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Press Release

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

• 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.

Abivax Reports Positive Interim Efficacy and Safety Analysis of Once-Daily 25mg Obefazimod in Moderate to Severe Ulcerative Colitis Patients After 2-Years of Open-Label Maintenance

• Patients treated with a de-escalated dose of 25 mg of obefazimod once daily demonstrated maintenance of clinical remission at weeks 48 and 96
• Efficacy and safety demonstrated out to six years of treatment
• The treatment was well-tolerated, with a safety profile consistent with previous studies and no new safety signals detected

PARIS, France, October 3, 2024, 8:30 a.m. CEST – Abivax SA (Euronext Paris & Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, announced the results of an interim  efficacy and safety analysis of an open-label maintenance (OLM) study that enrolled patients with UC at the conclusion of the Phase 2a and Phase 2b OLM studies, where they had received obefazimod 50mg once daily. The data demonstrated maintenance of clinical remission and a safety profile consistent with prior studies of oral, once-daily obefazimod when administered at a reduced dose of 25mg for up to an additional two years.

“These important data further support the potential of obefazimod as a promising therapeutic option for patients with UC,” said Marla Dubinsky, MD, Co-Director, Susan and Leonard Feinstein IBD Clinical Center at Icahn School of Medicine at Mount Sinai New York. “The results observed at a lower dose are particularly encouraging, as clinicians often like to have the option to de-escalate dosing once patients achieve remission”.

In this open-label maintenance study, patients who had completed the 4-year Phase 2a or 2-year Phase 2b OLM studies, where they had received 50 mg of once-daily obefazimod, were given the opportunity to continue receiving obefazimod at a reduced dose of 25mg daily for up to five additional years (provided they met the eligibility criteria of Mayo Endoscopic Subscore = 0 or 1). A total of 130 patients entered the study, as of Sep 11, 2024, the data cut-off date, 113 have been evaluated out to 48 weeks and 74 have undergone the full 96-week evaluation. 

At study baseline, 89% (116/130) of patients were in clinical remission.  At weeks 48 and 96 of treatment, 84% (95/113) and 87% (64/74) of patients evaluated were in clinical remission, respectively.  Similarly, 92% (119/130) of patients were in symptomatic remission at study baseline.  At weeks 48 and 96, 91% (103/113) and 92% (68/74) of patients evaluated were in symptomatic remission, respectively. Similar trends were observed with other efficacy analyses.

Silvio Danese, MD, Professor of Gastroenterology at the San Raffaele University, Milan, Italy, stated “For patients with UC, a significant need exists for an oral treatment option that is not only well-tolerated and convenient, but that provides maintenance of remission over a long period of time. The obefazimod data released today, with patients maintained for up to 6 years of treatment, provides me with great hope that we are getting closer to meeting that significant need.”

The safety results were consistent with previous studies, with no new safety signals detected.  Patient retention rates were high, with only 12% (16/130) of patients discontinuing in the first year and 5% (6/114) discontinuing during the second year of treatment (33 patients have not reached week 96 as of Sept 11, 2024, the data cutoff date.

“The maintenance of clinical remission and the promising tolerability data observed to date, underscores the potential of obefazimod as a treatment for ulcerative colitis. We look forward to presenting this data at an upcoming medical meeting,” said Fabio Cataldi, MD, Chief Medical Officer, Abivax.

About Obefazimod

Obefazimod, Abivax’s lead investigational drug candidate, is an orally administered small molecule that was demonstrated to potentially enhance the expression of a single microRNA, miR-124. Phase 2 clinical trials in patients with UC have generated positive data, resulting in the initiation of a pivotal global Phase 3 clinical trial program (ABTECT Program), with first patients enrolled in the United States in October 2022. Initiation of a Phase 2b clinical trial in Crohn’s disease is expected in Q4 2024, and exploration of potential combination therapy opportunities in UC is ongoing.

About Abivax

Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. More information on the Company is available at www.abivax.com. Follow us on LinkedIn and on X, formerly Twitter, @Abivax.

