PETACH TIKVA, Israel, Sept. 03, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced that senior management will participate in the upcoming 27th Annual H.C. Wainwright Global Investment Conference taking place on September 8-9, 2025, at the Lotte New York Palace Hotel, New York City. PolyPid's fireside chat with H.C. Wainwright Managing Director, Equity Research, Brandon Folkes, will take place ...

PETACH TIKVA, Israel, Sept. 02, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced that Dalit Hazan, Deputy CEO, EVP R&D, Clinical, and Regulatory Affairs, will present at the 14th meeting of the Israel Controlled Release Society (ICRS) Conference taking place at the Enjoy Hotel, Dead Sea, in Israel from September 7-9, 2025. The presentation, titled "Novel Local Prolonged Drug Delivery: From P ...

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]

Positive Phase 3 SHIELD II Trial Results - D-PLEX₁₀₀ successfully met its primary efficacy endpoint and demonstrated 58% reduction in SSI NDA submission expected in Q1 2026 Unveiled a Long-Acting GLP-1 Receptor Agonists Delivery Platform Targeting the Obesity and Diabetes Market Successful Warrant Exercise Significantly Strengthened Balance Sheet with Cash Runway into 2026 Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, Aug. 13, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (" ...

Dr. Tweezer-Zaks holds M.D. and B.S. degrees from Ben-Gurion University School of Medicine in Beer Sheva, Israel, and earned an M.B.A. from the Kellogg-Recanati International Executive MBA Program, a global partnership program between Northwestern University's Kellogg School of Management in Evanston, IL, and Tel Aviv University's Recanati Graduate School of Business Administration in Israel. About PolyPid PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Thr ...

PETACH TIKVA, Israel, July 30, 2025 (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 second quarter 2025 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, August 13, 2025. 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. To ...

Core Viewpoint - PolyPid Ltd. has introduced a long-acting GLP-1 receptor agonists delivery platform that aims to provide subcutaneous release of GLP-1 for approximately 60 days, significantly extending the duration compared to current weekly injection regimens, which could transform patient care in diabetes and weight management markets [2][3]. 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 therapeutics [4]. - The company is preparing for a New Drug Application (NDA) submission for its lead product candidate, D-PLEX100, aimed at preventing abdominal colorectal surgical site infections, expected in early 2026 [4]. Product and Technology - The new GLP-1 delivery platform utilizes a polymer-lipid based matrix that enables linear drug release, overcoming the burst release associated with current weekly delivered molecules [2][3]. - This technology has been clinically validated in over 1,000 patients, including two Phase 3 trials, with no major safety concerns reported [3]. Market Potential - The market for GLP-1 therapies is projected to reach $100 billion by 2030, driven by increasing demand in diabetes and obesity treatment [2][9]. - The introduction of the long-acting GLP-1 delivery platform could significantly expand PolyPid's offerings in this growing market [2][3].

Core Viewpoint - PolyPid Ltd. has secured additional funding of $26.7 million through the exercise of warrants, extending its financial runway beyond the anticipated FDA approval of its lead product candidate, D-PLEX₁₀₀ [1][4]. Funding Details - The funding was obtained through new agreements with existing warrant holders for the immediate exercise of warrants to purchase up to 7,626,514 ordinary shares at a price of $3.50 per share [2]. - In exchange for the immediate cash exercise of the warrants, PolyPid will issue new unregistered warrants for the purchase of an equal number of ordinary shares at an exercise price of $4.50 per share, valid for two years [3]. Use of Proceeds - The net proceeds from this funding will be utilized for new drug application (NDA) submission, launch preparations, working capital, and general corporate purposes [4]. Product Information - D-PLEX₁₀₀ is designed to provide prolonged and controlled antibacterial activity at surgical sites to prevent surgical site infections (SSIs) and has received Breakthrough Therapy designation from the FDA [7]. - The product demonstrated a statistically significant reduction in SSIs in the Phase 3 SHIELD II trial, meeting all primary and key secondary endpoints [8][9].

