Pentixapharm Welcomes CMS Decision to Enhance Reimbursement for Diagnostic Radiopharmaceuticals

Berlin and Würzburg, Germany, November 4, 2024 – Pentixapharm, a biopharmaceutical company developing innovative first-in-class radiopharmaceuticals, welcomes the recent announcement by the U.S. Centers for Medicare & Medicaid Services (CMS) to implement separate payments for specialized diagnostic radiopharmaceuticals used in the hospital outpatient setting, extending beyond the transitional pass-through payment period. This significant policy shift could have a direct impact on future reimbursement streams for Pentixapharm’s Ga68-PentixaFor, a diagnostic radiopharmaceutical for which Pentixapharm intends to start a U.S. centric phase III clinical trial next year. The pivotal clinical trial could lead to a U.S. market authorization in primary aldosteronism (PA), one of the major causes of secondary hypertension, as early as 2028.

The CMS pass-through payment period is a temporary reimbursement mechanism under the Hospital Outpatient Prospective Payment System (OPPS). Lasting up to three years, this period provides additional payments for newly introduced medical devices, drugs, and biologicals, encouraging hospitals to adopt cutting-edge technologies by covering their costs beyond standard rates. However, under previous policies, after the pass-through period ended, products would typically revert to standard OPPS payment bundles. With this new policy announcement, CMS has changed this approach, allowing for separate payments beyond the pass-through period for qualifying high-cost diagnostics.

This decision by CMS is highly significant given the size and impact of the Medicare and Medicaid systems, which together insure more than 140 million Americans. As the primary healthcare payer for older adults and individuals with disabilities, CMS’s reimbursement policies shape access to medical innovations across the country. The new rule, effective in 2025, also has the potential to set a market precedent that may influence private insurers to follow CMS’s lead in reimbursing innovative diagnostic tools, further expanding the accessibility of these advanced diagnostics. By providing consistent reimbursement for diagnostic radiopharmaceuticals that exceed a per-day cost threshold of US$630, CMS encourages other insurers to consider similar reimbursement strategies.

The separate payment rule will most likely apply to Pentixapharm's lead diagnostic compound, Ga68-PentixaFor, following its anticipated approval and the expiration of its pass-through status. Ga68-PentixaFor is a novel tracer for positron emission tomography (PET) imaging used to detect aldosterone-hypersecreting adenomas in patients diagnosed with primary Aldosteronism (PA). With rising prevalence rates for PA, now exceeding 20% in some populations with resistant hypertension, the need for accessible and precise diagnostics is greater than ever.

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

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

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, 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

Nuclear Medicine Specialist Ken Herrmann Joins Supervisory Board of Pentixapharm Holding AG

Berlin, Germany, October 28, 2024 – Prof. Dr. Ken Herrmann, a distinguished scientist and Head of the Department of Nuclear Medicine at Universitätsklinikum Essen, Germany, has as of today formally assumed his seat on the Supervisory Board of Pentixapharm Holding AG. While the appointment dates back to the shareholder meeting in June 2024 and has been effective with the registration of the split-off of Pentixapharm AG from Eckert & Ziegler SE in the commercial register, the assumption of his position was up until now hindered by delayed permits to take up secondary employment.

“We are thrilled to welcome Ken Herrmann to our Supervisory Board,” said Dr. Andreas Eckert, Executive Chairman of Pentixapharm Holding AG. “Ken Herrmann is one of the most influential clinicians in the field of radiopharmaceuticals. We look forward to benefiting from his expertise, particularly in advancing our oncology pipeline, which includes Y90-PentixaTher and Ga68-PentixaFor for the treatment and diagnosis of non-Hodgkin lymphomas (NHL).

Prof. Herrmann is an internationally recognized expert in nuclear medicine and theranostics. Apart from his position at the university clinic of Essen, he headed the Chair of the European Association of Nuclear Medicine (EANM) Oncology & Theranostics Committee. He serves as a section editor for The Journal of Nuclear Medicine (JNM) and has (co-)authored over 700 peer-reviewed articles.

After earning his medical degree from Charité Berlin and completing a habilitation in nuclear medicine at Technical University of Munich, Prof. Dr. Herrmann further advanced his education with an executive MBA from the University of Zürich. He frequently shares his expertise at major industry events, including the annual conferences of the EANM and the Society of Nuclear Medicine and Molecular Imaging (SNMMI). Notably, he participated in Pentixapharm’s CXCR4 Symposium at last year's EANM and the 2nd Boston Radionuclide Theranostics Forum hosted by Eckert & Ziegler SE this year.

Prof. Dr. Herrmann joins an esteemed Supervisory Board chaired by Frank Perschmann. Apart from Harald Hasselmann, CEO of Eckert & Ziegler SE and Jens Giltsch, it includes Pentixapharm’s Founder Dr. Hakim Bouterfa and the endocrinologist Prof. Dr. med. Marcus Quinkler, who contributes his experience for the development of Ga68-PentixaFor in the indication of primary aldosteronism, one of the major causes of secondary hypertension.

About Pentixapharm

Pentixapharm is a clinical-stage radiopharmaceutical development company with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceuticals for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

Pentixapharm’s clinical pipeline includes PentixaTher, an Yttrium-90-based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68-based companion diagnostic. 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. Additionally, PentixaFor is being developed as a diagnostic tool for primary aldosteronism (PA), a major cause of hypertension. Pentixapharm is currently preparing a Phase III registration study with PentixaFor in PA that will start in Europe and the United States in 2025.

For more information, please contact:

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

Pentixapharm Holding AG: Upcoming Changes in the Management and Supervisory Boards of the Pentixapharm Group

Berlin, Germany, October 25, 2024 - Following the receipt of various approvals, consents, and registrations, Pentixapharm Holding AG will implement, at the end of October 2024, a series of changes to the group's management bodies.

As announced, Dr. Hakim Bouterfa, founder and CEO of Pentixapharm AG, will step down from his positions on the Management Boards of both Pentixapharm AG and Pentixapharm Holding AG, effective October 27, 2024. He will transition to the Supervisory Board of Pentixapharm Holding AG. This transition does not require a shareholder resolution, as the major shareholder, Eckert Wagniskapital und Frühphasenfinanzierung GmbH, exercised its nomination right, and Dr. Bouterfa accepted the appointment.

Simultaneously, with Dr. Bouterfa’s transition, nuclear medicine specialist Prof. Dr. Ken Herrmann will join the Supervisory Board of Pentixapharm Holding AG. He was appointed to this position at the Annual General Meeting in June 2024 and has now received the necessary consents. The physicist Paola Eckert-Palvarini, who temporarily held this role as an elected substitute, will step down at this time.

Until all changes are formally completed, including the execution of various supplementary agreements, Dr. Andreas Eckert will temporarily assume the role of Executive Chairman on the Management Board of Pentixapharm Holding AG. In the interim, Frank Perschmann will serve as Chairman of the Supervisory Board.

Dr. Dirk Pleimes has been appointed as CEO of Pentixapharm AG by the Supervisory Board, effective October 27, 2024. He will continue to serve as Chief Medical Officer, with no changes to the other operational management positions.

These restructuring measures represent the organizational completion of the spin-off from the former parent company, Eckert & Ziegler SE. A full list of the new management and supervisory board members is expected to be available on the company’s website starting Monday. Biographical information on Prof. Herrmann will be provided in a separate press release upon his assumption of office.

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.

For more information, please contact:

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

Pentixapharm’s CXCR4 Core Compound Subject of 17 Abstract Presentations at the Hamburg European Association of Nuclear Medicine (EANM)

Hamburg, Germany, October 19, 2024 - The CXCR4 targeting compounds developed clinically by Pentixapharm in a number of diagnostic and therapeutic indications are subject of 17 abstract presentations at the 37th Annual Congress of the European Association of Nuclear Medicine (EANM) which takes place in Hamburg from 19 – 23 October 2024. The presentations feature the company’s ongoing theranostic development efforts and CXCR4 targeting research initiatives in areas such as primary aldosteronism, high-grade gliomas, muscle invasive bladder cancer, multiple myeloma, as well as in cardiovascular disease and inflammation. On the economic side, there is an assessment of the economic implications of CXCR4-directed molecular imaging.

Dr. Dirk Pleimes, Pentixapharm’s Chief Medical Officer, commented, “We are excited about the opportunity to highlight the many applications of CXCR4 targeting compounds and the work of our collaborators at one the largest gatherings of nuclear medicine professionals globally. The abstracts accepted from investigator-initiated studies supported by Pentixapharm and others also demonstrate the ongoing interest of academia in CXCR4 and the still untapped potential. We look forward to welcoming friends and collaborators at Pentixapharm’s booth in Hall H, stand H19 for updates and discussions”.

A list of abstracts presentations featuring CXCR4 targeting compounds can be found here.

About Pentixapharm

Pentixapharm is a clinical-stage radiopharmaceutical development company with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceuticals for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

Pentixapharm’s clinical pipeline includes PentixaTher, an Yttrium-90-based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68-based companion diagnostic. 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. Additionally, PentixaFor is being developed as a diagnostic tool for primary aldosteronism (PA), a major cause of hypertension. Pentixapharm is currently preparing a Phase III registration study with PentixaFor in PA that will start in Europe and in the United States in 2025.

For more information, please contact:

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

EMA Grants PRIME Status to Pentixapharm’s Lead Candidate PentixaFor

Disclosure of Insider Information according to Article 17 of Regulation (EU) No. 596/2014

Würzburg and Berlin, Germany, October 18, 2024 - The European Medicine Agency (EMA) has granted PRIME Status to Pentixapharm’s lead candidate Ga68-PentixaFor, thereby granting an early and proactive support for the development of the radiodiagnostic and the possibility of an accelerated approval. The benefits of PRIME status include an early appointment of CHMP or CAT rapporteurs, iterative scientific advice on development plans, introductory meeting on regulatory requirements, and potentially a total fee exemption for scientific advice. The status also confirms that PentixaFor has the potential to address, in primary aldosteronism (PA), an unmet medical need to a significant extent.

PentixaFor is a novel tracer for positron emission tomography (PET) imaging targeting the C-X-C receptor 4 (CXCR4). High expression of CXCR4 has been identified in aldosterone-producing tissue, which is responsible for the aldosterone over-secretion that causes PA. PentixaFor aims to be a non-invasive and accurate alternative to adrenal venous sampling (AVS), the current invasive and difficult Standard of Care procedure, offering the potential to transform diagnostic subtyping in PA.

PRIME is a status granted by the EMA for promising medicines that target an unmet medical need with the goal of optimizing these medicines’ development. The PRIME scheme is based on enhanced interaction and dialogue between EMA and Sponsor, to improve the development plans and speed up the evaluation, so that the medicines can earlier reach the patients. In particular, the PRIME scheme allows iterative scientific advice on the overall development plans and key issues, expedited follow-up scientific advice with shortened timelines, and potential accelerated assessment at the time of application for a marketing authorization. Since the start of the program in 2016, only 139 applications were granted, with Ga68-CXCR4 being the first radiodiagnostic.

Primary aldosteronism, also known as Conn’s syndrome, is an adrenal gland disorder and the most common cause of secondary hypertension. However, it remains difficult to diagnose and to effectively treat with current methods. Pentixapharm is currently preparing a Phase III pivotal study to obtain marketing authorization in PA that will start in 2025.

About Pentixapharm

Pentixapharm is a clinical-stage radiopharmaceutical development company with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceuticals for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

Pentixapharm’s clinical pipeline includes PentixaTher, an Yttrium-90-based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68-based companion diagnostic. 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. Additionally, PentixaFor is being developed as a diagnostic tool for primary aldosteronism (PA), a major cause of hypertension. Pentixapharm is currently preparing a Phase III registration study with PentixaFor in PA that will start in Europe and in the United States in 2025.

For more information, please contact:

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

Pentixapharm Holding AG Completes IPO in the Prime Standard of the Frankfurt Stock Exchange

ADVERTISEMENT: NOT FOR DISTRIBUTION OR ANNOUNCEMENT, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR ANNOUNCEMENT WOULD BE UNLAWFUL

• Spin-off from Eckert & Ziegler SE completed

• First trading price at EUR 5.10

• Market capitalization of EUR 126.5 million

• Book-entry delivery of shares scheduled for next week

• Funding secured for upcoming milestones

Berlin and Würzburg, Germany, October 3, 2024 – Pentixapharm Holding AG (“Pentixapharm”) made its debut today in the Prime Standard of the Frankfurt Stock Exchange under the ticker symbol PTP and the international securities identification number (ISIN) DE000A40AEG0. The initial trading price was EUR 5.10, resulting in a market capitalization of EUR 126.5 million at the start of trading. The biopharmaceutical company focuses on developing innovative first-in-class radiopharmaceuticals for the diagnosis and therapy (theranostics) of blood cancers and other widespread indications that are currently untreated by radiopharmaceuticals.

