commercialization of mRNA-based vaccines and monoclonal antibodies targeting infectious disease pathogens. In the first three months of 2020, revenue primarily consisted of EUR2.0 million recognized under our collaboration with Eli Lilly, which terminated later in June 2020. Operating result Operating loss was EUR115.8 million for the first three months of 2021, representing an increase of EUR92.6 million, or 339.0%, from operating loss of EUR23.2 million for the same period in 2020. This increase in operating loss was mainly driven by higher research and development costs from our ongoing Phase 2/3 clinical trials of CVnCoV. Such increased R&D costs consist primarily of cost incurred to clinical research organizations and for personnel costs for employees involved in the CVnCoV development, as well as materials used in the administration of CVnCoV clinical trials. We also recognized increased cost of sales mainly due to set-up activities for production processes for our COVID-19 vaccine candidate. Additionally, we recognized increased general and administrative expenses mainly due to consulting services for product launch readiness and personnel-related costs from an increased headcount. These increases in expenses were partially offset by other operating income recognized under our grant from the German Federal Ministry of Education and Research (BMBF) for the development and production of our COVID-19 vaccine candidate. Financial Result Financial result for the first three months of 2021 was a gain of EUR3.6 million, representing an increase of EUR4.3 million, or 630.9%, from a loss of EUR0.7 million for the same period in 2020. This net gain was driven mainly by foreign exchange gains, which were partly offset by negative interest on cash, which is being held in liquid funds to be available for use in our CVnCoV R&D and manufacturing activities. Pre-Tax Loss Pre-tax loss was EUR112.2 million for the first three months of 2021, compared to EUR23.9 million for the same period in 2020. About CVnCoV CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020. The vaccine candidate chosen for first clinical development, CVnCoV, is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus, and formulated within Lipid Nanoparticles (LNPs). Phase 1 and 2a clinical trials of CVnCoV began in June and September 2020, respectively. Phase 1 interim data reported in November 2020 showed that CVnCoV was generally well tolerated across all tested doses and induced strong antibody responses in addition to first indication of T cell activation. The quality of the immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection. In December 2020, CureVac initiated a pivotal Phase 2b/3, the HERALD study, with a 12µg dose of CVnCoV. In February 2021, CureVac initiated a rolling submission with the European Medicines Agency (EMA) for CVnCoV. About CureVac CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. The principle of CureVac's proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. Based on its proprietary technology, CureVac has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac had its initial public offering on the New York Nasdaq in August 2020. It is headquartered in Tübingen, Germany, and employs more than 600 people at its sites in Tübingen, Frankfurt, and Boston, USA. Further information can be found at www.curevac.com. CureVac Media Contact Anna Kamilli, Manager Communications CureVac, Tübingen, Germany T: +49 7071 9883-1684 anna.kamilli@curevac.com Bettina Jödicke-Braas, Manager Communications CureVac, Tübingen, Germany T: +49 7071 9883-1087 bettina.joedicke-braas@curevac.com CureVac Investor Relations Contact Dr. Sarah Fakih, Vice President 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 AG, CureVac Real Estate GmbH, CureVac Inc. and CureVac Swiss AG (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, 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, and fluctuations of operating results due to the effect of exchange rates 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. Cash and Condensed Consolidated Profit and Loss Data (in EUR millions) December 31, 2020 March 31, 2021 (unaudited) Cash and Cash Equivalents 1,322.6 1,496.9 Three months ended March 31, (in EUR millions) 2020 2021 (unaudited) (unaudited) Revenue 3.1 10.0 Cost of Sales, Operating Expenses & Other Operating Income -26.3 -125.8 Operating Result -23.2 -115.8 Financial Result -0.7 3.6 Pre-Tax Loss -23.9 -112.2 -----------------------------------------------------------------------------------------------------------------------
2021-05-26 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de -----------------------------------------------------------------------------------------------------------------------
Language: English Company: CureVac Friedrich-Miescher-Str. 15 72076 Tübingen Germany EQS News ID: 1200854 End of News DGAP News Service =------------
1200854 2021-05-26
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May 26, 2021 07:01 ET (11:01 GMT)