2026 poised to be a catalyst-rich year for BioNTech with continued late-stage pipeline progress with candidates across immunomodulators, antibody-drug conjugates and mRNA immunotherapiesExpected 2026 oncology milestones include seven late-stage data readouts and to have 15 Phase 3 clinical trials ongoing by year endAdditional late-stage trial readouts through 2030+ set to create multiple launch opportunities across tumor types, building BioNTech into a multi-product oncology company Financial strength with €17.2 billion in cash and cash equivalents plus security investments1,COVID-19 vaccine revenue stream, disciplined R&D spend, and strategic partnerships will continue to enable sustainable innovationPresentation and webcast at the 44th Annual J.P. Morgan Healthcare Conference from 2:15 – 2:55 pm PT / 11:15 – 11:55 pm CET on Tuesday, January 13, 2026Mainz, Germany, January 12, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will provide a strategic business update and outline the Company’s focus areas for 2026, including an overview of expected near- to longer-term milestones, at the 44th Annual J.P. Morgan Healthcare Conference this week in San Francisco, California.
“We concluded 2025 with strong momentum, driven by our execution in research and development, partnerships, acquisitions, and our financial strength. We continued to advance our next wave of innovation, including the initiation of novel-novel combination trials. These achievements have successfully positioned us as a late-stage biopharmaceutical company,” said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. “We see 2026 as a year when science translates into tangible results. We will report on a series of milestones, including readouts from late-stage trials and earlier trials evaluating novel-novel combinations, as well as new Phase 3 clinical trial initiations. If positive, they will help unlock our path towards multiple near- and mid-term product launch opportunities with the aim to benefit patients across cancer types.”
Ugur Sahin will present at the 44th Annual J.P. Morgan Healthcare Conference from 2:15 – 2:55 pm PT / 11:15 – 11:55 pm CET on Tuesday, January 13, 2026. The live webcast of the presentation can be accessed via the “Events & Presentations” page in the Investor Relations section of the Company’s website. The slide deck will be available there after the presentation. A replay of the webcast will be archived on the Company’s website for 30 days following the conference.
Oncology Areas of Focus for 2026
BioNTech will continue to execute its strategy in 2026 towards becoming a multi-product oncology company. Its diversified oncology pipeline comprises late-stage candidates spanning immunomodulators, antibody drug conjugates (“ADCs”), and mRNA cancer immunotherapies. BioNTech is developing several assets with pan-tumor potential, including novel-novel combination approaches, with the aim of addressing the full continuum from early- to late-stage disease across selected tumor types.
1. Late-Stage Acceleration
BioNTech is focused on advancing its late-stage oncology pipeline towards potential launches. Within the past two years, the Company has more than doubled the number of Phase 2 and 3 oncology trials across key modalities with now more than 25 Phase 2 or 3 trials ongoing. In 2026, BioNTech plans to initiate six additional Phase 3 clinical trials, bringing the total number of anticipated Phase 3 clinical trials to 15, and expects seven late-stage data readouts. The clinical trials and resulting data will inform regulatory and launch plans.
2. Combination Therapy Momentum
BioNTech has more than ten novel-novel combination clinical trials in its pipeline with multiple data updates expected in 2026. These trials explore pumitamig (BNT327/BMS986545), which is being partnered with Bristol Myers Squibb (“BMS”), in combination with other investigational immunomodulators, ADCs, and mRNA cancer immunotherapies and will inform the dose selection and explore anti-tumor activity in multiple tumors for later-stage development.
3. From Modalities to Disease Area
With the maturation of the oncology pipeline, BioNTech will focus on specific disease areas across major cancer types, including lung, breast, gynecologic, gastrointestinal, and genitourinary cancers.
