BioNTech : BNTX 4QFY 2025 Presentation FINAL 200326 v2

Published: 2026-05-05 07:49:10 ET BNTX

Published on 05/05/2026 at 07:49 am EDT

4th Quarter & Full Year 2025

Financial Results & Corporate Update

March 10th, 2026

Progress Highlights

Prof. Ugur Sahin, Co-founder & Chief Executive Officer

Oncology Execution

Prof. Özlem Türeci, Co-founder & Chief Medical Officer

Financial Performance

Ramón Zapata, Chief Financial Officer

Progress Highlights

Ugur Sahin, Co-founder &

Chief Executive Officer

Building a Global Immunotherapy Powerhouse

2025 and Recent Achievements: Strong Performance and Pipeline Momentum

Launched variant-adapted

COVID-19 vaccine

Leading COVID-19 vaccine market share1

Over 25 phase 2 & 3 oncology trials ongoing2

10 novel-combination trials ongoing with pumitamig3

Strategic BMS partnership

Acquired Biotheus Acquired CureVac

Beat increased 2025 revenue guidance

€17.2 billion in cash, cash equivalents and securities4

1. Over 50%, including Italy, Spain, France, Germany, USA, Japan, Australia; 2. Includes Phase 2 or 3 trials for BNT111, BNT113, autogene cevumeran (partnered with Genentech, a member of the Roche Group), gotistobart (partnered with OncoC4), trastuzumab pamirtecan (partnered with DualityBio) and pumitamig (partnered with Bristol Myers Squibb) 3. Partnered with Bristol Myers Squibb (BMS); 4. Cash and cash equivalents plus security investments as of December 31, 2025, reached €17,235.6 million, comprising €7,675.4 million in cash and cash equivalents, €7,158.5 million in security investments disclosed as current financial assets and €2,401.7 million in security investments disclosed as non-current financial assets.

Late-Stage Acceleration

Key late-stage data readouts expected for first wave of oncology assets

Combination Therapy Momentum

Novel-novel pumitamig1 combination data readouts expected

Modalities to Disease Areas

Transition to a focused disease area specific approach

1. Partnered with Bristol Myers Squibb 7

Building a Multi-Product Company by 2030

Targeting 18+ Late-Stage/Pivotal Trial Readouts Through 2030+ Informing Multiple Launch Opportunities

Tumor Type Incidence1 Assets Late-Stage/Pivotal Trials

Expected Data Readouts2

2026 2027 2028 2029 2030+

1L NSCLC

400K

Pumitamig3

ROSETTA Lung-02

Stage III unresectable NSCLC

65K

Pumitamig3

ROSETTA Lung-201

1L NSCLC - PD-L1 ≥ 50%

60K

Pumitamig3

ROSETTA Lung-202

2L+ sqNSCLC1

55K

Gotistobart4

PRESERVE-003

1L ES-SCLC

1L TNBC - all comers

80k

20k

Pumitamig3

ROSETTA Lung-01

Phase 3 in China

1L TNBC - CPS < 10

15k

Pumitamig3

ROSETTA Breast-01

2L+ HR+ BC1 - HER2-low

1L RCC

55k

40k

Trastuzumab-pamirtecan5

Pumitamig3

DYNASTY Breast-02

ROSETTA RCC-2087

1L CRPC

1L MSS-CRC

110k

230k

BNT324/DB-13115

Pumitamig3

BNT324-03

ROSETTA CRC-203

1L Gastric - HER2-neg, PD-L1+

40k

Pumitamig3

ROSETTA Gastric-204

1L HCC

25k

Pumitamig3

ROSETTA HCC-2067

Adj. CRC - ctDNA+

70k

Autogene cevumeran6

BNT122-01

Adj. PDAC

30k

Autogene cevumeran6

IMCODE003

2L+ Endometrial1 -

10k

Trastuzumab-pamirtecan5

Single-arm Phase 2

HER2-expressing

Trastuzumab-pamirtecan5

Fern-EC-01

1L HNSCC

160k

Pumitamig3

ROSETTA HNSCC-205

1L HNSCC - PD-L1 CPS ≥ 1, HPV16+

50k

BNT113

AHEAD-MERIT

Lung

Breast

Genitourinary

Gastrointestinal

Gynecologic

Additional Tumors

1. Estimated 1L or adjuvant incidence (incidence + newly recurrent patients), or 2L+ drug-treated in 2030 in the G7 markets derived from Oracle CancerMPact as of Feb 2026; Incidence information is for informational purposes only and is not intended to indicate the potential market size or reach of BioNTech's and its collaborators' product candidates, if approved. 2. Expected data readouts may be from interim or final analyses, and in some cases may not translate into commercial launches; Partnered with 3. Bristol Myers Squibb; 4. OncoC4; 5. DualityBio; 6. Genentech, a member of the Roche group; 7. These are Phase 1/2 trials. The anticipated pivotal trials evaluating pumitamig in these tumor types are expected to readout after 2030.

