of Association Material Contracts Exchange Controls Taxation Dividends and Paying Agents Annual Report 2024 1 1 1 1 1 1 1 23 23 24 41 42 42 42 42 48 51 52 52 53 53 55 66 68 68 68 69 69 69 70 71 71 71 71 71 71 71 71 71 71 72 72 72 76 76 77 82 G. H. I. J. Statement by Experts Documents on Display Subsidiary Information Annual Report to Security Holders 82 82 83 83 i Annual Report 2024 ITEM 11. ITEM 12. A. B. C. D. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES Debt Securities Warrants and Rights Other Securities American Depositary Shares PART II 85 ITEM 13. ITEM 14. ITEM 15. ITEM 16. ITEM 16A. ITEM 16B. ITEM 16C. ITEM 16D. ITEM 16E. ITEM 16F. ITEM 16G. ITEM 16H. ITEM 16I. ITEM 16J. ITEM 16K. 83 83 83 83 83 84 A. B. C. D. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS CONTROLS AND PROCEDURES Disclosure Controls and Procedures Management’s Report on Internal Control over Financial Reporting Attestation Report of the Registered Public Accounting Firm Changes in Internal Control over Financial Reporting RESERVED AUDIT COMMITTEE FINANCIAL EXPERT 85 85 CODE OF ETHICS 86 PRINCIPAL ACCOUNTANT FEES AND SERVICES 86 EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES 87 PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT 87 CORPORATE GOVERNANCE 87 MINE SAFETY DISCLOSURE 87 DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS INSIDER TRADING POLICIES 87 CYBERSECURITY 87 85 85 85 86 86 86 86 87 87 PART III 88 ITEM 17. FINANCIAL STATEMENTS ITEM 18. FINANCIAL STATEMENTS ITEM 19. EXHIBITS SIGNATURE 88 88 89 90 ii Annual Report 2024 PART I ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS Not applicable. ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE Not applicable. ITEM 3. KEY INFORMATION A. [RESERVED] B. CAPITALIZATION AND INDEBTEDNESS Not applicable. C. REASONS FOR THE OFFER AND USE OF PROCEEDS Not applicable. D. RISK FACTORS Investing in our ADSs involves a high degree of risk and uncertainty. You should carefully consider the risks and uncertainties described below before investing in our ADSs. Additional risks and uncertainties not presently known to us or that we believe to be immaterial may also adversely affect our business. If any of the following risks actually occurs, our business, prospects, financial condition and results of operations could be harmed. In that case, the price of our ADSs could decline, and you could lose all or part of your investment. Summary of Risk Factors The following summarizes some, but not all, of the risks provided below. Please carefully consider all of the information discussed in this Item 3.D. “Risk Factors” in this annual report for a more thorough description of these and other risks: Summary of Risks Related to Our Financial Condition As a company undertaking research and development activities of our existing patent portfolio we have incurred operating losses; we may continue to incur operating losses for the foreseeable future and may never achieve or maintain profitability. Summary of Risks Related to Our Business Clinical trials are expensive and time consuming, and their outcome is uncertain. We may not be successful in obtaining or maintaining other rights necessary for the development of our pipeline through acquisitions and in- licenses. We grant licenses to our collaborators to use our hyper-immune colostrum technology exclusively for the development of product candidates for certain conditions. Annual Report 2024 We may not be able to complete the development of IMM-124E, CampETEC, IMM-529 or develop other pharmaceutical products. Our research and development efforts will be seriously jeopardized if we are unable to retain key personnel and cultivate key academic and scientific collaborations. Acceptance of our products in the marketplace is uncertain, and failure to achieve market acceptance will negatively impact our business and operations. We face competition from entities that have developed or may develop product candidates for our target disease indications, including companies developing novel treatments and technology platforms based on modalities and technology similar to ours. If these companies develop technologies or product candidates more rapidly than we do or their technologies, including delivery technologies, are more effective, our ability to develop and successfully commercialize product candidates may be compromised. Our product candidates and the process for administering our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following any potential marketing approval. 