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]

Financial Performance - Net loss for the six months ended June 30, 2025, was $18,245,000, compared to a net loss of $12,742,000 for the same period in 2024, reflecting a 43.5% increase in losses[7] - The company reported a net loss of $18,245,000 for the six months ended June 30, 2025, compared to a net loss of $12,742,000 for the same period in 2024, representing a 43.9% increase in losses year-over-year[23] - Cash flows from operating activities resulted in a net cash outflow of $12,711,000 for the six months ended June 30, 2025, compared to a net cash outflow of $8,494,000 for the same period in 2024, indicating a 49.0% increase in cash used[23] - The company incurred a loss of $18,245,000 during the six-month period ended June 30, 2025, with negative cash flows from operating activities of $12,711,000[23] - The accumulated deficit as of June 30, 2025, was $285,576,000, reflecting the ongoing financial challenges faced by the company[23] Assets and Liabilities - Total assets increased to $37,687,000 as of June 30, 2025, compared to $25,220,000 as of December 31, 2024, representing a 49.5% growth[3] - Current assets rose to $29,988,000, up from $16,573,000, marking an increase of 80.6%[3] - Total current liabilities increased to $13,155,000 as of June 30, 2025, from $12,681,000 at the end of 2024, an increase of 3.7%[5] - Long-term liabilities decreased to $4,056,000 as of June 30, 2025, from $4,855,000 at the end of 2024, a reduction of 16.4%[5] - Cash and cash equivalents increased to $17,448,000 as of June 30, 2025, compared to $15,641,000 as of December 31, 2024, a rise of 11.5%[3] Shareholder Equity and Shares - Total shareholders' equity increased to $20,476,000 as of June 30, 2025, from $7,684,000 at the end of 2024, a growth of 166.5%[5] - The number of ordinary shares outstanding increased to 15,654,129 as of June 30, 2025, from 10,190,904 at the end of 2024, representing a 54.1% increase[5] - Basic and diluted loss per share for the six months ended June 30, 2025, was $1.48, compared to $2.62 for the same period in 2024, a decrease of 43.5%[7] Research and Development - Research and development expenses for the six months ended June 30, 2025, were $12,332,000, up from $9,810,000 in 2024, indicating a 25.4% increase[7] - The company plans to continue incurring substantial losses during its clinical development phase, which may span many years and require significant expenditures[23] - The company successfully completed the SHIELD II Phase 3 trial for its lead product candidate D-PLEX100, achieving a 58% reduction in surgical site infections compared to the standard of care[23] Financing and Funding - The company plans to seek additional equity financing through private and public offerings or strategic partnerships to support its operations[24] - The Company sold 419,680 Ordinary shares under an at-the-market offering for a total amount of $1,472 during the six months ended June 30, 2025[46] - On January 4, 2024, the Company raised $14,999 from a private placement financing by selling 3,143,693 Ordinary shares at $4.81 per share[46] - The Company received $26,690 from the exercise of Existing Warrants under an inducement offer letter agreement on June 16, 2025[51] Warrants and Options - As of June 30, 2025, the company has a total of 11,124,135 outstanding warrants, with an average exercise price of $4.50 per share[63] - The company has 1,181,191 warrants exercisable at an exercise price of $5.50, expiring in January 2026[63] - The company has 7,626,514 warrants exercisable at an exercise price of $4.50, expiring in June 2027[63] - The company has 593,351 warrants with an exercise price of $0.0001 and no maturity date[63] - The company has 1,676,588 warrants exercisable at an exercise price of $3.61, expiring in August 2026[63] - As of June 30, 2025, there were 2,886,193 options outstanding under the Company's Share Option Plan, with a weighted average exercise price of $8.88[62] - The Company increased its options pool by 1,200,000 options on May 12, 2025, bringing the total to 3,512,403[56] - The average exercise price for milestone-based options granted in May 2025 was $2.67, linked to top-line results from the SHIELD II Phase 3 trial[59] Regulatory and Legislative Impact - The One Big Beautiful Bill Act (OBBBA) was signed into law on July 4, 2025, which includes changes to U.S. federal tax law[67] - The company is currently assessing the impact of new legislation on its consolidated financial statements[66] Other Financial Information - The Company recognized interest expenses of $626,000 for the six-month period ended June 30, 2025, compared to $756,000 for the same period in 2024, showing a decrease of 17.2%[40] - The Company has unrecognized compensation costs of $6,908 expected to be recognized over approximately 2.69 years[62] - The total share-based compensation expense recognized for the six months ended June 30, 2025, was $2,875, compared to $1,440 for the same period in 2024[62] - The company excluded 11,112,391 potential ordinary shares from the computation of diluted loss per share for the six months ended June 30, 2025, due to anti-dilutive effects[65] - The company reported 10,530,784 warrants excluded from diluted loss per share computation for the six months ended June 30, 2025[65] - In July 2025, the company sold 243,072 ordinary shares under the ATM for a total amount of $861, net of issuance costs[67] - The Company received participation payments totaling $4,888 from the Israel Innovation Authority, with a commitment to pay royalties at a rate of 3% of sales of developed products[41] - As of June 30, 2025, the Company has not paid or accrued any royalties[43]

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]

Core Insights - PolyPid Ltd. has appointed Dr. Nurit Tweezer-Zaks as Chief Medical Officer, effective August 18, 2025, transitioning from her role on the Board of Directors [1][2][3] - The appointment comes after positive results from the Phase 3 SHIELD II trial, as the company prepares for a New Drug Application (NDA) submission for its lead product candidate, D-PLEX₁₀₀ [2][4] - Dr. Tweezer-Zaks brings extensive experience in medical and executive roles, including her previous position as CEO of MediCane Health Inc. and senior roles at aMOON Venture Capital Fund and Sanofi [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 an NDA submission for D-PLEX₁₀₀, aimed at preventing abdominal colorectal surgical site infections, expected in early 2026 [4] - PolyPid has a pipeline that includes innovative programs in oncology, obesity, and diabetes [4]

Core Viewpoint - PolyPid Ltd. is set to report its second quarter 2025 financial results and operational highlights on August 13, 2025, with a conference call scheduled for 8:30 AM Eastern Time to discuss these results and provide business updates [1]. 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 [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]. Conference Call Information - The conference call will take place on August 13, 2025, at 8:30 AM Eastern Time, and participants are encouraged to register at least 5 minutes prior to the call [2][3].

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].