PolyPid NASDAQ: PYPD said its second-quarter 2026 was marked by the FDA’s acceptance of its new drug application for D-PLEX100 and a commercialization agreement with Azurity Pharmaceuticals covering the United States and Canada.
D-PLEX100 is being developed to prevent surgical site infections in patients undergoing abdominal corrective surgery. CEO Dikla Czaczkes Akselbrad said the FDA accepted the company’s NDA for filing on July 27, after the company completed its submission during the second quarter. The agency granted priority review and set a Prescription Drug User Fee Act goal date of Nov. 28, 2026.
Akselbrad said the FDA identified no filing review issues in the acceptance notice. Priority review reduces the standard review timeline to six months from 10 months, according to the company. PolyPid expects an FDA pre-approval inspection of its manufacturing facility as part of the review process and continues to prepare for that inspection through mock audits and outside consultants.
Azurity Partnership Adds Upfront Payments and Potential Milestones
On July 17, PolyPid entered an exclusive agreement with Azurity Pharmaceuticals to commercialize D-PLEX100 in the U.S. and Canada. PolyPid said it has secured $30 million in aggregate upfront and near-term milestone payments, consisting of a $15 million payment at signing and a further $15 million payment following FDA acceptance of the NDA.
The agreement also provides PolyPid eligibility for more than $290 million in additional regulatory, launch and sales milestones. The company is entitled to tiered royalties on Azurity’s net sales ranging from the mid-teens to mid-20s percentages. PolyPid will retain global manufacturing responsibility and will receive an agreed transfer price for each unit supplied to Azurity.
Chief Operating Officer Ori Warshavsky said Azurity was selected after a competitive partnering process involving multiple prospective commercial partners. He cited Azurity’s portfolio of more than 50 medicines, its hospital and surgical-channel presence, and relationships with more than 1,700 hospitals and academic institutions as factors supporting the selection.
Azurity will lead commercial activities including sales force development, national account planning, medical affairs and pharmacy-channel work. PolyPid will retain global regulatory strategy and manufacturing responsibilities. The companies have established joint forums for medical, regulatory and commercial launch preparations, management said.
PolyPid expects Azurity to launch D-PLEX100 in the U.S. in early 2027, assuming regulatory approval. Management said the commercial rollout is expected to proceed hospital by hospital and integrated delivery network by integrated delivery network rather than reaching all target institutions immediately.
Manufacturing, Reimbursement and European Plans
The company said its manufacturing site in Israel has passed four consecutive good manufacturing practice inspections, including an inspection by Israel’s Ministry of Health in September 2025. Prospective commercial partners, including Azurity, also conducted on-site diligence of the facility during the partnering process, management said.
In response to analyst questions, Akselbrad said PolyPid has had several communications with the FDA since filing the NDA, including discussions relating to expected audits, but did not provide a specific date for the agency’s pre-approval inspection.
Management said commercial launch metrics will include hospital adoption, pharmacy and therapeutics committee approvals, pilot usage by physicians, reimbursement progress and discussions with payers. If D-PLEX100 launches in early 2027, PolyPid expects to recognize revenue as it supplies vials to Azurity under the agreed transfer price, while royalty and milestone revenue would be recognized as applicable.
Warshavsky said Azurity is pursuing a New Technology Add-on Payment, or NTAP, application for the next government fiscal year. He said FDA approval is not required before submitting an NTAP application, provided the product is under FDA review, and noted an October deadline.
PolyPid also plans to submit a marketing authorization application to the European Medicines Agency during the third quarter of 2026. Akselbrad said the company held meetings during the quarter with the EMA rapporteur and co-rapporteur and characterized them as productive. She said the discussions did not identify issues requiring additional data or changes that would delay the planned submission timeline.
Label Expansion and Pipeline Opportunities
The Azurity agreement includes an Azurity-funded joint development framework intended to pursue label expansion opportunities beyond the initial abdominal surgery indication. Management identified cardiac procedures, including coronary artery bypass grafting, orthopedic procedures such as hip and knee replacement, and breast mastectomy and reconstruction as potential areas of interest.
PolyPid also cited expansion into territories outside the U.S. and Canada and further development of its PLEX technology platform as longer-term growth drivers. Warshavsky said the company is exploring applications beyond infection prevention, including treatment applications and a long-acting metabolic program, but did not provide specific product details or development timelines.
Second-Quarter Financial Results
Research and development expense was $6.1 million in the second quarter, compared with $6.2 million a year earlier. General and administrative expense fell to $1.3 million from $2.5 million, primarily due to lower non-cash expenses related to performance-based options. Marketing and business development expense was $0.5 million, compared with $0.7 million in the prior-year period.
Net loss totaled $7.8 million, or $0.35 per share, compared with a loss of $10 million, or $0.78 per share, in the second quarter of 2025. For the first six months of 2026, net loss was $15.6 million, compared with $18.2 million in the prior-year period.
As of June 30, PolyPid had $6.6 million in cash and cash equivalents, compared with $12.9 million in cash equivalents and short-term deposits at Dec. 31, 2025. CFO Jonny Missulawin said the subsequent $30 million in Azurity payments strengthened the company’s capital position. Based on current plans and assumptions, PolyPid expects available resources, partnership proceeds and potential future proceeds to fund operations into 2028.
About PolyPid (NASDAQ:PYPD)
PolyPid Ltd is a clinical‐stage biotechnology company focused on polymer‐based drug delivery technologies designed to enhance the performance of therapeutic agents at mucosal surfaces. Leveraging its proprietary Mucoadhesive & Mucus‐Penetrating (MMP) platform, PolyPid develops long‐acting formulations for ocular, oral and pulmonary indications. Its lead candidates include OncoTears and OralTear, therapies targeting dry eye and dry mouth conditions, respectively, as well as Paclical, a polymer‐formulated paclitaxel designed to improve tolerability and antitumor activity in oncology patients.
Founded in 2003 and headquartered in Jerusalem, Israel, PolyPid has assembled an international patent portfolio covering key markets in North America, Europe and Asia.
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