Focus

Steps

BioNTech

Becoming a multi-product company by 2030

Sharpening focus on growing late-stage clinical pipeline spanning immunomodulator, ADC and mRNA candidates

CEO and CMO transition by end of 2026

Executive search underway

New Company

Pioneering next-generation

mRNA innovations with disruptive potential

BioNTech planning to contribute related rights and mRNA technologies in

exchange for a minority stake

Signing of binding agreements

expected by end of H1 2026

The information above is based on a non-binding letter of intent and is subject to the relevant parties entering into a final, definitive agreement.

Strategic Focus to Maximize Value for Patients and Shareholders

Oncology Execution

Özlem Türeci, Co-founder &

Chief Medical Officer

Immunomodulators

Focus on the critical IO pathways

Targeting different complementary pathways in cancer immunity cycle may promote a durable anti-tumor effect

Precise and potent modalities for fast onset tumor reduction

ADC as potential "augmenters" of immunomodulators and mRNA cancer immunotherapies

HER2, TROP2, B7H3, HER3,

and EGFR/HER3 ADCs as combination partners

Synergy1

Targeted therapies

Space for curative approaches

Synergy1

mRNA cancer immunotherapies

Eliminate polyclonal residual disease with multi-antigen and individualized approaches

Polyspecific activity by targeting multiple antigens at once

Establish long-lasting immunological memory to prevent relapses

Synergistic potential

Multi-Modal Immunotherapy Oncology Strategy

Pumitamig Strategy to Build a Proprietary IO Franchise

Establish

Expand

Elevate

SCLC

Registrational-Intent

Combining with our ADCs targeting

1L Ph3 (Global) 2L Ph3 (China)

NSCLC

1L Gastric Ph2/3 (Global) 1L CRC Ph2/3 (Global) 1L HNSCC Ph2/3 (Global)

HER2

TROP2

B7H3

HER3

EGFR x HER3

Novel targets

1L Ph2/3 (Global)

1L NSCLC Stage III unres. Ph3

(Global)

1L NSCLC PD-L1 ≥ 50% Ph3

(Global)

TNBC

1L Ph3 trial (Global) 1L Ph3 (China)

Signal-Seeking

1L PDAC Ph2 (China) 1L GBM Ph2 (China) 1L RCC Ph1/2 (Global) 1L HCC Ph1/2 (Global) And others

Exploring potential synergies with our IO agents

EpCam x 4-1BB

TIGIT x PVRIG

mRNA cancer immunotherapy

Potential New Standards of Care

10+ novel-novel combinations

Broad Pan-Tumor Applicability With Standard-of-Care Chemotherapy

12+ trials exploring pumitamig1 in 10+ new indications

Foundational Registrations

Registrational trials with pumitamig1 ongoing in 3 high-impact tumors

Pumitamig Strategy to Build a Proprietary IO Franchise

Elevate

Combining with our ADCs targeting

• HER2 • HER3

• TROP2 • EGFR x HER3

• B7H3 • Novel targets

Exploring potential synergies with our IO agents

• EpCam x 4-1BB

• TIGIT x PVRIG

• mRNA cancer immunotherapy

Potential New Standards of Care

10+ novel-novel combinations

Establish Expand

SCLC

1L Ph3 (Global) 2L Ph3 (China)

NSCLC

1L Ph2/3 (Global)

1L NSCLC Stage III unres. Ph3

(Global)

1L NSCLC PD-L1 ≥ 50% Ph3

(Global)

TNBC

1L Ph3 trial (Global) 1L Ph3 (China)

Registrational-Intent

1L Gastric Ph2/3 (Global) 1L CRC Ph2/3 (Global) 1L HNSCC Ph2/3 (Global)

Signal-Seeking

1L PDAC Ph2 (China) 1L GBM Ph2 (China) 1L RCC Ph1/2 (Global) 1L HCC Ph1/2 (Global) And others

