Core Insights - PolyPid Ltd. has announced that its lead candidate D-PLEX₁₀₀ has been awarded "Therapeutics Solution of the Year" by BioTech Breakthrough, highlighting its innovative approach to improving surgical outcomes [1][3]. Product Overview - D-PLEX₁₀₀ utilizes PolyPid's proprietary PLEX technology to deliver localized antibiotic treatment, specifically doxycycline, directly at the surgical site for a duration of 30 days, aimed at preventing surgical site infections (SSIs) [2][4]. - The product has shown a statistically significant 58% relative risk reduction in SSIs following abdominal colorectal surgery, as demonstrated in the Phase 3 SHIELD II trial [4]. Industry Context - Surgical site infections are a major concern in healthcare, accounting for 20% to 31% of all hospital-acquired infections, leading to increased hospital stays and healthcare costs [3][4]. - D-PLEX₁₀₀ addresses the challenge of standard antibiotics failing to reach surgical sites effectively due to disrupted blood supply, thus potentially transforming surgical care and improving patient outcomes [3][4]. Regulatory Status - D-PLEX₁₀₀ has received Breakthrough Therapy Designation, three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations from the U.S. Food and Drug Administration, with a New Drug Application (NDA) submission expected in early 2026 [4][5]. Company Profile - PolyPid Ltd. is a late-stage biopharma company focused on enhancing surgical outcomes through controlled, prolonged-release therapeutics, with a pipeline that includes innovations in oncology, obesity, and diabetes [5].

Core Points - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes and will report its Q3 2025 financial results on November 12, 2025 [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 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 NDA submission expected in early 2026 following positive phase 3 results [4] - The company has a pipeline that includes innovative treatments in oncology, obesity, and diabetes [4]

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.

Core Insights - PolyPid Ltd. will present topline results from its Phase 3 SHIELD II trial at the 2025 American College of Surgeons Clinical Congress in Chicago [1][2] - The SHIELD II trial demonstrated significant efficacy of D-PLEX₁₀₀ in reducing surgical site infections and related complications [4] 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 [5] - The company plans to submit a New Drug Application (NDA) for D-PLEX₁₀₀ in early 2026 following positive Phase 3 results [5] Trial Details - The SHIELD II trial was a multinational, randomized, double-blind study that met its primary and key secondary efficacy endpoints [4] - D-PLEX₁₀₀ achieved a 38% reduction in the combined endpoint of surgical site infections, reinterventions, or mortality compared to standard care alone, with a p-value of less than 0.005 [4] - The trial also showed a 58% reduction in the rate of surgical site infections in the treatment arm with D-PLEX₁₀₀, also with a p-value of less than 0.005 [4] Conference Information - The presentation will take place on October 5, 2025, at 11:30 AM CT during the high-impact clinical trials session [2][8] - PolyPid management will be available for meetings during the conference [3]

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]

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]