<SEC-DOCUMENT>0001213900-22-028716.txt : 20220523
<SEC-HEADER>0001213900-22-028716.hdr.sgml : 20220523
<ACCEPTANCE-DATETIME>20220523070517
ACCESSION NUMBER: 0001213900-22-028716
CONFORMED SUBMISSION TYPE: 6-K
PUBLIC DOCUMENT COUNT: 2
CONFORMED PERIOD OF REPORT: 20220523
FILED AS OF DATE: 20220523
DATE AS OF CHANGE: 20220523
FILER:
COMPANY DATA:
COMPANY CONFORMED NAME: PolyPid Ltd.
CENTRAL INDEX KEY: 0001611842
STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
IRS NUMBER: 000000000
STATE OF INCORPORATION: L3
FISCAL YEAR END: 1231
FILING VALUES:
FORM TYPE: 6-K
SEC ACT: 1934 Act
SEC FILE NUMBER: 001-38428
FILM NUMBER: 22949577
BUSINESS ADDRESS:
STREET 1: 18 HASIVIM STREET
CITY: PETACH TIKVA
STATE: L3
ZIP: 495376
BUSINESS PHONE: 972-74-7195700
MAIL ADDRESS:
STREET 1: 18 HASIVIM STREET
CITY: PETACH TIKVA
STATE: L3
ZIP: 495376
</SEC-HEADER>
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<TYPE>6-K
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<FILENAME>ea160448-6k_polypidltd.htm
<DESCRIPTION>REPORT OF FOREIGN PRIVATE ISSUER
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Washington, D.C. 20549</B></P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>FORM 6-K</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B> </B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>REPORT OF FOREIGN PRIVATE ISSUER</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>PURSUANT TO RULE 13a-16 OR 15d-16</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>UNDER THE SECURITIES EXCHANGE ACT OF 1934</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B> </B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>For the Month of: May 2022 (Report No. 3)</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B> </B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Commission File Number: 001-38428</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B> </B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>PolyPid Ltd.</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>(Translation of registrant’s name into
English)</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"> </P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>18 Hasivim Street</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Petach Tikva 495376, Israel</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(Address of principal executive office)</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"> </P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F:</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"> </P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">☒ Form 20-F ☐ Form
40-F</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"> </P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Indicate by check mark if the registrant is submitting
the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"> </P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Indicate by check mark if the registrant is submitting
the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"> </P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>CONTENTS</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white">Attached
hereto and incorporated herein is PolyPid Ltd.’s (the “Registrant”) press release issued on May 23, 2022, titled “PolyPid
Announces Recommendation by Data Safety Monitoring Board to Conclude Enrollment of Phase 3 SHIELD I Trial of D-PLEX<SUB>100</SUB> at the
Minimum Number of Patients Targeted Following Unblinded Interim Efficacy Analysis.”</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"> </P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The first three paragraphs
and the section titled “Forward-looking Statements” in the press release are incorporated by reference into the Registrant’s
registration statements on <A HREF="http://www.sec.gov/Archives/edgar/data/1611842/000121390021035574/ea143509-f3_polypidltd.htm">Form F-3</A> (File No. 333-257651) and <A HREF="http://www.sec.gov/Archives/edgar/data/1611842/000110465920077735/tm209265d11_s8.htm">Form S-8</A> (File No. 333-239517), 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.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B> </B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>EXHIBIT INDEX</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </P>
<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
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<TD STYLE="width: 9%; border-bottom: black 1.5pt solid"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Exhibit No.</B></FONT></TD>
<TD STYLE="width: 1%; text-align: justify"> </TD>
<TD STYLE="width: 90%; text-align: justify"> </TD></TR>
<TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
<TD STYLE="text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">99.1</FONT></TD>
<TD STYLE="text-align: justify"> </TD>
<TD STYLE="text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="ea160448ex99-1_polypidltd.htm">Press
Release issued by PolyPid Ltd. on May 23, 2022, titled “PolyPid Announces Recommendation by Data Safety Monitoring Board to
Conclude Enrollment of Phase 3 SHIELD I Trial of D-PLEX<SUB>100</SUB> at the Minimum Number of Patients Targeted Following Unblinded
Interim Efficacy Analysis.”</A></FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B> </B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><U>SIGNATURES</U></B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"> </P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">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.</P>
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<TD> </TD>
<TD COLSPAN="3"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>POLYPID LTD.</B></FONT></TD></TR>
<TR>
<TD> </TD>
<TD> </TD>
<TD COLSPAN="2"> </TD></TR>
<TR STYLE="vertical-align: top">
<TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Date: May 23, 2022</FONT></TD>
<TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">By:</FONT></TD>
<TD COLSPAN="2" STYLE="border-bottom: black 1.5pt solid"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">/s/ Dikla Czaczkes Akselbrad</FONT></TD></TR>
<TR STYLE="vertical-align: top">
<TD STYLE="width: 60%"> </TD>
<TD STYLE="width: 4%"> </TD>
<TD STYLE="width: 5%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Name </FONT></TD>
<TD STYLE="width: 31%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dikla Czaczkes Akselbrad</FONT></TD></TR>
<TR STYLE="vertical-align: top">
<TD> </TD>
<TD> </TD>
<TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Title:</FONT></TD>
<TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Executive Vice President and<BR>
Chief Financial Officer</FONT></TD></TR>
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<P STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt">3</P>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>ea160448ex99-1_polypidltd.htm
<DESCRIPTION>PRESS RELEASE ISSUED BY POLYPID LTD. ON MAY 23, 2022, TITLED "POLYPID ANNOUNCES RECOMMENDATION BY DATA SAFETY MONITORING BOARD TO CONCLUDE ENROLLMENT OF PHASE 3 SHIELD I TRIAL OF D-PLEX100 AT THE MINIMUM NUMBER OF PATIENTS TARGETED FOLLOWING
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><B>Exhibit 99.1</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B> </B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>PolyPid Announces Recommendation by Data Safety
Monitoring Board to Conclude Enrollment of</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Phase 3 SHIELD I Trial of <FONT STYLE="background-color: white">D-PLEX<SUB>100 </SUB></FONT>at
the Minimum Number of Patients Targeted Following Unblinded</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Interim Efficacy Analysis</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><I></I></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I> </I></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; text-align: center">● <I>Enrollment of 950
Patients, the Minimum Number of Patients Targeted for the SHIELD I Study, Expected Within Days</I></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><I> </I></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; text-align: center">● <I>Top-line Results Expected
by End of Q3 2022; <FONT STYLE="background-color: white">Potential NDA and MAA Submissions Targeted for H1 2023</FONT></I></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><I> </I></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; text-align: center">● <I>Conference Call Scheduled
for Today at 8:30 a.m. ET</I></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"> </P>
<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">PETACH TIKVA, Israel, May 23, 2022 -- <FONT STYLE="background-color: white">PolyPid
Ltd. (Nasdaq: PYPD)</FONT> (“PolyPid” or the “Company”)<FONT STYLE="background-color: white">, a late-stage biopharma
company aiming to improve surgical outcomes, announced today that following the </FONT>independent Data Safety Monitoring Board (DSMB)
review of unblinded efficacy data from the first 750 enrolled patients in the SHIELD I Phase 3 study of <FONT STYLE="background-color: white">D-PLEX<SUB>100
</SUB>for the prevention of surgical site infections (SSIs) in abdominal tissue surgery</FONT>, the recommendation was to conclude the
study upon enrollment of 950 patients, which is the minimum number of targeted patients in the study protocol. The enrollment of the 950<SUP>th</SUP>
patient is expected to occur within days.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </P>
<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="background-color: white">The SHIELD I study is designed
to demonstrate at least a 50 percent reduction in incisional SSIs in the D-PLEX<SUB>100</SUB> treatment arm compared to the control arm,
with 90 percent power and a maximum alpha level of 0.04. </FONT></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </P>
<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="background-color: white">The Company anticipates </FONT>reporting
top-line results by the end of the third quarter of 2022, followed by a potential New Drug Application (NDA) submission to the U.S. Food
and Drug Administration (FDA) and a European Union Marketing Authorization Application (MAA) filing, both targeted for the first half
of 2023.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </P>
<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">“We are pleased with the DSMB recommendation and expect to conclude
the SHIELD I trial shortly,” stated Amir Weisberg, PolyPid’s CEO. “SSIs represent a major unmet medical need and a large
commercial opportunity for D-PLEX<SUB>100</SUB>. We look forward to completing the SHIELD I study and advancing preparations for our planned
NDA submission and pre-launch activities, while expediting partnership discussions in and outside of the United States.”</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </P>
<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">“<FONT STYLE="background-color: white">D-PLEX<SUB>100</SUB></FONT>,
if approved, could significantly alter the surgical landscape, where postoperative infections remain a costly problem,” stated Dr.
Kyle Cologne, Associate Professor of Colorectal Surgery, University of Southern California, who serves as an advisor to PolyPid. “SSIs
are among the most prevalent complications following surgery, occurring in 6-26 percent of patients undergoing abdominal surgeries, particularly
after open colorectal resection. Currently, the lack of effective infection prevention methods exposes patients to higher risk. When they
occur, SSIs lead to hospital readmission, increased resource utilization and cost the U.S. healthcare system nearly $10 billion annually.
