BioNTech SE · NASDAQ:BNTX
BioNTech — 42nd J.P. Morgan Healthcare Conference (January 2024)
45 slides from BioNTech's conference presentation, Jan 9, 2024
Slide 1: 42nd J.P. Morgan Healthcare Conference
42nd J.P. Morgan Healthcare Conference Prof. Ugur Sahin, M.D. CEO & Co-founder 9 January 2024 – 9:40 AM PST Exhibit 99.2
Slide 2: This Slide Presentation Includes Forward-Looking Statements
This Slide Presentation Includes Forward-Looking Statements 2 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: planned next steps in BioNTech’s pipeline
Slide 3: Our Vision: Harnessing the Power of the Immune System to Fight Human Disease
Our Vision: Harnessing the Power of the Immune System to Fight Human Disease 3 Diversified innovative precision medicine pipeline targeting multiple product approvals per year Multi-product immunotherapy pioneer addressing medical need worldwide BioNTech’s Vision Powered by breakthrough science, dis
Slide 4: BioNTech Today
BioNTech Today Execution 4 Innovative pipeline with 27 clinical programs in oncology and infectious diseases Long-term sustainable seasonal respiratory vaccine business Building a commercial organization behind a growing late-stage pipeline with 6 ongoing potentially registrational trials mRNA pione
Slide 5: BioNTech Today
BioNTech Today Execution 5 Innovative pipeline with 27 clinical programs in oncology and infectious diseases Long-term sustainable seasonal respiratory vaccine business Building a commercial organization behind a growing late-stage pipeline with 6 ongoing potentially registrational trials mRNA pione
Slide 6: Building and Expanding a Long-term and Successful COVID-19 Franchise
2023 accomplishments Franchise highlights Building and Expanding a Long-term and Successful COVID-19 Franchise1 6 1. Partnered with Pfizer, 2. Cumulative doses shipped in the years 2021-2023; 3. COVID-19 Excess Mortality Collaborators: Lancet. 2022. 4. January to December 3, 2023. 5. September to De
Slide 7: BioNTech Today
BioNTech Today Execution 7 Innovative pipeline with 27 clinical programs in oncology and infectious diseases Long-term sustainable seasonal respiratory vaccine business Building a commercial organization behind a growing late-stage pipeline with 6 ongoing potentially registrational trials mRNA pione
Slide 8: Multi-Technology Innovation Engine
Multi-Technology Innovation Engine 8 1. mRNA encoded cancer-targeting antibodies and cytokines. CAR = chimeric antigen receptor; TCR = T cell receptor. Individualized and/or targeted therapies ANTIBODY DRUG CONJUGATES TARGETED CANCER THERAPIES RIBOLYSIN mRNA-encoded lysins OFF-THE- SHELF mRNA CANCER
Slide 9: mRNA: A Broad Technology Toolbox
mRNA: A Broad Technology Toolbox 9 Holtkamp et al. Blood 2006; Kuhn et al. Gene Therapy 2010; Sahin et al. 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 nanopart
Slide 10: Building a Leading Biotechnology and AI Company at Scale
Reinforcement learning & large language models Supporting R&D efforts and biology-focused generative AI Building a Leading Biotechnology and AI Company at Scale 10 AI = artificial intelligence; ML = machine learning; GPU = Graphics Processing Unit; RL = reinforcement learning; LLM = large language m
Slide 11: BioNTech Today
BioNTech Today Execution 11 Innovative pipeline with 27 clinical programs in oncology and infectious diseases Long-term sustainable seasonal respiratory vaccine business Building a commercial organization behind a growing late-stage pipeline with 6 ongoing potentially registrational trials mRNA pion
Slide 12: Developing an Innovative Pipeline Focused on Oncology and Infectious Disease
