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

EQS-News: Biotest AG

/ Key word(s): Market Launch

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

02.10.2024 / 14:00 CET/CEST

The issuer is solely responsible for the content of this announcement.

 

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.

 


02.10.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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Eckert & Ziegler: Spin-off of Pentixapharm AG Registered with the Commercial Register

EQS-News: Eckert & Ziegler SE

/ Key word(s): Miscellaneous

Eckert & Ziegler: Spin-off of Pentixapharm AG Registered with the Commercial Register

02.10.2024 / 11:43 CET/CEST

The issuer is solely responsible for the content of this announcement.

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 


02.10.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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Pentixapharm Holding AG: Placement Price Set at EUR 5.10 per Share, All 3.9 Million Offer Shares Placed

Pentixapharm Holding AG / Key word(s): IPO

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

01-Oct-2024 / 18:48 CET/CEST

Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group AG.

The issuer is solely responsible for the content of this announcement.


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.

End of Inside Information


Information and Explanation of the Issuer to this announcement:

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.


01-Oct-2024 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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Heidelberg Pharma: New Clinical Data on Lead ADC Candidate HDP-101 Presented at IMS 2024 Demonstrating Complete Remission in One Patient

EQS-News: Heidelberg Pharma AG

/ Key word(s): Study results

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

01.10.2024 / 17:29 CET/CEST

The issuer is solely responsible for the content of this announcement.

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.

 

Contact
Heidelberg Pharma AG
Sylvia Wimmer
Director Corporate Communications
Tel.: +49 89 41 31 38-29
E-mail: investors@hdpharma.com
 
IR/PR-Support
MC Services AG
Katja Arnold (CIRO)
Managing Partner
Tel.: +49 89 210 228-40
E-mail: katja.arnold@mc-services.eu  
 
International IR/PR-Support
Optimum Strategic Communications
Mary Clark, Zoe Bolt, Katie Flint
Tel: +44 20 3882 9621
E-mail: HeidelbergPharma@optimumcomms.com
 

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.


01.10.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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Mainz Biomed Publishes CEO Statement; CEO Guido Baechler Eyes Major Growth and U.S. FDA Trials in 2025

Issuer: Mainz BioMed N.V.

/ Key word(s): Miscellaneous

01.10.2024 / 14:01 CET/CEST

The issuer is solely responsible for the content of this announcement.

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

Please follow us to stay up to date:
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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.


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Drägerwerk AG & Co. KGaA: 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

EQS-News: Drägerwerk AG & Co. KGaA

/ Key word(s): Miscellaneous

Drägerwerk AG & Co. KGaA: 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

01.10.2024 / 09:35 CET/CEST

The issuer is solely responsible for the content of this announcement.

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.


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

EQS-News: PharmaSGP Holding SE

/ Key word(s): Share Buyback

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

01.10.2024 / 08:15 CET/CEST

The issuer is solely responsible for the content of this announcement.

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.
 


01.10.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
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Biophytis Publishes First-Half Financial Results and Provides an Update on its Business Activities

Biophytis

/ Key word(s): Half Year Results

Biophytis Publishes First-Half Financial Results and Provides an Update on its Business Activities

30-Sep-2024 / 23:00 CET/CEST

 

Biophytis Publishes First-Half Financial Results
and Provides an Update on its Business Activities

 

Paris (France) and Cambridge (Massachusetts, USA), September 30, 2024 – 11:00pm CET – Biophytis SA (Euronext Growth Paris: ALBPS) (“Biophytis” or the “Company”), a clinical-stage biotechnology company focused on developing treatments for age-related diseases, publishes today its financial results for the first half of 2024 and provides an update on the company’s key achievements.

 

Stanislas Veillet, CEO of Biophytis, commented:

 

“We are particularly pleased with the progress made in the first half of 2024. The launch of our clinical program OBA for obesity, addressing a major public health issue, and our partnership with Blanver to develop BIO101 in Latin America, are key milestones that demonstrate Biophytis’ ability to innovate and capitalize on market opportunities.