The opportunity to make significant inroads to reduce these numbers is an exciting possibility with D-PLEX<SUB>100</SUB>.”</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Conference Call Dial-In & Webcast Information:</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in">Date: Monday, May 23, 2022</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in">Time: 8:30 AM Eastern Time</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in">United States: +1 877-870-9135</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in">Israel: +972 1809 213-985</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in">International: +44 (0) 2071 928338</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in">Conference ID: 4857305</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in">Webcast: https://edge.media-server.com/mmc/p/84mxrrtd</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in"> </P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; margin-top: 0pt; margin-bottom: 0pt"><B><U>About <FONT STYLE="background-color: white">SHIELD I</FONT></U></B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </P>
<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; background-color: white"><B>SHIELD
I (</B></FONT><B>S</B><FONT STYLE="background-color: white">urgical site </FONT><B>H</B><FONT STYLE="background-color: white">ospital
acquired </FONT><B>I</B><FONT STYLE="background-color: white">nfection pr</FONT><B>E</B><FONT STYLE="background-color: white">vention
with </FONT><B>L</B><FONT STYLE="background-color: white">ocal </FONT><B>D</B><FONT STYLE="background-color: white">-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 a SoC alone arm, in prevention
of post abdominal surgery incisional infection. The primary endpoint of the trial is the combination of incisional SSIs and mortality
rate as measured by the proportion of subjects with either an SSIs event, as determined by a blinded and independent adjudication committee,
or mortality for any reason within 30 days post-surgery. The trial has enrolled patients in more than 60 centers in the United States, Europe and Israel.
</FONT></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B> </B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B></B></P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><U>About <FONT STYLE="background-color: white">D-PLEX<SUB>100</SUB></FONT></U></B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </P>
<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="background-color: white">D-PLEX<SUB>100, </SUB>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-PLEX<SUB>100</SUB> into the surgical site, the </FONT>PLEX (Polymer-Lipid Encapsulation
matriX) <FONT STYLE="background-color: white">technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous
release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of four weeks for
the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX<SUB>100</SUB>
received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery.
D-PLEX<SUB>100</SUB> also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations for
the prevention of SSIs in patients undergoing elective colorectal surgery, post-abdominal surgery incisional infection and for the prevention
of sternal wound infection post-cardiac surgery.</FONT></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>About PolyPid</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </P>
<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">PolyPid Ltd. (Nasdaq: PYPD<FONT STYLE="font-family: Times New Roman, Times, Serif">)
</FONT>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,
enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid’s lead product
candidate <FONT STYLE="background-color: white">D-PLEX<SUB>100</SUB></FONT> is in Phase 3 clinical trials for the prevention of soft tissue
abdominal and sternal bone surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy
of OncoPLEX for treatment of solid tumors, beginning with glioblastoma. For additional Company information, please visit http://www.polypid.com
and follow us on Twitter <FONT STYLE="font-family: Times New Roman, Times, Serif">and </FONT>LinkedIn.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I> </I></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Forward-looking Statements</B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B> </B></P>
<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B></B>This press release contains “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words <FONT STYLE="background-color: white">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 </FONT>that the enrollment of the 950<SUP>th</SUP> patient
is expected to occur within days<FONT STYLE="background-color: white">, the Company’s anticipation to </FONT>report top-line results
by the end of the third quarter of 2022, followed by potential NDA submission to FDA and a European Union MAA filing targeted for the
first half of 2023, expedition of partnership discussions in and outside of the United States, that <FONT STYLE="background-color: white">D-PLEX<SUB>100</SUB></FONT>,
if approved, could significantly alter the surgical landscape, that the opportunity to make significant inroads to reduce these numbers
is an exciting possibility with D-PLEX<SUB>100</SUB> and the potential for D-PLEX<SUB>100</SUB> to reduce hospital readmissions, resource
utilization and costs. 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 February 28, 2022. 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.</P>
<P STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"> </P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0; background-color: white">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.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B> </B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Corporate Contact </B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">PolyPid Ltd.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Dikla Czaczkes Akselbrad</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">EVP & CFO</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Tel: +972-747195700</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Investor Contact </B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Bob Yedid</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">LifeSci Advisors</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">646-597-6989</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Bob@LifeSciAdvisors.com</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Media Contact </B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Nechama Feuerstein</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">FINN Partners</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">551-444-0784</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Nechama.Feuerstein@finnpartners.com</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </P>
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