PolyPid (NASDAQ:PYPD) Chief Executive Officer and board member Dikla Czaczkes Akselbrad said the company expects 2026 to be a “transformative year” as it advances regulatory filings for its lead product candidate, D-PLEX100, a locally administered antibiotic product designed to prevent surgical site infections.
Speaking during the Lytham Partners Spring 2026 investor conference, Czaczkes Akselbrad said PolyPid initiated a rolling New Drug Application submission to the U.S. Food and Drug Administration on March 30 and expects to finalize the submission shortly. She said the company expects an FDA acceptance decision within 74 days from that point.
D-PLEX100 Targets Surgical Site Infections
PolyPid’s lead product is based on the company’s PLEX technology, which Czaczkes Akselbrad described as a platform for long-acting controlled release of drugs in the body over periods ranging from weeks to several months. She said the technology has been developed for more than a decade and is covered by more than 170 patents.
Czaczkes Akselbrad said D-PLEX100 provides 30 days of broad-spectrum antibiotic coverage at the surgical incision site. The 30-day timeframe is important, she said, because surgical site infections in the relevant procedures are defined as infections occurring within 30 days after surgery.
“Once the drug is administered at the end of the surgery, applied all over the incision, the abdominal incision in this case, although easily applied in any surgical site infection, the patient has coverage for 30 days of antibiotic at the incision,” she said.
Phase 3 Data Showed Infection Reduction
Czaczkes Akselbrad reviewed results from an 800-patient multinational, multicenter Phase 3 study in patients undergoing open colorectal surgery. She said the primary endpoint, requested by the FDA, was a composite of infection, mortality and reoperation.
According to Czaczkes Akselbrad, the study showed a 40% reduction in the primary endpoint. She said the standard-of-care arm had about an 18% occurrence of mortality, reoperation or infection, compared with 10% in the D-PLEX100 arm.
She also highlighted surgical site infection data as a key secondary endpoint. In patients who were “mostly cancer patient,” she said the infection rate was about 10% without D-PLEX100 and was reduced to 3.8% with treatment, representing a 60% relative risk reduction and a P value of 0.001.
Czaczkes Akselbrad said PolyPid also met all key secondary endpoints, noting that the company recently presented findings at the Surgical Infection Society. She discussed an ASEPSIS score analysis, which measures the severity and consequences of infection, including factors such as IV antibiotic treatment, readmission and reoperation. She said the study showed a 64% reduction in patients with severe infections.
Regulatory Plans Include U.S. and Europe
In addition to the U.S. regulatory process, Czaczkes Akselbrad said PolyPid plans to meet this quarter with European authorities, including the rapporteur and co-rapporteur, in what she described as the equivalent of a pre-NDA meeting. The goal is to align on the Marketing Authorization Application submission in terms of timeline and scope.
She said PolyPid plans to submit the MAA a quarter after that meeting. The company is targeting FDA approval in the first quarter of 2027 and European approval in the second half of 2027, according to the presentation.
Czaczkes Akselbrad also said PolyPid expects to apply for the New Technology Add-on Payment program in the second half of 2026. She said D-PLEX100 is eligible for the program, which could allow hospitals to receive up to 75% reimbursement of the drug’s cost in the first two to three years of commercialization.
Market Opportunity and Commercialization
Czaczkes Akselbrad said PolyPid is analyzing a U.S. market of about 12 million inpatient surgical procedures that have a high or relatively high prevalence of infection, or where infection consequences could lead to disability or mortality. She said 4.4 million of those procedures are abdominal procedures, including colorectal surgeries, which represent the company’s first target market opportunity.
She said PolyPid views its Phase 3 colorectal surgery study as an initial entry into abdominal surgery, with the potential to expand into other surgical settings over time.
Czaczkes Akselbrad also cited potential economic benefits for hospitals, saying surgical site infections can carry an average direct cost of $30,000. She also referenced potential indirect costs, including Centers for Medicare & Medicaid Services penalties that she said could range from 1% to 3% annually.
PolyPid recently conducted market research after the Phase 3 results, Czaczkes Akselbrad said. She said 80% of surgeons surveyed were “extremely likely” to prescribe D-PLEX100 to prevent surgical site infections, while pharmacy directors were also highly likely to prescribe. With the NTAP component included, she said the likelihood among pharmacy directors rose to 90%.
The company is in discussions with a potential U.S. commercialization partner that has a hospital presence, Czaczkes Akselbrad said. PolyPid is looking toward a U.S. launch in early 2027 with a partner.
She added that D-PLEX100 is manufactured in PolyPid’s own GMP facility, which she described as a unique aseptic manufacturing facility built for the company’s platform and expected to be part of the commercialization partnership.
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.
