Polypid Ltd. Stock Price, News & Analysis

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.

PolyPid (NASDAQ: PYPD) has announced a research and development collaboration with ImmunoGenesis to enhance cancer immunotherapy treatments. The partnership combines PolyPid's PLEX Technology, which enables controlled and prolonged intratumoral drug delivery, with ImmunoGenesis' STING agonist drug candidate to potentially improve solid tumor treatments. The collaboration specifically aims to address the challenge of rapid clearance of STING agonists during intratumoral administration, which currently limits their effectiveness in the tumor microenvironment.

PolyPid has received notification from Nasdaq of non-compliance with minimum stockholders' equity requirement, as it failed to maintain the required $2.5 million threshold, reporting approximately $2.158 million as of September 30, 2024. The company has until January 9, 2025, to submit a compliance plan, with potential extension up to 180 days if accepted. Trading continues under 'PYPD'. The company anticipates results from SHIELD II Phase 3 trial in December 2024, with potential additional funding of $18.5 million from January PIPE and $6.1 million from August PIPE warrants, contingent on positive trial outcomes.

PolyPid provided updates on its SHIELD II Phase 3 trial of D-PLEX100 for preventing abdominal colorectal surgical site infections. Over 540 patients are enrolled, with the last patient required for the planned unblinded interim analysis now completed. The analysis, expected this quarter, will determine trial continuation or conclusion. Trial enrollment completion of up to 630 patients is expected in December 2024, with top-line results in Q1 2025.

Financial results show R&D expenses of $6.0 million in Q3 2024, up from $3.8 million in Q3 2023. Net loss was $7.8 million ($1.22 per share) compared to $5.6 million ($3.40 per share) in Q3 2023. Cash position stands at $9.5 million, expected to fund operations into Q1 2025.