630 patients registered so far; Registration is now expected to be completed in the first quarter of 2025, with final results expected in the second quarter of 2025;
¢ Based on potential positive Phase III data, the Company expects to file a New Drug Application (NDA) for D-PLEX100 under the Rapid Innovative Therapy designations, which were previously granted to D-PLEX100 by the US Food and Drug Administration;
 The proceeds from this financing and exercise of the data operating memorandum are expected to extend the cash runway beyond potential NDA approval
Petah Tikva, Israel, December 24, 2024 (GLOBE NEWSWIRE) — Polypid Ltd. (Nasdaq: NASDAQ:) (PolyPid or the Company), a novel biopharmaceutical company aiming to improve surgical outcomes, today announced that following an independent Data Safety Monitoring Board (DSMB) review of unblinded efficacy data from the first 430 patients enrolled in the SHIELD II trial Phase 3 trial of D-PLEX100 for the prevention of surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery with significant infection. Notches, the DSMB's recommendation was to conclude the study at enrollment of 800 patients, the lowest cutoff for sample size reassessment beyond the planned minimum of 624 patients. In this interim analysis, the DSMB also had the option of recommending discontinuation of SHIELD II due to its lack of feasibility or overwhelming efficacy or reevaluating the trial's sample size to a maximum of 1,100 patients. In addition, the DSMB has confirmed the good safety profile of D-PLEX100 in SHIELD II to date.
We consider the DSMB's recommendation to conclude SHIELD II at 800 patients with a positive result, because it suggests positive efficacy signals from D-PLEX100,” said Decla Chaczkis-Axelbrad, CEO of PolyPid. Reevaluating the sample size represents an opportunity to ensure that the study has sufficient power to conclusively confirm the benefit of D-PLEX100 treatment, and we believe this increases the likelihood of overall trial success. We are now focused on completing the trial, with the development of planned NDA and Marketing Authorization (MAA) submissions, preparation of pre-launch activities, and accelerating partnership discussions within the US and abroad.
The study has enrolled 630 patients so far, and the last 170 patients are expected to be enrolled in the first quarter of 2025. The company expects to announce final results in the second quarter of 2025. Based on potentially positive Phase 3 data, the company expects to file a N.A.D. Disclosure with Benefits Fast Track and Breakthrough Therapy designations, which were awarded to D-PLEX100 in 2020.
PolyPid also announced that it has entered into a securities purchase agreement to finance a private placement (PIPE) led by existing institutional shareholders for $14.5 million in gross proceeds at a price of $3.22 per share, the closing price on December 20, 2024. In connection with the PIPE financing, it agreed The Company is considering appointing Yitzhak Jacobovitz, CFA, Partner and Principal Healthcare Analyst at AIGH Capital Management, for appointment to the Company's Board of Directors.
Pursuant to the Securities Purchase Agreement, investors have agreed to purchase 4,493,830 shares of the Company's common stock, no par value per share (common stock), or pre-funded warrants in lieu thereof, at a purchase price of $3.22 per share (or earlier-funded warrant). . Investors will also receive warrants to purchase up to 6,740,745 common shares at an exercise price of $4.00 per share. The warrants expire on the earlier of nine months from the date of issuance and 10 trading days after PolyPid announces final results from the SHIELD II Phase 3 trial. The full exercise of the warrants will result in an additional $27.0 million in gross proceeds to the company.
The PIPE is expected to close on December 26, 2024, subject to customary closing conditions being satisfied. The Company intends to use the net proceeds from the sale of the securities for its ongoing Phase III clinical trial of SHIELD II, working capital and general corporate purposes. The gross proceeds from the financing extend PolyPid's cash runway into Q3 2025, exceeding expected results from SHIELD II.
The proceeds of all warrants issued in this transaction, if exercised, will provide the Company with capital in excess of the approval of the NDA.
Citizens JMP is acting as the exclusive recruitment agent for the show.
