Nimodipine

PRINCETON, N.J., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) formerly Acasti Pharma Inc. (Nasdaq: ACST) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aneurysmal subarachnoid hemorrhage (aSAH) patients to address significant unmet medical needs, today announced that Chief Executive Officer Prashant Kohli will participate the following investor and industry networking events during the month of January 2025. 14th Annual LifeSci Partners Corporate Access Event – (January 13, 2025) BIO One-on-One Partnering™ – (January 14, 2025) Mr. Kohli will be presenting and available to meet with investors and potential strategic partners on the dates indicated during these events. To schedule a meeting, contact Mike Moyer at mmoyer@lifesciadvisors.com KOL Event on aneurysmal Subarachnoid Hemorrhage (aSAH) Grace Therapeutics hosted a virtual key opinion leader (KOL) event on November 20, 2024. The event featured Abhishek Ray, MD (University Hospitals) and Andrew Webb, PharmD, BCCCP (Massachusetts General Hospital), who discussed the high unmet medical need and current treatment landscape for patients suffering from aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency. To access the replay, click here. About aneurysmal Subarachnoid Hemorrhage (aSAH) aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm. the brain. A primary cause of such bleeding is rupture of an aneurysm. The result is a relatively uncommon type of stroke (aSAH) that accounts for about 5% of all strokes and has an incidence of six per 100,000 person years. About the Grace Therapeutics Asset Portfolio GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 150 healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine. The addressable market in the United States for GTx-104 is estimated to be about $300 million, based on market research. About Grace Therapeutics Grace Therapeutics, Inc. (formerly Acasti, Grace Therapeutics or the Company) is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Grace Therapeutics’ novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Grace Therapeutic’s lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Grace Therapeutics’ lead clinical asset, GTx-104, is an intravenous infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. For more information, please