Metabolic Disease: When Biology Advances, but Care Lags
These disorders disrupt energy metabolism and alter the mechanisms for generating, storing, and utilizing energy. T2D is characterized by insulin resistance and chronic hyperglycemia. Obesity exacerbates insulin resistance and triggers persistent low-grade inflammation, leading to compounded metabolic dysfunctions. Currently, 39% of adults are overweight, and 13% are classified as obese.
Metabolic syndromes include abdominal obesity, hypertension, dyslipidemia, and insulin resistance, together with a significantly increased risk for cardiovascular disease and T2D. This rising prevalence is driven by population aging and unhealthy lifestyles. Nonalcoholic fatty liver disease, also known as metabolic dysfunction-associated steatotic liver disease (MASLD), is a common complication of metabolic syndrome and is among the top causes of chronic liver disease globally.
Coexisting T2D, obesity, and metabolic syndrome sharply increase the risk for myocardial infarction, stroke, kidney failure, and neuropathy. This cluster leads to severe health consequences and increased costs, reinforcing the need for integrated preventive and therapeutic strategies.
Therapeutic Approaches
Current treatments for metabolic diseases, particularly T2D, include metformin; SGLT2 inhibitors such as empagliflozin, canagliflozin, and dapagliflozin; and GLP‑1 agonists, for example, liraglutide, semaglutide, and dulaglutide. Metformin remains the first-line therapy due to its proven efficacy, low cost, and tolerability. SGLT2 inhibitors lower blood glucose levels by increasing urinary glucose excretion and offer added benefits for weight and cardiovascular health but may increase the risk for urinary and genital infections. GLP‑1 agonists improve glycemic control and support weight loss and cardiovascular protection, although they often cause gastrointestinal side effects. Emerging therapies include dual GLP‑1/glucose-dependent insulinotropic polypeptide (GIP) agonists such as tirzepatide and triple agonists targeting GLP‑1, GIP, and glucagon, which aim to enhance efficacy, improve weight loss, and reduce dosing frequency to support better treatment adherence.
Research Highlights
Recent findings have reshaped the understanding and management of metabolic diseases by targeting the underlying biological mechanisms. Mitochondrial dysfunction in adipose tissue is a key contributor to insulin resistance in patients with T2D. Thus, enhancing mitochondrial biogenesis and function may offer an effective therapeutic strategy for treating these diseases. Disruption of circadian rhythms impairs energy metabolism and worsens obesity, T2D, and metabolic syndrome, supporting the use of chronotherapy by aligning meals, light exposure, and medication timing with the body's natural rhythms. A 2024 report, 'Heart Disease and Stroke Statistics,' provides comprehensive data on cardiovascular health and its link with metabolic diseases. This report underscores the importance of therapies that address both glucose regulation and subclinical vascular damage associated with metabolic conditions. A review in Frontiers in Medicine identified insulin resistance as a central factor in metabolic diseases and explored gut microbiome-based therapies for MASLD, including probiotics, prebiotics, targeted antibiotics, and fecal transplantation. Patient phenotype-based treatment was proposed to improve outcomes in T2D, aiming to tailor therapies based on individual metabolic profiles. Advances in imaging and biomarkers have been highlighted for the early detection of metabolic disorders, enabling timely intervention before the development of clinical symptoms.
Therapeutic Innovations
Gene therapy and gut-liver axis modulation improve insulin sensitivity and reduce liver fat in MASLD models, although safety and durability remain challenging. Dual and triple agonists targeting GLP‑1, GIP, and glucagon receptors improve glycemic control, weight loss, and cardiovascular health. These therapies may also alter gene expression through epigenetic mechanisms, thereby supporting personalized treatment approaches.
Early metabolic changes are linked to vascular damage, supporting early intervention in at-risk patients. mRNA therapies delivered via lipid nanoparticles improve glucose control with fewer side effects in diabetes models. Triple agonists show superior metabolic control, weight loss, and cardiovascular benefits, with better adherence and tolerability.
Future Challenges
Despite recent advances in the treatment of metabolic diseases, several barriers have hindered the widespread adoption of new therapies. A recent analysis highlighted the need for long-term clinical trials to validate therapies that target mitochondrial function in humans. Similarly, the implementation of personalized chronotherapy based on circadian rhythms remains technically and clinically challenging. In cardiovascular care, early vascular damage in young individuals at metabolic risk often goes undetected, delaying preventive intervention. Microbiome-based treatments for MASLD also face limitations due to individual variability and the lack of standardized protocols.
Environmental factors, such as diet and stress, can amplify gene expression linked to metabolic disorders, underscoring the need for multisectoral prevention strategies. Phenotypic classification of T2D could support personalized care, but its implementation requires resources and infrastructure that are not widely available. Advanced metabolic imaging and molecular diagnostics are still inaccessible with many limited resources, restricting early detection and personalized treatment. The long-term use of GLP-1 agonists may be limited by gastrointestinal side effects in some patients, highlighting the need for more precise therapeutic selection.
Triple GLP-1/GIP/glucagon agonists show strong potential but are costly and lack data in diverse populations, limiting global rollout. High costs, investment needs for gene and mRNA therapies, gaps in medical training, and public awareness are significant barriers. Addressing these challenges requires sustainable care models and innovative financing policies. Furthermore, the ongoing training of medical personnel and public education campaigns are key to ensuring effective prevention, early diagnosis, and equitable application of recent therapeutic advances.
