Corporate Presentation
May 2024
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/(loss) related to sales of BioNTech's COVID-19 vaccine, referred to as COMIRNATY where approved for use under full or conditional marketing authorization, in territories controlled by BioNTech's collaboration partners, particularly for those figures that are derived from preliminary estimates provided by BioNTech's partners; the rate and degree of market acceptance of BioNTech's COVID-19 vaccine and, if approved, BioNTech's investigational medicines; expectations regarding anticipated changes in COVID-19 vaccine demand, including changes to the ordering environment and expected regulatory recommendations to adapt vaccines to address new variants or sublineages; the initiation, timing, progress, results, and cost of BioNTech's research and development programs, including BioNTech's current and future preclinical studies and clinical trials, including statements regarding the timing of initiation, enrollment, and completion of studies or trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations; the targeted timing and number of additional potentially registrational trials, and the registrational potential of any trial BioNTech may initiate; discussions with regulatory agencies; BioNTech's expectations with respect to intellectual property; the impact of BioNTech's acquisition of InstaDeep Ltd. and its collaboration and licensing agreements; the development, nature and feasibility of sustainable vaccine production and supply solutions; and BioNTech's estimates of revenues, research and development expenses, selling, general and administrative expenses, and capital expenditures for operating activities. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.
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Furthermore, certain statements contained in this presentation relate to or are based on studies, publications, surveys and other data obtained from third-party sources and BioNTech's own internal estimates and research. While BioNTech believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, any market data included in this presentation involves assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. While BioNTech believes its own internal research is reliable, such research has not been verified by any independent source. In addition, BioNTech is the owner of various trademarks, trade names and service marks that may appear in this presentation. Certain other trademarks, trade names and service marks appearing in this presentation are the property of third parties. Solely for convenience, the trademarks and trade names in this presentation may be referred to without the ® and TM symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.
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A Global Immunotherapy Leader
COVID-19 VACCINE GLOBAL LEADERSHIP1
Comirnaty | Doses distributed | Potential introduction of combination | |||
2 | respiratory vaccines in late 2025 or 2026, | ||||
>50 % Market Share | >460 m in 2023 | ||||
if approved2 | |||||
STRONG FINANCIAL POSITION
€ 16.9 bn
total cash plus security investments3
MULTIPLATFORM ONCOLOGY PORTFOLIO
21 Clinical programs across
11 Technology Platforms
EXPANDING INFECTIOUS DISEASE PIPELINE
7 Clinical programs in high unmet need indications
Growing proprietary pipeline
Partnership with Pfizer in respiratory and other high need indications
BROAD COLLABORATION NETWORK
LEADER IN ARTIFICIAL
Aim for 10+ potentially registrational trials ongoing by year end 2024
Yearly oncology launches planned from 2026 onwards2
INTELLIGENCE
Building a multi-product global biotechnology company to address the world's most pressing health challenges with
pioneering technologies delivered at scale
1. Partnered with Pfizer; 2. Subject to successful clinical development and regulatory approval; 3. Consists of cash and cash equivalents of €8,976.6 million and security investments of €7,962.7 million, as of March 31, 2024.
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Our Vision: Harnessing the Power of the Immune System to Fight Human Disease
Elevating success beyond our historical achievement
Innovative precision | Multi-product | |
medicine pipeline | ||
Sustainable respiratory | targeting multiple | immunotherapy pioneer |
vaccine business | product approvals in | addressing medical need |
oncology in the coming | worldwide | |
years |
BioNTech's key objectives for the next phase
Powered by breakthrough science, disruptive technologies & AI
AI = artificial intelligence.
