Charles E. Edmiston, Ph.D., Emeritus Professor of Surgery, Medical College of Wisconsin, to discuss the significant unmet medical need in surgical site infections preventionCompany to Provide an Update on SHIELD II Phase 3 Study Enrollment During Event PETACH TIKVA, Israel, June 10, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it will host a virtual Key Opinion Leader (KOL) event on ...

Charles E. Edmiston, Ph.D., Emeritus Professor of Surgery, Medical College of Wisconsin, to discuss the significant unmet medical need in surgical site infections preventionCompany to Provide an Update on SHIELD II Phase 3 Study Enrollment During Event PETACH TIKVA, Israel, June 10, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it will host a virtual Key Opinion Leader (KOL) event on ...

财务数据和关键指标变化 - 截至2024年3月31日,公司现金及短期存款为1450万美元,相比2023年底的530万美元有大幅增加,主要来自于2024年1月进行的1600万美元的私募融资 [20] - 2024年第一季度研发费用为510万美元,相比2023年同期的380万美元有所增加,主要是由于SHIELD II III期临床试验的推进 [21] - 2024年第一季度市场及业务发展费用为23.6万美元,相比2023年同期的38.5万美元有所下降,反映了公司的成本控制努力 [22] - 2024年第一季度管理费用为100万美元,相比2023年同期的160万美元有所下降 [22] - 2024年第一季度公司净亏损为640万美元,相比2023年同期的610万美元有所增加 [22] 各条业务线数据和关键指标变化 - 公司目前主要专注于D-PLEX100的SHIELD II III期临床试验,尚未有其他业务线的相关数据和指标变化 各个市场数据和关键指标变化 - SHIELD II III期临床试验已在美国、德国、意大利、爱尔兰、葡萄牙、匈牙利和以色列等多个国家开展,目前已有约50家中心参与 [7][31] - 预计在试验高峰期每月将有约90名患者入组,与SHIELD I试验的入组速度相当 [8] - SHIELD II试验入组的患者人群特征,如年龄中位数、男女比例和癌症患者占比等,与SHIELD I大切口亚组的患者特征相似,这是一个积极的信号 [9] 公司战略和发展方向及行业竞争 - 公司有明确的监管路径,FDA已确认SHIELD I的结果可为D-PLEX100的安全性和有效性提供支持性证据,并表示SHIELD II成功将足以支持新药申请提交 [13] - 公司拥有近175项已授权和待批专利,其中包括大量针对D-PLEX100预防手术部位感染的长期专利保护,如D-PLEX100手术部位感染专利预计将在2035年前有效 [14][15] - 公司正在积极推进OncoPLEX肿瘤适应症的临床前研究,这是公司管线的第二大优先方向 [34][35][36] 管理层对经营环境和未来前景的评论 - 公司对SHIELD II试验的顺利推进以及最终结果持乐观态度,认为这是一个去风险的III期试验 [10] - 公司已加强临床运营团队,并利用SHIELD I试验的经验选择了最佳的参与中心,这有助于SHIELD II的成功执行 [11] - 数据安全监测委员会两次建议继续SHIELD II试验而无需修改,表明至今未观察到D-PLEX100的安全性问题 [12] - 公司有望在2025年上半年提交D-PLEX100的新药申请,并在2025年底获得FDA批准 [28][29] - 公司正在为未来管线拓展做准备,包括肿瘤适应症OncoPLEX的临床前研究 [34][35][36] 问答环节重要的提问和回答 问题1 **Roy Buchanan 提问** 请详细说明D-PLEX100新药申请的时间线,包括预计的FDA审评时间 [25] **Ori Warshavsky 回答** - SHIELD II预计在今年中期完成400例患者的中期分析,结果将在今年秋季公布 - 如果顺利,公司将继续完成600例患者的入组,预计在今年底完成 - 公司计划在2025年上半年提交新药申请,并在2025年底获得FDA批准 [27][28] - 公司也在同步推进在欧洲的上市申请,预计将紧随美国市场 [29] 问题2 **Roy Buchanan 提问** 请详细说明SHIELD II试验的地理分布情况,以及未来新增中心的计划 [30] **Ori Warshavsky 回答** - SHIELD II试验目前已在美国、德国、意大利、爱尔兰、葡萄牙、匈牙利和以色列等国家开展,每个国家大约有3-5个中心 - 美国中心数量相对较多,其他国家则以东欧国家为主 - 这种广泛的地理分布有助于数据的一致性和可重复性 [31][32] 问题3 **Roy Buchanan 提问** 如果SHIELD II成功,公司是否有计划尽快推进管线其他产品,特别是OncoPLEX? [33] **Ori Warshavsky 回答** - 目前D-PLEX100是公司的最优先项目,但公司也高度重视OncoPLEX肿瘤适应症 - 公司已与FDA进行了成功的IND前沟通,为I/II期临床试验做好准备 - 公司正在深入评估管线的整体优先次序,希望在D-PLEX100SHIELD II结果公布后能够尽快推进OncoPLEX等其他产品 [34][35][36]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANTTO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission ...