Contact:

Patrick Malloy
SVP, Investor Relations, Abivax
patrick.malloy@abivax.com
+1 847 987 4878

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business and financial objectives. Words such as “expect,” “plan,” “potential,” “will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning or implying the therapeutic potential of Abivax’s drug candidates, the timing of initiation of clinical trials, obefazimod’s potential, as monotherapy or in combination with other therapies, to provide meaningful benefit to patients suffering from UC, Crohn’s disease, IBD or other indications, and other statements that are not historical fact. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 5, 2024, under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates. Current results are not necessarily indicative of future results. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development including further assessment by the company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.

PRESS RELEASE

Strategic agreement signed for distribution of Yimmugo^® in the United States based on the framework established in July

• All contractual terms finalized and definitive agreement with Kedrion signed
• Expected to generate revenues of more than $1 billion for Biotest during the 7-year term
• Preparations for U.S. launch of Yimmugo^® in 2025 well underway

Dreieich, Germany, October 2, 2024. Following the agreement of binding terms in July, the parties have now finalized all contractual terms and Biotest, part of the Grifols Group, has entered into a long-term agreement with Kedrion Biopharma Inc., Fort Lee (NJ), USA, for the full commercialization and distribution of its immunoglobulin Yimmugo^® in the United States.

The distribution agreement requires Biotest to supply and Kedrion to purchase minimum quantities of Yimmugo^® over the seven-year term, representing approximately $1 billion in sales for Biotest. This agreement represents Biotest’s largest commercial agreement since its founding.

Production of the quantities needed to enter the United States began immediately after the Biologic License Application (BLA) was approved and is ongoing. Preparations for the market launch of the product in 2025 have already begun and are now in full preparation.

With Yimmugo^®, a Biotest product is entering a U.S. market which, with more than 100 tons and annual IVIG sales of $10 billion, represents the most important market for the plasma derivatives sector.

About Yimmugo^® (IgG Next Generation)

Yimmugo^® is a newly developed polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIg). The sugar-free ready-to-use solution is approved in European markets for substitution therapy in primary antibody deficiency syndromes and secondary immune deficiency, as well as for immunomodulation in autoimmune diseases such as ITP, GBS, CIDP, MMN and Kawasaki syndrome. Under the U.S. license Biotest is authorized to manufacture Yimmugo^® for the treatment of primary humoral deficiency (PI) in patients 2 years of age or older. Yimmugo^® is the first approved product from Biotest’s new Next Level production facility. The modern production process stands for highest product quality and responsible use of resources.

About Biotest

Biotest (www.biotest.com) is a provider of biological therapeutics derived from human plasma. With a value-added chain that extends from preclinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. Biotest has more than 2,400 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German Stock Exchange. Since May 2022, Biotest has been a part of the Grifols Group, headquartered in Barcelona, Spain (www.grifols.com).

IR contact

Dr Monika Baumann (Buttkereit)

Phone: +49-6103-801-4406
Mail: ir@biotest.com

PR contact

Dirk Neumüller

Phone: +49-6103-801-269
Mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201

Preference shares: securities’ ID No. 522723; ISIN DE0005227235

Listing: Frankfurt (Prime Standard)

Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

Berlin, 2 October 2024. Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) announces that the spin-off resolution approved at the Annual General Meeting on 26 June 2024 was entered in the commercial register of the Charlottenburg (Berlin) District Court today. With the entry in the commercial register of Eckert & Ziegler SE, the spin-off of Pentixapharm AG became legally effective. All shares in Pentixapharm AG held by Eckert & Ziegler have thus been legally transferred from Eckert & Ziegler SE to Pentixapharm Holding AG.

In compensation, the shareholders of Eckert & Ziegler SE will receive Pentixapharm Holding AG shares at a ratio of 1:1. The number of Eckert & Ziegler shares held by each Eckert & Ziegler shareholder after the close of trading today, taking into account any outstanding stock market transactions, will determine their entitlement. All Pentixapharm Holding AG shares created as part of the spin-off are expected to be admitted to the Regulated Market of the Frankfurt Stock Exchange in the Prime Standard segment on 2 October 2024.

Initial trading of the Pentixapharm Holding AG shares is scheduled for 3 October 2024. On the same day, the listing of the Eckert & Ziegler SE shares ‘ex spin-off’ is planned. The deposit-side posting of the Pentixapharm Holding shares to the securities accounts of Eckert & Ziegler shareholders is expected to take place on 7 October 2024.

