24.04.2024 13:06:24 - dpa-AFX: EQS-News: CureVac Announces Financial Results for the Fourth Quarter and Full-Year 2023 and Provides Business Update (english)

CureVac Announces Financial Results for the Fourth Quarter and Full-Year
2023 and Provides Business Update

Issuer: CureVac / Key word(s): Annual Results
CureVac Announces Financial Results for the Fourth Quarter and Full-Year
2023 and Provides Business Update

24.04.2024 / 13:06 CET/CEST
The issuer is solely responsible for the content of this announcement.

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CureVac Announces Financial Results for the Fourth Quarter and Full-Year
2023
and Provides Business Update

  * Organizational redesign and rightsizing initiated across company to
    streamline structures, increase efficiency and reduce operating costs


  * Together with GSK, ended Pandemic Preparedness Agreement (PPA) with
    Federal Republic of Germany, after consultation with the German Federal
    Ministry of Health


  * Cash and cash equivalents position of EUR402.5 million as of December 31,
    2023; cash runway extended into Q4 2025 with organizational redesign and
    despite PPA wind-down


  * Strategic collaboration signed with world-leading oncology center MD
    Anderson, creating unique expertise to jointly discover and develop
    novel cancer vaccines


  * Appointment of Thaminda Ramanayake as Chief Business Officer, bringing
    more than 15 years of biopharma company development and deal-making
    experience


  * Promising COVID-19 and seasonal flu Phase 2 data confirms proprietary
    mRNA platform elicits strong overall antibody titers at well-tolerated
    dose levels


  * New Phase 1/2 study in avian flu started in collaboration with GSK
    addressing potential future pandemic threat


  * Successful safety review of data from glioblastoma Phase 1 Part A with
    multiepitope cancer vaccine candidate, CVGBM, enables progressing to
    Part B with expected start mid-2024


  * CureVac to host conference call and webcast today at 9 a.m. ET / 3 p.m.
    CET


TÜBINGEN, Germany/BOSTON, USA - April 24, 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 fourth quarter and full-year 2023 and
provided a business update.

"We closed out 2023 on a sturdy footing and are poised to advance strongly
through 2024 with strategic initiatives to make CureVac fit-for-purpose. We
are adapting unnecessary residual pandemic infrastructure, optimizing our
workforce and aligning our structures and resources to the right size for
our business scope and development priorities. Under this streamlined
structure, we intend to move forward with purpose and determination," said
Dr. Alexander Zehnder, Chief Executive Officer of CureVac. "As we advance
our pipeline in both infectious disease and oncology, we continue to seize
opportunities to accelerate development of our differentiated mRNA approach.
This is most recently evidenced by our collaboration with MD Anderson, one
of the world's leading cancer centers. Further expanding such strategic
collaborations and partnerships will be the key focus for Thaminda
Ramanayake, who will join the management team as Chief Business Officer in
June."

"We finished 2023 with a robust cash position of EUR402.5 million supported in
Q4 by the recognition of a EUR15 million milestone from GSK for the start of
the Phase 2 development of our joint seasonal flu program," said Pierre
Kemula, Chief Financial Officer of CureVac. "Going into 2024, we have had a
strong focus on cost management and increased operational efficiency.
Importantly, and despite the wind-down of the Pandemic Preparedness
Agreement with the German government, these efforts enable us to extend our
runway into the fourth quarter of 2025."

Selected Business Updates

Organizational Redesign

Following a comprehensive operational assessment in 2023, CureVac is
implementing in 2024 an organizational redesign to streamline structures and
reduce operating costs across most areas of the company. The program was
initiated with a "voluntary leaver" program, with the aim to reduce 150
positions. The redesign will be 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
initiated redesign is expected to result in financial savings from the
second half of 2024 onwards and extend the company's cash runway.

Termination of the Pandemic Preparedness Agreement

Due to a rapidly changing epidemiological environment following the end of
the COVID-19 pandemic, CureVac and GSK decided to end the Pandemic
Preparedness Agreement jointly concluded with the Federal Republic of
Germany in April 2022. This decision was made after consultation with the
German Federal Ministry of Health and the German Center for Pandemic
Vaccines and Therapeutics (ZEPAI). The agreement included the provision of
production capacity and supply of mRNA-based vaccines in the event of a
public health emergency in Germany.

Termination will take effect on May 31, 2024, with no further financial
obligations. Completion of CureVac's GMP IV manufacturing plant for the
production mRNA-based vaccines is unaffected and progressing. Contingent
upon regulatory approval, the facility is expected to be certified in the
second half of 2024.

