| Yesterday | ||||
PolyPid Ltd. announced… PolyPid Ltd. announced that it has commenced an underwritten public offering of its ordinary shares. PolyPid intends to use the net proceeds from the offering to fund ongoing clinical activities and development of D-PLEX100, working capital and other general corporate purposes. Newbridge Securities Corporation is acting as the sole book-running manager of the offering. | ||||
| Over a month ago | ||||
As of December 31, 2022,… As of December 31, 2022, the Company had cash and cash equivalents and deposits in the amount of $12.6 million, compared to $32.2 million at December 31, 2021. PolyPid expects that this cash balance will be sufficient to fund operations well into the third quarter of this year. | ||||
"We are thrilled to… "We are thrilled to now have a clear regulatory pathway to possible approval of D-PLEX100 in the U.S. following confirmation from the FDA that the ongoing SHIELD II trial can potentially be used to complete our clinical testing," stated Dikla Czaczkes Akselbrad, PolyPid's CEO. "Importantly, the ability to leverage the SHIELD II study will significantly reduce the time and resources needed to finalize the clinical study as compared to having to initiate a new trial. We look forward to resuming patient recruitment in the second quarter. We view SHIELD II as a de-risked Phase 3 trial given the more focused patient population with large incisions in which we have already generated highly positive data in SHIELD I, and the fact that it will not be conducted within tight COVID-19 related restrictions. The recruitment of the additional 550 patients into SHIELD II is expected to take approximately 12 months and the top-line results are anticipated in mid-2024." | ||||
PolyPid provided a… PolyPid provided a positive regulatory update for D-PLEX100 for the prevention of abdominal colorectal surgical site infections, SSIs. Following a recent type D meeting communication with the U.S. Food and Drug Administration, FDA, on the SHIELD I Phase 3 data, the Company now has clarity regarding the regulatory pathway toward a potential New Drug Application, NDA, submission. PolyPid provided to the FDA currently available data from the SHIELD I study evaluating D-PLEX100 for the prevention of abdominal colorectal SSIs. Based on the data, particularly the 54% reduction observed in the primary endpoint in complex surgeries in a pre-specified subgroup analysis of patients with large incisions compared to standard of care, the FDA acknowledged that the SHIELD I results may provide supportive evidence on this population and recommended that the Company conduct an additional study to support a potential NDA submission. "We are pleased with the outcome of our recent interactions with the FDA and are grateful to the Agency for their supportive feedback," stated Ms. Dikla Czaczkes Akselbrad, PolyPid's Chief Executive Officer. "We now have a clear regulatory pathway for the possible approval of D-PLEX100 in United States, and we remain highly confident in the potential of our promising late-stage product candidate. We are focused on evaluating the most appropriate measures to implement the FDA's recommendations and are also preparing for near-term interactions with the EU regulatory authorities regarding D-PLEX100. We look forward to providing further clinical and regulatory updates on both U.S. and European markets." | ||||
PolyPid announced the… PolyPid announced the peer-reviewed publication of a post-hoc analysis from the previously-completed Phase 2 study of D-PLEX100 for the prevention of surgical site infections, SSIs, in abdominal surgery. The paper, entitled, "Reduction in Surgical Site Infections by Localized Administration with D-PLEX100 in Patients with Multiple Risk Factors Undergoing Colorectal Surgery," was published in the American Journal of Surgery and can be found here. The Phase 2 trial was a prospective, multicenter, randomized, controlled, single-blind, two arm study and was designed to assess the efficacy and the safety of D-PLEX100 in addition to standard of care in preventing superficial and deep SSIs in patients undergoing elective colorectal surgery. Thirty-day SSI rates were examined in patients in the Intention-to-treat population and in those with two or more patient related risk factors. The distribution of the assessed risk factors between the D-PLEX100 plus SoC and SoC cohorts was approximately even. Two hundred and one patients were evaluated in the ITT population, 101 in the intervention arm and 100 in the control arm. The study showed a 53% statistically significant relative risk reduction of the SSI rate within 30 days post-index surgery in the D-PLEX100 cohort compared to SoC. In patients with two or more risk factors, the SSI rate in the D-PLEX100 plus SOC cohort was 15.8% compared to 37.5% in the SOC alone cohort, demonstrating a statistically significant relative risk reduction of 58%. | ||||
| Over a quarter ago | ||||
PolyPid announced that a… PolyPid announced that a Type D meeting has been scheduled for January 2023 with the U.S. Food and Drug Administration to discuss the results of SHIELD I Phase 3 study and regulatory requirements to support the indication of D-PLEX100 for the prevention of abdominal colorectal surgical site infections. In advance of the meeting, PolyPid recently provided the FDA with currently available data from the completed SHIELD I study. | ||||
PolyPid announced it has… PolyPid announced it has received a written notice from Nasdaq Stock indicating that the company is not in compliance with the minimum bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550, which requires listed securities to maintain a minimum bid price of $1.00 per share. Under Nasdaq Listing Rule 5810, the company has been granted a period of 180 calendar days to regain compliance with the minimum bid price requirement. The notice has no immediate effect on the company's Nasdaq listing or the trading of its ordinary shares, and during the grace period, as may be extended, the company's ordinary shares will continue to trade on Nasdaq under the symbol (PYPD). | ||||
Implemented a cost… Implemented a cost reduction plan, including a 20% decrease in headcount across all departments, which is expected to extend available cash into the third quarter of 2023 in support of the Company's long-term growth strategy. | ||||
As of September 30, 2022,… As of September 30, 2022, the Company had cash and cash equivalents and deposits in the amount of $18.1 million, including the $2.6 million upfront payment from ADVANZ PHARMA received during the third quarter. Following the recently announced cost reduction plan, PolyPid expects that its current cash balance will be sufficient to fund operations into the third quarter of 2023. | ||||
"Since the top-line… "Since the top-line results were announced, we have continued to gather and analyze additional data from SHIELD I," stated Dikla Czaczkes Akselbrad, PolyPid's Chief Executive Officer. "These data have been increasingly encouraging. While SHIELD I did not meet its primary endpoint, the significant reduction in SSIs in complex surgeries with large incisions and in high-risk patients, as well as the safety data, are very compelling. As such, we are in the process of preparing a comprehensive package of D-PLEX100 data for a planned meeting with the U.S. Food and Drug Administration (FDA). We expect to meet the FDA and EU regulatory authorities regarding the regulatory pathway for D-PLEX100 in the first quarter of 2023. In parallel to preparing for these important regulatory interactions, we recently implemented a cost reduction plan, including a 20% decrease in headcount across all departments," continued Ms. Czaczkes Akselbrad. "We expect that these significant measures will extend our cash runway into the third quarter of 2023 in support of the Company's long-term growth strategy." | ||||
