BioNTech SE · NASDAQ:BNTX
BioNTech — Investor Day (November 2025)
175 slides from BioNTech's investor day presentation, Nov 12, 2025
Slide 1: Innovation Series: R&D Day 2025
Innovation Series: R&D Day 2025 November 11th, 2025 Exhibit 99.1
Slide 2: Introductory Remarks
Introductory Remarks Douglas Maffei, PhD, Vice President, Strategy and Investor Relations 1
Slide 3: Forward-Looking Statements
3 This Slide Presentation Includes Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: BioNTech’s expected revenues and net profi
Slide 4: Innovation Series R&D Day 2025 Agenda
Innovation Series R&D Day 2025 Agenda 1 Introductory Remarks Douglas Maffei, PhD, Vice President, Strategy and Investor Relations 2 BioNTech’s Unique Approach to Innovation Prof. Uğur Şahin Co-founder and Chief Executive Officer 3 BioNTech’s Differentiated Clinical Strategy to Advance the Treatment
Slide 5: BioNTech's Unique Approach to Innovation
BioNTech’s Unique Approach to Innovation Prof. Uğur Şahin CEO and Co-founder 2
Slide 6: Translating Science into Survival
Translating Science into Survival Building a Global Immunotherapy Powerhouse
Slide 7: BioNTech – Disruptive Tech-Bio Company
7 BioNTech – Disruptive Tech-Bio Company with Pioneering Technologies Developed Through Full AI Integration Multiplatform oncology company Infectious diseases pipeline COVID-19 vaccine global impact Leader in integrated AI capabilities In-house manufacturing 16 >20Clinical programs Ongoing Phase 2 o
Slide 8: Interindividual variability & intratumoral heterogeneity
Interindividual variability & intratumoral heterogeneity Root cause of cancer treatment failureR ot Cause of Cancer Tre tm nt Failure Mutations Mutations Mutations Healthy cell Pre-cancer cell Individual patients DNA mutations Cancer evolution 5-20 years – up to 10,000 mutations 8
Slide 9: Space for curative approaches
Space for curative approaches Immunomodulators mRNA cancer immunotherapies Targeted therapies Synergy1Synergy1 Synergy1 • Focus on the critical IO pathways • Targeting different complementary pathways in cancer immunity cycle may promote a durable anti-tumor effect • Eliminate polyclonal residual di
Slide 10: Space for curative approaches
Space for curative approaches Immunomodulators mRNA cancer immunotherapies Targeted therapies Synergy1 Synergy1 Synergy1 • Focus on the critical IO pathways • Targeting different complementary pathways in cancer immunity cycle may promote a durable anti-tumor effect • Eliminate polyclonal residual d
Slide 11: Prioritized Immunomodulator Pipeline
Prioritized Immunomodulator Pipeline 11 1. Partnered with Bristol Myers Squibb; 2. Partnered with OncoC4; 3. Partnered with Genmab. Anti-EpCAMAnti-4-1BB Inert Fc Anti-PD-1 CD39 Anti-TIGIT PVRIG Clinical status Phase 1, Phase 1/2, exploratory trials ongoing BNT314/ GEN10593 BNT3213 BNT317 Anti-VEGF A
Slide 12: Pumitamig: PD-L1 x VEGF-A Bispecific Antibody
Pumitamig1: PD-L1 x VEGF-A Bispecific Antibody 12 Miao X et al. AACR 2025. Poster #6061; 1. Partnered with Bristol Myers Squibb Anti-PD-L1 VHH LALA silencing mutations Stable linkers Anti-VEGF-A PD-L1 checkpoint blockade Reverses immunosuppression of T-cells VEGF-A neutralization Vascular normalizat
Slide 13: Pumitamig dose-dependently inhibited VEGF-A / VEGFR2 engagement
13 Anti-PD-L1 Anti-VEGFnti- F Pumitamig dose-dependently inhibited functional VEGF-A / VEGFR2 engagement 0.01 0.1 1 10 100 0 200000 400000 600000 800000 1000000 Antibody concentration [nM] R L U Pumitamig Bevacizumab Ivonescimab analog IgG1-ctrl-LALA No antibody... Antibody IC50 ± SD (nM) Pumitamig
Slide 14: Pumitamig: Combined Anti-Angiogenesis and Checkpoint Blockade
0.0001 0.01 1 100 10000 0 10 20 30 40 50 CD107a/GrzmB expression Antibody [nM] C D 1 0 7 a + G rz B + [ % ] 0.001 0.01 0.1 1 10 100 0 1000 2000 3000 Antibody [nM] IF N -γ [ p g /m l] 0.001 0.01 0.1 1 10 100 0 5 10 15 20 Antibody [nM] T N F -α [ p g /m l] 0.001 0.01 0.1 1 10 100 0 10 20 30 40 Antibod
Slide 15: Pumitamig is More than the Sum of Two Monospecific Antibodies
Pumitamig1 is More than the Sum of Two Monospecific Antibodies 15 Anti-VEGF Anti-PD-L1 Anti-VEGF Pumitamig Anti-PD-L1 + = Monospecific Bivalent Monospecific Bivalent Bispecific Bivalent 1. Partnered with Bristol Myers Squibb
Slide 16: VEGF-A / Bispecific Antibody Complex Formation
VEGF-A / Bispecific Antibody Complex Formation is a Function of Antibody-to- VEGF-A Molar Ratio 16 Data on file. Complex formation occurs at optimal antibody-to-VEGF-A molar ratios in a bell-shaped response curve 1× 10 6 :1 1× 10 5 :1 1× 10 4 :1 1× 10 3 :1 10 0: 1 10 :1 5: 1 2: 1 1: 1 1: 2 1: 5 1: 1
Slide 17: Pumitamig / VEGF-A Complexation Enhances Binding Affinity to PD-L1
1×10 -4 1×10 -3 1×10 -2 106 107 108 109 1010 Off-rate, kdis [s-1] O n -r a te , k a [ M -1 s -1 ] Pumitamig only Pumitamig + VEGF-A (100:1) Pumitamig + VEGF-A (10:1) Pumitamig + VEGF-A (5:1) Pumitamig + VEGF-A (2:1) Pumitamig + VEGF-A (1:1) 100 fM 1 pM 10 pM 100 pM 1 nM Pumitamig1 / VEGF-A Complexat
Slide 18: Rapid Anti-VEGF-A Dependent Internalisation of Pumitamig
18 0 5 10 0 10000 20000 30000 40000 50000 60000 Time [hours] In te rn a li z a ti o n [f lu o re s c e n t a re a ] PD-L1xVEGF-A PD-L1xOVA Anti-VEGF-A Anti-PD-L1 VHH Anti-OVA Anti-PD-L1 VHH Rapid anti-VEGF-A Dependent Internalisation of Pumitamig1 Upon Binding to PD-L1+ Cells Data on file. 1. Partne
Slide 19: Pumitamig: Synergistic Targeting of PD-L1 and VEGF-A
Pumitamig1: Synergistic Targeting of PD-L1 and VEGF-A 19 Targeting of PD-1/PD-L1 blockade to VEGF-A high tumors PD-L1 ligand binding on tumor cells Selected NSCLC IHC3 Bispecific MOA Anti-VEGF-A (Fab) Anti-PD-L1 (VHH) VEGF-A dimer in the TME PD-L1 ligand on tumor cells Tumor microenvironment (TME) P
Slide 20: Differentiation of Pumitamig by Binding to PD-L1
Blocking of PD-1/PD-L1 signaling Neutralization of VEGF Cooperative effect linking PD-L1 and VEGF binding TME Targeting by anti-PD-L1 Pumitamig PD-L1/VEGF Bispecific PD-1/VEGF Bispecific PD(L)1 + VEGF Monospecific Dual targeting of TME Anti-PD-L1 Anti-VEGF-AYES YES YES NO YESYES YES 1. Partnered wit
Slide 21: Pumitamig May Drive Clinical Benefit Irrespective of PD-L1 Status
Pumitamig1 + chemo in 1L TNBC, Y. Meng et al. ESMO 2024 384MO Pumitamig1 May Drive Clinical Benefit Irrespective of PD-L1 Status 21 76.9% 56.3% 100.0% ORR Objective response rate Pumitamig1 has the potential to become a backbone IO therapy for significant patient populations currently not addressed
Slide 22: Pumitamig with Chemo in EGFRm NSCLC
-80 -60 -40 -20 0 20 40 60 SD PD PR 22 1. Partnered with Bristol Myers Squibb; *NCT05756972 B e s t C h a n g e f ro m B a s e li n e ( % ) Negative Low Expression High Expression Study months 0 1 2 3 4 5 6 7 8 9 10 11 12 13 PD SD PR On treatment N e g a ti v e L o w E x p re s s io n H ig h E x p r
Slide 23: Broad Combination Strategy Across Indications
Broad Combination Strategy Across Indications Aiming to Establish Next-Generation IO-Backbone 23 1. NCI SEER https://training.seer.cancer.gov/index.html. 2.US incidence source: NIH and American Cancer Society data EU incidence source: European Cancer Information System Anti-PD-L1 Anti-VEGF Anti-PD-(
Slide 24: Pumitamig: Parallel Three-Wave Strategy
