Full Press Release Details
PolyPid Provides Corporate Update and Reports
First Quarter 2022 Financial Results
Planned Unblinded Interim Analysis of Phase 3 SHIELD I Trial of D-PLEX100 in
Abdominal Soft Tissue Surgery Expected to Occur Imminently
Recruitment Progressing as Planned with Approximately 900 Patients Enrolled into Phase 3
SHIELD I Trial of D-PLEX100 in Abdominal Soft Tissue Surgery
Extended Cash Runway into the Second Quarter of 2023 with $15 million
Non-Dilutive Secured Term Loan Facility
Strengthened Executive Management Team
Conference Call Scheduled for Today at 8:30 AM ET
TIKVA, Israel, May 11, 2022 -- 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
Recent Corporate Highlights:
"We are thrilled with the significant momentum
throughout all aspects of our business," stated Amir Weisberg, PolyPid's Chief Executive Officer. "We now have approximately
900 patients enrolled into SHIELD I, and we expect that the planned unblinded interim analysis in the study will occur very shortly, providing
an exceptional opportunity for PolyPid to determine the patient enrollment target".
"The appointment of Evgeny to oversee our
technical operations and the promotion of Dalit to a senior role within our clinical development function further strengthens our commercial
readiness and enhances our clinical development organization," added Mr. Weisberg.
Dikla Czaczkes Akselbrad, Executive Vice President and Chief Financial
Officer of PolyPid, stated, "The secured loan agreement we recently entered into for up to $15
million will be used to support commercialization preparations for the launch of D-PLEX100 for
the prevention of abdominal soft tissue SSIs, as well as further advancement of our unique PLEX technology platform. Importantly,
our cash runway now extends into the second quarter of 2023."
Financial results for three months ended March
Balance Sheet Highlights
Conference Call Dial-In & Webcast Information:
| Date: | Wednesday, May 11, 2022 |
| Time: | 8:30 AM Eastern Time |
| United States: | +1 877-870-9135 |
| Israel: | +972 1809 213-985 |
| International: | +44 (0) 2071 928338 |
| Conference ID: | 3450787 |
| Webcast: | https://edge.media-server.com/mmc/p/djs2mjt6 |
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 soft tissue abdominal and sternal bone surgical site infections. In addition, the Company
is currently in preclinical stages to test the efficacy of OncoPLEX for treatment of solid tumors. For additional Company information,
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 ongoing clinical trials, its expectations regarding the unblinded interim
analysis in SHIELD I and its timing, that interim analysis could allow for an early trial
stopping, its expectation that the planned interim analysis will provide an exceptional opportunity to determine the
patient enrollment target, the pace of enrollment in SHIELD I trial, its use of proceeds from the Kreos loan, commercialization
preparations for the launch of D-PLEX100 for the prevention of abdominal soft tissue SSIs, extension of the Company's
cash runway into the second quarter of 2023 and its expectation that its cash balance, together with the proceeds from the Kreos loan,
will be sufficient to fund operations into the second quarter of 2023. 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.
Dikla Czaczkes Akselbrad
Tel: +972-74-719-5700
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| March 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 11,434 | $ | 9,819 | ||||
| Restricted cash | 393 | 397 | ||||||
| Short-term deposits | 12,187 | 22,384 | ||||||
| Prepaid expenses and other current assets | 1,478 | 2,211 | ||||||
| Total current assets | 25,492 | 34,811 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 9,338 | 8,761 | ||||||
| Other long-term assets | 651 | 663 | ||||||
| Total long-term assets | 9,989 | 9,424 | ||||||
| Total assets | $ | 35,481 | $ | 44,235 |
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| March 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 3,214 | $ | 4,136 | ||||
| Accrued expenses and other current liabilities | 3,227 | 3,940 | ||||||
| Total current liabilities | 6,441 | 8,076 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Other liabilities | 195 | 199 | ||||||
| Total long-term liabilities | 195 | 199 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Ordinary shares with no par value - Authorized: 47,800,000 shares at March 31, 2022 (unaudited) and December 31, 2021; Issued and outstanding: 19,470,757 and 18,756,570 shares at March 31, 2022 (unaudited) and December 31, 2021, respectively | - | - | ||||||
| Additional paid-in capital | 215,606 | 210,847 | ||||||
| Accumulated deficit | (186,761 | ) | (174,887 | ) | ||||
| Total shareholders' equity | 28,845 | 35,960 | ||||||
| Total liabilities and shareholders' equity | $ | 35,481 | $ | 44,235 |
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and
| Three Months Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Unaudited | ||||||||
| Operating expenses: | ||||||||
| Research and development, net | $ | 8,697 | $ | 6,018 | ||||
| Marketing and business development | 775 | 652 | ||||||
| General and administrative | 2,480 | 2,127 | ||||||
| Operating loss | 11,952 | 8,797 | ||||||
| Financial income, net | 78 | 110 | ||||||
| Loss | $ | 11,874 | $ | 8,687 | ||||
| Basic and diluted loss per Ordinary share | $ | 0.63 | $ | 0.47 | ||||
| Weighted average number of Ordinary shares used in computing basic and diluted loss per share | 18,936,457 | 18,623,154 |