 

We are now entering a critical phase where the results of our clinical trials, especially in the obesity field, along with our continued strategy of regional pharmaceutical partnerships, particularly in Asia, could significantly transform the company’s future.

 

Despite the ongoing challenges in financial markets, the Company has been able to extend its bond financing line, and is actively working on recapitalization solutions to support its future growth.”

 

Key Highlights for the First Half of 2024:

 

Launch of a new obesity program with BIO101 (20-hydroxyecdysone): In April 2024, Biophytis announced the launch of its OBA program targeting obesity with BIO101 (20-hydroxyecdysone). The global market for obesity treatments, valued at $6 billion in 2023, is projected to reach $100 billion by 2030, with an average annual growth rate of 42%. Biophytis is positioned to capitalize on this trend with BIO101, the first oral MAS receptor activator, already recognized for its beneficial effects on muscle mass and fat mass regulation in preclinical models. A phase 2 clinical trial for the OBA program, involving 164 patients with obesity, is set to begin in the second half of 2024. Results from this pivotal study are expected by the end of 2025 and could pave the way for new therapeutic options for millions of patients struggling with obesity.

 

Exclusive Licensing Agreement with Blanver for Latin America: In June 2024, Biophytis entered into an exclusive licensing agreement with Blanver, a leading pharmaceutical player in Latin America, for the registration and commercialization of BIO101 across all its current indications: sarcopenia, obesity, COVID-19, and Duchenne muscular dystrophy. This strategic partnership could generate up to €108 million in revenue for Biophytis through milestone payments and sales-based royalties. The first phase of the agreement involves regulatory submissions in several key Latin American countries at the beginning of 2025.

 

Expansion of Financing Capabilities: During the first half of 2024, Biophytis leveraged its bond financing line with Atlas through a new issuance of €4 million. The contract, set to expire in June 2024, was renewed for two years with a total value of €16 million, allowing the Company to draw €2 million every 40 trading days. This amendment provides the Company with a bond financing facility, complementing equity financing or non-dilutive funding options.

 

 

Financial highlights :

 

 

06/30/2023

 

06/30/2024

(amounts in thousands of euros, except share data)

 

6 months

 

6 months

 

 

 

 

 

 

 

 

 

Research and development costs, net

 

(3,763)

 

           (2,105)

General and administrative expenses

 

(2,761)

 

           (2,285)

Operating income

 

(6,524)

 

         (4,390)

 

 

 

 

 

Financial expenses

 

(795)

 

           (1,545)

Financial income

 

143

 

 121

Change in fair value of convertible bonds

 

(589)

 

              (3)

Net financial income

 

(1,240)

 

           (1,427)

 

 

 

 

 

Profit before tax

 

(7,764)

 

         (5,817)

 

 

 

 

 

Income tax

 

–

 

                   –  

Net income (loss)

 

(7,764)

 

(5,817) 

 

Biophytis’ operating result shows a loss of €4.4 million as of June 30, 2024, compared to €6.5 million a year earlier. External expenses have significantly decreased, particularly in R&D activities. This change is explained by the completion of clinical trials for the COVA and SARA programs in the first half of 2023, along with substantial internalization of regulatory and clinical work associated with the launch of the OBA obesity program initiated in April 2024, as well as a global reduction in overhead expenses.

 

The financial result decreased from -€1.2 million as of June 30, 2023, to -€1.4 million as of June 30, 2024, mainly driven by expenses related to convertible and non-convertible bond borrowings with Atlas Capital and Blackrock (formerly Kreos Capital).

 

The net loss amounts to €5.7 million as of June 30, 2024, compared to €7.8 million for the same period in 2023.

 

The company’s available cash stood at €2.2 million as of June 30, 2024, compared to €5.6 million as of December 31, 2023. These resources, which include non-dilutive financing obtained during the summer totaling €0.8 million (including Bpifrance subsidies and partial pre-financing of the 2024 CIR), are expected to fund operations until the end of October 2024. Drawing a new €2 million tranche from the bond facility with Atlas Capital could extend the cash horizon until the end of 2024. This drawdown is conditional upon the outstanding debt with Atlas, which must not exceed €2 million at the time of the drawdown. It is noted that the current outstanding debt is €2.3 million.

