UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE
ISSUER
PURSUANT TO RULE 13a-16
OR 15d-16 OF THE
SECURITIES EXCHANGE ACT
OF 1934
For the month of November 2023
Commission File Number: 001-39446
CureVac N.V.
(Exact Name of Registrant as Specified in Its
Charter)
Friedrich-Miescher-Strasse 15, 72076
Tübingen, Germany
+49 7071 9883 0
(Address of principal executive office)
Indicate by check mark whether the registrant files
or will file annual reports under cover of Form 20-F or Form 40-F:
On November 1, 2023, CureVac N.V. (the “Company”) issued
a press release reporting progress in Phase 2 COVID-19 and Seasonal Flu Clinical Development Programs in Collaboration with GSK.
The information included in this Form 6-K (including Exhibit 99.1,
but excluding the statements of the Company’s Chief Development Officer contained in Exhibit 99.1 hereto) is hereby incorporated
by reference into the Company’s Registration Statement on Form F-3 (File No. 333-259613).
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
CUREVAC N.V. |
|
|
|
|
By: |
/s/ Alexander Zehnder |
|
|
|
Chief Executive Officer |
Date: November 1, 2023
EXHIBIT INDEX
Exhibit 99.1
CureVac Announces Solid Progress in Phase 2
COVID-19 and Seasonal Flu Clinical Development Programs in Collaboration with GSK
| · | COVID-19 Phase 2 clinical trial fully enrolled |
| o | Study compares mono- and bivalent vaccine candidates against licensed comparator COVID-19 vaccine |
| · | First participant dosed in seasonal flu Phase 2 part of combined Phase 1/2
study |
| o | Study compares a potentially differentiated, multivalent vaccine candidate with broad antigen coverage against licensed comparator
vaccine |
TÜBINGEN, Germany
/ BOSTON, USA – November 1, 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 solid progress
in its clinical vaccine development programs in COVID-19 and seasonal flu, conducted in collaboration with GSK.
“Through the successful
execution of Phase 1 and 2 studies, together with our partner GSK, we are on track to move our most advanced COVID-19 and seasonal flu
programs forward into the later stages of clinical development,” said Dr. Myriam Mendila, Chief Development Officer of CureVac.
“The impact of mRNA technology continues to transform healthcare. As a company at the forefront of continuing mRNA innovation, we
are excited to move potentially disruptive vaccine candidates toward the market.”
In the joint COVID-19
development program, recruitment of the ongoing Phase 2 study was completed at 427 randomized participants after the first participant
was dosed in August 2023. The study assesses the safety and immunogenicity of different single booster doses 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 protein of the omicron BA.4-5 variant as well as the original SARS-CoV-2 strain. Vaccine candidates are compared
to a licensed or authorized bivalent COVID-19 comparator vaccine. Interim Phase 2 data are expected in early 2024.
In the joint seasonal
flu development program, the first participant was dosed in the Phase 2 part of the combined Phase 1/2 study, following selection of a
promising vaccine candidate based on positive Phase 1 interim data announced September 12, 2023. The potentially differentiated, multivalent
candidate encodes antigens matched to all WHO-recommended flu strains. It was selected from the Phase 1 part of the study that compared
a comprehensive series of multivalent, modified mRNA seasonal flu vaccine candidates with up to eight separate mRNA constructs per candidate.
In Phase 2, the selected candidate will be tested in younger and older adults at different dose levels compared to age-appropriate licensed
seasonal flu comparator vaccines. Data are expected in 2024.
About CureVac
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 Tübingen, 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 and Investor Relations Contact
Dr. Sarah
Fakih, Vice President Corporate Communications and Investor Relations
CureVac, Tübingen,
Germany
T: +49 7071
9883-1298
M: +49 160
90 496949
sarah.fakih@curevac.com
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 discussion of the potential efficacy of the company’s
vaccine and treatment candidates and the company’s strategies, financing plans, growth opportunities and market growth. 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 and collaboration partners, ability to commercialize products, ability
to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from
increasing competition and consolidation in the company’s industry, the effects of the COVID-19 pandemic on the company’s
business and results of operations, ability to manage growth, reliance on key personnel, reliance on intellectual property protection,
ability to provide for patient safety and fluctuations of operating results due to the effect of exchange rates or other factors. Such
risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements.
Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought
would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake,
and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such
statements to reflect future events or developments, except as required by law.
For further information, please reference the
company’s reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting
EDGAR on the SEC website at www.sec.gov.
CureVac NV (NASDAQ:CVAC)
Historical Stock Chart
From Nov 2024 to Dec 2024
CureVac NV (NASDAQ:CVAC)
Historical Stock Chart
From Dec 2023 to Dec 2024