Full Press Release Details
PolyPid Provides Corporate Update and Reports
Fourth Quarter and Full-Year 2024 Financial Results
Positive Recommendation
by DSMB to Continue Enrollment of Phase 3 SHIELD II Trial of D-PLEX to 800 Patients
more than 700 Patients to Date; Enrollment Completion Expected in March 2025, with Top-Line Results Anticipated in Second Quarter of 2025
Company Completed Private
Placement of Up to $41 Million; Proceeds and Exercise of Data-Triggered Warrants Expected to Extend Cash Runway Beyond Potential NDA Approval
Conference Call Scheduled for Today at 8:30
PETACH TIKVA, Israel, February
12, 2025 -- 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, 2024.
Recent Corporate Highlights:
with the impressive clinical and operational progress achieved in 2024 and believe that we are well-positioned for a potentially transformational
year in 2025," stated Dikla Czaczkes Akselbrad, PolyPid's Chief Executive Officer. "Importantly, we remain confident
that the DSMB's recent recommendation to conclude SHIELD II upon the enrollment of 800 patients is suggestive
of positive efficacy signals from D-PLEX100. Moreover, the sample size reassessment was an opportunity to ensure the study
has sufficient power to conclusively confirm D-PLEX100's treatment benefit, and we believe this increases the trial's
overall probability of success. We continue to focus on completing the trial, while advancing our planned NDA and Marketing Authorization
Application ("MAA") submissions, preparing pre-launch activities, and expediting partnership discussions in and outside of
the United States. We are also excited to welcome Mr. Jacobovitz to the Board of Directors and are pleased that AIGH was the lead investor
in our most recent equity offering. Mr. Jacobovitz brings extensive healthcare investment experience to our board and we look forward
to his contributions."
Financial results for three months ended December
Financial results for the full year ended December
Balance Sheet Highlights
Conference Call Dial-In & Webcast Information:
| Date: | Wednesday, February 12, 2025 |
| Time: | 8:30 AM Eastern Time |
| Conference Call: | https://register.vevent.com/register/BI4e72dffa5a7b4167a28a33a6b3097df3 |
| Webcast: | https://edge.media-server.com/mmc/p/7uzqoye3 |
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,
Fast Track and Qualified Infectious Disease Product (QIDP) Designations 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.
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 visit http://www.polypid.com and
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 completion of enrollment of the SHIELD
II trial, expected timing for top-line results from the SHIELD II trial, potential NDA and MAA submissions, potential clinical benefits
of D-PLEX100, including safety and efficacy, and potential success of the trial, pre-launch activities and partnership discussions,
that the gross proceeds from the financing extend the Company's cash runway into the third quarter of 2025, that proceeds from
the exercise of all warrants issued in the financing transaction would provide the Company with capital beyond NDA approval, that the
Company is well-positioned for a potentially transformational year in 2025, the potential of the Company's collaboration with ImmunoGenesis
to enhance treatment for solid tumors, and the expectation that the Company's current cash balance will be sufficient to fund operations
into the third quarter of 2025. 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.
U.S. dollars in thousands
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 15,641 | $ | 5,309 | ||||
| Restricted deposits | 168 | 300 | ||||||
| Prepaid expenses and other current assets | 764 | 458 | ||||||
| Total current assets | 16,573 | 6,067 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 6,075 | 7,621 | ||||||
| Operating lease right-of-use assets | 2,295 | 1,597 | ||||||
| Other long-term assets | 277 | 87 | ||||||
| Total long-term assets | 8,647 | 9,305 | ||||||
| Total assets | $ | 25,220 | $ | 15,372 |
U.S. dollars in thousands (except share
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| (Unaudited) | ||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 2,409 | $ | 772 | ||||
| Accrued expenses and other current liabilities | 2,566 | 1,971 | ||||||
| Current maturities of long-term debt | 6,787 | 4,003 | ||||||
| Current maturities of operating lease liabilities | 919 | 540 | ||||||
| Total current liabilities | 12,681 | 7,286 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term debt | 634 | 6,379 | ||||||
| Deferred revenues | 2,548 | 2,548 | ||||||
| Long-term operating lease liabilities | 1,277 | 857 | ||||||
| Other liabilities | 396 | 398 | ||||||
| Total long-term liabilities | 4,855 | 10,182 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES (NOTE 8) | ||||||||
| SHAREHOLDERS' EQUITY (DEFICIT): | ||||||||
| Ordinary shares, no par value - Authorized: 107,800,000 shares at December 31, 2024 and 2023, respectively; Issued and outstanding: 10,190,904 and 1,653,559 shares at December 31, 2024 and 2023, respectively | - | - | ||||||
| Additional paid-in capital | 275,015 | 236,213 | ||||||
| Accumulated deficit | (267,331 | ) | (238,309 | ) | ||||
| Total shareholders' equity (deficit) | 7,684 | (2,096 | ) | |||||
| Total liabilities and shareholders' equity (deficit) | $ | 25,220 | $ | 15,372 |
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share
| Year Ended December 31, | ||||||||||||
| 2024 | 2023 | 2022 | ||||||||||
| (Unaudited) | ||||||||||||
| Operating expenses: | ||||||||||||
| Research and development, net | $ | 22,811 | $ | 16,148 | $ | 27,990 | ||||||
| Marketing and business development | 945 | 1,196 | 2,888 | |||||||||
| General and administrative | 4,273 | 5,523 | 8,010 | |||||||||
| Operating loss | 28,029 | 22,867 | 38,888 | |||||||||
| Financial expense, net | 951 | 929 | 540 | |||||||||
| Loss before income tax | 28,980 | 23,796 | 39,428 | |||||||||
| Income tax expense | 42 | 69 | 129 | |||||||||
| Net loss | $ | 29,022 | $ | 23,865 | $ | 39,557 | ||||||
| Loss per share *): | ||||||||||||
| Basic | $ | 4.91 | $ | 16.99 | $ | 61.09 | ||||||
| Diluted | $ | 4.91 | $ | 16.93 | $ | 61.09 | ||||||
| Weighted-average Ordinary shares outstanding *): | ||||||||||||
| Basic | 5,912,890 | 1,404,368 | 647,556 | |||||||||
| Diluted | 5,912,890 | 1,421,308 | 647,556 |