Broad Pan-Tumor Applicability With Standard-of-Care Chemotherapy

12+ trials exploring pumitamig1 in 10+ new indications

Foundational Registrations

Registrational trials with pumitamig1 ongoing in 3 high-impact tumors

Establishing & Expanding Pumitamig1 in Combination with Current SoC

Phase 2

Phase 3

Status

Dose Selection

Global Initiation

Primary Completion

SCLC

2028

TNBC

2029

NSCLC

Stg. III unresectable

2026

2030+

1L PD-L1 ≥50%

2026

2030+

CRC

Ongoing

2026

2030

Gastric

Ongoing

2026

2030

HNSCC

2026

2030+

HCC

Ongoing

RCC 1L

GBM 1L

PDAC 1L

1. Partnered with Bristol Myers Squibb.

Ongoing Ongoing in China Ongoing in China

Phase 2 trials to inform pivotal development

Pumitamig2 + ADC (BNT3244)

ADC mono

BNT3244

Pumitamig2 + chemo

ROSETTA LUNG-01

SCLC

35K

80K

Incidence1

ADC monos

BNT3244, BNT3254, BNT3265

Pumitamig2 + ADCs

BNT3244, BNT3254, BNT3265

Pumitamig2 + FixVac

LuCa-MERIT-1

Pumitamig2 + chemo

ROSETTA LUNG-02

Pumitamig2

ROSETTA LUNG-201

NSCLC

Pumitamig2 + chemo

IIT6

Incidence1

Resectable

Stage III Unresectable

1L metastatic

2L+ metastatic

220K 65K 400K 230K

Pumitamig2

ROSETTA LUNG-202

Gotistobart3

PRESERVE-003 (sq)

FixVac + Gotistobart3/ADCs

LuCa-MERIT-1

1. Estimated 1L or adjuvant incidence (incidence + newly recurrent patients), or 2L+ drug-treated in 2030 in the G7 markets derived from Oracle CancerMPact as of Feb 2026; Incidence information is for informational purposes only and is not intended to indicate the potential market size or reach of BioNTech's and its collaborators' product candidates, if approved; Partnered with: 2. Bristol Myers Squibb; 3. OncoC4; 4. DualityBio (BNT324/DB-1311, BNT325/DB-1305); 5. MediLink (BNT326/YL202); 6. Being conducted in China.

Expanding BioNTech's Focus on Lung Cancer to Maximize Pipeline Potential

Executing a Parallel Three-Wave Strategy to Build a Proprietary IO Franchise

Establish

SCLC

1L Ph3 (Global) 2L Ph3 (China)

NSCLC

1L Ph2/3 (Global)

1L NSCLC St III unres. Ph3

(Global)

1L NSCLC PD-L1 ≥ 50% Ph3

(Global)

TNBC

1L Ph3 trial (Global) 1L Ph3 (China)

Expand

Registrational-Intent

1L Gastric Ph2/3 (Global) 1L CRC Ph2/3 (Global) 1L HNSCC Ph2/3 (Global)

Signal-Seeking

1L PDAC Ph2 (China) 1L GBM Ph2 (China) 1L RCC Ph1/2 (Global) 1L HCC Ph1/2 (Global) And others

Elevate

Combining with our ADCs targeting

HER2

TROP2

B7H3

HER3

EGFR x HER3

Novel targets

Exploring potential synergies with our IO agents

EpCam x 4-1BB

TIGIT x PVRIG

mRNA cancer immunotherapy

Potential New Standards of Care

10+ novel-novel combinations

Broad Pan-Tumor Applicability With Standard-of-Care Chemotherapy

12+ trials exploring pumitamig1 in 10+ new indications

Foundational Registrations

Registrational trials with pumitamig1 ongoing in 3 high-impact tumors

1. Partnered with Bristol Myers Squibb.

Lung

Breast

Genitou-

rinary

Gastrointestinal

Gynecologic

Additional

Tumors

NSCLC AGA-

NSCLC EGFRm

SCLC

TNBC

HR+/ HER2- BC

RCC

Prostate

GC/GEJ

CRC

PDAC

HCC

Endometrial

Cervical

GBM

HNSCC

Melanoma

T-Pam1

BNT324/

DB-13111

BNT325/

DB-13051

BNT326/

YL2022

T-Pam1 BC Phase 3 fully enrolled with interim data expected in late 2026

T-Pam1 EC Phase 2 fully enrolled with data expected in 2026, confirmatory Phase 3 ongoing

BNT324/DB-13111 Phase 3 in

1L mCRPC to start in 2026

BNT326/YL2022 Phase 2 in 2L+ HER2-low/-null BC presented at SABCS 2025

Partnered with 1. DualityBio; 2. MediLink.