ElevateEstablish Pumitamig1: Executing a Parallel Three-Wave Strategy to Build a Proprietary IO Franchise 24 Partnered with 1. Bristol Myers Squibb. Expand Expanding Into Multiple Disease Indications In Combination With Standard-of-care Chemotherapy Synergistic Novel- Novel Combinations Foundational
Slide 25: Prioritized Immunomodulator Pipeline
Prioritized Immunomodulator Pipeline 25 1. Partnered with Bristol Myers Squibb; 2. Partnered with OncoC4; 3. Partnered with Genmab. Anti-EpCAMAnti-4-1BB Inert Fc Anti-PD-1 CD39 Anti-TIGIT PVRIG Clinical status Phase1, Phase 1/2, exploratory trials ongoing BNT314/ GEN10593 BNT3213 BNT317 Anti-VEGF A
Slide 26: Novel Concept: Selective Depletion of Tregs in the TME
26 The Novel Concept: Selective Depletion of Tregs in the TME Prevailing View: CTLA-4 Blockade Antitumor response intrinsically linked to concomitant autoimmunity, constraining the therapeutic window Opportunity for better therapeutic index by tumor selectivity Yang Liu, Pan Zheng et al British Medi
Slide 27: Gotistobart: Differentiated Mechanism
Avoiding lysosomal degradation of CTLA-4 for safer and more effective immunotherapy may lead to uncoupling cancer therapeutic effect from immunotherapy-related adverse effects Gotistobart:1 Differentiated Mechanism with Potential to Become Best-in-Class Anti-CTLA-4 Antibody 27 1. Partnered with Onco
Slide 28: Preclinical Data: Improved Therapeutic Index of Gotistobart
Preclinical Data Demonstrate Improved Therapeutic Index of Gotistobart1 28 Days after MC38 inoculation 17 20 23 26 29 32 35 5 10 15 20 hIgG Ipi HL12 HL32 Days after MC38 inoculation T u m o r si ze ( m m ) * hIg Ipi HL12 HL32 *** -100 0 500 1000 T u m o r v o lu m e c h a n g e f ro m b a s e lin e
Slide 29: Treg Concentrations Decrease with Gotistobart Treatment
CD3+, CD4+ and FoxP3+ Treg Concentrations Decrease with Gotistobart1 Treatment 29 P re -t re at m en t P ost -t re at m en t 0.00000 0.00005 0.00010 0.00015 Treg (CD3+CD4+FoxP3+) cell density C D 3 + C D 4 + F o x P 3 + c e ll c o u n t p e r μ m 2 101-029 (C4D1) 118-004 (C3D1) 118-005 (C3D1) P re -
Slide 30: Pivotal Development of Gotistobart in 2L Squamous NSCLC
Phase 3 Stage 1 data to be presented at NACLC on December 6, 2025 Pivotal Development of Gotistobart1 in 2L Squamous Non-Small Cell Lung Cancer 30 1. Partnered with OncoC4 . 2. Ahn et al. J Clin Oncol 43, 260-272(2025); NCT05671510 Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3W (n=239) Do
Slide 31: Space for curative approaches
Space for curative approaches Immunomodulators mRNA cancer immunotherapies Targeted therapies Synergy1 Synergy1 Synergy1 • Focus on the critical IO pathways • Targeting different complementary pathways in cancer immunity cycle may promote a durable anti-tumor effect • Eliminate polyclonal residual d
Slide 32: mRNA-Technology Toolbox
mRNA-Technology Toolbox Holtkamp et al. Blood 2006; Kuhn et al. Gene Therapy 2010; Sahin, Türeci & Kariko Nat Drug Discovery 2014; Vogel et al. Mol Therapy 2018; Beissert et al. Mol Therapy 2020. mRNA formats Local Tissue-specific Systemic Lipoplex nanoparticles Lipid nanoparticles Polymer nanoparti
Slide 33: Nanoparticulate mRNA Vaccines
Type-I Interferon Innate immune Response N Y -E S O -1 m u lt im e r Induction of Antigen Specific Immunity Blood Cytokines BNT111 mRNA LPX Vaccine Systemic Targeting to Lymphoid Dendritic Cells Kranz, Diken et al., Nature 2016 33 Nanoparticulate mRNA Vaccines
Slide 34: Nanoparticulate mRNA-LPX Vaccines for Cancer Immunotherapy
34 Nanoparticulate mRNA-LPX Vaccines for Cancer Immunotherapy • RNA-LPX vaccine targeting dendritic cells • TLR7 driven adjuvant effect • Type-I Interferon driven innate & adaptive immune stimulation • Universally applicable for almost all type of tumor antigens • Overcomes tolerance against self-an
Slide 35: Space for curative approaches
Space for curative approaches Immunomodulators mRNA cancer immunotherapies Targeted therapies Synergy1 Synergy1 Synergy1 • Focus on the critical IO pathways • Targeting different complementary pathways in cancer immunity cycle may promote a durable anti-tumor effect • Eliminate polyclonal residual d
Slide 36: ADC Innovation Cycle is Just Beginning
36 ADC Innovation Cycle is Just Beginning Distinguished ADC linker technology • Stability improving safety profile • Higher efficacy Novel mechanisms of actions • Tumor specific activation • Improved and novel payloads Novel targets and novel epitopes • Targeting broader spectrum of tumors • Higher
Slide 37: ADC Driven Mechanisms May Synergize with Other Immune Mechanisms
ADC Driven Mechanisms May Synergize with Other Immune Mechanisms 37 Adapted from Fucà G, et al. Int J Gynecol Cancer. 2024 Nov TROP2 HER3 CA19-9 EGFRxHER3 HER2 B7H3 Targeted Tumor Cell Killing Bystander Tumor Cell Killing Immunogenic Cell Death Promoting Innate and Adaptive Immunity Opportunity for
Slide 38: Space for curative approaches
Space for curative approaches Immunomodulators mRNA cancer immunotherapies Targeted therapies Synergy1 Synergy1 Synergy1 • Focus on the critical IO pathways • Targeting different complementary pathways in cancer immunity cycle may promote a durable anti-tumor effect • Eliminate polyclonal residual d
Slide 39: Pumitamig in Combination with ADCs: Preclinical Activity
Pumitamig1 in Combination with ADCs Showed Superior Anti-Tumor Activity Compared with Each Treatment Alone in Pre-Clinical Tumor Models 39 Pumitamig refers to the total mouse surrogate Pumitamig antibody that binds murine VEGF-A/PD-L1 targets; Data shown represents mean±SEM; Statistical significance
Slide 40: Pumitamig + BNT3212 Synergistic Anti-Tumor Activity
Pumitamig1 in Combination with BNT3212 Showed Synergistic Anti-Tumor Activity 40 1. Partnered with Bristol Myers Squibb. A375 tumor cells and human PBMCs were co-implanted subcutaneously in B-NDG B2M KO Plus mice. BNT3212 Anti-EGFR x HER3-ADC Topoisomerase inhibitor PBS Pumitamig 9.6 mg/kg BNT3212 2
Slide 41: BNT3213 and Pumitamig Superior Anti-Tumor Activity
BNT3213 and Pumitamig1 Showed Superior Anti-Tumor Activity Compared with Each Treatment Alone in Pre-Clinical Tumor Models 41 1. Partnered with Bristol Myers Squibb; A375 tumor cells and human PBMCs were co-implanted subcutaneously in NOD-SCID mice. PBS Anti-PD-L1 mAb 20 mg/kg Anti-PD-L1 mAb 20mg/kg
Slide 42: Pumitamig plus BNT314/GEN1059 In Vitro
Combined Checkpoint Inhibition and 4-1BB Agonism of Pumitamig1 plus BNT314/GEN10592 In Vitro 42 1. Partnered with Bristol Myers Squibb; 2. Partnered with Genmab. ***, P<0.001; **, P<0.01; *, P<0.05 Pumitamig1 + BNT314/GEN10592 enhanced expression of cytotoxic markers and cytotoxic activity of CD8+ T
Slide 43: Novel Combination Trials Across Multiple Tumor Types
Novel Combination Trials Across Multiple Tumor Types 43 Partnered with: 1. Bristol Myers Squibb; 2. DualityBio ; 3. MediLink; 4. Genmab; 5. Onco C4; 6. Trial ongoing in China. Combination Partners Indications Next Gen IO + ADC Pumitamig1 + T-Pam2 HR+ HER2-low, ultra-low/null BC or TNBC + BNT324/DB-1
Slide 44: Integrated Capabilities Under One Roof
Capabilities to build tomorrow’s personalized precision medicines BioNTech: Advancing Tomorrow's Personalized Precision Medicine with Integrated Capabilities Under One Roof 44 . Automated in-house manufacturing to serve patients on time and globally Drug classes Interindividual variability Off-the-s
