BioNTech (NASDAQ:BNTX) management outlined a strategy centered on late-stage oncology execution and combination-based development during the company’s fourth-quarter and full-year 2025 earnings call, while also disclosing plans to create a separate company focused on next-generation mRNA innovation.
Strategic focus: oncology combinations and a “tumor-centric” development model
CEO and co-founder Ugur Sahin reiterated BioNTech’s long-term vision of “translating science into survival,” emphasizing a pipeline designed to enable rational therapeutic combinations across solid tumors. Sahin said BioNTech believes future cancer treatment will rely on combinations that pair “potent, precise mechanisms of action to achieve biological synergies,” supported by a diversified pipeline across immunomodulators, antibody-drug conjugates (ADCs), and mRNA immunotherapies.
Looking ahead, Sahin said BioNTech’s 2026 priorities include accelerating late-stage development of its first wave of oncology assets, advancing combination approaches with multiple pumitamab combination readouts expected in 2026, and continuing a shift from a platform-centric approach to a tumor-centric clinical development program focused on high-incidence cancers such as lung and breast cancer.
New mRNA-focused company planned; leadership transition targeted for end of 2026
BioNTech also announced plans to pursue next-generation mRNA innovations in a new independent company. Sahin said the new entity will be founded and led by Sahin and co-founder and Chief Medical Officer Özlem Türeci, with a binding agreement expected by the end of the first half of the year. Under the contemplated structure, BioNTech would contribute certain rights and mRNA technologies to the new company in exchange for a minority stake.
Management repeatedly stressed that BioNTech’s existing pipeline and disclosed programs will remain with the parent company. In the Q&A, Sahin said “everything that is visible today will stay with BioNTech,” and Türeci added the company will retain Comirnaty and its mRNA oncology programs. CFO Ramón Zapata-Gomez later clarified that, based on what was contemplated, BioNTech’s contribution to the new company would be related to rights and mRNA technologies “not cash.”
Regarding leadership succession, management said Sahin and Türeci will remain in their roles through the transition period, with the supervisory board initiating executive searches. The company described the desired profile as leaders with strong experience in late-stage development and commercial execution.
Pipeline updates: pumitamab waves, ADC progress, and mRNA immunotherapies
Türeci described BioNTech’s oncology execution as a “synergy-driven development strategy” spanning three modalities. She detailed a three-wave plan for pumitamab being pursued with partner Bristol Myers Squibb (BMS):
- Wave one: Three foundational first-line programs in small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), and triple-negative breast cancer (TNBC), each anchored by a global Phase 3 trial designed for registration, combined with standard-of-care chemotherapy.
- Wave two: Expansion into additional indications through registrational-intent trials and “signal-seeking” studies to guide selection of additional registrational opportunities.
- Wave three: Novel-novel combinations, beginning with BioNTech’s in-house ADCs and later expanding to other next-generation immunomodulators to deepen and prolong responses.
In lung cancer, Türeci highlighted ROSETTA Lung-02 (pumitamab plus chemotherapy in first-line metastatic NSCLC without actionable genomic alterations) and said BioNTech plans to initiate two additional NSCLC trials this year: ROSETTA Lung-201 (stage 3 unresectable NSCLC after chemoradiation without progression) and ROSETTA Lung-202 (pumitamab monotherapy in first-line PD-L1-high metastatic NSCLC). She also explained that ROSETTA Lung-02 increased its sample size across both squamous and non-squamous histologies, and that the trial was amended to use progression-free survival (PFS) as the primary endpoint with overall survival (OS) as a key secondary endpoint, which she said supports speed.
On ADCs, Türeci said BioNTech has generated single-agent clinical data in more than 2,800 patients across its first four ADC programs. She highlighted BNT324 (a B7-H3 ADC), saying it has shown pan-tumor activity with “low single-digit rates” of grade 3 treatment-related adverse events and low rates of ILD/pneumonitis, and noted particular interest in metastatic castration-resistant prostate cancer with activity in heavily pretreated patients. She said a Phase 3 trial in the first-line setting is designed and recruitment is expected to begin “in the coming weeks.”
For mRNA cancer immunotherapies, Türeci discussed autogene cevumeran (partnered with Roche/Genentech) and said the companies are focusing on the adjuvant setting. She noted a decision to discontinue the trial in high-risk muscle-invasive urothelial carcinoma due to a rapidly changing treatment landscape and shifting standard of care, while randomized Phase 2 trials in adjuvant pancreatic ductal adenocarcinoma and adjuvant colorectal cancer continue. She said the colorectal cancer Phase 2 final analysis (DFS primary endpoint) is expected in 2027 on an event-driven basis. For FixVac in first-line HPV16-positive, PD-L1-high head and neck cancer (BNT113) in combination with pembrolizumab, she said recruitment is ongoing and a Phase 3 interim analysis is expected in 2026.
Late-stage readouts highlighted for 2026
Türeci said 2026 is expected to bring “potentially value-creating readouts and catalysts,” including multiple interim analyses. She highlighted late-stage programs where BioNTech expects updates later this year, including:
- Trastuzumab pamirtecan (TPAM): Phase 2 data in endometrial cancer and a Phase 3 interim analysis in HR-positive, HER2-low breast cancer.
- Gotistobart: Phase 3 interim analysis in second-line and beyond squamous NSCLC.
- Pumitamab: Phase 3 interim analysis from a China trial in first-line TNBC.
In the Q&A, management said positive gotistobart interim data could support a potential path toward accelerated approval, depending on the results. Sahin also commented that if the OS hazard ratio were around 0.5, it would be disruptive in the difficult second-line NSCLC setting, though he said the company would provide market projections once data are available.
Financial results and 2026 outlook
CFO Ramón Zapata-Gomez said BioNTech’s 2025 results exceeded revenue guidance and met reduced R&D and SG&A expense guidance. Total 2025 revenue was EUR 2.9 billion, which he said was slightly higher than the prior year despite a year-over-year decline in COVID-19 vaccine revenue. He attributed the offset in part to EUR 613 million recognized from non-contingent upfront and anniversary payments from the BMS collaboration.
R&D expense was approximately EUR 2.1 billion, slightly lower than the prior year, which management attributed to active portfolio management and cost-sharing with BMS. BioNTech ended 2025 with EUR 17.2 billion in cash equivalents and securities investments.
Zapata-Gomez also announced that BioNTech will supplement IFRS reporting with adjusted non-IFRS measures excluding specified items (including legal proceedings, impairments, certain restructuring expenses, bargain purchase income, and divestiture-related IPO items). Excluding those factors, BioNTech reported an adjusted non-IFRS net loss of EUR 117 million for 2025.
For 2026 (on an adjusted basis), the company guided for:
- Total revenue: EUR 2.0 billion to EUR 2.3 billion
- Adjusted R&D expense: EUR 2.2 billion to EUR 2.5 billion
- Adjusted SG&A expense: EUR 700 million to EUR 800 million
Management said it expects lower COVID-19 vaccine revenue in 2026 versus 2025, driven by declines in both Europe and the United States, while expecting the same amount and quarterly timing of BMS collaboration revenue recognition (with the EUR 613 million recognition expected in the third quarter of 2026). Zapata-Gomez described Comirnaty as a “cash generative franchise with favorable economics” under the Pfizer collaboration as markets shift toward an endemic environment.
During Q&A, management said it does not expect revenue from cancer vaccines in 2026 because those products remain in clinical development, and reiterated that capital allocation priorities remain focused on advancing the late-stage oncology pipeline, preparing for potential launches, and supporting the COVID-19 franchise.
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.
