Regencell Bioscience Holdings Ltd

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HK HK NASDAQ U.S. GAAP false FY 0001829667 0000 000

Ordinary shares, par value $0.00001 RGC The Nasdaq Stock Market LLC

Securities registered or to be registered pursuant to Section 12(g) of the Act: None (Title of Class) Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None (Title of Class)

Large accelerated filer ☒ Accelerated filer ☐

† 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. Yes ☒ No ☐ 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 ☒ (APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE YEARS) Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☐ No ☐

TABLE OF CONTENTS INTRODUCTION ii PART I ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS 1 ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE 1 ITEM 3. KEY INFORMATION 1 ITEM 4. INFORMATION ON THE COMPANY 30 ITEM 4A. UNRESOLVED STAFF COMMENTS 54 ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS 54 ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES 63 ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS 73 ITEM 8. FINANCIAL INFORMATION 76 ITEM 9. THE OFFER AND LISTING 77 ITEM 10. ADDITIONAL INFORMATION 77 ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 101 ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES 102 PART II ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES 103 ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS 103 ITEM 15. CONTROLS AND PROCEDURES 103 ITEM 16. [RESERVED] 105 ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT 105 ITEM 16B. CODE OF ETHICS 105 ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES 105 ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES 106 ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS 106 ITEM 16F. CHANGE IN REGISTRANT'S CERTIFYING ACCOUNTANT 106 ITEM 16G. CORPORATE GOVERNANCE 106 ITEM 16H. MINE SAFETY DISCLOSURE 106 ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 106 ITEM 16J. INSIDER TRADING POLICIES 106 ITEM 16K. CYBERSECURITY 107 PART III ITEM 17. FINANCIAL STATEMENTS 108 ITEM 18. FINANCIAL STATEMENTS 108 ITEM 19. EXHIBITS 108 SIGNATURES 110 i

INTRODUCTION Unless otherwise indicated, numerical figures included in this Annual Report on Form 20-F (the "Annual Report") have been subject to rounding adjustments. Accordingly, numerical figures shown as totals in various tables may not be arithmetic aggregations of the figures that precede them. For the sake of clarity, this Annual Report follows the English naming convention of first name followed by last name, regardless of whether an individual's name is Chinese or English. Certain market data and other statistical information contained in this Annual Report are based on information from independent industry organizations, publications, surveys and forecasts. Some market data and statistical information contained in this Annual Report are also based on management's estimates and calculations, which are derived from our review and interpretation of the independent sources listed above. While we believe such information is reliable, we have not independently verified any third-party information and our internal data has not been verified by any independent source. Unless otherwise indicated or the context requires otherwise, references in this Annual Report to: ● "China"or the"PRC" are to the People's Republic of China, excluding Taiwan and the special administrative regions of Hong Kong and Macau for the purposes of this Annual Report only; ● "Hong Kong" is to the Hong Kong Special Administrative Region of the People's Republic of China for the purposes of this Annual Report only; ● "HK$"or"Hong Kong dollar"refers to the legal currency of Hong Kong; ●"Regencell Bioscience Holdings Limited"or"Regencell" is to Regencell Bioscience Holdings Limited, a Cayman Islands exempted company incorporated under the laws of the Cayman Islands;

● "Regencell Bioscience Limited" is to Regencell Bioscience Limited, a Hong Kong limited liability company organized under the laws of Hong Kong and a wholly-owned subsidiary of Regencell Bioscience Holdings Limited; ● "Regencell Bioscience North America Limited" is to Regencell Bioscience North America Limited, a company incorporated in the British Virgin Islands and a wholly-owned subsidiary of Regencell Bioscience Holdings Limited; ● "Regencell (BVI) Limited" is to Regencell (BVI) Limited, a British Virgin Islands business company organized under the laws of British Virgin Islands;

● "Regencell Limited" is to Regencell Limited, a Hong Kong limited liability company organized under the laws of Hong Kong and a wholly-owned subsidiary of Regencell Bioscience Holdings Limited;

● "Shares," "shares"or"Ordinary Shares" are to the ordinary shares of Regencell Bioscience Holdings, Limited par value $0.00001 per share; ● "TCM"refers to Traditional Chinese Medicine; ●"The TCM Practitioner"or"our TCM Practitioner" refers to our strategic TCM research partner, Mr. Sik-Kee Au, father of our Chief Executive Officer ("CEO") and director;

● "US$," "$"or"US dollar"refers to the legal currency of the United States; and

●"We", "us", "RGC", the "Company", "our company"or the"Group" are to one or more of Regencell Bioscience Holdings Limited and its affiliated entities.

