Polypid Ltd. Stock Price, News & Analysis

PolyPid (NASDAQ: PYPD) has completed enrollment of 800 patients in its SHIELD II Phase 3 trial for D-PLEX100, targeting abdominal colorectal surgical site infections. The Data Safety Monitoring Board recommended concluding the study at the lowest sample size, suggesting positive efficacy signals. Top-line results are expected by Q2 2025. Following potential positive results, PolyPid plans to submit an NDA to FDA in early 2026, followed by an EU MAA submission. The company reported Q1 2025 financials with R&D expenses of $6.1M, a net loss of $8.3M, and cash position of $8.0M. Warrant exercises could potentially generate an additional $27.0M upon Phase 3 data announcement, extending runway beyond anticipated NDA approval.

PolyPid (Nasdaq: PYPD), a late-stage biopharma company focused on improving surgical outcomes, has scheduled its Q1 2025 financial results announcement for May 14, 2025, before U.S. markets open. The company will host a conference call and webcast at 8:30 AM Eastern Time.

Key highlights:

• Conference participants are advised to register 5 minutes before the call
• The company's core technology, PLEX (Polymer-Lipid Encapsulation matriX), enables controlled drug release over extended periods
• Their lead product, D-PLEX100, is in Phase 3 trials for preventing abdominal colorectal surgical site infections
• A preclinical candidate, OncoPLEX, is being tested for solid tumor treatment, starting with glioblastoma

The PLEX technology pairs with Active Pharmaceutical Ingredients (APIs) to deliver drugs at optimal release rates, ranging from days to months.

PolyPid (Nasdaq: PYPD), a late-stage biopharma company focused on improving surgical outcomes, has announced its participation in The Citizens Life Sciences Conference in New York. The company's management will engage in a fireside chat on Wednesday, May 7, 2025, at 10:30 AM ET.

During the two-day conference, scheduled for May 7-8, 2025, the PolyPid management team will also be available for one-on-one investor meetings. Interested investors can arrange meetings through their Citizens JMP representatives.

PolyPid (Nasdaq: PYPD) has completed enrollment in the SHIELD II Phase 3 trial for D-PLEX₁₀₀, targeting the prevention of surgical site infections in abdominal colorectal surgery patients. The independent Data Safety Monitoring Board (DSMB) recommended concluding the study at 800 patients after analyzing unblinded efficacy data from the first 430 participants.

The company expects to report top-line results by Q2 2025, and if positive, plans to submit a New Drug Application (NDA) to the FDA. The submission will leverage the FDA's Fast Track and Breakthrough Therapy designations. PolyPid is currently engaged in discussions with potential partners for D-PLEX₁₀₀'s commercialization across various regions, with initial focus on the U.S. market.

PolyPid (Nasdaq: PYPD), a late-stage biopharma company focused on improving surgical outcomes, has announced its participation in the 37th Annual ROTH Conference in Dana Point, California, scheduled for March 17-18, 2025.

The company will conduct a fireside chat, which will be available on-demand starting Monday, March 17, 2025, at 2:00 PM PT. Additionally, the management team will engage in one-on-one investor meetings during the event. Interested investors seeking meetings with PolyPid should coordinate through their ROTH representative.

PolyPid reported its Q4 and full-year 2024 financial results, highlighting significant progress in its SHIELD II Phase 3 trial of D-PLEX₁₀₀. The trial has enrolled over 700 patients, with completion expected in March 2025 and top-line results in Q2 2025. The DSMB recommended concluding the trial at 800 patients.

The company secured a private placement financing of $14.5 million, with potential additional proceeds of $27.0 million through warrants. Financial results showed R&D expenses of $7.0 million for Q4 2024 and $22.8 million for the full year. Net loss was $8.5 million for Q4 and $29.0 million for 2024. Cash position stood at $15.6 million as of December 31, 2024, expected to fund operations into Q3 2025.

PolyPid (Nasdaq: PYPD), a late-stage biopharma company focused on improving surgical outcomes, has announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference. The virtual event is scheduled for February 11-12, 2025.

The company's presentation will be available on-demand starting Wednesday, February 12, 2025, at 11:20 AM Eastern Time and will remain accessible for 365 days through the conference platform. PolyPid's management team will also conduct one-on-one investor meetings during the event. Interested investors can arrange meetings through their Oppenheimer representative.

PolyPid (Nasdaq: PYPD), a late-stage biopharma company focused on improving surgical outcomes, has scheduled its fourth quarter and full-year 2024 financial results and operational highlights announcement for Wednesday, February 12, 2025, before U.S. markets open.

The company will host a conference call and webcast at 8:30 AM Eastern Time to discuss results and provide business updates. Management recommends participants register at least 5 minutes before the call starts. Those not planning to ask questions are advised to join via webcast.

PolyPid announced positive developments for its SHIELD II Phase 3 trial of D-PLEX₁₀₀, designed to prevent surgical site infections in abdominal colorectal surgery. The Data Safety Monitoring Board (DSMB) recommended continuing enrollment to 800 patients, with 630 patients already enrolled. Trial completion is expected in Q1 2025 with top-line results in Q2 2025.

The company also secured a private placement financing of $14.5 million at $3.22 per share, with additional warrants that could provide up to $27 million in gross proceeds. The financing extends PolyPid's cash runway into Q3 2025, beyond the expected trial results. Upon positive Phase 3 data, the company plans to submit a New Drug Application under previously granted Fast Track and Breakthrough Therapy designations.