Full Press Release Details
CureVac Announces Financial Results
and Business Updates for the Third Quarter and First Nine Months of 2020
Germany/ BOSTON, USA - November 30, 2020 - CureVac N.V. (Nasdaq: CVAC), a clinical-stage biopharmaceutical company
developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced business
updates and financial results for the third quarter and first nine months of 2020.
first nine months of 2020 have been a transformative time for us at CureVac and also for the world around us," said Franz-Werner
Haas, Chief Executive Officer of CureVac. "From the very start of the year, we made it a priority to address COVID-19. Over
the first nine months of 2020, we have remained focused on the development of our mRNA-based vaccine candidate to help stop the
spread of this severe disease. Our team's tremendous efforts were reflected in the positive Phase 1 interim data in early
November as well as positive stability data, which indicates that our vaccine remains stable for at least three months at refrigerator
temperature, and up to 24 hours at room temperature. These advancements, combined with our recent Advanced Purchase Agreement
with the European Commission to supply 225 million doses of CVnCoV and an option for an additional 180 million doses, are highly
promising for the anticipated large-scale vaccination efforts."
achievement of our financial milestones to date in 2020 has put us in a favorable financial position," said Pierre Kemula,
Chief Financial Officer of CureVac. "Proceeds of our successful IPO, additional investments and a grant from the German
government allow us to expand the business, advance the clinical development of our COVID-19 vaccine candidate, CVnCoV, and support
the ramp up of our manufacturing capacity in the coming months. For the remainder of 2020 and moving into 2021, we are focused
on supporting CVnCoV commercialization and developing our unique technology platform across our clinical pipeline."
Updates for the Third Quarter and First Nine Months of 2020
Prophylactic Vaccines
CVnCoV - Covid-19 Vaccine Candidate
1 In June 2020, CureVac entered into a clinical Phase 1 dose escalation trial at clinical sites in Germany and Belgium to
assess safety, reactogenicity and immunogenicity of CVnCoV. On November 10, 2020, the company reported detailed interim data
based on more than 250 study participants tested in the dose range of 2 g to 12 g.
interim data showed that CVnCoV was generally well tolerated and induced strong binding and virus-neutralizing antibody responses
across all tested doses. First indication of T cell activation was detected, and full T cell analysis will follow before the end
of 2020. The quality of the immune response was found to be comparable to recovered COVID-19 patients, mimicking the immune
response after natural COVID-19 infection. The data support advancement of the 12 g dose into a pivotal Phase 2b/3 trial.
Detailed data can be accessed through a manuscript available on the medRxiv pre-print server.
2a In September 2020, CureVac entered into a clinical Phase 2a study in Peru and Panama to further expand the clinical database
of CVnCoV in a geographical environment with a high incidence of COVID-19 infection. The study includes individuals between 18
and 60 years old, but focuses on adults older than 60 years to further confirm safety and evaluate reactogenicity in this age group.
The study will enroll approximately 690 individuals and includes testing at the 12 g dose.
2b/3 Contingent on regulatory approval, CureVac plans to initiate a pivotal Phase 2b/3 study of more than 35,000 individuals
shortly. The Phase 2b component will assess safety, reactogenicity and immunogenicity in study participants stratified according
to age (>18 and >60 years old), initially at clinical testing sites in Europe and South America. The Phase 3 component will
further assess safety and efficacy. If CureVac gains authorization to initiate the pivotal trial, an interim analysis could be
carried out within the first quarter of 2021.
Study On November 12, 2020, CureVac announced initial data from its ongoing CVnCoV stability study. The data shows that CVnCoV
remained stable and within defined analytical specifications for at least three months when stored at a standard refrigerator temperature
of +5 C (+41 F), and for up to 24 hours at room temperature as a ready-to-use vaccine.
stability profile has the potential to be compatible with existing standard cold chain logistics. This will support large-scale
vaccination efforts by enabling decentralized storage and positively impacting immunization cost and waste. The stability study
is ongoing with the goal to further evaluate the potential for a longer commercial product shelf-life.
Commercialization of
COVID-19 vaccine candidate, CVnCoV
November 17, 2020, the European Commission announced the approval of a contract for the initial purchase of 225 million doses
of CureVac's COVID-19 vaccine candidate, CVnCoV, including the option to request an additional 180 million doses on
behalf of the European Union member states. CureVac is the fifth company to finalize an agreement with the European
Commission. The doses will be supplied once CVnCoV has proven to be safe and effective against COVID-19. CureVac will
receive an upfront payment to support the advanced clinical development of CVnCoV and the current expansion of its
manufacturing network, as well as market launch and supply preparations.
