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. (PYPD) unveiled an expanded pipeline strategy and introduced PD01B, a product candidate for moderate to severe diabetic foot infections. Built on Kynatrix technology, PD01B is designed to deliver doxycycline locally after wound debridement. PolyPid expects a pre-IND meeting and first-in-human study in the second half of 2027.
The company’s lead candidate, D-PLEX₁₀₀, is under FDA Priority Review with a November 28, 2026 PDUFA goal date. A U.S. launch is expected in early 2027, subject to FDA approval. PolyPid reported positive Phase 3 SHIELD II results, including a 60% relative risk reduction at the secondary endpoint (p=0.0013). Its timeline places initiation of FDA communications on additional abdominal-surgery label expansion in the fourth quarter of 2026, with potential expansion in 2028.
PolyPid Ltd. announced that the European Medicines Agency validated its marketing authorization application for D-PLEX₁₀₀, confirming the application is complete and starting formal review by its Committee for Medicinal Products for Human Use. PolyPid submitted the application on September 14, 2026, under the Centralized Procedure based on therapeutic innovation. If approved, D-PLEX₁₀₀ would receive one marketing authorization valid across European Union member states.
The U.S. Food and Drug Administration has accepted the drug’s New Drug Application for Priority Review, with a November 28, 2026 PDUFA goal date. PolyPid says the Phase 3 SHIELD II trial met its primary and all key secondary endpoints and showed a 60% relative risk reduction in surgical site infections compared with standard of care (p=0.0013).
PolyPid Ltd. (PYPD) and ADVANZ PHARMA mutually terminated their 2022 exclusive License, Distribution and Supply Agreement for D-PLEX₁₀₀ in Europe, and the exclusive European commercialization rights reverted to PolyPid. The agreement was dated August 2, 2022. PolyPid also cited completion of its Phase 3 SHIELD II trial and submission of its New Drug Application to the U.S. Food and Drug Administration, an EMA submission, and its North American commercialization partnership with Azurity Pharmaceuticals. The company described these as milestones achieved since entering the European agreement.
PolyPid Ltd. received an amended Schedule 13G/A from a group of related investors led by Xenia Venture Capital Limited and its upstream holding structure. The filing reports beneficial ownership of up to 2,722,707 Ordinary Shares for Rodney Hodges, Geneva Holding Company (GHC) SA and Geneva Trust Company (GTC) SA, each representing 13.4% of PolyPid’s 20,311,766 Ordinary Shares outstanding as of June 30, 2026. Centaurus Investments Limited reports beneficial ownership of 2,624,307 shares (12.9%), and Xenia Venture Capital Limited reports 1,892,462 shares (9.3%).
The ownership figures include 860,764 warrants held by Xenia and 274,471 warrants held by Oriella Limited, which are described as exercisable within 60 days of August 13, 2026. The structure places Xenia under Centaurus, which is ultimately controlled through Geneva Trust Company (as trustee of VT Two Trust) and Geneva Holding Company, whose entire share capital is held by Rodney Hodges. Hodges states he does not make day‑to‑day voting or investment decisions and disclaims beneficial ownership except to the extent of his pecuniary interest.
PolyPid Ltd. reported interim results for the six months ended June 30, 2026, showing an operating loss of $15.6 million and a net loss of $15.6 million, improved from a $18.2 million net loss a year earlier. Cash, cash equivalents and restricted deposits totaled $6.8 million, with total assets of $15.2 million and shareholders’ equity of $5.4 million.
The company completed the SHIELD II Phase 3 trial of D‑PLEX100 with statistically significant results and has submitted a New Drug Application to the FDA, expecting a potential decision in the fourth quarter of 2026. On July 17, 2026, PolyPid entered a license and supply agreement with Azurity, receiving a $15 million upfront payment and earning an additional $15 million upon FDA acceptance of the NDA, and is eligible for over $290 million in future milestones plus tiered mid‑teen to mid‑twenties royalties and product supply revenue.
Despite these advances, management disclosed that funding secured to date is insufficient to support operations for at least one year from approval of the statements, and there is substantial doubt about the company’s ability to continue as a going concern. PolyPid repaid its secured loan with Kreos in May 2026 and continues to rely on equity offerings and warrant exercises for liquidity.
Rosalind Advisors Inc., Rosalind Master Fund L.P., Steven Salamon, and Gilad Aharon report beneficial ownership in PolyPid Ltd. common shares. Based on 19,174,078 ordinary shares outstanding as of March 31, 2026, each reporting person is shown on the cover pages with 5,124,011 shares and 9.9% of the class, which reflects common shares plus shares issuable upon full warrant exercise without giving effect to ownership blockers.
The narrative ownership discussion states Rosalind Master Fund L.P. may be deemed to beneficially own 565,655 common shares, or about 2.95% of the class, excluding 4,558,356 warrant shares because a 9.99% blocker provision prevents warrant exercises that would push ownership above that threshold. Rosalind Advisors Inc. and Mr. Salamon may be deemed beneficial owners through their advisory and portfolio management roles but expressly disclaim beneficial ownership.
PolyPid Ltd. reported second-quarter and first-half 2026 results and key regulatory milestones. The FDA accepted the NDA for lead product D-PLEX₁₀₀ with Priority Review, setting a PDUFA goal date of November 28, 2026, approximately one quarter earlier than previously guided. The company also entered an exclusive U.S. and Canada commercialization partnership with Azurity Pharmaceuticals, receiving $30 million in upfront and near-term milestone payments following NDA acceptance, with the potential for over $290 million in additional milestones plus tiered royalties up to the mid-twenties percentages. A potential U.S. commercial launch by Azurity is targeted for early 2027.
For the six months ended June 30, 2026, PolyPid recorded a net loss of $15.6 million, improving from a $18.2 million loss a year earlier, with basic and diluted loss per share of $0.70 versus $1.48. For the second quarter, net loss was $7.8 million compared to $10.0 million in 2025, or $0.35 per share versus $0.78. Total assets declined to $15.2 million from $22.3 million at year-end 2025, and shareholders’ equity decreased to $5.4 million from $11.0 million, while ordinary shares outstanding increased to 20.3 million.
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.