The spin-off from Eckert & Ziegler SE was completed yesterday following registration in the commercial register. As an independent listed company, Pentixapharm is financially well-positioned with approximately EUR 19.9 million in gross proceeds from the IPO placement, along with additional funding from the issuance of a convertible bond worth EUR 18.5 million to Eckert & Ziegler SE. This solid financial base allows Pentixapharm to continue advancing its growth strategy, with a focus on the clinical development and approval of its lead candidates Ga68-PentixaFor and Y90-PentixaTher.

Dr. Hakim Bouterfa, CEO of Pentixapharm Holding AG, stated: “We are thrilled by the strong interest shown by investors and the media in our IPO. The listing provides us with the flexibility to finance our growth in stages and to continually attract new investors who want to share in Pentixapharm’s long-term success. Through partnerships with leading companies in the biopharma industry, we aim to expand both our technological and commercial reach.”

Today’s listing included both the existing shares and the spin-off shares. The offer shares will be traded starting October 10, 2024, following the registration of the capital increase in the commercial register and approval by Deutsche Börse AG. The book-entry delivery is scheduled for October 7, 2024, for the spin-off shares and October 10, 2024, for the offer shares.

BankM AG acted as Sole Global Coordinator and Sole Bookrunner for the transaction. MC Services AG acted as the selling agent (tied agent of CapSolutions GmbH) and also served as press and investor relations advisor. Legal advice was provided by HEUKING.

About Pentixapharm Holding AG

Pentixapharm Holding AG was founded in 2024 to incorporate all shares held by Eckert & Ziegler SE in Pentixapharm AG, based in Würzburg, following the spin-off resolved by the Annual General Meetings of Eckert & Ziegler SE and Pentixapharm Holding AG on June 26, 2024. Pentixapharm Holding AG is listed in the Prime Standard of the Frankfurt Stock Exchange.

Pentixapharm AG is a clinical-stage radiopharmaceutical development company founded in 2019 with its headquarters in Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

Pentixapharm’s clinical pipeline includes PentixaTher, an Yttrium-90-based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68-based companion diagnostic. 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. Additionally, PentixaFor is being developed as a diagnostic tool for primary aldosteronism (PA), a major cause of hypertension. Pentixapharm is currently preparing a US-centric Phase III registration study with PentixaFor in PA that will start in 2025.

For more information, please contact:

Pentixapharm Holding 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
Tel. +49 211 529252 22
anne.hennecke@mc-services.eu

IMPORTANT NOTICE

This release is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy any securities of the Company. The securities have already been sold. This release is not a prospectus within the meaning of the Prospectus Regulation (Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC), as amended.

This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, securities to any person in the United States, Australia, Canada, South Africa, Japan or in any jurisdiction to whom or in which such offer or solicitation is unlawful.

Neither this announcement nor the publication in which it is contained is for publication or distribution, directly or indirectly, in whole or in part, in or into the United States of America, including its territories and possessions, any state of the United States and the District of Columbia (“United States”). The information in this announcement does not contain or constitute an offer to acquire, subscribe or otherwise trade in shares in Pentixapharm Holding AG in any jurisdiction. Any securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (“Securities Act”), or the securities laws of any state or other jurisdiction of the United States, and may not be offered, subscribed, used, pledged, sold, resold, allotted, delivered or otherwise transferred, directly or indirectly, in or into the United States absent such registration, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements under the Securities Act, in each case in compliance with any applicable securities laws of any state or other jurisdiction of the United States. There will be no public offer of the securities in the United States.

Subject to certain exceptions under applicable law, the securities referred to in this announcement may not be offered or sold in Australia, Canada, South Africa or Japan or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada, South Africa or Japan. There will be no public offer of the securities in Australia, Canada, South Africa or Japan.

In member states of the European Economic Area (other than Germany), this announcement is only addressed to and directed at persons who are "qualified investors" within the meaning of Article 2(e) of the Prospectus Regulation.

In the United Kingdom, this announcement is only addressed to and directed at persons who are "qualified investors" within the meaning of Article 2 of the Prospectus Regulation (Regulation (EU) 2017/1129 and amendments thereto) as it forms part of United Kingdom domestic law by virtue of the European Union (Withdrawal) Act 2018 and who (i) have professional experience in matters relating to investments falling within article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (“Order”) or (ii) are high net worth entities falling within article 49(2)(a) to (d) of the Order (all such persons being referred to as “Relevant Persons”). In the United Kingdom, this announcement is directed only at Relevant Persons. Any person who is not a Relevant Person should not act or rely on this announcement or any of its contents. Any investment or investment activity to which this announcement relates is available only to Relevant Persons and will be engaged in only with Relevant Persons and it should not be relied on by anyone other than a relevant person.

This announcement does not purport to contain all information required to evaluate the Pentixapharm Holding AG and its future combined subsidiaries (i.e. Pentixapharm AG, Würzburg , and the 100 % subsidiary of Pentixapharm AG, Myelo Therapeutics GmbH, Berlin) upon the completion of the spin-off by absorption (Abspaltung zur Aufnahme) in accordance with the German Transformation Act (Umwandlungsgesetz) of all of the shares held by Eckert & Ziegler SE, Berlin in Pentixapharm AG to Pentixapharm Holding AG (“Spin-off” and such combined subsidiaries together with Pentixapharm Holding AG “Pentixapharm Group”) and/or their financial position and, in particular, is subject to amendment, revision, verification, correction, completion and updating in its entirety. Neither (i) Pentixapharm Holding AG nor (ii) BankM AG ("Bank", and together with Pentixapharm Holding AG "Persons"), or any of the respective directors, officers, personally liable partners, employees, agents, affiliates, shareholders or advisers of such Persons may notify you of changes nor is under an obligation to update or keep current the announcement or to provide the recipient thereof with access to any additional information that may arise in connection with it, save for the making of such disclosures as are required by mandatory provisions of law. This announcement does not constitute investment, legal, accounting, regulatory, taxation or other advice.

No person is authorized to give any information or to make any representation not contained in and not consistent with this announcement and, if given or made, such information or representation must not be relied upon as having been authorized by or on behalf of Pentixapharm Holding AG or any Person.

Certain market positioning data about Pentixapharm Holding AG and Pentixapharm Group included in this announcement is sourced from or based on third-party sources. Third-party industry publications, studies and surveys generally state that the data contained therein have been obtained from sources believed to be reliable, but that there is no guarantee of the fairness, quality, accuracy, relevance, completeness or sufficiency of such data. Such research, estimates and forecasts, and their underlying methodology and assumptions, have not been verified by any independent source for accuracy or completeness and are subject to change without notice. Accordingly, Pentixapharm Holding AG expressly disclaims any responsibility for, or liability in respect of, such information and undue reliance should not be placed on such data.

This announcement may contain forward-looking statements which reflect Pentixapharm Holding AG’s and Pentixapharm Group's current view on future events and financial and operational development. Forward-looking statements are sometimes, but not always, identified by their use of a date in the future or such words as “will”, “anticipates”, “aims”, “could”, “may”, “should”, “expects”, “believes”, “intends”, “plans”, “prepares” or “targets” (including in their negative form or other variations). By their nature, forward-looking statements are inherently predictive, speculative and involve risk and uncertainty because they relate to events and depend on circumstances that may or may not occur in the future. There are a number of factors that could cause actual results, performance and developments to differ materially from those expressed or implied by these forward-looking statements. All subsequent written or oral forward-looking statements attributable to Pentixapharm Holding AG or its affiliates, or any persons acting on their behalf are expressly qualified in their entirety by the factors referred to above. No assurances can be given that the forward-looking statements in this announcement will be realized. Any forward-looking statements are made of the date of this announcement.

Subject to compliance with applicable law and regulations, neither Pentixapharm Holding AG, nor the Bank nor their respective affiliates intend to update, review, revise or conform any forward-looking statement contained in this announcement to actual events or developments whether as a result of new information, future developments or otherwise, and do not undertake any obligation to do so.

The information contained in this announcement does not purport to be comprehensive and has not been subject to any independent audit or review.

Certain figures, including financial and market data, contained in this announcement have been rounded and the relevant sums may not add up to 100% due to rounding.

The Bank is acting exclusively for Pentixapharm Holding AG and no-one else in connection with the planned offering of shares of Pentixapharm Holding AG ("Offering"). It will not regard any other person as their respective clients in relation to the Offering and will not be responsible to anyone other than Pentixapharm Holding AG for providing the protections afforded to their respective clients, nor for providing advice in relation to the Offering, the contents of this announcement or any transaction, arrangement or other matter referred to in this announcement.

In connection with the Offering, the Bank and any of its affiliates, acting as investors for their own accounts, may subscribe for or purchase securities of Pentixapharm Holding AG and in that capacity may retain, purchase, sell, offer to sell or otherwise deal for their own accounts in such securities and other securities of Pentixapharm Holding AG or related investments in connection with the Offering or otherwise. Accordingly, references in the prospectus, once published, to the securities being issued, offered, subscribed, acquired, placed or otherwise dealt in should be read as including any issue or offer to, or subscription, acquisition, placing or dealing by the Bank and any of its affiliates acting as investors for their own accounts.

In addition, the Bank or its affiliates may enter into financing arrangements and swaps with investors in connection with which the Bank (or its affiliates) may from time to time acquire, hold or dispose of Pentixapharm Holding AG’s shares. The Bank does not intend to disclose the extent of any such investment or transactions otherwise than in accordance with any legal or regulatory obligations to do so.

None of the Bank or any of its affiliates, directors, officers, personally liable partners, employees, advisers or agents accepts any responsibility or liability whatsoever for or makes any representation or warranty, express or implied, as to the truth, accuracy or completeness of the information in this announcement (or whether any information has been omitted from the announcement) or any other information relating to Pentixapharm Holding AG, its combined subsidiaries or associated companies, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of this announcement or its contents or otherwise arising in connection therewith.

The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed by any person for any purpose on the information contained in this announcement or its accuracy, fairness or completeness.

The dates of the admission(s) to trading of shares of Pentixapharm Holding AG on the regulated market segment (regulierter Markt) of the Frankfurt Stock Exchange (Frankfurter Wertpapierbörse) with simultaneous admission to the sub-segment of the regulated market with additional post-admission obligations (Prime Standard) of the Frankfurt Stock Exchange (Frankfurter Wertpapierbörse) (together "Admission") may be influenced by things such as market conditions. There is no guarantee that Admission will occur and no financial decision should be based on the intentions of Pentixapharm Holding AG in relation to Admission at this stage. Acquiring investments to which this announcement relates may expose an investor to a significant risk of losing all of the amount invested. Persons considering making such investments should consult an authorized person specializing in advising on such investments. This announcement does not constitute a recommendation concerning the Offering. The value of shares can decrease as well as increase. Potential investors should consult a professional advisor as to the suitability of the Offering for the person concerned.

Pentixapharm Holding AG: Placement Price Set at EUR 5.10 per Share, All 3.9 Million Offer Shares Placed

NOT FOR DISTRIBUTION OR ANNOUNCEMENT, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR ANNOUNCEMENT WOULD BE UNLAWFUL

Disclosure of Insider Information according to Article 17 of Regulation (EU) No. 596/2014

Berlin and Würzburg, Germany, October 1, 2024 – Pentixapharm Holding AG (“Pentixapharm”) today set the final placement price for its initial public offering (“IPO”) at EUR 5.10 per share following the completion of the bookbuilding phase. All 3,900,000 offer shares, issued from a capital increase, were placed as part of a public offering in the Federal Republic of Germany and an international private placement to institutional investors as well as interested private investors. Based on the final placement price, the total gross proceeds to Pentixapharm amount to EUR 19.9 million.

