Full Press Release Details
Provides Corporate Update and Reports Second Quarter 2022 Financial Results
TIKVA, Israel, August
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, 2022.
Corporate Highlights:
we rapidly approach top-line results for SHIELD I, which are anticipated by the end of the current quarter, PolyPid is in the strongest
operational and financial position that it has ever been in," stated Dikla Czaczkes Akselbrad, PolyPid's Chief Executive
Officer. "Our recent licensing agreement with ADVANZ PHARMA to commercialize D-PLEX100 in the European markets supports
the significant commercial potential of this promising therapy, represents substantial value for PolyPid and further validates our unique
technology platform. This agreement is the first step in our transformation from a pure research & development company to a commercial
results for three months ended June 30, 2022
results for six months ended June 30, 2022
Call Dial-In & Webcast Information:
| Date: | Wednesday, August 10, 2022 | |
| Time: | 8:30 AM Eastern Time | |
| Q&A Participants: | https://register.vevent.com/register/BI985b31488d2141f99e4e9db5d66810fd | |
| Webcast: | https://edge.media-server.com/mmc/p/itwzz9g3 |
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
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.
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.
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 timing of top-line results from the SHIELD-I study and potential NDA submission and MAA filing, potential milestone payments
under the license agreement with ADVANZ PHARMA, the strength of its financial position and its expectation that its cash balance, together
with the upfront payment from ADVANZ PHARMA and the proceeds from the Kreos loan, will be sufficient to fund operations through the end
of 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
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.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 11,640 | $ | 9,819 | ||||
| Restricted cash | 576 | 397 | ||||||
| Short-term deposits | 12,139 | 22,384 | ||||||
| Prepaid expenses and other current assets | 661 | 2,211 | ||||||
| Total current assets | 25,016 | 34,811 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 9,183 | 8,761 | ||||||
| Other long-term assets | 618 | 663 | ||||||
| Total long-term assets | 9,801 | 9,424 | ||||||
| Total assets | $ | 34,817 | $ | 44,235 |
accompanying notes are an integral part of the interim condensed consolidated financial statements.
CONDENSED CONSOLIDATED BALANCE SHEETS
dollars in thousands (except share and per share data)
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current maturities of long-term debt | $ | 2,168 | $ | - | ||||
| Trade payables | 2,430 | 4,136 | ||||||
| Accrued expenses and other current liabilities | 4,106 | 3,940 | ||||||
| Total current liabilities | 8,704 | 8,076 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term debt | 6,919 | - | ||||||
| Other liabilities | 84 | 199 | ||||||
| Total long-term liabilities | 7,003 | 199 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Ordinary shares with no par value - Authorized: 47,800,000 shares at June 30, 2022 (unaudited) and December 31, 2021 (audited); Issued and outstanding: 19,551,173 and 18,756,570 shares at June 30, 2022 (unaudited) and December 31, 2021 (audited), respectively | - | - | ||||||
| Additional paid-in capital | 217,716 | 210,847 | ||||||
| Accumulated deficit | (198,606 | ) | (174,887 | ) | ||||
| Total shareholders' equity | 19,110 | 35,960 | ||||||
| Total liabilities and shareholders' equity | $ | 34,817 | $ | 44,235 |
accompanying notes are an integral part of the interim condensed consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
dollars in thousands (except share and per share data)
| Six Months Ended | Three Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net | $ | 17,095 | $ | 13,460 | $ | 8,398 | $ | 7,442 | ||||||||
| Marketing and business development | 1,698 | 1,391 | 923 | 739 | ||||||||||||
| General and administrative | 4,723 | 4,576 | 2,243 | 2,449 | ||||||||||||
| Operating loss | 23,516 | 19,427 | 11,564 | 10,630 | ||||||||||||
| Financial expense (income), net | 203 | (263 | ) | 281 | (153 | ) | ||||||||||
| Loss | $ | 23,719 | $ | 19,164 | $ | 11,845 | $ | 10,477 | ||||||||
| Basic and diluted loss per Ordinary share | $ | 1.23 | $ | 1.03 | $ | 0.61 | $ | 0.56 | ||||||||
| Weighted average number of Ordinary shares used in computing basic and diluted loss per share | 19,222,423 | 18,685,906 | 19,505,246 | 18,747,967 |
accompanying notes are an integral part of the interim condensed consolidated financial statements.