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Yahoo
2 days ago
- Business
- Yahoo
CERo Therapeutics Holdings, Inc. Announces Continued Enhancement of Intellectual Property Portfolio with Two Granted U.S. Patents and European Patent Application Allowance Regarding Company's Lead Compound CER-1236
Results in 18 Issued Patents and Allowed Patent Applications Internationally with Nine Total Patent Families SOUTH SAN FRANSCISCO, Calif., June 02, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) ('CERo' or the 'Company') an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that deploy phagocytic (i.e., target-cell eating) mechanisms alongside the array of built-in target cell destroying mechanisms used by T cells, announces two previously announced U.S. patent applications have been granted by the U.S. Patent and Trademark Office (USPTO), and one European patent application has been allowed by the European Patent Office, all of which significantly expand the Company's intellectual property portfolio. The USPTO granted U.S. Patent No. 12,291,557, titled, 'CHIMERIC TIM4 RECEPTORS AND USES THEREOF' on May 6, 2025. The granted claims cover certain design aspects of CER-1236, the Company's lead compound. This patent provides composition of matter protection for a chimeric TIM4 receptor comprising a TIM4 binding domain and canonical T cell signaling domains. Additionally, the European Patent Office has allowed European Patent Application No. 1882166.7 titled, 'CHIMERIC ENGULFMENT RECEPTOR MOLECULES AND METHODS OF USE' on May 16, 2025. The allowed claims encompass a chimeric engulfment receptor comprising a TIM4 binding domain and TLR2 signaling domain. The allowance of this European patent application expands protection of additional design aspects of CER-1236, which have already been granted in the U.S., Japan, and China. Finally, the USPTO granted U.S. Patent No. 12,303,551, titled, 'CELLULAR IMMUNOTHERAPY COMPOSITIONS AND USES THEREOF,' on May 20, 2025. This patent provides coverage for combination cellular immunotherapy compositions and methods of use for CER-1236. The patent covers combination of a chimeric engulfment receptor CD4+ T cell (CD4+ CER-T cell) with a chimeric antigen receptor CD8+ T cell (CD8+ CAR-T cell) or T cell receptor CD8+ T cell (CD8+ TCR-T cell), and their use to treat cancer. This type of combination therapy could be an exciting avenue to complement the CER-T cell technology with other powerful anti-cancer therapies. CERo's intellectual property portfolio now includes 9 total patent families with protection out to 2042 in the United States. With these additional granted patents and allowed application, CER-1236 and its platform technology is supported by 18 total issued patents and allowed patent application internationally. Chris Ehrlich, CERo Therapeutics CEO, commented, 'We continue to aggressively expand our intellectual property portfolio, as it ensures CERo's success in the market. These patents protect the core innovations of the CER-T technology that differentiate it from other cell therapies and demonstrate the true novelty of our design . We continue to seek a robust range of patents across multiple geographies that cover this technology in general, and CER-1236 in particular. The appreciation of the novelty of the CER-T technology by the patent offices validates the innovation and therapeutic potential of this approach, and we believe that we will continue to grow the portfolio. In the near term, we anticipate updates on our clinical trial progress in AML, and the announcement of initiating human trials to treat ovarian and non-small cell lung cancers.' About CERo Therapeutics Holdings, Inc. CERo is an innovative immunotherapy company advancing the development of next generation engineered T cell therapeutics for the treatment of cancer. Its proprietary approach to T cell engineering, which enables it to integrate certain desirable characteristics of both innate and adaptive immunity into a single therapeutic construct, is designed to engage the body's full immune repertoire to achieve optimized cancer therapy. This novel cellular immunotherapy platform is expected to redirect patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells ('CER-T'). CERo believes the differentiated activity of CER-T cells will afford them greater therapeutic application than currently approved chimeric antigen receptor ('CAR-T') cell therapy, as the use of CER-T may potentially span both hematological malignancies and solid tumors. CERo has commenced clinical trials for its lead product candidate CER-1236 for hematological malignancies. Forward-Looking Statements This communication contains statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding the financial position, business strategy and the plans and objectives of management for future operations of CERo. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this communication, words such as 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'should,' 'strive,' 'would' and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When CERo discusses its strategies or plans, it is making projections, forecasts or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, CERo's management. Actual results could differ from those implied by the forward-looking statements in this communication. Certain risks that could cause actual results to differ are set forth in CERo's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and the documents incorporated by reference therein. The risks described in CERo's filings with the Securities and Exchange Commission are not exhaustive. New risk factors emerge from time to time, and it is not possible to predict all such risk factors, nor can CERo assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements made by CERo or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. CERo undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contact:Chris EhrlichChief Executive Officerchris@ Investors:CORE IRinvestors@