Conclusions
Advances in the understanding of mitochondrial dysfunction, circadian rhythms, and the gut microbiome are transforming the management of metabolic diseases into clinical practice. Gene therapy and mRNA-based treatments show promise for T2D, obesity, and MASLD; however, further research is required to confirm their safety, effectiveness, and long-term outcomes.
Standard treatments, such as metformin, SGLT2 inhibitors, and GLP-1 agonists, remain widely used, whereas newer dual and triple agonists offer additional benefits for glycemic control, weight loss, and cardiovascular protection. Personalized medicine based on phenotypic and molecular data may improve treatment outcomes but faces logistical, technological, and economic barriers.
Limited access to advanced therapies in low- and middle-income countries highlights the global equity gap, which necessitates innovative public funding and sustainable care models. Strengthening diagnostic capacity, medical education, and public awareness are key to improving prevention, early diagnosis, and treatment.
A coordinated global effort involving healthcare professionals, policymakers, researchers, and communities is essential to ensure that new therapies lead to meaningful and equitable improvements in public health.
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BioNTech Announces Second Quarter 2025 Financial Results and Corporate Update
Continued execution of BioNTech's oncology strategy with focus on two pan-tumor programs including two announced transactions: mRNA-based cancer immunotherapy candidates and BNT327, a bispecific antibody candidate targeting PD-L11 and VEGF-A Entered a global strategic co-development and co-commercialization collaboration with Bristol Myers Squibb ('BMS') to jointly execute a broad clinical development program to evaluate and advance BNT327 across numerous solid tumor types Announced strategic transaction to acquire CureVac N.V. ('CureVac') to strengthen the research, development, manufacturing and commercialization of mRNA-based cancer immunotherapy candidates Presented multiple clinical updates across diversified oncology pipeline at medical meetings validating the Company's oncology combination strategy Approval received for new variant-adapted COVID-19 vaccine by the European Commission ('EC'); further launch preparation underway as recommended by regulators, with deliveries expected to be ready as early as August, subject to regulatory approval in respective markets Second quarter 2025 revenues of €0.3 billion2, net loss of €0.4 billion and basic and diluted loss per share of €1.60 ($1.823) Maintained strong financial position with €16.0 billion in cash, cash equivalents and security investments as of June 30, 2025; Partnership with Bristol Myers Squibb expected4 to further strengthen BioNTech's financial position with $1.5 billion expected to be reflected in third quarter 2025 cash position Full year 2025 financial guidance reaffirmed5 Conference call and webcast scheduled for August 4, 2025, at 8:00 a.m. EDT (2:00 p.m. CEST) MAINZ, Germany, August 4, 2025 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, 'BioNTech' or 'the Company') today reported financial results for the six months ended June 30, 2025 and provided an update on its corporate progress. 'In the second quarter, we took significant steps to advance BioNTech into a multiproduct biotechnology company by strengthening the two pillars of our oncology strategy,' said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. 'We entered into a collaboration with BMS to accelerate and expand the development of our PD-L1xVEGF-A bispecific antibody candidate BNT327 and announced a strategic transaction to acquire CureVac to complement our own capabilities and proprietary technologies in mRNA design, delivery formulations, and mRNA manufacturing. These transformative transactions contribute to our mission of delivering truly transformative options for patients in need.' Financial Review for Second Quarter and First Half of 2025 in millions €, except per share data Second Quarter 2025 Second Quarter 2024 First Half 2025 First Half2024 Revenues 260.8 128.7 443.6 316.3 Net loss (386.6) (807.8) (802.4) (1,122.9) Basic and diluted loss per share (1.60) (3.36) (3.33) (4.67) Revenues for the three months ended June 30, 2025, were €260.8 million, compared to €128.7 million for the comparative prior year period. For the six months ended June 30, 2025, revenues were €443.6 million, compared to €316.3 million for the comparative prior year period. The increases were mainly driven by higher revenues derived from BioNTech's COVID-19 vaccine collaboration. Research and development ('R&D') expenses were €509.1 million for the three months ended June 30, 2025, compared to €584.6 million for the comparative prior year period. For the six months ended June 30, 2025, R&D expenses were €1,034.7 million, compared to €1,092.1 million for the comparative prior year period. The decreases were mainly driven by the reprioritization of clinical trials towards focus programs. Sales, general and administrative ('SG&A') expenses, in total, amounted to €137.4 million for the three months ended June 30, 2025, compared to €183.8 million for the comparative prior year period. For the six months ended June 30, 2025, SG&A expenses were €258.0 million, compared to €316.4 million for the comparative prior year period. The decreases were primarily driven by a reduction in external services. Net loss was €386.6 million for the three months ended June 30, 2025, compared to a net loss of €807.8 million for the comparative prior year period. For the six months ended June 30, 2025, net loss was €802.4 million, compared to a net loss of €1,122.9 million for the comparative prior year and diluted loss per share was €1.60 for the three months ended June 30, 2025, compared to a basic and diluted loss per share of €3.36 for the comparative prior year period. For the six months ended June 30, 2025, basic and diluted loss per share was €3.33, compared to a basic and diluted loss per share of €4.67 for the comparative prior year period. Cash and cash equivalents plus security investments as of June 30, 2025, reached €15,989.3 million, comprising €10,269.5 million in cash and cash equivalents, €3,363.8 million in current security investments and €2,356.0 million in non-current security investments. Shares outstanding as of June 30, 2025, were 240,398,724, excluding 8,153,476 shares held in treasury. 