CureVac Announces Financial Results for the Third Quarter and First Nine Months of 2023 and Provides Business Update
TÜBINGEN, Germany/BOSTON, USA – November 14, 2023 – CureVac N. V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company introducing a new generation of messenger ribonucleic acid (“mRNA”) transformative medicines, announced financial effects for the third quarter and first nine months of 2023 and provided an update on its operations.
“The targeted execution of our clinical progression systems in 2023 was accompanied by significant financial milestones, which was compounded by our successful follow-up provision in February 2023. We also activated a €15 million momentary progression milestone payment. euros from GSK when our joint seasonal flu vaccine program moved into phase 2,” said Pierre Kemula, Chief Financial Officer of CureVac. “These steps allow us to firm our money through mid-2025, underpinned by an even more disciplined approach to rate control through 2024. “
Selected Business Updates
Prophylactic vaccines
Implementation of a second generation mRNA vaccine programme, jointly developed with GSK
Seasonal Flu Program
In the ongoing Phase 1/2 study of seasonal influenza, CureVac announced on November 1 the lead of the first player in the Phase 2 study, following the emergence of a promising vaccine candidate based on interim positive data of phase 1. announced on September 12. The multivalent and potentially differentiated candidate encodes antigens corresponding to all WHO-recommended influenza strains. In the phase 1 study it was decided that, compared to a full series of multivalent and modified seasonal influenza mRNA vaccine candidates with up to eight different mRNA constructs compatible with the candidate at other dose levels in 270 healthy young adults (from 18 to 50). Interim Phase 1 protection data showed no protection concerns at all dose levels for multivalent applicants. Humorous responses supported the selection of the favorite vaccine candidate for further evaluation in Phase 2. During Phase 2, the chosen candidate will be tested in younger and older adults at other dose levels and in comparison to influenza vaccines approved age-appropriate seasonal comparison kits. Data is expected in 2024.
COVID-19 Program
Enrollment for the ongoing Phase 2 COVID-19 study ended with 427 randomized participants following the announcement of the first participant’s dose in August 2023. The study evaluates the protection and immunogenicity of a single other booster dose from two applicants of the modified mRNA COVID-19 vaccine. : the monovalent candidate, CV0601, which encodes the spike protein of the BA. 4-5 omicron variant and the bivalent candidate, CV0701, which encodes the spike protein of the BA. 4-5 omicron variant, as well as the original SARS-CoV-2 strain. Vaccine applicants are compared to a comparable legal or legal bivalent mRNA COVID-19 vaccine. Interim Phase 2 data is expected in early 2024 and will indicate the design of a pivotal Phase 3 study expected to begin in 2024. The Phase 3 study is expected to provide an updated vaccine candidate and a comparator vaccine in accordance with the latest COVID-19 standard of care.
Oncology
Expanding the Oncology Footprint with mRNA Cancer Vaccines
CureVac continues to execute on its strategy to expand the next generation of mRNA-based targeted cancer vaccines, based on antigen discovery technologies combined with CureVac’s second-generation mRNA backbone.
The strategy focuses on two approaches: 1) progression of commercially available cancer vaccines based on shared tumor antigens in other cancer indications and 2) progression of fully personalized cancer vaccines based on the genomic profile of a patient’s individual tumor.
Phase 1 of CureVac in patients with resected glioblastoma is on track without any dose-limiting toxicity and has reached the point of the third dose after administering its multiple epitope cancer vaccine candidate, CVGBM, to the first patient. June 2023.
Open-label evaluates the protection and tolerability of CVGBM in up to 54 patients with newly diagnosed MGMT unmethylated glioblastoma or astrocytoma surgically resected with a glioblastoma molecular signature. CVGBM has an unmodified single mRNA encoding 8 epitopes derived from known antigens related to tumors with demonstrated immunogenicity in glioblastoma. A first reading of the knowledge is expected in the second part of 2024.
You can find out more at clinictrials. gov (NCT05938387).
Preclinical Research in Oncology
A multi-epitope mRNA construct encoding ten epitopes derived from the murine melanoma mobile line B. 16. F10 was tested in mice. The study implemented three 5 μg doses of mRNA B. 16 formulated with LNP, administered intramuscularly at weekly intervals. Data received on day 21 showed significant induction of CD8 and CD4 T cell responses detecting epitopes in the complete multiepitope structure. Median animal survival increased to 30. 9 days for treated mice, compared to 23. 2 days for mice vaccinated with the formulated mRNA.
