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CureVac Announces Financial Results for the Fourth Quarter and Full-Year 2023 and Provides Business Update Organizational redesign and rightsizing initiated across company to streamline structures, increase efficiency an

Key Takeaway: CureVac Announces Financial Results for the Fourth Quarter and Full-Year 2023 and Provides Business Update Organizational redesign and rightsizing initiated across company to streamline structures, increase efficiency and reduce operating costs Together with GSK, ended Pan

Full Press Release Details

CureVac Announces Financial Results for the
Fourth Quarter and Full-Year 2023
and Provides Business Update
Organizational redesign and rightsizing initiated across company to streamline structures, increase efficiency and reduce operating costs
Together with GSK, ended Pandemic Preparedness Agreement (PPA) with Federal Republic of Germany, after consultation with the German Federal Ministry of Health
Cash and cash equivalents position of 402.5 million as of December 31, 2023; cash runway extended into Q4 2025 with organizational redesign and despite PPA wind-down
Strategic collaboration signed with world-leading oncology center MD Anderson, creating unique expertise to jointly discover and develop novel cancer vaccines
Appointment of Thaminda Ramanayake as Chief Business Officer, bringing more than 15 years of biopharma company development and deal-making experience
Promising COVID-19 and seasonal flu Phase 2 data confirms proprietary mRNA platform elicits strong overall antibody titers at well-tolerated dose levels
New Phase 1/2 study in avian flu started in collaboration with GSK addressing potential future pandemic threat
Successful safety review of data from glioblastoma Phase 1 Part A with multiepitope cancer vaccine candidate, CVGBM, enables progressing to Part B with expected start mid-2024
CureVac to host conference call and webcast today at 9 a.m. ET / 3 p.m. CET
T BINGEN, Germany/BOSTON, USA -
April 24, 2024 - 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 2023 and provided a business update.
"We closed out 2023 on a sturdy footing
and are poised to advance strongly through 2024 with strategic initiatives to make CureVac fit-for-purpose. We are adapting unnecessary
residual pandemic infrastructure, optimizing our workforce and aligning our structures and resources to the right size for our business
scope and development priorities. Under this streamlined structure, we intend to move forward with purpose and determination,"
said Dr. Alexander Zehnder, Chief Executive Officer of CureVac. "As we advance our pipeline in both infectious disease and oncology,
we continue to seize opportunities to accelerate development of our differentiated mRNA approach. This is most recently evidenced by
our collaboration with MD Anderson, one of the world's leading cancer centers. Further expanding such strategic collaborations
and partnerships will be the key focus for Thaminda Ramanayake, who will join the management team as Chief Business Officer in June."
"We finished 2023 with a robust cash position
of 402.5 million supported in Q4 by the recognition of a 15 million milestone from GSK for the start of the Phase 2 development
of our joint seasonal flu program," said Pierre Kemula, Chief Financial Officer of CureVac. "Going into 2024, we have had
a strong focus on cost management and increased operational efficiency. Importantly, and despite the wind-down of the Pandemic Preparedness
Agreement with the German government, these efforts enable us to extend our runway into the fourth quarter of 2025."
Following a comprehensive operational assessment
in 2023, CureVac is implementing in 2024 an organizational redesign to streamline structures and reduce operating costs across most areas
of the company. The program was initiated with a "voluntary leaver" program, with the aim to reduce 150 positions. The redesign
will be tailored to CureVac's business scope and pipeline priorities, significantly increasing efficiency and performance while
maintaining a strong focus on innovation and R&D activities. The initiated redesign is expected to result in financial savings from
the second half of 2024 onwards and extend the company's cash runway.
the Pandemic Preparedness Agreement
Due to a rapidly changing epidemiological environment
following the end of the COVID-19 pandemic, CureVac and GSK decided to end the Pandemic Preparedness Agreement jointly concluded with
the Federal Republic of Germany in April 2022. This decision was made after consultation with the German Federal Ministry of Health and
the German Center for Pandemic Vaccines and Therapeutics (ZEPAI). The agreement included the provision of production capacity and supply
of mRNA-based vaccines in the event of a public health emergency in Germany.
Termination will take effect on May 31, 2024,
with no further financial obligations. Completion of CureVac's GMP IV manufacturing plant for the production mRNA-based vaccines
is unaffected and progressing. Contingent upon regulatory approval, the facility is expected to be certified in the second half of 2024.
Strategic Collaborations
In April 2024, CureVac entered into a
strategic co-development and licensing agreement with The University of Texas MD Anderson Cancer Center, one of the world's leading
academic oncology centers. The collaboration centers on the joint development of novel, off-the-shelf mRNA-based cancer vaccine candidates
in selected hematological and solid tumor indications with high unmet medical need. It creates strong synergies between CureVac's
unique end-to-end capabilities for cancer antigen discovery, mRNA design, and manufacturing and MD Anderson's world-class expertise