Yahoo
20-05-2025
- Business
- Yahoo
CureVac Announces Financial Results for the First Quarter of 2025 and Provides Business Updates
U.S. FDA clears lung cancer IND for CVHNLC, a proprietary off-the-shelf candidate targeting squamous non-small cell lung cancer (sqNCLC), with clinical study expected to begin H2 2025; Clinical Trial Application filed in Europe with decision expected in Q2 2025 Glioblastoma study fully enrolled with Part B of Phase 1 CVGBM trial completing enrolment in Q1 2025; go/no-go decision on moving to Phase 2 planned for H2 2025 First urinary tract infection vaccine moving forward with U.S. IND filing planned for H2 2025 Core mRNA patents upheld as European Patent Office confirmed validity of two key patents in amended form; infringement hearing against BioNTech/Pfizer before the Regional Court Düsseldorf set for July 1, 2025 Strong cash and cash equivalents position of €438.3 million as of March 31, 2025; reaffirming expected cash runway into 2028 TÜBINGEN, GERMANY and BOSTON, MA / ACCESS Newswire / May 20, 2025 / CureVac N.V. (Nasdaq:CVAC), a pioneering multinational biotech company developing a new class of transformative medicines based on messenger RNA (mRNA), today announced financial results for the first quarter of 2025 and provided a business update. "We entered 2025 with a strong momentum and robust balance sheet, driven by progress across our oncology and infectious disease programs, as well as successful execution of our strategic realignment," said Dr. Alexander Zehnder, Chief Executive Officer of CureVac. "With the FDA's clearance of the IND for our lung cancer program and our glioblastoma study fully enrolled, we are steadily advancing an oncology pipeline that addresses high-unmet-need tumors. At the same time, we believe the European Patent Office's recent rulings upholding two of our patents in amended form confirm the strength of our mRNA intellectual property estate. Backed by €438 million in cash, we are well positioned to unlock multiple pipeline catalysts later this year and continue to expand and execute on our next generation mRNA portfolio." Selected Business Updates Oncology CureVac is strengthening its oncology pipeline following two complementary approaches: off-the-shelf precision immunotherapies targeting tumor antigens shared across different patient populations and/or tumor types as well as fully personalized precision immunotherapies based on a patient's individual tumor genomic profile. CVGBM (glioblastoma): Data from Phase 1 Part B and the decision on advancing the program to Phase 2 remain on track for H2 2025. Enrolment was completed in Q1 2025 and data in H2 2025 is expected to include 20 patients with a follow up period of at least 6 months. CVHNLC (squamous non-small cell lung cancer): U.S. Phase 1 initiation anticipated in H2 2025 following receipt of FDA Investigational New Drug (IND) clearance; Clinical Trial Application (CTA) filed in Europe with decision expected Q2 2025. As previously communicated, first Phase 1 study with a personalized precision immunotherapy candidate expected to start in H2 2026. Prophylactic Vaccines Urinary tract infection (UTI) program announced in November 2024 progressing on track. FDA IND submission scheduled for H2 2025 and start of Phase 1 trial planned for H1 2026. Protection of Intellectual Property Rights European Patent Office largely dismisses, subject to amendments, oppositions filed in December 2023 by BioNTech SE, Pfizer Inc., and others challenging the validity of EP 3 708 668 B1 and EP 4 023 755 B1 with the infringement hearing scheduled for July 1, 2025, before the Regional Court Düsseldorf. A positive infringement decision would trigger proceedings to assess damages in the same court. Both patents EP 3 708 668 B1 and EP 4 023 755 B1 describe split poly-A tail technology, which enhances medical efficacy by improving expression of the protein encoded on an mRNA construct, a foundational invention of CureVac. As previously communicated, jury trial in U.S. litigation before the U.S. District Court of the Eastern District of Virginia is planned for September 8, 2025. Financial Update for the First Quarter of 2025 Cash Position Cash and cash equivalents amounted to €438.3 million at the end of March 2025, decreasing from €481.7 million at the end of December 2024. In the first three months 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. As a result of the strategic restructuring initiated in July 2024, the cash outflow for the first quarter of 2025 decreased compared to the first quarter of 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 €0.9 million for the