PolyPid Ltd. Ordinary Shares - PYPD STOCK NEWS

PolyPid Ltd. (Nasdaq: PYPD) has received a notification from Nasdaq regarding its non-compliance with the minimum stockholders' equity requirement of $10 million, as its equity stood at only $5.83 million as of December 31, 2022. The company has 45 days to submit a compliance plan, potentially extending the deadline for compliance verification by 180 days. The notification does not affect its current listing status, as shares will continue to trade on Nasdaq during this period. Following a recent offering that raised approximately $11.4 million, PolyPid is optimistic about regaining compliance. The company is focused on improving surgical outcomes through its proprietary PLEX technology and has a lead product candidate in Phase 3 trials aimed at preventing surgical site infections.

PolyPid Ltd. (Nasdaq: PYPD) has announced a successful underwritten public offering generating approximately $7.1 million and a private placement raising $4.35 million. The public offering consisted of 14,660,000 Ordinary Shares priced at $0.42 each, with additional shares sold to cover overallotments. Concurrently, the company restructured its loan with Kreos Capital, delaying over $3 million in repayments until August 2024. The proceeds will fund ongoing clinical activities for D-PLEX₁₀₀ and other corporate purposes, as PolyPid aims to enhance surgical outcomes through innovative drug delivery methods.

PolyPid (Nasdaq: PYPD), a late-stage biopharma company, has announced a public offering of 14,660,000 ordinary shares priced at $0.42 each, aiming for gross proceeds of approximately $6.2 million. The offering is set to close around March 31, 2023. Additionally, PolyPid will engage in a private placement of 10,357,139 pre-funded warrants at $0.4199 each, expected to yield around $4.4 million. Proceeds will support clinical activities for D-PLEX100, its lead product for colorectal surgical site infection prevention, along with working capital and general corporate purposes. The company has granted underwriters a 30-day option for additional shares.

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.