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 ...

Financial Data and Key Metrics Changes - As of September 30, 2024, the company had cash and cash equivalents of $9.5 million, which is expected to fund operations into the first quarter of 2025 [21] - The net loss for the three months ended September 30, 2024, was $7.8 million, compared to $5.6 million in the same period of 2023 [26] - Research and development expenses increased to $6 million from $3.8 million year-over-year, driven by the ramp-up in patient enrollment for the SHIELD II trial [25] Business Line Data and Key Metrics Changes - The SHIELD II trial has enrolled approximately 550 subjects, with over 80 subjects enrolled each month since the end of summer, indicating a substantial ramp-up in recruitment [11][12] - The trial is expected to complete patient enrollment by December, with top-line results anticipated in the coming quarter [12] Market Data and Key Metrics Changes - The SHIELD I trial results were published in the International Journal of Surgery, highlighting significant improvements in surgical site infection rates for patients with lengthy incisions [15][17] - The CDC reported a 3% increase in overall surgical site infections in 2023 compared to 2022, indicating a rising trend in infection rates post-COVID [28] Company Strategy and Development Direction - The company aims to commercialize D-PLEX100 with a strategic partner in the U.S. and is in discussions to accelerate these talks following top-line results [45] - The global market for D-PLEX100 is seen as significant, with opportunities in regions such as South America, China, India, and Japan, as well as emerging markets like Vietnam and South Africa [46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term prospects of D-PLEX100, especially with the upcoming interim analysis and potential catalysts [51] - The company is operating from a position of financial strength, with funding secured into 2026 if all warrants from recent private placements are exercised [8][24] Other Important Information - The SHIELD II trial is viewed as a derisked Phase 3 trial due to previously positive results from SHIELD I, which included nearly 1,000 patients [13][15] - The company has a detailed plan for regulatory submission to the FDA, expecting to submit an NDA during 2026 following the SHIELD II trial results [48] Q&A Session Summary Question: Can you provide insight into the blinded infection rate in SHIELD II? - Management indicated that the blinded infection rate is in line with expectations, but specific details cannot be disclosed due to the blinded nature of the trial [27][30] Question: What should investors expect from the interim analysis? - A formal recommendation from the Data Safety Monitoring Board will be issued, indicating whether to stop for efficacy, continue to the planned study size, or consider futility [35] Question: What is the breakdown of patients in the trial between the U.S. and ex-U.S.? - Most patients are from outside the U.S., with specific criteria for the interim analysis requiring a p-value of 0.01 or lower [30] Question: What are the commercial plans for D-PLEX100? - The company is looking for a strategic partner for commercialization in the U.S. and is in discussions that are expected to accelerate after top-line results [45] Question: What are the key regional markets for D-PLEX100? - Key markets include South America, China, India, Japan, and emerging markets like Vietnam and South Africa, where surgical infections are a significant issue [46]

PETACH TIKVA, Israel, Oct. 30, 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 will report its third quarter 2024 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, November 13, 2024. 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 ...

SHIELD I Study is One of the Largest Phase 3 Trials in the Prevention of SSIs in Colorectal Resection Conducted in Over a Decade Pre-Specified and Post-Hoc Analyses Suggested that D-PLEX100 May Benefit Patients with Increased SSI Risk, Including Those with Lengthy Incisions SHIELD II Study, the Ongoing Second Phase 3 with D-PLEX100, Focuses on Patients with Large Surgical Incisions; Top-line Results Expected in Q1 2025 PETACH TIKVA, Israel, Oct. 21, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“Po ...

Unblinded Interim Analysis to be Conducted During the Current Quarter Top-line Results Anticipated in First Quarter of 2025 PETACH TIKVA, Israel, Oct. 01, 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 enrolled the last patient required in order to conduct the planned unblinded interim analysis in its ongoing SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical ...

PETACH TIKVA, Israel, Sept. 03, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD), ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced that the Company's management will participate in the following three investor conferences: H.C. Wainwright 26th Annual Global Investment Conference PolyPid's presentation will be available on-demand beginning on Monday, September 9, 2024, at 7:00 AM ET and throughout the conference, via the conference platform ...

Exhibit 99.1 POLYPID LTD. AND ITS SUBSIDIARIES INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2024 U.S. DOLLARS IN THOUSANDS UNAUDITED INDEX Page | --- | --- | |-------------------------------------------------------------------------------------------|------------| | | | | Interim Condensed Consolidated Balance Sheets | 1 - 2 | | | | | Interim Condensed Consolidated Statements of Operations | 3 | | | | | Interim Condensed Consolidated Statements of Shareholders' Equity (Deficit) | 4 - 6 ...