Further information on the IPO of Pentixapharm AG can be found here: www.pentixapharm.com

About Eckert & Ziegler.
Eckert & Ziegler SE 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:
Eckert & Ziegler SE, Karolin Riehle, Investor Relations
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Tel.: +49 (0) 30 / 94 10 84-138, karolin.riehle@ezag.de, www.ezag.com 

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

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

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.

PRESS RELEASE

Heidelberg Pharma: New Clinical Data on Lead ADC Candidate HDP-101 Presented at IMS 2024 Demonstrating Complete Remission in One Patient

• Data from the study with the lead ADC candidate, HDP-101, show elimination of tumor cells in one patient
• Clinical data from IMS will be presented in R&D webinar on 15 October at 17:00 CEST / 11:00 EDT

Ladenburg, Germany, 1 October 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage company developing innovative Antibody Drug Conjugates (ADCs), today announces that new clinical data from its lead Amanitin-based ADC candidate, HDP-101, were presented at the International Myeloma Society (IMS) Annual Meeting, held in Rio de Janeiro, Brazil on 27 September 2024.

HDP-101 is being evaluated in an ongoing Phase I/IIa clinical trial in the indication of relapsed or refractory multiple myeloma, a bone marrow cancer with a high unmet medical need. Clinical data from the fifth cohort demonstrated complete remission in one patient who had been heavily pre-treated. This patient showed an objective improvement (“partial response”) in the 2nd cycle of treatment and complete remission was confirmed after the 11th cycle.

In addition, several patients showed promising biological activity and an objective improvement demonstrating the potential of HDP-101 as a treatment option for patients with the disease.

Following the presentation at IMS, Heidelberg Pharma will host an R&D webinar on 15 October 2024 at 17:00 CEST/ 11:00 EDT, for investors, analysts, and media.

The R&D webinar will feature presentations by the Heidelberg Pharma management team, alongside Key Opinion Leaders (KOLs) in the myeloma field: Shambavi Richard, MD, Associate Professor Icahn School of Medicine at Mount Sinai Hospital, New York, USA and Robert Z. Orlowski, MD, PhD, (Ad Interim) Director of Myeloma, and Professor of Medicine in the Departments of Lymphoma/Myeloma and Experimental Therapeutics, University of Texas, Houston, Texas, and principal investigator at MD Anderson Cancer Center, Houston, Texas, USA.

Webinar participants will have the opportunity to submit questions in advance of the webinar or ask questions live during the event.

For further information on the R&D webinar, or to register your attendance, please use the link below:

https://lifescievents.com/event/heidelberg/

A live recording of the R&D webinar will be accessible via the press & investor section of the Company website.

About Heidelberg Pharma

Heidelberg Pharma is a biopharmaceutical company working on a new treatment approach in oncology and developing novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with cytotoxic compounds, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells.

Heidelberg Pharma uses several compounds and has built up an ADC toolbox that overcomes tumor resistance via numerous pathways and addresses different types of cancer using various antibodies. The goal is to develop targeted and highly effective ADCs for the treatment of a variety of malignant hematologic and solid tumors.

Heidelberg Pharma is the first company to use the compound Amanitin from the green death cap mushroom in cancer therapy. The biological mechanism of action of the toxin represents a new therapeutic modality and is used as a compound in the Amanitin-based ADC technology, the so-called ATAC technology. It offers the opportunity to overcome therapy resistance and also eliminate dormant tumor cells, which could lead to significant progress in cancer therapy – even for patients who no longer respond to other treatment. The Amanitin-based ADC development candidates are called ATACs.

The most advanced product candidate HDP-101 is a BCMA-ATAC for the indication multiple myeloma, which is currently in clinical development.

The first candidate that Heidelberg Pharma is developing with a toxin other than Amanitin is HDP-201, an exatecan-based ADC. Exatecan is a topoisomerase I inhibitor that has proven itself in cancer therapy and is used in two already approved ADCs. It differs in its mode of action from that of Amanitin and thus expands the company’s range of compounds.

The company is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com.

ATAC^® is a registered trademark of Heidelberg Pharma Research GmbH.

This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will” “should” “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.

Mainz Biomed Publishes CEO Statement; CEO Guido Baechler Eyes Major Growth and U.S. FDA Trials in 2025

BERKELEY, US and MAINZ, Germany – October 1, 2024 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today released a statement to shareholders highlighting its strategic plans for maximizing shareholder value, clinical developments, and its upcoming FDA trial anticipated for 2025, which aims to pave the way for entry into the U.S. market. Management believes 2025 will be a transformative year, positioning Mainz Biomed for substantial growth in global markets, particularly through its innovative diagnostic solutions.

