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 ...

PolyPid (NasdaqCM:PYPD) Q4 2025 Earnings call February 11, 2026 08:30 AM ET Company ParticipantsBrandon Folkes - Managing DirectorDikla Czaczkes Akselbrad - CEOJonny Missulawin - CFOOri Warshavsky - COO for US OperationsYehuda Leibler - Investor RelationsConference Call ParticipantsBoobalan Pachaiyappan - Managing Director and Senior Biotechnology Equity Research AnalystChase Knickerbocker - Senior Equity AnalystJason Butler - Managing Director and Senior Biotechnology Equity Research AnalystOperatorGreetin ...

PolyPid (NasdaqCM:PYPD) Q4 2025 Earnings call February 11, 2026 08:30 AM ET Company ParticipantsBrandon Folkes - Managing DirectorDikla Czaczkes Akselbrad - CEOJonny Missulawin - CFOOri Warshavsky - COO for US OperationsYehuda Leibler - Investor RelationsConference Call ParticipantsBoobalan Pachaiyappan - Managing Director and Senior Biotechnology Equity Research AnalystChase Knickerbocker - Senior Equity AnalystJason Butler - Managing Director and Senior Biotechnology Equity Research AnalystOperatorGreetin ...

Financial Data and Key Metrics Changes - In Q4 2025, research and development expenses decreased to $6.2 million from $7 million in Q4 2024, reflecting the completion of the SHIELD II Phase 3 trial [15] - General and administrative expenses increased to $1.8 million in Q4 2025 from $1 million in Q4 2024, primarily due to non-cash expenses related to performance-based options [16] - The net loss for Q4 2025 was $8.5 million or $0.41 per share, unchanged from the previous year but improved on a per-share basis from $1.13 in Q4 2024 [16] - For the full year 2025, net loss was $34.2 million or $2.09 per share, compared to a net loss of $29 million or $4.91 per share in 2024 [17] - As of December 31, 2025, the company had $12.9 million in cash and equivalents, with additional gross proceeds of $3.7 million generated from warrant exercises post-quarter [18] Business Line Data and Key Metrics Changes - The company successfully completed the SHIELD II Phase 3 trial for D-PLEX100, achieving its primary and key secondary endpoints [5] - The focus remains on advancing the regulatory pathway for D-PLEX100 and commercial partnership discussions in the U.S. [5][7] Market Data and Key Metrics Changes - The company is engaging with potential U.S. commercial partners that have strong hospital-based commercialization experience [11] - Discussions with partners have progressed to advanced stages, reflecting the strong clinical profile of D-PLEX100 [7] Company Strategy and Development Direction - The company is transitioning from a primarily R&D-focused organization to one preparing for commercialization, with a renewed corporate brand to reflect this change [11][12] - The introduction of Kynatrix technology aims to expand capabilities beyond localized delivery, targeting metabolic diseases with a long-acting GLP-1 receptor agonist program [14] Management's Comments on Operating Environment and Future Outlook - Management believes 2026 could be transformative, with the rolling NDA submission expected to begin by the end of Q1 2026 [9] - Positive feedback from the FDA supports the regulatory pathway for D-PLEX100, with expectations for a rolling NDA submission [6][9] Other Important Information - The company appointed Ms. Brooke Story as chairman of the board in December 2025, bringing extensive experience in medical technology [9] Q&A Session Summary Question: Can you share how discussions around the scope of the label progressed? - The company is targeting an initial label for the prevention of surgical site infections in abdominal colorectal surgery, supported by Phase 3 data [22] Question: Any thoughts on plans for broader label expansion? - There may be opportunities for label expansion into broader abdominal surgical applications as the review process progresses [24] Question: What work is being done to prepare for potential approval of D-PLEX100? - The company is focusing on building awareness, market research, and creating a KOL network to prepare for commercialization [32] Question: How do you view the strategic timing for the GLP-1 program? - The company plans to partner at an early stage, leveraging robust preclinical data to attract interest [35] Question: What factors will play a role in identifying the final partner? - The ideal partner will have broad hospital-based capabilities and presence in the surgical suite [41] Question: What percentage of potential target IDNs would likely include D-PLEX on formulary within the first 12 months after approval? - The uptake will take time, with a few months before seeing meaningful updates, but once on formulary, usage is expected to grow steadily [50]