Eckert & Ziegler Subsidiary Pentixapharm Receives Encouraging FDA Feedback
to Initiate Phase III Trial with PentixaFor as Radiopharmaceutical Diagnostic in
Primary Aldosteronism

EQS-News: Eckert & Ziegler SE / Key word(s): Study
Eckert & Ziegler Subsidiary Pentixapharm Receives Encouraging FDA Feedback
to Initiate Phase III Trial with PentixaFor as Radiopharmaceutical
Diagnostic in Primary Aldosteronism

25.06.2024 / 12:00 CET/CEST
The issuer is solely responsible for the content of this announcement.

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Würzburg/Berlin, Germany, 25 June 2024. Pentixapharm AG, a
radiopharmaceutical development company wholly owned by Eckert & Ziegler SE,
today announced that it has received encouraging feedback from the U.S. Food
and Drug Administration (FDA) following a recent Type C meeting with the
Agency to directly proceed into a pivotal phase III registration study with
its radiopharmaceutical diagnostic Ga68-PentixaFor in Primary Aldosteronism
(PA). PA is an adrenal gland disorder also known as Conn's syndrome and the
most frequent cause of secondary hypertension (high blood pressure).

While the FDA minutes from the Type C meeting do not constitute a formal
approval of a particular development plan, they indicate that the clinical
data compiled by various academic groups independently from Pentixapharm
might serve as confirmatory evidence, relieving the Company of the
requirement to conduct a second well-controlled clinical investigation. The
minutes also confirm that Ga68-PentixaFor addresses an unmet medical need
for a serious condition and therefore meets two essential criteria for fast
track and breakthrough designation, which Pentixapharm can request with its
Investigational New Drug (IND) submission to initiate the phase III trial.

Ga68-PentixaFor is a novel tracer used in the positron emission tomography
(PET) imaging of aldosterone-hypersecreting adenomas in patients diagnosed
with PA. The estimated prevalence of this disease has increased considerably
over the years, exceeding 20% in some populations of resistant hypertension1.
The disorder is characterized by either a unilateral aldosterone-producing
adenoma (APA) or bilateral adrenal hyperplasia (BAH). The current gold
standard for differentiating these conditions is adrenal venous sampling
(AVS), a complex and invasive procedure. The vast majority of patients with
unilateral PA who undergo adrenalectomy after successful AVS experience
complete biochemical normalization2. However, there is a risk of
misdiagnosing a bilateral case, in which a patient would not benefit from
the removal of the gland.

Dr. Dirk Pleimes, Chief Scientific & Medical Officer at Pentixapharm AG,
commented: 'The FDA feedback represents a major milestone for our Company in
the development of our lead diagnostic. We aim to evaluate Ga68-PentixaFor
as a first-in-class, non-invasive and accurate alternative to adrenal venous
sampling, offering the potential to transform diagnostic subtyping in
Primary Aldosteronism and improve patient outcomes. This discussion with US
regulatory authorities provided important feedback, enabling us to proceed
to a US-centric registrational Phase III trial to support global
authorization applications.'

About Pentixapharm AG
Pentixapharm is a radiopharmaceutical development company founded in 2019,
with its headquarters in Würzburg, Germany. It is wholly owned by the Eckert
& Ziegler Group, one of the world's largest providers of isotope technology
for medical, scientific and industrial use. Pentixapharm is committed to
developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches
with a clear commercial pathway for diagnostic and therapeutic programs in a
number of hematological and solid cancers, as well as cardiovascular and
endocrine diseases.

(1) Yozamp N, Vaidya A. The Prevalence of Primary Aldosteronism and Evolving
Approaches for Treatment. Curr Opin Endocr Metab Res. 2019 Oct;8:30-39. doi:
10.1016/j.coemr.2019.07.001. Epub 2019 Jul 9. PMID: 32832727; PMCID:
PMC7442120.

(2) Zhou, Y., Zhang, M., Ke, S., & Liu, L. (2017). Hypertension outcomes of
adrenalectomy in patients with primary aldosteronism: a systematic review
and meta-analysis. BMC endocrine disorders, 17(1), 1-9.

For more information, please contact:

Eckert & Ziegler SE
Karolin Riehle, Investor Relations
Robert-Rössle-Str. 10,
13125 Berlin, Germany
Tel.: +49 30 94 10 84-138
karolin.riehle@ezag.de, www.ezag.com

Pentixapharm AG
Phillip Eckert, Investor Relations
phillip.eckert@pentixapharm.com
Tel. +49 30 94 10 84 227
www.pentixapharm.com

Media Contact:
MC Services AG
Anne Hennecke
anne.hennecke@mc-services.eu
Tel. +49 211 529252 22


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25.06.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS
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The issuer is solely responsible for the content of this announcement.

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   Language:       English
   Company:        Eckert & Ziegler SE
                   Robert-Rössle-Str.10
                   13125 Berlin
                   Germany
   Phone:          +49 30 941084-138
   Fax:            +49 30 941084-0
   Internet:       www.ezag.de
   ISIN:           DE0005659700
   WKN:            565970
   Indices:        SDAX, TecDax,
   Listed:         Regulated Market in Frankfurt (Prime Standard);
                   Regulated Unofficial Market in Berlin, Dusseldorf,
                   Hamburg, Munich, Stuttgart, Tradegate Exchange
   EQS News ID:    1931807

End of News EQS News Service
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1931807 25.06.2024 CET/CEST