Strategic Collaborations

In April 2024, CureVac entered into a strategic co-development and licensing
agreement with The University of Texas MD Anderson Cancer Center, one of the
world's leading academic oncology centers. The collaboration centers on the
joint development of novel, off-the-shelf mRNA-based cancer vaccine
candidates in selected hematological and solid tumor indications with high
unmet medical need. It creates strong synergies between CureVac's unique
end-to-end capabilities for cancer antigen discovery, mRNA design, and
manufacturing and MD Anderson's world-class expertise in cancer antigen
discovery and validation, translational drug development, and clinical
research.

Both parties will contribute to the identification of differentiated cancer
antigens based on whole genome sequencing, combined with long- and
short-read RNA-sequencing and cutting-edge bioinformatics. Joint preclinical
validation of the highest-quality cancer antigens and subsequent selection
of promising clinical lead candidates is expected to be followed by initial
Phase 1/2 studies in appropriate clinical indications.

Under the terms of the agreement, CureVac has worldwide exclusive rights to
late-stage development, commercialization, or partnering of the candidates.
MD Anderson is eligible for downstream payments based on potential future
commercialization.

Corporate Development

Thaminda Ramanayake was appointed to the CureVac Management Team as Chief
Business Officer effective June 1, 2024. Mr. Ramanayake has more than 15
years of international experience in biopharma company development and
deal-making. He has built a strong track record of successful clinical
collaborations, M&A, asset in-licensing and strategic financing initiatives
as well as deep expertise in the fields of immunology and oncology. His
focus will be on business strategies to accelerate CureVac's pipeline,
mature the organization, and enable further strategic partnerships.

Mr. Ramanayake joins CureVac from Affini-T Therapeutics, where he served as
Chief Business Officer and was responsible for creating the company's
business development organization. He previously served as Vice President
and Global Head of Business Development in Oncology at Sanofi, where he
established the Clinical Trial Supply Agreement Center of Excellence and
negotiated collaborations valued in the hundreds of millions to billions of
dollars. He also held positions at BioMarin Pharmaceuticals where he
in-licensed numerous gene therapy and oligonucleotide-based assets in
hearing loss, cardiology, neurology and other therapeutic areas, and at
Amgen, where he negotiated a number of international commercialization
agreements.

Mr. Ramanayake holds a master's degree in immunology from the University of
Rochester and an MBA in Finance from the University of Rochester Simon
School of Business. He holds a bachelor's degree in cellular, molecular and
systems biology.

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 currently tested
candidates 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

Start of the Phase 1 part of a combined Phase 1/2 study of an
investigational influenza A (H5N1) pre-pandemic vaccine candidate was
announced on April 24, 2024. The H5N1 avian flu virus is considered a
potential future pandemic threat, known to sporadically cross species from
its original bird host to other animals and humans. The study represents the
latest program progressing to clinical trials under the broad infectious
disease collaboration agreement with GSK, first announced in July 2020. It
assesses the safety, reactogenicity and immunogenicity of a monovalent
vaccine candidate based on CureVac's proprietary second-generation mRNA
backbone, encoding an influenza A H5-antigen. In the initial Phase 1
dose-escalation part of the study, up to five dose levels will be assessed
compared to a placebo control in healthy younger adults aged 18 to 64 and
healthy older adults aged 65 to 85.

Seasonal Flu Program

In the ongoing Phase 2 part of the combined 1/2 study in seasonal flu,
CureVac reported promising data from a planned interim analysis on April 4,
2024. The Phase 2 part assessed the reactogenicity, safety, and
immunogenicity of a potentially differentiated, multivalent vaccine
candidate in 960 healthy younger and older adults. The candidate was tested
in comparison to age-matched licensed comparator vaccines, which featured a
standard dose seasonal vaccine for younger adults and a high dose seasonal
vaccine for older adults. It encodes antigens matched to all four WHO
recommended flu strains and was selected from a comprehensive Phase 1 part,
which tested mRNA vaccine candidates with up to eight separate mRNA
constructs per candidate.

The vaccine candidate was shown to have an acceptable safety and
tolerability profile, confirming previous findings that CureVac's mRNA
platform elicits strong overall antibody titers at well-tolerated dose
levels. It boosted antibody titers against all encoded flu strains and
across all age groups and tested dose levels. Among younger and older
adults, geometric mean titers generated by the vaccine candidate against
influenza A strains numerically exceeded the geometric mean titers of the
licensed comparator vaccines across all tested dose levels. For influenza B
strains, geometric mean titers were lower than those elicited by the
licensed comparator vaccines, in line with expectations and other initial
mRNA-based clinical flu development programs. Further optimizations to
enhance immune responses against influenza B strains will be tested in an
additional Phase 2 study.

