Executive Summary / Key Takeaways

• CureVac N.V. is undergoing a transformative period, pivoting from a broad pandemic-era focus to a streamlined, R&D-centric biotech specializing in high-value oncology and infectious disease mRNA therapeutics.
• A landmark €1.45 billion licensing agreement with GSK and a subsequent acquisition by BioNTech , valued at approximately $1.25 billion, have fundamentally reshaped CureVac's financial stability, strategic direction, and competitive landscape.
• The company's proprietary second-generation mRNA backbone, advanced antigen discovery platform, and thermostable LNP delivery systems represent significant technological differentiators, driving a pipeline of off-the-shelf and personalized cancer immunotherapies, alongside novel non-respiratory infectious disease vaccines.
• Financially, CureVac reported a substantial operating profit of €177.7 million in 2024, primarily due to the GSK upfront payment, and projects a cash runway into 2028, underpinned by significant cost reductions and a focused R&D spend.
• The BioNTech acquisition, expected to close in 2025, is poised to resolve ongoing patent litigation and integrate CureVac's innovative capabilities into a larger mRNA oncology powerhouse, offering a new chapter for its pioneering technology.

Setting the Scene: A New Era for mRNA Innovation

CureVac N.V., founded in 2000 in Tübingen, Germany, has long stood as a pioneer in messenger RNA (mRNA) technology, boasting over two decades of scientific leadership. The company's journey, marked by foundational innovations such as the first clinical introduction of a lipid nanoparticle (LNP) design in 2018, has recently entered a transformative phase. Under the leadership of CEO Alexander Zehnder, CureVac has strategically refocused its efforts, shedding pandemic-era infrastructure and streamlining operations to concentrate on high-value research and development in oncology and infectious diseases. This strategic pivot aims to leverage its proprietary mRNA platform to address critical unmet medical needs and capitalize on compelling market opportunities.

The broader mRNA industry is characterized by intense innovation and significant competitive dynamics. Key players like Moderna (MRNA), BioNTech (BNTX), and Pfizer (PFE) have established strong positions, particularly in the infectious disease vaccine market. CureVac's strategy is to carve out a differentiated niche through its advanced technological capabilities and a targeted pipeline, rather than competing head-on in all segments. The global market for mRNA therapeutics is expanding, driven by the proven versatility of the technology in vaccine development and its burgeoning potential in oncology. For instance, lung cancer alone affects over two million patients annually worldwide, with squamous non-small cell lung cancer (sqNSCLC) representing a significant and aggressive subtype with high unmet medical needs. Similarly, uropathogenic E. coli (UPEC) is the primary cause of urinary tract infections (UTIs), one of the most common infections globally, exacerbated by rising antibiotic resistance. These substantial market opportunities underscore CureVac's strategic focus.

Technological Edge: The Core of CureVac's Value

CureVac's investment thesis is fundamentally anchored in its highly differentiated mRNA technology platform. The company's core technological advantage lies in its second-generation mRNA backbone, which is meticulously optimized for strong and broad immune responses, crucially including cellular immune responses. This backbone has demonstrated clinical validation in Phase 1 and 2 studies across both infectious diseases and oncology.

A key differentiator is CureVac's proprietary and highly differentiated whole genome-based antigen discovery platform. This platform provides access to new classes of tumor antigens, enhancing the precision and effectiveness of its therapies. For example, in its squamous non-small cell lung cancer program, four novel antigens were discovered outside the exome through a collaboration with myNEO Therapeutics, a unique approach not previously tested in cancer immunotherapy trials. Patient coverage calculations for this candidate predict that approximately 95% of patients will express epitopes from at least one encoded antigen, and about 50% from at least four, allowing for broad applicability without extensive patient selection.

Furthermore, CureVac is advancing its proprietary mRNA delivery technologies with improved lipid nanoparticles (LNPs), which are tailored for specific therapeutic areas. For prophylactic vaccines, the company has developed an LNP system featuring a PEG-free lipid composition. This system has demonstrated strong humoral and cellular immune responses in preclinical models, highly localized bio-distribution in the immune compartment, and, critically, promising thermostability for at least 12 months when stored as a freeze-dried powder at room temperature (25°C) or under refrigeration (2-8°C). This enhanced stability provides a competitive advantage, enabling global utilization without complex cold chain storage requirements. For oncology, LNPs are designed to induce robust systemic immune responses, tolerating greater reactogenicity to activate tumor-killing T-cells.

