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. ...

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]

PolyPid (PYPD) Q1 2025 Earnings Call May 14, 2025 08:30 AM ET Company Participants Brian Ritchie - Managing DirectorDikla Akselbrad - CEOOri Warshavsky - Chief Operating Officer - USJonny Missulawin - Chief Financial Officer Conference Call Participants Roy Buchanan - Equity Research AnalystChase Knickerbocker - Senior Equity Research Analyst - HealthcareBoobalan Pachaiyappan - Managing Director, Senior Research Analyst Operator and thank you for standing by. Welcome to the Polypede First Quarter twenty twe ...

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]

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].

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]