Full Press Release Details
PolyPid Provides Corporate Update and Reports
Third Quarter 2023 Financial Results
Currently Open with Approximately 40 Expected by End of 2023 in SHIELD II Phase 3 Trial Evaluating D-PLEX100 for the Prevention
of Abdominal Colorectal Surgical Site Infections
Completed Production and Release of Three
Process Validation Batches of D-PLEX100
Successful Completion of Good Manufacturing
Practice Audit of Company's Manufacturing Facility
Conference Call Scheduled for Today at 8:30
PETACH TIKVA, Israel,
November 8, 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 nine months ended September 30, 2023.
Recent Corporate Highlights:
ongoing SHIELD II Phase 3 trial for our promising lead product candidate, D-PLEX100, is progressing as anticipated,"
stated Dikla Czaczkes Akselbrad, PolyPid's Chief Executive Officer. "We currently have 20 centers open, many of which have
just recently begun recruiting patients, and we expect enrollment to ramp-up shortly. We anticipate having approximately 40 centers open
by the end of 2023. Importantly, we continue to expect top-line results from SHIELD II in second half of 2024."
"While we focus on enrollment into SHIELD
II, we have also recently achieved several key D-PLEX100 manufacturing-related milestones that have helped evolve PolyPid
into a fully-integrated biopharmaceutical company," continued Ms. Czaczkes Akselbrad. "First, we successfully completed the
production and release of three process validation batches of D-PLEX100, thus completing a substantial requirement toward
our planned submission of D-PLEX100's New Drug Application and EU Marketing Authorization Application regulatory filings.
In addition, a successful Good Manufacturing Practice audit of our manufacturing facility was completed without any critical or major
findings, and the Company can now produce D-PLEX100 at scale to meet the expected commercial demand for the product."
As to the current situation in Israel, our
immediate focus is to support our employees and their families while staying focused on running the business. As
of today, there has been no material impact on our operations and business activity.
Financial results for three months ended September
Financial results for nine months ended September
Balance Sheet Highlights
Conference Call Dial-In & Webcast Information:
| Date: | Wednesday, November 8, 2023 | |
| Time: | 8:30 AM Eastern Time | |
| Q&A Participants: | https://register.vevent.com/register/BIbd0a9baa57b1427e809302152ba58bd3 | |
| Webcast: | https://edge.media-server.com/mmc/p/r9ot5d24 |
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 surgical site infections (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 open abdominal colorectal
surgery with large incisions (>20cm).
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
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 number of centers expected to open by the end of 2023,
the expected timing of top-line data, the planned submission of a New Drug Application and EU Marketing Authorization Application regulatory
filings, potential commercial demand for D-PLEX100 and the expected sufficiency of the Company's cash balance. 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 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.
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| September 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 1,353 | $ | 8,552 | ||||
| Short-term deposits | 8,801 | 4,042 | ||||||
| Restricted cash | 495 | 511 | ||||||
| Prepaid expenses and other current assets | 473 | 1,089 | ||||||
| Total current assets | 11,122 | 14,194 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 8,077 | 9,247 | ||||||
| Operating lease right-of-use assets | 1,632 | 2,431 | ||||||
| Other long-term assets | 101 | 99 | ||||||
| Total long-term assets | 9,810 | 11,777 | ||||||
| Total assets | $ | 20,932 | $ | 25,971 |
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and
| September 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current maturities of long-term debt | $ | 2,859 | $ | 4,024 | ||||
| Accrued expenses and other current liabilities | 2,024 | 2,429 | ||||||
| Trade payables | 529 | 1,141 | ||||||
| Current maturities of operating lease liabilities | 486 | 959 | ||||||
| Total current liabilities | 5,898 | 8,553 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term debt | 7,665 | 7,574 | ||||||
| Deferred revenues | 2,548 | 2,548 | ||||||
| Long-term operating lease liabilities | 832 | 1,173 | ||||||
| Other liabilities | 451 | 294 | ||||||
| Total long-term liabilities | 11,496 | 11,589 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Ordinary shares with no par value - | ||||||||
| Authorized: 107,800,000 and 47,800,000 shares at September 30, 2023 (unaudited) and December 31, 2022, respectively; Issued and outstanding: 1,653,559 and 669,605 shares at September 30, 2023 (unaudited) and December 31, 2022, respectively *) | - | - | ||||||
| Additional paid-in capital | 235,491 | 220,273 | ||||||
| Accumulated deficit | (231,953 | ) | (214,444 | ) | ||||
| Total shareholders' equity | 3,538 | 5,829 | ||||||
| Total liabilities and shareholders' equity | $ | 20,932 | $ | 25,971 |
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and
| Nine Months Ended | Three Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net | $ | 11,560 | $ | 23,335 | $ | 3,806 | $ | 6,240 | ||||||||
| Marketing and business development | 1,003 | 2,538 | 261 | 840 | ||||||||||||
| General and administrative | 4,305 | 6,403 | 1,193 | 1,680 | ||||||||||||
| Operating loss | 16,868 | 32,276 | 5,260 | 8,760 | ||||||||||||
| Financial expense, net | 581 | 640 | 319 | 437 | ||||||||||||
| Loss before income tax | 17,449 | 32,916 | 5,579 | 9,197 | ||||||||||||
| Income tax expenses | 60 | 74 | 25 | 74 | ||||||||||||
| Net loss | $ | 17,509 | $ | 32,990 | $ | 5,604 | $ | 9,271 | ||||||||
| Basic and diluted loss per ordinary share *) | $ | 13.59 | $ | 51.15 | $ | 3.40 | $ | 14.19 | ||||||||
| Weighted average number of ordinary shares used in computing basic and diluted loss per share | 1,288,678 | 644,958 | 1,650,259 | 653,240 |