BioNTech (Nasdaq: BNTX) maps 2026 pipeline milestones and COVID shift

Rhea-AI Filing Summary

BioNTech SE is using a 2026 strategic update to highlight its shift toward becoming a multi-product oncology company while relying on its COVID-19 franchise and strong balance sheet. The company expects seven late-stage oncology data readouts in 2026 and plans to have 15 Phase 3 clinical trials ongoing by year-end, across immunomodulators, antibody-drug conjugates and mRNA cancer immunotherapies. By 2030+, BioNTech anticipates at least 17 late-stage or pivotal data readouts that could support multiple product launches in major tumors such as lung, breast, gynecologic and head and neck cancers.

Financially, BioNTech reported approximately €17.2 billion in cash, cash equivalents and security investments as of December 31, 2025 and in November 2025 raised its 2025 revenue guidance to €2.6–2.8 billion while lowering expense guidance ranges. For 2026, it anticipates a modest decline in Comirnaty revenues and does not expect to recognize revenues from oncology product sales, while revenues from its Bristol Myers Squibb collaboration are expected to be broadly in line with 2025.

Insights

Biopharma pipeline and strategy analyst

BioNTech details a cash-rich balance sheet and a crowded late-stage oncology pipeline, but oncology revenue is not expected in 2026.

BioNTech emphasizes a transition from a COVID-19 vaccine-focused profile toward a diversified oncology business. It highlights more than 25 ongoing Phase 2 or 3 oncology trials and plans to reach 15 Phase 3 trials by the end of 2026, with seven late-stage oncology data readouts expected in 2026. The strategic focus spans immunomodulators, antibody-drug conjugates and mRNA cancer immunotherapies, with assets such as pumitamig, T-Pam, Gotistobart, BNT113 and autogene cevumeran targeting major tumor types.

The company pairs this pipeline narrative with a strong financial base, reporting approximately €17.2 billion in cash, cash equivalents and security investments as of December 31, 2025. It previously increased 2025 revenue guidance to €2.6–2.8 billion and lowered expense guidance ranges, suggesting discipline around R&D and operating spend. For 2026, BioNTech anticipates a modest decline in Comirnaty revenues and does not expect oncology product revenue, while collaboration revenues from Bristol Myers Squibb are expected to remain broadly in line with 2025.

Looking further out, BioNTech expects at least 17 late-stage data readouts, including pivotal trials, by 2030+, which could underpin multiple launch opportunities if trial results and regulatory decisions are favorable. Concrete near-term checkpoints for investors include the seven late-stage readouts and new Phase 3 trial initiations expected in 2026, as well as the scheduled full year and fourth quarter 2025 financial results on March 10, 2026 and the annual general meeting on May 15, 2026.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a‑16 OR 15d‑16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

FOR THE MONTH OF JANUARY 2026

COMMISSION FILE NUMBER 001-39081

BioNTech SE
(Translation of registrant’s name into English)

An der Goldgrube 12

D-55131 Mainz

Germany

+49 6131-9084-0
(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20‑F or Form 40‑F: Form 20‑F ☒ Form 40‑F ☐

Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(7): ☐

DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K

On January 12, 2026, BioNTech SE announced that it will provide a strategic business update and outline the Company’s focus areas for 2026, including an overview of expected near- to longer-term milestones, on January 13, 2026 at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, California. The press release is attached hereto as Exhibit 99.1.

SIGNATURE

Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

BioNTech SE

By:

/s/ Ramon Zapata-Gomez

By:

/s/ Dr. Sierk Poetting

Name: Ramon Zapata-Gomez

Name: Dr. Sierk Poetting

Title: Chief Financial Officer

Title: Chief Operating Officer

Date: January 12, 2026

EXHIBIT INDEX

Exhibit			Description of Exhibit
99.1			BioNTech Provides Strategic Business Update and Outlines 2026 Areas of Focus at 44th Annual J.P. Morgan Healthcare Conference

Exhibit 99.1

BioNTech Provides Strategic Business Update and Outlines 2026 Areas of Focus at 44th Annual J.P. Morgan Healthcare Conference

•2026 poised to be a catalyst-rich year for BioNTech with continued late-stage pipeline progress with candidates across immunomodulators, antibody-drug conjugates and mRNA immunotherapies

•Expected 2026 oncology milestones include seven late-stage data readouts and to have 15 Phase 3 clinical trials ongoing by year end

•Additional late-stage trial readouts through 2030+ set to create multiple launch opportunities across tumor types, building BioNTech into a multi-product oncology company

•Financial strength with €17.2 billion in cash and cash equivalents plus security investments1, COVID-19 vaccine revenue stream, disciplined R&D spend, and strategic partnerships will continue to enable sustainable innovation

•Presentation and webcast at the 44th Annual J.P. Morgan Healthcare Conference from 2:15 – 2:55 pm PT / 11:15 – 11:55 pm CET on Tuesday, January 13, 2026

Mainz, Germany, January 12, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will provide a strategic business update and outline the Company’s focus areas for 2026, including an overview of expected near- to longer-term milestones, at the 44th Annual J.P. Morgan Healthcare Conference this week in San Francisco, California.

“We concluded 2025 with strong momentum, driven by our execution in research and development, partnerships, acquisitions, and our financial strength. We continued to advance our next wave of innovation, including the initiation of novel-novel combination trials. These achievements have successfully positioned us as a late-stage biopharmaceutical company,” said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. “We see 2026 as a year when science translates into tangible results. We will report on a series of milestones, including readouts from late-stage trials and earlier trials evaluating novel-novel combinations, as well as new Phase 3 clinical trial initiations. If positive, they will help unlock our path towards multiple near- and mid-term product launch opportunities with the aim to benefit patients across cancer types.”

Ugur Sahin will present at the 44th Annual J.P. Morgan Healthcare Conference from 2:15 – 2:55 pm PT / 11:15 – 11:55 pm CET on Tuesday, January 13, 2026. The live webcast of the presentation can be accessed via the “Events & Presentations” page in the Investor Relations section of the Company's website. The slide deck will be available there after the presentation. A replay of the webcast will be archived on the Company’s website for 30 days following the conference.

Oncology Areas of Focus for 2026

BioNTech will continue to execute its strategy in 2026 towards becoming a multi-product oncology company. Its diversified oncology pipeline comprises late-stage candidates spanning immunomodulators, antibody drug conjugates (“ADCs”), and mRNA cancer immunotherapies. BioNTech is developing several assets with pan-tumor potential, including novel-novel combination approaches, with the aim of addressing the full continuum from early- to late-stage disease across selected tumor types.

1. Late-Stage Acceleration

BioNTech is focused on advancing its late-stage oncology pipeline towards potential launches. Within the past two years, the Company has more than doubled the number of Phase 2 and 3 oncology trials across key modalities with now more than 25 Phase 2 or 3 trials ongoing. In 2026, BioNTech plans to initiate six additional Phase 3 clinical trials, bringing the total number of anticipated Phase 3 clinical trials to 15, and expects seven late-stage data readouts. The clinical trials and resulting data will inform regulatory and launch plans.

1 Preliminary, unaudited figure; consists of cash and cash equivalents plus security investments, as of December 31, 2025.

2. Combination Therapy Momentum

BioNTech has more than ten novel-novel combination clinical trials in its pipeline with multiple data updates expected in 2026. These trials explore pumitamig (BNT327/BMS986545), which is being partnered with Bristol Myers Squibb (“BMS”), in combination with other investigational immunomodulators, ADCs, and mRNA cancer immunotherapies and will inform the dose selection and explore anti-tumor activity in multiple tumors for later-stage development.

3. From Modalities to Disease Area

With the maturation of the oncology pipeline, BioNTech will focus on specific disease areas across major cancer types, including lung, breast, gynecologic, gastrointestinal, and genitourinary cancers.

Expected 2026 Milestones

Program

Modality

Trial Phase

Indication

Late-Stage Trial Readouts

Trastuzumab pamirtecan (“T-Pam”)4

ADC

Single-arm Phase 2

2L+ HER2-expressing endometrial cancer

Phase 3

Chemo naïve HR+ HER2-low breast cancer

Gotistobart2

Immunomodulator

Phase 3

2L+ sqNSCLC

Phase 2

2L+ mCRPC

BNT113

mRNA cancer immunotherapy

Phase 3

1L HPV16+ PD-L1+ HNSCC

Pumitamig1

Immunomodulator

Phase 3 in China

1L TNBC

Autogene cevumeran3

mRNA cancer immunotherapy

Phase 2

Adj. ctDNA+ stage II (high risk) / stage III CRC

Early-Stage Pumitamig & ADC Trial Readouts

Pumitamig1

Immunomodulator

Phase 2

1L NSCLC

Phase 2

1L ES-SCLC

Phase 2 in China

1L HCC

Phase 2 in China

1L MSS-CRC

Pumitamig1 + T-Pam (HER2-ADC)4

Immunomodulator + ADC

Phase 1/2

Breast cancer

Pumitamig1 + BNT324/DB-1311 (B7H3-ADC)4

Phase 1/2

Advanced solid tumors

Phase 2

NSCLC/SCLC

Pumitamig1 + BNT325/DB-1305 (TROP2-ADC)4

Phase 2

TNBC

Pumitamig1 + BNT326/YL202 (HER3-ADC)5

Phase 1/2

2L+ EGFRm NSCLC

BNT324/DB-1311 (B7H3-ADC)4

ADC

Phase 1/2

2L+ mCRPC

Phase 3 Trial Initiations

Pumitamig1

Immunomodulator

Phase 3

1L MSS-CRC

Phase 3

1L HER2- PD-L1+ gastric cancer

Phase 3

1L HNSCC

BNT324 /DB-1311 (B7H3-ADC)4

ADC

Phase 3

1L mCRPC

BLA Submission

T-Pam (HER2-ADC)4

ADC

-

2L+ HER2-expressing endometrial cancer

Partnered with: 1. BMS; 2. OncoC4, Inc. (“OncoC4”); 3. Genentech, a member of the Roche Group; 4. Duality Biologics (Suzhou) Co. Ltd. ("DualityBio"); 5. MediLink Therapeutics (Suzhou) Co., Ltd. (“MediLink").

Abbreviations: 1L = first line; 2L = second line; adj. = adjuvant; HER2 = human epidermal growth factor receptor 2; HR = hormone receptor; (sq) NSCLC = (squamous) non-small cell lung cancer; mCRPC = metastatic castration resistant prostate cancer; HPV16 = human papilloma virus 16; PD-L1 = programmed cell death protein ligand 1; HNSCC = head and neck squamous cell carcinoma; TNBC = triple-negative breast cancer; ctDNA = circulating tumor DNA; (MSS-)CRC = (microsatellite stable-) colorectal cancer; ES-SCLC = extensive-stage small cell lung cancer; HCC = hepatocellular carcinoma; EGFRm = mutated epidermal growth factor receptor

Overview of oncology data readouts expected by 2030+

BioNTech expects at least 17 late-stage data readouts, including from pivotal trials, by 2030+. The respective trials are set to inform multiple launch opportunities for BioNTech to become a multi-product oncology company by 2030. Potential further data readouts will be added with the evolution and maturation of the clinical pipeline.

Tumor Type

Incidence1

Assets

Late-Stage / Pivotal Trials

Expected Data Readouts2

Lung

1L NSCLC

400k

Pumitamig3

ROSETTA Lung-02

2029

Gotistobart4

PRESERVE-003

2026

1L ES-SCLC

80k

Pumitamig3

ROSETTA Lung-01

2028

Breast

1L TNBC - all comers

25k

Pumitamig3

Phase 3 in China

2026

1L TNBC - CPS < 10

15k

Pumitamig3

ROSETTA Breast-01

2029

2L+ HR+ BC – HER2-low

50k

T-Pam5

DYNASTY Breast-02

2026

Genitourinary

1L RCC

25k

Pumitamig3

ROSETTA RCC-2087

2030+

1L CRPC

100k

BNT324/DB-13115

BNT324-03

2029

Adj. MIUC

50k

Autogene cevumeran6

IMCODE004

2029

Gastrointestinal

1L MSS-CRC

220k

Pumitamig3

ROSETTA CRC-203

2030+

1L Gastric – HER2-neg, PD-L1+

35k

Pumitamig3

ROSETTA Gastric-204

2030+

1L HCC

25k

Pumitamig3

ROSETTA HCC-2067

2030+

Adj. CRC – ctDNA+

70k

Autogene cevumeran6

BNT122-01

2026

Adj. PDAC

40k

Autogene cevumeran6

IMCODE003

2029

Gynecologic

2L+ Endometrial – HER2-expressing

30k

T-Pam5

Single-arm Phase 2

2026

T-Pam5

Fern-EC-01

2028

Additional Tumors

1L HNSCC

150k

Pumitamig3

ROSETTA HNSCC-205

2030+

1L HNSCC – PDL1 CPS ≥ 1, HPV16+

50k

BNT113

AHEAD-MERIT

2026

1. Estimated 1L or adjuvant incidence (incidence + newly recurrent patients) in 2030 in the G7 markets derived from Oracle CancerMPact as of Dec 2025; incidence information is for informational purposes only and is not intended to indicate the potential market size or reach of BioNTech’s and its collaborators’ product candidates, if approved; 2. Expected data readouts may be from interim or final analyses, and in some cases may not translate into commercial launches; partnered with 3. BMS; 4. OncoC4; 5. DualityBio; 6. Genentech, a member of the Roche group; 7. These are Phase 1/2 trials. The anticipated pivotal trials evaluating pumitamig in these tumor types are expected to readout after 2030.

Abbreviations: CPS = combined positive score; BC = breast cancer; MIUC = muscle-invasive urothelial carcinoma; PDAC = pancreatic ductal adenocarcinoma.

Financial Position and Outlook

BioNTech maintained a strong financial position throughout 2025, driven by its revenue-generating COVID-19 vaccine business and strategic partnership with BMS. BioNTech held approximately €17.2 billion in cash, cash equivalents and security investments2 as of December 31, 2025. In November 2025, the Company increased its 2025 revenue guidance to a range of €2.6-2.8 billion, and lowered expense guidance ranges for R&D, SG&A and capital expenditures.

In 2026, BioNTech anticipates a modest decline in Comirnaty revenues compared to 2025, reflecting COVID-19 vaccine market dynamics, which are influenced by various factors, including but not limited to changing vaccine recommendations, specifically in the United States, and the continued transition from multi-year contracts to private markets in different geographies. BioNTech does not currently anticipate the recognition of revenues from the sale of any oncology products in 2026. Per the outlined partnership terms, revenues to BioNTech from the collaboration with BMS in 2026 are expected to be broadly in line with 2025.

Upcoming Investor and Analyst Events

•Full Year and Fourth Quarter 2025 Financial Results: March 10, 2026

•Annual General Meeting: May 15, 2026

About BioNTech

Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes immunomodulators, targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies, and mRNA cancer immunotherapies. Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Bristol Myers Squibb, Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, Pfizer and Regeneron.

For more information, please visit www.BioNTech.com.

2 Preliminary, unaudited figure; consists of cash, cash equivalents and security investments, as of December 31, 2025.

Forward-Looking Statements

This press release 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 collaborations, including its collaboration with Bristol Myers Squibb (BMS); BioNTech and its collaborators’ ability to successfully co-develop and co-commercialize their candidates, if approved; the rate and degree of market acceptance of BioNTech and its collaborators’ product candidates, if approved; the initiation, timing, progress, and results of BioNTech’s research and development programs, including BioNTech’s current and future clinical trials, including statements regarding the expected timing of initiation, enrollment, and completion of trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations, including expectations regarding the potential indications in which product candidates may be approved, if at all; the targeted timing and number of additional potentially registrational trials, and the registrational potential of any trial BioNTech may initiate; and discussions with regulatory agencies. 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 press release 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, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data, 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 clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the impact of tariffs and escalations in trade policy; competition related to BioNTech’s product candidates; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; 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; 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 its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments in the United States and other countries and regions; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; 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 September 30, 2025 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at 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 press release in the event of new information, future developments or otherwise.

CONTACTS

Investor Relations
Douglas Maffei, PhD
Investors@biontech.de

Media Relations
Jasmina Alatovic
Media@biontech.de

FAQ

What strategic focus does BioNTech (BNTX) outline for 2026?

BioNTech plans to advance its late-stage oncology pipeline toward becoming a multi-product oncology company, emphasizing immunomodulators, antibody-drug conjugates and mRNA cancer immunotherapies, and targeting major tumor types such as lung, breast, gynecologic, gastrointestinal and genitourinary cancers.

How many oncology trials and data readouts does BioNTech expect in 2026?

BioNTech expects seven late-stage oncology data readouts in 2026 and plans to have 15 Phase 3 clinical trials ongoing by year-end, supported by a broader set of more than 25 Phase 2 and 3 oncology trials across its pipeline.

What is BioNTech’s long-term oncology data outlook through 2030+?

By 2030+, BioNTech expects at least 17 late-stage data readouts, including from pivotal trials, across multiple tumor types, which are intended to create several launch opportunities as it aims to become a multi-product oncology company.

What is BioNTech’s cash position at year-end 2025?

As of December 31, 2025, BioNTech held approximately €17.2 billion in cash, cash equivalents and security investments, a preliminary, unaudited figure that underpins its ability to fund ongoing research, development and clinical programs.

What revenue guidance did BioNTech provide for 2025 and how does it view 2026?

In November 2025, BioNTech increased its 2025 revenue guidance to a range of €2.6–2.8 billion and lowered guidance ranges for R&D, SG&A and capital expenditures. For 2026, it anticipates a modest decline in Comirnaty revenues and does not currently expect to recognize revenues from the sale of oncology products.

What does BioNTech say about revenues from its Bristol Myers Squibb collaboration in 2026?

BioNTech states that, under the outlined partnership terms, revenues to BioNTech from its collaboration with Bristol Myers Squibb in 2026 are expected to be broadly in line with 2025.

When will BioNTech report full year and Q4 2025 results and hold its 2026 AGM?

BioNTech plans to report full year and fourth quarter 2025 financial results on March 10, 2026, and to hold its annual general meeting on May 15, 2026.