Core Insights - PolyPid Ltd. has successfully completed enrollment in the SHIELD II Phase 3 trial for D-PLEX100, aimed at preventing surgical site infections in abdominal colorectal surgery patients [1][2][3] - The company anticipates reporting top-line results by the end of Q2 2025 and plans to submit a New Drug Application (NDA) to the FDA if the results are positive [2][3] - D-PLEX100 utilizes PLEX technology for prolonged and controlled release of doxycycline, targeting surgical site infections, and has received multiple FDA designations [5][6] Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through locally administered therapeutics [6] - The company is also in preclinical stages testing OncoPLEX for solid tumors, starting with glioblastoma [6] SHIELD II Trial Details - The SHIELD II trial is a multinational, randomized, double-blind Phase 3 study assessing the efficacy and safety of D-PLEX100 compared to standard of care in preventing post-surgical infections [4] - The primary endpoint is the proportion of subjects with surgical site infection events within 30 days post-surgery [4]

Core Viewpoint - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through innovative drug delivery systems [3]. Group 1: Company Overview - PolyPid Ltd. (Nasdaq: PYPD) specializes in locally administered, controlled, prolonged-release therapeutics using its proprietary PLEX technology [3]. - The lead product candidate, D-PLEX100, is currently in Phase 3 clinical trials aimed at preventing abdominal colorectal surgical site infections [3]. - The company is also in preclinical stages testing OncoPLEX for treating solid tumors, starting with glioblastoma [3]. Group 2: Upcoming Events - PolyPid's management will present at the 37th Annual ROTH Conference in Dana Point, California, on March 17-18, 2025 [1]. - A fireside chat will be available on-demand starting March 17, 2025, at 2:00 PM PT [1]. - The management team will engage in one-on-one investor meetings during the conference [2].

Financial Performance - The company incurred a net cash used in operating activities of $22 million for the year ended December 31, 2024, compared to $17.2 million for the previous year, primarily due to ongoing clinical trials [529]. - The company has not generated any revenue from product sales and does not expect to do so for at least the next few years, necessitating substantial additional funding [533]. - The company has a shareholders' equity of $7.7 million as of December 31, 2024, and anticipates continued losses and negative cash flows until products reach commercial profitability [534]. - As of September 30, 2024, the company's stockholders' equity was approximately $2.2 million, below the Nasdaq minimum requirement of $2.5 million [538]. - The company does not expect to generate any revenue from product sales for at least the next few years [541]. - The company has not generated any revenue from product sales to date and does not anticipate doing so in the near future [541]. Funding and Capital Raising - The company raised $32.4 million from financing activities in 2024, a significant increase from $10 million in 2023, mainly attributed to private placements [532]. - The company sold 3,143,693 Ordinary Shares at $4.81 per share in January 2024, resulting in gross proceeds of $16.2 million, intended for clinical trials and working capital [522]. - The company sold 3,386,962 Ordinary Shares at $3.22 per share in December 2024, generating gross proceeds of $14.5 million for ongoing clinical trials [524]. - The company plans to continue raising capital through the sale of equity securities, debt, or strategic partnerships to mitigate going concern risks [534]. - The company entered into a Loan Agreement for up to $15 million, with the first tranche of $10 million drawn in April 2022 and a restructuring amendment in March 2023 [516][519]. Research and Development - The company incurred $174.4 million in research and development expenses from inception through December 31, 2024, to advance clinical-stage product candidates [541]. - The company has a research and development team of 50 scientists, doctors, and clinicians based in Petach Tikva, Israel [539]. - Non-cash share-based compensation expenses were $4.3 million, $3.4 million, and $2.8 million for the years ended December 31, 2022, 2023, and 2024, respectively [548]. Commercialization and Regulatory Compliance - The company expects to incur significant commercialization expenses if marketing approval is obtained for any product candidates [533]. - The company expects to incur significant commercialization expenses if it obtains marketing approval for any product candidates [541]. - The company must comply with restrictions associated with IIA grants, which may affect its ability to outsource manufacturing or engage in change of control transactions [553]. Intellectual Property - The patent estate includes 156 issued patents and 20 pending patent applications as of February 26, 2025, covering the PLEX technology platform and product candidates [540]. - The company has received royalty-bearing grants totaling $4.9 million, with a royalty obligation of 3.0% on revenues from products developed with these grants [552].

