remember me
Signing a new licensing agreement with GSK for up to €1. 45 billion, adding €400 million upfront; Provides physically powerful validation of CureVac’s mRNA platform
Initiate a strategic relief of approximately 30% through the end of 2024, optimizing the business to focus on high-value opportunities in oncology, infectious diseases and other areas.
Invoicing of a milestone payment of €10 million following the transition to Phase 2 of the pre-pandemic avian influenza (H5N1) programme; Fully cleared candidate for GSK’s new deal
Dosing of the first patient in Phase 1, Part B glioblastoma with CVGBM to identify dose confirmation; Part A Initial Dose Escalation Knowledge Accepted for Oral Presentation in ESMO
Strengthening the supervisory board with the appointment of innovator Birgit Hoffman and clinical oncologist Mehdi Shahidi, M. D.
Chief Financial Officer Pierre Kemula will step down at the end of his term on 31 October 2024; A replacement is being sought with a transition plan in place
Cash and cash equivalents of €202. 5 million as at 30 June 2024, advance of €400 million under the GSK agreement; They reaffirm that they will have money until 2028
TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / Aug. 15, 2024 / CureVac N. V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company introducing a new generation of messenger ribonucleic acid (“mRNA”) transforming medicines, announced its monetary effects for the second quarter and first part of 2024 and provided a business update.
“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 a strong validation of our proprietary mRNA platform. In parallel, our recently strategic restructuring announced streamlines our commercial operations and focuses our attention on CureVac’s core strength in innovation in mRNA generation, specifically in critical disease areas such as oncology, where we continue to advance the Phase 1 study of our cancer vaccine CVGBM in glioblastoma. Initial awareness of 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 appointment and appointment of two new members who will help us advance our updated priorities. At the same time, we say goodbye to our CFO 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 all the best in his future endeavors.
“The first part of 2024 marked the last phase of bills such as our first-generation vaccine, which, basically represented in 2023, still impacted our monetary position with more than 80 million euros. As we approach the conclusion of all negotiations as COVID-19 similar commitments, we expect a final arbitration-like payment in the third quarter, after which all commitments will be fully settled. We are now focused on obtaining better operating power and are moving forward together in our restructuring initiative. of the new agreement with GSK puts us in a strong monetary position,” said Pierre Kemula, Chief Financial Officer of CureVac. “As I step down, I am confident that the company is well positioned for good luck in the future, and I would like to express my sincere thanks to the entire CureVac team for those incredible 8 years combined. “
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 currently in Phase 2 clinical progression with insights supporting their potential new, best-in-class vaccines.
Under the terms of the new agreement, GSK has taken over the development and production of vaccine applicants and holds global marketing rights. In exchange, CureVac won an advance of 400 million euros and could get even other euros. 1,050 million for the progression, regulatory and sale stages, as well as staggered royalties ranging from 10% to 10%.
The new agreement marks a vital milestone for CureVac. It firmly validates CureVac’s proprietary mRNA platform and allows the company to focus on technological innovation to expand potentially transformative medicines in oncology and infectious diseases, where mRNA has immense potential, as well as in other spaces where significant medical wishes are not fulfilled. CureVac retains exclusive rights to the previous collaboration’s undisclosed, preclinically validated infectious disease targets, 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 power 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% expected through 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.
As a result of the restructuring, CureVac expects operating expenses to be reduced by more than 30% from 2025, adding an annual cut in workforce costs of around €25 million. The company estimates that it will incur one-time restructuring expenses of approximately €15 million, adding similar severance packages, benefits and costs, which it expects to incur in the second half of 2024. These expenses are subject to a number of assumptions, adding local legal requirements, and actual expenses could differ materially from estimates.
These cost savings, combined with proceeds from the GSK licensing deal, increase CureVac’s expected cash flow through 2028. The company expects to provide additional financial and strategic updates in the third quarter earnings call 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 state-of-the-art 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 customized cancer vaccines based on the genomic profile of a patient’s individual tumor.
For the first, off-the-shelf approach, CureVac plans to eventually select two clinical applicants for vaccines against shared antigen cancer instead of artificial tumors and hematologic cancers, adding one in collaboration with researchers at M. D. Cancer Center. Anderson of the University of Texas until 2025, with plans to publish two more phase 1 studies by the end of 2026.
Standard Clinical Schedule for Glioblastoma
Enrollment in Part B with confirmed dose of open-label Phase 1 has effectively begun in patients with resected glioblastoma. Part B is expected to include up to 20 patients to generate detailed knowledge about the safety, tolerability, and immunogenicity of the investigational study. Cancer vaccine candidate, CVGBM.
The initiation of Part B follows a review by the Data Security Monitoring Board (DSMB) of the Part A Safety Data in increasing doses. The DSMB did not confirm any dose-limiting toxicity and a dose of one hundred μg for Part B of the Part A data from the first-line dose escalation, which aggregates 16 patients, will be presented in an oral presentation at the European Society for Medical Oncology (ESMO) Congress on 13 September 2024.
