DA-1726 Also Exhibited Superior Glucose Lowering Compared to Survodutide Lipid-Lowering Effect of DA-1726 Shown to be Superior Compared to Tirzepatide Data Presented at the ADA 84th Scientific Sessions CAMBRIDGE, Mass., June 22, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on the transformation of cardiometabolic diseases, today announced pre-clinical data which indicates that DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 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 001-37809 NeuroBo Pharmaceuticals, Inc. (Exact name of Registrant as specified in its charter) Delaware 47-2389984 ( ...

Exhibit 99.1 NeuroBo Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Corporate Update Dosed First Patient in the Single Ascending Dose Part 1 of the Phase 1 Clinical Trial of DA-1726 in Obesity, With Top-Line Data Readout Expected in the Third Quarter of 2024 Anticipate First Patient to be Dosed in the Multiple Ascending Dose Part 2 of the Phase 1 Clinical Trial of DA-1726 in the Third Quarter of 2024 Part 2 of the Phase 2a Trial of DA-1241 for the Treatment of MASH Underway After ...

Dosed First Patient in the Single Ascending Dose Part 1 of the Phase 1 Clinical Trial of DA-1726 in Obesity, With Top-Line Data Readout Expected in the Third Quarter of 2024 Anticipate First Patient to be Dosed in the Multiple Ascending Dose Part 2 of the Phase 1 Clinical Trial of DA- 1726 in the Third Quarter of 2024 Part 2 of the Phase 2a Trial of DA-1241 for the Treatment of MASH Underway After Enrollment of Part 1 Completed, With Data Expected in the Fourth Quarter of 2024 Cash of $16.0 Million, Expecte ...

CAMBRIDGE, Mass., April 30, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on the transformation of cardiometabolic diseases, today announced the acceptance of poster presentations for its promising cardiometabolic assets, DA-1241 and DA- 1726, at the EASL Congress 2024 and the American Diabetes Association (ADA) 84th Scientific Sessions in June. "Having multiple posters selected for presentation at two of the most esteemed scientific forums ...

知识产权 - 公司依赖专利、商业秘密和技术创新来维持竞争地位[79] - 公司的知识产权组合包括多项专利和专利申请，涉及多个国家和地区[80] - 公司的知识产权组合中包括针对不同产品的专利和专利申请，预计到2035年至2041年间到期[80] FDA审批流程 - 公司的产品开发受到美国FDA等政府机构的广泛监管，包括临床试验、新药申请和审批等方面[85] - 临床试验通常分为三个阶段，需要提交充分的数据以证明药物的安全性和有效性[91] - 提交新药申请(NDA)给FDA后，FDA有180天进行审查，但实际审查时间可能会延长[93] - FDA可能会将新药申请提交给咨询委员会进行评估，但不一定会遵循委员会的建议[96] - FDA审批过程包括批准信和完整回应信[97] - 快速通道计划可加速药物开发和审查[99] 法规合规 - 孤儿药品法案授予孤儿药品指定七年独家营销期[104] - 儿童信息要求根据儿童研究公平法提供数据以支持药物在所有相关儿童亚群中的安全性和有效性[105] - 特殊协议评估允许公司与FDA就新药品的有效性主张形成主要基础的临床试验的设计和规模达成协议[107] - 临床试验信息披露要求赞助商在美国国家卫生研究院维护的公共网站上注册和披露某些临床试验信息[108] - 后批准要求包括记录保存、定期报告、产品抽样和分发、广告和促销以及报告产品不良事件[109] - 制造商必须继续投入时间、金钱和精力以维持GMP合规性并确保符合FDCA等其他法定要求[110] - 违规可能导致产品召回、罚款、警告信、拒绝批准待定的NDA或批准NDA补充申请、产品扣押或拘留、禁止进口或出口产品、禁令或对违规方施加民事或刑事处罚[111] - 美国药品监管法规要求公司只能针对获批适应症进行药品推广[114] - Hatch-Waxman修正案授权FDA批准与先前获批药品相同的仿制药[114] - 505(b)(2) NDA允许提交新药申请，其中部分信息来自非申请人进行的研究[115] - ANDA/505(b)(2)申请人需对FDA关于RLD的专利进行认证[116] - ANDA/505(b)(2)申请人若未挑战创新药专利，申请将等待所有专利过期后获批[119] - 专利期延长最多可达5年，取决于药物的测试和审查阶段[122] 国际市场准入 - 欧盟和其他国家的药品监管规定要求公司在开始临床试验或在这些国家市场上销售产品之前获得当地监管机构的批准[127] - 欧盟要求提交类似NDA的营销授权申请，包括关于产品制造、质量、非临床和临床试验信息[132] - 欧洲委员会为了促进在整个欧盟范围内有效的市场授权，创立了集中程序[133] - 在欧盟的集中程序中，EMA对营销授权申请的评估最长时间为210天[134] - 对于那些不适用集中程序的药品，申请人必须通过三种程序之一向国家药品监管机构提交营销授权申请[135] - 互认程序是为了促进欧盟内各国的国家营销授权而采取的一种替代方法[137] - 互认程序基于欧盟成员国的现有营销授权，以在其他欧盟成员国获得营销授权[138] - 在欧盟，新化学实体(NCEs)获得营销授权后享有八年的数据排他性和额外两年的市场排他性[140] 医疗改革影响 - 美国的医疗保健改革措施可能会对公司的产品价格和市场准入产生影响[141] - 美国的医疗改革法案对公司的产品候选人可能产生重要影响[148] - ACA以及未来可能采纳的其他医疗改革措施可能会对公司的产品价格和市场准入产生更严格的覆盖标准和价格下行压力[151] - 美国最高法院在2021年6月驳回了对ACA的最新司法挑战，未明确裁定ACA的合宪性[152] 公司信息 - 公司的主要目标是通过股票和现金激励计划来吸引、留住和奖励员工，以提高股东价值和公司的成功[157] - NeuroBo成立于2014年，总部位于马萨诸塞州剑桥市，公司网站为www.neurobopharma.com[159] 风险管理 - 公司存在市场风险，包括战略和运营风险，如果未能进行业务运营或筹集足够的股本和/或债务融资，可能会出现机会或威胁[484] - 公司的财务交易中存在着与美元不同的货币，因此其经营业绩受到货币交易风险的影响[485] - 公司目前没有针对外汇汇率的套期保值协议，也没有购买任何工具来对冲可能的货币风险[486]

Exhibit 99.1 NeuroBo Pharmaceuticals Reports Year End 2023 Financial Results and Provides Corporate Update Received First Site Institutional Review Board (IRB) Approval to Proceed With the Phase 1 Trial of DA-1726 in Obesity Phase 1 Trial of DA-1726 Expected to Dose First Patient in Second Quarter of 2024 Received Safety Review Committee (SRC) Approval Recommending That the Two-Part Phase 2a Trial of DA-1241 for the Treatment of MASH Continue Without Modification Data from the Phase 2a Trial of DA-1241 Expe ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) ☒ 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 001-37809 NeuroBo Pharmaceuticals, Inc. (Exact name of Registrant as specified in its charter) Delaware 47-23899 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) ☒ 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 001-37809 NeuroBo Pharmaceuticals, Inc. (Exact name of Registrant as specified in its charter) Delaware 47-2389984 (S ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) ☒ 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 001-37809 NeuroBo Pharmaceuticals, Inc. (Exact name of Registrant as specified in its charter) Delaware 47-2389984 ( ...