Full Press Release Details
PolyPid Provides Corporate Update and Reports
Second Quarter 2023 Financial Results
Reached Agreement with U.S. FDA on Design of
SHIELD II Phase 3 Trial Evaluating D-PLEX100 for the Prevention of Abdominal Colorectal
Surgical Site Infections
Resumed Recruitment into SHIELD II Phase 3 Trial
Total of 20 centers in U.S., Europe and Israel
Expected to be Opened by End of Current Quarter
Conference Call Scheduled for Today at 8:30
PETACH TIKVA, Israel,
August 9, 2023 -- 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, 2023.
Recent Corporate Highlights:
our agreement with the FDA on the design of the SHIELD II Phase 3 trial and the
subsequent resumption of the trial, our promising lead product candidate, D-PLEX100, is advancing as planned in the clinic,"
stated Dikla Czaczkes Akselbrad, PolyPid's Chief Executive Officer. "As we expect to have 20 centers open by the end of the
current quarter, we anticipate that the rate of enrollment will increase rapidly."
we are beginning to see the impact of our cost containment efforts," continued Ms. Czaczkes Akselbrad. "Despite a challenging
inflationary environment, we have generated over $1 million in cost savings year-to-date, and our net cash used in operating activities
decreased by 59% in the first six months of the year as compared to the first six months of 2022."
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 9, 2023 |
| Time: | 8:30 AM Eastern Time |
| Q&A Participants: | https://register.vevent.com/register/BIdd3e958085d54167a5e9a8d8a59daff3 |
| Webcast: | https://edge.media-server.com/mmc/p/82gmauqc |
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 surgeries with incisions
greater than 20 cm. The primary endpoint of the trial is measured by the proportion of subjects with either an 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.
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 with glioblastoma.
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 its expectation to have 20 centers open in U.S., Europe and Israel by the end
of the current quarter and its anticipation that the rate of enrollment will increase rapidly thereafter, the timing of the unblinded
interim analysis, total recruitment time into the trial and top-line results, D-PLEX100 's potential
as an effective prophylactic drug against the most prevalent bacteria causing surgical site infections and the expected benefits from
cost containment efforts. 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 ("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
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, | |||||||
| 2023 | 2022 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 3,396 | $ | 8,552 | ||||
| Short-term deposits | 11,710 | 4,042 | ||||||
| Restricted deposits | 503 | 511 | ||||||
| Prepaid expenses and other current assets | 144 | 1,089 | ||||||
| Total current assets | 15,753 | 14,194 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 8,529 | 9,247 | ||||||
| Operating lease right-of-use assets | 1,892 | 2,431 | ||||||
| Other long-term assets | 89 | 99 | ||||||
| Total long-term assets | 10,510 | 11,777 | ||||||
| Total assets | $ | 26,263 | $ | 25,971 |
INTERIM CONDENSED CONSOLIDATED
U.S. dollars in thousands (except share
| June 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current maturities of long-term debt | $ | 2,068 | $ | 4,024 | ||||
| Accrued expenses and other current liabilities | 1,842 | 2,429 | ||||||
| Trade payables | 903 | 1,141 | ||||||
| Current maturities of operating lease liabilities | 638 | 959 | ||||||
| Total current liabilities | 5,451 | 8,553 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term debt | 8,538 | 7,574 | ||||||
| Deferred revenues | 2,548 | 2,548 | ||||||
| Long-term operating lease liabilities | 933 | 1,173 | ||||||
| Other liabilities | 446 | 294 | ||||||
| Total long-term liabilities | 12,465 | 11,589 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Ordinary shares with no par value - Authorized: 107,800,000 and 47,800,000 shares at June 30, 2023 (unaudited) and December 31, 2022, respectively; Issued and outstanding: 49,048,703 and 19,851,833 shares at June 30, 2023 (unaudited) and December 31, 2022, respectively | - | - | ||||||
| Additional paid-in capital | 234,696 | 220,273 | ||||||
| Accumulated deficit | (226,349 | ) | (214,444 | ) | ||||
| Total shareholders' equity | 8,347 | 5,829 | ||||||
| Total liabilities and shareholders' equity | $ | 26,263 | $ | 25,971 |
INTERIM CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and
| Six Months Ended | Three Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net | $ | 7,754 | $ | 17,095 | $ | 3,960 | $ | 8,398 | ||||||||
| Marketing and business development | 742 | 1,698 | 357 | 923 | ||||||||||||
| General and administrative | 3,112 | 4,723 | 1,503 | 2,243 | ||||||||||||
| Operating loss | 11,608 | 23,516 | 5,820 | 11,564 | ||||||||||||
| Financial expense , net | 262 | 203 | 7 | 281 | ||||||||||||
| Loss before income tax | 11,870 | 23,719 | 5,827 | 11,845 | ||||||||||||
| Income tax expenses | 35 | - | 10 | - | ||||||||||||
| Net loss | $ | 11,905 | $ | 23,719 | $ | 5,837 | $ | 11,845 | ||||||||
| Basic and diluted loss per ordinary share | $ | 0.36 | $ | 1.23 | $ | 0.13 | $ | 0.61 | ||||||||
| Weighted average number of ordinary shares used in computing basic and diluted loss per share | 32,910,446 | 19,222,423 | 44,383,474 | 19,505,246 |