Pentixapharm Holding AG
ISIN: DE000A40AEG0
WKN: A40AEG
29 October 2024 11:46AM

EQS-News: Pentixapharm Holding AG: US National Cancer Institute Starts Advanced Clinical Trial with PentixaFor

Pentixapharm Holding AG · ISIN: DE000A40AEG0 · EQS - Company News
Country: Germany · Primary market: Germany · EQS NID: 2018285

EQS-News: Pentixapharm Holding AG / Key word(s): Study
Pentixapharm Holding AG: US National Cancer Institute Starts Advanced Clinical Trial with PentixaFor

29.10.2024 / 11:46 CET/CEST
The issuer is solely responsible for the content of this announcement.


Berlin and Würzburg, Germany, October 29, 2024 – The National Cancer Institute (NCI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), two highly respected research organizations belonging to the US government's National Institutes of Health (NIH), have started a clinical trial involving 77 patients to see if Pentixapharm’s new radioactive tracer PentixaFor ([68Ga]Ga-PentixaFor) can make it easier to identify functional adrenal tumors through positron emission tomography (PET) scans.

The FDA-endorsed and US-located investigator-initiated phase II study, conducted by Dr. Liza Lindenberg and Prof. Dr. Peter Choyke (Clinical Trial number: NCT06246357) investigates the performance of PentixaFor in subtyping hormone-secreting adenomas in people suffering from primary aldosteronism (PA) or hypercortisolism (Cushing´s syndrome). The first patient was recently examined.

Primary aldosteronism is among the most common causes of secondary hypertension, a disorder affecting tens of millions of people in the United States alone. In some subtypes PA can be cured completely through a short surgical intervention, so finding a reliable tool for accurate subtyping is important and potentially beneficial to a large segment of the population. In contrast, Cushing's syndrome, also described as hypercortisolism, is a rare endocrine disorder designated as an orphan disease that is caused by chronic exposure of the body's tissues to excess levels of cortisol.

Pentixapharm itself is currently preparing a US-centric Phase III pivotal study to obtain marketing authorization for PentixaFor in PA. The work of the NCI/NIDDK will add to the global clinical evidence about the compound and make it easier to compile the necessary data.

“We are pleased that the NIH investigate the clinical value of PentixaFor at its own initiative and see this as a token of confidence in the potential of CXCR4 targeting imaging in unexplored indications expanding market opportunities for PET/CT diagnostics. In our opinion, PentixaFor has broad potential as a novel imaging modality for adrenal diseases and could be particularly helpful for individuals grappling with primary aldosteronism-induced resistant hypertension or Cushing’s disease,” stated Dr. Dirk Pleimes, Group CEO and Chief Medical Officer at Pentixapharm. 

About Pentixapharm

Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with its offices in Berlin and Würzburg, Germany. It 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, endocrine and inflammatory diseases.

PentixaFor (Gallium (68Ga) boclatixafortide) is an innovative PET tracer that specifically targets the chemokine-4 receptor (CXCR4), with broad applications in oncological, cardiovascular, and inflammatory diseases. Particularly in hypertension, PentixaFor has the potential to significantly improve patient management by identifying the presence of hormone-secreting adenomas through non-invasive and broadly available PET/CT imaging.

Apart from PentixaFor, the clinical pipeline also encompasses PentixaTher, an Yttrium-90 or Lutetium-177 based therapeutic against non-Hodgkin lymphomas (NHL). Clinical studies for both compounds have already commenced in Europe, including a dose-finding study for PentixaTher and a Phase III registration study for PentixaFor in marginal zone lymphoma. Recently, the EMA granted PRIME status to PentixaFor in the indication PA.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com



29.10.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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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 Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2018285

 
End of News EQS News Service

2018285  29.10.2024 CET/CEST

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The most important financial data at a glance
  2018 2019 2020 2021 2022 2023 2024e
Sales1 0,00 0,00 0,07 0,06 0,05 1,77 0,00
EBITDA1,2 0,00 0,00 -1,85 -4,07 -5,89 -10,62 0,00
EBITDA-Margin3 0,00 0,00 -2.642,86 -6.783,33 -11.780,00 -600,00 0,00
EBIT1,4 0,00 0,00 -1,92 -4,18 -6,00 -10,76 0,00
EBIT-Margin5 0,00 0,00 -2.742,86 -6.966,67 -12.000,00 -607,91 0,00
Net Profit (Loss)1 0,00 0,00 -1,92 -4,18 -1,96 -7,64 -8,00
Net-Margin6 0,00 0,00 -2.742,86 -6.966,67 -3.920,00 -431,64 0,00
Cashflow1,7 0,00 0,00 -1,85 -2,49 -2,20 2,13 0,00
Earnings per share8 0,00 0,00 -0,08 -0,17 -0,08 -0,30 -0,32
Dividend per share8 0,00 0,00 0,00 0,00 0,00 0,00 0,00
Quelle: boersengefluester.de and Company information
Explanation

1 in Mio. Euro; 2 EBITDA = Earnings before interest, taxes, depreciation and amortisation; 3 EBITDA in relation to sales; 4 EBIT = Earnings before interest and taxes; 5 EBIT in relation to sales; 6 Net profit (-loss) in relation to sales; 7 Cashflow from operations; 8 in Euro; Source: boersengefluester.de

Auditor: Forvis Mazars

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INVESTOR-INFORMATION
©boersengefluester.de
Pentixapharm Holding
WKN ISIN Legal Type Marketcap IPO Recommendation Plus Code
A40AEG DE000A40AEG0 AG 69,55 Mio € 03.10.2024 8FXFRW2H+CF
* * *
PE 2025e PE 10Y-Ø BGFL-Ratio Shiller-PE PB PCF KUV
0,00 0,00 0,00 -3,12 1,43 32,70 39,29
Dividends
Dividend '2022
in €
Dividend '2023
in €
Dividend '2024e
in €
Div.-Yield '2024e
in %
0,00 0,00 0,00 0,00%
Financial calendar
Annual General Meeting Q1-figures Q2-figures Q3-figures Annual press conference
27.05.2025 08.05.2025 06.08.2025 12.11.2024 10.04.2025
Performance
Distance 60-days-line Distance 200-days-line Performance YtD Performance 52 weeks IPO
Last Price (EoD)
-6,19%
2,81 €
ATH 5,15 €
0,00% 0,00% +0,00% +0,00% -45,00%

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