PolyPid (NASDAQ:PYPD) is approaching a Nov. 28 U.S. regulatory decision on D-PLEX100, its experimental product for preventing surgical site infections in patients undergoing colorectal surgery, while preparing with partner Azurity Pharmaceuticals for a potential launch in early 2027.
On the company’s third-quarter earnings call Nov. 11, Chief Executive Officer Dikla Czaczkes Akselbrad said the application is under priority review and labeling discussions with the Food and Drug Administration are underway. She said scheduled interactions with the agency remain on track for the decision date, but declined to discuss the proposed label.
Asked whether a pre-approval inspection of PolyPid’s manufacturing facility had been completed or had identified any compliance issues, Czaczkes Akselbrad declined to provide specifics. She said activities had either been scheduled to support the regulatory milestone or had already been completed.
Launch preparations and reimbursement
Subject to FDA approval, Azurity plans to begin U.S. launch activities in early 2027. Chief Operating Officer U.S. Ori Warshavsky said adoption would likely develop over several months as individual hospitals review the product and decide whether to add it to their formularies.
Azurity is building its sales, national accounts, market access and medical affairs teams, Warshavsky said. Its medical teams plan to engage surgeons and infectious disease specialists at target hospitals who can bring D-PLEX100 to pharmacy and therapeutics committees for review.
Warshavsky said PolyPid believes its existing health-economic data is sufficient for launch. Some hospitals may conduct small pilot studies involving approximately seven to 10 patients to assess usability and operating-room workflow rather than efficacy, he said.
PolyPid has applied to the Centers for Medicare & Medicaid Services for a New Technology Add-on Payment, or NTAP, with a decision expected in August 2027. If granted, the payment could provide hospitals additional reimbursement of up to 75% of the product cost above the standard diagnosis-related group payment, Czaczkes Akselbrad said.
Warshavsky said market research found that close to 90% of participating pharmacists who lead hospital formulary committees expressed willingness to add the product, rising to 100% when asked how NTAP would affect their answer. He said hospitals would still want to see an economic case for the product without the additional payment.
Azurity will disclose pricing at launch, Czaczkes Akselbrad said. She also said PolyPid has received $30 million from the partnership and is eligible for more than $290 million in development, regulatory and sales milestones. The company has not disclosed the breakdown of those potential payments.
Expansion plans and European review
PolyPid and Azurity intend to pursue a broader D-PLEX100 indication in abdominal surgery, including gastrointestinal procedures and hysterectomies. Czaczkes Akselbrad said the companies plan to begin discussions with the FDA in the fourth quarter, but that it was premature to predict the agency’s requirements.
She said further opportunities could include soft tissue and bone surgery. Under the Azurity agreement, the partner will fund clinical development once the companies jointly prioritize indications.
In Europe, the European Medicines Agency validated PolyPid’s marketing authorization application after the end of the third quarter and began its review. The company expects a decision in the second half of 2027 and a potential European launch in 2028.
PolyPid and ADVANZ PHARMA also mutually agreed to terminate their 2022 European commercialization agreement, returning exclusive European rights to PolyPid. Czaczkes Akselbrad said the company is in active discussions with potential partners. A Canadian drug submission under the Azurity collaboration is planned for 2027.
Pipeline and financial results
PolyPid is developing PD01B for moderate to severe diabetic foot infections. The candidate is designed to be applied directly to a wound and deliver sustained, localized doxycycline levels over weeks, Warshavsky said. The company expects a pre-investigational new drug meeting with the FDA and the start of a first-in-human study in the second half of 2027. Its long-acting obesity program, PD03A, remains in early preclinical development.
For the third quarter, PolyPid reported 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, a year earlier. Research and development expenses rose to $6.5 million from $5.3 million, primarily because of regulatory application work and commercial readiness preparations, Chief Financial Officer Jonny Missulawin said.
The company ended September with $15.5 million in cash equivalents and short-term deposits, excluding a $15 million Azurity milestone payment received in early October. Missulawin said existing cash, expected proceeds from the Azurity agreement and potential future proceeds are expected to fund operations into 2028, based on the company’s current plans and assumptions.
About PolyPid (NASDAQ:PYPD)
PolyPid Ltd. (NASDAQ: PYPD) is a clinical-stage biopharmaceutical company focused on developing locally administered therapies designed to provide controlled and sustained drug release at treatment sites. The company’s technology is intended to maintain therapeutic drug concentrations over extended periods while limiting systemic exposure. PolyPid’s lead product candidate is D-PLEX100, an investigational formulation based on doxycycline and the company’s proprietary PLEX polymeric matrix. It is being developed for the prevention of surgical-site infections, initially in patients undergoing colorectal surgery.
