BioNTech SE · NASDAQ:BNTX
BioNTech — 43rd J.P. Morgan Healthcare Conference (January 2025)
32 slides from BioNTech's conference presentation, Jan 14, 2025
Slide 1: 43rd J.P. Morgan Healthcare Conference
43rd J.P. Morgan Healthcare Conference Prof. Ugur Sahin, M.D. CEO & Co-founder 14 January 2025 9:00 – 9:40 AM PST Exhibit 99.2
Slide 2: 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 3: Building a Global Immunotherapy Powerhouse
3 Building a Global Immunotherapy Powerhouse Translating Science into Survival
Slide 4: 2024 Accomplishments Position Us for Success in 2025
Strengthened position by planned Biotheus acquisition2: Securing global control of BNT3271 and expanded pipeline and in-house immunotherapy capabilities 2024 Accomplishments Position Us for Success in 2025 4 1. BNT327/PM8002 partnered with Biotheus. In this presentation, BNT327/PM8002 will further b
Slide 5: Unique Capabilities to Build Tomorrow's Personalized Precision Medicines
We Have Unique Capabilities to Build Tomorrow’s Personalized Precision Medicines 5 . Deep genomics & immunology expertise to analyze patient data Individualized treatment platforms to address inter-individual variability AI-infused, digitally-integrated target & drug discovery and development Automa
Slide 6: Scientific Capabilities Fueled by AI to Pioneer Personalized Immunotherapies
Our Leading Scientific Capabilities are Fueled by AI to Pioneer Personalized Immunotherapies 6 1. Partnered with Genentech, a member of the Roche Group. 2. From trials BNT122-01, GO39733, GO40558 and ML41081; 3. Castle et al. 2011 Cancer Res; 4.“Top 500, The List”, June 2023. Semi-automated manufact
Slide 7: Uniquely Positioned to Combine Approaches to Transform Cancer Care
Space for curative approaches Immunomodulators Novel checkpoint inhibitors cytokines, immune agonists mRNA cancer immunotherapies Targeted therapies ADCs, CAR-T, Ribomabs SynergySynergy Synergy • Focus on the critical IO pathways • Targeting different complementary pathways in cancer immunity cycle
Slide 8: Our Unique Pipeline Has the Potential for a Curative Approach to Cancer
8 Targeted therapies Targeted therapies Immunomodulators Space for curative approaches mRNA cancer immunotherapies SynergySynergy Synergy Immunomodulators BNT312/ GEN10425 BNT315/ GEN10535 Anti-OX40 BNT316/ ONC-3926 Anti-CTLA4 Anti-4-1BB Anti- CD40 / BNT314/ GEN10595 Anti-4-1BB Anti-EpCAM / BNT3273
Slide 9: Priorities are Novel mRNA Cancer Immunotherapy and Next-Generation IO-Backbone
PD-L1/VEGF-A antibody BNT3272 Novel mRNA cancer immunotherapy Potential to become the next-generation IO-backboneNext-generation of personalized cancer therapy targeting tumor associated antigens and mutations 9 1. Partnered with Genentech, a member of the Roche Group; 2. BNT327/PM8002 partnered wit
Slide 10: BNT327 as Potential Next-Generation IO-Backbone
PD-L1/VEGF-A antibody BNT3272 Novel mRNA cancer immunotherapy Potential to become the next-generation IO-backboneNext-generation of personalized cancer therapy targeting tumor associated antigens and mutations 10 FixVac & iNeST1 Our next-generation IO-backbone BNT327 as Potential Next-Generation IO-
Slide 11: BNT327: Data Across Multiple Indications Highlight Potential New Standard of Care
BNT3271: Data from 750 Patients Across Multiple Indications Highlight the Potential to Establish a New Standard of Care 11 10+ indications studied2 >750 patients enrolled 20 clinical trials ongoing or planned 3 global potentially registrational trials Clinical activity across indications Including S
Slide 12: Differentiation of BNT327 by Binding to PD-L1