Slide 45: Key Areas of Focus 2026
Key Areas of Focus 2026 BioNTech Operating from Position of Strength 1 Combination Therapy Momentum Anticipate additional datasets from novel-novel combination trials with pumitamig 2 Modalities to Disease Areas 2026 marks BioNTech’s movement to a focused disease area specific approach 3 Late-Stage
Slide 46: BioNTech's Differentiated Clinical Strategy for Solid Tumors
BioNTech’s Differentiated Clinical Strategy to Advance the Treatment of Solid Tumors Prof. Özlem Türeci, M.D. Chief Medical Officer and Co-founder 3
Slide 47: Oncology Pipeline Overview by Drug Class
47 1. Synergistic potential. Partnered with 2. DualityBio; 3. MediLink; 4. Bristol Myers Squibb; 5. Genentech, a member of the Roche Group; 6. Genmab; 7. OncoC4. Immunomodulators mRNA cancer immunotherapies Gotistobart7 BNT314/ GEN10596 Pumitamig4 Anti-CTLA4 Anti-EpCAM/ Anti-4-1BB Anti-PD-L1/ Anti-V
Slide 48: Pumitamig: Parallel Three-Wave Strategy
ElevateEstablish SCLC 1L Ph3 (Global) 2L Ph3 (China) 1L/2L Ph2 (Global) NSCLC 1L Ph2/3 (Global) 2L Ph2 (Global) 2L EGFRmut Ph2 (China) IIT neoadjuvant (China) TNBC 1L Ph3 trial (Global) 1L Ph3 (China) Pumitamig:Executing a Parallel Three-Wave Strategy to Build a Proprietary IO Franchise 48 Partnered
Slide 49: Clinical Stage ADC Program
Clinical Stage ADC Program 49 1. Partnered with DualityBio; 2. Partnered with MediLink. 3. Human Protein Atlas. ADC structures shown for illustration-purpose only BNT324/DB-13111T-Pam1 BNT325/DB-13051 BNT326/YL2022 Clinical status • 1,100+ patients dosed • Ph3: HR+HER2-low mBC • Ph1/2: multiple soli
Slide 50: Pumitamig Studied as Monotherapy and SOC Chemo Combo
Lung cancers Breast cancers Gyn cancers GI cancers GU cancers Other cancers N S C L C A G A - N S C L C E G F R m S C L C T N B C H R + / H E R 2 - B C E n d o m e tr ia l C e rv ic a l O C G C /G E J C R C P D A C H C C R C C P ro s ta te G B M H N S C C M e la n o m a Pumitamig1 Monotherapy Pumita
Slide 51: Single Activity of ADCs Explored Across Indications
Lung cancers Breast cancers Gyn cancers GI cancers GU cancers Other cancers N S C L C A G A - N S C L C E G F R m S C L C T N B C H R + / H E R 2 - B C E n d o m e tr ia l C e rv ic a l O C G C /G E J C R C P D A C H C C R C C P ro s ta te G B M H N S C C M e la n o m a T-Pam1 BNT324/ DB-13111 BNT32
Slide 52: Expanding Pumitamig Opportunity with Novel ADC Combinations
Lung cancers Breast cancers Gyn cancers GI cancers GU cancers Other cancers N S C L C A G A - N S C L C E G F R m S C L C T N B C H R + / H E R 2 - B C E n d o m e tr ia l C e rv ic a l O C G C /G E J C R C P D A C H C C R C C P ro s ta te G B M H N S C C M e la n o m a Pumitamig1 Chemo combo Pumita
Slide 53: Our Diverse Lung Cancer Pipeline
Our Diverse Lung Cancer Pipeline 53 1. Synergistic potential; Partnered with 2 DualityBio; 3. MediLink; 4. Bristol Myers Squibb; 5. OncoC4. BNT324/ DB-13112 Anti-B7H3 ADC BNT325/ DB-13052 Anti-TROP2 ADC BNT326/ YL2023 Anti-HER3 ADC Targeted therapies Immunomodulators Space for curative approaches Sy
Slide 54: Ongoing Trials in Lung Cancer
Neoadj / Resectable 1L metastatic 2L+ metastatic NSCLC without AGA NSCLC with EGFR mut SCLC BioNTech’s Currently Ongoing Trials* in Lung Cancer 54 Partnered with: 1. Bristol Myers Squibb; 2. OncoC4; 3. DualityBio; 4. MediLink; *As of November 2025; **being conducted in China ADC mono and FixVac data
Slide 55: Our Diverse Breast Cancer Pipeline
Immunomodulators Our Diverse Breast Cancer Pipeline 55 1. Synergistic potential; Partnered with 2. DualityBio; 3. MediLink; 4. Bristol Myers Squibb. Trastuzumab pamirtecan2 Anti-HER2 ADC BNT326/ YL2023 Anti-HER3 ADC Targeted therapies BNT325/ DB-13052 Anti-TROP2 ADC Anti-PD-L1/ Anti-VEGF Pumitamig4
Slide 56: Ongoing Trials in Breast Cancer
1L metastatic 2L+ metastatic TNBC HR+ HER2 low HER2+ BC BioNTech’s Currently Ongoing Trials* in Breast Cancer 56 Partnered with: 1. Bristol Myers Squibb; 2. DualityBio; 3. MediLink *As of November 2025 Pumitamig1 + chemo ROSETTA Breast-01 (CPS<10) Pumitamig1 + chemo China Phase 3 (all-comers) Emergi
Slide 57: Our Diverse GI Cancer Pipeline
Anti-PD-L1/ Anti-VEGF Pumitamig4 Autogene cevumeran6 Immunomodulators mRNA cancer immunotherapy Our Diverse GI Cancer Pipeline 57 1. Synergistic potential. Partnered with 2. DualityBio; 3. MediLink; 4. Bristol Myers Squibb; 5. Genmab; 6. Genentech, a member of the Roche Group. Targeted therapies iNe
Slide 58: Ongoing Trials in GI Cancers
Adjuvant 1L metastatic 2L+ metastatic CRC Gastric PDAC BioNTech’s Currently Ongoing Trials* in GI Cancers 58 Partnered with: 1. Bristol Myers Squibb; 2. Genmab; 3. DualitiyBio; 4. MediLink.*As of November 2025 Pumitamig1 + chemo (CRC - MSS) ROSETTA CRC-203 Sponsored by BMS Pumitamig1 + chemo BNT327-
Slide 59: Establishing Pumitamig in Foundational Tumor Types
Establishing Pumitamig in Foundational Tumor Types Prof. Ilhan Celik, M.D. Vice President, Clinical Development Michael Wenger, M.D. Vice President, Clinical Development 4
Slide 60: Thoracic Cancer
Thoracic _ Cancer BIONT=CrH
Slide 61: Our Diverse Lung Cancer Pipeline
Our Diverse Lung Cancer Pipeline 61 1. Synergistic potential; Partnered with 2 DualityBio; 3. MediLink; 4. Bristol Myers Squibb; 5. OncoC4. BNT324/ DB-13112 Anti-B7H3 ADC BNT325/ DB-13052 Anti-TROP2 ADC BNT326/ YL2023 Anti-HER3 ADC Targeted therapies Immunomodulators Space for curative approaches Sy
Slide 62: Ongoing Trials in Lung Cancer
Neoadj / Resectable 1L metastatic 2L+ metastatic NSCLC without AGA NSCLC with EGFR mut SCLC BioNTech’s Currently Ongoing Trials* in Lung Cancer 62 Partnered with: 1. Bristol Myers Squibb; 2. OncoC4; 3. DualityBio; 4. MediLink; *As of Nov 2025; **being conducted in China ADC mono and FixVac data prov
Slide 63: NSCLC is One of the Highest Incidence Cancers Globally
Treatment outcomes vary based on histology and PD-L1 levels in 1L NSCLC patients without actionable genomic alterations Non-Small Cell Lung Cancer is One of the Highest Incidence Cancers Globally1 63 1. Globocan – Cancer Tomorrow. 2. CancerMPact® 2024 Treatment Architecture EU5 and US; Note that 5-y
Slide 64: Pumitamig Efficacy in NSCLC
64 Patient Population 1L EGFR/ALK WT PD-L1+ (TPS≥1) NSQ NSCLC 20 mg/kg 2L/3L EGFR mut TKI-experienced NSQ NSCLC 20 mg/kg 2L EGFR/ALK WT PD-(L)1 r/r NSQ NSCLC 20 mg/kg 2L/3L EGFR- mutated TKI- experienced NSQ NSCLC 30 mg/kg N 17 36 8 64 cORR (%) 47.1 19.4 12.5 57.8 DCR (%) 100.0 69.4 62.5 95.3 mPFS (
Slide 65: Global Phase 2/3 Trial to Establish Pumitamig in NSCLC
Seamless Phase 2/3 multi-site, randomized trial of pumitamig in combination with chemotherapy in 1L NSCLC Benchmark Data 1L NSCLC Histologies Regimen ORR mPFS mOS Study NSQ NSCLC Pembro + chemo2 48% 9.0 mo 22.0 mo KEYNOTE-1894 SQ NSCLC Pembro + chemo3 62% 8.0 mo 17.2 mo KEYNOTE-4075 Global Phase 2/3
Slide 66: Squamous NSCLC Remains an Area of High Unmet Need
Squamous NSCLC Remains an Area of High Unmet Need 66 1. CancerMPact; 2. Clarivate / Clarivate Survey| By 2030 55k squamous patients start in 1L (non-AGA population) 1 ~30% continue into 2L treatment and are IO addressable Limited treatment options for patients without actionable genetic alterations
Slide 67: Data Support Pivotal Phase 3 of Gotistobart in NSCLC
