Full Press Release Details
PolyPid Provides Corporate Update and Reports
Fourth Quarter and Full Year 2022 Financial Results
Positive Communication with the FDA, Regulatory
Pathway Clarified for D-PLEX100 for Prevention of Abdominal Colorectal
Surgical Site Infections
Expects to Resume Patient Recruitment in Q2 2023 into Ongoing SHIELD II Trial, which will be Enriched with Approximately 550 Additional
Patients to Complete Clinical Testing for Potential NDA
Results from SHIELD II Trial Anticipated mid-2024
Conference Call Scheduled for Today at 8:30
PETACH TIKVA, Israel, February
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 months and full year ended December 31, 2022.
Recent Corporate Highlights:
"We are thrilled to now
have a clear regulatory pathway to possible approval of D-PLEX100 in the U.S. following confirmation from the FDA
that the ongoing SHIELD II trial can potentially be used to complete our clinical
testing," stated Dikla Czaczkes Akselbrad, PolyPid's
Chief Executive Officer. "Importantly, the ability to leverage the SHIELD II study will significantly reduce the time and resources
needed to finalize the clinical study as compared to having to initiate a new trial. We look forward to resuming patient recruitment in
the second quarter."
"We view SHIELD II as a
de-risked Phase 3 trial given the more focused patient population with large incisions in which we have already generated highly positive
data in SHIELD I, and the fact that it will not be conducted within tight COVID-related restrictions," continued Ms. Czaczkes Akselbrad.
"The recruitment of the additional 550 patients into SHIELD II is expected to take approximately 12 months and the top-line
results are anticipated in mid-2024."
Financial results for three months ended December
Financial results for the full year ended December
Balance Sheet Highlights
Conference Call Dial-In & Webcast Information:
| Date: | Wednesday, February 8, 2023 |
| Time: | 8:30 AM Eastern Time |
| Q&A Participants: | https://register.vevent.com/register/BIdad8bd318dec4d3cb9437ab9c40bd263 |
| Webcast: | https://edge.media-server.com/mmc/p/rak4fxxm |
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), 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 trials 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 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 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 regulatory pathway for the potential NDA submission for D-PLEX100, including
the potential of the SHIELD I results and SHIELD II study to provide support, the timing of resumption, completion of patient recruitment
and top-line results of the revised SHIELD II study, and the timing of the unblinded analysis thereof, and the Company's expectations
regarding its 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 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
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 (except share
| December 31, | ||||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 8,552 | $ | 9,819 | ||||
| Restricted cash | 511 | 397 | ||||||
| Short-term deposits | 4,042 | 22,384 | ||||||
| Prepaid expenses and other current assets | 1,089 | 2,211 | ||||||
| Total current assets | 14,194 | 34,811 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 9,247 | 8,761 | ||||||
| Operating lease right-of-use assets | 2,431 | - | ||||||
| Other long-term assets | 99 | 663 | ||||||
| Total long-term assets | 11,777 | 9,424 | ||||||
| Total assets | $ | 25,971 | $ | 44,235 |
The accompanying notes are an integral part of
the consolidated financial statements.
U.S. dollars in thousands (except share
| December 31, | ||||||||
| 2022 | 2021 | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current maturities of long-term debt | $ | 4,024 | $ | - | ||||
| Accrued expenses and other current liabilities | 2,517 | 3,940 | ||||||
| Trade payables | 1,141 | 4,136 | ||||||
| Current maturities of operating lease liabilities | 959 | - | ||||||
| Total current liabilities | 8,641 | 8,076 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term debt | 7,574 | - | ||||||
| Deferred revenues | 2,548 | - | ||||||
| Long-term operating lease liabilities | 1,173 | - | ||||||
| Other liabilities | 174 | 199 | ||||||
| Total long-term liabilities | 11,469 | 199 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Ordinary shares with no par value - Authorized: 47,800,000 shares at December 31, 2022 and 2021; Issued and outstanding: 19,851,833 and 18,756,570 shares at December 31, 2022 and 2021, respectively | - | - | ||||||
| Additional paid-in capital | 220,273 | 210,847 | ||||||
| Accumulated deficit | (214,412 | ) | (174,887 | ) | ||||
| Total shareholders' equity | 5,861 | 35,960 | ||||||
| Total liabilities and shareholders' equity | $ | 25,971 | $ | 44,235 |
The accompanying notes are an integral part of
the consolidated financial statements.
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share
| Year Ended December 31, | ||||||||||||
| 2022 | 2021 | 2020 | ||||||||||
| Operating expenses: | ||||||||||||
| Research and development, net | $ | 27,990 | $ | 30,553 | $ | 16,954 | ||||||
| Marketing and business development | 2,888 | 2,983 | 1,614 | |||||||||
| General and administrative | 8,010 | 9,609 | 7,704 | |||||||||
| Operating loss | 38,888 | 43,145 | 26,272 | |||||||||
| Financial (income) expense, net | 540 | (544 | ) | 10,597 | ||||||||
| Loss before income tax | 39,428 | 42,601 | 36,869 | |||||||||
| Income tax expense | 97 | - | - | |||||||||
| Net loss | 39,525 | 42,601 | 36,869 | |||||||||
| Deemed dividend | - | - | 2,114 | |||||||||
| Net loss attributable to Ordinary shares | $ | 39,525 | $ | 42,601 | $ | 38,983 | ||||||
| Basic and diluted net loss per Ordinary share | $ | 2.03 | $ | 2.28 | $ | 4.48 | ||||||
| Weighted average number of Ordinary shares used in computing basic and diluted loss per share | 19,426,692 | 18,721,528 | 9,582,405 |
The accompanying notes are an integral part of
the consolidated financial statements.
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
| Three Months Ended December 31, | ||||||||
| 2022 | 2021 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Operating expenses: | ||||||||
| Research and development, net | $ | 4,655 | $ | 9,617 | ||||
| Marketing and business development expenses | 350 | 1,147 | ||||||
| General and administrative | 1,607 | 2,890 | ||||||
| Operating loss | 6,612 | 13,654 | ||||||
| Financial income, net | 100 | 152 | ||||||
| Loss before income tax | 6,512 | 13,502 | ||||||
| Income tax expense | 23 | - | ||||||
| Net loss attributable to Ordinary shares | $ | 6,535 | $ | 13,502 | ||||
| Basic and Diluted loss per Ordinary share | $ | 0.32 | $ | 0.72 | ||||
| Weighted average number of Ordinary shares used in computing basic and diluted loss per share | 19,658,048 | 18,756,570 |