Gerresheimer: EcoVadis Gold with further improved score

• Gerresheimer among the top 3 % of all rated companies
• Overall result increased to 76/100 points
• Award underlines consistent implementation of the sustainability strategy

Düsseldorf, September 16, 2024 – Gerresheimer, an innovative systems and solutions provider and global partner for the pharma, biotech and cosmetics industries, has once again been awarded Gold by the sustainability rating provider EcoVadis. EcoVadis evaluates the management systems of companies in the categories of environment, labor and human rights, ethics and sustainable procurement. More than 130,000 companies worldwide have their sustainability performance assessed by EcoVadis. In 2024, Gerresheimer was again among the top 3% of all companies assessed by EcoVadis and among the top 1% in the industry. The rating result rose to 76 out of 100 points (2023: 74 out of 100 points). The rating result underlines Gerresheimer’s progress in implementing its sustainability strategy. Sustainability is an integral part of Gerresheimer’s corporate strategy formula g.

 “Our sustainability standards are high, and our goals are ambitious,” explains Dietmar Siemssen, CEO of Gerresheimer AG. “Independent external assessments such as the one from EcoVadis confirm the maturity of our management system, which we use to consistently embed sustainability in our company. EcoVadis Gold is both an award and an incentive for us to continuously improve our sustainability performance.”

Gerresheimer among the top 3% in the industry

Since 2011, Gerresheimer has been using EcoVadis to have its sustainability management in the four different dimensions assessed by an independent body. In 2022, Gerresheimer achieved gold status for the first time with 68 out of 100 points. In 2024, the company was once again able to increase its score to 76 out of 100 points. Gerresheimer is thus not only among the top 3% of all companies assessed by EcoVadis, but also among the top 1% in the industry.

Comprehensive evaluation catalog and detailed monitoring
EcoVadis’ extensive Corporate Social Responsibility (CSR) assessment catalog is based on internationally recognized standards such as the UN Global Compact, the conventions of the International Labour Organization (ILO), the standards of the Global Reporting Initiative (GRI), the ISO 26000 standard, the CERES principles and the UN Guiding Principles on Business and Human Rights. The EcoVadis rating thus covers a wide range of information on the performance of companies in the areas of the environment, labor and human rights, ethics and sustainable procurement, taking into account industry-specific characteristics. As part of its 360° monitoring, EcoVadis also includes a wide range of publicly available information such as news, NGO reports, government publications and court rulings in its assessment.

Transparency and independent external evaluation

Gerresheimer aims to provide transparent, well-founded and comparable information on the targets, measures and results of its sustainability activities in accordance with best practice standards.

Gerresheimer publishes an annual sustainability report and discloses relevant data on the EcoVadis platform and as part of the CDP rating. In addition, MSCI, Sustainalytics and ISS assess the company’s sustainability performance. An overview of Gerresheimer’s external sustainability ratings can be found here.

About Gerresheimer 
Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as solutions for the health industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, ampoules, tablet containers, dropper bottles, other bottles and more. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With 35 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. With around 12,000 employees, the company generated revenues of around €2bn in 2023. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).  
www.gerresheimer.com 

Contact Gerresheimer AG

Furthermore, the Company is negotiating with an additional investor a potential second capital increase of up to 154,053 additional shares to be issued under the Authorized Capital 2024, which would be issued pursuant to the authorization to exclude the statutory subscription rights of existing shareholders in Section 5 paragraph 6 of the Company’s articles of association (the “Second Capital Increase”). The Management Board resolved to set the same price range per new share for the potential Second Capital Increase, whereby the Management Board – with the consent of the Supervisory Board and upon satisfaction of the other necessary conditions – intends to set the same offer price for the Second Capital Increase as for the First Capital Increase.

The actual implementation of the respective capital increase is subject to the outcome of the negotiations of details with the respective investors and the conclusion of the respective transaction documents. At present, no subscription agreements have been concluded and there are no binding subscription declarations from investors for either of the two capital increases. In addition to the further resolutions of the Management Board and the approvals by the Supervisory Board required in each case, a report on the planned exclusion of statutory subscription rights for the Second Capital Increase must also be published at least two weeks before the required Supervisory Board resolution. Furthermore, the restructuring administrator must give her consent due to the ongoing restructuring proceedings. This consent has not been obtained so far for either of the two capital increases.

