TÜBINGEN, Germany/BOSTON, United States – August 15, 2024 – CureVac N. V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company introducing a new generation of transformative medicines based on messenger ribonucleic acid (” mRNA”), announced monetary effects for the second quarter and first part of 2024 and provided an update on its business.
“Last quarter marked the beginning of an exciting new bankruptcy for CureVac. Our new licensing agreement with GSK, valued at €1. 45 billion plus royalties, represents strong validation of our proprietary mRNA platform. In parallel, our recently announced strategic restructuring streamlines our business operations and increases our focus on CureVac’s core strength in innovation in mRNA generation, specifically in vital cure areas such as oncology, where we continue to advance the Phase 1 study of our cancer vaccine CVGBM in glioblastoma. . Array We look forward to presenting the first data from this study at ESMO in September,” said Dr. Alexander Zehnder, CEO of CureVac. “To our evolving strategic direction, we are adding valuable experience to our Supervisory Board with the nomination and appointment of two new members who will help us advance our updated priorities. At the same time, we say goodbye to our Chief Financial Officer Pierre Kemula, who will leave the company at the end of his term on October 31, 2024. We thank Pierre for his many contributions and wish him the best for his next term. efforts. »
Selected Business Updates
New licenses with GSK
On July 3, 2024, CureVac and GSK announced a restructuring of their existing collaboration in a new licensing agreement, which replaces two previous agreements and allows the company to prioritize its investments and concentrate its respective mRNA progression activities. After satisfying the standard final conditions, as well as obtaining regulatory and antitrust approvals, the deal was closed on July 11, 2024.
CureVac and GSK have been working in combination since 2020 to expand mRNA vaccines against infectious diseases, resulting in promising applicants for seasonal influenza, avian influenza and COVID-19 vaccines. All applicants are based on CureVac’s proprietary second-generation mRNA backbone and are ultimately in phase 2 of clinical progression with knowledge supporting their potential new, best-in-class vaccines.
The new agreement marks a vital milestone for CureVac. It strongly validates CureVac’s proprietary mRNA platform and enables the company to use technological innovation to expand potentially transformative medicines in oncology and infectious diseases, where mRNA has immense potential, as well as in other select spaces. where significant unmet medical wishes are available. CureVac retains exclusive rights to undisclosed and preclinically validated infectious disease targets from the previous collaboration, as well as the freedom to independently expand and collaborate with mRNA vaccines in any other infectious disease or other indication.
The new agreement replaces all previous monetary considerations of the collaboration agreement between CureVac and GSK. CureVac’s ongoing patent litigation against Pfizer/BioNTech is not affected.
Strategic restructuring
CureVac has embarked on a transformative strategic restructuring to particularly develop potency and functionality while focusing its resources on high-value mRNA projects in oncology, infectious diseases, and other spaces where significant unmet medical desires are available. The strategic initiative includes a general relief of the workforce. of approximately 30% planned until the end of 2024 to create a more efficient and agile organization that adapts to the commercial scope and priorities of CureVac’s portfolio and is committed to innovation, studies and technological development.
These cost savings, combined with benefits from GSK’s licensing agreement, increase CureVac’s expected cash flow through 2028. The company plans to provide additional financial and strategic updates in the third quarter earnings call. quarter in November 2024.
Oncology
Expanding the oncology footprint with mRNA vaccines
CureVac continues to expand the next generation of mRNA-based targeted cancer vaccines by combining next-generation antigen discovery technologies with its second-generation mRNA backbone. The initial focus is the progression of commercially available cancer vaccines targeting tumor antigens shared by other patient populations and/or tumor types, followed by the progression of fully personalized cancer vaccines based on the individual tumor genomic profile of a patient.
Standard clinical program for glioblastoma
Recruitment for open-label Part B dose confirmation in patients with resected glioblastoma has effectively begun. Part B is expected to include up to 20 patients to generate detailed knowledge about the safety, tolerability, and immunogenicity of the investigational cancer vaccine candidate, CVGBM.
The initiation of Phase B follows a review by the Data Safety Monitoring Board (DSMB) of Phase A safety data in increasing doses. The DSMB showed no dose-limiting toxicities and a dose of one hundred mcg for Part B of the study. The first insights into dose-escalating Part A, totaling 16 patients, will be presented in an oral presentation at the European Society for Medical Oncology (ESMO) Congress on September 13, 2024.
