Seattle Biomedical Research Institute

Conference Call to be held Tuesday, July 26th at 4:30pm ET NEW YORK, July 26, 2022 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX) ("the Company"), a clinical-stage biopharmaceutical company developing regenerative therapeutics for neurodegenerative disorders, today announced changes to its Scientific Advisory Board (SAB) in preparation for Phase 2 data from its Phase 2b clinical trial of Bryostatin-1 for patients suffering from advanced and moderately severe Alzheimer's disease (AD). The SAB is comprised of industry and academic leaders in science and drug development and will be instrumental in the further development of the Company's regenerative therapies across AD, Fragile X syndrome, and multiple sclerosis (MS). The SAB will be chaired by Dr. George Perry , who will serve along with Dr. Marwan Sabbagh, Dr. Paul Coleman, Professor Robert Howard, and Dr. Zaven Khachaturian. "We are extremely pleased to have assembled this world class Scientific Advisory Board. The expertise and experience within this group will be invaluable as we prepare for Phase 2 data later this year, as well as the next steps we will take to advance the development of our regenerative therapies," stated Dr. Alan Tuchman, Chief Executive Officer. "Each of these distinguished leaders in AD research brings pioneering expertise in diverse scientific disciplines, including molecular mechanisms of neurodegeneration and regeneration, clinical trials of AD therapeutics, and interacting biochemical pathways of aging, synaptic loss, and neuronal loss," stated Dr. Daniel Alkon, President and Chief Scientific Officer. Scientific Advisory Board members include: Dr. George Perry, former Dean of the College of Sciences, Semmes Distinguished University Chair in Neurobiology, Professor of Biology and Chemistry at the University of Texas at San Antonio. Dr. Perry is recognized in the field of Alzheimer's disease research particularly for his work on oxidative stress. His research is primarily focused on the mechanisms and pathophysiological consequences of the cytopathology of Alzheimer disease. Dr. Perry is the current and founding editor-in-chief for the Journal of Alzheimer's Disease, an international multidisciplinary journal that specializes in Alzheimer's disease. Dr. Marwan Sabbagh, a leader in the field of Alzheimer's disease and related disorders, is professor of Neurology in the Alzheimer's and Memory Disorders Division at the Barrow Neurological Institute in Phoenix, Arizona. Previously, Dr. Sabbagh served as the Director of the Cleveland Clinic Lou Ruvo Center for Brain Health. Dr. Sabbagh has published over 400 scientific and medical research articles on Alzheimer's disease and remains a prominent investigator and key opinion leader in nationally recognized Alzheimer's prevention and treatment trials. Dr. Paul Coleman, several decades as a Full Professor at the University of Rochester School of Medicine during which time he was Director of the University of Rochester Medical Center Alzheimer's Disease Center and Director of an NIH Training Program in Neurobiology of Aging. In 2015, he moved his laboratory to the Neurodegenerative Disease Research Center at the Bio-design Institute, Arizona State University. Dr. Coleman's work has focused on differentiating changes in the brain in Alzheimer's disease from changes related to normal, non-demented ageing. Most recently, Dr. Coleman's work has expanded into the realm of epigenetics. Dr. Coleman has received a number of awards for his work, including a Leadership and Excellence in Alzheimer's Disease Award from the National Institutes of Health (one of 12 ever awarded) and a Pioneer Award from the National Alzheimer's Association. Professor Robert Howard, Professor of Old Age Psychiatry at University College London, and Mental Health Lead of the University College London Hospitals' Biomedical Research Centre. He and his colleagues investigate ways in which mental health symptoms in older people can be treated most effectively and safely through development of new psychological therapy approaches, optimizing