'Joining BioNTech is a privilege, especially during this decisive phase in which we aim to capitalize on our innovative pipeline with clear strategic focus. While we continue to significantly invest into the execution of our strategy, our commitment to operational and financial discipline is starting to show tangible results,' said Ramón Zapata, Chief Financial Officer at BioNTech. 'With the strategic BMS collaboration we will further strengthen our topline and cash position. As such, we will receive an upfront cash-payment of $1.5 billion in Q3 that we anticipate to be recognized as revenue over the development phase of BNT327.' Anticipated Financial Effect4 of the BMS Partnership As part of the agreement with BMS, BioNTech expects to receive $1.5 billion in an upfront cash payment this year, and for this payment to be reflected in the Company's reported cash position as of the third quarter 2025. BioNTech also expects to receive $2.0 billion in total non-contingent anniversary cash payments from 2026 through 2028. The upfront and non-contingent cash payments, amounting to $3.5 billion, are expected to be recognized as revenues over the development phase of BNT327. In addition, BioNTech will be eligible to receive up to $7.6 billion in development, regulatory and commercial milestones, with the majority of milestone payments expected to be triggered upon approvals and during commercialization. All milestones payments are anticipated to be reflected in the Company's cash position and to be recognized as revenues following milestone achievement. Under the agreement, BioNTech and BMS will share joint development and manufacturing costs of BNT327 on a 50:50 basis, subject to certain exceptions. Global profits and losses will be equally shared between BioNTech and BMS. 2025 Financial Year Guidance Reaffirmed5: Revenues for the 2025 financial year €1,700 million - €2,200 million BioNTech expects its revenues for the full 2025 financial year to be in the range of €1,700 - €2,200 million and revenue phasing primarily concentrated in the last three to four months, driving the full year revenue figure. The revenue guidance assumes: relatively stable pricing and market share as compared to 2024; inventory write-downs and other charges estimated to be approximately 15% of BioNTech's share of gross profit from COVID-19 vaccines sales in Pfizer Inc.'s ('Pfizer') territory; anticipated revenues from a pandemic preparedness contract with the German government, from collaborations and from the BioNTech Group service businesses. Current and potential further developments in law, public policy, international trade, and public sentiment as they continue to evolve could further negatively impact the anticipated COVID-19 vaccine revenues and expenses. Planned 2025 Financial Year Expenses and Capex R&D expenses €2,600 million - €2,800 million SG&A expenses €650 million - €750 million Capital expenditures for operating activities €250 million - €350 million BioNTech expects to continuously focus investments on R&D and scaling the business for late-stage development and commercial readiness in oncology, while remaining cost-disciplined. Strategic capital allocation will continue to be a key driver of the Company's trajectory. As part of BioNTech's strategy, the Company may continue to evaluate appropriate corporate development opportunities with the aim of driving sustainable long-term growth and create future value. The full interim unaudited condensed consolidated financial statements can be found in BioNTech's Report on Form 6-K for the period ended June 30, 2025, filed today with the United States Securities and Exchange Commission ('SEC') and is available at Endnotes1 An overview of target abbreviations is compiled in a directory at the end of this press release.2 All numbers in this press release have been rounded.3 Calculated applying the average foreign exchange rate for the three months ended June 30, 2025, as published by the German Central Bank (Deutsche Bundesbank).4 These statements, including the anticipated timing of certain events, are based on BioNTech's current expectations regarding the BMS collaboration and are subject to the successful co-development, approval and co-commercialization of BNT327. These statements are also based in part on assumptions and judgments that the Company has made, which may be subject to significant uncertainties. Although the Company's approach to revenue recognition is based on facts and circumstances known to the Company and various other assumptions that the Company believes to be reasonable under the circumstances, the revenue assessment is ongoing, and its actual results may deviate from its current expectations. Revenue of initially constrained milestone payments may be recognized at the point of satisfaction or over time, including catch-up effects for prior periods as applicable. More information can be found in BioNTech's Report on Form 6-K for the three and six months ended June 30, 2025, filed today, and in BioNTech's Report on Form 20-F for the year ended December 31, 2024 filed on March 10, 2025, both of which are available at Financial guidance excludes external risks that are not yet known and/or quantifiable, including, but not limited to the effects of ongoing and/or future legal disputes and related activities as well as certain potential one-time