administration of both vaccines. The study aims to enroll approximately 1,000 participants. Further age-related data is expected to be generated in an upcoming Phase 2 trial, focusing on immunogenicity, including a deep characterization of the immune response in older adults above the age of 65 compared to younger adults aged 18-45. With a focus on sophisticated immunogenicity markers, the non-randomized, open-label clinical trial is expected to start in the second quarter. It will be conducted in France and aims to include approximately 180 participants. Regulatory Pathway To expedite the route to potential market authorization of CVnCoV, CureVac initiated a rolling submission with the European Medicines Agency (EMA) on February 12, 2021. The process was started with the submission of a first preclinical data package and was recently advanced with two additional data packages, including CMC data as well as first clinical data from CureVac's dose-escalation Phase 1 trial. CureVac currently anticipates completing data submission in time to file for conditional approval of CVnCoV in Q2 2021. Executing on Advancing a Commercial Infrastructure As a part of the corporate transformation, CureVac is developing its commercial organization and has started the preparation of commercial territories for the anticipated launch of CVnCoV and future products. A commercial infrastructure is rapidly growing under the leadership of Dr. Antony Blanc, appointed as Chief Business and Chief Commercial Officer in December 2020. In March 2021, CureVac established a legal entity in Switzerland, which represents a first step in preparing access to commercial territories outside the European Union. Next to Germany and Austria, Switzerland represents one of the three countries for which CureVac holds exclusive commercialization rights for Program Products in the context of CureVac's broad GSK partnership in vaccines for infectious diseases as well as second-generation vaccines for COVID-19. Manufacturing of COVID-19 vaccine candidate, CVnCoV As announced on November 17, 2020, CureVac is ramping up its broad and integrated European vaccine-manufacturing network with highly experienced Contract Development and Manufacturing Organization (CDMO) partners and the additional support of its strategic partners Bayer and GSK. The network is supported by CureVac's in-house GMP III manufacturing suite - the blueprint for the optimized production processes for CVnCoV established in 2020. Since initiation, several partners have joined the network, covering the main manufacturing steps for CVnCoV, thereby expected to mitigate supply chain risks and increase manufacturing flexibility. Manufacturing experts, such as Wacker Chemie, Fareva, Rentschler Biopharma, Novartis, and most recently Celonic Group, make up most of the network of CDMO partners. The network is expected to expand throughout 2021 to provide an anticipated manufacturing capacity of up to 300 million doses. For 2022, CureVac raised its capacity guidance from up to 600 million to up to 1 billion doses. In-house manufacturing capacity is expected to further expand when GMP IV, CureVac's large-scale production facility supported by the European Investment Bank, comes online. This new facility is anticipated to open in the second half of 2022. In 2020, CureVac also advanced the RNA Printer(R), a novel downsized, mobile and automated GMP production system for downscaled manufacturing of mRNA therapeutics. With its modular design and decentralized concept, the RNA Printer(R) is particularly well suited for pandemic preparedness in outbreak scenarios or as a stand-alone device in front lines of epidemic areas. Partnership Agreements CureVac recently entered into three strategic COVID-19 collaborations, with highly experienced pharma and science partners, to accelerate the continued development of a broad pipeline of first and second-generation COVID-19 vaccines. Together with its partners, CureVac aims to provide a robust solution for the pandemic and the rapid spread of new variants based on its first-generation COVID-19 lead vaccine candidate, CVnCoV, as well as advanced next-generation vaccines to create value also beyond the COVID-19 pandemic. To expedite market readiness of CVnCoV, CureVac and Bayer announced a collaboration and service agreement on January 7, 2021, under which Bayer will contribute expertise, infrastructure and workforce to support CVnCoV in areas such as clinical operations, regulatory affairs, pharmacovigilance, medical affairs and supply chain performance as well as operational support in selected countries. On February 3, 2021, CureVac and GSK announced the extension of their July 2020 strategic technology collaboration in infectious diseases to jointly develop second-generation COVID-19 vaccines based on new mRNA backbones in single and multivalent formats. As a targeted approach to rapidly spreading Variants of Concern, both collaborations will be complemented by the scientific expertise provided via CureVac's R&D