BioNTech SE · NASDAQ:BNTX

BioNTech — Investor Presentation (January 2020)

55 slides from BioNTech's investor presentation, Jan 13, 2020

  1. Slide 1: Corporate Presentation January 2020

    Corporate Presentation January 2020 Exhibit 99.1

  2. 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

  3. Slide 3: Agenda

    Agenda Who we are and what we do Our key platforms and programs Outlook in 2020 and beyond +

  4. Slide 4: Our Vision: We aspire to individualize cancer medicine

    Our Vision: We aspire to individualize cancer medicine Executive Summary Large addressable market opportunity in solid tumors Targeting some of the largest oncology indications with first-in-class potential Commercialization or co-commercialization rights retained in key geographies World-leading co

  5. Slide 5: Our unique approach

    Our unique approach Harnessing the full potential of the immune system Broadening the universe of eligible patients Improving the treatment success rate Focusing on curative approaches Overview

  6. Slide 6: Achievements 2019 and Outlook 2020

    Achievements 2019 and Outlook 2020 2019 accomplishments: Raised $225m in Series B financing and $149m in Nasdaq IPO Initiated 6 clinical trials across 2 drug classes and 4 different platforms Entered into strategically important agreements with Bill & Melinda Gates Foundation and Regeneron Site for

  7. Slide 7: 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

  8. Slide 8: A technology agnostic approach increases our addressable market

    A technology agnostic approach increases our addressable market… Our approach Cancer segment Patient Population Addressed Problem Our Therapeutic Strategy High mutational burden/ adjuvant stage cancers Significant portion of cancer patients Poor risk-benefit profile of checkpoint inhibitors mRNA Neo

  9. Slide 9: 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

  10. Slide 10: 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

  11. Slide 11: 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

  12. Slide 12: 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 p

  13. Slide 13: 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

  14. 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

  15. 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

  16. Slide 16: Agenda

    Agenda Who we are and what we do Our key platforms and programs Outlook in 2020 and beyond +

  17. 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

  18. Slide 18: Broad pipeline of mRNA product candidates in oncology (continued)

    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

  19. Slide 19: Additional oncology trial starts in 2020, 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

  20. Slide 20: First trial starts outside of oncology expected by end of 2020

    Our first trial starts outside of oncology are expected by the end of 2020 Our pipeline Drug Class Platform Indication (Targets) Discovery Preclinical Phase 1 Phase 2 Rights Partner Milestones Other mRNA Infectious Disease Immunotherapies Influenza Pfizer start first study by end of 2020 up to 10 in

  21. 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 blockade + co-stimulation) TLR agonist Engineered Cyt

  22. Slide 22: We own one of the broadest mRNA toolkits in the industry

    We own 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

  23. Slide 23: 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

  24. Slide 24: 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

  25. Slide 25: Agenda

    Agenda Who we are and what we do Our key platforms and programs FixVac: off-the-shelf mRNA immunotherapy Individualized Neoantigen Specific Immunotherapy Antibody programs Leveraging platform synergies: CARVac + CAR-T Outlook in 2020 and beyond Small molecule immunomodulator program

  26. Slide 26: FixVac: mRNA immunotherapy targeting shared tumor associated antigens

    FixVac: mRNA immunotherapy targeting shared tumor associated antigens Off-the-shelf mRNA immunotherapy Targeting a fixed combination of tumor shared antigens Antigen selection on the basis of antigens shared among patients within a particular cancer type Applicable for almost all types of tumor anti

  27. Slide 27: 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

  28. Slide 28: BNT111 has demonstrated strong antigen specific immune responses in melanoma

    BNT111 has demonstrated strong antigen specific immune responses in melanoma Shared Antigens Targeted NY-ESO-1 / MAGE-A3 / Tyrosinase / TPTE Phase 1 Study Overview Dose escalation to evaluate safety and tolerability 8 treatment cycles Planned total 115 patients with stage III/IV melanoma First patie

  29. Slide 29: FixVac: Induced immune responses were robust

    FixVac: Induced immune responses were robust Control CMVpp65 HLA-A201 NY-ESO-1 HLA-Cw0304 Pre-Treatment Post-Treatment Objective responses are associated with strong T-cell expansion 1,000 fold expansion within 4-8 weeks Evidence of strong tumor cell killing activity Patient Case: Antigen specific T

  30. Slide 30: 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 25 patients with metastatic melanoma who re

  31. Slide 31: 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

  32. Slide 32: FixVac: A flexible format 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 HPV positive head & neck cancer (IIT) Triple negative breast cancer Prostate cancer BNT111 BNT113 BNT114 BNT112 BNT115 Preclinica

  33. Slide 33: Agenda

    Agenda Who we are and what we do Our key platforms and programs FixVac: off-the-shelf mRNA immunotherapy Individualized Neoantigen Specific Immunotherapy Antibody programs Leveraging platform synergies: CARVAC + CAR-T Outlook in 2020 and beyond Small molecule immunomodulator program

  34. Slide 34: Conclusions from iNeST clinical trials

    Conclusions from iNeST clinical trials iNeST Clinical trials Preliminary observations in ongoing trials with BNT122 (IV administration): iNeST can be manufactured for individual patients with clinically relevant turn-around times across a range of tumor types iNeST +/- anti-PDL1 has a manageable saf