visit: www.gracetx.com Forward-Looking Statements Statements in this press release that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Grace Therapeutics to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms "believes," "belief," "expects," "intends," "anticipates," "estimates", "potential," "should," "may," "will," "plans," "continue", "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding the Company's upcoming participation in the ASHP mid-year clinical meeting, GTx-104’s commercial prospects; the size of the addressable market for GTx-104, and the Company’s beliefs regarding the potential benefits of GTx-104, including GTx-104's potential to bring enhanced treatment options to patients suffering from aSAH, are based upon Grace Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of the Phase 3 STRIVE-ON safety trial for GTx-104; (ii) regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTx-104; (iii) changes to clinical trial designs and regulatory pathways; (iv) legislative, regulatory, political and economic developments; and (v) actual costs associated with Grace Therapeutics' clinical trials as compared to management's current expectations. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in the "Special Note Regarding Forward-Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2024, Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024, the Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024 and other documents that have been and will be filed by Grace Therapeutics from time to time with the Securities and Exchange Commission and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Grace Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws. For more information, please contact: Grace Therapeutics Contact: Prashant KohliChief Executive OfficerTel: 450-686-4555Email: info@gracetx.comwww.gracetx.com Investor Relations: LifeSci AdvisorsMike MoyerManaging DirectorPhone: 617-308-4306Email: mmoyer@lifesciadvisors.com