1 Annual Report 2024 We currently depend upon a sole manufacturer of our lead compound and on a sole manufacturer to produce finished drug products and could incur significant costs and delays if we are unable to promptly find a replacement for either of them. Our future prospects may also be dependent on our or our collaborators’ ability to successfully develop a pipeline of additional product candidates, and we and our collaborators may not be successful in efforts to use our platform technologies to identify or discover additional product candidates. We may not be able to obtain orphan drug exclusivity for some of our product candidates. Summary of Risks Related to Government Regulation If we do not obtain the necessary governmental approvals, we will be unable to commercialize our pharmaceutical products. Our product candidates are based on our hyper-immune colostrum technology. Currently, no prescription product candidates utilizing our technology have been approved for commercial sale and our approach to the development of our technology may not result in safe, effective or marketable products. We are early in our product development efforts and have only two product candidates in early-stage clinical trials. All of our other current product candidates are still in preclinical development. We have no late-stage clinical trials (post-proof of concept) and may not be able to obtain regulatory approvals for the commercialization of some or all of our product candidates. Summary of Risks Related to Our Intellectual Property Our success depends upon our ability to protect our intellectual property and our proprietary technology, to operate without infringing the proprietary rights of third parties and to obtain marketing exclusivity for our products and technologies. We may face difficulties in certain jurisdictions in protecting our intellectual property rights, which may diminish the value of our intellectual property rights in those jurisdictions. Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and protect other proprietary information. Summary of Risks Related to Our Securities The dual listing of our ordinary shares and the ADSs may adversely affect the liquidity and value of the ADS. As a foreign private issuer, we are permitted, and we expect to follow certain home country corporate governance practices in lieu of certain NASDAQ requirements applicable to domestic issuers. This may afford less protection to holders of our ADSs. As a foreign private issuer, we are permitted to file less information with the SEC than a company incorporated in the U.S. Accordingly, there may be less publicly available information concerning us than there is for companies incorporated in the U.S. If we fail to comply with the rules under the Sarbanes-Oxley Act of 2002 related to accounting controls and procedures in the future, or, if we discover additional material weaknesses and other deficiencies in our internal control and accounting procedures, the price of our ordinary shares and ADSs could decline significantly and raising capital could be more difficult. Annual Report 2024 ADS holders may be subject to additional risks related to holding ADS rather than ordinary shares. Our Constitution and Australian laws and regulations applicable to us may adversely affect our ability to take actions that could be beneficial to our shareholders. You will have limited ability to bring an action against us or against our directors and officers, or to enforce a judgment against us or them, because we are incorporated in Australia and certain of our directors and officers reside outside the U.S. Australian companies may not be able to initiate shareholder derivative actions, thereby depriving shareholders of the ability to protect their interests. Anti-takeover provisions in our Constitution and our right to issue preference shares could make a third-party acquisition of us difficult. 2 Annual Report 2024 Risks Related to Our Financial Condition As a company undertaking research and development activities of our existing patent portfolio we have incurred operating losses; we may continue to incur operating losses for the foreseeable future and may never achieve or maintain profitability. We have incurred losses in every period since we began operations in 1994 and we have reported net losses of A$6,936,957, A$3,786,507 and A$2,854,254 during the fiscal years ended June 30, 2024, 2023, and 2022, respectively. As of June 30, 2024, our accumulated deficit was A$78,968,396. We may continue to incur additional operating losses for the next several years as we expand our research and development activities for the treatment of infectious diseases, commence new trials for our product candidates IMM-124E for Traveler’s Diarrhea and IMM529 for C. difficile, and potential other assets/indications. We may never be able to achieve or maintain profitability. Our actual cash requirements may vary materially from those now planned and will depend upon numerous factors, including: ● the continued increase in sales of our marketed products, Travelan® and Protectyn®; ● the continued progress of our research and development programs; ● the timing, scope, results and costs of pre-clinical studies and clinical trials; ● the cost, timing and outcome of regulatory submissions and approvals; ● determinations as to the commercial potential of our product candidates; ● spending on our marketed assets; ● our ability to successfully expand our contract manufacturing services; ● our ability to establish and maintain collaborative arrangements; and ● the status and timing of competitive developments. As of June 30, 2024, we had A$11,657,315 in cash and cash equivalents. Developing prescription products is expensive and we may need to secure additional financing in order to continue to meet our longer-term business objectives, including advancement of our research and development programs. We may also require additional funds to pursue regulatory clearances, defend our intellectual property rights, establish commercial