Single-Agent Activity of ADCs Being Explored Across Indications

Advancing Single-Agent Towards

Commercial Stage

Lung

Breast

Genitourinary

Gastrointestinal

Gyneco

-logic

Additional Tumors

NSCLC AGA-

NSCLC EGFRm

SCLC

TNBC

HR+/ HER2-BC

RCC

Prostate

GC/GEJ

CRC

PDAC

HCC

Cervical

GBM

HNSCC

Melanoma

SoC

T-Pam2

BNT324/ DB-13112

BNT325/ DB-13052

BNT326/

YL2023

10 novel-novel combination trials ongoing with pumitamig1

Generating clinical data from pumitamig1 combined with ADCs

Pumitamig1 +

Multiple data readouts expected in 2026

Partnered with 1. Bristol Myers Squibb; 2. DualityBio; 3. MediLink.

Novel Combinations to Expand Pumitamig Opportunity Across Cancer Types

Building Foundations for

Registrational Combinations

Development Focus of mRNA Cancer Immunotherapy

iNeST and FixVac Portfolios

Autogene cevumeran1 BNT113 BNT1162

Adjuvant 1L Multiple settings

CRC

Phase 2 Monotherapy

PDAC

Phase 2

+ Atezolizumab + mFOLFIRINOX

HPV16+ PD-L1 CPS ≥1 HNSCC

Mono & combo with IO & ADCs

NSCLC

Phase 1 & 2

Phase 2/3

+ Pembrolizumab

Recruitment ongoing

Data presented from epi sub-study at ASCO 2024 and from biomarker sub-study at ESMO-GI 2024

Recruitment ongoing

Data from Phase 1 trial published: Rojas et al., Nature 2023; Sethna et al., Nature 2025

Recruitment ongoing

Recruitment completed in Phase 2 in 1L NSCLC2

Data presented at SITC 2023, AACR 2024 and SITC 2024

Data in frail patients presented at

AACR 2025

Data in patients after CRT presented at WCLC 2025

Trial updated to Phase 2/3

Phase 2 final analysis expected in 2027

Primary Completion Date in 2031

Phase 3 interim analysis expected in 2026

Individualized Immunotherapy - iNeST1 Off-the-shelf Immunotherapy - FixVac

Partnered with: 1. Genentech, a member of the Roche Group; 2. In collaboration with Regeneron.

Late-Stage Trial Readouts

Program Trial Readout Phase Indication

Trastuzumab-pamirtecan3 Single arm Phase 2 2L+ HER2-expressing endometrial cancer Phase 35 interim analysis Chemo naïve HR+ HER2-low breast cancer

Gotistobart2 Phase 35 interim analysis 2L+ sqNSCLC Phase 2 2L+ mCRPC

BNT113 Phase 35 interim analysis HPV16+ PD-L1+ HNSCC

Pumitamig1 Phase 35 in China interim analysis 1L TNBC

Early-Stage Pumitamig & ADC Trial Readouts

Pumitamig1

Phase 2

1L NSCLC

Phase 2

1L ES-SCLC

Phase 2 in China

1L HCC

Phase 2 in China

1L MSS-CRC

Pumitamig1 + Trastuzumab-pamirtecan3

Phase 1/2

Breast cancer

Pumitamig1 + BNT324/DB-13113

Phase 2

Advanced solid tumors

Phase 1/2

NSCLC/SCLC

Pumitamig1 + BNT325/DB-13053

Phase 2

TNBC

Pumitamig1 + BNT326/YL2024

Phase 1/2

NSCLC

BNT324/DB-13113

Phase 1/2

2L+ mCRPC

Phase 3

Trial Initiations

Pumitamig1 Phase 35

1L MSS-CRC

1L HER2- PD-L1+ gastric cancer 1L HNSCC

1L NSCLC - PD-L1 ≥ 50%

Stage III unresectable NSCLC

BNT324/DB-13113 Phase 3 1L mCRPC

BLA Submission Trastuzumab-pamirtecan3 - 2L+ HER2-expressing endometrial cancer

Data from the final analysis of the autogene cevumeran study BNT122-01 were previously expected in 2026. Given events have accrued more slowly than projected, the data from the final analysis are now expected in 2027. Some data readouts may be event-driven and subject to change based on actual event accrual rates.