+++ End of ad-hoc announcement +++
 

CureVac’s CVGBM Cancer Vaccine Induces Promising Immune Responses in Phase 1 Study
in Glioblastoma Presented at the ESMO 2024 Congress
 

• Preliminary immunogenicity results demonstrate induction of cancer antigen-specific T-cell responses in 77% of evaluable patients following CVGBM monotherapy
• 84% of immune responses were de novo, observed in patients without pre-existing
  T-cell activity against encoded cancer antigens
• CVGBM was generally well tolerated up to the highest tested dose level of 100 µg with no dose-limiting toxicities
• Most common adverse events were mild to moderate systemic reactions such as headache, fever and chills, which resolved within 1–2 days post injection
• 100 µg was selected as the recommended dose for the dose expansion phase, which recently started enrollment

TÜBINGEN, Germany/BOSTON, USA – September 13, 2024 – CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today presented compelling data from the dose-escalation Part A of its ongoing Phase 1 CVGBM cancer vaccine study in patients with glioblastoma at the European Society for Medical Oncology (ESMO) Congress. The presented data include safety, tolerability and initial immunogenicity data provided for all evaluable patients treated within Part A of the trial with CVGBM dose levels of 12-100 µg. The presentation can be reviewed here.

In this highly aggressive and challenging cancer indication, preliminary immunogenicity results demonstrate that treatment with CVGBM-only following chemo-radiation therapy successfully induces cancer antigen-specific T-cell responses in 77% of evaluable patients. Most notably, within the group of responding patients, 84% of immune responses were generated de novo by the CVGBM vaccination, inducing T-cell activity in patients who had no pre-existing T-cell activity against the encoded antigens. While CD8⁺ T-cells primarily attack and destroy cancer cells, CD4⁺ T-cells play a critical role in coordinating the immune response and supporting the activity of CD8⁺ T-cells over time. The majority of responding patients (69%) showed cancer antigen-specific CD8⁺ responses, 31% of responding patients had CD4⁺ responses and 23% had both a CD8⁺ and a CD4⁺ response.

“These early data are encouraging. Most importantly, the strong de novo T-cell responses seen in a significant number of patients reflect the vaccine’s ability to break through immune tolerance to the tumor and generate a new immune response,” said Prof. Dr. Dr. Ghazaleh Tabatabai, Chair, Department of Neurology & Interdisciplinary Neuro-Oncology, University Hospital Tübingen and Hertie Institute for Clinical Brain Research. “The CVGBM safety profile is acceptable, and we are eager to see these results further validated in the next phase of the study. This could mark an important moment in the fight against this devastating disease.”

CureVac’s Chief Scientific Officer, Dr. Myriam Mendila, added: “These first-in-human data highlight for the first time the broader potential of our second-generation mRNA backbone in cancer immunotherapy. The ability of CVGBM to elicit both CD8⁺ and CD4⁺ de novo T-cell responses suggests that the vaccine is enhancing the immune system’s capacity for a coordinated defense against the cancer. As we conduct the next phase of the trial, we are building a strong foundation for future shared antigen as well as personalized cancer vaccines across different tumor types that could offer significant benefits to patients.”

Immune activation was accompanied by a favorable safety and tolerability profile, with no dose-limiting toxicities observed up to and including the highest tested dose of 100 µg, as confirmed by an independent Data and Safety Monitoring Board. The majority of treatment-related adverse events (TRAEs) were reported as grade 1 (mild) and grade 2 (moderate) systemic reactions characteristic to mRNA-based therapeutics. These included headache, chills, fever and fatigue, which resolved within 1-2 days following the injection. Seven patients reported a total of nine grade 3 (severe) TRAEs, of which four were classified as serious adverse events (SAEs). No grade 4 or 5 adverse events occurred. Correspondingly, a 100 µg dose was selected as the recommended dose for the already initiated dose-confirmation Part B of the study.

The open-label study is evaluating the safety and tolerability of CVGBM in HLA-*02:01-positive patients with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma or astrocytoma with a molecular signature of glioblastoma. CVGBM replaces the temozolomide maintenance phase. It is administered as a monotherapy after surgical resection and completion of radiotherapy with or without chemotherapy. The study consists of two parts, a dose-escalation part (Part A) and a dose-expansion part (Part B). In the fully enrolled Part A, patients received seven intramuscular vaccinations at escalating doses in the range of 12 to 100 µg on days 1, 8, 15, 29, 43, 57 and 71 and optional maintenance vaccinations in case of non-progression or potential benefit. 16 patients were enrolled, of which 13 were evaluable for immune responses. All patients completed surgery, 44% with complete tumor resection and 56% with only partial resection followed by chemo-radiation with temozolomide. Antigen-specific CD4⁺ and CD8⁺ T-cell responses were assessed at relevant pre-determined timepoints until day 99. Part B of the study is currently ongoing at the recommended dose of 100 µg.

