PETACH TIKVA, Israel, Oct. 29, 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 third quarter 2025 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, November 12, 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 ...

Summary of PolyPid's Investor Conference Call Company Overview - **Company**: PolyPid (Ticker: PYPD) - **Industry**: Specialty Pharmaceuticals, Biotech, Medical Technology - **Key Product**: D-PLEX100, a drug delivery system aimed at preventing surgical site infections [4][5] Core Points and Arguments - **Platform Technology**: PolyPid has developed a unique platform technology for prolonged and constant linear drug delivery, initially focusing on surgical site infection prevention [4] - **Clinical Data**: - D-PLEX100 has shown a nearly 40% reduction in composite primary endpoints and over 50% reduction in surgical site infections in pivotal studies [5][8] - In the SHIELD 2 study, a significant reduction in infection rates was observed, from 9.5% to 3.8%, with a p-value of less than 0.005, indicating strong statistical significance [8][9] - **Market Opportunity**: - The average cost of a surgical site infection (SSI) per patient in the U.S. is approximately $25,000, which is not reimbursed, leading to potential financial losses for hospitals [12] - The initial target market for D-PLEX100 includes about 7.4 million abdominal surgeries annually in the U.S. and Europe [13] - **Regulatory Path**: - PolyPid plans to submit a New Drug Application (NDA) in Q1 of the following year and has been in frequent communication with the FDA due to its breakthrough therapy designation [19][20] - The company has passed inspections from European authorities and the Israeli Ministry of Health, which are considered to be on par with FDA standards [21][23] Additional Insights - **Future Indications**: PolyPid aims to expand D-PLEX100's applications to other surgical areas, including open heart surgery and orthopedics, which could significantly increase the market size [13][14] - **Commercial Partnerships**: The company is in discussions with potential commercial partners in the U.S. and is optimistic about the interest shown by companies with robust hospital sales forces [26] - **GLP-1 Program**: PolyPid has initiated a GLP-1 program in early clinical stages, focusing on a unique drug delivery profile that minimizes adverse effects and extends dosing intervals [27][28] - **Financial Position**: PolyPid has sufficient cash to operate into 2026, which will support activities post-NDA submission [34] Conclusion PolyPid is positioned to make a significant impact in the specialty pharmaceuticals market with its innovative D-PLEX100 product, backed by strong clinical data and a clear regulatory pathway. The company is actively pursuing commercial partnerships and exploring additional therapeutic areas, which could enhance its growth potential in the coming years.

The Company will present the reported topline results from its phase 3 SHIELD II trial at one of the world’s leading surgical conferencesPETACH TIKVA, Israel, Sept. 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 Dr. Shmuel Sharoni will present the topline results from the Company's successful Phase 3 SHIELD II trial of D-PLEX₁₀₀ at the upcoming 2025 American College of Surgeons (A ...

Core Insights - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through innovative therapeutics [4] - The company will present at the Lytham Partners Fall 2025 Virtual Investor Conference on September 30, 2025, and participate in the 4th Annual ROTH Healthcare Opportunities Conference on October 9, 2025 [1][2][3] Conference Participation - At the Lytham Partners conference, management will engage in a fireside chat with Craig-Hallum Senior Research Analyst, Chase Knickerbocker, at 4:15 p.m. ET and will be available for one-on-one virtual meetings [2] - During the ROTH Healthcare Opportunities Conference, management will also participate in one-on-one meetings, with interested investors encouraged to contact their ROTH representative [3] Company Overview - PolyPid's proprietary PLEX technology allows for controlled, prolonged-release of therapeutics, enabling precise drug delivery over several days to months [4] - 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 [4] - PolyPid has a diverse pipeline that includes innovative treatments in oncology, obesity, and diabetes [4]

