Pfizer's Sickle-Cell Treatment Efforts Falter As Drug Fails Study

CureVac Announces Financial Results for the Second Quarter and First Half of 2025 and Provides Business Updates

• Entered into a definitive Purchase Agreement pursuant to which BioNTech intends to acquire all shares of CureVac, uniting two highly complementary German companies to bring transformative mRNA-based treatments to patients globally

• Entered into agreements to resolve and dismiss all pending patent litigation in the U.S. with Pfizer/BioNTech related to mRNA-based COVID-19 vaccines and to set a framework for resolving related ongoing patent disputes outside the U.S. upon closing of BioNTech's acquisition of CureVac

• Received Clinical Trial Application (CTA) clearance from the European Medicines Agency (EMA) for CVHNLC, a proprietary off-the-shelf cancer immunotherapy candidate targeting squamous non-small cell lung cancer (sqNSCLC)

• CVGBM glioblastomadata from Part B of Phase 1 remain on track for H2 2025

• Strong cash and cash equivalents position of €392.7 million as of June 30, 2025; expected cash runway into 2028

TÜBINGEN, GERMANY AND BOSTON, MA / ACCESS Newswire / August 15, 2025 / CureVac N.V. , a pioneering multinational biotech company developing a new class of transformative medicines based on messenger RNA (mRNA), today announced financial results for the second quarter and first half of 2025 and provided a business update.

"By entering into a definitive purchase agreement with BioNTech, we intend to unite two highly complementary German companies that are well positioned to drive long-term shareholder value. Together, we believe we can deliver significant benefits to patients with mRNA-based immunotherapies and realize our full potential in a combined company," said Dr. Alexander Zehnder, Chief Executive Officer of CureVac. "The proposed transaction will bring together some of Europe's best mRNA scientists and can create significant opportunities across our collective research, development and manufacturing platforms, while establishing the combined company as a global leader in mRNA-based medicines."

Selected Business Updates

Protection of Intellectual Property Rights - Resolution of Patent Litigation with Pfizer/BioNTech

• CureVac and GSK to receive in aggregate a payment of $740 million as well as single-digit royalties on sales of COVID-19 vaccines in the U.S. going forward.

• CureVac to receive additional $50 million from GSK for monetizing a portion of U.S. product royalties due under its existing license agreement announced on July 3, 2024.

• CureVac to grant Pfizer/BioNTech a non-exclusive license to manufacture, use, import into the U.S. and sell mRNA-based COVID-19 and/or influenza products, expanding into a worldwide license post-closing of BioNTech's acquisition of CureVac.

2025 Catalysts

Oncology

• CTA clearance received by EMA for CVHNLC (sqNSCLC), a proprietary off-the-shelf cancer immunotherapy candidate targeting squamous non-small cell lung cancer.

• Data from Part B of the Phase 1 study for CVGBM (glioblastoma) and the decision to continue the program in Phase 2 remain on schedule for H2 2025. Recruitment was completed in Q1 2025, and the data evaluation is expected to include at least 20 patients with a follow-up period of at least six months.

Infectious Diseases

• Submission of the IND application to the FDA is scheduled for H2 2025, and the Phase 1 trial is scheduled to start in H1 2026.

Financial Update for the Second Quarter and First Half of 2025

Cash Position

Cash and cash equivalents amounted to €392.7 million at the end of June 2025, decreasing from €481.7 million at the end of 2024. In the first half of 2025, cash used in operations was mainly allocated to ongoing research and development (R&D) activities to advance candidates in oncology precision immunotherapies and prophylactic vaccines and to further develop CureVac's mRNA technology. The cash outflow for the first half of 2025 decreased significantly compared to the first half of 2024 resulting from:

• the prior year period being impacted by extraordinary payments related to the termination of raw material commitments and the payment of a contract manufacturing organization (CMO)-related arbitration award for the first-generation COVID-19 vaccine, CVnCoV, and

• the strategic restructuring initiated in July 2024. CureVac completed the intended workforce reduction as part of the strategic restructuring resulting in decreased personnel expenses, while implementing further cost reductions and increasing cost discipline through the organization.

The company reaffirms its expected cash runway into 2028.

Revenues

Revenues amounted to €1.2 million and €2.1 million for the three and six months ended June 30, 2025, representing a decrease of €13.2 million and €24.7 million, or 91% and 92%, from €14.4 million and €26.8 million for the same period in 2024.

The decrease year-over-year was primarily driven by lower revenues from GSK following the restructuring of the partnership in July 2024 from a Collaboration into a Licensing Agreement as well as lower sales to CRISPR Therapeutics.