the use of existing medications and of novel and repurposed agents. Their trials have shown the cognitive, functional, and independent living benefits of continuing dementia drugs until the late stages of Alzheimer's disease. Dr. Zaven Khachaturian is the President of the Campaign to Prevent Alzheimer Disease (PAD2020.org). He is the former Director, Office of Alzheimer's Disease at the National Institutes of Health (NIH), which was responsible for coordinating all Alzheimer's disease related activities NIH-wide. He also serves as the Associate Director, Neuroscience & Neuropsychology of Aging Program at the National Institution on Aging NIA / NIH. He is widely recognized as the Chief Architect of NIH-funded programs of research on brain aging and dementia-Alzheimer syndrome. As a reminder, Synaptogenix will hold a corporate update conference call this afternoon for investors. The call will take place at 4:30pm ET and will be hosted by the Company's Chief Executive Officer, Dr. Alan Tuchman, and its President and Chief Scientific Officer, Dr. Daniel Alkon. Drs. Tuchman and Alkon will also take live Q&A following their prepared remarks. The U.S. toll free dial-in for the conference call is (877) 407-8293, and the international dial-in number is 1-(201) 689-8349. About Synaptogenix, Inc. Synaptogenix is a clinical-stage biopharmaceutical company that has historically worked to develop novel therapies for neurodegenerative diseases. Synaptogenix has conducted clinical and preclinical studies of its lead therapeutic candidate, Bryostatin-1, in Alzheimer's disease. Preclinical studies have also demonstrated Bryostatin's regenerative mechanisms of action for the rare disease, Fragile X syndrome, and for other neurodegenerative disorders such as multiple sclerosis, stroke, and traumatic brain injury. The U.S. Food and Drug Administration has granted Orphan Drug Designation to Synaptogenix for Bryostatin-1 as a treatment for Fragile X syndrome. Bryostatin-1 has already undergone testing in more than 1,500 people in cancer studies, thus creating a large safety data base that will further inform clinical trial designs. Additional information about Synaptogenix, Inc. may be found on its website: . Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. These forward-looking statements include statements regarding the anticipated initiation of a clinical trial to treat Multiple Sclerosis with Bryostatin and continued development of use of Bryostatin-1 for Alzheimer's disease, Fragile X and other cognitive diseases. Such forward-looking statements are subject to risks and uncertainties and other influences, many of which the Company has no control over. There can be no assurance that the clinical program for Bryostatin-1 will be successful in demonstrating safety and/or efficacy, that we will not encounter problems or delays in clinical development, or that Bryostatin-1 will ever receive regulatory approval or be successfully commercialized. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Additional factors that may influence or cause actual results to differ materially from expected or desired results may include, without limitation, the Company's inability to obtain adequate financing, the significant length of time associated with drug development and related insufficient cash flows and resulting illiquidity, the Company's patent portfolio, the Company's inability to expand its business, significant government regulation of pharmaceuticals and the healthcare industry, lack of product diversification, availability of the Company's raw materials, existing or increased competition, stock volatility and illiquidity, and the Company's failure to implement its business plans or strategies. These and other factors are identified and described in more detail in the Company's filings with the Securities and Exchange Commission. The Company does not undertake to update these forward-looking statements. Contact Information: Investors and Media 800-811-5591 [email protected] Robert Weinstein Chief Financial Officer Synaptogenix, Inc. [email protected] SOURCE Synaptogenix, Inc.

