Full Press Release Details
PolyPid Announces Positive Recommendation by
DSMB to Continue Enrollment of Phase 3 SHIELD II Trial of D-PLEX100 to 800 Patients
with a Concurrent Private Placement of up to $41 Million
PETACH TIKVA, Israel, December 23, 2024 -- PolyPid
Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma
company aiming to improve surgical outcomes, announced today that following the independent Data Safety Monitoring Board's
("DSMB") review of unblinded efficacy data from the first 430 enrolled patients in the SHIELD
II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections ("SSIs") in patients undergoing
abdominal colorectal surgery with large incisions, the DSMB's recommendation was to conclude the study upon enrollment of
800 patients, which is the lowest sample size reassessment stop after the minimum planned number of 624 patients. At this interim analysis,
the DSMB also had the option to recommend stopping SHIELD II due to futility or overwhelming efficacy or to reassess the trial's
sample size to a maximum of 1,100 patients. In addition, the DSMB's confirmed the good safety profile of D-PLEX100 in
"We view the DSMB's recommendation to conclude SHIELD II
upon the enrollment of 800 patients as a favorable outcome, as it is suggestive of positive efficacy signals from D-PLEX100,"
said Dikla Czaczkes Akselbrad, PolyPid's Chief Executive Officer. "The sample
size reassessment is an opportunity to ensure the study has sufficient power to conclusively confirm D-PLEX100's treatment
benefit, and we believe this increases the trial's overall probability of success. We are now focused on completing the trial, while
advancing our planned NDA and Marketing Authorization Application ("MAA") submissions, preparing pre-launch activities, and
expediting partnership discussions in and outside of the United States."
The study has enrolled 630 patients to date and enrollment of the last
170 patients is expected to occur in the first quarter of 2025. The Company anticipates reporting
top-line results in the second quarter of 2025. Upon potential positive Phase 3 data, the Company expects to submit an NDA with the advantages
of the Fast Track and Breakthrough Therapy designations, which were granted to D-PLEX100 in 2020.
PolyPid also announced that it has entered into a securities purchase
agreement for a private placement financing (the "PIPE") led by existing institutional shareholders for $14.5
million in gross proceeds priced at $3.22 per share, the closing price on December 20, 2024. In connection with the PIPE
financing, the Company has agreed to consider Yitzchak Jacobovitz, CFA, partner and lead healthcare analyst at AIGH Capital Management,
for appointment to the Company's board of directors.
Under the securities purchase agreement, the investors have agreed
to purchase 4,493,830 of the Company's ordinary shares, no par value per share (the "Ordinary Shares"), or pre-funded
warrants in lieu thereof, at a purchase price of $3.22 per share (or pre-funded warrant). The investors will also receive warrants
to purchase up to 6,740,745 Ordinary Shares at an exercise price of $4.00 per share. The warrants expire upon the earlier of
nine months from the date of issuance and 10 trading days following PolyPid's announcement of top-line results from its
SHIELD II Phase 3 trial. Exercise of the warrants in full would result in an additional $27.0 million in gross proceeds to the
The PIPE is expected to close on December 26, 2024, subject to
the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the sale of the securities for its
ongoing SHIELD II Phase 3 clinical trial, working capital and general corporate purposes. The gross proceeds from the financing
extend PolyPid's cash runway into the third quarter of 2025, beyond expected top-line results from SHIELD II.
Proceeds of all warrants issued in this transaction, if exercised,
would provide the Company with capital beyond NDA approval.
Citizens JMP is acting as exclusive placement agent in the offering.
The offer and sale of the foregoing securities are being made in a
transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the
"Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the
United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements
of the Securities Act and such applicable state securities laws. Pursuant to a registration rights agreement with the PIPE investors,
the Company has agreed to file within 30 calendar days of closing one or more registration statements with the Securities and Exchange
Commission (the "SEC") covering the resale of the Ordinary Shares and Ordinary Shares issuable upon exercise of the warrants
and pre-funded warrants.
This press release does not constitute an offer to sell or the solicitation
of an offer to buy the securities, nor shall there be any sale of the securities in any state or jurisdiction in which such offer, solicitation
or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.
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 enrolls patients in centers in the United States, Europe and Israel.
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.
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
For additional Company information, please
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 completion of enrollment of the SHIELD II trial, expected timing for top-line results from the
SHIELD II trial, potential NDA and MAA submissions, potential clinical benefits of D-PLEX100,
including safety and efficacy, pre-launch activities and partnership discussions, the gross proceeds to be received from the PIPE, intended
use of proceeds from the PIPE, the anticipated closing date for the PIPE, the anticipated gross proceeds from the exercise of warrants
issued in the PIPE if such warrants are exercised in full, that the gross proceeds from the financing extend the Company's cash
runway into the third quarter of 2025, that proceeds of all warrants issued in this transaction, if exercised, would provide the Company
with capital beyond NDA approval, and the potential addition of Mr. Jacobovitz to the Company's board of directors. 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, 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.