Cooperative effect linking PD-L1 and VEGF binding Blocking of PD-L1 signaling Neutralization of VEGF TME Targeting by anti-PD-L1 BNT3271 PD-L1/VEGF PD-1/VEGF bispecifics Dual targeting of TME Anti-PD-L1 Anti-VEGF YES YES YES YES NO YESYES YES 1. BNT327/PM8002 partnered with Biotheus; TME: Tumor Micr
Slide 13: BNT327 May Drive Clinical Benefit Irrespective of PD-L1 Status
BNT3271 + chemo in 1L TNBC, Y. Meng et al. Presented at ESMO 2024. Presentation 384MO BNT3271 May Drive Clinical Benefit Irrespective of PD-L1 Status 13 76.9% 56.3% 100.0% ORR Objective response rate BNT3271 has the potential to become a backbone IO therapy for significant patient populations curren
Slide 14: In 1L TNBC BNT327 with CTx Shows Encouraging Efficacy Irrespective of PD-L1 Status
In 1L TNBC BNT3271 with CTx Shows Encouraging Efficacy Irrespective of PD-L1 Status 14 1. BNT327/PM8002 partnered with Biotheus; 2. PD-L1 testing was not done in 4 patients (not shown): ORR: 75.0% and mPFS 14.0 months. CPS 10 9 9 9 9 8 7 7 7 6 3 2 0 1 CPS < 10 16 16 16 16 15 13 12 9 8 6 4 2 1 CP
Slide 15: Broad Combination Strategy Across Indications
Broad Combination Strategy Across Indications Aiming to Establish Next-Generation IO-Backbone 15 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 16: Accelerating Our Global Clinical Development Program for BNT327
Accelerating Our Global Clinical Development Program for BNT3271 1. BNT327/PM8002 partnered with Biotheus; Partnered with: 2. DualityBio; 3. MediLink. Explore potential of BNT3271 in three waves of focused development • Phase 2 in TNBC • Phase 2 in SCLC • Phase 2/3 in NSCLC • Phase 3 in SCLC Ongoing
Slide 17: BNT327: Data Readouts Expected in 2025
BNT3271: Data Readouts Expected in 2025 17 1. BNT327/PM8002 partnered with Biotheus; 2. Partnered with DualityBio. Indication Target Population Regimen Phase Region SCLC 1L or 2L + chemo 2 Global TNBC 1L or 2L + chemo 2 Global Multiple solid tumors Multiple lines + BNT325/DB-13052 1/2 Global SCLC 1L
Slide 18: BNT327 as Potential Next-Generation IO-Backbone
PD-L1/VEGF-A antibody BNT3272 Novel mRNA cancer immunotherapy Potential to become the next-generation IO-backboneNext-generation of personalized cancer therapy targeting tumor associated antigens and mutations 18 FixVac & iNeST1 Our next-generation IO-backbone BNT327 as Potential Next-Generation IO-
Slide 19: Leveraging Our Leadership in mRNA to Exploit Cancer Immunotherapy Target Space
Leveraging Our Leadership in mRNA to Fully Exploit Cancer Immunotherapy Target Space with Two Approaches 19 Fixed combination of shared tumor antigens2 Multi-antigen approach tailored to each indication Neoantigens Individualized therapy Multiple shared antigens Off-the-shelf therapy iNeST1 FixVac i
Slide 20: T Cell Neoantigen Recognition is Critical for Effective Anti-PD-1 Therapy
T Cell Neoantigen Recognition is Critical for Effective Anti-PD-1 Therapy 20 Vormehr et al., Curr Opin Immunol 2016 Tumors with lower mutation burdenM u ta ti o n / T u m o r ( n s S N V s ) Mechanism of anti-PD-1 immunotherapy Anti-PD1 therapy is most effective in an environment where T cells are a
Slide 21: Autogene Cevumeran Induces Neoantigen Specific T cells in a Broad Range of Cancers
Encoded mutations 21 First-in-human study (NCT03289962) in advanced and metastatic solid tumors Autogene cevumeran1 monotherapy (n=30) Combination with atezolizumab (n=183) Neoantigen mRNA design B a s e li n e T C R c lo n o ty p e s Post-Induction TCR clonotypes (log10) Neoantigen specific T cell
Slide 22: Evaluating Autogene Cevumeran in the Adjuvant Treatment Setting
