Group 1 - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through innovative therapeutics [4] - The company will host a conference call on June 9, 2025, to report topline data from the SHIELD II Phase 3 trial for D-PLEX100, aimed at preventing surgical site infections in abdominal colorectal surgery [1][2] - D-PLEX100 is currently in Phase 3 clinical trials, while PolyPid is also testing OncoPLEX for solid tumors, starting with glioblastoma [4] Group 2 - The conference call is scheduled for 8:30 AM Eastern Time, and participants are encouraged to register at least 5 minutes prior to the call [2][3] - PolyPid's proprietary PLEX technology allows for controlled, prolonged-release of drugs, enhancing the delivery of Active Pharmaceutical Ingredients [4]

Core Insights - PolyPid Ltd. is positioned at a pivotal moment in the surgical site infection (SSI) prevention market, with the upcoming topline results from the SHIELD II Phase 3 trial expected by the end of Q2 2025 [3][12] - The company's D-PLEX100 technology utilizes a novel polymer-lipid encapsulation matrix (PLEX) for localized antibiotic delivery, potentially transforming surgical care practices [3][7] Company Overview - PolyPid Ltd. is a late-stage biopharmaceutical company focused on developing localized drug delivery technologies aimed at preventing surgical infections [1] - The D-PLEX100 product is designed to release antibiotics directly at surgical sites for 30 days, addressing a significant unmet medical need in the market [3][8] Market Context - Surgical site infections account for 20% of healthcare-associated infections in US hospitals, with rates in high-risk procedures like colorectal surgery reaching up to 30% [5] - The economic burden of SSIs is substantial, with direct costs per infection ranging from $11,000 to $26,000 and total annual costs in the US estimated at approximately $10 billion [5] Technology and Innovation - The PLEX technology allows for controlled drug release, embedding active pharmaceutical ingredients within layers of biocompatible polymers and lipids [7] - D-PLEX100 achieves local antibiotic concentrations 10-115 times higher than traditional systemic administration, potentially reducing systemic exposure and side effects [8] Clinical Development - In Phase 2 trials, D-PLEX100 demonstrated a 59% reduction in SSIs compared to standard care, with zero deaths in the treatment group [9] - The SHIELD I Phase 3 trial showed a 54% reduction in SSIs among patients with large surgical incisions, informing the design of the ongoing SHIELD II trial [10][12] Regulatory Recognition - D-PLEX100 has received Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product (QIDP) designations from the FDA, highlighting its potential significance in addressing serious conditions [11] Broader Implications - The success of D-PLEX100 could lead to wider adoption of localized drug delivery systems in surgical settings and potential applications in localized chemotherapy through the OncoPLEX program [14] - The market opportunity is significant, with approximately 12 million eligible procedures annually in the US and 8 million in Europe [15] Conclusion - The approaching data readout for D-PLEX100 represents a critical milestone in the fight against antimicrobial resistance and the search for cost-effective solutions in surgical infection prevention [16]

Summary of PolyPid (PYPD) Conference Call Company Overview - PolyPid is a clinical-stage biopharmaceutical company focused on drug delivery platforms, specifically the PLEX (polymer lipid encapsulation metrics) technology [2][4] - The company is based in Israel and has capabilities in R&D, regulatory, clinical, and manufacturing [4] PLEX Technology - PLEX allows for the prolonged release of various active pharmaceutical ingredients (APIs) over days to months, significantly longer than competitors who offer 72 to 96 hours [3] - The lead product, DIPLEX 100, is nearing the end of Phase 3 trials, with data expected by the end of the current quarter [3][16] DIPLEX 100 Product Details - DIPLEX 100 combines the PLEX platform with doxycycline to prevent surgical site infections (SSIs) post-abdominal surgeries [7][10] - The product is designed for a 30-day release, aligning with CDC guidelines for SSIs [11] - The total addressable market includes approximately 12 million procedures annually in the U.S. and 8 million in Europe [11][24] Clinical Trials and Results - The Phase 3 trial (SHIELD 2) involves 800 patients comparing DIPLEX 100 with standard IV antibiotics [16][18] - Previous trial (SHIELD 1) showed a 55% reduction in infection rates, 40% reduction in mortality, and 55% reduction in reintervention rates [22] - The trial is designed to meet both FDA and EMEA requirements, with plans for simultaneous filings in the U.S. and Europe [24] Commercial Strategy - The pricing strategy is approximately $600 per vial, with an average of 2.2 vials used per procedure [25] - The company is targeting hospitals directly, as they bear the costs of infections, which can be substantial [26][28] - PolyPid has partnered with Advanced Pharma for European commercialization, valued at over $110 million [30] Financial Position - The company ended the last quarter with $8 million, sufficient to fund operations through Q3 [34] - There are $27 million in warrants tied to trial success, with additional potential funding from commercial partners [35][47] Future Directions - Post-trial, resources will be allocated to other products like OncoPlex, which combines PLEX with chemotherapy for solid tumors [41][42] - The company is exploring additional applications for the PLEX platform in various local treatments [44] Key Takeaways - PolyPid is positioned to address a significant market need with its innovative DIPLEX 100 product, backed by promising clinical trial results and a solid commercialization strategy [11][22][30] - The financial structure appears robust, with multiple avenues for funding and a clear path to market entry following successful trial outcomes [35][47]

Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through innovative therapeutics [4] - The company utilizes its proprietary PLEX technology for controlled, prolonged-release of drugs, enabling precise delivery over several days to months [4] - PolyPid's lead product candidate, D-PLEX100, is currently in Phase 3 clinical trials aimed at preventing abdominal colorectal surgical site infections [4] Upcoming Events - PolyPid will participate in the Lytham Partners Spring 2025 Investor Conference, with a webcast presentation scheduled for May 29, 2025, at 10:15 a.m. ET [2] - The webcast will be accessible via the conference homepage and will be available for replay after the event [2] - Management will also engage in virtual one-on-one meetings with investors during the conference [3]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had cash and cash equivalents of $8 million, which is expected to fund operations into the third quarter of 2025 [16] - Research and development expenses for Q1 2025 were $6.1 million, up from $5.1 million in the same period of 2024, driven by the ongoing SHIELD II Phase III trial [17] - The net loss for Q1 2025 was $8.3 million, compared to a net loss of $6.4 million in Q1 2024 [17] Business Line Data and Key Metrics Changes - The SHIELD II Phase III trial for DPLEX100 has successfully concluded enrollment with 800 patients, following a recommendation from the Data Safety Monitoring Board [7][8] - The company anticipates top line data availability by the end of next month, with plans for NDA submission in early 2026 [8][9] Market Data and Key Metrics Changes - The total addressable market for DPLEX100 in the U.S. is estimated at over 12 million surgeries annually, with approximately 4.4 million being abdominal soft tissue surgeries [12] - Recent market research identified four groups of surgeons as potential users for DPLEX100, indicating a significant unmet need in high-risk surgical procedures [13] Company Strategy and Development Direction - The company is focused on identifying a U.S. partner with an existing dedicated hospital product sales force to maximize DPLEX100's sales potential [10] - An exclusive licensing agreement is already in place with Advanced Pharma for commercialization in Europe, with pre-launch activities being planned [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term prospects of DPLEX100 and is preparing for regulatory submissions while awaiting SHIELD II trial results [51] - The company is actively engaging in partnership discussions in the U.S. as interest in DPLEX100 is gaining momentum [15] Other Important Information - The company is in the finalization stages of CMC and nonclinical NDA modules, with plans for a pre-NDA meeting with the FDA [30][32] - The company plans to conduct several mock inspections to prepare for FDA review [43] Q&A Session Summary Question: Pricing strategy for DPLEX100 - Management has not finalized the pricing strategy but is considering a preliminary price of $600 per vial, with an average usage of 2.5 vials per procedure [21] Question: NDA filing requirements - The NDA will consist of three modules, with the company preparing the CMC and preclinical data while working on the clinical module post top line data [29][30] Question: Expectations for top line data - The company expects to report both primary and key secondary endpoints upon unblinding the data, with plans for an investor call shortly after [41][36] Question: Inspection readiness and capacity - The company is prioritizing inspection readiness and believes its facility will be sufficient for the first four to five years post-launch [44]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had cash and cash equivalents of $8 million, which is expected to fund operations into the third quarter of 2025 [15] - Research and development expenses for Q1 2025 were $6.1 million, up from $5.1 million in Q1 2024, driven by the ongoing SHIELD II Phase III trial [16] - The net loss for Q1 2025 was $8.3 million, compared to a net loss of $6.4 million in Q1 2024 [16] Business Line Data and Key Metrics Changes - The company is focused on the SHIELD II Phase III trial for DPLEX100, which has recently concluded enrollment with 800 patients, following a recommendation from the Data Safety Monitoring Board [5][6] - The anticipated top line data from the SHIELD II trial is expected by the end of the current quarter [15] Market Data and Key Metrics Changes - The total addressable market for DPLEX100 in the U.S. is estimated to be over 12 million surgeries annually, with approximately 4.4 million being abdominal soft tissue surgeries [11] - The company identified four groups of surgeons as potential users for DPLEX100, indicating a significant market opportunity [12] Company Strategy and Development Direction - The company aims to submit a New Drug Application (NDA) in early 2026, with preparations for regulatory submissions already underway [7][8] - The strategy includes finding a U.S. partner with an existing dedicated hospital product sales force to maximize sales potential [9][13] - An exclusive licensing agreement is already in place with Advanced Pharma for commercialization in Europe [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term prospects of DPLEX100 and the potential to transform the surgical landscape [47] - The company is actively preparing for regulatory submissions and engaging in partnership discussions as they await SHIELD II trial results [8][13] Other Important Information - The company has received Fast Track and Breakthrough Therapy designations for DPLEX100, which may expedite the regulatory process [7] - The company is in advanced discussions with multiple potential partners in the U.S. as they approach pivotal data readout [13] Q&A Session Summary Question: Pricing strategy for DPLEX100 - Management has not finalized the pricing strategy but anticipates an average of 2.5 vials per procedure at a preliminary price of $600 per vial [20] Question: NDA filing requirements - The NDA will consist of three modules, with the company currently finalizing the CMC and preclinical modules [27] Question: Expectations for top line data - The company expects to report both primary and key secondary endpoints upon unblinding the data [32] Question: Inspection readiness for commercial manufacturing - The company is preparing for FDA inspections and plans to conduct several mock inspections prior to the review [40] Question: Comparison of SSI data pre-COVID and post-COVID - The CDC reported a 3% increase in SSIs in 2023 compared to 2022, marking the first uptick since the COVID pandemic [42]

