Key Highlights

  • Net loss was USD 5.8 million, or USD 0.24 per share, against USD 7.5 million, or USD 0.37.
  • Nine month net loss was USD 21.3 million, or USD 0.94 per share, against USD 25.7 million, or USD 1.72.
  • Cash, equivalents and short-term deposits were USD 15.5 million, excluding a USD 15 million milestone received in early October.
  • The FDA goal date for the D-PLEX100 application under priority review is November 28, and the company reported no revenue.

PolyPid Ltd. (NASDAQ:PYPD) reported a third quarter 2026 net loss of USD 5.8 million, or USD 0.24 per share, compared with a net loss of USD 7.5 million, or USD 0.37 per share, a year earlier. The source table listed an Earnings estimate of positive USD 0.91 per share and a Revenue estimate of USD 30.00 million, with no revenue reported, so the reported loss differs substantially from the estimate. The company reported before the market open on November 11, 2026, and held its Earnings Call that day.

For the first nine months, net loss was USD 21.3 million, or USD 0.94 per share, against USD 25.7 million, or USD 1.72 per share.

Cash and Milestones

As of September 30, 2026, the company had cash equivalents and short term deposits of USD 15.5 million, compared with USD 12.9 million at December 31, 2025. Management said this does not yet include a USD 15 million milestone payment from its commercial partner for the acceptance of the new drug application, which is recorded as a receivable and was received in early October. The Partnership has delivered USD 30 million to the company.

Management stated its expectation that cash resources are sufficient to fund operations into 2028.

Regulatory Status

Management said the application for its lead candidate, for prevention of surgical site infection in patients undergoing colorectal surgery, is under priority review with a goal date of November 28, just over two weeks from the call. Management said the company is working with its partner toward a launch in early 2027, subject to FDA approval.

The company said an application for a New Technology Add-on Payment has been submitted to the Centers for Medicare and Medicaid Services, with a decision anticipated in August 2027. If granted, the payment would provide additional reimbursement to hospitals of up to 75% of the product cost above the standard payment.

Shortly after quarter end, the European Medicines Agency validated the company's application and began its formal review, with a decision anticipated in the second half of 2027 and a potential European launch in 2028. A Canadian submission is planned for 2027.

Items to Follow

Management said the first step in label expansion is broader abdominal surgery, including gastrointestinal procedures and hysterectomies, representing approximately four million surgeries a year in the United States. It described a 2030 vision with three levers of growth, including maximizing the lead candidate through its partner, new territories starting with Europe, and expanding its pipeline.

The items to follow are the FDA decision on the goal date, labeling discussions, the pre-approval inspection, reimbursement decisions and cash use. Regulatory outcomes are determined by the agencies, and management's statements about timing are forward looking. The company's legal proceedings and related disclosures are flagged for human legal review.