Pentixapharm Holding AG: FDA grants "Study May Proceed" for Phase 3 Study; Intended Capital Increase with Subscription Rights of up to 10 Million Shares; BaFin Financial Reporting Enforcement Review of the 2024 Consolidated Financial Statements

DISCLOSURE OF INSIDE INFORMATION PURSUANT TO ART. 17 OF REGULATION (EU) No. 596/2014 (MARKET ABUSE REGULATION)

BERLIN, June 9, 2026 /PRNewswire/ -- Pentixapharm Holding AG: FDA grants "Study May Proceed" for PANDA Phase 3 Study; Intended Capital Increase with Subscription Rights in a Volume of Up to 10 Million Shares; BaFin Financial Reporting Enforcement Review of the 2024 Consolidated Financial Statements.

• PANDA Phase 3 Study to commence in the second half of 2026
• Capital increase with subscription rights intended; major shareholder Eckert Wagniskapital intends to fully exercise its subscription rights
• Information on key aspects of an ongoing financial reporting enforcement proceeding by the German Federal Financial Supervisory Authority (BaFin) to ensure transparency

1. FDA grants "Study May Proceed" for the pivotal Phase 3 registrational PANDA trial

Pentixapharm Holding AG (ISIN: DE000A40AEG0) has received clearance from the FDA for the Investigational New Drug (IND) application for its lead program PentixaFor within the 30-day review period. The planned multi-center Phase 3 study PANDA in the United States can now be initiated with approximately 270 patients with primary aldosteronism, with the aim of replacing and expanding the existing diagnostic procedure for patient subtyping. Preparations for the activation of study sites are proceeding as planned; enrollment of the first patient is expected in the second half of 2026.

The registration-relevant Phase 3 study PANDA is designed on the basis of extensive regulatory interactions with the FDA, including formal feedback from a Type B Pre-IND meeting. The study aims to evaluate a novel imaging approach for the classification of patients with primary aldosteronism, who predominantly suffer from difficult-to-control or treatment-resistant hypertension. This classification forms a key basis for the treatment decision and enables the selection between a surgical and a medical therapy pathway.

In the United States alone, primary aldosteronism is the underlying cause of treatment resistance in 6.5–7 million hypertensive patients. Compared to the currently used diagnostic procedure, the Executive Board considers PentixaFor to offer a simpler process, a lower burden for both physicians and patients, and a precise diagnosis at reduced costs. The US market launch is planned for 2030.

2. Intended Capital Increase Against Cash Contributions with Subscription Rights; Major Shareholder Eckert Wagniskapital Intends to Fully Exercise Its Subscription Rights

To finance key steps of the PANDA Phase 3 trial as well as the Company's further corporate development and expansion in the US market, Pentixapharm Holding AG intends to increase the Company's share capital by issuing up to 10,000,000 new no-par value registered shares against cash contributions from authorized capital. Based on current planning, the capital measure is intended to generate gross proceeds of at least EUR 20 million. 

The new shares are to be offered to existing shareholders by way of statutory subscription rights. The implementation is intended to be effected by way of indirect subscription rights. Eckert Wagniskapital und Frühphasenfinanzierung GmbH, the Company's major shareholder holding just under 36% of the shares in Pentixapharm Holding AG, has informed the Company that, if the capital increase is implemented, it intends to fully exercise its subscription rights within the framework of the subscription offer.

The Executive Board and Supervisory Board will resolve on the capital measure and determine the further details of the capital increase at a later time.

3. BaFin Financial Reporting Enforcement Review of the 2024 Consolidated Financial Statements

In order to ensure transparency in view of the capital measure, Pentixapharm Holding AG is providing information on an ongoing financial reporting enforcement review of the consolidated financial statements as of December 31, 2024 by the German Federal Financial Supervisory Authority (BaFin) as part of its random sampling-based supervision of corporate financial statements. Pentixapharm Holding AG has until June 25, 2026 to comment on a draft administrative decision by which BaFin intends, pursuant to Section 109 para. 1 sentence 1 of the German Securities Trading Act (WpHG), to determine that the published consolidated financial statements as of December 31, 2024 contain several errors and to publish those findings pursuant to Section 109 para. 2 WpHG.

Following careful review and consultation with the Company's auditors, the Executive Board of the Company is of the view that the consolidated financial statements as of December 31, 2024, do not contain any material errors within the meaning of Section 109 WpHG and will submit a timely and substantive response to BaFin. The matters primarily relate to balance sheet items, including intangible assets, capital reserves, and equity. Any correction would also affect the consolidated financial statements for fiscal years following fiscal year 2024, but would not have any cash impact and, in the Company's assessment, would not have any material impact on its operating activities, liquidity, or business prospects.

According to BaFin's preliminary view, the intangible assets recognized in the consolidated financial statements as of December 31, 2024, in particular, are overstated by EUR 34.7 million. This relates to development costs recognized in connection with the spin-off, for which BaFin considers the capitalization requirements not to have been met. In the event of a corresponding correction, intangible assets, equity, and thus balance sheet total would decrease accordingly. In addition, BaFin has objected to the accounting treatment of a sale of patents and licenses, which would have no effect on profit or loss, as well as to the disclosure of the ultimate controlling party and, on that basis, the absence of comparative and prior-year information regarding business activities prior to the acquisition of Pentixapharm AG, the disclosures on Management Board remuneration, and disclosures on transactions with related parties.

The above summary of BaFin's objections is provided in condensed form and is not exhaustive. If, contrary to the assessment of the Management Board, BaFin's view is confirmed in whole or in part, a formal finding of error and publication thereof by BaFin would be expected. In that event, the Company would have the option to take legal action against any such finding of error.

Pentixapharm Holding AG, Berlin
The Executive Board
Contact: [email protected]

Media Contact: [email protected] 

SOURCE Pentixapharm Holding AG