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: 001-38556 ENTERA BIO LTD. (Exact name of Registrant as specified in its charter) Israel Not applicable (State or othe ...

Entera公司产品及发展 - Entera是一家临床阶段的生物制药公司，专注于口服大分子治疗药物的开发，包括肽类和治疗蛋白[13] - 目前有两个处于临床阶段的产品候选药物：EB613和EB612，分别用于骨质疏松症和甲状旁腺功能减退症[15] - EB613和EB612是合成人类PTH（1-34）（特里帕肽）的首个一日一次迷你片剂制剂，具有不同的药代动力学（PK）特性[18] - 目标是开发首个口服迷你片剂肽类治疗药物，改变治疗范式，为患者提供注射免费的治疗方式[20] - EB613是首个一日一次骨代谢促进迷你片剂，用于骨质疏松症治疗，已通过第二阶段试验并计划在2023年下半年启动第三阶段试验[20] - EB612新制剂将作为首个一日一次PTH迷你片剂用于治疗甲状旁腺功能减退症，已获得孤儿药物认定[21] - 公司计划与生物制药公司合作，探索全球和区域发展和商业合作伙伴关系，以降低后期项目风险[22] - 公司打算利用技术平台开发额外的产品，应用于已获FDA批准的可注射蛋白质治疗药物的开发[23] - EB613和EB612口服PTH片剂已在两个阶段1研究中安全地给予72名健康受试者，无严重不良事件报告[35] - EB613每日片剂的PK特性表现为血浆PTH(1-34)水平的快速增加，30分钟内达到峰值，然后迅速下降，血液半衰期小于五分钟[37] 监管和市场环境 - 美国食品药品监督管理局（FDA）批准孤儿药品后，只有第一个获得该药品孤儿适应症批准的赞助商将获得市场排他性[122] - 孤儿药品指定不会缩短药物开发时间或监管审查时间，也不会在监管审查或批准过程中给予药物任何优势[123] - 美国《生物类似药品价格竞争与创新法案》（BPCIA）授权FDA批准生物类似药品和可互换的生物类似药品[125] - FDA必须在批准生物类似药品时确定参考产品和拟议生物类似药品在安全性、纯度和效力方面没有临床意义上的差异[126] - 生物类似药品的申请必须在参考产品获得批准后的四年后提交给FDA[127] - 美国专利局（USPTO）会与FDA协商审批任何专利期延长或恢复的申请[128] - 在美国以外市场产品，公司必须遵守其他国家和司法管辖区的质量、安全和功效的监管要求[129] - 欧洲药品管理局（EMA）负责评估和监测新药和生物药品的申请，以及提供科学建议给赞助商[130] - 在欧盟，药品的批准过程与美国大致相同，包括实验室测试、动物研究、临床试验和制造设施检查等步骤[131] - 在欧盟，药品的临床试验需遵守临床试验指令，必须获得当地主管机构和伦理委员会的批准[134] - 在欧盟，获得药品上市许可后，新化学实体可获得8年数据排他性和额外2年市场排他性[147] - 获得药品在欧盟的授权后，必须遵守制造、市场营销、推广和销售药品的一系列要求[148]

Entera Bio Ltd. (NASDAQ:ENTX) Q1 2022 Earnings Conference Call May 17, 2022 8:00 AM ET Company Participants Spiros Jamas - Chief Executive Officer Miranda Toledano - Chief Business Officer, Chief Financial Officer & Head of Strategy Arthur Santora - Chief Medical Officer Conference Call Participants Kalpit Patel - B. Riley Nathan Weinstein - Aegis Capital Operator Greetings, and welcome to Entera Bio's First Quarter '22 Update Conference Call. At this time, all participants are in a listen-only mode. The qu ...

1 Entera Bio Investor Presentation March 2022 Forward-Looking Statements 2 This presentation includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward- looki ...

Entera Bio Ltd. (NASDAQ:ENTX) Q4 2021 Earnings Conference Call March 8, 2022 8:30 AM ET Company Participants Ramesh Ratan - CFO Spiros Jamas - CEO Arthur Santora - CMO Phillip Schwartz - Founder & President, R&D Conference Call Participants Kalpit Patel - B. Riley Nathan Weinstein - Aegis Capital Operator Greetings and welcome to the Entera Bio's Fourth Quarter and Year-End 2021 Earnings Call. At this time, all participants are in a listen-only mode. The question-and-answer session will follow the formal pr ...

Entera Bio Ltd. (NASDAQ:ENTX) Q2 2021 Earnings Conference Call August 16, 2021 8:30 AM ET Company Participants Spiros Jamas - CEO Ramesh Ratan - US-based CFO Arthur Santora - CMO Phillip Schwartz – President, R&D Conference Call Participants Kalpit Patel – B. Riley Financial, Inc. Operator Good morning, and welcome to Entera Bio's Conference Call to discuss the Financial and Operating Results for the six months Ended June 30, 2021. At this time, all participants are in a listen-only mode. After the speakers ...

Entera Bio Ltd. (NASDAQ:ENTX) Q4 2020 Earnings Conference Call March 18, 2021 8:30 AM ET Company Participants Jon Lieber – US-based Chief Financial Officer Spiros Jamas – Chief Executive Officer Art Santora – Chief Medical Officer Phillip Schwartz – President-R&D Conference Call Participants Jason McCarthy – Maxim Group Calvin Hori – Hori Capital Operator Good morning, and welcome to Entera Bio's Conference Call to discuss the Financial and Operating Results for the Year Ended December 31, 2020. At this tim ...

Entera Bio Ltd. (NASDAQ:ENTX) Q3 2020 Earnings Conference Call November 19, 2020 8:30 AM ET Company Participants Jon Lieber - U.S. Chief Financial Officer Roger Garceau - Interim CEO Phillip Schwartz - President of R&D Arthur Santora - Chief Medical Officer Conference Call Participants Operator Good morning, and welcome to Entera Bio's Conference Call to discuss the Financial and Operating Results from the Third Quarter of 2020. At this time, all participants lines are in a listen-only mode. After the speak ...

Entera Bio Ltd. (NASDAQ:ENTX) Q2 2020 Results Conference Call August 20, 2020 8:30 AM ET Company Participants Jon Lieber - U.S. CFO, Entera Roger Garceau - Interim CEO Dr. Phillip Schwartz - President of R&D Arthur Santora - Chief Medical Officer Conference Call Participants Brett Hoffman - Maxim Group Operator Good morning and welcome to Entera Bio's Conference Call to discuss the Interim Six Month Results from the EB613 Phase 2 Clinical Trial and the Financial and Operating Results from the Second Quarter ...

Call Start: 08:30 January 1, 0000 8:56 AM ET Entera Bio Ltd. (NASDAQ:ENTX) Q1 2020 Results Earnings Conference Call May 21, 2020, 08:30 AM ET Company Participants Jonathan Lieber - U.S. CFO, Entera Adam Gridley - CEO Phillip Schwartz - President of R&D Arthur Santora - Chief Medical Officer Conference Call Participants Operator Good morning and welcome to Entera BioÂ's Conference Call to discuss the Interim Biomarker Data from the Phase 2 clinical trial of EB613 and the Financial and Operative Results from ...