PolyPid Ltd Reports Strong Clinical Results for D-PLEX100 in SHIELD II Trial, Raises Q4 2025 Cash Guidance

PolyPid Ltd reported successful results from its SHIELD II Phase 3 trial, showing a 58% reduction in surgical site infections with D-PLEX100. The company is on track with its regulatory submissions, planning a pre-NDA meeting with the FDA by year-end and NDA submission in early 2026. However, PolyPid Ltd reported a net loss of $10 million for Q2 2025, an increase from the $6.3 million loss in Q2 2024, due to rising research and development expenses.

PolyPid Ltd (Nasdaq: PYPD) has reported successful results from its SHIELD II Phase 3 trial, demonstrating a 58% reduction in surgical site infections (SSIs) with its lead product candidate, D-PLEX₁₀₀. The company is on track with its regulatory submissions, planning a pre-New Drug Application (NDA) meeting with the FDA by year-end and anticipating NDA submission in early 2026. However, PolyPid Ltd reported a net loss of $10 million for Q2 2025, an increase from the $6.3 million loss in Q2 2024, primarily due to rising research and development (R&D) expenses.

The SHIELD II Phase 3 trial showed statistically significant reductions in SSIs in patients treated with D-PLEX₁₀₀ compared to the standard of care arm. The study revealed a 38% reduction in the primary endpoint and a robust 58% reduction in the rate of SSIs, including a significant reduction in deep SSIs. The positive trial results have generated substantial interest from potential commercial partners and reinforced the company's conviction in D-PLEX₁₀₀'s potential to address a significant unmet medical need.

PolyPid's R&D expenses for the three months ended June 30, 2025, were $6.2 million, compared to $4.8 million in the same period of 2024. The increase was primarily due to activities related to the completion of the SHIELD II Phase 3 trial and preparation for regulatory submissions. General and administrative (G&A) expenses also increased, rising from $1.1 million to $2.5 million over the same period. Marketing and business development expenses increased from $0.3 million to $0.7 million.

PolyPid's financial results for the six months ended June 30, 2025, showed a net loss of $18.2 million, compared to a net loss of $12.7 million in the same period of 2024. The company's balance sheet highlights a cash balance of $29.5 million as of June 30, 2025, compared to $15.6 million on December 31, 2024. PolyPid expects its current cash balance to be sufficient to fund operations well into 2026.

The company has appointed Dr. Nurit Tweezer-Zaks, M.D., M.B.A., as its new Chief Medical Officer, transitioning from her role on PolyPid's Board of Directors. Dr. Tweezer-Zaks brings extensive medical, R&D, and business development expertise to strengthen the company's leadership team as it advances toward NDA submission and commercial preparations following the positive Phase 3 SHIELD II results.

PolyPid's innovative pipeline includes an obesity and diabetes market-targeting GLP-1 delivery platform, which aims to deliver approximately 60 days of no-burst GLP-1 for improved patient compliance and enhanced therapeutic outcomes.

The company's stock price has shown positive momentum following the announcement of the successful trial results, indicating investor confidence in PolyPid's potential to address a significant unmet medical need.

PolyPid Ltd is scheduled to hold a conference call on Wednesday, August 13, 2025, at 8:30 AM Eastern Time to discuss the results of the SHIELD II Phase 3 trial and provide additional insights into the company's regulatory and commercialization plans.

References:
[1] https://investors.polypid.com/news-releases/news-release-details/polypid-provides-corporate-update-and-reports-second-quarter-2