Polypid Ltd. Stock Price, News & Analysis

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.

PolyPid announced a virtual Key Opinion Leader (KOL) event on June 17, 2024, at 10:00 AM ET to discuss the unmet medical need in surgical site infections (SSIs). Charles E. Edmiston, Ph.D., an Emeritus Professor of Surgery at the Medical College of Wisconsin, will highlight the clinical and economic burden of SSIs and current practices for their prevention. The event will also provide an update on PolyPid's Phase 3 SHIELD II trial for D-PLEX100, a product aimed at preventing abdominal colorectal SSIs. During the event, PolyPid management will update on patient enrollment status. A live Q&A session with Professor Edmiston and the management team will follow.