Nasdaq-listed biopharmaceutical company PolyPid is working with The Sage Group to secure a licensing partnership for US commercialization of its lead product, said CEO Dikla Czaczkes Akselbrad.

The Petach Tiqva, Israel-based company is in late-stage discussions for US sales of D-PLEX100, which delivers concentrated, broad-spectrum antibiotics at a surgical incision site for 30 days, the most critical postoperative risk period, according to Akselbrad.

The CEO said PolyPid could receive Food and Drug Administration (FDA) approval for D-PLEX100 as soon as later this year or in early 2027.

Potential licensing partners, according to Akselbrad, include large medical device companies such as Medtronic, Becton Dickinson, Johnson & Johnson, Baxter, and Solventum, and specialty pharmaceutical companies such as Innoviva, Fresenius, Pacira BioSciences, and Paratek Pharmaceuticals.

PolyPid’s current cash balance is expected to fund operations until a deal is inked, Akselbrad said. As of 31 December, PolyPid reported cash, cash equivalents, and short-term deposits of USD 12.9m.

Though focused first on a US licensing partner for D-PLEX100, Akselbrad said PolyPid is also seeking partners for international sales. The company could have European approval within roughly three months of US approval, the CEO added, while noting other regions of interest as South America, China, Japan and Australia.

Additionally, PolyPid is pursuing development partners for pre-clinical products around metabolic disease (including long-acting GLP-1 drugs) and cancer, Akselbrad said. PolyPid already has a research and development (R&D) collaboration with ImmunoGenesis to develop novel formulations that enhance treatment for solid tumors.

PolyPid’s PLEX technology is anchored in the surgical site to provide controlled and continuous delivery of medications over days or months to improve patient outcomes in localized medical conditions such as infection, pain, inflammation, and cancer. Its Kynatrix platform eliminates burst and fluctuating drug release and enables delivery of a broad range of active pharmaceutical ingredients, including small molecules, cytotoxic agents, biologics, nucleic acids, and peptides.

Akselbrad said PolyPid is first targeting surgical site infections (SSI), including infections due to antibiotic-resistant bacteria. SSIs are the second most prevalent type of healthcare acquired infections (HAI), with a 5% to 30% risk of infection, according to Akselbrad. The Centers for Disease Control estimates that the annual cost burden of SSIs to the healthcare system ranges from USD 3.3bn to USD 10bn.

After completing a Phase 3 trial and testing its product on more than 2,000 patients, D-PLEX100 has demonstrated a clinically meaningful 60% reduction in surgical site infections compared with standard of care. It has already been granted FDA Fast Track, Breakthrough Therapy, and Qualified Infectious Disease Product designations.

According to Akselbrad, the addressable market for D-PLEX100 is around 12 million procedures, with the company initially focusing on 4 million high-risk abdominal surgeries.

PolyPid has no direct competitor, Akselbrad said. Companies taking other approaches to infection prevention include CorMedix and BoneSupport AB, while Pacira is a player in the extended drug release market, she noted.

CorMedix’s DefenCath, designed to prevent catheter-related bloodstream infections in adult hemodialysis patients, received FDA approval in late 2023 and is projecting 2026 revenue between USD 150m and USD 170m. BoneSupport’s CERAMENT bone infection treatment generated US revenue of USD 18.3m and USD 21.5m in the second and third quarters of 2025, respectively. Pacira, which has three commercial products, reported 2025 revenue of approximately USD 726m.

PolyPid was founded in 2008 and went public in 2020. Akselbrad, who joined as chief strategy officer in 2014, was promoted to EVP and CFO before being named CEO in 2022. She previously was CFO of cancer immunotherapy company Compugen.

PolyPid operates an approximately 18,000 square-foot, GMP-certified, manufacturing facility to support commercialization of D-PLEX100. The company has about 80 employees and a US office in Nutley, New Jersey.

Its market capitalization was approximately USD 87m at press time.

PolyPid uses law firm Sullivan & Worcester, accounting firm EY, and FDA consulting practice The Weinberg Group.