The placement price results in a post-money market capitalization for Pentixapharm of EUR 126.5 million. Following the IPO, the expected free float will be 61.6%, facilitating liquid trading of the company's shares. This is supported by the inclusion of retail investors in the IPO capital increase. Each order placed by a retail investor was filled at approximately two thirds of the demand. The largest single shareholder of Pentixapharm is Eckert Wagniskapital und Frühphasenfinanzierung GmbH, which will hold 34.5% of the share capital following the transaction.

Admission to trading is expected on October 2, 2024, with the listing of the existing shares and spin-off shares of Pentixapharm Holding AG under the ticker symbol PTP and the international securities identification number (ISIN) DE000A40AEG0 in the Regulated Market (Prime Standard) of the Frankfurt Stock Exchange scheduled for October 3, 2024. The offer shares will be traded starting October 10, 2024, following the registration of the capital increase in the commercial register and approval by Deutsche Börse AG. Delivery of the allocated offer shares is also planned for October 10, 2024.

About Pentixapharm Holding AG

Pentixapharm Holding AG was founded in 2024 to incorporate all shares held by Eckert & Ziegler SE in Pentixapharm AG, based in Würzburg, following the spin-off resolved by the Annual General Meetings of Eckert & Ziegler SE and Pentixapharm Holding AG on June 26, 2024. It is intended to list Pentixapharm Holding AG on the Prime Standard of the Frankfurt Stock Exchange.

Pentixapharm AG is a clinical-stage radiopharmaceutical development company founded in 2019 with its headquarters in Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

Pentixapharm’s clinical pipeline includes PentixaTher, an Yttrium-90-based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68-based companion diagnostic. 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. Additionally, PentixaFor is being developed as a diagnostic tool for primary aldosteronism (PA), a major cause of hypertension. Pentixapharm is currently preparing a US-centric Phase III registration study with PentixaFor in PA that will start in 2025.

For more information, please contact:

Pentixapharm Holding 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
Tel. +49 211 529252 22
anne.hennecke@mc-services.eu
 

IMPORTANT NOTICE

This release is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy any securities of the Company. The securities have already been sold. This release is not a prospectus within the meaning of the Prospectus Regulation (Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC), as amended.

This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, securities to any person in the United States, Australia, Canada, South Africa, Japan or in any jurisdiction to whom or in which such offer or solicitation is unlawful.

Neither this announcement nor the publication in which it is contained is for publication or distribution, directly or indirectly, in whole or in part, in or into the United States of America, including its territories and possessions, any state of the United States and the District of Columbia (“United States”). The information in this announcement does not contain or constitute an offer to acquire, subscribe or otherwise trade in shares in Pentixapharm Holding AG in any jurisdiction. Any securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (“Securities Act”), or the securities laws of any state or other jurisdiction of the United States, and may not be offered, subscribed, used, pledged, sold, resold, allotted, delivered or otherwise transferred, directly or indirectly, in or into the United States absent such registration, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements under the Securities Act, in each case in compliance with any applicable securities laws of any state or other jurisdiction of the United States. There will be no public offer of the securities in the United States.

Subject to certain exceptions under applicable law, the securities referred to in this announcement may not be offered or sold in Australia, Canada, South Africa or Japan or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada, South Africa or Japan. There will be no public offer of the securities in Australia, Canada, South Africa or Japan.

In member states of the European Economic Area (other than Germany), this announcement is only addressed to and directed at persons who are "qualified investors" within the meaning of Article 2(e) of the Prospectus Regulation.

In the United Kingdom, this announcement is only addressed to and directed at persons who are "qualified investors" within the meaning of Article 2 of the Prospectus Regulation (Regulation (EU) 2017/1129 and amendments thereto) as it forms part of United Kingdom domestic law by virtue of the European Union (Withdrawal) Act 2018 and who (i) have professional experience in matters relating to investments falling within article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (“Order”) or (ii) are high net worth entities falling within article 49(2)(a) to (d) of the Order (all such persons being referred to as “Relevant Persons”). In the United Kingdom, this announcement is directed only at Relevant Persons. Any person who is not a Relevant Person should not act or rely on this announcement or any of its contents. Any investment or investment activity to which this announcement relates is available only to Relevant Persons and will be engaged in only with Relevant Persons and it should not be relied on by anyone other than a relevant person.

This announcement does not purport to contain all information required to evaluate the Pentixapharm Holding AG and its future combined subsidiaries (i.e. Pentixapharm AG, Würzburg , and the 100 % subsidiary of Pentixapharm AG, Myelo Therapeutics GmbH, Berlin) upon the completion of the spin-off by absorption (Abspaltung zur Aufnahme) in accordance with the German Transformation Act (Umwandlungsgesetz) of all of the shares held by Eckert & Ziegler SE, Berlin in Pentixapharm AG to Pentixapharm Holding AG (“Spin-off” and such combined subsidiaries together with Pentixapharm Holding AG “Pentixapharm Group”) and/or their financial position and, in particular, is subject to amendment, revision, verification, correction, completion and updating in its entirety. Neither (i) Pentixapharm Holding AG nor (ii) BankM AG ("Bank", and together with Pentixapharm Holding AG "Persons"), or any of the respective directors, officers, personally liable partners, employees, agents, affiliates, shareholders or advisers of such Persons may notify you of changes nor is under an obligation to update or keep current the announcement or to provide the recipient thereof with access to any additional information that may arise in connection with it, save for the making of such disclosures as are required by mandatory provisions of law. This announcement does not constitute investment, legal, accounting, regulatory, taxation or other advice.

No person is authorized to give any information or to make any representation not contained in and not consistent with this announcement and, if given or made, such information or representation must not be relied upon as having been authorized by or on behalf of Pentixapharm Holding AG or any Person.

Certain market positioning data about Pentixapharm Holding AG and Pentixapharm Group included in this announcement is sourced from or based on third-party sources. Third-party industry publications, studies and surveys generally state that the data contained therein have been obtained from sources believed to be reliable, but that there is no guarantee of the fairness, quality, accuracy, relevance, completeness or sufficiency of such data. Such research, estimates and forecasts, and their underlying methodology and assumptions, have not been verified by any independent source for accuracy or completeness and are subject to change without notice. Accordingly, Pentixapharm Holding AG expressly disclaims any responsibility for, or liability in respect of, such information and undue reliance should not be placed on such data.

This announcement may contain forward-looking statements which reflect Pentixapharm Holding AG’s and Pentixapharm Group's current view on future events and financial and operational development. Forward-looking statements are sometimes, but not always, identified by their use of a date in the future or such words as “will”, “anticipates”, “aims”, “could”, “may”, “should”, “expects”, “believes”, “intends”, “plans”, “prepares” or “targets” (including in their negative form or other variations). By their nature, forward-looking statements are inherently predictive, speculative and involve risk and uncertainty because they relate to events and depend on circumstances that may or may not occur in the future. There are a number of factors that could cause actual results, performance and developments to differ materially from those expressed or implied by these forward-looking statements. All subsequent written or oral forward-looking statements attributable to Pentixapharm Holding AG or its affiliates, or any persons acting on their behalf are expressly qualified in their entirety by the factors referred to above. No assurances can be given that the forward-looking statements in this announcement will be realized. Any forward-looking statements are made of the date of this announcement.

Subject to compliance with applicable law and regulations, neither Pentixapharm Holding AG, nor the Bank nor their respective affiliates intend to update, review, revise or conform any forward-looking statement contained in this announcement to actual events or developments whether as a result of new information, future developments or otherwise, and do not undertake any obligation to do so.

The information contained in this announcement does not purport to be comprehensive and has not been subject to any independent audit or review.

Certain figures, including financial and market data, contained in this announcement have been rounded and the relevant sums may not add up to 100% due to rounding.

The Bank is acting exclusively for Pentixapharm Holding AG and no-one else in connection with the planned offering of shares of Pentixapharm Holding AG ("Offering"). It will not regard any other person as their respective clients in relation to the Offering and will not be responsible to anyone other than Pentixapharm Holding AG for providing the protections afforded to their respective clients, nor for providing advice in relation to the Offering, the contents of this announcement or any transaction, arrangement or other matter referred to in this announcement.

In connection with the Offering, the Bank and any of its affiliates, acting as investors for their own accounts, may subscribe for or purchase securities of Pentixapharm Holding AG and in that capacity may retain, purchase, sell, offer to sell or otherwise deal for their own accounts in such securities and other securities of Pentixapharm Holding AG or related investments in connection with the Offering or otherwise. Accordingly, references in the prospectus, once published, to the securities being issued, offered, subscribed, acquired, placed or otherwise dealt in should be read as including any issue or offer to, or subscription, acquisition, placing or dealing by the Bank and any of its affiliates acting as investors for their own accounts.

In addition, the Bank or its affiliates may enter into financing arrangements and swaps with investors in connection with which the Bank (or its affiliates) may from time to time acquire, hold or dispose of Pentixapharm Holding AG’s shares. The Bank does not intend to disclose the extent of any such investment or transactions otherwise than in accordance with any legal or regulatory obligations to do so.

None of the Bank or any of its affiliates, directors, officers, personally liable partners, employees, advisers or agents accepts any responsibility or liability whatsoever for or makes any representation or warranty, express or implied, as to the truth, accuracy or completeness of the information in this announcement (or whether any information has been omitted from the announcement) or any other information relating to Pentixapharm Holding AG, its combined subsidiaries or associated companies, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of this announcement or its contents or otherwise arising in connection therewith.

The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed by any person for any purpose on the information contained in this announcement or its accuracy, fairness or completeness.

The dates of the admission(s) to trading of shares of Pentixapharm Holding AG on the regulated market segment (regulierter Markt) of the Frankfurt Stock Exchange (Frankfurter Wertpapierbörse) with simultaneous admission to the sub-segment of the regulated market with additional post-admission obligations (Prime Standard) of the Frankfurt Stock Exchange (Frankfurter Wertpapierbörse) (together "Admission") may be influenced by things such as market conditions. There is no guarantee that Admission will occur and no financial decision should be based on the intentions of Pentixapharm Holding AG in relation to Admission at this stage. Acquiring investments to which this announcement relates may expose an investor to a significant risk of losing all of the amount invested. Persons considering making such investments should consult an authorized person specializing in advising on such investments. This announcement does not constitute a recommendation concerning the Offering. The value of shares can decrease as well as increase. Potential investors should consult a professional advisor as to the suitability of the Offering for the person concerned.

Pentixapharm Holding AG Sets Price Range for Planned IPO

ADVERTISEMENT: NOT FOR DISTRIBUTION OR ANNOUNCEMENT, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR ANNOUNCEMENT WOULD BE UNLAWFUL

• Offering of up to 3.9 million new shares at a price range of EUR 4.70 to EUR 6.00 per share

• IPO proceeds to secure financing for further development of promising product pipeline in the rapidly growing field of radioligand therapies

• Subscription period for institutional and retail investors begins on September 24, 2024, and is expected to end on October 1, 2024

• First trading day on the Prime Standard of the Frankfurt Stock Exchange anticipated on October 3, 2024

• High free float of over 60% expected post-IPO

Berlin and Würzburg, Germany, September 23, 2024 – Pentixapharm Holding AG ("Pentixapharm"), a biopharmaceutical company focused on developing innovative first-in-class radiopharmaceuticals for the diagnosis and therapy ("theranostics") of blood cancer and other widespread indications not yet treated with radiopharmaceuticals, announces details of its planned initial public offering ("IPO") on the Prime Standard of the Frankfurt Stock Exchange. The German Federal Financial Supervisory Authority (BaFin) has today approved the prospectus for the public offering in Germany and the listing of Pentixapharm shares.

The IPO price range has been set at EUR 4.70 to EUR 6.00 per share. The final offer price will be determined based on a bookbuilding process at the end of the offering period, which begins on September 24, 2024, and is expected to end on October 1, 2024, at 12:00 p.m. CEST for retail investors and at 2:00 p.m. CEST for institutional investors.

The public offering comprises up to 3,900,000 registered shares. There is no over-allotment option (“greenshoe”). In addition to the offered shares, 50,000 nominal shares and 20,845,477 spin-off shares will be admitted to trading on the regulated market of the Frankfurt Stock Exchange (Prime Standard). The spin-off shares result from a capital increase in kind resolved by the extraordinary general meeting on June 26, 2024, consisting of all shares held by Eckert & Ziegler SE in Pentixapharm AG following the spin-off of Pentixapharm AG approved by Eckert & Ziegler SE's general meeting on the same day. In total, up to 24,795,477 registered shares of Pentixapharm Holding AG will be admitted to trading. All shares have a notional value of EUR 1.00 per share in the company's share capital and carry full dividend rights from March 25, 2024.

