BioNTech SE · NASDAQ:BNTX
BioNTech — Investor Day (November 2024)
111 slides from BioNTech's investor day presentation, Nov 14, 2024
Slide 1: Innovation Series 2024
Innovation Series 2024 November 14, 2024 10:30 AM – 2:15 PM ET
Slide 2: Welcome & Introductory Remarks
1 Welcome & Introductory Remarks Ryan Richardson, Chief Strategy Officer
Slide 3: This Slide Presentation Includes Forward-Looking Statements
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 profit/
Slide 4: Innovation Series 2024 – Today's Presenters
Innovation Series 2024 – Today’s Presenters Prof. Ugur Sahin, M.D. Prof. Özlem Türeci, M.D. Ryan Richardson Chief Executive Officer, Co-founder Chief Medical Officer, Co-founder Chief Strategy Officer Annemarie Hanekamp Prof. Ilhan Celik, M.D. Michael Wenger, M.D. Chief Commercial Officer Vice Presi
Slide 5: Innovation Series 2024 Agenda
Innovation Series 2024 Agenda 1 Welcome and Introductory Remarks 10:30 AM 10 min 2 The Next Frontiers in Oncology 10:40 AM 45 min 3 Commercialization: Next Era of BioNTech 11:25 AM 15 min 4 BNT3271 Clinical Development Strategy 11:40 AM 45 min Break 12:25 PM 15 min 5 mRNA Cancer Vaccines 12:40 PM 30
Slide 6: BioNTech's Journey
BioNTech’s Journey 2008 2019 2020-2022 From 2023 Founding & Platform Nasdaq IPO COMIRNATY®1 Advancing towards Building Development, approval becoming Seed financing & first & worldwide launch a multi-product collaborations biotechnology company BNT327/PM80022 Autogene cevumeran3 FixVac BNT211 (CAR-T
Slide 7: Driven to Address the World's Most Pressing Health Challenges
Driven to Address the World’s Most Pressing Health Challenges With pioneering technologies delivered at scale COVID-19 VACCINE 1 GLOBAL LEADERSHIP STRONG FINANCIAL POSITION >4.9 billion >80 countries >50 % € 17.8 bn doses distributed globally Comirnaty market share2 total cash plus security investm
Slide 8: Developing and Approving the First mRNA Medicine
Developing and Approving the First mRNA Medicine The fastest vaccine development in the history of The strongest launch of any pharmaceutical medicine1 product2 >4.9 billion doses of BNT162b2 shipped >180 countries and territories3 1. Ball P. Nature. 2021; 2. Measured by sales recorded for a single
Slide 9: Long-Term Need for Seasonally Adapted Vaccines Anticipated
Long-Term Need for Seasonally Adapted Vaccines Anticipated Continuous evolution Risk remains high Ongoing antigenic evolution For severe COVID-19 in of SARS-CoV-21,2 vulnerable populations3 Annual and/or SEASONAL Long-term health VACCINATION with variant-adapted consequences vaccines expected for th
Slide 10: COVID-19 and Influenza Disease Burdens Show Different Seasonality Patterns
COVID-19 and Influenza Disease Burdens Show Different Seasonality Patterns Weekly new patient hospital admissions from surveillance sites in the U.S.1 10 Period of peak US 9 influenza vaccine distribution2 US Hospitalization rate per 100,000 8 7 6 population 5 4 3 2 1 0 July 2023 Aug Sep Oct Nov Dec
Slide 11: Variant-Adapted Vaccine Approval Timelines Came Earlier as Compared to 2023
Variant-Adapted Vaccine Approval Timelines Came Earlier as Compared to 2023 Approval dates of variant-adapted COVID-19 vaccines1 2023 2024 Approval Date Change US Sep 11 (XBB.1.5) Aug 22 (KP.2) 20 days EC Sep 1 (XBB.1.5) Jul 3 (JN.1) 60 days UK Sep 5 (XBB.1.5) Jul 24 (JN.1) 43 days JP Sep 1 (XBB.1.5
Slide 12: COVID-19 Vaccine Franchise with Lean Cost Structure
COVID-19 Vaccine Franchise1 with Lean Cost Structure Key Business Features: 2024 Financials up to 30 September (Q1-Q3) Revenue €1,310m 1. Global Market Leadership 2. Lean Fixed Cost Base Business OPEX €573m COGS €298m 3. Potential for Cashflow Generation R&D €228m S&M €47m 1. Partnered with Pfizer.