Evaluating Autogene Cevumeran1 in the Adjuvant Treatment Setting for Cancers of High Unmet Need 22 1. Partnered with Genentech, a member of the Roche Group; 2 Jones et al., Journal of American Medical Association (JAMA) Surgery 2019; 3. Conroy et al., JAMA Oncology 2022; 4. Bajorin et al., 2021 New
Slide 23: Response to Autogene Cevumeran Correlates with Delayed PDAC Recurrence
Response to Autogene Cevumeran1 Correlates with Delayed PDAC Recurrence 23 1. Partnered with Genentech, a member of the Roche Group. Phase 1, investigator-initiated trial in resectable PDAC: 3-year follow-up data Balachandran et al., AACR 2024. #CT025 & Rojas et al., Nature 2023 Years At risk Respon
Slide 24: CRC Patients with Post-Surgery ctDNA Positivity Have Significantly Shorter DFS
DFS in patients who were ctDNA+ vs ctDNA- post surgery1 Reinacker-Schick. et al., ASCO 2024. Abstract #3526. 24 1. Patients who transferred to BNT122-01 (n=56) were excluded from this analysis. ctDNA- 741 489 402 295 187 120 64 30 6 1 0 ctDNA+ 55 33 22 15 8 4 2 1 0 P ro b a b il it y o f D F S Time,
Slide 25: Vaccine-Induced T Cells are Long-Lived in CRC Patients
Kinetics and persistence of T cell responses to immunotherapy-encoded neoantigens Elez et. al., Biomarker sub-study results of Phase 2 trial (NCT04486378), ESMO-GI 2024. Vaccine-Induced T Cells are Long-Lived, Still Detected 1 Year After Last Vaccination with Autogene Cevumeran1 in CRC Patients 25 1
Slide 26: Ongoing Randomized Phase 2 Trial in ctDNA+ CRC Patients
Adjuvant SoC chemotherapy for 12–24 weeks Ongoing Randomized Phase 2 Trial Evaluating Autogene Cevumeran in ctDNA+ CRC Patients 26 1. Partnered with Genentech, a member of the Roche Group. Autogene cevumeran1 15 doses: 6×Q1W, 2×Q2W, 7×Q6W Observational watchful waiting Key inclusion criteria • Patie
Slide 27: Multiple Clinical Trials Across iNeST and FixVac Portfolios
Multiple Clinical Trials Demonstrate Execution Across iNeST and FixVac Portfolios 27 1. Partnered with Genentech, a member of the Roche Group; 2. In collaboration with Regeneron. Individualized immunotherapy: iNeST FixVac Autogene cevumeran (BNT122/RO7198457)1 BNT1112 BNT113 BNT116 Adjuvant 1L R/R R
Slide 28: Our Priorities for 2025
Our Priorities for 2025 1. Partnered with Pfizer; 2. BNT327/PM8002 partnered with Biotheus; 3. Partnered with DualityBio. mRNA Cancer Immunotherapy BNT3272 Commercial Readiness in OncologyCOVID-19 Vaccine1 & ID » Expect multiple randomized Phase 2 data readouts » Execute 7 ongoing Phase 2 trials and
Slide 29: Advancing Our Vision for Oncology
Advancing Our Vision for Oncology: A Once In a Generation Opportunity to Transform Medicine for Cancer Patients Execute on late-stage trials for BNT3271 and our mRNA cancer immunotherapy portfolio Continuation of our novel combination strategy Prepare and execute launches of multiple oncology produc
Slide 30: Thank you
Thank you BIONT=CrH
Slide 31: Expected Potential Value Creating Milestones and Trials
BNT3271 1L SCLC Phase 2 data BNT3271 2L SCLC Phase 1/2 data BNT3271 1L ES-SCLC and 2L SCLC Phase 2 DO data BNT3271 1L and 2L TNBC Phase 2 DO data BNT3271 + BNT325 / DB-13052 Multiple solid tumors Phase 1 data BNT323 / DB-13032 2L+ HER2 EC Phase 2 data Autogene cevumeran (BNT122 / RO7198457)3 ctDNA+
Slide 32: Glossary
Glossary n L nth line HPV Human papilloma virus PDAC Pancreatic ductal adenocarcinoma AACR American Association for Cancer Research HR Hazard ratio / hormone receptor PD-(L)1 Programmed cell death protein (ligand) 1 ADC Antibody-drug conjugate ID Infectious disease PFS Progression-free survival AI A
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