Proceeds from the Offering to Fund Further Development of the Product Pipeline

Assuming full placement of the shares, the IPO would result in a market capitalization of EUR 132.7 million at the midpoint of the bookbuilding range. The expected gross proceeds for Pentixapharm from the placement of new shares amount to between EUR 18.3 million and EUR 23.4 million, based on the bookbuilding range and the maximum number of 3.9 million offer shares. With an additional convertible bond of up to EUR 18.5 million subscribed by the listed Eckert & Ziegler SE, Pentixapharm would have over EUR 39 million in additional financial resources at the midpoint of the bookbuilding range to implement the first phase of its growth strategy.

The proceeds from the IPO are primarily intended for the further development of the company’s product pipeline. The growth strategy in the coming years is focused on the clinical development and approval of main candidates, Ga68-PentixaFor and Y90-PentixaTher, as well as on strategic partnerships and potential acquisitions in the field of radiopharmaceuticals. The IPO is thus a milestone on the planned path toward commercialization of well-validated programs. Lead candidate PentixaFor is already in Phase III clinical development in Europe.

Dr. Hakim Bouterfa, CEO of Pentixapharm Holding AG, commented: "We are now in the home stretch with our IPO plans and are pleased with the positive feedback from investors. Our goal is to make the stock attractive to investors who join early and to minimize the dilution of Eckert & Ziegler SE shareholders who become Pentixapharm shareholders as a result of the spin-off. Therefore, only a limited number of shares are being offered in the IPO. We are convinced of a positive development of Pentixapharm and aim to achieve further milestones in the coming months."

Dr. Andreas Eckert, Chairman of the Supervisory Board of Pentixapharm Holding AG, stated: "Pentixapharm has an attractive product pipeline and is gaining access to capital market investors through the IPO. As previously announced, as part of the spin-off of Pentixapharm from Eckert & Ziegler SE, Eckert Wagniskapital und Frühphasenfinanzierung GmbH is also participating in the IPO, underscoring its confidence in Pentixapharm. For future investments, several options are available, including further capital measures or other financing possibilities such as collaborations with established pharmaceutical companies. The current valuations of companies in the field of radiopharmaceuticals with programs in clinical trials in the US underscore the potential that investors see in this field."

IPO Targeted at Both Institutional and Retail Investors Interested in Pentixapharm's Innovative Growth Model

The shares will be offered as part of a public offering in Germany and an international private placement. The offering is aimed at both institutional and retail investors. Retail investors in Germany can place purchase orders in the public offering one day after the start of the offer period, i.e., from September 25, 2024, exclusively via the DirectPlace© subscription functionality of the Frankfurt Stock Exchange or through their custodian bank. Qualified investors can place purchase orders directly with BankM AG, acting as sole global coordinator and sole bookrunner, during the offer period. The free float after the IPO is expected to be over 60%. The main shareholder of Pentixapharm is Eckert Wagniskapital und Frühphasenfinanzierung GmbH, which will hold 31.57% of the share capital after the completion of the spin-off.

Admission to trading is expected on October 2, 2024. On October 3, 2024, the listing of the existing shares and the spin-off shares of Pentixapharm Holding AG under the ticker symbol "PTP" and the International Securities Identification Number (ISIN) DE000A40AEG0 is scheduled to take place on the regulated market (Prime Standard) of the Frankfurt Stock Exchange. The offer shares are expected to be traded from October 10, 2024, following the registration of the capital increase in the commercial register and the admission decision by the Deutsche Börse AG.

The securities prospectus regarding the public offering and the admission of the shares to trading on the regulated market (Prime Standard) was approved today by the German Federal Financial Supervisory Authority (BaFin) and is available in the Investor Relations section of the company's website at www.pentixapharm.com.

About Pentixapharm Holding AG

Pentixapharm Holding AG was founded in 2024 to incorporate all shares held by Eckert & Ziegler SE in Pentixapharm AG, based in Würzburg, following the spin-off resolved by the Annual General Meetings of Eckert & Ziegler SE and Pentixapharm Holding AG on June 26, 2024. It is intended to list Pentixapharm Holding AG on the Prime Standard of the Frankfurt Stock Exchange.

Pentixapharm AG is a clinical-stage radiopharmaceutical development company founded in 2019 with its headquarters in Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

Pentixapharm’s clinical pipeline includes PentixaTher, an Yttrium-90-based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68-based companion diagnostic. 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. Additionally, PentixaFor is being developed as a diagnostic tool for primary aldosteronism (PA), a major cause of hypertension. Pentixapharm is currently preparing a US-centric Phase III registration study with PentixaFor in PA that will start in 2025.

For more information, please contact:

Pentixapharm Holding 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
Tel. +49 211 529252 22
anne.hennecke@mc-services.eu

Important Notice

This announcement constitutes advertising within the meaning of Article 2(e) of EU Regulation 2017/1129, as amended (“Prospectus Regulation”). It does not constitute an offer to purchase shares in Pentixapharm Holding AG and does not replace the securities prospectus, which is available free of charge together with the relevant translations of the summary in the IR section of the Pentixapharm Group website at https://www.pentixapharm.com/. A public offer in Germany will be made exclusively by means of and on the basis of the published securities prospectus, which has been approved by the German Federal Financial Supervisory Authority (Bundesanstalt für Finanzdienstleistungsaufsicht, “BaFin”). The approval of the securities prospectus by BaFin should not be construed as an endorsement of the shares of Pentixapharm Holding AG. Investors should purchase shares solely on the basis of the prospectus relating to the shares (including any supplements thereto) and should read the prospectus (including any supplements thereto) before making an investment decision in order to fully understand the potential risks and rewards associated with the investment decision. Investing in shares involves numerous risks, including the total loss of the capital invested.

This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, securities to any person in the United States, Australia, Canada, South Africa, Japan or in any jurisdiction to whom or in which such offer or solicitation is unlawful.

Neither this announcement nor the publication in which it is contained is for publication or distribution, directly or indirectly, in whole or in part, in or into the United States of America, including its territories and possessions, any state of the United States and the District of Columbia (“United States”). The information in this announcement does not contain or constitute an offer to acquire, subscribe or otherwise trade in shares in Pentixapharm Holding AG in any jurisdiction. Any securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (“Securities Act”), or the securities laws of any state or other jurisdiction of the United States, and may not be offered, subscribed, used, pledged, sold, resold, allotted, delivered or otherwise transferred, directly or indirectly, in or into the United States absent such registration, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements under the Securities Act, in each case in compliance with any applicable securities laws of any state or other jurisdiction of the United States. There will be no public offer of the securities in the United States.

Subject to certain exceptions under applicable law, the securities referred to in this announcement may not be offered or sold in Australia, Canada, South Africa or Japan or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada, South Africa or Japan. There will be no public offer of the securities in Australia, Canada, South Africa or Japan.

In member states of the European Economic Area (other than Germany), this announcement is only addressed to and directed at persons who are "qualified investors" within the meaning of Article 2(e) of the Prospectus Regulation.

In the United Kingdom, this announcement is only addressed to and directed at persons who are "qualified investors" within the meaning of Article 2 of the Prospectus Regulation (Regulation (EU) 2017/1129 and amendments thereto) as it forms part of United Kingdom domestic law by virtue of the European Union (Withdrawal) Act 2018 and who (i) have professional experience in matters relating to investments falling within article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (“Order”) or (ii) are high net worth entities falling within article 49(2)(a) to (d) of the Order (all such persons being referred to as “Relevant Persons”). In the United Kingdom, this announcement is directed only at Relevant Persons. Any person who is not a Relevant Person should not act or rely on this announcement or any of its contents. Any investment or investment activity to which this announcement relates is available only to Relevant Persons and will be engaged in only with Relevant Persons and it should not be relied on by anyone other than a relevant person.

This announcement does not purport to contain all information required to evaluate the Pentixapharm Holding AG and its future combined subsidiaries (i.e. Pentixapharm AG, Würzburg , and the 100 % subsidiary of Pentixapharm AG, Myelo Therapeutics GmbH, Berlin) upon the completion of the spin-off by absorption (Abspaltung zur Aufnahme) in accordance with the German Transformation Act (Umwandlungsgesetz) of all of the shares held by Eckert & Ziegler SE, Berlin in Pentixapharm AG to Pentixapharm Holding AG (“Spin-off” and such combined subsidiaries together with Pentixapharm Holding AG “Pentixapharm Group”) and/or their financial position and, in particular, is subject to amendment, revision, verification, correction, completion and updating in its entirety. Neither (i) Pentixapharm Holding AG nor (ii) BankM AG ("Bank", and together with Pentixapharm Holding AG "Persons"), or any of the respective directors, officers, personally liable partners, employees, agents, affiliates, shareholders or advisers of such Persons may notify you of changes nor is under an obligation to update or keep current the announcement or to provide the recipient thereof with access to any additional information that may arise in connection with it, save for the making of such disclosures as are required by mandatory provisions of law. This announcement does not constitute investment, legal, accounting, regulatory, taxation or other advice.

No person is authorized to give any information or to make any representation not contained in and not consistent with this announcement and, if given or made, such information or representation must not be relied upon as having been authorized by or on behalf of Pentixapharm Holding AG or any Person.

Certain market positioning data about Pentixapharm Holding AG and Pentixapharm Group included in this announcement is sourced from or based on third-party sources. Third-party industry publications, studies and surveys generally state that the data contained therein have been obtained from sources believed to be reliable, but that there is no guarantee of the fairness, quality, accuracy, relevance, completeness or sufficiency of such data. Such research, estimates and forecasts, and their underlying methodology and assumptions, have not been verified by any independent source for accuracy or completeness and are subject to change without notice. Accordingly, Pentixapharm Holding AG expressly disclaims any responsibility for, or liability in respect of, such information and undue reliance should not be placed on such data.

This announcement may contain forward-looking statements which reflect Pentixapharm Holding AG’s and Pentixapharm Group's current view on future events and financial and operational development. Forward-looking statements are sometimes, but not always, identified by their use of a date in the future or such words as “will”, “anticipates”, “aims”, “could”, “may”, “should”, “expects”, “believes”, “intends”, “plans”, “prepares” or “targets” (including in their negative form or other variations). By their nature, forward-looking statements are inherently predictive, speculative and involve risk and uncertainty because they relate to events and depend on circumstances that may or may not occur in the future. There are a number of factors that could cause actual results, performance and developments to differ materially from those expressed or implied by these forward-looking statements. All subsequent written or oral forward-looking statements attributable to Pentixapharm Holding AG or its affiliates, or any persons acting on their behalf are expressly qualified in their entirety by the factors referred to above. No assurances can be given that the forward-looking statements in this announcement will be realized. Any forward-looking statements are made of the date of this announcement.

Subject to compliance with applicable law and regulations, neither Pentixapharm Holding AG, nor the Bank nor their respective affiliates intend to update, review, revise or conform any forward-looking statement contained in this announcement to actual events or developments whether as a result of new information, future developments or otherwise, and do not undertake any obligation to do so.

The information contained in this announcement does not purport to be comprehensive and has not been subject to any independent audit or review.

Certain figures, including financial and market data, contained in this announcement have been rounded and the relevant sums may not add up to 100% due to rounding.

The Bank is acting exclusively for Pentixapharm Holding AG and no-one else in connection with the planned offering of shares of Pentixapharm Holding AG ("Offering"). It will not regard any other person as their respective clients in relation to the Offering and will not be responsible to anyone other than Pentixapharm Holding AG for providing the protections afforded to their respective clients, nor for providing advice in relation to the Offering, the contents of this announcement or any transaction, arrangement or other matter referred to in this announcement.

In connection with the Offering, the Bank and any of its affiliates, acting as investors for their own accounts, may subscribe for or purchase securities of Pentixapharm Holding AG and in that capacity may retain, purchase, sell, offer to sell or otherwise deal for their own accounts in such securities and other securities of Pentixapharm Holding AG or related investments in connection with the Offering or otherwise. Accordingly, references in the prospectus, once published, to the securities being issued, offered, subscribed, acquired, placed or otherwise dealt in should be read as including any issue or offer to, or subscription, acquisition, placing or dealing by the Bank and any of its affiliates acting as investors for their own accounts.