Financial results for three months ended March 31, 2025 PolyPid Successfully Completed Enrollment in Phase 3 SHIELD II Trial of D-PLEX100, with Top-Line Results Anticipated in Current Quarter Company Continues to Advance Regulatory Submission Preparations, Commercial Launch Preparations and Partnering Discussions Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, May 14, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aim ...

Core Viewpoint - PolyPid Ltd. is set to report its first quarter 2025 financial results and operational highlights on May 14, 2025, with a conference call scheduled for 8:30 AM Eastern Time to discuss these results and provide business updates [1]. Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through its proprietary PLEX technology, which allows for controlled, prolonged-release of therapeutics [4]. - The lead product candidate, D-PLEX100, is currently in Phase 3 clinical trials aimed at preventing abdominal colorectal surgical site infections [4]. - The company is also in preclinical stages testing OncoPLEX for treating solid tumors, starting with glioblastoma [4]. Conference Call Details - The conference call will take place on May 14, 2025, at 8:30 AM Eastern Time, and participants are encouraged to register at least 5 minutes prior to the call [2][3]. - For those not asking questions, listening via the webcast is recommended [2].

Group 1 - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through innovative drug delivery systems [2] - The company utilizes its proprietary PLEX technology for controlled, prolonged-release therapeutics, allowing for precise drug delivery over extended periods [2] - PolyPid's lead product candidate, D-PLEX100, is currently in Phase 3 clinical trials aimed at preventing abdominal colorectal surgical site infections [2] Group 2 - The company is also in preclinical stages testing OncoPLEX for the treatment of solid tumors, starting with glioblastoma [2] - PolyPid management will participate in a fireside chat at The Citizens Life Sciences Conference in New York on May 7, 2025 [1] - Investors interested in meeting with PolyPid during the conference can contact their Citizens JMP representative [1]

Core Insights - PolyPid Ltd. has successfully completed enrollment in the SHIELD II Phase 3 trial for D-PLEX100, aimed at preventing surgical site infections in abdominal colorectal surgery patients [1][2][3] - The company anticipates reporting top-line results by the end of Q2 2025 and plans to submit a New Drug Application (NDA) to the FDA if the results are positive [2][3] - D-PLEX100 utilizes PLEX technology for prolonged and controlled release of doxycycline, targeting surgical site infections, and has received multiple FDA designations [5][6] Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through locally administered therapeutics [6] - The company is also in preclinical stages testing OncoPLEX for solid tumors, starting with glioblastoma [6] SHIELD II Trial Details - The SHIELD II trial is a multinational, randomized, double-blind Phase 3 study assessing the efficacy and safety of D-PLEX100 compared to standard of care in preventing post-surgical infections [4] - The primary endpoint is the proportion of subjects with surgical site infection events within 30 days post-surgery [4]