Core Insights - PolyPid Ltd. has successfully completed a Good Manufacturing Practice (GMP) inspection by the Israeli Ministry of Health, marking the fourth consecutive successful inspection of its manufacturing facility [1][3] - This inspection confirms that PolyPid's facility meets the standards required for commercial production in the European market under the EU-Israel Agreement on Conformity Assessment and Acceptance (ACAA) framework [2] - The company is preparing for a New Drug Application (NDA) submission for its lead product candidate D-PLEX₁₀₀ in early 2026, following positive results from the Phase 3 SHIELD II trial [3][5] Product Information - D-PLEX₁₀₀ is designed to provide local prolonged and controlled anti-bacterial activity at the surgical site to prevent surgical site infections (SSIs) [4] - The product utilizes Polymer-Lipid Encapsulation matriX (PLEX) technology to enable a continuous release of the antibiotic doxycycline for 30 days, targeting SSIs, including those caused by antibiotic-resistant bacteria [4] - In the Phase 3 SHIELD II trial, D-PLEX₁₀₀ achieved a statistically significant 58% relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions [4] Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through locally administered, controlled, prolonged-release therapeutics [5] - The company has an innovative pipeline that includes products targeting oncology, obesity, and diabetes, in addition to D-PLEX₁₀₀ [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 [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 [3] Upcoming Events - Senior management of PolyPid will participate in the 27th Annual H.C. Wainwright Global Investment Conference on September 8-9, 2025, in New York City [1] - A fireside chat with H.C. Wainwright Managing Director, Brandon Folkes, is scheduled for September 8, 2025, from 11:30 AM to 12:00 PM ET [2] - The management team will engage in both virtual and in-person one-on-one investor meetings during the conference [2]

Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through locally administered, controlled, prolonged-release therapeutics [2] - The company utilizes its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology to enable precise delivery of drugs at optimal release rates over durations ranging from several days to months [2] Recent Developments - Dalit Hazan, Deputy CEO, will present at the 14th meeting of the Israel Controlled Release Society (ICRS) Conference from September 7-9, 2025 [1] - The presentation will cover the topic "Novel Local Prolonged Drug Delivery: From Platform Idea to a Successful Phase III Trial" on September 7, 2025 [2] Product Pipeline - PolyPid's 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 [2] - The company also has an innovative pipeline targeting oncology, obesity, and diabetes [2]

Exhibit 99.1 INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) POLYPID LTD. AND ITS SUBSIDIARIES INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2025 U.S. DOLLARS IN THOUSANDS UNAUDITED INDEX | | Page | | --- | --- | | Interim Condensed Consolidated Balance Sheets | 2 - 3 | | Interim Condensed Consolidated Statements of Operations | 4 | | Interim Condensed Consolidated Statements of Shareholders' Equity | 5 - 7 | | Interim Condensed Consolidated Statements of Cash Flows | 8 - 9 | ...

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]

Core Insights - PolyPid Ltd. reported positive results from the SHIELD II Phase 3 trial for D-PLEX₁₀₀, achieving a 58% reduction in surgical site infections (SSIs) compared to standard care [1][4] - The company plans to submit a New Drug Application (NDA) to the U.S. FDA in Q1 2026, leveraging Fast Track and Breakthrough Therapy designations [1][4] - A successful warrant exercise has strengthened the company's balance sheet, providing a cash runway into 2026 [1][4] Recent Corporate Highlights - The SHIELD II trial demonstrated significant clinical benefits, generating interest from potential commercial partners [3] - Healthcare professionals have shown enthusiasm for D-PLEX₁₀₀, recognizing its potential to reduce SSI burden and improve patient outcomes [3] - The company is well-positioned to maximize the value of its technology with a strengthened balance sheet and strategic options [3] Clinical Trial Results - The SHIELD II trial showed a statistically significant 38% reduction in the primary endpoint and a robust 58% reduction in SSIs [4] - Safety data indicated no difference in serious treatment-emergent adverse events between D-PLEX₁₀₀ and standard care [4] - The company is advancing its NDA preparation following the positive trial results [4] Pipeline Developments - PolyPid is making progress on a GLP-1 delivery platform aimed at the obesity and diabetes market, targeting approximately 60 days of no-burst GLP-1 delivery [4] - The appointment of Dr. Nurit Tweezer-Zaks as Chief Medical Officer is expected to strengthen the leadership team as the company prepares for NDA submission [4] Financial Position - As of June 30, 2025, the company had cash and cash equivalents of $29.5 million, up from $15.6 million at the end of 2024 [7] - The net loss for the three months ended June 30, 2025, was $10.0 million, compared to a net loss of $6.3 million for the same period in 2024 [10] - For the six months ended June 30, 2025, the net loss was $18.2 million, compared to $12.7 million for the same period in 2024 [10]