Core Insights - PolyPid Ltd. announced significant topline results from the SHIELD II Phase 3 trial, showing that D-PLEX100 effectively reduces surgical site infections (SSIs) [1][2][18] - The study demonstrated a 58% reduction in SSIs, a 38% reduction in the composite primary endpoint, and a 62% reduction in severe wound infections, validating the PLEX technology platform [2][6][18] Clinical Efficacy - The SHIELD II trial involved 798 patients with large abdominal incisions, achieving a 38% reduction in the composite primary endpoint (10.9% vs 18.1% in the control arm, p<0.005) [6] - D-PLEX100 treatment resulted in a 58% reduction in deep and superficial SSIs (3.8% vs 9.5% in the control arm, p<0.005), indicating a significant improvement in infection rates [6][7] Technology Validation - The results validate PolyPid's PLEX technology, which allows for sustained, localized antibiotic delivery for 30 days at surgical sites [8][9] - D-PLEX100 uses only 55-164 mg of doxycycline compared to 6,000 mg in systemic formulations, addressing limitations of current prophylactic strategies [9] Market Impact - SSIs affect up to 30% of colorectal surgeries, leading to extended hospital stays and direct costs of $11,000-26,000 per infection; the 58% reduction in SSI rates could lead to significant healthcare cost savings [11] - PolyPid targets a total addressable U.S. market of over 12 million annual surgeries, with potential for label expansion beyond colorectal indications [15] Regulatory Pathway - PolyPid plans to submit regulatory filings for FDA New Drug Application (NDA) and European Medicines Agency Marketing Authorization Application (MAA) in early 2026 [12] - The FDA has previously assigned Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product (QIDP) designations to D-PLEX100, facilitating expedited review [13] Broader Implications - The SHIELD II results not only support D-PLEX100 but also validate the broader PLEX technology platform for future therapeutic applications, including localized chemotherapy delivery [16][17] - The successful demonstration of clinical efficacy opens new possibilities for addressing unmet medical needs across various therapeutic areas [19][20]

Core Insights - PolyPid Ltd. announced significant topline results from its SHIELD II Phase 3 trial, showing that D-PLEX100 significantly reduces surgical site infections (SSIs) [1][2][18] - The study demonstrated a 58% reduction in SSIs, a 38% reduction in the composite primary endpoint, and a 62% reduction in severe wound infections, validating the PLEX technology platform [2][6][18] Clinical Efficacy - The SHIELD II trial involved 798 patients with large abdominal incisions, achieving a 38% reduction in the composite primary endpoint (10.9% vs 18.1% in the control arm, p<0.005) [6] - D-PLEX100 treatment resulted in a 58% reduction in deep and superficial SSIs (3.8% vs 9.5% in the control arm, p<0.005), indicating a clinically meaningful improvement [6][7] - The results suggest D-PLEX100's effectiveness extends beyond high-risk patients, with a 62% reduction in severe infections indicated by ASEPSIS scores [14] Technology Validation - The SHIELD II results validate PolyPid's PLEX technology, which allows for sustained, localized antibiotic delivery for 30 days at surgical sites [8][9] - D-PLEX100 uses significantly lower amounts of doxycycline (55-164 mg) compared to systemic formulations (6,000 mg), addressing limitations of current prophylactic strategies [9][10] Market Impact - SSIs affect up to 30% of colorectal surgeries, leading to extended hospital stays and direct costs of $11,000-26,000 per infection; the 58% reduction in SSI rates could lead to substantial healthcare savings [11] - PolyPid targets a total addressable U.S. market of over 12 million annual surgeries, with approximately 4.4 million soft-tissue surgeries potentially benefiting from D-PLEX100 [15] Regulatory Pathway - PolyPid plans to submit regulatory filings for D-PLEX100 in early 2026, with Breakthrough Therapy and Fast Track designations from the FDA facilitating expedited review [12][13] Broader Implications - The SHIELD II results not only support D-PLEX100 but also validate the broader PLEX technology platform for future therapeutic applications, including localized chemotherapy delivery [16][17] - The convergence of clinical efficacy, market opportunity, and regulatory support positions D-PLEX100 as a significant advancement in surgical infection prevention [20]