FDA Grants $4.3 Million Small Business Waiver, Enabling Focus on Commercialization Preparations Company On Track to Initiate NDA Submission by the End of this Month PETACH TIKVA, Israel, March 17, 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 care begins, today announced that the U.S. Food and Drug Administration (FDA) has granted a small busi ...

Summary of PolyPid Conference Call Company Overview - **Company**: PolyPid (NasdaqCM:PYPD) - **Product**: D-PLEX100, a drug designed to deliver 30 days of antibiotic coverage in surgical sites, particularly for colorectal surgeries Key Points NDA Submission and FDA Interaction - PolyPid is preparing for an NDA submission for D-PLEX100, expected to be announced shortly, with a rolling submission plan in place [2][3][13] - The product has received Breakthrough Therapy designation, allowing for more frequent communication with the FDA [5] - The FDA agreed that the Phase 3 SHIELD I study data is sufficient for NDA approval, confirming alignment on efficacy and safety [6] Clinical Data and Efficacy - Top-line data from the Phase 3 trial showed a 60% reduction in surgical site infections (SSI) for patients undergoing colorectal resection, with a p-value of less than 0.005 [2][34] - The study included 1,000 patients, with a primary endpoint showing a 40% reduction in mortality, reoperation, and SSI [34] - Secondary endpoints also demonstrated significant reductions in infection severity, as measured by the ASEPSIS score [34] Market Opportunity - The U.S. market for abdominal surgeries is approximately 4.4 million procedures annually, with significant potential for D-PLEX100 to be used in various surgical contexts beyond colorectal procedures [53] - The product is expected to initially receive a colorectal label, with potential for expansion to other abdominal surgeries, such as breast mastectomy and abdominoplasty [49][50] Launch and Commercialization Strategy - PolyPid is focusing on partnerships with companies that have strong hospital and surgical suite presence to facilitate product adoption [69] - The company is conducting market research and engaging with pharmacy directors and surgeons to prepare for product launch [62][63] - The product is eligible for the New Technology Add-on Payment (NTAP), which may drive adoption [67] Platform Technology - The PLEX platform allows for a unique drug delivery system with thousands of layers, providing localized antibiotic exposure while minimizing systemic effects [84] - Future developments include a long-acting GLP-1 program aimed at metabolic health, which is currently in preclinical stages [85][95] Conclusion - PolyPid is on track for significant milestones with D-PLEX100, including NDA submission and potential market expansion, supported by robust clinical data and a strategic commercialization plan [2][3][13][49]

Financial Performance - The company incurred a net cash used in operating activities of $27.9 million for the year ended December 31, 2025, compared to $21.96 million for the year ended December 31, 2024, primarily due to the completed SHIELD II Phase 3 clinical trial and NDA submission preparations [478]. - The company reported net cash used in investing activities of $6.7 million for the year ended December 31, 2025, compared to $330,000 for the year ended December 31, 2024 [476]. - Net cash provided by financing activities decreased to $25.4 million for the year ended December 31, 2025, from $32.4 million in 2024, mainly due to changes in financing sources [481]. - The company has not generated any revenue since its inception and has incurred operating losses and negative cash flows from operations [463]. - The company does not expect to generate revenue from product sales for the foreseeable future, relying on additional financing to achieve business objectives [485]. Cash and Financing - The company had $12.9 million in cash and cash equivalents and short-term deposits as of December 31, 2025 [475]. - The company raised gross proceeds of $16.2 million from a private placement financing in January 2024, selling 3,143,693 Ordinary Shares at $4.81 per share [470]. - The company sold 1,650,827 Ordinary Shares under a new sales agreement for total proceeds of $6.14 million during the year ended December 31, 2025 [469]. - The company reported a net cash provided by financing activities of $25.37 million for the year ended December 31, 2025 [476]. - The company has a loan agreement with Kreos for up to $15 million, with the first tranche of $10 million drawn on April 26, 2022 [464]. - The company issued a warrant to purchase 40,000 Ordinary Shares at an exercise price of $3.61 per share as part of the second amendment to the loan agreement [468]. Research and Development - As of December 31, 2025, the company incurred $198.2 million in research and development expenses since inception, with ongoing expenses expected as clinical trials and product development continue [488]. - The company anticipates significant commercialization expenses if marketing approval is obtained for any product candidates, impacting future financial performance [482]. - The company capitalized $1.1 million of pre-launch inventories as of December 31, 2025, based on the assessment of regulatory approval likelihood for D-PLEX100 [500]. Equity and Future Outlook - The company has a shareholders' equity of $11.0 million as of December 31, 2025, and anticipates continued losses and negative cash flows until products reach commercial profitability [483]. - The company expects to need additional capital to fund clinical and regulatory programs for D-PLEX100 and other product candidates, with substantial doubt about its ability to continue as a going concern if additional funding is not secured [483]. Non-Cash Expenses - The company incurred non-cash share-based compensation expenses of $4.9 million, $2.8 million, and $3.4 million during the years ended December 31, 2025, 2024, and 2023, respectively [496]. Currency Fluctuations - The company experienced a 5% and 10% fluctuation in the U.S. dollar/NIS exchange rate, which would have increased/decreased operating expenses by approximately 1.2% and 2.3%, respectively, during the year ended December 31, 2025 [458]. Grants and Obligations - The company has received royalty-bearing grants totaling $4.9 million, with a royalty obligation of 3.0% on revenues from products developed with these grants [498].

