{"__slider":[],"__countdown":[{"gallery":[],"secstyle":"","imageObject":"202311161011093671.png","imageSecond":false,"sectionbg":"","background_image":false,"id":221,"title":"","subtitle":"","social":{"instagram":"","facebook":"","linkedin":"","youtube":""},"content":"\u003Cdiv class=\"_content\"\u003E\u003Cp style=\"text-align:justify\"\u003EInvestors have faced challenging and volatile markets so far in 2022 as they sort through issues of inflation, supply chain disruption, continued covid issues, rising interest rates, and the disruption of the war in Ukraine. The S&P 500 has come close to bear market levels, down 19% in mid-June.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003ETimes of turbulence affect all stocks, large and small. It can be particularly challenging for pre-revenue microcap stocks, where the volatility is often magnified by small changes in perception, whether driven by news or technical trading signals.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003EWe first wrote on Regencell Bioscience (NASDAQ:RGC) and its preliminary trials for ASD\/ADHD, in\u00a0\u003Ca href=\"https:\/\/scr.zacks.com\/news\/news-details\/2021\/RGC-Traditional-Chinese-Medicine-Approach-for-treatment-of-neurodevelopmental-conditions\/default.aspx\"\u003ENovember 2021\u003C\/a\u003E. At that time, the stock was trading around $20\/share. It rose to $40 by mid-February 2022, before dropping back to the low 20s in early April.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003EWhile the overall markets continue to be weak, RGC\u2019s share price has performed well since April. Shares have since recovered to the high-$30s to $40. In our view, RGC\u2019s recent share price recovery stems from encouraging study results for Regencell\u2019s RGC-COV19\u003Csup\u003ETM\u003C\/sup\u003E\u00a0Traditional Chinese Medicine (TCM) formula for treating COVID-19 symptoms, frequent shareholder communication, and support for the shares in the market.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u003Cstrong\u003E\u003Cem\u003EManagement\u2019s commitment to meet Regencell\u2019s strategic goals\u003C\/em\u003E\u003C\/strong\u003E\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003EFounded in 2014, Hong Kong-based Regencell Bioscience is an early clinical stage bioscience company using traditional Chinese medicine (TCM) approach to develop standardized TCM formulas to holistically treat autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in children, and infectious diseases which affects the immune system such as COVID-19.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003EThe formulae candidates aim to address the fundamental causes of disorders while alleviating symptoms and improving overall health at the same time. Taking a holistic approach, RGC\u2019s TCM uses natural ingredients to treat different elements in the body and every bodily function is taken into consideration when preparing the TCM formulae for patients.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003EUnlike some early-stage companies, where it can be difficult to parse the many ways in which founders and executives may benefit whether or not the company succeeds, RGC has taken a more transparent approach that is well-aligned with shareholders\u2019 long-term interests.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022\u00a0\u003Cstrong\u003EChairman and CEO support.\u00a0\u003C\/strong\u003ESince RGC\u2019s incorporation in October 2014 up to the IPO, the Company has been fully funded by its Chairman and CEO, Mr. Yat-Gai Au.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u25e6 Upon the IPO, the Chairman\u2019s loan of USD $3.25 million, was converted into ~342,000 common shares at the initial offering price of USD $9.50.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u25e6 Pledged to not draw salary and bonus of more than USD $1 until the Company reaches USD $1 billion market capitalization;\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u25e6 Will not award share options for himself;\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u25e6 Since the IPO, RGC\u2019s Chairman and CEO has purchased over USD $5 million in common shares on the open market. Most recently, he purchased\u00a0\u003Ca href=\"https:\/\/www.sec.gov\/Archives\/edgar\/data\/0001829667\/000121390022026630\/ea160018-13da4regen_regen.htm\"\u003E49,010 shares\u003C\/a\u003E\u00a0(~ USD $1.1 million) between April 1 and May 16, 2022, bringing his ownership to 81% of outstanding shares (~10.5 million).\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022\u00a0\u003Cstrong\u003EBillionaire investor backing.\u003C\/strong\u003E\u00a0Samuel Chen, a successful early Zoom Video Communications (NASDAQ:ZM) investor is one of the major backers of RGC. Last reported 13G filing shows he holds a 7.63% stake in the company.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022\u00a0\u003Cstrong\u003EStock option lock-up extended.\u003C\/strong\u003E\u00a0All directors and employees who were previously granted stock options upon the Company\u2019s IPO have agreed to a further lock-up undertaking for a period of six months after their stock options become vested. As their stock options are set to vest on July 16, 2022, their shares will remain locked up until January 16, 2023.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022\u00a0\u003Cstrong\u003ERoyalties.