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
EQS-Ad-hoc: Pentixapharm Holding AG / Key word(s): Capital measures /
Capital increase
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
09-Jun-2026 / 07:45 CET/CEST
Disclosure of an inside information acc. to Article 17 MAR of the Regulation
(EU) No 596/2014, transmitted by EQS News - a service of EQS Group.
The issuer is solely responsible for the content of this announcement.
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- English -
DISCLOSURE OF INSIDE INFORMATION PURSUANT TO ART. 17 OF REGULATION (EU) No.
596/2014 (MARKET ABUSE REGULATION)
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.
09 June 2026
Pentixapharm Holding AG, Berlin
The Executive Board
Contact: ir@pentixapharm.com
End of Inside Information
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Language: English
Company: Pentixapharm Holding AG
Robert-Rössle-Straße 10
13125 Berlin
Germany
E-mail: info@pentixapharm.com
Internet: https://www.pentixapharm.com/
ISIN: DE000A40AEG0
WKN: A40AEG
Listed: Regulated Market in Frankfurt (Prime Standard);
Regulated Unofficial Market in Dusseldorf, Hamburg,
Hanover, Munich, Stuttgart, Tradegate BSX
EQS News ID: 2341822
End of Announcement EQS News Service
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2341822 09-Jun-2026 CET/CEST