Full Press Release Details
CureVac Announces Financial
Results for the Third Quarter and First Nine Months of 2022
and Provides Business Update
BOSTON, USA - November 17, 2022 - CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class
of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced financial results for the third
quarter and first nine months of 2022 and provided a business update.
a highly productive year for CureVac, with a significant expansion of our operational bandwidth and further extension of applications
for our mRNA technology," said Franz-Werner Haas, Chief Executive Officer of CureVac. "Looking across our three core competencies,
we have expanded our broad technology platform into modified as well as multivalent mRNA approaches by starting four clinical trials in
COVID-19 and flu. All trials are on track to deliver important clinical data in the near future. These trials diversify and advance our
product development pipeline with promising candidates, as do the new technologies fueling our growing oncology footprint and our innovations
in molecular therapies. We have increased integration of our flexible and scalable manufacturing to now serve the early clinical trial
stage through to commercial supply based on a unitary framework. This contributes to the speed of our product developments, further supported
by our integrated end-to-end solution, The RNA Printer , for which we have successfully filed applications for manufacturing licenses
to support our oncology area."
"In the third quarter
of 2022, we further advanced our corporate transformation from a research-oriented biotech to an integrated and commercial-ready biopharma
company by focusing our resources on clear priorities in our technology platform, product pipeline and manufacturing landscape,"
said Pierre Kemula, Chief Financial Officer of CureVac. "For the first time since the fourth quarter of 2021, the headwind from
wind-down costs related to our first-generation vaccine candidate, CVnCoV, has subsided, demonstrating our diligent work to resolve or
reallocate prior commitments."
Prophylactic Vaccines
CureVac is delivering on its previously announced
2022 clinical development program in prophylactic vaccines and has initiated a total of four Phase 1 studies in COVID-19 and flu in collaboration
with GSK. All clinical candidates are based on CureVac's second-generation mRNA backbone and are being tested as a booster vaccination.
In line with the company's development strategy to take an unrestricted technology approach, each program features a candidate applying
unmodified mRNA as well as a candidate applying modified mRNA to identify the best-performing candidate for later-stage clinical development.
All trials are well on track to deliver clinical
data in early Q1 2023. Data are expected to be reported as combined data sets for both candidates per indication.
Broadening of Oncology
Footprint with mRNA Cancer Vaccines - Targeted Antigen Approach
CureVac continues to
deliver on its previously communicated three-pillared oncology strategy, which includes validation and optimization of its broad mRNA
technology approach against different classes of cancer antigens, the build-up of its pipeline of cancer vaccine candidates targeting
novel antigens predicted to be highly immunogenic, and the addition of complementary platform technologies.
With the integration
of novel antigen discovery technologies from the recent acquisition of Frame Cancer Therapeutics, and its partnership with immunotherapy
company myNEO, CureVac is well-positioned to execute on the development of a meaningful portfolio of novel cancer vaccine candidates.
Within this portfolio, CureVac is following two approaches. The first approach assesses tumor antigens shared by different cancer patients
for the development of off-the-shelf cancer vaccines. The second approach is tailored to a patient's individual tumor profile.
To validate and optimize
CureVac's broad mRNA technology in oncology, most notably the second-generation mRNA backbone, the company intends to start two
clinical proof-of-concept studies. These studies will define the safety, immunogenicity and T cell-mediated immune activation of specific
antigen-encoding mRNA cancer vaccine candidates based on the second-generation backbone. The first Phase 1 proof-of-principle study will
test an mRNA construct encoding for multiple epitopes from eight tumor-associated antigens in patients with surgically resected glioblastoma.
It is expected to start in the first half of 2023. The second Phase 1 proof-of-principle study will investigate an mRNA construct featuring
a full-length tumor-associated antigen in solid tumors with an initial focus on melanoma patients. It is expected to start in the second
Cancer Immuno-Modulator in Solid Tumors
CureVac's non-coding
RNA oncology candidate, CV8102, is being assessed in a fully recruited dose-escalation and expansion Phase 1 study to confirm safety,
tolerability, and efficacy as a single agent and in combination with licensed anti-PD-1 antibodies. Preliminary results from the completed
dose-escalation part of the study in a range of solid tumors were previously reported at the European Society for Medical Oncology (ESMO)
conference in September 2021.
On November 11, 2022,
results from the completed expansion part of the study, focusing on patients with PD-1 refractory melanoma, were presented at the Society
for Immunotherapy of Cancer (SITC) conference. Preliminary efficacy was observed in patients of the anti-PD-1 combination cohort, 40%
of whom were pretreated with anti-CTLA-4 antibodies. In this cohort, 17% of patients experienced a partial response. Responses appear
durable for up to one year from the start of treatment. No objective responses were observed in the 10 patients of the single-agent cohort,
50% of whom were pretreated with anti-CTLA-4 antibodies.
Extensive analysis of
immune cell activation to better understand CV8102-induced mobilization of the immune system against injected tumors as well as non-injected
tumors confirmed, after the first dose, activation of systemic pathways of immune response. Preliminary analysis of the tumor microenvironment
in a subgroup of patients showed the positive outcome of increased T cell infiltration and reduced tumor cell content in a number of analyzed
paired biopsy samples. The final results are expected to be submitted for publication in a peer-reviewed journal in H1 2023.
In the context of our
current strategic focus on the development of novel mRNA-based cancer vaccines, data from the planned proof-of-principle studies and parallel
progress in the discovery of new tumor-specific antigens will provide the basis for any potential integration of CV8102 into this priority
program as a strong immune-modulatory adjunct. Further clinical development of CV8102 will only be considered in combination with a defined
mRNA cancer vaccine.
The RNA Printer , CureVac's
end-to-end solution for integrated and automated manufacturing of GMP-grade vaccines and therapeutics, forms an integral part of CureVac's
oncology strategy. Designed for small-scale quantities, the automated output of The RNA Printer will support the rapid and flexible
provision of clinical trial material to screen and advance new antigens into clinical studies.
The system is currently
undergoing regulatory approval processes to obtain its first manufacturing licenses for the mRNA constructs of the previously described
planned proof-of-principle studies to support the supply of clinical trial material out of our GMP I and II facilities. The applications
for the licenses were submitted to the German regional authorities in October 2022.
Presenting at the 10th
International mRNA Health Conference
CureVac is committed to driving
science and innovation in the field of mRNA. It presented on several lines of research at the 10th International mRNA Health
Conference, the dedicated yearly meeting for mRNA science on November 8-10, 2022, in Boston, Massachusetts.
Highlights of presented preclinical
studies include a new and proprietary lipid nanoparticle (LNP) mRNA delivery system as well as extended data for the previously reported
study in liver fibrosis and cirrhosis.
The new LNP delivery system,
which features a novel non-PEG lipid composition, was preclinically shown to provide highly localized delivery and transcription of mRNA
in the immune compartment, enabling strong immune responses. A dried presentation of the new LNP was proven to be highly robust and stable
at room temperature for an extended period.
A preclinical study carried
out in collaboration with the REBIRTH-Research Center of the Hannover Medical School previously demonstrated restoration of hepatocyte
function and inhibition of liver fibrosis and cirrhosis by HNF4A-encoding mRNA. Extended data on optimized HNF4A mRNA constructs enabled
further reduction of the injected dose while triggering strong suppression of fibrogenesis.
Financial Update for the Third Quarter
Cash and cash equivalents were 540.9 million
as of September 30, 2022, down from 811.5 million as of December 31, 2021. In the first nine months of 2022, cash used in operations
was mainly allocated to payment of accounts payables, payments in connection with capital expenditures for our new production facility,
purchases of materials for use in R&D and settling CMO contracts as part of the wind-down activities for our first-generation CVnCoV
vaccine program; in the same period of 2021, cash used in operations was mainly allocated to prepayments to CROs and CMOs in relation
to the CVnCoV program. As of September 30, 2022, CureVac has settled most of its financial obligations related to the CVnCoV program.