 

Outlook and Next Steps

 

The Company will continue in 2024 and 2025 with its value creation strategy focused on the development of its therapeutic innovations.

 

Based on its financing capabilities, the Company plans to advance its drug candidate BIO101 (20-hydroxyecdysone) through proof of concept in humans, demonstrating tolerance and efficacy in a phase 2 study across two indications: obesity and Duchenne muscular dystrophy. For its sarcopenia and severe COVID-19 programs with BIO101, the Company will actively seek co-development partnerships based on the positive results already achieved in terms of efficacy and safety.

 

  • OBA Program – Development of BIO101 for Obesity

The Company plans to initiate the Phase 2 OBA study in the second half of 2024, in the United States, with potential additional centers in Europe. Preliminary results on the efficacy of BIO101 are expected by the end of 2025.

  • MYODA – Development of BIO101 for Duchenne Muscular Dystrophy (DMD)

The Company plans to start a phase 1/2 OBA study in non-ambulant DMD patients in 2025.

  • SARA (development of BIO101 in sarcopenia) and COVA (development of BIO101 in severe forms of COVID-19) programs

Over the past few years, the Company has achieved significant results in terms of efficacy, particularly in patients with sarcopenia and severe forms of COVID-19, while demonstrating good tolerance in these fragile patients. The next development steps for the SARA and COVA programs will require long and costly Phase 3 studies, for which the support of a pharmaceutical partner will be necessary through co-development and licensing agreements.

Following the agreement with Blanver in June 2024 for Latin America, Biophytis is now focusing its search for potential partners in the Asia region. Sarcopenia is a widespread condition in this region, particularly in China and Japan. In these two countries, nearly 38 million people over the age of 65 suffer from sarcopenia[1], and this population is expected to grow by over 5% per year through 2030[2], making it an especially attractive target market.

Upcoming events:

 

  • October 2, 2024: European Midcap Event – Paris
  • December 6-8, 2024: International Conference on Sarcopenia, Cachexia, and Wasting Disorders (SCWD International Conference) – Washington DC, USA

About BIOPHYTIS

Biophytis SA is a clinical-stage biotechnology company focused on developing drug candidates for age-related diseases. BIO101 (20-hydroxyecdysone), our lead drug candidate, is a small molecule in development for muscular diseases (sarcopenia, Phase 3 ready to start, and Duchenne muscular dystrophy, Phase 1-2 to be started), respiratory diseases (COVID-19, Phase 2-3 completed), and metabolic disorders (obesity, Phase 2 to be started). The company is headquartered in Paris, France, with subsidiaries in Cambridge, Massachusetts, USA, and Brazil. The Company’s ordinary shares are listed on Euronext Growth Paris (ALBPS – FR001400OLP5) and its ADS (American Depositary Shares) are listed on the OTC market (BPTSY – US 09076G401). For more information, visit www.biophytis.com.

 

 

 

 

 

 

Disclaimer

This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “trends,” “plans,” “estimates,” “anticipates,” or the negative version of these words or comparable words. These forward-looking statements are based on assumptions that Biophytis considers reasonable. However, there is no guarantee that the forward-looking statements contained in these statements will be accurate, as they are subject to various risks and uncertainties. The forward-looking statements contained in this press release are also subject to risks not yet known to Biophytis or not currently considered significant by Biophytis. Therefore, there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. Please also refer to the “Risks and Uncertainties” section of the Company’s 2023 annual financial report available on the BIOPHYTIS website (www.biophytis.com), and as outlined in the “Risk Factors” section of Form 20-F and other forms filed with the SEC (Securities and Exchange Commission, USA). We do not undertake to publicly update or revise forward-looking statements, whether as a result of new information, future developments, or otherwise, unless required by law.