“As we enter a critical phase in our company’s journey, Mainz Biomed’s vision remains focused on leading the way in cancer diagnostics,” said Guido Baechler, CEO of Mainz Biomed. “Our groundbreaking clinical results with our mRNA based next generation CRC screening test and our strategic pathway to FDA trials, which we plan to start in 2025, demonstrate our commitment to expanding into the world’s largest healthcare market. These efforts, combined with our growing international footprint, underscore why we believe Mainz Biomed is currently undervalued relative to its potential.”  In the notes below, you will find more information about our current status and upcoming plans that we are executing, reaffirming our commitment to early cancer detection and the exciting developments that are currently underway.”  Baechler commented further, “like all our shareholders, management and the Board of Directors are concerned and disappointed with the performance of our stock price.  We commit to our shareholders that we will continue to strive to deliver what we have promised under difficult market conditions.”  Baechler commented further, “We are strongly convinced that 2025 will be a transformative year, positioning Mainz Biomed for substantial growth in global markets, particularly through our innovative diagnostic solutions.”

Corporate Flagship Product: Breakthrough Data and U.S. Expansion

mRNA-based next-generation CRC screening tests are redefining standards in early cancer detection. Mainz Biomed’s flagship non-invasive test not only targets the early detection of colorectal cancer but also focuses on precancerous lesions, particularly advanced adenomas, demonstrating significant clinical success in both US and European trials. Presentations at DDW and ASCO this year have highlighted sensitivities exceeding 90% for detecting colorectal cancer and over 80% for advanced adenomas. Detecting advanced adenomas is crucial in preventing colorectal cancer, as identifying patients with these lesions allows for timely intervention through colonoscopy and adenoma removal, thereby averting cancer development.

Mainz Biomed, alongside other companies, emphasizes the use of stool-based samples for CRC and advanced adenoma detection due to their direct connection to cancer cells and adenomas. Recent reports suggesting the ease of blood tests over stool tests must be carefully evaluated, as extensive studies in the US and Europe have shown significantly lower sensitivity of blood tests in identifying advanced adenomas. This limitation arises because early-stage advanced adenomas are not typically connected to the body’s blood supply, making them undetectable through blood samples.

In early July the Company has announced that based on its robust clinical data package it submitted for FDA Breakthrough Device Designation (BDD) for its next generation CRC screening test. Following encouraging feedback from the FDA, the Company has made the strategic decision to withdraw its BDD application to focus on extending its clinical research program. Mainz Biomed will expand its dataset to include a larger average-risk patient population with its pivotal ReconAAsense trial. The Company plans to submit this comprehensive data in 2025 to FDA.

The consistently positive data from the Company’s clinical feasibility studies presented at ASCO 2024 and Digestive Disease Week (DDW), provide a strong foundation as Mainz Biomed prepares for U.S. FDA clinical trials in 2025, a key milestone in its strategy to penetrate the U.S. market. Successful completion of the FDA trial will allow Mainz Biomed’s next generation CRC screening test to be marketed to millions of Americans at risk of colorectal cancer, representing a major revenue growth opportunity for the company.

Innovative Diagnostic Pipeline

In addition to its mRNA next generation CRC screening test, Mainz Biomed is advancing a robust pipeline of cutting-edge diagnostic technologies aimed at detecting multiple cancers, with PancAlert leading the way. Our focus on molecular diagnostics, powered by proprietary biomarkers, positions us to address a wide range of cancers early, improving patient outcomes and reducing healthcare costs globally. The success of our upcoming products will help diversify our revenue streams and strengthen our leadership in cancer diagnostics.

Current development and expansion of the current ColoAlert screening test

Mainz Biomed has redeveloped and relaunched an expanded version of its first-generation CRC screening test currently commercialized in Germany and selected other countries in Europe. The change implemented in the ColoAlert product significantly simplified the workflow and reduced the retest rates. The feedback from the lab communities has been very positive and the Company expects this new product to further accelerate the growth and lab expansion.