We listed our Ordinary Shares on the Nasdaq Capital Market under the symbol "RGC" on July 16, 2021. On June 13, 2025, we, as an exempted company with limited liability incorporated under the laws of the Cayman Islands, capitalized an amount standing to the credit of the share premium account of the Company, and appropriated such sum and applied it on behalf of the shareholders towards paying in full (as to the full par value of $0.00001 per Ordinary Share) an aggregate of 481,476,042 Ordinary Shares (representing the receipt by each shareholder of the Company of 37 additional Ordinary Shares for every Ordinary Share held on the record date). This did not result in any changes in authorized share capital or par value of our Ordinary Shares, nor involve any cash outflow. This is treated as an equity reclassification of a 38-for-1 forward stock split (the "38-for-1 forward stock split") under accounting principles generally accepted in the United States of America ("U.S. GAAP") . The authorized share capital remained as $1,000,000 divided into 100,000,000,000 Ordinary Shares of $0.00001 par value each. All the share numbers, option numbers and option exercise prices appearing in this Annual Report have been adjusted to give retroactive effect to the 38-for-1 forward stock split, unless otherwise indicated or unless the context suggests otherwise. iii

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 You should carefully consider the following risk factors, together with all of the other information included in this Annual Report. Investment in our securities involves a high degree of risk. You should carefully consider the risks described below together with all of the other information included in this Annual Report before making an investment decision. The risks and uncertainties described below represent our known material risks to our business. If any of the following risks actually occurs, our business, financial condition or results of operations could suffer. In that case, you may lose all or part of your investment. Risks Related to Our Financial Position and Need for Capital We are an early - stage TCM bioscience company with a limited operating history. We expect to incur additional losses in the future. We are an early-stage TCM bioscience company with a limited operating history that focuses on the research, development and commercialization of TCM for the treatment of neurocognitive disorders and degenerations, specifically Attention Deficit Hyperactivity Disorder ("ADHD") and Autism Spectrum Disorder ("ASD") with no currently approved products. To date, we have focused almost exclusively on developing our product candidates. We have funded our operations to date primarily through proceeds from our initial public offering of our Ordinary Shares. We have no saleable products and have not generated any revenue from product sales. We have incurred operating losses since our formation. We incurred total net losses of $11.70 million and $3.58 million, respectively, for the fiscal years ended June 30, 2026 and 2025. Substantially all of our operating losses resulted from costs incurred in connection with our development programs and from general and administrative costs. We expect to continue to incur research and development expenses in the future as we continue the advancement of our efficacy trials and as we potentially pursue additional indications. We may also incur expenses in connection with third-party trials involving our TCM formula or other intellectual property. In addition, if we obtain marketing approval for any of our TCM formula, we may initially incur significant outsourced sales, marketing and manufacturing expenses, as well as continued research and development expenses. As a result, we expect to continue to incur increasing operating losses for the foreseeable future. The likelihood of success of our business plan and growth strategy must be considered in light of the problems, substantial expenses, difficulties, complications and delays frequently encountered in connection with developing and expanding early-stage businesses and the regulatory and competitive environment in which we operate.

Accordingly, you should consider our annual report in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in the early stages of development, especially early-stage bioscience research companies such as ours. Potential investors should carefully consider the risks and uncertainties that a company with a limited operating history, like us, will face. In particular, potential investors should consider that we cannot assure you that we will be able to, among other things: ● successfully implement or execute our current business plan, and we cannot assure you that our business plan is sound;

● successfully manufacture and commercialize our standardized liquid-based TCM formula treatment for ADHD and ASD patients;

● successfully complete the research studies to obtain regulatory approval for the marketing of our TCM formula;

● obtain, secure, maintain and, as necessary, defend our intellectual property rights;

● attract and retain an experienced management and research team;

● launch commercial sales of our standardized liquid-based TCM formula, whether alone or in collaboration with others;

● raise sufficient funds in the capital markets or otherwise to effectuate our business plan; and ● utilize the funds that we do have and/or raise in the future to efficiently execute our business strategy.

