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| Period | Printed figure | Scope as printed |
|---|---|---|
| FY 2024 | Approximately 180 million | Variant-adapted COVID-19 vaccine doses delivered worldwide (Pfizer/BioNTech) |
| As of March 2025 (Q3 2025 6-K) | 5 billion | Doses shipped globally since first approval. Cumulative, not a 2025 seasonal count |
| As of March 2026 (Q1 2026 6-K) | Over 5 billion (floor) | Doses shipped globally since first approval. Cumulative floor, not a period volume |
| As of June 2026 (Q2 2026 6-K) | Over 5 billion (floor) | Same cumulative floor restated. Q2 2026 attributes the COVID-19 vaccine revenue decline to a lower volume of doses sold but does not print that volume |
| Period | Program / trial | Printed status |
|---|---|---|
| Q2 2026. Pivotal count | Company-wide late-stage oncology | 14 ongoing pivotal trials. Six pivotal trials initiated in H1 2026 (five pumitamig, one elfetabart drozuntecan). No oncology product revenue guided for 2026 |
| Q2 2026. COMIRNATY commercial | BNT162 COVID-19 vaccine (Pfizer; Fosun in China) | Only marketed product. EC approved the XFG variant-adapted monovalent 2026-2027 formula in July 2026 after CHMP. FDA supplement submitted. Seasonal cash residual, not the 2026 oncology thesis |
| Q2 2026. Pumitamig ROSETTA Lung-02 | BNT327/BMS986545 PD-L1 x VEGF-A. NCT06712316 | Global Phase 2/3 in first-line NSCLC vs pembrolizumab plus chemotherapy. Phase 3 portion underway after Phase 2 completed. May 2026 ASCO Phase 2: high response rates in squamous and non-squamous NSCLC across PD-L1 levels |
| Q2 2026. Pumitamig ROSETTA Lung-01 | NCT06712355 | Global Phase 3 first-line ES-SCLC: pumitamig plus chemotherapy vs atezolizumab plus chemotherapy |
| Q2 2026. Pumitamig ROSETTA Lung-201 and Lung-202 | NCT07361497 and NCT07361510 | Two of the five pumitamig pivotal trials started in H1 2026. Lung-201: global Phase 3 unresectable stage III NSCLC vs durvalumab after concurrent chemoradiation. Lung-202: global Phase 3 first-line PD-L1 >= 50% NSCLC vs pembrolizumab |
| Q2 2026. Pumitamig ROSETTA Breast-01, CRC-203, Gastric-204 | NCT07173751, NCT07221357, NCT07221149 | Global Phase 3 first-line PD-L1-negative TNBC plus chemotherapy. Global Phase 2/3 first-line MSS / MSI-L/pMMR metastatic CRC. Global Phase 2/3 first-line metastatic gastric cancer vs nivolumab plus chemotherapy. BMS collaboration: seven global registrational trials ongoing |
| Q2 2026. Gotistobart PRESERVE-003 | BNT316/ONC-392 CTLA-4. OncoC4. NCT05671510 | Two-stage global Phase 3 monotherapy vs docetaxel in metastatic NSCLC after platinum and PD-(L)1. Stage 2 first interim analysis expected in 2026 (event-driven, IDMC). March 2026 ELCC Stage 1: OS hazard ratio 0.46 vs chemotherapy in squamous NSCLC |
| Q2 2026. Trastuzumab pamirtecan DYNASTY-Breast02 | BNT323/DB-1303 HER2 ADC. DualityBio. NCT06018337 | Phase 3 HR-positive, HER2-low metastatic breast cancer vs investigator-choice chemotherapy. 541 patients enrolled. Interim data expected Q4 2026 on current event accrual |
| Q2 2026. Trastuzumab pamirtecan endometrial | NCT05150691 Phase 1/2 and FERN-EC-01 NCT06340568 Phase 3 | Potentially registrational endometrial cohort fully recruited. June 2026 ESMO Gynaecological Cancers: durable activity in HER2-expressing endometrial cancer. BLA planned in 2026; path depends on endometrial plus breast data. FERN-EC-01 Phase 3 vs chemotherapy ongoing, about 480 patients expected |
| Q2 2026. Elfetabart drozuntecan mCRPC | BNT324/DB-1311 B7-H3 ADC. DualityBio. NCT07365995 | Phase 3 vs docetaxel in mCRPC. First patient dosed May 2026. More than 1,000 patients treated across indications, including 400 with pumitamig combinations |
| Q2 2026. Autogene cevumeran BNT122-01 | iNeST mRNA. Genentech/Roche. NCT04486378 | Phase 2 adjuvant ctDNA-positive Stage II (high risk)/Stage III CRC vs watchful waiting. Enrollment completed April 2026. June 2026 DSMB interim on DFS: continue without modification, still masked. Final analysis event-driven, currently expected 2027 |
| Q2 2026. BNT113 AHEAD-MERIT | FixVac HPV16 E6/E7. NCT04534205 | Phase 2/3 first-line PD-L1-positive, HPV16-positive HNSCC: BNT113 plus pembrolizumab vs pembrolizumab. First Phase 3 interim analysis expected in 2026 on current event accrual |
Ugur Sahin, Ozlem Tureci, and Christoph Huber found BioNTech in Mainz to apply mRNA to individualized cancer vaccines. Infectious-disease mRNA is a later overlay.
BioNTech IPOs on Nasdaq as BNTX (Oct 2019). The listing predates Comirnaty and funds the oncology platform that 2026 guidance still waits on.
FDA EUA for Comirnaty with Pfizer. BioNTech still held more than 50% of global COVID share in fall 2025.
BioNTech closes the CureVac tender. mRNA design and LNP manufacturing depth. 2026 guidance still assumes no oncology product revenue.