BioNTech Results Presentation Deck

Made public by

sourced by PitchSend

19 of 30

Creator

biontech logo
Biontech

Category

Healthcare

Published

August 2020

Slides

Transcriptions

#1Second Quarter 2020 Corporate update and financial results August 11, 2020 X 121 40 11 BIONTECH#2Forward-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; the planned next steps in BioNTech's pipeline programs and specifically including, but not limited to, statements regarding plans to initiate clinical trials of BioNTech's product candidates and expectations for data announcements with respect to BioNTech's product candidates; the development of commercial capabilities and the transition of BioNTech to a fully integrated biopharmaceutical company; its expectations with respect to interactions with regulatory authorities such as FDA and EMA, including the potential approval of BioNTech's or its collaborators' current or future drug candidates; expected royalty and milestone payments in connection with BioNTech's collaborations; BioNTech's anticipated cash usage for fiscal year 2020 and beyond; the creation of long-term value for BioNTech shareholders; the ability of BioNTech to successfully develop and commercialize a vaccine for COVID-19 in partnership with Pfizer and Fosun Pharma; the timing for any potential emergency use authorizations or approvals for BNT162; and the ability of BioNTech to supply the quantities of BNT 162 to support clinical development and, if approved, market demand, including its production estimates for 2020 and 2021 and the impact of COVID-19 on our clinical trials and business operations, are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "expects," "plans," "potential," "target," "continue" and variations of these words or similar expressions are intended to identify forward-looking statements. Such statements are based on the current beliefs and assumptions of the management team of BioNTech and on the information currently available to the management team of BioNTech, and are subject to change. The Company will not necessarily inform you of such changes. These forward looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that could cause the Company's actual results, performance or achievements to be materially different than any future results, performance or achievements expressed or implied by the forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including the Company's ability to discover and develop its novel product candidates and successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for its product candidates, which may not support further development of product candidates; actions of the Company's collaborators regarding continued product development and product commercialization; actions of regulatory authorities, which may affect the initiation, timing and progress of clinical trials or the ability of the Company to obtain marketing authorization for its product candidates; the Company's ability to obtain, maintain and protect its intellectual property; the Company's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; competition from others using technology similar to the Company's and others developing products for similar uses; the Company's ability to manage operating expenses; the Company's ability to obtain additional funding to support its business activities and establish and maintain its existing and future collaborations and new business initiatives; the Company's dependence on collaborators and other third parties for development, manufacture, marketing, sales and distribution of products; the outcome of litigation; and unexpected expenditures. Any forward-looking statements represent the Company's views only as of today and should not be relied upon as representing its views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements. The mRNA vaccines and other product candidates discussed in this slide presentation are investigational products being developed by BioNTech and its collaborators and are not currently approved by the FDA, EMA