The securities described above are being offered and sold in a transaction that does not involve a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the “Securities Act), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. Pursuant to the registration rights agreement with PIPE Investors, the Company has agreed to file one or more registration statements within 30 calendar days with the Securities and Exchange Commission (“SEC”) covering the resale of common stock and common stock. Issueable upon exercise of pre-funded warrants and warrants.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy securities, nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. .
About SHIELD II
SHIELD II (Prevention of Surgical Site Acquired Infection with Local D-PLEX) is a prospective, multinational, randomized, double-blind, phase III trial designed to evaluate the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (SoC), which includes antibiotics Systemic prophylaxis, compared with the SoC alone arm, was used in preventing surgical infections after abdominal surgery in patients undergoing abdominal colorectal resection. Surgical operations with large incisions. The primary endpoint of the trial is measured by the proportion of subjects who have a surgical site infection (SSI) event as determined by a blinded, independent adjudicator, reintervention, or death from any cause within 30 days after surgery. Patient safety will be monitored for an additional 30 days. The trial is enrolling patients at centers in the United States, Europe and Israel.
About D-Plex100
D-PLEX100, PolyPid's lead product candidate, is designed to provide prolonged, controlled local antibacterial activity directly at the surgical site to prevent SSI infection. After D-PLEX100 is inserted into the surgical site, PLEX (lipidic polymer encapsulation matrix) technology is coupled with Active Pharmaceutical (Circulation:) Components, which allow prolonged and sustained release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for 30 days for the prevention of SSIs, with the additional possibility of preventing SSIs induced by antibiotic-resistant bacteria. At the surgical site. D-PLEX100 has received Breakthrough Therapy designation from the FDA for SSI prophylaxis in patients undergoing elective colorectal surgery. D-PLEX100 is currently in the Phase III SHIELD II trial for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions.
About Polybed
PolyPid Ltd. (Nasdaq: PYPD) is a cutting-edge biopharmaceutical company aiming to improve surgical outcomes. Through locally administered, controlled, long-lasting treatments, PolyPid's proprietary PLEX (lipidic polymer encapsulation matrix) technology is coupled with active pharmaceutical ingredients (APIs), enabling precise drug delivery at optimal release rates over periods ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in a phase III clinical trial for the prevention of abdominal colorectal surgery site infections. Additionally, the company is currently in the preclinical stages of testing the efficacy of OncoPLEX for the treatment of solid tumors, starting 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, expects, intends, plans, believes, seeks, estimates and similar expressions or variations of these words are intended to identify forward-looking statements. For example, the Company uses forward-looking statements when it discusses the expected timing of completion of enrollment in the SHIELD II trial, the expected timing of key results from the SHIELD II trial, potential NDA and MAA submissions, the potential clinical benefits of D-PLEX100, including safety and efficacy, and Pre-launch and partnership discussions, total proceeds to be received from PIPE, intended use of proceeds from PIPE, and expected closing date of PIPE PIPE, total The expected proceeds from the exercise of the warrants issued in the PIPE if such warrants are fully exercised, that the gross proceeds from the financing extend the Company's cash runway into the third quarter of 2025, and that the proceeds of all warrants issued in this transaction, if exercised, will provide the Company with capital in excess of approval Non-Disclosure Agreement, and the potential addition of Mr. Jacobovitz to the Company's Board of Directors. Forward-looking statements are not historical facts and are based on management's current expectations, beliefs and projections, many of which are, by their nature, inherently uncertain. These expectations, beliefs and expectations are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and expectations will be achieved, and actual results may differ materially from what is expressed or indicated in 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 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, without limitation, the risks detailed in the Company's Annual Report on Form. 20-F Filed March 6, 2024. Forward-looking statements speak only as of the date they are made. The Company undertakes 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 updates one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect to them or with respect to other forward-looking statements.
References and links to websites are provided for convenience, and the information contained on these websites is not incorporated by reference into this news release. PolyPid is not responsible for the content of third party websites.
Contacts:
POLYBED LIMITED.
Uri Varshavsky
Director of Operations “U.S
908-858-5995
IR@Polypid.com
Investors:
Brian Ritchie
LifeSci Consultants
212-915-2578
BRitchie@lifesciadvisors.com
Source: Polypid Limited.