导读 THECAPITAL “地主家”余粮也紧张！ 本文4493字，约6.2分钟 作者 | 顾白  编辑 | 吾人 来源 | 融中财经 （ID：thecapital） “广西国资闹哪出？身为莱美药业大股东，资金链断了还是估值太低舍不得出手？暂缓转让让人摸不清头脑。” 前不久，重庆莱美药业发布公告，称控股股东广西梧州中恒集团计划转让公司股票约2.47亿股，预计总价10.92亿元。中恒集团是广西首家“世界500强”企业，由广西投资集团有限公司控股，2019年成为莱美药业最大表决权份额的单一股东，广西国资委也顺势成为莱美药业实际控制人。不过，不足半月，中恒集团即态度发生转换，决定暂缓转让，理由是意向受让方未能完成充分尽调，且转让条款未能达成一致。 值得一提的还有，当年广西国资接手后，莱美药业原实控人——邱宇和邱炜两兄弟一系列操作持续套现累计约14亿元。而广西国资，在莱美药业困境时伸出援手“救”了邱氏，但随后的五年持续亏损，且长期亏损的现状并未得到根本性改变，似乎已经失去耐心。此次转让也是为了优化自身的资产结构，改善经营业绩。 这两年，全球医药医疗行业处于低迷阶段，无论是创业阶段的独角兽还是上市公司，业绩承压，产业融资遇冷，生存发展都面临着严重问题，行业创新链和产业链变革迫在眉睫。 而在今年“并购六条”的刺激下，并购似乎成了国内医药公司的破局之道，尤其是前几年曾引入国资的多家医药企业，国资股份变动明显，国资“进场”和“离场”动作越来越多。 国资接盘后，原老板套现14亿离场 莱美药业是一家集研发、生产、销售于一体的上市公司，主要产品涵盖抗感染类、特色专科类（主要包括抗肿瘤药、消化系统药、肠外营养药）等。莱美药业研发的莱美舒也是首家上市（独家）国产艾司奥美拉唑口服制剂。 2019年算是莱美药业的一个转折点。在这之前，公司由邱宇与重庆制药六厂于1999年携手创立，讲起来重庆制药六厂还是莱美药业的创始股东。2002年重庆制药六厂改制退出莱美药业。2009年10月，莱美药业成为了创业板首批28家公司之一，也是重庆市首家登陆创业板的上市公司。然而IPO后，实控人邱炜限售期刚结束就急不可耐进行了大规模减持。2013年至2018年间，通过二级市场套现4.2亿元，更令人意想不到的是，邱宇和邱炜两兄弟此后债务暴雷，股权相继被司法冻结。 2019年7月，莱美药业披露公司实际控制人邱宇所持全部股份（持股22.71%）被司法冻结，同时西藏莱美所持的公司全部股份（持股比例为5.95%）也遭遇了同样命运。据中国执行信息公开网查询的被执行人信息，邱氏兄弟（邱炜、邱宇）、西藏莱美股份涉案共计1.5亿元，其案由为民间借贷。尽管当年公司营收18.59亿，同比增长18.99%，但归属于母公司股东的净利润却为-1.55亿元。此后，莱美药业业绩一蹶不振，即便是国资接手也未能扭转颓势。2020年，公司归母净利润为-3.27亿元。这是后话。 在邱宇和邱炜两兄弟陷入债务危机四处求助时，最初是重庆国资下属的南岸城建公司提出纾困方案，计划接手莱美药业的控股权。不过方案经过一年多时间未能取得实质性进展，公司困境依然。关键时刻，广西国资作为白衣骑士出现了。 2019年11月25日，中恒集团与莱美药业签订《战略合作框架协议》，取得了原大股东邱宇22.71%股份对应的表决权。随后，广西国资不断进行增持操作——2020年3月，买入约1.7亿元股份，之后一年又认购了约9.4亿元定向增发股份。也就是说由广西国资委控股的中恒集团，前后花费了约11.1亿控股这家企业。 合作之初，双方还是充满了期待。彼时，莱美药业虽然问题多多但是已经建立了多层次的科研创新体系。莱美药业表示，引入国资战略投资方有利于公司经营稳定和持续增长，双方通过产业协同合作、金融资源支持等方式，可以促进公司在生物医药产业做大做强。而中恒集团尽快打造现代化健康产业，提升集团整体研发水平和核心竞争力。 从业绩层面看，合作并没有为莱美药业带来改观。2019年-2023年营收分别为18.59亿元、15.84亿元、12.25亿元、8.85亿元、8.96亿元，对应净亏损分别为-1.55亿元、-3.27亿元、-1.01亿元、-6871万元和-892.7万元。换句话说，从2019年开始，莱美药业连续亏损5年约8.7亿元。进入2024年，业绩再次显著下滑，前三季度营收6.06亿元，归属净利润-2642万元。持续的亏损，已经与中恒集团初衷诉求相悖。 然而，更令人惊奇的是，在广西国资接手后，莱美药业原实控人——邱宇和邱炜两兄弟还在持续套现。邱炜在2020年通过拍卖完全清空了所持股份，套现约2.63亿元；邱宇的股份也在2021年通过拍卖出售，金额约为6.03亿元。紧接着邱宇在后续年份还因司法裁定等原因被动减持了部分股份。一系列操作使得邱宇与邱炜兄弟累计套现约14亿元。 莱美药业2019-2023年归属于母公司所有者净利润 对于这次“分手”，中恒集团也称其是为实现资产结构的优化，改善经营业绩。 值得注意的是，虽然莱美药业业绩不佳，但自今年9月以来，股价开始明显上涨，涨幅达到约150%。业内人猜测，这波上涨可能与公司产品的最新动态有关。9月份，莱美药业控股子公司的肿瘤治疗疫苗CUD002获得临床试验批准。10月份，莱美药业又宣布获得国家药品监督管理局核发的多项药品注册证书及批准通知书，包括尼莫地平注射液、艾司奥美拉唑镁肠溶胶囊以及氨甲环酸氯化钠注射液等。 当然，从11亿入场成本到现在的股权大约价值14亿，账面上还是赚的。但无论如何，莱美药业亏损已久，要想翻盘并不容易，next接盘者也要做好“持久战”的准备才行。 中国药企，艰难的2024 2024年，大量药企面临专利到期、药品定价监管变化以及临床前资产投资放缓等问题，裁员降薪潮席卷着全球生物药企业。仅上半年，就有超过80家生物技术公司在全球范围内进行了裁员，裁员人数上万，到年末，仍在继续。 一方面，全球医疗健康投融资阶段性下行。有数据显示，交易数量同比下降超2成，但平均交易金额上涨近3成。下半年，对于制药公司而言，降低成本更是成了关键词。 11月底，吉利德宣布新一轮裁员计划，计划解雇其位于福斯特城（Foster City）总部的104名员工；12月，诺华宣布将关闭位于德国和美国的MorphoSys工厂，并计划裁员约330人。