BioNTech swings to €185M profit in Q3 2026
The revised revenue range comes alongside €16,163.8 million in cash, cash equivalents and security investments.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Form Type
6-K
Rhea-AI Filing Summary
BioNTech SE (BNTX) reported third-quarter 2026 revenue of €1,289.2 million and IFRS net profit of €184.5 million, versus €1,518.9 million revenue and a €28.7 million net loss a year earlier. Lower expected COVID-19 vaccine demand primarily drove the revenue decline. Year-to-date net loss was €1,168.2 million.
BioNTech raised full-year revenue guidance to €1.7–€1.9 billion from €1.6–€1.9 billion; adjusted R&D and SG&A expense guidance was unchanged. As of September 30, 2026, cash, cash equivalents and security investments totaled €16,163.8 million. Through that date, it repurchased 5,037,452 ADSs under a program permitting purchases of up to $1.0 billion through May 6, 2027.
Non-pivotal stage 1 data showed median overall survival of 18.5 months with gotistobart versus 10.0 months with docetaxel. BNT113 plus pembrolizumab did not demonstrate a statistically significant improvement in progression-free survival; its Phase 2/3 trial continues to assess overall survival. A global Phase 3 trial of pumitamig with sacituzumab govitecan is planned, pending regulatory approval. Under an exercised Roche/Genentech option, future program R&D costs will generally be assigned to Roche/Genentech effective January 1, 2027; BioNTech will be eligible for royalties in case of successful development and commercialization.
2 points · 0 major0 major · 4 points
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointThird-quarter IFRS net profit was €184.5 million, versus a €28.7 million loss.
- Minor pointNon-pivotal stage 1 data: gotistobart median OS was 18.5 months versus 10.0 months.
Negative
- Moderate pointThird-quarter revenue fell to €1,289.2 million from €1,518.9 million.
- Moderate pointYear-to-date net loss widened to €1,168.2 million from €831.1 million.
- Moderate pointOperating cash flow was €540.3 million used, versus €146.5 million provided.
- Moderate pointBNT113 plus pembrolizumab did not demonstrate statistically significant PFS improvement.
Filing Explained
BioNTech says trastuzumab pamirtecan’s breast-cancer benefit may be limited; its colorectal study is being terminated early, while a separate pancreatic study continues.
This Form 6-K furnishes quarterly results and a corporate update; its additional oncology disclosures place one colorectal trial in early termination and leave the next step for a breast-cancer program undecided.
In DYNASTY-Breast02, the Phase 3 trial met its primary progression-free-survival endpoint with a statistically significant but modest improvement, while overall-survival data were not mature at interim analysis. BioNTech says the available efficacy and safety data suggest the potential patient benefit may be limited in the treatment landscape. The trial also showed a higher rate of interstitial lung disease than prior trials, with Grade 3 to 5 events reported.
BioNTech and DualityBio are discussing the total clinical data and plans for a biologics license application, and say they will update the market. Separately, early termination was initiated for the randomized Phase 2 autogene cevumeran trial in adjuvant colorectal cancer; the Phase 2 pancreatic-cancer trial is unaffected, completed enrollment in
Key Figures
Third-quarter revenue: €1,289.2 million
Third-quarter IFRS net profit: €184.5 million
Year-to-date net loss: €1,168.2 million
+5 more
8 metrics
Third-quarter revenue
€1,289.2 million
Third quarter 2026; €1,518.9 million in third quarter 2025.
Third-quarter IFRS net profit
€184.5 million
Third quarter 2026; compared with a €28.7 million net loss in third quarter 2025.
Year-to-date net loss
€1,168.2 million
Nine months ended September 30, 2026; €831.1 million loss in the comparable 2025 period.
Operating cash flow
€540.3 million used
Nine months ended September 30, 2026; €146.5 million provided in the comparable 2025 period.
Cash, cash equivalents and security investments
€16,163.8 million
As of September 30, 2026.
Full-year revenue guidance
€1.7–€1.9 billion
FY 2026 guidance announced November 3, 2026; prior range was €1.6–€1.9 billion.
ADSs repurchased
5,037,452 ADSs
Repurchased through September 30, 2026; average price $91.98 (€80.10), total consideration $463.3 million (€403.5 million).
Median overall survival with gotistobart
18.5 months
Non-pivotal stage 1 data; docetaxel comparator was 10.0 months; gotistobart n=45 and docetaxel n=42.
Key Terms
Adjusted Results, antibody-drug conjugate, progression-free survival, overall survival, +1 more
5 terms
Adjusted Results financial
"referred to with the prefix “Adjusted” or, as a whole, “Adjusted Results”"
antibody-drug conjugate medical
"TROP2-directed antibody-drug conjugate sacituzumab govitecan"
An antibody-drug conjugate is a targeted medicine that combines an antibody, which can identify specific cells, with a powerful drug designed to destroy those cells. This approach allows for precise treatment, minimizing damage to healthy tissue. For investors, developments in this area can signal advances in cancer therapies and potential growth opportunities in the biotech sector.
progression-free survival medical
"statistically significant improvement in progression-free survival"
Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.
overall survival medical
"median overall survival (“OS”) versus chemotherapy"
Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.
interim analysis medical
"first interim analysis from stage 2 of the Phase 3 clinical trial"
An interim analysis is an early review of a project or process before it is fully completed. For investors, it provides a snapshot of progress or performance, helping to identify whether things are on track, need adjustment, or should be stopped early. Think of it as a progress report that can influence decisions before the final outcome is known.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were BNTX's third-quarter 2026 revenue and net profit?
BioNTech reported third-quarter revenue of €1,289.2 million and IFRS net profit of €184.5 million. In third quarter 2025, revenue was €1,518.9 million and the company recorded a €28.7 million net loss.
How much cash and security investments did BNTX report?
BioNTech reported €16,163.8 million in cash, cash equivalents and security investments as of September 30, 2026. The total comprised €10,200.8 million in cash and cash equivalents, €4,390.2 million in current security investments and €1,572.8 million in non-current security investments.
How many ADSs has BNTX repurchased, and at what average price?
Through September 30, 2026, BioNTech had repurchased 5,037,452 ADSs at an average price of $91.98 (€80.10), for total consideration of $463.3 million (€403.5 million). The program permits purchases of up to $1.0 billion through and including May 6, 2027.
Did BNTX's BNT113 trial meet its progression-free survival endpoint?
BNT113 in combination with pembrolizumab did not demonstrate a statistically significant improvement in progression-free survival versus pembrolizumab alone in the AHEAD-MERIT trial. The Independent Data Monitoring Committee recommended that the trial continue as planned to evaluate overall survival; BioNTech remains blinded to ongoing trial data.
AI-generated analysis. How Rhea-AI works. Not financial advice.
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 NOVEMBER 2026
COMMISSION FILE NUMBER 001-39081
BioNTech SE
(Translation of registrant’s name into English)
(Translation of registrant’s name into English)
An der Goldgrube 12
D-55131 Mainz
Germany
+49 6131-9084-0
(Address of principal executive offices)
(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 November 3, 2026, BioNTech SE (the “Company”) issued a press release announcing its third quarter 2026 financial results and corporate update and details of a conference call to be held at 8:00 am EST on November 3, 2026 to discuss the results. The press release and the conference call presentation are attached as Exhibits 99.1 and 99.2, respectively, and incorporated by reference herein.
The information contained in Exhibits 99.1 and 99.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, unless expressly set forth by specific reference in such a filing.
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/ Ramón Zapata-Gomez | By: | /s/ Dr. Sierk Poetting | |||||||||||
Name: Ramón Zapata-Gomez | Name: Dr. Sierk Poetting | |||||||||||||
Title: Chief Financial Officer | Title: Chief Operating Officer | |||||||||||||
Date: November 3, 2026
EXHIBIT INDEX
Exhibit | Description of Exhibit | ||||
99.1 | BioNTech Announces Third Quarter 2026 Financial Results and Corporate Update | ||||
99.2 | Third Quarter 2026: Corporate Update and Financial Results | ||||
Exhibit 99.1
BioNTech Announces Third Quarter 2026 Financial Results
and Corporate Update
and Corporate Update
•Delivered the first global data for any PD-(L)1xVEGF bispecific immunomodulator candidate in combination with an investigational antibody-drug conjugate in lung cancer, with pumitamig plus elfetabart drozuntecan
•Advanced the first global Phase 3 clinical trial to evaluate pumitamig in combination with Gilead’s TROP2-directed antibody-drug conjugate sacituzumab govitecan in triple-negative breast cancer, pending regulatory approval
•Presented data demonstrating gotistobart nearly doubled median overall survival versus chemotherapy in previously treated squamous non-small cell lung cancer
•Launched variant-adapted COVID-19 vaccine for the 2026/2027 vaccination season in multiple regions worldwide
•Third quarter 2026 revenues of €1,289.2 million1, adjusted2 R&D expenses of €578.5 million (IFRS R&D expenses of €748.1 million), and adjusted SG&A3 expenses of €178.5 million
•Raised full-year 2026 revenue guidance midpoint and updated range to €1.7–1.9 billion, and maintained strong financial position with cash, cash equivalents and security investments of €16.2 billion4
Conference call and webcast scheduled for November 3, 2026, at 8:00 a.m. EST (2:00 p.m. CET)
MAINZ, Germany, November 3, 2026 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today reported financial results for the three and nine months ended September 30, 2026 and provided an update on its corporate progress.
“As 2026 draws to a close, the achievement of numerous important milestones throughout the year demonstrates our commitment to advancing our oncology pipeline, and our combination therapy strategy continues to gain momentum, underscored by the announced first global Phase 3 trial of pumitamig in combination with an antibody-drug conjugate,” said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. “With a growing pipeline, key registrational trials, strategic partnerships, and financial strength, BioNTech is well positioned for its next phase of growth as we advance toward becoming a diversified, multi-product company by 2030.”
