Regencell Bioscience Holdings Ltd

Regencell Bioscience Holdings Limited operates as an early-stage Traditional Chinese Medicine bioscience company focused on the research, development and commercialization of TCM for the treatment of neurocognitive disorders and degenerations, specifically Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder. The company has no currently approved products and has not generated any revenue from product sales. The TCM industry in which the company operates is characterized by a long, complex and costly regulatory approval process, with the Hong Kong Chinese Medicines Board serving as the primary regulatory authority for the company's intended first market. The company's standardized TCM formula for ADHD and ASD patients remains under research and development, and none of the formula is currently in the process of regulatory approval and commercialization. The company's second efficacy trial in ADHD and ASD in Hong Kong is ongoing.

The company faces competition from other therapies and alternative drugs, particularly those for ADHD and ASD. The company has no granted or pending patent applications and no distribution capabilities or experience. The company's competitive positioning rests on its standardized liquid-based TCM formula treatment, which is being developed based on the TCM Practitioner's brain theory and his over 30 years of experience in treating ADHD and ASD patients. The company's assessment tools include the Sik-Kee Au TCM Brain Theory for ADHD/ASD Assessment, a 48-item questionnaire developed by its research and development team, as well as globally recognized tools including the Autism Treatment Evaluation Checklist, the Gilliam Autism Rating Scale, the Vanderbilt ADHD Diagnostic Parent Rating Scale, and the Swanson, Nolan, and Pelham (SNAP)-IV 26-item Parent Rating Scale.

The company generates no revenue from product sales and has funded its operations primarily through proceeds from its initial public offering of Ordinary Shares. The company has no saleable products and has incurred operating losses since its formation. The company's business model is entirely dependent on obtaining regulatory approval for its standardized TCM formula, producing and commercializing products based on such formula, and generating revenue from product sales. The company has no sales and marketing, or distribution capabilities or experience, and would need to build these capabilities or enter into arrangements with third parties to commercialize its products.

The company's primary product candidate is its standardized liquid-based TCM formula treatment for ADHD and ASD patients. The company's research and development of TCM formula candidates is at an early stage of development, and all of its TCM formula candidates may require significant interactions with regulatory authorities and investments before their respective commercial launches. The company's ability to generate future revenue from sales of products based on its TCM formula depends heavily on obtaining favorable results from and progressing the research studies of its TCM formula, developing and obtaining regulatory approval for registration for its TCM formula, accurately identifying demand for its product candidates, continued consumer interest in treatments to the symptoms of ADHD and ASD, obtaining market acceptance of its liquid-based TCM formula treatment, negotiating favorable terms in any collaboration, licensing or other arrangements, and recruiting and retaining qualified personnel.

During the fiscal year ended June 30, 2026, the company incurred total net losses of $11.70 million ¹, compared to $3.58 million ² for the fiscal year ended June 30, 2025. The company expects to continue to incur research and development expenses in the future as it continues the advancement of its efficacy trials and as it potentially pursues additional indications. The company may also incur expenses in connection with third-party trials involving its TCM formula or other intellectual property. If the company obtains marketing approval for any of its TCM formula, it may initially incur significant outsourced sales, marketing and manufacturing expenses, as well as continued research and development expenses. As a result, the company expects to continue to incur increasing operating losses for the foreseeable future.

The company's working capital required to implement its business plan will most likely be provided by funds obtained through offerings of its equity, debt, debt-linked securities, and/or equity-linked securities, and, in the future, revenues generated by it after its TCM formula is approved for marketing and production. Any additional capital raised through the sale of equity or equity-linked securities may dilute its current shareholders' ownership and could also result in a decrease in the market price of its Ordinary Shares. The company may incur substantial offering expenses in pursuing future external financing and may be required to recognize non-cash expenses in connection with certain securities it issues, such as convertible notes and warrants, which may adversely impact its financial condition and results of operations.