\u00a0\u003C\/strong\u003EUnder the agreement with their strategic partner and TCM practitioner, Mr. Sik-Kee Au, creator of the original TCM formulae that form the basis of RGC\u2019s intellectual property, RGC will pay 3% of net revenue, which will in turn be donated to charitable institutions\/trusts at the choice of the TCM Practitioner.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u003Cem\u003E\u003Cstrong\u003ERecent news and upcoming catalysts\u003C\/strong\u003E\u003C\/em\u003E\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003EOn May 18, 2022, RGC announced a follow-on study of its investigational liquid formula RGC-COV19\u003Csup\u003ETM\u003C\/sup\u003E\u00a0in the elimination for COVID-19 symptoms (\u003Ca href=\"https:\/\/scr.zacks.com\/news\/news-details\/2022\/RGC-Second-investigational-study-of-RGC-COV19-replicates-results-of-earlier-trial-in-eliminating-COVID-19-symptoms.-\/default.aspx\"\u003EEARTH-B Trial\u003C\/a\u003E). The follow-on study built on the promising results reported in the first EARTH trial (\u003Ca href=\"https:\/\/scr.zacks.com\/news\/news-details\/2022\/RGC-Regencell-Bioscience---Investigational-Liquid-Formula-RGC-COV19-shows-promise-in-eliminating-COVID-19-symptoms\/default.aspx\"\u003EEARTH-A Trial\u003C\/a\u003E), conducted in 2020-2021. Across the two trials, 95.5% of subjects (n=81), reported complete symptom alleviation within six days following treatment, (except for loss or reduce of sense of smell and\/or taste (Sensory Dysfunction) or occasional cough).\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003EIn the next few months, RGC expects to report data from its second clinical study of its standardized TCM formula for the treatment of ASD and ADHD.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003ERegencell Bioscience\u2019s first clinical trial was designed to establish benchmarks for treatment, dosing, adverse effects (AEs) and measuring patient response in a systematic and repeatable way. The study, conducted in 2018-2019, included seven adolescents, aged five to eleven, with professionally-diagnosed ASD or ADHD. After discontinuing any current therapies and medication, subjects received a customized version of the TCM formula for up to three months. Patients\u2019 responses were measured through parental interviews and four validated assessment instruments including the Autism Treatment Evaluation Checklist (ATEC), Gilliam Autism Rating Scale (GARS), Vanderbilt ADHD Diagnostic Parent Rating Scale (VADRS) and Pelham (SNAP)-IV 26-item Parent Rating Scale (SNAP-IV-26). All seven patients showed a lessening of symptoms during the treatment period across all four scales.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003EThe second clinical study evaluates response to three standardized mixtures of the TCM formula (for mild, moderate and severe impairment) on children in the same age group. The study design calls for twice daily dosing for three to 12 months, weekly practitioner meetings and monthly assessments. The results will be used to file for proprietary Chinese medicine (pCm) registration in Hong Kong making the product available to for sale in other clinics as well as over the counter.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003ERegencell is focused on its clinical studies in order to corroborate its results. These efforts will lead to the building of manufacturing and supply chain infrastructure required to gain pCm registration. Regencell Bioscience has a four-year timeframe to commercialize its standardized formulations and gain pCm registration in Hong Kong. The Company has a number of tasks ahead:\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022 Completing its second clinical trial and evaluating results.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022 Conducting additional clinical trials to support its proprietary formulae in ASD\/ADHD and other applications.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022 Obtaining patents and other forms of IP protection in Hong Kong and other markets.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022 Establishing manufacturing capability and supply chain that will meet registration requirements.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022 Assembling and filing documentation for pCm approval.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022 Build out its marketing and distribution strategy and infrastructure.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003ERGC\u2019s steady share price ascension in recent weeks may be a sign of greater things to come as its moves towards commercialization, we are encouraged by its thoughtful, systematic approach to developing its therapies, and communicating its progress to shareholders.