Polypid Ltd. Stock Price, News & Analysis

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.

PolyPid provided a corporate update and reported financial results for the first quarter of 2024. The company enrolled over 200 patients in the SHIELD II Phase 3 trial for D-PLEX100 to prevent abdominal colorectal surgical site infections. The unblinded interim analysis is expected to be conducted after around 400 patients complete their 30-day follow-up, with top-line results anticipated in the second half of 2024. Additionally, PolyPid closed a private placement financing for $16 million, extending its cash runway beyond the planned analysis.

PolyPid (Nasdaq: PYPD) will participate in the Citizens JMP Life Sciences Conference in New York to present their late-stage biopharma innovations aimed at enhancing surgical outcomes. The event will be held from May 13 – 14, 2024, with a management presentation scheduled for May 13 at 2:30 PM ET.

PolyPid announced the enrollment of the 200th patient in the SHIELD II Phase 3 trial for D-PLEX100 to prevent surgical site infections. The study is one-third enrolled with top-line results expected in the second half of 2024. The company completed a $16 million financing and has the potential to secure an additional $19 million based on positive interim analysis results.