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

Press Release 

Pentixapharm 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.

PharmaSGP continues dynamic growth path in the first half of 2024

Gräfelfing, September 12, 2024 – The German OTC pharmaceutical company PharmaSGP Holding SE continued its dynamic growth path in the first half of 2024, achieving half-year revenues of €58.4 million based on preliminary, unaudited figures. This represents an increase of 17.4% compared to the previous year (€49.7 million). Adjusted earnings before interest, taxes, depreciation and amortization (adjusted EBITDA) increased from €15.3 million to €16.9 million in the first half of 2024 compared to the same period of the previous year. The resulting adjusted EBITDA margin amounted to 28.9% (previous year: 30.9%).

CEO Natalie Weigand comments: “We can look back on a successful first half of 2024 with record revenues. Once again, we were able to benefit from the strength of our business model, combining our scalable platform with our multi-channel marketing approach. The appointment of Peter Gerckens to the PharmaSGP Management Board was a further significant step in accelerating our growth path. As Chief Commercial Officer, he is responsible for the expansion of international markets, sales and new businesses since July 1, 2024.”

CFO Michael Rudolf adds: “We are on track to achieve our growth targets for the full year 2024. PharmaSGP is particularly focused on the internationalization of our business. In this context, we are very pleased with the development in our key growth market Italy, where we almost doubled revenues in the first half of 2024. This highlights the effectiveness of our sales strategy and shows the great market potential for PharmaSGP beyond the DACH region.”

For the current financial year 2024, the Management Board continues to expect revenues in the range of €107.0 million to €112.0 million. Adjusted EBITDA is projected to increase to between €35.0 million and €38.0 million. This corresponds to an adjusted EBITDA margin of 32.7% to 33.9%. 

PharmaSGP will publish its full report for the first half of 2024 on September 26, 2024.

OVERVIEW OF PRELIMINARY YEAR-ON-YEAR FIGURES

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.

Marinomed Biotech AG: First Carragelose products receive new Medical Device Regulation (MDR) certification

• Two Carragelose nasal sprays have received declaration of conformity under the new medical device regulation – certificates for further products expected later in the year
• Extensive clinical data for Carragelose facilitates challenging demands for MDR transition
• MDR-compliance is a major asset for medical devices and adds significant value to Carragelose portfolio
• Evaluation process regarding strategic options for the Carragelose business ongoing; due diligence phase continuing but no agreements made to date

Korneuburg, Austria, 11. September 2024 – Marinomed Biotech AG (VSE:MARI) has received the certificates for the first two Carragelose products under the new medical device regulation (MDR). The European Union (EU) implemented the new medical device regulation in May 2021, replacing the previously valid medical device directive (MDD) and increasing scrutiny on medical device safety throughout the full product lifecycle. The MDR sets new EU-wide standards regarding the requirements for safety, performance, quality of clinical data and overall technical documentation for medical devices. Compliance with the new MDR is the prerequisite for the marketing of medical devices in the EU after the end of the transition period in 2028.

The declaration of conformity for the first Carragelose products represents a major milestone for the whole portfolio and creates a promising foundation for the certification of the other Carragelose products. Furthermore, successful MDR transition adds significant value to the Carragelose asset. As announced mid-December 2023, the Company commenced an evaluation process regarding strategic options for the Carragelose business area. Without any relevant interim step having occurred, the Company updates the market that potential buyers are still in the process of conducting due diligence. To date, no binding agreements have been concluded. In this process, Marinomed aims for a decision to be made and announced by the end of the year.

Eva Prieschl-Grassauer, CSO of Marinomed, comments: “MDR-transition and the associated necessary documentation is very demanding. However, thanks to the excellent work of our regulatory affairs team and the extensive clinical data that we have generated for Carragelose over the years, we are able to meet the new requirements. The issuing of these certificates is further confirmation of the quality, safety and appropriate technical documentation of our Carragelose products and increases the value of this asset, also for a potential strategic partner. We are proud to have received the first certificates well before the end of the transition period in 2028. We are confident that the other products will also be certified under the new MDR and will therefore continue to be approved for marketing and distribution in the EU.”

About Carragelose®

Carragelose® is a sulfated polymer from red seaweed and a unique, broadly active virus- and allergen-blocking compound. It is known as a gentle, effective, and safe prevention and treatment of various viral respiratory infections. Several clinical and preclinical studies have shown that Carragelose® forms a protective layer on the mucosa that prevents viruses from infecting cells. Laboratory and clinical data have demonstrated that Carragelose® can also inhibit the spreading of SARS-CoV-2.^[1],[2] Marinomed is the holder of the IP rights and has licensed Carragelose® for marketing in Europe, North America, Australia, and parts of Asia and Latin America. Marinomed’s portfolio of Carragelose®-containing nasal sprays and oral products can be accessed at https://www.carragelose.com/en/portfolio/launched-products, scientific publications on Carragelose® at https://www.carragelose.com/en/publications.

