Regencell Bioscience Holdings (hereinafter referred to as "Regencell") is an early-stage biotech company headquartered in Hong Kong, China. The company claims to have developed traditional Chinese herbal therapies for the treatment of pediatric attention deficit hyperactivity disorder (ADHD) and autism, but has not yet generated any revenue. Regencell was founded in 2014 and has been trading on the NASDAQ under the ticker symbol "RGC" since 2021. On March 22, 2021, Regencell Bioscience Holdings filed an application with the SEC to raise up to $18 million through an initial public offering (IPO). Regencell Bioscience Holdings first made a confidential filing on November 13, 2020. Shares of Regencell more than doubled on Monday, and have surged more than 280% since the 38-for-1 stock split announced on June 2 went into effect. As of Monday's close, Regencell's total market capitalization had reached $29.7 billion, according to S&P Capital IQ. Regencell's stock price often sees sharp single-day swings. For example, on March 21, its stock rose approximately 30%, only to fall 30% the next trading day. Vague Treatments, Zero Revenue Despite Regencell's sharp stock rally, little is known about the efficacy and commercialization of its treatments for ADHD and autism spectrum disorder (ASD). In its latest annual report filed last October, Regencell stated that it has not generated any revenue and has not applied for any regulatory approval for its Chinese herbal formula. Regencell's business centers on its proprietary traditional Chinese medicine (TCM) formulas, which were developed in collaboration with Chinese medicine practitioner Sik-Kee Au, based on his "Sik-Kee Au TCM Brain Theory". The company said in a 2022 statement that Sik-Kee Au is the father of Yat-Gai Au, Regencell's chief executive officer. Data from financial data tool FactSet shows that the company's CEO controls 86.24% of the company's total outstanding shares. On Regencell's website, it states: "These Chinese herbal formulations form the basis of our TCM candidate products, which we intend to develop and commercialize for the treatment of ADHD and ASD." The three liquid-based oral TCM candidate formulations are claimed to treat mild, moderate, and severe conditions, and only contain natural ingredients such as so-called "detoxifying herbs", blood-activating herbs, and digestive herbs. According to filings with the U.S. Securities and Exchange Commission (SEC), Regencell reported total net losses of $4.36 million and $6.06 million in the fiscal years ending June 2024 and June 2023, respectively. The company wrote in its disclosure filings: "We have not generated revenue from any of our TCM candidate formulations, have not applied for approval from any regulatory authority, nor do we have distribution capabilities or experience, nor do we have any granted patents or pending patents, and may never become profitable." According to Regencell's corporate webpage, the company's latest patient case study, conducted on November 15, 2023, stated that in a second efficacy trial, 28 patients received treatment over three months, and their symptoms of attention deficit hyperactivity disorder (ADHD) and autism (ASD) improved. Previously, Regencell said in a 2021 press release that the company used Au's modified proprietary TCM formula for colds and flu to treat more than a dozen suspected or confirmed COVID-19 patients. The statement said that as COVID-19 conditions improved, Regencell established a joint venture with Honor Epic Enterprises Limited in September 2021 to further test the company's COVID-19 therapy and commercialize it in member states of the Association of Southeast Asian Nations (ASEAN). © 2021 Meishun (Hong Kong) Management Consulting Co., Ltd. and Meishun (Hangzhou) Management Consulting Co., Ltd. All rights reserved. Meishun Meiyin (Hangzhou) Consulting Management Co., Ltd. is the domestic subsidiary of Hong Kong Meishun Management Consulting Co., Ltd. under the same ultimate controlling shareholder. Both companies share the same ultimate controlling party, operate under a unified Chinese management framework, and comply with the laws of Hong Kong and mainland China.