Full Press Release Details
CureVac Announces Financial
Results for the First Quarter of 2023 and Provides Business Update
Germany/BOSTON, USA - May 30, 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 first quarter of 2023 and provided a business update.
"During the first quarter of 2023, we continued
to execute on our multipronged clinical development strategy in prophylactic vaccines with the initiation of a Phase 1/2 clinical study
in seasonal flu, evaluating multivalent, modified mRNA vaccine candidates. In oncology, the first proof-of-principle clinical study to
validate our second-generation mRNA backbone in patients with glioblastoma has been activated and is expected to start recruitment shortly,"
said Alexander Zehnder, Chief Executive Officer at CureVac. "As we continue to make progress with our pipeline, we are also seeing
progress in our efforts to have our intellectual property innovations recognized. Our scientists have pioneered fundamental breakthroughs
in mRNA technology over the last two decades. These contributions have underpinned many developments in the mRNA field and resulted in
a broad IP portfolio that we intent to defend and further strengthen in pursuit of our mission to leverage our mRNA technology for the
development of transformative medicines."
"In the first quarter of 2023, we
successfully raised $250 million in gross proceeds in a follow-on offering, extending our cash runway into 2025 and successfully diversifying
our investor base with new healthcare-specialized shareholders that share the company's vision" said Pierre Kemula, Chief
Financial Officer of CureVac. "We continue to build the company and advance our pipeline based on our unique mRNA technology to
bring new and better solutions to people and patients in need."
Selected Business Updates
Prophylactic Vaccines
Executing on Broad Second-Generation mRNA Vaccine Program, Jointly
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.
The flu clinical development program was broadened
on May 8, 2023, when dosing of the first participant was announced in the Phase 1 part of a combined Phase 1/2 study of multivalent, modified
mRNA seasonal flu vaccine candidates. The study evaluates flu vaccine candidates for safety, reactogenicity and immune responses. The
first, Phase 1 part of the trial is being conducted in the U.S. and Belgium. The tested multivalent vaccine candidates address all four
WHO-recommended flu strains and are compared to a licensed flu comparator vaccine.
Protection of Intellectual Property Rights
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.
On May 19, CureVac announced the granting of its
motion to transfer U.S. patent litigation initiated by Pfizer/BioNTech in late July 2022 from the federal district court of Massachusetts
to the Eastern District of Virginia. The transfer is expected to significantly accelerate progress of the litigation, allowing for a likely
The motion to transfer the case is part
of a broadened counterclaim CureVac filed on May 19, 2023, that alleges infringement of nine U.S. patents by the manufacture and sale
of the SARS-CoV-2 vaccine Comirnaty : 11,135,312; 11,149,278; 11,286,492; 11,345,920; 10,760,070; 11,241,493; 11,471,525; 11,576,966;
and 11,596,686. This significantly expands the scope of the case beyond the three patents for which Pfizer/BioNTech had originally sought
confirmation of non-infringement. These nine patents cover foundational and highly relevant separate innovations in mRNA vaccine design,
formulation and manufacturing specific to SARS-CoV-2 vaccines.
Corresponding patent litigation in Germany
has been ongoing since June 2022. One of the patents at issue (EP 1 857 122) was challenged in a nullity action by Pfizer/BioNTech
in September 2022. A preliminary opinion issued in April 2023 by the German Federal Patent Court supports the validity of the
patent. The German litigation, which originated with a filing by CureVac regarding four of its intellectual property rights, now
also covers a fifth intellectual property right (EP 3 708 668 B1).
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. The development
of safe and efficacious COVID-19 vaccines is based on decades of scientific research and innovation, supported by CureVac as the earliest
pioneer in mRNA technology. Accordingly, CureVac's intellectual property rights need to be acknowledged and respected in the form
of fair compensation that enables reinvestment into the further advancement of mRNA technology and the ongoing development of new classes
of life-saving medicines.
Financial Update for the First Quarter of 2023
Cash and cash equivalents amounted to
617.5 million at the end of March 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 three months of 2023, cash used
in operations was mainly allocated to payments in connection with ongoing R&D activities and the purchase of raw materials.
Revenues amounted to 7.1 million
for the first quarter of 2023, representing a decrease of 17.3 million, or 71%, from 24.4 million for the same period in 2022.
The decrease was primarily driven by lower revenues from the two GSK
collaborations. For both GSK collaboration agreements, total revenues of 6.5 million were recognized for the three months ending
March 31, 2023, compared to 23.7 million in the prior year period at which point an important part of the milestone related to
starting the flu clinical trial in Panama was recognized.
Operating loss amounted to 60.4 million
for the first quarter of 2023, representing an increase of 45.1 million, from 15.3 million for the same period in 2022.
The operating result was affected by several key drivers:
Financial Result (Finance Income and Expenses)
Net financial result for the first quarter
of 2023, amounted to 3.0 million, or an increase of 2.9 million from 0.1 million for the same period in 2022. This was
mainly driven by interest income on cash investments.
Pre-tax loss was 57.4 million for
the first quarter of 2023 compared to 15.2 million in the same period of 2022.
CureVac Media and Investor Relations Contact
Dr. Sarah Fakih, Vice President Corporate Communications
and Investor Relations CureVac, T bingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
Forward-Looking Statements CureVac
This press release contains statements
that constitute "forward looking statements" as that term is defined in the United States Private Securities Litigation Reform
Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of
CureVac N.V. and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate
Services GmbH, CureVac RNA Printer GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the "company") regarding future
events or future results, in contrast with statements that reflect historical facts. Examples include statements regarding the completion,
size and terms of the proposed public offering. In some cases, you can identify such forward-looking statements by terminology such as
"anticipate," "intend," "believe," "estimate," "plan," "seek,"
"project," or "expect," "may," "will," "would," "could," "potential,"
"intend," or "should," the negative of these terms or similar expressions. Forward-looking statements are based
on management's current beliefs and assumptions and on information currently available to the company. However, these forward-looking
statements are not a guarantee of the company's performance, and you should not place undue reliance on such statements. Forward-looking
statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions
and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and
future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties