Full Press Release Details
CureVac Announces Financial Results for the
Second Quarter and First Half of 2023
and Provides Business Update
T BINGEN, Germany/BOSTON, USA -
August 17, 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 second
quarter and first half of 2023 and provided a business update.
"During the first six months of 2023, we
continued building on the momentum from the strong start to the year. In particular, our clinical development programs in prophylactic
vaccines, in collaboration with GSK, and our in-house cancer vaccine programs are advancing well and are on track since the start of clinical
trials with differentiated candidates based on our advanced second-generation mRNA backbone. The Phase 2 study in COVID-19, assessing
booster doses of mono- and bivalent mRNA vaccine candidates, is expected to provide data early in the first half of 2024. In oncology,
our Phase 1 study in patients with resected glioblastoma has progressed through the first dose cohort without safety concerns, enabling
opening of the second dose patient cohort," said Dr. Alexander Zehnder, Chief Executive Officer of CureVac. "Our unwavering
commitment to innovation has enabled us to further expand our intellectual property portfolio, strengthening our mRNA technology ownership.
Accordingly, we recently bolstered our position in the litigations in Germany and the U.S. by asserting new intellectual property rights,
demonstrating that we continue to be at the forefront of innovation in the mRNA field."
"After successfully raising $250 million
in gross proceeds through a follow-on offering during the first quarter of 2023, we are focused on executing on our programs and priorities
and continuing CureVac's transformation from a research-oriented to a fully integrated and commercial-ready biopharma company,"
said Pierre Kemula, Chief Financial Officer of CureVac. "We continue to grow the company, expand our competencies and advance our
pipeline to deliver on the broad promise of mRNA technology."
Prophylactic Vaccines
Second-Generation mRNA Vaccine Program, Jointly Developed with GSK
CureVac continues to advance its broad clinical
development program in prophylactic vaccines in collaboration with GSK. Positive preliminary data reported in early 2023 from Phase 1
studies with modified, monovalent mRNA candidates in COVID-19 and flu provided strong validation of CureVac's mRNA technology platform.
All jointly tested 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 protection against one
or more emerging COVID-19 variants or multiple strains of other infectious diseases, such as flu, with potential for combination vaccines
against multiple different viruses as well.
On August 1, CureVac announced dosing of the first
participant in a Phase 2 study of monovalent and bivalent modified mRNA COVID-19 vaccine candidates, developed in collaboration with GSK.
The Phase 2 study will evaluate safety, reactogenicity and immune responses of single booster doses of two modified mRNA COVID-19 vaccine
candidates. The monovalent candidate, CV0601, encodes the spike protein of the omicron BA.4-5 variant. In line with the current standard
of care, the bivalent candidate, CV0701, encodes the spike protein of both the omicron BA.4-5 variant as well as the original SARS-CoV-2
virus. The study is active-controlled, including a licensed bivalent COVID-19 comparator vaccine. Enrollment started at clinical sites
in Australia. The study is expected to enroll approximately 415 healthy adult participants. An initial data readout of the study is expected
early in the first half of 2024.
Broadening of Oncology
Footprint with mRNA Cancer Vaccines
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, which recently established clinical validation in prophylactic vaccines. CureVac focuses on two approaches: 1) the development
of off-the-shelf cancer vaccines based on tumor antigens shared across different cancer indications and 2) the development of fully personalized
cancer vaccines based on a patient's individual tumor genomic profile.
execution phase of its cancer vaccine development strategy with the start of a Phase 1 study in patients with resected glioblastoma.
Dosing of the first patient with its cancer vaccine candidate, CVGBM, was announced on June 20. Since then, recruitment has
successfully progressed without safety concerns at the doses tested to date. CVGBM is based on CureVac's proprietary
second-generation mRNA backbone and features a single unmodified mRNA encoding eight epitopes derived from known tumor-associated
antigens with demonstrated relevance in glioblastoma.
The open-label study
evaluates the safety and tolerability of CVGBM in up to 54 patients with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma
or astrocytoma with a molecular signature of glioblastoma. The study is being conducted in Germany, Belgium and the Netherlands. CVGBM
is administered as a monotherapy after surgical resection and completion of radiotherapy with or without chemotherapy. The study consists
of two parts, a dose-escalation part (Part A) and a dose-expansion part (Part B). In the initiated Part A, patients will receive a total
of seven intramuscular administrations of CVGBM at escalating doses in the range of 12 to 100 g on days 1, 8, 15, 29, 43, 57,
and 71. In patients without disease progression, vaccinations can continue beyond day 71 every 6 weeks until one year after the first
CVGBM vaccination, disease progression or undue toxicity. More information can be found at clinicaltrials.gov (NCT05938387). A
first data readout is expected in the second half of 2024.
Interested patients and doctors seeking further
information, please contact:
zno@med.uni-tuebingen.de, subject: CureVac Study'
Protection of Intellectual
Over the last 23 years,
CureVac has developed proprietary foundational technology related to mRNA design, delivery and manufacturing that has materially contributed
to the development of safe and efficacious COVID-19 vaccines.
German patent litigation
against Pfizer/BioNTech moved forward with a public hearing before the Regional Court D sseldorf on August 15. The hearing covered
the four intellectual property rights under which CureVac originally filed for patent infringement in June 2022, as well as a fifth intellectual
property right, which was added by CureVac as announced in May 2023. During the hearing, the court announced that a ruling on infringement
or suspension for these five intellectual property rights will be given for four of these rights at the end of September and in respect
of EP1857122 at the end of December.
On July 13, CureVac announced
that it had strengthened its position in the ongoing patent litigations with Pfizer/BioNTech in Germany and the U.S. by asserting new
intellectual property rights, expanding the scope of both cases.
In Germany, the previously
asserted five intellectual property rights were extended by three more recent intellectual property rights: DE202021004123U1 and DE202021004130U1,
providing protection to COVID-19 variant adapted vaccines, including the Omicron and XBB1.5 variants, and EP4023755, relating to split
poly A tail mRNA vaccines. The three newly asserted intellectual patent rights will be considered at a separate hearing expected to be
In the U.S., CureVac's counterclaim alleging
infringement of nine U.S. patents was broadened by asserting a tenth patent (US11667910), which relates to mRNA purification methods,
a critical part of the overall mRNA manufacturing process.
CureVac does not seek an injunction nor intend
to take legal action that impedes the production, sale or distribution of Comirnaty by BioNTech and its partner Pfizer. Rather,
CureVac seeks recognition that the development of safe and efficacious COVID-19 vaccines is based on decades of scientific research and
innovation. CureVac, as the earliest pioneer in mRNA technology, continues to be at the forefront of innovation in the mRNA field. Accordingly,
CureVac's intellectual property rights need to be acknowledged and respected in the form of fair compensation that enables reinvestment
into the advancement of mRNA technology and the ongoing development of new classes of life-saving medicines.
Financial Update for the Second Quarter
and First Half of 2023
Cash and cash equivalents amounted to 537.9
million at the end of June 2023, increasing from 495.8 million at the end of 2022. The increase was mainly driven by 219.8
million in net proceeds raised in a follow-on offering during February 2023. In the first six months of 2023, cash used in operations
was mainly allocated to payments in connection with ongoing R&D activities, for expenditures for CureVac's GMP IV manufacturing
facility and the purchase of raw materials.
Revenues amounted to 7.6 million and 14.7
million for the three and six months ended June 30, 2023, representing a decrease of 12.5 million and 29.8 million, or 62.2%
and 67.0%, from 20.1 million and 44.5 million for the same period in 2022.