effects and charges related to portfolio prioritization. It includes effects identified from licensing arrangements, collaborations and M&A transactions to the extent disclosed and completed and may be subject to update. It excludes the effect of the announced transaction to acquire CureVac, which is ongoing. The Company does not expect to report a positive net income figure for the 2025 financial year. These statements are also based in part on assumptions and judgments that the Company has made, which may be subject to significant uncertainties. Although the Company's approach to revenue recognition is based on facts and circumstances known to the Company and various other assumptions that the Company believes to be reasonable under the circumstances, the revenue assessment is ongoing and its actual results may deviate from its current expectations. Operational Review for the Second Quarter 2025, Key Post Period-End Events and 2025 Outlook Variant-adapted COVID-19 Vaccine BioNTech and Pfizer have submitted regulatory applications to the European Medicines Agency ('EMA') and to the United States Food and Drug Administration ('FDA') for approval of their LP.8.1-adapted monovalent COVID-19 vaccine for the 2025-2026 vaccination season. In July, BioNTech and Pfizer's LP.8.1-adapted monovalent COVID-19 vaccine was approved by the European Commission following recommendation for marketing authorization by the EMA's Committee for Medicinal Products for Human Use ('CHMP'). The new variant-adapted COVID-19 vaccine will be ready to ship to applicable EU member states in August. Selected Oncology Pipeline Updates Next-Generation Immunomodulators and Combinations BNT327 is a bispecific antibody candidate combining PD-L1 checkpoint inhibition with VEGF-A neutralization. A global Phase 3 clinical trial (ROSETTA Lung-01; NCT06712355) is being conducted to evaluate BNT327 as a first-line treatment in combination with chemotherapy compared to atezolizumab in combination with chemotherapy in patients with untreated extensive-stage small cell lung cancer ('ES-SCLC'). A global Phase 2 clinical trial (NCT06449209) to evaluate BNT327 in combination with chemotherapy in patients with untreated ES-SCLC and in patients with SCLC whose disease progressed after first- or second-line treatment is fully enrolled and treatment is ongoing. Data from this clinical trial is expected in 2025. In June, BNT327 received Orphan Drug Designation from the FDA for the treatment of SCLC. A global Phase 2/3 clinical trial (ROSETTA Lung-02; NCT06712316) is being conducted to evaluate BNT327 in combination with chemotherapy compared to pembrolizumab and chemotherapy in patients with first-line non-small cell lung cancer ('NSCLC'). A global Phase 2 clinical trial (NCT06449222) is being conducted to evaluate BNT327 in combination with chemotherapy as a first- and second-line treatment for patients with locally advanced or metastatic triple-negative breast cancer ('TNBC'). Data from this clinical trial is expected in 2025. A global Phase 3 clinical trial in patients with first-line TNBC (ROSETTA Breast-01) is planned to start in 2025. In June, at the 2025 American Society of Clinical Oncology ('ASCO') Annual Meeting, preliminary data were presented from an ongoing Phase 2 clinical trial (NCT05918107) evaluating BNT327 in combination with chemotherapy in first-line mesothelioma. The preliminary data indicated anti-tumor activity and a manageable safety profile. Two trial-in-progress posters were also presented for ROSETTA Lung-01 and ROSETTA Lung-02. In the last quarter, BioNTech initiated several signal-seeking clinical trials to evaluate BNT327 with the Company's proprietary novel assets: In May, the first patient was dosed in a Phase 1/2 clinical trial (NCT06827236) evaluating BNT327 in combination with BioNTech and Duality Biologics (Suzhou) Co. Ltd.'s ('DualityBio') HER2 antibody-drug conjugate ('ADC') candidate BNT323/DB-1303 in patients with HR+ or HR-, HER2-low, ultra-low, or null advanced metastatic breast cancer or TNBC. In May, the first patient was dosed in a Phase 1/2 clinical trial (NCT06892548) evaluating BNT327 in combination with BioNTech and DualityBio's B7-H3 ADC candidate BNT324/DB-1311 in patients with advanced lung cancers. In July, the first patient was dosed in a Phase 2 clinical trial (NCT06953089) evaluating BNT324/DB-1311 in combination with BNT327 or with BioNTech and DualityBio's TROP2 ADC candidate BNT325/DB-1305 in patients with advanced solid tumors. A Phase 1/2 clinical trial (NCT07070232) to evaluate BNT327 in combination with BioNTech and MediLink Therapeutics's ('MediLink') HER3 ADC candidate BNT326/YL202 and BNT326/YL202 as monotherapy in advanced solid tumors is expected to start in 2025. A Phase 1/2 clinical trial (NCT07079631) to evaluate BNT327 and/or chemotherapy in combination with BioNTech and Genmab AS's ('Genmab') novel EpCAM x 4-1BB bispecific antibody BNT314/GEN1059 in patients with advanced colorectal cancer is expected to start in 2025. Antibody-Drug Conjugates BNT323/DB-1303 (trastuzumab pamirtecan) is an ADC candidate targeting HER2 that is being developed in collaboration with DualityBio. A Phase 1/2 clinical trial (NCT05150691) is being conducted to evaluate BNT323/DB-1303 in patients with advanced HER2-expressing tumors. A potentially registrational cohort with HER2-expressing (IHC3+, 2+, 1+ or ISH-positive) patients with recurrent endometrial cancer is ongoing. Data are planned to be shared at a medical conference in 2026. A global Phase 3 clinical trial (NCT06340568) to evaluate BNT323/DB-1303 in patients with advanced endometrial cancer is expected to start in 2025. BNT324/DB-1311 is an B7-H3-targeted ADC candidate that is being developed in collaboration with DualityBio. In June, preliminary data from the ongoing Phase 1/2 clinical trial (NCT05914116) evaluating BNT324/DB-1311 in patients with advanced solid tumors were presented at the 2025 ASCO Annual Meeting. In 73 patients with heavily pretreated castration-resistant prostate cancer ('CRPC'), BNT324/DB-1311 was observed to have a manageable safety profile and showed encouraging preliminary clinical activity. mRNA Cancer Immunotherapies BNT116 is based on BioNTech's fully owned, off-the-shelf FixVac platform, and is designed to elicit an immune response to six tumor-associated antigens that were identified to be frequently expressed in NSCLC. A Phase 1 clinical trial (LuCa-MERIT-1; NCT05142189) is being conducted in collaboration with Regeneron Pharmaceuticals Inc. ('Regeneron') to evaluate BNT116 as monotherapy and in several combinations including with chemotherapy, cemiplimab, and some of BioNTech's proprietary assets across various treatment lines and clinical settings in patients with NSCLC. In May, the first patient was dosed in a new cohort in the LuCa-MERIT-1 clinical trial to evaluate BNT116 in combination with BNT324/DB-1311. Data from a cohort from the LuCa-MERIT-1 clinical trial evaluating BNT116 in combination with cemiplimab in patients with NSCLC who have received chemoradiotherapy will be provided in a mini-oral session at the 2025 World Conference on Lung Cancer ('WCLC') in Barcelona, Spain, September 6-9, 2025. Corporate Update for the Second Quarter 2025 In June, BioNTech and BMS entered into an agreement for the global co-development and co-commercialization of BNT327 across numerous solid tumor types. Under the agreement, BMS will pay BioNTech $1.5 billion in an upfront cash payment and $2 billion total in non-contingent anniversary payments from 2026 through 2028. In addition, BioNTech will be eligible to receive up to $7.6 billion in additional development, regulatory and commercial milestones. In June, BioNTech entered into a definitive Purchase Agreement pursuant to which BioNTech intends to acquire all of the shares of CureVac, a clinical-stage biotech company developing a novel class of transformative medicines in oncology and infectious diseases based on mRNA. The transaction is expected to close in 2025. In May, BioNTech signed a grant agreement with the United Kingdom ('UK') Government to broaden the Company's R&D activities for innovative medicines in the UK. As part of the agreement, BioNTech is committed to investing up to £1 billion over the next 10 years. The Company's efforts will be supported by a grant of up to £129 million for a period of 10 years by the UK Government, which marks one of the largest grants of its kind in UK history for a pharmaceutical company. Upcoming Investor and Analyst Events AI Day: October 1, 2025, in London, United Kingdom Innovation Series R&D Day: November 11, 2025, in New York City, United States Conference Call and Webcast Information BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, August 4, 2025, at 8:00 a.m. EDT (2:00 p.m. CEST) to report its financial results and provide a corporate update for the second quarter of 2025. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN number will be provided. The slide presentation and audio of the webcast will be available via this link. Participants may also access the slides and the webcast of the conference call via the 'Events & Presentations' page of the Investor section of the Company's website at A replay of the webcast will be made available shortly after the closing of the call and archived on the Company's website for 30 days following the call. About BioNTechBiopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies. Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Bristol Myers Squibb, Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron. For more information, please visit Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: BioNTech's expected revenues and net profit/(loss) related to sales of BioNTech's COVID-19 vaccine in territories controlled by BioNTech's collaboration partners, particularly for those figures that are derived from preliminary estimates provided by BioNTech's partners; the rate and degree of market acceptance of BioNTech's COVID-19 vaccine and, if approved, BioNTech's investigational medicines; expectations regarding anticipated changes in COVID-19 vaccine demand, including changes to the ordering environment and expected regulatory recommendations to adapt vaccines to address new variants or sublineages; the initiation, timing, progress, results, and cost of BioNTech's research and development programs, including BioNTech's current and future preclinical studies and clinical trials, including statements regarding the expected timing of initiation, enrollment, and completion of studies or clinical trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations; BioNTech's expectations regarding potential future commercialization in oncology, including goals regarding timing and indications; the targeted timing and number of additional potentially registrational clinical trials, and the registrational potential of any clinical trial BioNTech may initiate; discussions with regulatory agencies; BioNTech's expectations with respect to intellectual property; the impact of BioNTech's collaboration and licensing agreements, including BioNTech's partnership with Bristol Myers Squibb; BioNTech's planned acquisition of CureVac; the development, nature and feasibility of sustainable vaccine production and supply solutions; the deployment of AI across BioNTech's preclinical and clinical operations; BioNTech's expectations with respect to developments in law, public policy, and international trade; BioNTech's estimates of revenues, research and development expenses, selling, general and administrative expenses and capital expenditures for operating activities; BioNTech's expectations regarding upcoming payments relating to litigation settlements; BioNTech's expectations for upcoming scientific and investor presentations; and BioNTech's expectations of net profit / (loss). In