Slide 13: Leveraging COVID-19 Vaccine Business Model for Sustainable Value Creation
Leveraging COVID-19 Vaccine Business Model for Sustainable Value Creation Financial Strength Innovative R&D Engine Progressive Path Towards Value Creation Cash generative COVID-19 vaccine Multi-product business1 portfolio First launches in oncology Data updates across pipeline Balance sheet 2025 202
Slide 14: Today's Focus: Key Value-Driving Oncology Programs
Today’s Focus: Key Value-Driving Oncology Programs Transformational Opportunities with Pan Tumor Potential BNT327/PM8002 (bispecific PD-L1xVEGF)1 Autogene cevumeran2 (personalized mRNA cancer vaccine) FixVac (off-the-shelf TAA-targeting mRNA cancer vaccine) BNT211 (CLDN6-targeted CAR-T + CLDN6 CAR-T
Slide 15: The Next Frontiers in Oncology
2 The Next Frontiers in Oncology Prof. Ugur Sahin, M.D. CEO and Co-founder
Slide 16: Charting the Course for Tomorrow's Personalized Precision Medicine
Charting the Course for Tomorrow’s Personalized Precision Medicine Personalized Omics Deep genomics & immunology expertise to analyze patient data Clinical samples Therapeutic Modalities Individualized treatment platforms Immunomodulators to address inter-individual variability Inter- individual var
Slide 17: Our Concept Towards a Potentially Curative Approach to Cancer
Our Concept Towards a Potentially Curative Approach to Cancer Immunomodulators • Aiming to augment anti-tumor- immunity Immunomodulators • Focus on crucial IO pathways Novel checkpoint inhibitors cytokines, immune agonists • Bispecific targeting aimed for synergy • Intended to promote durable anti-
Slide 18: Programs Currently Evaluated in Clinical Stage
Programs Currently Evaluated in Clinical Stage Immunomodulators BNT151 BNT312/ BNT314/ BNT152 GEN10425 GEN10595 BNT153 Ribocytokines Immunomodulators Anti- CD40 / Anti-EpCAM / IL2, IL7 BNT327/ Anti-4-1BB Anti-4-1BB Novel checkpoint inhibitors PM80023 cytokines, immune agonists BNT315/ BNT316/ Anti-P
Slide 19: Select Candidates Suitable for Late-Stage Development Across Multiple Cancer Indications
Select Candidates Suitable for Late-Stage Development Across Multiple Cancer Indications Immunomodulators mRNA Cancer Vaccines Targeted Therapy BNT327/PM80021 BNT122 Autogene BNT211 PD-L1 × VEGF bispecific antibody cevumeran2 Autologous CLDN6-targeting CAR-T Validated across Individualized Cancer Va
Slide 20: BNT327/PM8002: Synergistic Targeting of PD-L1 and VEGF
BNT327/PM80021: Synergistic Targeting of PD-L1 and VEGF BNT327/PM80021 characteristics: combined tumor targeting2 Tumor Selected NSCLC IHC3 microenvironment Bispecific MOA (TME) VEGF-A VEGF-A dimer in the TME PD-L1 ligand Targeting of PD-1 on tumor cells /PD-L1 blockade to Anti-VEGF-A (Fab) Anti-PD-
Slide 21: Anti-VEGF Treatment May Reverse Immune-Suppressive Effects
Anti-VEGF Treatment May Reverse Immune-Suppressive Effects and Potentially Improve Outcome of IO Treatment VEGF signaling has immunosuppressive effects in addition to angiogenesis Tumor microenvironment (TME) Tumor angiogenesis Abnormal blood vessel formation leads to hypoxia, acidosis, and restrict
Slide 22: BNT327/PM8002 Investigated Across Multiple Tumor Types with >700 Patients Treated
BNT327/PM80021 is Being Investigated Across Multiple Tumor Types with >700 Patients Treated Mono Combo Mono Combo 1L NSCLC WT PD-L1+ Breast 1L TNBC + Nab-Paclitaxel 2L+ NSCLC + Pemetrexed/Carboplatin 1L HCC + FOLFOX4 EGFRm Lung Gastro- intestinal 2L SCLC + Paclitaxel Advanced BTC 1L SCLC + Etoposide
Slide 23: BNT327/PM8002 with nab-paclitaxel Shows Efficacy Irrespective of PD-L1 Status in 1L TNBC
BNT327/PM80021 with nab-paclitaxel Shows Clinically Meaningful Efficacy Irrespective of PD-L1 Status in 1L TNBC Phase 1/2b (NCT05918133): clinical activity of BNT327/PM80021 in combination with nab-paclitaxel Y. Meng et al. Presented at ESMO 2024. Presentation 384MO PD-L1 PD-L1 PD-L1 20 Variable ITT
Slide 24: BNT327/PM8002 May Drive Clinical Benefit Irrespective of PD-L1 Status
BNT327/PM80021 May Drive Clinical Benefit Irrespective of PD-L1 Status BNT327/PM80021 can potentially become backbone IO therapy irrespective of PD-L1 status BNT327/PM80021 + chemo in 1L TNBC Y. Meng et al. Presented at ESMO 2024. Presentation 384MO BNT327/PM80021 MOA dual mechanisms: tumor PD-L1 ta
Slide 25: Next-generation Bispecific Can Potentially Expand the Reach of IO Therapy
Next-generation Bispecific Can Potentially Expand the Reach of IO Therapy PD-(L)1 monotherapy PD-(L)1 approved as combination therapy or in later line PD-(L)1 not currently approved approved in front line NSCLC PD-L1 ≥ 50% NSCLC PD-L1 <50% TNBC PD-L1 ≥ 10% TNBC PD-L1 <10% SCLC EGFRmut NSCLC HNSCC PD
Slide 26: Anti-PD-(L)1 Therapy Only Addresses a Fraction of Cancer Incidence
Anti-PD-(L)1 Therapy Only Addresses a Fraction of Cancer Incidence PD-(L)1 not approved CRC (MSI-H) Gastric PD-(L)1 approved HCC Breast (non TNBC) TNBC PD-L1 >10% HNSCC/nasopharyngeal Endometrial Anti-PD-(L)1 therapy TNBC PD-L1 <10% addresses US and EU RCC Cancer Incidence1 ~1.5 M new cancer cases C
Slide 27: Significant Patient Population Not Addressed by Existing IO Therapies