Core Insights - PolyPid Ltd. is an innovative biopharmaceutical company focused on enhancing treatment effectiveness at the point of care, with a diverse pipeline addressing unmet medical needs [4] Company Participation in Conferences - PolyPid management will participate in two investor conferences in March 2026, providing opportunities for one-on-one meetings with investors [2][3] Product Development - PolyPid's lead product, D-PLEX₁₀₀, has successfully met its primary and all key secondary endpoints in the Phase 3 SHIELD II trial aimed at preventing surgical site infections [4]

Core Insights - PolyPid is targeting an initial label for D-PLEX100 focused on preventing surgical site infections in abdominal colorectal surgery, supported by SHIELD II data and breakthrough therapy designation from the FDA [1] - The FDA has indicated that the existing clinical data package is adequate for NDA submission, providing clarity on submission structure and expectations [2] - The company plans to begin a rolling NDA submission for D-PLEX100 by the end of Q1 2026, with a six-month priority review expected [3][7] Regulatory and Clinical Developments - PolyPid completed its SHIELD II Phase 3 trial in 2025 and is advancing towards regulatory preparation for D-PLEX100, with a new drug application submission planned for early 2026 [4] - The FDA has supported the rolling NDA review path for D-PLEX100, with initial submissions focusing on chemistry, manufacturing, and controls, followed by clinical modules [7] - Management anticipates a European submission approximately one quarter after the FDA filing [9] Financial Overview - As of December 31, 2025, PolyPid reported $12.9 million in cash and a net loss of $34.2 million for the full year, with expectations to fund operations into the second half of 2026 [5][19] - Research and development expenses for Q4 2025 were $6.2 million, down from $7.0 million in the prior year, while general and administrative expenses rose to $1.8 million [17] - Full-year R&D expenses increased to $23.8 million, attributed to activities related to the SHIELD II trial and regulatory preparations [18] Commercial Strategy - The company is advancing U.S. commercial partnership discussions with hospital-focused partners and preparing for pre-launch activities [6][8] - PolyPid's top commercial priority is the U.S. market, with potential interest in other geographies as part of discussions [9] - Management is focusing on building awareness and readiness for D-PLEX100 through market research, pricing work, and external clinical engagement [12][13] Corporate Updates - Brooke Story was appointed as chair of the board in December 2025, bringing experience in medical technology and surgical solutions [14] - PolyPid has rebranded to reflect its transition from an R&D-focused organization to one preparing for commercialization [15] - The company introduced "Kynatrix" as the name for its next-generation technology umbrella, which includes expanded controlled-release capabilities [16]

Financial Data and Key Metrics Changes - For 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 III trial [14] - 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 [15] - The net loss for Q4 2025 was $8.5 million or $0.41 per share, unchanged from the net loss of $8.5 million or $1.13 per share in Q4 2024 [15] - 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 [16] Business Line Data and Key Metrics Changes - The company successfully completed the SHIELD II Phase III trial, with D-PLEX100 meeting its primary and key secondary endpoints [6] - The company is advancing its long-acting GLP-1 receptor agonist program alongside D-PLEX100 [6] Market Data and Key Metrics Changes - The company received positive feedback from the FDA regarding the regulatory pathway for D-PLEX100, supporting a rolling NDA submission expected to begin by the end of Q1 2026 [7] - The company is in advanced stages of partnership discussions in the U.S., reflecting recognition of D-PLEX100's strong clinical profile [8] Company Strategy and Development Direction - The company is transitioning from a primarily R&D-focused organization to one preparing for commercialization, with a focus on regulatory pathways and commercial partnerships [6][10] - The introduction of Kynatrix technology represents an expansion of the company's capabilities beyond localized delivery, targeting systemic therapeutic needs [13] Management's Comments on Operating Environment and Future Outlook - Management believes 2026 could be a transformative year, with the rolling NDA submission and ongoing partnership discussions [9] - The company is preparing for market approval and launch, emphasizing the importance of building awareness and readiness among stakeholders [30] 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 All Questions and Answers 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 patients undergoing abdominal colorectal surgery, supported by Phase III data [21] Question: Any thoughts on plans for a broader label or further expansion opportunities for D-PLEX100? - The company plans to meet with the FDA to discuss potential label expansion opportunities during the review process [23] Question: What work is being done to prepare for potential approval of D-PLEX100? - The company is focusing on market research, building awareness, and creating a KOL network to prepare for commercialization [31] Question: How do you think about strategic partnerships for the GLP-1 program? - The company aims to partner at an early stage, leveraging robust preclinical data to attract interest from potential partners [34] Question: What factors will play a role in identifying the final partner for D-PLEX100? - The ideal partner will have broad hospital-based capabilities and presence in the surgical suite, essential for marketing the product [40] 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 [48]