In addition, the Bank or its affiliates may enter into financing arrangements and swaps with investors in connection with which the Bank (or its affiliates) may from time to time acquire, hold or dispose of Pentixapharm Holding AG’s shares. The Bank does not intend to disclose the extent of any such investment or transactions otherwise than in accordance with any legal or regulatory obligations to do so.

None of the Bank or any of its affiliates, directors, officers, personally liable partners, employees, advisers or agents accepts any responsibility or liability whatsoever for or makes any representation or warranty, express or implied, as to the truth, accuracy or completeness of the information in this announcement (or whether any information has been omitted from the announcement) or any other information relating to Pentixapharm Holding AG, its combined subsidiaries or associated companies, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of this announcement or its contents or otherwise arising in connection therewith.

The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed by any person for any purpose on the information contained in this announcement or its accuracy, fairness or completeness.

The dates of the admission(s) to trading of shares of Pentixapharm Holding AG on the regulated market segment (regulierter Markt) of the Frankfurt Stock Exchange (Frankfurter Wertpapierbörse) with simultaneous admission to the sub-segment of the regulated market with additional post-admission obligations (Prime Standard) of the Frankfurt Stock Exchange (Frankfurter Wertpapierbörse) (together "Admission") may be influenced by things such as market conditions. There is no guarantee that Admission will occur and no financial decision should be based on the intentions of Pentixapharm Holding AG in relation to Admission at this stage. Acquiring investments to which this announcement relates may expose an investor to a significant risk of losing all of the amount invested. Persons considering making such investments should consult an authorized person specializing in advising on such investments. This announcement does not constitute a recommendation concerning the Offering. The value of shares can decrease as well as increase. Potential investors should consult a professional advisor as to the suitability of the Offering for the person concerned.

Pentixapharm Holding AG, a Subsidiary of Eckert & Ziegler SE, Plans IPO on the Prime Standard of the Frankfurt Stock Exchange

ADVERTISEMENT - NOT FOR DISTRIBUTION OR ANNOUNCEMENT, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR ANNOUNCEMENT WOULD BE UNLAWFUL

• Business model focused on innovative radiopharmaceuticals for the diagnosis and therapy (theranostics) of various indications

• Institutional environment characterized by high market growth and intense M&A activity

• IPO as a strategic step to secure short- and long-term financing

• Lead candidate PentixaFor already in Phase III

• Commercial rights to over 20 investigator-initiated studies (IIS) for accelerated pipeline development

Berlin and Würzburg, Germany, September 12, 2024 – Pentixapharm Holding AG (“Pentixapharm”) is planning a public offering of new shares as part of its spin-off from Eckert & Ziegler SE, with the goal of listing on the Regulated Market (Prime Standard) of the Frankfurt Stock Exchange in the fourth quarter of 2024. The offering will primarily target institutional investors but will also be open to retail investors.

Pentixapharm focuses on the development of radiopharmaceuticals for various therapeutic areas. For some of the indications, Pentixapharm’s development candidates would represent first-in-class radiopharmaceuticals. This includes radiotherapeutics against multiple forms of blood cancer. Pentixapharm here aims to confirm and replicate, in controlled clinical trials, the promising results of a first small study with its lead candidate PentixaTher in patients with hard-to-treat T-cell lymphomas that had previously not responded to standard therapies reported in 2022 by the University of Würzburg.

In addition, Pentixapharm plans to initiate a Phase III registration trial in the United States for its most advanced development candidate, PentixaFor, in the indication of primary aldosteronism (PA). In a recent pre-submission (Type-C) meeting, the U.S. Food and Drug Administration (FDA) indicated that key pre-conditions for a phase III trial have been met. PA, a significant cause of hypertension, remains difficult to diagnose and treat effectively with current methods.

The medical significance and economic potential of radiopharmaceutical therapies are underscored by several international M&A transactions in the last 12 months, totaling around USD 8 billion. Through its planned IPO, Pentixapharm aims to strategically position itself in this growing market, expand its financial resources for continued pipeline development in the short term, and secure long-term capital access. The IPO will be led by BankM AG, acting as Bookrunner and Lead Manager.

Dr. Andreas Eckert, Chairman of the Supervisory Board of Pentixapharm Holding AG: "We are pursuing a highly promising, differentiated, and well-validated approach with Pentixapharm in the rapidly growing international radiopharmaceutical market. With our extensive experience and network, we are in an excellent position to quickly deliver a broad pipeline of diagnostic and therapeutic solutions, not only for cancer but also for other indications. The planned IPO is a significant milestone on our path toward the commercial use of our diagnostic and therapeutic programs."

Clear focus on well-researched targets, lead program in Phase III clinical development

At the core of Pentixapharm's operations are the exclusive global rights to a patent family developed by the University of Munich, centered around radioisotope-labeled ligands targeting the cell membrane receptor CXCR4. This protein plays a critical role in tumor growth, metastatic spread, and the development of inflammatory processes.

Dr. Hakim Bouterfa, CEO of Pentixapharm Holding AG: "The theranostic approach allows us to detect, treat, and precisely monitor disease progression and response to therapy. The specific binding of the ligand to the pathological surface structure of the target cell is identical for both diagnosis and therapy, enabling a targeted treatment according to the principle of 'find, fight, and follow'. The choice of radioisotope then determines the outcome: high-energy isotopes are used to destroy targeted cells, while lower-energy isotopes are employed for imaging purposes."

Pentixapharm’s clinical pipeline encompasses PentixaTher, an Yttrium-90 based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68-based companion diagnostic. 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. Additionally, PentixaFor is being developed as a diagnostic tool for primary aldosteronism (PA), a significant cause of hypertension. Pentixapharm is currently preparing a US-centric Phase III registration study with PentixaFor in PA that is expected to start in 2025.

Unique network and extensive data pool for accelerated pipeline development

Leveraging the longstanding experience of Eckert & Ziegler, one of the world's largest providers of isotope technology for medical, scientific, and industrial applications, Pentixapharm, as a former subsidiary, benefits from outstanding expertise and a broad network in the field of radiopharmaceuticals. Currently, Pentixapharm can access data from over 20 academic partners who have investigated the potential of the CXCR4 cell membrane receptor in developing radiopharmaceuticals through investigator-initiated studies (IIS).

The spin-off of Pentixapharm, approved by Eckert & Ziegler SE's Annual General Meeting on June 26, 2024, is based on the distinct business focuses of the two companies. While Eckert & Ziegler's core business revolves around the production and distribution of radioisotopes, Pentixapharm is dedicated to the development and approval of new radiopharmaceuticals. The planned IPO enables Pentixapharm to target investors specifically interested in the company's innovative and forward-looking pipeline. As an independent company, Pentixapharm can now operate more flexibly to advance its research and development projects.

About Pentixapharm Holding AG

Pentixapharm Holding AG was founded in 2024 to incorporate all shares held by Eckert & Ziegler SE in Pentixapharm AG, based in Würzburg, Germany, following the spin-off resolved by the Annual General Meetings of Eckert & Ziegler SE and Pentixapharm Holding AG on June 26, 2024. It is intended to list Pentixapharm Holding AG in the Regulated Market (Prime Standard) of the Frankfurt Stock Exchange.

Pentixapharm AG is a clinical-stage radiopharmaceutical development company founded in 2019. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

For more information, please contact:

Pentixapharm Holding 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
Tel. +49 211 529252 22
anne.hennecke@mc-services.eu

Important Notice

This announcement is an advertisement for the purposes of the prospectus regulation EU 2017/1129, as amended ("Prospectus Regulation"): lt does not constitute an offer to purchase any shares in Pentixapharm Holding AG and does not replace the securities prospectus which will be available free of charge, together with the relevant translation of the summary, in the IR section of the Pentixapharm Group website at https://www.pentixapharm.com/. The approval of the securities prospectus by the German Federal Financial Supervisory Authority (“BaFin”) should not be understood as an endorsement of the investment in any shares in Pentixapharm Holding AG. Investors should purchase shares solely on the basis of the prospectus (including any supplements thereto, if any) relating to the shares and should read the prospectus which is yet to be published (including any supplements thereto, if any) before making an investment decision in order to fully understand the potential risks and rewards associated with the decision to invest in the shares. Investment in shares entails numerous risks, including a total loss of the initial investment.

This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, securities to any person in the United States, Australia, Canada, South Africa, Japan or in any jurisdiction to whom or in which such offer or solicitation is unlawful.

Neither this announcement nor the publication in which it is contained is for publication or distribution, directly or indirectly, in whole or in part, in or into the United States of America, including its territories and possessions, any state of the United States and the District of Columbia (“United States”). The information in this announcement does not contain or constitute an offer to acquire, subscribe or otherwise trade in shares in Pentixapharm Holding AG in any jurisdiction. Any securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (“Securities Act”), or the securities laws of any state or other jurisdiction of the United States, and may not be offered, subscribed, used, pledged, sold, resold, allotted, delivered or otherwise transferred, directly or indirectly, in or into the United States absent such registration, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements under the Securities Act, in each case in compliance with any applicable securities laws of any state or other jurisdiction of the United States. There will be no public offer of the securities in the United States.

Subject to certain exceptions under applicable law, the securities referred to in this announcement may not be offered or sold in Australia, Canada, South Africa or Japan or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada, South Africa or Japan. There will be no public offer of the securities in Australia, Canada, South Africa or Japan.

In member states of the European Economic Area (other than Germany), this announcement is only addressed to and directed at persons who are "qualified investors" within the meaning of Article 2(e) of the Prospectus Regulation.

In the United Kingdom, this announcement is only addressed to and directed at persons who are "qualified investors" within the meaning of Article 2 of the Prospectus Regulation (Regulation (EU) 2017/1129 and amendments thereto) as it forms part of United Kingdom domestic law by virtue of the European Union (Withdrawal) Act 2018 and who (i) have professional experience in matters relating to investments falling within article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (“Order”) or (ii) are high net worth entities falling within article 49(2)(a) to (d) of the Order (all such persons being referred to as “Relevant Persons”). In the United Kingdom, this announcement is directed only at Relevant Persons. Any person who is not a Relevant Person should not act or rely on this announcement or any of its contents. Any investment or investment activity to which this announcement relates is available only to Relevant Persons and will be engaged in only with Relevant Persons and it should not be relied on by anyone other than a relevant person.

This announcement does not purport to contain all information required to evaluate the Pentixapharm Holding AG and its future combined subsidiaries (i.e. Pentixapharm AG, Würzburg , and the 100 % subsidiary of Pentixapharm AG, Myelo Therapeutics GmbH, Berlin) upon the completion of the spin-off by absorption (Abspaltung zur Aufnahme) in accordance with the German Transformation Act (Umwandlungsgesetz) of all of the shares held by Eckert & Ziegler SE, Berlin in Pentixapharm AG to Pentixapharm Holding AG (“Spin-off” and such combined subsidiaries together with Pentixapharm Holding AG “Pentixapharm Group”) and/or their financial position and, in particular, is subject to amendment, revision, verification, correction, completion and updating in its entirety. Neither (i) Pentixapharm Holding AG nor (ii) BankM AG ("Bank", and together with Pentixapharm Holding AG "Persons"), or any of the respective directors, officers, personally liable partners, employees, agents, affiliates, shareholders or advisers of such Persons may notify you of changes nor is under an obligation to update or keep current the announcement or to provide the recipient thereof with access to any additional information that may arise in connection with it, save for the making of such disclosures as are required by mandatory provisions of law. This announcement does not constitute investment, legal, accounting, regulatory, taxation or other advice.

No person is authorized to give any information or to make any representation not contained in and not consistent with this announcement and, if given or made, such information or representation must not be relied upon as having been authorized by or on behalf of Pentixapharm Holding AG or any Person.

Certain market positioning data about Pentixapharm Holding AG and Pentixapharm Group included in this announcement is sourced from or based on third-party sources. Third-party industry publications, studies and surveys generally state that the data contained therein have been obtained from sources believed to be reliable, but that there is no guarantee of the fairness, quality, accuracy, relevance, completeness or sufficiency of such data. Such research, estimates and forecasts, and their underlying methodology and assumptions, have not been verified by any independent source for accuracy or completeness and are subject to change without notice. Accordingly, Pentixapharm Holding AG expressly disclaims any responsibility for, or liability in respect of, such information and undue reliance should not be placed on such data.

