Full Press Release Details
Provides Corporate Update and Reports Third Quarter 2024 Financial Results
Patient Enrolled for Planned Unblinded Interim Analysis in Ongoing SHIELD II Phase 3 Trial of D-PLEX100
Unblinded Interim Analysis Outcome Expected Later this Quarter
II Enrollment Completion Expected in December 2024 with Top-Line Results Anticipated in First Quarter of 2025
Call Scheduled for Today at 8:30 AM ET
TIKVA, Israel, November
13, 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 and nine months ended September 30, 2024.
Corporate Highlights:
are very encouraged by the recent significant acceleration in patient enrollment due to the opening of all 60 planned centers in the
study and the increase in the volume of surgical procedures following the conclusion of the slower summer months," stated Dikla
Czaczkes Akselbrad, PolyPid's Chief Executive Officer. "With more than 540 patients
enrolled to date in SHIELD II, we look forward to the upcoming interim analysis later this quarter. Importantly, we are funded beyond
this key data catalyst and, if all the warrants issued in both of our most recent private placement financings are exercised, we would
be funded into 2026."
results for three months ended September 30, 2024
results for nine months ended September 30, 2024
Call Dial-In & Webcast Information:
| Date: | Wednesday, November 13, 2024 |
| Time: | 8:30 AM Eastern Time |
| Conference Call: | https://register.vevent.com/register/BI198de55d5c06495994d35cbb213655eb |
| Webcast: | https://edge.media-server.com/mmc/p/j6bnvt8c |
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"), which includes prophylactic systemic antibiotics, compared to SoC alone arm, in the prevention of post abdominal-surgery
incisional infection in patients undergoing abdominal colorectal surgeries with large incisions. The primary endpoint of the trial is
measured by the proportion of subjects with either a surgical site infection ("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.
D-PLEX100, PolyPid's
lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to
prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation
matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic
doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional
potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough
Therapy Designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective
colorectal surgery. D-PLEX100 is currently in Phase 3 SHIELD II trial for the prevention of surgical site infections
in patients undergoing abdominal colorectal surgery with large incisions.
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 enrollment pace, the expected
timing for top-line results from the SHIELD II trial and of the unblinded interim analysis,
the Company's expected cash runway and that if all warrants issued in both of Company's
most recent private placement financings are exercised, the Company would be funded into 2026. 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, including, but not limited to, the risks detailed in the Company's Annual
Report on Form 20-F filed on March 6, 2024. 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, | |||||||
| 2024 | 2023 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 4,804 | $ | 5,309 | ||||
| Restricted deposits | 165 | 300 | ||||||
| Short-term bank deposits | 4,728 | - | ||||||
| Prepaid expenses and other current assets | 750 | 458 | ||||||
| Total current assets | 10,447 | 6,067 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 6,414 | 7,621 | ||||||
| Operating lease right-of-use assets | 2,464 | 1,597 | ||||||
| Other long-term assets | 269 | 87 | ||||||
| Total long-term assets | 9,147 | 9,305 | ||||||
| Total assets | $ | 19,594 | $ | 15,372 |
CONDENSED CONSOLIDATED BALANCE SHEETS
dollars in thousands (except share and per share data)
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current maturities of long-term debt | $ | 5,178 | $ | 4,003 | ||||
| Accrued expenses and other current liabilities | 2,770 | 1,971 | ||||||
| Trade payables | 1,641 | 772 | ||||||
| Current maturities of operating lease liabilities | 888 | 540 | ||||||
| Total current liabilities | 10,477 | 7,286 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term debt | 2,529 | 6,379 | ||||||
| Deferred revenues | 2,548 | 2,548 | ||||||
| Long-term operating lease liabilities | 1,421 | 857 | ||||||
| Other liabilities | 461 | 398 | ||||||
| Total long-term liabilities | 6,959 | 10,182 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| SHAREHOLDERS' EQUITY (DEFICIT): | ||||||||
| Ordinary shares with no par value - Authorized: 107,800,000 and 107,800,000 shares at September 30, 2024 (unaudited) and December 31, 2023, respectively; Issued and outstanding: 6,803,478 and 1,653,559 shares at September 30, 2024 (unaudited) and December 31, 2023, respectively. | - | - | ||||||
| Additional paid-in capital | 260,969 | 236,213 | ||||||
| Accumulated deficit | (258,811 | ) | (238,309 | ) | ||||
| Total shareholders' equity (deficit) | 2,158 | (2,096 | ) | |||||
| Total liabilities and shareholders' equity (deficit) | $ | 19,594 | $ | 15,372 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
dollars in thousands (except share and per share data)
| Nine Months Ended | Three Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net | $ | 15,784 | $ | 11,560 | $ | 5,974 | $ | 3,806 | ||||||||
| Marketing and business development | 747 | 1,003 | 246 | 261 | ||||||||||||
| General and administrative | 3,277 | 4,305 | 1,166 | 1,193 | ||||||||||||
| Operating loss | 19,808 | 16,868 | 7,386 | 5,260 | ||||||||||||
| Financial expense, net | 665 | 581 | 354 | 319 | ||||||||||||
| Loss before income tax | 20,473 | 17,449 | 7,740 | 5,579 | ||||||||||||
| Income tax expenses | 29 | 60 | 20 | 25 | ||||||||||||
| Net loss | $ | 20,502 | $ | 17,509 | $ | 7,760 | $ | 5,604 | ||||||||
| Basic and diluted loss per ordinary share | $ | 3.82 | $ | 13.59 | $ | 1.22 | $ | 3.40 | ||||||||
| Weighted average number of ordinary shares used in computing basic and diluted loss per share | 5,362,858 | 1,288,678 | 6,361,286 | 1,650,259 |