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]