Financial Review for Third Quarter and Year-to-Date 2026
in millions €, except per share data | Third Quarter 2026 | Third Quarter 2025 | ||||||||||||
IFRS Results | Adjusted Results2 | IFRS Results | Adjusted Results2 | |||||||||||
Revenues | 1,289.2 | 1,289.2 | 1,518.9 | 1,518.9 | ||||||||||
Net profit / (loss) | 184.5 | 440.9 | (28.7) | 752.5 | ||||||||||
Diluted profit / (loss) per share | 0.73 | 1.76 | (0.12) | 3.11 | ||||||||||
Weighted average number of shares outstanding (in millions)5 | 251 | 251 | 241 | 242 | ||||||||||
1
in millions €, except per share data | Year-to-date 2026 | Year-to-date 2025 | ||||||||||||
IFRS Results | Adjusted Results2 | IFRS Results | Adjusted Results2 | |||||||||||
Revenues | 1,512.9 | 1,512.9 | 1,962.5 | 1,962.5 | ||||||||||
Net loss | (1,168.2) | (615.9) | (831.1) | (27.1) | ||||||||||
Diluted loss per share | (4.63) | (2.44) | (3.45) | (0.11) | ||||||||||
Weighted average number of shares outstanding (in millions)5 | 252 | 252 | 241 | 241 | ||||||||||
The figures below compare the third quarter of 2026 and the year-to-date period ended September 30, 2026, to the corresponding prior year periods, except where noted.
Revenues were €1,289.2 million for the third quarter of 2026, compared to €1,518.9 million. Year-to-date revenues were €1,512.9 million, compared to €1,962.5 million. The decreases were primarily driven by expected lower market demand for BioNTech’s COVID-19 vaccines.
Research and development (“R&D”) expenses were €748.1 million for the third quarter of 2026, compared to €564.8 million. Year-to-date R&D expenses were €1,856.1 million, compared to €1,599.5 million. R&D expenses were mainly driven by higher expenses for the development of BioNTech’s late-stage immuno-oncology (“IO”) and antibody-drug conjugate (“ADC”) programs and impairment expenses related to intangible assets which are outside of BioNTech’s strategic focus.
Adjusted R&D expenses were €578.5 million for the third quarter of 2026, compared to €479.4 million. Year-to-date adjusted R&D expenses were €1,582.7 million, compared to €1,514.1 million. Adjusted R&D expenses for both the third quarter and year-to-date period in 2026 exclude impairment expenses related to intangible assets which are outside of BioNTech’s strategic focus.
Sales, general and administrative (“SG&A”) expenses were €178.5 million for the third quarter of 2026, compared to €148.5 million. Year-to-date SG&A expenses were €527.1 million, compared to €406.5 million. The increases were mainly driven by the ongoing pre‑launch activities and commercial build-up, expenses associated with BioNTech’s global initiative on scaling processes and ERP infrastructure to strengthen operational execution and the inclusion of operations from CureVac. This was partly offset by cost reductions resulting from the execution of initiatives related to BioNTech’s pipeline prioritization.
Other operating result was negative €134.3 million for the third quarter of 2026, compared to negative €704.2 million. Year-to-date other operating result was negative €358.6 million, compared to negative €730.1 million. The quarterly and year-to-date results were primarily driven by impairment losses and employee related restructuring costs derived from BioNTech’s pipeline prioritization execution.
Adjusted other operating result was negative €58.9 million for the third quarter of 2026, compared to negative €8.4 million. Year-to-date adjusted other operating result was negative €91.1 million, compared to negative €11.5 million. Adjusted other operating result for the third quarter of 2026 excludes impairment losses and employee-related costs related to BioNTech’s pipeline prioritization execution as well as settlement expenses, while the comparable prior year result excludes employee-related costs and settlement expenses. Year-to-date periods in 2026 and 2025 exclude impairment losses, employee-related costs and settlement expenses, while 2025 also excludes a bargain purchase.
Net profit was €184.5 million for the third quarter of 2026, compared to a net loss of €28.7 million. Year-to-date net loss was €1,168.2 million, compared to a net loss of €831.1 million.
2
Adjusted net profit was €440.9 million for the third quarter of 2026, compared to an adjusted net profit of €752.5 million. Year-to-date adjusted net loss was €615.9 million, compared to an adjusted net loss of €27.1 million.
Diluted profit per share was €0.73 for the third quarter of 2026, compared to a diluted loss per share of €0.12. Year-to-date diluted loss per share was €4.63, compared to a diluted loss per share of €3.45.
Adjusted diluted profit per share was €1.76 for the third quarter of 2026, compared to adjusted diluted profit per share of €3.11. Year-to-date adjusted diluted loss per share was €2.44, compared to an adjusted diluted loss per share of €0.11.
Cash, cash equivalents and security investments as of September 30, 2026 were €16,163.8 million, comprising €10,200.8 million in cash and cash equivalents, €4,390.2 million in current security investments disclosed as financial assets and €1,572.8 million in non-current security investments disclosed as financial assets.
Shares outstanding as of September 30, 2026 were 247,928,180, excluding 11,099,307 shares held in treasury.
In May 2026, BioNTech entered into a share repurchase program, pursuant to which the Company may purchase American Depositary Shares (“ADSs”), each representing one ordinary share of the Company, in the amount of up to $1.0 billion until and including May 6, 2027. Since the inception of the program through September 30, 2026, 5,037,452 ADSs were repurchased at an average price of $91.98 (€80.10), for total consideration of $463.3 million (€403.5 million).
“Our performance in the third quarter allowed us to narrow our full-year 2026 revenue guidance to the upper end of the previous guidance range,” said Ramón Zapata, Chief Financial Officer at BioNTech. “Fueled by our financial strength, we continue to focus our investments on our prioritized late-stage oncology programs. While we further enhance our operational efficiency and cost discipline, we return capital to shareholders through our share repurchase program. Together, these steps are aimed at creating sustainable long-term value.”
Updated 2026 Financial Year Guidance6:
FY 2026 non-IFRS Guidance | ||||||||
Current Nov. 3, 2026 | Prior Aug. 4, 2026 | |||||||
Revenues | €1,700 – €1,900 million | €1,600 – €1,900 million | ||||||
Adjusted R&D expenses | Unchanged | €2,000 – €2,300 million | ||||||
Adjusted SG&A expenses3 | Unchanged | €700 – €800 million | ||||||
BioNTech is raising the midpoint of its previously provided full-year 2026 revenue guidance. The updated guidance follows the Company’s revenue performance in the third quarter. The guidance for adjusted R&D expenses as well as adjusted SG&A expenses remains unchanged.
BioNTech exercised an option in the existing collaboration agreement with Roche/Genentech where, under the terms of the agreement, future R&D costs related to the program will be generally assigned to Roche/Genentech effective January 1, 2027, while BioNTech will be eligible to receive royalties in case of successful development and commercialization.
3
The updated terms pursuant to the exercised option under the existing agreement align with BioNTech’s broader capital allocation framework and will not affect the ongoing pancreatic ductal adenocarcinoma (“PDAC”) trial, which will continue as planned.
While this decision follows the regular assessment of the financial structure of existing collaborations, BioNTech’s broader commitment to mRNA and its potential in oncology remains unchanged. Its conviction in mRNA is anchored by over a decade of translational and clinical research, as well as deep experience in the field. BioNTech continues to advance mRNA cancer immunotherapies and invest in them as a key pillar of its oncology strategy, including novel combination approaches intended to maximize the potential of its diversified oncology pipeline.
The full interim unaudited condensed consolidated financial statements can be found in BioNTech’s Report on Form 6-K for the period ended September 30, 2026, filed today with the United States Securities and Exchange Commission (“SEC”) and available at www.sec.gov.
Endnotes
1 All numbers in this press release have been rounded.
2 In addition to BioNTech’s results determined in accordance with International Financial Reporting Standards (“IFRS”), or IFRS Accounting Standards, or IFRS results, BioNTech reports certain adjusted, non-IFRS measures used internally as a supplemental measure of the Company’s business performance (each referred to with the prefix “Adjusted” or, as a whole, “Adjusted Results”). The calculation of these measures and the adjusted results as a whole is based on the concepts of the applicable IFRS Accounting Standards, but includes certain adjustments. Reconciliation of the adjusted results to BioNTech’s measures based on IFRS Accounting Standards and more information can be found at the end of this press release and in BioNTech’s Report on Form 6-K for the period ended September 30, 2026, filed on November 3, 2026, which is available at www.sec.gov. The weighted average number of shares outstanding is excluded from that reconciliation. While non-IFRS measures may offer additional insights, BioNTech’s non-IFRS measures are not, and should not be viewed as, a substitute for their most directly comparable IFRS Accounting Standards measures, and should always be considered alongside the Company’s financial statements prepared in accordance with IFRS Accounting Standards. Unless otherwise indicated, Adjusted Results are identical to IFRS Results.
3 Sales, general and administrative expenses (“SG&A”) include sales and marketing expenses as well as general and administrative expenses. Adjusted SG&A expenses include adjusted sales and marketing expenses as well as adjusted general and administrative expenses.
4 As of September 30, 2026.
5 Only basic EPS are calculated in loss making periods. Diluted EPS include outstanding instruments from BioNTech’s share-based payment programs. The weighted average number of shares outstanding is determined as described in BioNTech’s Annual Report on Form 20-F as of and for the year ended December 31, 2025, as amended and is not adjusted by non-IFRS measures.
6 Excludes risks that are not yet known and/or quantifiable and related activities. Includes effects identified from licensing arrangements, collaborations and Merger & Acquisitions (“M&A”) transactions to the extent disclosed. The guidance is based on non-IFRS measures and excludes certain effects compared to measures based on IFRS Accounting Standards. More information can be found in BioNTech’s Report on Form 6-K for the period ended September 30, 2026, filed on November 3, 2026, which is available at www.sec.gov.
7 An overview of abbreviations of target structures and indications is compiled in a directory at the end of this press release.
Variant-adapted COVID-19 Vaccine
In the third quarter of 2026, BioNTech and Pfizer executed the commercial launch of their variant-adapted COVID-19 vaccine for the 2026/2027 vaccination season.