PRESERVE-001: Phase 1/2 multicenter, non-randomized, open-label, multiple-dose, FIH trial He K. et al. ASCO 2023 #9024. Data Support Initiation of Pivotal Phase 3 Trial Evaluating Gotistobart1 in CPI-resistant NSCLC 67 Target lesion best overall response (n=27 evaluable) Dosing 10 mg/kg x 2, then 6
Slide 68: Pivotal Development of Gotistobart in 2L Squamous NSCLC
Phase 3 Stage 1 data to be presented at NACLC on December 6, 2025 Pivotal Development of Gotistobart1 in 2L Squamous Non-Small Cell Lung Cancer 68 1. Partnered with OncoC4 . 2. Ahn et al. J Clin Oncol 43, 260-272(2025); NCT05671510 Gotistobart 6 mg/kg with 2 loading doses of 10mg/kg, Q3W (n=239) Doc
Slide 69: SCLC Incidence and Treatment Landscape
69 ~60k 2030 U.S., EU4, U.K. SCLC incidence1 1. Incidence from: SEER data for diagnosed SCLC incidence in US; Cancer Research UK; Zentrum für Krebsregisterdaten; Sante Publique; AIOM; EPDATA. 2 Statistics from Dayen et al (2019); CancerMPact® Patient Metrics US & EU5, accessed February 2024. *Due to
Slide 70: Global Phase 2 Dose Optimization in SCLC
Fully enrolled Global Phase 2 dose-optimization of pumitamig1 + chemotherapy in patients with 1L/2L SCLC Expeditious Set Up of Global Phase 2 Trial To Confirm Optimal Dose For Pivotal Development 70 1. Partnered with Bristol Myers Squibb; 2. L. Horn et al. N. Engl. J. Med., 379 (2018), pp. 2220-2229
Slide 71: Pumitamig Efficacy in SCLC
71 cORR 66.7%cORR 85.0% 20 0 -20 -40 -60 -80 -100 30 mg/kg20 mg/kg B e s t C h a n g e f ro m B a s e lin e ( % ) PD SD PR CR Patient Population 2L SCLC China IO Naïve 30 mg/kg Q3W 2L SCLC China IO Treated 30 mg/kg Q3W 1L ES-SCLC China 30 mg/kg Q3W 1L ES-SCLC Global 20 mg/kg Q3W 1L ES-SCLC Global 30
Slide 72: Pumitamig Early Signs of Durable Activity in SCLC
mDoR: 4.9 months (overall) mPFS: 6.8 months (overall) Pumitamig1 Shows Early Signs Of Durable Antitumor Activity in SCLC Data cut-off: 07 Aug 2025; median follow-up 28.3 weeks (min, max 3.9,; 45.6) overall. Median treatment duration: 25.3 weeks (Q1 12.9, Q3 30.6). Overall treatment duration (weeks)
Slide 73: Global Phase 3 Trial in ES-SCLC
Phase 3 multi-site, double-blinded, randomized trial of pumitamig in combination with chemotherapy compared to atezolizumab with chemotherapy in previously untreated ES-SCLC 73 1. Partnered with Bristol Myers Squibb; 2. L. Horn et al., New England Journal of Medicine, 2018; NCT06712355. Global Phase
Slide 74: Ongoing Trials in Lung Cancer
Neoadj / Resectable 1L metastatic 2L+ metastatic NSCLC without AGA NSCLC with EGFR mut SCLC BioNTech’s Currently Ongoing Trials* in Lung Cancer 74 Partnered with: 1. Bristol Myers Squibb; 2. OncoC4; 3. DualityBio; 4. MediLink; *As of Nov 2025; **being conducted in China ADC mono and FixVac data prov
Slide 75: Our Diverse Lung Cancer Pipeline
Anti-PD-L1/ Anti-VEGF Pumitamig4 Gotistobart5 Anti-CTLA-4 Immunomodulators Our Diverse Lung Cancer Pipeline 75 1. Synergistic potential; Partnered with 2 DualityBio; 3. MediLink; 4. Bristol Myers Squibb; 5. OncoC4. BNT116 FixVAC Off-the-shelf mRNA mRNA cancer immunotherapy BNT324/ DB-13112 Anti-B7H3
Slide 76: High B7-H3 Expression in Solid Tumors
B7-H3 IHC analysis in tumor vs. normal tissueB7-H3 IHC analysis in tumor microarrays High B7-H3 Protein Expression Observed in Various Solid Tumors 76 Yamato et al., Mol Cancer Ther 2022 H-score of B7-H3 expression on tumor cells in each sample was calculated. Number in parentheses indicates the num
Slide 77: BNT324/DB-1311 Monotherapy Development
BNT324/DB-13111 Monotherapy Development Focused on Fifteen Phase 2 Dose Optimization and Expansion Cohorts .An intermediate dose of 10.5 mg/kg was evaluated after 2 DLTs occurred with 12 mg/kg. 1. Partnered with DualityBio; Cheng Y et al. ESMO Asia 2024 #57O NCT05914116 BNT324/DB-1311 IV Q3W Until d
Slide 78: BNT324/DB-1311 Activity in NSCLC
Early Signs Of Encouraging Activity With BNT324/DB-13111 in NSCLC 1. Partnered with DualityBio; EGFRm EGFRm NSCLC (n=14) ORR: 3 (21.4%) 60 40 –20 0 –40 –60 –80 20 Data cut-off: 27-Sep-2024 Non-squamous NSCLC Squamous NSCLC 78 Non-squamous NSCLC (n=41) Squamous NSCLC (n=25) ORR, n (%) [95% CI] 9 (22.
Slide 79: BNT324/DB-1311 Activity in SCLC
SCLC 6 mg/kg (n=33) SCLC 9 mg/kg (n=34) ORR, n (%) [95% CI] 18 (54.5) [36.4, 71.9] 20 (58.8) [40.7, 75.4] Confirmed ORR, n (%) 9 (27.3) 12 (35.3) Pending confirmation, n 6 4 DCR, n (%) [95% CI] 29 (87.9) [71.8, 96.6] 31 (91.2) [76.3, 98.1] 3-month PFS rate, % 67.4 79.3 Prior IO + no prior TOP1i n=15
Slide 80: BNT324/DB-1311 Safety Profile
BNT324/DB-13111 Safety Profile 80 1. Partnered with DualityBio; *Includes 3 mg/kg (n=4), 10.5 mg/kg (n=4), and 12 mg/kg (n=6). The overall population includes patients with other tumors such as SCLC, NSCLC, ESCC, melanoma, HCC, cervical cancer, and HNSCC. †TRAEs leading to death: pneumonitis/respira
Slide 81: BNT324/DB-1311 plus Pumitamig in Advanced Lung Cancer
Two-part study to evaluate efficacy and safety of a combination therapy with BNT324/DB-1311 and pumitamig in patients with advanced lung cancer 81 Partnered with: 1. Duality Bio; 2. Bristol Myers Squibb; NCT06892548 Evaluating BNT324/DB-13111 in Combination with Pumitamig2 in Patients With Advanced
Slide 82: Our Diverse Lung Cancer Pipeline
Anti-PD-L1/ Anti-VEGF Pumitamig4 Gotistobart5 Anti-CTLA-4 Immunomodulators Our Diverse Lung Cancer Pipeline 82 1. Synergistic potential; Partnered with 2 DualityBio; 3. MediLink; 4. Bristol Myers Squibb; 5. OncoC4. BNT116 FixVAC Off-the-shelf mRNA mRNA cancer immunotherapy BNT324/ DB-13112 Anti-B7H3
Slide 83: Evaluating BNT326/YL202 in Advanced NSCLC and BC
DL1 DL2 DL3 DL4 DL5 DL6 DL7 Dose escalation (n=80): A BOIN dose escalation scheme was used for escalation/ de-escalation decisions, followed by cohort backfill at selected doses. Evaluating BNT326/YL2021in Patients with Advanced NSCLC and BC 83 1. Partnered with MediLink. Key Inclusion Criteria Incl
Slide 84: BNT326/YL202: Activity and Disease Control
BNT326/YL2021: Encouraging Activity and Near-Complete Disease Control in Patients with Advanced Disease 84 1. Partnered with MediLink. * One patient had non measurable target lesions at PD due to obstructive atelectasis induced by PD in non-target lesions and is therefore not presented in plot. ** C
Slide 85: BNT326/YL202 Monotherapy in Various Cancers
Broad Phase 2 Study to Evaluate BNT326/YL2021 as a Monotherapy in Various Cancers 85 Phase 2 trial enrolling patients in China across NSCLC/BC/HNSCC and more 3L+ EGFRm NSCLC post TKI & chemo 2L EGFRm NSCLC chemo naïve 2L HR+, HER2- BC post CDK4/6i Key Inclusion Criteria • Pretreated advanced or meta
Slide 86: BNT326/YL202 plus Pumitamig in NSCLC
600+ patients have been treated with BNT326/YL202; being also evaluated in combination with pumitamig in NSCLC across histologies, treatment lines 86 Partnered with: 1. MediLink; 2. Bristol Myers Squibb; (BNT326-02, NCT07111520) Evaluating BNT326/YL2021 in Combination with Pumitamig2 in Patients wit
Slide 87: Our Diverse Lung Cancer Pipeline
BNT324/ DB-13112 Anti-B7H3 ADC BNT325/ DB-13052 Anti-TROP2 ADC BNT326/ YL2023 Anti-HER3 ADC Anti-PD-L1/ Anti-VEGF Pumitamig4 Gotistobart5 Anti-CTLA-4 Targeted therapies Our Diverse Lung Cancer Pipeline 87 1. Synergistic potential; Partnered with 2 DualityBio; 3. MediLink; 4. Bristol Myers Squibb; 5.