Expected 2026 Milestones
ProgramModalityTrial PhaseIndicationLate-Stage Trial ReadoutsTrastuzumab pamirtecan
(“T-Pam”)4
ADCSingle-arm Phase 22L+ HER2-expressing endometrial cancerPhase 3Chemo naïve HR+ HER2-low breast cancerGotistobart2ImmunomodulatorPhase 32L+ sqNSCLCPhase 22L+ mCRPCBNT113mRNA cancer immunotherapyPhase 31L HPV16+ PD-L1+ HNSCCPumitamig1ImmunomodulatorPhase 3 in China1L TNBCAutogene cevumeran3mRNA cancer immunotherapyPhase 2Adj. ctDNA+ stage II (high risk) / stage III CRC Early-Stage Pumitamig & ADC Trial ReadoutsPumitamig1ImmunomodulatorPhase 21L NSCLCPhase 21L ES-SCLCPhase 2 in China1L HCCPhase 2 in China1L MSS-CRCPumitamig1 +
T-Pam (HER2-ADC)4
Immunomodulator
+ ADC
Phase 1/2Breast cancerPumitamig1 + BNT324/DB-1311
(B7H3-ADC)4
Phase 1/2 Advanced solid tumorsPhase 2NSCLC/SCLCPumitamig1 + BNT325/DB-1305
(TROP2-ADC)4
Phase 2 TNBCPumitamig1 + BNT326/YL202
(HER3-ADC)5
Phase 1/2 2L+ EGFRm NSCLCBNT324/DB-1311
(B7H3-ADC)4
ADCPhase 1/22L+ mCRPC Phase 3 Trial InitiationsPumitamig1ImmunomodulatorPhase 31L MSS-CRCPhase 31L HER2- PD-L1+ gastric cancerPhase 31L HNSCCBNT324 /DB-1311
(B7H3-ADC)4
ADCPhase 31L mCRPC BLA SubmissionT-Pam (HER2-ADC)4ADC-2L+ HER2-expressing endometrial cancer Partnered with: 1. BMS; 2. OncoC4, Inc. (“OncoC4”); 3. Genentech, a member of the Roche Group; 4. Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”); 5. MediLink Therapeutics (Suzhou) Co., Ltd. (“MediLink”).
Abbreviations: 1L = first line; 2L = second line; adj. = adjuvant; HER2 = human epidermal growth factor receptor 2; HR = hormone receptor; (sq) NSCLC = (squamous) non-small cell lung cancer; mCRPC = metastatic castration resistant prostate cancer; HPV16 = human papilloma virus 16; PD-L1 = programmed cell death protein ligand 1; HNSCC = head and neck squamous cell carcinoma; TNBC = triple-negative breast cancer; ctDNA = circulating tumor DNA; (MSS-)CRC = (microsatellite stable-) colorectal cancer; ES-SCLC = extensive-stage small cell lung cancer; HCC = hepatocellular carcinoma; EGFRm = mutated epidermal growth factor receptor
Overview of oncology data readouts expected by 2030+
BioNTech expects at least 17 late-stage data readouts, including from pivotal trials, by 2030+. The respective trials are set to inform multiple launch opportunities for BioNTech to become a multi-product oncology company by 2030. Potential further data readouts will be added with the evolution and maturation of the clinical pipeline.
Tumor typeIncidence1AssetsLate-Stage/ Pivotal TrialsExpected Data Readouts2 Lung1L NSCLC400kPumitamig3ROSETTA Lung-022029Gotistobart4PRESERVE-00320261L ES-SCLC80kPumitamig3ROSETTA Lung-012028Breast1L TNBC – all comers25kPumitamig3Phase 3 in China20261L TNBC – CPS 15kPumitamig3ROSETTA Breast-0120292L+ HR+ BC – HER2-low50k T-Pam5DYNASTY Breast-022026Genitourinary1L RCC25kPumitamig3ROSETTA RCC-2087 2030+1L CRPC100kBNT324/
DB-13115
BNT324-032029Adj. MIUC50kAutogene cevumeran6IMCODE0042029Gastrointestinal1L mMSS-CRC220kPumitamig3ROSETTA CRC-2032030+1L Gastric- HER2-neg, PD-L1+35kPumitamig3ROSETTA Gastric-2042030+1L HCC25kPumitamig3ROSETTA HCC-20672030+Adj. CRC – ctDNA+ 70kAutogene cevumeran6BNT122-012026Adj. PDAC40kAutogene cevumeran6IMCODE0032029Gynecologic2L+ Endometrial- HER2-expressing