4
•In July 2026, BioNTech and Pfizer’s monovalent XFG-adapted COVID-19 vaccine was approved by the European Commission following recommendation for marketing authorization by the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”). The companies began shipments of the vaccine after approval to ensure rapid access of the season’s vaccine.
•In August 2026, the United States Food and Drug Administration (“FDA”) approved the supplemental Biologics License Application (“sBLA”) for BioNTech and Pfizer’s monovalent XFG-adapted COVID-19 vaccine for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. The new variant-adapted COVID-19 vaccine was shipped immediately following approval and was made available in pharmacies, hospitals, and clinics across the United States.
Select Oncology Pipeline Updates
Next-Generation Immunomodulators and Combinations
Pumitamig (BNT327/BMS986545) is an investigational bispecific immunomodulator combining PD-L17 checkpoint inhibition with VEGF-A neutralization that is being developed in collaboration with Bristol Myers Squibb Company (“BMS”).
•Pumitamig is currently being evaluated in seven pivotal trials across the ROSETTA clinical development program, with five new global clinical trials initiated in 2026 spanning triple-negative breast cancer (“TNBC”), colorectal cancer (“CRC”), gastric cancer, and non-small cell lung cancer (“NSCLC”), including two clinical trials in patients with unresectable stage III NSCLC, advanced disease and high PD-L1 expression (TPS ≥50%), respectively.
•A global Phase 2 clinical trial (ROSETTA Lung-107; NCT06841055) is being conducted to evaluate pumitamig in combination with docetaxel as a second-line treatment for patients with NSCLC. In October 2026, data from this trial were presented at the European Society for Medical Oncology (“ESMO”) Congress 2026. Pumitamig in combination with docetaxel showed encouraging antitumor activity with a manageable safety profile in patients with metastatic NSCLC post-chemoimmunotherapy. These data extend evidence for pumitamig’s NSCLC development program into the second-line setting where there remains high unmet medical need, representing the third global Phase 2 dataset in lung cancer.
•Global Phase 2 clinical trials (NCT06449209 and NCT06449222) are being conducted to evaluate pumitamig in combination with chemotherapy in patients with untreated extensive-stage small cell lung cancer (“ES-SCLC”) and in patients with small cell lung cancer (“SCLC”) that progressed after first- or second-line treatment and as a first- and second-line treatment for patients with locally advanced or metastatic TNBC, respectively. In October 2026, data from a subgroup analysis in patients with brain metastases from these trials were presented at the ESMO Congress 2026. Patients with TNBC or SCLC and brain metastases at baseline benefited clinically from pumitamig plus chemotherapy both systemically and intracranially, supporting pumitamig’s potential across difficult-to-treat tumor types and patient populations.
•BioNTech entered into a clinical trial collaboration and supply agreement with Gilead Sciences Inc. (“Gilead”) to evaluate pumitamig in combination with the TROP2-directed ADC sacituzumab govitecan as first-line treatment for patients with PD-L1 low or negative locally advanced or metastatic TNBC in the ROSETTA Breast-01 trial. Pending regulatory approval, this will be the first global Phase 3 clinical trial (NCT07173751) of pumitamig in combination with an ADC, reflecting the evolving standard of care in 1L TNBC.
5
•Pumitamig is also being evaluated in additional solid tumor indications, including first-line hepatocellular carcinoma (“HCC”), second-line glioblastoma (“GBM”), first-line PDAC and first-line renal cell carcinoma (“RCC”) in various Phase 1/2 and Phase 2 trials, both as monotherapy and in combination with standard of care.
BioNTech has several signal-seeking clinical trials ongoing evaluating pumitamig with the Company’s proprietary assets:
•A Phase 2 clinical trial (NCT06953089) is being conducted to evaluate elfetabart drozuntecan (BNT324/DB-1311) in combination with pumitamig. In October 2026, data from this trial were presented at the ESMO Congress 2026. Elfetabart drozuntecan in combination with pumitamig was well tolerated and encouraging antitumor activity was observed in patients across multiple tumor types. These data support the potential of pumitamig as a backbone in novel treatment combinations, furthering BioNTech’s combination strategy across multiple tumor types with high unmet medical need. They also help build the body of evidence for pumitamig in combination with ADCs that will inform potential registrational trials.
•A Phase 1/2 clinical trial (NCT06892548) is being conducted to evaluate elfetabart drozuntecan (BNT324/DB-1311) in combination with pumitamig in patients with advanced lung cancers. In September 2026, data from this trial were presented at the IASLC 2026 World Conference on Lung Cancer (“WCLC”). Elfetabart drozuntecan in combination with pumitamig showed encouraging early efficacy and a manageable safety profile in SCLC, across lines of therapy and dose levels. These were the first data in lung cancer for any investigational PD-(L)1xVEGF bispecific immunomodulator combined with an ADC candidate, underscoring BioNTech’s leadership in developing novel-novel combination treatment strategies.
Gotistobart (BNT316/ONC-392) is a tumor microenvironment-selective regulatory T cell depletion candidate that targets CTLA-4 and is being developed in collaboration with OncoC4, Inc. (“OncoC4”).
•A global Phase 3 clinical trial (PRESERVE-003; NCT05671510) is ongoing to evaluate the efficacy and safety of gotistobart as monotherapy in patients with metastatic squamous NSCLC that progressed on previous platinum-based chemotherapy and PD-(L)1-inhibitor treatment.
•In September 2026, updated data from the stage 1 of this trial were presented at WCLC. Data demonstrated that gotistobart nearly doubled median overall survival (“OS”) versus chemotherapy in patients with squamous NSCLC who had progressed on PD-(L)1 inhibitors.
•Gotistobart continues to show potential as a chemotherapy-free monotherapy in a hard-to-treat lung cancer setting.
•Based on current event accrual projections, the first interim analysis from stage 2 of the Phase 3 clinical trial is expected in 2026. This will be assessed by the Independent Data Monitoring Committee (“IDMC”) to recommend whether to unblind the trial or continue to the next pre-planned interim analysis.
Antibody-Drug Conjugates
Trastuzumab pamirtecan (BNT323/DB-1303) is an ADC candidate targeting HER2 that is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”).
•Trastuzumab pamirtecan is being evaluated in two Phase 3 clinical trials in HR-positive, HER2-low metastatic breast cancer (NCT06018337) and HER2-expressing endometrial cancer (“EC”) (NCT06340568).
6
•The global Phase 3 clinical trial DYNASTY-Breast02 (NCT06018337) to evaluate trastuzumab pamirtecan in patients with HR-positive, HER2-low metastatic breast cancer met its primary endpoint demonstrating a statistically significant, yet modest improvement in progression-free survival (“PFS”) compared to investigator’s choice of chemotherapy. At this interim analysis for the secondary endpoint of OS, data were not mature. A higher rate of interstitial lung disease (“ILD”) was reported in this trial compared to prior trials with trastuzumab pamirtecan, with most cases being Grade 1 and 2. Severe and fatal events were reported in a small proportion of patients (Grade 3 to 5). Otherwise, the overall safety profile was consistent with prior clinical trials and no new safety signals were observed.
•The available efficacy and safety data, as of this data cut-off date, suggest that the potential benefit to patients would be limited in the context of the HR+/HER2-low metastatic breast cancer treatment landscape.
•BioNTech and DualityBio are currently discussing the totality of clinical data for trastuzumab pamirtecan across endometrial and breast cancer, within the context of the evolving treatment landscape, and areas of unmet medical need, and will determine the next steps.
•As part of this, BioNTech and DualityBio are discussing plans for a BLA submission and will update the markets accordingly.
mRNA Cancer Immunotherapies
Autogene cevumeran (BNT122/RO7198457) is an mRNA cancer immunotherapy candidate for individualized neoantigen-specific immunotherapy (“iNeST”) that is being developed in collaboration with Genentech, Inc. (“Genentech”), a member of the Roche Group (“Roche”).
•Early termination was initiated in a randomized Phase 2 clinical trial (NCT04486378) to evaluate autogene cevumeran as an adjuvant treatment of circulating tumor DNA, or ctDNA, positive, surgically resected Stage II (high risk)/Stage III CRC compared to watchful waiting after surgery and chemotherapy, which is the current standard of care for these high-risk patients.
•The Phase 2 clinical trial IMcode003 (NCT05968326) evaluating autogene cevumeran in combination with checkpoint inhibition and chemotherapy in adjuvant PDAC is not affected and continues as planned. In August 2026, the trial completed enrollment.
BNT113 is an mRNA cancer immunotherapy candidate and based on BioNTech’s fully owned, off-the-shelf FixVac platform, encoding the two oncoproteins E6 and E7 that are frequently found in human papillomavirus type 16 positive (“HPV16+”) solid tumors.
•In October 2026, the first topline results from the AHEAD-MERIT Phase 2/3 clinical trial (NCT04534205) were announced. The Phase 3 part of AHEAD-MERIT has dual primary endpoints, PFS and OS, providing complementary measures of clinical benefit. At the analysis for PFS, BNT113 in combination with pembrolizumab did not demonstrate a statistically significant improvement in PFS versus pembrolizumab alone. The IDMC has recommended that the clinical trial continues as planned to evaluate the second primary endpoint of OS to complete the assessment of the potential of this approach to help patients live longer. As immune-mediated anti-tumor effects build and deepen over time, the analysis of the second dual primary endpoint, OS, will be critical to fully assess the potential of this approach. Under the trial’s pre-specified statistical design, a statistically significant improvement in OS would establish a positive trial outcome, even if the PFS dual primary endpoint was not met. BioNTech remains blinded to ongoing trial data in accordance with the trial’s governance procedures.
Upcoming Investor and Analyst Events
7
•BioNTech Fourth Quarter and Full Year 2026 Financial Results and Corporate Update: March 2, 2027
Conference Call and Webcast Information
BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, November 3, 2026, at 8:00 a.m. EST (2:00 p.m. CET) to report its financial results and provide a corporate update for the third quarter of 2026.
To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN number will be provided.
The slide presentation and audio of the webcast will be available via this link.
