CureVac's Q4 2024 Earnings: A Pivotal Moment for mRNA Innovation

CureVac's Q4 2024 earnings call was a pivotal moment for the biotech company, showcasing its strategic repositioning around R&D and technology innovation. The call highlighted several key developments that position CureVac for future growth and competitive advantage in the biotech industry.



One of the most significant developments was the completion of the enrollment of Part B of the Phase 1 glioblastoma study with the investigational precision immunotherapy CVGBM. This program is anticipated to have its first data readout in the second half of 2025, demonstrating CureVac's progress in oncology research. The company is also strengthening its clinical development pipeline with two complementary approaches in oncology: off-the-shelf precision immunotherapies and fully personalized precision immunotherapies. The new off-the-shelf program in squamous non-small cell lung cancer (sqNSCLC) is a prime example, with recent IND and CTA submissions to regulatory authorities in the U.S. and Europe. The FDA clearance received on April 7, 2025, to proceed with the Phase 1 study of CureVac’s investigational precision immunotherapy, CVHNLC, in patients with sqNSCLC, further validates this approach.

CureVac's improved financial discipline is evident in the €10 million milestone payment invoiced following the initiation of Phase 1 of the combined Phase 1/2 study of a seasonal influenza/COVID-19 combination vaccine, which is fully licensed to GSK. This financial stability, coupled with a cash and cash equivalents position of €481.7 million as of December 31, 2024, reaffirms CureVac's expected cash runway into 2028, providing a solid foundation for future growth.

The positive patent ruling by the European Patent Office (EPO) has significant implications for CureVac's intellectual property portfolio and its ongoing litigation with BioNTech SE. The EPO's decision to confirm the validity of CureVac’s European patent EP 3 708 668 B1, subject to amendments, is a major milestone. This patent describes CureVac's foundational invention, the split poly-A tail technology, which aims to enhance medical efficacy by improving the expression of the protein encoded on an mRNA construct. The ruling largely dismissed the opposition originally filed by BioNTech SE in April 2023, challenging the patent’s validity, and maintained the patent in amended form. This decision reinforces the strength and impact of CureVac's patent portfolio, which is one of the broadest and most diverse in the mRNA space. CureVac believes that this patent is infringed in its amended form, and an infringement hearing is scheduled for July 1, 2025, before the Regional Court Düsseldorf. A positive infringement decision would trigger proceedings to assess damages in the same court.

In summary, CureVac's strategic repositioning around R&D and technology innovation, supported by financial discipline, strong intellectual property, and strategic partnerships, positions the company for sustained growth and a competitive edge in the biotech industry. The Q4 2024 earnings call was a testament to CureVac's commitment to innovation and its potential to revolutionize the field of mRNA-based therapies.