Mainz, Germany, January 12, 2026 — BioNTech SE (Nasdaq: BNTX) said 2026 will be a catalyst-rich year for its oncology business as the company advances late-stage candidates across immunomodulators, antibody‑drug conjugates (ADCs) and mRNA cancer immunotherapies.
The company expects seven late‑stage data readouts in 2026 and plans to have 15 Phase 3 clinical trials ongoing by year end. BioNTech also plans to initiate six additional Phase 3 trials in 2026 and currently has more than 25 Phase 2 and 3 oncology trials underway. Management said additional late‑stage readouts through 2030 and beyond are expected to create multiple product launch opportunities across tumor types.
“We concluded 2025 with strong momentum, driven by our execution in research and development, partnerships, acquisitions, and our financial strength,” said Prof. Ugur Sahin, CEO and co‑founder. “We see 2026 as a year when science translates into tangible results. Positive late‑stage readouts and new Phase 3 initiations would help unlock multiple near‑ and mid‑term launch opportunities to benefit patients across cancer types.”
BioNTech will outline its 2026 strategy and expected milestones at the 44th Annual J.P. Morgan Healthcare Conference. Sahin will present from 2:15–2:55 pm PT / 11:15–11:55 pm CET on Tuesday, January 13, 2026. The live webcast and slide deck will be available on the company’s Investor Relations website; a replay will be archived for 30 days.
Oncology priorities for 2026 include accelerating late‑stage programs toward potential launches, expanding novel‑novel combination trials, and focusing development on specific disease areas such as lung, breast, gynecologic, gastrointestinal and genitourinary cancers. BioNTech highlighted combination trials involving pumitamig (BNT327/BMS986545), partnered with Bristol Myers Squibb, tested with other investigational immunomodulators, ADCs and mRNA immunotherapies to inform dose selection and anti‑tumor activity across indications.
Key programs expected to generate data or milestones in 2026 include late‑stage readouts or pivotal activity across therapies such as pumitamig, trastuzumab pamirtecan (T‑Pam), gotistobart, BNT113, autogene cevumeran and several ADC programs (including BNT324/DB‑1311). The company said these readouts will inform regulatory and launch planning and that additional pivotal results are expected through 2030+.
Financial position and outlook
BioNTech reported approximately €17.2 billion in cash, cash equivalents and security investments as of December 31, 2025. In November 2025 the company raised its full‑year revenue guidance for 2025 to €2.6–2.8 billion and narrowed guidance ranges for R&D, SG&A and capital expenditures.
The company expects a modest decline in Comirnaty COVID‑19 vaccine revenues in 2026 due to market dynamics and changing vaccine recommendations. BioNTech does not currently anticipate oncology product revenues in 2026. Revenues from the collaboration with Bristol Myers Squibb are expected to be broadly in line with 2025.
Upcoming investor events
Full year and fourth quarter 2025 financial results: March 10, 2026
Annual General Meeting: May 15, 2026
About BioNTech
BioNTech is a global immunotherapy company developing treatments for cancer and other serious diseases. Its oncology portfolio includes immunomodulators, targeted therapies such as ADCs, CAR T cell therapies and mRNA cancer immunotherapies. BioNTech also develops mRNA vaccine candidates for infectious diseases and collaborates with global pharmaceutical partners including Bristol Myers Squibb, Duality Biologics, Fosun Pharma, Genentech (Roche), Genmab, MediLink, OncoC4, Pfizer and Regeneron. More information is available at www.biontech.com.
Forward‑looking statements
This release contains forward‑looking statements regarding BioNTech’s development plans, clinical trial timelines, expected data readouts, regulatory prospects, commercial potential and financial outlook. Actual results may differ materially due to risks and uncertainties described in BioNTech’s SEC filings, including under “Risk Factors.” These statements speak only as of the date hereof.
Contacts
Investor Relations: Douglas Maffei, PhD, [email protected]
Media Relations: Jasmina Alatovic, [email protected]
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