Relief Therapeutics Completes Clinical Phase in RLF-OD032 Proof-of-Concept Study; Topline Results Expected in October 2024
 

GENEVA (SEPT. 18, 2024) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced that it has completed dosing in its proof-of-concept clinical study of RLF-OD032 for the treatment of phenylketonuria (PKU), a rare inherited disorder affecting phenylalanine metabolism.

The primary objectives of the study include the comparison of RLF-OD032 to a currently marketed sapropterin dihydrochloride product, with a focus on bioavailability under fed and fasting conditions. The Company expects topline results in October 2024. These results will inform further development of RLF-OD032 toward a pivotal trial and potential regulatory submission under the 505(b)(2) NDA pathway in the United States.

RLF-OD032, an innovative and highly concentrated liquid formulation of sapropterin dihydrochloride, is designed to lower blood phenylalanine in adult and pediatric PKU patients. It offers a more patient-friendly solution by significantly reducing the volume of medication required compared to current formulations. This advancement aims to enhance compliance, particularly among pediatric patients, who often struggle with the high volumes associated with existing sapropterin treatments. If approved, RLF-OD032 would be the first and only portable, ready-to-use liquid formulation of sapropterin dihydrochloride.
 

ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief’s portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO™ and Physiomimic™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

CONTACT:
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com

DISCLAIMER
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief’s filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief. Copies of Relief’s filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date.

Viromed Medical AG plans to acquire all shares in ActivCell Group AG by way of a capital increase against contribution in kind with exclusion of subscription rights

Pinneberg, 17 September 2024 – Viromed Medical AG (Ticker: VMED; ISIN: DE000A3MQR65; “Viromed”; the “Company”) plans to acquire all shares in ActivCell Group AG, Switzerland, and thus strategically expand its product portfolio. To this end, the Company has today signed a term sheet with the owners of ActivCell Group AG and will immediately enter into further negotiations with the objective of concluding an agreement. With the acquisition of ActivCell Group AG, Viromed expands the treatment spectrum of its products with additional indications and expects an accelerated market launch in the European Union with its own cold plasma product series.

ActivCell Group AG is active in the development and manufacture of cold plasma therapy pens and has received approval for its products (CE-Notified-Body-No. 0297) in category 2a in accordance with the EU directive 2017/745 on medical devices (Medical Device Regulation, MDR) for use in skin and wound treatment in human medicine.

The transaction is expected to be completed in the current 2024 financial year. The purchase price for the 100% takeover of ActivCell Group AG is expected to be in the mid-single-digit million-euro range. The purchase price is to be paid exclusively by granting new shares in the Company by making partial use of the Authorized Capital 2022 by means of a capital increase against contributions in kind, excluding shareholders’ subscription rights.

The closing of the transaction is subject to a final agreement with the shareholders of ActivCell Group AG.

Contact Viromed Medical AG

Uwe Perbandt
CEO
Flensburger Strasse 18
25421 Pinneberg
Germany
Email: kontakt@viromed-medical.de
www.viromed-medical-ag.de

Cinven to sell minority stake in SYNLAB to strategic investor Labcorp

International private equity firm, Cinven, has reached an agreement to sell an indirect minority stake in SYNLAB, a leader in medical diagnostic services and specialty testing in Europe, to strategic investor Labcorp. Labcorp is a global leader of innovative and comprehensive laboratory services headquartered in the United States. Labcorp will acquire the indirect minority stake through an intermediate holding company established to hold the investment with SYNLAB and will be represented on the holding company board along with Cinven and the other co-investors. The purchase price for this indirect minority stake of 15 percent was approximately €140 million.

SYNLAB offers a full range of innovative and reliable medical diagnostic services to patients, practising doctors, hospitals and clinics, governments and corporates. With more than 27,000 employees, including over 2,000 medical experts, SYNLAB operates in over 30 countries across four continents and has leading positions in many markets. The company performed approximately 600 million laboratory tests and achieved revenues of €2.64 billion in 2023.