in cancer antigen discovery and validation, translational drug development, and clinical research.
Both parties will contribute to the identification
of differentiated cancer antigens based on whole genome sequencing, combined with long- and short-read RNA-sequencing and cutting-edge
bioinformatics. Joint preclinical validation of the highest-quality cancer antigens and subsequent selection of promising clinical lead
candidates is expected to be followed by initial Phase 1/2 studies in appropriate clinical indications.
Under the terms of the agreement, CureVac has
worldwide exclusive rights to late-stage development, commercialization, or partnering of the candidates. MD Anderson is eligible for
downstream payments based on potential future commercialization.
Corporate Development
was appointed to the CureVac Management Team as Chief Business Officer effective June 1, 2024. Mr. Ramanayake has more than 15 years
of international experience in biopharma company development and deal-making. He has built a strong track record of successful clinical
collaborations, M&A, asset in-licensing and strategic financing initiatives as well as deep expertise in the fields of immunology
and oncology. His focus will be on business strategies to accelerate CureVac's pipeline, mature the organization, and enable further
strategic partnerships.
Mr. Ramanayake joins
CureVac from Affini-T Therapeutics, where he served as Chief Business Officer and was responsible for creating the company's business
development organization. He previously served as Vice President and Global Head of Business Development in Oncology at Sanofi, where
he established the Clinical Trial Supply Agreement Center of Excellence and negotiated collaborations valued in the hundreds of millions
to billions of dollars. He also held positions at BioMarin Pharmaceuticals where he in-licensed numerous gene therapy and oligonucleotide-based
assets in hearing loss, cardiology, neurology and other therapeutic areas, and at Amgen, where he negotiated a number of international
commercialization agreements.
Mr. Ramanayake holds
a master's degree in immunology from the University of Rochester and an MBA in Finance from the University of Rochester Simon School
of Business. He holds a bachelor's degree in cellular, molecular and systems biology.
Prophylactic Vaccines
Second-Generation mRNA Vaccine Program, Jointly Developed with GSK
CureVac continues to advance its clinical development
programs in prophylactic vaccines in collaboration with GSK. All currently tested candidates apply modified mRNA and are based on CureVac's
proprietary second-generation mRNA backbone, targeting improved intracellular mRNA translation for early and strong immune responses.
Avian Flu (H5N1) Program
Start of the Phase 1 part of a combined Phase
1/2 study of an investigational influenza A (H5N1) pre-pandemic vaccine candidate was announced on April 24, 2024. The H5N1 avian flu
virus is considered a potential future pandemic threat, known to sporadically cross species from its original bird host to other animals
and humans. The study represents the latest program progressing to clinical trials under the broad infectious disease collaboration agreement
with GSK, first announced in July 2020. It assesses the safety, reactogenicity and immunogenicity of a monovalent vaccine candidate based
on CureVac's proprietary second-generation mRNA backbone, encoding an influenza A H5-antigen. In the initial Phase 1 dose-escalation
part of the study, up to five dose levels will be assessed compared to a placebo control in healthy younger adults aged 18 to 64 and
healthy older adults aged 65 to 85.
Seasonal Flu Program
In the ongoing Phase
2 part of the combined 1/2 study in seasonal flu, CureVac reported promising data from a planned interim analysis on April 4, 2024.
The Phase 2 part assessed the reactogenicity, safety, and immunogenicity of a potentially differentiated, multivalent vaccine candidate
in 960 healthy younger and older adults. The candidate was tested in comparison to age-matched licensed comparator vaccines, which featured
a standard dose seasonal vaccine for younger adults and a high dose seasonal vaccine for older adults. It encodes antigens matched to
all four WHO recommended flu strains and was selected from a comprehensive Phase 1 part, which tested mRNA vaccine candidates with up
to eight separate mRNA constructs per candidate.
The vaccine candidate
was shown to have an acceptable safety and tolerability profile, confirming previous findings that CureVac's mRNA platform elicits
strong overall antibody titers at well-tolerated dose levels. It boosted antibody titers against all encoded flu strains and across all
age groups and tested dose levels. Among younger and older adults, geometric mean titers generated by the vaccine candidate against influenza
A strains numerically exceeded the geometric mean titers of the licensed comparator vaccines across all tested dose levels. For influenza
B strains, geometric mean titers were lower than those elicited by the licensed comparator vaccines, in line with expectations and other
initial mRNA-based clinical flu development programs. Further optimizations to enhance immune responses against influenza B strains will
be tested in an additional Phase 2 study.
On January 5, 2024, CureVac reported positive
results from the planned interim analysis of the ongoing Phase 2 study in COVID-19. The study assessed the safety and immunogenicity
of two modified mRNA COVID-19 vaccine candidates: the monovalent candidate, CV0601, encoding the spike protein of the omicron BA.4-5
variant and the bivalent candidate, CV0701, encoding the spike proteins of the omicron BA.4-5 variant and the original SARS-CoV-2 strain.
Last updated: Apr 24, 2024