PolyPid NASDAQ: PYPD said 2025 marked a “pivotal year” as the company completed its SHIELD II Phase 3 trial and moved D-PLEX100 into the final stages of regulatory preparation, while also advancing U.S. commercial partnership discussions ahead of a planned new drug application submission in early 2026.
Regulatory path: FDA supports rolling NDA submission
Chief Executive Officer Dikla Czaczkes Akselbrad said the company recently received positive written feedback from the U.S. Food and Drug Administration following pre-NDA meeting communications. According to management, the FDA supported PolyPid’s plan to pursue a rolling NDA review for D-PLEX100, and the company expects to begin the rolling submission by the end of the first quarter of 2026.
PolyPid also said the FDA agreed that the existing clinical data package, including results from the SHIELD II Phase 3 trial, “appears adequate” to support NDA submission and review. Management described that feedback as providing clarity on submission structure and expectations.
During the Q&A, Akselbrad said PolyPid is targeting an initial label focused on prevention of surgical site infections in patients undergoing abdominal colorectal surgery, noting that this indication is directly supported by SHIELD II data and aligns with D-PLEX100’s breakthrough therapy designation. She added that the company expects there “may be an opportunity” to evaluate potential label expansion into broader abdominal surgical applications during the review process and said PolyPid plans to meet with the FDA to discuss broader label considerations as part of its planning timeframe.
On timing, management said the company expects to submit the NDA by the end of the first quarter, with the chemistry, manufacturing and controls (CMC) and non-clinical modules submitted first, followed by the clinical module. The company said the gap between those submissions is expected to be no more than a couple of months. Management also pointed to Fast Track and Breakthrough Therapy designations that support rolling submission and priority review, and said it expects a six-month review timeline versus the standard 10 months.
Commercial strategy: U.S. partnership talks advance
Chief Operating Officer, U.S., Ori Warshavsky said PolyPid continued to advance discussions during the quarter with potential U.S. commercial partners, focusing on organizations with hospital-based commercialization experience and a strong presence in the surgical ecosystem. He said the conversations have become “increasingly detailed and operational,” reflecting both the maturity of the opportunity after the Phase 3 results and progress on the regulatory front.
Management reiterated that the company’s top commercial priority is the United States, though it acknowledged there “might be interest” in other geographies as part of discussions. Akselbrad said the company expects a European submission later—about a quarter after finalizing the FDA submission.
In response to a question on hospital adoption dynamics, Warshavsky emphasized that formulary uptake is typically a multi-step, network-by-network process and said the pace will not be “day one peak of sales.” He described steps including identifying clinical champions, pharmacy and therapeutics (P&T) review incorporating clinical and economic considerations, and potential pilot use before broader implementation, followed by hospital system updates. He added that once a product is on formulary and used successfully, it can be “sticky,” with usage potentially growing steadily over time.
Commercial readiness efforts: awareness, publications, and health economics
Management said PolyPid is working on a range of pre-launch preparations, including packaging work for D-PLEX100 and market development activities such as market research, pricing work, and building awareness. Warshavsky said conferences and publications will be a “big part” of the effort in 2026, and the company expects to share more abstracts and articles during the year. He also said work in health economics is “kicking off now” to support market access discussions.
PolyPid highlighted a virtual key opinion leader webinar featuring colorectal surgeon Dr. Steven D. Wexner, which focused on the clinical and economic burden of surgical site infections and the unmet need in abdominal colorectal procedures. Management said such external clinical engagement is part of building awareness and readiness ahead of a potential approval and launch.
Corporate updates: new board chair, rebrand, and “Kynatrix” technology
PolyPid said it appointed Brooke Story as chair of the board in December 2025. Akselbrad said Story brings leadership experience in medical technology and surgical solutions, including senior executive roles at Becton, Dickinson and Medtronic, and that her background should be valuable as PolyPid transitions toward commercialization and engages with strategic partners.
The company also introduced a refreshed corporate brand and website. Warshavsky said the rebrand is intended to reflect PolyPid’s shift from a primarily R&D-focused organization to one preparing for commercialization and engaging more broadly with external stakeholders, including surgeons, pharmacists, hospital administrators, value committees, and potential partners.
In addition, PolyPid formally introduced “Kynatrix” as the name for its next-generation technology umbrella. Warshavsky said Kynatrix encompasses expanded controlled-release and delivery capabilities and a growing intellectual property portfolio that extends beyond the original FLEX platform. He emphasized that FLEX remains foundational, but said the company’s technology is no longer limited to localized delivery of small molecules such as antibiotics. As an example, PolyPid cited its move into metabolic disease with an ultra long-acting GLP-1 receptor agonist program. Management stressed, however, that D-PLEX100 remains “firmly at the center” of near-term execution and commercial focus.
Financial results: R&D down in Q4, cash runway into 2H 2026
Chief Financial Officer Jonny Missulawin reported that fourth-quarter 2025 research and development expenses were $6.2 million, down from $7.0 million in the prior-year quarter, primarily reflecting completion of the SHIELD II Phase 3 trial and a transition toward regulatory submission and preparation activities. Fourth-quarter general and administrative expenses rose to $1.8 million from $1.0 million, while marketing and business development expenses were $0.6 million versus $0.2 million a year earlier. Net loss for the quarter was $8.5 million, or $0.41 per share, compared with a net loss of $8.5 million, or $1.13 per share, in the fourth quarter of 2024.
For full-year 2025, PolyPid reported R&D expenses of $23.8 million, up from $22.8 million in 2024, which management attributed to activities related to completing SHIELD II, regulatory preparation, and advancement of development programs. G&A expenses increased to $7.2 million from $4.3 million, primarily due to non-cash expenses related to vesting of performance-based options after successful completion of SHIELD II. Marketing and business development expenses rose to $2.0 million from $0.9 million, reflecting increased business development and commercial preparation. Full-year net loss was $34.2 million, or $2.09 per share, compared with $29.0 million, or $4.91 per share, in 2024.
As of Dec. 31, 2025, the company reported $12.9 million in cash, cash equivalents, and short-term deposits. Missulawin said that after year-end, several longtime shareholders exercised warrants ahead of expiration at prices ranging from $3.61 to $4.50 per share, generating $3.7 million in additional gross proceeds. Management said it expects existing cash resources to fund operations into the second half of 2026.
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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