Phase 1 evaluates the protection and tolerability of CVGBM in patients with newly diagnosed and surgically resected MGMT glioblastoma or unmethylated astrocytoma with a molecular signature of glioblastoma. CVGBM presents a single unmodified mRNA encoding 8 epitopes derived from known tumor-associated antigens, with demonstrated immunogenicity. in glioblastoma.
You can find out more at clinictrials. gov (NCT05938387).
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
In July 2024, the combined phase of the avian influenza study, which compared a pre-pandemic monovalent influenza A (H5N1) vaccine candidate encoding an H5 antigen, effectively moved to phase 2 of the study. The transition triggered a significant payment of 10 million euros. for CureVac.
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 obtained Fast Track designation from the FDA to allow for facilitated 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
Birgit Hofmann was appointed independent director of the company’s supervisory board by vote at the annual shareholders meeting on June 24. Hofmann heads the Department for Environmental Innovations, Electromobility and Batteries at the German Federal Ministry for Economic Affairs and Climate Action. She has led several teams in the creation and progression of new businesses and in the progression of methods for structural replacement in commercial sectors, with the goal of construction industries that are sustainable and technologically advanced. She previously held positions in the Department of European Aspects of Industrial Policy and as Permanent Representative of Germany to the OECD.
Mehdi Shahidi, M. D.
CureVac has named clinical oncologist Mehdi Shahidi, M. D. , independent director of the company’s Supervisory Board. Shahidi is currently CEO of Petalion Therapeutics, a UK-based biotechnology company developing targeted dendrimer therapeutics in oncology, as well as a venture capital partner at Medicxi, a leading European life sciences investment firm. He is global head of medicine and chief medical officer at Boehringer Ingelheim International, where, over a 15-year career, he oversaw the approval of five drugs and the advancement of more than 30 applicants into the clinic. Dr. Shahidi’s appointment is effective upon CureVac SE’s appointment in early September 2024 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 8 years as CureVac’s Chief Financial Officer, 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 would like to thank you and wish you well in your next steps.
Financial update for the second quarter and first part of 2024
cash position
Cash and monetary equivalents amounted to 202. 5 million euros at the end of June 2024, compared to 402. 5 million euros at the end of 2023. In the first part of 2024, the money used in the operation was It was basically allocated to expenses such as the cessation of raw materials activities. commitments for the first generation COVID-19 vaccine, CVnCoV, for a global amount of 52 million euros and the payment of an arbitration award linked to the OCM. All CMO-like arbitrations are closed and a final payment is expected in the third quarter of 2024. Going forward, there will be no more CVnCoV-like bills. The remaining money expenditures were mainly similar to ongoing R&D activities.
The company obtained the initial payment of €400 million under the agreement with GSK in August 2024. The payment is not included in the monetary position at the end of June 2024. The company reaffirms its expected financial position until 2028.
Gain
Revenue of €14. 4 million and €26. 8 million for the three and six months ended June 30, 2024, an increase of €6. 8 million and €12. 1 million, or 90% and 82%, compared to €7. 6 million and €14. 7 million for the 3 months ended June 30, 2024. it was in 2023.
The year-over-year accumulation is basically due to higher revenues from GSK and CRISPR collaborations. For 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 in the same period of the previous year.
Operating result
Operating loss amounts to €73. 6 million and €146. 9 million for the quarter and six months ended June 30, 2024, an increase of €1. 8 million and €14. 7 million to 71 . 8 million euros and 132. 2 million euros for the same period in 2023.
The operating source of revenue was impacted through several key points similar in component to the final first-generation COVID-19 vaccination effort:
Cost of sales increased primarily due to the accrual of contract termination provisions as a component of an arbitration award related to the operations of the contract manufacturing organization similar to the first-generation COVID-19 vaccine.
Research and progression expenses increase mainly due to increased activity in oncology R&D projects. Additionally, the first part of 2024 was affected by a backlog of expenses similar to litigation aimed at enforcing rights to intellectual assets.
General and administrative expenses decreased compared to the same period last year, mainly due to lower personnel costs.
Another source of income increases year-on-year from the sale of raw fabrics to GSK.
Financial result (financial source of income and expenses)
Net financial result for the quarter and six months ended June 30, 2024 amounted to €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 in the same period. in 2023. This reduction is basically explained by the fall in the source of interest income from monetary investments.
loss tax
The pre-tax loss amounted to €71. 2 million and €141. 1 million for the quarter and six months ended June 30, 2024, to €67. 4 million and €124. 8 million. euros for the same era of 2023.
For more information, please refer to the Company’s reports and filings with the U. S. Securities and Exchange Commission. (SEC). You can download those documents by visiting EDGAR at the SEC in www. sec. gov.
Cash Flow Knowledge and Condensed Consolidated Profit and Loss Knowledge
402. 5
202. 5
Quarter ended June 30
2023
2024
7. 6
14. 4
-79,4
-88. 0
-71. 8
-73,6
4. 4
2. 4
-67,4
-71,2
Semester ended June 30
2023
2024
14. 7
26,8
-146,9
-173,7
-132,2
-146. 9
7. 4
5. 8
-124,8
-141. 1
SOURCE: CureVac