Significant Patient Population Not Addressed by Existing IO Therapies PD-(L)1 not approved CRC (MSI-H) Gastric PD-(L)1 approved HCC Breast (non TNBC) TNBC PD-L1 >10% HNSCC/nasopharyngeal Endometrial US and EU TNBC PD-L1 <10% >1.4 M RCC Cancer Incidence1 new cancer cases in the US and EU that cannot
Slide 28: New Approaches Across Indications through Our Combination Strategy
We Aim to Bring New Approaches Across Indications through Our Combination Strategy PD-(L)1 not approved CRC (MSI-H) PD-(L)1 approved Gastric HCC Breast (non TNBC) TNBC PD-L1 >10% HNSCC/nasopharyngeal Endometrial TNBC PD-L1 <10% RCC CRC (MSS) Melanoma EGFRmut NSCLC Lung Pancreatic Ovarian GBM 1. US i
Slide 29: Focus on BNT327/PM8002 as Backbone for Late-Stage Development
Focus on BNT327/PM80021 as Backbone for Late-Stage Development Immunomodulator Monotherapy Activity, and Synergy in Combination with Chemotherapy in Various Indications Synergy Synergy Preclinical Synergy Space for with ADC2 curative approaches Targeted mRNA therapy vaccines Synergy ADCs, CAR-T 1. P
Slide 30: BNT327/PM8002 + BNT325/DB-1305 TROP2-ADC: Preclinical Data
BNT327/PM80021 + BNT325/DB-13052 TROP2-ADC: Preclinical Data Demonstrate Enhanced Anti-Tumor Efficacy when Combined Xenograft A375 PBMC-co injection model – hTROP2-MC38 in wt mice A375 expressing TROP2 in B-NDG B2M 2500 2000 Tumor volume (mm³) 1500 1000 500 0 13 15 18 20 22 25 27 29 BNT327/PM8002 BN
Slide 31: BNT327/PM8002 Clinical Development: Taking Full Control of Global Rights
BNT327/PM80021 Clinical Development Taking Full Control of Global Rights and Clinical Programs Target Indication Regimen Phase Status Global clinical population BNT327/PM8002 trials SCLC 1L or 2L + chemo 2 Ongoing Proven capabilities of TNBC 1L or 2L + chemo 2 Ongoing SCLC 1L + chemo vs. atezolizuma
Slide 32: Accelerating Global Clinical Development Program for BNT327/PM8002
Accelerating Global Clinical Development Program for BNT327/PM80021 Explore potential of BNT327/PM80021 in three waves of focused development 1 Establish 2 Combine 3 Broaden Ongoing Ongoing • Phase 1/2 with BNT325/DB-13052 • Phase 2 in SCLC (TROP2) in solid tumors • Phase 2 in TNBC Planned Planned •
Slide 33: Announced Planned Acquisition of Biotheus
Announced Planned Acquisition of Biotheus Upfront cash and BioNTech stock payment of $800 Million Milestone-based cash earn-out of up to $150 million Biotheus to become a wholly-owned BioNTech subsidiary Closing expected Q1 20251 1. Subject to regulatory approvals and other customary closing conditi
Slide 34: Biotheus Acquisition to Accelerate BNT327/PM8002 Development Execution
Biotheus Acquisition to Accelerate BNT327/PM80021 Development Execution Anti-VEGF A Advancing BNT327/PM80021 in multiple indications, aiming for first-to-market approvals Anti-PD-L1 VHH BNT327/ PM80021 Clinical development Manufacturing site Full pipeline and platform development acceleration capabi
Slide 35: Biotheus Manufacturing Facility to Supply Clinical Trial Expansion and Early Launches
Biotheus Manufacturing Facility to Supply Clinical Trial Expansion and Early Launches Biotheus Brings Fully-Integrated CMC, Manufacturing and Fill Finish Capabilities 200L Pilot plant: support IND and Phase 1 studies 2000L Production plant: Support global clinical development and early launches IND
Slide 36: Oncology Treatment is Entering the Bispecific Antibody Era
Oncology Treatment is Entering the Bispecific Antibody Era IO therapies have relied on Bispecific antibodies enable new opportunities mAbs with a single target1 10 new bispecifics approved in the U.S. since 2021 2022 Tebentafusp (gp100 × CD3) FDA approval 2017 Faricimab (Ang-2 × VEGF) 2024 of bispec
Slide 37: Biotheus' Fully-Integrated Antibody Discovery and Engineering Workflow
Biotheus' Fully-Integrated Antibody Discovery and Engineering Workflow “Plug and Play” design enables screening of multiple formats for optimized lead selection 24 months for BNT327/PM80021 from discovery to IND submission Selected antibody formats generated 9 clinical stage bispecifics generated 30
Slide 38: Biotheus Pipeline Enables Exploration of Novel IO + IO Combinations
Biotheus Pipeline Enables Exploration of Novel IO + IO Combinations Biotheus Pipeline overview A broad range of targets to be explored for IO+IO combos Selected Clinical Assets BNT327/PM80021 Phase 2 / Phase 3 in China (PD-L1 × VEGF bispecific) PM1009 Phase 1 (TIGIT × PVRIG bispecific) PM1022 Phase
Slide 39: Commercialization: Next Era of BioNTech
3 Commercialization: Next Era of BioNTech Annemarie Hanekamp, Chief Commercial Officer
Slide 40: BioNTech is in Transition to a Multi-Product Commercial Oncology Company
BioNTech is in Transition to a Multi-Product Commercial Oncology Company BNT327/PM80023 + ADC combinations Strategic launch Autogene cevumeran4 (Adj. PDAC, Adj. MIUC) Novel-novel combinations sequence for Expand oncology portfolio BNT327/PM80023 >400K (1L SCLC, 1L NSCLC, 1L TNBC) patients Autogene c
Slide 41: Maintaining COVID-19 Vaccine Franchise with Lean Commercial Infrastructure
Maintaining COVID-19 Vaccine Franchise1 with Lean Commercial Infrastructure Cash generating COVID-19 Lean commercial organization in Germany and Türkiye, leveraging business structure partners’ commercial infrastructures for global rollout of Comirnaty Maintained ~80% gross margin3 Low sales & marke
