Full Press Release Details
CureVac Announces Financial
Results for the Fourth Quarter and Full-Year 2022 and Provides Business Update
T BINGEN, Germany/BOSTON, USA -
April 25, 2023 - CureVac N.V. (Nasdaq: CVAC) ("CureVac"), a global biopharmaceutical company developing a new class
of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced financial results for the fourth
quarter and full-year 2022 and provided a business update.
"Last year was transformative for CureVac,
as we have made significant strides in advancing our unique end-to-end mRNA capabilities," said Alexander Zehnder, Chief Executive
Officer at CureVac. "We have successfully executed on clinical programs in COVID-19 and flu as demonstrated by positive preliminary
data reported in early 2023, validating our differentiated mRNA technology platform. We have acquired and successfully integrated Frame
Cancer Therapeutics, adding state-of-the-art antigen discovery technologies to our expanding oncology footprint. The German pandemic preparedness
agreement reached in April 2022 has accelerated the build-up of our commercial-scale GMP IV plant as a safeguard against future infectious
disease outbreaks, forming an integral part of our highly scalable manufacturing landscape. With these key achievements, we have reached
an inflection point. Future success will depend on strong execution discipline, which we will focus in 2023 on later stage clinical trials
in prophylactic vaccines and initial clinical developments in oncology. As CureVac's new CEO, I am deeply impressed by the vast
potential of our technology as well as the scientific rigor and passion of our employees, and I am excited to build on our momentum to
deliver on our goals in 2023."
"In 2022, CureVac experienced another year
of significant transformation. We advanced our development from a biotech to a fully integrated biopharma company and achieved key milestones
in both our clinical and corporate growth," said Pierre Kemula, Chief Financial Officer of CureVac. "Our 2022 income statement
underlines this transformative period, phasing out the commitments related to our first-generation vaccine candidate and focusing on our
second-generation programs co-financed by GSK, technical development and small to large scale manufacturing. The successful raise of $250
million in gross proceeds this February has significantly extended our financial runway for continued execution on our priorities in 2023
Prophylactic Vaccines
Second-Generation mRNA Vaccine Program, Jointly Developed with GSK
CureVac is executing on its broad clinical development
program in prophylactic vaccines in collaboration with GSK and initiated four Phase 1 studies in COVID-19 and flu in 2022, testing both
unmodified and modified mRNA candidates to identify the best performing candidate. Positive preliminary data reported in early 2023 confirmed
modified mRNA as the preferred technology for further clinical development in the COVID-19 and seasonal flu vaccine program. All candidates
are based on CureVac's proprietary second-generation mRNA backbone, targeting improved intracellular mRNA translation for early
and strong immune responses. The second-generation mRNA backbone is expected to enable flexible protection against one or more emerging
COVID-19 variants as well as other infectious diseases, such as flu and potential combinations against different viruses.
On January 6 and January 30, 2023, CureVac announced
positive preliminary data from ongoing Phase 1 clinical programs in COVID-19 and flu. Preliminary results generated in younger as well
as older adult populations showed that the constructs elicited promising immune responses starting at low doses as well as good reactogenicity
profiles in both indications.
In the COVID-19 Phase
1 trial, the reported preliminary data for the tested monovalent vaccine candidate, CV0501, are based on cohort sizes of up to 20 participants
in the younger adults age group (age 18-64) and 10 participants in the older adults age group (age 65). Previously reported safety
data covered the 12, 25, 50, 100 and 200 g dose groups in the younger adult age group. Newly available data from 3 and 6 g
dose levels in this age group show a consistent safety profile. One grade 3 solicited adverse event occurred in the 3 g dose group
reported as fatigue. In the older adult age group, safety data were initially reported for doses levels of 12, 25 and 50 g. Newly
available safety data for the 100 and 200 g dose levels showed no grade 3 solicited adverse events at these dose levels in this
age group. CV0501 was shown to be generally well tolerated across both age groups and all dose levels. Immunogenicity data for the full
dose ranges in both age groups showed relevant titers of neutralizing antibodies beginning at the lowest tested dose.
On day 29 at the 12 g
dose level, CV0501 generated a ratio of post-boost to pre-boost serum neutralizing titers against the Omicron BA.1 variant of 8.1 in younger
adults and 13.3 in older adults. The data read-outs for both age groups are currently being finalized.
While CV0501 encodes
the Omicron BA.1 variant, a Phase 2 clinical study, expected to start later in 2023, will assess monovalent and bivalent vaccine candidates
designed to target clinically relevant variants.
