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PolyPid Ltd. (Nasdaq: PYPD) is a cutting-edge biopharmaceutical company focused on enhancing surgical outcomes through its innovative drug delivery technology, PLEX™ (Polymer-Lipid Encapsulation matriX). This proprietary technology allows for the precise, prolonged release of drugs directly at the target site, optimizing therapeutic performance and clinical outcomes. PolyPid specializes in the development and manufacturing of products that address unmet medical needs, particularly in the prevention of surgical site infections (SSIs) and treatment of solid tumors.
The company's lead product candidate, D-PLEX100, is designed to provide localized, controlled anti-bacterial activity at surgical sites to prevent SSIs. It is currently undergoing a Phase 3 clinical trial, known as SHIELD II, aimed at preventing infections in patients undergoing open abdominal colorectal surgery. D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, highlighting its potential to address significant medical needs.
PolyPid's product pipeline also includes OncoPLEX, intended for the treatment of solid tumors, beginning with glioblastoma. This product is currently in preclinical stages, showing promising potential in oncology. Additionally, the company's proprietary technology, PLEX™, can encapsulate various drugs, enabling targeted and localized delivery over extended periods, ranging from several days to months.
In terms of recent achievements, PolyPid has successfully enrolled and randomized over 200 patients in its SHIELD II trial, with top-line results expected in the second half of 2024. Moreover, the company recently closed a $16 million private placement financing, which will support ongoing clinical development efforts and extend its cash runway beyond the anticipated interim analysis of the SHIELD II trial.
For more detailed information, visit PolyPid's official website or follow the company on Twitter and LinkedIn.
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.
PolyPid (Nasdaq: PYPD) has announced the enrollment of the last patient required for the planned unblinded interim analysis in its ongoing SHIELD II Phase 3 trial for D-PLEX100. This trial aims to prevent surgical site infections in patients undergoing abdominal colorectal surgery with large incisions. The unblinded interim analysis will be conducted in the current quarter, following the 30-day follow-up assessment for the last patient.
Key points:
- Approximately 430 subjects enrolled to date
- The trial is nearly three-quarters enrolled to full planned enrollment (up to 630 subjects)
- Top-line results anticipated in Q1 2025
- Potential for additional funding of $18.5 million from January PIPE and $6.1 million from August PIPE, depending on interim analysis results
- If all warrants are exercised, the company could be funded into 2026
PolyPid (Nasdaq: PYPD), a late-stage biopharma company focused on improving surgical outcomes, has announced its participation in three upcoming investor conferences:
- H.C. Wainwright 26th Annual Global Investment Conference: On-demand presentation available from September 9, 2024, at 7:00 AM ET.
- Lytham Partners Fall 2024 Investor Conference: On-demand fireside chat available from October 1, 2024, for 90 days.
- Sidoti & Company Micro-Cap Virtual Conference: Scheduled for November 13-14, 2024.
The PolyPid management team will be available for one-on-one investor meetings during these events. Interested investors should contact the respective conference organizers directly to arrange meetings.
PolyPid (Nasdaq: PYPD) provided a corporate update and reported Q2 2024 financial results. Key highlights include:
- SHIELD II Phase 3 trial of D-PLEX100 has enrolled approximately 320 patients, with an unblinded interim analysis expected in Q4 2024 and top-line results in Q1 2025.
- Successful financing of up to $14 million, extending cash runway into Q2 2025.
- Q2 2024 financial results: R&D expenses $4.8M, G&A expenses $1.1M, net loss $6.3M ($1.25 per share).
- Cash and equivalents of $9.3M as of June 30, 2024, not including $8.1M from recent PIPE financing.
PolyPid (Nasdaq: PYPD) has announced a private placement financing (PIPE) for $8.1 million in gross proceeds, priced at $3.61 per share. The deal includes the purchase of 2,235,457 ordinary shares and warrants to purchase up to 1,676,588 additional shares. If fully exercised, the warrants could bring in an extra $6.1 million. This funding extends PolyPid's cash runway into Q2 2025, beyond the anticipated timing for SHIELD II top-line results.
The ongoing SHIELD II Phase 3 trial of D-PLEX100 for preventing abdominal colorectal surgical site infections has enrolled over 300 patients. An unblinded interim analysis is planned for Q4 2024 when about 400 patients complete their 30-day follow-up. Top-line results are expected in Q1 2025. Additionally, PolyPid has restructured its loan agreement with Kreos Capital, deferring over $2 million in repayments to April 2025.
PolyPid (Nasdaq: PYPD), a late-stage biopharma company focused on improving surgical outcomes, has announced it will release its second quarter 2024 financial results and operational highlights on August 14, 2024, before the U.S. financial markets open. The company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide a business update.
Interested parties can register for the conference call via a provided link, with registration recommended at least 5 minutes before the call starts. For those not planning to ask questions, listening via the webcast is suggested. Both conference call and webcast links are provided in the announcement.
PolyPid, a biopharma company, hosted a Key Opinion Leader event to address the increasing rates of Surgical Site Infections (SSIs) post-COVID and provided an update on its SHIELD II Phase 3 trial for D-PLEX100. The event highlighted the rising SSI rates, the significant cost to payers, and the potential of D-PLEX100 to reduce SSIs in colorectal surgeries. Approximately 250 of the planned 600 patients are enrolled in the SHIELD II trial, with unblinded interim analysis expected once 400 patients complete their 30-day follow-up. Top-line results are anticipated in Q1 2025.
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