Polypid Ltd. - PYPD STOCK NEWS

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.

PolyPid (Nasdaq: PYPD), a late-stage biopharma company focused on improving surgical outcomes, has announced its participation in the Craig-Hallum 15th Annual Alpha Select Conference. The event will take place on November 19, 2024, in New York, NY. Company management will be available for investor meetings during the conference. Interested investors are advised to contact conference representatives directly to schedule meetings.

PolyPid (Nasdaq: PYPD), a late-stage biopharma company focused on improving surgical outcomes, has scheduled its third quarter 2024 financial results announcement for November 13, 2024, 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. Interested parties can register for the call through the provided link, with registration recommended at least 5 minutes before the start time. For those not planning to ask questions, the company suggests following via webcast.

PolyPid (Nasdaq: PYPD) announced the publication of results from its Phase 3 SHIELD I trial of D-PLEX₁₀₀ in the International Journal of Surgery. The study, one of the largest Phase 3 trials in surgical site infection (SSI) prevention in colorectal resection in over a decade, did not meet its primary endpoint. However, pre-specified and post-hoc analyses suggested D-PLEX100 may benefit patients with increased SSI risk, particularly those with lengthy incisions.

Key findings include:

• 23% event reduction in the D-PLEX100 arm (not statistically significant)
• 54% reduction in primary outcome events for incisions >20 cm (statistically significant)
• 54.6% reduction in incisional SSI for incisions >20 cm
• No safety concerns raised

The ongoing SHIELD II study focuses on patients with large surgical incisions, with top-line results expected in Q1 2025.