Phase 1 evaluates the protection and tolerability of GBVC in patients with newly diagnosed and surgically resected MGMT glioblastoma or unmethylated astrocytoma with a glioblastoma molecular signature. CVGBM presents an unmodified single mRNA encoding 8 epitopes derived from known tumor-associated antigens, with demonstrated immunogenicity. in glioblastoma.
Prophylactic vaccines
GSK-licensed CureVac generation for COVID-19 and flu vaccines
In July 2024, CureVac and GSK restructured their existing collaboration into a new licensing agreement. Under the new agreement, GSK has taken over the global progression, production and commercialization of mRNA influenza and COVID-19 vaccine applicants, adding combinations. All vaccine applicants lately in clinical progression rely on CureVac’s proprietary second-generation mRNA backbone, aimed at enhanced intracellular mRNA translation for early and strong immune responses.
Avian Influenza (H5N1) Programme: Phase 2 launch triggers GSK milestone payment
The Phase 1/2 study, announced on April 24, 2024, evaluates the safety, reactogenicity, and immunogenicity of the vaccine candidate in healthy young and older adults. In May 2024, it announced that the program had earned Fast Track designation from the FDA to allow for less difficult and accelerated development.
The H5N1 avian influenza virus is known to sporadically cross species from its original host, the bird, to other animals and humans and is a potential long-term pandemic threat.
Business Development
Birgit Hofmann
Mehdi Shahidi, M. D.
CureVac has named clinical oncologist Mehdi Shahidi, M. D. , independent director of the company’s supervisory board. Dr. Shahidi is currently CEO of Petalion Therapeutics, a UK-based biotechnology company developing dendrimer-based targeted treatments in oncology, as well as a venture capital partner in Medicxi, a leading European investment corporation in life sciences. He previously served as Senior Vice President, Global Chief Medical Officer and Chief Medical Officer of Boehringer Ingelheim International, where over a 15-year career he oversaw the approval of five drugs and the advancement of more than 30 candidates. in the clinic. Dr. Shahidi’s appointment takes effect at CureVac SE from early September 2024, and his appointment as a member of the supervisory board of CureVac N. V. will be considered at the next annual general meeting in June 2025.
Departure of CFO Pierre Kemula
After eight years as CureVac’s CFO, Pierre Kemula will leave CureVac at the end of his contract on October 31, 2024. The search for his succession is underway. Kemula’s departure marks the end of a notable bankruptcy for him at CureVac. During his tenure, the company has overcome many challenges and achieved milestones. The company wants to express its gratitude and wish him the best in his next steps.
cash position
Cash and cash equivalents amounted to €202. 5 million at the end of June 2024, compared to €402. 5 million at the end of 2023. In the first part of 2024, the money used in the operation was basically used for expenses such as the cessation of raw materials activities. commitments for the first-generation COVID-19 vaccine, CVnCoV, for a total amount of €52 million and the payment of an arbitration award linked to the CMO. All CMO-like arbitrations are closed and a final payment is expected in the third quarter of 2024. In the future, there will be no more CVnCoV-like bills. The remaining expenditures of money were mainly similar to ongoing R&D activities.
The company secured the initial payment of €400 million under the agreement with GSK in August 2024. Therefore, the payment is not included in the monetary position at the end of June 2024. The company reaffirms its expected investment until 2028.
Income
The year-over-year accumulation was mainly due to higher revenues from GSK and CRISPR collaborations. During the six months ended June 30, 2024, total revenues of €17. 6 million and €9. 2 million, respectively, were recognized, compared to €12. 8 million and €1. 1 million last year.
Operating income
Operating losses of €73. 6 million and €146. 9 million for the three and six months ended June 30, 2024, an increase of €1. 8 million and €14. 7 million compared to €71. 8 million and €132. 2 million for the same period in 2023.
Operating source of revenue affected through several key points similar in component to the final touch of the first-generation COVID-19 vaccination effort:
Net source of financial income for the three and six months ended June 30, 2024 €2. 4 million and €5. 8 million, a cut of €2. 0 million and €1. 6 million, compared to €4. 4 million and €7. 4 million for the same period in 2023. Minimization is primarily due to minimizing the source of interest income on monetary investments.
Loss tax