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ProQR Therapeutics N.V. submitted a report as a foreign private issuer to make public a new press release titled “ProQR Announces Encouraging AX-0810 Phase 1 Safety and PK Data, Development Candidate Selections, and 2026 Outlook.” The press release, attached as an exhibit, highlights early safety and pharmacokinetic results for the AX-0810 program, the selection of development candidates, and the company’s outlook for 2026. ProQR also states that this information is incorporated by reference into several of its existing Form F-3 registration statements.
ProQR Therapeutics N.V. has filed a Form 6-K furnishing unaudited financial statements for the three and nine-month periods ended September 30, 2025, and a related press release. The press release, titled “ProQR Announces Third Quarter 2025 Operating and Financial Results,” also provides a business update.
The information in this report, including the exhibits, is incorporated by reference into ProQR’s existing shelf registration statements on Form F-3. This links the latest quarterly financial and operating information directly to ProQR’s current securities registration framework.
ProQR Therapeutics N.V. filed a Form 6-K noting it hosted a virtual analyst and investor event titled “Entering the Clinic with AX-0810: Establishing Safety, PK, and the Biomarker Roadmap for Proof of Target Engagement.” The session covered its AX-0810 lead program, a strategic overview, and corporate outlook.
The related investor presentation is furnished as Exhibit 99.1. The company states that the information is incorporated by reference into its Form F-3 registration statements (File Nos. 333-282419, 333-270943, 333-263166, and 333-285767).
Van Herk group disclosed ownership of 14,329,690 ordinary shares of ProQR Therapeutics N.V. (PRQR), representing 13.6% of the company based on 105,344,052 shares outstanding as of June 30, 2025. The filing (Amendment No. 3 to a Schedule 13D) reports that Van Herk Investments B.V. purchased 1,055,000 ordinary shares in open-market transactions from September 5, 2025 to September 29, 2025 for an aggregate net amount of $2,300,635.14 using its general working capital. The reporting group is a network of Netherlands entities and related parties coordinated through Adrianus van Herk, and they state the shares were acquired for investment purposes in the ordinary course of business and that they may review or change their position over time, including engaging with management, acquiring or selling shares, or pursuing other strategic actions.
Van Herk group now holds a 12.6% stake in ProQR Therapeutics N.V. The Schedule 13D/A reports that Van Herk Investments B.V. and affiliated entities beneficially own 13,274,690 ordinary shares out of 105,344,052 outstanding shares as of June 30, 2025. From August 20, 2025 to September 3, 2025, Van Herk Investments B.V. purchased 1,072,500 ordinary shares in open market transactions for an aggregate net amount of $2,401,687.56, funded from its general working capital. The filing states the shares were acquired for investment purposes and that the Reporting Persons will continue to review their investment and may, depending on circumstances, communicate with management or the board, make proposals regarding capitalization or board composition, buy or sell shares, or use hedging or derivative transactions.
Van Herk Investments and affiliated entities report beneficial ownership of 12,202,190 ordinary shares of ProQR Therapeutics N.V., representing 11.6% of the 105,344,052 shares outstanding. The Schedule 13D/A states that Van Herk Investments B.V. purchased 700,195 shares in open market transactions between June 12, 2025 and July 21, 2025 for a total net amount of $1,319,201.27, funded from its general working capital.
The filing adds that on August 19, 2025 Van Herk sent a follow-up letter urging ProQR's board to limit the terms of two directors to the 2026 AGM, explain the rationale for one reappointment, present a board rotation plan and commit to governance standards. The reporting persons state their shares were acquired for investment purposes and reserve the right to engage in communications with management, pursue transactions, buy or sell shares or use derivatives in the future.
Adage Capital Management reports a passive beneficial ownership position in ProQR Therapeutics N.V., holding 6,601,938 ordinary shares, which represents 6.27% of the company's 105,212,527 ordinary shares outstanding (per the company's annual report). The shares are held directly by Adage Capital Partners, L.P., for which Adage Capital Management acts as investment manager, and the filing shows shared voting and shared dispositive power for the reported position.
The Schedule 13G filing is made as a passive disclosure: the Reporting Persons certify the securities were acquired and are held in the ordinary course of business and not for the purpose of changing or influencing control of the issuer. The filing names the reporting entities and key individuals and identifies their principal business address.
ProQR Therapeutics has submitted a Clinical Trial Application (CTA) for a Phase 1 study of AX-0810, a novel drug candidate targeting NTCP (sodium taurocholate co-transporting polypeptide). This regulatory filing marks a significant milestone in the company's drug development pipeline.
Key points from the Form 6-K filing:
- The announcement was made via press release on June 26, 2025
- The filing includes a press release as Exhibit 99.1
- The information is being furnished under Form 6-K and is not considered "filed" under Section 18 of the Securities Exchange Act
- The document was signed by Dennis Hom, Chief Financial Officer
This development represents a strategic advancement in ProQR's clinical program, potentially expanding their therapeutic portfolio. The CTA submission indicates the company is progressing toward clinical trials for AX-0810, which could have implications for investors following ProQR's drug development pipeline.