Announcement PDF ABN 80 063 114 045 ANNUAL REPORT 20 23 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. Content Chairman's letter Review of operations and activities Form 20-F Consolidated Financial Statements Auditor's Independence Declaration Independent Auditor's Report Shareholder Information Corporate Directory    3 75 76 81 83 Annual Report 2023 2 Chairman’s letter Dear shareholders, On behalf of the Immuron Board, I am pleased to present the 2022-2023 annual report. During FY23, your company continued to pursue opportunities to develop and commercialise our proprietary oral immunotherapeutic products. The company is pleased to report an uplift of sales in Australia and the USA as international travel continues to increase and significant progression of Immuron’s clinical programs. North America, Travelan® sales were up by 14%, reaching AU $644,020 in FY23, compared to AU $564,400 in FY22. North America, Travelan® sales were up by 147%, reaching AU $1,744,745 in FY23, compared to AU $707,778 in FY22. Global sales of Travelan® and Protectyn® increased by 136% in the 2023 fiscal year to AU $1,804,705, compared to AU $765,193 in FY22. This growth was attributable to increasing sales in both Australian pharmacy and US Passport Health Travel Clinics. Sales numbers in Australia were 90% of the pre-pandemic peak in FY20 while cumulative Australian resident short-term departures during the 12 months to June 2023 were 74% of those during the prepandemic 12 months to June 2019. Immuron’s FY22 decision to focus on the clinical development of our most advanced stage therapeutic drug candidates has yielded positive outcomes with the US Food and Drug Administration (FDA) approval of Investigational New Drug (IND) applications for both Travelan® and our new Campylobacter ETEC therapeutic developed in collaboration with the US Naval Medical Research Command. The strength and character of our international relationships, particularly with the United States Department of Defense (DoD) and its agencies the Naval Medical Research Centre (NMRC) and the Uniformed Services University of the Health Sciences (USU), continue to shine. Following Institutional Review Board (IRB) human ethics approval, Immuron received approval from the US Army Medical Research and Development Command (USAMRDC) Office of Human and Animal Research Oversight (OHRO) to proceed with the clinical trial to evaluate the efficacy of Travelan® to prevent infectious diarrhoea caused by enterotoxigenic Escherichia coli (ETEC). Immuron appointed clinical research organisation (CRO), Pharmaron to commence screening of candidates for a Phase 2 clinical trial which is designed to evaluate the safety and efficacy of Travelan® compared to placebo in a controlled human infection model (CHIM) in up to 60 healthy participants. FDA Clinical Hold on the Campylobacter ETEC IND was lifted in May 2023 and the NMRC will launch two controlled human infection model trials in the US. One trial will focus on the ability of the hyperimmune product to prevent infectious diarrhea caused by ETEC and the second trial will focus on protecting volunteers against moderate to severe campylobacteriosis. USU also reported details of its clinical trial program to evaluate Travelan® in a major field study to assess the products ability to maintain normal gut function during deployment or travel to high-risk destinations for Travelers’ Diarrhea. Annual Report 2023 3 The grant of European Patent entitled “Methods and Compositions for the treatment and/or prophylaxis of Clostridium difficile associated disease” extended our commercial and legal safety net in the region. In June 2023, the Immuron Board approved proceeding with IMM-529 cGMP manufacturing and to proceed with FDA pre-IND submission. IMM-529 was developed for the treatment of Clostridioides difficile infection (CDI). CDI can cause lifethreatening diarrhoea and is one of the leading healthcare-related gastrointestinal infections in the world. In addition to the further commercial development of our lead candidates, Immuron remains committed to pursuing in parallel organic and M&A growth strategies focusing on increasing penetration of existing products in existing markets while seeking to increase product offering, market geographies and sales channels to drive revenue growth and ultimately shareholder value. In November 2022, Immuron completed a strategic investment in Ateria Health Limited to advance the company’s objective to enter the broader IBS market with leading products and to strengthen distribution of Immuron’s Travelan® product through B2C online platforms and pharmacy and retail channels (B2B) in target markets. Our results show a loss for the year of A$3,786,507, increasing 33% on 2021-22 as a result of a 136% increase in sales, a 105% in cost of goods sold, a 171% increase in other income, a 68% increase in total expenses and an increase of A$640,770 in other gains/(losses). I thank my fellow Directors for their dedication and focus which has helped achieve these positive outcomes. Sincerely, Paul Brennan Independent Non-Executive Chairman September 28, 2023 Annual Report 2023 4 Review of operations and activities Key highlights • • • • • • • Sales up 136% Immuron Board approves IMM-529 manufacturing and to proceed with FDA pre-IND submission European patent awarded to Immuron on drug composition to treat Clostridioides difficile associated disease Recruitment and Screening Update for Travelan® for use by US military forces FDA Removed Clinical Hold on Campylobacter ETEC Therapeutic Update on US Uniformed Services University