O nc ol og y In fe ct io us D is ea se 7 clinical trials started Growing clinical stage pipeline 6 clinical assets in-licensed 3 first-in-human trials started 11 Phase 2 & 3 trials ongoing Developing an Innovative Pipeline Focused on Oncology and Infectious Disease 12 1. Partnered with Pfizer; 2. In
Slide 13: BioNTech Today
BioNTech Today Execution 13 Innovative pipeline with 27 clinical programs in oncology and infectious diseases Long-term sustainable seasonal respiratory vaccine business Building a commercial organization behind a growing late-stage pipeline with 6 ongoing potentially registrational trials mRNA pion
Slide 14: Progressing Innovation to Address a Broad Range of Unmet Needs
Progressing Innovation to Address a Broad Range of Unmet Needs 14 1. Partnered with OncoC4; 2. Partnered with DualityBio; 3. Partnered with Genentech, member of Roche Group. NSCLC = non-small cell lung cancer; HPV = human papillomavirus; PDAC = pancreatic ductal adenocarcinoma; CRC = colorectal canc
Slide 15: Corporate Execution in 2023
Grew team and expanded global presence on 5 continents >1,600 new employees joined in 2023 Corporate Execution in 2023 1. Preliminary, unaudited figure; consists of cash, cash equivalents and security investments, as of December 31, 2023. 15 Strengthened balance sheet with strong financial performan
Slide 16: Infectious Disease Overview
Infectious Disease Overview
Slide 17: Long-Term Need for Annually Adapted Vaccines Anticipated
Variant-adapted vaccines Designed to be effective against multiple variants of concern5 Long-term health consequences Accumulating evidence demonstrates that COVID-19 vaccination reduces long- COVID4 Continuous evolution Ongoing antigenic evolution of SARS-CoV-21,2 Risk remains high For severe COVID
Slide 18: Seasonal Covid-Flu Combination Vaccine Could Address Dual Disease Burden
Collaborative work with Pfizer to develop combination vaccines for various respiratory diseases* Seasonal Covid-Flu Combination Vaccine Could Address Dual Disease Burden In Overlapping Populations 18 1. Investigator’s Brochure Version 5.0. BNT162/PF-07302048. Available at: https://www.tga.gov.au/sit
Slide 19: COVID-19 Franchise: Adaptable Approach in the Face of Dynamic Virus Evolution
COVID-19 Franchise1: Adaptable Approach in the Face of Dynamic Virus Evolution for Continued Success 19 1 Partnered with Pfizer. 2023 2024 2025 Launch of seasonal adapted vaccine If approved, earliest potential introduction of combination respiratory vaccines Expect continued shift to single dose vi
Slide 20: Infectious Diseases: Important Growth Area Addressing High Medical and Global Health Needs
20 HSV Malaria Tuberculosis Mpox 3.7 billion people under age 50 globally infected with HSV-2 ~491 million people aged 15-49 infected with HSV-1 worldwide ~249 million cases in 2022 608,000 deaths in 2022 in 85 countries Children under 5 accounted for 80% of all malaria deaths 10.6 million cases glo
Slide 21: Healthcare and Social Responsibility
Healthcare and Social Responsibility 21 1. Tuberculosis program run in collaboration with the Bill & Melinda Gates Foundation, Mpox partnered with the Coalition for Epidemic Preparedness Innovations (CEPI), Malaria wholly owned program; 2. Partnered with Pfizer, 3. As of December, 2023. Recently ina
Slide 22: Oncology Overview
— Oncology Overview
Slide 23: Root Cause of Cancer Treatment Failure
Intraindividual variability & intratumoral heterogeneity driving evasion and secondary resistance mechanism Root Cause of Cancer Treatment Failure Cancer cells Genetically diverse & adaptable5-20 Years – up to 10,000 mutations Mutations DNA Mutation Healthy Cell Mutations Mutations Mutations Mutatio