Financial Data and Key Metrics Changes - For 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 [14] - General and administrative expenses increased to $1.8 million in Q4 2025 from $1 million in Q4 2024 [15] - The net loss for Q4 2025 was $8.5 million or $0.41 per share, compared to a net loss of $8.5 million or $1.13 per share in Q4 2024 [15] - 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 [16] - As of December 31, 2025, the company had $12.9 million in cash and equivalents [16] Business Line Data and Key Metrics Changes - The company advanced D-PLEX100 into final stages of regulatory preparation after successful Phase 3 trial results [6][7] - Marketing and business development expenses for the year increased to $2 million from $0.9 million in 2024, reflecting increased efforts as the company moves closer to commercialization [16] Market Data and Key Metrics Changes - The company is focusing on the U.S. market for D-PLEX100, with plans for NDA submission expected by the end of Q1 2026 [9][39] - Discussions with potential U.S. commercial partners are advancing, reflecting the strong clinical profile of D-PLEX100 [11] Company Strategy and Development Direction - The company aims to transition from a primarily R&D-focused organization to one preparing for commercialization [12] - The introduction of Kynatrix technology represents a broader long-term opportunity, while D-PLEX100 remains the focus for near-term execution [13] - The company is engaging with external stakeholders, including surgeons and hospital administrators, to build awareness and readiness for market approval [9][12] Management Comments on Operating Environment and Future Outlook - Management believes 2026 could be transformative, with the rolling NDA submission expected to begin soon and ongoing partnership discussions [9] - Positive feedback from the FDA supports the regulatory pathway for D-PLEX100, indicating that existing clinical data is adequate for NDA submission [21][44] Other Important Information - The company appointed Brooke Story as chairman of the board in December 2025, bringing extensive experience in medical technology [9] - The company is preparing for commercial readiness, including market research and building a KOL network [31] Q&A Session Summary Question: Scope of the label for D-PLEX100 - Management is targeting an initial label for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, with potential for broader applications [21][22] Question: Plans for broader label and expansion opportunities - Management is planning to meet with the FDA to discuss potential label expansion as part of their ongoing strategy [23] Question: Preparation for potential approval of D-PLEX100 - The company is focused on building awareness, preparing packaging, and conducting market research to ensure readiness for commercial launch [30] Question: Strategic plans for GLP-1 program - The GLP-1 program aims for improved patient compliance with a sustained release mechanism, with plans to partner at an early stage [33] Question: Factors influencing partnership discussions - The ideal partner will have hospital-based capabilities and presence in the surgical suite, which is crucial for marketing D-PLEX100 [40] Question: Timeline for rolling submission - The NDA submission is expected to begin by the end of Q1 2026, with a shortened review period anticipated due to Fast Track and Breakthrough Therapy Designation [56]

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]

Core Insights - PolyPid Ltd. is advancing discussions for a commercial partnership in the U.S. for its product D-PLEX₁₀₀, following positive Phase 3 trial results and FDA engagement [3][5] - The company expects to begin the rolling NDA submission process by the end of Q1 2026, marking a significant step towards regulatory approval [3][5] - 2026 is anticipated to be a transformative year for PolyPid as it transitions from late-stage development to full commercial execution [3][14] Recent Corporate Highlights - The completion of the SHIELD II Phase 3 trial has positioned D-PLEX₁₀₀ for advanced partnership discussions in the U.S. [3][5] - Positive FDA feedback supports the planned rolling NDA submission for D-PLEX₁₀₀ aimed at preventing surgical site infections [5][14] - Brooke Story has been appointed as Chairman of the Board, bringing extensive experience in medical technology [5] - A Key Opinion Leader event highlighted the clinical and economic burden of surgical site infections and the potential of D-PLEX₁₀₀ to improve outcomes [5] Financial Results - For Q4 2025, R&D expenses decreased to $6.2 million from $7.0 million in Q4 2024, reflecting the completion of the SHIELD II trial [6] - G&A expenses increased to $1.8 million in Q4 2025 from $1.0 million in Q4 2024, while marketing expenses rose to $0.6 million from $0.2 million [6] - The net loss for Q4 2025 was $8.5 million, or $0.41 per share, compared to a net loss of $8.5 million, or $1.13 per share, in Q4 2024 [7][20] Full Year Financial Overview - For the full year 2025, R&D expenses totaled $23.8 million, up from $22.8 million in 2024, driven by trial completion and regulatory preparations [13] - G&A expenses for 2025 were $7.2 million, compared to $4.3 million in 2024, primarily due to non-cash expenses related to performance-based options [13] - The net loss for 2025 was $34.2 million, or $2.09 per share, compared to a net loss of $29.0 million, or $4.91 per share, in 2024 [13][18] Balance Sheet Highlights - As of December 31, 2025, the company had cash and cash equivalents of $6.4 million, down from $15.6 million in 2024 [15] - Total assets decreased to $22.3 million in 2025 from $25.2 million in 2024 [16] - Shareholders' equity increased to $10.973 million in 2025 from $7.684 million in 2024, reflecting additional capital raised through warrant exercises [13][17]

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]