PolyPid's proprietary and clinically validated, prolonged-release drug delivery technology aims to subcutaneously deliver GLP-1 for approximately 60 days, compared to current standard of care of weekly injections. The GLP-1 delivery platform expands PolyPid's product portfolio beyond the recently successful Phase 3 D- PLEX100 , demonstrating versatility of the Company's proprietary drug delivery platforms in multiple major therapeutic areas. PETACH TIKVA, Israel, July 15, 2025 (GLOBE NEWSWIRE) -- PolyPid Lt ...

Core Viewpoint - PolyPid Ltd. has secured additional funding of $26.7 million through the exercise of warrants, extending its financial runway beyond the anticipated FDA approval of its lead product candidate, D-PLEX₁₀₀ [1][4]. Funding Details - The funding was obtained through new agreements with existing warrant holders for the immediate exercise of warrants to purchase up to 7,626,514 ordinary shares at a price of $3.50 per share [2]. - In exchange for the immediate cash exercise of the warrants, PolyPid will issue new unregistered warrants for the purchase of an equal number of ordinary shares at an exercise price of $4.50 per share, valid for two years [3]. Use of Proceeds - The net proceeds from this funding will be utilized for new drug application (NDA) submission, launch preparations, working capital, and general corporate purposes [4]. Product Information - D-PLEX₁₀₀ is designed to provide prolonged and controlled antibacterial activity at surgical sites to prevent surgical site infections (SSIs) and has received Breakthrough Therapy designation from the FDA [7]. - The product demonstrated a statistically significant reduction in SSIs in the Phase 3 SHIELD II trial, meeting all primary and key secondary endpoints [8][9].

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 ...

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 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 ...

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]