Full Press Release Details
PolyPid Provides Corporate Update and Reports
Second Quarter 2024 Financial Results
Approximately 320 Patients
Enrolled in Ongoing SHIELD II Phase 3 Trial of D-PLEX100 for the Prevention of Abdominal Colorectal Surgical Site
Unblinded Interim Analysis
to be Conducted Once Approximately 400 Patients Complete Their 30-Day Follow-up, Which is Expected in Fourth Quarter of 2024; Top-Line
Results Anticipated in First Quarter of 2025
Recent Successful Financing
of Up to $14 Million Extends Company's Cash Runway into Second Quarter of 2025, Beyond the Anticipated Timing for SHIELD II Top-line
Results, Assuming Warrants are Fully Exercised
Conference Call Scheduled for Today at 8:30
TIKVA, Israel, August 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 and six months ended June 30, 2024.
Recent Corporate Highlights:
with the important clinical and operational progress recently achieved," stated Dikla Czaczkes Akselbrad, PolyPid's Chief
Executive Officer. "With around 320 patients enrolled to date in SHIELD II, we look forward
to the upcoming interim analysis and remain on track for the top-line data readout in the first quarter of next year. Moreover,
in support of the further advancement of SHIELD II, we successfully completed a financing of up
to $14 million that included participation from multiple U.S. life
sciences-focused investors," continued Ms. Czaczkes Akselbrad.
Financial results for three months ended June
Financial results for six months ended June
Balance Sheet Highlights
Conference Call Dial-In & Webcast Information:
| Date: | Wednesday, August 14, 2024 |
| Time: | 8:30 AM Eastern Time |
| Q&A Participants: | https://register.vevent.com/register/BI016c6fe17c794f8ea594d9e8bfca69f4 |
| Webcast: | https://edge.media-server.com/mmc/p/hcwb4pob |
SHIELD 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.
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 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
For additional Company information, please
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 the expected timing for top-line results from the SHIELD II trial and of the unblinded
interim analysis, and the Company's expected cash runway and the potential to secure additional funds if all of the warrants
issued through the PIPE 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 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.
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.
INTERIM CONDENSED CONSOLIDATED
U.S. dollars in thousands
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 3,076 | $ | 5,309 | ||||
| Restricted deposits | 163 | 300 | ||||||
| Short-term deposits | 6,271 | - | ||||||
| Prepaid expenses and other current assets | 268 | 458 | ||||||
| Total current assets | 9,778 | 6,067 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 6,813 | 7,621 | ||||||
| Operating lease right-of-use assets | 2,679 | 1,597 | ||||||
| Other long-term assets | 257 | 87 | ||||||
| Tota l long-term assets | 9,749 | 9,305 | ||||||
| Total assets | $ | 19,527 | $ | 15,372 |
INTERIM CONDENSED CONSOLIDATED
U.S. dollars in thousands (except share and
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current maturities of long-term debt | $ | 5,437 | $ | 4,003 | ||||
| Accrued expenses and other current liabilities | 2,984 | 1,971 | ||||||
| Trade payables | 992 | 772 | ||||||
| Current maturities of operating lease liabilities | 873 | 540 | ||||||
| Total current liabilities | 10,286 | 7,286 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term debt | 3,127 | 6,379 | ||||||
| Deferred revenues | 2,548 | 2,548 | ||||||
| Long-term operating lease liabilities | 1,594 | 857 | ||||||
| Other liabilities | 371 | 398 | ||||||
| Total long-term liabilities | 7,640 | 10,182 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| SHAREHOLDERS' EQUITY (DEFICIT): | ||||||||
| Ordinary shares with no par value - Authorized: 107,800,000 shares at June 30, 2024 (unaudited) and December 31, 2023; Issued and outstanding: 4,797,252 and 1,653,559 shares at June 30, 2024 (unaudited) and December 31, 2023, respectively | - | - | ||||||
| Additional paid-in capital | 252,652 | 236,213 | ||||||
| Accumulated deficit | (251,051 | ) | (238,309 | ) | ||||
| Total shareholders' equity (deficit) | 1,601 | (2,096 | ) | |||||
| Total liabilities and shareholders' equity | 19,527 | 15,372 |
INTERIM CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and
| Six Months Ended | Three Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net | $ | 9,810 | $ | 7,754 | $ | 4,760 | $ | 3,960 | ||||||||
| Marketing and business development | 501 | 742 | 265 | 357 | ||||||||||||
| General and administrative | 2,111 | 3,112 | 1,096 | 1,503 | ||||||||||||
| Operating loss | 12,422 | 11,608 | 6,121 | 5,820 | ||||||||||||
| Financial expense, net | 311 | 262 | 171 | 7 | ||||||||||||
| Loss before income tax | 12,733 | 11,870 | 6,292 | 5,827 | ||||||||||||
| Income tax expenses | 9 | 35 | 2 | 10 | ||||||||||||
| Net loss | $ | 12,742 | $ | 11,905 | $ | 6,294 | $ | 5,837 | ||||||||
| Basic and diluted loss per ordinary share *) | $ | 2.62 | $ | 10.85 | $ | 1.25 | $ | 3.95 | ||||||||
| Weighted average number of ordinary shares used in computing basic and diluted loss per share *) | 4,858,158 | 1,097,015 | 5,024,871 | 1,479,449 |