About Marinomed Biotech AG

Marinomed Biotech AG is an Austrian, science-based biotech company with a growing development pipeline and globally marketed therapeutics. The Company develops innovative patent-protected products in the therapeutic areas immunology and virology based on the platform Marinosolv® and the virus-blocking activity of Carragelose®. The Marinosolv® technology improves the solubility and bioavailability of hardly soluble compounds and is used to develop new therapeutics for autoreactive immune disorders. The virology segment includes Carragelose®-based over-the-counter (OTC) products to prevent and treat respiratory viral infections that are partnered in more than 40 countries. The Company is headquartered in Korneuburg, Austria, and is listed on the Vienna Stock Exchange (VSE:MARI). For further information, please visit: https://www.marinomed.com.

For further inquiries contact:

Disclaimer

This press release contains forward-looking statements, which are based on current views, expectations and projections of the management of Marinomed Biotech AG about future events. These forward-looking statements are subject to risks, uncertainties and assumptions that could cause actual results, performance or events to differ materially from those described in, or expressed or implied by, such statements. The current views, expectations and projections of the management of Marinomed Biotech AG may be identified by the context of such statements or words such as “anticipate,” “believe”, “estimate”, “expect”, “intend”, “plan”, “project” and “target”. Forward-looking statements are only valid as of the date they are made and Marinomed Biotech AG does not assume any obligation to update, review or revise any forward-looking statements contained in this press release whether as a result of new information, future developments or otherwise. Marinomed, Marinosolv® and Carragelose® are registered trademarks of Marinomed Biotech AG. These trademarks may be owned or licensed in select locations only.

^[1]  https://www.dovepress.com/efficacy-of-a-nasal-spray-containing-iota-carrageenan-in-the-postexpos-peer-reviewed-fulltext-article-IJGM

^[2]  https://www.marinomed.com/en/news/marinomed-biotech-ag-shares-positive-clinical-trial-results-for-iota-carrageenan-nasal-spray-in-the-prevention-of-covid-19-1

Abivax presents first-half 2024 financial results

• Cash balance of EUR 222M at June 30, 2024; cash runway in to Q4 2025

PARIS, France, September 9, 2024, 10:00 p.m. CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to modulate the inflammatory response in patients with chronic inflammatory diseases, announces today its 2024 half-year financial results, as of June 30, 2024. The interim financial statements for the first half of 2024, approved by the Company’s Board of Directors on September 5, 2024, have been reviewed by the Company’s external auditors.

Abivax recently provided updates on its business and operational goals in press releases published on July 15, 2024 (“Abivax provides operational and key program update”) and August 6, 2024 (“Abivax Announces ABTECT Phase 3 Trial Achieves Key Enrollment Milestone”).

First-half 2024 financial highlights (IFRS figures)

• Operating loss increased by EUR 42.7M to EUR -80.0M compared to EUR -37.3M for the six months ending June 30, 2023. Operating income, consisting predominantly of Research Tax Credit and Subsidies, increased by EUR 4.5M to EUR 6.8M compared to EUR 2.3M for the six months ending June 30, 2023. The increase in operating loss was driven by operating expenses as described further below.

• Research and development (R&D) expenses increased by EUR 32.1M to EUR -64.7M in the first half of 2024 compared to EUR -32.6M in the same period 2023. This increase was predominantly driven by expenses related to:
  • A EUR 25.6M, or 98%, increase related to our Ulcerative Colitis (UC) clinical program, driven by the progression of Phase 3 clinical trials for obefazimod in UC (where Phase 3 clinical trial costs were significantly higher than in Phase 2);
  • EUR 0.9M in expenses related to our Crohn’s disease (CD) clinical program, compared to no expenses in first half of 2023, driven by planning costs incurred for the Phase 2b CD trial; and
  • A EUR 4.8M, or 113%, increase in transversal personnel expenses related to the overall expansion of the R&D headcount to support our organizational growth and the issuance of new equity awards to officers and employees in R&D.

• Sales and marketing (S&M) expenses increased to EUR -4.2M for the six-month period ending June 30, 2024 compared to EUR -0.2M for the same period 2023. These expenses consist primarily of consulting costs associated with market research in preparation for our future sales and commercialization efforts in the U.S.

• General and administrative (G&A) expenses increased to EUR -17.9M compared to EUR -6.8M for the first half of 2023. This increase was primarily due to:
  • An increase in personnel costs of EUR 7.9M, resulting from an increase in headcount to support the expansion of the Company along with the issuance of new equity awards to our officers and employees; and
  • Increased legal and professional fees and other costs associated with operating as a dual-listed public company.

