23.05.2024 13:00:30 - dpa-AFX: EQS-News: CureVac Announces Financial Results for the First Quarter of 2024 and Provides Business Update (english)

CureVac Announces Financial Results for the First Quarter of 2024 and
Provides Business Update

Issuer: CureVac / Key word(s): Quarter Results
CureVac Announces Financial Results for the First Quarter of 2024 and
Provides Business Update

23.05.2024 / 13:00 CET/CEST
The issuer is solely responsible for the content of this announcement.

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CureVac Announces Financial Results for the First Quarter of 2024
and Provides Business Update

  * Organizational redesign on track, trimming residual pandemic
    infrastructure and reducing 150 positions by year end


  * U.S. FDA Fast Track designation granted for pre-pandemic avian influenza
    (H5N1) vaccine currently in Phase 1 development; candidate jointly
    developed with GSK


  * Settlement with Acuitas Therapeutics includes acknowledgment of
    CureVac's ownership of certain patent claims and Acuitas's licenses to
    selected patents


  * Continuation of U.S. patent litigation against Pfizer/BioNTech with
    trial expected to begin in Q2 2025; litigation continues under seven
    U.S. patents with three patents to be withdrawn due to out-licensing to
    Acuitas Therapeutics


  * Progress in German patent litigation against Pfizer/BioNTech after
    filing appeal with Supreme Court of Justice for EP 1 857 122 B1;
    litigation continues under six IP rights with two utility models to be
    withdrawn due to out-licensing to Acuitas Therapeutics


  * Cash and cash equivalents position of EUR300.2 million as of March 31,
    2024; reaffirming cash runway into fourth quarter of 2025


TÜBINGEN, 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.

"We 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 of January 2025."

"We closed the first quarter of 2024 with EUR300.2 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

Organizational Redesign

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

Executing on Broad 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 Track Designation

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 the H5N1 virus.


Protection of Intellectual Property Rights

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 Position

Cash and cash equivalents amounted to EUR300.2 million at the end of March
2024, decreasing from EUR402.5 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 EUR52 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 of 2025.

Revenues

Revenues amounted to EUR12.4 million for the first quarter of 2024,
representing an increase of EUR5.3 million, or 74%, from EUR7.1 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 EUR8.9 million and EUR3.5 million were recognized,
respectively, compared to EUR6.5 million and EUR0.2 million in the prior year
period.

Operating Result

Operating loss amounted to EUR73.3 million for the first quarter of 2024,
representing an increase of EUR12.9 million from EUR60.4 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:

  * Cost of sales increased primarily due to an increase of contract
    termination provisions as part of an arbitration ruling for Contract
    Manufacturing Organization activities related to the first-generation
    COVID-19 vaccine.


  * Research and development expenses increased primarily with increased
    activity in oncology R&D projects and development of the R&D workforce.
    Additionally, the first quarter of 2024 was impacted by increased
    expenses related to the litigation to enforce intellectual property
    rights.


  * General and administrative expenses decreased compared to the prior year
    period due to lower workforce in the corporate service functions and in
    the Management Board.


  * Other income increased year-on-year due to the sale of raw materials to
    GSK.


Financial Result (Finance Income and Expenses)

Net financial result for the first quarter of 2024 amounted to EUR3.4 million,
or an increase of EUR0.4 million, from EUR3.0 million for the same period in
2023. This increase was mainly driven by interest income on cash
investments.

Pre-Tax Loss

Pre-tax loss was EUR69.9 million for the first quarter of 2024, compared to
EUR57.4 million in the same period of 2023.


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 Contact
Patrick Perez, Junior Manager Public Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1831
patrick.perez@curevac.com

CureVac 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, cash
runway, 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, fluctuations of operating
results due to the effect of exchange rates, delays in litigation
proceedings, different judicial outcomes 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.

Cash and Condensed Consolidated Profit and Loss Data


   (in EUR millions)                                  December      March
                                                    31, 2023        31,
                                                                   2024
   Cash and Cash Equivalents                           402.5        300.2



                                  Three months
                                 ended March 31,
   (in EUR millions)                                    2023         2024
   Revenue                                               7.1         12.4
   Cost of Sales, Operating                            -67.5        -85.7
   Expenses & Other Operating
   Income
   Operating Result                                    -60.4        -73.3
   Financial Result                                      3.0          3.4
   Pre-Tax Loss                                        -57.4        -69.9



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   Language:       English
   Company:        CureVac
                   Friedrich-Miescher-Str. 15
                   72076 Tübingen
                   Germany
   EQS News ID:    1909919




End of News EQS News Service
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Name WKN Börse Kurs Datum/Zeit Diff. Diff. % Geld Brief Erster Schluss
CUREVAC N.V. O.N. A2P71U Frankfurt 3,272 17.06.24 18:06:21 -0,132 -3,88% 3,262 3,310 3,462 3,404

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