Slide 88: BNT116-Induced T-Cell Responses in NSCLC
Induced T cell response (ex vivo ELISpot) De novo and vaccine-expanded T- cell responses were observed across patients Atmaca A, et. al. SITC 2024 P 1486 BNT1161-Induced T-Cell Responses Have Been Observed in NSCLC 88 Vaccine induced CD4+ and CD8+ T-cell responses observed consistently Öven BB, et.
Slide 89: FixVac Combinations in Lung Cancer
Broad Evaluation of FixVac mRNA Immunotherapy in Combination with ADCs and Immunomodulators in Lung Cancer 1. In collaboration with Regeneron; Partnered with: 2. DualityBio; 3. OncoC4; 4. MediLink; 5. Bristol Myers Squibb; NCT05142189. Cohort 1, n=30 BNT116 + cemiplimab (frail patients) Frail patien
Slide 90: BNT116 Clinical Activity in Advanced NSCLC
BNT116 Has Shown Clinical Activity as Single Agent & in Combination with Chemo or Anti-PD-1 in Advanced NSCLC in Phase 1 Trial1 90 1. In collaboration with Regeneron; NCT05142189. Progression after PD-(L)1 therapy, platinum-based chemotherapy, and one other systemic therapy Progression after PD-(L)1
Slide 91: BNT116 plus Anti-PD-1 Clinical Activity
BNT116 plus cemiplimab in frail patients Dziadziuszko et al. AACR 2025 BNT116 plus cemiplimab as consolidation treatment Atmaca et al. WCLC 2025 BNT116 Has Shown Clinical Activity in Combination with Anti-PD-1 in Advanced NSCLC in Phase 1 Trial1 91 1. In collaboration with Regeneron; NCT05142189 Fra
Slide 92: Ongoing and Next Steps | Thoracic Cancer
Partnered with: 1. Bristol Myers Squibb; 2. OncoC4. Ongoing and Next Steps | Thoracic Cancer Establishing pumitamig as a potential frontline treatment for lung cancer Exploring novel combinations to identify potential future standards-of-care Providing new options for IO experienced sqNSCLC ROSETTA
Slide 93: Coffee Break
Coffee _ Break 15 minutes BIONT=CrH
Slide 94: Breast Cancer
Breast _ Cancer BIONT=CrH
Slide 95: Our Diverse Breast Cancer Pipeline
Our Diverse Breast Cancer Pipeline 95 1. Synergistic potential; Partnered with 2. DualityBio; 3. MediLink; 4. Bristol Myers Squibb. Trastuzumab pamirtecan2 Anti-HER2 ADC BNT326/ YL2023 Anti-HER3 ADC Targeted therapies BNT325/ DB-13052 Anti-TROP2 ADC mRNA cancer immunotherapies Immunomodulators Anti-
Slide 96: Ongoing Trials in Breast Cancer
1L metastatic 2L+ metastatic TNBC HR+ HER2 low HER2+ BC BioNTech’s Currently Ongoing Trials* in Breast Cancer 96 Partnered with: 1. Bristol Myers Squibb; 2. DualityBio; 3. MediLink *As of November 2025 Pumitamig1 + chemo ROSETTA Breast-01 (CPS<10) Pumitamig1 + chemo China Phase 3 (all-comers) Emergi
Slide 97: TNBC Patients Face Poor Outcomes
Treatment outcomes vary based on PD-L1 levels in 1L TNBC TNBC Patients Face Poor Outcomes Due to Limited Therapeutic Options 97 1. Incidence from SEER (US); Zentrum für Krebsregisterdaten (DE); Globocan (ES); Sante Publique (FR); AIOM (IT); Cancer Research UK 2. CancerMPact® 2024 Treatment Architect
Slide 98: Pumitamig in 1L TNBC
98 Patient Population ITT2 PD-L1 CPS<1 PD-L1 1≤CPS<10 PD-L1 CPS≥10 N 42 13 16 9 cORR (%) 73.8 76.9 56.3 100.0 DCR (%) 95.2 100.0 93.8 100.0 mPFS (months) 13.5 18.1 14.0 10.8 18-mo OS rate % 69.7 76.9 64.6 55.6 Congress SABCS 2024 Novel Combinations Being Evaluated in ParallelManageable Safety Profil
Slide 99: Pumitamig Global Phase 2 in 1L/2L TNBC
Trial enrolling heterogenous population across 1L/2L, IO naïve and experienced Arm 1 Arm 2 Pumitamig1 Global Phase 2 in Combination with Chemotherapy for 1L/2L Triple Negative Breast Cancer 99 1. Partnered with Bristol Myers Squibb 2. Cortes, J, et al. N. Engl. J. Med. 2022; BNT327-02: NCT06449222.
Slide 100: Phase 3 Study of Pumitamig in PD-L1 negative TNBC
Phase 3, multi-site, randomized, double-blind trial of pumitamig in combination with chemotherapy versus placebo with chemotherapy in previously untreated locally recurrent inoperable or metastatic PD-L1 negative TNBC 100 1. Partnered with Bristol Myers Squibb; 2. Cortes, J, et al. N. Engl. J. Med.
Slide 101: Our Diverse Breast Cancer Pipeline
Our Diverse Breast Cancer Pipeline 101 1. Synergistic potential; Partnered with 2. DualityBio; 3. MediLink; 4. Bristol Myers Squibb. Trastuzumab pamirtecan2 Anti-HER2 ADC BNT326/ YL2023 Anti-HER3 ADC Targeted therapies BNT325/ DB-13052 Anti-TROP2 ADC mRNA cancer immunotherapies Immunomodulators Anti
Slide 102: Evaluating T-Pam in HER2-Expressing Solid Tumors
Evaluating T-Pam1 in Patients With Advanced HER2-Expressing Solid Tumors 1. Partnered with DualityBio; NCT05150691.. 102 10.0 mg/kg 12.0 mg/kg 8.0 mg/kg 7.0 mg/kg 6.0 mg/kg 4.4 mg/kg 2.2 mg/kg Both HER2 overexpression and HER2 low (IHC3+,2+,1+ or ISH positive) endometrial carcinoma HR+/HER2 Low (IHC
Slide 103: Trastuzumab-Pamirtecan Antitumor Activity in HER2-Expressing Patients
Trastuzumab-Pamirtecan1 Demonstrates Encouraging Antitumor Activity in HER2-Expressing Patients 103 1. Partnered with DualityBio; *NCT05150691. Anti-tumor activity in heavily pretreated HER2- expressing patients ORR, % DCR, % All patients (n=52) 44.2 88.5 HER2+ breast cancer (n=26) 50.0 96.2 HER2 lo
Slide 104: Phase 3 Trial Design of T-Pam in HR+ HER2-Low Breast Cancer
Investigator's choice single agent chemotherapy (paclitaxel or nab-paclitaxel or capecitabine) Phase 3 Trial Design T-Pam1 in Chemotherapy-Naïve Patients with HR+ HER2- Low Breast Cancer 104 1. Partnered with DualityBio; 2. Twelves C. et al. Clinical Breast Cancer. 202;. NCT06018337; * Subjects who
Slide 105: Ongoing Trials in Breast Cancer
1L metastatic 2L+ metastatic TNBC HR+ HER2 low HER2+ BC BioNTech’s Currently Ongoing Trials* in Breast Cancer 105 Partnered with: 1. Bristol Myers Squibb; 2. DualityBio; 3. MediLink *As of November 2025 Pumitamig1 + chemo ROSETTA Breast-01 (CPS<10) Pumitamig1 + chemo China Phase 3 (all-comers) Emerg
Slide 106: Our Diverse Breast Cancer Pipeline
Immunomodulators Our Diverse Breast Cancer Pipeline 106 1. Synergistic potential; Partnered with 2. DualityBio; 3. MediLink. BNT326/ YL2023 Anti-HER3 ADC Targeted therapies BNT325/ DB-13052 Anti-TROP2 ADC Anti-PD-L1/ Anti-VEGF Pumitamig4 Space for curative approaches Synergy1 Targeted therapies Syne
Slide 107: Phase 1/2 Study of T-Pam plus Pumitamig
Phase 1/2 trial to evaluate efficacy, safety and pharmacokinetics of T-Pam in combination with pumitamig in participants with advanced breast cancer 107 Partnered with: 1. DualityBio; 2. Bristol Myers Squibb; NCT06827236. T-Pam: Phase 1/2 Study of T-Pam1 in Combination with Pumitamig2 in Advanced Br
Slide 108: Our Diverse Breast Cancer Pipeline
Immunomodulators Our Diverse Breast Cancer Pipeline 108 1. Synergistic potential; Partnered with 2. DualityBio; 3. MediLink. Trastuzumab pamirtecan2 Anti-HER2 ADC Targeted therapies BNT325/ DB-13052 Anti-TROP2 ADC Anti-PD-L1/ Anti-VEGF Pumitamig4 Space for curative approaches Synergy1 Targeted thera
Slide 109: BNT326/YL202 Monotherapy in Advanced Breast Cancer
Phase 2 Trials Evaluating BNT326/YL2021 as a Monotherapy in Patients with Advanced Breast Cancer 109 Cohorts Cohort A: TNBC HER2 IHC score of 0, 1+, 2+/ISH-, estrogen receptor (ER) and progresterone receptor (PR) expression <1% Cohort B: HR+ and HER2-null and HER2- low expression) HR+ and HER2-null