some cases, forward-looking statements can be identified by terminology such as 'will,' 'may,' 'should,' 'expects,' 'intends,' 'plans,' 'aims,' 'anticipates,' 'believes,' 'estimates,' 'predicts,' 'potential,' 'continue,' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are based on BioNTech's current expectations and beliefs of future events, and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech's control and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, projected data release timelines, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; BioNTech's pricing and coverage negotiations regarding its COVID-19 vaccine with governmental authorities, private health insurers and other third-party payors; the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine; the impact of tariffs and escalations in trade policy; competition from other COVID-19 vaccines or related to BioNTech's other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the timing of and BioNTech's ability to obtain and maintain regulatory approval for its product candidates; the ability of BioNTech's COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech's and its counterparties' ability to manage and source necessary energy resources; BioNTech's ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech's third-party collaborators to continue research and development activities relating to BioNTech's development candidates and investigational medicines; the impact of COVID-19 on BioNTech's development programs, supply chain, collaborators and financial performance; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech's and its collaborators' ability to commercialize and market BioNTech's COVID-19 vaccine and, if approved, its product candidates; BioNTech's ability to manage its development and related expenses; regulatory and political developments; BioNTech's ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time. You should review the risks and uncertainties described under the heading 'Risk Factors' in BioNTech's Report on Form 6-K for the period ended June 30, 2025 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC's website at These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. CONTACTS Investor RelationsDouglas Maffei, PhDInvestors@ Media Relations Jasmina Alatovic Media@ Target Overview B7-H3 Also known as CD276, cluster of differentiation 276 EpCAM Epithelial cell adhesion molecule HER2 (or HER3) Human epidermal growth factor receptor 2 (or 3) HR Hormone Receptor PD-(L)1 Programmed cell death protein (death-ligand) 1 TROP2 Trophoblast cell-surface antigen 2 VEGF-A Vascular endothelial growth factor A Interim Condensed Consolidated Statements of Profit or Loss Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 (in millions €, except per share data) (unaudited) (unaudited) (unaudited) (unaudited) Revenues 260.8 128.7 443.6 316.3 Cost of sales (76.4) (59.8) (160.2) (118.9) Research and development expenses (509.1) (584.6) (1,034.7) (1,092.1) Sales and marketing expenses (19.7) (12.9) (33.4) (28.5) General and administrative expenses (117.7) (170.9) (224.6) (287.9) Other operating expenses (117.2) (290.8) (165.7) (314.7) Other operating income 78.2 24.1 139.8 52.4 Operating loss (501.1) (966.2) (1,035.2) (1,473.4) Finance income 105.4 167.7 228.0 345.3 Finance expenses (7.0) (7.3) (40.9) (9.5) Loss before tax (402.7) (805.8) (848.1) (1,137.6) Income taxes 16.1 (2.0) 45.7 14.7 Net loss (386.6) (807.8) (802.4) (1,122.9) Loss per share Basic and diluted loss per share (1.60) (3.36) (3.33) (4.67) Interim Condensed Consolidated Statements of Financial Position June 30, December 31, (in millions €) 2025 2024 Assets (unaudited) Non-current assets Goodwill 364.1 380.6 Other intangible assets 1,487.0 790.4 Property, plant and equipment 1,017.8 935.3 Right-of-use assets 224.3 248.1 Contract assets 5.9 9.8 Other financial assets 2,504.8 1,254.0 Other non-financial assets 26.8 26.3 Deferred tax assets 77.8 81.7 Total non-current assets 5,708.5 3,726.2 Current assets Inventories 230.7 283.3 Trade and other receivables 1,368.3 1,463.9 Contract assets 8.7 10.0 Other financial assets 3,767.2 7,021.7 Other non-financial assets 215.0 212.7 Income tax assets 69.7 50.0 Cash and cash equivalents 10,269.5 9,761.9 Total current assets 15,929.1 18,803.5 Total assets 21,637.6 22,529.7 Equity and liabilities Equity Share capital 248.6 248.6 Capital reserve 1,447.9 1,398.6 Treasury shares (8.2) (8.6) Retained earnings 18,295.6 19,098.0 Other reserves (1,478.8) (1,325.5) Total equity 18,505.1 19,411.1 Non-current liabilities Lease liabilities, loans and borrowings 217.2 214.7 Other financial liabilities 145.0 46.9 Provisions 22.9 20.9 Contract liabilities 787.7 183.0 Other non-financial liabilities 80.4 87.5 Deferred tax liabilities 28.5 42.4 Total non-current liabilities 1,281.7 595.4 Current liabilities Lease liabilities, loans and borrowings 52.4 39.5 Trade payables and other payables 504.2 426.7 Other financial liabilities 40.9 1,443.4 Income tax liabilities 3.7 4.5 Provisions 145.6 144.8 Contract liabilities 945.4 294.9 Other non-financial liabilities 158.6 169.4 Total current liabilities 1,850.8 2,523.2 Total liabilities 3,132.5 3,118.6 Total equity and liabilities 21,637.6 22,529.7 Interim Condensed Consolidated Statements of Cash Flows Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 (in millions €) (unaudited) (unaudited) (unaudited) (unaudited) Operating activities Net loss (386.6) (807.8) (802.4) (1,122.9) Income taxes (16.1) 2.0 (45.7) (14.7) Loss before tax (402.7) (805.8) (848.1) (1,137.6) Adjustments to reconcile loss before tax to net cash flows: Depreciation and amortization of property, plant, equipment, intangible assets and right-of-use assets 51.0 49.9 93.8 88.2 Share-based payment expenses 32.1 20.2 54.2 36.5 Net foreign exchange differences 12.2 (13.2) 60.5 (41.9) Gain on disposal of property, plant and equipment (0.3) (0.2) (0.4) (0.2) Finance