BioNTech SE · NASDAQ:BNTX
BioNTech — Investor Presentation (January 2020)
55 slides from BioNTech's investor presentation, Jan 27, 2020
Slide 1: Corporate Presentation January 2020
Corporate Presentation January 2020 Exhibit 99.1
Slide 2: Forward-Looking Statements
This slide presentation includes forward-looking statements Forward-Looking Statements Various statements in this slide presentation concerning the future expectations of BioNTech, its plans and prospects, including the Company’s views with respect to the potential for mRNA therapeutics, its expecta
Slide 3: Agenda
Agenda Who we are and what we do Our key platforms and programs Outlook in 2020 and beyond +
Slide 4: Building a 21st century individualized immunotherapy company: Executive summary
Building a 21st century individualized immunotherapy company Executive summary Large addressable market opportunity in solid tumors More than USD 90bn solid tumor market3 addressed Commercialization or co-commercialization rights retained in key geographies World-leading collaborators 7 pharmaceutic
Slide 5: Our Vision: We aspire to individualize cancer medicine
Our Vision: We aspire to individualize cancer medicine Overview mRNA Therapeutics Engineered Cell Therapies Antibodies Small Molecule Immunomodulators Off-the-shelf drugs Interindividual variability Tailored-on-demand immunotherapies Clinical samples Sample profiling bioinformatics big data, deep da
Slide 6: Achievements 2019 and Outlook 2020
Achievements 2019 and Outlook 2020 2019 accomplishments: Raised USD 225m in Series B financing and USD 149m in Nasdaq IPO Initiated 6 clinical trials across 2 drug classes and 4 different platforms Started first randomized phase 2 trial for iNeST Dosed more than 440 patients across all BNTX programs
Slide 7: A technology agnostic approach increases our addressable market
A technology agnostic approach increases our addressable market Solid tumor market segmentation Cancer segment Patient Population Challenge Our Therapeutic Strategy High mutational burden/ adjuvant stage cancers Significant portion of cancer patients Poor risk-benefit profile of checkpoint inhibitor
Slide 8: Exploiting our proprietary cancer antigen library
…and enables us to exploit our proprietary cancer antigen library Our approach Tumor Associated Antigens (TAAs) Cancer-selective antigens Over the past 15 years, we have built up a database of ~200 of tumor associated antigens, including proprietary targets Viral Neoantigens Mutant Neoantigens Virus
Slide 9: We have pioneered a truly individualized immunotherapy approach
We have pioneered a truly individualized immunotherapy approach… Our approach Sequencing Sequence patient’s tumor and healthy tissue using next-generation sequencing technology Compare patient’s sequenced tumor and healthy samples to identify targets for the design of individualized cancer immunothe
Slide 10: Ability to leverage deep OMICS capabilities across all our platforms
…and ability to leverage deep OMICS capabilities across all our platforms Our approach: deep OMICS capabilities HT NGS HiSeq NovaSeq 6000 10X Genomics Chromium HT qRT-PCR Fluidigm Biomark NGS analysis pipelines seq2HLA MyMut® uMut® Target validation (CD8+, CD4+, antibodies) Pre-clinical models & mod
Slide 11: Collaborating with leaders in oncology
Collaborating with leaders in oncology 50:50 Cost and Profit share (2016) 50:50 Cost and Profit share (2015) Cost and Profit share (2015) Co-development and Co-commercialization of novel mRNA-based, individualized cancer vaccines (iNeST – BNT122) USD 310m upfront & near-term payments 50/50 cost and
