Full Press Release Details
CureVac Announces Financial Results for the
First Quarter of 2024
and Provides Business Update
T BINGEN, Germany/BOSTON, USA -
May 23, 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 first
quarter of 2024 and provided a business update.
have met an important first milestone in our ongoing organizational redesign by trimming our residual pandemic infrastructure. This achievement
marks a crucial step in our journey towards greater efficiency and adaptability, ensuring we are well-positioned for the next phase of
our corporate development. On the clinical development front, the pre-pandemic vaccine candidate against avian influenza, jointly developed
with GSK, has received Fast Track designation from the U.S. FDA, which will support our efforts to provide pandemic preparedness and advance
novel healthcare solutions," said Dr. Alexander Zehnder, Chief Executive Officer of CureVac. "Similarly,
we have seen distinct signs of progress in our intellectual property litigation, with the quick resolution of co-ownership and co-inventorship
claims made by Acuitas Therapeutics and expect our Pfizer/BioNTech U.S. case to reach court not long after its previously scheduled date
"We closed the first quarter of 2024 with
300.2 million in cash and cash equivalents. During this quarter, we fully settled the raw material commitments related to CVnCoV,
our first-generation SARS-CoV-2 vaccine candidate," said Pierre Kemula, Chief Financial Officer of CureVac. "More than half
of the cash spent in the first three months was related to such commitments. Looking forward, we consider this the end of a strong Q1
spend seasonality for CureVac. The second quarter will see the end of the remaining CVnCoV-related contract
termination provisions. Together with the ongoing
organizational redesign, we anticipate a significantly lower cash burn in the future."
Selected Business Updates
The organizational redesign, initiated in April
2024, is on track with the aim to streamline structures and reduce operating costs across most areas of the company. Rightsizing the company
with a focus on trimming residual pandemic infrastructure is ongoing, with a planned reduction of 150 positions by year end. The organizational
redesign is 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 redesign will continue throughout 2024 through
measures that are expected to result in financial savings from the second half of 2024 onwards and extend the company's cash runway
into the fourth quarter of 2025.
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 vaccine candidates currently in clinical development 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 - U.S. FDA Fast
In April 2024, the U.S. Food and Drug Administration
(FDA) granted Fast Track designation for a monovalent influenza A (H5N1) pre-pandemic vaccine candidate encoding an H5-antigen. The candidate
is being developed in collaboration with GSK. The start of the Phase 1 part of a combined Phase 1/2 study was announced on April 24, 2024,
assessing the safety, reactogenicity and immunogenicity of the vaccine candidate in healthy younger and older adults.
The FDA Fast Track designation enables facilitated
development and accelerated review of drug candidates addressing serious conditions and fulfilling an unmet medical need. The H5N1 avian
influenza virus is known to sporadically cross species from its original bird host to other animals and humans and is considered a potential
future pandemic threat. Based on CureVac's proprietary second-generation mRNA backbone, the vaccine candidate aims to contribute
to pandemic preparedness against avian influenza and provide an effective countermeasure in the event of human-to-human transmission of
Protection of Intellectual
CureVac is asserting
its intellectual property rights in litigation against Pfizer/BioNTech in Germany, the U.S. and the UK.
On April 25, 2024, a settlement with Acuitas Therapeutics
was reached, resolving co-ownership and co-inventorship claims regarding one patent family covering four patents that are at issue in
the U.S. litigation against Pfizer/BioNTech. Under the terms of the settlement, Acuitas acknowledges CureVac's ownership of certain
patent claims and has agreed to dismiss its co-ownership and co-inventorship claims. In return, CureVac acknowledges that Acuitas holds
licenses to selected patents, including three out of four disputed U.S. patents. These three patents will be withdrawn from the U.S. patent
litigation against Pfizer/BioNTech.
Accordingly, the U.S. litigation against Pfizer/BioNTech
will proceed under the original four patent families, now covering seven U.S. patents. A trial is expected to begin in the second quarter
of 2025, with the date to be announced within the next few weeks.
In Germany, the settlement
and out-licensing of selected patents to Acuitas Therapeutics will lead to the withdrawal of two utility models from the Pfizer/BioNTech
litigation, covering equivalent claims to the three patents withdrawn in the United States. Accordingly, litigation in Germany will proceed
with a total of six IP rights.
The German litigation
recently progressed after CureVac filed an appeal with the Supreme Court of Justice, opposing the first-instance decision by the German
Federal Patent Court on December 19, 2023 to nullify the German part of CureVac patent EP 1 857 122 B1. A trial date is expected in the
second half of 2025.
Financial Update for the First Quarter of 2024
Cash and cash equivalents amounted to 300.2
million at the end of March 2024, decreasing from 402.5 million at the end of 2023. In the first three months of 2024, cash used
in operations was mainly allocated to the last payments related to the termination of raw material commitments for the first-generation
vaccine, amounting to a total of 52 million. Looking forward there will be no further raw material payments related to CVnCoV. The
remaining cash spend was mainly related to ongoing R&D activities.
In the second quarter of 2024, the company expects
to fully settle all remaining CMO-related provisions stemming from CVnCoV. The company reaffirms its cash runway into the fourth quarter
Revenues amounted to 12.4 million for the
first quarter of 2024, representing an increase of 5.3 million, or 74%, from 7.1 million for the same period in 2023.
The year-on-year increase was primarily driven
by higher revenues from the GSK and CRISPR collaborations. For the three months ending March 31, 2024, total revenues of 8.9 million
and 3.5 million were recognized, respectively, compared to 6.5 million and 0.2 million in the prior year period.
Operating loss amounted to 73.3 million
for the first quarter of 2024, representing an increase of 12.9 million from 60.4 million for the same period in 2023.
The operating result was affected by several key
drivers mainly related to the closing of the first-generation vaccine effort in COVID-19:
Financial Result (Finance Income and Expenses)
Net financial result for the first quarter of
2024 amounted to 3.4 million, or an increase of 0.4 million, from 3.0 million for the same period in 2023. This increase
was mainly driven by interest income on cash investments.
Pre-tax loss was 69.9 million for the first
quarter of 2024, compared to 57.4 million in the same period of 2023.
CureVac (Nasdaq: CVAC) is a global biopharmaceutical
company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing, optimizing, and manufacturing
this versatile biological molecule for medical purposes. The principle of CureVac's proprietary technology is the use of optimized
mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. In July
2020, CureVac entered in a collaboration with GSK to jointly develop new products in prophylactic vaccines for infectious diseases based
on CureVac's second-generation mRNA technology. This collaboration was later extended to the development of second-generation COVID-19
vaccine candidates, and modified mRNA vaccine technologies. Based on its proprietary technology, CureVac has built a deep clinical pipeline
across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac N.V. has
its headquarters in T bingen, Germany, and has more than 1,100 employees across its sites in Germany, the Netherlands, Belgium,
Switzerland and the U.S. Further information can be found at www.curevac.com.
CureVac Media Contact