The "so what" for investors is clear: these technological advancements are not merely incremental improvements but represent a foundational competitive moat. The optimized mRNA backbone and novel antigen discovery capabilities aim to deliver superior efficacy and broader patient applicability, potentially leading to higher adoption rates and stronger pricing power. The thermostable LNPs could significantly reduce logistical costs and expand market access, particularly in regions with limited cold chain infrastructure. These technological advantages directly contribute to CureVac's long-term growth strategy by enabling the development of best-in-class products and strengthening its market positioning against rivals.

Strategic Transformation and Operational Streamlining

The year 2024 marked a pivotal strategic shift for CureVac. The company embarked on a comprehensive corporate restructuring, including a significant 30% reduction in its workforce, which was completed by the end of 2024. This initiative, executed approximately 70% below its allocated budget, aimed to enhance efficiency and agility, allowing CureVac to refocus on its core strengths of technology innovation and R&D. Management anticipates a substantial decrease in operating expenses by over 30% starting in 2025, including a notable €25 million reduction in personnel costs.

A cornerstone of this transformation was the new licensing agreement with GSK , signed in July 2024. This agreement, valued at up to €1.45 billion plus royalties, included a non-refundable upfront payment of €400 million, which was fully recognized as revenue in 2024. This partnership not only provided significant capital but also leveraged GSK's expertise for the development and commercialization of respiratory infectious disease programs, including seasonal influenza and COVID-19 vaccines. This strategic move eliminated the need for CureVac's commercial buildup and large-scale manufacturing activities for these programs, further streamlining its operations. The company also successfully terminated all remaining raw material commitments and resolved contract manufacturing organization (CMO) related arbitrations for its first-generation COVID-19 vaccine, ensuring no further related payments.

Pipeline Progress and Future Outlook

CureVac's refocused pipeline demonstrates clear progress in both oncology and infectious diseases.

In Oncology, the lead program, CVGBM, an off-the-shelf precision immunotherapy for resected glioblastoma, has completed enrollment of Part B of its Phase 1 study. First data from Part B is anticipated in the second half of 2025. A go/no-go decision for advancing to Phase 2 is planned for the second half of 2025, with management setting a high threshold: expecting either a median overall survival of 50 months or longer, or an overall response rate of approximately 20%. The new off-the-shelf program for squamous non-small cell lung cancer (CVHNLC) received U.S. FDA IND clearance, with the Phase 1 study expected to begin in the second half of 2025. This program, featuring novel antigens from the myNEO Therapeutics collaboration, will be tested in combination with pembrolizumab. Furthermore, CureVac expects to disclose additional off-the-shelf oncology programs and select new clinical candidates in 2026, with the first clinical Phase 1 study for a personalized cancer vaccine candidate anticipated to start in the second half of 2026. The collaboration with MD Anderson Cancer Center is expected to be a significant driver for new cancer vaccine development.

In Infectious Diseases, proprietary efforts are now directed towards new non-respiratory indications. The UPEC vaccine program, targeting uropathogenic E. coli for urinary tract infections, is advancing rapidly. An IND submission for a Phase 1 study is expected in the second half of 2025, with clinical development commencing in the first half of 2026. This program leverages a unique nanoparticle design that has shown superior immunogenicity in preclinical studies compared to protein-based vaccines. For the GSK -licensed respiratory programs, GSK confirmed that its standalone seasonal influenza vaccine program is being prepared for Phase 3, which will trigger a significant milestone payment for CureVac. Additionally, GSK initiated a combined Phase 1/2 study for a seasonal influenza/COVID-19 combination vaccine in November 2024, which already triggered a €10 million milestone payment to CureVac.

Financial Performance and Liquidity

CureVac's financial performance in 2024 marked a significant turnaround, primarily driven by the strategic shifts. The company reported a substantial operating profit of €177.7 million for the full year 2024, a dramatic improvement from an operating loss of €274.2 million in 2023. This was largely fueled by a revenue surge to €535.2 million in 2024, up from €53.8 million in 2023, with the €400 million upfront payment from the GSK licensing agreement being a primary contributor. However, the first quarter of 2025 saw revenues decrease to €0.9 million, reflecting the one-time nature of the GSK upfront payment and the restructuring of the partnership.

Despite the variability in quarterly revenue, the company's liquidity remains robust. CureVac closed 2024 with a strong cash and cash equivalents position of €481.7 million, increasing from €402.5 million at the end of 2023. This strong cash position, combined with anticipated operating expense reductions of over 30% from 2025 onwards, underpins management's reaffirmation of an expected financial runway into 2028.

While R&D expenses increased in 2024 due to higher investments in oncology and IP litigation, general and administrative expenses decreased, reflecting the benefits of the organizational redesign. The company also incurred €137 million in extraordinary payments in 2024 related to its first-generation COVID-19 vaccine, strategic redesign, and patent litigation, which are now largely behind it. CureVac's latest TTM Gross Profit Margin stands at an impressive 94.81%, with an Operating Profit Margin of 40.77% and a Net Profit Margin of 37.93%, reflecting the impact of the GSK deal. Its Current Ratio of 6.17 indicates strong short-term liquidity.

Competitive Dynamics and Risks

CureVac operates in a highly competitive mRNA landscape, primarily contending with established players like Moderna (MRNA) and BioNTech , as well as large pharmaceutical companies like Pfizer (PFE). While Moderna (MRNA) and BioNTech have demonstrated faster commercialization and broader market penetration with their COVID-19 vaccines, CureVac's competitive edge lies in its foundational mRNA research, advanced antigen discovery, and innovative LNP systems, particularly the thermostable LNP for infectious diseases. However, the company has historically faced challenges in scaling commercialization and achieving profitability compared to its larger rivals.

A significant development in the competitive landscape, and a major de-risking event, was the announcement in June 2025 that BioNTech intends to acquire all shares of CureVac in an all-stock deal valued at approximately $1.25 billion. This acquisition, expected to close in 2025, aims to strengthen BioNTech's mRNA cancer immunotherapy portfolio by integrating CureVac's research and manufacturing site in Tübingen. Crucially, as part of this acquisition, agreements were made to resolve and dismiss all pending patent litigation in the U.S. with Pfizer (PFE)/BioNTech and to establish a framework for resolving related ongoing patent disputes outside the U.S. upon the closing of the acquisition. This development transforms CureVac's competitive outlook, moving it from an independent contender to an integrated part of a larger, well-capitalized mRNA leader, effectively resolving long-standing and costly patent disputes.

Despite this positive development, risks remain. The inherent uncertainties of clinical development, including the pace of patient enrollment and data readouts for its oncology programs, could still impact timelines. While the BioNTech acquisition addresses patent litigation, the successful integration of CureVac's assets and pipeline into BioNTech's operations will be critical. Historically, CureVac has faced financial sustainability concerns due to substantial losses, but the BioNTech acquisition and the extended cash runway into 2028 significantly mitigate this risk.

Conclusion

CureVac N.V. stands at the precipice of a new chapter, having transformed itself from an independent mRNA pioneer into a strategically focused entity poised for integration into a larger, formidable player in the biotech space. The company's rigorous strategic restructuring, coupled with the substantial GSK (GSK) licensing agreement, has fortified its financial position, extending its cash runway into 2028 and enabling a concentrated investment in its innovative R&D pipeline. CureVac's technological differentiators—its second-generation mRNA backbone, advanced antigen discovery platform, and thermostable LNP systems—represent a robust foundation for developing next-generation therapeutics in oncology and non-respiratory infectious diseases.

The impending acquisition by BioNTech is a watershed moment, promising to resolve complex patent disputes and integrate CureVac's deep scientific expertise and promising pipeline into a broader mRNA oncology strategy. This strategic alignment offers a compelling outlook for investors, as CureVac's pioneering contributions are set to be leveraged within a larger, commercially adept organization. While the inherent risks of clinical development persist, the financial stability, strategic clarity, and the resolution of patent litigation through the BioNTech (BNTX) acquisition position CureVac for a potentially impactful future within the evolving mRNA landscape.