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PolyPid Announces Enrollment of the 100th Patient in the Ongoing SHIELD II Phase 3 Trial

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PolyPid Ltd. (Nasdaq: PYPD) announces enrollment of 100th patient in SHIELD II Phase 3 trial for D-PLEX100, with approximately 40 centers open. Unblinded interim analysis expected after 400 patients complete follow-up in mid-2024. Recent $16 million financing extends cash runway through late Q3 2024, with potential additional $19 million if warrants are exercised for NDA submission.
Positive
  • PolyPid enrolled the 100th patient in its SHIELD II Phase 3 trial for D-PLEX100.
  • Approximately 40 centers are currently open for the trial.
  • An unblinded interim analysis will be conducted after approximately 400 patients complete their 30-day follow-up in mid-2024.
  • Top-line results from the SHIELD II trial are expected in the second half of 2024.
  • PolyPid recently closed a $16 million private placement financing.
  • The financing extends the company's cash runway through late Q3 2024.
  • There is potential for an additional $19 million if warrants are exercised for NDA submission.
  • New and existing investors, including U.S. life sciences-focused investors, participated in the financing.
Negative
  • None.

The recent financing of PolyPid Ltd. is a critical event with significant implications for the company's financial stability and its ability to continue operations without the need for immediate additional capital. The $16 million in gross proceeds from the private placement financing (PIPE) provides the company with a cash runway extension through late Q3 2024. This is essential for a late-stage biopharma company, as it allows them to maintain momentum in clinical development without the pressure of imminent funding shortages.

The participation of life sciences-focused investors in the PIPE, such as DAFNA Capital Management and Rosalind Advisors, is a strong signal of investor confidence in the company's prospects. The potential for an additional $19 million in funding through warrant exercises contingent on positive interim analysis results adds a milestone-triggered financing layer, which is a common strategy to mitigate investment risks in the biopharma industry. This conditional funding mechanism aligns investor interests with clinical trial outcomes, creating a more resilient financial structure for the company.

Enrollment milestones in clinical trials, such as the 100th patient in PolyPid's SHIELD II Phase 3 trial, are indicative of the company's progress in developing D-PLEX100 for the prevention of surgical site infections. The planned unblinded interim analysis after the 30-day follow-up of approximately 400 patients is a significant event that will provide early insights into the efficacy and safety of the drug. This analysis is critical as it could influence the direction of the trial and the subsequent regulatory pathway.

Top-line results expected in the second half of 2024 will be pivotal for the company's future. Positive results could lead to a New Drug Application (NDA) submission, which is the last step before potential market approval. The outcome of this trial will have substantial implications for the company's valuation and the stock's performance, as it directly correlates with the drug's potential to generate future revenues.

The market for surgical site infection prevention is significant, as these infections represent a common complication that can lead to increased patient morbidity and higher healthcare costs. A successful entry of D-PLEX100 into this market could address a substantial unmet medical need. PolyPid's focus on abdominal colorectal surgery with large incisions targets a specific patient population that is at a heightened risk for such infections, potentially allowing for a differentiated and targeted approach in their marketing strategy.

Moreover, the expansion to approximately 40 centers for the SHIELD II trial demonstrates the company's operational capacity to scale up and manage large, multi-center studies. This is a positive indicator of the company's ability to execute on its clinical development plans and may reassure investors of its competency in managing complex trial logistics.

Approximately 40 Centers Currently Open

Unblinded Interim Analysis to be Conducted Once Approximately 400 Patients Complete Their 30-Day Follow-up; Top-line Results Expected in Second Half of 2024

Recent Successful $16 Million Financing Extends Company’s Cash Runway Through Late Q3 2024 and Beyond Expected Timing of Unblinded Interim Analysis; Potential Additional $19 Million if Warrants are Exercised to Fund PolyPid to the Start of a Planned New Drug Application Submission for D-PLEX100 

PETACH TIKVA, Israel, Feb. 12, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it has enrolled and randomized the 100th patient in its ongoing SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions. There are currently approximately 40 centers open.

The Company intends to conduct an unblinded interim analysis once a total of approximately 400 patients complete their 30-day follow-up, which is expected to occur in mid-2024.

“As anticipated, since last November, we have doubled the number of open centers, and enrollment into SHIELD II has recently begun to ramp-up,” said Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “We continue to expect top-line results from SHIELD II in the second half of 2024.”

PolyPid recently closed a private placement financing (the “PIPE”) for $16 million of gross proceeds. The PIPE syndicate was comprised of new and existing investors, including participation from new U.S. life sciences-focused investors, DAFNA Capital Management and Rosalind Advisors. Moreover, the Company has the potential to secure an additional $19 million if the results of the unblinded interim analysis are positive and all warrants issued in the recent financing are exercised, which would fund PolyPid to the start of a planned New Drug Application (“NDA”) submission for D-PLEX100.

About SHIELD II

SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (“SoC”), which includes prophylactic systemic antibiotics, compared to SoC alone arm, in the prevention of post abdominal-surgery incisional infection in patients undergoing abdominal colorectal surgeries with large incisions. The primary endpoint of the trial is measured by the proportion of subjects with either a surgical site infection (“SSI”) event as determined by a blinded and independent adjudication committee, reintervention, or mortality for any reason within 30 days post-surgery. Patient safety will be monitored for an additional 30 days. The trial will enroll patients in centers in the United States, Europe and Israel.

About D-PLEX100

D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100  is currently in Phase 3 SHIELD II trial for the prevention of surgical site infections in patients undergoing open abdominal colorectal surgery with large incisions.

About PolyPid

PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid’s lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma.

For additional Company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

Forward-looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the expected timing for top-line results from the SHIELD II trial and of the unblinded interim analysis, the planned NDA submission for D-PLEX100, the Company’s expected cash runway, and the potential to receive additional funds if warrants are exercised. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s Annual Report on Form 20-F filed on March 31, 2023. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.

References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

Contacts:
PolyPid Ltd. 
Ori Warshavsky
COO – US
908-858-5995
IR@Polypid.com 

Investors:
Brian Ritchie
LifeSci Advisors
212-915-2578
britchie@lifesciadvisors.com


PolyPid has enrolled the 100th patient in the SHIELD II Phase 3 trial for D-PLEX100.

Approximately 40 centers are currently open for the SHIELD II Phase 3 trial for D-PLEX100.

The unblinded interim analysis is expected to be conducted once approximately 400 patients complete their 30-day follow-up in mid-2024.

The top-line results from the SHIELD II trial are expected in the second half of 2024.

PolyPid recently closed a $16 million private placement financing.

The recent $16 million financing extends PolyPid's cash runway through late Q3 2024.

PolyPid has the potential to secure an additional $19 million if warrants are exercised for NDA submission.

New and existing investors, including U.S. life sciences-focused investors, participated in the recent financing.
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About PYPD

polypid®, a specialty pharmaceutical company, develops and manufactures products based on its plex™ technology. so far, 70 patients have been treated in clinical trials with polypid’s anti-infection products demonstrating safety and efficacy. polypid is in the process of submitting its lead product for phase-iii trial in the us and eu. plex™ is able to optimize drugs'​ therapeutic performance and clinical outcomes. plex™-based protected drug reservoir is implanted directly into the body’s target area thus enabling prolonged delivery of drugs, over periods ranging from days to several months. polypid’s pipeline focuses on 3 products: d-plex™ - intended for prevention and treatment of surgical infections caused by bacteria. its effectiveness is currently being tested in patients undergoing open-heart surgery, with a view to preventing infections that may occur following surgery. the product is currently undergoing clinical studies at several medical centers. bonypid®-1000 - designed to e