or any other regulatory authority. BIONTECH 2#33 Next generation immunotherapy Harnessing the full potential of the immune system $₂ Broad suite of novel technology platforms Immunotherapies for cancer and infectious diseases Fully integrated with in-house GMP manufacturing Industry-leading global collaborations BIONTECH#4Agenda • Q2 Highlights Oncology Pipeline Update • BNT162 (COVID-19 vaccine program) ● Financial Update and 2H 2020 Outlook ● ● 4 BIONTECH#5Q2 2020 highlights 0000 5 $ es ))))) I I I 12 immunotherapies across 3 drug classes now in the clinic (mRNA, Antibodies, Small molecule) Initiated pivotal Phase 2b/3 trial for BNT162b2 COVID-19 vaccine Commercial supply agreements signed for >250 million doses of BNT162 in 2020/21, subject to approval or emergency authorization Published Phase 1 data and started recruiting for randomized Phase 2 trials of iNeST in adjuvant cancers First patient dosed in FIH Phase 1/2 trial of BNT411 small molecule TLR7 agonist Ongoing scale-up of mRNA manufacturing infrastructure and supply chain in Germany Strategic collaboration with Regeneron to conduct randomized Phase 2 trial with Libtayo® and Fix Vac in Melanoma Entered agreements for $1.1 billion in gross proceeds from non-dilutive payments and equity / debt financings in year to-date BIONTECH#6We expanded our base of strategic collaborators in 2020 to-date CO 6 Covid-19 vaccine 50:50 Gross Profit share¹ Pfizer FOSUNPHARMA Collaborations for clinical stage programs Bispecific mABs 50:50 Cost & Profit share Fix Vac Melanoma Each company to keep 100% of rights to own product REGENERON Seasonal Influenza Royalties & Milestones Pfizer iNeST 50:50 Cost & Profit share Genentech Pre-clinical Collaborations Up to 10 Infectious Disease Indications Worldwide opt-in right University of Pennsylvania 150:50 Cost & Profit share refers to terms of Pfizer collaboration only (world-wide ex-China) HIV, Tuberculosis Developed world rights BILL & MELINDA Genmab GATES foundation Intra-tumoral mRNA Cost & Profit share SANOFI 5 Rare Disease Indications 50:50 Cost & Profit share GENEVANT BIONTECH#7Broad progress in executing our multi-platform 10 strategy 7 mRNA Cancer Vaccines Randomized Phase 2 trial starts for FixVac and iNeST in multiple solid tumors expected in 2H 2020 Cell Therapies Phase 1/2 trial start for CARVac planned in 2H 2020 Filed IND for Phase 1 trial of ex- vivo neoantigen T cell therapy ff1 sti argeting Cancer Antibodies Immunomodulai + Small Molecule Immunomodulators Next Generation Immunomodulators First Phase 1/2 data expected for PD- L1 x 4-1BB antibody in 2H 2020 Engineered Cytokines First Phase 1/2 data from intratumoral mRNA in 2H 2020 Ribocytokines to enter the clinic in 2021 Ongoing Phase 1/2 trial for CA 19-9 antibody in pancreatic cancer First-in-human Phase 1/2 trial for TLR7 agonist initiated in early July 2020 Potential for multiple blockbuster opportunities with powerful combinations BIONTECH#8Agenda • Q2 Highlights ● • Oncology Pipeline Update • BNT162 (COVID-19 vaccine program) Financial Update and 2H 2020 Outlook ● 8 BIONTECH#9Expanded clinical stage pipeline to 12 product candidates across 13 trials Drug class mRNA Antibodies SMIM6 Platform Fix Vac (fixed combination of shared cancer antigens) iNeST (patient specific cancer antigen therapy) Intratumoral Immunotherapy Infectious Disease Immunotherapy Next-Gen CP² Immunomodulators Targeted Cancer Antibodies Toll-Like Receptor Binding Product Candidate BNT111 BNT112 BNT113 BNT114 BNT115 RO7198457 (BNT1224) SAR441000 (BNT131) BNT 162 GEN1046 (BNT311) GEN1042 (BNT312) BNT321 (MVT-5873) BNT411 Indication (Targets) advanced melanoma (adjuvant & metastatic) prostate cancer HPV16+ head and neck cancer¹ triple negative breast cancer4 ovarian cancer¹ 1L melanoma with CP12 multiple solid tumors solid tumors (IL-12sc, IL-15sushi, GM-CSF, IFN a) COVID-19 multiple solid tumors (PD-L1x4-1BB) multiple solid tumors (CD40×4-1BB) pancreatic cancer (sLea) solid tumors (TLR7) Rights / Preclinical Phase 1 Phase 2 Collaborator fully-owned (Regeneron) fully-owned fully-owned fully-owned fully-owned Genentech (global 50:50 profit/loss) Sanofi (global profit/ loss share) Pfizer/Fosun Genmab (global 50:50 profit/loss) fully-owned fully-owned 1 BNT113 and BNT115 are currently being studied in investigator-initiated phase 1 trials; 2 Checkpoint Inhibitor; 3 Update on the ongoing study including patient enrollment number, efficacy and safety data for an interim update expected in the second half of 2021; 4 BNT122 (iNeST) is also being investigated in arm 2 (N=15) of the 3 arm TNBC-MERIT trial, with BNT114 as an optional treatment; BNT114 is investigated in arm 1 (N=12) and arm 3 (N=15) of the TNBC-MERIT trial (total patients in study: N=42); 5 As the trial is sponsored and conducted by Sanofi, the timing of data updates is not under our control, and is subject to change by Sanofi; Small Molecule Immunomodulators 9 1 i BNT111 Fix Vac Melanoma data in Nature and Regeneron collaboration 2 3 ! Update for anti-PDL1x4-1BB bi- specific antibody expected in 2H I 2020 4 iNeST AACR Phase 1 data update and planned Phase 2 trials in adjuvant NSCLC and CRC I Initiation of Phase 1/2 trial for TLR-7 agonist in ES-SCLC BIONTECH I#101 BNT111 Fixvac Melanoma: Planning to initiate randomized phase 2 trial 10 Ongoing Phase 1 trial in Advanced Melanoma published in Nature Regeneron strategic collaboration and planned Phase 2 trial ● ● ● Phase 1 trial data in CPI-experienced patients in monotherapy and in combination with anti-PD1 previously reported in July 2020 and published in Nature All patients showed tumor associated antigen (TAA) specific T cell responses with In vitro stimulation, and > 75% of patients showed immune responses against ≥ 1 TAA on an ex vivo basis - T cells responses ramped up over 4-8 weeks and increased or remained stable up to over one year with monthly maintenance therapy. Reported durable clinical responses in monotherapy and in combination with anti-PD1 accompanied by high magnitude CD4+ and CD8+ response Signed strategic collaboration to jointly conduct randomized Phase 2 trial with BNT111 and Libtayo® (cemiplim ab anti-PD-1 therapy) Targeting patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV cutaneous melanoma Companies to share development costs equally and keep full commercial rights to own programs Plan to initiate potentially registrational Phase 2 trial by the end of 2020 - more details on anticipated trial design to be released in Q3 BIONTECH#115' Targeting of lymphoid DC for vaccine delivery & type I IFN activity 5' 1 SP Cap analogue 5' 5' 5' UTR BNT111 publication in Nature highlights NY-ESO-1 11 Tyrosinase MAGE-A3 Vaccine constructs Pre TPTE Post FDG PET P2, P16 3' UTR H-AAAA Linker MITD Poly(A) tail Spleen High Low IFN-a (pg ml-¹) IFN-Y (pg ml-¹) 200 150- 100- 50- 0 800 600- 400- 200 AAAA HAAAA Pre- AAAA 201 6hd 24 ht 48 h P26 24 24 0 7.2 14.4 29 50 75 Vaccine dose (ug) Blood Cytokines 100 IP-10 (pg ml-¹) Strong CD4+, CD8+ T cell responses Multifunctional CD8+ PD1+ T cells Ex vivo CD8 T cells in Blood 15 Multimer APC → PBL Patient 53-02 NY-ESO-1, Ex vivo 15- CD8+ (%) 99 10- O 0 3 TNF BV421->> N WAS 96-104 IFN-Y+ → IFN-Y+ TNF+ 50 100 150 200 250 300 350 Days after treatment start Pre -Post- 4 NY-ESO-1 Pre (day -6) 0.00 0.04 3 4 5 IFN-Y PE-Cy7 0.02 5 CD8 8.37 0.58 6.78 94-104 HLA-B*3501 Post (day 76) 99.6 26.5 3 4 PD1 Objective responses in CPI-experienced melanoma patients with evaluable disease at baseline: ● ● ORR of BNT111 alone: 4/25 ORR of BNT111+ anti-PD1: 6/17 (35%) (CPI resensitizing activity of BNT111) Patient C2-31 Day upper lobe Right lung Right lung middle lobe -113 Pembrolizumab -71 -14 Vaccination 84 CECC Lung CT scans before & after BNT111 BIONTECH#122 iNeST: BNT122 recent AACR data update Ongoing Phase 1 trial of iNeST presented at AACR 2020 Blood and tumor biopsy collection 12 5' Cap analog Sequencing Evaluation of BNT122 safety & feasibility with/without Tecentriq in > 10 indications 5' UTR SEC RNA backbone Bioinformatics Neoantigen Prediction RNA-lipoplex manufacturing NEOANTIGENS Innate Immune Stimulation Intrinsic TLR7/8 agonist ● 3' UTR ● MITD- ● Cold storage and distribution AAAA Poly(A) tail Data from ongoing Phase 1 trial in heavily pre-treated, PD-1 low patients across multiple tumor types Demonstrated ability to elicit significant T cell responses of both effector and memory phenotype as monotherapy and in combination (multiple patients with > 5% T cell response per neoepitope) RNA backbone Treatment-related adverse events were primarily transient systemic reactions, manifesting as low grade CRS, IRR or flu-like symptoms Initial signals of clinical activity observed in monotherapy dose-escalation cohort (1 CR, 12 SD) Intravenous administration Single-stranded mRNA Antigen Expression Up to 20 neoantigens (2 decatopes) BNT122 induces CD8+ T cells in CPI-sensitive and CPI-insensitive tumor types PE Multimer Patient With Prostate Cancer Treated With RO7198457 (38 µg) C3D1 2.49% Baseline 0.03% 97.79% Te rring m BV605 Multimer CCR7 C2D1 1.95% 95.69% CD45RO Tem 195.88% Phenotype of MHC Multimer-Positive Cells Effector Memory Phenotype Tem T₁₁ 87.7% pang ang PD-1 PD-1+ Cells PD-1+ CD8 T cells 99.6% CD8 C4D1 4.7% 193.89% per TOME TITT BNT122 induces CD8+ T cell Infiltrates in tumors Frequency of TCRs (log,0) in Baseline Tumor -1.6- -1.8- -2- -2.2 -24 -2.6 -2.8- -3.2- -34- -3.6 O OCCIOXPED contentco BLOOO 0 O он рос CO DO 0 00 Ф О RO7198457-specific TCRs Other TCRs OOOOO 32-36-34-32 -3 -28 -26-24-22 -2 -18-16-4 O RO7198457-specific TCRs are present only in post-treatment tumor. Frequency of TCRs (log 10) in Post-Treatment Tumor BIONTECH#132 BNT122 iNeST randomized Phase 2 trials ongoing and planned Study Design and Patient Population 13 Rationale Status First-Line Advanced Melanoma A Phase 2, open-label, multicenter randomized trial of the efficacy and safety of BNT122 in combination with pembrolizumab vs. pembrolizumab in patients with previously untreated Advanced Melanoma ● Evaluate added benefit of 1L BNT122 in an advanced CPI- sensitive tumor (PFS, ORR) Success ungates 1L use of iNeST in CPI-sensitive advanced cancers for combination therapy Enrollment update in 2H 2020 ● Adjuvant Non-Small Cell Lung Cancer A Phase 2, open-label, multicenter, randomized trial of the efficacy and safety of BNT122 in combination with atezolizumab vs. atezolizumab alone following adjuvant platinum-doublet chemotherapy in patients who are ctDNA positive after surgical resection of Stage II-III NSCLC Evaluate added benefit of BNT122 in a micrometastatic CPI-sensitive tumor (RFS) Success ungates adjuvant use of iNeST in CPI-sensitive ctDNA+ cancer types To start in 2H 2020 ● Adjuvant Colorectal Cancer A Phase 2, open-label, multicenter randomized trial to compare the efficacy of BNT122 versus watchful waiting in patients with ctDNA positive, surgically resected Stage 2/3 rectal cancer, or Stage 2 high risk/stage 3 colon cancer Evaluate added benefit of BNT122 in a micrometastatic CPI-insensitive tumor (RFS) Success ungates adjuvant use of iNeST for CPI-insensitive ctDNA+ cancer types To start in 2H 2020 BIONTECH#14Two bispecific antibodies partnered with Genmab ● ● 3 Next-Gen checkpoint immunomodulators ● 50:50 profit/loss share Both programs in the clinic Potential "first-in-class" bispecific antibodies Designed to address 10 resistance mechanisms 14 Checkpoint Blockade PD-L1 BNT311 Costimulus on T and NK cells Product Candidate BNT311 (GEN1046) BNT312 (GEN1042) 4-1BB Preclinical Costimulus on tumor stroma CD-40 BNT312 PD-L1x4-1BB CD-40x4-1BB Phase 1 Ph1/2a Ph1/2a Costimulus on T and NK cells 4-1BB Phase 2 Data update 2H 2020 BIONTECH#153 BNT311 (anti-PDL1-anti-4-1BB) Mode of action Constitutive PD-L1 blockade & Conditional 4-1BB agonism PDL1 Blockade 0.001 0.01 PD-L1 x 4-1 B B Anti-P D-L1 (parental). Tumor size (mm³) 15 1024 Antibody concentration (g/mL) 512- 256- 128- 64- 32- 16- 0.1 8. 4- T 0 1 10 100 Anti-PD-L1 O Isotype control 751 41BB Agonism 0.001 Preclinical antitumor activity beyond PD1/PDL1 blockade 0.01 PD-L1 x 4-1 BB Antibody concentration (pg/mL) HIN 10 20 30 days post tumor implantation 0.1 40 T ctrl PD-L1 x Control Control x 4-1 BB mbs-PD-L1x4-1BB mbs-PD-L1xctrl mbs-ctrlx4-1BB Clinical trial objectives 1 Evaluate safety, PK & mode of action Evaluate clinical activity in 2 ● ● 10 refractory, progressive tumors 10 insensitive tumor types Study design: First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1046 (BNT311) IV once every 21 days in subjects with malignant solid tumors Non-small Cell Lung Cancer, Urothelial Carcinoma, Endometrial Carcinoma, Triple Negative Breast Cancer, Squamous Cell Carcinoma of the Head and Neck, Ovarian and Cervical Cancer Enrollment: ~192 patients First Data expected in 2H 2020 *SITC 2018, Altintas et al BIONTECH#164 BNT411: initiated FIH Phase 1 trial for our TLR7 agonist in July 2020 BNT411 is an intravenously administered small molecule TLR7 (toll-like receptor 7) agonist Engineered for high potency and high TLR7 receptor-selectivity at the therapeutically active dose range Activation of both adaptive and innate immune system has been observed, in particular in combination with cytotoxic therapies and CPIs ● ● ● ● ● 16 Type 1 interferon-dominated release of cytokines and chemokines and potent stimulation of antigen-specific CD8+ T cells, B cells and innate immune cells such as NK cells and macrophages Expected to have therapeutic potential across various solid tumor indications Phase 1/2a clinical trial as a mono and combination therapy initiated in July 2020 Study design: Phase 1/2a, first-in-human, open-label, dose-escalation trial Evaluation of safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BNT411 as a monotherapy in patients with solid tumors and in combination with atezolizumab, carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC) Enrollment: ~60 participants ● BIONTECH#17Agenda • Q2 Highlights ● • Oncology Pipeline Update •BNT162 (COVID-19 vaccine program) • Financial Update and 2H 2020 Outlook ● 17 BIONTECH#18Status of COVID-19 vaccine program Note: All future dates represented in graphic reflect anticipated timelines and are subject to clinical, technical, regulatory and manufacturing success SARS-CoV-2 Genetic Sequence Made public January 12, 2020 Dijk 18 0000 Announced Collaborations Fosun Pharma, March 16 Pfizer, March 17 ши Initiated Project "Lightspeed" Candidate selection Animal Studies Toxicology Studies GMP manufacturing Preliminary Data: BNT162b1 From Ongoing Phase 1 US trial, July 1 From Ongoing Phase 1 EU trial, July 20 Euro Pivotal Phase 2b/3 Trial with BNT162b2 First patient Dosed: July 27 Approximately 6 months to initiate Pivotal Trial Fast track designation for BNT162b1 and BNT162b2 July 13 Phase 1/2 Trials ongoing in Europe, U.S. and in China (started later in July) 4 vaccine candidates in the clinic > 500 subjects = Potential Filing for Regulatory Approval or Emergency Authorization Goal: Q4 - as early as October 2020 BIONTECH#19BNT162b2 selected as lead candidate for Phase 2b/3 2 SARS-COV-2 ¹ Wrapp et al., Science, 2020 19 Spike-Antigen Receptor Binding whole protein Domain (RBD) SARS-COV-2 Spike Protein 3D Structure ¹ Variant 162a1 162b1 162b2 162c2 Target RBD subunit RBD subunit 2P-mutated full spike protein 2P-mutated full spike protein Received Fast Track designation RNA construct uRNA modRNA modRNA saRNA Immunization prime/ boost prime/ boost prime/ boost single injection BIONTECH#20Rationale for selection of BNT162b2 for pivotal Phase 2/3 trial BNT162b2 advanced into Phase 2/3 study, at 30 µg dose level as a 2-dose regimen, based on preclinical and clinical data ● ● ● 20 Preliminary Phase 1/2 data from nearly 120 patients demonstrated favorable overall tolerability profile ▪ A reactogenicity profile that is more favorable than BNT162b1 in both younger and older adults Generally mild to moderate and transient local and systemic adverse events and no serious adverse events ■ Two 30 µg doses of BNT162b2 elicited neutralizing GMTs generally similar to GMTs elicited by BNT162b1 ▪ US and German Phase 1 data BNT162b1 demonstrated GMTs 2.8 and 3.3 times of COVID-19 patient convalescence serum panel at 30 µg (day 28) ▪ In older adults BNT162b2 elicited GMT higher than COVID19 patient sera panel BNT162b2 vaccinated participants displayed favorable breadth of epitopes recognized by T cell responses as compared to BNT162b1 ■ Concurrent induction of high magnitude CD4+ and CD8+ ▪ An evidence for broader T cell immunity and trend for stronger CD8+ T cell responses BNT162b2 Phase 1 data is expected to be published within the upcoming weeks BIONTECH#21BNT162b2: Global Phase 2b/3 design ● 21 Planned to enroll up to 30,000 participants between 18 and 85 years of age at approximately 120 clinical investigational sites around world Designed as 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review Co-Primary endpoints: Prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization ▪ Prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2 I Secondary endpoints include prevention of severe COVID-19 Design allows for interim analyses and unblinded reviews by independent external Data Monitoring Committee = Goal of filing for emergency authorization or approval as early as October, if trial is deemed to be successful BIONTECH#22BNT162 Commercial update 22 Pfizer FOSUNPHARMA 复星医药 Co-development and Co-commercialization worldwide (ex China) if approved Combined upfront payment and equity investment of $185 million to BioN Tech received in April Capital expenditures to be funded by each party independently Companies to share development expenses and gross profits on a 50:50 basis • BioNTech eligible to receive further development & sales milestones up to $563 million. ● ● ● ● Co-development with Fosun Pharma to hold exclusive marketing rights in China if approved • Combined upfront payment and equity investment of $51 million to BioNTech received in April ● Fosun Pharma to fund development expenses in China • BioNTech and Fosun to share gross profits on the sale of the vaccine in China BioN Tech eligible to receive further China development & sales milestones up to $84 million ● ● BIONTECH#23BNT162 Commercial update ● ● 23 Both BioN Tech and Pfizer jointly scaling up manufacturing capacity to enable global supply: ▪ BioN Tech already producing vaccine for clinical supply at 2 manufacturing sites in Germany ▪ Pfizer will activate 3 manufacturing sites in the U.S. and 1 site in Europe Joint BioN Tech and Pfizer capacity targets for 2020 and 2021: ■ ■ Up 100 million doses by the end of 2020 Approximately 1.3 billion doses by the end of 2021 BioNTech and Fosun working separately to build up manufacturing capacity for China market Commercial supply contracts signed to-date # of doses 30 million Region United Kingdom United States Japan Canada 100 million with option for additional 500 million 120 million Not disclosed Contract value Not disclosed $1.95 billion for first 100 million doses Not disclosed Not disclosed >250m doses contracted for 2020 and 2021 subject to clinical success and regulatory approval Commercial discussions ongoing with additional governments around the world BIONTECH#24Agenda • Q2 Highlights ● • Oncology Pipeline Update • BNT162 (COVID-19 vaccine program) Financial Update and 2H 2020 Outlook 24 BIONTECH#25Second Quarter 2020 Financial Results (unaudited) - Profit and Loss (in millions) ¹ Revenues resulting from collaboration and license agreements Revenues from other sales transactions Total revenues 25 Cost of sales Gross profit Research and development expenses Sales and marketing expenses General and administrative expenses Other operating income less expenses Finance income less expenses Income taxes Loss for the period 1 Due to rounding, numbers presented may not add up precisely to the totals. Three months ended June 30, 2019 € 20.1 5.7 € 25.8 2020 € 32.6 9.2 € 41.8 (5.7) € 36.1 (95.2) (3.0) (18.8) 0.0 (9.6) 2.2 € (88.3) (5.5) € 20.3 (53.4) (0.7) (14.6) 0.5 (2.2) 0.0 € (50.1) Six months ended June 30, 2019 € 42.0 9.9 € 51.9 2020 € 53.7 15.7 € 69.4 (11.5) € 57.9 (160.3) (3.5) (34.6) 0.3 (3.7) 2.2 € (141.7) (8.7) € 43.2 (110.6) (1.2) (23.9) 0.8 0.9 0.0 € (90.8) BIONTECH#26Second Quarter 2020 Financial Results (unaudited) - Balance Sheet 26 Balance Sheet Position 2020 Full Year Financial Guidance Cash and cash equivalents of €573.0m ($641.6m¹) as of June 30, 2020 • After the end of the second quarter, the Company raised €680.7m ($762.2m1) in expected gross proceeds from private equity placement and follow-on underwritten. offering leading to an expected pro-forma cash and cash equivalents balance of €1.25b ($1.40b¹) as of June 30, 2020 Announced debt financing of up to €100.0m ($112.0m¹) from the EIB in June 2020² ● ● ● ● As a result of increased spending related to BNT162, net cash used in operating activities and for purchases of property and equipment expected to be between €450m and €600m for the full year 2020 Existing cash and cash equivalents, the net proceeds from the recent underwritten offering and the expected net proceeds from the private investment are expected to enable the Company to fund operating expenses and capital requirements through at least the next 24 months 1 Translated using the exchange rate published by the German Central Bank (Deutsche Bundesbank) in effect as of June 30, 2020 BIONTECH#27Outlook for 2H 2020 27 Platform Fix Vac iNeST Intratumoral Immunotherapy CAR-T Cells Neoantigen-based T cell therapy Next-Gen CP Immunomodulators Infectious Diseases Candidate BNT111 BNT113 BNT114 ● RO7198457 (BNT122) SAR441000 (BNT131) BNT211 BNT221 (NEO-PTC-01) BNT311 BNT162 Indication (Target) advanced melanoma HPV16+ H&N cancer triple negative breast cancer 1L melanoma with CPI NSCLC (adjuvant) CRC (adjuvant) Solid tumors (IL-12sc, IL-15sushi, GM-CSF, IFN a) multiple solid tumors (CLDN6) multiple solid tumors multiple solid tumors (PD-L1x4-1BB) COVID-19 Next Expected Milestones ³ Start Phase 2 with in 2H 2020 Start Phase 2 with in 2H 2020 Data update Phase 1 in 2H 20204 Enrollment update in 2H 2020¹ Start Phase 2 in 2H 2020 Start Phase 2 in 2H 2020 Data update Phase 1/2 in 2H 2020² Start Phase 1/2 in 2H 2020 Start Phase 1 in 2H 2020 Data update Phase 1/2 in 2H 2020 Data update Phase 1 (BNT162b2) in Q3 2020 Data update Phase 2/3 in Q4 2020 Expected news flow / milestones: Phase 1 data for BNT162b2 COVID-19 vaccine and update from Phase 2b/3 trial as early as October 2020 Data updates for 3 oncology trials (BNT114, 131, and 311) To initiate up to 4 randomized phase 2 trials for FixVac and iNeST To initiate up to 2 first-in-human phase 1 trials for our Engineered Cell Therapy product candidates 1 We expect this update to include an update on the ongoing study, including patient enrollment numbers, with full efficacy and safety data for an interim update expected in the second half of 2021; 2As the trial is sponsored and conducted by Sanofi, the timing of data updates is not under our control, and is subject to change by Sanofi. ³Our expectations for timing of milestones beyond 2020 are premised on and subject to the achievement of earlier milestones on their expected timelines. Press releases will be issued once first patient has been dosed; 4BNT122 (iNeST) is also being investigated in arm 2 (N=15) of the 3 arm TNBC-MERIT trial, with BNT114 as an optional BIONTECH treatment; BNT114 is investigated in arm 1 (N=12) and arm 3 (N=15) of the TNBC-MERIT trial (total patients in study: N=42); 1 I I I I I 1 I I I I I I#28180 HD=INO12

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Fiscal 3Q Investor Presentation image

Fiscal 3Q Investor Presentation

Healthcare

FY23 Full-Year Results Presentation image

FY23 Full-Year Results Presentation

Healthcare

Healthcare Network P&L Statement and Expansion Projects image

Healthcare Network P&L Statement and Expansion Projects

Healthcare

Accreditation and Quality Assurance Overview image

Accreditation and Quality Assurance Overview

Healthcare

Investment Highlights image

Investment Highlights

Healthcare

Investor Presentation image

Investor Presentation

Healthcare

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update image

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update

Healthcare

BioAtla Investor Presentation Deck image

BioAtla Investor Presentation Deck

Healthcare