This announcement may contain forward-looking statements which reflect Pentixapharm Holding AG’s and Pentixapharm Group's current view on future events and financial and operational development. Forward-looking statements are sometimes, but not always, identified by their use of a date in the future or such words as “will”, “anticipates”, “aims”, “could”, “may”, “should”, “expects”, “believes”, “intends”, “plans”, “prepares” or “targets” (including in their negative form or other variations). By their nature, forward-looking statements are inherently predictive, speculative and involve risk and uncertainty because they relate to events and depend on circumstances that may or may not occur in the future. There are a number of factors that could cause actual results, performance and developments to differ materially from those expressed or implied by these forward-looking statements. All subsequent written or oral forward-looking statements attributable to Pentixapharm Holding AG or its affiliates, or any persons acting on their behalf are expressly qualified in their entirety by the factors referred to above. No assurances can be given that the forward-looking statements in this announcement will be realized. Any forward-looking statements are made of the date of this announcement.

Subject to compliance with applicable law and regulations, neither Pentixapharm Holding AG, nor the Bank nor their respective affiliates intend to update, review, revise or conform any forward-looking statement contained in this announcement to actual events or developments whether as a result of new information, future developments or otherwise, and do not undertake any obligation to do so.

The information contained in this announcement does not purport to be comprehensive and has not been subject to any independent audit or review.

Certain figures, including financial and market data, contained in this announcement have been rounded and the relevant sums may not add up to 100% due to rounding.

The Bank is acting exclusively for Pentixapharm Holding AG and no-one else in connection with the planned offering of shares of Pentixapharm Holding AG ("Offering"). It will not regard any other person as their respective clients in relation to the Offering and will not be responsible to anyone other than Pentixapharm Holding AG for providing the protections afforded to their respective clients, nor for providing advice in relation to the Offering, the contents of this announcement or any transaction, arrangement or other matter referred to in this announcement.

In connection with the Offering, the Bank and any of its affiliates, acting as investors for their own accounts, may subscribe for or purchase securities of Pentixapharm Holding AG and in that capacity may retain, purchase, sell, offer to sell or otherwise deal for their own accounts in such securities and other securities of Pentixapharm Holding AG or related investments in connection with the Offering or otherwise. Accordingly, references in the prospectus, once published, to the securities being issued, offered, subscribed, acquired, placed or otherwise dealt in should be read as including any issue or offer to, or subscription, acquisition, placing or dealing by the Bank and any of its affiliates acting as investors for their own accounts.

In addition, the Bank or its affiliates may enter into financing arrangements and swaps with investors in connection with which the Bank (or its affiliates) may from time to time acquire, hold or dispose of Pentixapharm Holding AG’s shares. The Bank does not intend to disclose the extent of any such investment or transactions otherwise than in accordance with any legal or regulatory obligations to do so.

None of the Bank or any of its affiliates, directors, officers, personally liable partners, employees, advisers or agents accepts any responsibility or liability whatsoever for or makes any representation or warranty, express or implied, as to the truth, accuracy or completeness of the information in this announcement (or whether any information has been omitted from the announcement) or any other information relating to Pentixapharm Holding AG, its combined subsidiaries or associated companies, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of this announcement or its contents or otherwise arising in connection therewith.

The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed by any person for any purpose on the information contained in this announcement or its accuracy, fairness or completeness.

The dates of the admission(s) to trading of shares of Pentixapharm Holding AG on the regulated market segment (regulierter Markt) of the Frankfurt Stock Exchange (Frankfurter Wertpapierbörse) with simultaneous admission to the sub-segment of the regulated market with additional post-admission obligations (Prime Standard) of the Frankfurt Stock Exchange (Frankfurter Wertpapierbörse) (together "Admission") may be influenced by things such as market conditions. There is no guarantee that Admission will occur and no financial decision should be based on the intentions of Pentixapharm Holding AG in relation to Admission at this stage. Acquiring investments to which this announcement relates may expose an investor to a significant risk of losing all of the amount invested. Persons considering making such investments should consult an authorized person specializing in advising on such investments. This announcement does not constitute a recommendation concerning the Offering. The value of shares can decrease as well as increase. Potential investors should consult a professional advisor as to the suitability of the Offering for the person concerned.

Pentixapharm AG Receives Orphan Drug Designation for its Radiodiagnostic Tracer PentixaFor in Marginal Zone Lymphoma by the European Medicines Agency

Berlin and Würzburg, Germany, August 26, 2024 - Pentixapharm Holding AG, the future holding company of Pentixapharm AG, a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals, today announced that the European Medicines Agency (EMA) and the European Commission (EC) have granted an Orphan Drug Designation for the diagnostic tracer PentixaFor, also known as Gallium (68Ga) boclatixafortide, for the diagnosis and staging of Marginal Zone Lymphoma.

Marginal Zone Lymphoma (MZL) is a type of non-Hodgkin’s Lymphoma (NHL) and has been recognized by the EMA as a chronically debilitating and life-threatening condition. Pentixapharm currently sponsors a European Phase III clinical trial to assess the performance of PentixaFor for the imaging and staging in patients with confirmed MZL.

PentixaFor is a novel tracer for positron emission tomography (PET) imaging targeting the C-X-C receptor 4 (CXCR4), which is overexpressed on MZL cells. Preclinical and clinical studies indicate that PentixaFor has a high sensitivity and specificity for the diagnosis and staging of MZL, with potentially better outcomes than the currently used [18F]FDG. An improved staging of the malignant disease is key to a more successful treatment.

The European Orphan Drug Program aims to support companies that develop medicinal products for diseases which affect no more than 5 in 10,000 people in the EU. The benefits of an Orphan Drug Designation include the possibility of seeking EMA protocol advice for PentixaFor development in MZL, regulatory fee reductions and waivers, and the access to the European centralized marketing authorization application. Additionally, upon market approval, PentixaFor could benefit from 10 years of market exclusivity within the EU for the diagnosis and staging of MZL.

About Pentixapharm Holding AG

Pentixapharm Holding AG was founded in 2024 to incorporate all shares held by Eckert & Ziegler SE in Pentixapharm AG, based in Würzburg, following the spin-off resolved by the Annual General Meetings of Eckert & Ziegler SE and Pentixapharm Holding AG on June 26, 2024. It is intended to list Pentixapharm Holding AG in the Prime Standard of the Frankfurt Stock Exchange.

Pentixapharm AG is a clinical-stage radiopharmaceutical development company founded in 2019 with its headquarters in Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

Pentixapharm’s clinical pipeline encompasses PentixaTher, an Yttrium-90 based therapeutic against Non-Hodgkin Lymphomas (NHL), and PentixaFor, a Gallium-68-based companion diagnostic. 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. Additionally, PentixaFor is being developed as a diagnostic tool for Primary Aldosteronism (PA), a significant cause of hypertension. Pentixapharm is currently preparing a US-centric Phase III registration study with PentixaFor in PA that will start in 2025.

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 Holding 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
Tel. +49 211 529252 22
anne.hennecke@mc-services.eu

---

Important Notice

This announcement is an advertisement for the purposes of the prospectus regulation EU 2017/1129, as amended ("Prospectus Regulation"): lt does not constitute an offer to purchase any shares in Pentixapharm Holding AG and does not replace the securities prospectus which will be available free of charge, together with the relevant translation of the summary, in the IR section of the Pentixapharm Group website at https://www.pentixapharm.com/. The approval of the securities prospectus by the German Federal Financial Supervisory Authority (“BaFin”) should not be understood as an endorsement of the investment in any shares in Pentixapharm Holding AG. Investors should purchase shares solely on the basis of the prospectus (including any supplements thereto, if any) relating to the shares and should read the prospectus which is yet to be published (including any supplements thereto, if any) before making an investment decision in order to fully understand the potential risks and rewards associated with the decision to invest in the shares. Investment in shares entails numerous risks, including a total loss of the initial investment.

This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, securities to any person in the United States, Australia, Canada, South Africa, Japan or in any jurisdiction to whom or in which such offer or solicitation is unlawful.

Neither this announcement nor the publication in which it is contained is for publication or distribution, directly or indirectly, in whole or in part, in or into the United States of America, including its territories and possessions, any state of the United States and the District of Columbia (“United States”). The information in this announcement does not contain or constitute an offer to acquire, subscribe or otherwise trade in shares in Pentixapharm Holding AG in any jurisdiction. Any securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (“Securities Act”), or the securities laws of any state or other jurisdiction of the United States, and may not be offered, subscribed, used, pledged, sold, resold, allotted, delivered or otherwise transferred, directly or indirectly, in or into the United States absent such registration, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements under the Securities Act, in each case in compliance with any applicable securities laws of any state or other jurisdiction of the United States. There will be no public offer of the securities in the United States.

Subject to certain exceptions under applicable law, the securities referred to in this announcement may not be offered or sold in Australia, Canada, South Africa or Japan or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada, South Africa or Japan. There will be no public offer of the securities in Australia, Canada, South Africa or Japan.

In member states of the European Economic Area (other than Germany), this announcement is only addressed to and directed at persons who are "qualified investors" within the meaning of Article 2(e) of the Prospectus Regulation.

In the United Kingdom, this announcement is only addressed to and directed at persons who are "qualified investors" within the meaning of Article 2 of the Prospectus Regulation (Regulation (EU) 2017/1129 and amendments thereto) as it forms part of United Kingdom domestic law by virtue of the European Union (Withdrawal) Act 2018 and who (i) have professional experience in matters relating to investments falling within article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (“Order”) or (ii) are high net worth entities falling within article 49(2)(a) to (d) of the Order (all such persons being referred to as “Relevant Persons”). In the United Kingdom, this announcement is directed only at Relevant Persons. Any person who is not a Relevant Person should not act or rely on this announcement or any of its contents. Any investment or investment activity to which this announcement relates is available only to Relevant Persons and will be engaged in only with Relevant Persons and it should not be relied on by anyone other than a relevant person.

This announcement does not purport to contain all information required to evaluate the Pentixapharm Holding AG and its future combined subsidiaries (i.e. Pentixapharm AG, Würzburg , and the 100 % subsidiary of Pentixapharm AG, Myelo Therapeutics GmbH, Berlin) upon the completion of the spin-off by absorption (Abspaltung zur Aufnahme) in accordance with the German Transformation Act (Umwandlungsgesetz) of all of the shares held by Eckert & Ziegler SE, Berlin in Pentixapharm AG to Pentixapharm Holding AG (“Spin-off” and such combined subsidiaries together with Pentixapharm Holding AG “Pentixapharm Group”) and/or their financial position and, in particular, is subject to amendment, revision, verification, correction, completion and updating in its entirety. Neither (i) Pentixapharm Holding AG nor (ii) BankM AG ("Bank", and together with Pentixapharm Holding AG "Persons"), or any of the respective directors, officers, personally liable partners, employees, agents, affiliates, shareholders or advisers of such Persons may notify you of changes nor is under an obligation to update or keep current the announcement or to provide the recipient thereof with access to any additional information that may arise in connection with it, save for the making of such disclosures as are required by mandatory provisions of law. This announcement does not constitute investment, legal, accounting, regulatory, taxation or other advice.

No person is authorized to give any information or to make any representation not contained in and not consistent with this announcement and, if given or made, such information or representation must not be relied upon as having been authorized by or on behalf of Pentixapharm Holding AG or any Person.

Certain market positioning data about Pentixapharm Holding AG and Pentixapharm Group included in this announcement is sourced from or based on third-party sources. Third-party industry publications, studies and surveys generally state that the data contained therein have been obtained from sources believed to be reliable, but that there is no guarantee of the fairness, quality, accuracy, relevance, completeness or sufficiency of such data. Such research, estimates and forecasts, and their underlying methodology and assumptions, have not been verified by any independent source for accuracy or completeness and are subject to change without notice. Accordingly, Pentixapharm Holding AG expressly disclaims any responsibility for, or liability in respect of, such information and undue reliance should not be placed on such data.

This announcement may contain forward-looking statements which reflect Pentixapharm Holding AG’s and Pentixapharm Group's current view on future events and financial and operational development. Forward-looking statements are sometimes, but not always, identified by their use of a date in the future or such words as “will”, “anticipates”, “aims”, “could”, “may”, “should”, “expects”, “believes”, “intends”, “plans”, “prepares” or “targets” (including in their negative form or other variations). By their nature, forward-looking statements are inherently predictive, speculative and involve risk and uncertainty because they relate to events and depend on circumstances that may or may not occur in the future. There are a number of factors that could cause actual results, performance and developments to differ materially from those expressed or implied by these forward-looking statements. All subsequent written or oral forward-looking statements attributable to Pentixapharm Holding AG or its affiliates, or any persons acting on their behalf are expressly qualified in their entirety by the factors referred to above. No assurances can be given that the forward-looking statements in this announcement will be realized. Any forward-looking statements are made of the date of this announcement.