  35. Slide 35: Update for BNT121 (as of October 2019)

    Update for BNT121 (as of October 2019) iNeST Clinical trials Metastatic Relapse Analyses 9 of 13 patients without documented PFS Events Melanoma Stage IIIb, IIIc, and IV, 13 patients, intranodal delivery against 10 neoantigens Stable progression free survival in adjuvant melanoma

  36. Slide 36: 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

  37. Slide 37: iNeST: Results expected in 2020

    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

  38. Slide 38: Individualized Neoantigen Specific Immunotherapy (iNeST)

    Individualized Neoantigen Specific Immunotherapy (iNeST) iNeST summary Overview Dosed first-in-human individualized mRNA immunotherapy Targeting multiple neoantigens Intended to be a universal approach applicable for the majority of cancers 50:50 profit/loss share with Genentech Turnaround time redu

  39. Slide 39: Agenda

    Agenda Who we are and what we do Our key platforms and programs FixVac: off-the-shelf mRNA immunotherapy Individualized Neoantigen Specific Immunotherapy Antibody programs Leveraging platform synergies: CARVac + CAR-T Outlook in 2020 and beyond Small molecule immunomodulator program

  40. Slide 40: BNT311 (GEN1046) and BNT312 (GEN1042) next-gen checkpoint immunomodulators

    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

  41. Slide 41: Bispecific antibody mode of action

    Characteristics Bi-specific 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 lymph

  42. Slide 42: 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: 1H 2021 Tumor types:Malignant Solid Tumors Interv

  43. Slide 43: BNT321 (MVT-5873): 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

  44. Slide 44: Agenda

    Agenda Who we are and what we do Our key platforms and programs FixVac: off-the-shelf mRNA immunotherapy Individualized Neoantigen Specific Immunotherapy Antibody programs Leveraging platform synergies: CARVac + CAR-T Why invest in BioNTech Small molecule immunomodulator program

  45. Slide 45: BNT211: Next generation CAR-T targeting CLDN6 with CARVac primer

    Complete eradication of advanced tumors in an ovarian carcinoma xenograft model BNT211: Next generation CAR-T targeting CLDN6 with CARVac “primer” Engineered Cell Therapies | CAR-T therapies | BNT211 CLDN6 is not present in healthy tissues CLDN6 is expressed in multiple cancers Ovarian cancer Testic

  46. Slide 46: Second-generation CAR-T therapy targeting CLDN6 combined with CARVac

    Second-generation CAR-T therapy targeting CLDN6 combined with CLDN6 Engineered Cell Therapies | CAR-T therapies | BNT211 1° RNA(LIP) vacc. 2° RNA(LIP) vacc. 3° RNA(LIP) vacc. CLDN6 Ctrl CLDN6 Ctrl CLDN6 Ctrl CART cells (i.v.) d0 d7 d8 d11 d15 d17 d25 d22 ACT RNA-lipoplex vaccine enhances expansion &

  47. Slide 47: Agenda

    Agenda Who we are and what we do Our key platforms and programs FixVac: off-the-shelf mRNA immunotherapy Individualized Neoantigen Specific Immunotherapy Antibody programs Leveraging platform synergies: CARVac + CAR-T Outlook in 2020 and beyond Small molecule immunomodulator program

  48. Slide 48: 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

  49. Slide 49: Agenda

    Agenda Who we are and what we do Our key platforms and programs Outlook in 2020 and beyond +

  50. Slide 50: We expect significant news flow in the next 12-18 months

    We expect a significant news flow in the upcoming next 12-18 months Platform Candidate Indication (Target) 1H-2020 2H-2020 20213 20223 FixVac BNT111 Advanced Melanoma BNT112 Prostate Cancer BNT113 HPV+ H&N Cancer BNT114 Triple Negative Breast Cancer iNeST RO7198457 (BNT122) 1L Melanoma with CPI Mult

  51. Slide 51: Back-up

    BpIONT=Cr Back-up

  52. Slide 52: Year End Cash Balance 2019 (unaudited) and Outlook

    Year End Cash Balance 2019 (unaudited) – and Outlook Total Business In EURm December 31, December 31, 2019 2018 Cash and cash equivalents 520* 411 We expect net cash used in operating activities and other investments to total of approx. EUR 300m** in 2020. * EUR 520m -> approx. USD 584m **EUR 300m -

  53. Slide 53: Our RNA-LPX vaccine approach

    . 2.1% 10.1% 10.3% Our RNA-LPX vaccine approach mRNA drug class | vaccine platforms Strong vaccine-induced ex vivo CD8 + T cell responses* 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

  54. Slide 54: Ribocytokines boost therapeutic efficacy of vaccination and PD-L1 blockade

    Ribocytokines boost therapeutic efficacy of vaccination and PD-L1 blockade RiboCytokines Effect of tumor size on treatment success of vaccination + aPD-L1 Therapeutic efficacy of vaccination + aPD-L1 is reduced in large tumors CT26 tumor model, vaccine antigen:gp70 Complete rejection of large tumors

  55. Slide 55: Copyright BioNTech SE 2019

    © Copyright BioNTech SE 2019. All Rights Reserved. Jan 13, 2020 An der Goldgrube 12 55131 Mainz Germany T: +49 6131 9084-0 F: +49 6131 9084-390 M: info@biontech.de

BioNTech — Investor Presentation (January 2020) on 6ix