The company's Ordinary Shares are listed on the Nasdaq Capital Market under the symbol RGC. As of June 30, 2026, the company had 495,884,376 ordinary shares issued and outstanding ³. On June 13, 2025, the company capitalized an amount standing to the credit of the share premium account and appropriated such sum and applied it on behalf of the shareholders towards paying in full an aggregate of 481,476,042 Ordinary Shares ⁴, representing the receipt by each shareholder of 37 additional Ordinary Shares for every Ordinary Share held on the record date. This was treated as an equity reclassification of a 38-for-1 forward stock split under 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 ⁵.

The company's growth strategy is substantially dependent on its ability to complete the research and development of, obtain regulatory approval for, and successfully commercialize its standardized liquid-based TCM formula treatment and other TCM formula candidates for ADHD and ASD patients in a timely manner. The company cannot commercialize standardized TCM formula in Hong Kong, where it intends to launch its first standardized TCM formula and products, without first obtaining regulatory approval from authorities concerned in Hong Kong. The company's second efficacy trial in ADHD and ASD in Hong Kong is ongoing, and there is no assurance whether this second efficacy trial needs to be redesigned. The company's ability to generate revenues from its standardized TCM formula is dependent on the completion of its research and development, receipt of regulatory approval and successfully commercializing products based on such formula, which may never occur.

The company's TCM formula will require additional research and development, regulatory approval in Hong Kong and other jurisdictions where it plans to sell, development of manufacturing supply and capacity, substantial investment, and significant marketing efforts before it generates any revenue from product sales. The success of the company's standardized TCM formula will depend on several factors, including 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 its standardized TCM formula intends to sell; developing commercial manufacturing capabilities to the specifications for its 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 its standardized TCM formula; launching commercial sales of its standardized liquid-based TCM formula treatment, if and when approved, whether alone or in collaboration with others; acceptance of the standardized liquid-based TCM formula treatment, if and when approved, by patients and the medical community; effectively competing with other therapies and alternative drugs, particularly those for ADHD and ASD; successfully enforcing and defending intellectual property rights and claims; and maintaining a continued acceptable safety profile of the standardized TCM formula following regulatory approval.

The company expects to continue to incur research and development expenses in the future as it continues the advancement of its efficacy trials and as it potentially pursues additional indications. The company may also incur expenses in connection with third-party trials involving its TCM formula or other intellectual property. If the company obtains marketing approval for any of its TCM formula, it may initially incur significant outsourced sales, marketing and manufacturing expenses, as well as continued research and development expenses. As a result, the company expects to continue to incur increasing operating losses for the foreseeable future. The company's research and development of TCM formula candidates is at an early stage of development and all of its TCM formula candidates may require significant interactions with regulatory authorities and investments before their respective commercial launches.

The company currently has no sales and marketing, or distribution capabilities or experience. In order to commercialize its standardized TCM formula, if approved, the company must build marketing and sales capabilities or decide to make arrangements with third parties to produce and sell products, and it may not be successful in doing so. Building the requisite sales, marketing or distribution capabilities will be expensive and time-consuming and will require significant attention of its leadership team to manage. The competition for talented individuals experienced in selling and marketing TCM products is intense, and the company cannot assure that it can assemble an effective team. The company may choose to collaborate with third parties on the commercialization of its standardized TCM formula candidate.

The company's working capital required to implement its business plan will most likely be provided by funds obtained through offerings of its equity, debt, debt-linked securities, and/or equity-linked securities, and, in the future, revenues generated by it after its TCM formula is approved for marketing and production. Any additional capital raised through the sale of equity or equity-linked securities may dilute its current shareholders' ownership and could also result in a decrease in the market price of its Ordinary Shares. The terms of the securities issued by the company 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. The company may incur substantial offering expenses in pursuing future external financing and may be required to recognize non-cash expenses in connection with certain securities it issues, such as convertible notes and warrants, which may adversely impact its financial condition and results of operations.

The company may engage third parties, such as clinical investigators and contract laboratories, to oversee some or all of the operations of its efficacy trials and to perform data collection and analysis. As a result, the company may face delays outside of its control if these parties do not fulfill their obligations in a timely fashion or in accordance with regulatory requirements. If these third parties do not successfully carry out their contractual duties or obligations and meet expected deadlines, if they need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to the company's clinical protocols or for other reasons, the company's financial results and the commercial prospects for its TCM formula could be harmed, its costs could increase and its ability to obtain regulatory approval and commence product sales could be delayed.

