PolyPid (PYPD, Financial) has revealed promising topline results from its critical SHIELD II Phase 3 trial concerning D-PLEX100, a treatment designed to prevent surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery. This drug, which has received Fast Track designation from the FDA, demonstrated a significant reduction in SSIs when compared to standard care alone. The trial, involving large incisions, showed a notable 38% decrease in primary endpoint events, including deep and superficial SSIs, mortality, and surgical reinterventions.
Key secondary outcomes were also achieved, indicating a 58% reduction in SSI rates and a 62% decrease in patients with high ASEPSIS scores when D-PLEX100 was used alongside standard care. The ASEPSIS score is a recognized tool for evaluating surgical wound infections. Importantly, the independent Data Safety Monitoring Board reported no safety concerns throughout the SHIELD II study.
PolyPid is targeting a substantial U.S. market with D-PLEX100, addressing over 12 million surgeries annually. The company anticipates submitting a New Drug Application (NDA) in early 2026, which could bolster ongoing global partnership discussions.
Wall Street Analysts Forecast
Based on the one-year price targets offered by 4 analysts, the average target price for PolyPid Ltd (PYPD, Financial) is $10.75 with a high estimate of $13.00 and a low estimate of $9.00. The average target implies an upside of 228.75% from the current price of $3.27. More detailed estimate data can be found on the PolyPid Ltd (PYPD) Forecast page.
Based on the consensus recommendation from 4 brokerage firms, PolyPid Ltd's (PYPD, Financial) average brokerage recommendation is currently 2.0, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
PYPD Key Business Developments
Release Date: May 14, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- PolyPid Ltd (PYPD, Financial) successfully concluded enrollment of the Shield 2 phase 3 trial, which is a significant milestone for the company.
- The company anticipates submitting a new drug application (NDA) for Dplex 100 in early 2026, leveraging fast track and breakthrough therapy designations.
- PolyPid Ltd (PYPD) has secured $15 million in financing, extending its cash runway into the third quarter of 2025.
- There is growing interest from potential US partners for Dplex 100, indicating strong commercial potential.
- The total addressable market for Dplex 100 in the US is substantial, with over 12 million surgeries annually, providing a significant commercial opportunity.
Negative Points
- PolyPid Ltd (PYPD) reported a net loss of $8.3 million for the first quarter of 2025, an increase from the $6.4 million loss in the same period of 2024.
- Research and development expenses increased to $6.1 million, up from $5.1 million in the previous year, driven by the Shield 2 trial.
- The company has not finalized its pricing strategy for Dplex 100, which could impact future revenue projections.
- There are uncertainties regarding the FDA inspection readiness and capacity to meet demand post-launch.
- The company's cash and cash equivalents stand at $8 million, which may not be sufficient if additional funding is not secured.