More information can be found at clinicaltrials.gov (NCT05938387).

About CVGBM

Based on CureVac’s proprietary second-generation mRNA backbone, designed for improved mRNA translation, increased protein expression and optimized induction of T-cell responses, CVGBM encodes a single fusion protein comprising eight epitopes derived from four tumor-associated antigens (TAA) with relevance in glioblastoma, including five HLA class I (HLA-*02:01) epitopes and three class II epitopes. CVGBM applies unmodified mRNA and is formulated within lipid nanoparticles (LNPs). The Phase 1 proof-of-principle study of CVGBM is currently being conducted in Germany, Belgium and the Netherlands.

About CureVac

CureVac (Nasdaq: CVAC) is a pioneering multinational biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine. In more than two decades of developing, optimizing, and manufacturing this versatile biological molecule for medical purposes, CureVac has introduced and refined key underlying technologies that were essential to the production of mRNA vaccines against COVID-19, and is currently laying the groundwork for application of mRNA in new therapeutic areas of major unmet need. CureVac is leveraging mRNA technology, combined with advanced omics and computational tools, to design and develop off-the-shelf and personalized cancer vaccine product candidates. It also develops programs in prophylactic vaccines and in treatments that enable the human body to produce its own therapeutic proteins. Headquartered in Tübingen, Germany, CureVac also operates sites in the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.

CureVac Media and Investor Relations Contact

Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations

CureVac, Tübingen, Germany

T: +49 7071 9883-1298

M: +49 160 90 496949

sarah.fakih@curevac.com

Forward-Looking Statements CureVac

This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac N.V. and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH, CureVac RNA Printer GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the “company”) regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the potential efficacy of the company’s vaccine and treatment candidates and the company’s strategies, financing plans, cash runway expectations, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” or “expect,” “may,” “will,” “would,” “could,” “potential,” “intend,” or “should,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company’s industry, the effects of the COVID-19 pandemic on the company’s business and results of operations, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect of exchange rates, delays in litigation proceedings, different judicial outcomes or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please reference the company’s reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

MEDIA RELEASE

Medacta Introduces a Simplified Approach for the M-ARS ACL Technique at the AGA Congress 2024, Mimicking the Native Ligament Footprint with an Optimized Surgical Flow

CASTEL SAN PIETRO, September 12, 2024 – Medacta Group SA (“Medacta,” SIX:MOVE), announces the introduction of a simplified approach for its M-ARS (Medacta – Anatomic Ribbon Surgery) ACL (Anterior Cruciate Ligament) technique at the AGA Congress 2024 in Zürich, Switzerland. The M-ARS technique offers a more natural approach to ACL reconstruction than traditional round-graft-tunnel single-bundle techniques. It is designed to optimize knee biomechanics and enhance graft healing following ACL reconstruction, mimicking the native footprint by using a flat graft to enhance stress distribution and biological healing at the insertion site, potentially improving patient outcomes in terms of recovery time and return to an active lifestyle.

“Medacta’s new simplified approach for M-ARS ACL offers multiple advantages: it streamlines the creation of flat graft tunnels, making the surgical procedure more efficient and easier to perform, and it preserves the M-ARS philosophy of natural ACL reconstruction,” explains Prof. Dr. Fink, Austria.

“I prefer the simplified approach for the M-ARS ACL Reconstruction system in combination with the MectaQTH minimally invasive quad-tendon harvesting system. This provides me with a wide range of devices to perform personalized primary and revision ACL reconstruction, as well as multi-ligament reconstruction,” says Prof. Dr. Herbort, Germany.

Medacta’s Sports Medicine knee platform offers surgeons a comprehensive range of surgical approaches to improve personalized medicine for primary, revision, and multi-ligament reconstruction. The platform includes innovative devices, techniques, and education programs to support surgeons in achieving optimal patient outcomes.

Medacta’s M.O.R.E. Medical education program provides surgeons easy access to globally renowned reference centers and wet lab training. This program helps to accelerate the transition to arthroscopic natural anatomy knee reconstruction with the Sports Medicine knee platform.

Discover more about Medacta’s Sportsmed knee offering at https://www.medacta.com/EN/sports-med-knee.