Travelan field study clinical trial Immuron Strategic Investment in Leading Gut Health Biotech Ateria Health Sales up 136% The company is pleased to report an uplift of sales in Australia and the USA as international travel continued to increase. Australia, Travelan® sales were up by 147%, reaching AU $1,744,745 in FY23, compared to AU $707,778 in FY22. North America, Travelan® sales were up by 14%, reaching AU $644,020 in FY23, compared to AU $564,400 in FY22. Global sales of Travelan® and Protectyn® increased by 136% in the 2023 fiscal year to AU $1,804,705, compared to AU $765,193 in FY22. This growth was attributable to increasing sales in both Australian pharmacy and US Passport Health Travel Clinics. Sales numbers in Australia were 90% of the pre-pandemic peak in FY20 while cumulative Australian resident short-term departures during the 12 months to June 2023 were 8274% in April 2023 compared to April 2019of those during the pre-pandemic 12 months to June 2019. Immuron Board approves IMM-529 manufacturing and to proceed with FDA pre-IND submission Immuron reported on June 21, 2023, that it has approved proceeding with IMM-529 cGMP manufacturing and to proceed with FDA pre-IND submission. IMM-529 was developed for treatment of Clostridioides difficile (C. difficile) which is an anaerobic, spore-forming, gram-positive bacillus typically associated with gastrointestinal disease. Transmission of C. difficile occurs by ingestion of spores either through person-to-person contact, animal-to-person contact or environment-to-person contact. C. difficile infection (CDI) can cause life-threatening diarrhoea and is the leading healthcare-related gastrointestinal infection in the world. European patent awarded to Immuron on drug composition to treat Clostridioides difficile associated disease Notification of grant of European patent entitled “Methods and Compositions for the treatment and/or prophylaxis of Clostridium difficile associated disease” was received in January 2023 from the European Patent Office (EPO). Recruitment and Screening Update for Travelan® for use by US military forces In October 2022, Immuron executed a clinical trial agreement with US-based clinical research organisation, Pharmaron. On December 5, 2022, Immuron submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for Travelan®. On December 23, 2022, Immuron received FDA approval for the Travelan® IND. On May 30, 2023, following Institutional Review Board (IRB) human ethics approval, Immuron received approval from the US Army Medical Research and Development Command (USAMRDC) Office of Human and Animal Research Oversight (OHRO) to proceed with the clinical trial to evaluate the efficacy of Travelan® to prevent infectious diarrhoea caused by enterotoxigenic Escherichia coli (ETEC). On June 22, 2023, Immuron reported that Pharmaron had selected 81 potential candidates for in-person screening visits which were anticipated to commence on June 28, 2023, at Pharmaron’s Clinical Research Facility Inpatient Unit located in Baltimore, Maryland, US. The Phase 2 clinical trial is designed to evaluate the safety and efficacy of Travelan® compared to placebo in a controlled human infection model (CHIM) in up to 60 healthy participants. Immuron has funding of AU$6.2 million for a research agreement with the US Department of Defense entitled “Biologics License Application (BLA) of a therapeutic Bovine Immunoglobulin supplement targeting Travelers’ Diarrhea caused by Enterotoxigenic Escherichia Coli (ETEC)”. The company was awarded AU$4.8M (US$3.43M) from the US Department of Defense to test the efficacy of one large daily dose regimen of Travelan® in a controlled human infection model (CHIM) clinical study using the ETEC Annual Report 2023 5 strain H10407. This dose regime is potentially more amenable for use in military populations. The US Naval Medical Research Center (NMRC), Silver Spring, MD, USA was also awarded over AU$1.4M (USD $1M) in a separate grant to provide immunological support for the Immuron clinical program. The company plans to submit an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA). The clinical program will enroll up to 60 health volunteers who will be randomly assigned to receive either a once-daily dose of 1200 mg of Travelan® or placebo. The program is to be based on historic clinical trials with Travelan® and ETEC. These showed the product delivered between 84 per cent and more than 90 per cent protective efficacy against moderate to severe diarrhoea. FDA Removed Clinical Hold on Campylobacter ETEC Therapeutic Our collaboration with the US Department of Defense’s Naval Medical Research Center (NMRC) has led to an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) which was approved in May 2023. The IND application is for a new oral therapeutic targeting Campylobacter and enterotoxigenic Escherichia coli (ETEC). NMRC will launch two controlled human infection model trials in the US. One trial will focus on the ability of the hyperimmune product to prevent infectious diarrhea caused by ETEC and the second trial will focus on protecting volunteers against moderate to severe campylobacteriosis. Infectious diarrhoea is the most common illness reported by travellers visiting developing countries and among US troops deployed overseas. The morbidity and associated discomfort stemming from diarrhoea decreases daily performance, affects judgment, decreases morale and declines operational readiness. The first line of treatment for infectious diarrhoea is the prescription of antibiotics. Unfortunately, in the last decade, several enteric