PolyPid Ltd (NASDAQ:PYPD) Q4 2023 Earnings Call Transcript February 14, 2024 8:30 AM ET Company Participants Brian Ritchie - IR Dikla Czaczkes Akselbrad - CEO & Director Jonny Missulawin - Chief Financial Officer Conference Call Participants Roy Buchanan - JMP Boobalan Pachaiyappan - HC Wainwright Operator Greeting morning and welcome to the PolyPid Fourth Quarter and Full Year 2023 Conference Call. At this time, all participants are in a listen-only mode. As a reminder, this call is being recorded. And I ...

PolyPid Ltd. (NASDAQ:PYPD) Q3 2023 Earnings Conference Call November 11, 2023 8:00 AM ET Company Participants Dikla Czaczkes Akselbrad - Chief Executive Officer Jonny Missulawin - Chief Financial Officer Ori Warshavsky - Chief Operating Officer Conference Call Participants Roy Buchanan - JMP Raghuram Selvaraju - H.C. Wainwright Operator Thank you all for participating in PolyPid's third quarter 2023 earnings conference call. Joining me on the call today will be Dikla Czaczkes Akselbrad, Chief Executive Offi ...

PolyPid Ltd (NASDAQ:PYPD) Q2 2023 Earnings Conference Call August 9, 2023 8:30 AM ET Company Participants Brian Ritchie - LifeSci Advisors Dikla Akselbrad - CEO & Director Jonny Missulawin - CFO Ori Warshavsky - COO Conference Call Participants Douglas Buchanan - JMP Securities Operator Greetings, and welcome to the PolyPid Second Quarter 2023 Conference Call. [Operator Instructions]. And I would now like to introduce your host for today's conference, Brian Ritchie, from LifeSci Advisors. Mr. Ritchie, you ...

| --- | --- | --- | |------------------------|-------|-------| | | | | | | | | | P&LYPID | | @ | | OPTIMIZED THERAPEUTICS | | | | Q1 2022 EARNINGS CALL | | | Forward looking statement This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward ...

PolyPid Ltd. (NASDAQ:PYPD) Q1 2023 Earnings Conference Call May 10, 2023 8:30 AM ET Company Participants Brian Ritchie - LifeSci Advisors Dikla Czaczkes Akselbrad - Chief Executive Officer Jonny Missulawin - Chief Financial Officer Ori Warshavsky - Chief Operating Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald Roy Buchanan - JMP Securities Operator Greetings, and welcome to the PolyPid First Quarter 2023 Conference Call. At this time participants are in a listen-only mode. As a remi ...

Exhibit 99.2 POLYPID LTD. PETACH TIKVA, ISRAEL PROXY STATEMENT ANNUAL AND EXTRAORDINARY GENERAL MEETING OF SHAREHOLDERS TO BE HELD ON MAY 5, 2023 The enclosed proxy is being solicited by the board of directors (the “Board of Directors”) of PolyPid Ltd. (the “Company”) for use at the Company’s annual and extraordinary general meeting of shareholders (the “Meeting”) to be held on May 5, 2023, at 2:00 p.m. Israel time, or at any adjournment or postponement thereof. Upon the receipt of a properly executed proxy ...