 

Biophytis Contacts

 

Investor Relations

Nicolas Fellmann, Chief Financial Officer
Investors@biophytis.com

 

Media Contacts

Antoine Denry : antoine.denry@taddeo.fr – +33 6 18 07 83 27

Nizar Berrada : nizar.berrada@taddeo.fr – +33 6 38 31 90 50

 

 

 

 

 

       

 

12/31/2023

 

06/30/2024

(amounts in thousands of euros)

 

 

 

 

 

 

 

ASSETS

 

 

 

Patents and software

2,637

 

2,535  

Property, plant and equipment

315

 

 275

Property, plant and equipment – right of use

186

 

160

Other non-current financial assets

158

 

 161

Total non-current assets

3,110

 

 2,970

 

 

 

 

Other receivables

2,916

 

 3,442

Other current financial assets

368

 

113 

Cash and cash equivalents

5,567

 

 2189

Total current assets

8,850

 

 5,744

 

 

 

 

TOTAL ASSETS

11,960

 

 8,714

 

 

 

 

LIABILITIES

 

 

 

Capital

2,081

 

 4,203

Additional paid-in capital

13,483

 

 14,062

Own shares

(12)

 

                  (9)

Conversion differences

(25)

 

 (58)

Reserves – Group share

(2,357)

 

             (18,771)

Net income – Group share

(17,026)

 

           (5,812)

Shareholder equity – Group share

(3,857)

 

           (6,385)

Non-controlling interests

(32)

 

                  (33)

Total shareholder equity

(3,889)

 

             (6,418)

 

 

 

 

Staff commitments

237

 

 224

Non-current borrowing

3,247

 

 818

Total non-current liabilities

3,484

 

 1,041

 

 

 

 

Current borrowings

5,023

 

 8,838

Short-term lease liabilities

 

 

54

Provision

223

 

                    179

Trade accounts payable

5,392

 

 3,758

Tax and social security liabilities

1,348

 

 940

Current derivative liabilities

1

 

 

Other creditors and accrued liabilities

378

 

 322

Total current liabilities

12,365

 

 14,091

 

 

 

 

TOTAL LIABILITIES

11,960

 

8,714

           

 

 

 

 

06/30/2023

 

06/30/2024

(amounts in thousands of euros, except share data)

 

6 months

 

6 months

 

 

 

 

 

 

 

 

 

Revenues

 

–

 

–

Cost of sales

 

–

 

–

Gross margin

 

–

 

–

 

 

 

 

 

Research and development costs, net

 

(3,763)

 

           (2,105)

General and administrative expenses

 

(2,761)

 

           (2,285)

Operating income

 

(6,524)

 

         (4,390)

 

 

 

 

 

Financial expenses

 

(795)

 

           (1,545)

Financial income

 

143

 

 121

Change in fair value of convertible bonds

 

(589)

 

              (3)

Net financial income

 

(1,240)

 

           (1,427)

 

 

 

 

 

Profit before tax

 

(7,764)

 

         (5,817)

 

 

 

 

 

Income tax

 

–

 

                   –  

Net income (loss)

 

(7,764)

 

(5,817) 

 

 

 

 

 

Of which Group share

 

(7,764)

 

(5,812)

Of which non-controlling interests

 

–

 

(5)

 

 

 

 

 

Weighted average number of shares outstanding (excluding treasury shares)

 

818,873

 

3,499,971

Basic earnings per share (€/share)

 

(9.48)

 

(1.66)

Diluted earnings per share (€/share)

 

(9.48)

 

(1.66)

 

Note: for comparison purposes, the number of shares used to calculate earnings per share as of 06/30/2023 retrospectively takes into account the reverse stock-split of May 3, 2024 on the basis of one new share for 400 old shares

 

 

 

06/30/2023

 

06/30/2023

 

 

6 months

 

6 months

(amounts in thousands of euros)

 

 

 

 

 

 

 

 

 

Net income (loss)

 

(7,764)

 

(5,817)

Items not recyclable in the income statement

 

 

 

 

Actuarial gains and losses on post-employment benefits

 

23

 

10

Items recyclable in the income statement

 

 

 

 

Conversion difference variation

 

18

 

10

Other comprehensive income items

 

41

 

20

 

 

 

 

 

Comprehensive income (loss)

 

(7,724)

 