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003ESource from:\u00a0\u003Ca href=\"https:\/\/scr.zacks.com\/news\/news-details\/2022\/RGC-CEO-Figuratively-Putting-His-Money-Where-His-Mouth-Is\/default.aspx\"\u003EZacks SCR\u003C\/a\u003E\u003C\/p\u003E\u003C\/div\u003E","blurb":"","link":"","linktitle":"","links":[],"alink":"","buttons":"","imageObjectTitle":"","imageObjectSrc":"management.file\/img\/202311161011093671.png","imageObjectImg":"\u003Cdiv class=\"_imgobj p-r\"\u003E\u003Cimg src=\"management.file\/img\/202311161011093671.png\" \/\u003E\u003C\/div\u003E","imageObjectBg":"background-image: url(management.file\/img\/202311161011093671.png);","imageSecondTitle":"","imageSecondSrc":"","imageSecondImg":"","imageSecondBg":"","ittlsec":"","h":"","maintitle":"","sectitle":"\u003Cdiv class=\"_secttlbx\"\u003E\n \n \u003Cdiv class=\"ttldecor- ttldecor-top\"\u003E\u003C\/div\u003E\u003Cdiv class=\"ttldecor- ttldecor-btm\"\u003E\u003C\/div\u003E\n \n \u003Cdiv class=\"_ttlcontent _content\"\u003E\u003Cp style=\"text-align:justify\"\u003EInvestors have faced challenging and volatile markets so far in 2022 as they sort through issues of inflation, supply chain disruption, continued covid issues, rising interest rates, and the disruption of the war in Ukraine. The S&P 500 has come close to bear market levels, down 19% in mid-June.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003ETimes of turbulence affect all stocks, large and small. It can be particularly challenging for pre-revenue microcap stocks, where the volatility is often magnified by small changes in perception, whether driven by news or technical trading signals.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003EWe first wrote on Regencell Bioscience (NASDAQ:RGC) and its preliminary trials for ASD\/ADHD, in\u00a0\u003Ca href=\"https:\/\/scr.zacks.com\/news\/news-details\/2021\/RGC-Traditional-Chinese-Medicine-Approach-for-treatment-of-neurodevelopmental-conditions\/default.aspx\"\u003ENovember 2021\u003C\/a\u003E. At that time, the stock was trading around $20\/share. It rose to $40 by mid-February 2022, before dropping back to the low 20s in early April.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003EWhile the overall markets continue to be weak, RGC\u2019s share price has performed well since April. Shares have since recovered to the high-$30s to $40. In our view, RGC\u2019s recent share price recovery stems from encouraging study results for Regencell\u2019s RGC-COV19\u003Csup\u003ETM\u003C\/sup\u003E\u00a0Traditional Chinese Medicine (TCM) formula for treating COVID-19 symptoms, frequent shareholder communication, and support for the shares in the market.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u003Cstrong\u003E\u003Cem\u003EManagement\u2019s commitment to meet Regencell\u2019s strategic goals\u003C\/em\u003E\u003C\/strong\u003E\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003EFounded in 2014, Hong Kong-based Regencell Bioscience is an early clinical stage bioscience company using traditional Chinese medicine (TCM) approach to develop standardized TCM formulas to holistically treat autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in children, and infectious diseases which affects the immune system such as COVID-19.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003EThe formulae candidates aim to address the fundamental causes of disorders while alleviating symptoms and improving overall health at the same time. Taking a holistic approach, RGC\u2019s TCM uses natural ingredients to treat different elements in the body and every bodily function is taken into consideration when preparing the TCM formulae for patients.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003EUnlike some early-stage companies, where it can be difficult to parse the many ways in which founders and executives may benefit whether or not the company succeeds, RGC has taken a more transparent approach that is well-aligned with shareholders\u2019 long-term interests.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022\u00a0\u003Cstrong\u003EChairman and CEO support.\u00a0\u003C\/strong\u003ESince RGC\u2019s incorporation in October 2014 up to the IPO, the Company has been fully funded by its Chairman and CEO, Mr. Yat-Gai Au.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u25e6 Upon the IPO, the Chairman\u2019s loan of USD $3.25 million, was converted into ~342,000 common shares at the initial offering price of USD $9.50.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u25e6 Pledged to not draw salary and bonus of more than USD $1 until the Company reaches USD $1 billion market capitalization;\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u25e6 Will not award share options for himself;\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u25e6 Since the IPO, RGC\u2019s Chairman and CEO has purchased over USD $5 million in common shares on the open market. Most recently, he purchased\u00a0\u003Ca href=\"https:\/\/www.sec.gov\/Archives\/edgar\/data\/0001829667\/000121390022026630\/ea160018-13da4regen_regen.htm\"\u003E49,010 shares\u003C\/a\u003E\u00a0(~ USD $1.1 million) between April 1 and May 16, 2022, bringing his ownership to 81% of outstanding shares (~10.5 million).\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022\u00a0\u003Cstrong\u003EBillionaire investor backing.\u003C\/strong\u003E\u00a0Samuel Chen, a successful early Zoom Video Communications (NASDAQ:ZM) investor is one of the major backers of RGC. Last reported 13G filing shows he holds a 7.63% stake in the company.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022\u00a0\u003Cstrong\u003EStock option lock-up extended.\u003C\/strong\u003E\u00a0All directors and employees who were previously granted stock options upon the Company\u2019s IPO have agreed to a further lock-up undertaking for a period of six months after their stock options become vested. As their stock options are set to vest on July 16, 2022, their shares will remain locked up until January 16, 2023.