Slide 12: Collaborating with leaders in oncology, infectious diseases and rare diseases
Collaborating with leaders in oncology, infectious diseases and rare diseases Our other collaboration agreements are structured to expand our footprint while managing risk Co-development Co-commercialization (2018) Co-development and Co-commercialization agreement for 5 mRNA protein replacement ther
Slide 13: We own in-house manufacturing capabilities for individualized treatments
We own in-house manufacturing capabilities for individualized treatments mRNA Manufacturing: Unique process utilizing digitization and automation/robotics to ensure robust, consistent repeatability, quality control and on-demand manufacturing 2 mRNA GMP production facilities: Idar-Oberstein (GMP sin
Slide 14: We are led by an experienced and entrepreneurial team
We are led by an experienced and entrepreneurial team Management team Supervisory Board Helmut Jeggle Managing Director, Athos Former Head of Business Planning & Analyses at Hexal Michael Motschmann Founder of MIG Verwaltungs AG Significant experience in building companies Prof. Christoph Huber, MD
Slide 15: Building a global biotechnology company
Building a global biotechnology company Company footprint BNT office planned San Diego Mainz Berlin Munich Idar-Oberstein USA Germany
Slide 16: Agenda
Agenda Who we are and what we do Our key platforms and programs Outlook in 2020 and beyond +
Slide 17: We have a broad pipeline of mRNA product candidates in oncology
We have a broad pipeline of mRNA product candidates in oncology Our pipeline Drug Class Platform Product Candidate Indication (Targets) Preclinical Phase 1 Phase 2 Rights Collaborator Milestones Oncology mRNA FixVac (fixed combination of shared cancer antigens) BNT111 advanced melanoma (adjuvant & m
Slide 18: We have a broad pipeline of mRNA product candidates in oncology...
We have a broad pipeline of mRNA product candidates in oncology... Our pipeline Drug Class Platform Product Candidate Indication (Targets) Preclinical Phase 1 Phase 2 Rights Collaborator Milestones Oncology mRNA RiboMabs (mRNA-encoded antibodies) BNT141 multiple solid tumors fully-owned phase 1 star
Slide 19: We expect additional oncology trial starts in 2020 - with first data in 2021
We expect additional oncology trial starts in 2020 - with first data in 2021 Our pipeline Drug Class Platform Product Candidate Indication (Targets) Preclinical Phase 1 Phase 2 Rights Collaborator Milestones Oncology Engineered Cell Therapies CAR-T Cells BNT211 multiple solid tumors (CLDN6) fully-ow
Slide 20: Our first trial starts outside of oncology are expected by the end of 2020
Our first trial starts outside of oncology are expected by the end of 2020 Our pipeline 1We are eligible to receive worldwide licenses; 2Protein Replacement Therapy Drug Class Platform Product Candidate Indication (Targets) Preclinical Phase 1 Phase 2 Rights Collaborator Milestones Other mRNA Infect
Slide 21: Our IO strategy exploits complementary therapeutic platforms
Targeting Cancer Immunomodulation mRNA Cancer Vaccines Antibody Targeting Small Molecule Immunomodulators Next Generation Immunomodulators FixVac, iNeST Targeted Antibodies RiboMabs Engineered Cell Therapies CAR-T, TCRs Bispecific Antibodies (CPI + co-stimulation) TLR agonist Engineered Cytokines In
Slide 22: Agenda
Agenda Who we are and what we do Our key platforms and programs mRNA vaccines – FixVac and iNeST Antibodies CARVac platform – CLDN6 CAR-T RiboCytokines Outlook in 2020 and beyond Small Molecule Immunomodulator program
Slide 23: One of the broadest mRNA toolkits in the industry