(5,797)

Of which Group share

 

(7,724)

 

(5,796)

Of which non-controlling interests

 

–

 

(1)

 

 

Statement of consolidated cash flows

 

 

 

06/30/2023

 

06/30/2024

 (amounts in thousands of euros)

 

 

6 months

 

 

6 months

 

 

 

 

 

 

 

Cash flow from operating activities

 

 

 

 

 

Net income (loss)

 

 

(7,764)

 

(5,817)

Elimination of depreciation on fixed assets

 

 

256

 

148

Provisions, net of reversals

 

 

(200)

 

(64)

Share-based payment costs

 

 

322

 

515

Gross interest paid

 

 

549

 

547

Change in fair value of convertible bonds

 

 

589

 

236

Discounting / undiscounting advances

 

 

12

 

 

Amortized cost of convertible and non-convertible bonds

 

 

149

 

 

Other items without cash impact

 

 

 

 

760

Cash flow from operating activities before changes in working capital

 

 

(6,086)

 

(3,674)

(+) Change in working capital (net of impairment of trade receivables and inventories)

 

 

(2,075)

 

(2,278)

(Increase) decrease in other non-current financial assets

 

 

9

 

 

(Increase) decrease in other receivables

 

 

2,018

 

122

 

 

(3,230)

 

(1,574)

           

Increase (decrease) in tax and social security liabilities

 

 

(876)

 

(735)

 

 

4

 

(91)

           

 

 

 

 

 

 

Cash flow from operating activities

 

 

(8,204)

 

(5,951)

 

 

 

 

 

 

Cash flow related to investment operations

 

 

 

 

 

Acquisition of intangible assets and property, plant and equipment

 

 

(90)

 

(9)

Subscription of term deposits classified as other current financial assets

 

 

(695)

 

 

Decrease (increase) in term deposits classified as other non-current financial assets

 

 

8

 

 

 

 

 

 

 

 

Cash flow related to investment operations

 

 

(177)

 

(9)

 

 

 

 

 

 

Cash flow related to financing operations

 

 

 

 

 

Capital increase

 

 

2,303

 

–

Expenses relating to capital increase

 

 

(339)

 

–

Exercise of ‘BSA’ warrants and ‘BSPCE’ warrants

 

 

–

 

9

Receipt of grants

 

 

–

 

–

Payment of CIR (Research tax credit) pre-financing net of deposit

 

 

1,059

 

164

Payment of repayable advances

 

 

–

 

 

Repayment of repayable advances

 

 

(165)

 

(110)

Gross interest paid

 

 

(246)

 

(547)

Issue of convertible and non-convertible bonds

 

 

1,890

 

4,000

Repayments of convertible and non-convertible bonds

 

 

(615)

 

(680)

Repayment of lease liabilities

 

 

(144)

 

(26)

Bond issue costs

 

 

(55)

 

(220)

Other cash flows related to financing operations

 

 

 

 

(8)

 

 

 

 

 

 

Cash flow related to financing operations

 

 

3,691

 

2,582

Impact of exchange rate fluctuations

 

 

(24)

 

 

Increase (decrease) in cash flow

 

 

 (5,272)

 

 (3,378)

 

 

 

 

 

 

Opening cash and cash equivalents

 

 

11,053

 

5,567

End of year cash and cash equivalents

 

 

5,782

 

2,189

 

 

 

 

 

 

 

 

 

                     

 


[1] Yuan 2023, Epidemiology of Sarcopenia, Metabolism; Shafiee 2017, Prevalence of Sarcopenia in the world, Journal of diabetes & metabolic disorders; http://dx.doi.org/10.1590/1809-9823.2015.14139

[2] Marché du traitement de la sarcopénie – Analyse des tendances et de la croissance | Année de prévision 2030 – https://www.theinsightpartners.com/fr/reports/sarcopenia-treatment-market –


Dissemination of a Financial Wire News, transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.


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Xlife Sciences AG enables international co-investors to enter the stock and is planning a dual listing on the London Stock Exchange Group (LSEG)

Xlife Sciences AG / Key word(s): Alliance/Strategic Company Decision

30-Sep-2024 / 20:00 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 LR

The issuer is solely responsible for the content of this announcement.