01前言 今天的“故事”的主角包括两位，就是跨国制药巨擘默沙东，大名鼎鼎的MSD，和ADC领域的“学霸”级明星企业Seagen。 正如Fiona专栏文章《Fiona Yu专栏 | 默沙东(MSD)能凭K药乘风破浪，霸王再起吗？》中介绍的，“默沙东是一家总部位于新泽西州Kenilworth的地道美国公司，但追根溯源，它的骨子里却流淌着德国日耳曼民族的血脉。1668年，一家名为“默克天使”的小药店在德国达姆施塔特开张了，时间比美国建国还早了108年。这家药店在创始人默克家族中一代代传承，先后踩踏着近代制药发展历史中的每一个关键性节点，一步步光大了门楣。1827年，小药店长大为一家制药厂，开始生产吗啡、可待因和可卡因，逐步积累了丰厚的财富。1899年，家族中一位名为乔治·默克（George Merck）的子孙远渡重洋来到了美国，在这片新大陆上创立了一家独立于德国默克公司的美国默克公司（Merck & Co.）。” 另一位主角就是ADC领域的明星企业Seagen。 美国时间2020年10月8日，ADC药物研发先驱之一Seattle Genetics官宣该公司将更名为Seagen，标志着这家总部位于西雅图的生物技术公司的业务将扩展至全球，为更多的肿瘤患者带去健康以及有质量的生活。 对于此次名称的变更，Seagen公司的联合创始人、时任首席执行官Clay B. Siegall博士表示：我们的目标是帮助全球的肿瘤患者。作为一家面向全球的肿瘤生物技术公司，此次名称的变更意义重大。肿瘤患者没有国界之分。 Seagen接替Seattle Genetics，这位先驱与他的ADC药物是否即将开启新的健康篇章？ 过去一段时间，这家在ADC领域具有非常高知名度的公司陷入困境。上个月受到家庭暴力指控后，Siegall博士离开了Seagen，同时也放弃了他在Umoja Biopharma等其它公司的董事会职位。据警方报告，他于4月23日凌晨被捕，此前他与妻子发生肢体冲突，导致她身上多处瘀伤。Siegall博士否认了这些指控，并称正在办理离婚。 这一消息完全出人意料，立即引起轩然大波。原来，一家企业面临的风险不局限于靶点、赛道、监管政策、医保体系等方面，还有各种各样你始料不及的新状况。 02收购传闻 据华尔街日报上周五（就是本地时间6月17日）报道，全球制药巨擘默沙东（MSD）公司正在评估收购Seagen的可能性。 这是该生物技术公司在前任首席执行官Clay Siegall博士从公司辞职后的最新进展。 在指控和逮捕一事浮出水面之前，Siegall博士是生物技术领域最知名的CEO之一，曾在百时美施贵宝和NCI工作。1998年，他与合作伙伴联合创立了Seattle Genetics（Seagen的前身），将其从零发展成为一家价值数十亿美元的药企，在抗体偶联药物（ADC）研发领域处于全球领先地位。 《华尔街日报》补充说，这笔潜在的交易并非迫在眉睫。据其消息人士称，谈判已经进行了一段时间。两家公司最终可能会签署新的营销协议。 该报告补充说，其它未具名的公司也将Seagen作为潜在的收购目标，对其进行密切关注。 Seagen的投资者似乎对这一传闻感到满意。消息一出，Seagen（SGEN）的股价立即上涨了18%以上，收盘时上涨12.72%。公司市值从270亿美元涨到304.6亿美元 （图片来源：MSN Money） 03两家制药英雄的“缘分” 2020年9月，默沙东与Seagen（当时是西雅图基因公司）达成一项联合投资协议。默沙东向后者支付6亿美元现金及10亿美元股权投资，默沙东已经拥有Seagen的靶向LIV-1的在研ADC新药ladiratuzumab vedotin和其它针对同一靶点的在研ADC新药的50/50权利。此交易被列为2020全球生物医药交易TOP10之一。 默沙东与Seagen还有其它方面的合作。去年的10月18日，中国药物临床试验登记与信息公示平台显示，两家公司等已在中国启动了HER2高度特异性小分子口服抑制剂tucatinib的一项3期临床试验，目标适应症是治疗局部晚期或转移性HER2阳性乳腺癌。Tucatinib已在美国获批上市，曾被FDA授予快速通道资格、孤儿药资格和突破性疗法认定。 在刚刚结束的2022年ASCO年会上，默沙东表示，到2028年公司有望有多达80多项肿瘤适应症获批。 Seagen公司的高管与默沙东颇有渊源。 Roger Dansey医学博士首席医学官 Roger Dansey医学博士在2018年加入西雅图生物技术公司之前曾在默沙东工作，负责后期临床肿瘤管线的开发，其中包括著名的PD-1药物Keytruda（“K药”）在多个瘤种的注册工作。上个月，他被任命为公司的临时CEO。 04未来可期！ 上个月，在Siegall博士辞职的三天前，公司的年度股东大会召开，公司公布年度销售目标为17亿美元，首席财务官Todd Simpson先生在会上向股东们表示，“我们致力于成为一家盈利的公司”。 Simpson先生当时还表示，“虽然我们现在可以盈利，但我们认为基于长期增长战略，我们要投资于我们的三个关键当务之急，”，并指出重点将放在扩张和商业执行上。 公司还表示，它正在考虑被收购的可能性和机会，尽管公司账上有20亿美元的现金。 Seagen的一位发言人回复知名行业媒体Endpoints News的询问时表示，公司“不对市场谣言或猜测发表评论”。 中国企业对于Seagen应该非常熟悉。2021年8月8日，荣昌生物（09995.HK）与Seagen达成一项全球独家许可协议，以开发和商业化其ADC新药维迪西妥单抗。 参考资料：1.Updated: Merck looking at Seagen takeover bid in the wake of Clay Siegall's resignation — repor2.t默沙东/Seagen在中国启动HER2小分子抑制剂3期临床，治疗乳腺癌！3.Seagen被传或被默沙东收购，股价大涨15%4.26亿美元新纪录！荣昌生物与西雅图基因签约维迪西妥单抗2020全球生物医药交易TOP105.K药打头阵，默沙东2028年之前将斩获超80个抗肿瘤适应症？6.Fiona Yu专栏 | 默沙东(MSD)能凭K药乘风破浪，霸王再起吗？7.Keytruda的故事8.其它公开资料 内容来源于网络，如有侵权，请联系删除。

