PETACH TIKVA, Israel, May 08, 2024 (GLOBE NEWSWIRE) -- 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, 2024.
Recent Corporate Highlights:
“We are excited about the substantial momentum throughout our business, most importantly as it relates to enrollment in our ongoing SHIELD II pivotal Phase 3 trial for D-PLEX100,” stated Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “With more than 200 patients, the SHIELD II study is now more than half enrolled for the interim analysis, which is planned to be conducted in mid-2024. We expect to continue enrollment at a pace of 1.5 patients per recruiting center per month. There are approximately 50 centers currently open in multiple countries and approximately 10 more centers are anticipated to open over the next couple of months.”
Financial results for three months ended March 31, 2024
Balance Sheet Highlights
Conference Call Dial-In & Webcast Information:
| Date: | Wednesday, May 8, 2024 |
| Time: | 8:30 AM Eastern Time |
| Q&A Participants: | https://register.vevent.com/register/BI6c0218de1fe64ed5b4d221783eb70bba |
| Webcast: | https://edge.media-server.com/mmc/p/34fyspqn |
About SHIELD II
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.
About D-PLEX100
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.
About PolyPid
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 follow us on Twitter and LinkedIn.
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, that observing similar demographics between SHIELD I and SHIELD II in large incision pre-specified subgroup could be an important de-risking factor for SHIELD II, the expected enrollment pace, the expectation to add approximately 10 more centers over the next couple of months, the planned NDA submission for D-PLEX100, the Company’s expected cash runway and the potential to receive additional funds if the results of the unblinded interim analysis are positive and 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.
Contacts:
PolyPid Ltd.
Ori Warshavsky
COO – US
908-858-5995
This email address is being protected from spambots. You need JavaScript enabled to view it.
Investors:
Brian Ritchie
LifeSci Advisors
212-915-2578
This email address is being protected from spambots. You need JavaScript enabled to view it.
| CONSOLIDATED BALANCE SHEETS | ||||||
| U.S. dollars in thousands | ||||||
| March 31, | December 31, | |||||
| 2024 | 2023 | |||||
| (Unaudited) | (Audited) | |||||
| ASSETS | ||||||
| CURRENT ASSETS: | ||||||
| Cash and cash equivalents | $ | 3,844 | $ | 5,309 | ||
| Restricted cash | 166 | 300 | ||||
| Short-term deposits | 10,612 | - | ||||
| Prepaid expenses and other current assets | 471 | 458 | ||||
| Total current assets | 15,093 | 6,067 | ||||
| LONG-TERM ASSETS: | ||||||
| Property and equipment, net | 7,201 | 7,621 | ||||
| Operating lease right-of-use assets | 2,883 | 1,597 | ||||
| Other long-term assets | 218 | 87 | ||||
| Total long-term assets | 10,302 | 9,305 | ||||
| Total assets | $ | 25,395 | $ | 15,372 | ||
| CONSOLIDATED BALANCE SHEETS | |||||||||
| U.S. dollars in thousands (except share and per share data) | |||||||||
| March 31, | December 31, | ||||||||
| 2024 | 2023 | ||||||||
| (Unaudited) | (Audited) | ||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) | |||||||||
| CURRENT LIABILITIES: | |||||||||
| Current maturities of long-term debt | $ | 4,436 | $ | 4,003 | |||||
| Accrued expenses and other current liabilities | 2,609 | 1,971 | |||||||
| Trade payables | 1,288 | 772 | |||||||
| Current maturities of operating lease liabilities | 862 | 540 | |||||||
| Total current liabilities | 9,195 | 7,286 | |||||||
| LONG-TERM LIABILITIES: | |||||||||
| Long-term debt | 4,288 | 6,379 | |||||||
| Deferred revenues | 2,548 | 2,548 | |||||||
| Long-term operating lease liabilities | 1,816 | 857 | |||||||
| Other liabilities | 403 | 398 | |||||||
| Total long-term liabilities | 9,055 | 10,182 | |||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | |||||||||
| SHAREHOLDERS' EQUITY (DEFICIT): | |||||||||
| Ordinary shares, no par value *) - | |||||||||
| Authorized: 107,800,000 shares at March 31, 2024 (Unaudited) and December 31, 2023; Issued and outstanding: 4,797,252 and 1,653,559 shares at March 31, 2024 (Unaudited) and December 31, 2023, respectively | - | - | |||||||
| Additional paid-in capital | 251,902 | 236,213 | |||||||
| Accumulated deficit | (244,757 | ) | (238,309 | ) | |||||
| Total shareholders' equity (deficit) | 7,145 | (2,096 | ) | ||||||
| Total liabilities and shareholders' equity (deficit) | $ | 25,395 | $ | 15,372 | |||||
*) Prior period results have been retroactively adjusted to reflect the 1-for-30 reverse share split affected on September 18, 2023.
| CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||
| U.S. dollars in thousands (except share and per share data) | ||||||
| Three Months Ended March 31, | ||||||
| 2024 | 2023 | |||||
| (Unaudited) | (Unaudited) | |||||
| Operating expenses: | ||||||
| Research and development, net | $ | 5,050 | $ | 3,794 | ||
| Marketing and business development expenses | 236 | 385 | ||||
| General and administrative | 1,015 | 1,609 | ||||
| Operating loss | 6,301 | 5,788 | ||||
| Financial expense, net | 140 | 255 | ||||
| Loss before income tax | 6,441 | 6,043 | ||||
| Income tax expense | 7 | 25 | ||||
| Net loss | $ | 6,448 | 6,068 | |||
| Basic and Diluted loss per Ordinary share *) | $ | 1.37 | $ | 8.47 | ||
| Weighted average number of Ordinary shares used in computing basic and diluted loss per share *) | 4,691,445 | 716,555 | ||||
*) Prior period results have been retroactively adjusted to reflect the 1-for-30 reverse share split affected on September 18, 2023.
| Last Trade: | US$2.99 |
| Daily Change: | 0.09 3.24 |
| Daily Volume: | 3,780 |
| Market Cap: | US$20.360M |
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