Contact
Gianluca Olgiati
Group Vice President Marketing
+41 91 696 60 60
media@medacta.ch

Medacta is a key global player specializing in the design, production, and distribution of innovative, personalized, and sustainable solutions for joint replacement, sports medicine, and spine surgery. Established in 1999 in Switzerland, Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Through close collaboration with expert surgeons globally, continuous investments in R&D, and the adoption of cutting-edge technologies, Medacta’s innovation prioritizes minimally invasive surgery and personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 60 countries. Follow us on Medacta TV, YouTube, LinkedIn and X.

RELATED TRADEMARKS

Medacta Group Related Trademarks are registered at least in Switzerland. The products and services listed below may not be all-inclusive, and other Medacta products and services not listed below may be covered by one or more trademarks. The following products and services may be covered by additional trademarks not listed below. Note that Swiss trademarks may have foreign counterparts. M-ARS ACL^®, Mecta^®QTH.

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Press Release 

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

• Business model focused on innovative radiopharmaceuticals for the diagnosis and therapy (“theranostics”) of various indications
• Institutional environment characterized by high market growth and intense M&A activity
• IPO as a strategic step to secure short- and long-term financing
• Lead candidate PentixaFor already in Phase III
• Commercial rights to over 20 investigator-initiated studies (IIS) for accelerated pipeline development

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

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

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

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

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

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

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

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

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

Unique network and extensive data pool for accelerated pipeline development

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

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

About Pentixapharm Holding AG

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

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

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
phillip.eckert@pentixapharm.com
Tel. +49 30 94 10 84 227
www.pentixapharm.com

Media Contact:
MC Services AG
Anne Hennecke
Tel. +49 211 529252 22
anne.hennecke@mc-services.eu

Important Notice

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

PRESS RELEASE

Change in the Chief Financial Officer at Biotest AG

• Martin Möller to assume role of Chief Financial Officer (CFO) on the Management Board for 6 months starting September 14

Dreieich, Germany, September 12, 2024. The Supervisory Board of Biotest AG announced today that the former Chief Financial Officer, Ms. Ainhoa Mendizabal Zubiaga, is leaving the company for personal reasons. We would like to thank Ms. Mendizabal Zubiaga for her tireless efforts and dedication. The entire team wishes her every success and all the best for her future professional and personal endeavors.

As part of this change, we welcome Mr. Martin Möller (52) as the new Interim Chief Financial Officer. Mr. Möller will assume this position for the next six months, effective September 14, 2024 and will be responsible for the
CFO-activities of the company during this period. We are pleased to have Mr. Möller on board as an experienced leader to support us during this transition period.

The company would like to thank both individuals and looks forward with confidence to the next six months under Mr. Möller’s leadership.

About Biotest

Biotest is a provider of biological therapeutics derived from human plasma. With a value added chain that extends from pre-clinical 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, based 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.

CureVac Partner GSK Announces Positive Phase 2 Data from Seasonal Influenza
mRNA Vaccine Program
 

• Phase 2 data demonstrated positive immune responses to A and B strains, with acceptable safety and reactogenicity profile, meeting all pre-defined study endpoints 
• Vaccine candidate based on CureVac’s proprietary second-generation mRNA backbone
• GSK confirmed data support advancing program to Phase 3; dosing of first Phase 3 participant is associated with a significant milestone payment for CureVac
• In July 2024, GSK assumed full control for the development, manufacturing and commercialization of influenza vaccines through new licensing agreement

TÜBINGEN, Germany/BOSTON, USA – September 12, 2024 – CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced that GSK has reported positive Phase 2 headline data from the seasonal influenza mRNA vaccine program. The program was fully licensed to GSK under the terms of a licensing agreement announced on July 3, 2024.

According to GSK, the data demonstrated positive immune responses against influenza A and B strains compared to the current standard of care, meeting all predefined success criteria in the tested age groups of older and younger adults. The interim data further suggests the tested vaccine candidate has an acceptable safety and reactogenicity profile. The vaccine candidate is based on CureVac’s second-generation mRNA backbone.

“The positive Phase 2 results once again highlight the immense potential of our second-generation mRNA backbone to develop best in class vaccines against influenza and other infectious diseases,” said Dr. Myriam Mendila, Chief Scientific Officer of CureVac. “We are strongly encouraged by a positive response against influenza A strains but particularly excited about adequate immune responses against influenza B. We look forward to seeing advanced data from the study and potential transition of the program to Phase 3, which would be associated with a significant milestone payment for CureVac.”