SYNLAB has made significant progress under Cinven’s ownership and the leadership of CEO, Mathieu Floreani. The combination of a successful buy-and-build strategy, growth investments and a series of commercial and operational initiatives have enabled SYNLAB to achieve strong organic growth and successfully navigate a challenging market environment over the last two years. Key initiatives included:

• Making significant investments in state-of-the-art laboratory and information technology to enhance efficiency and improve the customer experience;
• Establishing a strong track record of partnerships with public hospitals;
• Improving the accessibility of medical diagnostic services for consumers and expanding the availability of the latest innovations and specialty testing across its network;
• Advancing medical research in partnership with the scientific community, publishing more than 300 articles annually in scientific journals;
• Strengthening the capabilities and global network of SYNLAB through a successful track record of strategic and bolt-on acquisitions;
• Expanding into new markets internationally, particularly across Latin America; and
• Supporting the development and implementation of a strong ESG and sustainability programme.

Anastasya Molodykh-McFarlane, Senior Principal and member of Cinven’s Healthcare sector team, stated:

“We are very pleased to welcome Labcorp as a shareholder in SYNLAB. We have great respect for the long-term growth story and healthcare excellence at Labcorp and believe that Labcorp’s investment underscores the future potential of SYNLAB. The investment by Labcorp is another significant milestone in Cinven’s strong Healthcare track record.”

Glenn Eisenberg, Chief Financial Officer, Labcorp, commented:

“Our investment in SYNLAB as a minority shareholder provides Labcorp with a role on the co-investors’ holding company board and the commitment to explore possible opportunities in the future to bring Labcorp’s innovative specialty tests to markets in Europe, consider possible procurement collaborations, evaluate opportunities to support advances in clinical trials and enrollment and improve personalized care.”

Mathieu Floreani, CEO of SYNLAB, added:

“With Cinven, SYNLAB has a strong majority shareholder who knows the company and the sector very well. Together, we have built the leading European clinical laboratory and medical diagnostic services company. Through Labcorp’s minority investment, SYNLAB now receives additional backing from a strategic investor that is deeply embedded in the diagnostics market. I am excited to continue our development together with the Cinven team and Labcorp and explore opportunities to bring Labcorp’s innovative specialty tests into markets across Europe.”

Completion of the transaction is expected in the first quarter of 2025 and is subject to regulatory approvals.

Media contacts

About Cinven

Cinven is a leading international private equity firm focused on building world-class global and European companies. Its funds invest in six key sectors: Business Services, Consumer, Financial Services, Healthcare, Industrials and Technology, Media and Telecommunications (TMT). Cinven has offices in London, New York, Frankfurt, Paris, Milan, Madrid, Guernsey and Luxembourg.

Cinven takes a responsible approach towards its portfolio companies, their employees, suppliers, local communities, the environment and society.

Cinven Capital Management (V) General Partner Limited, Cinven Capital Management (VI) General Partner Limited, Cinven Capital Management (VII) General Partner Limited and Cinven Capital Management (SFF) General Partner Limited are each authorised and regulated by the Guernsey Financial Services Commission, and Cinven Limited is authorised and regulated by the Financial Conduct Authority.

In this press release ‘Cinven’ means, depending on the context, any of or collectively, Cinven Holdings Guernsey Limited, Cinven Partnership LLP, and their respective Associates (as defined in the Companies Act 2006) and/or funds managed or advised by any of the foregoing.

For additional information on Cinven please visit www.cinven.com and www.linkedin.com/company/cinven/.

About Labcorp

Labcorp(NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions.We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities.The company’s more than 67,000 employees serve clients in approximately 100 countries, provided support for 84% of the new drugs and therapeutic products approved in 2023 by the FDA and performed more than 600 million tests for patients around the world.Learn more about us atwww.labcorp.com.

