BioNTech (NASDAQ:BNTX) used a presentation and question-and-answer session at the J.P. Morgan Healthcare Conference to highlight its transition back toward oncology, outline a slate of upcoming clinical readouts, and discuss how it plans to deploy its cash resources while continuing to fund late-stage development.
Company update: shifting focus back to oncology
Chief Executive Officer Ugur Sahin said BioNTech’s long-term vision remains “translating science into survival,” noting that the company and partner Pfizer have delivered five billion doses of COVID-19 vaccine globally and distributed vaccines in more than 180 countries. Sahin said BioNTech has also engaged in global health programs using its mRNA technology and is now “pivoted back to oncology,” with 25 clinical trials ongoing and 16 clinical programs.
On the financial side, Sahin said BioNTech increased 2025 revenue guidance and ended the year with “more than $17 billion in cash and cash equivalents and securities.” He added that the company continues to use COVID vaccine revenues to finance oncology programs, while aiming to maintain “disciplined resource allocation” and active portfolio management focused on late-stage programs.
COVID vaccine evidence and a real-world mortality study
Sahin emphasized what he described as extensive evidence supporting the clinical benefit of COVID vaccines, citing “hundreds of studies.” He singled out a recently published real-world study from France involving about 27 million adults, including 22 million who received the vaccine and 5 million who did not. According to Sahin, the study showed reduced overall mortality and more than a 70% reduction in COVID-associated mortality, including in adults aged 18 to 50.
2026 objectives and a tumor-centric development approach
Looking ahead, Sahin outlined three priorities for 2026:
- Accelerate late-stage development of the first wave of oncology assets
- Build momentum through multiple combination strategies
- Shift from a platform-centric to a tumor-centric clinical development approach
Sahin said BioNTech’s oncology strategy is “synergy-driven,” spanning three modalities: next-generation immunomodulators, targeted therapies with a focus on antibody-drug conjugates (ADCs), and mRNA cancer immunotherapies, including fixed combinations and personalized mRNA vaccines. He argued that combining these modalities could help prevent or overcome resistance and enable more durable responses, while diversification across assets and partnerships helps mitigate execution risk.
Spotlight on three oncology programs
Prometimic (PD-L1/VEGF bispecific; partnered with BMS): Sahin described Prometimic as an Fc-silenced bispecific engineered to deliver dual blockade of VEGF and PD-L1. He said preclinical work suggests a differentiated mechanism involving complex formation that increases PD-L1 internalization. BioNTech highlighted efficacy signals across indications “regardless of PD-L1 expression,” and said that with BMS it expects eight pivotal studies to be ongoing by year-end 2026.
In a global phase II study BioNTech had recently announced, Sahin said Prometimic showed an 85% objective response rate in first-line small cell lung cancer and a 70% objective response rate in triple-negative breast cancer, with activity reported irrespective of PD-L1 levels. During Q&A, Sahin added that the company has seen particularly strong activity in settings with low PD-L1 expression, citing data in triple-negative breast cancer below 10% PD-L1 from China showing progression-free survival of 13 months and overall survival “going more into the direction of 20+ months,” which he said the company has been able to reproduce in a global trial. Sahin also said that in more than 10 indications combining Prometimic with chemotherapy, clinical benefit rates have been “in the range of 80%–100%.”
Responding to questions about comparisons within the PD-(L)1/VEGF bispecific class, Sahin said BioNTech is not conducting head-to-head studies and therefore cannot draw firm conclusions given heterogeneity across patient populations. He said differentiation could come from molecular engineering and mechanism, breadth of development across indications, and combination approaches, including combinations with ADCs and mRNA vaccines. He described Prometimic as both an immune modulator and a targeted therapy that can direct VEGF inhibition effects into the tumor microenvironment.
Gotistobart (CTLA-4 targeting; partnered with OncoC4): Sahin described Gotistobart as going “beyond checkpoint blockade” by selectively killing regulatory T cells in the tumor microenvironment. He emphasized that it is not “just another CTLA-4 blockade,” arguing that eliminating regulatory T cells could address multiple immunosuppressive mechanisms. BioNTech said data have been generated in more than 1,000 patients and that the program is now in pivotal phase development in second-line squamous non-small cell lung cancer, with a recent FDA orphan drug designation.
Sahin presented an unblinded stage 1 analysis from a phase III study comparing Gotistobart against docetaxel, stating the trial showed a 54% reduction in the risk of death versus chemotherapy. The first interim efficacy readout is expected in 2026, he said, and BioNTech views the setting as high unmet need given limited options after prior checkpoint therapy and multiple recent phase III failures in this population.
BNT324 / DB-1311 (B7-H3 ADC; partnered with Duality): Sahin said BioNTech’s B7-H3 ADC has shown pan-tumor activity and a favorable safety profile, and is being evaluated in more than 10 cancer indications. He said BioNTech has observed encouraging activity across tumor types with low single-digit rates of grade 3 treatment-related adverse events and low rates of ILD pneumonitis, with some patients treated for up to a year or longer. He highlighted metastatic castration-resistant prostate cancer as an area of interest with strong activity in heavily pretreated patients, and said a phase III first-line trial in mCRPC is planned, with the IND cleared and recruitment expected to start in the coming months.
Readouts ahead and how BioNTech plans to use its cash
Sahin said BioNTech expects 15 phase III readouts in 2026 and 2027, and characterized 2026 as “packed” with catalysts. He listed five late-stage readouts expected in 2026: a HER2 ADC program (TPAM), Gotistobart, BNT113 (an HPV vaccine for head and neck cancer), Prometimic data from a Chinese triple-negative breast cancer study, and a personalized vaccine trial in high-risk colorectal cancer. He added that these would be complemented by early-stage combination data, including Prometimic plus different ADCs, with “15+ data readouts” anticipated overall.
During Q&A, Chief Financial Officer Ramón Zapata said BioNTech’s “utmost priority” for its cash balance is to continue developing the internal pipeline and grow organically, at least until there is more visibility on future revenues from late-stage assets and combinations. He said a second priority would be inorganic acquisitions or collaborations, with other potential uses of cash to be considered later as launch timing and opportunity size become clearer.
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.
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