PolyPid Ltd. reported a net loss of $7.5 million for the third quarter of 2025, translating to a loss of $0.37 per share. The figure represents a 4 % improvement over the $7.8 million loss ($1.22 per share) recorded in the same quarter of 2024 and a 0.13‑point beat against the consensus estimate of a $0.54 loss per share. The nine‑month loss for the period ended September 30, 2025, was $25.7 million ($1.72 per share), down from $20.5 million ($3.82 per share) in the prior year.
PolyPid’s revenue for Q3 2025 was modest, reflecting its status as a clinical‑stage biopharmaceutical company that generates income primarily through collaboration and licensing agreements. The company did not report a significant revenue increase, and the limited top‑line growth underscores the importance of its pipeline milestones over current sales.
Management maintained its guidance for the fourth quarter, indicating that operating expenses will remain in line with the current year and that the company expects to continue narrowing its net loss as R&D spending stabilizes. The guidance signals confidence that the company’s cost structure will support the projected financial trajectory.
The company highlighted progress on its lead product candidate, D‑Plex100, which received Breakthrough Therapy and Fast Track designations from the FDA. Positive Phase 3 SHIELD II results were announced, and PolyPid is preparing for a pre‑NDA meeting with the FDA in early December 2025, with an NDA filing slated for early 2026. The company also completed a GMP inspection by the Israeli Ministry of Health, advancing its readiness for commercial manufacturing and positioning it to secure a U.S. commercial partner.
PolyPid’s cash, cash equivalents, and short‑term deposits totaled $18.8 million as of September 30, 2025, providing a runway that extends into 2026. The company bolstered its liquidity with a $26.7 million funding round in June 2025 through warrant exercises, further extending its financial runway beyond the anticipated FDA approval timeline.
The narrowing net loss and EPS beat reflect disciplined cost management amid continued investment in R&D. While the company remains in a development phase with limited revenue, the positive regulatory milestones and strengthened cash position position PolyPid to advance D‑Plex100 toward market entry and to pursue commercial partnerships that could generate substantive revenue once the product is approved.
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