Full Press Release Details
CureVac Announces Financial Results for the
Second Quarter and First Half of 2024
and Provides Business Update
T BINGEN, Germany/BOSTON, USA -
August 15, 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
second quarter and first half of 2024 and provided a business update.
"The last quarter marked the beginning
of an exciting new chapter for CureVac. Our new licensing agreement with GSK, valued at up to 1.45 billion plus royalties, represents
a strong validation of our proprietary mRNA platform. In parallel, our recently announced strategic restructuring streamlines our business
operations and sharpens our focus on CureVac's core strength in mRNA technology innovation, especially in important disease areas
such as oncology, where we continue to advance the Phase 1 study of our CVGBM cancer vaccine in glioblastoma. We are looking forward
to presenting the initial data from this study at ESMO in September," said Dr. Alexander
Zehnder, Chief Executive Officer of CureVac. "To support our evolving strategic focus, we are adding valuable expertise to our
Supervisory Board with the appointment and nomination of two new members who will help us advance our updated priorities. At the same
time, we are saying farewell to our Chief Financial Officer Pierre Kemula, who will depart the company at the end of his term on October
31, 2024. We thank Pierre for his many contributions and wish him all the best with his next endeavors."
"The first half of 2024 marked the final
phase of payments related to our first-generation vaccine, which, although mostly accounted for in 2023, still impacted our cash position
by over 80 million. As we near the conclusion of all COVID-19 related commitments, we anticipate one final arbitration-related
payment in the third quarter, after which all commitments will be fully settled. We are now focusing on enhancing operational efficiency,
and we are making good progress with our restructuring initiative. The associated cost savings together with the proceeds from the new
GSK agreement put us in a strong financial position," said Pierre Kemula, Chief Financial Officer of CureVac. "As I step
down, I am confident that the company is well-positioned for future success, and I want to extend my heartfelt thanks to the entire CureVac
team for an incredible eight years together."
Selected Business Updates
New Licensing Agreement with GSK
CureVac and GSK announced a restructuring of their existing collaboration into a new licensing agreement, superseding two former agreements
and allowing each company to prioritize investment and focus their respective mRNA development activities. Following completion of customary
closing conditions, as well as certain antitrust and regulatory approvals, the agreement was closed on July 11, 2024.
CureVac and GSK have
worked together since 2020 to develop mRNA vaccines for infectious diseases, yielding promising vaccine candidates for seasonal influenza,
avian influenza and COVID-19. All candidates are based on CureVac's proprietary second-generation mRNA backbone and are currently
in Phase 2 clinical development with data supporting their potential to be best-in-class new vaccines.
Under the new agreement,
GSK has assumed full control of developing and manufacturing these candidate vaccines and holds worldwide commercialization rights. In
return, CureVac received an upfront payment of 400 million and may receive up to an additional 1.05 billion in development,
regulatory and sales milestones plus tiered royalties in the high single digit to low teens range.
The new agreement marks
a significant milestone for CureVac. It strongly validates CureVac's proprietary mRNA platform and enables the company to concentrate
on technology innovation to develop potentially transformational medicines in oncology and infectious diseases, where mRNA has immense
potential, as well as other select areas of substantial unmet medical need. CureVac retains exclusive rights to the undisclosed and preclinically
validated infectious disease targets from the prior collaboration together with the freedom to independently develop and partner mRNA
vaccines in any other infectious disease or other indication.
The new agreement replaces
all previous financial considerations from the prior collaboration agreement between CureVac and GSK. CureVac's ongoing patent
litigation against Pfizer/ BioNTech is unaffected.
Strategic Restructuring
CureVac has embarked
on a transformative strategic restructuring to significantly increase efficiency and performance while focusing its resources on high-value
mRNA projects in oncology, infectious diseases and other select areas of substantial unmet medical need. The strategic initiative includes
a total workforce reduction of approximately 30% expected by the end of 2024 to create a leaner, more agile organization tailored to
CureVac's business scope and pipeline priorities and dedicated to technology innovation, research and development.
As a result of the restructuring,
CureVac expects operational expenses to decrease by more than 30% from 2025 onward, including an annual decrease of personnel costs of
approximately 25 million. The company estimates that it will incur one-time restructuring charges of approximately 15
million, including employee severance, benefits and related costs, which it expects to incur in the second half of 2024. These charges
are subject to a number of assumptions, including local law requirements, and actual expenses may differ materially from the estimates.
combined with revenue from the GSK licensing agreement, extend CureVac's expected cash runway into 2028. The company expects to
provide additional financial and strategic updates during the Q3 earnings call in November 2024.
Oncology Footprint with mRNA Cancer Vaccines
CureVac continues to
develop the next generation of targeted mRNA-based cancer vaccines by combining cutting-edge technologies for antigen discovery with
its second-generation mRNA backbone. The initial focus is on the development of off-the-shelf cancer vaccines targeting tumor antigens
shared across different patient populations and/or tumor types, to be followed by the development of fully personalized cancer vaccines
based on a patient's individual tumor genomic profile.
For the first, off-the-shelf
approach, CureVac expects to select two clinical candidates for shared-antigen cancer vaccines in solid tumor and hematological cancers,
including one in collaboration with researchers at the University of Texas M.D. Anderson Cancer Center, by the end of 2025, with plans
to initiate two additional Phase 1 studies by the end of 2026.
Clinical off-the-shelf
program in glioblastoma
Enrollment for the dose-confirmation Part B of
the open-label Phase 1 study in patients with resected glioblastoma has successfully started. Part B is expected to include up to 20
patients to generate extended data on safety, tolerability and immunogenicity of the investigational cancer vaccine candidate CVGBM.
The start of Part B follows a Data Safety Monitoring
Board (DSMB) review of safety data from the dose-escalation Part A. The DSMB confirmed no dose-limiting toxicities and recommended a
100 g dose for Part B of the study. Initial data on the dose-escalation Part A, including 16 patients will be presented in an oral
presentation at the European Society for Medical Oncology Congress (ESMO) on September 13, 2024.
The Phase 1 study is evaluating the safety and
tolerability of CVGBM in patients with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma or astrocytoma with a molecular
signature of glioblastoma. CVGBM features a single unmodified mRNA encoding eight epitopes derived from known tumor-associated antigens,
with demonstrated immunogenicity in glioblastoma.
More information can
be found at clinicaltrials.gov (NCT05938387).
Prophylactic Vaccines
Licensed to GSK for COVID-19 and Influenza Vaccines
In July 2024, CureVac and GSK restructured
their existing collaboration into a new licensing agreement. Under the new agreement, GSK has assumed full control of the development,
manufacturing and global commercialization of mRNA vaccine candidates against COVID-19 and influenza, including combinations. All vaccine
candidates currently in clinical development 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 - Phase 2 Start
Triggers GSK Milestone Payment
In July 2024, the combined Phase 1/2 study for
avian influenza, assessing a monovalent influenza A (H5N1) pre-pandemic vaccine candidate encoding a H5-antigen, successfully transitioned
to the Phase 2 part of the study. The transition triggered a 10 million milestone payment for CureVac.
The Phase 1/2 study, announced on April 24,
2024, is assessing the safety, reactogenicity and immunogenicity of the vaccine candidate in healthy younger and older adults. In
May 2024, it was announced that the program received FDA Fast Track designation to enable facilitated and accelerated development.