Partnered with: 1. Bristol Myers Squibb; 2. OncoC4; 3. DualityBio; 4. MediLink; 5. Pivotal trial.

Catalyst-Rich Year Ahead with Multiple Expected 2026 Milestones

Financial Performance

Ramón Zapata,

Chief Financial Officer

In € millions

FY 2025 IFRS Results1

FY 2025 IFRS Guidance

Total Revenues

2,870

2,600 - 2,800

R&D Expenses

2,105

2,000 - 2,200

SG&A Expenses

624

550 - 650

Capital Expenditures for Operating Activities

198 200 - 250

1. Numbers have been rounded. More information can be found in BioNTech's Report on Form 20-F for the year ended December 31, 2025, filed on March 10, 2026, which is available at https://www.sec.gov.

Full Year 2025 Financial Results Compared to Guidance

In € millions

except per share data1

IFRS Results

FY 2025

Adjusted Results2

IFRS Results

FY 2024

Adjusted Results2

Revenues

2,870

2,751

Cost of sales

(642)

(611)

(541)

(493)

Research and development expenses

(2,105)

(2,020)

(2,254)

(2,173)

Sales, marketing, general and administrative expenses

(624)

(599)

Other operating result

(904)

(1)

(671)

(14)

Operating loss

(1,405)

(386)

(1,314)

(527)

Net profit / (loss)

(1,136)

(117)

(665)

122

Diluted earnings / (loss) per share

(4.70)

(0.48)

(2.77)

0.50

Full Year 2025 Financial Results

In € millions

except per share data1

IFRS Results

4Q 2025

Adjusted Results2

IFRS Results

4Q 2024

Adjusted Results2

Revenues

907

1,190

Cost of sales

(333)

(302)

(244)

(205)

Research and development expenses

(505)

(612)

(530)

Sales, marketing, general and administrative expenses

(218)

(132)

Other operating result

(174)

(54)

(2)

Operating profit / (loss)

(323)

(97)

149

322

Net profit / (loss)

(305)

(80)

260

432

Diluted earnings / (loss) per share

(1.25)

(0.33)

1.08

1.79

Fourth Quarter 2025 Financial Results

In € millions FY 2026 non-IFRS Guidance

Total Revenues 2,000 - 2,300

Adjusted R&D Expenses 2,200 - 2,500

Adjusted SG&A Expenses 700 - 800

Revenue Guidance Considerations

Competitive market dynamics in the United States

Begin managing transition of multi-year contracts in Europe, and specifically in Germany where BioNTech recognizes direct sales

Stable revenues from the collaboration with BMS, from a pandemic preparedness contract with the German government, and from the BioNTech Group service businesses

No one-time revenue from Pfizer opt-out from further development of shingles program

1. Excludes risks that are not yet known and/or quantifiable and related activities. It includes effects identified from licensing arrangements, collaborations and Merger & Acquisitions ("M&A") transactions to the extent disclosed. The guidance is based on non-IFRS measures and excludes certain effects compared to measures based on IFRS Accounting Standards. More information can be found in BioNTech's Report on Form 20-F for the year ended December 31, 2025 filed on March 10, 2026, which is available at https://www.sec.gov.

Full Year 2026 Financial Guidance1

2025 2026 - 2029 2030

Advanced Strategy, Matured Pipeline and De-risked Development

Progressed key programs into pivotal stage, established partnership with BMS, fortified balance sheet with €17.2 billion in cash1 to fund our pipeline

Drive Oncology Execution at Scale and Speed

Advance combination therapy studies, accelerate pivotal trial execution, build indication-specific oncology portfolios and execute oncology launches

Diversified Multi-Product Company

Build a diversified, multi-product global immunotherapy powerhouse addressing high unmet medical need of cancer patients worldwide

1. Preliminary, unaudited figure; consists of cash, cash equivalents and security investments, as of December 31, 2025.

Thank you

Appendix

In € millions

except per share data1

IFRS

Results

FY 2025

Non-IFRS

Adjustments

FY 2024

Adjusted Results2

IFRS

Results

Non-IFRS

Adjustments

Adjusted Results2

Revenues

2,870

2,751

Cost of sales

(642)

