Financial Data and Key Metrics Changes - As of March 31, 2025, the company had cash and cash equivalents of $8 million, which is expected to fund operations into the third quarter of 2025 [15] - Research and development expenses for Q1 2025 were $6.1 million, up from $5.1 million in Q1 2024, driven by the ongoing SHIELD II Phase III trial [16] - The net loss for Q1 2025 was $8.3 million, compared to a net loss of $6.4 million in Q1 2024 [16] Business Line Data and Key Metrics Changes - The company is focused on the SHIELD II Phase III trial for DPLEX100, which has recently concluded enrollment with 800 patients, following a recommendation from the Data Safety Monitoring Board [5][6] - The anticipated top line data from the SHIELD II trial is expected by the end of the current quarter [15] Market Data and Key Metrics Changes - The total addressable market for DPLEX100 in the U.S. is estimated to be over 12 million surgeries annually, with approximately 4.4 million being abdominal soft tissue surgeries [11] - The company identified four groups of surgeons as potential users for DPLEX100, indicating a significant market opportunity [12] Company Strategy and Development Direction - The company aims to submit a New Drug Application (NDA) in early 2026, with preparations for regulatory submissions already underway [7][8] - The strategy includes finding a U.S. partner with an existing dedicated hospital product sales force to maximize sales potential [9][13] - An exclusive licensing agreement is already in place with Advanced Pharma for commercialization in Europe [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term prospects of DPLEX100 and the potential to transform the surgical landscape [47] - The company is actively preparing for regulatory submissions and engaging in partnership discussions as they await SHIELD II trial results [8][13] Other Important Information - The company has received Fast Track and Breakthrough Therapy designations for DPLEX100, which may expedite the regulatory process [7] - The company is in advanced discussions with multiple potential partners in the U.S. as they approach pivotal data readout [13] Q&A Session Summary Question: Pricing strategy for DPLEX100 - Management has not finalized the pricing strategy but anticipates an average of 2.5 vials per procedure at a preliminary price of $600 per vial [20] Question: NDA filing requirements - The NDA will consist of three modules, with the company currently finalizing the CMC and preclinical modules [27] Question: Expectations for top line data - The company expects to report both primary and key secondary endpoints upon unblinding the data [32] Question: Inspection readiness for commercial manufacturing - The company is preparing for FDA inspections and plans to conduct several mock inspections prior to the review [40] Question: Comparison of SSI data pre-COVID and post-COVID - The CDC reported a 3% increase in SSIs in 2023 compared to 2022, marking the first uptick since the COVID pandemic [42]

Core Viewpoint - PolyPid Ltd. is set to report its first quarter 2025 financial results and operational highlights on May 14, 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 lead product candidate, D-PLEX100, is currently in Phase 3 clinical trials aimed at preventing abdominal colorectal surgical site infections [4]. - The company is also in preclinical stages testing OncoPLEX for treating solid tumors, starting with glioblastoma [4]. Conference Call Details - The conference call will take place on May 14, 2025, at 8:30 AM Eastern Time, and participants are encouraged to register at least 5 minutes prior to the call [2][3]. - For those not asking questions, listening via the webcast is recommended [2].

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 ...