MAULDIN, S.C., March 17, 2021 /PRNewswire/ -- Xcelerate, Inc. (OTC: XCRT), formerly known as Union Dental Holdings Inc., announced today it has been issued a new ticker symbol due to the Company's recent name change. The new symbol is "XCRT". "We believe this new ticker symbol is major step forward in giving Xcelerate a clear identity," said Michael O'Shea, Xcelerate's CEO. While the Company is currently pursuing innovative acquisitions at the patent/engineering level to join with early stage medtech companies in a controlled clinical care setting where developments will be trialed, tested, and applied, no specific agreements have yet been entered into. Xcelerate, led by CEO Michael O'Shea, has a distinguished advisory board including world renowned neurosurgeon, Dr. Dilan Ellegala and Nobel Prize Laureate Dr. Barry Marshall. Dr. Marshall AC FRACP FRS FAA recently joined its Advisory Board. In 2005 Dr. Marshall and his longtime collaborator Dr. Robin Warren were awarded the Nobel Prize in Physiology or Medicine for their discovery of the bacterium Helicobacter pylori (H. pylori) and its role in peptic ulcer disease. This discovery also established the causative link between Helicobacter pylori infection and stomach cancer. Currently Dr. Marshall serves as Clinical Professor and Director of The Marshall Centre for Infectious Diseases Research at University of Western Australia. Additionally, Dr. Marshall has been involved with the establishment of the Marshall Laboratory for Biomedical Engineering at Shenzhen University. Safe Harbor Statement This press release may contain forward looking statements which are based on current expectations, forecasts, and assumptions that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected, including statements related to the amount and timing of expected revenues as well as any payment of dividends on our common and preferred stock, statements related to our financial performance, expected income, distributions, and future growth for upcoming quarterly and annual periods. Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors among other matters, the Company may not be able to sustain growth or achieve profitability based upon many factors including but not limited to general stock market conditions. We have incurred and will continue to incur significant expenses in our expansion of our existing business and there is no assurance that we will generate enough revenues to offset those costs in both the near and long term. Additional expansion of our service offerings may expose us to additional legal and regulatory costs and unknown exposure(s) based upon the various geopolitical locations we will be providing services in, the impact of which cannot be predicted at this time. Company Codes: OTC-BB:XCRT, OtherOTC:XCRT