Slide 110: Ongoing and Next Steps | Breast Cancer
Ongoing and Next Steps | Breast Cancer Partnered with: 1. Bristol Myers Squibb; 2. DualityBio. Establishing pumitamig1 as a potential frontline treatment for TNBC Evaluating novel pumitamig1 + ADC combinations to bring checkpoint inhibition to additional breast cancer subtypes and treatment settings
Slide 111: Gynecologic Cancers
Gynecologic _ Cancers BIONT=CrH
Slide 112: Our Diverse Gyn Cancer Pipeline
Our Diverse Gyn Cancer Pipeline 112 1. Synergistic potential; Partnered with 2. DualityBio; 3. MediLink; 4. Bristol Myers Squibb. Trastuzumab pamirtecan2 Anti-HER2 ADC BNT326/ YL2023 Anti-HER3 ADC Targeted therapies BNT325/ DB-13052 Anti-TROP2 ADC mRNA cancer immunotherapies Immunomodulators Anti-PD
Slide 113: Ongoing Trials in Gynecologic Cancers
BioNTech’s Currently Ongoing Trials* in Gynecologic Cancers 113 Partnered with: 1. Bristol Myers Squibb; 2. DualityBio *As of November 2025 Pumitamig1 demonstrated encouraging efficacy as monotherapy in gyn cancers Emerging ADC data informed the start of PoC trials for pumitamig1 + ADC combinations
Slide 114: T-Pam Clinical Activity in Endometrial Cancer
T-Pam1 Clinical Activity Across HER2-Expression Levels in Endometrial Cancer 114 1. Partnered with DualityBio; 2. Makker V. et al. NEJM 2022 (ITT population), NCT05150691 Phase 1/2 FIH study: Clinical Efficacy Moore K. et al. Presented at ESGO 2023. Abstract # 430 Responsea Dose Escalation Dose Expa
Slide 115: Phase 3 Trial of T-Pam vs Chemotherapy in Endometrial Cancer
Phase 3 Trial of T-Pam1 vs Chemotherapy in 2L+ HER2-Expressing Endometrial Cancer 115 1. Partnered with DualityBio; 2. Makker V. et al. NEJM 2022.; NCT06340568 Arm 1 n=280 Arm 2 n=140 Trastuzumab-pamirtecan monotherapy Investigator’s choice single-agent chemo 2:1 Treatment continued until Disease pr
Slide 116: BNT325/DB-1305 Monotherapy in Platinum Resistant Ovarian Cancer
A multicohort, first-in-human Phase 1/2 trial evaluating BNT325/DB-13051 in patients with advanced/metastatic solid tumors unselected for TROP2 expression Evaluating BNT325/DB-13051 as a Monotherapy in Platinum Resistant Ovarian Cancer 116 1. Partnered with DualityBio. Key Endpoints Primary: ORR, sa
Slide 117: BNT325/DB-1305 Durable Activity in Ovarian Cancer
Overall mPFS of 7.4 months Responders* (n) mDOR (months) 8 7.3 Encouraging antitumor activity in previously treated ovarian cancer BNT325/DB-13051 Shows Durable Antitumor Activity in Previously Treated Ovarian Cancer 1. Partnered with DualityBio; *BOR not included for 3 patients (3 mg/kg). In 2 mg/k
Slide 118: BNT324/DB-1311 Emerging Activity in Melanoma, HCC, CC, HNSCC
BNT324/DB-13111 Shows Emerging Activity in Melanoma, HCC, Cervical Cancer and HNSCC 118 1. Partnered with DualityBio; All patients received either 6 mg/kg or 9 mg/kg except for 1 patient with SCCHN who received 10.5 mg/kg. The difference between the number of patients treated and those evaluable for
Slide 119: Pumitamig in Combination with Novel ADCs
Pumitamig1 in Combination with Novel ADCs in High Unmet Need Indications Partnered with: 1. Bristol Myers Squibb; 2.Duality; NCT05438329 DL1: BNT325/DB-1305 3 mg/kg Q3W DL2: BNT325/DB-1305 3.5 mg/kg Q3W “3+3” + backfill Key Inclusion Criteria • ≥18 years of age • ≥1 measurable lesion per RECIST v1.1
Slide 120: Pumitamig plus ADC Safety Profile and Clinical Activity
Preliminary Data Combining Pumitamig1 with ADC Showed a Manageable Safety Profile with Few Overlapping Toxicities and Signs of Clinical Activity 120 Phase 1/2: Pumitamig1 combined with TROP2 ADC BNT325/DB-13052 in 2L–4L PROC Erika Hamilton et al. AACR 2025 P648 1. Partnered with: 1. Bristol Myers S
Slide 121: Our Diverse Gyn Cancer Pipeline
Our Diverse Gyn Cancer Pipeline 121 1. Synergistic potential; Partnered with 2. DualityBio; 3. MediLink; 4. Bristol Myers Squibb. Trastuzumab pamirtecan2 Anti-HER2 ADC BNT326/ YL2023 Anti-HER3 ADC Targeted therapies BNT325/ DB-13052 Anti-TROP2 ADC mRNA cancer immunotherapies Immunomodulators Anti-PD
Slide 122: Pumitamig Monotherapy in Advanced CC and PROC
Evaluating Pumitamig1 Monotherapy in Patients with Advanced CC and PROC 1. Partnered with Bristol Myers Squibb; NCT05918445 122 Key Inclusion Criteria • Advanced or metastatic CC ( 2 prior treatment lines) and PROC ( 1 prior treatment line after platinum resistance) • Age 18-75 years • ECOG PS 0-1
Slide 123: Pumitamig Monotherapy Efficacy in PROC
Pumitamig1 as Monotherapy Showed Encouraging Efficacy Signals in Patients with PROC 123 1. Partnered with Bristol Myers Squibb; NCT05918445 Phase 1/2 trial: Efficacy signals PROC Wu, L. et al. ASCO 2024 #5524 PROC: N=34 | 7 PR | 16 SD | ORR of 20.6% and DCR of 67.7% mPFS was 5.5 months B e s t C h a
Slide 124: Pumitamig Monotherapy Efficacy in CC
Pumitamig1 as Monotherapy Showed Encouraging Efficacy Signals in Patients with CC 124 1. Partnered with Bristol Myers Squibb; *NCT05918445 Phase 1/2 trial: Efficacy signals CC Wu, L. et al. ASCO 2024 #5524 CC: N=45 | 1 CR | 18 PR | 23 SD | ORR was 42.2% and DCR 93.3% | ORR in patients with PD-L1-pos
Slide 125: Ongoing and Next Steps | Gynecological Cancer
Partnered with: 1. Bristol Myers Squibb; 2. DualityBio. Ongoing and Next Steps | Gynecological Cancer Establishing trastuzumab pamirtecan2 in HER2-expressing endometrial cancer Evaluating ADC monotherapy and novel pumitamig1 + ADC combinations in ovarian and cervical cancers Pumitamig1 + ADCs Novel
Slide 126: Gastrointestinal Cancers
Gastrointestinal Cancers BIONT=CrH
Slide 127: Our Diverse GI Cancer Pipeline
Anti-PD-L1/ Anti-VEGF Pumitamig4 Autogene cevumeran6 Immunomodulators mRNA cancer immunotherapy Our Diverse GI Cancer Pipeline 127 1. Synergistic potential; Partnered with 2. DualityBio; 3. MediLink; 4. Bristol Myers Squibb; 5. Genmab; 6. Genentech, a member of the Roche Group. Targeted therapies iN
Slide 128: Ongoing Trials in GI Cancers
Adjuvant 1L metastatic 2L+ metastatic CRC Gastric PDAC BioNTech’s Currently Ongoing Trials* in GI Cancers 128 Partnered with: 1. Bristol Myers Squibb; 2. Genmab; 3. DualitiyBio; 4. MediLink.*As of November 2025 Pumitamig1 + chemo (CRC - MSS) ROSETTA CRC-203 Sponsored by BMS Pumitamig1 + chemo BNT327
Slide 129: MSS CRC: Significant Incidence with Unmet Need
Patients with metastatic MSS-CRC have few treatment options and require new therapeutic strategies MSS CRC: Significant Global Incidence with Unmet Need for New Therapies 129 1. Globocan – Cancer Tomorrow. 2. CancerMPact® 2024 Treatment Architecture EU5 and US. 3. André, Ann Oncol., 2024. 4. Cremoli
Slide 130: Phase 2 Trial of Pumitamig plus Chemotherapy in CRC
Phase 2, multicenter, open label trial to evaluate efficacy and safety of pumitamig in combination with chemotherapy in 1L MSS or MSI-L/pMMR metastatic CRC Phase 2 Signal Seeking Trial of Pumitamig1 in Combination with Chemotherapy in Colorectal Cancer 130 1. Partnered with Bristol Myers Squibb; NCT
Slide 131: Phase 2/3 Study of Pumitamig in CRC
Phase 2/3, randomized study to evaluate safety and efficacy of pumitamig in combination with CTx vs. Bevacizumab in combination with CTx in participants with previously untreated, unresectable, or metastatic CRC Phase 2/3 Study with Pumitamig1 in Combination with Chemotherapy in Patients with CRC 13