Committed on delivering on key milestones for fair Company valuation

Mainz Biomed’s strong clinical results, expanding pipeline, and upcoming FDA trial, it is the management’s position that the Company’s current stock price does not adequately reflect its true value. While the Mainz Biomed cannot directly influence the stock market, the management team is fully focused on delivering on key milestones and executing its strategy to unlock value for shareholders.

Pursuant to Nasdaq and SEC rules the June 30, 2024, financials are required by December 31, 2024.  The Company plans to file during the fourth quarter of 2024. 

Looking Ahead: FDA Trials and Major Growth in 2025

2024 is a year of continued clinical progress and market expansion, but the FDA trials anticipated for 2025 represent a pivotal moment for Mainz Biomed. Successfully navigating the regulatory landscape in the U.S. will unlock significant opportunities to serve millions of patients in the world’s largest healthcare market.

In the meantime, the Company will continue to scale operations across Europe and other international markets, building on its scientific leadership in cancer diagnostics. With exciting innovations in the pipeline, Management is confident that Mainz Biomed is on track to revolutionize early cancer detection globally.

Further, we are pleased to have added a leader like Petra Starke to our team as a Brand Ambassador.  Petra is a thought leader in the field of colorectal cancer.  Her insights will continue to be invaluable as we focus our efforts in both Europe and the U.S. 

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information

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About Mainz Biomed NV

Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe. The Company is currently running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries

MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu

For investor inquiries, please contact info@mainzbiomed.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 9, 2024. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

Notification pursuant to Art. 5 (1) of the Regulation (EU) No 596/2014 and Art. 2 (1) of the Delegated Regulation (EU) 2016/1052 of the Commission

On September 2, 2024, the Executive Board of Drägerwerk Verwaltungs AG resolved an employee participation program for Drägerwerk AG & Co. KGaA (“Dräger”). For this purpose, Dräger will buy back some of its own preferred shares on the stock exchange in the period from October 7 to probably November 18, 2024. The corresponding shares will not be retired, but will remain in the share accounts of the participating employees during the two-year lock-up period.

Within the last year’s employee participation program, Dräger bought back 80,460 of a theoretical 692,872 shares. In the current year, Dräger could buy back up to 676,000 shares. However, this would only occur if all eligible employees and the Executive Board participate fully in the program.

The Executive Board will no longer participate in the program due to the new regulations on share-based remuneration. Accordingly, since the 2023 fiscal year, the members of the Executive Board are obliged to convert 40% of their one-year variable remuneration into virtual shares, which are locked for a period of five years. The aim of this regulation is to strengthen the long-term nature of variable remuneration and thus align the interests of the Executive Board and shareholders.

The share buyback principally complies with rules and regulations set forth in Sec. 71 (1) Sentence 1 No 2 AktG (Aktiengesetz − German Stock Corporation Act). The buyback of preferred shares held by persons not employed by the Company or any associated company, neither at the present time nor in the past, will take place in accordance with the authorization issued by the Company’s annual shareholders’ meeting dated 7 May 2021, which permits the buyback of up to 10% of capital stock held in the form of own shares.

A bank will be tasked with the buyback. The bank will make its decisions concerning the time of purchase of the preferred shares independently of Dräger and free of its influence. The right of Dräger to terminate its contract with the bank early and assign the task to a different bank remains unaffected.

In both cases, the buyback complies with the so-called safe-harbor rules set forth in Art. 5 of the Regulation (EU) No 596/2014 in connection with the Delegated Regulation (EU) 2016/1052 of the Commission.

The buyback will be made on the stock exchange. The purchase price will comply with the requirements set forth in the safe-harbor rules. In addition, the purchase price per preferred share (excluding acquisition charges) of those preferred shares to be acquired on the basis of the authorization issued by the annual shareholders’ meeting may not exceed or fall below the price of the preferred shares in the opening auction in Xetra trading on the Frankfurt Stock Exchange on the corresponding trading day in question by more than 10%.

The share buyback may be suspended and resumed at any time in accordance with the relevant legal guidelines.

The transactions will be announced by the end of the seventh trading day after their conclusion at the latest in a method in accordance with the requirements set forth in Art. 2 (2) in connection with (3) of the Delegated Regulation (EU) 2016/1052 of the Commission.

Dräger will report on the course of the buyback program in accordance with the legal provisions on the Company’s website (www.draeger.com) in the Investor Relations section.