About SYNLAB

SYNLAB Group is the leader in medical diagnostic services and specialty testing in Europe. The Group offers a full range of innovative and reliable medical diagnostics to patients, practising doctors, hospitals and clinics, governments and corporates.

Providing the leading level of service within the industry, SYNLAB is the partner of choice for routine and specialty diagnostics in human medicine. The Group continuously innovates medical diagnostic services for the benefit of patients and customers.

SYNLAB operates in more than 30 countries across four continents and holds leading positions in most markets, regularly reinforcing the strength of its network through a proven acquisition strategy. More than 27,000 employees, including over 2,000 medical experts, contribute every day to the Group’s worldwide success.

SYNLAB performed around 600 million laboratory tests and achieved revenues of €2.64 billion in 2023.

More information can be found on www.synlab.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements, including but not limited to statements with respect to the benefits of Labcorp’s indirect minority investment in SYNLAB, potential opportunities to bring Labcorp’s innovative specialty tests to market in Europe, potential procurement collaborations between Labcorp and SYNLAB and potential support for advances in clinical trials and the expected timing to close the transaction.

Each of the forward-looking statements is subject to change based on various important factors, many of which are beyond the parties control, including without limitation: (i) the risk that the transaction may not be completed in a timely manner or at all; (ii) expected timing to closing; (iii) the failure to satisfy closing conditions, including the receipt of certain regulatory approvals; (iv) the occurrence of any event, change or other circumstance that could give rise to the termination of the transaction agreements; (v) potential difficulties with employee retention and employee relations; (vi) the trading price of Labcorp’s stock, competitive actions and other unforeseen changes and general uncertainties in the marketplace;  (vii) changes in government regulations; (viii) customer purchasing decisions, including changes in payer regulations or policies; (ix) other adverse actions of governmental and third-party payers; (x) changes in testing guidelines or recommendations; (xi) the impact of global geopolitical events; (xii) the effect of public opinion on each party’s reputation; (xiii) adverse results in material litigation matters, if applicable; (xiv) the impact of changes in tax laws and regulations; (xv) failure to maintain or develop customer relationships; (xvi) failure in information technology, systems or data security; (xvii) personnel costs; (xviii) inflation, and (xix) increased competition. These factors, in some cases, have affected and in the future (together with other factors) could affect Labcorp’s ability to implement its business strategy, and actual results could differ materially from those suggested by these forward-looking statements. As a result, readers are cautioned not to place undue reliance on any forward-looking statements.

Labcorp has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in the most recent Annual Report on Form 10-K and subsequent Forms 10-Q, including in each case under the heading RISK FACTORS, and in the other Labcorp filings with the SEC. The information in this press release should be read in conjunction with a review of Labcorp’s filings with the SEC including the information in the company’s most recent Annual Report on Form 10-K, and subsequent Forms 10-Q, under the heading MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

Classification of NuWays AG to SynBiotic SE

SynBiotic transformation: Reaching new operational high(t)s

Topic: The new CEO Daniel Kruse has been in charge for roughly one year now. The implemented structural changes to the company coupled with regulatory changes in Germany, especially the loss of the narcotic drug status of medical cannabis, should become visible in strong improved financials.

Today, SynBiotic is a Buy-and-Build operator in the European hemp, cannabis and cannabinoid market with an objective to establish a fully integrated platform-company with activities across the entire value chain from cultivation to production and retail, essentially from the field to the shelf.

Dynamic market growth. SynBiotic is active across three end markets, recreational cannabis, industrial hemp and medical cannabis. All three markets should benefit from favourable trends. Demand for industrial hemp is seen to 4x until 2030, carried by regulatory changes and novel food classification of CBDbased products. At the same time, demand for medical cannabis should 10x vs 2023, thanks to the Cannabis Act, which took effect in April. While recreational cannabis (regulated commercial market for cannabis sales) has so far not been approved, the market for i. a. cannabis seeds and gardening equipment is now a legally growing.

