Full Press Release Details
CureVac Announces Financial Results and
Business Updates for the Fourth Quarter and Full-Year of 2020
Germany/ BOSTON, USA - April 15, 2021 - CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new
class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced business updates and financial
results for the fourth quarter and full-year 2020.
was a year of fundamental corporate transformation, which has propelled CureVac forward in its growth from a research-oriented biotech
to an integrated, commercial biopharma company based on our unique mRNA technology and a broad clinical COVID-19 vaccine program,"
said Franz-Werner Haas, Chief Executive Officer of CureVac. "mRNA has emerged as a key technology that leads the charge against
the COVID-19 pandemic, but it is only starting to realize its full potential in the development of new prophylactic vaccines and therapeutics
in other areas such as oncology. Moving into 2021, we will continue the development of our company and, subject to regulatory approval,
execute on our core mandate to broadly deliver a safe and effective COVID-19 vaccine. We have made great progress in achieving these goals
and are now leveraging the solid foundation we laid to further tackle emerging variants in our COVID-19 vaccine program, advance into
second-generation COVID-19 vaccines and infectious diseases and expand our clinical pipeline in oncology and protein therapies."
2020 with a strong cash position of 1.32 billion, including the proceeds of a private round financing in July, our IPO in August
and a grant from the German government in September. This was further complemented by a significant upfront payment from our Advanced
Purchase Agreement with the European Commission for 225 million doses of CVnCoV with an option for an additional 180 million doses,"
said Pierre Kemula, Chief Financial Officer of CureVac. "In addition, in February 2021, we successfully raised aggregated gross
proceeds of approximately $517.5 million in our first follow-on financing. With our strong cash position, we believe we are in a great
position to accelerate our corporate transformation from a research-oriented biotech to a commercial-stage biopharma company and to continue
to grow the business around our broad clinical pipeline while building up commercial expertise and infrastructure."
Prophylactic Vaccines
CVnCoV - Covid-19 Vaccine Candidate
CVnCoV is CureVac's first-generation vaccine
candidate in its clinical COVID-19 vaccine program. Based on optimized, non-chemically modified mRNA, CVnCoV has shown to be well tolerated
and to induce robust immune responses at a 12 g dose. CureVac's technology enables CVnCoV to remain stable at standard refrigerator
temperature for at least three months - a critical advantage as the world faces a pandemic that demands safe vaccines produced and
distributed on a global scale.
Phase 2b/3 in Europe and Latin America
Phase 2b/3 study (HERALD), initiated on December 14, 2020, has successfully completed recruitment, with currently over 40,000 participants.
Of those participants, approximately 75% were enrolled in Latin America and 25% were enrolled in Europe. The initial Phase 2b component
of the study, assessing safety, reactogenicity and immunogenicity in study participants stratified according to age (18-60 and >60
years old), was completed in February 2021. Subsequently, the study advanced into the current Phase 3 safety and efficacy component.
spread of new virus variants across the world has supported the need to identify variants causing COVID-19 infections in the countries
where the study is conducted for the case-driven interim analysis anticipated in the second quarter of 2021 as well as for all later trial
analyses. According to variant surveillance sources (e.g. nextstrain.org), Variants of Concern, such as B.1.1.7 (UK strain), B.1.351 (South
Africa strain) and P.1 (Brazil strain) currently constitute more than 50% of COVID-19 cases in Latin America and more than 80% in Europe.
The highest prevalence is attributable to B.1.1.7. On March 30, CureVac submitted a trial protocol amendment to the regulatory authorities
to address presently circulating virus variants via the implementation of a corresponding secondary endpoint.
Phase 2a, which served as a dose-confirmation trial following the selection of a 12 g dose for advanced clinical testing, has completed
recruitment with 674 participants. Based on the high prevalence of COVID-19 in both countries since trial initiation, a relevant number
of COVID-19 infections were detected within the still blinded trial. To harness the potential of this prevalence, CureVac submitted a
protocol amendment to include a secondary endpoint for vaccine efficacy on March 31, 2021. The trial analysis is expected to allow collection
of relevant efficacy data in the total population of the trial with a focus on the important sub-group of approximately 270 participants
above the age of 60, who received 12 g of CVnCoV, thereby complementing Phase 2b/3 efficacy data.
Challenge Study on Variant of Concern B.1.351 (South Africa Variant)
CureVac published the first challenge infection study in a preclinical mouse model to show protection against a SARS-CoV-2 Variant of
Concern. The data demonstrate the protection efficiency of CVnCoV from the SARS-CoV-2 original strain, BavPat1, and the novel Variant
of Concern, B.1.351 (South African variant), in a transgenic mouse model. CVnCoV has shown to fully protect mice from lethal infection
caused by BavPat1 or B.1.351. Immunization resulted in the induction of RBD binding and virus-neutralizing antibodies and conferred complete
and robust protection from viral replication in the lung and the brain. In this model, very limited viral replication was observed in
the upper respiratory tract of mRNA-vaccinated animals challenged with B.1.351.
expands the data basis of existing preclinical studies of CVnCoV by providing relevant SARS-CoV-2 variant-specific data and adds further
evidence on the overall protection efficiency of CVnCoV. Detailed data can be accessed through a manuscript available on the bioRxiv pre-print
of the Clinical COVID-19 Vaccine Program
continuously expanding the COVID-19 vaccine program to generate important clinical data on CVnCoV to better serve differentiated protection
needs during the pandemic.
a protocol amendment was filed for the ongoing Phase 2a study in Peru and Panama to enroll approximately 40 adolescent participants between
the ages of 12 and 17. Enrollment of the first participants is expected to start toward the end of April and it forms the first part of
a broader study in this age group. Contingent on a successful safety review, the study is planned to recruit a larger number of adolescent
participants and allow for geographical reach into other Latin American countries and Europe.
Phase 3 trial, to evaluate the safety, reactogenicity and immunogenicity of CVnCoV in adults with an elevated risk of severe COVID-19
infection due to comorbidities is expected to start shortly. Selected comorbidities include obesity, chronic cardiovascular disease, chronic
kidney disease, chronic obstructive pulmonary disease (COPD), HIV, type 2 diabetes mellitus and post-renal transplantation. The multicenter
clinical trial will be conducted in Belgium and is expected to enroll approximately 1,200 participants.
CureVac together with its partner Bayer plans to initiate a flu-co-administration study to assess compatibility with established seasonal
vaccines in case of seasonal COVID-19 vaccinations. The Phase 3 multicenter study will evaluate the safety, reactogenicity and immunogenicity
of CVnCoV co-administered with a licensed quadrivalent influenza vaccine in adults 60 years and older. The co-administration will be tested
versus the separate administration of both vaccines. The study aims to enroll approximately 1,000 participants.
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.
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.
on Advancing a Commercial Infrastructure
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
Manufacturing of COVID-19 vaccine
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 ,
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 is particularly well suited for pandemic preparedness in outbreak scenarios or as a stand-alone
device in front lines of epidemic areas.
Partnership Agreements