Lübeck, Germany, October 1, 2024

Executive Board
Drägerwerk Verwaltungs AG, acting as the general partner of
Drägerwerk AG & Co. KGaA

Moislinger Allee 53–55
23558 Lübeck, Germany
www.draeger.com

Disclaimer
This release contains statements on the future development of Dräger Group. These forward-looking statements are based on the current expectations, presumptions, and forecasts of the Executive Board as well as the information available to it to date and have been prepared to the best of its knowledge and belief. No guarantee or liability for the occurrence of the future developments and results specified can be assumed in respect of such forward-looking statements. Rather, the future developments and results are dependent on a number of factors. They entail risks and uncertainties beyond the Company’s control and are based on assumptions which could prove to be incorrect. Notwithstanding any legal requirements to adjust forecasts, Dräger does not assume any obligation to update the forward-looking statements contained in this report. You will find all important financial dates on our Company website at www.draeger.com under Investors / Financial Calendar.

NOT FOR DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA OR JAPAN OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL. OTHER RESTRICTIONS ARE APPLICABLE. PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THIS ANNOUNCEMENT.

PharmaSGP Holding SE has purchased 477,701 own shares through its public share repurchase offer

Gräfelfing, October 1, 2024 – Based on the public share repurchase offer by PharmaSGP Holding SE, a total number of 477,701 shares have been tendered to the company by the end of the acceptance period on September 26, 2024, 24:00 (CEST).

The offer by PharmaSGP Holding SE was for a maximum of up to 594,405 shares (ISIN DE000A2P4LJ5 / WKN A2P4LJ) corresponding to a maximum of up to approximately 4.95% of the company’s registered share capital. The acceptance ratio is approximately 80.37%.

It is expected, that the custodian banks will transfer the tendered and accepted shares from the customer accounts against payment of the offer price between October 4, 2024 and October 8, 2024.

The company now holds 487,488 own shares (treasury shares), corresponding to approximately 4.06% of the issued share capital. It is intended to redeem the repurchased shares and reduce the share capital.

CONTACT

cometis AG
Claudius Krause
Phone: +49-611-20585528
Email: ir@pharmasgp.com

ABOUT PHARMASGP HOLDING SE

PharmaSGP is a leading consumer health company with a diversified portfolio of over-the-counter (OTC) pharmaceuticals and other healthcare products that are marketed with a focus on the pharmacy distribution channel. These products are mostly based on natural active pharmaceutical ingredients with documented efficacy and few known side effects.

The Company’s core brands cover chronic indications, including rheumatic pain, nerve pain and other age-related ailments. In Germany, PharmaSGP is the market leader for systemic chemical-free pain remedies with its brand families RubaXX^® for rheumatic pain and Restaxil^® for neuralgic pain. Furthermore, PharmaSGP also offers leading products against sexual weakness and vertigo symptoms. Since introducing the first product from the current product portfolio in 2012, PharmaSGP has successfully established its business model in other European countries, including Austria, Italy, Belgium, Spain and France. In September 2021, the product portfolio was expanded by the brands Baldriparan^®, Formigran^®, Spalt^® and Kamol^®, thus also strengthening or developing the indications pain and sleep disorder. The sales territory was expanded to include Switzerland and Eastern Europe. In 2023, PharmaSGP generated revenues of €101.1 million at an adjusted EBITDA margin of 33.7%.

In order to further expand its competitive position, PharmaSGP plans to increase the number of indications covered by PharmaSGP’s product offering, increase PharmaSGP’s European footprint, and accelerate its growth strategy especially by capitalizing on selected M&A opportunities.

DISCLAIMER / IMPORTANT NOTE

This release may not be published, distributed or transmitted in the United States, Canada, Australia or Japan. This release is not directed to or intended for distribution to or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction.

Neither this release nor its content may be published, dispatched, distributed or disseminated within the United States of America, and in each case neither by means of utilization of any postal service nor by any other means or instruments of business communication between single states or foreign trade or any facilities of a national stock exchange of the United States of America. This includes, among others, submission by fax, electronic post, telex, telephone and the internet. Copies of this release or any other documents related to this release may also not be distributed or submitted to or within the United States of America.

These materials do not constitute an offer of securities for sale or a solicitation of an offer to purchase securities of the Company in the United States, Germany or any other jurisdiction.