Full Press Release Details
PolyPid Provides Corporate Update and Reports
First Quarter 2023 Financial Results
Submitted Revised Protocol for SHIELD II Phase
3 Trial to FDA to Evaluate D-PLEX100 for
Prevention of Abdominal Colorectal Surgical Site Infections; Recruitment Expected to Resume Imminently
Advice from the Swedish Medical Products Agency Consistent with Feedback Received
a Series of Transactions to Further Solidify Financial Position and Extend Cash Runway to Late in Q1 2024
Strengthened Board of Directors Through Appointment
of Yossi BenAmram, Former SVP and President of Merck & Co.'s
Europe, Russia, Africa, and Middle East Region
Conference Call Scheduled for Today at 8:30
PETACH TIKVA, Israel, May
10, 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 months ended March 31, 2023.
Recent Corporate Highlights:
"We are pleased with the
recent progress we have achieved throughout our business," stated Dikla Czaczkes Akselbrad, PolyPid's Chief Executive Officer.
"The feedback received from the FDA and the Swedish Medical Products Agency, coupled with the successful financial transactions
that extended our cash runway, further solidify our clear and compelling path forward for D-PLEX100 and the SHIELD II study,
which we expect will resume patient recruitment very shortly."
"I would like to thank Mr.
Hurvitz for his many years of support for PolyPid and welcome Mr. BenAmram as a new member of our Board of Directors. Mr. BenAmram's
vast global experience in the pharma industry will be invaluable to PolyPid as we progress in the further advancement of D-PLEX100
and continue our business development activities for our lead product candidate and the PLEX platform."
Financial results for three months ended March
Balance Sheet Highlights
Conference Call Dial-In & Webcast Information:
| Date: | Wednesday, May 10, 2023 | |
| Time: | 8:30 AM Eastern Time | |
| Q&A Participants: | https://register.vevent.com/register/BI4643e991c9604c539af94f4d0682274c | |
| Webcast: | https://edge.media-server.com/mmc/p/2ymp9poq |
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 complex 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 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 the expected resumption of recruitment for the SHIELD II Phase 3 trial and the timing of top-line results therefrom,
a potential MAA submission, and the Company's expectations regarding its cash balance.
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 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
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 6,366 | $ | 8,552 | ||||
| Restricted cash | 504 | 511 | ||||||
| Short-term deposits | 7,061 | 4,042 | ||||||
| Receipts on account of shares | 6,206 | 131 | ||||||
| Prepaid expenses and other current assets | 448 | 958 | ||||||
| Total current assets | 20,585 | 14,194 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 8,822 | 9,247 | ||||||
| Operating lease right-of-use assets | 2,181 | 2,431 | ||||||
| Other long-term assets | 107 | 99 | ||||||
| Total long-term assets | 11,110 | 11,777 | ||||||
| Total assets | $ | 31,695 | $ | 25,971 |
INTERIM CONDENSED CONSOLIDATED
U.S. dollars in thousands (except share and
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current maturities of long-term debt 1 | $ | 4,210 | $ | 4,024 | ||||
| Accrued expenses and other current liabilities | 1,396 | 2,429 | ||||||
| Trade payables | 1,083 | 1,141 | ||||||
| Current maturities of operating lease liabilities | 808 | 959 | ||||||
| Total current liabilities | 7,497 | 8,553 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term debt 1 | 6,760 | 7,574 | ||||||
| Deferred revenues | 2,548 | 2,548 | ||||||
| Warrant liability | 2,106 | - | ||||||
| Long-term operating lease liabilities | 1,063 | 1,173 | ||||||
| Other liabilities | 314 | 294 | ||||||
| Total long-term liabilities | 12,791 | 11,589 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Ordinary shares with no par value - Authorized: 47,800,000 shares at March 31, 2023 (unaudited) and December 31, 2022; Issued and outstanding: 38,694,171 and 19,851,833 shares at March 31, 2023 (unaudited) and December 31, 2022, respectively | - | - | ||||||
| Additional paid-in capital | 231,919 | 220,273 | ||||||
| Accumulated deficit | (220,512 | ) | (214,444 | ) | ||||
| Total shareholders' equity | 11,407 | 5,829 | ||||||
| Total liabilities and shareholders' equity | $ | 31,695 | $ | 25,971 |
INTERIM CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Unaudited | ||||||||
| Operating expenses: | ||||||||
| Research and development, net | $ | 3,794 | $ | 8,697 | ||||
| Marketing and business development | 385 | 775 | ||||||
| General and administrative | 1,609 | 2,480 | ||||||
| Operating loss | 5,788 | 11,952 | ||||||
| Financial expense (income), net | 255 | (78 | ) | |||||
| Loss before income tax | 6,043 | 11,874 | ||||||
| Income tax expense | 25 | - | ||||||
| Net loss | 6,068 | 11,874 | ||||||
| Basic and diluted loss per Ordinary share | $ | 0.28 | $ | 0.63 | ||||
| Weighted average number of Ordinary shares used in computing basic and diluted loss per share | 21,496,651 | 18,936,457 |