Slide 132: Gastric Cancer: Poor Outcomes and Restricted Therapies
132 ~75k 2030 U.S., EU4, U.K. gastric cancer incidence1 1.1. Globocan – Cancer Tomorrow; 2. CancerMPact® 2024 Treatment Architecture EU5 and US; 3. Janjigian, NEJM 2024; 4. Janjigian, JCO 2024 Gastric Cancer: Poor Outcomes and Restricted Therapies in Biomarker Negative Patients 15% 12% 21% 19% 26% 2
Slide 133: Phase 2/3 Study of Pumitamig in 1L Gastric Cancer
Phase 2/3 Study with Pumitamig1 in Combination with Chemotherapy in 1L Gastric Cancer 133 1. Partnered with Bristol Myers Squibb; NCT07221149 Pumitamig + FOLFOX or CAPOX Nivolumab + FOLFOX or CAPOX Pumitamig DL1 + FOLFOX Pumitamig DL2 + FOLFOX Nivolumab + FOLFOX Phase 2/3 study of pumitamig in combi
Slide 134: BNT314/GEN1059 plus Pumitamig in Metastatic CRC
Phase 1/2 trial across 482 patients to evaluate combination BNT314/GEN1059 and pumitamig and chemotherapy in patients with advanced metastatic CRC 134 Partnered with: 1. Genmab; 2. Bristol Myers Squibb. 3. Bennouna J. et al. Lancet Oncol. 2013. Evaluating BNT314/GEN10591 in Combination with Pumitami
Slide 135: Pancreatic Cancer: Poor Survival and Limited Options
135 ~153k 2030 U.S., EU4, U.K. pancreatic cancer incidence1 1.1. Globocan – Cancer Tomorrow; 2. CancerMPact® 2024 Treatment Architecture EU5 and US; 3. Conroy et al., JAMA Oncol, 2022; 4. Von Hoff et al., N Engl J Med, 2013; 5. Conroy et al., N Engl J Med, 2011; 6. CancerMPact® 2024 Treatment Archit
Slide 136: Pumitamig plus Chemotherapy in PDAC
Phase 2 Trial with Pumitamig1 in Combination with Chemotherapy in Patients with PDAC 136 Patient Population 1L PDAC patients Key Endpoints Benchmark Data for 1L PDAC Benchmark regimen ORR mPFS mOS Benchmark study mFOLFIRINOX 32% 6.4 mo 11.1 mo MPACT2 GnP 23% 5.5 mo 8.7 mo PRODIGE-IV3 Primary: ORR, s
Slide 137: CA19-9-ADC BNT329 in GI Cancers
Exploring CA19-9-ADC BNT329 To Build Presence in GI Cancers 137 Adapted from Loy et al. 1993 1. Passerini R, et al. Am J Clin Pathol 2012;138(2):281–7; 2. Data on file; 3. Lee et al. World J Gastrointest Surg. 2020 Dec 2712(12): 468-490; 4. Loy et al. Am J Clin Pathol.1993;99:726-728 CA19-9 is highl
Slide 138: Ongoing and Next Steps | Gastrointestinal Cancer
Partnered with: 1. Bristol Myers Squibb. Ongoing and Next Steps | Gastrointestinal Cancer 138 Establishing pumitamig1 in gastrointestinal cancers Evaluating novel pumitamig1 + immunomodulator and ADC monotherapy in late-stage disease ROSETTA CRC1 Pumitamig1 + chemotherapy in 1L MSS-CRC ROSETTA Gastr
Slide 139: Genitourinary Cancers
Genitourinary Cancers BIONT=CrH
Slide 140: Our Diverse GU Cancer Pipeline
Anti-PD-L1/ Anti-VEGF Pumitamig3 Gotistobart4 Anti-CTLA-4 Immunomodulators Our Diverse GU Cancer Pipeline 140 1. Synergistic potential; Partnered with: 2. DualityBio; 3. Bristol Myers Squibb; 4. OncoC4. Targeted therapies Immunomodulators Space for curative approaches Synergy1 Targeted therapies mRN
Slide 141: Current Development in GU Cancer
1L metastatic 2L+ metastatic RCC Prostate BioNTech’s Current Development in GU Cancer 141 Partnered with: 1. Bristol Myers Squibb; 2. DualityBio; 3. OncoC4. China Phase 1/2 pumitamig1 (non-clear cell) China Phase 1/2 pumitamig1 (clear cell) Immunomodulator + RLT (Gotistobart3) PoC trials in GU cance
Slide 142: Pumitamig Monotherapy in Clear Cell and Non-Clear Cell RCC
Phase 1/2 multiple cohort monotherapy trial to evaluate safety and efficacy of pumitamig in patients with advanced solid tumors, including RCC Evaluating Pumitamig1 Monotherapy in Patients with 2L Clear Cell RCC and 1L Non-Clear Cell RCC 1. Partnered with Bristol Myers Squibb; NCT05918445 Confidenti
Slide 143: Pumitamig Activity in 2L+ Clear Cell RCC
mPFS: 10.9 months Pumitamig1 Showed Encouraging Anti-Tumor Activity in Patients with 2L+ Clear Cell RCC 143 1. Partnered with Bristol Myers Squibb; Xinan Sheng al. ESMO 2024 1692P ORR: 25.0%; DCR: 82.1% (n=28) mDOR: 19.6 months P ro b o b il it y o f P F S 0.0 0.2 0.4 0.6 0.8 1.0 0 2 4 6 8 10 12 14
Slide 144: Pumitamig Activity in 1L nccRCC
Pumitamig1 Showed Encouraging Anti-Tumor Activity in Patients with 1L nccRCC Across Subtypes 144 1. Partnered with Bristol Myers Squibb; Xinan Sheng, et. al. ESMO 2024 1692P. mPFS: 15.1 months ORR: 36.4%; DCR: 90.9% (n=22) DOR of up to 24.9 months 0 3 6 9 12 15 18 21 24 27 Study Months DOR: 24.9M DO
Slide 145: Our Diverse GU Cancer Pipeline
Anti-PD-L1/ Anti-VEGF Pumitamig3 Gotistobart4 Anti-CTLA-4 Immunomodulators Our Diverse GU Cancer Pipeline 145 1. Synergistic potential; Partnered with: 2. DualityBio; 3. Bristol Myers Squibb; 4. OncoC4. Targeted therapies Immunomodulators Space for curative approaches Synergy1 Targeted therapies mRN
Slide 146: Broad Exploration of BNT324/DB-1311
Phase 1/2, multicenter trial of BNT324/DB-1311 enrolling 465 patients with advanced/metastatic solid tumors unselected for B7H3 expression, including in Prostate Cancer Broad Exploration of BNT324/DB-13111 146 1. Partnered with DualityBio; BNT324/DB-1311 treatment continued until disease progression
Slide 147: BNT324/DB-1311 Efficacy in Late-Line mCRPC
Encouraging Efficacy with BNT324/DB-13111 in Late-Line mCRPC 147 1. Partnered with DualityBio: Overall (n=73) 6 mg/kg (n=38) 9 mg/kg (n=33) Response evaluable, n 52 24 28 ORR, (%) [95% CI] 42.3 [28.7, 56.8] 41.7 [22.1, 63.4] 42.9 [24.5, 62.8] cORR, (%) [95% CI] 30.8 [18.7, 45.1] 29.2 [12.6, 51.1] 32
Slide 148: Ongoing and Next Steps | Genitourinary Cancer
Partnered with: 1. Bristol Myers Squibb. Ongoing and Next Steps | Genitourinary Cancer Exploring pumitamig in GU cancers Evaluating ADCs and novel combinations in GU cancers ADCs China Phase 1/2 Pumitamig1 in 2L+ ccRCC and 1L nccRCC 148
Slide 149: Innovating Early-Stage Cancer Treatment with mRNA Cancer Immunotherapies
Innovating Early- Stage Cancer Treatment with mRNA Cancer Immunotherapies Prof. Özlem Türeci, M.D. Chief Medical Officer and Co-founder 5
Slide 150: SARS-CoV-2 mRNA Vaccines Sensitize Tumors to CPI
SARS-CoV-2 mRNA Vaccines Sensitize Tumors to CPI Adam Grippin et al, Nature, 2025; Controlling for 39 covariables with COX proportional hazards regression ~25% of these patients received mRNA COVID-19 vaccines within 100 days of initiating immunotherapy Demonstrates potential of mRNA vaccines to sti
Slide 151: RNA-LPX Platform Design
151 Uridine-based mRNA-lipoplexes (RNA- LPX) administered IV for preferential delivery to the APCs in spleen, lymph nodes and bone marrow RNA-LPX is optimized for immune response stimulation RNA-LPX combines targeted antigen delivery with stimulation innate immune signature Secretory signal peptide
Slide 152: iNeST and FixVac Approaches
152 Individual patient samples (blood and tissue) Artificial intelligence- driven neoantigen prediction On-demand tailored RNA manufacturing Individualized immuno- therapy Mapping of mutations Fixed combination of shared tumor antigens2 Multi-antigen approach tailored to each indication Neo- antigen
Slide 153: mRNA Immunotherapies: iNeST and FixVac Programs