scale manufacturing facilities, develop marketing and sales capabilities and fund operating expenses. We may seek such additional funding through public or private financings and/or through licensing of our assets or strategic alliances or other arrangements with corporate partners. The global economic climate could adversely impact our ability to obtain such funding, license our assets or enter into alliances or other arrangements with corporate partners. Any shortfall in funding could result in our having to curtail or cease our operations, including our research and development activities, which would be expected to adversely affect our business, financial condition and results of operations. We have never generated any revenue from prescription product sales and this area of our business may never be profitable. Our ability to generate significant revenue from prescription products and achieve profitability depends on our ability to, alone or with strategic collaboration partners, successfully complete the development of and obtain the regulatory approvals for our prescription product candidates, to manufacture sufficient supply of our product candidates, to establish a sales and marketing organization or suitable third-party alternative for the marketing of any approved products and to successfully commercialize any approved products on commercially reasonable terms. All Annual Report 2024 of these activities will require us to raise sufficient funds to finance business activities. Currently, we do not expect any milestone payments from our collaborative partners to be significant in the foreseeable future. However, we are actively pursuing potential partner collaboration. In addition, we do not anticipate generating revenue from commercializing new product candidates for the foreseeable future, if ever. Our ability to generate future revenues from commercializing our intellectual property (“IP”) assets depends heavily on our success in: ● increasing sales of commercial products through investment in sales and marketing initiatives, expansion in sales channels and geographies, product development and broader applications; ● establishing proof of concept in preclinical studies and clinical trials for our product candidates; ● successfully completing clinical trials of our product candidates; 3 Annual Report 2024 ● obtaining regulatory and marketing approvals for product candidates for which we complete clinical trials; ● maintaining, protecting and expanding our intellectual property portfolio, and avoiding infringing on intellectual property of third parties; ● establishing and maintaining successful licenses, collaborations and alliances with third parties; ● developing a sustainable, scalable, reproducible and transferable manufacturing process for our product candidates; ● establishing and maintaining supply and manufacturing relationships with third parties that can provide products and services adequate, in amount and quality, to support clinical development and commercialization of our product candidates, if approved; ● launching and commercializing any product candidates for which we obtain regulatory and marketing approval, either by collaborating with a partner or, if launched independently, by establishing a sales, marketing and distribution infrastructure; ● obtaining market acceptance of any product candidates that receive regulatory approval as viable treatment options; ● obtaining favorable coverage and reimbursement rates for our products from third-party payors; ● addressing any competing technological and market developments; ● identifying and validating new product candidates; and ● negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter. The process of developing product candidates for the prevention and treatment of gut mediated pathogens contains several inherent risks and uncertainties, including clinical and regulatory risks. Even if one or more of our product candidates is approved for commercial sale, we may incur significant costs associated with commercializing any approved product candidate. As one example, our expenses could increase beyond expectations if we are required by the Food and Drug Administration, or FDA, or other regulatory agencies, domestic or foreign, to perform clinical and other studies in addition to those that we currently anticipate. Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations, which could have an adverse effect on our business, financial condition, results of operations and prospects. We are a commercial and development stage company and our success is uncertain. We are a commercial and clinical-stage biopharmaceutical company and our pharmaceutical products are designed to treat a range of infectious diseases. Other than our Travelan and Protectyn products, we have not sufficiently advanced the development of any of our products, including our current lead product candidate, IMM124E, to market or generate revenues from their commercial application. Our current or any future product candidates, if successfully developed, may not generate sufficient or sustainable revenues to enable us to be profitable. We receive Australian government research and development tax incentive refunds. If our research and development expenditures are not deemed