Slide 42: First Launch with BNT323/DB-1303 in Endometrial and Breast Cancer
First Launch with BNT323/DB-13031 to Address Unmet Need in Endometrial and Breast Cancer Patients Strategic launch to build-up BioNTech commercialization capabilities for future launches Endometrial cancer Breast cancer Establish relationships with oncology community and payors ~120K ~615K Incidence
Slide 43: BNT327/PM8002: Combine with SoC Chemotherapy in Fast-to-Market Indications
BNT327/PM80021: Combine with SoC Chemotherapy in Potential Fast-to- Market Indications Building on existing commercial infrastructure, rapidly scaling up to establish lung and breast cancer franchises NSCLC SCLC TNBC Aiming to address remaining high unmet need through ~415K ~60K ~65K improved durati
Slide 44: Creating an AI Infused Commercialization Model
Creating an AI Infused Commercialization Model Focused on Delivering our Innovations to Patients at Scale Launch Establish Expand Build AI infused, optimized yet Leverage initial build to rapidly scale Future proof AI commercial model to scalable commercial capabilities to for BNT327/PM80022 and exe
Slide 45: New Pillar of Care for Early-Stage Colorectal Cancer with Autogene Cevumeran
Aiming to Establish New Pillar of Care for Early-Stage Colorectal Cancer Patients with Autogene Cevumeran1 Phased expansion into early-stage tumors with a novel platform modality CRC (2030) US Incidence | 151K2 Percentage of stage II high risk / stage III patients who are expected 65% Stage II (high
Slide 46: Patient-Centric Commercialization Model for Individualized mRNA Cancer Therapies
Building a Patient-Centric Commercialization Model to Support the Establishment of Individualized mRNA Cancer Therapies End-to-End capabilities orchestration required Intra- / inter- Sample Infusion clinic practice preparation & capabilities / coordination shipment capacity Product ordering process
Slide 47: BioNTech is in Transition to a Multi-Product Commercial Oncology Company
BioNTech is in Transition to a Multi-Product Commercial Oncology Company BNT327/PM80023 + ADC combinations Strategic launch Autogene cevumeran4 (Adj. PDAC, Adj. MIUC) Novel-novel combinations sequence for Expand oncology portfolio BNT327/PM80023 >400K (1L SCLC, 1L NSCLC, 1L TNBC) patients Autogene c
Slide 48: BNT327 Clinical Development Strategy
4 BNT327 Clinical Development Strategy Prof. Ilhan Celik, M.D. VP Clinical Development
Slide 49: Accelerating Global Clinical Development Program for BNT327/PM8002
Accelerating Global Clinical Development Program for BNT327/PM80021 Explore potential of BNT327/PM80021 in three waves of focused development 1 Establish 2 Combine 3 Broaden Ongoing Ongoing • Phase 1/2 with BNT325/DB-13052 • Phase 2 in SCLC (TROP2) in solid tumors • Phase 2 in TNBC Planned Planned •
Slide 50: Next-generation Bispecific Can Potentially Expand the Reach of IO Therapy
Next-generation Bispecific Can Potentially Expand the Reach of IO Therapy PD-(L)1 monotherapy PD-(L)1 approved as combination therapy or in later line PD-(L)1 not currently approved approved in front line NSCLC PD-L1 ≥ 50% NSCLC PD-L1 <50% TNBC PD-L1 ≥ 10% TNBC PD-L1 <10% SCLC EGFRmut NSCLC HNSCC PD
Slide 51: TNBC Patients Face Poor Outcomes Due to Limited Therapeutic Options
TNBC Patients Face Poor Outcomes Due to Limited Therapeutic Options 2030 U.S., EU4, U.K. TNBC incidence1 ~65k Treatment outcomes vary based on PD-L1 levels in 1L TNBC BC staging distribution 2 PD-L1 CPS < 10 (~ 55%)3,4 PD-L1 CPS > 10 (~ 45%)3,4 33% Chemo: 15.0 mos Pembro + chemo: 23.0 mos 39% Stage
Slide 52: BNT327/PM8002 with Nab-Paclitaxel for 1L Metastatic TNBC
BNT327/PM80021 in Combination with Nab-Paclitaxel for 1L Metastatic TNBC Phase 1b/2 (NCT05918133) Y. Meng et al. Presented at ESMO 2024. Presentation 384MO Key inclusion criteria • Age 18-75 years with life expectancy ≥ 12 weeks • Histologically or cytologically confirmed Treatment unresectable adv.
Slide 53: BNT327/PM8002: Safety Profile Appears Manageable in 1L TNBC
BNT327/PM80021: Safety Profile Appears Manageable in 1L TNBC Phase 1b/2 (NCT05918133) Y. Meng et al. Presented at ESMO 2024. Presentation 384MO Safety Overview (N=42) n (%) TRAEs of Interest (N=42) All grades, n (%) Grade > 3, n (%) All TRAEs 42 (100) Neutrophil count decreased 36 (85.7) 13 (31.0) G
Slide 54: BNT327/PM8002 with Chemo Shows Efficacy in 1L TNBC
BNT327/PM80021 in Combination with Chemo Shows Clinically Meaningful Efficacy in 1L TNBC Irrespective of PD-L1 Status Data update at SABCS Phase 1/2b (NCT05918133): Y. Meng et al. Presented at ESMO 2024. Presentation 384MO December 11, 2024 PD-L1 PD-L1 PD-L1 20 Variable ITT* CPS<1 1≤CPS<10 CPS≥10 0
Slide 55: BNT327/PM8002 Phase 2 with Chemotherapy for 1L/2L TNBC
BNT327/PM80021 Phase 2 in Combination with Chemotherapy for 1L/2L Triple Negative Breast Cancer BNT327-02 (NCT06449222) Arm 1 Key inclusion criteria BNT327/PM80021 dose level 1+ Taxane A • Histologically confirmed, 1:1 Selected dose from la/ mTNBC n=40 cohort 1 will be BNT327/PM80021 dose level 2+ u
