UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of: June 2024
Commission File Number: 001-38428
PolyPid Ltd.
(Translation of registrant’s name into
English)
18 Hasivim Street
Petach Tikva 495376, Israel
(Address of principal executive office)
Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
CONTENTS
Attached hereto and incorporated
herein is PolyPid Ltd.’s (the “Registrant”) press release issued on June 18, 2024, titled “PolyPid Hosts KOL Call
to Discuss Significant Unmet Medical Need in Surgical Site Infections Prevention and Provides Update on its Ongoing SHIELD II Phase 3
Trial.”
The first, second and fourth
paragraphs and the section titled “Forward-looking Statements” in the press release are incorporated
by reference into the Registrant’s registration statements on Form
F-3 (File No. 333-257651
and File No. 333-276826) and
Form S-8 (File No. 333-239517, File
No. 333-271060,
and File No. 333-277703), filed
with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded
by documents or reports subsequently filed or furnished.
EXHIBIT INDEX
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
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POLYPID LTD. |
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|
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| Date: June 18, 2024 |
By: |
/s/ Dikla Czaczkes Akselbrad |
| |
|
Name: |
Dikla Czaczkes Akselbrad |
| |
|
Title: |
Chief Executive Officer |
3
Exhibit 99.1
PolyPid Hosts KOL Call to Discuss Significant
Unmet Medical Need in Surgical Site Infections Prevention and Provides Update on its Ongoing SHIELD
II Phase 3 Trial
After a Reduction in Surgical Site Infection
(SSI) Rates During COVID, Rates are Now Increasing, Signaling a Return to Pre-COVID Levels
Known Procedure and Patient Risk-Factors Significantly
Increase the Risk of SSIs and Impact Payer Costs
Approximately 250 Patients of a Planned Total
of 600 Subjects Currently Enrolled in SHIELD II
Unblinded
Interim Analysis to be Conducted Once Approximately 400 Patients Complete
Their 30-Day Follow-up; Top-line Results Expected in the First Quarter of 2025
PETACH TIKVA, Israel, June 18, 2024 (GLOBE NEWSWIRE)
– PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve
surgical outcomes, today hosted a virtual Key Opinion Leader event discussing the significant unmet medical need in the prevention of
surgical site infections (SSIs). The Company also provided an update on its ongoing SHIELD II Phase 3 trial for D-PLEX100.
Charles E. Edmiston, Ph.D. (Emeritus Professor
of Surgery, Division of Vascular Surgery, Medical College of Wisconsin), discussed several key topics surrounding SSIs. Key
takeaways include:
| ● | The return to higher pre-COVID SSI rates due
to the increase in the number of elective surgeries conducted and the surgical environment normalizing to levels found prior to 2020. |
| ● | SSIs are under-reported, and up to 30-35% of
colorectal infections are missed due to sub-optimal surveillance strategies. |
| ● | Procedural and patient-related risk factors such
as smoking, alcohol abuse, type 2 diabetes and a high BMI have a significant negative impact on the risk of developing a SSI, and this
increase in risk is compounded when patients have multiple risk factors. |
| ● | Long term cost to commercial payers of a single
colorectal SSI event over a period of 24 months can range from $44,000 (superficial SSI) to $64,000 (deep SSI), with the cost for Medicare
ranging from $20,000 to $45,000, respectively. |
| ● | Surgical care bundles in patients undergoing
colorectal surgery significantly reduce the risk of SSIs. The 30-day high concentration release of antibiotics achieved with D-PLEX100
has the potential to add additional benefit to infection prevention bundles. |
“Studies show traditional evidence-based
interventions have maximum benefit within the perioperative and immediate postoperative period. Building upon this, D-PLEX100
supports prolonged doxycycline concentrations within the surgical wound during and beyond this critical period and exceeds the minimum
inhibitory concentration for the most common surgical wound pathogens regardless of length of the surgical incision,” said Dr. Edmiston.
“There remains an opportunity to improve upon the existing clinical standard of care to reduce the rate of SSIs in and beyond the
colorectal surgical setting, improving the patient experience and lowering costs for payers.”
PolyPid also provided
an update on the enrollment of its ongoing Phase 3 SHIELD II trial of its lead product candidate, D-PLEX100. The
SHIELD II clinical study includes patients undergoing abdominal colorectal surgery with large incisions
and has now enrolled approximately 250 patients of a planned total of approximately 600 subjects. Approximately 50 centers are currently
open and recruiting patients. Top-line results are expected in the first quarter of 2025. The Company intends to conduct an unblinded
interim analysis once a total of approximately 400 patients complete their 30-day follow-up, which is anticipated to occur in the fourth
quarter of 2024.
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 surgeries with incisions greater than 20 cm. The primary endpoint of the trial is measured by the proportion of
subjects with either an 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 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 potential benefits and advantages of D-PLEX100, that there remains an opportunity
to improve upon the existing clinical standard of care to reduce the rate of SSIs in and beyond the colorectal surgical setting, improving
the patient experience and lowering costs for payers, total recruitment time into the study and the timing of the top-line results and
an unblinded interim analysis. 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 6, 2024. 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
3
PolyPid (NASDAQ:PYPD)
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