BioNTech (NASDAQ:BNTX) reported second-quarter 2026 revenue of €106 million, down from €261 million a year earlier, as lower U.S. demand for its COVID-19 vaccine weighed on results. The prior-year quarter also benefited from a one-time compensation payment from Pfizer related to its decision to opt out of a shingles vaccine development program.
The company lowered its full-year revenue outlook to €1.6 billion to €1.9 billion, citing softer-than-expected global COVID-19 vaccine demand, Germany’s planned use of previously manufactured vaccine inventory for the upcoming season, and the delayed timing of an out-licensed research-and-development milestone. BioNTech expects most of its 2026 revenue in the second half, including a €613 million collaboration payment from Bristol Myers Squibb expected in the third quarter.
CEO Transition and Oncology Strategy
Oelkers most recently served as CEO of Sobi, where Jeggle said he more than quadrupled revenue over nine years. Current CEO and co-founder Ugur Sahin said he will remain actively involved in preparing for Oelkers’ onboarding and characterized the transition as part of BioNTech’s evolution from a research-focused organization into a multi-product biopharmaceutical company.
Sahin said BioNTech is advancing a tumor-focused oncology strategy spanning next-generation immunomodulators, antibody-drug conjugates, or ADCs, and mRNA cancer immunotherapies. The company is targeting more than 17 late-stage and pivotal-trial readouts through 2030 and beyond.
Lung Cancer Programs Advance
Chief Medical Officer and co-founder Özlem Türeci highlighted progress for pumitamig, BioNTech’s investigational bispecific immunomodulator targeting PD-L1 and VEGF-A that is being developed with Bristol Myers Squibb. The company is running four registrational lung-cancer programs for the candidate, including trials in small cell lung cancer, first-line non-small cell lung cancer, PD-L1-high non-small cell lung cancer and unresectable stage 3 non-small cell lung cancer.
At the American Society of Clinical Oncology meeting in June, BioNTech presented global phase II data from ROSETTA-Lung 02, which is evaluating pumitamig plus chemotherapy in previously untreated advanced non-small cell lung cancer. Among 40 evaluable patients, the combination generated unconfirmed and confirmed overall response rates of 72.5% and 62.5%, respectively, according to Türeci.
In patients with PD-L1 tumor proportion scores below 1%, the confirmed objective response rate was 47.6%. It was 77.8% among patients with scores between 1% and 49%, while all six patients with scores of at least 50% responded. Türeci said the safety profile was manageable, with no new safety signals, and that the results support the ongoing global phase III program.
BioNTech also expects a first interim analysis for gotistobart in late 2026 in pivotal-stage testing for metastatic squamous non-small cell lung cancer. Gotistobart is a selective regulatory T-cell-depleting CTLA-4 antibody being developed with OncoC4. In the non-pivotal first stage of the PRESERVE-003 study, Türeci said gotistobart reduced the risk of death by 54% versus docetaxel, with a hazard ratio of 0.46. Median overall survival had not been reached in the gotistobart arm, compared with about 10 months for docetaxel.
ADC and mRNA Programs
The company dosed the first patient in a phase III study of elfetabart drozuntecan, formerly known as BNT324, in taxane-naive metastatic castration-resistant prostate cancer. The B7-H3-targeting ADC is being developed with DualityBio and is being tested against docetaxel in patients whose disease progressed after second-generation androgen receptor pathway inhibitors.
Sahin said more than 1,000 patients have received the ADC across more than 10 tumor types, including 400 treated in combination with pumitamig. He said the company has seen durable disease control and a tolerable safety profile, including no significant interstitial lung disease events observed so far among patients treated for more than a year.
BioNTech expects to present data later in 2026 from a phase I/II trial of pumitamig plus BNT324 in advanced non-small cell and small cell lung cancers. Türeci described the dataset as the first clinical data for a PD-L1/VEGF-A bispecific antibody combined with an ADC in lung cancer.
In mRNA cancer immunotherapy, enrollment has been completed in a randomized phase II trial of autogene cevumeran in high-risk stage 2 or stage 3 colorectal cancer. An independent data safety monitoring board reviewed an interim analysis in June and recommended continuing the trial without modification. BioNTech expects the final, event-driven analysis in 2027.
The company also expects a phase III progression-free-survival interim analysis later this year for BNT113, its HPV16-targeting mRNA immunotherapy being tested with pembrolizumab in first-line, PD-L1-positive HPV16-positive head and neck cancer.
Guidance, Expenses and Capital Allocation
BioNTech reported adjusted research-and-development expense of €477 million in the second quarter, down from €509 million a year earlier, reflecting portfolio prioritization and favorable partner cost-sharing effects. Adjusted selling, general and administrative expense rose to €198 million from €137 million, driven by investments in operational systems, prelaunch activities and the inclusion of CureVac operations following the merger.
For 2026, the company now expects adjusted R&D expense of €2 billion to €2.3 billion, while maintaining adjusted SG&A guidance of €700 million to €800 million. BioNTech ended the quarter with €16.6 billion in cash equivalents and security investments.
CFO Ramon Zapata said the company has repurchased $152 million of shares under its up-to-$1 billion repurchase authorization. He said BioNTech’s capital-allocation priorities remain funding its priority pipeline and commercial capabilities, maintaining flexibility for external opportunities, and returning capital to shareholders.
About BioNTech (NASDAQ:BNTX)
BioNTech SE (NASDAQ: BNTX) is a Germany-based biotechnology company that develops next-generation immunotherapies and vaccines, with a primary focus on messenger RNA (mRNA) technology. Founded in 2008 and headquartered in Mainz, BioNTech advances a platform approach to design and manufacture therapeutics across oncology, infectious diseases and other high unmet-need areas. The company is publicly traded on the NASDAQ exchange and became widely known for its rapid development and global deployment of an mRNA-based COVID-19 vaccine in collaboration with Pfizer.
BioNTech’s core activities include discovery research, clinical development and manufacturing of mRNA-based medicines, personalized cancer immunotherapies, engineered cell therapies, and antibody- and protein-based therapeutics.