Subject to compliance with applicable law and regulations, neither Pentixapharm Holding AG, nor the Bank nor their respective affiliates intend to update, review, revise or conform any forward-looking statement contained in this announcement to actual events or developments whether as a result of new information, future developments or otherwise, and do not undertake any obligation to do so.

The information contained in this announcement does not purport to be comprehensive and has not been subject to any independent audit or review.

Certain figures, including financial and market data, contained in this announcement have been rounded and the relevant sums may not add up to 100% due to rounding.

The Bank is acting exclusively for Pentixapharm Holding AG and no-one else in connection with the planned offering of shares of Pentixapharm Holding AG ("Offering"). It will not regard any other person as their respective clients in relation to the Offering and will not be responsible to anyone other than Pentixapharm Holding AG for providing the protections afforded to their respective clients, nor for providing advice in relation to the Offering, the contents of this announcement or any transaction, arrangement or other matter referred to in this announcement.

In connection with the Offering, the Bank and any of its affiliates, acting as investors for their own accounts, may subscribe for or purchase securities of Pentixapharm Holding AG and in that capacity may retain, purchase, sell, offer to sell or otherwise deal for their own accounts in such securities and other securities of Pentixapharm Holding AG or related investments in connection with the Offering or otherwise. Accordingly, references in the prospectus, once published, to the securities being issued, offered, subscribed, acquired, placed or otherwise dealt in should be read as including any issue or offer to, or subscription, acquisition, placing or dealing by the Bank and any of its affiliates acting as investors for their own accounts.

In addition, the Bank or its affiliates may enter into financing arrangements and swaps with investors in connection with which the Bank (or its affiliates) may from time to time acquire, hold or dispose of Pentixapharm Holding AG’s shares. The Bank does not intend to disclose the extent of any such investment or transactions otherwise than in accordance with any legal or regulatory obligations to do so.

None of the Bank or any of its affiliates, directors, officers, personally liable partners, employees, advisers or agents accepts any responsibility or liability whatsoever for or makes any representation or warranty, express or implied, as to the truth, accuracy or completeness of the information in this announcement (or whether any information has been omitted from the announcement) or any other information relating to Pentixapharm Holding AG, its combined subsidiaries or associated companies, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of this announcement or its contents or otherwise arising in connection therewith.

The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed by any person for any purpose on the information contained in this announcement or its accuracy, fairness or completeness.

The dates of the admission(s) to trading of shares of Pentixapharm Holding AG on the regulated market segment (regulierter Markt) of the Frankfurt Stock Exchange (Frankfurter Wertpapierbörse) with simultaneous admission to the sub-segment of the regulated market with additional post-admission obligations (Prime Standard) of the Frankfurt Stock Exchange (Frankfurter Wertpapierbörse) (together "Admission") may be influenced by things such as market conditions. There is no guarantee that Admission will occur and no financial decision should be based on the intentions of Pentixapharm Holding AG in relation to Admission at this stage. Acquiring investments to which this announcement relates may expose an investor to a significant risk of losing all of the amount invested. Persons considering making such investments should consult an authorized person specializing in advising on such investments. This announcement does not constitute a recommendation concerning the Offering. The value of shares can decrease as well as increase. Potential investors should consult a professional advisor as to the suitability of the Offering for the person concerned.

Pentixapharm Acquires Target Discovery Business of Glycotope

Würzburg and Berlin, Germany, July 3rd, 2024 – Pentixapharm AG, a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals against a range of malignancies, has announced the execution of an agreement, effective July 1st, to acquire the target discovery business of Berlin-based Glycotope GmbH.

The deal encompasses a portfolio of preclinical antibodies against multiple oncology targets that can be developed into radiopharmaceuticals. It also includes Glycotope’s laboratories, cell banks, tumor target data base, and the equipment needed to exploit the discovery platform, along with a range of patents, licenses, and other tangible assets. In total, Pentixapharm will be able to add an integrated team of 40 seasoned executives, R&D specialists, and administrators to its staff.

“The acquisition will broaden Pentixapharm’s Intellectual Property portfolio beyond the one built around the CXCR4 receptor. This will immediately double the development pipeline and significantly expand the associated business and clinical development opportunities,” explained Hakim Bouterfa, CEO of Pentixapharm AG. “Glycotope’s pipeline comprises several candidates that can be used immediately for proof-of-concept studies as next generation radiopharmaceuticals. We look forward to maximizing the synergy of Pentixapharm’s know-how and Glycotope’s target discovery for the benefit of patients in both diagnostics and therapeutic applications.”

“The transaction provides Pentixapharm not just with a chance to build a clinical pipeline beyond the company’s current CXCR4-ligand based programs, but also substantially strengthens its administrative and managerial capacities,” noted Andreas Eckert, Chairman of the Supervisory Board of both Pentixapharm and mother company Eckert & Ziegler SE (EZAG). “It adds a critical number of talents to the planned secession of Pentixapharm to Frankfurt Stock Exchange, thereby facilitating a seamless separation from EZAG. The offices and laboratories included in the deal are large enough to allow a consolidation of all Berlin-based activities into one location.”

The transaction will also affect the composition of the Pentixapharm Management Board once the company becomes listed on the Frankfurt Stock Exchange. Hakim Bouterfa, current CEO of Pentixapharm, is designated to move to the Company’s Supervisory Board. He will be succeeded by Dirk Pleimes, currently Pentixapharm’s Chief Medical Officer. Patrik Kehler, former Chief Scientific Officer (CSO) of Glycotope, will assume the CSO position at Pentixapharm, while Glycotope’s former CEO, Henner Kollenberg, will take over the responsibility for administrative and business development issues as Chief Business Officer.

Patrik Kehler, newly appointed Chief Scientific Officer of Pentixapharm, explained: “The target discovery unit’s development activities focus on tumor-associated carbohydrate structures, so-called GlycoTargets. Their major advantage is the reduced normal tissue binding compared to conventional antibodies. Based on their superior tumor-specificity, they are suitable for development in an array of different modes of action. In the radiopharmaceuticals field, they have the potential to close the treatment gap that exists for the majority of solid tumors.”

About the Glycotope Target Discovery Unit

The target discovery unit utilizes a proprietary technology platform to develop uniquely tumor-specific monoclonal antibodies or fragments thereof. They target specific tumor-associated carbohydrate structures or protein/carbohydrate combined glycoepitopes (GlycoTargets). The unit has to date discovered in excess of 200 GlycoTargets (www.glycotope.com). Many of these have been outlicensed to major pharmaceutical companies around the world, where they are currently in pre-clinical and clinical development.

About Pentixapharm AG

Pentixapharm is a radiopharmaceutical development company founded in 2019 with its headquarters in Würzburg, Germany. It is currently wholly owned by the Eckert & Ziegler Group but bound to be spun-off to the Frankfurt Stock Exchange soon. 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, endocrine and inflammatory diseases.

Pentixapharm’s clinical pipeline encompasses PENTIXATHER, am Yttrium-90 based therapeutic against CNS lymphoma, and PENTIXAFOR, a Gallium-68 based companion diagnostic. Clinical studies for both compounds have already commenced in Europe, with a dose-finding study for PENTIXATHER and a Phase III registration study for PENTIXAFOR. Additionally, PENTIXAFOR is being developed as a diagnostic tool for primary aldosteronism (PA), a significant cause of hypertension. Pentixapharm is currently preparing a US centric Phase III registration study in PA that will start in 2025.

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
Tel. +49 211 529252 22
anne.hennecke@mc-services.eu
 

Pentixapharm Announces Expansion of Supervisory Board with the Appointment of Distinguished Endocrinologist Marcus Quinkler

Würzburg and Berlin, Germany, July 1st, 2024 – Pentixapharm Holding AG, a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals against a broad range of malignancies, announced today that the General Shareholder Meeting of Pentixapharm resolved the appointment of the distinguished endocrinologist Prof. Dr. med. Marcus Quinkler to the Company's Supervisory Board. The assignment will become effective with the registration of the split-off of Pentixapharm Holding AG from Eckert & Ziegler SE in the commercial register.

“We welcome Marcus Quinkler as a valuable addition to our Board. He is a recognized expert among others in primary aldosteronism, the focus area of our Phase III lead program PENTIXAFOR (PTF-302). He will also help Pentixapharm to advance its ongoing clinical assessments of the Company’s novel, CXCR4-based radiopharmaceutical therapeutic and diagnostic programs.” explained Dr. Hakim Bouterfa, Founder and Chief Executive Officer of the Pentixapharm Holding AG.

Marcus Quinkler is a specialist of internal medicine and endocrinology, diabetology and andrology. Formerly at the endocrinology department at the Charité-Universitätsmedizin, Campus Mitte, Berlin, currently leading a specialized endocrine practice in Berlin, Dr. Quinkler has significantly contributed to the field, serving as an adjunct professor at Charité.

His academic training includes a medical degree and doctorate from the Free University of Berlin, a research fellowship at the University of Birmingham, U.K., funded by the DFG, and a postdoctoral thesis at the Charité to qualify as a professor. Dr. Quinkler has led significant clinical guideline developments and held editorial roles in prominent journals. His accolades include the Schoeller-Junkmann Prize and the Arthur-Jores Honorary Prize from the German Society for Endocrinology (DGE). From 1996 to 2024, Dr. Quinkler has authored over 270 peer-reviewed publications.

Dr. Marcus Quinkler added: “Pentixapharm’s CXCR4-ligand technologies are being evaluated not only in hematological indications but also for a range of other applications beyond cancer. Notably, their advanced diagnostic program in Primary Aldosteronism holds significant promise as a meaningful alternative to the current gold standard, potentially improving patient outcomes and enhancing cardiovascular health. I am pleased to join the Board at this pivotal moment and support the Company in their future growth.”

Dr. Quinkler will strengthen the Supervisory Board of Pentixapharm Holding AG next to Chairman Dr. Andreas Eckert, Jens Giltsch and Dr. Harald Hasselmann, who also serves as CEO of Eckert & Ziegler SE.

About Pentixapharm AG

Pentixapharm is a radiopharmaceutical development company founded in 2019 with its headquarters in Würzburg, Germany. It is currently wholly owned by the Eckert & Ziegler Group but bound to be spun-off to the Frankfurt Stock Exchange soon. 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.

Pentixapharm’s clinical program encompasses PENTIXATHER, am Yttrium-90 based therapeutic against CNS lymphoma, and PENTIXAFOR, a Gallium-68 based companion diagnostic. Clinical studies for both compounds have already commenced in Europe, with a dose-finding study for PENTIXATHER and a Phase III registration study for PENTIXAFOR.  Additionally, PENTIXAFOR is being developed as a diagnostic tool for primary aldosteronism, a significant cause of hypertension. Pentixapharm aims to initiate an advanced clinical trial in the United States in 2025.

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

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

Würzburg, Germany, June 25th, 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 hypertension [1]. 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 normalization [2]. 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

First CNS Lymphoma Patient Dosed in Phase I/II PTT101 Study with Yttrium-90 Anditixafortide (PentixaTher)

(Only Available in English)

Berlin and Würzburg, Germany, November 22nd, 2023 - Pentixapharm AG, a developer of innovative radiopharmaceuticals owned by Eckert & Ziegler Strahlen- und Medizintechnik AG (ISIN DE0005659700) today has announced that a first patient has been treated in a dose-finding clinical phase I/II study with Yttrium (90Y) anditixafortide (PentixaTher) at the University Hospital in Essen, Germany.

This study, PTT101 (ClinicalTrials.Gov ID: NCT06132737), is a prospective, open-label dose-escalation, multicenter study to evaluate the safety, tolerability, biodistribution and efficacy of PentixaTher in patients with CNS lymphoma (cancer affecting the central nervous systems). PentixaTher is targeting the CXCR-4 cytokine receptor which is widely expressed in different cancer indications.

Before treatment, patients will be screened with Gallium-68 (68Ga)-based PentixaFor to confirm the presence of the CXCR-4 receptors. If the PET scan turns out to be positive, PentixaTher will be given in various doses to different dose group (in total 9 to 15 patients). The enrollment is planned to last 12 months.

