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CureVac N.V. - CVAC STOCK NEWS

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CureVac N.V. (NASDAQ: CVAC) is a pioneering biopharmaceutical company based in Germany, known for its groundbreaking work in the field of messenger RNA (mRNA) technology. Founded in 2000 as a spin-off from the University of Tübingen, CureVac has developed a unique position as a leader in mRNA research and development. The company's core technology uses mRNA as a data carrier that instructs the human body to produce its own proteins capable of fighting a wide range of diseases, including cancer, infectious diseases, and rare genetic disorders.

CureVac's proprietary mRNA technology has a broad range of applications. In oncology, the company is developing both off-the-shelf and personalized cancer vaccines. Their off-the-shelf cancer vaccines target tumor antigens shared across different cancer types, while the personalized vaccines are tailored to individual patients based on their unique tumor profiles. CureVac has recently entered a collaboration with The University of Texas MD Anderson Cancer Center to further this mission.

In infectious disease, CureVac has partnered with pharmaceutical giant GSK to develop a suite of prophylactic vaccines. This includes second-generation COVID-19 vaccines and a promising seasonal influenza vaccine program. Recent Phase 2 interim data showed that CureVac's influenza vaccine candidates produce higher geometric mean titers against influenza A strains compared to licensed vaccines, though optimizations are ongoing for influenza B strains. Additionally, a new Phase 2 study has been initiated to further enhance the immune response against the relevant influenza B strain.

Financially, CureVac remains robust, with cash and cash equivalents amounting to €402.5 million at the end of 2023. The company's strategic initiatives, such as organizational redesign and partnerships, aim to extend this runway into the fourth quarter of 2025. As of late, CureVac has also achieved significant milestones in its clinical pipeline, which includes a move to Phase 2 studies for its H5N1 avian flu vaccine candidate and ongoing litigation to defend its intellectual property rights.

Overall, CureVac continues to push the boundaries of mRNA technology, with a deep clinical pipeline and strong collaborations to back its innovative discoveries. For more information, visit their official website at www.curevac.com.

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CureVac has announced updates on its ongoing patent litigation against Pfizer/BioNTech across the U.S., UK, and Germany. A U.S. trial date has been set for March 3, 2025, following a settlement with Acuitas Therapeutics that led to the withdrawal of three disputed patents. In Europe, the European Patent Office will decide on the validity of EP 3 708 668 B1 on March 25, 2025. German litigation sees a hearing scheduled in Düsseldorf on September 10, 2024. Meanwhile, a UK trial began on July 10, 2024, with a judgement expected later this year. These litigations involve patents related to split poly-A tail technology and COVID-19 vaccine design.

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Agomab Therapeutics NV has appointed Pierre Kemula as its new Chief Financial Officer, effective November 1, 2024. Mr. Kemula joins from CureVac N.V. (Nasdaq: CVAC), where he led significant financial achievements, including a successful Nasdaq listing and raising over $1.6 billion in equity. He will replace Tolga Hassan, who recently departed to explore new opportunities. During the transition, Paul van der Horst has been serving as interim CFO. Agomab CEO Tim Knotnerus expressed confidence in Kemula’s expertise to drive the company’s growth. Kemula brings over 15 years of experience in biotech financial leadership, with previous roles at Pixium Vision, Ipsen, and major consulting firms.

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CureVac has announced a strategic restructuring to focus on high-value mRNA pipeline opportunities, particularly in oncology and other critical diseases. This includes a 30% workforce reduction to create a leaner organization, emphasizing research and development. The company aims to deliver two clinical candidates by the end of 2025 and initiate two new Phase 1 studies by the end of 2026. A recent licensing agreement with GSK, worth up to €1.45 billion plus royalties, will extend CureVac's cash runway into 2028. Operational expenses are expected to decrease by over 30% from 2025, with one-time restructuring charges of approximately €15 million anticipated in Q4 2024.

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GSK and CureVac have restructured their existing collaboration into a new licensing agreement. GSK will acquire full rights to develop, manufacture, and commercialize mRNA candidate vaccines for influenza and COVID-19 globally. CureVac will receive an upfront payment of €400 million, and up to an additional €1.05 billion in milestone payments, along with tiered royalties. This new agreement supersedes any previous financial terms from their prior collaboration. The candidate vaccines are in various stages of clinical development and utilize CureVac's second-generation mRNA technology. GSK aims to leverage its capabilities to advance these vaccines, while CureVac retains rights to develop other mRNA vaccines independently. The agreement is subject to antitrust and regulatory approvals.