Slide 24: Our Oncology Approach
Our Oncology Approach 24 Strategy Portfolio strategy covering compound classes with synergistic mechanism of actions • Immunomodulators • Targeted therapies • Personalized mRNA vaccines Programs across a wide range of solid tumors and stages of treatment Programs with first-in-class and / or best-in
Slide 25: Towards a Potentially Curative Approach to Cancer
Towards a Potentially Curative Approach to Cancer: Differentiated Combinations of Multiplatform Assets Space for curative approaches Immunomodulators Novel checkpoint inhibitors, cytokines, immune agonists mRNA vaccines Targeted therapy ADCs, CAR-T, TCR-T, small molecules SynergySynergy Synergy 25 C
Slide 26: Towards a Potentially Curative Approach to Cancer
Towards a Potentially Curative Approach to Cancer: Differentiated Combinations of Multiplatform Assets Space for curative approaches Immunomodulators Novel checkpoint inhibitors, cytokines, immune agonists mRNA vaccines Targeted therapy ADCs, CAR-T, TCR-T, small molecules SynergySynergy Synergy 26 C
Slide 27: Therapeutic IO Candidates with Novel Mode of Action Across Multiple Solid Tumors
27 1. Partnered with Genmab; 2. Partnered with OncoC4; 3. Partnered with Biotheus. CTLA4 = Cytotoxic T-Lymphocyte-Associated Protein 4; CD27, CD40, 4-1BB = members of the tumor necrosis factor receptor superfamily; PDL-1 =Programmed cell death ligand 1; HER2 = human epidermal growth factor receptor
Slide 28: BNT327/PM8002 Combined with Nab-Paclitaxel in TNBC
BNT327/PM80021 Combined with Nab-Paclitaxel: Antitumor Activity as First Line Therapy in Patients with TNBC 28 1. Partnered with Biotheus; TNBC = triple negative breast cancer; ORR = objective response rate; DCR = disease control rate, DoR = duration of response; PFS = progression free survival; PD
Slide 29: Towards a Potentially Curative Approach to Cancer
Towards a Potentially Curative Approach to Cancer: Differentiated Combinations of Multiplatform Assets Space for curative approaches Immunomodulators Novel checkpoint inhibitors, cytokines, immune agonists mRNA vaccines Targeted therapy ADCs, CAR-T, TCR-T, small molecules SynergySynergy Synergy 29 C
Slide 30: ADCs: The Innovation Cycle is Just Beginning
30 ADCs: The Innovation Cycle is Just Beginning Differentiated 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 •
Slide 31: Clinical Stage ADC Portfolio
Targeting TROP2, cleavable linker and topoisomerase I inhibitor DAR: 4 Targeting B7H3, cleavable linker and topoisomerase I inhibitor DAR: 6 Targeting HER3, cleavable linker allows for intracellular and extracellular release of topoisomerase I inhibitor DAR: 8 Targeting HER2, cleavable linker and to
Slide 32: ADC Portfolio Constructed with Thoughtful Considerations
ADC Portfolio Constructed with Thoughtful Considerations 1. RNAseq data from AACR Project GENIE; 2. Partnered with DualityBio. *The completion of the agreement with MediLink is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act. ADC =
Slide 33: Towards a Potentially Curative Approach to Cancer
Towards a Potentially Curative Approach to Cancer: Differentiated Combinations of Multiplatform Assets Space for curative approaches Immunomodulators Novel checkpoint inhibitors, cytokines, immune agonists mRNA vaccines Targeted therapy ADCs, CAR-T, TCR-T, small molecules SynergySynergy Synergy 33 C
Slide 34: mRNA Cancer Vaccines May Become the Next Tangible Transformation in Oncology