COVID-19 Program

On January 5, 2024, CureVac reported positive results from the planned
interim analysis of the ongoing Phase 2 study in COVID-19. The study
assessed the safety and immunogenicity 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 proteins of the omicron BA.4-5 variant and the original SARS-CoV-2
strain. Vaccine candidates were compared to a licensed bivalent mRNA
COVID-19 comparator vaccine. All tested dose levels of the vaccine
candidates were below those used in mRNA-based COVID-19 vaccines licensed in
the U.S. and EU. The study is fully enrolled with 427 healthy adults aged 18
and older equally randomized between dose groups.

The data confirmed favorable reactogenicity profiles for both candidates
across all dose levels, showing a lower or similar proportion of
participants reporting solicited adverse events relative to the comparator
vaccine. Interim immunogenicity data for CV0601, tested at a single dose
level, showed neutralizing antibody titers against the Omicron BA.4-5
variant on day 29 following the booster vaccination that were 5.0 times the
pre-boosting titers, numerically exceeding the 3.6-fold ratio generated by
the licensed comparator vaccine. For the three dose levels tested for
CV0701, neutralizing antibody titers against BA.4-5 on day 29 following the
booster vaccination were 2.7-fold, 3.7-fold and 4.6-fold the titers before
the booster, compared to a 3.6-fold ratio of post- to pre-booster titers for
the comparator vaccine. The Phase 2 study is currently ongoing with Part B,
assessing different vaccine candidate shelf-life conditions.

Oncology

Broadening of Oncology Footprint with mRNA Cancer Vaccines

CureVac continues to develop the next generation of targeted mRNA-based
cancer vaccines based on cutting-edge technologies for antigen discovery and
its second-generation mRNA backbone, focusing on two approaches: 1) the
development of off-the-shelf cancer vaccines based on tumor antigens shared
across different cancer indications and 2) the development of fully
personalized cancer vaccines based on a patient's individual tumor genomic
profile.

Clinical off-the-shelf program in glioblastoma

CureVac's Phase 1 study of patients with glioblastoma has successfully
completed enrollment of all four dose levels within the study's
dose-escalation Part A with multiepitope cancer vaccine candidate, CVGBM.

Following review of the Part A safety data, the Data Safety Monitoring Board
(DSMB) has confirmed no dose-limiting toxicities and recommended a 100 µg
dose for the subsequent dose-confirmation Part B of the study. Part B is
expected to start recruitment mid-2024. A first data readout of the study is
expected in the second half of 2024.

The open-label study evaluates 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).

The RNA Printer® in Oncology

The RNA Printer®, CureVac's end-to-end solution for integrated and automated
manufacturing of GMP-grade mRNA vaccines and therapeutics, successfully
achieved the next milestone in an ongoing regulatory review process. The
system was granted a framework license that significantly broadens its
regulatory freedom and flexibility to manufacture different mRNA vaccine
candidates in support of CureVac's oncology strategy. The framework license
represents an extension of the initial manufacturing license CureVac
announced on November 14, 2023.

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.

In the U.S., a magistrate judge recently granted a motion by Acuitas
Therapeutics to intervene, sever and stay the CureVac's U.S. litigation
against Pfizer/BioNTech. The motion is based on co-ownership and
co-inventorship claims related to one patent family covering four patents
out of the 10 patents at issue in the U.S. These four patents cover the
specific design of a COVID-19 vaccine, using a lipid nanoparticle. The
magistrate judge recommended to stay litigation of all ten patents before
the District Court of the Eastern District of Virginia until the Acuitas
Therapeutics claim is resolved. CureVac is preparing objections to this
recommendation and anticipates a decision within the next two months.

In Germany, on December 19, 2023, the German Federal Patent Court granted in
the first instance the request filed by BioNTech SE to nullify the German
part of CureVac patent EP 1 857 122 B1. CureVac will appeal the decision to
the German Federal Court of Justice once a written decision has been issued,
remaining highly confident in the strength of its broad intellectual
property portfolio and its essential contributions to safe and efficacious
COVID-19 vaccines. The decision does not affect the ongoing litigation in
Germany regarding seven other intellectual property rights that cover strong
foundational as well as COVID-19-specific mRNA innovation. Following this
decision, the Regional Court Düsseldorf suspended infringement proceedings
in the German part of EP 1 857 122 B1 on December 28, 2023.

Conference call and webcast details

CureVac will host a conference call and webcast today at 3 p.m. CET / 9 a.m.
ET.
Dial-in numbers to participate in the conference call:

U.S. Toll-Free: +1-877-407-0989

International: +1-201-389-0921

Germany: 0800-182-0040 (landline access) / 0800-184-4713 (cell phone access)

The live webcast link can be accessed via the newsroom section of the
CureVac website at https://www.curevac.com/en/newsroom/events/

Corresponding presentation slides will be posted shortly before the start of
the webcast.