(611)

(541)

(493)

Research and development

expenses

(2,105)

(2,020)

(2,254)

(2,173)

Sales, marketing, general and administrative expenses

(624)

(599)

Other operating result

(904)

903

(1)

(671)

657

(14)

Operating loss

(1,405)

1,019

(386)

(1,314)

786

(527)

Net profit / (loss)3

(1,136)

1,019

(117)

(665)

786

122

Basic earnings / (loss) per share

(4.70)

(0.48)

(2.77)

0.51

Diluted earnings / (loss) per share

(4.70)

(0.48)

(2.77)

0.50

Reconciliation of Adjusted to IFRS Results - FY 2025 & 2024 Financial Results

In € millions

except per share data1

IFRS

Results

4Q 2025

Non-IFRS

Adjustments

4Q 2024

Adjusted Results2

IFRS

Results

Non-IFRS

Adjustments

Adjusted Results2

Revenues

907

1,190

Cost of sales

(333)

(302)

(244)

(205)

Research and development

expenses

(505)

(612)

(530)

Sales, marketing, general and administrative expenses

(218)

(132)

Other operating result

(174)

195

(54)

(2)

Operating profit / (loss)

(323)

226

(97)

149

173

322

Net profit / (loss)3

(305)

226

(80)

260

173

432

Basic earnings / (loss) per share

(1.25)

(0.33)

1.08

1.80

Diluted earnings / (loss) per share

(1.25)

(0.33)

