‌May 5th, 2025‌

1st Quarter 2025

Financial Results & Corporate Update



‌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 expected 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; BioNTech's expectations regarding potential future commercialization in oncology, including goals regarding timing and indications; 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 collaboration and licensing agreements; the development, nature and feasibility of sustainable vaccine production and supply solutions; the deployment of AI across BioNTech's preclinical and clinical operations; BioNTech's expectations with respect to tariff policy; BioNTech's estimates of revenues, research and development expenses, selling, general and administrative expenses, and capital expenditures for operating activities; BioNTech's expectations regarding upcoming payments relating to litigation settlements; BioNTech's expectations for upcoming scientific and investor presentations; and BioNTech's expectations of net profit / (loss). 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.

The forward-looking statements in this presentation are based on BioNTech's current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech's control, and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, projected data release timelines, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; BioNTech's pricing and coverage negotiations regarding its COVID-19 vaccine with governmental authorities, private health insurers and other third-party payors; the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine; the impact of tariffs and escalations in trade policy; competition from other COVID-19 vaccines or related to BioNTech's other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the timing of and BioNTech's ability to obtain and maintain regulatory approval for its product candidates; the ability of BioNTech's COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech's and its counterparties' ability to manage and source necessary energy resources; BioNTech's ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech's third-party collaborators to continue research and development activities relating to BioNTech's development candidates and investigational medicines; the impact of COVID-19 on BioNTech's development programs, supply chain, collaborators and financial performance; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech's and its collaborators' ability to commercialize and market BioNTech's COVID-19 vaccine and, if approved, its product candidates; BioNTech's ability to manage its development and related expenses; regulatory and political developments in the United States and other countries; BioNTech's ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time. You should review the risks and uncertainties described under the heading "Risk Factors" in BioNTech's Report on Form 6-K for the period ended March 31, 2025, and in subsequent filings made by BioNTech with the SEC, which are available on the SEC's website at https://www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this presentation in the event of new information, future developments or otherwise.

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.

An abbreviation directory of defined terms can be found at the end of the presentation.



2

1

‌1st Quarter 2025 Update

Ugur Sahin, Co-founder & Chief Executive Officer

2

Oncology Pipeline Update

Özlem Türeci, Co-founder & Chief Medical Officer

3

Financial Update

Jens Holstein, Chief Financial Officer

4

Strategic Outlook

Ryan Richardson, Chief Strategy Officer



1

‌1st Quarter 2025 Updates‌

Ugur Sahin, Co-founder & Chief Executive Officer



‌Building a

Global Immunotherapy Powerhouse Translating Science into Survival



‌Progress in Q1 2025 Towards Our Strategic Goals



Execution in Oncology

BNT327

mRNA Cancer Immunotherapies

Presented Phase 2 data1 for BNT327 in 1L SCLC

Reported first BNT327+ADC combo data1 with TROP2- targeting ADC, BNT325/DB-13052

Reported Phase 1 data1 for BNT1163 in NSCLC

Published two manuscripts for autogene cevumeran4 in Nature and Nature Medicine

BNT323/DB-13032

COVID-19 Leadership

COMIRNATY

Corporate Update

Corporate Development Financials

Preparing for regulator discussions with planned BLA submission by end of 2025, pending regulatory feedback

Maintained >50% global COVID-19 vaccine5 market share

Completed acquisition of Biotheus, securing global control of BNT327

Appointed Ramón Zapata to Management Board as Chief Financial Officer effective July 1, 2025

Strong balance sheet : ~€ 15.9 bn total cash and cash equivalents plus security investments6

1. Phase 1 data for BNT116 (AACR); BNT327 data included: Phase 2 data in ES-SCLC and SCLC (ELCC) and Phase 1/2 data (AACR); 2. Partnered with DualityBio; 3. In collaboration with Regeneron; 4. Partnered with Genentech, a member of the Roche Group; 5. Partnered with Pfizer; 6. Cash and cash equivalents plus security investments as of March 31, 2025, reached €15,854.4 million, comprising €10,184.9 million cash and cash equivalents, €3,542.0 million current security investments and €2,127.5 million non-current security investments, respectively. A settlement payment of $400 million related to a contractual dispute with the University of Pennsylvania is expected to be reflected in the Company's second quarter 2025 financial results. In connection with this and another settlement with the NIH, BioNTech expects to be reimbursed approximately $535 million by its collaboration partner during 2025 and 2026. Reimbursement payments have begun to be received in the first quarter of 2025.

‌We are Uniquely Positioned to Combine Approaches to Transform Cancer Care



Immunomodulators

Immunomodulators

  • Focus on the critical IO pathways

  • Targeting different complementary pathways in cancer immunity cycle may promote a durable anti-tumor effect

Targeted therapies

  • Precise and potent modalities for

    Synergy1

    Space for curative

    Synergy1

    mRNA cancer immunotherapies

  • Eliminate polyclonal residual

    fast onset tumor reduction

  • ADC as potential "augmenters" of immunomodulators and mRNA cancer immunotherapies

  • Focus on HER2, HER3, TROP2,

B7H3 ADCs as combination partners

Targeted

therapies

approaches

Synergy1

mRNA cancer immunotherapies

disease with multi-antigen and individualized approaches

  • Polyspecific activity by targeting

    multiple antigens at once

  • Establish long-lasting immunological memory to prevent relapses

    1. Synergistic potential.

‌Our Priorities are Novel mRNA Cancer Immunotherapy and Next-Generation

IO-Backbone



Novel mRNA cancer immunotherapy

FixVac & iNeST1

Next-generation of personalized cancer therapy targeting

tumor associated antigens and cancer mutations

Our next-generation IO-backbone

PD-L1/VEGF-A antibody BNT327

Potential to become the next-generation IO-backbone

Clinical stage candidates for combination therapy

IO molecules mRNA immunotherapies

ADCs Cell and gene therapies

advanced/metastatic

Resected cancers (adjuvant) Neoadjuvant, 1L

Late stage, refractory cancers

  1. Partnered with Genentech, a member of the Roche Group.

2

‌Oncology Pipeline Update‌

Özlem Türeci, Co-founder & Chief Medical Officer





‌Advancing Towards Commercial Stage in Oncology

BNT327 mRNA Cancer Immunotherapies BNT323/DB-13031

BNT327 data continue to support potential as a next-generation IO-backbone for combination approaches

Updates for off-the-shelf and individualized mRNA cancer immunotherapies expected in 2H 2025

Advance BNT323/DB-13031 towards

BLA submission

  1. Partnered with DualityBio.

‌BNT327: Synergistic Targeting of PD-L1 and VEGF

VEGF-A dimer

in the TME

Anti-VEGF-A (Fab)

Anti-PD-L1 (VHH)

Tumor microenvironment (TME)

BNT327

PD-L1 ligand on tumor cells

Anti-PD-L1 (VHH)

Anti-VEGF-A (Fab)

NSCLC IHC1 Bispecific MOA

VEGF-A



Local neutralization of angiogenic and immunosuppressive VEGF-A effects

PD-L1

Targeting the TME and

PD-L1 ligand

on tumor cells

VEGF-A dimer in the TME

blockade of PD-1/PD-L1

signaling

  1. IHC data: Human Protein Atlas.

‌Accelerating BNT327 Global Clinical Development



Explore potential of BNT327 in three waves of focused development

1 Establish

Ongoing

  • Phase 2 in TNBC

  • Phase 2 in SCLC

  • Phase 3 in SCLC (ROSETTA Lung-01)

  • Phase 2/3 in NSCLC (ROSETTA Lung-02)

    Planned

  • Phase 3 in TNBC (ROSETTA Breast-01) for 2025

2 Combine

Ongoing

  • Phase 1/2 with BNT325/DB-13051

    (TROP2) in solid tumors

    Planned

  • Phase 1/2 with BNT323/DB-13031 (HER2)

  • Phase 1/2 with BNT324/DB-13111 (B7H3)

  • Phase 1/2 with BNT326/YL2022 (HER3)

  • Additional combinations in 2025+

    3 Broaden

    Portfolio of 20+ clinical oncology

    assets in-house

  • Combine with IO bispecifics

  • Combine with cell therapies

  • Combine with novel ADCs

BNT327 + novel assets: Broaden to further indications

BNT327 + ADC: Explore expansion to novel combinations with ADCs in high unmet need indications

BNT327 + chemo: Establish in combination with CTx in potential fast-to-market indications

Partnered with: 1. DualityBio; 2. MediLink.

‌BNT327 Combined With Chemotherapy Indicated Encouraging Efficacy in 1L TNBC Irrespective of PD-L1 Status in Phase 1/2 Study

Unmet medical need remains high for patients with TNBC

Patients with Stage IV TNBC1 have a 5-year survival rate of 10%

Benchmark2 comparator data by PD-L1 expression level (Keynote-355)

Cortes, J, et al., New England Journal of Medicine, 2022

1L TNBC

(CPS <10)4,5

1L TNBC

(CPS ≥ 10)

Benchmark regimen

Chemo

Pembro + Chemo

ORR

35 %

53 %

Median PFS

5.7 months

9.7 months

Median OS

15.2 months

23.0 months

Phase 1/2 Study (NCT05918133): Interim overall survival

Jiong Wu et al. presented at SABCS 2024

ITT population (n=42)

Confirmed ORR

(95% CI)

73.8 %

(58.0, 86.1)

Median PFS

(95% CI)

13.5 months

(9.4, 19.3)

12-month OS rate

(95% CI)

80.8 %

(65.3, 89.9)

18-month OS rate

(95% CI)

69.7 %

(52.7, 81.6)

A manageable safety profile was observed, with no new safety signals beyond those typically described for nab-paclitaxel and anti- PD-1/PD-L1 and anti-VEGF monotherapies.

The above data are not based on a head-to-head study comparing BioNTech's investigational products with other products/candidates

- no conclusions can be drawn.

We believe BNT327 has the potential to become a first-line treatment option for patients with TNBC3, including those currently not addressed by existing IO therapies

1. Incidence from SEER (US); Zentrum für Krebsregisterdaten (DE); Globocan (ES); Sante Publique (FR); AIOM (IT); Cancer Research UK . 2 Benchmark study: KEYNOTE-355 as reported in Cortes, J, et al. New England Journal of Medicine,. 2022. 3. The above information is not based on head-to-head trials between BioNTech's investigational candidates and other products or product candidates. Furthermore, definitive conclusions cannot be drawn from cross-trial comparisons or anticipated data, as they may be confounded by various factors, and should be interpreted with caution. 4. Obtained from subgroup analysis. 5. mPFS for CPS < 10 subgroup from Cortes, J. et al. Lancet, 2020.

‌BNT327 Combined With Chemotherapy Indicated Encouraging Efficacy in 1L ES-SCLC in Phase 2 Study

Unmet medical need remains high for patients with ES-SCLC

Patients with ES-SCLC1 have a 5-year survival rate of 3%

Phase 2 Study (NCT05844150): Emerging efficacy profile

Ying Cheng et al. presented at ELCC 2025

ITT population (n=48)

Confirmed ORR

(95% CI)

85.4 %

(72.2, 93.9)

Median PFS

(95% CI)

6.9 months

(4.34, 8.21)

Median OS

(95% CI)

OS events, n (%)

16.8 months

(14.3, --)

17 (35.4)

12-month OS rate

(95% CI)

72.7 %

(57.6, 83.1)

A manageable safety profile was observed, with no new safety signals beyond those typically described for chemotherapy agents and anti-PD-(L)1 and anti-VEGF monotherapies.

Benchmark2 comparator data (IMpower133)

L. Horn et al., New England Journal of Medicine, 2018

1L ES-SCLC

Benchmark regimen

Atezo + Chemo

ORR

60%

Median PFS

5.2 months

Median OS

12.3 months

The above data are not based on a head-to-head study comparing BioNTech's investigational products with other products/candidates - no conclusions can be drawn.

We believe BNT327 has the potential to become a new first-line treatment option for patients with ES-SCLC3

1. Incidence from: SEER data for diagnosed SCLC incidence in US; Cancer Research UK; Zentrum für Krebsregisterdaten; Sante Publique; AIOM; EPDATA. 2. Benchmark study: IMpower133 as reported in L. Horn et al., New England Journal of Medicine, 2018 3. The above information is not based on head-to-head trials between BioNTech's investigational candidates and other products or product candidates. Furthermore, definitive conclusions cannot be drawn from cross-trial comparisons or anticipated data, as they may be confounded by various factors, and should be interpreted with caution.

‌Non-Small Cell Lung Cancer is One of the Highest Incidence Cancers Globally1

2030 U.S., EU4, U.K.

NSCLC projected incidence

1 ~415k

Treatment outcomes vary based on histology and PD-L1 levels in 1L NSCLC patients without actionable genomic alterations

10%

37%

46%

11%

44%

37%

Non-squamous (~ 70%)3

Squamous (~ 30%)3

PD-L1 ≥ 50%

(~ 25 - 30%)4,5

5-year OS: 30% (KN-189)6

5-year OS: 23% (KN-407)7

PD-L1 1 - 49%

(~ 30 - 40%)4,5

5-year OS: 20% (KN-189)6

5-year OS: 21% (KN-407)7

PD-L1 < 1%

(~ 30 - 40%)4,5

5-year OS: 10% (KN-189)6

5-year OS: 11% (KN-407)7

NSCLC Staging distribution2

Stage IV
Stage III

Stage II
Stage I

7%

8%

US EU5

1. Globocan - Cancer Tomorrow; 2. CancerMPact® 2024 Treatment Architecture EU5 and US; Note that 5-year survival reported includes all comer NSCLC population ie including with actionable genetic alterations; 3. Ganti AK, et al., Update of Incidence, Prevalence, Survival, and Initial Treatment in Patients With Non-Small Cell Lung Cancer in the US. JAMA Oncology, 2021 Dec; 4. Mansour MSI et al., PD-L1 Expression in Non-Small Cell Lung Cancer Specimens: Association with Clinicopathological Factors and Molecular Alterations, International Journal of Molecular Sciences, 2022 Apr 19;23(9):4517; 5. Saez de Gordoa, K. et al. PD-L1 Expression in Non-Small Cell Lung Cancer: Data from a Referral Center in

Spain. Diagnostics 2021, 11, 1452; 6. Garassino MC, et al. Pembrolizumab Plus Pemetrexed and Platinum in Nonsquamous Non-Small-Cell Lung Cancer: 5-Year Outcomes From the Phase 3 KEYNOTE-189 Study. Journal of Clinical Oncology, 2023 Apr 10;41(11):1992-1998; 7. Silvia Novello et al., Pembrolizumab Plus Chemotherapy in Squamous Non-Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study, Journal of Clinical Oncology, 41, 1999-2006(2023).

‌BNT327 Indicates Single Agent Activity in 1L NSCLC in Phase 1b/2a Study



Phase 1b/2a (NCT05918445); Cohort 1: 1L NSCLC (EGFR & ALK WT)

Wu, C. et al. presented at ASCO 2024

60

Best change from baseline (%)

40

20

0

−20

−40

−60

PD-L1 ≥50% PD-L1 1-49%

SD 50

PR

Change from baseline (%)

30

10

−10

−30

−50

−70

SD PR

PD On Treatment

−80

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Months Data cut off date: 2024-03-15

BNT327 indicated manageable safety in this patient population. Safety events were consistent with those described for anti-PD-L1 and anti-VEGF monotherapy.

Benchmark1 comparator data

Indication

Benchmark2 regimen

ORR

mPFS

mOS

1L NSCLC (PD-L1 > 50%)

Pembrolizumab monotherapy

45%

7.7 months

26.3 months

The above data are not based on a head-to-head study comparing BioNTech's investigational products with other products/candidates - no conclusions can be drawn.

. 1L NSCLC mono tx (cohort 1, n=17): ORR 47%, DCR 100%, mPFS 13.6 months

Comparable ORR in PD-L1 1-49% (n=9) and PD-L1 ≥50% (n=8)

  1. Benchmark study: KEYNOTE-024 as reported in Reck, M. et al. New England Journal of Medicine, 2016; 2. The above information is not based on head-to-head trials between BioNTech's investigational candidates and other products or product candidates. Furthermore, definitive conclusions cannot be drawn from cross-trial comparisons or anticipated data, as they may be confounded by various factors, and should be interpreted with caution

    ‌ROSETTA Lung-02 - Our First Global Registrational Trial in NSCLC

    A Phase 2/3, multisite, randomized global trial of BNT327 in combination with

    Phase 2 (n=40)

chemotherapy in first-line non-small cell lung cancer (NCT06712316)

Key eligibility criteria

  • Treatment naïve Stage IIIB/IIIC or IV NSCLC

  • RECIST 1.1 measurable disease

  • ECOG PS 0 or 1

  • PD-L1 all-comers

    Stratification factors

    Phase 3

  • PD-L1 (negative, 1-49%,

    ≥50%)

  • Brain metastasis (Y/N)

  • Region (East Asia vs RoW)

1:1

Substudy B

(squamous NSCLC)

Substudy A

(non-squamous NSCLC)

1:1

Phase 3 (n=942)

Four cycles Pembrolizumab 200 mg Q3W + Carboplatin

+ Pemetrexed followed by pembrolizumab + Pemetrexed

BNT327 DL2 + Carboplatin + Pemetrexed followed by BNT327 DL2 + Pemetrexed

Four cycles BNT327 selected DL + Carboplatin + Pemetrexed followed by BNT327 + Pemetrexed

BNT327 DL1 + Carboplatin + Pemetrexed followed by BNT327 DL1 + Pemetrexed

1:1

Four cycles BNT327 selected DL + Carboplatin + Paclitaxel followed by BNT327

Four cycles Pembrolizumab 200 mg Q3W + Carboplatin

+ Paclitaxel followed by pembrolizumab

BNT327 DL2 + Carboplatin + Paclitaxel followed by BNT327 DL2

BNT327 DL1 + Carboplatin + Paclitaxel followed by BNT327 DL1

1:1

Key endpoints

(Phase 3)

Primary: PFS, OS

Secondary: ORR, DOR, Safety



‌BioNTech at ASCO 2025







Related Program

Indication

Content

BNT327

1L NSCLC

Phase 2/3 TiP

(ROSETTA Lung-02)

BNT327

1L SCLC

Phase 3 TiP (ROSETTA Lung-01)

BNT327

1L Mesothelioma

Phase 2 data

BNT3161

2L+ Melanoma

Phase 2 data

BNT3161

2L+ CRPC

Phase 1 data

BNT324/DB-13112

2L+ CRPC

Phase 2 data

BNT142

CLDN6+ Solid Tumors

Phase 1/2 data

Across portfolio





Data for making informed decisions about the direction of further development



1. Partnered with 1. OncoC4; 2. DualityBio.

3

‌Financial Update‌

Jens Holstein, Chief Financial Officer



‌Q1 2025 Financial Results

Three months ended March 31

(in millions €, except per share data)1

2025

2024

Total Revenues

183

188

Cost of sales

(84)

(59)

Research and development expenses

(526)

(508)

Sales and marketing expenses

(14)

(16)

General and administrative expenses

(107)

(117)

Other operating result

14

5

Operating loss

(534)

(507)

Finance result

89

175

Income taxes

29

17

Net loss

(416)

(315)

Loss per share

Basic and diluted loss per share

(1.73)

(1.31)

Balance Sheet as of March 31, 2025

€15.9 bn

Cash and cash equivalents plus security investments2

1. Numbers have been rounded; numbers presented may not add up precisely to the totals and may have been adjusted in the table. Presentation of the consolidated statements of profit or loss has been condensed. More information can be found in BioNTech's Report on Form 6-K for the three months ended March 31, 2025, filed today with the United States Securities and Exchange Commission and available at https://www.sec.gov/; 2. Cash and cash equivalents plus security investments as of March 31, 2025, reached €15,854.4 million, comprising €10,184.9 million cash and cash equivalents, €3,542.0 million current security investments and €2,127.5 million non-current security investments, respectively. A settlement payment of $400 million related to a contractual dispute with the University of Pennsylvania is expected to be reflected in the Company's second quarter 2025 financial results. In connection with this and another settlement with the NIH, BioNTech expects to be reimbursed approximately $535 million by its collaboration partner during 2025 and 2026. Reimbursement payments have begun to be received in the first quarter of 2025.

‌2025 Financial Year Guidance Confirmed1

FY 2025 Guidance

Planned FY 2025 revenues

Total revenues

€1,700 - €2,200 m

Planned FY 2025 expenses and capex4

R&D expenses

€2,600 - €2,800 m

SG&A expenses

€650 - €750 m

Capital expenditure for operating activities

€250 - €350 m

Guidance considerations

  • Our revenue guidance assumes relatively stable vaccination rates, pricing and market share as compared to 2024. We also anticipate a revenue phasing similar to 2024 with the last 3-4 months driving the full year revenue figure. However, potential changes to the law or governmental policy, including tariffs and public health policy, and evolving public sentiment worldwide, could further negatively impact our anticipated revenues and expenses.

  • Inventory write-downs and other charges are estimated to be ~15% of BioNTech's share of

    gross profit from COVID-19 vaccines sales in Pfizer's territory

  • Anticipated revenues related to service businesses include InstaDeep, JPT Peptide and IMFS as well as revenues from the German pandemic preparedness agreement

1. Financial guidance excludes external risks that are not yet known and/or quantifiable, including, but not limited to the effects of ongoing and/or future legal disputes and related activities, certain potential one-time effects and charges related to portfolio prioritization. It includes effects identified from licensing arrangements, collaborations or potential M&A transactions to the extent disclosed and may be subject to update. The Company does not expect to report a positive net income figure for the 2025 financial year.

4

‌Strategic Outlook‌

Ryan Richardson, Chief Strategy Officer



‌Strategic Priority Areas in 2025

mRNA Cancer Immunotherapy

» Expect first randomized data in the adjuvant setting (CRC)

» Continue to execute 7 ongoing Phase 2 trials and first novel combination trials

Commercial Readiness in Oncology

» Advance BNT323/DB-13031 towards BLA submission

» Continue to build targeted

AI-enabled commercialization team in key markets

BNT327

» Advance 3 global registration-

enabling trials in potential fast-to-market indications

» Generate first BNT327+ ADC

combination datasets

2025

COVID-19 Vaccine2

» Maintain global COVID-19

vaccine market leadership

» Advance next-gen and combination vaccine programs

Partnered with: 1. DualityBio; 2. Pfizer.

‌Save the date

Annual General Meeting

May 16, 2025

Innovation Series R&D Day

November 11, 2025


‌Thank you



‌Appendix‌



‌Selected Pipeline Milestones in 2025 and Beyond

Program

Indication

2025+ Milestone

Next-generation

immunomodulator

BNT327

1L SCLC

China Phase 2 data

1L/2L SCLC

Global Phase 2 dose optimization data

1L/2L TNBC

Global Phase 2 dose optimization data

BNT327 + BNT325/DB-13051

Solid tumors

Global Phase 1 data

mRNA cancer immunotherapy

Autogene cevumeran (BNT122 / RO7198457)2

ctDNA+ adj. CRC

Phase 2 data

BNT1113

2L+ melanoma

Phase 2 data

BNT1163

PD-L1 > 1% NSCLC

Phase 1 data

Targeted therapy

BNT3231

2L+ HER2 EC

Phase 2 data

Regulatory submission

Partnered with: 1. DualityBio; 2. Genentech, a member of the Roche Group; 3. In collaboration with Regeneron.

‌BioNTech's Oncology Pipeline - Phase 2 and Phase 3 Clinical Trials

Phase 2 Phase 3

Autogene cevumeran (BNT122/RO7198457)1

Adj. ctDNA+ stage II or III CRC

Autogene cevumeran (BNT122/RO7198457)1

Adj. PDAC, + atezolizumab + mFOLFIRINOX

Autogene cevumeran (BNT122/RO7198457)1

Adj. MIUC, + nivolumab

BNT1116

aPD-(L)1-R/R melanoma, + cemiplimab

BNT113

1L rel./met. HPV16+ PD-L-1+ HNC,

+ pembrolizumab

BNT1166

1L adv. PD-L1 50% NSCLC, + cemiplimab

BNT323/DB-13035 (trastuzumab pamirtecan)

PLANNED

BNT211 (CLDN6)

CLDN6+ testicular cancer

(HER2), multiple solid tumors

BNT316/ONC-392 (gotistobart)4

(CTLA-4), PROC, + pembrolizumab

BNT327 (PD-L1 x VEGF-A) 2L NSCLC, + CTx

NEW

BNT327 (PD-L1 x VEGF-A) 1L/2L+ (ES-)SCLC, + CTx

BNT327 (PD-L1 x VEGF-A) 1L SCLC, + CTx

BNT327 (PD-L1 x VEGF-A) 1L NSCLC, + CTx

BNT327 (PD-L1 x VEGF-A) 1L TNBC, + CTx

PLANNED

BNT327 (PD-L1 x VEGF-A) 2L SCLC, + CTx7

BNT327 (PD-L1 x VEGF-A) 1L TNBC, + CTx7

BNT316/ONC-392 (gotistobart)4 (CTLA-4) aPD-1/PD-L1 experienced squamous NSCLC

BNT323/DB-13035 (trastuzumab pamirtecan)

(HER2) HR+/HER2-low met. breast cancer

BNT323/DB-13035 (trastuzumab pamirtecan)

(HER2) HER2+ endometrial cancer

PLANNED

BNT327 (PD-L1 x VEGF-A) 1L/2L met. TNBC, + CTx

BNT327 (PD-L1 x VEGF-A) 2L ES-SCLC, + CTx7

BNT327 (PD-L1 x VEGF-A) 1L ES-SCLC + CTx7

BNT327 (PD-L1 x VEGF-A)

EGFR TKI experienced, EGFRm NSCLC, + CTx7

BNT327 (PD-L1 x VEGF-A) 1L MPM, + CTx7

BNT327 (PD-L1 x VEGF-A) 1L HCC + CTx7

BNT327 (PD-L1 x VEGF-A) 2L NEN, + CTx7

mRNA immunotherapy Next generation IO Targeted therapy

Partnered with: 1. Genentech, member of Roche Group; 2. Genmab; 3. MediLink Therapeutics; 4. OncoC4; 5. DualityBio. 6. In collaboration with Regeneron; 7. Trial ongoing in China only.

‌BioNTech's Oncology Pipeline - Phase 1 and Phase 1/2 Clinical Trials

Phase 1 Phase 1/2

Autogene cevumeran (BNT122/RO7198457)1

Multiple solid tumors

BNT142 (CD3xCLDN6)

Multiple CLDN6-pos. adv. solid tumors

BNT327 (PD-L1 x VEGF-A) 1L TNBC7

BNT116

Adv. NSCLC

BNT312/GEN10422 (CD40x4-1BB)

Multiple solid tumors

BNT327 (PD-L1 x VEGF-A)

Multiple solid tumors7

BNT152 + BNT153 (IL-7, IL-2)

Multiple solid tumors

BNT314/GEN10592 (EpCAMx4-1BB)

Multiple solid tumors

BNT327 / BNT3213 combination

1L HCC7

BNT315/GEN10552 (OX40)

Multiple solid tumors

BNT322/GEN10562

Multiple solid tumors

BNT3173

Multiple solid tumors

BNT326/YL2024 (HER3)

Multiple solid tumors

BNT316/ONC-392 (gotistobart)5 (CTLA-4) mCRPC, + radiotherapy

BNT316/ONC-392 (gotistobart)5 (CTLA-4) Multiple solid tumors

BNT324/DB-13116 (B7-H3)

Multiple solid tumors

BNT325/DB-13056 (TROP-2)

Multiple solid tumors

BNT327 / BNT3256 combination

BNT327 / BNT3236 (trastuzumab pamirtecan) combination

Adv. or metastatic breast cancer

PLANNED

PLANNED

BNT327 / BNT3264

combination

Multiple solid tumors

PLANNED

BNT327 / BNT3246

combination

Multiple solid tumors

Multiple solid tumors

BNT211 (CLDN6)

Multiple solid tumors

mRNA immunotherapy Next generation IO Targeted therapy

Partnered with: 1. Genentech, member of Roche Group; 2. Genmab; 3. In collaboration with Regeneron; 4. MediLink Therapeutics; 5. OncoC4; 6. DualityBio. 7. Trial ongoing in China only.

‌Abbreviation Directory

n L

nth line

EU4(5)

Includes Germany, France, Italy, Spain (UK)

OX40

CD134

AACR

American Association for Cancer Research

Fab

Fragment antigen binding

PD

Progressive disease

ADC

Antibody-drug conjugate

FixVac

Fixed Antigen Vaccine

PDAC

Pancreatic ductal adenocarcinoma

adj.

Adjuvant

FY

Fiscal year

PD-(L)1

Programmed cell death protein (ligand) 1

AI

Artificial intelligence

HCC

Hepatocellular carcinoma

PFS

Progression-free survival

AIOM

Associazione Italiana di Oncologia Medica

HER2 (or 3)

Human epidermal growth factor receptor 2 (or 3)

PR

Partial response

ALK

Anaplastic large-cell lymphoma kinase

HNC

Head and neck cancer

PROC

Platinum-resistant ovarian cancer

ASCO

American Society of Clinical Oncology

HPV

Human papilloma virus

QxW

Every x week(s)

BLA

Biologics License Applications

HR

Hormone receptor

R&D

Research and development

CAPEX

Capital expenditures

IHC

Immunohistochemistry

RECIST

Response Evaluation Criteria in Solid Tumors

CD-x

Cluster of differentiation

IMFS

BioNTech Innovative Manufacturing Services

RoW

Rest of world

CI

Confidence interval

iNeST

Individualized NeoAntigen-Specific Therapy

R/R

Relapsed/refractory

CLDN6

Claudin 6

IO

Immuno-oncology

SABCS

San Antonio Breast Cancer Symposium

CPS

Combined positive score

ITT

Intention to treat

(ES)SCLC

(Extensive stage) small cell lung cancer

CRC

Colorectal cancer

JAMA

Journal of the American Medical Association

SD

Stable disease

CRPC

Castration resistant prostate cancer

m

Median

SEC

U.S. Securities and Exchange Commission

ctDNA

Circulating tumor DNA

M&A

Merger and acquisitions

SEER

Surveillance, epidemiology, and end results

CTLA

Cytotoxic T-lymphocyte-associated protein

MIUC

Muscle-invasive urothelial carcinoma

SG&A

Selling, general and administrative expenses

CTx

Chemotherapy

MOA

Mechanism of Action

TKI

Tyrosine kinase inhibitor

DCR

Disease control rate

MPM

Malignant pleural mesothelioma

TME

Tumor microenvironment

DL

Dose level

mRNA

Messenger ribonucleic acid

TNBC

Triple-negative breast cancer

DOR

Duration of response

NCT

National clinical trial

TROP2

Trophoblast cell-surface antigen 2

EC

Endometrial cancer

NEN

Neuroendocrine neoplasm

UK

United Kingdom

ECOG

Eastern Cooperative Oncology Group

NIH

National Institutes of Health

U.S.

United States

EGFR

Epidermal growth factor receptor

NSCLC

Non-small cell lung cancer

VEGF-A

Vascular endothelial growth factor A

ELCC

European Lung Cancer Congress

ORR

Objective response rate

VHH

Heavy chain variable

EpCAM

Epithelial cell adhesion molecule

OS

Overall survival

WT

Wild type

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BioNTech SE published this content on May 05, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 05, 2025 at 13:22 UTC.