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Our Multi-PlatformImmuno-Oncology Pipeline Today
Phase 1 | Phase 1/2 | Phase 2 | Phase 3 | ||||
BNT116
Adv. NSCLC
Autogene cevumeran (BNT122)1 Multiple solid tumors
BNT152 + BNT153 (IL-7, IL-2)Multiple solid tumors
BNT221
Refractory metastatic melanoma
BNT321 (sLea)
Metastatic PDAC
BNT322/GEN10563
Multiple solid tumors
BNT326/YL2026 (HER3)
Multiple solid tumors
BNT142 (CD3xCLDN6)
Multiple CLDN6-pos. adv. solid tumors
BNT151 (IL-2 variant)
Multiple solid tumors
BNT211 (CLDN6)
Multiple solid tumors
BNT311/GEN10463 (acasunlimab; PD-L1x4-1BB) Multiple solid tumors
BNT312/GEN10423 * (CD40x4-1BB)
Multiple solid tumors
BNT313/GEN10533 (CD27)
Multiple solid tumors
BNT314/GEN10593 (EpCAMx4-1BB)
Multiple solid tumors
BNT316/ONC-392 (gotistobart)4 (CTLA-4)mCRPC, + radiotherapy
BNT316/ONC-392 (gotistobart)4 (CTLA-4)Multiple solid tumors
BNT321 (sLea)
adjuvant PDAC, +mFOLFIRINOX
BNT323/DB-13035 (HER2)
Multiple solid tumors
BNT324/DB-13115 (B7H3)
Multiple solid tumors
BNT325/DB-13055 (TROP2)
Multiple solid tumors
BNT411 (TLR7)
Multiple solid tumors
BNT1112
aPD(L)1-R/R melanoma, + cemiplimab
BNT113
1L rel./met. HPV16+ PDL-1+ head and neck cancer, + pembrolizumab
BNT1162
1L adv. PD-L1≥ 50% NSCLC, + cemiplimab
Autogene cevumeran (BNT122)1
1L adv. melanoma, + pembrolizumab
Autogene cevumeran (BNT122)1
Adj. ctDNA+ stage II or III CRC
Autogene cevumeran (BNT122)1
Adj. PDAC, + atezolizumab + mFOLFIRINOX
BNT311/GEN10463 (acasunlimab; PD-L1x4-1BB) R/R met. NSCLC, +/- pembrolizumab
BNT316/ONC-392 (gotistobart)4 (CTLA-4) Plat.-R.ovarian cancer, + pembrolizumab
BNT316/ONC-392 (gotistobart)4 (CTLA-4) anti-PD-1/PD-L1experienced NSCLC
BNT323/DB-13035 (HER2)
HR+/HER2-low met. breast cancer
BNT323/DB-13035 (HER2)PLANNED
HER2-expressing rec. endometrial cancer
Legend
mRNA
Cell therapy
Next generation IO
ADCs
Small molecules
1. Partnered with Genentech, member of Roche Group; 2. Partnered with Regeneron; 3. Partnered with Genmab; 4. Partnered with OncoC4; 5. Partnered with DualityBio; 6. Partnered with MediLink Therapeutics. *Two phase 1/2 clinical trials in patients with solid tumors are ongoing in combination with immune checkpoint inhibitor +/- chemotherapy
NSCLC = non-small cell lung cancer; SCLC = small cell lung cancer; mCRPC = metastatic castration resistant prostate cancer; HPV = human papillomavirus; PDAC = pancreatic ductal adenocarcinoma; CRC = colorectal cancer; CLDN = claudin; IL = interleukin; 1L = first line; R/R = relapsed/refractory; HER2/HER3 = human epidermal growth factor 2/3; sLeA = sialyl-Lewis A antigen; TROP2 = trophoblast cell-surface antigen 2; TNBC = triple negative breast cancer.