Slide 56: BNT327/PM8002 with Chemotherapy for EGFR-mutated, post-TKI NSCLC
BNT327/PM80021 in Combination with Chemotherapy for EGFR-mutated, post-TKI NSCLC Phase 2 study of BNT327/PM80021 + carbo/pem in EGFRm NSCLC post EGFR TKI (NCT05756972) Adapted from Wu YL et al. Presented at ESMO 2024. Mini oral 1255MO. Inclusion criteria • Age ≥ 18 years • Nonsquamous Stage IIIB/C a
Slide 57: Safety Profile of BNT327/PM8002 + Chemotherapy in EGFRm NSCLC
Safety Profile of BNT327/PM80021 + Chemotherapy in Patients with EGFRm NSCLC after Progressing on Prior EGFR TKI Phase 2 study of BNT327/PM80021 + carbo/pem in EGFRm NSCLC post EGFR TKI (NCT05756972) Adapted from Wu YL et al. Presented at ESMO 2024. Mini oral 1255MO. Safety Overview, TRAE, (n=64) n
Slide 58: BNT327/PM8002 with Chemo Shows Efficacy in EGFRm NSCLC
BNT327/PM80021 in Combination with Chemo Shows Clinically Meaningful Efficacy in EGFRm NSCLC Irrespective of PD-L1 Status Phase 2 study of BNT327/PM80021 + carbo/pem in EGFRm NSCLC post EGFR TKI (NCT05756972) Adapted from Wu YL et al. Presented at ESMO 2024. Mini oral 1255MO. PD-L1 Negative PD-L1 Lo
Slide 59: Non-Small Cell Lung Cancer is One of the Highest Incidence Cancers Globally
Non-Small Cell Lung Cancer is One of the Highest Incidence Cancers Globally1 2030 U.S., EU4, U.K. Treatment outcomes vary based on histology and PD-L1 levels in NSCLC incidence1 ~415k 1L NSCLC patients without actionable genomic alterations Non-squamous (~ 70%)3 Squamous (~ 30%)3 NSCLC Staging distr
Slide 60: BNT327/PM8002: Phase 1/2 Dose Expansion Trial with Monotherapy in 1L NSCLC
BNT327/PM80021: Phase 1/2 Dose Expansion Trial with Monotherapy in 1L NSCLC Phase 1b/2a (NCT05918445): Safety across all 3 NSCLC cohorts Wu, C. et al. presented at ASCO 2024. Poster #8533. Cohorts*: Key inclusion criteria • Age ≥ 18 years with expected Cohort 1 (n = 17) survival rate 12 weeks 1L N
Slide 61: BNT327/PM8002: Monotherapy Safety Profile Manageable in 1L NSCLC
BNT327/PM80021: Monotherapy Safety Profile Appeared Manageable in 1L NSCLC Phase 1b/2a (NCT05918445): Safety across all 3 NSCLC cohorts Wu, C. et al. presented at ASCO 2024. Poster #8533. Safety overview (n=61) n (%) Common TRAEs (n=61) All grades, n (%) Grade > 3, n (%) All TRAEs 52 (85.2) Proteinu
Slide 62: BNT327/PM8002 Monotherapy Efficacy in 1L NSCLC
BNT327/PM80021 Monotherapy Efficacy in 1L NSCLC Phase 1b/2a (NCT05918445): cohort 1, 1L NSCLC (EGFR & ALK WT) Wu, C. et al. presented at ASCO 2024. Poster #8533. Indication Benchmark regimen ORR mPFS mOS Benchmark Study Waterfall/spider plots and Kaplan-Meier curves (PFS) 1L NSCLC (PD-L1 > 50%) Pemb
Slide 63: Extensive-Stage SCLC is a High-Incidence Cancer with Poor Survival Rates
Extensive-Stage Small Cell Lung Cancer is a High-Incidence Cancer with Poor Long-term Survival Rates 2030 U.S., EU4, U.K. High unmet need for ES-SCLC patients as long-term survival SCLC incidence1 ~60k outcomes remain very poor SCLC Staging distribution2 Limited-Stage SCLC Extensive-Stage SCLC CRT:
Slide 64: BNT327/PM8002 in Combination with Paclitaxel for 2L SCLC
BNT327/PM80021 in Combination with Paclitaxel for 2L SCLC Phase 2 (NCT05879068) Key Inclusion criteria Treatment Patients with advanced SCLC continued until who progressed after platinum- Induction Maintenance Disease progression based chemotherapy with or without checkpoint inhibitors BNT327/PM8002
Slide 65: BNT327/PM8002 with Paclitaxel Shows Acceptable Safety Profile in 2L SCLC
BNT327/PM80021 Combined with Paclitaxel Shows Acceptable Safety Profile in 2L SCLC Phase 2 (NCT05879068) Ying Cheng et al. Presented at ESMO 2023. Poster#1992P Safety overview (n=48) n (%) TRAE ≥10% of patients All grades, n (%) Grade > 3, n (%) All TRAEs 45 (93.8) Neutropenia 23 (47.9) 22 (45.9) TR
Slide 66: BNT327/PM8002 with Paclitaxel Shows Efficacy in 2L SCLC
BNT327/PM80021 Combined with Paclitaxel Shows Efficacy in 2L SCLC Phase 2 (NCT05879068) Ying Cheng et al. Presented at ESMO 2023. Poster#1992P Efficacy Evaluation Population Efficacy Evaluation Population • Received prior anti-PD- IO- IO- 1/PD-L1 : ~46% ITT IO-naïve treated ITT IO-naïve treated Resp
Slide 67: BNT327/PM8002: Phase 2 Dose Optimization with Chemotherapy for 1L/2L SCLC
BNT327/PM80021: Phase 2 Dose Optimization in Combination with Chemotherapy for 1L/2L SCLC BNT327-01 (NCT06449209) Key Inclusion criteria Treatment • Cohort 1: Untreated ES-SCLC BNT327/PM80021 (dose level 1) + chemo continued until or LS-SCLC with TFI≤6 months since last treatment Disease progression
Slide 68: Accelerating Global Clinical Development Program for BNT327/PM8002
Accelerating Global Clinical Development Program for BNT327/PM80021 Explore potential of BNT327/PM80021 in three waves of focused development 1 Establish 2 Combine 3 Broaden Ongoing Ongoing • Phase 1/2 with BNT325/DB-13052 • Phase 2 in SCLC (TROP2) in solid tumors • Phase 2 in TNBC Planned Planned •
Slide 69: Well-Positioned in ADCs with Therapeutic Candidates Across Multiple Tumors
Well-Positioned in ADCs with Therapeutic Candidates Across Multiple Tumors BNT323/DB-13031 BNT324/DB-13111 BNT325/DB-13051 BNT326/YL2022 HER2 B7H3 TROP2 HER3 Targeting HER2, cleavable Targeting B7H3, cleavable linker Targeting TROP2, cleavable Targeting HER3, cleavable linker and topoisomerase I and
