PolyPid Posts $5.8 Million Loss, Awaits FDA Decision on D-PLEX100 on November 28

Key Facts

PolyPid reported third-quarter 2026 results, posting a net loss of $5.8 million, or $0.24 per share, compared with a loss of $7.5 million, or $0.37 per share, in the same period of 2025. The results come as the U.S. Food and Drug Administration reviews the D-PLEX100 application. The company aims to use the drug to prevent surgical-site infections in patients undergoing abdominal colorectal surgery. The FDA accepted the application for review and granted it priority review, setting November 28, 2026, as the target action date under the Prescription Drug User Fee Act. The company said the FDA identified no issues during its filing-completeness review. The date remains a target action date, and the application is still under review.

PolyPid said priority review shortened the FDA’s target review timeline from 10 months to about 6 months. The November 28 date is also about a quarter earlier than the company’s previous guidance, which pointed to the first quarter of 2027. That puts the regulatory decision among the drug’s near-term milestones, ahead of any potential commercial launch. In the Phase 3 SHIELD II trial, the company said D-PLEX100 relatively reduced the incidence of surgical-site infections by 60% compared with standard care in patients undergoing major-incision abdominal colorectal surgery, with a p-value of 0.0013. The company says the drug is designed to deliver doxycycline locally at the surgical site in a sustained and controlled manner for 30 days, with the aim of providing a high local concentration of the antibiotic.

Research and development expenses fell in the third quarter? No; they rose to $6.5 million from $5.3 million in the same period of 2025. The company attributed the increase to drug application preparation and commercial readiness activities. For the nine months ended September 30, 2026, the net loss was $21.3 million, compared with $25.7 million in the same period a year earlier. Cash, cash equivalents and short-term deposits totaled $15.5 million on September 30, compared with $12.9 million on December 31, 2025. After the quarter ended, the company said it received an additional $15 million milestone payment from Azurity.

The U.S. marketing plan is based on an exclusive agreement PolyPid signed with Azurity in July 2026 to market D-PLEX100 in the United States and Canada. Under the agreement, the company said it is eligible to receive up to about $320 million in upfront and milestone payments. It said the FDA’s acceptance of the application in July triggered eligibility for $30 million in upfront and near-term milestone payments from Azurity. The companies are preparing for a potential U.S. launch in early 2027, subject to approval. PolyPid said Azurity’s current network reaches more than 1,700 U.S. hospitals and academic centers. The company said in an earlier statement that available cash and financial resources, together with partnership proceeds, are expected to fund operations through 2028.

In Europe, PolyPid submitted its marketing application to the European Medicines Agency on September 14, 2026. After the quarter ended, the agency validated the application and began its formal review, and the company expects a decision in the second half of 2027. In a parallel development, PolyPid and ADVANZ PHARMA agreed to terminate their exclusive European licensing, distribution and supply agreement signed in 2022, and the drug’s exclusive European marketing rights returned to PolyPid. The company also submitted an application to the Centers for Medicare & Medicaid Services to add a new technology add-on payment for the drug, with a decision expected in August 2027. If granted, the payment would provide hospitals with additional reimbursement for using the drug in the hospital.

PolyPid said discussions with the FDA on expanding the D-PLEX100 label to cover broader abdominal surgeries are expected to begin in the fourth quarter of 2026. In the market, the company’s shares closed at $6.31 in the November 10 session, according to EL7 data. The close came before the publication of its third-quarter results statement on November 11. The next announced milestones center on the FDA’s target date of November 28, 2026, followed by a potential U.S. launch in early 2027 if approval is granted. In Europe, the company expects a decision from the European Medicines Agency in the second half of 2027 and a decision on the technology add-on payment application in August 2027.