first quarter of 2025, representing a decrease of €11.5 million from €12.4 million for the same period in 2024. The year-on-year decrease was primarily driven by lower revenues from GSK following the restructuring of the partnership in July 2024 from a Collaboration into a Licence Agreement as well as lower sales to CRISPR Therapeutics. For the three months ending March 31, 2025, total revenues of €0.3 million and €0.6 million were recognized with GSK and CRISPR Therapeutics, respectively, compared to €8.9 million and €3.5 million in the prior year period. Operating Result Operating loss amounted to €54.7 million for the first quarter of 2025, representing a decrease of €18.6 million from €73.3 million for the same period in 2024. The decrease year-over-year is primary attributable 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. R&D 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 decreased primarily due to 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 first quarter of 2025 amounted to €3.0 million, representing a decrease of €0.4 million from €3.4 million for the same period in 2024. Pre-Tax Loss Pre-tax loss was €51.7 million for the first quarter of 2025, compared to €69.9 million in the same period of 2024. About CureVac CureVac (Nasdaq:CVAC) 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 CureVac Media and Investor Relations Contact CureVac, Tübingen, GermanyT: +49 7071 9883-0communications@ 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 discussion of the potential efficacy of the company's vaccine and treatment candidates and the company's strategies, financing plans, cash runway expectations, timing of various milestones, the 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 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 and the company's and the company's collaborators' ability to obtain, maintain, defend and enforce such intellectual property, scope of intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect of exchange rates, delays in litigation proceedings, different 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 Cash and Condensed Consolidated Profit and Loss Data (in € millions) December 31, 2024 March 31, 2025 Cash and Cash Equivalents 481.7 438.3 Three months ended March 31, (in € millions) 2024 2025 Revenue 12.4 0.9 Cost of Sales, R&D, SG&A, Other Operating Expenses & Other Operating Income -85.7 -55.6 Operating Result -73.3 -54.7 Financial Result 3.4 3.0 Pre-Tax Loss -69.9 -51.7 SOURCE: CureVac View the original press release on ACCESS Newswire Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
20-05-2025
- Business
- Yahoo
CureVac Announces Financial Results for the First Quarter of 2025 and Provides Business Updates
U.S. FDA clears lung cancer IND for CVHNLC, a proprietary off-the-shelf candidate targeting squamous non-small cell lung cancer (sqNCLC), with clinical study expected to begin H2 2025; Clinical Trial Application filed in Europe with decision expected in Q2 2025 Glioblastoma study fully enrolled with Part B of Phase 1 CVGBM trial completing enrolment in Q1 2025; go/no-go decision on moving to Phase 2 planned for H2 2025 First urinary tract infection vaccine moving forward with U.S. IND filing planned for H2 2025 Core mRNA patents upheld as European Patent Office confirmed validity of two key patents in amended form; infringement hearing against BioNTech/Pfizer before the Regional Court Düsseldorf set for July 1, 2025 Strong cash and cash equivalents position of €438.3 million as of March 31, 2025; reaffirming expected cash runway into 2028 TÜBINGEN, GERMANY and BOSTON, MA / ACCESS Newswire / May 20, 2025 / CureVac N.V. (Nasdaq:CVAC), a pioneering multinational biotech company developing a new class of transformative medicines based on messenger RNA (mRNA), today announced financial results for the first quarter of 2025 and provided a business update. "We entered 2025 with a strong momentum and robust balance sheet, driven by progress across our oncology and infectious disease programs, as well as successful execution of our strategic realignment," said Dr. Alexander Zehnder, Chief Executive Officer of CureVac. "With the FDA's clearance of the IND for our lung cancer program and our glioblastoma study fully enrolled, we are steadily advancing an oncology pipeline that addresses high-unmet-need tumors. At the same time, we believe the European Patent Office's recent rulings upholding two of our patents in amended form confirm the strength of our mRNA intellectual property estate. Backed by €438 million in cash, we are well positioned to unlock multiple pipeline catalysts later this year and continue to expand and execute on our next generation mRNA portfolio." Selected Business Updates Oncology CureVac is strengthening its oncology pipeline following two complementary approaches: off-the-shelf precision immunotherapies targeting tumor antigens shared across different patient populations and/or tumor types as well as fully personalized precision immunotherapies based on a patient's individual tumor genomic profile. CVGBM (glioblastoma): Data from Phase 1 Part B and the decision on advancing the program to Phase 2 remain on track for H2 2025. Enrolment was completed in Q1 2025 and data in H2 2025 is expected to include 20 patients with a follow up period of at least 