153 1. Partnered with: 1. Genentech, a member of the Roche Group; 2. In collaboration with Regeneron. Individualized immunotherapy: iNeST FixVac Autogene cevumeran1 BNT1112 BNT113 BNT116 Adjuvant 1L R/R R/R 1L Multiple settings MIUC Phase 2 CRC Phase 2 PDAC Phase 2 Melanoma Phase 2 Solid tumors Phas
Slide 154: iNeST Phase 2 in 1L Melanoma: Study Design and Primary Endpoint
Key inclusion criteria • Unresectable/metastatic melanoma • Naïve to metastatic treatment setting Stratification factors • PD-L1 (≥5% vs. <5% or unknown) • M-stage & LDH Trial Design Investigator-assessed PFS Key Findings iNeST1 Phase 2 in 1L Melanoma – Study Design and Primary endpoint 154 1. Partn
Slide 155: Neoantigen-Specific T-Cell Responses in Melanoma
Bulk PBMCs CD8+T cells Patients Longitudinal analysis of neoantigen-specific CD8 T-cell clones Sullivan et al. ESMO 2025 #954P High patient-level immunogenicity: 47/56 (84%) patients mounted ≥1 ex vivo T-cell response N u m b e r o f V a c c in e A n ti g e n s IF N y S p o ts (p e r 1 x 1 0 6 c e l
Slide 156: PFS Trend by Neoantigen Response Breadth
156 1. Partnered with Genentech, a member of the Roche Group; 2. Exploratory, non-powered analyses; Group “<= cutoff” includes ELISpot negative patients Trend of incremental PFS improvement observed in patients with higher neoantigen response breadth2 0 0 6 12 20 40 60 80 100 2418 30 36 42 48 54 P a
Slide 157: Autogene Cevumeran Data in 1L Melanoma
Autogene Cevumeran1 Phase 2 Data in 1L Melanoma Yield Insights That Support Current Development Focus 1. Partnered with Genentech, a member of the Roche Group; 2. The primary analysis occurred after 79 PFS events; the median follow-up time for PFS was 36 months and for OS was 45.1 months in the ITT
Slide 158: Ongoing and Next Steps | mRNA Cancer Immunotherapies
Partnered with: 1. Bristol Myers Squibb; 2. Genentech, member of the Roche Group; 3. OncoC4. Ongoing and Next Steps | mRNA Cancer Immunotherapies 158 Evaluating autogene cevumeran2 in adjuvant-stage disease Evaluating novel combinations for FixVac Phase 2 Autogene cevumeran2 in adjuvant ctDNA+ stage
Slide 159: BioNTech's Path to Value Creation
BioNTech’s Path to Value Creation Ramón Zapata Chief Financial Officer 6
Slide 160: 2025 Accomplishments
✓ Launched variant-adapted COVID-19 vaccine ✓ Leading COVID-19 market share globally (>50%) ✓ >20 phase 2 and 3 oncology trials ongoing ✓ 30+ novel-novel combination cohorts ongoing across tumors ✓ Completed Biotheus acquisition ✓ Strategic BMS partnership to maximize pumitamig ✓ Increased 2025 reve
Slide 161: Expansion of Later-Stage Oncology Trials While Maintaining R&D Expenditure
Driving Impact with Expansion of Later-Stage Oncology Pivotal Trials, While Maintaining R&D Expenditure 161 1 YTD October 31, 2025. Visualization illustrative and not to scale. 1210 Phase 2 and 3 Oncology Trials Ongoing: Annual R&D Spend: 2023 €1.8 billion 2024 €2.2 billion 2025 €2.0 - 2.2 billion >
Slide 162: Financial Levers Enable Dynamic R&D Investment
Financial Levers Enable BioNTech’s Dynamic R&D Investment 162 R&D Investment Control Levers Active portfolio management strategy sets high bar for late- stage investment and balance with high risk/reward programs Innovative, tailored partnerships to advance priority programs cost effectively, while
Slide 163: BMS Partnership Structured to Accelerate Pumitamig
163 Innovative BMS Partnership Structured to Accelerate and Maximize Pumitamig, While Strengthening BioNTech Short- and Long-Term P&L Maximizing potential of next-generation PD-L1xVEGF-A bispecific antibody, pumitamig, with global co-development and co-commercialization BMS partnership • Advancing t
Slide 164: Key Principles on the Path to Value Creation
BioNTech Key Principles on the Path to Value Creation 164 Speed and Scalability: Commercial Readiness and First-to-Market Approach Ensure operational agility and organizational readiness to scale rapidly, build commercial infrastructure, prioritize speed to market Financial Efficiency: Ensuring Cash
Slide 165: Key Areas of Focus 2026
Key Areas of Focus BioNTech Operating from Position of Strength 1 Combination Therapy Momentum Anticipate additional datasets from novel-novel combination trials with pumitamig 2 Modalities to Disease Areas 2026 marks BioNTech’s movement to a focused disease area specific approach 3 Late-Stage Accel
Slide 166: Q&A Panel Discussion
Prof. Uğur Şahin, M.D. Chief Executive Officer Co-founder Annemarie Hanekamp Chief Commercial Officer Prof. Özlem Türeci, M.D. Chief Medical Officer Co-founder Ramón Zapata Chief Financial Officer Michael Wenger, M.D. Vice President, Clinical Development Prof. Ilhan Celik, M.D. Vice President, Clini
Slide 167: Thank you
Thank you
Slide 168: Appendix
— Appendix BIONT=CrH
Slide 169: Oncology Pipeline – Phase 2 and 3 Clinical Trials
BioNTech’s Oncology Pipeline – Phase 2 and Phase 3 Clinical Trials Partnered with 1. Bristol Myers Squibb; 2. Genentech, member of Roche Group; 3. DualityBio; 4. OncoC4; 5. In collaboration with Regeneron; 6. Trial ongoing in China. Gotistobart4 (CTLA-4) PROC, + pembrolizumab Autogene cevumeran2 Adj
Slide 170: Oncology Pipeline – Phase 1 and 1/2 Clinical Trials
BioNTech’s Oncology Pipeline – Phase 1 and Phase 1/2 Clinical Trials 170 Partnered with: 1. Bristol Myers Squibb; 2. Genmab; 3. DualityBio; 4. Onco C4; 5. MediLink; 6. Trial ongoing in China. Phase 1/2Phase 1 BNT312/GEN10422 (CD40x4-1BB) Multiple solid tumors Gotistobart4 (CTLA-4) Multiple solid tum
Slide 171: Upcoming Data Readouts at Medical Conferences in 2025
Upcoming Data Readouts at Medical Conferences in 2025 171 Indication Milestone Congress Pumitamig1 1L/2L TNBC Global Phase 2 dose optimization data SABCS Gotistobart2 2L sq NSCLC Phase 3 Stage 1 data NACLC BNT324/DB-13113 CC and PROC Phase 1/2 data ESMO ASIA BNT326/YL2024 HR+HER2-null or low BC Phas
Slide 172: Select Data Readouts Set Up Catalyst-Rich Period
Select Data Readouts Set BioNTech Up For Catalyst-Rich Period Ahead 172 Partnered with: 1. Bristol Myers Squibb; 2. OncoC4; 3.Genentech, a member of the Roche Group; 4. DualityBio. Indication Milestone Expected Timing Pumitamig1 1L NSCLC Global Phase 2 data 2026 1L/2L TNBC Global Phase 2 dose optimi
Slide 173: Abbreviation Directory (1)
Abbreviation Directory (1) 4-1BB CD137 CCA Cholangiocarcinoma EC Endometrial cancer n L nth line cCRT Concurrent chemoradiotherapy ECOG Eastern Cooperative Oncology Group AACR American Association for Cancer Research CDx Cluster of differentiation EGFR Epidermal growth factor receptor (bs)AB (bispec
Slide 174: Abbreviation Directory (2)
Abbreviation Directory (2) H&N Head and neck JCO Journal of Clinical Oncology NCI PRO- National Cancer Institute Patient Reported Outcome Common HCC Hepatocellular carcinoma KD Dissociation constant CTCAE Terminology Criteria for Adverse Events HER2/3 Human epidermal growth factor receptor 2/3 KK-LC
Slide 175: Abbreviation Directory (3)
Abbreviation Directory (3) PBMC Peripheral blood mononuclear cell RP2/3D Recommended phase 2/3 dose TLR Toll-like receptor PBS Phosphate buffered saline RPL18 Ribosomal Protein L18 TMB-H (or L) Tumor mutational burden-high or low PCWG3 Prostate Cancer Working Group 3 R/R Relapsed/refractory TME Tumo