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Our Oncology Approach
Goals
Address the continuum of cancer
Bring novel therapies to cancer patients and establish new treatment paradigms
Open up novel options to combine platforms and therapies
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Strategy
Portfolio covering compound classes with synergistic mechanisms of action
- Immunomodulators
- Targeted therapies
- Individualized and off-the-shelf mRNA vaccines
Programs across a wide range of solid tumors and stages of treatment
Programs with first-in-class and / or best-in-class potential
Unique therapeutic combinations
Towards a Potentially Curative Approach to Cancer: Differentiated Combinations
Immunomodulators
Novel checkpoint inhibitors, cytokines, immune agonists
Immunomodulators
- Focus on the most relevant and crucial IO pathways
- Targeting different complementary players in the complex cancer immunity cycle may promote a thorough and durable anti-tumor effect
Targeted therapy
- Potent and precise therapies could rapidly reduce tumor burden
- Designed to have clinical efficacy across the entire disease continuum including late lines
SynergySynergy
Space for potentially curative
Targeted | approaches | mRNA |
therapy | Synergy | vaccines |
ADCs, CAR-T, | ||
TCR-T, small | ||
molecules |
mRNA cancer vaccines
- Could eliminate polyclonal residual disease with individualized vaccines for potential long-term impact
- Polyspecific activity by targeting multiple antigens at once
ADC = antibody-drug conjugate; CAR = chimeric antigen receptor; TCR-T = T-cell receptor engineered T cell; IO = immune oncology.
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BioNTech - Full Exploration of Cancer Vaccine Target Space
Neo- Individualized
antigens therapy
iNeST1
individualized
Neoantigen-Specific immunoTherapy
mRNA- Lipoplex platform
Fixed Antigen
Vaccine
FixVac
Multiple Off-the-shelf
shared therapy antigens
Artificial | |||||||||||||
Individual | intelligence- | Individualized | |||||||||||
driven | |||||||||||||
patient samples | immuno- | ||||||||||||
neoantigen | |||||||||||||
(blood and tissue) | therapy | ||||||||||||
prediction | |||||||||||||
Mapping of | On-demand |
mutations | tailored RNA |
manufacturing |
ANTIGEN 1 | |
ANTIGEN 2 | |
ANTIGEN 3 | |
ANTIGEN 4 | Multi-antigen |
Fixed combination of | |
approach tailored | |
shared tumor antigens2 | to each indication |
Strong vaccine- induced ex vivo CD8+
- cell responses across different cancer types3
10.3%
Mutant Neoantigen
TNBC, BNT114
TNBC-MERIT trial
MAGE-A3 | NY-ESO-1 |
Melanoma, BNT111, | Melanoma , BNT111, |
Lipo-MERIT trial | Lipo-MERIT trial |
2.1% | 10.1% |
5%
HPV16-E7
Head & Neck Cancer
BNT113, HARE40 trial
1. iNeST, or autogene cevumeran (BNT122), is being developed in collaboration with Genentech, a member of the Roche Group. 2. Amount of tumor antigens varies across programs; 3. T cell responses analyzed by ex vivo multimer staining analysis in blood.
TNBC = triple-negative breast cancer; MAGE = melanoma-associated antigen; NY-ESO-1 = New York esophageal squamous cell carcinoma-1; HPV = human papillomavirus E7.
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Growing Portfolio of Cancer Vaccine Candidates Across Multiple Solid Tumors
Six ongoing Phase 2 trials with cancer vaccine candidates in multiple disease settings
Individualized vaccine: iNeST1 | FixVac | ||||||||
Adjuvant | 1L | R/R | R/R | Post-adj. | Neo-adj, mCR | 1L | Multiple settings | ||
CRC | PDAC | Melanoma | Solid Tumors | Melanoma | TNBC | Prostate Cancer | HPV16+ HNSCC | NSCLC | |
Phase 2 | Phase 2 | Phase 2 | Phase 1 | Phase 2 | Phase 1 | Phase 1/2 | Phase 2 | Phase 1 & 2 | |
Autogene | Autogene | Autogene | Autogene | BNT111 | BNT114 | BNT112 | BNT113 + | BNT116 | |