今年以来包括拜耳、百时美施贵宝（BMS）、葛兰素史克、武田、强生等多家巨头曝出裁员消息，此外还涉及管线精简、临床终止等整改消息的发布。 另一方面，国内医疗反腐工作还在向基层延伸。据不完全统计，自2023年下半年以来，已有33家医药企业的高管因涉嫌违法违纪被留置、刑拘、立案或调查。在这33家企业中，超过20家为A股上市公司，包括卫宁健康、赛伦生物、沃华医药、上海医药、云南白药、阳普医疗、大参林、海正药业、翰宇药业、白云山、香雪制药、四环生物、诺泰生物、南卫股份、莱茵生物和金花股份等。 业内人士告诉记者，药企高管被查事件的密集发生，一方面反映了市场固有的逐利性导致腐败现象依然严峻，部分董监高人员在利益驱使下法律意识淡薄，未能坚守道德和法律底线；另一方面，也暴露出部分公司在制度建设上的不足，未能建立健全规章制度以形成有效的内部制衡机制。尤其生物医药领域，腐败案件的成因不一而足，涉及权力寻租与利益输送、监管不足与制度缺陷、行业特性与利润驱动以及文化因素与道德缺失等多个方面。 一直以来，医药行业资金链长且权力集中、行业利润空间大、医疗机构主导权而为人熟知，医药代表、医药招标、医疗器械采销、医保支付等环节的腐败风险点分布广泛，导致权力寻租、收受回扣、行贿受贿等情况难以禁绝。随着对重点医药企业及其高层管理人员的监管力度持续加码，医疗领域反腐正在向纵深推进，医疗企业也在艰难度日中。 面对竞争激烈的医药市场，中国医药企业纷纷宣布转让公司直接或间接持股的股权，以更好地盘活公司存量资产、集中优势资源聚焦主业等，以及开启“瘦身”模式或许也是发展的一条出路。仅今年上半年就有近10家药企出售资产、股权，陆续开卖。最引人注意的一笔并购交易还要属天士力，向华润三九和国新投资转让28%和5%的股份，总价达到73亿元，成为近年来“国家队”并购中药企业的峰值。而在并购天士力以前，华润系已经将至少5家知名中药上市公司收入麾下。 事实上，随着“并购六条”的落地，医药领域的并购重组、资产收购可以说是掀起了新一轮浪潮。包括科源制药、千红制药、新里程、四川双马、新诺威、药师帮、多瑞医药、康惠制药等多家上市公司纷纷披露资产并购、股权转让及相关进展公告。各家公司都有野心：有的豪掷重金收购标的股权，旨在进一步拓展核心产品管线，增强研发和生产能力；有的拟IPO公司在“冲A”铩羽后，谋求通过上市公司并购曲线登陆A股市场；还有公司尝试“跨界”并购，意欲实现对现有业务的突破，押注新蓝海。 当前，中国医药并购市场已经出现了结构性机会，基于市场供需趋势及政策出台，预计未来并购案例将显著增长。此外，回顾2024，科创板上的医药企业也还是有许多出彩瞬间。 截至2024年12月24日，110家科创板生物医药企业总市值为1.13万亿元，百济神州以2231.29亿元的市值排名第一，前10的企业中创新药企业占据多数。尤其A股回购热潮蔓延至科创板。截至2024年12月24日，对外宣布回购的科创板生物医药企业数量为47家，较2023年同期的29家增长62.07%。 没项目可投 医疗投资人“保媒拉纤” 给青年才俊医生介绍对象 莱美药业在公告中多次将业绩下滑归因于“医药集采”，公司部分产品一直以来因市场需求稳定而享有较高的利润空间。而随着集采的推进，产品价格大幅下降，缺乏核心竞争力的仿制药利润空间被严重压缩。 某机构医药投资人温良勤告诉记者“其实，仿制药轻松获利的时代早已经过去了。这两年全球医药医疗行业处于低迷阶段，资本会更倾向于市场预期更明确的项目。创新药依然是核心主题，但想要吸引资本入局，与以往不同，投资人对创新价值的认知已经逐渐从‘极致技术’向‘效率提升’转变，企业需要持续加大研发投入。” 进入2024年以来，我国医药健康行业发展新周期特征明显，核酸药物、核药、CGT等新兴疗法即将步入收获期，国产高端医疗设备进口替代趋势显著，CXO行业洗牌加速。医疗投融资处于寒冬更是共识。从2021年中期以来，医药健康领域的投资明显降温，尤其创新药领域，面临募资难、二级市场遇冷等情况。这背后是创新药研发同质化现象严重、适应症开发拥挤。通过暂停部分在研管线，已有部分创新药企开始节流续命。这是非常凛冽的寒冬，从二级市场扩散到一级市场早期阶段，从生物制药到医疗器械、医疗服务等几乎整个医疗健康板块，投资逻辑都在发生改变。 在温良勤看来，“中国医疗健康产业经过20多年高速发展以及10多年的风险投资助推，现在生物医药产业整体健康状态其实并不太好。医疗投资人都能感受到日益加深的寒意。特别是疫情后，大量资金涌入医疗健康行业，市场从‘资金荒’转为‘资产荒’，然后2022年再度进入泡沫后的恐慌期，机构出手越来越谨慎。前几年还在意气风发指点江山，今年能进投决会的都是少数。年底也见了一些关系好的同行，大家还是普遍比较悲观，2025可能更难。我现在都在给认识的那些医疗行业的青年才俊找对象。” 当然，过去几年，中国医药企业创新实力持续增强也已经得到海外市场的高度认可，创新药企业出海呈现百花齐放的态势。在此背景下，中国生物科技企业还是要主动布局全球市场，利用全球资源开展临床研究，提供更多优质、高效的医药创新产品与服务，推动全球医药健康事业蓬勃发展。 # 线索爆料 # rzcj@thecapital.com.cn 融中官方粉丝群  在这里，你可以获取丰富的股权投资行业资讯、热点报道；前沿行业报告、重点课题研究、最新业内动态。链接资本，连接市场，联结资源，共同打造创投交流新平台、合作共赢朋友圈。 END 媒体合作：010-84464881 商务合作：010-84467811 转载请点击菜单栏-联系我们