PETACH TIKVA, Israel, Jan. 28, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it will report its fourth quarter 2025 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, February 11, 2026. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations. T ...

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.

Core Viewpoint - PolyPid Ltd. is set to submit a New Drug Application (NDA) for its lead product candidate D-PLEX100, aimed at preventing surgical site infections in abdominal colorectal surgeries, with submissions beginning in early 2026 following positive feedback from the FDA [1][2][4]. Group 1: NDA Submission and FDA Interaction - The FDA has confirmed that PolyPid's existing clinical data, including results from the Phase 3 SHIELD II trial, is adequate for NDA submission and review [2][4]. - A rolling NDA review has been agreed upon, allowing PolyPid to submit completed sections starting in early 2026 [2][4]. - The in-person pre-NDA meeting originally scheduled for December 3, 2025, is no longer necessary as the objectives have been met [3]. Group 2: Product Details and Clinical Results - D-PLEX100 utilizes PLEX technology to provide prolonged and controlled antibacterial activity at the surgical site, releasing doxycycline over 30 days to prevent surgical site infections [5][6]. - The Phase 3 SHIELD II trial demonstrated a statistically significant 58% relative risk reduction in surgical site infection incidence following abdominal colorectal surgery with large incisions [5]. - D-PLEX100 has received Breakthrough Therapy designation from the FDA for its potential in preventing surgical site infections in elective colorectal surgery patients [5]. Group 3: Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through locally administered therapeutics [6]. - The company is also developing an innovative pipeline targeting oncology, obesity, and diabetes [6].

Core Insights - PolyPid Ltd. is participating in a virtual Key Opinion Leader event to discuss the clinical and economic burden of surgical site infections and the therapeutic potential of D-PLEX100 [1][2] Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through locally administered, controlled, prolonged-release therapeutics [6] - The company utilizes proprietary PLEX technology to enable precise drug delivery at optimal release rates over durations from several days to months [6] Product Information - D-PLEX100 is PolyPid's lead product candidate designed to provide local prolonged and controlled antibacterial activity at the surgical site to prevent surgical site infections (SSIs) [5] - D-PLEX100 demonstrated a statistically significant 58% relative risk reduction in SSI incidence following abdominal colorectal surgery in the Phase 3 SHIELD II trial [5] - The product received Breakthrough Therapy designation from the U.S. FDA for the prevention of SSIs in elective colorectal surgery [5] Upcoming Events - The KOL event titled "The Science and Business Case for D-PLEX100" is scheduled for December 10, 2025, featuring Dr. Steven D. Wexner discussing SSIs and D-PLEX100's role in addressing this unmet medical need [2][3] Future Plans - PolyPid plans to submit a New Drug Application (NDA) for D-PLEX100 in early 2026 following positive Phase 3 results [7] - The company is also developing an innovative pipeline in oncology, obesity, and diabetes [7]

Financial Data and Key Metrics Changes - Research and development expenses totaled $5.3 million, down from $6.2 million in Q2 2025 and $6 million in Q3 2024, reflecting the completion of the SHIELD II phase 3 trial [12] - General and administrative expenses were $1.8 million, compared to $1.2 million in Q3 2024, while marketing and business development expenses increased to $0.4 million from $0.2 million in the same period last year [12] - The net loss for the quarter was $7.5 million, or $0.37 per share, an improvement from the net loss of $7.8 million, or $1.22 per share in Q3 2024 [12] - For the nine months ended September 30, 2025, net loss was $25.7 million, or $1.72 per share, compared to $20.5 million, or $3.82 per share for the same period in 2024 [13] Business Line Data and Key Metrics Changes - The successful completion of the Israeli Ministry of Health Good Manufacturing Practice inspection marked an important step towards commercial manufacturing readiness for D-PLEX100 [6] - A new US market access study confirmed strong interest from both surgeons and hospital pharmacy directors, with 80% of surgeons indicating they are extremely likely to use D-PLEX100 for their next eligible patients [10] Market Data and Key Metrics Changes - The market access study showed that D-PLEX100 was viewed as more valuable than current SSI prevention measures, with 70% of hospital pharmacy directors reporting a high likelihood to add and stock D-PLEX100 [10] - The study indicated that D-PLEX100 addresses a significant unmet need in the market for surgical site infection prevention [10] Company Strategy and Development Direction - The company is focused on bringing D-PLEX100 to market, with a pre-NDA meeting with the FDA scheduled for early December and an NDA submission expected in early 2026 [5] - Strategic discussions with potential US partners are ongoing, building on the positive momentum from the SHIELD II trial results [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in passing the upcoming FDA inspection, highlighting ongoing improvements in facility and quality control processes [17] - The company anticipates that the pre-NDA meeting will align on the data package and submission format, setting the stage for an early 2026 submission [24] Other Important Information - The company reported a cash balance of $18.8 million as of September 30, 2025, up from $15.6 million at year-end 2024, indicating a strong cash runway into 2026 [14] - Significant progress was made in reducing debt, with current maturities decreasing from $6.5 million to $2.4 million [15] Q&A Session Summary Question: Insights on the Israeli Ministry of Health inspection - Management confirmed the successful inspection and expressed confidence in passing the upcoming FDA inspection, noting ongoing improvements in their facility [17] Question: Specific items for the pre-NDA meeting - The focus will be on reviewing the data package, submission format, and label scope to ensure alignment with the FDA [24] Question: Pricing strategy for D-PLEX100 - Management indicated strong interest in premium pricing based on market research and stakeholder feedback, suggesting that there is room to stretch pricing higher [26] Question: Growth of the PolyPid pipeline post-partnership - Management outlined plans for expanding the pipeline in oncology, obesity, and diabetes, while also emphasizing the importance of a US partner for the abdominal indication [33] Question: Market research sample size and decision-making involvement - The market research included 20 participants, all of whom were involved in the decision-making process regarding formulary inclusion [42] Question: Challenges in commercializing D-PLEX100 in the U.S. - Management acknowledged the need for future facility expansion to meet peak sales demands and is considering local manufacturing trends in their planning [46]