• Total headcount at the end of June 2024 was 84 and increased compared to December 2023, due to the implementation of the U.S. and European operational infrastructure.

• For the six-months ended June 30, 2024, our EUR -1.6M net financial loss was driven primarily by the following items:
  • Interest expenses of EUR -4.2M in relation to borrowings and loans;
  • Non-cash expense of EUR -1.9M in relation in relation to our royalty certificates;
  • Non-cash expense of EUR -1.6M related to the amortization of prepaid expenses related to the transaction costs of the Kreos/Claret tranche C bond loans;
  • Non-cash expense of EUR -1.5M in relation to an increase in the fair value of warrant derivatives issued in relation to the Kreos/Claret financing; and
  • Mostly offset by interest income of EUR 4.8M in relation to the invested proceeds from our U.S. initial public offering and listing on Nasdaq and foreign exchange gains of EUR 2.3M.

• Cash position as of June 30, 2024, was EUR 222.3M compared to EUR 260.0M (including other financial assets of EUR 9.0M) as of December 31, 2023. The decrease was due to EUR -85.2M used in operations, offset by EUR 48.5 M in net proceeds from a drawdown of tranche B and tranche C of the Kreos/Claret Financing (see below).

• As part of the structured debt financing transaction for a total amount of up to EUR 75M with Kreos Capital and Claret European Growth Capital entered into on August 21, 2023 (the “Kreos/Claret financing”), Abivax proceeded with the drawdown of the second and third tranches of the Kreos/Claret financing for EUR 25M each.
  • Both the second and third tranches consist of 25,000,000 senior secured non-convertible bonds with a par value of EUR 1.00 each, which will not be listed on any market;
  • The issuance of the second and third tranches of the Kreos/Claret non-convertible bonds occurred on March 28, 2024 and June 21, 2024, respectively;
  • A variable interest rate of 7.5% European Central Bank Base Rate (MRO) (with a floor at 2.5% and a cap at 4%) applies to both tranches. These non-convertible bonds will be repaid monthly through March 31, 2027, after a deferred repayment of the principal until February 1, 2025.

• Abivax and Bpifrance agreed on the termination of the RNP-VIR and Carena projects. In connection with such termination, Abivax is to repay respectively EUR 2.4M and EUR 0.2M to Bpifrance in accordance with the terms of the financing made available by Bpifrance to Abivax in connection with such projects.

• The drawdown period for Tranche B of the structured debt financing transaction with Heights entered into on August 20, 2023 expired on August 24, 2024. Abivax did not draw down Tranche B prior to such date.

• The Company is in the process of terminating the liquidity contract signed on February 4, 2019 with TRADITION SECURITIES AND FUTURE (TSAF SA). The termination is expected to be effective from September 30, 2024.

Based on the currently available funds, Abivax expects to be able to finance its operating cash flow requirements into the fourth quarter of 2025.

*****

About Abivax

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

Contact:

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

FORWARD-LOOKING STATEMENTS

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

Secarna Pharmaceuticals will present data at 6th Inflammasome Therapeutics Summit demonstrating the potential of ASOs to target the expression of NLRP3

• NLRP3 is a promising target with a well-validated role in various inflammatory disease
• Secarna has shown the potential of the company’s ASOs to effectively and specifically suppress NLRP3 and IL-1β release
• In a CAPS mouse model, Secarna demonstrated prolonged survival and a significant reduction in systemic inflammation

Munich/Martinsried, Germany, September 09, 2024 – Secarna Pharmaceuticals GmbH & Co. KG (“Secarna”), a company redefining the discovery and development of best-in-class oligonucleotide therapeutics, announced today the presentation of conclusive data showcasing the potential of Secarna’s third generation antisense oligonucleotides (ASOs) to specifically target NLR family pyrin domain containing 3 (NLRP3), a promising therapeutic target for the treatment of inflammatory diseases. The data will be presented at the 6^th Inflammasome Therapeutics Summit taking place September 10 – 12, 2024 in Boston, MA, USA. The conference brings together leading biopharma professionals with 30 expert speakers on cutting-edge discussions to troubleshoot the most pressing topics in inflammasome research.

The talk entitled “Leveraging the Power of ASOs to Target the Expression of NLRP3 for Enhanced Specificity of Inflammasome Inhibition” will be held by Julia Hinterdobler, PhD on September 11th, 2024, at 11:30 EDT. The data were generated in collaboration with Prof. Ariel Feldstein and Prof. Hal Hoffman from the University of California San Diego, who are world-leading specialists in NLRP3-mediated inflammation and Cryopyrin-associated periodic syndrome (CAPS), a group of rare inherited autoinflammatory diseases. These findings suggest that ASO therapy could be a potential treatment of CAPS or other NLRP3-mediated diseases (data published in The Journal of Immunology).