The Phase 2 study was initiated following interim data reported on April 4, 2024, from the Phase 2 part of the ongoing combined Phase 1/2 study in seasonal influenza. It assesses the reactogenicity, safety, and immunogenicity of different dose levels of a modified, multivalent vaccine candidate, encoding antigens matched to all three WHO-recommended flu strains. The study includes 250 healthy younger adults aged 18 to 64 and 250 healthy older adults aged 65 to 85. In each age group, different dose levels will be tested in comparison to an age-appropriate, licensed comparator vaccine.

About CureVac

CureVac (Nasdaq: CVAC) is a pioneering multinational biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine. In more than two decades of developing, optimizing, and manufacturing this versatile biological molecule for medical purposes, CureVac has introduced and refined key underlying technologies that were essential to the production of mRNA vaccines against COVID-19, and is currently laying the groundwork for application of mRNA in new therapeutic areas of major unmet need. CureVac is leveraging mRNA technology, combined with advanced omics and computational tools, to design and develop off-the-shelf and personalized cancer vaccine product candidates. It also develops programs in prophylactic vaccines and in treatments that enable the human body to produce its own therapeutic proteins. Headquartered in Tübingen, Germany, CureVac also operates sites in the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.

CureVac Media and Investor Relations Contact

Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations

CureVac, Tübingen, Germany

T: +49 7071 9883-1298

M: +49 160 90 496949

sarah.fakih@curevac.com

Forward-Looking Statements CureVac

This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac N.V. and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH, CureVac RNA Printer GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the “company”) regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the potential efficacy of the company’s vaccine and treatment candidates and the company’s strategies, financing plans, cash runway expectations, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” or “expect,” “may,” “will,” “would,” “could,” “potential,” “intend,” or “should,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company’s industry, the effects of the COVID-19 pandemic on the company’s business and results of operations, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect of exchange rates, delays in litigation proceedings, different judicial outcomes or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please reference the company’s reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

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 THE AD-HOC RELEASE.

Disclosure of an inside information acc. to Art. 17 Sec. 1 of the Regulation (EU) No. 596/2014 (Market Abuse Regulation – MAR)
 

PharmaSGP Holding SE resolves on public share repurchase offer to buy back own shares for up to 594,405 shares

Gräfelfing, Germany, September 12, 2024 – The management board of PharmaSGP Holding SE (the “Company”) (ISIN DE000A2P4LJ5 / WKN A2P4LJ) resolved today, with the approval of the supervisory board, utilizing the authorization of the annual general meeting of June 26, 2024, to buy back up to 594,405 shares of the Company (corresponding to up to 4.95% of the Company’s registered share capital (Grundkapital)) by way of a public share repurchase offer for a consideration amounting to EUR 21.45 per share. It is currently intended to redeem the shares so repurchased and decrease the share capital accordingly.

The Company’s two largest shareholders, FUTRUE GmbH that holds approximately 73.6% of the Company’s share capital, and MVH Beteiligungs- und Beratungs-GmbH that holds approximately 7.8% of the Company’s share capital, have irrevocably committed themselves vis-à-vis the Company not to accept the share repurchase offer for all shares directly or indirectly held by them.

The acceptance period will commence on September 13, 2024, 00:00 (CEST), and is expected to terminate on September 26, 2024, 24:00 (CEST). If the shares tendered into the share repurchase offer exceed 594,405, the declarations of acceptance will be considered proportionally, i.e., in a ratio of the 594,405 shares to the aggregate number of shares tendered into the share repurchase offer. Further details on the public share repurchase offer can be found in the offer document, which will be published on the Company’s website (https://www.pharmasgp.com) under the heading “Investor Relations – The share – Share buy-backs – Share buy-back 2024” prior to the commencement of the acceptance period as well as in the German Federal Gazette under www.bundesanzeiger.de.

Contact

PharmaSGP Holding SE
Claudius Krause (cometis AG)
Lochhamer Schlag 1
82166 Gräfelfing
Germany
Phone: +49 611 205855-28
E-Mail: ir@pharmasgp.com

Disclaimer

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.

This release contains forward-looking statements. These statements are based on the current views, expectations and assumptions of the management of PharmaSGP Holding SE and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Actual results, performance or events may differ materially from those described in such statements due to, among other things, changes in the general economic and competitive environment, risks associated with capital markets, currency exchange rate fluctuations and competition from other companies, changes in international and national laws and regulations, in particular with respect to tax laws and regulations, and other factors. PharmaSGP Holding SE does not assume any obligations to update any forward-looking statements.