Recent Updates
Recently added Catalysts
PYPD Positive Sentiment Score: 80/100

PolyPid Provides Corporate Update and Reports Second Quarter 2023 Financial Results Reached Agreement with U.S. FDA on Design of SHIELD II Phase 3 Trial E valuating D-PLEX 100 for the Prevention of Abdominal Colorectal S

Key Takeaway: PolyPid Ltd. has provided a corporate update and reported its financial results for the second quarter of 2023. The company has reached an agreement with the U.S. FDA on the design of its SHIELD II Phase 3 trial for D-PLEX100, aimed at preventing abdominal colorectal surgical site infections. Enrollment in the trial has resumed, with 20 centers expected to open by the end of the current quarter. Despite positive developments, the company reported a net loss of $11.9 million and highlighted ongoing challenges related to high operating expenses and the current economic environment.

Market Sentiment Analysis

POSITIVE FACTORS

  • Agreement with the FDA on the SHIELD II trial design is a significant milestone.
  • Resumption of enrollment in a multinational Phase 3 trial showcases progress.
  • Cost containment efforts have led to over $1 million in savings.
  • Anticipation of increased enrollment with 20 centers opening soon.

CONCERNS & RISKS

  • Still experiencing financial losses, with a net loss of $11.9 million reported.
  • Operating expenses remain high despite cost-saving measures.
  • Continued uncertainties associated with clinical trial outcomes.
  • The inflationary environment poses ongoing challenges for financial stability.

Full Press Release Details

PolyPid Provides Corporate Update and Reports
Second Quarter 2023 Financial Results
Reached Agreement with U.S. FDA on Design of
SHIELD II Phase 3 Trial Evaluating D-PLEX100 for the Prevention of Abdominal Colorectal
Surgical Site Infections
Resumed Recruitment into SHIELD II Phase 3 Trial
Total of 20 centers in U.S., Europe and Israel
Expected to be Opened by End of Current Quarter
Conference Call Scheduled for Today at 8:30
PETACH TIKVA, Israel,
August 9, 2023 -- 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 and six months ended June 30, 2023.
Recent Corporate Highlights:
our agreement with the FDA on the design of the SHIELD II Phase 3 trial and the
subsequent resumption of the trial, our promising lead product candidate, D-PLEX100, is advancing as planned in the clinic,"
stated Dikla Czaczkes Akselbrad, PolyPid's Chief Executive Officer. "As we expect to have 20 centers open by the end of the
current quarter, we anticipate that the rate of enrollment will increase rapidly."
we are beginning to see the impact of our cost containment efforts," continued Ms. Czaczkes Akselbrad. "Despite a challenging
inflationary environment, we have generated over $1 million in cost savings year-to-date, and our net cash used in operating activities
decreased by 59% in the first six months of the year as compared to the first six months of 2022."
Financial results for three months ended June
Financial results for six months ended June
Balance Sheet Highlights
Conference Call Dial-In & Webcast Information:
Date: Wednesday, August 9, 2023
Time: 8:30 AM Eastern Time
Q&A Participants: https://register.vevent.com/register/BIdd3e958085d54167a5e9a8d8a59daff3
Webcast: https://edge.media-server.com/mmc/p/82gmauqc
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.
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
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 its expectation to have 20 centers open in U.S., Europe and Israel by the end
of the current quarter and its anticipation that the rate of enrollment will increase rapidly thereafter, the timing of the unblinded
interim analysis, total recruitment time into the trial and top-line results, D-PLEX100 's potential
as an effective prophylactic drug against the most prevalent bacteria causing surgical site infections and the expected benefits from
cost containment efforts. 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
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
June 30, December 31,
2023 2022
Unaudited Audited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 3,396 $ 8,552
Short-term deposits 11,710 4,042
Restricted deposits 503 511
Prepaid expenses and other current assets 144 1,089
Total current assets 15,753 14,194
LONG-TERM ASSETS:
Property and equipment, net 8,529 9,247
Operating lease right-of-use assets 1,892 2,431
Other long-term assets 89 99
Total long-term assets 10,510 11,777
Total assets $ 26,263 $ 25,971
INTERIM CONDENSED CONSOLIDATED
U.S. dollars in thousands (except share
June 30, December 31,
2023 2022
Unaudited Audited
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Current maturities of long-term debt $ 2,068 $ 4,024
Accrued expenses and other current liabilities 1,842 2,429
Trade payables 903 1,141
Current maturities of operating lease liabilities 638 959
Total current liabilities 5,451 8,553
LONG-TERM LIABILITIES:
Long-term debt 8,538 7,574
Deferred revenues 2,548 2,548
Long-term operating lease liabilities 933 1,173
Other liabilities 446 294
Total long-term liabilities 12,465 11,589
COMMITMENTS AND CONTINGENT LIABILITIES
SHAREHOLDERS' EQUITY:
Ordinary shares with no par value - Authorized: 107,800,000 and 47,800,000 shares at June 30, 2023 (unaudited) and December 31, 2022, respectively; Issued and outstanding: 49,048,703 and 19,851,833 shares at June 30, 2023 (unaudited) and December 31, 2022, respectively - -
Additional paid-in capital 234,696 220,273
Accumulated deficit (226,349 ) (214,444 )
Total shareholders' equity 8,347 5,829
Total liabilities and shareholders' equity $ 26,263 $ 25,971
INTERIM CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and
Six Months Ended Three Months Ended
June 30, June 30,
2023 2022 2023 2022
Operating expenses:
Research and development, net $ 7,754 $ 17,095 $ 3,960 $ 8,398
Marketing and business development 742 1,698 357 923
General and administrative 3,112 4,723 1,503 2,243
Operating loss 11,608 23,516 5,820 11,564
Financial expense , net 262 203 7 281
Loss before income tax 11,870 23,719 5,827 11,845
Income tax expenses 35 - 10 -
Net loss $ 11,905 $ 23,719 $ 5,837 $ 11,845
Basic and diluted loss per ordinary share $ 0.36 $ 1.23 $ 0.13 $ 0.61
Weighted average number of ordinary shares used in computing basic and diluted loss per share 32,910,446 19,222,423 44,383,474 19,505,246

Frequently Asked Questions

What is the SHIELD II Phase 3 trial?

The SHIELD II Phase 3 trial evaluates D-PLEX100 for preventing abdominal surgical site infections.

How many centers are participating in the SHIELD II trial?

The trial will involve a total of 20 centers located in the U.S., Europe, and Israel.

What has been PolyPid's financial performance in 2023?

PolyPid reported a 59% decrease in net cash used in operating activities compared to 2022.

What is D-PLEX100 used for?

D-PLEX100 is a lead product candidate aimed at preventing abdominal colorectal surgical site infections.

When is the PolyPid conference call scheduled?

The conference call is scheduled for August 9, 2023, at 8:30 AM Eastern Time.

Last updated: Aug 9, 2023