One of the broadest mRNA toolkits in the industry Local Intratumoral Systemic Tissue specific Adjustable activity in vivo from minutes up to weeks Various delivery routes Liposomes / LPX LNPs Polyplexes Broad formulation spectrum Multiple mRNA formats uRNA modRNA saRNA taRNA 5’ Cap 5’ UTR ORF 3’ UTR
Slide 24: We have developed multiple proprietary mRNA formats and formulations
We have developed multiple proprietary mRNA formats and formulations Our mRNA formats Lipoplex: Our lipoplex formulation, or LPX, embeds the mRNA between a lipid bilayer, which is used for our FixVac and iNeST platforms LNPs: For other applications, we encapsulate our mRNA in lipid nanoparticles, or
Slide 25: We are developing multiple mRNA therapeutic platforms
We are developing multiple mRNA therapeutic platforms mRNA Platform Drug Targets mRNA Formats Delivery Formulations 7 mRNA platforms Broad range of biological targets 4 types of mRNA Multiple optimized formulations Oncology FixVac Shared Antigens uRNA RNA-LPX iNeST Neoepitopes uRNA RNA-LPX Intratumo
Slide 26: Our mRNA vaccine platforms: FixVac and iNeST
Our mRNA vaccine platforms: FixVac and iNeST mRNA drug class | vaccine platforms Off-the-shelf mRNA immunotherapy Targeting a fixed combination of shared antigens Non-mutated antigens shared among patients with a specific cancer type Applicable for almost all types of tumor antigens FixVac iNeST Fix
Slide 27: Strong vaccine-induced ex vivo CD8+ T cell responses across different cancer types
. 2.1% 10.1% 10.3% Strong vaccine-induced ex vivo CD8+ T cell responses1 across different cancer types FixVac iNeST HPV16-E7 Head Neck Cancer BNT113, HARE40 trial Mutant Neoantigen TNBC BNT114, TNBC MERIT trial MAGE-A3 Melanoma BNT111, Lipo-MERIT trial NY-ESO-1 Melanoma BNT111, Lipo-MERIT trial 5.0%
Slide 28: Cumulative patient coverage of FixVac Melanoma targets is over 90%
Cumulative patient coverage of FixVac Melanoma targets is over 90% Computational pipeline for antigen-discovery and RT-PCR validation RNA-Seq data from 337 melanoma samples in TCGA Target-criteria High expression in melanoma No expression in toxicity-relevant normal cells and tissues Coverage of as
Slide 29: FixVac: BNT111 Interim clinical activity data
FixVac: BNT111 Interim clinical activity data (dose range 14µg -100µg) Summary Advanced melanoma patients (stage III, IV) Out of 74 patients with available follow-u radiological imaging 42 patients were assessed for preliminary analysis as of July 29, 2019 of 25 patients with metastatic melanoma who
Slide 30: BNT112: FixVac Prostate Cancer
BNT112: FixVac Prostate Cancer mRNA drug class | FixVac platform | BNT112 (FixVac Prostate Cancer) Ph1/2: first patient enrolled in December 2019 Multipronged vaccine: Targeted antigens of BNT112 are 5 prostate cancer specific antigens (PAP, PSA and 3 undisclosed antigens) RNA-LPX vaccine format val
Slide 31: FixVac: a flexible format which can rapidly be adapted for different tumors
FixVac: a flexible format which can rapidly be adapted for different tumors Initiation of additional clinical studies in other solid tumor indications Metastatic melanoma HPV16+ positive head & neck cancer (IIT) Triple negative breast cancer Prostate cancer BNT111 BNT113 BNT114 BNT112 BNT115 Preclin
Slide 32: Individualized Neoantigen Specific Immunotherapy (iNeST)
Individualized Neoantigen Specific Immunotherapy (iNeST) mRNA drug class | iNeST platform | clinical trials Overview Targeting multiple neoantigens Intended to be a universal approach applicable for the majority of cancers 50:50 profit/loss share with Genentech Turnaround time reduced from three mon
Slide 33: Conclusions from iNeST clinical trials