cevumeran | cevumeran | cevumeran | cevumeran | +/- Cemiplimab | Monotherapy & | Pembrolizumab | Monotherapy & | ||
(BNT122) | (BNT122) | (BNT122) | (BNT122) | ||||||
+ Cemiplimab | vs. | Cemiplimab | |||||||
Monotherapy | + Atezolizumab | + Pembrolizumab | + Atezolizumab | ||||||
+ ADT | Pembrolizumab | or CTx | |||||||
Study ongoing | Study ongoing | Enrollment | Enrollment | Enrollment | Study completed | Discontinued | Study ongoing | Ph 1 study in | |
Data presented | completed, | completed, | completed, | Data presented at | Data presented | Data presented at | multiple settings | ||
study is ongoing | study is ongoing | study is ongoing | ongoing | ||||||
from investigator- | SITC 2020 | at SITC 2021 | ESMO-IO 2022 | ||||||
initiated Ph 1 study | Analysis of PFS as | Data presented at | Data presented | Manuscript in | Data presented at | ||||
at ASCO 2022 & | primary endpoint | AACR 2020 | from Ph1 at SITC | SITC 2023 and | |||||
preparation | |||||||||
AACR 2024 and | will be based on | Manuscript | 2021 and published | AACR 2024 | |||||
published (Rojas | events and define | (Sahin et al., Nature | |||||||
in preparation | Ph 2 study in 1L | ||||||||
et al. Nature.2023) | when we will report | 2020) | |||||||
NSCLC ongoing2 | |||||||||
results | |||||||||
1. Partnered with Genentech, member of Roche Group; 2. Sponsored by Regeneron.
iNeST = individualized Neoantigen Specific Immunotherapy;1L = first line; R/R = relapsed/refractory; CRC = colorectal cancer; PDAC = pancreatic ductal adenocarcinoma; TNBC = triple-negative breast cancer; HPV = human papillomavirus; HNSCC = head and neck squamous carcinoma; NSCLC = non-small cell lung cancer; ADT = androgen deprivation therapy; CTx = chemotherapy; PFS = progression-free survival; ASCO = American Society of Clinical Oncology; AACR = American Association for Cancer Research; SITC = Society for Immunotherapy of Cancer; ESMO-IO = European Society for Medical Oncology Immuno-Oncology.
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Therapeutic IO Candidates with Novel Modes of Action Across Multiple Solid Tumors
BNT316/ | BNT311/ | BNT312/ | BNT313/ | BNT314/ | BNT315/ |
ONC-3922 | GEN10461 | ||||
GEN10421 | GEN10531 | GEN10591 | GEN10551 | ||
(gotistobart) | (acasunlimab) | ||||
Anti-CTLA4 | Anti-PD-L1Anti-4-1BB | Anti CD40 Anti-4-1BB | Anti-CD27 | Anti-EpCAMAnti-4-1BB | Anti-OX40 |
BNT327/ PM80023
Anti-VEGF
Optimized Fc | Inert Fc | Inert Fc | Inert Fc | ||||
Clinical status | Clinical status | Clinical status | Clinical status | ||||
• Ph1/2 in multiple | • Ph1/2 in multiple | • Ph1/2 trials in | • Ph1/2 in multiple | ||||
solid tumors | solid tumors | multiple | solid tumors | ||||
• Ph2 in PROC | • Ph2 in mNSCLC | solid tumors |
• Ph3 in 2L+ mNSCLC
Inert Fc | Inert Fc | ||
Clinical status | Clinical status | ||
• IND approved | • IND approved | ||
• FPD achieved in FIH | • FIH planned | ||
in Q1 2024 |
Inert Fc
Anti-PD-L1 VHH
Clinical status
- Several Ph2/3 in patients in China ongoing
- Investigational New Drug Application accepted for further studies in the U.S.
Additional trial starts and data readouts planned in 2024
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 2; ADCC = Antibody dependent cell-mediated cytotoxicity; ADCP = Antibody dependent cellular phagocytosis; PROC = platinum-resistant ovarian cancer; NSCLC = non-small cell lung cancer; EC = endometrial cancer APC = antigen presenting cells; VEGF = vascular endothelial growth factor; TME = tumor microenvironment; CTx = chemotherapy; IND = investigational new drug application; FIH = first in human.
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BioNTech SE published this content on 13 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 May 2024 20:57:02 UTC.