1.08

1.79

Reconciliation of Adjusted to IFRS Results - 4Q 2025 & 2024 Financial Results

BioNTech's Oncology Pipeline

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

BNT116

Adv. NSCLC

BNT211

Multiple solid tumors

BNT314/GEN10596

Multiple solid tumors

BNT324/DB-13113

Multiple solid tumors

BNT325/DB-13053

Multiple solid tumors

BNT329

Multiple solid tumors

Pumitamig1 + BNT314/GEN10596 Met. CRC9

Pumitamig1 + BNT3212

Multiple solid tumors

Pumitamig1 + BNT3213

1L HCC8,9

Autogene cevumeran2 Adj. CRC

Autogene cevumeran2 Adj. PDAC

BNT1167

1L adv. NSCLC

Pumitamig1

2L ES-SCLC8

Pumitamig1

2L+ EGFRm NSCLC8

Pumitamig1

2L Glioblastoma8

Pumitamig1 or BNT325/DB-1305 + BNT324/DB-13113

Multiple solid tumors9

BNT113

1L HPV16+ HNSCC

Pumitamig1

1L met. CRC

PLANNED

Pumitamig1

1L met. Gastric

BNT324/ DB-13113 Met. CRPC

Gotistobart4

Met. NSCLC

Pumitamig1

1L ES-SCLC

PLANNED

Trastuzumab pamirtecan3 Met. BC

Trastuzumab pamirtecan3 2L EC

BNT317

Multiple solid tumors

BNT326/YL2025

Multiple solid tumors

Gotistobart4

Met. CRPC

Gotistobart4

Multiple solid tumors

Pumitamig1

Multiple solid tumors

PLANNED

Pumitamig1

Pumitamig1 + BNT324/DB-13113

Adv./met. NSCLC and SCLC9

Pumitamig1 + BNT325/DB-13053

Multiple solid tumors9

Pumitamig1 + BNT326/YL2025

Multiple solid tumors

Pumitamig1 +

BNT326/YL2025

Multiple solid tumors8

BNT326/YL2025

Adv./met. BC8

Gotistobart4

PROC

Pumitamig1

1L HCC8

Pumitamig1

1L MPM8

Pumitamig1

2L NEN8

Pumitamig1

1L HNSCC

Pumitamig1

1L NSCLC

PLANNED

Pumitamig1

1L adv. NSCLC

Pumitamig1 Unresectable Stage III NSCLC

Pumitamig1

2L SCLC8

Pumitamig1

PLANNED

1L adv. HCC

Pumitamig1

Adv. RCC

Pumitamig1

PLANNED

BNT326/YL2025

Adv. NSCLC

Pumitamig1 + Trastuzumab pamirtecan3 Adv./met. BC9

Trastuzumab

1L met. CRC8

Pumitamig1

1L ES-SCLC8

Pumitamig1

2L adv./met. NSCLC

Pumitamig1

1L met. PDAC8

Pumitamig1

1L adv./met. TNBC

Pumitamig1

1L adv./met.TNBC8

1L adv./met. TNBC8

pamirtecan3

Multiple solid tumors

1L/2L+ ES-SCLC

1L/2L adv./met. TNBC

Next generation immunomodulator Targeted therapy

mRNA immunotherapy

Novel-novel combination

Partnered with: 1. Bristol Myers Squibb; 2. Genentech, a member of the Roche Group; 3. DualityBio; 4. OncoC4; 5. MediLink; 6. Genmab; 7. In collaboration with Regeneron; 8.Trial ongoing in China only; 9.Trial is currently being conducted by or on behalf of BioNTech. Bristol Myers Squibb holds co-exclusive rights to pumitamig.

BioNTech's Infectious Diseases Pipeline

Phase 1

Phase 1/2

Phase 2

Commercial

BNT1631

HSV

BNT162 + BNT1612

COVID-19 - Influenza combination

BNT1665

Mpox

BNT1622,3

COVID-19

BNT351

HIV

BNT1644

Tuberculosis

BNT165

Malaria

BNT1665

Mpox

Antibody mRNA

Partnered with: 1. University of Pennsylvania; 2. Pfizer; 3. Fosun Pharma; 4. Funded by the Gates Foundation; 5. Funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

4-1BB

CD137

G7 markets

Canada, France, Germany, Italy, Japan, GB, USA

(sq) NSCLC

(squamous) Non-small cell lung cancer

n L

nth line

Great Britain

Ovarian cancer

AACR

American Association for Cancer Research

GBM

Glioblastoma

PCD

Projected Commercialization Date

ADC

Antibody-drug conjugate

GC/GEJ

Gastric/Gastro-esophageal junction cancer

PD-(L)1

Programmed cell death protein (ligand) 1

adj.

Adjuvant

HCC

Hepatocellular carcinoma

PDAC

Pancreatic ductal adenocarcinoma

adv.

Advanced

HER2 (or 3)

Human epidermal growth factor receptor 2 (or 3)

PoC

Proof of concept

AGA

Actionable oncogenic alteration

HIV

Human immunodeficiency virus

PROC

Platinum-resistant ovarian cancer

ASCO

American Society of Clinical Oncology

HNC

Head and neck cancer

PVRIG

Poliovirus receptor-related immunoglobulin

B7-H3

B7 Homolog 3

HNSCC

Head and neck squamous cell carcinoma

R&D

Research and development

Breast cancer

HPV

Human papilloma virus

(ncc/cc)RCC

((non-)clear cell) Renal cell carcinoma

BLA

Biologics License Applications

Hormone receptor

SABCS

San Antonio Breast Cancer Symposium

BMS

Bristol Myers Squibb

HSV

Herpes simplex virus

(ES)SCLC

(Extensive stage) small cell lung cancer

CPS

Combined positive score

IFRS

International financial reporting standards

SEC

U.S. Securities and Exchange Commission

CRC

Colorectal cancer

IIT

Investigator initiated trial

SG&A

Selling, general and administrative expenses

(m)CRPC

(met.) Castration resistant prostate cancer

iNeST

Individualized NeoAntigen-Specific Therapy

SITC

Society of Immunotherapy of Cancer

CRT

Chemoradiation therapy

Immuno-oncology

SoC

Standard of care

ctDNA

Circulating tumor DNA

M&A

Merger and acquisitions

TIGIT

T cell immunoreceptor with Ig and ITIM domains

Endometrial cancer

met.

Metastatic

Trademark

EGFR(m)

(mutated) Epidermal growth factor receptor

MIUC

Muscle-invasive urothelial carcinoma

TNBC

Triple-negative breast cancer

EpCAM

Epithelial cell adhesion molecule

MPM

Malignant pleural mesothelioma

T-Pam

Trastuzumab pamirtecan

ESMO

European Society for Medical Oncology

Mpox

Monkeypox

TROP2

Trophoblast cell-surface antigen 2

EU4(5)

Germany, France, Italy, Spain, (UK)

mRNA

Messenger ribonucleic acid

U.S.

United States

FixVac

Fixed Antigen Vaccine

MSS

Microsatellite stability

United Kingdom

Fiscal year

NEN

Neuroendocrine neoplasm

WCLC

World Conference of Lung Cancer

Abbreviation Directory

Disclaimer

BioNTech SE published this content on May 05, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 05, 2026 at 11:48 UTC.