Efficacy Results - The primary efficacy endpoint showed a statistically significant reduction of 38% (p<0.005) in the D-PLEX100 + SOC group (10.9%, n=405) compared to the SOC group (18.1%, n=393) [15] - Surgical Site Infection (SSI) rate was reduced by 58% (p<0.005) in the D-PLEX100 + SOC group (3.8%, n=391) compared to the SOC group (9.5%, n=377) [18] - The combined efficacy endpoint in the overall study population showed a 36% reduction (p<0.005) in the D-PLEX100 + SOC group (11.1%, n=487) compared to the SOC group (17.4%, n=488) [21] - ASEPSIS Score >20 was reduced by 62% (p<0.05) in the D-PLEX100 + SOC group (2.0%, n=391) compared to the SOC group (5.6%, n=377) [25] Study Design and Patient Population - The study was a prospective, multinational, randomized, controlled, two-arm, double-blind trial assessing D-PLEX100 in preventing post-abdominal surgery incisional infections [6] - The trial included approximately 60 sites in the US, Europe, and Israel [6] - The ITT cohort consisted of 798 patients undergoing elective abdominal colorectal surgery with incision length > 20 cm, randomized 1:1 [6] - The primary efficacy endpoint was a combination of surgical site infections, all-cause mortality, and reintervention within 30 days post-surgery [11, 13] Demographics - In the ITT cohort, the average age was 67.0 years in the D-PLEX 100 group (N=405) and 68.0 years in the SoC group (N=393) [10] - The percentage of female patients was 44.0% in the D-PLEX 100 group and 37.9% in the SoC group [10] Next Steps - A pre-NDA meeting with the FDA is planned by the end of 2025 [26] - An NDA submission is planned for early 2026 [26]

Summary of PolyPid's SHIELD II Phase III Trial Conference Call Company Overview - **Company**: PolyPid - **Product**: DPLEX100 - **Trial**: SHIELD II Phase III trial Key Industry Insights - **Industry**: Pharmaceutical/Biotechnology - **Focus**: Prevention of surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery Core Findings and Arguments 1. **Successful Trial Results**: The SHIELD II trial met its primary and key secondary endpoints, demonstrating the efficacy of DPLEX100 in reducing SSIs [2][9][10] 2. **Primary Efficacy Endpoint**: DPLEX100 plus standard of care resulted in a 38% reduction in the primary efficacy endpoint (deep and superficial SSIs, all-cause mortality, and surgical reinterventions) compared to standard care alone, with a statistically significant p-value of less than 0.005 [9][10] 3. **Secondary Efficacy Endpoint**: There was a 58% reduction in SSI rates (from 9.5% to 3.8%) in the DPLEX100 group compared to the control group, also statistically significant with a p-value of less than 0.005 [10] 4. **Additional Secondary Endpoints**: The DPLEX100 arm showed a 36% reduction in combined SSI mortality and reintervention events, and a 62% reduction in patients with a sepsis score greater than 20 [12][13] 5. **Unmet Medical Need**: SSIs are a significant burden, costing the U.S. healthcare system approximately $10 billion annually and increasing hospital stays by an average of 9.7 days [13][14] 6. **Regulatory Pathway**: Plans for a pre-NDA meeting with the FDA by the end of 2025, followed by NDA submission in early 2026 and MAA submission in Europe shortly thereafter [15][16] 7. **Breakthrough Designation**: DPLEX100 has received Breakthrough Therapy, Fast Track, and QIDP designations from the FDA, enhancing its regulatory pathway and market exclusivity [16] Additional Important Insights 1. **Patient Demographics**: The trial included 798 patients, primarily cancer patients, with balanced demographics across treatment groups [6][8] 2. **Partnership Discussions**: Ongoing global partnership discussions are expected to accelerate following the positive trial results, with potential partners already engaged [30][32] 3. **Warrant Information**: There are 6.7 million warrants with a $4 exercise price, expiring soon, which could provide additional funding [27][28] 4. **Future Development**: The company is prioritizing its pipeline and exploring additional partnerships for new molecules, leveraging the validation of its platform technology [45][46] 5. **Market Launch Timeline**: Anticipated timeline for product launch in the U.S. is approximately 6 to 9 months post-approval, contingent on finding a suitable partner [56] Conclusion - The SHIELD II trial results position PolyPid favorably for regulatory approval and market entry, with significant implications for addressing SSIs in surgical settings. The company is poised for strategic partnerships and further development of its product pipeline.

Core Insights - PolyPid Ltd. announced successful topline results from its SHIELD II Phase 3 trial of D-PLEX100, showing a 38% reduction in the primary composite endpoint and a 58% reduction in surgical site infection (SSI) rates from 9.5% to 3.8% compared to standard care alone [1][2][17] Trial Results - The SHIELD II trial included 798 patients and achieved statistical significance across all endpoints, with a p-value lower than 0.005 [1][15] - D-PLEX100 demonstrated a 58% reduction in SSI rates, positioning it among the most effective prophylactic interventions for abdominal colorectal surgery [2][17] - The trial's primary endpoint showed a 38% reduction in deep and superficial SSIs, all-cause mortality, and surgical reinterventions within 30 days of surgery [15][21] Market Implications - SSIs represent a significant burden on the U.S. healthcare system, costing up to $10 billion annually and increasing hospitalization costs by over $20,000 per patient [2][21] - PolyPid plans to hold a pre-NDA meeting with the FDA by the end of 2025, followed by NDA submission in early 2026, which is expected to expedite global partnership discussions for commercialization [2][22] Regulatory Designations - D-PLEX100 has received FDA Fast Track, Breakthrough Therapy, and Qualified Infectious Disease Product (QIDP) designations, enhancing its regulatory pathway and market exclusivity [2][22] Future Steps - The company is preparing to present its comprehensive dataset at major medical conferences to generate attention from the surgical community [23]

PETACH TIKVA, Israel, June 09, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced positive topline results from its pivotal SHIELD II Phase 3 trial of D-PLEX100 for the prevention of SSIs in patients undergoing abdominal colorectal surgery with large incisions, which has received Fast Track designation from the FDA. Image: SHIELD II Results on Primary Endpoint and First Key Secondary Endpoint ...

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]