“Previous studies have shown that up to 90% of CNS lymphoma patients overexpress the CXCR4 receptor. We therefore hope that the clinical results in CNS lymphomas with Yttrium (90Y) anditixafortide PentixaTher will show similar outstanding effects on tumor growth as we have observed it in other indications like T-cell lymphomas or Multiple Myelomas” commented Dr. Hakim Bouterfa, Chief Medical Officer at Eckert & Ziegler, and Member of the Board at Pentixapharm AG.

About Eckert & Ziegler
Eckert & Ziegler Strahlen- und Medizintechnik AG with more than 1.000 employees is a leading specialist for isotope-related components in nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the SDAX index of Deutsche Börse.
Contributing to saving lives.

Contact

Anne Lobach, Finance and Administration Manager, Pentixapharm AG

anne.lobach@pentixapharm.com

EANM 2023: The theranostics future is now: Innovative diagnostic application and therapeutic potential of CXCR4

(Only Available in English)

Pentixapharm to hold Symposium at EANM 2023 in Vienna

Monday, September 11, 2023 (13:15 - 14:45), Hall K 

Chairperson:

Prof. Ken Herrmann (Clinic of Nuclear Medicine University Hospital Essen)

Program:

CXCR4-directed Theranostics in Hematooncology
Speaker: Prof. Andreas Buck (Clinic of Nuclear Medicine University Hospital Würzburg)

Innovative CXCR4 directed diagnostic application in a common endocrine cause of hypertension
Speaker: Dr. Elisabeth Ng (Monash University Australia)

The Castus Trial: Aim, Design and Current Status
Speaker: Prof. Martin Gotthardt (University Medical Center Radboud University Nijmegen)

Panel Discussion

PentixaPharm Receives BfArM-Clearance for its Therapeutic to conduct a Clinical Trial in Lymphoma

(Only Available in English)

Phase I with PentixaTher

Würzburg / Berlin (Germany), June 8th, 2023 PentixaPharm GmbH, a developer of innovative radiopharmaceuticals fully owned by Eckert & Ziegler Strahlen- und Medizintechnik AG (ISIN DE0005659700; TecDax) has received the approval from the German Federal Institute for Drugs and Medical Devices (BfArM) to start PTT101, its open-label dose escalation study to evaluate the safety, tolerability, biodistribution and efficacy of PentixaTher.

The Yttrium-90 labelled CXCR4-compound PentixaTher will be tested as a radiotherapeutic against recurrent or refractory primary or isolated secondary central nervous system lymphoma. The phase I/II, dose-finding study will be conducted at the University Hospital in Essen, North Rhine Westphalia, Germany. “After showing up to 90% of CNS lymphoma patients overexpressing the target CXCR4 with the Ga68-labeled tracer PentixaFor in CNS lymphoma patients, we are happy to test now the therapeutic impact when attacking CXCR-4 with [90Y]Y-PentixaTher (yttrium (90Y) anditixafortide). The study will start after getting final endorsement from the German Radiation Safety Department (BfS)“, commented Dr. Hakim Bouterfa, Chief Medical Officer at Eckert & Ziegler.

In addition, radiolabelled PentixaTher has shown outstanding results under named-patient programs in patients with T-cell lymphoma as conducted at the University Hospital Würzburg (DOI: 10.2967/jnumed.122.264207) (1). 

1)  Buck AK, Grigoleit GU, Kraus S, Schirbel A, Heinsch M, Dreher N, Higuchi T, Lapa C, Hänscheid H, Samnick S, Einsele H, Serfling SE, Werner RA. C-X-C Motif Chemokine Receptor 4-Targeted Radioligand Therapy in Patients with Advanced T-Cell Lymphoma. J Nucl Med. 2023 Jan;64(1):34-39. doi: 10.2967/jnumed.122.264207. Epub 2022 Jun 23. PMID: 35738903; PMCID: PMC9841250.

About Eckert & Ziegler
Eckert & Ziegler Strahlen- und Medizintechnik AG with more than 1.000 employees is a leading specialist for isotope-related components in nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
Contributing to saving lives.

Contact

Anne Lobach, Executive Assistant, PentixaPharm GmbH

anne.lobach@pentixapharm.com

Lausanne University Hospital Investigates Use of PENTIXAFOR in Cardio-Vascular Setting

Phase II with PentixaFor

Würzburg / Berlin (Germany), February 1st, 2023 

The Lausanne University Hospital (CHUV) has reported the initial dosing of a patient in a phase II clinical study investigating the sensitivity of PENTIXAFOR (Boclatixafotide) in a cardiovascular and inflammatory setting. It is the first time that Eckert & Ziegler’s proprietary CXCR4-compound is used in an advanced clinical test in a non-cancer indication, opening the way for a broader use of PENTIXAFOR outside of oncology.

The Gallium-68 based radio-diagnostic PENTIXAFOR promises to significantly improve the sensitivity in the detection of acute myocardial inflammation, which may allow for future early clinical management of patients with myocarditis, avoiding the progression to more severe stages.

To investigate the potential of PENTIXAFOR the CHUV will recruit, on its own account, up to 60 patients in a so-called investigator initiated study (ISS). Eckert & Ziegler, owner of the rights to the CXCR4 targeted tracer used in this study, supports the CHUV team under Professor John Prior and Professor Niklaus Schaefer by providing the compound. Also, part of the CHUV team is Professor Margret Schottelius, Head of the Translational Radiopharmaceutical Sciences lab at CHUV/Agora, who was involved in the preclinical development and clinical translation of PENTIXAFOR and Dr Judith Delage, Head of the Radiopharmacy Unit, in charge, together with her team, of the clinical transfer and of the GMP internal production.

Acute myocardial inflammation is a heterogenic inflammatory disease of the heart muscle involving different clinical pathologies and outcome. The CHUV study focuses on the three entities acute cellular cardiac allograft rejection, cardiac sarcoidosis and the immune checkpoint inhibitor induced myocarditis, as non-invasive diagnosis remains challenging for these life-threatening conditions with current standards.

“Including cardiovascular indications in our prognostic development program in addition to oncology demonstrates the exciting potential of PENTIXAFOR,” comments Dr Jens Kaufmann, co-founder and general manager of Pentixapharm. “We are delighted to collaborate with an excellent centre such as the CHUV in this field, led by Dr Christel Kamani as principal investigator.”

Dr Kamani is triple-certified in cardiology (2017), internal medicine (2018) and in nuclear medicine (2022). Dr Kamani has learned all techniques of multimodality cardiovascular imaging. His research interest focuses on non-invasive multimodality tools for the detection of cardiovascular disease.

PENTIXAFOR is being developed by Eckert & Ziegler’s subsidiary Pentixapharm GmbH primarily as a superiorly sensitive diagnostic for rare blood cancers, among them myelomas, lymphoma and leukaemia.

About Eckert & Ziegler
Eckert & Ziegler Strahlen- und Medizintechnik AG with more than 900 employees is a leading specialist for isotope-related components in nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the SDAX index of Deutsche Börse.
Contributing to saving lives.

About Lausanne University Hospital
The Lausanne University Hospital (CHUV) is one of Switzerland's five university hospitals and a well-known center of medical education and research thanks to its collaboration with the Faculty of Biology and Medicine of the University of Lausanne and the Swiss Federal Institute of Technology in Lausanne (EPFL). 

Contacts

Anne Lobach, Executive Assistant, PentixaPharm GmbH

anne.lobach@pentixapharm.com

Eckert & Ziegler Receives Green Light for Phase III Study with PENTIXAFOR

Phase III with PentixaFor

Würzburg / Berlin (Germany), November 25th, 2022 

PentixaPharm GmbH, a 100% subsidiary of Eckert & Ziegler AG (ISIN DE0005659700, SDAX), received green light from the European Medicines Agency (EMA) to conduct a phase III registration study in patients suffering from various forms of Non-Hodgkin-Lymphomas. Following several rounds of scientific advice, the EMA Committee for Medicinal Products for Human Use (CHMP) endorsed a study design presented by PENTIXAPHARM’s management, which envisions treating up to 500 lymphoma patients with the Gallium-68 based radiotracer PENTIXAFOR in about 30 participating European clinics. In its endorsement the CHMP adopted the advice given by the EMA Scientific Advice Working Party, a multidisciplinary group, which comprises delegates from several national European Health Agencies, members of the Committee for Orphan Medicinal Products, the Paediatric Committee, the Committee for Advanced Therapies, and the Pharmacovigilance Risk Assessment Committee. The first treatments with PENTIXAFOR are expected to start in the first half of 2023, subject to approval by national health authorities.

The Executive Board expects to have completed the clinical trials and approval of PENTIXAFOR by the end of 2025 and estimates development costs of EUR 50 million, which will initially be capitalized in the balance sheet and thus not be recognized in the income statement. In addition to the diagnostic agent, Eckert & Ziegler is also developing radiotherapeutics for several hematological indications based on CXCR4 peptides. The Group acquired the global property rights to the CXCR4 receptor addressing agents from the patent licensing office of the Technical University of Munich.

Contacts

Anne Lobach, Executive Assistant, PentixaPharm GmbH

anne.lobach@pentixapharm.com

First CNS Lymphoma Patient Imaged with PentixaFor in Phase II Trial

(Only Available in English)

Treatment with PentixaFor

Berlin (Germany)/ Aalborg (Denmark), October 27th, 2022 – The University Hospital Aalborg (Denmark) yesterday has imaged the first patient with Eckert and Ziegler’s Gallium (68Ga) boclatixafortide (PENTIXAFOR) in an international phase II trial. Code named PTF202, the clinical examination tries to measure the predictive potential of the CXCR4 receptor targeting radiotracer for the treatment of central nervous system lymphoma (CNSL). If successful, PENTIXAFOR could change the way that chemotherapy in the future will be prescribed. Among others, it could save CNSL patients who do not respond to treatment from unnecessary hardship.

CNSL are severe tumors with a poor prognosis. They force oncologists to retort to aggressive chemotherapy regimens, which not only have strong side effects, but often fail to even stop tumor growth. In this situation, knowing quickly whether a lymphoma responds to treatment is very valuable. This can be achieved by looking for CXCR4 receptors, which central nervous system tumors often express while progressing. PENTIXAFOR detects such receptors. The information from the innovative radiotracer hence has the potential to significantly increase the options for an improved response and risk assessment and for the optimization of CNSL patient’s therapeutic needs.

“We are very excited to enrol the first patient into the trial." stated Jakob Madsen, MD, Head of the Department for Hematology at the University Hospital Aalborg and principal investigator of the trial. Helle Zacho, MD, Professor at the Nuclear Medicine Department at the University Hospital Aalborg added, "The overall aim of the study is to prospectively and systematically investigate whether PENTIXAFOR can be used for response assessment in CNSL and in addition, can serve as a prognostic marker.”

The PTF202 phase II trial, which includes 50 patients from up to eight clinics in Europe and the United States, is expected to be finished by the first quarter of 2025. It is only a part of Eckert & Ziegler’s broader drive to develop the CXCR4 compound. The European Medicine Agency (EMA) is currently reviewing a study design from Eckert & Ziegler for an even larger phase III trial with PENTIXAFOR which aims at patients suffering from various other forms of lymphoma. It may include up to 500 participants and could be finished as early as 2025. A decision of the EMA for the go-ahead of this diagnostic radiotracer is expected still within this year.

Further, Eckert & Ziegler is preparing an application for a phase I clinical trial in which a modified version of PENTIXAFOR is used to directly attack tumor cells that express the CXCR4 receptor. This modified version of the radiopharmaceutical, Yttrium (90Y) anditixafortide (PENTIXATHER), would hopefully show therapeutic effects. The clinical development of the therapeutic, however, is still at the beginning.

Dr. Hakim Bouterfa, Managing Director of Eckert & Ziegler’s subsidiary PentixaPharm, which conducts and sponsors the study, explains: “We are very optimistic about the prospects of radiopharmaceuticals using the CXCR4 receptor. The target has already shown its usefulness in a broad array of academic studies, under compassionate-use, and in investigator-initiated study settings. Scans with radiopharmaceuticals targeting the CXCR4 receptor have been summarized in over 70 publications which include more than 1100 patients. PTF202 is our first step in clinically exploring the potential of this compound."

Contacts

Anne Lobach, Executive Assistant, PentixaPharm GmbH

anne.lobach@pentixapharm.com