income excluding foreign exchange differences (105.4) (167.7) (228.0) (342.6) Finance expense excluding foreign exchange differences 6.6 4.8 14.5 9.5 Government grants (18.5) (3.1) (33.0) (12.2) Other non-cash (income) / loss — — (15.0) — Unrealized (gain) / loss on derivative instruments at fair value through profit or loss (17.3) 5.0 (28.6) 6.7 Working capital adjustments: Decrease / (Increase) in trade and other receivables, contract assets and other assets (400.4) 1,599.6 121.0 2,097.8 Decrease in inventories 22.8 5.3 56.6 17.6 (Decrease) / Increase in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions 914.6 760.8 (56.4) 472.8 Interest received and realized gains from cash and cash equivalents 73.1 80.8 191.7 280.2 Interest paid and realized losses from cash and cash equivalents (2.7) (1.6) (5.8) (5.3) Income tax received / (paid), net (14.9) 66.4 (27.1) (192.4) Share-based payments (11.5) (6.8) (15.1) (9.2) Government grants received 7.8 32.8 31.0 42.0 Net cash flows from / (used in) operating activities 146.5 1,627.2 (634.2) 1,309.9 Investing activities Purchase of property, plant and equipment (27.1) (88.6) (76.0) (147.1) Proceeds from sale of property, plant and equipment 0.5 0.2 1.0 0.2 Purchase of intangible assets (3.1) (52.7) (572.3) (131.1) Acquisition of subsidiaries and businesses, net of cash acquired — — (78.5) — Investment in other financial assets (1,670.0) (2,448.2) (4,177.7) (7,343.3) Proceeds from maturity of other financial assets 1,635.3 2,347.9 6,085.9 5,075.5 Net cash flows from / (used in) investing activities (64.4) (241.4) 1,182.4 (2,545.8) Financing activities Repayment of loans and borrowings (3.7) (2.3) (8.2) (2.3) Payments related to lease liabilities (9.6) (20.6) (18.9) (28.4) Net cash flows used in financing activities (13.3) (22.9) (27.1) (30.7) Net increase / (decrease) in cash and cash equivalents 68.8 1,362.9 521.1 (1,266.6) Change in cash and cash equivalents resulting from exchange rate differences 9.2 (3.3) (6.9) 3.5 Change in cash and cash equivalents resulting from other valuation effects 6.6 40.5 (6.6) (23.9) Cash and cash equivalents at the beginning of the period 10,184.9 8,976.6 9,761.9 11,663.7 Cash and cash equivalents as of June 30 10,269.5 10,376.7 10,269.5 10,376.7 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
Medscape
10 minutes ago
- Medscape
Why Your Arm Shape Skews Blood Pressure Readings
Blood pressure (BP) measurement is a core component of patient assessment in clinical care. It helps guide medication dosing, supports treatment decisions, and is essential for the diagnosis of hypertension. As high BP is often asymptomatic, its accuracy is critical. Measurement errors can lead to misdiagnosis and inappropriate treatment. The Riva-Rocci-Korotkoff method, which uses a cuff sphygmomanometer to measure brachial BP, has been used in clinical practice for more than 100 years. Although BP thresholds and treatments have evolved, this method, which is now built into automated oscillometric cuff devices, remains the standard. It forms the basis of the World Health Organization recommendations and clinical hypertension guidelines. Although this technique may seem simple, it requires multiple steps to ensure accurate and consistent reading. A difference of 5 mm Hg in systolic BP could lead to the misclassification of hypertension in 84 million people worldwide. Measurement Accuracy Sex Differences Recent studies have shown sex-based differences in the accuracy of automated BP measurements compared with intra-arterial BP measurements. At the same intra-arterial BP level, systolic BP measured using an automated cuff was consistently lower in women than in men, suggesting an underestimation of cardiovascular risk in women. This discrepancy may lead to unrecognized undertreatment and could help explain why women face a higher risk for cardiovascular disease at brachial cuff BP levels similar to those of men. Anatomical Factors Anatomical differences may partially explain this variation. Individuals with a large difference between proximal and distal arm circumferences are more likely to receive inaccurate BP readings than those with a more uniform mid-arm shape. Consequently, women are more likely to experience poor fit with cylindrical cuffs that often extend beyond the elbow. Cuff Size Limited data exist on how cuff size affects the agreement between automated and manual BP readings and whether this varies by sex. A study of 3735 participants from the National Health and Nutrition Examination Survey (49% women; average age, 45 years) found that automated systolic BP readings were lower than manual readings. In women, the gap widened with larger cuffs, up to -6.4 mm Hg with extra-large cuffs. In men, underestimation occurred only with extra-large cuffs (-2.4 mm Hg). Differences in arm shape, body size, and adiposity were associated with discrepancies between automated and manual systolic BP readings in both sexes, particularly in extra-large cuffs. The agreement between the automated and manual systolic BP classifications decreased as cuff size decreased from moderate for adults and large cuffs to poor for extra-large cuffs. This pattern was similar in both women and men. Clinical Implications In women, automated systolic BP progressively underestimates manual systolic BP as cuff size increases. In men, this underestimation occurred only with extra-large cuffs. Differences between automated and manual systolic BP measurements were linked to arm size, body size, and adiposity in both sexes, particularly in extra-large cuffs. The agreement in hypertension classification between automated and manual systolic BP declined as cuff size increased, with similar patterns for women and men. The reduced accuracy of automated systolic BP measurements with larger cuffs may lead to inappropriate clinical decisions and requires further study. This story was translated from Univadis Italy.