In the flu Phase 1 trial, preliminary data were
reported on the tested monovalent construct Flu-SV-mRNA, expressing an H1N1 hemagglutinin antigen (subtype of influenza A). A number of
doses ranging from 2 to 54 g with up to 25 subjects per dose cohort were evaluated in younger adults (age 18-45). In this age group,
preliminary safety and reactogenicity data showed that Flu-SV-mRNA was generally well tolerated with no safety concerns observed to date
across all tested dose levels. A single dose of Flu-SV-mRNA was assessed for safety and reactogenicity in older adults (age 60-80) and
was also observed to be safe and well tolerated with no grade 3 adverse events in the 32 subjects who were administered the mRNA construct.
Immunogenicity of the monovalent Flu-SV-mRNA was assessed in parallel with a licensed seasonal flu vaccine comparator in both age groups.
In younger adults, adjusted geometric mean hemagglutinin inhibition antibody titers increased up to approximately 3.3 times those elicited
by the licensed flu vaccine comparator. In older adults, adjusted geometric mean hemagglutinin inhibition antibody titers were approximately
2.3 times those elicited by the licensed flu vaccine comparator. In the same age group, the percentage of subjects achieving seroconversion
was 89.7% for Flu-SV-mRNA and 56.2% for the licensed flu vaccine comparator.
The vaccine candidate for future clinical development
in flu is expected to be a multivalent candidate, targeting all four strains recommended by the WHO. A combined Phase 1/2 study for multivalent
vaccine candidates is expected to start in the second quarter of 2023.
Broadening of Oncology Footprint with
mRNA Cancer Vaccines -
Differentiated Antigen Discovery Approach
CureVac continues to
execute on its strategy to develop the next generation of targeted mRNA-based cancer vaccines and expand in the oncology area with its
differentiated antigen discovery approach. An initial portfolio of cancer vaccine candidates will be based on CureVac's second-generation
mRNA backbone, supported by its recent clinical validation in prophylactic vaccines. CureVac focuses on two approaches 1) the development
of off-the-shelf cancer vaccines based on tumor antigens shared by different cancer patients and 2) the development of fully personalized
cancer vaccines based on a patient's individual tumor genomic profile. Innovation in cancer vaccine development is further enabled
by CureVac's proprietary lipid nanoparticle (LNP) research to further enhance T cell mediated immune responses for strongly immunogenic
cancer vaccine candidates.
A previously announced
clinical proof-of-principle study, which is designed to validate and optimize the second-generation mRNA backbone in an oncology setting,
is on track to start in the second quarter of 2023. The Phase 1 study will test a single mRNA construct encoding for eight epitopes from
tumor-associated antigens to assess the safety, immunogenicity and T cell-mediated immune activation in patients with surgically resected
glioblastoma. Successful study setup and manufacture of clinical trial material of the complex mRNA construct represent important milestones
that have already been achieved well in advance of the Phase 1 study starting, which is expected to enroll up to 54 patients at clinical
sites in Germany, Belgium and the Netherlands.
A second previously announced
clinical proof-of-principle study in patients with melanoma was anticipated to start in the second half of 2023. Following an extensive
portfolio review, CureVac has refocused its clinical development in oncology. Instead of a proof-of-principle study, featuring an established
full-length shared tumor antigen, CureVac expects to initiate a Phase 1 study assessing a state-of-the-art multiepitope design derived
from CureVac's proprietary antigen discovery platform. The study, which will be conducted in combination with PD-1 antibodies, is
expected to start in 2024.
CureVac is advancing
its research on proprietary lipid nanoparticles (LNP) for improved and targeted mRNA delivery within the body. At the European Molecular
Biology Organization (EMBO) workshop in April this year, the company presented data on mRNA-LNP complexes of varied composition exhibiting
distinct biological activities that open new routes for bespoke applications in prophylactic and cancer vaccines.
The presented in vitro
and preclinical data demonstrate that targeted changes to the ratio or composition of the LNP constituents can be applied to fine tune
LNP physicochemical properties and elicit distinct immune responses and biological activities. These data complement previously reported
data on a new PEG-free LNP delivery system, which was preclinically shown to provide highly localized transcription of mRNA in the immune
compartment and to be highly stable at room temperature as a dried presentation for an extended period.
Financial Update for the Fourth Quarter
and Full-Year of 2022