Zurich, 30th of September 2024: The management of Xlife Sciences AG (SIX:XLS) was commissioned on September 3, 2024, after an intensive review of all available options and offers from the Board of Directors, to implement a strategy to increase market capitalization and, consequently, the stock price, as well as the liquidity and tradability of the stock.

In close coordination with new international co-investors, a dual listing on the London Stock Exchange Group (LSEG) is being developed as the first step towards implementing the value enhancement and growth strategy, and it will be executed promptly in cooperation with investment banks, funds, and market makers.

Xlife Sciences AG is confident that this will provide our valued shareholders with the greatest added value in the short term. Additionally, the company is tapping into an important, international, and continuously growing investor base, which not only enables the ambitious growth targets to be achieved but also helps align the discrepancy between market capitalization and valuation.

The Swiss Exchange (SIX Group) has already established the necessary foundation for this with the introduction of stock equivalence with the London Stock Exchange Group (LSEG).

Xlife Sciences AG would like to sincerely thank its investors for their trust and patience.

Financial calendar

Annual Report 2024 25 April 2025
Annual Shareholders Meeting 2025 24 June 2025
Half-Year Report 2025 23 September 2025

Contact 
Information for investors and journalists: Xlife Sciences AG, Dr. Dennis Fink, dennis.fink@xlifesciences.ch

Xlife Sciences AG, 
Talacker 35, 
8001 Zurich, 
Switzerland,
Phone +41 44 385 84 60
info@xlifesciences.ch, www.xlifesciences.ch, 
Commercial Register Zurich CHE-330.279.788 
Stock Exchange: SIX Swiss Exchange


End of Inside Information


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Gerresheimer AG: Adjustment of growth guidance for 2024 and 2025

Gerresheimer AG / Key word(s): Change in Forecast/Development of Sales

Gerresheimer AG: Adjustment of growth guidance for 2024 and 2025

30-Sep-2024 / 16:21 CET/CEST

Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group AG.

The issuer is solely responsible for the content of this announcement.


Gerresheimer AG: Adjustment of growth guidance for 2024 and 2025

 Düsseldorf, September 30, 2024 – Gerresheimer AG (ISIN: DE000A0LD6E6) is adjusting its growth guidance for 2024 and 2025 due to the significantly slower than expected market recovery 2024 and lower anticipated market growth in 2025 in the vial market. The guidance is also affected by the current flooding at the Morganton vial plant in the United States caused by Hurricane Helene, which will halt production for several weeks.

In the 2024 financial year, the company now expects organic revenue growth between 3 and 4% compared to the previous year (previously: 5 to 10%). Adjusted EBITDA is expected to be between EUR 415 million and EUR 430 million (previously: EUR 430 million to EUR 450 million). Compared to the previous year, adjusted EPS for the financial year 2024 is expected to grow between 2 and 8% (previously 8 to 12%).

For the 2025 financial year, the company now expects organic revenue growth between 7 and 10% compared to the previous year (previously 10 to 15%). The adjusted EBITDA margin for the 2025 financial year is expected to be around 22% (previously: ≥ 22%). Adjusted EPS growth for 2025 will be updated with the publication of our full-year 2024 results in February 2025.

The mid-term guidance remains unchanged.

 

End of inside information

Conference Call

Gerresheimer will hold a conference call today, September 30, 2024 at 5:30 pm CEST.
Registration Telephone Conference: 
https://services.choruscall.it/DiamondPassRegistration/register?confirmationNumber=2350002&linkSecurityString=5694d72a4 
Registration Webcast: https://www.webcast-eqs.com/gerresheimer-2024-09-30

Contact Gerresheimer AG

Guido Pickert
Vice President Investor Relations
T +49 211 6181-220
gerresheimer.ir@gerresheimer.com

Jutta Lorberg
Head of Corporate Communication
T +49 211 6181 264
jutta.lorberg@gerresheimer.com

End of Inside Information


30-Sep-2024 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


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