The Company Anticipates that with this Additional Funding, PolyPid’s Runway would be Extended beyond Anticipated U.S. Food and Drug Administration (“FDA”) Approval of D-PLEX₁₀₀.The Company Recently Announced Successful Topline Results from its Phase 3 SHIELD II Trial; D-PLEX₁₀₀ Demonstrated a Statistically Significant Reduction in Surgical Site Infections (“SSIs”) and Successfully Met the Study’s Primary Endpoint and all Key Secondary Endpoints. PETACH TIKVA, Israel, June 17, 2025 (GLOBE NEWSWIRE) -- PolyPi ...

On June 9th, PolyPid Ltd.* announced landmark topline results from its pivotal SHIELD II Phase 3 trial, demonstrating that D-PLEX100 achieved statistically significant reductions across all primary and secondary endpoints in preventing surgical site infections (SSIs). The study's compelling efficacy profile—including a 58% reduction in SSIs, 38% reduction in the composite primary endpoint, and 62% reduction in severe wound infections—validates the company's innovative PLEX technology platform and positions ...

On June 9th, PolyPid Ltd.* announced landmark topline results from its pivotal SHIELD II Phase 3 trial, demonstrating that D-PLEX100 achieved statistically significant reductions across all primary and secondary endpoints in preventing surgical site infections (SSIs). The study's compelling efficacy profile—including a 58% reduction in SSIs, 38% reduction in the composite primary endpoint, and 62% reduction in severe wound infections—validates the company's innovative PLEX technology platform and positions ...

Cautionary Note Regarding Forward Looking Statements This presentation of PolyPid Ltd. (the "Company") 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-looking statements. For example, the Company is using forward-looking statements when it discusses ...

PolyPid (PYPD) Update / Briefing June 09, 2025 08:30 AM ET Speaker0 Greetings and welcome to Polyvich Shield II Top Line Results Conference Call. At this time, participants are in a listen only mode. As a reminder, this call is being recorded. And I would now like to introduce your host for today's conference, Brian Ritchie from LifeSci Advisors. Mr. Ritchie, you may begin. Speaker1 Thank you all for participating in Polypede's conference call discussing the top line results of the SHIELD II Phase III trial ...

In a call hosted today, June 9, 2025, PolyPid Ltd. unveiled highly successful topline results from its SHIELD II Phase 3 trial of D-PLEX100 for preventing surgical site infections (SSIs) in abdominal colorectal surgery patients with large incisions. The double-blind trial of 798 patients achieved statistical significance across all endpoints, demonstrating a 38% reduction in the primary composite endpoint and a remarkable 58% reduction in SSI rates from 9.5% to 3.8% compared to standard care alone. These ...

PETACH TIKVA, Israel, June 06, 2025 (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 conference call and webcast to report topline data for the SHIELD II Phase 3 trial, evaluating D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, on Monday, June 9, at 8:30 a.m. ET. To ensure you are connected prior to the beginning o ...

New York, May 30, 2025 (GLOBE NEWSWIRE) -- PESG Research is releasing a report  today examining PolyPid Ltd.*, an innovative late-stage biopharmaceutical company developing revolutionary localized drug delivery technologies for surgical infection prevention. The below report explores the company's breakthrough PLEX platform technology, its upcoming topline phase 3 data, and potential implications for transforming surgical care practices in the multi-billion dollar surgical site infection prevention market. ...

纪要涉及的公司 PolyPid（股票代码PYPD）是一家临床阶段的生物制药公司，拥有药物递送平台PLEX [2]。 核心观点和论据 1. **PLEX平台优势**：PLEX能将多种类型的活性药物成分（APIs）转化为局部高浓度、长时间释放的形式，释放时长可达数天、数周甚至数月，而部分竞争对手仅能实现72 - 96小时的局部释放 [3]。 2. **DIPLEX 100产品特点** - **作用机制**：结合Plex平台与多西环素，用于预防腹部手术部位感染（SSIs），属于医院获得性感染范畴 [7]。 - **市场独占性**：拥有505(b)(2)批准，可获得3年市场独占权，还有突破性疗法、快速通道和合格传染病产品（QIDP）指定，额外获得5年市场独占权，总计8年半（含6个月儿科扩展） [10]。 - **释放定制**：定制为30天的延长释放，与CDC关于手术部位感染的指南一致，为患者提供全程保护 [11]。 - **市场规模**：美国可寻址市场接近1200万例手术，欧洲为800万例手术 [11][24]。 - **使用方式**：手术结束时，医生将粉末状的Diplex与盐水混合成糊状物，直接涂抹在切口上，一次性给药，无需重新涂抹或清洗，随后30天持续释放药物 [14][15]。 3. **临床进展** - **Shield 2试验**：处于III期最后阶段，800名患者参与，比较标准护理（静脉注射抗生素）与在标准护理基础上加用DeepLex的效果，观察感染、再干预和死亡率的降低情况，以及30天的安全性评估 [16]。 - **试验进度**：最后一名患者于3月11日入组，30天评估于4月11日完成，60天随访于5月10 - 11日完成，预计本季度末（6月）公布顶线结果 [17][18]。 - **过往试验结果**：2022年完成的Shield 1试验中，产品在主要终点上显示出超过50%的降低效果，感染降低55%，死亡率降低40%，再干预降低55% [22]。 - **高风险患者效果**：在高风险患者（如吸烟者、高BMI、糖尿病患者）中，产品也表现良好，p值很低 [23]。 4. **商业计划** - **审批计划**：Shield 2试验设计符合FDA和EMEA要求，将先申请FDA批准，随后申请欧洲批准，欧洲当局已表示将根据结直肠切除术数据给予所有腹部手术的广泛标签 [24]。 - **定价与用量**：每瓶约600美元，小切口用1瓶，中等切口用2瓶，超过20厘米的大切口用3瓶，平均每次手术约2.2瓶 [25]。 - **市场推广**：通过向医院展示产品预防感染、降低成本的优势，以及利用CMS的NTAP计划为医院报销高达75%的药物成本，促进产品使用 [26][28][29]。 - **合作伙伴**：在欧洲与Advanced Pharma合作，交易价值超过1000万美元，包括预付款、里程碑付款和特许权使用费，还在寻找美国等其他市场的合作伙伴 [30]。 5. **其他产品管线** - **OncoPlex**：结合Plex平台与化疗药物，针对实体肿瘤，已与FDA就胶质母细胞瘤进行了临床前会议，FDA建议其可作为胶质母细胞瘤切除术后的一线治疗，下一步将进行一些临床前研究 [42]。 - **与Immunogenesis合作**：将其STING激动剂分子与rPlex结合，直接注射到肿瘤中，实现数周的高浓度分子延长释放，避免静脉注射的全身毒性，目前处于早期阶段，预计今年晚些时候报告进展 [33][34]。 6. **财务状况**：第一季度末现金为800万美元，足以支撑到今年第三季度，试验已全额资助。还有2700万美元的认股权证在顶线结果公布后10天到期，若试验成功，还将获得欧洲合作伙伴的预付款，这些资金将支持到新药申请（NDA）提交和批准 [34][35][36]。 其他重要但可能被忽略的内容 1. **生产能力**：公司在以色列拥有自己的完全符合GMP标准的制造套件，已通过欧洲检查，可用于欧洲商业制造，将在NDA过程中接受FDA检查，并有产能扩张计划 [31][32]。 2. **合作兴趣**：过去几个月对产品感兴趣的公司增多，已有几家公司进行尽职调查，还有一些公司等待数据公布后加入，目标是在年底前宣布合作协议 [39][40]。

PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdom ...