Exhibit 99.1

BioNTech SE

Quarterly Report for the Three and Nine Months ended September 30, 2020

Exhibit 99.1

BioNTech SE

Quarterly Report for the Three and Nine Months ended September 30, 2020

Index

Interim Condensed Consolidated Financial Statements

Operating and Financial Review and Prospects

Interim Condensed Consolidated Financial Statements

Interim Condensed Consolidated Statements of Financial Position

The accompanying notes form an integral part of these interim condensed consolidated financial statements.

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Interim Condensed Consolidated Statements of Operations

The accompanying notes form an integral part of these interim consolidated financial statements.

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Interim Condensed Consolidated Statements of Comprehensive Loss

The accompanying notes form an integral part of these interim condensed consolidated financial statements.

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Interim Condensed Consolidated Statements of Changes in Stockholders’ Equity

The accompanying notes form an integral part of these interim condensed consolidated financial statements.

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Interim Condensed Consolidated Statements of Cash Flows

The accompanying notes form an integral part of these interim condensed consolidated financial statements.

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Selected Explanatory Notes to the Interim Condensed Consolidated Financial Statements

BioNTech SE is a limited company incorporated and domiciled in Germany. American Depositary Shares (“ADS”) representing BioNTech’s shares have been publicly traded on the Nasdaq Global Select Market since October 10, 2019. The registered office is located in Mainz, An der Goldgrube 12, 55131 Germany. The accompanying International Financial Reporting Standards, or IFRS, unaudited interim condensed consolidated financial statements present the financial position and the results of operation of BioNTech SE and its subsidiaries, hereinafter also referred to as “BioNTech” or the “Group” and have been prepared on a going concern basis in accordance with the IFRS as issued by the International Accounting Standards Board, or IASB.

BioNTech combines decades of groundbreaking research in immunology, cutting-edge therapeutic platforms and a suite of patient profiling and bioinformatic tools to develop immunotherapies for cancer and other diseases. BioNTech leverages powerful new therapeutic mechanisms and exploits a diverse array of biological targets to harness the power of each patient’s immune system to address the unique molecular signature of each patient’s underlying disease. The breadth of BioNTech’s immunotherapy technologies and expertise has enabled the Group to develop therapies to address a range of rare and infectious diseases, and BioNTech has recently rapidly mobilized these with the aim of addressing the COVID-19 pandemic.

During the nine months ended September 30, 2020, the following changes to the Group structure occurred:

These unaudited interim condensed consolidated financial statements of the Group as of and for the three and nine months ended September 30, 2020 were authorized for issuance in accordance with a resolution of the audit committee on November 10, 2020.

Basis of Preparation and Principles of Consolidation

The accompanying unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2020 have been prepared in accordance with IAS 34 Interim Financial Reporting.

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The unaudited interim condensed consolidated financial statements do not include all the in-formation and disclosures required in the consolidated financial statements and should be read in conjunction with the Group’s consolidated financial statements and accompanying notes included in the Group’s Annual Report on Form 20-F as of and for the year ended December 31, 2019.

BioNTech prepares and presents its unaudited interim condensed consolidated financial statements in Euros. Numbers have been rounded, may not add up precisely to the totals provided and percentages may not precisely reflect the absolute figures.

The unaudited interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2020 include BioNTech SE and its subsidiaries. All intercompany transactions and balances have been eliminated in consolidation.

Use of Estimates

The preparation of the unaudited interim condensed consolidated financial statements requires management to make judgments, estimates and assumptions that affect the reported amounts. Management continually evaluates its judgments and estimates in relation to assets, liabilities, which also includes the fair value measurement of derivatives, contingent liabilities, revenue and expenses. Management bases its judgments and estimates on historical experience and on other various factors it believes to be reasonable under the circumstances, the result of which forms the basis of the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions and conditions and may materially affect the financial results or the financial position reported in future periods.

Significant Accounting Policies

The accounting policies adopted in the preparation of the unaudited interim condensed consolidated financial statements are consistent with those followed in the preparation of the Group’s consolidated financial statements for the year ended December 31, 2019. Certain policies have been further specified as described below due to the activities related to and the progress made in the Covid-19 vaccine development.

Research and Development Expenses

Research and development expenses consist of costs incurred in performing research and development activities, including personnel-related expenses, contract services and costs for purchased materials, laboratory supplies and non-capital equipment used in the research and development process. Research and development expenses include BioNTech’s share of expenses under the terms of collaboration agreements and 100% of the expenses for wholly-owned product candidates. Research and development expenses shared under collaboration agreements which are initially incurred by the collaboration partners and subsequently charged to BioNTech are recorded as purchased services classified within research and development. Cost reimbursements from partners for research and development expenses initially incurred by BioNTech and due to BioNTech under the agreements, are recorded as a reduction to purchased services classified within research and development expenses. The value of goods and services received from contract research organizations and contract manufacturing organizations in the reporting period are estimated based on the level of services performed and progress made in the respective period. Amounts are recorded as accrued expenses in cases where BioNTech has not received an invoice from the service provider. Advance payments for goods or services that will be used or rendered for future research and development activities are recognized as other current assets or other current financial assets respectively. The amounts are currently expensed as the related goods are delivered or the services performed. Management’s estimates are based on the best information available at the time. However, additional information may become available in the future and management may adjust the estimate in such future periods. In this event, BioNTech may be required to record adjustments to research and development expenses in future periods when the actual level of activity becomes

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more certain. BioNTech considers resulting increases or decreases in cost as changes in estimates and reflects such changes in research and development expenses in the period identified.

Research costs are expensed as incurred. Development expenditures on an individual project are recognized as an intangible asset if, and only if, all of the following six criteria can be demonstrated by the Group:

Due to the inherent risk of failure in drug development and the uncertainty of approval, management has determined that these criteria are not met in the Biotech business sector until regulatory approval has been obtained. Therefore, as the Group has not yet obtained regulatory approval for any of its programs, or product candidates, no development expenditures have been capitalized. The related expenditure is reflected in the statements of operations in the period in which the expenditure is incurred.

Pre-launch products

Prior to initial regulatory approval, costs relating to production of products are expensed as research and development expenses in the period incurred. If pre-launch products are sold, the respective product gross margin may be higher compared to the expected recurring margin as the underlying costs will not be included in cost of sales. For the three and nine months ended September 30, 2020 and 2019, no revenues have been recorded related to pre-launch products.

Government grants

The Group has specified its accounting for government grant with respect to the presentation of grants related to assets. In September 2020, in connection with becoming eligible for funding from an initiative by the German Federal Ministry of Education (Bundesministerium für Bildung und Forschung, or the BMBF), the Group elected to present grants received related to assets as deferred income within the statements of financial position. Income is subsequently recognized in profit or loss over the useful live of the underlying asset subject to funding.

The standards applied for the first time as of January 1, 2020, as disclosed in the notes to the consolidated financial statements as of December 31, 2019, had no impact on the unaudited interim condensed consolidated financial statements of the Group as of September 30, 2020. In the course of 2020 an amendment to IFRS 16 Leases with an effective date June 1, 2020 was issued by the International Accounting Standards Board addressing COVID-19-related rent concessions which does not have an impact on the interim condensed consolidated financial statements of the Group.

Impact of COVID-19

On March 11, 2020, the World Health Organization declared the outbreak of COVID-19 as a pandemic, which continues to spread around the world.

In response, BioNTech’s BNT162 program is evaluating several vaccine candidates against COVID-19, including BNT162b2 as the lead candidate currently being developed in a global Phase 3 trial. As part of the program, BioNTech executed two strategic collaborations with large pharmaceutical companies to globally develop BioNTech’s vaccine candidates and to support a global supply of a vaccine upon approval. The collaboration with Pfizer Inc. (NYSE: PFE), or Pfizer, aims to rapidly advance multiple COVID-19 vaccine candidates based on BioNTech’s proprietary mRNA vaccine technology. As part of their strategic collaboration, BioNTech and Shanghai Fosun Pharmaceutical (Group) Co.,

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Ltd (Stock Symbol: 600196.SH, 02196.HK), or Fosun Pharma, will jointly conduct clinical trials in China, leveraging BioNTech’s proprietary mRNA vaccine technology and Fosun Pharma’s clinical development and commercialization capabilities in China. Fosun Pharma will commercialize the vaccine in China upon regulatory approval.

As BioNTech advances its clinical programs, it is in close contact with its principal investigators and clinical sites, which are located in jurisdictions affected by the COVID-19 pandemic, and is assessing the impact of the COVID-19 pandemic on its clinical trials, expected timelines and costs on an ongoing basis. BioNTech has modified its business practices, in response to the spread of COVID-19, including restricting employee travel, developing social distancing plans for employees and cancelling physical participation in meetings, events and conferences. In addition, for certain programs, including BNT111, BNT113, BNT122, BNT141 and BNT142 (RiboMabs), BNT151 and BNT152/153 (RiboCytokines), BNT221, BNT161 (Influenza) and BNT171 (Rare Disease), the commencement of trials has been delayed, partially due to slowed patient enrollment or other delays as a result of the COVID-19 pandemic. This delay had an impact on revenue recognition related to non-COVID-19 collaborations. The partial disruption, even temporary, may severely impact BioNTech’s operations and overall business by delaying the progress of its clinical trials and preclinical studies. BioNTech’s operations, including research and manufacturing, could also be disrupted due to the potential of the impact of staff absences as a result of self-isolation procedures or extended illness. Such factors were evaluated and considered carefully when preparing these unaudited interim condensed consolidated financial statements. BioNTech will continue to evaluate potential effects of the COVID-19 pandemic.

For the three and nine months ended September 30, 2020 and 2019, respectively, the following tables present revenue and operating results for the Group’s operating segments consistent with the presentation in the notes to the consolidated financial statements as of December 31, 2019. The tables below reconcile segment figures to Group figures for the periods indicated.

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The segments are managed based on external sales and operating profit/loss, which represents the operating profit/loss incurred within each segment. Segment figures are reported consolidated, which reflects the way management steers the business.

BioNTech’s internal reporting is generally in accordance with IFRS and in line with the Group’s accounting policies, except for deviations in classification between cost of sales and research and development cost. In order to reconcile the segment figures to the Group’s unaudited interim condensed consolidated financial statements, some of the research and development expenses are reclassified to cost of sales. Whenever revenues are attributable to different segments, these revenues are split based on the cost incurred. Internal overhead costs are allocated to segments based on revenues when they are directly attributable to a service rendered. Sales and marketing expenses, general and administrative expenses and other results that are not directly attributable to one of the segments are allocated to Business Service.

Revenue at BioNTech is differentiated between revenues resulting from collaboration and license agreements and revenues from other sales transactions. The Company collaborates with pharmaceutical and healthcare companies and several global academic collaborators. During the three and nine months ended September 30, 2020, revenue generated from the Genentech, Inc., or Genentech, and Pfizer collaboration agreements each represented more than 10% of BioNTech’s overall revenue from collaboration and license agreements. Revenues were partly recorded in the Clinical and the Manufacturing segment and, with respect to Pfizer, in the Technology Platform segment as well. During the three and nine months ended September 30, 2019, revenue generated from the Genentech and Pfizer collaboration agreements represented more than 10% of BioNTech’s overall revenue from collaboration and license agreements. Revenues were recorded in the Clinical segment and, with respect to Genentech, also in the Manufacturing segment. Total amounts of revenues from these collaboration and license agreements in the periods presented are disclosed in Note 4.

Revenues from other sales transactions are from the sale of medical products (e.g., peptides and retroviral vectors) for clinical supply. Research and development activities are managed on a worldwide basis while manufacturing facilities and sales offices are located and managed in Germany. External sales originate in Germany.

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Disaggregated revenue information

Set out below is the disaggregation of the Group’s revenues from contracts with customers:

During the nine months ended September 30, 2020, revenues from BioNTech’s two new collaboration agreements aimed at developing a COVID 19 vaccine were recognized for the first time.

On March 13, 2020, BioNTech entered into a collaboration and license agreement with Fosun Pharma. Fosun Pharma paid BioNTech a non-refundable upfront cash payment of k€901 (k$1,000) upon signing the agreement in addition to an equity investment of k€45,568 (k$50,000) (see Note 12 for the capital contribution). BioNTech is eligible to receive future milestone payments of up to k$84,000 for potential aggregate consideration of k$135,000.

The non-refundable upfront cash payment received from Fosun Pharma was subsequently fully recognized as revenue. In addition, during the three months ended September 30, 2020, revenue of k€1,697 was recognized by achieving a development milestone. In total, during the nine months ended September 30, 2020, k€2,598 revenue was recognized from the Fosun Pharma collaboration and license agreement.

On April 9, 2020, BioNTech entered into a collaboration and license agreement with Pfizer in which BioNTech and Pfizer equally share development costs. Pfizer agreed to pay BioNTech k€170,146 (k$185,000), including an equity investment of k€103,890 (k$113,000) (see Note 12 for the capital contribution) and a non-refundable upfront cash payment of k€66,256 (k$72,000) which were received in late April 2020 and May 2020, respectively. BioNTech is eligible to receive future milestone payments of up to k$563,000 for potential aggregate consideration of k$748,000.

The non-refundable upfront cash payment received from Pfizer that was initially classified as a contract liability was fully recognized as revenue during the nine months ended September 30, 2020 based on costs incurred. During the three and nine months ended September 30, 2020, revenues of k€45,643 and k€66,256 were recorded respectively.

As services are performed under a collaboration agreement, revenue recognition will be continued in future periods in accordance with BioNTech’s accounting policy as described in “—Critical Accounting Policies and Use of Estimates” and Note 2.3.4 to BioNTech’s consolidated financial statements included in its Annual Report on Form 20-F as of and for the year ended December 31, 2019.

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Product sales included within revenue from other sales transactions are displayed below:

Lipocalyx GmbH

In December 2019, BioNTech Delivery Technologies GmbH (previously BioNTech Protein Therapeutics GmbH), or BioNTech Delivery Technologies, a wholly-owned subsidiary of BioNTech SE, entered into an agreement to acquire all assets, employees and proprietary know-how of Lipocalyx GmbH, or Lipocalyx, and its related parties in exchange for a total consideration of cash at an amount of k€6,516 and additional contingent consideration estimated at the closing date of January 6, 2020 at an amount of k€572. The employees of Lipocalyx were transferred automatically to BioNTech Delivery Technologies with effect as of the closing date.

The Group acquired the assets of Lipocalyx and its related parties to combine the acquired technologies and the related know-how with already existing product candidates of the Group to improve their functionality and performance.

The final fair values of the identifiable net assets of Lipocalyx as at the date of acquisition were:

The interim condensed consolidated statements of operations include the result of Lipocalyx since the acquisition date. From the date of acquisition through September 30, 2020, Lipocalyx contributed k€1,082 to operating loss in the Technology Platform business segment of the Group. From the date of acquisition through September 30, 2020, Lipocalyx generated k€176 in revenues. Given the timing of closing, the contribution to operating loss and revenues, if the transaction had occurred at the beginning of the reporting period, would not differ materially. Goodwill recognized is primarily attributed to the expected synergies and other benefits from combining the assets and activities of Lipocalyx with those of the Group. The goodwill resulting from the Lipocalyx acquisition during the nine months ended September 30, 2020 was allocated to the Technology Platform segment.

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Transaction costs of k€17 relating to the acquisition have been expensed and are included in the general and administrative expenses in the interim condensed consolidated statements of operations and are included in cash flows used in operating activities in the interim condensed consolidated statements of cash flows.

The purchase agreement with Lipocalyx includes the following contingent cash considerations to the previous owners:

At the acquisition date, the fair value of the contingent consideration was k€572. The contingent consideration is presented in ‘non-current financial liabilities’ in the interim condensed consolidated statements of financial position (see Note 10).

BioNTech US Inc. (formerly Neon Therapeutics, Inc.)

On May 6, 2020, BioNTech acquired Neon, a biotechnology company developing novel neoantigen-based T-cell therapies (“the Merger”). Through the acquisition, BioNTech will be able to leverage Neon’s expertise in the development of neoantigen therapies, with both vaccine and T cell capabilities.

Based on the acquisition date share price, the aggregate value of the merger consideration was k€89,890 (k$97,144) financed by issuing 1,935,488 American Depositary Shares representing BioNTech’s ordinary shares as a stock transaction and including a de minimis cash consideration which was paid to settle Neon’s outstanding stock options.

The fair values and values in accordance with IFRS 3 of the identifiable net assets of BioNTech US Inc. as at the date of acquisition were as follows:

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As at the date of acquisition, k€8,043 of deferred tax liabilities had been provisionally recorded arising from the assets acquired in the business combination. Provisionally, tax benefits acquired as part of the business combination were assessed as not satisfying the criteria for separate recognition. During the three months ended September 30, 2020, BioNTech finalized its assessment of deferred taxes related to the acquisition of Neon and determined that loss carryforwards which existed as of the acquisition date, should be recognized to the extent of acquired deferred tax liabilities (k€8,043) and therefore recorded a deferred tax asset of k€8,043 against goodwill. Since the conditions to offset were fulfilled, the deferred tax assets and liabilities were offset. Additionally, the deferred tax asset on tax losses incurred since acquisition through June 30, 2020 (k€2,317) which had been offset against the acquired deferred tax liability as of June 30, 2020, was reversed through income tax expense during the three months ended September 30, 2020 as this deferred tax asset was no longer deemed recoverable as the entire acquired deferred tax liability was offset with the acquired deferred tax asset with the finalization of the purchase price allocation. The net impact on income tax expense in the nine months ended September 30, 2020 is nil.

The interim condensed consolidated statements of operations include the results of BioNTech US since the acquisition date. From the date of acquisition through September 30, 2020, BioNTech US contributed k€17,912 to the operating loss in all biotech business unit operating segments of the Group, primarily in the Technology Platform segment. If the transaction had occurred at the beginning of the reporting period, k€49,202 would have contributed to the operating loss. This amount includes expenses resulting from the Merger and should not necessarily be considered representative of the future consolidated results of operations or financial condition on a consolidated basis. From the date of acquisition, BioNTech US did not generate any revenue and no revenue would have been generated if the transaction had occurred at the beginning of the reporting period.

Goodwill recognized is primarily attributable to the expected synergies and other benefits from combining two organizations with a common culture of pioneering translational science and a shared vision for the future of cancer immunotherapy as described above. The goodwill resulting from the BioNTech US acquisition during the nine months ended September 30, 2020 was allocated to the Technology Platform segment.

Transaction costs of k€1,073 relating to the acquisition have been expensed and are included in the general and administrative expenses in the interim condensed consolidated statements of operations. In the interim condensed consolidated statements of cash flows they are included in cash flows used in operating activities. The attributable costs of the issuance of the shares of k€1,320 were recorded in equity as a deduction from the capital reserve and are included in cash flows from financing activities in the interim condensed consolidated statements of cash flows.

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Reconciliation of goodwill

The reconciliation of the carrying amount of goodwill at the beginning and end of the reporting period is presented below

The amount of goodwill recognized from acquiring subsidiaries and businesses includes the measurement period adjustment of k€8,043 resulting from the subsequent recognition of deferred tax assets during the reporting period (see above and Note 7).

BioNTech’s nature of business and primary focus of activities, including development of its platforms and manufacturing technologies, generate a significant amount of research and development expenses which are the largest component of total operating expenses.

The research and development expenses recognized during the three and nine months ended September 30, 2020 and September 30, 2019 are shown in the following table:

During the three and nine months ended September 30, 2020, research and development expenses increased mainly due to an increase in development expenses from BioNTech’s BNT162 program, the vaccine program against COVID-19. Research and development expenses include BioNTech’s share of expenses derived from the collaboration with Pfizer under which shared development costs are shared equally between the partners.

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The Group calculates the interim income tax expense using the tax rate that would be applicable to the expected total annual earnings. Deferred tax assets on tax losses of subsidiaries incorporated in Germany have not been capitalized as there is not sufficient probability that there will be future taxable profits against which the unused tax losses can be utilized. During the three months ended September 30, 2020, BioNTech finalized its assessment of deferred taxes related to the acquisition of Neon and determined that loss carryforwards which existed as of the acquisition date, should be recognized to the extent of acquired deferred tax liabilities (k€8,043) and therefore recorded a deferred tax asset of k€8,043 against goodwill. Since the conditions to offset were fulfilled, the deferred tax assets and liabilities were offset. Additionally, the deferred tax asset on tax losses incurred since acquisition through June 30, 2020 (k€2,317) which had been offset against the acquired deferred tax liability as of June 30, 2020, was reversed through income tax expense during the three months ended September 30, 2020 as this deferred tax asset was no longer deemed recoverable as the entire acquired deferred tax liability was offset with the acquired deferred tax asset with the finalization of the purchase price allocation. The net impact on income tax expense in the nine months ended September 30, 2020 is nil. Accumulated tax losses relate to Germany and the United States. There is no expiration date for any of the accumulated tax losses under German tax law. With respect to accumulated losses incurred at the level of BioNTech USA Holding LLC and BioNTech Research and Development Inc. since their incorporation and tax losses of BioNTech US incurred since 2018 have no expiration date under U.S. tax law. The carry forward of tax losses prior 2018 of BioNTech US is partially limited in time and amount. Deviating federal and state rules apply.

During the nine months ended September 30, 2020, the Group acquired intangible assets with a cost of k€5,248 (nine months ended September 30, 2019: k€13,721), excluding intangible assets acquired through business combinations (see Note 5). The acquisitions during the nine months ended September 30, 2020 mainly related to advance payments (k€2,626) as well as concessions, licenses, in-process R&D and similar rights (k€2,622). During the nine months ended September 30, 2019, the acquisitions mainly related to concessions, licenses, in-process R&D and similar rights (k€8,318) as well as advance payments (k€5,403).

During the nine months ended September 30, 2020, the Group acquired property, plant and equipment with a cost of k€40,664 (nine months ended September 30, 2019: k€28,621), excluding property, plant and equipment acquired through business combinations (see Note 5). The acquisitions during the nine months ended September 30, 2020 were related to construction in progress and advance payments (k€30,036), equipment, tools and installations (k€8,034) as well as land and buildings (k€2,594). During the nine months ended September 30, 2019, the acquisitions were related to construction in progress and advance payments (k€12,012), equipment, tools and installations (k€9,433) as well as land and buildings (k€7,176).

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Set out below, is an overview of financial assets, other than cash and cash equivalents, held by the Group as of September 30, 2020 and December 31, 2019:

Set out below, is an overview of financial liabilities, other financial liabilities and trade payables held by the Group as of September 30, 2020 and December 31, 2019:

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Manufacturing Financing

BioNTech entered into an agreement with the European Investment Bank (EIB) for a €100 million credit facility to partially support the development of BNT162 and fund expansion of BioNTech’s manufacturing capacity to provide worldwide supply of BNT162 in response to the COVID-19 pandemic. Under this arrangement, the EIB agreed to provide BioNTech with a credit in an amount up to €100 million to partially finance such development and expansion. The credit consists of (i) a term loan in the amount of €50 million that may be drawn in a single tranche upon the achievement of certain milestone events (Credit A), and (ii) a term loan in the amount of €50 million that may be drawn in a single tranche (Credit B). Credit B may only be drawn after Credit A has been drawn down and upon the additional achievement of certain milestone events. Each tranche under Credit A and Credit B must be repaid within six years from the date on which the tranche is disbursed. As of September 30, 2020, there has been no draw down.

June 2020 Private Placement – Convertible Note

A fund associated with Temasek Capital Management Pte. Ltd., or Temasek, and another accredited investor have contributed a private investment which BioNTech refers to as the “June 2020 Private Placement”. The private placement includes an investment in ordinary shares (see Note 12) and a k€100,000 investment in a 4-year mandatory convertible note. The four-year mandatory convertible note has a coupon of 4.5% per annum and a conversion premium of 20% above its reference price. Subject to customary closing conditions, the investment closed as of August 28, 2020. As of that date, the convertible note has been classified as a financial liability according to IAS 32 because the conversion features of the note lead to a conversion into a variable number of shares and is measured at amortized costs since the fair value option was not applied. On initial recognition, the financial liability was measured at the present value of the contractually determined future cash flows discounted at the effective interest rate of 9.0%. The financial liability is subsequently measured at amortized cost by using the effective interest rate method until extinguished upon conversion. The conversion features provided for in the contract were identified as a combined embedded derivative since they share the same risk exposure and are interdependent. The embedded derivative was bifurcated from the convertible note, as host contract, and is recognized as a separate financial instrument. Based on the classification as derivative, the instrument is measured at fair value through profit and loss until it is extinguished upon conversion. The fair value of the embedded derivative is determined by modeling the stock price movement using the Cox-Rubinstein binomial tree model to derive the value of the conversion right. The primary inputs used in the model include stock price volatility, credit spreads, risk-free interest rate and foreign exchange forward rates. Stock price volatility is based on implied volatility for BioNTech, credit risk is model implied and adjusted for movement in credit spreads for B-rated corporates at each valuation date, the risk-free interest rate is based on currency specific time congruent IBOR and swap rates whereas the foreign exchange forward rates are based on observable market data.

Risk management activities

No changes have occurred regarding the Group’s risk management activities as disclosed in the notes to the consolidated financial statements as of December 31, 2019.

Fair values

Fair values of cash and cash equivalents, trade receivables, trade payables, and other current financial assets and liabilities approximate their carrying amounts largely due to the short-term maturities of these instruments.

The financial liabilities measured at amortized cost include two fixed-interest rate loans as well as a recently issued convertible note. As of September 30, 2020 and December 31, 2019, the carrying value approximates their fair values as there have been no significant changes in relevant interest rates since the inception of the respective loans and note.

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The fair values of financial instruments measured at fair value are reassessed on a quarterly basis. The valuation technique used for measuring the fair value of the embedded derivative is based on significant observable inputs (Level 2).

During the three and nine months ended September 30, 2020, the fair value adjustment derived from remeasuring the embedded derivative was recognized as finance expenses in profit or loss and amounted to k€6,296. The initial fair value of the contingent consideration determined at acquisition remains valid since no changes of the underlying performance criteria have occurred.

Set out below, is an overview of other assets as of September 30, 2020 and December 31, 2019:

Government Grant

In September 2020, BioNTech became eligible to receive up to €375.0 million in funding from an initiative by the German Federal Ministry of Education (Bundesministerium für Bildung und Forschung, or the BMBF) to support the COVID-19 vaccine program BNT162. The milestone-based BMBF funding will be used to accelerate BioNTech’s vaccine development, as well as for upscaling of manufacturing capabilities in Germany. As of September 30, 2020, k€8,500 were recorded as other current asset since they relate to amounts drawn down for which there is reasonable assurance that the government grant will be received, and all conditions, wholly in the control of the company, will be complied with. The funding drawn down represents a compensation for expenses already incurred in the period ended September 30, 2020. Therefore, k€8,500 were recognized as other operating income within the statements of operations during the three months ended September 30, 2020.

On September 18, 2019, BioNTech effected a 1:18 share split by issuing 206,595,492 shares by way of a capital increase from its own funds; thus, no outside proceeds were received. This capital increase came into effect upon registration with the commercial register (Handelsregister). The accompanying unaudited interim condensed consolidated financial statements and notes to the unaudited interim condensed consolidated financial statements give retroactive effect to the share split for all periods presented.

Capital transactions during the nine months ended September 30, 2020

During the nine months ended September 30, 2020, the issued share capital of BioNTech increased by k€14,006. Each share has a nominal value of €1.00. As a result of the financing transactions the capital reserve increased by k€785,150. Costs of k€30,233 related to these equity transactions were recorded in equity as deduction from the capital reserve. The financing transactions that occurred during the nine months ended September 30, 2020, were as follows:

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Shanghai Fosun Pharmaceuticals (Group) Co., Ltd

As part of the BNT162 program, BioNTech entered a strategic alliance with Fosun Pharma to develop COVID-19 vaccine candidates in China. Fosun Pharma agreed to make an equity investment of k€45,568 (k$50,000) for 1,580,777 ordinary shares in BioNTech via Fosun Industrial Co., Limited, Hong Kong. The increase in share capital with a nominal amount of k€1,581 was subject to execution of share subscription documentation and approval from regulatory authorities in China and became effective with the registration with the commercial register (Handelsregister) on April 23, 2020. As a result of the transaction the capital reserve increased by k€43,987.

Pfizer Inc., New York, New York, United States

As part of the collaboration between BioNTech and Pfizer, for the co-development of BNT162, Pfizer agreed to make an equity investment of k€103,890 (k$113,000). The issuance of 2,377,446 ordinary shares with the nominal amount of k€ 2,377 was registered with the commercial register (Handelsregister) on May 5, 2020. As a result of the transaction the capital reserve increased by k€101,513.

Neon Therapeutics, Inc., Cambridge, Massachusetts, United States

BioNTech acquired Neon by issuing 1,935,488 American Depositary Shares representing BioNTech’s ordinary shares with the nominal amount of k€ 1,935 to former stockholders of Neon in the Merger. The capital increase was registered with the commercial register (Handelsregister) on May 8, 2020. As a result of the transaction the capital reserve increased by k€87,613.

Global Offering

On July 27, 2020 BioNTech increased its share capital by k€5,500 (k$6,379) in conjunction with the underwritten offering of 5,500,000 ADS each representing one of BioNTech’s ordinary shares at a public offering price of $93.00 per ADS (“Underwritten Offering”). On August 27, 2020, following the Underwritten Offering, BioNTech increased its share capital by additional k€16 (k$19) in conjunction with the rights offering of 16,124 ADS each representing one of BioNTech’s ordinary shares at a public offering price of $93.00 per ADS (“Rights Offering”). The Underwritten Offering and the Rights Offering are part of a single, global offering which BioNTech refers to as the Global Offering. The gross proceeds of the Global Offering were k€436,295 (k$513,000) including k€5,516 increase in share capital and k€430,779 increase in capital reserve.

June 2020 Private Placement – Equity Investment

A fund associated with Temasek Capital Management Pte. Ltd., or Temasek, and another accredited investor have contributed a private investment which BioNTech refers to as the “June 2020 Private Placement”. The private placement includes an investment in a 4-year mandatory convertible note (see Note 10) and an investment of k€123,855 in ordinary shares. The issuance of 2,595,996 ordinary shares with the nominal amount of k€ 2,596 was registered with the commercial register (Handelsregister) on September 8, 2020. As result of the transaction the capital reserve increased by k€121,259.

Capital transactions during the nine months ended September 30, 2019

During the comparative period of nine months ended September 30, 2019, the issued share capital of BioNTech increased by k€28,491. Each share has a nominal value of €1.00. As a result of the financing transactions the capital reserve increased by k€226,494. Costs of k€858 related to these equity transactions were recorded in equity as deduction from the capital reserve.

In January 2019, BioNTech issued 5,088,204 shares and increased its share capital by k€5,088. The cash investment of k€80,006 was received in 2018 (k€79,997).

As of March 14, 2019, BioNTech acquired the remaining 5.5% of non-controlling interests in BioNTech Cell & Gene Therapies GmbH previously held by Eli Lilly Nederland B.V. in exchange for issuing 2,374,794 new ordinary shares with an imputed nominal value of €1.00 each. This acquisition was recognized within equity and resulted in the derecognition of the non-controlling interest of k€731 as

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well as an increase in share capital of k€2,375. The net effect of the transaction of k€1,644 was recognized as a decrease in the capital reserve.

Of the share capital issued in 2019, k€12,465 relates to a new financing round (referred to as the Series B round). As part of the Series B round, 12,465,288 ordinary shares (excluding 5,524,506 ordinary shares which were issued to a Hong Kong-based investor and subsequently transferred to BioNTech for no consideration; these shares are held as treasury shares) were issued to certain new and existing shareholders. As a result of the Series B round, the capital reserve increased by k€186,083.

On August 30, 2019, BioNTech entered into agreements with the Bill & Melinda Gates Foundation (“BMGF”) under which BioNTech is required to perform certain research and development activities. The issuance of 3,038,674 ordinary shares with the nominal amount of k€ 3,039 was registered with the commercial register (Handelsregister) on September 26, 2019. As result of the transaction the capital reserve increased by k€46,826.

Management Board Grant (Cash-Settled)

Since the beginning of 2020, the first year following the completion of BioNTech’s initial public offering (“IPO”), the current service agreements with BioNTech’s Management Board have provided for a short-term incentive compensation of up to a maximum of fifty percent of the annual base salary for the years 2020, 2021 and 2022. The amount of such short-term incentive compensation will depend on the achievement of certain company goals in the particular fiscal year, which goals will be set uniformly for all members of the Management Board. Fifty percent of the incentive compensation will be paid promptly upon achievement of the applicable company goals (first installment), with the remaining amount payable one year later, subject to adjustment relative to the performance of the price of the American Depositary Shares representing BioNTech’s ordinary shares during that year (second installment).

For each of the three yearly awards, the second installment of the short-term incentive compensation that is dependent on the price of the American Depositary Shares representing BioNTech’s ordinary shares, represents a cash-settled share-based payment arrangement. The fair values of the liabilities are recognized over the award’s vesting period beginning as of the service commencement date (January 1, 2020) until each separate determination date and are remeasured until settlement date.

During the three months ended September 30, 2020, the Group recognized share-based payment expenses of k€83 as research & development expenses and of k€124 as general & administrative expenses in the interim condensed consolidated statements of operations (three months ended September 30, 2019: Nil).

During the nine months ended September 30, 2020, the Group recognized share-based payment expenses of k€248 as research & development expenses and of k€373 as general & administrative expenses in the interim condensed consolidated statements of operations (nine months ended September 30, 2019: Nil).

Management Board Grant (Equity-Settled)

From the beginning of 2020, the first year following the completion of BioNTech’s IPO, until the end of the term of the Management Board member’s employment agreement, the service agreements with BioNTech’s Management Board provide for a long-term incentive compensation in terms of a yearly grant of options to purchase BioNTech shares. The right to receive options in 2020, 2021 and 2022 represents an equity-settled share-based payment arrangement.

The options allocated each year will be subject to the terms, conditions, definitions and provisions of the Employee Stock Ownership Plan (“ESOP”) and the applicable option agreement thereunder. The

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number of options to be allocated each year to Prof. Ugur Sahin, Sean Marett, Dr. Sierk Poetting, Dr. Özlem Türeci and Ryan Richardson is to be calculated based on a value of €750,000, €300,000, €300,000, €300,000 and €260,000, respectively, in each case divided by the amount by which a certain target share price exceeds the exercise price. The value used to calculate the number of options for Ryan Richardson increases to €280,000 for the year 2022.

The allocation of the number of options to be received in 2020 took place on February 13, 2020 (allocation date). The allocations of the number of options to be received in 2021 and 2022 are estimated to take place on the first and second anniversary of the allocation date (estimated allocation dates).

The share options allocated and expected to be allocated to BioNTech’s Management Board as of the dates indicated are presented in the tables below.

* Valuation parameter derived from the Monte-Carlo simulation model

* Valuation parameter derived from the Monte-Carlo simulation model

For the awards with estimated allocation dates, the numbers of awards expected to be allocated have been calculated using the valuation parameter derived from the Monte-Carlo simulation model. The numbers will be adjusted until the actual allocation has occurred and the number of options granted has ultimately been determined. The options will vest annually in equal installments over four years commencing on the first anniversary of the allocation date and will be exercisable four years after the allocation date.

The options will be subject to the terms, conditions, definitions and provisions of the ESOP and the applicable option agreement thereunder. The vested options can only be exercised if and to the extent that each of the following performance criteria has been achieved: (i) at the time of exercise, the current price is equal to or greater than the threshold amount (that is, the exercise price, provided that such amount increases by seven percentage points on each anniversary of the allocation date); (ii) at the time of exercise, the current price is at least equal to the target price (that is, (a) for the twelve-month period

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starting on the fourth anniversary of the allocation date, $8.5 billion divided by the total number of the ordinary shares outstanding immediately following the initial public offering (other than ordinary shares owned by BioNTech), and (b) for each twelve-month period starting on the fifth or subsequent anniversary of the allocation date, 107% of the target share price applicable for the prior twelve-month period); and (iii) the closing price for the fifth trading day prior to the start of the relevant exercise window is higher than the exercise price by at least the same percentage by which the Nasdaq Biotechnology Index or a comparable successor index as of such time is higher than such index was as of the last trading day before the allocation date. The options can be exercised at the latest ten years after the allocation date. If they have not been exercised by that date, they will lapse without compensation.

A Monte-Carlo simulation model has been used to measure the fair values at the (estimated) allocation dates of the Management Board Grant. This model incorporates the impact of the performance criteria regarding share price and index development described above. The parameters used for measuring the fair values as of the respective (estimated) allocation dates were as follows:

* Valuation parameter derived from the Monte-Carlo simulation model

The exercise of the option rights in accordance with the terms of the ESOP gives the Management Board members the right to obtain shares against payment of the exercise price. The per share exercise price of the options is the Euro equivalent of the arithmetic mean of the closing prices of the ten last trading days prior to the allocation date. For the award allocated as of February 13, 2020 the exercise price has been determined to be $30.78 (€28.32). The exercise prices for the awards with estimated allocation dates as of February 13, 2021 and February 13, 2022 have been derived from the Monte-Carlo simulation model. Expected volatility was based on an evaluation of the historical volatilities of comparable companies over the historical period commensurate with the expected option term. The expected term was based on general optionholder behavior for employee options.

The share options allocated and expected to be allocated under the Management Board Grant were as follows:

* Valuation parameter derived from the Monte-Carlo simulation model

As of September 30, 2020, the share options allocated and expected to be allocated had a remaining weighted-average expected life of 4.95 years.

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The expenses recognized for employee services received during the three and nine months ended September 30, 2020 are shown in the following table:

Chief Executive Officer Grant (Equity-Settled)

In September 2019, BioNTech agreed to grant Prof. Ugur Sahin, M.D. an option to purchase 4,374,963 ordinary shares, subject to Prof. Sahin’s continuous employment with BioNTech. As disclosed in the notes to the consolidated financial statements as of December 31, 2019, the option will be subject to the terms, conditions, definitions and provisions of the ESOP and the applicable option agreement thereunder.

During the three and nine months ended September 30, 2020, no further options were granted or forfeited.

As of September 30, 2020, the share options outstanding had a remaining expected life of 4.37 years.

During the three months ended September 30, 2020 the Group has recognized k€3,208 of share-based payment expenses as research & development expenses in the interim condensed consolidated statements of operations (three months ended September 30, 2019: Nil).

During the nine months ended September 30, 2020 the Group has recognized k€9,624 of share-based payment expenses as research & development expenses in the interim condensed consolidated statements of operations (nine months ended September 30, 2019: Nil).

Employee Stock Ownership Plan (Equity-Settled)

On November 15, 2018, the Group established a share option program that grants selected employees options to receive shares in the company. The program is designed as an Employee Stock Ownership Plan (ESOP) as disclosed in the notes to the consolidated financial statements as of December 31, 2019. The amounts disclosed in this note have been retrospectively adjusted to reflect the share split as described in Note 12.

Set out below is an overview of changes to share options outstanding and number of ordinary shares underlying these options that occurred during the nine months ended September 30, 2020.

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During the nine months ended September 30, 2020 no further options were granted but 9,144 share options were forfeited. During the nine months ended September 30, 2019, 14,511 options were granted and 12,612 were forfeited.

As of September 30, 2020, the share options outstanding had a remaining weighted-average expected life of 3.98 years.

The expenses recognized for employee services received during the three and nine months ended September 30, 2020 and September 30, 2019 are shown in the following table:

Key Management Personnel Transactions

A number of key management personnel or their related parties hold positions in other companies that results in them having control or significant influence over these companies. A number of these companies have consummated transactions with the Group during the period.

BioNTech has a longstanding relationship with Translational Oncology at the University Medical Center of the Johannes Gutenberg University Mainz (Translationale Onkologie an der Universitätsmedizin der Johannes Gutenberg Universität Mainz gemeinnützige GmbH), or TRON. TRON is a non-profit limited liability company engaged in biopharmaceutical research. Prof. Ugur Sahin, M.D., BioNTech’s co-founder and Chief Executive Officer, is a significant shareholder of TRON.

The aggregate value of transactions related to key management personnel were as follows for the periods indicated:

The outstanding balances of transactions related to key management personnel were as follows as of the dates indicated:

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Other Related Party Transactions

ATHOS KG, Holzkirchen, Germany owns 100% of shares in AT Impf GmbH, Munich, Germany and is the beneficial owner of BioNTech SE. AT Impf GmbH, Munich, Germany is the parent company of the Group. Entities controlled by ATHOS KG mainly provide rental and property management activities and sell property, plant and equipment to BioNTech. The total amount of transactions with ATHOS KG or entities controlled by them was as follows for the periods indicated:

The outstanding balances of transactions with ATHOS KG or entities controlled by them were as follows as of the dates indicated:

None of the balances are secured and no bad debt expense has been recognized in respect of amounts owed by related parties.

On October 20, 2020, BioNTech Pharmaceuticals Asia Pacific Pte. Ltd., Singapore, was incorporated as a wholly-owned subsidiary of BioNTech SE, and is intended to serve as to serve as BioNTech’s headquarters for the region.

In September 2020, BioNTech signed a share purchase agreement with Novartis AG to acquire their manufacturing facility in Marburg, Germany which was closed at the end of October 2020. Based on a preliminary calculation, BioNTech will acquire the entire share capital of Novartis Manufacturing GmbH in exchange for a total cash consideration of k€78,194. The amount may change since it is subject to adjustments based on closing statements. Preliminary to any purchase price allocation, the book values of current and non-current assets of Novartis Manufacturing GmbH amounted to k€23,127 and k€111,066, respectively. Current and non-current liabilities had been recorded with an amount of k€16,292 and k€40,805, respectively. All amounts disclosed are derived from unaudited financial information prepared in accordance with IFRS by the acquiree. The Marburg production site is a state-of-the-art, multi-platform GMP certified manufacturing facility that currently employs approximately 300 employees. The well-established biotechnology drug substance and drug product manufacturing equipment, as well as an experienced team offers favorable conditions for a rapid transition to a mRNA manufacturing site and the third site in the BioNTech manufacturing network in Germany expected to produce BNT162 for global supply, pending regulatory authorization or approval. It is expected to be fully operational in the first half of 2021 with an annual production capacity of up to 750 million doses of potential COVID-19 vaccine.

On November 9, 2020, BioNTech filed a universal shelf registration statement on Form F-3 (File No. 333-249991) (the “Registration Statement”) with the U.S. Securities and Exchange Commission

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(the “SEC”). In addition, BioNTech entered into a sales agreement (the “Sales Agreement”) with Jefferies LLC and SVB Leerink LLC (the “Agents”) pursuant to which the Company may offer and sell American Depoitary Shares representing ordinary shares for aggregate gross sale proceeds of up to $500,000,000 (the “ADSs”) from time to time through the Agents (the “Offering”). We are not obligated to make any sales of ADSs under the Sales Agreement.  BioNTech filed a prospectus supplement with the SEC in connection with the Offering, which is included in the Registration Statement. Upon delivery of an issuance notice and subject to the terms and conditions of the Sales Agreement, the Agents may sell the ADSs by any method permitted that is deemed an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, including sales made directly on or through The Nasdaq Global Select Market (“Nasdaq”), the existing trading market for the ADSs. BioNTech or the Agents may suspend or terminate the offering of ADSs upon notice to the other party, subject to certain conditions.  The Agents will act as sales agents on a commercially reasonable efforts basis consistent with their normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of Nasdaq. BioNTech has agreed to pay the Agents commissions for their services of acting as agent of up to 3.0% of the gross proceeds from the sale of the ADSs pursuant to the Sales Agreement.  BioNTech has also agreed to provide the Agents with customary indemnification and contribution rights. The offering of the ADSs pursuant to the Sales Agreement will terminate upon the earlier of (a) the sale of all of the ADSs subject to the Sales Agreement or (b) the termination of the Sales Agreement by Agents or us, as permitted therein.

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Operating and Financial Review and Prospects

In this report, unless stated or the context otherwise requires, references to the “Company,” “BioNTech,” “we,” “us” and “our” refer to BioNTech SE and its consolidated subsidiaries. The following “Operating and Financial Review and Prospects” should be read together with the unaudited interim condensed consolidated financial statements and related notes as presented above. The following discussion is based on our financial information prepared in accordance with the International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB, which may differ in material respects from generally accepted accounting principles in other jurisdictions, including U.S. GAAP. The following discussion includes forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors, including but not limited to those described in the “Risk Factors” section further below. Please also see “Forward-Looking Statements” included at the end of this quarterly report for the three and nine months ended September 30, 2020.

Operating Results

Overview

BioNTech was founded in 2008 on the understanding that every cancer patient’s tumor is unique and that in order to effectively address this challenge, we must create individualized treatments for each patient. To realize this vision, we combine decades of groundbreaking research in immunology, cutting-edge therapeutic platforms and a suite of patient profiling and bioinformatic tools to develop immunotherapies for cancer and other diseases. We leverage powerful new therapeutic mechanisms and exploit a diverse array of biological targets to harness the power of each patient’s immune system to address the unique molecular signature of each patient’s underlying disease. The breadth of our immunotherapy technologies and expertise has also enabled us to develop therapies to address a range of rare and infectious diseases, and we have rapidly mobilized these with the aim of addressing the COVID-19 pandemic. We believe we are uniquely positioned to develop and commercialize the next generation of immunotherapies with the potential to significantly improve clinical outcomes and usher in a new era of immunotherapy.

We and our collaborators have advanced a development pipeline of over 20 product candidates, of which 12 have entered 13 ongoing clinical trials. Based on our deep understanding of the human immunsystem and in-house manufacturing capabilities, we and our collaborators are developing multiple mRNA-based vaccine candidates for a range of infectious diseases alongside our diverse oncology pipeline. As part of our BNT162 vaccine program against COVID-19, the lead candidate BNT162b2 was selected to be advanced into a currently ongoing Phase 3 study enrolling up to 44,000 participants. As part of our programs focusing on oncology, we have treated over 500 patients across 17 tumor types to date. Our immunotherapy drug classes consist of messenger ribonucleic acid, or mRNA, therapeutics, cell therapies, antibodies and small molecule immunomodulators. Our product candidates span across oncology, infectious diseases and rare diseases. As part of our vertically-integrated business model, we have built comprehensive, highly automated, on-demand in-house manufacturing capabilities aimed at complementing the development our immunotherapy pipeline.

We have assembled an exceptional team of over 1,800 employees, including approximately 300 employees from our acquisition of the production site in Marburg in October 2020. We have established relationships with eight pharmaceutical collaborators, including Bayer AG, or Bayer, Genentech, Inc., or Genentech, Genevant Sciences GmbH, or Genevant, Genmab A/S, or Genmab, Pfizer Inc., or Pfizer, Regeneron Pharmaceuticals, Inc., or Regeneron, Sanofi S.A., or Sanofi and Shanghai Fosun Pharmaceutical (Group) Co., Ltd., or Fosun Pharma.

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Key Pipeline Updates

Below is a summary of our clinical product candidates, organized by platform and indication.

Oncology

BioNTech has continued to advance its broad oncology pipeline of 11 product candidates in 12 ongoing trials. Since the beginning of the third quarter, the Company has provided data updates for BNT111, BNT114, BNT131 and BNT311.

FixVac

Our FixVac product candidates contain selected combinations of pharmacologically optimized uridine mRNA encoding known cancer-specific shared antigens. These candidates feature our proprietary immunogenic mRNA backbone and proprietary RNA-lipoplex, or RNA-LPX, delivery formulation, designed to enhance stability and translation, target dendritic cells and trigger both innate and adaptive immune responses. FixVac is currently being evaluating in five clinical trials including:

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Individualized neoantigen specific immunotherapy (iNeST)

Our iNeST immunotherapies contain unmodified, pharmacologically optimized mRNA encoding up to 20 patient-specific neoantigens and also feature our proprietary RNA-LPX formulation. RO7198457 (BNT122/ RG6180) is partnered with Genentech.

mRNA intratumoral immunotherapy

In collaboration with Sanofi, we are conducting a Phase 1 trial of SAR441000 (BNT131), our first mRNA-based intratumoral immunotherapy, as a monotherapy and in combination with cemiplimab in patients with solid tumors. SAR441000 (BNT131) consists of a modified mRNA that encodes the IL-12sc, IL-15sushi, GM-CSF and IFN-a cytokines. SAR441000 (BNT131) is designed to be administered directly into the tumor in order to alter the tumor microenvironment and enhance the immune system’s ability to recognize and fight cancer within the tumor (proximal) as well as in other untreated locations (distal).

CLDN6 CAR-T cell immunotherapy

We are developing a proprietary chimeric antigen receptor T cell, or CAR-T, product candidate, BNT211, targeting Claudin-6, or CLDN6, a novel solid tumor-specific antigen. We developed BNT211 utilizing our target discovery engine, and we plan to administer it along with a CARVac “primer” to boost the immune response and promote CAR-T cell persistence.

Neo-antigen targeting T cells

Through our recent Neon acquisition, we obtained a neoantigen-targeting T cell platform that can be utilized to develop product candidates across several neoantigen-targeting non-engineered and engineered T cell therapies. Our lead product candidate under this platform is our individualized neoantigen-targeting T cell therapy, BNT221.

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Next-generation checkpoint immunomodulators

We are developing, in collaboration with Genmab, novel next-generation bispecific antibodies that are designed for conditional activation of immunostimulatory checkpoint molecules. Our first bispecific candidates are GEN1046 (BNT311), which targets PD-L1 in conjunction with 4-1BB, and GEN1042 (BNT312), which targets CD40 in conjunction with 4-1BB. While 4-1BB is a known immune checkpoint target that is expressed on T cells and natural killer, or NK, cells, prior attempts to target 4-1BB with monoclonal antibodies have been severely limited by liver toxicities. Our 4-1BB targeting product candidates are designed to avoid toxicities by conditionally activating a 4-1BB receptor only together with the binding of either PD-L1 or CD40.

Targeted cancer antibodies

MVT-5873 (BNT321) is a fully human IgG1 monoclonal antibody targeting sialyl Lewis A (sLea), a novel epitope expressed specifically in pancreatic and other solid tumors. MVT-5873 (BNT321) is currently in Phase 1 clinical development in pancreatic cancer.

Small molecule immunomodulators

BNT411 is our novel small molecule TLR7 agonist product candidate. BNT411 is engineered for high potency and high selectivity for the TLR7 receptor to activate both the adaptive and innate immune system.

In addition, we have several other cancer immunotherapy programs in pre-clinical development including:

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Infectious Disease Immunotherapies

COVID-19 Vaccine Program

In response to the coronavirus global pandemic, the company assembled a global consortium of partners including Pfizer (worldwide collaboration outside of China) and Fosun Pharma (China). BioNTech's vaccine program against COVID-19, BNT162, leverages our proprietary mRNA platform. Currently there are four vaccine candidates: two of the four vaccine candidates include a nucleoside modified mRNA (modRNA), one includes a uridine containing mRNA (uRNA), and the fourth vaccine candidate utilizes self-amplifying mRNA (saRNA). Each mRNA format is combined with a lipid nanoparticle (LNP) formulation. The larger spike sequence is included in two of the vaccine candidates, and the smaller optimized receptor binding domain (RBD) from the spike protein is included in the other two candidates.

Clinical

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Commercial

Regulatory

Flu vaccine

We have a collaboration with Pfizer to develop mRNA-based immunotherapies for the prevention of influenza, product candidate BNT161.

Infectious diseases

We have a research collaboration with the University of Pennsylvania, under which we have the exclusive option to develop and commercialize mRNA immunotherapies for the treatment of up to 10 infectious disease indications. We have also entered into a letter agreement and investment agreement with the Bill & Melinda Gates Foundation to advance the development of immunotherapies for the prevention and/or treatment of HIV and tuberculosis, and up to three additional infectious diseases.

Rare Disease Protein Replacement Therapies

We are collaborating with Genevant in order to capitalize on opportunities for our mRNA technology in rare disease indications potentially featuring expedited paths to market. We are combining our mRNA technology with Genevant’s lipid nanoparticle, or LNP, delivery technology to create up to five mRNA protein replacement therapies for the treatment of rare diseases with high unmet medical needs. BioNTech has put the programs under review in order to focus on other areas.  

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