Slide 70: BNT327/PM8002 + ADC Combinations are Planned or Ongoing
BNT327/PM8002 + ADC Combinations are Planned or Ongoing Combination with BNT325/DB-1305 BNT323/ DB-13032 Solid Tumor is ongoing and additional combinations are planned BNT324/ DB-13112 Solid Tumor BNT327/ + PM80021 BNT325/ DB-13052 Solid Tumor Planned Ongoing Partnered with 1. Biotheus; 2.DualityBio
Slide 71: Time for a 15 minute break
Time for a 15 minute break
Slide 72: mRNA Cancer Vaccines
5 mRNA Cancer Vaccines Prof. Özlem Türeci, M.D. CMO and Co-founder Michael Wenger, M.D. VP, Clinical Development
Slide 73: Uridine-based mRNA-LPX Vaccines for Systemic Delivery
Uridine-based mRNA-LPX Vaccines for Systemic Delivery and Induction of Potent Polyspecific Immune Responses Against Cancer Antigens Uridine-based RNA in formulated LPX RNA-LPX is optimized for immune RNA-LPX combines targeted antigen (RNA-LPX) and administered IV for response stimulation delivery wi
Slide 74: Full Exploitation of Cancer Vaccine Target Space
Full Exploitation of Cancer Vaccine Target Space Artificial intelligence- MHC-I-multimer staining of Individual Individualized patient samples driven immuno- PBMCs reveals vaccine antigen- neoantigen Individualized (blood and tissue) prediction therapy specific CD8+T cells: Neoantigens therapy iNeST
Slide 75: Multiple Clinical Trials Across iNeST and FixVac Portfolio
Multiple Clinical Trials Demonstrate Execution Across iNeST and FixVac Portfolio Individualized vaccine: iNeST FixVac Autogene cevumeran (BNT122/RO7198457) 1 BNT1112 BNT113 BNT116 Adjuvant 1L R/R R/R 1L Multiple settings MIUC CRC PDAC Melanoma Solid Tumors Melanoma HPV16+ HNSCC NSCLC Phase 2 Phase 2
Slide 76: Evaluating Autogene Cevumeran in Adjuvant Setting for High Unmet Need Cancers
Evaluating Autogene Cevumeran1 in the Adjuvant Treatment Setting for Cancers of High Unmet Need Rationale for adjuvant setting Unmet medical need Pancreatic Ductal Adenocarcinoma Colorectal Cancer Low tumor mass with 69−75% relapse rate within 5 years 20-35% relapse rate within 4 years residual canc
Slide 77: Response to Autogene Cevumeran Correlates with Delayed PDAC Recurrence
Response to Autogene Cevumeran1 Correlates with Delayed PDAC Recurrence Phase 1, investigator-initiated trial in resectable PDAC: 3-year follow-up data Balachandran et al., AACR 2024. #CT025 & Rojas et al., Nature 2023. Responders Non-responders (n=8) (n=8) 3-year median follow-up 20 P = 0.007, HR:
Slide 78: Autogene Cevumeran Phase 2 Randomized Trial vs SoC in Resected PDAC
Autogene Cevumeran1 Investigated in a Phase 2 Randomized Trial vs SoC in Resected PDAC Patients IMCODE003: Phase 2, open-label, multicenter, randomized trial (NCT05968326) Randomization Treatment phases and dosing schedules Key inclusion criteria 6-12 weeks Patients are monitored at scheduled interv
Slide 79: Post-Surgery ctDNA Positivity in CRC Associated with Shorter DFS
Post-Surgery ctDNA Positivity in CRC is Associated with Significantly Shorter DFS and Can Identify Patients at High Risk of Disease Recurrence BNT000-001: A Multi-Site Epidemiological Study of ctDNA Status in Stage II/III CRC Patients After Resection and Prior to Adjuvant Chemotherapy (NCT04813627)
Slide 80: Autogene Cevumeran Phase 2 Trial vs Watchful Waiting in Adjuvant CRC
Autogene Cevumeran1 Investigated in a Phase 2 Randomized Trial vs. Watchful Waiting in Adjuvant Colorectal Cancer BNT122-01: Phase 2, multi-site, open-label, randomized, controlled trial (NCT04486378) Key inclusion Adjuvant SoC chemotherapy for 12–24 weeks Autogene cevumeran1 criteria 15 doses: 6×Q1
Slide 81: Vaccine-Induced T Cells are Long-Lived in CRC Patients
Functional Vaccine-Induced T Cells are Long-Lived and Detected One Year After Last Vaccination with Autogene Cevumeran1 in all Evaluable CRC Patients Kinetics and persistence of T cell responses to vaccine-encoded neoantigens Elez et. al., Biomarker sub-study results of Phase 2 trial (NCT04486378),
Slide 82: Autogene Cevumeran Phase 2 Trial with Nivolumab in Adjuvant MIUC
Autogene Cevumeran1 Investigated in a Phase 2 Randomized Trial in Combination with Nivolumab in Adjuvant MIUC Patients Medical need IMCODE004: Phase 2, multi-site, open-label, randomized, controlled trial (NCT06534983) Standard of care Neoadjuvant chemotherapy, followed Inclusion criteria Part A: Sa
Slide 83: Multiple Clinical Trials Across iNeST and FixVac Portfolio
Multiple Clinical Trials Demonstrate Execution Across iNeST and FixVac Portfolio Individualized vaccine: iNeST1 FixVac Autogene cevumeran (BNT122/RO7198457) BNT1112 BNT113 BNT116 Adjuvant 1L R/R R/R 1L Multiple settings MIUC CRC PDAC Melanoma Solid Tumors Melanoma HPV16+ HNSCC NSCLC Phase 2 Phase 2
Slide 84: BNT113 Showed Consistent Immune Responses in Multiple Studies
BNT113 Showed Consistent Immune Responses in Adjuvant and Advanced Disease in Multiple Studies Vaccine induced T cell responses and consistent Vaccine-induced T cell count corresponded with volume of clonotype expansion observed in majority of patients tumor reduction Ottensmeier, et. al. ESMO 2024.