collaboration with the UK Government and its Vaccines Task Force. The collaboration, announced on February 5, 2021, and currently in final negotiation stage is designed to fast-track the development and regulatory pathway of variant-optimized vaccines based on the Vaccine Task Force's renowned expertise in variant epidemiology and genomics. Oncology CV8102 - Cancer immuno-modulator in solid tumors Phase 1 CureVac's lead oncology candidate, CV8102, is being assessed in a Phase 1 dose-escalation study, evaluating tolerability and activity in the dose range of 25µg to 900µg as a single agent and in combination with systemic anti-PD-1 antibodies. Intra-tumoral treatment tested in four types of solid tumors (cutaneous melanoma, adenoid cystic carcinoma, squamous cell carcinoma of skin and squamous cell carcinoma of head and neck) had formerly shown objective tumor responses in two melanoma patients and two additional patients with stable disease, including shrinkage of non-injected lesions in the single-agent cohort. At the Society for Immunotherapy of Cancer (SITC) conference on November 9, 2020, CureVac reported that these findings were further extended by a new partial response observed in a patient with cutaneous squamous cell carcinoma who was pre-treated with anti-PD-1, expanding activity from melanoma into a second indication. Additionally, the first RECIST response in the PD-1 combination cohort was observed in a PD-1 refractory melanoma patient with regression of non-injected lesions in the lung and liver. Based on the results, on February 4, 2021, CureVac announced the expansion of the Phase 1 study to confirm the safety, tolerability and efficacy of CV8102 at a 600?g dose, selected to be advanced in a Phase 2 clinical trial. The expansion part of the Phase 1 trial will enroll 30 patients with PD-1 refractory melanoma who will receive intra-tumoral injections of CV8102 in combination with PD-1 antibodies as well as 10 patients who will be treated with CV8102 only. Financial Update for the Fourth Quarter and Full-Year of 2020 Cash Position Cash increased from EUR30.7 million as of December 31, 2019, to EUR1,322.6 million as of December 31, 2020, mainly due to the EUR559.3 million raised in the 2020 Private Investment in July 2020, along with EUR192.9 million in proceeds, net of underwriting discounts and commission, from CureVac's initial public offering (IPO) on the Nasdaq in August 2020 and a EUR120 million non-refundable upfront payment received from GSK. The Company also received EUR103 million in payments from the grant provided by the German Federal Ministry of Education and Research (BMBF) in the fourth quarter of 2020. The total amount of the grant is EUR252 million; therefore, provided we fulfill the grant conditions, we are entitled for further EUR149 million in 2021. In addition, the Company collected an up-front payment of EUR450 million paid by the European Commission on behalf of the Member States in December 2020. Cash used in the operations in the year was mainly used to advance all R&D activities for CVnCoV, our COVID-19 vaccine candidate, during the second half of Fiscal Year 2020. Revenues Revenue was EUR6.0 million and EUR48.9 million for the three and twelve months ended December 31, 2020, respectively, representing a decrease of EUR0.8 million for the three months and an increase of EUR31.5 million, or -11.8% and +181.0%, from EUR6.8 million and EUR17.4 million for the same periods in 2019, respectively. These increases were primarily driven by the following events: in July 2020, GlaxoSmithKline plc (GSK) and CureVac signed a strategic collaboration agreement for the research, development, manufacturing and commercialization of mRNA-based vaccines and monoclonal antibodies targeting infectious disease pathogens. In addition to an equity investment of EUR150 million, made as part of the 2020 Private Investment, GSK made a non-refundable upfront payment of EUR120 million, which has been deferred and recognized as a contract liability. For the three months ended December 31, 2020, EUR4.1 million was released from contract liabilities and recognized as revenues. In June 2020, CureVac and Eli Lilly terminated their collaboration. As a result, on the termination date, EUR33.1 million in contract liabilities from an upfront payment was recognized as revenue as no further associated performance obligations remained. Operating result Operating loss was EUR46.6 million and EUR109.8 million for the three and twelve months ended December 31, 2020, respectively, representing an increase of EUR11.5 million and EUR10.3 million, or an increase of 32.8% and 10.4%, from EUR35.1 million and EUR99.5 million for the same periods in 2019, respectively. The increase in operating loss in the three months ended December 31, 2020 was mainly driven by higher research and development costs, primarily due to high costs for CVnCoV R&D activities, including research material manufacturing expenses. The increase
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