Julia Hinterdobler, PhD, Scientist at Secarna Pharmaceuticals commented: “NLRP3 is a promising target with a well-validated role in various inflammatory diseases, that is receiving strong interest from biotech and big pharma in identifying and developing potent as well as tolerated inhibitors. We have shown the significant potential of NLRP3-specific ASOs to effectively and specifically target and downregulate NLRP3 expression and IL-1β release, resulting in prolonged survival and reduced inflammation in CAPS models. We are eager to see the development of ASOs targeting inflammation and other indications, in particular for previously untreatable targets.”

Leveraging the Company’s unique AI-powered bioinformatics selection process, Secarna has designed ASOs to specifically suppress the expression of the NLR family pyrin domain containing 3 (NLRP3), the central component of the inflammasome pathway. Activation of NLRP3 results in the release of proinflammatory cytokines such as IL-1β, the major mediator of the proinflammatory response, and the overactivation of this pathway plays a pathological role in several inflammatory, such as arthritis, inflammatory bowel disease, acute and chronic kidney disease, as well as diseases of the central nervous system. In vitro, the administration of NLRP3-specific ASOs resulted in a potent reduction of Caspase-1 activity and complete blockade of the release of mature IL-1β. In a mouse model CAPS, Secarna demonstrated prolonged survival and a significant reduction in systemic inflammation.

Secarna is currently testing the potential of antisense oligonucleotides in inflammatory diseases with additional targets.

About Secarna Pharmaceuticals GmbH & Co. KG

Secarna Pharmaceuticals a biopharmaceutical company redefining the discovery and development of best-in-class oligonucleotides therapeuticsaddressing high unmet medical needs in immuno-oncology and immunology, as well as viral, neurodegenerative and cardiometabolic diseases. Secarna’s mission is to maximize the performance and output of its proprietary antisense oligonucleotide discovery and development platform to generate highly specific, safe, and efficacious best-in-class antisense therapies. With over 20 discovery and development programs, including both proprietary pipeline projects and partnered programs, Secarna focuses on targets in indications where antisense-based approaches have clear potential benefits over other therapeutic modalities. www.secarna.com

CureVac to Present First CVGBM Glioblastoma Cancer Vaccine Clinical Data
at ESMO 2024 Congress

TÜBINGEN, Germany/BOSTON, USA – September 9, 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 the first clinical data from CureVac’s ongoing Phase 1 CVGBM cancer vaccine study in patients with resected glioblastoma will be presented at the European Society for Medical Oncology (ESMO) Congress (Barcelona, Spain, September 13-17, 2024). Clinical data will be presented as an oral presentation on Friday, September 13, along with a poster presentation of preclinical data supporting the program’s development.

“Cancer vaccines have tremendous potential to improve the outcome of cancer patients and particularly, mRNA technologies offer innovative and promising platforms that could enable us to finally make cancer vaccines a reality in clinical practice,” said Dr. Myriam Mendila, Chief Scientific Officer of CureVac. “We are assessing a breakthrough approach to cancer vaccines that uses our distinctive mRNA technology in one of the most aggressive forms of brain cancer and are very excited to share the first-in-human results of our mRNA technology platform in the GBLM trial in glioblastoma at ESMO.”

The Phase 1 study includes a dose-escalation part (Part A) and dose-expansion part (Part B). Results for Part A will be covered in the oral presentation, with safety and tolerability as well as initial immunogenicity data provided for all evaluable patients at dose levels of 12-100 µg. A summary of treatment-emergent adverse events (TEAEs), which were mostly Grade 1-2 and yielded no dose-limiting toxicities as confirmed by a Data Safety Monitoring Board, will also be provided.

The Phase 1 study is evaluating the safety and tolerability of CVGBM in patients with newly diagnosed and surgically resected MGMT-promoter unmethylated glioblastoma or astrocytoma with a molecular signature of glioblastoma. CVGBM features a single unmodified mRNA encoding eight epitopes derived from known tumor-associated antigens, with demonstrated immunogenicity in glioblastoma. Enrollment began earlier this year for Part B of the study, which is expected to include up to an additional 20 patients at the recommended 100 µg dose.

Details on the presentations are below.

Abstract: 440O

Title: First in human study of the mRNA-based cancer vaccine CVGBM in patients with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma (GBM): First results from the dose escalation phase

Session type: Proffered Paper

Date and Time: September 13, 14:00-14:10 CEST

Location: Pamplona Auditorium (Hall 3)

Speaker: Prof. Dr. Dr. Ghazaleh Tabatabai

Abstract: 22P

Title: Pre-clinical development of CVGBM: A therapeutic mRNA-based multiepitope vaccine for glioblastoma

Session type: Basic Science Poster

Date and Time: September 15, 09:00-17:00 CEST

Location: Hall 6

Speaker: Dr. Ronja I. Mülfarth

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.