Slide 85: BNT113 Showed Activity with ORR of 40% in HPV16+ HNSCC
BNT113 Showed Activity with ORR1 of 40% in PD-L1+ HPV16+ HNSCC Patients Results from safety run-in of Phase 2 AHEAD-MERIT in 1L metastatic HNSCC (NCT04534205) Saba et. al., ESMO 2024 Antitumor activity2 N=15 Tumor overall response, treatment and survival status by BICR Unconfirmed ORR (BICR), % 40.0
Slide 86: BNT113 with Pembrolizumab as 1L Treatment in HPV16+ HNSCC
•. BNT113 in Combination with Pembrolizumab as 1L Treatment in Patients with R/R HPV16+ HNSCC Expressing PD-L1 Medical need AHEAD-MERIT: a Phase 2 controlled trial in 1L metastatic HNSCC (NCT04534205) Safety run-in Standard of care Inclusion criteria n=15 BNT113 (8xQ1W, then Q3W) + pembrolizumab (Q3
Slide 87: BNT116-Induced T Cell Responses Observed in NSCLC
BNT1161-Induced T cell Responses Have Been Observed in NSCLC Vaccine induced CD4+ and CD8+ T cell responses observed consistently De novo and vaccine-expanded T cell Öven BB, et. al., presented at AACR 2024. CT051 responses were observed across patients Atmaca A, et. al., presented at SITC 2024. Pos
Slide 88: Assessing BNT116's Potential in Multiple Combinations and Disease Settings
Assessing BNT116’s Potential in Multiple Combinations and Disease Settings1 LuCa-MERIT-1: FIH, open-label, Phase 1 trial in NSCLC (NCT05142189) Inclusion criteria Cohort 1, n=30 BNT116 monotherapy Optional: cemiplimab add-on from cycle 3 onwards Histologically confirmed NSCLC Cohort 1-4 and 7: unres
Slide 89: BNT116 Has Shown 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 BNT116 monotherapy plus BNT116 plus docetaxel BNT116 plus cemiplimab cemiplimab add-on from cycle 3 Öven et al. AACR 2024 Atmaca et al. SITC 2024 Deme et al. SITC 2023 Prog
Slide 90: Select Targeted Therapies: HER2-ADC BNT323, CLDN6 CART BNT211
6 Select Targeted Therapies: HER2-ADC BNT323 CLDN6 CART BNT211 Dr. Michael Wenger, MD VP Clinical Development Prof. Özlem Türeci, M.D. CMO and Co-founder
Slide 91: BNT323/DB-1303: A HER2 ADC with a Potentially Differentiated Profile
BNT323/DB-13031: A HER2 ADC with a Potentially Differentiated Profile BNT323/DB-13031 is Mode of action Preclinical Data a 3rd generation ADC Lin S. et al. Abstract #252. Presented at EORTC- NCI-AACR in 2022 & data on file. • A humanized anti-HER2 Targeted Cytotoxicity Bystander killing • Superior i
Slide 92: First-in-Human Trial with BNT323/DB-1303 in HER2-Expressing Solid Tumors
First-in-Human Trial with BNT323/DB-13031 in Patients with Advanced HER2-Expressing Solid Tumors Phase 1/2a trial design (NCT05150691), multicenter, non-randomized, open-label Moore K. et al. Presented at ASCO 2023. Abstract #3023 Key inclusion criteria Part 1: Dose escalation (n=88 patients) Part 2
Slide 93: BNT323/DB-1303 Data Facilitates Path to Registration in Endometrial Cancer
BNT323/DB-13031 Data Facilitates a Potential Path to Registration in HER2- Expressing Endometrial Cancer Phase 1/2a FIH study (NCT05150691): Clinical Efficacy Moore K. et al. Presented at ESGO 2023. Abstract # 430 • HER2 tumor expression of IHC 1, 2 and 3+: 31%, 41% and 25%, respectively. Clinical r
Slide 94: Phase 3 Study of BNT323/DB-1303 vs Chemotherapy in Endometrial Cancer
Phase 3 Study of BNT323/DB-13031 vs Chemotherapy in 2L+ HER2-expressing Endometrial Cancer BNT323-01: (NCT06340568) Key inclusion criteria • Recurrent, metastatic endometrial cancer (including HER2 1+, 2+, or Arm 1 3+ score on IHC by central testing) BNT323/DB-13031 Treatment n=280 monotherapy conti
Slide 95: Claudin-6 (CLDN6) is a Carcinoembryonic Cell Surface Antigen
Claudin-6 (CLDN6) is a Carcinoembryonic Cell Surface Antigen Human Tissue Panel a b c d e f g h i j k l Healthy tissues Claudins are tight junction- associated tetraspanins with Mouse Tissue Data m n o druggable extracellular loops Expressed exquisitely during p q r organogenesis and not in healthy
Slide 96: CLDN6 is Expressed in High Medical Need Cancers Including Lung Cancer
CLDN6 is Expressed in High Medical Need Cancers Including Lung Cancer Healthy Tumor CLDN6 IHC staining of a TMA with 355 NSCLC Testis Indication CLDN6+ CLDN6hig tested CLDN6+ h Testicular 93 % 90-93 % Squamous CA 120 0 Cancer* Ovarian 56 % 25-30 % AdenoCA 195 20 (10%) Ovary Cancer* Uterine 23 % 10-1
Slide 97: BNT211: a CLDN6 CAR-T-Cell Therapy + CLDN6-Encoding CARVac
BNT211: a CLDN6 CAR-T-Cell Therapy + CLDN6-Encoding CARVac that Enhances Expansion and Persistence of the Infused CAR-T Cells Potent 2nd generation CAR with high Combined with CARVac (CAR-T cell amplifying sensitivity and specificity RNA vaccine) to target APCs, Reinhard K, et al. Science Reinhard K