The strong activation of T-mobile is encouraging and relevant, as tumor type B16-F10 is characterized as a cytokine-deficient “cold” tumor type with very little immune cell infiltration and resistance to checkpoint inhibitors. The multiepitope B. 16 mRNA construction generated a physically powerful activation of T-mobiles in the tumor microenvironment, thereby inhibiting tumor expansion and prolonging survival in the implemented preclinical style.
The RNA Printer® in oncology
Designed to produce small quantities through an automated process, The RNA Printer® is expected to perform the immediate and flexible delivery of clinical trial material to detect and develop new antigens in clinical studies. A regulatory review is underway to unload early approval to cover the fully formulated vaccine. Candidates. Extending production licenses to come with the so-called framework license will ultimately allow for greater regulatory freedom and flexibility to manufacture other mRNA cancer vaccine candidates.
Protection of the rights of intellectual assets
Over the course of more than 23 years, CureVac has developed a proprietary foundational generation similar to mRNA design, delivery, and manufacturing that has particularly contributed to the progression and efficacy of COVID-19 vaccines.
CureVac announces its intellectual asset rights in a lawsuit against Pfizer/BioNTech in Germany, the United States and the United Kingdom. In Germany, where 8 intellectual asset rights are at stake, the Düsseldorf Regional Court decided to postpone its infringement ruling on 4 of the 8 rights on September 28 until BioNTech demanded its validity through the relevant patent offices.
In the United States, the trial date has been shown for October 1, 2024. The U. S. District Court for the Eastern District of Virginia will rule on infringement, validity, and damages in a single-jury trial. In the United States, CureVac’s counterclaim to a declaratory judgment action filed through Pfizer/BioNTech in July 2022 concerns ten of its U. S. patents.
CureVac, as a pioneer in mRNA generation, continues to be at the forefront of innovation in the field of mRNA. As a result, the rights to CureVac’s intellectual assets will need to be identified and reputable in the form of a fair rebate that allows for reinvestment in advancing mRNA generation and the continued progression of new transformative drug categories.
Company update
After 3 years on the CureVac leadership team, CureVac’s Chief Commercial Officer and Chief Commercial Officer, Dr. Antony Blanc, will leave CureVac at the end of his contract on November 30, 2023. In the search for a successor, CureVac CEO Dr. Alexander Zehnder will lead the advertising progression team.
Conference Call & Webcast Details
U. S. Toll Free: 1-877-407-0989
International: 1-201-389-0921
The live webcast link can be accessed from the newsroom segment of the CureVac online page on https://www. curevac. com/en/newsroom/events/
The corresponding presentation slides will be posted some time before the start of the webcast.
There will be a replay on this page online after the event.
Financial update for the 3rd quarter and first months of 2023
Cash and cash equivalents amounted to €464. 1 million at the end of September 2023, compared to €495. 8 million at the end of 2022. In the first nine months of 2023, money used in operations was mainly used for invoices similar to R activities
Gain
Revenue was €16. 5 million and €31. 2 million for the quarter and nine months ended September 30, 2023, an increase of €5. 3 million and a cut of €24Array€5 million, or 47. 3% and 44. 0%, to €11. 2 million and 44. 0%. 55. 7 million for the same time in 2022.
The year-on-year decline in the first nine months is mainly due to declining profits from the two collaboration agreements with GSK, as corporations agreed to focus on broader indications. As a result, GSK’s overall profit was recorded at €28. 7 million for the nine months ended September 30, 2023, compared to €52. 7 million in the same period last year. In addition, the 2022 profit is higher due to the milestone payment similar to the start-up of the flu clinical trial in Panama.
Operating Results
Operating losses amounted to €54. 0 million and €186. 2 million for the 3- and nine-month period ended September 30, 2023, an increase of €1. 6 million and €58. 3 million to €52. 4 million and €127. 9 million for the same period in 2022. .
Operational source of revenue impacted by several key factors, basically similar to the finishing touch of our first-generation COVID-19 vaccination campaign:
Financial result (financial source of income and expenditure)
Loss tax
Pre-tax loss of €48. 7 million and €173. 5 million for the 3- and nine-month period ended September 30, 2023, compared to €47. 7 million and €120. 4 million for the same period in 2022.
About CureVac
CureVac Media & Investor Relations
Dr. Sarah Fakih, Vice President of Corporate Communications and Investor Relations
CureVac, Tübingen, Germany
M: 49 160 496949
sarah. fakih@curevac. com
CureVac’s Forward-Looking Statements
For more information, please see the Company’s reports and documents filed with the U. S. Securities and Exchange Commission (SEC). You can download those documents by visiting EDGAR at the SEC at www. sec. gov.
Condensed Consolidated Treasury and Revenue Data