6 months. CVHNLC (squamous non-small cell lung cancer): U.S. Phase 1 initiation anticipated in H2 2025 following receipt of FDA Investigational New Drug (IND) clearance; Clinical Trial Application (CTA) filed in Europe with decision expected Q2 2025. As previously communicated, first Phase 1 study with a personalized precision immunotherapy candidate expected to start in H2 2026. Prophylactic Vaccines Urinary tract infection (UTI) program announced in November 2024 progressing on track. FDA IND submission scheduled for H2 2025 and start of Phase 1 trial planned for H1 2026. Protection of Intellectual Property Rights European Patent Office largely dismisses, subject to amendments, oppositions filed in December 2023 by BioNTech SE, Pfizer Inc., and others challenging the validity of EP 3 708 668 B1 and EP 4 023 755 B1 with the infringement hearing scheduled for July 1, 2025, before the Regional Court Düsseldorf. A positive infringement decision would trigger proceedings to assess damages in the same court. Both patents EP 3 708 668 B1 and EP 4 023 755 B1 describe split poly-A tail technology, which enhances medical efficacy by improving expression of the protein encoded on an mRNA construct, a foundational invention of CureVac. As previously communicated, jury trial in U.S. litigation before the U.S. District Court of the Eastern District of Virginia is planned for September 8, 2025. Financial Update for the First Quarter of 2025 Cash Position Cash and cash equivalents amounted to €438.3 million at the end of March 2025, decreasing from €481.7 million at the end of December 2024. In the first three months 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. As a result of the strategic restructuring initiated in July 2024, the cash outflow for the first quarter of 2025 decreased compared to the first quarter of 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 €0.9 million for the first quarter of 2025, representing a decrease of €11.5 million from €12.4 million for the same period in 2024. The year-on-year decrease was primarily driven by lower revenues from GSK following the restructuring of the partnership in July 2024 from a Collaboration into a Licence Agreement as well as lower sales to CRISPR Therapeutics. For the three months ending March 31, 2025, total revenues of €0.3 million and €0.6 million were recognized with GSK and CRISPR Therapeutics, respectively, compared to €8.9 million and €3.5 million in the prior year period. Operating Result Operating loss amounted to €54.7 million for the first quarter of 2025, representing a decrease of €18.6 million from €73.3 million for the same period in 2024. The decrease year-over-year is primary attributable 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. R&D 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 decreased primarily due to 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 first quarter of 2025 amounted to €3.0 million, representing a decrease of €0.4 million from €3.4 million for the same period in 2024. Pre-Tax Loss Pre-tax loss was €51.7 million for the first quarter of 2025, compared to €69.9 million in the same period of 2024. About CureVac CureVac (Nasdaq:CVAC) 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 CureVac Media and Investor Relations Contact CureVac, Tübingen, GermanyT: +49 7071 9883-0communications@ 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 discussion of the potential efficacy of the company's vaccine and treatment candidates and the company's strategies, financing plans, cash runway expectations, timing of various milestones, the 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 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 and the company's and the company's collaborators' ability to obtain, maintain, defend and enforce such intellectual property, scope of intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect of exchange rates, delays in litigation proceedings, different 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 Cash and Condensed Consolidated Profit and Loss Data (in € millions) December 31, 2024 March 31, 2025 Cash and Cash Equivalents 481.7 438.3 Three months ended March 31, (in € millions) 2024 2025 Revenue 12.4 0.9 Cost of Sales, R&D, SG&A, Other Operating Expenses & Other Operating Income -85.7 -55.6 Operating Result -73.3 -54.7 Financial Result 3.4 3.0 Pre-Tax Loss -69.9 -51.7 SOURCE: CureVac View the original press release on ACCESS Newswire Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
15-05-2025
- Business
- Yahoo
CureVac Receives Additional Positive Validity Decision from European Patent Office in Ongoing Litigation Against BioNTech SE
