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 - As of June 30, 2025, the company reported cash and cash equivalents of $17.4 million and short-term deposits of $12 million, totaling $29.5 million, a significant increase from $15.6 million as of December 31, 2024, primarily due to a successful warrant exercise [15][16] - For Q2 2025, the company reported a net loss of $10 million or $0.78 per share, compared to a net loss of $6.3 million or $1.25 per share in Q2 2024 [17] - For the six months ended June 30, 2025, the net loss was $18.2 million or $1.48 per share, compared to a net loss of $12.7 million or $2.62 per share in the same period of 2024 [17] Business Line Data and Key Metrics Changes - The SHIELD II Phase III trial for DPLEX100 demonstrated a statistically significant 38% reduction in the primary endpoint of surgical site infections (SSI) with a p-value below 0.005 [5] - The trial also showed a 58% reduction in the rate of surgical site infections in patients treated with DPLEX100 compared to standard care, with a significant reduction in deep surgical site infections [5][6] - The company is preparing for a New Drug Application (NDA) submission to the FDA in early 2026, following positive Phase III data [8][9] Market Data and Key Metrics Changes - The total addressable market for DPLEX100 in the US is estimated at over 12 million surgeries annually, with approximately 4.4 million being abdominal surgeries [11] - Surgical site infections are estimated to cost the US healthcare system up to $10 billion annually, highlighting the potential economic impact of DPLEX100 [12] Company Strategy and Development Direction - The company aims to leverage the positive Phase III results to enhance commercial preparations and explore partnership opportunities for DPLEX100 [11][46] - The GLP-1 program is positioned to address unmet needs in the treatment of metabolic diseases, with plans for robust preclinical studies and potential partnerships [9][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of DPLEX100 to significantly reduce surgical site infections and improve patient outcomes, which has generated substantial interest from commercial partners [7][8] - The company is focused on regulatory submissions and commercial preparations, with a strong emphasis on maximizing the value of DPLEX100 [46] Other Important Information - The company appointed Dr. Nuit Tyser Zacks as Chief Medical Officer, bringing extensive expertise to support regulatory efforts and pre-launch activities [10][36] - The company has strengthened its balance sheet through a successful warrant exercise, extending its cash runway well into 2026 [10][15] Q&A Session Summary Question: NDA filing preparations - Management indicated they are in the finalization stages of the CMC and clinical module, preparing for a pre-NDA meeting with the FDA by the end of the year, with NDA submission expected in early 2026 [19][22] Question: Path forward for the GLP-1 program - The GLP-1 program is entering robust preclinical studies, with plans to characterize the risk profile and pursue clinical collaboration with a large player in the field [23][24] Question: Advanced partnership milestones - Management confirmed that milestones are expected from the partnership, with ongoing discussions to finalize pre-launch activities [28][29] Question: Preferred methods for bolstering the balance sheet - The company is looking to collaborate with partners to finance efforts and expects payments from existing and new partners to support financial needs [40]