For the six months ending June 30, 2025, total revenues of €0.5 million and €1.6 million were recognized with GSK and CRISPR Therapeutics, respectively, compared to €17.6 million and €9.2 million in the prior year period.

Operating Result

Operating loss amounted to €61.7 million and €116.5 million for the three and six months ended June 30, 2025, representing a decrease of €11.9 million and €30.4 million from €73.6 million and €146.9 million for the same period in 2024.

The decrease year-over-year is primary attributable to less revenue associated with the restructuring of the GSK Collaboration and to the implemented cost reductions initiated with the strategic restructuring in July 2024:

• Cost of sales decreased significantly due to the change in strategy associated with the new license agreement with GSK, resulting to a change in the activities of the organization towards R&D. As CureVac's manufacturing organization is now solely serving the R&D pipeline, following the change such costs are no longer recognized as cost of sales. In addition, the prior year period was impacted by extraordinary expenses as part of an arbitration ruling for Contract Manufacturing Organization (CMO) activities related to the first-generation COVID-19 vaccine and by expenses associated with the write-down of raw materials which would have been recoverable under previous collaboration agreements.

• Research and development expenses increased primarily due to the costs of CureVac's manufacturing organization being recognized as R&D expenses rather than cost of sales. The increase was partially offset by implemented cost reductions initiated with the strategic restructuring in July 2024.

• General and administrative expenses increased compared to the prior year period primarily due to increased legal advice and third-party services related to the proposed transaction with BioNTech. The increase was partially offset by lower personnel expenses following the implemented workforce reduction as part of the strategic restructuring.

Financial Result (Finance Income and Expenses)

Net financial result for the three and six months ended June 30, 2025, amounted to €1.7 million and €4.9 million, representing a decrease of €0.7 million and €0.9 million from €2.4 million and €5.8 million for the same period in 2024. The decrease was mainly driven by higher foreign exchange losses.

Pre-Tax Loss

Pre-tax loss was €60.0 million and €111.6 million for the three and six months ended June 30, 2025, compared to €71.2 million and €141.1 million in the same period of 2024.

About CureVac

CureVac is a pioneering multinational biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine. In more than two decades of developing, optimizing, and manufacturing this versatile biological molecule for medical purposes, CureVac has introduced and refined key underlying technologies that were essential to the production of mRNA vaccines against COVID-19, and is currently laying the groundwork for application of mRNA in new therapeutic areas of major unmet need. CureVac is leveraging mRNA technology, combined with advanced omics and computational tools, to design and develop off-the-shelf and personalized precision immunotherapy candidates to treat cancer. It also develops programs in prophylactic vaccines and in treatments that enable the human body to produce its own therapeutic proteins. Headquartered in Tübingen, Germany, CureVac also operates sites in the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.

CureVac Media and Investor Relations Contact

CureVac, Tübingen, Germany

T: +49 7071 9883-1298

M: +49 160 90 496949

Forward-Looking Statements of CureVac

This press release contains statements that constitute "forward looking statements" as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac N.V. and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the "company") regarding future events or future results, in contrast with statements that reflect historical facts. Examples include the settlement of all pending patent disputes in the United States between the company, Pfizer, and BioNTech relating to mRNA-based COVID-19 vaccines, the Company's expectations regarding the outcome of pending litigation in other global jurisdictions, the expected completion of the public exchange offer between BioNTech and the Company, the discussion of the potential efficacy of the company's vaccine and treatment candidates and the company's strategies, financing plans, cash runway expectations, the timing and impact of restructuring, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as "anticipate," "intend," "believe," "estimate," "plan," "seek," "project," "expect," "may," "will," "would," "could," "potential," "intend," or "should," the negative of these terms or similar expressions. Forward-looking statements are based on management's current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company's performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including risks related to the proposed acquisition by BioNTech, negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, ability to implement our pipeline strategy, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company's industry, the effects of the COVID-19 pandemic on the company's business and results of operations, ability to manage growth, ability to implement, maintain and improve effective internal controls, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect of exchange rates, delays in litigation proceedings, the impact of adverse settlements or other judicial outcomes and other important factors discussed under the caption "Risk Factors" in the company's annual report on Form 20-F filed with the U.S. Securities and Exchange Commission (the "SEC") on April 11, 2025, as such factors may be updated form time to time in its other filings with the SEC. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company's control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please reference the company's reports and documents filed with the SEC. You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

Cash and Condensed Consolidated Profit and Loss Data

SOURCE: CureVac

View the original press release on ACCESS Newswire