Full Press Release Details
Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results
Than 100 Patients Enrolled in Ongoing SHIELD II Phase 3 Trial of D-PLEX100 for the Prevention of Abdominal Colorectal
Surgical Site Infections
Interim Analysis to be Conducted Once Approximately 400 Patients Complete Their 30-Day Follow-up;
Top-line Results Expected in Second
New Preclinical Data Showed OncoPLEX
Injected Intratumorally Reduced Tumor Volume and Improved Survival in New Animal Models
Successful $16 Million Financing Extends Company's Cash Runway Through Late Third Quarter 2024 and Beyond Expected Timing of Unblinded
Interim Analysis; Potential Additional $19 Million if Warrants are Exercised to Fund PolyPid to the Start of a Planned
New Drug Application Submission for D-PLEX100
Call Scheduled for Today at 8:30 AM ET
TIKVA, Israel, February
14, 2024 - 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, 2023.
Corporate Highlights:
are thrilled with the significant progress recently achieved throughout our business," stated Dikla Czaczkes Akselbrad, PolyPid's
Chief Executive Officer. "As we expected, enrollment in our ongoing SHIELD II Phase 3 pivotal trial for D-PLEX100 has
begun to ramp up, and we continue to anticipate top-line results from this study in the second half of 2024. We have also generated new
highly compelling preclinical data with OncoPLEX that demonstrate its potential in oncology and beyond."
in order to support our robust clinical development efforts, we successfully completed a $16 million financing that included participation
from multiple new U.S. life sciences-focused investors," continued Ms. Czaczkes Akselbrad. "Importantly, we also have the
potential to secure an additional $19 million if the warrants associated with this transaction are exercised, which would fund PolyPid
to the start of a planned New Drug Application submission for D-PLEX100."
results for three months ended December 31, 2023
results for the full year ended December 31, 2023
Call Dial-In & Webcast Information:
| Date: | Wednesday, February 14, 2024 |
| Time: | 8:30 AM Eastern Time |
| Q&A Participants: | https://register.vevent.com/register/BI8900a42f492b4240a3bba8285558d15f |
| Webcast: | https://edge.media-server.com/mmc/p/7iigty2s |
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 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 the expected timing for top-line results from
the SHIELD II trial and of the unblinded interim analysis, the planned NDA submission for
D-PLEX100, the potential impacts and uses for OncoPLEX and the PLEX platform,
the Company's expected cash runway, and the potential to receive additional funds if warrants are exercised. 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 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.
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.
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 5,309 | $ | 8,552 | ||||
| Restricted deposits | 300 | 511 | ||||||
| Short-term deposits | - | 4,042 | ||||||
| Prepaid expenses and other current assets | 458 | 1,089 | ||||||
| Total current assets | 6,067 | 14,194 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 7,621 | 9,247 | ||||||
| Operating lease right-of-use assets | 1,597 | 2,431 | ||||||
| Other long-term assets | 87 | 99 | ||||||
| Total long-term assets | 9,305 | 11,777 | ||||||
| Total assets | $ | 15,372 | $ | 25,971 |
in thousands (except share and per share data)
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| (Unaudited) | ||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current maturities of long-term debt | $ | 4,003 | $ | 4,024 | ||||
| Accrued expenses and other current liabilities | 1,971 | 2,429 | ||||||
| Trade payables | 772 | 1,141 | ||||||
| Current maturities of operating lease liabilities | 540 | 959 | ||||||
| Total current liabilities | 7,286 | 8,553 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term debt | 6,379 | 7,574 | ||||||
| Deferred revenues | 2,548 | 2,548 | ||||||
| Long-term operating lease liabilities | 857 | 1,173 | ||||||
| Other liabilities | 398 | 294 | ||||||
| Total long-term liabilities | 10,182 | 11,589 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Ordinary shares, no par value *)- Authorized: 107,800,000 and 47,800,000 shares at December 31, 2023 and 2022, respectively; Issued and outstanding: 1,653,559 and 669,605 shares at December 31, 2023 and 2022, respectively | - | - | ||||||
| Additional paid-in capital | 236,213 | 220,273 | ||||||
| Accumulated deficit | (238,309 | ) | (214,444 | ) | ||||
| Total shareholders' equity (deficit) | (2,096 | ) | 5,829 | |||||
| Total liabilities and shareholders' equity (deficit) | $ | 15,372 | $ | 25,971 |
STATEMENTS OF OPERATIONS
in thousands (except share and per share data)
| Year Ended December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| (Unaudited) | ||||||||||||
| Operating expenses: | ||||||||||||
| Research and development, net | $ | 16,148 | $ | 27,990 | $ | 30,553 | ||||||
| Marketing and business development | 1,196 | 2,888 | 2,983 | |||||||||
| General and administrative | 5,523 | 8,010 | 9,609 | |||||||||
| Operating loss | 22,867 | 38,888 | 43,145 | |||||||||
| Financial (income) expense, net | 929 | 540 | (544 | ) | ||||||||
| Loss before income tax | 23,796 | 39,428 | 42,601 | |||||||||
| Income tax expense | 69 | 129 | - | |||||||||
| Net loss | $ | 23,865 | $ | 39,557 | $ | 42,601 | ||||||
| Loss per share: | ||||||||||||
| Basic | $ | 16.99 | $ | 61.09 | $ | 68.27 | ||||||
| Diluted | $ | 16.93 | $ | 61.09 | $ | 68.27 | ||||||
| Weighted-average Ordinary shares outstanding: | ||||||||||||
| Basic | 1,404,368 | 647,556 | 624,051 | |||||||||
| Diluted | 1,421,308 | 647,556 | 624,051 |
STATEMENTS OF OPERATIONS
in thousands (except share and per share data)
| Three Months Ended December 31, | ||||||||
| 2023 | 2022 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Operating expenses: | ||||||||
| Research and development, net | $ | 4,588 | $ | 4,655 | ||||
| Marketing and business development expenses | 193 | 350 | ||||||
| General and administrative | 1,218 | 1,607 | ||||||
| Operating loss | 5,999 | 6,612 | ||||||
| Financial expense (income), net | 348 | (100 | ) | |||||
| Loss before income tax | 6,347 | 6,512 | ||||||
| Income tax expense | 9 | 55 | ||||||
| Net loss | $ | 6,356 | $ | 6,567 | ||||
| Loss per share: | ||||||||
| Basic | $ | 3.84 | $ | 9.90 | ||||
| Diluted | $ | 3.97 | $ | 9.90 | ||||
| Weighted average number of Ordinary shares used in computing basic and diluted loss per share | 1,653,559 | 663,145 |