PolyPid Announces Positive Recommendation by DSMB to Continue Enrollment of Phase 3 SHIELD II Trial of D-PLEX₁₀₀ to 800 Patients with a Concurrent Private Placement of up to $41 Million
PYPD 12.24.2024
Drug:D-PLEX100-001 D-PLEX100
Diseases:surgical site infections
About Gravity Analytica
Recent News
- 12.24.2024 - PolyPid Announces Positive Recommendation by DSMB to Continue Enrollment of Phase 3 SHIELD II Trial of D-PLEX₁₀₀ to 800 Patients with a Concurrent Private Placement of up to $41 Million
- 12.11.2024 - PolyPid Announces Research and Development Collaboration with ImmunoGenesis Leveraging PLEX Technology to Enhance Cancer Immunotherapy
- 11.29.2024 - PolyPid Announces Receipt of Nasdaq Notification of Minimum Stockholders’ Equity Non-Compliance
Recent Filings
• 630 Patients Enrolled To Date; Enrollment Completion Now Expected in Q1 2025 with Top-line Results Anticipated in Q2 2025;
• Upon Potential Positive Phase 3 Data the Company Expects to Submit a New Drug Application (“NDA”) forD-PLEX100under Fast Track and BreakthroughTherapyDesignations, Previously Granted toD-PLEX100by the FDA;
• Proceeds from this Financing and Exercise of Data-Triggered Warrant Expected to Extend Cash Runway Beyond Potential NDA Approval
PETACH TIKVA,
“We view the DSMB’s recommendation to conclude
The study has enrolled 630 patients to date and enrollment of the last 170 patients is expected to occur in the first quarter of 2025. The Company anticipates reporting top-line results in the second quarter of 2025. Upon potential positive Phase 3 data, the Company expects to submit an NDA with the advantages oftheFast Track and Breakthrough Therapy designations, which were granted to D-PLEX100in 2020.
Under the securities purchase agreement, the investors have agreed to purchase 4,493,830 of the Company’s ordinary shares, no par value per share (the “Ordinary Shares”), or pre-funded warrants in lieu thereof, at a purchase price of $3.22 per share (or pre-funded warrant). The investors will also receive warrants to purchase up to 6,740,745 Ordinary Shares at an exercise price of $4.00 per share. The warrants expire upon the earlier of nine months from the date of issuance and 10 trading days following PolyPid’s announcement of top-line results from its SHIELD II Phase 3 trial. Exercise of the warrants in full would 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 the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the sale of the securities for its ongoing SHIELD II Phase 3 clinical trial, working capital and general corporate purposes. The gross proceeds from the financing extend PolyPid’s cash runway into the third quarter of 2025, beyond expected top-line results from SHIELD II.
Proceeds of all warrants issued in this transaction, if exercised, would provide the Company with capital beyond NDA approval.
Citizens JMP is acting as exclusive placement agent in the offering.
The offer and sale of the foregoing securities are being made in a transaction not involving 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 such applicable state securities laws. Pursuant to a registration rights agreement with the PIPE investors, the Company has agreed to file within 30 calendar days of closing one or more registration statements with the Securities and Exchange Commission (the "SEC") covering the resale of the Ordinary Shares and Ordinary Shares issuable upon exercise of the warrants and pre-funded warrants.
This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.
About SHIELD IISHIELD 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-PLEX100administered 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 enrolls patients in centers in the United States, Europe and Israel.
About D-PLEX100D-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-PLEX100into 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-PLEX100received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100is 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
Forward-looking StatementsThis 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 completion of enrollment of the SHIELD II trial, expected timing for top-line results from the SHIELD II trial, potential NDA and MAA submissions, potential clinical benefits of D-PLEX100, including safety and efficacy, pre-launch activities and partnership discussions, the gross proceeds to be received from the PIPE, intended use of proceeds from the PIPE, the anticipated closing date for the PIPE, the anticipated gross proceeds from the exercise of warrants issued in the PIPE if such warrants are exercised in full, that the gross proceeds from the financing extend the Company’s cash runway into the third quarter of 2025, that proceeds of all warrants issued in this transaction, if exercised, would provide the Company with capital beyond NDA approval, and the potential addition of
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Contacts:PolyPid Ltd.
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Source: PolyPid Ltd.