Yahoo
44 minutes ago
- Yahoo
‘It's just PR': Skittles, Hershey and Nestle are removing artificial colors
The Trump administration declared victory after Kraft Heinz, Skittles and General Mills made splashy announcements to remove artificial colors — even taking credit for Coca-Cola's plan to replace high-fructose corn syrup with US cane sugar in a new version this fall. 'President Trump delivers on MAHA (Make America Healthy Again) push,' the White House said last month, touting the companies' changes to 'confront the chronic health crisis plaguing Americans.' But nutritionists and public health researchers don't buy the hype. So far, companies have only made performative changes, they say, many of which were long in the works due to consumer demand for natural ingredients. Meanwhile, the administration's funding cuts for health care, food stamps, research and public health programs run contrary to its goal of making Americans healthier. 'These are cosmetic changes with no health impact. They just allow the MAHA people to say they had a victory,' said Dr. Barry Popkin, a professor of nutrition at the University of North Carolina. 'It's just PR.' Health advocates do credit Robert F. Kennedy Jr., the Health and Human Services Department secretary, and his MAHA movement for bringing attention to unhealthy foods, chronic disease and major companies' influence on the food system in America. But researchers say Kennedy's focus on synthetic dyes misses the larger problem of the prevalence of cheap, convenient foods loaded with salt, sugar and fat. Ice cream is still ice cream and soda is still soda, even without artificial flavors, Popkin said. A spokesperson for the HHS said Kennedy is 'dismantling the status quo that fueled a nationwide chronic disease epidemic' and 'eliminating bureaucracy and restoring integrity to federal health programs.' 'HHS is confronting the root causes of chronic illness that previous administrations were too timid to address,' the spokesperson added. But for Kennedy and the administration to make a substantive impact on Americans' diets, researchers say they will have to implement policies that tightly regulate ultraprocessed foods. Ultraprocessed foods account for up to 70% of the US food supply, and include many popular brands of chips, cookies, candy, ice cream and pre-made meals. Studies have frequently linked them to obesity, cancer, diabetes, heart disease and other health disorders. Kennedy has called the easy availability of these foods a 'crisis,' and oversaw the White House's Make America Healthy Again Commission report released in May that identifies ultraprocessed foods as a key contributor to a national rise in chronic illnesses — particularly among children. The agency has yet to enact any significant measures to cut down on ultraprocessed foods. 'Right now, they're not going after the real food culprit,' Popkin said. 'If Kennedy does anything significant on ultraprocessed foods, it will be hugely important for health.' 'Aura of health foods' Synthetic dyes, made from petroleum, are often used to make food and beverages brightly colored and appealing to customers, especially children. But they have potential negative effects on animal and human health, including possible increased risk of cancer and neurobehavioral issues in some children. In January, the US Food and Drug Administration banned red dye No. 3 in food, beverages and ingested drugs. Kennedy has been pressuring food companies to voluntarily remove all food dyes from their products. But many have been moving away from synthetic dyes for years due to pressure from consumers, health advocates and bans or restrictions in states like California, Virginia and West Virginia. For example, both Kraft Heinz and General Mills — which the administration recently celebrated for pledging to remove synthetic colors — have already removed the additives from most of their products. '(As) much as I love the idea of getting rid of artificial colors, doing so is a nutritionally meaningless way of giving compliant junk foods the aura of health foods,' said Dr. Marion Nestle, an emeritus professor of nutrition and food studies at New York University. Roughly 64% of consumers now actively look for snacks perceived as 'good for them,' a figure that has increased sharply in recent years, according to market research firm Circana. Yogurt, cheeses and foods and drinks with protein have proliferated due to their nutritional appeal. This is also not the first time companies have made voluntary pledges to remove artificial dyes from their products. But many have backtracked on their commitments. 'We hope industry will voluntarily improve the food supply this time around,' said Aviva Musicus, the science director at the Center for Science in the Public Interest, a nonprofit consumer advocacy group. 'There has to be a plan to hold industry accountable for when they inevitably don't cooperate. I haven't seen that for this administration.' The Consumer Brands Association, a trade group representing major food, beverage and household product companies, did not respond directly to this criticism. But the group pointed to an April statement that said the industry has 'always prioritized transparency and it will continue to lead the way to ensure consumers have the information they want and need to make informed purchasing decisions.' And slapping foods with a broad definition of ultraprocessed may result in 'demonizing safe, shelf-ready foods' that will limit consumers' access to nutritious foods, the group said. Cuts to Medicaid and SNAP While HHS focuses on food additives, many of the Trump administration's other policies weaken government efforts to improve the food supply and Americans' health, critics say. Trump's sweeping tax and spending cuts package is expected to leave 10 million more people without health insurance in 2034, according to a Congressional Budget Office estimate. More than 22 million families will lose some or all of their Supplemental Nutrition Assistance Program (SNAP) benefits, according to the Urban Institute. The law eliminated funding for programs that offer cooking classes and nutrition education for SNAP recipients, and the Agriculture Department cut two pandemic-era programs that help schools and food banks buy from local farmers. 'While MAHA leadership celebrates hollow wins, we've seen the federal government cut SNAP benefits for millions of Americans, rip millions from their health insurance coverage (and) slash programs to help farmers bring local foods into schools,' Musicus said. The administration is not just cutting health care and food benefits — it also slashed billions in research funding and fired thousands of employees at the National Institutes of Health, Centers for Disease Control and other agencies. The top nutrition researcher at NIH, who focused on studying ultraprocessed foods, left the agency, citing censorship under Kennedy. (HHS previously denied the claims.) These research cuts and layoffs may make it impossible to enact stricter rules or investigate the food industry, said Dr. Jerold Mande, an adjunct professor at the Harvard School of Public Health and a senior policy official in the Obama and Clinton administrations. 'They've also lost tens of thousands of people across government to do these investigations,' he said. 'Incomplete' grade At the same time, some health experts are hopeful Kennedy will seize on political momentum to make major policy changes to improve Americans' diets. 'I do give RFK Jr. a lot of credit for making chronic disease caused by our food, principally obesity, a political priority,' Mande said. 'I give them an incomplete in terms of what they're going to do about it.' In August, the MAHA Commission will release the second report on its strategy for improving childhood chronic obesity. Advocates will be looking to see if the report signals the administration may try to mandate front-of-package warning labels or crack down on marketing junk food to children. The report may also provide clues to whether the administration will create dietary guidelines with recommendations for limits to ultraprocessed foods. These would be major moves, but they may clash with the administration's deregulatory agenda. 'People are right to question what the lasting policy change is going to be,' Mande said, noting that removing artificial colors matters only if Kennedy is 'laying the groundwork to take on ultraprocessed food broadly.' CNN's Kristen Rogers contributed to this article. Solve the daily Crossword
