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BioNTech reported Q3 revenue of €1.3 billion, down from €1.5 billion a year earlier due to weaker COVID-19 vaccine demand, but raised its 2026 revenue outlook to €1.7 billion–€1.9 billion. The company ended the quarter with €16.2 billion in cash and investments.
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The company highlighted progress in oncology, including encouraging gotistobart lung-cancer survival data and strong early response rates for pumitamig-based combinations. BioNTech expects to begin registrational-intent lung-cancer trials in 2027.
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BioNTech is reallocating resources toward late-stage programs while reviewing mixed mRNA and ADC results, including discontinuing one colorectal-cancer trial and assessing safety concerns with trastuzumab pamirtecan. CEO and co-founder Uğur Şahin said this would be his final earnings call before Guido Oelkers takes over by February 1.
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BioNTech (NASDAQ:BNTX) reported third-quarter 2026 revenue of €1.3 billion, down from €1.5 billion a year earlier, as lower demand for its COVID-19 vaccine weighed on results. The company raised the midpoint of its full-year revenue outlook while highlighting progress across its late-stage oncology pipeline, including lung cancer, breast cancer and mRNA cancer immunotherapy programs.
Chief Executive Officer and co-founder Uğur Şahin said BioNTech is advancing toward its objective of becoming a diversified, multi-product biopharmaceutical company by 2030. Şahin also said the call would be his last earnings call as CEO. The company previously announced that Guido Oelkers is expected to take office as CEO by Feb. 1 at the latest.
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"With a growing pipeline of potentially registrational trials, strong partnerships, and financial strength, we are on track to become a diversified multi-product company by 2030," Şahin said.
Financial Results and Updated Outlook
BioNTech recorded €613 million in third-quarter revenue from its global partnership with Bristol Myers Squibb related to the co-development and co-commercialization of pumitamig, its PD-L1 and VEGF-A-targeting bispecific antibody candidate.
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Adjusted research and development expense increased to €579 million from €479 million in the prior-year quarter, reflecting increased investment in prioritized immuno-oncology and antibody-drug conjugate, or ADC, programs. On an IFRS basis, R&D expense was €748 million, including €169 million of impairment losses related to intangible assets outside the company's strategic focus.
Selling, general and administrative expense rose to €179 million from €149 million, driven by pre-launch activities for late-stage programs, commercial buildout and investments in process and enterprise-resource-planning infrastructure, according to Chief Financial Officer Ramón Zapata.
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For the first nine months of 2026, revenue totaled €1.5 billion, compared with €2 billion in the comparable prior-year period. Adjusted R&D expense was €1.6 billion, while adjusted SG&A expense was €527 million.
BioNTech raised its 2026 revenue guidance to €1.7 billion to €1.9 billion. It maintained adjusted R&D guidance of €2 billion to €2.3 billion and adjusted SG&A guidance of €700 million to €800 million.
The company ended the quarter with €16.2 billion in cash equivalents and security investments. Since beginning its share repurchase program in June, BioNTech has repurchased about 5 million shares through Sept. 30, Zapata said.
Lung Cancer Programs Advance
BioNTech presented updated data for gotistobart, a CTLA-4-targeting antibody being developed with OncoC4 for metastatic squamous non-small cell lung cancer in patients whose disease progressed after platinum-based chemotherapy and checkpoint inhibitor treatment.
In the non-pivotal initial portion of a global Phase III trial, gotistobart produced median overall survival of 18.5 months, compared with 10 months for docetaxel chemotherapy, with a hazard ratio of 0.56. The data were based on a median follow-up of 25.4 months. The pivotal portion of the trial is ongoing, and BioNTech expects an interim analysis before the end of the year.
Chief Medical Officer and co-founder Özlem Türeci said the initial interim analysis is early and that the company would not be disappointed if it does not provide a clear signal. BioNTech said it would comment publicly on the outcome of the interim analysis, including if an independent data monitoring committee recommends that the trial continue.
BioNTech also reported early data for pumitamig in combination with Alpha-D, its B7-H3-targeting ADC developed with DualityBio, in small cell lung cancer. Among 71 patients treated across four dose levels, the combination showed a 92% overall response rate in the first-line setting, a 76% objective response rate in second line and a 52% response rate in third-line or later treatment.
The company said the safety profile was manageable, with no dose-limiting toxicities observed and a 2.9% interstitial lung disease rate for the combination. BioNTech expects its first registrational-intent trials of novel lung cancer combinations to begin in 2027.
Breast Cancer and mRNA Developments
In metastatic triple-negative breast cancer, BioNTech is adapting its ROSETTA Breast-01 Phase III trial to evaluate pumitamig with Gilead Sciences' TROP2-directed ADC sacituzumab govitecan, replacing chemotherapy in response to evolving treatment standards. The company said the collaboration remains subject to regulatory clearance.
Earlier data from a 30-patient first-line trial of pumitamig combined with a TROP2-targeted ADC showed a confirmed objective response rate of 76.7% and a disease control rate of 96.7%, according to Türeci.
BioNTech also discussed mixed developments in its mRNA cancer immunotherapy portfolio. In August, it discontinued a Phase II trial of autogene cevumeran as adjuvant monotherapy in circulating tumor DNA-positive colorectal cancer after an independent data safety monitoring board identified a numerical overall-survival imbalance between treatment arms and concluded that continuing the study was unlikely to change the efficacy outcome. No new safety signals were reported.
A Phase II trial of autogene cevumeran in adjuvant pancreatic cancer, in combination with atezolizumab and modified FOLFIRINOX, has completed enrollment and continues. BioNTech exercised an option in its Roche/Genentech collaboration under which future R&D costs for the program will shift to Roche/Genentech beginning Jan. 1, while BioNTech will remain eligible for royalties.
Zapata described the change as a capital-allocation decision rather than a reduced commitment to mRNA. BioNTech continues to develop its BNT113 program in HPV16-positive head and neck cancer, although its AHEAD-MERIT study did not meet its first dual primary endpoint of progression-free survival at the first interim analysis. The trial remains ongoing to evaluate overall survival, which could establish a positive outcome under the study's design if statistically significant.
ADC Review and Capital Allocation
BioNTech said its Phase III trial of trastuzumab pamirtecan, or T-Pam, in hormone receptor-positive, HER2-low metastatic breast cancer met its primary endpoint with a statistically significant but modest improvement in progression-free survival. Overall survival data were not mature.
The company reported a higher interstitial lung disease rate than in prior T-Pam studies, including a small proportion of severe and fatal events. BioNTech and DualityBio are reviewing the totality of clinical data across breast and endometrial cancer and are discussing potential plans for a biologics license application.
BioNTech said it initiated six Phase III trials during 2026 and is prioritizing investments in programs approaching potential approvals and launches. The company is also integrating its InstaDeep artificial intelligence and machine-learning subsidiary more closely into its core business and continuing to review its manufacturing footprint and cost structure.
About BioNTech (NASDAQ:BNTX)
BioNTech SE is a biotechnology company headquartered in Mainz, Germany, focused on developing medicines and vaccines based on messenger RNA and other immunotherapy technologies. The company's research programs address cancer, infectious diseases, and other serious medical conditions.
BioNTech's oncology portfolio includes individualized and off-the-shelf cancer immunotherapies, including mRNA-based treatments, cell therapies, antibody-based therapies, and immune-modulating approaches. Its infectious-disease activities include vaccine programs developed through proprietary platforms and collaborations.
In collaboration with Pfizer, BioNTech developed Comirnaty, an mRNA-based COVID-19 vaccine.
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The article " BioNTech Q3 Earnings Call Highlights " was originally published by MarketBeat.