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CureVac N.V. (NASDAQ:CVAC), a clinical-stage biopharmaceutical company specializing in mRNA-based medicines, announced the voting results of its annual general meeting held on June 24, 2024. Shareholders approved all proposed motions, including the appointment of Thaminda Ramanayake and the reappointment of Malte Greune to the Management Board. Additionally, Jean Stéphenne and Mathias Hothum were reappointed to the Supervisory Board, while Birgit Hofmann was appointed as a new Supervisory Board member. KPMG Accountants N.V. was reappointed as the external auditors for the financial year 2024. Detailed vote tabulations will be released soon.

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CureVac has commenced dosing of the first participant in a Phase 2 study for its multivalent seasonal influenza vaccine candidate, developed in collaboration with GSK. This follows interim data from a Phase 2 part of a combined Phase 1/2 study, which showed the vaccine candidate elicited stronger immune responses against influenza A strains but weaker responses against influenza B strains compared to licensed vaccines. The Phase 2 study's design has been updated to match the three flu strains recommended by the WHO, excluding the B/Yamagata lineage. The study will evaluate the safety, reactogenicity, and immunogenicity of the vaccine in 500 healthy adults, split between younger (18-64) and older (65-85) participants.

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CureVac (Nasdaq: CVAC) has announced its Q1 2024 financial results and business updates.

The company is in the process of an organizational redesign, reducing 150 positions by year-end to trim pandemic infrastructure and increase efficiency.

CureVac's pre-pandemic H5N1 vaccine, co-developed with GSK, received FDA Fast Track designation and is in Phase 1 development.

Settlements with Acuitas Therapeutics recognized CureVac’s patent claims, while ongoing litigation with Pfizer/BioNTech continues under seven U.S. patents, with a trial set for Q2 2025.

In Q1 2024, CureVac reported €300.2 million in cash, €12.4 million in revenue (up 74% YoY), and an operating loss of €73.3 million.

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CureVac announced financial results for Q4 and full-year 2023, highlighted by a strong cash position, strategic collaborations, positive clinical data in COVID-19 and flu vaccines, organizational redesign, and leadership appointments. Despite termination of the Pandemic Preparedness Agreement, the company extended its cash runway, signed a collaboration with MD Anderson, and progressed in avian flu studies. The appointment of Thaminda Ramanayake as Chief Business Officer aims to accelerate pipeline development and strategic partnerships.
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CureVac appoints Thaminda Ramanayake as Chief Business Officer, bringing over 15 years of experience in biopharma development and deal-making. Mr. Ramanayake's successful track record includes clinical collaborations, M&A, and strategic financing initiatives. He aims to accelerate the development of mRNA vaccines and medicines across various therapeutic areas at CureVac.
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CureVac initiates a Phase 1/2 study in collaboration with GSK to develop a pre-pandemic vaccine for the avian influenza (H5N1) virus, addressing a potential future pandemic threat. The study aims to assess the safety and efficacy of the vaccine candidate in healthy adults, utilizing CureVac's mRNA technology platform.
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FAQ

What does CureVac N.V. do?

CureVac N.V. specializes in developing mRNA-based therapies and vaccines for various diseases, including cancer and infectious diseases.

Where is CureVac headquartered?

CureVac is headquartered in Tübingen, Germany.

Who are CureVac's notable partners?

CureVac has partnerships with GSK for vaccine development and The University of Texas MD Anderson Cancer Center for cancer vaccine research.

What are CureVac's recent achievements in vaccine development?

Recent achievements include positive interim Phase 2 data for their seasonal influenza vaccine and initiation of a new Phase 2 study to optimize responses to influenza B strains.

How is CureVac financially positioned?

CureVac had €402.5 million in cash and cash equivalents at the end of 2023 and aims to extend their financial runway into the fourth quarter of 2025.

What is the role of mRNA in CureVac's technology?

CureVac uses mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting diseases.

What are CureVac's focus areas in oncology?

CureVac focuses on developing off-the-shelf cancer vaccines and personalized cancer vaccines based on individual tumor profiles.

What are some challenges CureVac has faced?

Challenges include optimizing immune responses to influenza B strains and defending its intellectual property rights in litigation.

What recent collaborations has CureVac entered into?

CureVac has entered into a collaboration with The University of Texas MD Anderson Cancer Center to develop mRNA-based cancer vaccines.

What is CureVac's latest financial result?

CureVac reported significant progress in Q1 2024, including a robust cash position and ongoing cost management initiatives.

CureVac N.V.

Nasdaq:CVAC

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