Participants may also access the slides and the webcast of the conference call via the “Events & Presentations” page of the Investor section of the Company’s website at www.BioNTech.com. A replay of the webcast will be made available shortly after the closing of the call and archived on the Company’s website for 30 days following the call.
About BioNTech
BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody-drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.
For more information, please visit www.BioNTech.com.
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 expected revenues and net profit/(loss) related to sales of BioNTech’s COVID-19 vaccine 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 clinical 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 clinical trials, and the registrational potential of any clinical trial BioNTech may initiate; BioNTech’s expectations regarding the impact of changes to its manufacturing operations; discussions with regulatory agencies; BioNTech’s expectations with respect to intellectual property; the impact of
8
BioNTech’s collaboration and licensing agreements; BioNTech’s expectations with respect to developments in law, public policy, and international trade; BioNTech’s estimates of revenues, research and development expenses, selling, general and administrative expenses and capital expenditures for operating activities; 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 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, 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 with governmental authorities, private health insurers and other third-party payors; the future commercial demand and medical need for initial or annual 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; 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 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; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; expected changes to BioNTech’s leadership and the transition of responsibilities at the Management Board, including identification and recruitment of successors; 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 September 30, 2026 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.
9
CONTACTS
Investor Relations
Douglas Maffei, PhD
Investors@biontech.de
Media Relations
Jasmina Alatovic
Media@biontech.de
Jasmina Alatovic
Media@biontech.de
10
Abbreviation Overview
ADC | Antibody-drug conjugate | ||||
BLA | Biologics license application | ||||
CRC | Colorectal cancer | ||||
ctDNA | Circulating tumor DNA | ||||
CTLA-4 | Cytotoxic T-lymphocyte-associated protein 4 | ||||
EC | Endometrial cancer | ||||
ES-SCLC | Extensive-stage small cell lung cancer | ||||
GBM | Glioblastoma | ||||
HCC | Hepatocellular carcinoma | ||||
HER2 | Human epidermal growth factor receptor 2 | ||||
HPV16+ | Human papillomavirus type 16 positive | ||||
HR | Hormone receptor | ||||
IDMC | Independent Data Monitoring Committee | ||||
ILD | Interstitial lung disease | ||||
iNeST | Individualized neoantigen-specific immunotherapy | ||||
| IO | Immuno-oncology | ||||
mRNA | Messenger ribonucleic acid | ||||
NSCLC | Non-small cell lung cancer | ||||
OS | Overall survival | ||||
PDAC | Pancreatic ductal adenocarcinoma | ||||
PD-(L)1 | Programmed cell death protein (death-ligand) 1 | ||||
PFS | Progression-free survival | ||||
RCC | Renal cell carcinoma | ||||
SCLC | Small cell lung cancer | ||||
TPS | Tumor Proportion Score | ||||
TNBC | Triple-negative breast cancer | ||||
TROP2 | Trophoblast cell surface antigen 2 | ||||
VEGF-A | Vascular endothelial growth factor A | ||||
11
Interim Condensed Consolidated Statements of Profit or Loss
Three months ended September 30, | Nine months ended September 30, | |||||||||||||
2026 | 2025 | 2026 | 2025 | |||||||||||
(in millions €, except per share data) | (unaudited) | (unaudited) | (unaudited) | (unaudited) | ||||||||||
Revenues | 1,289.2 | 1,518.9 | 1,512.9 | 1,962.5 | ||||||||||
Cost of sales | (103.3) | (148.3) | (271.7) | (308.5) | ||||||||||
Research and development expenses | (748.1) | (564.8) | (1,856.1) | (1,599.5) | ||||||||||
Sales and marketing expenses | (43.3) | (27.3) | (111.3) | (60.7) | ||||||||||
General and administrative expenses | (135.2) | (121.2) | (415.8) | (345.8) | ||||||||||
Other operating expenses | (163.6) | (729.5) | (443.7) | (884.7) | ||||||||||
Other operating income | 29.3 | 25.3 | 85.1 | 154.6 | ||||||||||
Operating profit / (loss) | 125.0 | (46.9) | (1,500.6) | (1,082.1) | ||||||||||
Finance income | 105.3 | 96.8 | 323.2 | 324.8 | ||||||||||
Finance expenses | (8.3) | (25.2) | (27.4) | (66.1) | ||||||||||
Profit / (Loss) before tax | 222.0 | 24.7 | (1,204.8) | (823.4) | ||||||||||
Income taxes | (37.5) | (53.4) | 36.6 | (7.7) | ||||||||||
Net profit / (loss) | 184.5 | (28.7) | (1,168.2) | (831.1) | ||||||||||
Earnings / (Loss) per share | ||||||||||||||
Basic profit / (loss) per share | 0.74 | (0.12) | (4.63) | (3.45) | ||||||||||
Diluted profit / (loss) per share | 0.73 | (0.12) | (4.63) | (3.45) | ||||||||||
12
Interim Condensed Consolidated Statements of Financial Position
September 30 | December 31, | |||||||
(in millions €) | 2026 | 2025 | ||||||
Assets | (unaudited) | |||||||
Non-current assets | ||||||||
Goodwill | 376.0 | 367.9 | ||||||
Other intangible assets | 1,201.6 | 1,606.0 | ||||||
Property, plant and equipment | 1,000.9 | 1,080.9 | ||||||
Right-of-use assets | 159.2 | 210.2 | ||||||
Contract assets | — | 2.0 | ||||||
Other financial assets | 1,727.3 | 2,554.2 | ||||||
Other assets | 15.0 | 7.3 | ||||||
Deferred tax assets | 20.0 | 13.5 | ||||||
Total non-current assets | 4,500.0 | 5,842.0 | ||||||
Current assets | ||||||||
Inventories | 64.9 | 110.7 | ||||||
Trade and other receivables | 666.3 | 924.2 | ||||||
Contract assets | 5.4 | 8.1 | ||||||
Other financial assets | 4,457.6 | 7,201.8 | ||||||
Other assets | 145.2 | 173.8 | ||||||
Income tax assets | 124.3 | 52.6 | ||||||
Cash and cash equivalents | 10,200.8 | 7,675.4 | ||||||
Assets held for sale | 9.3 | — | ||||||
Total current assets | 15,673.8 | 16,146.6 | ||||||
Total assets | 20,173.8 | 21,988.6 | ||||||
Equity and liabilities | ||||||||
Equity | ||||||||
Share capital | 259.0 | 259.0 | ||||||
Capital reserve | 2,076.5 | 2,473.3 | ||||||
Treasury shares | (11.1) | (7.7) | ||||||
Retained earnings | 16,793.7 | 17,961.9 | ||||||
Other reserves | (1,406.4) | (1,462.3) | ||||||
Total equity | 17,711.7 | 19,224.2 | ||||||
Non-current liabilities | ||||||||
Lease liabilities, loans and borrowings | 255.4 | 215.2 | ||||||
Other financial liabilities | 108.9 | 94.9 | ||||||
Provisions | 64.6 | 35.5 | ||||||
Contract liabilities | 0.7 | 88.0 | ||||||
Other liabilities | 117.1 | 104.2 | ||||||
Deferred tax liabilities | 82.6 | 84.3 | ||||||
Total non-current liabilities | 629.3 | 622.1 | ||||||
Current liabilities | ||||||||
Lease liabilities, loans and borrowings | 104.4 | 52.2 | ||||||
Trade payables and other payables | 523.1 | 534.9 | ||||||
Other financial liabilities | 141.2 | 351.7 | ||||||
Income tax liabilities | 13.2 | 65.6 | ||||||
Provisions | 244.2 | 145.3 | ||||||
Contract liabilities | 623.6 | 754.9 | ||||||
Other liabilities | 181.1 | 237.7 | ||||||
Liabilities related to assets held for sale | 2.0 | — | ||||||
Total current liabilities | 1,832.8 | 2,142.3 | ||||||
Total liabilities | 2,462.1 | 2,764.4 | ||||||
Total equity and liabilities | 20,173.8 | 21,988.6 | ||||||
13
Interim Condensed Consolidated Statements of Cash Flows
Three months ended September 30, | Nine months ended September 30, | |||||||||||||
2026 | 2025 | 2026 | 2025 | |||||||||||
(in millions €) | (unaudited) | (unaudited) | (unaudited) | (unaudited) | ||||||||||
Operating activities | ||||||||||||||
Net profit / (loss) | 184.5 | (28.7) | (1,168.2) | (831.1) | ||||||||||
Income taxes | 37.5 | 53.4 | (36.6) | 7.7 | ||||||||||
Profit / (Loss) before tax | 222.0 | 24.7 | (1,204.8) | (823.4) | ||||||||||
Adjustments to reconcile profit / (loss) before tax to net cash flows: | ||||||||||||||
Depreciation, amortization and impairment of property, plant, equipment, intangible assets and right-of-use assets | 332.3 | 124.2 | 719.7 | 218.0 | ||||||||||
Share-based payment expenses | 20.0 | 27.9 | 63.7 | 82.1 | ||||||||||
Net foreign exchange differences | (3.2) | (24.1) | 14.3 | 36.4 | ||||||||||
Gain on disposal of property, plant and equipment | (0.1) | (1.3) | (1.1) | (1.7) | ||||||||||
Finance income excluding foreign exchange differences | (96.3) | (96.8) | (301.9) | (324.8) | ||||||||||
Finance expense excluding foreign exchange differences | 8.3 | 2.6 | 27.4 | 17.1 | ||||||||||
Government and similar grants | (13.2) | (10.5) | (45.3) | (43.5) | ||||||||||
Other non-cash income | — | — | — | (15.0) | ||||||||||
Working capital adjustments: | ||||||||||||||
Decrease / (Increase) in trade and other receivables, contract assets and other assets | (489.1) | 897.1 | 308.1 | 1,005.5 | ||||||||||
Decrease in inventories | 33.5 | 5.1 | 43.7 | 61.7 | ||||||||||
Decrease in trade payables, other financial liabilities, other liabilities, contract liabilities, refund liabilities and provisions | (197.6) | (242.5) | (344.8) | (314.9) | ||||||||||
Interest received and realized gains from cash and cash equivalents | 78.0 | 83.5 | 235.4 | 275.2 | ||||||||||
Interest paid and realized losses from cash and cash equivalents | (2.8) | (2.4) | (8.4) | (8.2) | ||||||||||
Income tax paid, net | (33.7) | (9.6) | (91.4) | (36.7) | ||||||||||
Share-based payments | (4.2) | (4.2) | (19.2) | (19.3) | ||||||||||
Government and similar grants received | 16.3 | 7.0 | 64.3 | 38.0 | ||||||||||
Net cash flows from / (used in) operating activities | (129.8) | 780.7 | (540.3) | 146.5 | ||||||||||
Investing activities | ||||||||||||||
Purchase of property, plant and equipment | (33.6) | (35.9) | (145.0) | (111.9) | ||||||||||
Proceeds from sale of property, plant and equipment | 1.5 | 2.9 | 6.5 | 3.9 | ||||||||||
Purchase of intangible assets | (14.9) | (2.7) | (37.8) | (575.0) | ||||||||||
Acquisition of subsidiaries and businesses, net of cash acquired | (31.8) | — | (31.8) | (78.5) | ||||||||||
Investment in other financial assets | (1,504.9) | (2,869.0) | (5,111.0) | (7,046.7) | ||||||||||
Proceeds from maturity of other financial assets | 2,391.4 | 1,979.4 | 8,677.3 | 8,065.3 | ||||||||||
Net cash flows from / (used in) investing activities | 807.7 | (925.3) | 3,358.2 | 257.1 | ||||||||||
Financing activities | ||||||||||||||
Proceeds from loans and borrowings | 52.9 | — | 129.1 | — | ||||||||||
Repayment of loans and borrowings | — | (1.2) | (5.9) | (9.4) | ||||||||||
Payments related to lease liabilities | (11.2) | (10.3) | (34.4) | (29.2) | ||||||||||
Share repurchase program | (274.3) | — | (403.5) | — | ||||||||||
Net cash flows used in financing activities | (232.6) | (11.5) | (314.7) | (38.6) | ||||||||||
Net increase / (decrease) in cash and cash equivalents | 445.3 | (156.1) | 2,503.2 | 365.0 | ||||||||||
Change in cash and cash equivalents resulting from exchange rate differences | 2.0 | (21.5) | (4.7) | (28.4) | ||||||||||
Change in cash and cash equivalents resulting from other valuation effects | 12.5 | 1.0 | 26.9 | (5.6) | ||||||||||
Cash and cash equivalents at the beginning of the period | 9,741.0 | 10,269.5 | 7,675.4 | 9,761.9 | ||||||||||
Cash and cash equivalents as of September 30 | 10,200.8 | 10,092.9 | 10,200.8 | 10,092.9 | ||||||||||
Certain prior period lines were aggregated to conform to current period presentation and to improve readability.
14
Non-IFRS Reconciliation
Non-IFRS Reconciliation for the three months ended September 30, 2026 | ||||||||||||||||||||
non-IFRS adjustments (unaudited) | ||||||||||||||||||||
(in millions €, except per share data) | IFRS Results | Expenses and income from legal proceedings | Impairment and reversal | Employee-related expenses from restructuring | Income from bargain purchase and income and expenses from divestiture related items | Adjusted Results | ||||||||||||||
(unaudited) | (unaudited) | |||||||||||||||||||
Cost of sales | (103.3) | — | 11.4 | — | — | (91.9) | ||||||||||||||
Research and development expenses | (748.1) | — | 169.6 | — | — | (578.5) | ||||||||||||||
Other operating expenses | (163.6) | 13.5 | 42.2 | 19.7 | — | (88.2) | ||||||||||||||
Operating profit | 125.0 | 13.5 | 223.2 | 19.7 | — | 381.4 | ||||||||||||||
Profit before tax | 222.0 | 13.5 | 223.2 | 19.7 | — | 478.4 | ||||||||||||||
Net profit1 | 184.5 | 13.5 | 223.2 | 19.7 | — | 440.9 | ||||||||||||||
Earnings per share | ||||||||||||||||||||
Basic profit per share | 0.74 | 1.76 | ||||||||||||||||||
Diluted profit per share | 0.73 | 1.76 | ||||||||||||||||||
1 Tax effects are not considered as part of BioNTech's non-IFRS adjustments.
Non-IFRS Reconciliation for the three months ended September 30, 2025 | ||||||||||||||||||||
non-IFRS adjustments (unaudited) | ||||||||||||||||||||
(in millions €, except per share data) | IFRS Results | Expenses and income from legal proceedings | Impairment and reversal | Employee-related expenses from restructuring | Income from bargain purchase and income and expenses from divestiture related items | Adjusted Results | ||||||||||||||
(unaudited) | (unaudited) | |||||||||||||||||||
Research and development expenses | (564.8) | — | 85.4 | — | — | (479.4) | ||||||||||||||
Other operating expenses | (729.5) | 678.5 | — | 17.3 | — | (33.7) | ||||||||||||||
Operating profit / (loss) | (46.9) | 678.5 | 85.4 | 17.3 | — | 734.3 | ||||||||||||||
Profit before tax | 24.7 | 678.5 | 85.4 | 17.3 | — | 805.9 | ||||||||||||||
Net profit / (loss) | (28.7) | 678.5 | 85.4 | 17.3 | — | 752.5 | ||||||||||||||
Earnings / (Loss) per share | ||||||||||||||||||||
Basic profit / (loss) per share | (0.12) | 3.12 | ||||||||||||||||||
Diluted profit / (loss) per share | (0.12) | 3.11 | ||||||||||||||||||
1 Tax effects are not considered as part of BioNTech's non-IFRS adjustments.
15
Non-IFRS Reconciliation for the nine months ended September 30, 2026 | ||||||||||||||||||||
non-IFRS adjustments (unaudited) | ||||||||||||||||||||
(in millions €, except per share data) | IFRS Results | Expenses and income from legal proceedings | Impairment and reversal | Employee-related expenses from restructuring | Income from bargain purchase and income and expenses from divestiture related items | Adjusted Results | ||||||||||||||
(unaudited) | (unaudited) | |||||||||||||||||||
Cost of sales | (271.7) | — | 11.4 | — | — | (260.3) | ||||||||||||||
Research and development expenses | (1,856.1) | — | 273.4 | — | — | (1,582.7) | ||||||||||||||
Other operating expenses | (443.7) | 13.5 | 129.2 | 124.8 | — | (176.2) | ||||||||||||||
Operating loss | (1,500.6) | 13.5 | 414.0 | 124.8 | — | (948.3) | ||||||||||||||
Loss before tax | (1,204.8) | 13.5 | 414.0 | 124.8 | — | (652.5) | ||||||||||||||
Net loss1 | (1,168.2) | 13.5 | 414.0 | 124.8 | — | (615.9) | ||||||||||||||
Loss per share | ||||||||||||||||||||
Basic and diluted loss per share | (4.63) | (2.44) | ||||||||||||||||||
1 Tax effects are not considered as part of BioNTech's non-IFRS adjustments.
Non-IFRS Reconciliation for the nine months ended September 30, 2025 | ||||||||||||||||||||
non-IFRS adjustments (unaudited) | ||||||||||||||||||||
(in millions €, except per share data) | IFRS Results | Expenses and income from legal proceedings | Impairment and reversal | Employee-related expenses from restructuring | Income from bargain purchase and income and expenses from divestiture related items | Adjusted Results | ||||||||||||||
(unaudited) | (unaudited) | |||||||||||||||||||
Research and development expenses | (1,599.5) | — | 85.4 | — | — | (1,514.1) | ||||||||||||||
Other operating expenses | (884.7) | 678.5 | 10.0 | 45.1 | — | (151.1) | ||||||||||||||
Other operating income | 154.6 | — | — | — | (15.0) | 139.6 | ||||||||||||||
Operating loss | (1,082.1) | 678.5 | 95.4 | 45.1 | (15.0) | (278.1) | ||||||||||||||
Loss before tax | (823.4) | 678.5 | 95.4 | 45.1 | (15.0) | (19.4) | ||||||||||||||
Net loss1 | (831.1) | 678.5 | 95.4 | 45.1 | (15.0) | (27.1) | ||||||||||||||
Loss per share | ||||||||||||||||||||
Basic and diluted loss per share | (3.45) | (0.11) | ||||||||||||||||||
1 Tax effects are not considered as part of BioNTech's non-IFRS adjustments.
16
Third Quarter 2026 Financial Results & Corporate Update November 3, 2026 Exhibit 99.1
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; 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; BioNTech’s expectations regarding the impact of changes to its manufacturing operations; discussions with regulatory agencies; BioNTech’s expectations with respect to intellectual property; the impact of BioNTech’s collaboration and licensing agreements, including BioNTech’s partnership with BMS; BioNTech's expectations with respect to developments in law, public policy, and international trade; BioNTech’s estimates of revenues, research and development expenses, selling, general and administrative expenses, and capital expenditures for operating activities; 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 presentation, 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 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; 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 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; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; expected changes to BioNTech’s leadership and the transition of responsibilities at the Management Board, including identification and recruitment of successors; 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 June 30, 2026, 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 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. 2 An abbreviation directory of defined terms can be found at the end of the presentation. To be updated by Legal This Slide Presentation Includes Forward-Looking Statements
1 Progress Highlights Prof. Uğur Şahin, M.D., Co-Founder & Chief Executive Officer 2 Oncology Execution Prof. Özlem Türeci, M.D., Co-Founder & Chief Medical Officer 3 Financial Performance Ramón Zapata, Chief Financial Officer 3
Progress Highlights Prof. Uğur Şahin, M.D., Co-Founder & Chief Executive Officer 1 4
ONCOLOGY FOCUS IN 2026 PROGRESS IN Q3 Late-Stage Acceleration Key late-stage data readouts expected for first wave of oncology assets Gotistobart clinical benefit validated in OS data presented at WCLC Combination Therapy Momentum Pumitamig1 + ADC combination to advance into registrational path Pumitamig + TROP2 ADC3 to be evaluated in global Phase 3 trial Modalities to Disease Areas Transition to a focused disease area specific approach Strong Pumitamig + B7H3 ADC2 data presented at WCLC and ESMO 1 2 3 5 Partnered with 1. Bristol Myers Squibb; 2. DualityBio; 3. Phase 3 collaboration with Gilead.
Building a Multi-Product Company Across Tumor Focus Areas by 2030+ Targeting 17+ Late-Stage and Pivotal Trial Readouts Informing Multiple Launch Opportunities 6 Tumor Type Incidence1 Assets Late-Stage/Pivotal Trials Expected Data Readouts2 2026 2027 2028 2029 2030+ Lung 1L NSCLC 400K Pumitamig3 ROSETTA Lung-02 Stage III unresectable NSCLC 65K Pumitamig3 ROSETTA Lung-201 1L NSCLC – PD-L1 ≥ 50% 60K Pumitamig3 ROSETTA Lung-202 2L+ sqNSCLC1 55K Gotistobart4 PRESERVE-003 1L ES-SCLC 80K Pumitamig3 ROSETTA Lung-01 Breast 1L TNBC – all comers 20K Pumitamig3 Phase 3 in China 1L TNBC – PD-L1- 15K Pumitamig3 ROSETTA Breast-017,9 2L+ HR+ BC1 – HER2-low 55K Trastuzumab pamirtecan5 DYNASTY Breast-02 Genitourinary 1L RCC 40K Pumitamig3 ROSETTA RCC-2088 1L CRPC 110K Elfetabart drozuntecan5 BNT324-03 Gastrointestinal 1L MSS-CRC 230K Pumitamig3 ROSETTA CRC-203 1L Gastric – HER2-neg, PD-L1+ 40K Pumitamig3 ROSETTA Gastric-204 1L HCC 25K Pumitamig3 ROSETTA HCC-2068 Adj. PDAC 30K Autogene cevumeran6 IMCODE003 Gynecologic 2L+ Endometrial1 – HER2-expressing 10K Trastuzumab pamirtecan5 Single-arm Phase 2 Trastuzumab pamirtecan5 Fern-EC-01 Additional Tumors 1L HNSCC – PD-L1 CPS ≥ 1, HPV16+ 50K BNT113 AHEAD-MERIT 1. Estimated 1L or adjuvant incidence (incidence + newly recurrent patients), or 2L+ drug-treated in 2030 in the G7 markets derived from Oracle CancerMPact as of Feb. 2026; incidence information for informational purposes only and 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, are event-driven and in some cases may not translate into commercial launches; Partnered with: 3. Bristol Myers Squibb; 4. OncoC4; 5. DualityBio; 6. Genentech, a member of the Roche group; 7. Phase 3 collaboration with Gilead; 8. Phase 1/2 trials; anticipated pivotal trials evaluating pumitamig in these tumor types are expected to readout after 2030. 9. Expected primary completion date to be updated after clinicaltrials.gov update.
Oncology Execution Prof. Özlem Türeci, M.D., Co-Founder & Chief Medical Officer 3 7
Tumor-type Focused Strategy to Address Significant Oncology Unmet Medical Needs 8 GastrointestinalBreastLung Genitourinary Gynecologic Additional Tumors Data presented at WCLC and ESMO validate clinical benefit of BioNTech’s product candidates across key tumor types
Elfetabart Drozuntecan3 Unique Opportunity to Build a Diversified Lung Cancer Franchise 9 Partnered with: 1. Bristol Myers Squibb; 2. OncoC4; 3. DualityBio. Gotistobart2Pumitamig1 Bispecific antibody targeting PD-L1 and VEGF-A with next- gen IO backbone potential TME-selective regulatory T cell-depleting antibody targeting CTLA-4 Novel pan-tumor ADC targeting B7H3 with favorable safety profile
NSCLC SCLC Resectable Stage III Unresectable 1L Metastatic 2L+ Metastatic 1L Metastatic 2L+ Metastatic Incidence1 220K 65K 400K 230K 80K 35K Broadening BioNTech’s Lung Cancer Coverage to Maximize Pipeline Potential 10 1. Estimated 1L or adjuvant incidence (incidence + newly recurrent patients), or 2L+ drug-treated in 2030 in the G7 markets derived from Oracle CancerMPact as of Feb 2026; Incidence information for informational purposes only and not intended to indicate the potential market size or reach of BioNTech’s and its collaborators’ product candidates, if approved; Partnered with: 2. Bristol Myers Squibb; 3. OncoC4; 4. DualityBio; 5. MediLink (BNT326/YL202); 6. Being conducted in China. Next Generation IO Targeted Therapy mRNA Immunotherapy Registrational Trials Phase 1/2 PoC Trials Gotistobart3 PRESERVE-003 (sq) FixVac + Gotistobart3/ADCs LuCa-MERIT-1 Pumitamig2 + chemo IIT6 Pumitamig2 + chemo ROSETTA LUNG-02 ADC monos Elfetabart drozuntecan4, Sacituzumab drozuntecan4, Beruzatatug pelitecan5 Pumitamig2 + ADCs Elfetabart drozuntecan4, Sacituzumab drozuntecan4, Beruzatatug pelitecan5 Pumitamig2 ROSETTA LUNG-201 Pumitamig2 + FixVac LuCa-MERIT-1 Pumitamig2 ROSETTA LUNG-202 Pumitamig2 + chemo ROSETTA LUNG-01 Pumitamig2 + ADC (Elfetabart drozuntecan4) Pumitamig2 + TCE ADC mono Elfetabart drozuntecan4
Gotistobart Phase 3 Data Show Nearly Doubled Median Overall Survival vs SoC 11 Gotistobart (n=45) Docetaxel (n=42) Median OS, mos. 10.0 HR 0.56 Partnered with: 1. OncoC4, 2. Data presented at WCLC 2026. Median OS was 18.5 months with gotistobart1 vs 10.0 months with docetaxel2 Gotistobart continues to show potential as chemotherapy-free treatment option in a hard-to-treat lung cancer setting Gotistobart reduced the risk of death by 44% vs. chemotherapy 25.4 month follow-up data from non-pivotal part of Phase 3 presented at WCLC 2026 Observed overall safety profile aligns with its previously established safety findings Pivotal Phase 3 in sqNSCLC ongoing with gotistobart monotherapy as chemo-free 2L+ treatment option First interim analysis of pivotal Phase 3 expected in 2026 Development Status Clinical Evidence
NSCLC SCLC Resectable Stage III Unresectable 1L Metastatic 2L+ Metastatic 1L Metastatic 2L+ Metastatic Incidence1 220K 65K 400K 230K 80K 35K Broadening BioNTech’s Lung Cancer Coverage to Maximize Pipeline Potential 12 1. Estimated 1L or adjuvant incidence (incidence + newly recurrent patients), or 2L+ drug-treated in 2030 in the G7 markets derived from Oracle CancerMPact as of Feb 2026; Incidence information for informational purposes only and not intended to indicate the potential market size or reach of BioNTech’s and its collaborators’ product candidates, if approved; Partnered with: 2. Bristol Myers Squibb; 3. OncoC4; 4. DualityBio; 5. MediLink (BNT326/YL202); 6. Being conducted in China. Next Generation IO Targeted Therapy mRNA Immunotherapy Registrational Trials Phase 1/2 PoC Trials Gotistobart3 PRESERVE-003 (sq) FixVac + Gotistobart3/ADCs LuCa-MERIT-1 Pumitamig2 + chemo IIT6 Pumitamig2 + chemo ROSETTA LUNG-02 ADC monos Elfetabart drozuntecan4, Sacituzumab drozuntecan4, Beruzatatug pelitecan5 Pumitamig2 + ADCs Elfetabart drozuntecan4, Sacituzumab drozuntecan4, Beruzatatug pelitecan5 Pumitamig2 ROSETTA LUNG-201 Pumitamig2 + FixVac LuCa-MERIT-1 Pumitamig2 ROSETTA LUNG-202 Pumitamig2 + chemo ROSETTA LUNG-01 Pumitamig2 + ADC (Elfetabart drozuntecan4) Pumitamig2 + TCE ADC mono Elfetabart drozuntecan4
Pumitamig1 plus ADC elfe-D2 elicits 70.4% ORR in SCLC3 –100 –80 –60 –40 –20 0 20 40 60 Pe rc en ta ge c ha ng e fr om b as el in e (% ) Pumitamig + Elfetabart Drozuntecan Demonstrates Early Antitumor Activity Across SCLC Treatment Lines 13 ORR Overall (n=71) 70.4% 1L (n=13) 92.3% 2L (n=21) 76.2% 3L+ (n=21) 52.4% ORR Prior IO (n=48) 60.4% ORR Prior DLL3-TCE (n=8) 87.5% Elfe-D 6 mg/kg + pumitamig 30 mg/kg Elfe-D 4.5 mg/kg + pumitamig 30 mg/kg Elfe-D 6 mg/kg + pumitamig 20 mg/kg Elfe-D 4.5 mg/kg + pumitamig 20 mg/kg Clinical development strategy to address today’s unmet need and tomorrow’s evolving SCLC standard of care Partnered with 1. Bristol Myers Squibb; 2. DualityBio, 3. Data presented at WCLC 2026. First global efficacy data for a PD-(L)1xVEGF bsAb + ADC in lung cancer Encouraging early efficacy in SCLC across treatment lines and dose levels High response rates in patients previously treated with emerging SoC Manageable safety profile and limited overlap between pumitamig- and elfe-D- associated toxicities Clinical Evidence
Pumitamig + ADC Combination Development Enters Pivotal Phase 14 1. Phase 1/2 Data presented at ESMO BREAST 2026. Partnered with: 2. Bristol Myers Squibb; 3. DualityBio; 4. Phase 3 collaboration with Gilead. ROSETTA Breast-01: An ongoing Phase 3 trial updated to reflect the evolving 1L TNBC standard of care in collaboration with Gilead4 1:1 BioNTech’s first global Phase 3 combination trial evaluating pumitamig and an antibody-drug conjugate Compelling Phase 1/2 proof-of-concept data1 for pumitamig2 + TROP23 ADC support BioNTech’s clinical strategy in 1L TNBC 0 25 –25 –50 –75 –100B es t p er ce nt ag e ch an ge fr om b as el in e (% ) Median follow-up: 7.7 months Stable disease Partial response Pumitamig + BNT325 (n=30) Confirmed ORR, % 76.7% DCR, % 96.7% DoR, months NE (6.3, NE) 1L TNBC ARM A Pumitamig + sacituzumab govitecan ARM B Placebo + sacituzumab govitecan
mRNA Cancer Immunotherapy iNeST and FixVac Portfolio Development Focus 15 Partnered with: 1. Genentech, a member of the Roche Group; 2. In collaboration with Regeneron. Autogene cevumeran1 BNT113 BNT116 Adjuvant Adjuvant 1L Multiple settings CRC Phase 2 PDAC Phase 2 HPV16+ PD-L1 CPS ≥1 HNSCC Phase 2/3 NSCLC Phase 1 & 2 Monotherapy + Atezolizumab + mFOLFIRINOX + Pembrolizumab Mono & combo with IO & ADCs • Study terminated • Recruitment completed • Data from Phase 1 trial published: Rojas et al., Nature 2023; Sethna et al., Nature 2025, 6-year data update presented at AACR 2026 • Recruitment ongoing • Trial updated to Phase 2/3 • Recruitment completed in Phase 2 in 1L NSCLC2 • Data presented at SITC 2023, AACR 2024, SITC 2024 and AACR 2026 • Data in frail patients presented at AACR 2025 • Data in patients after CRT presented at WCLC 2025 • Data for neoadjuvant BNT116 + cemi + chemo presented at WCLC 2026 Primary completion date expected in 2031 Did not meet PFS at IA; Trial continues for OS Individualized Immunotherapy – iNeST1 Off-the-shelf Immunotherapy – FixVac
Multiple Milestones Achieved so Far in 2026 16 Program Trial Readout Phase Indication Status Context Late-Stage Trial Readouts Trastuzumab pamirtecan3 Single arm Phase 2 2L+ HER2-expressing endometrial cancer Achieved Phase 35 primary analysis Chemo naïve HR+ HER2-low breast cancer Achieved in Q3 Met PFS, modest improvement Gotistobart2 Phase 35 interim analysis 2L+ sqNSCLC On track Phase 2 2L+ mCRPC6 Updated Data maturity BNT113 Phase 35 interim analysis 1L HPV16+ PD-L1 CPS ≥1 HNSCC Achieved in Q3 Did not meet PFS, continues for OS Pumitamig1 Phase 35 in China interim analysis 1L TNBC6 Updated Data maturity Early-Stage Pumitamig & ADC Trial Readouts Pumitamig1 Phase 2 1L NSCLC Achieved Phase 2 1L ES-SCLC Achieved Phase 2 in China 1L HCC6 Updated Data maturity Phase 2 in China 1L MSS-CRC7 Updated Sample size increase Pumitamig1 + Trastuzumab pamirtecan3 Phase 1/2 Breast cancer Achieved in Q3 Pumitamig1 + Elfetabart drozuntecan3 Phase 2 Advanced solid tumors Achieved in Q3 Phase 1/2 NSCLC/SCLC Achieved in Q3 Pumitamig1 + Sacituzumab drozuntecan3 Phase 2 TNBC Achieved Pumitamig1 + Beruzatatug pelitecan4 Phase 1/2 NSCLC6 Updated Data maturity Elfetabart drozuntecan3 Phase 1/2 2L+ mCRPC Achieved Phase 3 Trial Initiations Pumitamig1 Phase 35 1L MSS-CRC Achieved 1L HER2- PD-L1+ gastric cancer Achieved 1L NSCLC – PD-L1 ≥ 50% Achieved Stage III unresectable NSCLC Achieved Elfetabart drozuntecan3 Phase 3 1L mCRPC Achieved BLA Submission Trastuzumab pamirtecan3 - 2L+ HER2-expressing endometrial cancer Updated Under discussion8 Some data readouts may be event-driven and subject to change based on actual event accrual rates or publication strategy. Partnered with: 1. Bristol Myers Squibb; 2. OncoC4; 3. DualityBio; 4. MediLink; 5. Pivotal trial. 6. The timing of this readout is no longer expected in 2026 due to data maturity. 7. The timing of this readout is no longer expected in 2026 due to an increase in the enrollment target of the trial. 8. BioNTech and DualityBio are discussing plans for BLA submission and will update the markets accordingly.
Financial Performance Ramón Zapata, Chief Financial Officer 4 17
In € millions except per share data1 Q3 2026 Q3 2025 IFRS Results Adjusted Results2 IFRS Results Adjusted Results2 Revenues 1,289 1,289 1,519 1,519 Cost of sales (103) (92) (148) (148) Research and development expenses (748) (579) (565) (479) Sales, marketing, general and administrative expenses (179) (179) (149) (149) Other operating result (134) (59) (704) (8) Operating profit / (loss) 125 381 (47) 734 Net profit / (loss) 185 441 (29) 753 Diluted earnings / (loss) per share 0.73 1.76 (0.12) 3.11 Weighted average number of shares outstanding (millions) 4 251 251 241 242 Third Quarter 2026 Financial Results Revenue from BMS partnership driving quarterly results 18 Balance Sheet as of September 30, 2026 – Cash and cash equivalents plus security investments3 €16.2 bn 1. All numbers have been rounded and may not add up to the totals. Presentation of the unaudited interim consolidated statements of profit or loss has been condensed. 2. In addition to BioNTech’s results determined in accordance with International Financial Reporting Standards (“IFRS”), or IFRS Accounting Standards, or IFRS results, BioNTech reports certain adjusted, non-IFRS measures used internally as a supplemental measure of our business performance (each referred to with the prefix “Adjusted” or, as a whole, “Adjusted Results”). The calculation of these measures and the adjusted results as a whole is based on the concepts of the applicable IFRS Accounting Standards, but includes certain adjustments. Reconciliation of the adjusted results to BioNTech’s measures based on IFRS Accounting Standards and more information can be found in the appendix and in BioNTech’s Report on Form 6-K for the period ended September 30, 2026, filed on November 3, 2026, which is available at www.sec.gov. The weighted average number of shares outstanding is excluded from that reconciliation. While non-IFRS measures may offer additional insights, BioNTech’s non-IFRS measures are not, and should not be viewed as a substitute for their most directly comparable IFRS Accounting Standards measures and should always be considered alongside our financial statements prepared in accordance with IFRS Accounting Standards. 3. Cash and cash equivalents plus security investments as of as of September 30, 2026, reached €16,163.8 million, comprising €10,200.8 million in cash and cash equivalents, €4,390.2 million in current security investments disclosed as financial assets and €1,572.8 million in non-current security investments disclosed as financial assets. 4. Only basic EPS are calculated in loss making periods. Diluted EPS are including outstanding instruments from BioNTech’s Share-Based Payment programs. The weighted average number of shares outstanding is determined as described in our Annual Report on Form 20-F as of and for the year ended December 31, 2025, as amended and is not adjusted by non-IFRS measures.
Q3 Year-to-Date 2026 Financial Results at a Glance1 Continued Focus on R&D Priority Programs 19 Revenues € 1,513 MILLION vs. €1,963 million year-to-date 2025 Adjusted R&D Expenses² € 1,583 MILLION vs. €1,514 million year-to-date 2025 IFRS R&D Expenses: €1,856 million vs. €1,600 million year-to-date 2025 Adjusted SG&A Expenses² € 527 MILLION vs. €407 million year-to-date 2025 IFRS SG&A Expenses: €527 million vs. €407 million year-to-date 2025 1. All numbers have been rounded. Presentation of the unaudited interim consolidated statements of profit or loss has been condensed. 2. In addition to BioNTech’s results determined in accordance with International Financial Reporting Standards (“IFRS”), or IFRS Accounting Standards, or IFRS results, BioNTech reports certain adjusted, non-IFRS measures used internally as a supplemental measure of our business performance (each referred to with the prefix “Adjusted” or, as a whole, “Adjusted Results”). The calculation of these measures and the adjusted results as a whole is based on the concepts of the applicable IFRS Accounting Standards, but includes certain adjustments. Reconciliation of the adjusted results to BioNTech’s measures based on IFRS Accounting Standards and more information can be found in the appendix and in BioNTech’s Report on Form 6-K for the period ended September 30, 2026, filed on November 3, 2026, which is available at www.sec.gov. While non-IFRS measures may offer additional insights, BioNTech’s non-IFRS measures are not, and should not be viewed as a substitute for their most directly comparable IFRS Accounting Standards measures and should always be considered alongside our financial statements prepared in accordance with IFRS Accounting Standards. Unless otherwise indicated, Adjusted Results are identical to IFRS Results.
Updated Full Year 2026 Financial Guidance1 1. Excludes risks that are not yet known and/or quantifiable and related activities. Includes effects identified from licensing arrangements, collaborations and Merger & Acquisitions (“M&A”) transactions to the extent disclosed. The guidance is based on non-IFRS measures and excludes certain effects compared to measures based on IFRS Accounting Standards. More information can be found in BioNTech’s Report on Form 6-K for the period ended September 30, 2026, filed on November 3, 2026, which is available at www.sec.gov. FY 2026 non-IFRS Guidance In € millions Current Nov. 3, 2026 Prior Aug. 4, 2026 Revenues 1,700 – 1,900 1,600 – 1,900 Adjusted R&D Expense Unchanged 2,000 – 2,300 Adjusted SG&A Expense Unchanged 700 - 800
Thank you
Appendix
Reconciliation of IFRS to Adjusted Results – Q3 2026 & 2025 Financial Results In € millions except per share data1 Q3 2026 Q3 2025 IFRS Results Non-IFRS Adjustments Adjusted Results2 IFRS Results Non-IFRS Adjustments Adjusted Results2 Revenues 1,289 – 1,289 1,519 – 1,519 Cost of sales (103) 11 (92) (148) – (148) Research and development expenses (748) 170 (579) (565) 85 (479) Sales, marketing, general and administrative expenses (179) – (179) (149) – (149) Other operating result (134) 75 (59) (704) 696 (8) Operating profit / (loss) 125 256 381 (47) 781 734 Net profit / (loss)3 185 256 441 (29) 781 753 Diluted earnings / (loss) per share 0.73 1.76 (0.12) 3.11 1. All Numbers have been rounded and may not add up to the totals. Presentation of the unaudited interim consolidated statements of profit or loss has been condensed. 2. In addition to BioNTech’s results determined in accordance with International Financial Reporting Standards (“IFRS”), or IFRS Accounting Standards, or IFRS results, BioNTech reports certain adjusted, non-IFRS measures used internally as a supplemental measure of our business performance (each referred to with the prefix “Adjusted” or, as a whole, “Adjusted Results”). The calculation of these measures and the adjusted results as a whole is based on the concepts of the applicable IFRS Accounting Standards, but includes certain adjustments. Reconciliation of the adjusted results to BioNTech’s measures based on IFRS Accounting Standards and more information can be found in the appendix and in BioNTech’s Report on Form 6-K for the period ended September 30, 2026, filed on November 3, 2026, which is available at www.sec.gov. While non-IFRS measures may offer additional insights, BioNTech’s non-IFRS measures are not, and should not be viewed as a substitute for their most directly comparable IFRS Accounting Standards measures and should always be considered alongside our financial statements prepared in accordance with IFRS Accounting Standards. 3. Tax effects are not considered as part of BioNTech’s non-IFRS adjustments. 23
Reconciliation of IFRS to Adjusted Results – YTD 2026 & 2025 Financial Results In € millions except per share data1 Year-to-date 2026 Year-to-date 2025 IFRS Results Non-IFRS Adjustments Adjusted Results2 IFRS Results Non-IFRS Adjustments Adjusted Results2 Revenues 1,513 – 1,513 1,963 – 1,963 Cost of sales (272) 11 (261) (308) – (308) Research and development expenses (1,856) 273 (1,583) (1,600) 85 (1,514) Sales, marketing, general and administrative expenses (527) – (527) (407) – (407) Other operating result (359) 268 (91) (730) 719 (11) Operating loss (1,501) 552 (948) (1,082) 804 (278) Net loss3 (1,168) (616) (831) (27) Diluted loss per share (4.63) (2.44) (3.45) (0.11) 1. All Numbers have been rounded and may not add up to the totals. Presentation of the unaudited interim consolidated statements of profit or loss has been condensed. 2. In addition to BioNTech’s results determined in accordance with International Financial Reporting Standards (“IFRS”), or IFRS Accounting Standards, or IFRS results, BioNTech reports certain adjusted, non-IFRS measures used internally as a supplemental measure of our business performance (each referred to with the prefix “Adjusted” or, as a whole, “Adjusted Results”). The calculation of these measures and the adjusted results as a whole is based on the concepts of the applicable IFRS Accounting Standards, but includes certain adjustments. Reconciliation of the adjusted results to BioNTech’s measures based on IFRS Accounting Standards and more information can be found in the appendix and in BioNTech’s Report on Form 6-K for the period ended September 30, 2026, filed on November 3, 2026, which is available at www.sec.gov. While non-IFRS measures may offer additional insights, BioNTech’s non-IFRS measures are not, and should not be viewed as a substitute for their most directly comparable IFRS Accounting Standards measures and should always be considered alongside our financial statements prepared in accordance with IFRS Accounting Standards. 3. Tax effects are not considered as part of BioNTech’s non-IFRS adjustments. 24
BioNTech’s Oncology Pipeline 25 Partnered with: 1. Bristol Myers Squibb; 2. Genentech, a member of the Roche Group; 3. DualityBio; 4. OncoC4; 5. MediLink; 6. Genmab; 7. In collaboration with Regeneron; 8. Trial ongoing in China only; 9. Trial is currently being conducted by or on behalf of BioNTech. Bristol Myers Squibb holds co-exclusive rights to pumitamig; 10. Phase 3 collaboration with Gilead. Phase 1 Phase 1/2 Phase 2 Phase 2/3 Phase 3 BNT116 Adv. NSCLC BNT317 Multiple solid tumors Pumitamig1 Adv. RCC Pumitamig1 + Beruzatatug pelitecan5 Multiple solid tumors Autogene cevumeran2 Adj. PDAC Pumitamig1 2L ES-SCLC8 Tenumomeran/ Raplemomeran 1L HPV16+ HNSCC Elfetabart Drozuntecan3 Met. CRPC Pumitamig1 1L adv./met.TNBC8 BNT211 Multiple solid tumors BNT3214 Multiple solid tumors Pumitamig1 Multiple solid tumors8 Pumitamig1 + Beruzatatug pelitecan5 Adv. NSCLC BNT1167 1L adv. NSCLC Pumitamig1 2L+ EGFRm NSCLC8 Pumitamig1 1L met. CRC Gotistobart4 2L+ sqNSCLC Trastuzumab pamirtecan3 Met. BC BNT314/GEN10596 Multiple solid tumors Elfetabart Drozuntecan3 Multiple solid tumors Pumitamig1 1L adv./met. TNBC8 Pumitamig1 + Trastuzumab pamirtecan3 Adv./met. BC9 Beruzatatug pelitecan5 Multiple solid tumors8 Pumitamig1 2L Glioblastoma8 Pumitamig1 1L met. Gastric Pumitamig1 1L ES-SCLC Trastuzumab pamirtecan3 2L EC Beruzatatug pelitecan5 Multiple solid tumors Sacituzumab drozuntecan3 Multiple solid tumors Pumitamig1 + BNT314/GEN10596 Met. CRC9 Trastuzumab pamirtecan3 Multiple solid tumors Beruzatatug pelitecan5 Adv./met. BC8 Pumitamig1 2L NEN8 Pumitamig1 1L NSCLC Pumitamig1 1L adv. NSCLC BNT329 Multiple solid tumors Pumitamig1 + BNT3212 Multiple solid tumors Gotistobart4 PROC Pumitamig1 2L adv./met. NSCLC Pumitamig1 Unresectable Stage III NSCLC Gotistobart4 Met. CRPC Pumitamig1 + BNT3213 1L HCC8,9 Pumitamig1 1L met. CRC8 Pumitamig1 1L met. PDAC Pumitamig1 2L SCLC8 Gotistobart4 Multiple solid tumors Pumitamig1 + Elfetabart Drozuntecan3 Adv./met. NSCLC and SCLC9 Pumitamig1 1L ES-SCLC8 Pumitamig1 1L/2L adv./met. TNBC Pumitamig1 1L adv./met. TNBC10 Pumitamig1 1L adv. HCC Pumitamig1 + Sacituzumab drozuntecan3 Multiple solid tumors9 Pumitamig1 1L/2L+ ES-SCLC Pumitamig1 or Sacituzumab drozuntecan + Elfetabart Drozuntecan3 Multiple solid tumors9 mRNA Immunotherapy Next Generation Immunomodulator Targeted Therapy Novel-novel Combination
26 Partnered with: 1. University of Pennsylvania; 2. Pfizer; 3. Fosun Pharma; 4. Funded by the Gates Foundation; 5. Funded by the Coalition for Epidemic Preparedness Innovations (CEPI). mRNAAntibody BioNTech’s Infectious Diseases Pipeline Phase 1 Phase 1/2 Phase 2 Commercial BNT1631 HSV BNT1644 Tuberculosis BNT1665 Mpox BNT1622,3 COVID-19 BNT351 HIV BNT1684 HIV
Abbreviation Directory 27 n L nth line FY Fiscal year OS Overall survival AACR American Association for Cancer Research G7 markets Canada, France, Germany, Italy, Japan, GB, USA PDAC Pancreatic ductal adenocarcinoma ADC Antibody-drug conjugate GB Great Britain PD-(L)1 Programmed cell death protein (ligand) 1 adj. Adjuvant HCC Hepatocellular carcinoma (m) PFS (Median) Progression-free survival adv. Advanced HER2 (or 3) Human epidermal growth factor receptor 2 (or 3) PoC Proof of concept B7-H3 Also known as CD276, cluster of HIV Human immunodeficiency virus PROC Platinum-resistant ovarian cancer differentiation 276 HNSCC Head and neck squamous cell carcinoma R&D Research and development BC Breast cancer HPV 16 Human papilloma virus 16 RCC Renal cell carcinoma BLA Biologics License Applications HR Hormone receptor (ES)SCLC (Extensive stage) Small cell lung cancer BMS Bristol Myers Squibb HSV Herpes simplex virus SEC Securities and Exchange Commission CEPI Coalition for Epidemic Preparedness IA Interim Analysis SG&A Selling, general and administrative expenses Innovations IFRS International financial reporting standards SITC Society of Immunotherapy of Cancer CPS Combined positive score IIT Investigator initiated trial SoC Standard of Care CRC Colorectal cancer iNeST Individualized NeoAntigen-Specific Therapy (n)Sq (non-)Squamous (m)CRPC (met.) Castration resistant prostate cancer IO Immuno-oncology TCE T cell engager CRT Chemoradiation therapy M&A Merger and acquisition TM Trademark CTLA-4 Cytotoxic T-Lymphocyte-Associated Protein 4 met. Metastatic TME Tumor microenvironment DCR Disease control rate Mpox Monkey pox TNBC Triple-negative breast cancer DLL3 Delta-like ligand 3 mRNA Messenger ribonucleic acid Treg Regulatory T DoR Duration of response MSS Microsatellite stability TROP2 Trophoblast cell surface antigen 2 EC Endometrial cancer NEN Neuroendocrine neoplasm VEGF-A Vascular endothelial growth factor A EGFR(m) (mutated) Epidermal growth factor receptor (sq) NSCLC (squamous) Non-small cell lung cancer WCLC World Conference of Lung Cancer ESMO European Society for Medical Oncology (c)ORR (confirmed) Objective response rate FixVac Fixed Antigen Vaccine (u)ORR (unconfirmed) Objective response rate