Financial Data and Key Metrics Changes - As of December 31, 2024, the company had cash and cash equivalents of $15.6 million, which is expected to fund operations into the third quarter of 2025 [23][24] - The net loss for Q4 2024 was $8.5 million, compared to a net loss of $6.4 million in Q4 2023 [27] - For the full year 2024, the net loss was $29 million, compared to a net loss of $23.9 million in 2023 [28] Business Line Data and Key Metrics Changes - Research and development expenses for Q4 2024 were $7 million, up from $4.6 million in Q4 2023, driven by the ongoing SHIELD II Phase 3 trial [26] - For the full year, R&D expenses were $22.8 million in 2024 compared to $16.1 million in 2023 [26] Market Data and Key Metrics Changes - The total addressable market for D-PLEX100 in the U.S. is estimated to be over 12 million surgeries annually, with approximately 4.4 million being abdominal soft tissue surgeries [15][18] - Surgical site infections (SSIs) account for 20% of all hospital-acquired infections, with an estimated annual cost of $3.3 billion [17] Company Strategy and Development Direction - The company plans to submit a new drug application (NDA) for D-PLEX100, leveraging Fast Track and Breakthrough Therapy designations, following potential positive Phase 3 data [12] - There is a focus on accelerating regulatory submissions and pre-launch activities, as well as expediting partnership discussions [14] - The company is actively seeking partnerships for commercialization, particularly in the U.S. market, after signing an exclusive licensing agreement for Europe [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term prospects of D-PLEX100, especially following the DSMB's recommendation to conclude the SHIELD II trial upon the enrollment of 800 patients [9][10] - The company anticipates reporting top-line results in the second quarter of 2025, with a focus on addressing the unmet need in the surgical landscape [12][18] Other Important Information - The company entered into a securities purchase agreement for a private placement financing, resulting in $14.5 million in gross proceeds, which extends the cash runway into the third quarter of 2025 [10][24] - A new board member, Yitzchak Jacobovitz, was welcomed, who is a partner and lead healthcare analyst at AIGH Capital Management [12] Q&A Session Summary Question: Expectations for the label and commercialization readiness - Management expects initial labeling in the U.S. and Europe to focus on abdominal surgery, with plans for gradual expansion [31][36] Question: Similarity of subsequent patient characteristics in the trial - Management confirmed that the characteristics of the new patients are in line with expectations and similar to those in the interim analysis [41][42] Question: Ideal commercial partner properties - The ideal partner would have a strong presence in the surgery suite and hospital, with a broad sales force to facilitate discussions with surgeons and pharmacy directors [49][50] Question: Responsibilities between the company and commercial partner - Day-to-day activities would be handled by the partner, while the company would focus on global activities and expansion of indications [55][56] Question: R&D capabilities and collaborations - The company has worked with various approved APIs and is exploring collaborations, including with ImmunoGenesis to enhance treatment for solid tumors [60][62]

Core Insights - The independent Data Safety Monitoring Board (DSMB) has recommended continuing the SHIELD II Phase 3 trial of D-PLEX100, suggesting positive efficacy signals, with enrollment expected to complete by March 2025 and top-line results anticipated in Q2 2025 [4][12] - PolyPid has completed a private placement financing of up to $41 million, which is expected to extend its cash runway beyond potential New Drug Application (NDA) approval [4][8] - The company has reported significant clinical and operational progress in 2024, positioning itself for a potentially transformative year in 2025 [4] Clinical Trial Updates - The SHIELD II trial has enrolled over 700 patients to date, with a target enrollment of 800 patients [4][12] - The trial aims to assess the efficacy and safety of D-PLEX100 in preventing surgical site infections (SSIs) in patients undergoing abdominal colorectal surgeries [12][13] - The primary endpoint is the proportion of subjects with SSI events within 30 days post-surgery [12] Financial Highlights - As of December 31, 2024, PolyPid had cash and cash equivalents of $15.6 million, up from $5.3 million a year earlier, which is expected to fund operations into Q3 2025 [8][22] - For the three months ended December 31, 2024, the company reported a net loss of $8.5 million, or ($1.13) per share, compared to a net loss of $6.4 million, or ($3.97) per share, in the same period of 2023 [11][23] - For the full year ended December 31, 2024, the net loss was $29.0 million, or ($4.91) per diluted share, compared to a net loss of $23.9 million, or ($16.93) per diluted share, in 2023 [11][23] Strategic Developments - PolyPid has announced a research and development collaboration with ImmunoGenesis, Inc. to enhance treatment for solid tumors using its proprietary PLEX Technology [4] - The company appointed Mr. Yitzchak Jacobovitz, CFA, to its Board of Directors, bringing extensive healthcare investment experience [4][5]

Core Insights - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through innovative drug delivery systems [1][3] - The company will present at the Oppenheimer 35 Annual Healthcare Life Sciences Conference on February 11-12, 2025, with on-demand access starting February 12, 2025 [2] Company Overview - PolyPid utilizes its proprietary PLEX technology for controlled, prolonged-release therapeutics, allowing for precise drug delivery over days to months [3] - The lead product candidate, D-PLEX100, is currently in Phase 3 clinical trials aimed at preventing abdominal colorectal surgical site infections [3] - PolyPid is also in preclinical stages testing OncoPLEX for treating solid tumors, starting with glioblastoma [3]

PETACH TIKVA, Israel, Jan. 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 fourth quarter and full-year 2024 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, February 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 ...

• 630 Patients Enrolled To Date; Enrollment Completion Now Expected in Q1 2025 with Top-line Results Anticipated in Q2 2025; • Upon Potential Positive Phase 3 Data the Company Expects to Submit a New Drug Application (“NDA”) for D-PLEX100 under Fast Track and Breakthrough Therapy Designations, Previously Granted to D-PLEX100 by the FDA; • Proceeds from this Financing and Exercise of Data-Triggered Warrant Expected to Extend Cash Runway Beyond Potential NDA Approval PETACH TIKVA, Israel, Dec. 24, 2024 (GLOBE ...

PETACH TIKVA, Israel, Dec. 11, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced a new research and development collaboration with ImmunoGenesis, Inc. (“ImmunoGenesis”), a Houston-based clinical-stage biotechnology company developing science-driven immunotherapies. The collaboration focuses on the development of novel formulations utilizing PolyPid’s experience with its proprietary PLEX Techn ...

PETACH TIKVA, Israel, Nov. 29, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it has received a written notification (the "Notification Letter") from the Listing Qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it is no longer in compliance with the minimum stockholders' equity requirement for continued listing on the Nasdaq Capital Market, lis ...