SynBiotic looks set to strongly benefit from those favorable market dynamics. Until the end of FY27e, we expect group sales to reach € 40.8m (vs. € 3.9m in FY23), implying a roughly 80% CAGR. Above all, this is seen to be carried by the medical cannabis segment, which should contribute some € 29m.

Additional pockets of growth could come from further acquisitions as per its Buy and Build strategy. In fact, we would expect another add-on until the end of the year.

More importantly, with strongly growing sales, SynBiotic should be on track to reach break-even by FY25e. This should also be possible thanks to the new CEO’s implemented cost-saving measures such as significantly reduced personnel expenses (FY23 -55% yoy; FY24e -19% vs FY22). During the subsequent years, the company looks set to reach double-digit EBIT margins (eNuW: by 2027e).

With only a few listed players in the German cannabis space, SynBiotic offers a unique opportunity to invest into a vertically integrated company that is also active in a variety of different end markets. We reinitiate the coverage with a BUY rating and a € 12.40 PT (old: € 9) based on DCF.

You can download the research here: http://www.more-ir.de/d/30801.pdf

For additional information visit our website: www.nuways-ag.com/research

Contact for questions:
NuWays AG – Equity Research
Web: www.nuways-ag.com
Email: research@nuways-ag.com
LinkedIn: https://www.linkedin.com/company/nuwaysag
Adresse: Mittelweg 16-17, 20148 Hamburg, Germany
++++++++++
Diese Meldung ist keine Anlageberatung oder Aufforderung zum Abschluss bestimmter Börsengeschäfte.
Offenlegung möglicher Interessenskonflikte nach § 85 WpHG beim oben analysierten Unternehmen befinden sich in der vollständigen Analyse.
++++++++++

Press Release // September 17, 2024

 
Formycon will present clinical data on its ustekinumab biosimilar candidate FYB202 at the EADV Congress in Amsterdam and the UEG Week in Vienna
 

Planegg-Martinsried – Formycon AG (FWB: FYB) will present clinical study data of its ustekinumab biosimilar candidate FYB202 at this year’s European Academy of Dermatology & Venerology (EADV) congress, taking place in Amsterdam from September 25 to 28, 2024. The randomized, double-blind, multicenter VESPUCCI Phase III study met the primary endpoint, demonstrating similar efficacy of FYB202 and the reference drug Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). The ePoster presentation shows details of the study design as well as the primary and secondary endpoints.

In addition, Formycon will present study data focusing on the pharmacokinetics of the ustekinumab biosimilar candidate FYB202 at the United European Gastroenterology (UEG) Week from October 12 to 15, 2024 in Vienna. In the Phase I pharmacokinetics study FYB202 showed bioequivalence to the reference drug for all primary endpoints.

Both posters were designed in cooperation with Fresenius Kabi, Formycon’s commercialization partner for FYB202.

Presentation details:

EADV Congress

• Session: ePoster
• Poster-ID: P0984
• Title: A randomised, double-blind trial to compare the efficacy, safety, and immunogenicity of the proposed biosimilar ustekinumab (FYB202) with reference ustekinumab in patients with moderate-to-severe plaque psoriasis
• Room: Poster Area
• Date: September 25 – 28, 2024

UEG Week

• Session:  ePoster incl. audio/video presentation on demand
• Poster-ID: PP0593
• Title: Proposed ustekinumab Biosimilar FYB202: Pharmacokinetic equivalence demonstrated in a randomised, double-blind, parallel-group, single-dose trial in healthy subjects (RUSTIC)
• Speaker: Sigrid Balser, Vice President Clinical Development & Operations, Formycon AG
• Room: Poster Area
• Date: October 13 – 15, 2024

¹ Stelara^® is a registered trademark of Johnson & Johnson

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. FYB203/aflibercept, received FDA approval. Another four biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

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.