Slide 98: BNT211 as Monotherapy or in Combination with RNA-LPX
BNT211 as Monotherapy or in Combination with Ribonucleic Acid Lipoplexes (RNA-LPX) in Patients with CLDN6-Positive Advanced Solid Tumors Phase 1, FIH, open-label, dose escalation study with expansion cohort to evaluate safety and efficacy of BNT211 with/without RNA-LPX in patients with CLDN6+ R/R so
Slide 99: BNT211-01: Overall Response Rate – Testicular Cancer
BNT211-01: Overall Response Rate – Testicular Cancer Overall ORR was 24%; at DL2 and DL3 ORR was 41.7%. Two patients had a surgical complete response that lasted for over a year. Haanen et. al., ESMO 2024 Best overall response per RECIST v1.1 Responsea Total (N=27)b Change in the sum of target lesio
Slide 100: BNT211-01: Overall Response Rate – Ovarian Cancer
BNT211-01: Overall Response Rate – Ovarian Cancer In the 24 evaluable patients across all dose levels, ORR was 33.3% and DCR was 75% - the same parameters when considered for Dose Level 2 and above were 58.3% and 83.3% respectively. Haanen et. al., ESMO 2024 Best overall response per RECIST v1.1 Res
Slide 101: Best Overall Response to CLDN6 CAR T + CARVac in a Patient with NSCLC
Best Overall Response to CLDN6 CAR T+ CARVac in a Patient with NSCLC1 Best overall response was PR • Patient with AGA-neg NSCLC, CLDN6+ (50% 2+/3+, 80% any Pre Post positivity), IO-experienced, • 2 previous treatment lines, former smoker • Received CAR T + 5x CARVac Pre Post Target lesion size Scree
Slide 102: CARVac Improves CAR T Persistence
CARVac Improves CAR T Persistence Adding CARVac limits the decline and induces a plateau of CAR-T cells with robust and ongoing detection in patients1 who received DL2+CARVac. Haanen et. al., ESMO 2024 DL2 (1x108) CAR T alone DL2 (1x108) CAR T + CARVac 105 D50 concentration, GCT 104 106 106 copies/µ
Slide 103: mOS of 7.7 Months in R/R Testicular Germ Cell Tumors
mOS of 7.7 Months in Patients with R/R Testicular Germ Cell Tumors After Initiating Palliative Chemotherapy Real-world evidence study: Results objective 1 Feldman, D. et al. ASCO 2024. OS among patients with R/R testicular GCT receiving palliative chemotherapy exposure with sufficient follow-up time
Slide 104: BNT211 Pivotal Trial in R/R Testicular Germ Cell Tumors
BNT211 Pivotal Trial in Patients with R/R Testicular Germ Cell Tumors BNT211-02 open-label, randomized Phase 2 study to evaluate safety and efficacy of BNT211 in adult patients with testicular or extragonadal germ cell tumors Key inclusion criteria Safety lead-in part: 3-arm, randomized (1:1:1) Main
Slide 105: Path to Value Creation
7 Path to Value Creation Ryan Richardson, Chief Strategy Officer
Slide 106: Progress in the Last Twelve Months Demonstrates the Strength of our Model
Progress in the Last Twelve Months Demonstrates the Strength of our Model and our Strategy 2023 2024 COVID-19 Maintained leading market share (>50%) 7 Phase 2/3 trial starts Oncology Portfolio >67% year-on-year increase in average quarterly patient enrollment in trials Infectious Disease Vaccine Por
Slide 107: Our Capital Allocation Strategy Will Continue to Focus on Value Creation
Our Capital Allocation Strategy Going Forward Will Continue to Focus on Value Creation 2023 2024e Outlook for 2025 2500 2000 Strategically invest behind late-stage programs with transformational potential 1500 Active portfolio management to create additional 1000 P&L headroom for pivotal trial inves
Slide 108: Expected Potential Value Creating Milestones and Trials
Expected Potential Value Creating Milestones and Trials Ongoing and Planned Trials with Anticipated Data 2024 - 2025+ 2H 2024 Disclosures Beyond 2025 2025+ Autogene cevumeran Autogene cevumeran BNT327/PM80022 BNT327/PM80022 BNT327/PM80022 BNT323/DB-13033 (BNT122/RO7198457)4 (BNT122/RO7198457)4 1L TN
Slide 109: Thank You
Innovation Series 2024 THANK YOU Contact us at investors@biontech.de
Slide 110: Abbreviations (1)
Abbreviations (1) nL nth line CRC Colorectal cancer FIH First in human AACR American Association for Cancer Research CRS Cytokine release syndrome Flu Fludarabine ACT Adoptic cell transfer CRT Chemoradiation therapy FPD First patient dosed ADC Antibody-drug conjugate CT Computer tomography GBM Gliob
Slide 111: Abbreviations (2)
Abbreviations (2) irAE Immune-related adverse event NSCLC Non-small cell lung cancer SITC Society of Immunotherapy of Cancer ISH in-situ hybridization NY-ESO-1 New York esophageal squamous cell carcinoma-1 S&M Sales and marketing ITT Intention to treat OPEX Operational expenditures SoC Standard of c