Welcome to our dedicated page for PolyPid Ltd. SEC filings (Ticker: PYPD), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
PolyPid Ltd. filings document foreign private issuer disclosures for a biopharmaceutical company developing PLEX-based controlled-release therapeutics. Form 6-K reports furnish corporate updates, financial results, FDA and NDA-related disclosures for D-PLEX100, SHIELD II clinical and pharmacokinetic information, GMP inspection updates, and business-operation summaries.
The company’s regulatory record also covers capital-structure and governance matters, including ordinary-share sales agreement disclosures, legal opinions tied to share issuance, Form F-3 and Form S-8 registration statement references, shareholder meeting results, board composition, director compensation approvals, and risk and operating disclosures incorporated into its SEC registration framework.
PolyPid Ltd. announced that the U.S. Food and Drug Administration accepted for filing its New Drug Application and granted Priority Review for D-PLEX100 to prevent surgical site infections in patients undergoing abdominal colorectal surgery. The FDA reported no filing review issues and set a PDUFA target action date of November 28, 2026, about one quarter earlier than the company’s previously communicated first-quarter 2027 timing.
Acceptance of the NDA triggers a $15 million milestone payment from Azurity Pharmaceuticals, completing $30 million in upfront and near-term milestones under their U.S. and Canada commercialization partnership. D-PLEX100 uses PolyPid’s Kynatrix technology to release doxycycline locally for 30 days and in the Phase 3 SHIELD II trial achieved its primary endpoint and a 60% relative risk reduction (p=0.0013) in surgical site infection incidence, and it holds FDA Breakthrough Therapy Designation.
PolyPid Ltd. entered into a 20-year exclusive License and Supply Agreement with Azurity Pharmaceuticals Ireland Ltd., granting Azurity rights to commercialize D-PLEX100 in the United States and Canada. PolyPid will receive an upfront payment of $15 million on execution and a further near-term milestone of $15 million upon expected U.S. FDA acceptance of the D-PLEX100 New Drug Application. PolyPid is also eligible for up to approximately $300 million in additional regulatory, development and sales-based milestone payments. Upon commercialization, PolyPid will manufacture and supply D-PLEX100 to Azurity for a transfer price and receive tiered royalties ranging from mid-teen to mid-twenties percentages. The parties may collaborate on label expansions for additional surgical site infection indications, with Azurity funding related development, while PolyPid retains rights outside the Territory, global manufacturing, and full ownership of its PLEX/Kynatrix platform.
PolyPid Ltd. granted Chief Operating Officer – US Ori Warshavsky a stock option for 46,000 Ordinary Shares with an exercise price of 4.4600 per share. The option vests quarterly from May 11, 2026 through May 11, 2030 and expires on May 11, 2036.
PolyPid Ltd. reported that Chief Financial Officer Jonathan Missulawin received a grant of stock options for 49,000 Ordinary Shares on May 11, 2026. The options have an exercise price of $4.46 per share, an exercise date of August 11, 2026, and expire on May 11, 2036. According to the vesting terms, they vest on a quarterly basis beginning May 11, 2026 until May 11, 2030, leaving him with 49,000 options outstanding.
PolyPid Ltd. granted its Deputy CEO, EVP, RD, CRA, Dalit Fellous Hazan 75,000 stock options on May 11, 2026, with an exercise price of $4.4600 per share for 75,000 Ordinary Shares.
The options vest on a quarterly basis from May 11, 2026 until May 11, 2030 and expire on May 11, 2036; following this grant she holds 75,000 options directly.
PolyPid Ltd. director Barenholz Yechezkel reported a grant of stock options covering 9,132 Ordinary Shares at an exercise price of 4.46 per share. The options vest on a quarterly basis beginning July 15, 2026 until April 15, 2030 and expire on 2036-07-15, leaving him holding 9,132 options directly.
Stein Robert Benjamin reported acquisition or exercise transactions in this Form 4 filing.
PolyPid Ltd. director Robert Benjamin Stein received a grant of 9,132 stock options to purchase Ordinary Shares at $4.46 per share. The options vest on a quarterly basis beginning July 15, 2026 until April 15, 2030 and expire on July 15, 2036. Following this grant, he holds 9,132 options directly.
PolyPid Ltd. director Dror-Darwish Nir received a grant of stock options covering 9,132 Ordinary Shares. The options have an exercise price of $4.46 per share, vest quarterly beginning July 15, 2026 until April 15, 2030, and expire on July 15, 2036. Following this award, he holds options for 9,132 shares, reported as direct ownership. The transaction is categorized as a grant or award acquisition rather than an open-market trade.
PolyPid Ltd. director Joseph BenAmram reported a compensation grant of stock options to acquire 9,132 Ordinary Shares. The options have an exercise price of $4.46 per share and expire on July 15, 2036. They vest on a quarterly basis beginning July 15, 2026 until April 15, 2030, and this award brings his reported stock option holdings to 9,132 options.
PolyPid Ltd. reported that director Itzhak Krinsky received a grant of stock options for 9,132 Ordinary Shares at an exercise price of $4.4600 per share. The options vest on a quarterly basis from July 15, 2026 until April 15, 2030 and expire on July 15, 2036.