公司合并与药物研发 - 公司于2023年9月21日与Applied Molecular Transport, Inc.达成合并协议，并于2023年12月27日完成了全股票交易[10] - 公司的主要药物候选品Trappsol® Cyclo™已获得FDA孤儿药物认定，为Niemann-Pick Type C病治疗提供了独家销售权[15] - 公司已完成了针对阿尔茨海默病的临床研究，并获得了FDA的IND清关，允许进行第二阶段研究[16] - 公司的专利申请针对阿尔茨海默病治疗已获得美国专利局的通知，预计专利期限将在2039年到期[17] Trappsol® Cyclo™药物疗效及市场潜力 - 公司估计Niemann-Pick Type C病的患病率为10万分之一，全球现有患者约3000人，每年新增约1370例病例，预计Trappsol® Cyclo™治疗NPC的市场潜力约为5.5亿美元[21] - Trappsol® Cyclo™是第一个将环糊精作为活性药物而不仅仅是作为无活性制剂辅料的产品[27] - 我们的临床研究初步表明Trappsol® Cyclo™在治疗NPC方面是安全和有效的[29] - 我们的全球III期临床研究(TransportNPC)正在进行中，旨在评估Trappsol® Cyclo™的安全性、耐受性和疗效[31] - Trappsol® Cyclo™通过临床研究清除了NPC患者肝细胞中的胆固醇[36] - Trappsol® Cyclo™降低了Tau蛋白的水平[38] 美国FDA监管及审批流程 - FDA在美国监管药物的过程中需要完成一系列步骤，包括完成临床试验、提交NDA申请等[48] - 在获得FDA批准前，公司必须确保生产过程符合cGMP要求，以保证产品的一致性生产[66] - FDA可能会根据申请人的要求或主动授予推迟提交部分或全部儿科数据的豁免，直到成人产品获得批准，或者免除儿科数据要求的全部或部分[71] - FDA可能要求提交REMS计划以确保药物的益处大于风险，REMS计划可能包括药物指南、医师沟通计划、评估计划和/或确保安全使用的元素[72] - FDA在提交NDA后的前60天内对所有NDA进行初步审查，以确定是否足够完整以进行实质性审查[73] 医疗保健法规及市场影响 - ACA法案于2010年3月生效，对政府和私人保险公司的医疗保健融资方式产生了重大影响[94] - ACA设立了一项年度不可抵扣费用，针对任何生产或进口特定品牌处方药品和生物制剂的实体；新的Medicare Part D覆盖缺口折扣计划；以及增加了制造商必须根据Medicaid药物折扣计划支付的回扣的新公式[94] - ACA延长了制造商的Medicaid回扣责任，扩大了Medicaid计划的资格标准，并扩大了符合公共卫生服务药品定价计划折扣资格的实体[94]

公司介绍 - Cyclo Therapeutics是一家专注于为患有疾病的患者和家庭开发改变生活的药物的临床阶段生物技术公司[3] 专利授予 - Cyclo Therapeutics宣布美国专利局授予了用于预防和治疗早发型阿尔茨海默病的专利[1] Trappsol® Cyclo™ - 公司首席执行官N. Scott Fine表示，Trappsol® Cyclo™有望满足早发型阿尔茨海默病患者、家庭和医生面临的医疗需求[2]

公司业务 - Cyclo Therapeutics宣布获得美国专利局关于治疗阿尔茨海默病的专利申请通知[1] - 公司的Trappsol® Cyclo™正在进行多项临床试验，包括治疗尼曼-匹克病C型和早期阿尔茨海默病[2] - 公司在未来期望Trappsol® Cyclo™能在治疗早发阿尔茨海默病中发挥重要作用[1]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended: September 30, 2023 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from ____ to ____ Commission file number: 0-25466 CYCLO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Nevada 59-3029743 (State or other juri ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended: June 30, 2023 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from ____ to ____ Commission file number: 0-25466 CYCLO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Nevada 59-3029743 (State or other jurisdict ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended: March 31, 2023 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from ____ to ____ Commission file number: 0-25466 CYCLO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Nevada 59-3029743 (State or other jurisdic ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark one) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2022 ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the period from ____________ to ___________ Commission file number 0-25466 CYCLO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Nevada 59-3029743 (State or other juri ...

NASDAQ: CYTH cyclotherapeutics.com Corporate Presentation 2 Forward-Looking Statements Some of the information in this presentation relates to future events or future business and financial performance. Such statements constitute forward-looking information within the meaning of the Private Securities Litigation Act of 1995. Such statements can be only predictions and the actual events or results may differ from those discussed due to, among other things, the risks described in the public filings and other ...

NASDAQ: CYTH cyclotherapeutics.com Corporate Presentation 2 Forward-Looking Statements Some of the information in this presentation relates to future events or future business and financial performance. Such statements constitute forward-looking information within the meaning of the Private Securities Litigation Act of 1995. Such statements can be only predictions and the actual events or results may differ from those discussed due to, among other things, the risks described in the public filings and other ...

NASDAQ: CYTH cyclotherapeutics.com Corporate Presentation 2 Forward-Looking Statements Some of the information in this presentation relates to future events or future business and financial performance. Such statements constitute forward-looking information within the meaning of the Private Securities Litigation Act of 1995. Such statements can be only predictions and the actual events or results may differ from those discussed due to, among other things, the risks described in the public filings and other ...