A replay will be made available at this website after the event.

Financial Update for the Fourth Quarter and Full-Year 2023

Cash Position

Cash and cash equivalents amounted to EUR402.5 million at the end of December
2023, decreasing from EUR495.8 million at the end of 2022. In 2023, cash used
in operations was mainly allocated to payments in connection with ongoing
R&D activities, for expenditures for CureVac's manufacturing facility, GMP
IV, and the purchase of raw materials. This decrease was partially
compensated by EUR219.8 million in net proceeds raised in a follow-on offering
in the first quarter of 2023.

Revenues

Revenues amounted to EUR22.6 million and EUR53.8 million for the three and
twelve months ended December 31, 2023, representing an increase of EUR10.9
million and a decrease of EUR13.6 million, or 93.1% and -20.3%, from EUR11.7
million and EUR67.4 million for the same period in 2022.

The year-on-year decrease was primarily driven by lower revenues from the
two GSK collaboration agreements as the companies agreed to focus on the
larger indications. As a consequence, total GSK related revenues of EUR47.1
million were recognized in 2023, representing a decrease of EUR15.2 million,
compared to EUR62.3 million in the prior year period. For the three months
ended December 31, 2023, revenue was higher compared to the prior year
period, as asignificant portion of the milestone related to the initiation
of Phase 2 of the seasonal flu clinical trial was recognized.

Operating Result

Operating loss amounted to EUR88.0 million and EUR274.2 million for the three
and twelve months ended December 31, 2023, representing a decrease of EUR33.5
million and an increase of EUR24.7 million from EUR121.5 million and EUR249.5
million for the same period in 2022.

The operating result was affected by several key drivers mainly related to
the closing of our first-generation vaccine effort in COVID-19:

  * Cost of sales decreased primarily due to lower write-off of raw
    materials. Furthermore, the prior year was impacted by additional costs
    related to the termination of CMO activities for the first-generation
    COVID-19 vaccine.


  * Research and development expenses increased primarily with increased
    activity in infectious disease and oncology R&D projects and development
    of the workforce. Additionally, the prior year period was positively
    impacted by EUR38.5 million related to the reversal of an outstanding CRO
    provision and by a one-off net gain for a change in the contract
    termination provision resulting primarily in GSK taking over from the
    company committed capacity at a CMO.


  * Other income decreased year-on-year due to a one-off compensation from
    GSK amounting to EUR32.5 million for reimbursement of prepayments and
    production set-up activities at a CMO positively impacting the previous
    year.


Financial Result (Finance Income and Expenses)

Net financial result for the three and twelve months ended December 31,
2023, amounted to EUR1.5 million and EUR14.2 million, or an increase of EUR8.7
million and EUR13.9 million from a financial loss of EUR7.2 million and a
financial gain of EUR0.3 million for the same periods in 2022. This increase
was mainly driven by interest income on cash investments.

Pre-Tax Loss

Pre-tax loss was EUR86.5 million and EUR260.0 million for the three and twelve
months ended December 31, 2023, compared to EUR128.7 million and EUR249.2
million in the same period of 2022.


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      December
                                                   31, 2022      31, 2023
   Cash and Cash Equivalents                          495.8           402.5



                                  Three months
                                 ended December
                                      31,
   (in EUR millions)                                   2022            2023
   Revenue                                             11.7            22.6
   Cost of Sales, Operating                          -133.2          -110.6
   Expenses & Other Operating
   Income
   Operating Result                                  -121.5           -88.0
   Financial Result                                    -7.2             1.5
   Pre-Tax Loss                                      -128.7           -86.5
                                 Twelve months
                                 ended December
                                      31,
   (in EUR millions)                                   2022            2023
   Revenue                                             67.4            53.8
   Cost of Sales, Operating                          -316.9          -328.0
   Expenses & Other Operating
   Income
   Operating Result                                  -249.5          -274.2
   Financial Result                                     0.3            14.2
   Pre-Tax Loss                                      -249.2          -260.0




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   Language:       English
   Company:        CureVac
                   Friedrich-Miescher-Str. 15
                   72076 Tübingen
                   Germany
   EQS News ID:    1888327




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Name WKN Börse Kurs Datum/Zeit Diff. Diff. % Geld Brief Erster Schluss
CUREVAC N.V. O.N. A2P71U Xetra 2,920 06.05.24 11:34:38 +0,102 +3,62% 2,912 2,920 2,940 2,818

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