Changes in regulatory requirements and guidance or unanticipated events during the company's efficacy trials may occur, and as a result, the company may need to amend its efficacy trial protocols. Amendments may require the company to resubmit its efficacy trial protocols to the applicable regulatory authorities for review and approval, which may adversely affect the cost, timing and successful completion of an efficacy trial. If the company experiences delays in the completion of, or if it terminates, any of its efficacy trials, the commercial prospects for its TCM formula would be harmed and its ability to generate product revenue would be delayed, possibly materially. The results of research studies of the company's personalized TCM formula may not be predictive of the results of standardized TCM formula candidate. Standardized TCM formula candidate may fail to show the desired safety and efficacy despite positive results of personalized TCM formula.

The company's TCM formula candidate may cause undesirable side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following regulatory approval, if any. Potential undesirable side effects caused by the company's TCM formula candidate may cause it to interrupt, delay, or halt research studies or could cause regulatory authorities to interrupt, delay, or halt its research studies or could result in a more restrictive label or the delay or denial of regulatory approval by the Hong Kong Chinese Medicines Board, or other regulatory authorities. The company may observe some potential side effects in future research studies that could affect patient recruitment or the ability of enrolled patients to complete the study or result in potential product liability claims.

The company is an early-stage TCM bioscience company with a limited operating history that has no saleable products and has not generated any revenue from product sales. The company incurred total net losses of $11.70 million and $3.58 million for the fiscal years ended June 30, 2026 and 2025, respectively, and expects to continue to incur increasing operating losses for the foreseeable future. The company has limited sources of working capital and may need substantial additional financing; if it is unable to obtain required additional capital, it may have to curtail its growth plans or cut back on existing business, which may affect its results of operations and financial condition or cause the cessation of its operations. The company's standardized TCM formula for ADHD and ASD patients is still in development, and none of the formula is currently in the process of regulatory approval and commercialization. The company cannot commercialize standardized TCM formula in Hong Kong, where it intends to launch its first standardized TCM formula and products, without first obtaining regulatory approval from authorities concerned in Hong Kong. The company has no granted or pending patent applications and no distribution capabilities or experience. The company's second efficacy trial in ADHD and ASD in Hong Kong is ongoing, and there is no assurance whether this second efficacy trial needs to be redesigned. The company relies on parents or caregivers of patients to provide initial data for which it cannot guarantee accuracy, and if they fail to observe and record accurately, the company may invest time and financial resources inefficiently in attempting to develop inappropriate TCM formula candidate. The company may engage third parties to conduct its efficacy trials, and may face delays outside of its control if these parties do not fulfill their obligations in a timely fashion or in accordance with regulatory requirements.

Management's message to shareholders emphasizes that Regencell is 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 ADHD and ASD, with no currently approved products. Management acknowledges that the company has no saleable products and has not generated any revenue from product sales, and that it has incurred operating losses since its formation. The company incurred total net losses of $11.70 million and $3.58 million , respectively, for the fiscal years ended June 30, 2026 and 2025. Management states that substantially all of the company's operating losses resulted from costs incurred in connection with its development programs and from general and administrative costs. Management expects to continue to incur research and development expenses in the future as the company continues the advancement of its efficacy trials and as it potentially pursues additional indications. Management also states that if the company obtains marketing approval for any of its TCM formula, it may initially incur significant outsourced sales, marketing and manufacturing expenses, as well as continued research and development expenses, and that as a result, the company expects to continue to incur increasing operating losses for the foreseeable future. The company's strategic priorities for the period ahead center on successfully implementing and executing its current business plan, successfully manufacturing and commercializing its standardized liquid-based TCM formula treatment for ADHD and ASD patients, successfully completing the research studies to obtain regulatory approval for the marketing of its TCM formula, and raising sufficient funds in the capital markets or otherwise to effectuate its business plan. Management notes that the company's second efficacy trial in ADHD and ASD in Hong Kong is ongoing, and that there is no assurance whether this second efficacy trial needs to be redesigned. Management further notes that the company has not applied for any regulatory approvals, has no granted or pending patent applications, and has no distribution capabilities or experience.