Financial Position - PolyPid had cash, cash equivalents, and short-term deposits of $18.8 million as of September 30, 2025, up from $15.6 million on December 31, 2024, indicating a strong liquidity position [8]. - The company reduced current maturities of long-term debt from $6.5 million as of June 30, 2025, to $2.4 million as of September 30, 2025, reflecting significant progress in debt management [8]. - Total assets increased to $26.8 million as of September 30, 2025, compared to $25.2 million on December 31, 2024, indicating growth in the company's financial position [16]. Research and Development - Research and development (R&D) expenses for Q3 2025 were $5.3 million, a decrease from $6.0 million in Q3 2024 and $6.2 million in Q2 2025, attributed to the completion of the SHIELD II Phase 3 trial [9]. - For the nine months ended September 30, 2025, R&D expenses totaled $17.6 million, up from $15.8 million in the same period of 2024, primarily due to activities related to the SHIELD II trial [9]. Net Loss - The net loss for Q3 2025 was $7.5 million, or ($0.37) per share, compared to a net loss of $7.8 million, or ($1.22) per share, in Q3 2024, showing an improvement in loss per share [9]. - For the nine months ended September 30, 2025, the company reported a net loss of $25.7 million, or ($1.72) per share, compared to a net loss of $20.5 million, or ($3.82) per share, in the same period of 2024 [9]. Regulatory and Market Position - The company is on track to submit a New Drug Application (NDA) for D-PLEX₁₀₀ in early 2026, following a pre-NDA meeting with the FDA scheduled for early December 2025 [5]. - PolyPid successfully completed the IMOH GMP inspection, marking the fourth consecutive successful GMP inspection of its manufacturing facility, which is crucial for commercial readiness [5]. - The company is engaged in strategic partnership discussions in the U.S. for D-PLEX₁₀₀, following positive Phase 3 trial results, enhancing its market positioning [5].

Core Insights - PolyPid Ltd. is progressing towards the market launch of D-PLEX₁₀₀, with a pre-NDA meeting with the FDA scheduled for early December and NDA submission expected in early 2026 [1][4][3] Regulatory Pathway Advancement - The company is on track to submit an NDA for D-PLEX₁₀₀ aimed at preventing abdominal colorectal surgical site infections (SSIs), leveraging Fast Track and Breakthrough Therapy designations [4] - A face-to-face pre-NDA meeting with the FDA is set for early December 2025 [4] Partnership Discussions - PolyPid is engaged in strategic discussions with potential U.S. partners for D-PLEX₁₀₀, which have advanced following positive Phase 3 trial results [4][3] Commercial Readiness - The company successfully completed the Israeli Ministry of Health Good Manufacturing Practice inspection, marking the fourth consecutive successful GMP inspection [4] - Recent U.S. market access research indicates a strong value proposition for D-PLEX₁₀₀ in reducing clinical and economic burdens of SSIs [4] Financial Performance - R&D expenses for Q3 2025 were $5.3 million, down from $6.0 million in Q3 2024 and $6.2 million in Q2 2025 [5] - G&A expenses for Q3 2025 were $1.8 million, compared to $1.2 million in Q3 2024 [5] - The company reported a net loss of $7.5 million, or ($0.37) per share, for Q3 2025, an improvement from a net loss of $7.8 million, or ($1.22) per share, in Q3 2024 [5] Balance Sheet Highlights - As of September 30, 2025, cash and cash equivalents totaled $18.8 million, up from $15.6 million on December 31, 2024 [7] - The company reduced current maturities of long-term debt from $6.5 million as of June 30, 2025, to $2.4 million as of September 30, 2025 [7] Overall Financial Results - For the nine months ended September 30, 2025, R&D expenses were $17.6 million, compared to $15.8 million for the same period in 2024 [11] - The net loss for the nine months ended September 30, 2025, was $25.7 million, or ($1.72) per share, compared to a net loss of $20.5 million, or ($3.82) per share, in the same period of 2024 [11]