European Patent Office largely dismisses opposition filed by BioNTech SE, Pfizer Inc., and others in December 2023 challenging validity of EP 4 023 755 B1 and maintains the patent subject to amendments to specific patent claims A hearing on infringement of EP 4 023 755 B1 which will also include EP 3 708 668 B1, the validity of which was confirmed in amended form in March 2025, is scheduled for July 1, 2025, before the Regional Court Düsseldorf, Germany TUBINGEN, GERMANY AND BOSTON, MA / / May 15, 2025 / CureVac N.V. (NASDAQ:CVAC) ("CureVac"), a global biotech company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that the European Patent Office (EPO) has confirmed the validity of CureVac's European patent EP 4 023 755 B1 subject to amendments to specify the scope of protection. This validity decision marks the second time the EPO has ruled in favor of CureVac, having decided in March to uphold the validity of patent EP 3 708 668 B1 also in amended form. Following today's hearing, the EPO opposition division dismissed the oppositions and maintained the patent in amended form. The ruling signals a positive development for CureVac in the ongoing patent litigation with BioNTech in Germany. The dispute encompasses a total of six intellectual property rights. With the validity of patent EP 4 023 755 B1 upheld in amended form, the Regional Court Düsseldorf will decide whether the patent in its amended form has been infringed. In the same hearing, taking place on July 1, 2025, the Court will hear the arguments on infringement of EP 3 708 668 B1, with a decision to come at a later date. A positive infringement decision on either or both patents would trigger proceedings to assess damages in the same court. Like EP 3 708 668 B1, patent EP 4 023 755 B1 describes split poly-A tail technology, which enhances medical efficacy by improving expression of the protein encoded on an mRNA construct, a foundational invention of CureVac. CureVac is represented in Germany by Oliver Jan Jüngst from Bird & Bird LLP and Andreas Graf von Stosch from Graf von Stosch Patentanwaltsgesellschaft and represented in the U.S. by Mark H. Izraelewicz from Marshall, Gerstein & Borun LLP and John M. Erbach from Spotts Fain, PC. About CureVac CureVac (Nasdaq:CVAC) 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 cancer vaccine product candidates. 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 CureVac Media and Investor Relations Contact Corporate Communications and Investor RelationsCureVac, Tübingen, GermanyT: +49 7071 9883 - 0communications@ Forward-Looking Statements 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 discussion of the strength of the company's intellectual property portfolio and plans for resolving certain intellectual property matters, potential efficacy of the company's vaccine and treatment candidates and the company's strategies and court judgements. 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 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 and the company's and the company's collaborators' ability to obtain, maintain, defend and enforce such intellectual property, scope of intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect of exchange rates, delays in litigation proceedings, different judicial outcomes factors 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 SOURCE: CureVac View the original press release on ACCESS Newswire Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
13-05-2025
- Automotive
- Yahoo
Electric Ferraris look set to get fake gearbox and engine sounds
Two recent patent applications suggest Ferrari is working on a virtual engine and gear-shift system for its upcoming electric vehicles. The patent specifications were filed with the European Patent Office headquartered in Munich in September last year but only recently published and reported on by automotive industry media. The patent with the number EP 4 527 667 A1 would see Ferrari using an electric motor to emulate the torque output of an internal combustion engine and the shifting processes of a gearbox. When the fake gearbox technology "shifts" and when it does not, or which virtual gear it selects, depends on the respective engine torque and the accelerator pedal position. However, it also allows simulated manual gear changes, which can be carried out via steering wheel paddles. Another patent, EP 4 523 947 A1, describes the coupled sound system with interior and exterior loudspeakers. This allows a digitally generated engine sound to be reproduced and according to the patent specification, this can be "historical, modern or futuristic, adrenaline-fuelled or relaxed" depending on preference. The gear changes are also acoustically accompanied. The system is also said to have a function with which other engine sounds can be recorded and played back. Ferrari is still fettling an electric car to bear the prancing horse badge, but brand boss Benedetto Vigna has said the finished car should go on sale in October 2026, if all goes well. Filing patents does not guarantee that the new EV will have the features described, but the company has repeatedly said it wants its battery electrics to match the emotional experience of its traditional, internal-combustion cars. Ferrari is not the first to go down this road either. Hyundai installed an 8,000-rpm turbocharged four-cylinder and eight-speed dual-clutch gearbox in the Ioniq 5 N. It pegs the torque output of its electric motor to give the driver a similar sensation to a combustion engine. The car can also manage either automated simulated shifts, or driver-controlled manual shifts via the paddles behind the steering wheel. In the US, Dodge also has an external and internal device to produce noise for its new Charger Daytona EV but it's a purely aural system, with no simulated torque outputs or gear-shifts. BMW has said it is developing something like the Hyundai system, but Porsche has been clear that it will not jump on this technical bandwagon.
