Full Press Release Details
Provides Corporate Update and Reports Third Quarter 2022 Financial Results
Company Intends to Meet with U.S. and EU Regulatory Authorities to Discuss Data from SHIELD I Phase 3 Study and Regulatory Pathway for D-PLEX100 in First Quarter of 2023
Implemented a Cost Reduction Plan, Including a 20% Decrease in Headcount Across All Departments
Conference Call Scheduled for Today at 8:30 AM ET
TIKVA, Israel, November
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,
Corporate Highlights:
the top-line results were announced, we have continued to gather and analyze additional data from SHIELD I," stated Dikla
Czaczkes Akselbrad, PolyPid's Chief Executive Officer. "These data have been increasingly
encouraging. While SHIELD I did not meet its primary endpoint, the significant reduction in SSIs in complex surgeries with
large incisions and in high-risk patients, as well as the safety data, are very compelling.
As such, we are in the process of preparing a comprehensive package of D-PLEX100 data for a planned meeting with the U.S.
Food and Drug Administration (FDA). We expect to meet the FDA and EU regulatory authorities regarding the regulatory pathway for D-PLEX100 in
the first quarter of 2023."
parallel to preparing for these important regulatory interactions, we recently implemented a cost reduction plan, including a 20% decrease
in headcount across all departments," continued Ms. Czaczkes
Akselbrad. "We expect that these significant measures will extend our cash runway into the
third quarter of 2023 in support of the Company's long-term growth strategy."
results for three months ended September 30, 2022
results for nine months ended September 30, 2022
Call Dial-In & Webcast Information:
| Date: | Wednesday, November 9, 2022 |
| Time: | 8:30 AM Eastern Time |
| Q&A Participants: | https://register.vevent.com/register/BI5e06285152a24249a0330f025cefc01e |
| Webcast: | https://edge.media-server.com/mmc/p/c6nr79zi |
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 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.
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 and the increasing encouragement from data analysis of the SHIELD I study outcome, its
expectation to extend the Company's available cash into the third quarter of 2023, its intention to meet with U.S. and EU
regulatory authorities to discuss data from SHIELD I Phase 3 study and regulatory
pathway for D-PLEX100 in first quarter of 2023 and the potential safety and efficacy of D-PLEX100.
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 statements.
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
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 16,108 | $ | 9,819 | ||||
| Restricted cash | 394 | 397 | ||||||
| Short-term deposits | 2,003 | 22,384 | ||||||
| Prepaid expenses and other current assets | 1,297 | 2,211 | ||||||
| Total current assets | 19,802 | 34,811 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 8,976 | 8,761 | ||||||
| Other long-term assets | 603 | 663 | ||||||
| Total long-term assets | 9,579 | 9,424 | ||||||
| Total assets | $ | 29,381 | $ | 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)
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current maturities of long-term debt | $ | 3,132 | $ | - | ||||
| Trade payables | 1,031 | 4,136 | ||||||
| Accrued expenses and other current liabilities | 2,722 | 3,940 | ||||||
| Total current liabilities | 6,885 | 8,076 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term debt | 8,354 | - | ||||||
| Deferred revenues | 2,548 | - | ||||||
| Other liabilities | 91 | 199 | ||||||
| Total long-term liabilities | 10,993 | 199 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Ordinary shares with no par value - Authorized: 47,800,000 shares at September 30, 2022 (unaudited) and December 31, 2021 (audited); Issued and outstanding: 19,655,608 and 18,756,570 shares at September 30, 2022 (unaudited) and December 31, 2021 (audited), respectively | - | - | ||||||
| Additional paid-in capital | 219,380 | 210,847 | ||||||
| Accumulated deficit | (207,877 | ) | (174,887 | ) | ||||
| Total shareholders' equity | 11,503 | 35,960 | ||||||
| Total liabilities and shareholders' equity | $ | 29,381 | $ | 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)
| Nine Months Ended | Three Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net | $ | 23,335 | $ | 20,936 | $ | 6,240 | $ | 7,476 | ||||||||
| Marketing and business development | 2,538 | 1,836 | 840 | 445 | ||||||||||||
| General and administrative | 6,403 | 6,719 | 1,680 | 2,143 | ||||||||||||
| Operating loss | 32,276 | 29,491 | 8,760 | 10,064 | ||||||||||||
| Financial expense (income), net | 640 | (392 | ) | 437 | (129 | ) | ||||||||||
| Net loss before income tax | 32,916 | 29,099 | 9,197 | 9,935 | ||||||||||||
| Income tax expense | 74 | - | 74 | - | ||||||||||||
| Net loss | $ | 32,990 | $ | 29,099 | $ | 9,271 | $ | 9,935 | ||||||||
| Basic and diluted loss per Ordinary share | $ | 1.71 | $ | 1.56 | $ | 0.48 | $ | 0.53 | ||||||||
| Weighted average number of Ordinary shares used in computing basic and diluted loss per share | 19,348,725 | 18,709,719 | 19,597,212 | 18,756,570 |
accompanying notes are an integral part of the interim condensed consolidated financial statements.