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]

The Company is in Advanced Stages of Commercial U.S. Partnership Discussions for D-PLEX₁₀₀ Positive FDA Pre-NDA Feedback Supports Rolling NDA Review; Submission Expected to Begin by the End of the First Quarter of 2026 Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, Feb. 11, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where ...

Core Insights - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes and will report its fourth quarter 2025 financial results on February 11, 2026 [1] - The company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and business operations [1][2] Company Overview - PolyPid utilizes its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology for controlled, prolonged-release therapeutics, enabling precise drug delivery over several days to months [4] - The lead product candidate, D-PLEX100, aims to prevent abdominal colorectal surgical site infections, with a New Drug Application (NDA) submission expected in early 2026 following positive phase 3 results [4] - The company also has a pipeline focused on oncology, obesity, and diabetes [4]

Summary of PolyPid's Company Webcast Company Overview - **Company Name**: PolyPid - **Ticker Symbol**: PYPD (traded on Nasdaq) - **Headquarters**: New Jersey and Israel - **Technology**: Unique platform technology for prolonged local drug delivery using a combination of polymer and lipids, supported by over 170 patents [2][3] Core Product and Pipeline - **Lead Asset**: D-PLEX 100, targeting the surgical site infection market with a potential NDA submission expected in early 2024 [3][10] - **Market Size**: Approximately 12 million surgical procedures in the U.S. that could benefit from D-PLEX 100 [4] - **Regulatory Designations**: Breakthrough therapy designation, fast track, and Qualified Infectious Disease Product (QIDP) status from the FDA [4] Clinical Data and Efficacy - **Phase 3 Study**: Conducted with nearly 1,000 patients across 60 centers in the U.S., EU, and Israel, focusing on colorectal resection surgeries [6] - **Results**: - 40% reduction in the incidence of mortality, surgical site infection, and re-operation (from 18% to 9.9%) [6] - Infection rate of 10% in standard care vs. 3.8% with D-PLEX 100, statistically significant with a P-value < 0.005 [7][8] - 60% reduction in patients with high sepsis scores in the treated group [9] Commercial Strategy - **Partnerships**: Actively seeking a U.S. partner with a strong presence in the hospital space to support the launch of D-PLEX 100 [10][17] - **Cost-Benefit Analysis**: Hospitals face penalties for surgical site infections, making D-PLEX 100 a financially attractive option due to its potential to reduce infection rates and associated costs [13][14] Future Plans - **NDA Submission Timeline**: Expected to submit the NDA within weeks, with a six-month review period leading to potential approval by late 2026 or early 2027 [10][16] - **Expansion of Indications**: Plans to explore additional indications, including GLP-1 delivery, with data expected to be shared later in 2024 [19] Financial Position - **Cash Position**: Approximately $20 million, sufficient to fund operations into 2026 and support the NDA approval process [20] Additional Insights - **Limitations of Current Standard of Care**: Current practices have not significantly reduced infection rates, indicating a need for innovative solutions like D-PLEX 100 [11][12] - **Transformational Potential**: D-PLEX 100's unique delivery mechanism allows for future expansion into other surgical areas without extensive additional development [19]

Core Insights - PolyPid Ltd. has appointed Brooke Story as Chairman of the Board of Directors, effective December 11, 2025, which is seen as a pivotal moment for the company [1][2] - Ms. Story brings over 25 years of leadership experience in the MedTech industry, having held senior roles at BD and Medtronic, and her expertise is expected to enhance PolyPid's strategic and commercial capabilities [2][3] - The company is preparing for the New Drug Application (NDA) submission of its lead product candidate, D-PLEX100, aimed at preventing abdominal colorectal surgical site infections, expected in early 2026 [5] Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through its proprietary PLEX technology, which allows for controlled, prolonged-release of therapeutics [5] - The company has a pipeline that includes innovative solutions in oncology, obesity, and diabetes, indicating a broad scope of potential market applications [5] Leadership and Strategy - Brooke Story's appointment is anticipated to support the transformation of PolyPid's clinical success into commercial reality, particularly in the area of surgical infection prevention [2][4] - Ms. Story's previous roles include overseeing global strategy and P&L for BD's Surgery business, which aligns with PolyPid's goals in the surgical market [2][3]

Company Overview - PolyPid is a company with a market capitalization of $78 million [1] - The company has developed a product named D-PLEX100, which will be discussed in detail during the webinar [1] Analyst Insights - The analyst covering PolyPid has a buy rating on the stock [2] - The 12-month price target for PolyPid is set at $9 per share [2]

Summary of Conference Call on PolyPid and D-PLEX100 Company Overview - **Company**: PolyPid - **Market Cap**: $78 million - **Product**: D-PLEX100, designed for the treatment of surgical site infections (SSIs) [1][5] Industry Context - **Industry**: Pharmaceuticals and Biotech, specifically focusing on surgical site infections - **Key Expert**: Dr. Steven Wexner, a prominent figure in colorectal surgery, providing insights on SSIs and their implications [2][4] Key Points Discussed Surgical Site Infections (SSIs) - **Definition**: SSIs are a major cause of morbidity, prolonged hospitalization, and mortality, particularly in colorectal surgeries [10] - **Financial Impact**: SSIs can cost the U.S. healthcare system over $3 billion annually, increasing hospital stays by approximately 10 days and doubling admission costs [11][12] - **Risk Factors**: Patients with diabetes, recent chemotherapy, or immunocompromised conditions are at higher risk for SSIs [15] - **Current Prevention Methods**: Standard care includes bowel cleansing and the use of antibiotics, but these methods can lead to complications such as antibiotic-induced diarrhea [17][18] D-PLEX100 Overview - **Mechanism**: D-PLEX100 is a formulation of doxycycline with polymers and lipids, designed to provide prolonged coverage at the surgical site [31][34] - **Clinical Trials**: The SHIELD II study aimed to show a reduction in SSIs within 30 days post-surgery, with a focus on open colorectal resection [41] - **Efficacy Results**: The study showed a 60% reduction in SSIs from nearly 10% in the standard care arm to less than 4% in the D-PLEX100 arm, with a p-value lower than 0.005 [45] Regulatory and Commercialization Plans - **NDA Submission**: PolyPid plans to submit a New Drug Application (NDA) in early 2026, with expectations for a PDUFA date by late 2026 or early 2027 [57][58] - **Designations**: D-PLEX100 has received breakthrough therapy designation and fast-track designation, which may expedite the review process [58] - **Manufacturing Preparedness**: PolyPid has established its own manufacturing facility to ensure compliance with Good Manufacturing Practices (GMP) [65] Market Implications - **Adoption Challenges**: The adoption of D-PLEX100 may require approval from formulary committees, which assess cost-effectiveness and safety [68][69] - **Potential for Broader Use**: Surgeons may explore using D-PLEX100 in other surgical fields beyond colorectal surgery due to its efficacy in reducing SSIs [70] Expert Opinions - **Dr. Wexner's Insights**: He emphasized the innovative nature of D-PLEX100, highlighting its potential to change the standard of care for SSI prevention [61][62] - **Safety Profile**: The safety of D-PLEX100 was affirmed, with no significant adverse events reported in clinical trials [50][48] Conclusion PolyPid's D-PLEX100 represents a significant advancement in the prevention of surgical site infections, with promising clinical data and a clear regulatory pathway. The upcoming NDA submission and potential for broad application across various surgical disciplines could position PolyPid favorably in the pharmaceutical market.