Conclusions from iNeST clinical trials mRNA drug class | iNeST platform | clinical trials Clinical efficacy evaluation in randomized phase 2 trials initiated Long-term follow-up of completed trial with BNT121 (Intra-nodal administration, RNA): Long-term relapse free disease activity with BNT121 iNeS
Slide 34: Update for BNT121 (as of October 2019)
Update for BNT121 (as of October 2019) mRNA drug class | iNeST platform | BNT121 Metastatic relapse analyses 9 of 13 patients without documented PFS events Melanoma Stage IIIB, IIIC, and IV, 13 patients, intranodal delivery against 10 neoantigens Sahin et al., Nature 2017 Stable progression free sur
Slide 35: BNT121: Interim clinical activity data
BNT121: Interim clinical activity data (dose range 14µg -100µg) New Metastases Relapse free disease control 13 High relapse risk melanoma patients (stage IIIB, IIIC, IV) 13 patients 8 5 Stable Disease Complete Response 1 Partial Response 1 Complete Response (Combination with CPI) 1 Progression after
Slide 36: iNeST: Phase 1 and phase 2 trial designs and expected results
iNeST: Results expected for phase 1 in 2020, for phase 2 in 2H 2020 Phase 1a/1b in Multiple Solid Tumors: Open-label, dose-escalation study of safety and pharmacokinetics Phase 2 in Advanced Melanoma: Interventional open-label, multicenter randomized study of efficacy and safety Enrollment: Up to 77
Slide 37: Agenda
Agenda Who we are and what we do Our key platforms and programs mRNA vaccines – FixVac and iNeST Antibodies CARVac platform – CLDN6 CAR-T RiboCytokines Outlook in 2020 and beyond Small Molecule Immunomodulator program
Slide 38: Next-Gen checkpoint immunomodulators BNT311 and BNT312
BNT311 (GEN1046) BNT312 (GEN1042) Next-Gen checkpoint immunomodulators PD-L1 4-1BB K409R F405L Fc-silencing mutations matched CH3 mutations L234F L235E D265A CD-40 4-1BB K409R F405L Fc-silencing mutations matched CH3 mutations L234F L235E D265A Two bispecific antibodies partnered with Genmab Potenti
Slide 39: Bispecific antibody mode of action
Characteristics Bispecific antibody combining constitutive CPI blockade and conditional co-stimulatory activity Enhanced prolife-ration of antigen specific activated T cells in the presence of PD-L1+ cell Constitutive PD-L1 blockade & conditional 4-1BB agonism 1 2 Increased tumor infiltrating lympho
Slide 40: Bispecific antibody GEN1046 (BNT311): Phase 1/2a in solid tumors
Bispecific antibody GEN1046 (BNT311): Phase 1/2a in solid tumors First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1046 (PD-L1x4-1BB) in subjects with malignant solid tumors Enrollment: 192 Data update: 2H 2020 Tumor types:Malignant Solid Tumors Interv
Slide 41: BNT321: Cancer antibody targeting sLea
BNT321 (MVT-5873) BNT321: Cancer antibody targeting Cancer Associated Carbohydrate sLea sLea Phase 1 resumed in 2H 2019 Antibodies drug class | targeted cancer antibodies Pancreatic ductal adenocarcinoma Colon carcinoma Lung adenocarcinoma Urinary bladder, mucinous adenocarcinoma Colon metastatic to
Slide 42: Agenda
Agenda Who we are and what we do Our key platforms and programs mRNA vaccines – FixVac and iNeST Antibodies CARVac platform – CLDN6 CAR-T RiboCytokines Outlook in 2020 and beyond Small Molecule Immunomodulator program
Slide 43: BNT211: Next generation CAR-T targeting CLDN6 with CARVac primer
Complete eradication of advanced tumors demonstrated in an ovarian carcinoma xenograft model BNT211: Next generation CAR-T targeting CLDN6 with CARVac “primer” Engineered Cell Therapies | CAR-T therapies | BNT211 CAR-T cell therapy + RNA Vaccine to amplify CAR-T cell in vivo CLDN6 is not present in
Slide 44: BNT211: CARVac RNA vaccine enhances expansion of CAR-T
BNT211: Next generation CAR-T targeting CLDN6 with CARVac “primer” Engineered Cell Therapies | CAR-T therapies | BNT211 RNA-lipoplex vaccine enhances expansion & persistence of CAR T Applicability shown for CLDN6, CLD18.2, CD19 CAR-T cells 1Reinhard et al, Science 2020: An RNA vaccine drives expansi
Slide 45: Further development of engineered T cell therapies
Further development of engineered T cell therapies Key Plans Start first-in-human trial for CLDN6 CAR-T in solid tumors Second CAR-T in pipeline for solid tumors: CLDN18.2 CAR-T Develop CARVac with other CAR-T therapies Plan to announce first TCRs for TCR engineered therapies Expansion of certified
Slide 46: Agenda
Agenda Who we are and what we do Our key platforms and programs mRNA vaccines – FixVac and iNeST Antibodies CARVac platform – CLDN6 CAR-T RiboCytokines Outlook in 2020 and beyond Small Molecule Immunomodulator program
Slide 47: RiboCytokines: a novel therapeutic platform
RiboCytokines: a novel therapeutic platform k Preclinical Product Candidate Optimized IL-2 Phase 1 Phase 2 IL-7, IL-2 BNT151 BNT152 Pharmacokinetic Profile RiboCytokine Recombinant cytokine Expected to enter the clinic in 2H 2020 k Preclinical Product Candidate Optimized IL-2 Phase 1 Phase 2 IL-7, I
Slide 48: RiboCytokines boost clinical activity of vaccination and PD-L1 blockade
CT26 tumor model, vaccine antigen: gp70 CT26 tumor model, tumor size: 60mm2 CR: complete response, vaccine antigen:gp70 Vaccine + aPD-L1 + Effect of tumor size on treatment success of vaccination + aPD-L1 RiboCytokines boost the clinical activity of vaccination + aPD-L1 in large tumors mRNA drug cla
Slide 49: Agenda
Agenda Who we are and what we do Our key platforms and programs mRNA vaccines – FixVac and iNeST Antibodies CARVac platform – CLDN6 CAR-T RiboCytokines Outlook in 2020 and beyond Small Molecule Immunomodulator program
Slide 50: BNT411: TLR7 agonist has entered the clinical stage
BNT411: TLR7 agonist has entered the clinical stage Intravenously administered small molecule TLR7 (toll-like receptor 7) agonist Engineered for high potency and high selectivity for TLR7 receptor at the therapeutically active dose range Activates both adaptive and innate immune system Type 1 interf
Slide 51: Multiple angles for therapeutic synergy across platforms
Multiple angles for therapeutic synergy across platforms Our multi-platform approach BNT211: First-of-kind CLDN-6 CAR-T approach utilizing CAR-T Amplifying RNA Vaccine (CARVac). Significant amplification of CAR-T cells in preclinical studies (published in SCIENCE, 2020) mRNA Cancer Vaccines Engineer
Slide 52: Agenda
Agenda Who we are and what we do Our key platforms and programs Outlook in 2020 and beyond +
Slide 53: We expect a significant news flow in the upcoming 12-18 months
We expect a significant news flow in the upcoming 12-18 months Platform Candidate Indication (Target) 1H-2020 2H-2020 20213 20223 FixVac BNT111 Advanced Melanoma BNT112 Prostate Cancer BNT113 HPV16+ H&N Cancer BNT114 Triple Negative Breast Cancer iNeST RO7198457 (BNT122) 1L Melanoma with CPI Multipl
Slide 54: Building a 21st century immunotherapy company: 2020 Outlook
Building a 21st century immunotherapy company Our goals 2020 Outlook 5 trial updates (incl. publishing BNT111 FixVac Melanoma phase 1/2 data in peer reviewed journal) Initiate phase 3 registrational trial for BNT111 FixVac Melanoma Initiate 2 additional iNeST trials in adjuvant stage cancers Initiat
Slide 55: Copyright BioNTech SE 2019
© Copyright BioNTech SE 2019. All Rights Reserved. Jan 27, 2020 An der Goldgrube 12 55131 Mainz Germany T: +49 6131 9084-0 F: +49 6131 9084-390 M: info@biontech.de