BioNTech SE (BNTX) SEC Filings

BioNTech SE (BNTX) reported third-quarter 2026 revenue of €1,289.2 million and IFRS net profit of €184.5 million, versus €1,518.9 million revenue and a €28.7 million net loss a year earlier. Lower expected COVID-19 vaccine demand primarily drove the revenue decline. Year-to-date net loss was €1,168.2 million.

BioNTech raised full-year revenue guidance to €1.7–€1.9 billion from €1.6–€1.9 billion; adjusted R&D and SG&A expense guidance was unchanged. As of September 30, 2026, cash, cash equivalents and security investments totaled €16,163.8 million. Through that date, it repurchased 5,037,452 ADSs under a program permitting purchases of up to $1.0 billion through May 6, 2027.

Non-pivotal stage 1 data showed median overall survival of 18.5 months with gotistobart versus 10.0 months with docetaxel. BNT113 plus pembrolizumab did not demonstrate a statistically significant improvement in progression-free survival; its Phase 2/3 trial continues to assess overall survival. A global Phase 3 trial of pumitamig with sacituzumab govitecan is planned, pending regulatory approval. Under an exercised Roche/Genentech option, future program R&D costs will generally be assigned to Roche/Genentech effective January 1, 2027; BioNTech will be eligible for royalties in case of successful development and commercialization.

BioNTech SE and Bristol Myers Squibb reported first global Phase 2 ROSETTA Lung-107 data for investigational pumitamig plus docetaxel in metastatic non-small cell lung cancer after progression on or after first-line immunotherapy plus chemotherapy. At the July 10, 2026 data cutoff, 50 patients were included, median follow-up was 12.2 weeks, and 33 patients remained on treatment. The open-label, single-arm study is evaluating pumitamig 1,400 mg with docetaxel every three weeks.

Among 30 efficacy-evaluable patients, confirmed objective response rate was 36.7% and disease control rate was 90.0%. In the 50-patient treated population, median progression-free survival was 6.9 months, and the six-month progression-free survival rate was 63.3%. Responses were reported across PD-L1 expression levels and squamous and non-squamous disease.

Grade 3 or higher treatment-related adverse events occurred in 18.0% of patients; four patients (8.0%) discontinued treatment. There were no pumitamig-related deaths or dose-limiting toxicities, and the companies reported no new safety signals.

BioNTech SE and DualityBiologics (Suzhou) Co., Ltd. announced that the global Phase 3 DYNASTY-Breast02 trial met its primary endpoint, with a statistically significant but modest improvement in progression-free survival (PFS) for trastuzumab pamirtecan versus investigator’s choice of chemotherapy in chemotherapy-naïve patients with HR+/HER2-low metastatic breast cancer whose disease progressed on endocrine therapy.

At the interim analysis, overall-survival (OS) data were not mature. The release reported a higher rate of interstitial lung disease (ILD) than in prior trials; most cases were Grade 1 or 2, and Grade 3–5 severe and fatal events were reported in a small proportion of patients. BioNTech and DualityBio said available efficacy and safety data suggest potential patient benefit would be limited in the treatment landscape, and said they will discuss the data and determine next steps.

BioNTech SE (BNTX) announced a clinical-trial collaboration and supply agreement with Gilead Sciences to evaluate investigational pumitamig with sacituzumab govitecan (Trodelvy), a TROP2-directed antibody-drug conjugate, as first-line treatment for locally advanced or metastatic PD-L1 low or negative triple-negative breast cancer. In the global Phase 3 ROSETTA Breast-01 trial, BioNTech and Bristol Myers Squibb plan to replace chemotherapy with sacituzumab govitecan, pending regulatory authority approval.

BioNTech will continue to sponsor and lead the trial, and Gilead will supply sacituzumab govitecan. The trial currently compares pumitamig plus chemotherapy with chemotherapy in patients with CPS < 10. Pumitamig is investigational, and the safety and efficacy of the combination have not been established.

BioNTech SE (BNTX) will present 16 abstracts spanning ten tumor types at ESMO 2026 in Madrid, October 23–27, with updates from its late-stage oncology pipeline.

Presentations include first data from global Phase 2 ROSETTA Lung-107, testing pumitamig plus docetaxel in metastatic NSCLC following prior immunotherapy plus chemotherapy, and first results from a global Phase 2 study of pumitamig plus elfetabart drozuntecan in advanced solid tumors. BioNTech also describes Phase 2 subgroup findings in SCLC and triple-negative breast cancer with brain metastases: systemic efficacy was generally consistent in patients with and without brain metastases, while early data suggested intracranial efficacy. Preliminary results in neuroendocrine neoplasms and advanced solid tumors showed antitumor activity and manageable safety profiles. BioNTech says 13 Phase 3 trials are ongoing.

BioNTech SE reported first topline results from AHEAD-MERIT, a Phase 2/3 trial testing investigational BNT113 plus pembrolizumab against pembrolizumab alone as first-line treatment for patients with unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma expressing PD-L1. The combination did not demonstrate a statistically significant improvement in progression-free survival at the first analysis, and the trial did not meet this first dual primary endpoint.

The independent data monitoring committee recommended that the trial continue as planned to evaluate overall survival, its second dual primary endpoint. Under the trial’s pre-specified design, a statistically significant improvement in overall survival would establish a positive trial outcome even if the progression-free survival endpoint was not met. BioNTech remains blinded to ongoing trial data.

BioNTech SE (BNTX) Chief Executive Officer Ugur Sahin reported direct sales of 36,209 ordinary shares at $95.3733 per share on October 9, 2026, and 27,000 ordinary shares at $92.3142 per share on October 8, 2026. Both sales were effected pursuant to a Rule 10b5-1 trading plan established by Sahin on June 3, 2026.

At BioNTech SE (BNTX), Chief Executive Officer Ugur Sahin sold 24,000 ordinary shares at $95.8597 per share on October 7, 2026, under a Rule 10b5-1 trading plan established by him on June 3, 2026. His direct holdings after the sale were 63,209 ordinary shares. Separately, 39,218,111 ordinary shares were held through Medine GmbH, of which Sahin is the sole shareholder and may be deemed to beneficially own the shares. Of those shares, 106,721 were held for an individual's benefit under a trust arrangement; Medine GmbH exercised voting power but not dispositive power over them while they were held in trust.

BioNTech SE (BNTX) Chief Executive Officer and ten percent owner Ugur Sahin reported direct sales of 72,000 ordinary shares on October 5, 2026, at $97.2312 per share and 21,000 ordinary shares on October 6, 2026, at $96.8093 per share. The sales were made pursuant to a Rule 10b5-1 trading plan established June 3, 2026.