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PolyPid Provides Corporate Update and Reports First Quarter 2025 Financial Results PolyPid Successfully Completed Enrollment in Phase 3 SHIELD II Trial of D-PLEX , with Top-Line Results Anticipated in Current Quarter Com

Key Takeaway: PolyPid Ltd. has provided an update regarding its corporate activities and reported its financial results for Q1 2025. The company has successfully completed enrollment in its Phase 3 SHIELD II trial for D-PLEX100, aimed at preventing surgical site infections. Top-line results from the trial are expected within the current quarter, while efforts to prepare for regulatory submissions and commercial launch are actively ongoing. PolyPid's CEO emphasized the study's strong design, enhancing confidence in the trial’s success probability.

Market Sentiment Analysis

POSITIVE FACTORS

  • Successful completion of enrollment in Phase 3 SHIELD II trial of D-PLEX.
  • Anticipation of top-line results within the current quarter.
  • Preparations for NDA and MAA submissions are advancing well.
  • The study design has been strengthened with an increased sample size.

Full Press Release Details

PolyPid Provides Corporate Update and Reports
First Quarter 2025 Financial Results
PolyPid Successfully
Completed Enrollment in Phase 3 SHIELD II Trial of D-PLEX , with Top-Line Results Anticipated in Current Quarter
Company Continues to
Advance Regulatory Submission Preparations, Commercial Launch Preparations and Partnering Discussions
Conference Call Scheduled for Today at 8:30
PETACH TIKVA, Israel, May
14, 2025 -- PolyPid Ltd. (Nasdaq: PYPD)
("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today provided
a corporate update and reported financial results for the three months ended March 31, 2025.
Recent Corporate Highlights:
track for a transformational year in 2025. We continue to view the SHIELD II Phase 3 trial as a derisked study. This assessment has been
further strengthened by the 800-patient sample size reassessment which helps 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", stated Dikla Czaczkes Akselbrad, PolyPid's Chief Executive Officer. "As we await the
top-line results from SHIELD II later this quarter, we continue to advance our preparations for NDA and MAA submissions in 2026. Moreover,
we continue to progress our commercial plans, as well as engage in partnership discussions with
multiple potential partners in the United States."
Financial results for three months ended March
Balance Sheet Highlights
Conference Call Dial-In & Webcast Information:
Date: Wednesday, May 14, 2025
Time: 8:30 AM Eastern Time
Conference Call: https://register-conf.media-server.com/register/BI326905131be34ceda978c4ff2ca7a54d
Webcast: https://edge.media-server.com/mmc/p/bqgwfbps
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.
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.
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 potential efficacy and benefits of D-PLEX100 and the probability of success
of the trial, that the current cash balance will be sufficient to fund the operations into the third quarter of 2025, the expected timing
for completion of enrollment of the SHIELD II trial, the expected timing for top-line results from the SHIELD II trial, potential NDA
and MAA submissions and the timing thereof, finalization of CMC and non-clinical modules,
potential clinical benefits of D-PLEX100, the potential to receive up to an additional $27.0 million from the exercise of the
warrants from the recent financing, Company's anticipation that with such additional funding,
PolyPid's runway would be extended beyond anticipated NDA approval, and the Company's potential strategic partnerships.
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 February 26, 2025. 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.
INTERIM CONDENSED CONSOLIDATED
U.S. dollars in thousands
March 31, December 31,
2025 2024
Unaudited Audited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 2,272 $ 15,641
Restricted deposits 165 168
Short-term deposits 5,767 -
Prepaid expenses and other current assets 568 764
Total current assets 8,772 16,573
LONG-TERM ASSETS:
Property and equipment, net 5,705 6,075
Operating lease right-of-use assets 2,088 2,295
Other long-term assets 284 277
Total long-term assets 8,077 8,647
Total assets $ 16,849 $ 25,220
INTERIM CONDENSED CONSOLIDATED
U.S. dollars in thousands (except share and
March 31, December 31,
2025 2024
Unaudited Audited
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables $ 2,016 $ 2,409
Accrued expenses and other current liabilities 2,967 2,566
Current maturities of long-term debt 6,498 6,787
Current maturities of operating lease liabilities 905 919
Total current liabilities 12,386 12,681
LONG-TERM LIABILITIES:
Long-term debt 381 634
Deferred revenues 2,548 2,548
Long-term operating lease liabilities 1,044 1,277
Other liabilities 404 396
Total long-term liabilities 4,377 4,855
SHAREHOLDERS' EQUITY:
Ordinary shares with no par value - Authorized: 107,800,000 shares at March 31, 2025 (unaudited) and December 31, 2024; Issued and outstanding: 10,190,904 shares at March 31, 2025 (unaudited) and December 31, 2024, respectively - -
Additional paid-in capital 275,685 275,015
Accumulated deficit (275,599 ) (267,331 )
Total shareholders' equity 86 7,684
Total liabilities and shareholders' equity $ 16,849 $ 25,220
INTERIM CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and
Three Months Ended March 31,
2025 2024
Unaudited
Operating expenses:
Research and development $ 6,117 $ 5,050
Marketing and business development 289 236
General and administrative 1,173 1,015
Operating loss 7,579 6,301
Financial expense, net 678 140
Loss before income tax 8,257 6,441
Income tax expense 11 7
Net loss $ 8,268 $ 6,448
Basic and diluted loss per ordinary share $ 0.70 $ 1.37
Weighted average number of ordinary shares used in computing basic and diluted loss per share 11,751,622 4,691,445

Frequently Asked Questions

What is the SHIELD II trial about?

The SHIELD II trial assesses the safety and efficacy of D-PLEX100 for preventing surgical site infections post-abdominal surgeries.

What is D-PLEX100's mechanism of action?

D-PLEX100 releases doxycycline locally at the surgical site to provide prolonged antibacterial activity.

When are top-line results for SHIELD II expected?

Top-line results from the SHIELD II trial are anticipated later this current quarter.

What recent designation did D-PLEX100 receive?

D-PLEX100 has received Breakthrough Therapy Designation from the FDA for preventing SSIs.

What are PolyPid's financial results for Q1 2025?

PolyPid reported a decrease in total assets to $16,849,000 for the three months ended March 31, 2025.

Last updated: May 14, 2025