If we cannot successfully execute any one of the foregoing, our business may fail and your investment will be adversely affected. We have not generated revenue from any TCM formula or applied for any regulatory approvals, nor have distribution capabilities or experience or any granted patents or pending patent applications and may never be profitable. Our ability to become profitable depends upon our ability to generate revenue. As of the date of this Annual Report, we have not applied for any regulatory approvals, we have no granted or pending patent applications and we have no distribution capabilities or experience, and we have not generated any revenue from our development stage TCM formula and we do not know when, or if, we will generate any such revenue. We do not expect to generate significant revenue unless and until we obtain regulatory approval of our standardized TCM formula, produce and commercialize products based on such TCM formula. Our ability to generate future revenue from sales of products based on our TCM formula depends heavily on our success in many areas, including but not limited to: ● obtaining favorable results from and progressing the research studies of our TCM formula;

● developing and obtaining regulatory approval for registration for our TCM formula;

● accurately identifying demand for our product candidates; ● continued consumer interest in treatments to the symptoms of ADHD and ASD; ● obtaining market acceptance of our liquid-based TCM formula treatment, if approved for marketing, as viable treatment options for ADHD and ASD;

● negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter; and ● recruiting and retaining qualified personnel.

We have limited sources of working capital and may need substantial additional financing. If we are unable to obtain the required additional capital, we may have to curtail our growth plans or cut back on existing business, which may affect our results of operations and financial condition or cause the cease of our operations. The working capital required to implement our business plan will most likely be provided by funds obtained through offerings of our equity, debt, debt-linked securities, and/or equity-linked securities, and, in the future, revenues generated by us after our TCM formula is approved for marketing and production. Any additional capital raised through the sale of equity or equity-linked securities may dilute our current shareholders' ownership in us and could also result in a decrease in the market price of our Ordinary Shares. The terms of the securities issued by us in future capital transactions may be more favorable to new investors and may include the issuance of warrants or other derivative securities, which may have a further dilutive effect. We may incur substantial offering expenses in pursuing future external financing. We may also be required to recognize non-cash expenses in connection with certain securities we issue, such as convertible notes and warrants, which may adversely impact our financial condition and results of operations. In addition, any debt or equity financing that we may need may not be available on terms favorable to us, or at all. If we obtain funding through a strategic collaboration or licensing arrangement, we may be required to relinquish our rights to certain of our technologies, products or marketing territories. No assurance can be given that we will have sufficient revenue to sustain our operations or that we would be able to obtain external financings. Our ability to complete additional financing is dependent on, among other things, the state of the capital markets at the time of any proposed offering, market reception of our company and the likelihood of the success of our business model and offering terms. There is no assurance that we will be able to obtain any such additional capital through asset sales, equity or debt financing, or any combination thereof, on satisfactory terms or at all. Additionally, no assurance can be given that any such financing, if obtained, will be adequate to meet our capital needs and to support our operations. If we do not obtain adequate capital on a timely basis and on satisfactory terms, we may need to delay the completion of or significantly reduce the scope of our current business plan; delay some of our research and development; or postpone the hiring of new personnel, which may affect our results of operations and financial condition. The value of our Ordinary Shares and any Ordinary Share equivalents would be materially negatively impacted, and under certain financial circumstances, we may need to curtail or cease our operations. Risks Related to Our Product Development, Regulatory Approval, Manufacturing and Commercialization Our standardized TCM formula for ADHD and ASD patients is still in development. If we are unable to obtain regulatory approval or ultimately commercialize our standardized TCM formula and/or products based on our TCM formula, or if we experience significant delays in doing so, our business, financial condition, results of operations and prospects will be materially and adversely affected. Currently, our standardized TCM formula for ADHD and ASD patients are under research and development. None of the formula is currently in the process of regulatory approval and commercialization. Our ability to generate revenues from our standardized TCM formula is dependent on the completion of our research and development, receipt of regulatory approval and successfully commercializing products based on such formula, which may never occur. Our TCM formula will require additional research and development, regulatory approval in Hong Kong and other jurisdictions where we plan to sell, development of manufacturing supply and capacity, substantial investment, and significant marketing efforts before we generate any revenue from product sales. The success of our standardized TCM formula will depend on several factors, including the following: ● successful enrollment in, and completion of, research studies;

● receipt of regulatory approvals from applicable regulatory authorities for planned research studies, future research studies, or drug registrations, manufacturing and commercialization;

● successful completion of all safety studies required to obtain regulatory approval in Hong Kong and other jurisdictions in which our standardized TCM formula intend to sell;

● developing commercial manufacturing capabilities to the specifications for our candidates for clinical supply and commercial manufacturing;

● making and maintaining arrangements with third-party TCM raw material suppliers or manufacturers;

● obtaining and maintaining patent, trade secret and other intellectual property protection and/or regulatory exclusivity for our standardized TCM formula;

● launching commercial sales of our standardized liquid-based TCM formula treatment, if and when approved, whether alone or in collaboration with others;