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022\u00a0\u003Cstrong\u003ERoyalties.\u00a0\u003C\/strong\u003EUnder the agreement with their strategic partner and TCM practitioner, Mr. Sik-Kee Au, creator of the original TCM formulae that form the basis of RGC\u2019s intellectual property, RGC will pay 3% of net revenue, which will in turn be donated to charitable institutions\/trusts at the choice of the TCM Practitioner.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u003Cem\u003E\u003Cstrong\u003ERecent news and upcoming catalysts\u003C\/strong\u003E\u003C\/em\u003E\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003EOn May 18, 2022, RGC announced a follow-on study of its investigational liquid formula RGC-COV19\u003Csup\u003ETM\u003C\/sup\u003E\u00a0in the elimination for COVID-19 symptoms (\u003Ca href=\"https:\/\/scr.zacks.com\/news\/news-details\/2022\/RGC-Second-investigational-study-of-RGC-COV19-replicates-results-of-earlier-trial-in-eliminating-COVID-19-symptoms.-\/default.aspx\"\u003EEARTH-B Trial\u003C\/a\u003E). The follow-on study built on the promising results reported in the first EARTH trial (\u003Ca href=\"https:\/\/scr.zacks.com\/news\/news-details\/2022\/RGC-Regencell-Bioscience---Investigational-Liquid-Formula-RGC-COV19-shows-promise-in-eliminating-COVID-19-symptoms\/default.aspx\"\u003EEARTH-A Trial\u003C\/a\u003E), conducted in 2020-2021. Across the two trials, 95.5% of subjects (n=81), reported complete symptom alleviation within six days following treatment, (except for loss or reduce of sense of smell and\/or taste (Sensory Dysfunction) or occasional cough).\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003EIn the next few months, RGC expects to report data from its second clinical study of its standardized TCM formula for the treatment of ASD and ADHD.\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003ERegencell Bioscience\u2019s first clinical trial was designed to establish benchmarks for treatment, dosing, adverse effects (AEs) and measuring patient response in a systematic and repeatable way. The study, conducted in 2018-2019, included seven adolescents, aged five to eleven, with professionally-diagnosed ASD or ADHD. After discontinuing any current therapies and medication, subjects received a customized version of the TCM formula for up to three months. Patients\u2019 responses were measured through parental interviews and four validated assessment instruments including the Autism Treatment Evaluation Checklist (ATEC), Gilliam Autism Rating Scale (GARS), Vanderbilt ADHD Diagnostic Parent Rating Scale (VADRS) and Pelham (SNAP)-IV 26-item Parent Rating Scale (SNAP-IV-26). All seven patients showed a lessening of symptoms during the treatment period across all four scales.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003EThe second clinical study evaluates response to three standardized mixtures of the TCM formula (for mild, moderate and severe impairment) on children in the same age group. The study design calls for twice daily dosing for three to 12 months, weekly practitioner meetings and monthly assessments. The results will be used to file for proprietary Chinese medicine (pCm) registration in Hong Kong making the product available to for sale in other clinics as well as over the counter.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003ERegencell is focused on its clinical studies in order to corroborate its results. These efforts will lead to the building of manufacturing and supply chain infrastructure required to gain pCm registration. Regencell Bioscience has a four-year timeframe to commercialize its standardized formulations and gain pCm registration in Hong Kong. The Company has a number of tasks ahead:\u00a0\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022 Completing its second clinical trial and evaluating results.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022 Conducting additional clinical trials to support its proprietary formulae in ASD\/ADHD and other applications.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022 Obtaining patents and other forms of IP protection in Hong Kong and other markets.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022 Establishing manufacturing capability and supply chain that will meet registration requirements.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022 Assembling and filing documentation for pCm approval.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003E\u2022 Build out its marketing and distribution strategy and infrastructure.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003ERGC\u2019s steady share price ascension in recent weeks may be a sign of greater things to come as its moves towards commercialization, we are encouraged by its thoughtful, systematic approach to developing its therapies, and communicating its progress to shareholders.\u003C\/p\u003E\r\n\r\n\u003Cp style=\"text-align:justify\"\u003ESource from:\u00a0\u003Ca href=\"https:\/\/scr.zacks.com\/news\/news-details\/2022\/RGC-CEO-Figuratively-Putting-His-Money-Where-His-Mouth-Is\/default.aspx\"\u003EZacks SCR\u003C\/a\u003E\u003C\/p\u003E\r\n\u003C\/div\u003E\n \u003C\/div\u003E","iframe":"","date":"","documentSrc":"","document":"","documentTitle":"","videoSrc":"","video":"","videoTitle":""}],"__step":[],"__otherstep":[],"__textslide":[],"__message1":[],"__message2":[],"__gallery":[]}