Manufacturing of COVID-19
vaccine candidate, CVnCoV
currently operates three Good Manufacturing Practice (GMP) certified suites. Capacity of the third GMP suite is currently dedicated
to the COVID-19 vaccine candidate, CVnCoV, to supply the ongoing Phase 1 and Phase 2a clinical trials, the planned pivotal Phase
2b/3 trial, as well as potential early commercialization activities. A fourth GMP facility is currently in development to handle
all manufacturing steps from starting material to formulation, operating at industry scale to support future commercial launches.
July 6, 2020, CureVac announced the closing of a 75 million loan agreement with the European Investment Bank to support
the company's efforts to expand existing GMP-certified production capabilities and accelerate the completion of the fourth
November 17, 2020, CureVac announced that it is building an integrated European vaccine manufacturing network with highly experienced
Contract Development and Manufacturing Organization (CDMO) partners for each major manufacturing step. This strategy further strengthens
the clinical development of CVnCoV, the preparations for a potential launch and rapid market supply. Based on the selection of
a 12 g dose to move into advanced clinical trials, the manufacturing network will significantly increase the existing capacity
to provide up to 300 million doses of CVnCoV in 2021 and up to 600 million doses in 2022.
GlaxoSmithKline Collaboration
2020, CureVac entered into a Collaboration and License Agreement with GSK, one of the industry's leading vaccine experts.
Within the scope of the agreement, the companies will combine their respective mRNA expertise to collaborate on development opportunities
across a range of infectious disease pathogens, selected with the potential to best leverage the advantages of this platform technology,
while addressing significant unmet medical need and economic burden.
strategic technology collaboration encompasses mRNA-based vaccines and monoclonal antibodies targeting infectious
disease pathogens. Under the terms of the deal, GSK made an equity investment in CureVac of 150m and an upfront cash payment
of 120m. CureVac is eligible to receive development and regulatory milestone payments, commercial milestone payments and
tiered royalties on product sales.
- Cancer immuno-modulator in solid tumors
Phase 1 On November 9 at the Society
for Immunotherapy of Cancer (SITC) conference, CureVac presented updated data from the ongoing Phase 1 dose-escalation study of
its lead oncology product candidate. The study assesses tolerability as well as activity of CV8102 in the dose range of 25 to
900 g as a single agent, and in combination with systemic anti-PD-1 antibodies for the intra-tumoral treatment of four types
of solid tumors: cutaneous melanoma, adenoid cystic carcinoma, squamous cell carcinoma of skin and squamous cell carcinoma of
head and neck. CV8102 showed an acceptable tolerability with adverse events mainly accumulating around mild to moderate fever,
fatigue, chills and headache.
Following a first data presentation at
the American Society of Clinical Oncology (ASCO) in April 2020, the data presented at SITC (Cut-off was October 5, 2020) featured
29 patients treated with CV8102 as a single agent and 21 patients treated with CV8102 in combination with anti-PD-1 antibodies.
The formerly observed objective tumor responses in two melanoma patients, and two additional patients with a stable disease, including
shrinkage of non-injected lesions in the single agent cohort, were extended by a new partial response observed in a patient with
cutaneous squamous cell carcinoma pre-treated with anti-PD-1. This observation expanded 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. CureVac plans to initiate an expansion cohort in early 2021.
Financial Update for the
Third Quarter and First Nine Months of 2020
Cash increased from 30.7 million
as of December 31, 2019 to 892.4 million as of September 30, 2020, mainly due to the 559.3 million raised in the 2020
Private Investment in July 2020, along with 192.9 million in proceeds, net of underwriting discounts and commission,
from CureVac's initial public offering (IPO) on the Nasdaq in August 2020, 100 million from the August 2020 concurrent
private placement to Dietmar Hopp and the 120 million non-refundable upfront payment received from GSK.
Revenue was 5.2 million and 42.8
million for the three and nine months ended September 30, 2020, respectively, representing an increase of 4.1 million and
32.2 million, or 371% and 304%, from 1.1 million and 10.6 million for the same periods in 2019, respectively.