pathogens have had an increasing resistance to commonly prescribed antibiotics. In addition, traveller’s diarrhoea is now recognised by the medical community to result in post-infectious sequelae, including post-infectious irritable bowel syndrome and several post-infectious autoimmune diseases. A preventative treatment that protects against enteric diseases is a high priority objective for the US Military. Update on US Uniformed Services University Travelan field study clinical trial In April 2023, the company provided shareholders and the market with a progress update on the planned clinical field trial to evaluate the efficacy of Travelan® sponsored by the Uniformed Services University (USU) in Travelers’ Diarrhea (TD). USU’s Infectious Diseases Clinical Research Program (IDCRP), the UK Ministry of Defense and the New York City Travel Clinic are jointly planning to conduct the randomized clinical trial to evaluate the efficacy of a commercially available nutraceutical product for TD and inform strategies for Defense Force Health Protection. 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, for prophylaxis 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). The clinical protocol was amended in February 2023 removing the probiotic (Florastor®) from the active study arms. USU estimates a primary completion date of July 20, 2023, and study completion date of December 31, 2023. Immuron Strategic Investment in Leading Gut Health Biotech Ateria Health In October 2022, the company reported that it had signed a subscription and option agreement to acquire 17.5% of the issued share capital of Ateria Health Limited, a UK based company that has developed a ground-breaking product for the treatment of irritable bowel syndrome (IBS). In November 2022, the company reported that it had completed settlement. The strategic investment advances Immuron’s objective to enter the broader IBS market with leading products and strengthen the distribution of Immuron’s Travelan® product through B2C online platforms and pharmacy and retail channels (B2B) in target markets. Steven Lydeamore Chief Executive Officer September 28, 2023 Annual Report 2023 6 Form 20-F Annual 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, 2023 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 +61 (0)3 9824 5254 (phone); +61 (0)3 9822 7735 (fax) (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 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 Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report: Ordinary Shares, as of June 30, 2023 Annual Report 2023 227,798,346 8 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: 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 2023 9 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® 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 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 2023 10 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. 1 1 1 1 1 1 1 24 24 24 41 42 42 42 42 47 50 51 51 52 52 54 65 67 67 68 68 68 69 70 70 70 70 70 70 70 70 70 70 71 71 71 75 75 76 81 81 81 82 82 IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS OFFER STATISTICS AND EXPECTED TIMETABLE KEY INFORMATION A. [RESERVED] B. Capitalization and Indebtedness C. Reasons for the Offer and Use of Proceeds D. Risk Factors INFORMATION ON THE COMPANY A. History and Development of the Company B. Business Overview C. Organizational Structure D. Property, Plant and Equipment UNRESOLVED STAFF COMMENTS OPERATING AND FINANCIAL REVIEW AND PROSPECTS A. Operating Results B. Liquidity and Capital Resources C. Research and Development, Patents and Licenses D. Trend Information E Critical Accounting Estimates DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES A. Directors and Senior Management B. Compensation C. Board Practices D. Employees E. Share Ownership MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS A. Major Shareholders B. Related Party Transactions C. Interests of Experts and Counsel FINANCIAL INFORMATION A. Financial Statements and Other Financial Information B. Significant Changes THE OFFER AND LISTING A. Offer and Listing Details B. Plan of Distribution C. Markets D. Selling Shareholders E. Dilution F. Expenses of the Issue ADDITIONAL INFORMATION A. Share Capital B. Memorandum and Articles of Association C. Material Contracts D. Exchange Controls E. Taxation F. Dividends and Paying Agents G. Statement by Experts H. Documents on Display I. Subsidiary Information J. Annual Report to Security Holders i Annual Report 2023 11 ITEM 11. ITEM 12. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES A. Debt Securities B. Warrants and Rights C. Other Securities D. American Depositary Shares 82 82 82 82 82 83 PART II 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. 84 DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS CONTROLS AND PROCEDURES A. Disclosure Controls and Procedures B. Management’s Report on Internal Control over Financial Reporting C. Attestation Report of the Registered Public Accounting Firm D. Changes in Internal Control over Financial Reporting RESERVED AUDIT COMMITTEE FINANCIAL EXPERT CODE OF ETHICS PRINCIPAL ACCOUNTANT FEES AND SERVICES EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT CORPORATE GOVERNANCE MINE SAFETY DISCLOSURE DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS INSIDER TRADING POLICIES 84 84 84 84 84 85 85 85 85 85 85 86 86 86 86 86 86 86 PART III ITEM 17. ITEM 18. ITEM 19. SIGNATURE 87 FINANCIAL STATEMENTS FINANCIAL STATEMENTS EXHIBITS 87 87 88 89 ii Annual Report 2023 12 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 paten