Pentixapharm AG Receives Orphan Drug Designation for its Radiodiagnostic Tracer PentixaFor in Marginal Zone Lymphoma by the European Medicines Agency
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EQS-News: Pentixapharm AG
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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 Press Release 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 Pentixapharm Holding AG Media Contact: 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.
26.08.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG. |
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