Full Press Release Details
PolyPid Provides Corporate Update and Reports
Second Quarter 2025 Financial Results
Positive Phase 3 SHIELD II Trial
Results - D-PLEX successfully met its primary efficacy endpoint and demonstrated 58% reduction in SSI;
NDA submission expected in Q1 2026;
Unveiled a Long-Acting GLP-1 Receptor
Agonists Delivery Platform Targeting the Obesity and Diabetes Market;
Successful Warrant Exercise Significantly
Strengthened Balance Sheet with Cash Runway into 2026
Conference Call Scheduled for Today at 8:30 AM ET
PETACH TIKVA, Israel, August 13, 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 and six months ended June 30, 2025.
Recent Corporate Highlights:
"The second quarter of 2025 was transformational for PolyPid with
the successful completion of our SHIELD II Phase 3 trial, which demonstrated significant clinical benefits of D-PLEX
in preventing SSIs in abdominal colorectal surgeries," stated Dikla Czaczkes Akselbrad, PolyPid's Chief Executive Officer. "The
positive data has generated substantial interest from potential commercial partners and reinforced our conviction in D-PLEX 's
potential to address a significant unmet medical need."
"Moreover, we are extremely encouraged by the enthusiastic reception
from healthcare professionals who recognize the potential of D-PLEX to substantially reduce the burden of SSIs, improve
patient outcomes, and generate meaningful healthcare cost savings," continued Ms. Czaczkes Akselbrad. "With our strengthened
balance sheet and multiple strategic options before us, we are well-positioned to maximize the value of our innovative technology."
Financial results for
three months ended June 30, 2025
results for six months ended June 30, 2025
Conference Call Dial-In & Webcast Information:
| Date: | Wednesday, August 13, 2025 |
| Time: | 8:30 AM Eastern Time |
| Conference Call: | https://register-conf.media-server.com/register/BI24f4e2ebaf86432084ad872a4496f74d |
| Webcast: | https://edge.media-server.com/mmc/p/aqeywg9m |
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. Following positive phase
3 results, New Drug Application (NDA) submission of D-PLEX100, PolyPid's lead product candidate, for the prevention
of abdominal colorectal surgical site infections, is expected in early 2026. In addition, the Company has an innovative pipeline in oncology,
obesity and diabetes.
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 D-PLEX 's potential clinical benefits , the expected NDA submission and its timing, its commercialization
preparations and strategic partnership discussions to maximize D-PLEX 's market potential, the aims of GLP-1 program,
the Company's potential commercial partners, D-PLEX 's potential to address a significant unmet medical need,
the Company's ability to maximize the value of its innovative technology and the Company's expectation that its current cash runway
will be sufficient well 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 February 26, 2025. 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.
Investor & IR Contact:
Arx | Capital Markets
North American Equities Desk
INTERIM CONDENSED CONSOLIDATED
BALANCE SHEETS (UNAUDITED)
U.S. dollars in thousands
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 17,448 | $ | 15,641 | ||||
| Restricted deposits | 182 | 168 | ||||||
| Short-term deposits | 12,007 | - | ||||||
| Prepaid expenses and other current assets | 351 | 764 | ||||||
| Total current assets | 29,988 | 16,573 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 5,339 | 6,075 | ||||||
| Operating lease right-of-use assets | 2,062 | 2,295 | ||||||
| Other long-term assets | 298 | 277 | ||||||
| Total long-term assets | 7,699 | 8,647 | ||||||
| Total assets | $ | 37,687 | $ | 25,220 |
INTERIM CONDENSED CONSOLIDATED
BALANCE SHEETS (UNAUDITED)
U.S. dollars in thousands (except share and
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 2,572 | $ | 2,409 | ||||
| Accrued expenses and other current liabilities | 2,967 | 2,566 | ||||||
| Current maturities of long-term debt | 6,548 | 6,787 | ||||||
| Current maturities of operating lease liabilities | 1,068 | 919 | ||||||
| Total current liabilities | 13,155 | 12,681 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term debt | - | 634 | ||||||
| Deferred revenues | 2,548 | 2,548 | ||||||
| Long-term operating lease liabilities | 1,054 | 1,277 | ||||||
| Other liabilities | 454 | 396 | ||||||
| Total long-term liabilities | 4,056 | 4,855 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Ordinary shares with no par value - Authorized: 107,800,000 shares at June 30, 2025 and December 31, 2024; Issued and outstanding: 15,654,129 and 10,190,904 shares at June 30, 2025 and December 31, 2024, respectively | ||||||||
| Additional paid-in capital | 306,052 | 275,015 | ||||||
| Accumulated deficit | (285,576 | ) | (267,331 | ) | ||||
| Total shareholders' equity | 20,476 | 7,684 | ||||||
| Total liabilities and shareholders' equity | $ | 37,687 | $ | 25,220 |
INTERIM CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (UNAUDITED)
U.S. dollars in thousands (except share and
| Six Months Ended | Three Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 12,332 | $ | 9,810 | $ | 6,215 | $ | 4,760 | ||||||||
| Marketing and business development | 989 | 501 | 700 | 265 | ||||||||||||
| General and administrative | 3,661 | 2,111 | 2,488 | 1,096 | ||||||||||||
| Operating loss | 16,982 | 12,422 | 9,403 | 6,121 | ||||||||||||
| Loss on extinguishment of debt | 512 | - | - | - | ||||||||||||
| Financial expenses, net | 687 | 311 | 521 | 171 | ||||||||||||
| Loss before income tax | 18,181 | 12,733 | 9,924 | 6,292 | ||||||||||||
| Income tax expenses | 64 | 9 | 53 | 2 | ||||||||||||
| Net loss | $ | 18,245 | $ | 12,742 | $ | 9,977 | $ | 6,294 | ||||||||
| Loss per share: | ||||||||||||||||
| Basic and diluted | $ | 1.48 | $ | 2.62 | $ | 0.78 | $ | 1.25 | ||||||||
| Weighted-average Ordinary shares outstanding: | ||||||||||||||||
| Basic and diluted | 12,298,113 | 4,858,158 | 12,841,621 | 5,024,871 |