mRNA Cancer Vaccines May Become the Next Tangible Transformation in Oncology 34 Individual patient samples (blood and tissue) AI-driven neoantigen prediction On-demand tailored RNA manufacturing Individualized immuno- therapy Mapping of mutations Fixed combination of shared tumor antigens** Multi-an
Slide 35: Personalized mRNA Cancer Vaccines: Key Takeaways
Personalized mRNA Cancer Vaccines: Key Takeaways 35 Aim to bring personalized cancer vaccines into the adjuvant setting in multiple indications including tumors with low mutational burden and cold tumor types Low tumor mass, with residual cancer cells Tumor resistance mechanisms not fully establishe
Slide 36: Contribute to a Potentially Curative Approach to Cancer
Contribute to a Potentially Curative Approach to Cancer: Differentiated Combinations of Multiplatform Assets 36 CAR = chimeric antigen receptor; ADC = antibody-drug conjugate; IO = immuno-oncology; TCR-T = T-cell receptor engineered T cell. Space for curative approaches Immunomodulators Novel checkp
Slide 37: Our Pipeline Holds Potential for Synergistic Drug Combinations
Our Pipeline Holds Potential for Synergistic Drug Combinations 1. Reinhard, K. et al. Science. 2020. CAR = chimeric antigen receptor; IO = immuno-oncology; ADC = antibody-drug conjugates; MoA = mechanism of action. 37 CAR Cancer vaccine+ IO Cancer vaccine+ IO ADC+ Cancer vaccineADC + IO IO+ ADCs del
Slide 38: BNT211 – A Potentially First-in-Class Approach for CLDN6+ Solid Tumors
BNT211 – A Potentially First-in-Class Approach for CLDN6+ Solid Tumors 1. Kranz LM, et al. Nature. 2016; 2. ŞahinU, et al. Nature. 2020; 3.Reinhard K, et al. Science. 2020. CLDN6 = Claudin 6; CAR = chimeric antigen receptor; scvf = single-chain variable fragment; CD = cluster of differentiation; EMA
Slide 39: BNT211-01: Antitumoral Activity at Dose Level
BNT211-01: Antitumoral Activity at Dose Level 2 39 Data cut-off: 10 Sep 2023. Waterfall plot showing best percent change from baseline in sum of target lesion diameters and spider plot showing percent change in target sum from baseline over time for patients treated with CLDN6 CAR-T ± CLDN6 CARVac a
Slide 40: BNT211-01: CARVac Improves CAR-T Persistence at Dose Level
BNT211-01: CARVac Improves CAR-T Persistence at Dose Level 2 Data cut-off: 1 Sep 2023. BioNTech data on file derived from peripheral blood applying semi-quantitative PCR directed against CAR transgene. Displayed as copies of transgene per µg of DNA input of isolated PBMC. Pending data up to day 50:
Slide 41: Our Achievements in 2023 Pave Way for the Next Stage of Growth in Oncology
Our Achievements in 2023 Pave Way for the Next Stage of Growth in Oncology 41 NSCLC = non-small cell lung cancer; HR = hormone receptor; HER = human epidermal growth receptor; BC = breast cancer; CRC = colorectal cancer; PDAC = pancreatic ductal adenocarcinoma. Prioritizing lead late-stage programs
Slide 42: Advancing Our Vision: A Once in a Generation Opportunity to Transform Medicine
Advancing Our Vision: A Once in a Generation Opportunity to Transform Medicine . 1. Partnered with Pfizer. YE = Year end; IND = Investigational new drug. Infectious diseases Globally marketed COVID-19 vaccine franchise1 Maintain and deepen COVID-19 vaccine leadership Launch multiple oncology product
Slide 43: Thank you
Thank you BIONT=CrH
Slide 44: Appendix
Appendix BIONT=CrH
Slide 45: Advancing our Pipeline: Select Data Milestones in 2024
Advancing our Pipeline: Select Data Milestones in 2024 45 1. Partnered with Genmab; 2. Partnered with OncoC4; 3. Partnered with DualityBio; 4. Partnered with Biotheus; 5. Partnered with Pfizer. NSCLC = non-small cell lung cancer, R/R = relapsed/refractors. Program Indication Targeted Milestone Oncol
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