Polypid Ltd. Stock Price, News & Analysis

PolyPid Ltd. (Nasdaq: PYPD) has announced an underwritten public offering of its ordinary shares, which will include an option for underwriters to purchase an additional 15% of shares within 30 days at the public offering price. The proceeds from the offering are intended to support ongoing clinical activities, including the development of D-PLEX₁₀₀, working capital, and other corporate purposes. Newbridge Securities Corporation is the sole book-running manager for this offering. The securities are being offered under a previously effective 'shelf' registration statement.

PolyPid Ltd. (Nasdaq: PYPD), a biopharma company focused on enhancing surgical outcomes, will present at the Barclays Global Healthcare Conference in Miami from March 14-16, 2023. Their presentation is scheduled for March 14 at 4:35 PM Eastern Time. Investors interested in discussing with PolyPid can reach out to their Barclays representative. PolyPid's lead product, D-PLEX₁₀₀, is currently undergoing Phase 3 trials to prevent soft tissue surgical site infections. The company is also in preclinical studies with OncoPLEX targeting solid tumors, starting with glioblastoma.

PolyPid Ltd. (Nasdaq: PYPD) clarified the regulatory pathway for D-PLEX100 to prevent abdominal colorectal surgical site infections following a positive FDA communication. The company plans to resume patient recruitment for the SHIELD II trial in Q2 2023, adding approximately 550 patients, with top-line results anticipated by mid-2024. Financially, R&D expenses decreased to $4.7 million in Q4 2022 from $9.6 million in Q4 2021, while net loss narrowed to $6.5 million, or ($0.32) per share. As of December 31, 2022, cash reserves were $12.6 million, down from $32.2 million in 2021, expected to sustain operations through Q3 2023.

PolyPid Ltd. (Nasdaq: PYPD) announced it will report its fourth quarter and full year 2022 financial results on February 8, 2023, before U.S. market open. The company will conduct a conference call at 8:30 AM ET to discuss these results and business updates. PolyPid is focused on enhancing surgical outcomes through its proprietary PLEX technology, which enables sustained drug delivery. Its lead candidate, D-PLEX100, is currently in Phase 3 trials for preventing surgical site infections, while OncoPLEX is under preclinical evaluation for solid tumors.

PolyPid Ltd. (Nasdaq: PYPD) announced a positive regulatory update for D-PLEX100, targeting the prevention of surgical site infections (SSIs) following abdominal colorectal surgery. Recent communications with the FDA clarified the regulatory pathway for a potential New Drug Application (NDA) submission. The FDA recognized significant findings from the SHIELD I study, noting a 54% reduction in complications in complex surgeries, encouraging a revised SHIELD II trial to support NDA efforts. The company expects to resume patient recruitment soon, enhancing confidence in this promising treatment.

PolyPid Ltd. (Nasdaq: PYPD) announced the publication of a post-hoc analysis from its Phase 2 trial of D-PLEX₁₀₀, highlighting a significant 53% reduction in surgical site infections (SSIs) compared to standard care in high-risk colorectal surgery patients. The study included 201 patients, showing a 58% risk reduction in those with multiple preoperative risk factors. D-PLEX₁₀₀ utilizes advanced Polymer-Lipid Encapsulation technology for prolonged antibiotic release, aiming to enhance surgical outcomes. This aligns with findings from the SHIELD I Phase 3 trial, indicating substantial potential for D-PLEX₁₀₀ in addressing the needs of vulnerable patient populations.

PolyPid Ltd. (Nasdaq: PYPD) has scheduled a Type D meeting with the FDA for January 2023 to discuss the outcomes and regulatory requirements related to its D-PLEX₁₀₀ product, aimed at preventing abdominal colorectal surgical site infections. The company has submitted existing data from the completed SHIELD I Phase 3 study prior to this meeting. CEO Dikla Czaczkes Akselbrad expressed confidence in D-PLEX₁₀₀'s efficacy, citing significant reductions in infections during complex surgeries.

PolyPid Ltd. (Nasdaq: PYPD) has received a notice from Nasdaq indicating non-compliance with the minimum bid price requirement of $1.00 per share. The company has 180 days until June 5, 2023, to regain compliance. During this grace period, trading of PYPD shares will continue on Nasdaq. If PolyPid fails to meet the requirement, it may be eligible for an additional compliance period, provided it meets other listing standards. The notice does not immediately affect the company’s listing status.

PolyPid Ltd. (Nasdaq: PYPD) announced the presentation of Phase 2 clinical data for D-PLEX₁₀₀ aimed at preventing surgical wound infections, including those caused by multi-drug resistant organisms. This will occur at the International Orthopaedic Trauma Association meeting from December 14-16, 2022, in Amsterdam. The presentation, titled 'Surgical wound infection reduction with locally administered product releasing doxycycline,' will be delivered by Chief Scientific Officer Noam Emanuel. D-PLEX₁₀₀ is currently in Phase 3 trials for soft tissue infections.