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Pumitamig plus docetaxel demonstrated encouraging responses in squamous and non-squamous non-small cell lung cancer across PD-L1 expression levels with a confirmed objective response rate of 36.7% following progression on or after immunotherapy plus chemotherapyAn early median progression-free survival of 6.9 months was observedSignificant unmet need remains for patients who have progressed on an immunotherapy-containing regimen, with the average progression-free survival below 4 months for standard of care docetaxel Data represent the third global Phase 2 dataset for pumitamig in lung cancer and reinforce its potential to improve outcomes over current standards of care  MAINZ, Germany, and PRINCETON, USA, October 25, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Bristol Myers Squibb Company (NYSE: BMY, “BMS”) today announced first data from the global Phase 2 ROSETTA Lung-107 clinical trial (NCT06841055) evaluating pumitamig, an investigational PD-L1xVEGF-A bispecific immunomodulator (BNT327/BMS986545), in combination with docetaxel in patients with metastatic non-small cell lung cancer (“NSCLC”) whose disease progressed on or after first-line immunotherapy plus chemotherapy.

The data showed encouraging antitumor activity, with responses observed in both squamous and non-squamous NSCLC and across PD-L1 expression levels, together with a manageable safety profile consistent with prior global datasets for pumitamig. The data were presented today in a late-breaking rapid oral presentation (abstract #LBA76) at the European Society for Medical Oncology (“ESMO”) Congress 2026 in Madrid, Spain.

“Despite meaningful advances in first-line treatment, outcomes remain poor for the many patients with non-small cell lung cancer whose disease progresses after immunotherapy plus chemotherapy, a setting where docetaxel has remained the standard of care for years,”1 said Byoung Chul Cho, M.D., Ph.D., Trial Investigator and Professor of Medical Oncology at Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. “These first data from ROSETTA Lung-107 show encouraging response rates and progression-free survival across PD-L1 expression levels and histology, suggesting that pumitamig may help re-engage antitumor immunity in patients who have progressed on prior immunotherapy plus chemotherapy. These findings support continued investigation of pumitamig in this population with high unmet need.”

ROSETTA Lung-107 is evaluating pumitamig 1400 mg in combination with docetaxel every three weeks. The July 10, 2026, data cut-off included 50 patients with a median follow-up of 12.2 weeks, and 33 patients remained on treatment. Among 30 efficacy-evaluable patients, pumitamig plus docetaxel showed a confirmed objective response rate (“cORR”) of 36.7% with a disease control rate (“DCR”) of 90.0%. Responses were observed across PD-L1 expression levels (cORR: 42.9% TPS ˂ 1%; 33.3% TPS 1–49%; 40.0% TPS ≥ 50%) and histologies (cORR: 57.1% squamous; 30.4% non-squamous), with DCRs above 80% in all subgroups. Median time to response was 1.4 months. In the overall treated population (n=50), median progression-free survival (“PFS”) was 6.9 months (95% CI: 4.2 – not reached), with a six-month PFS rate of 63.3%. Historically, standard-of-care docetaxel has delivered a median PFS of approximately 3.6 or 3.9 months for non-squamous and squamous metastatic NSCLC patients, respectively, following prior immunotherapy plus chemotherapy.1

“Our ambition is to improve outcomes for patients across the full spectrum of lung cancer, spanning disease subtypes, stages and lines of therapy,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “These encouraging results for pumitamig plus docetaxel extend the clinical evidence to patients whose disease has progressed after immunotherapy plus chemotherapy, a setting in which treatment options remain limited. Together with our findings in first-line NSCLC and extensive-stage small cell lung cancer, they support our strategy to develop pumitamig across a broad range of lung cancer settings, including those with particularly high unmet medical need.”

“This is the third global Phase 2 dataset to show consistent activity for pumitamig in lung cancer across PD-L1 expression levels, and it extends our evidence into a second-line setting where current options fall short,” said Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development at Bristol Myers Squibb. “Together with BioNTech, we are advancing one of the broadest development programs in the class as we continue to build the growing body of clinical evidence for pumitamig across multiple types and treatment lines of lung cancer, with four ongoing global Phase 3 trials, and we look forward to defining the path forward for pumitamig in second-line NSCLC.”

Across 50 patients in the safety evaluation, pumitamig plus chemotherapy showed a manageable safety profile, with no new safety signals. Pumitamig treatment-related adverse events (“TRAEs”) of any grade were reported in 52.0% of patients and grade ≥ 3 TRAEs in 18.0%, leading to treatment discontinuation in four (8.0%) patients. Immune- related AEs occurred in 11 (22.0%) patients and grade ≥ 3 immune- related AEs in five (10.0%) patients. VEGF-related events were reported in 13 (26.0%) patients; grade 3 events were rare (two patients, 4.0%), with no grade 4 or 5 events. Bleeding events occurred in eight (16.0%) patients and were limited to grade 1 or 2 severity. There were no pumitamig-related deaths or dose-limiting toxicities (“DLTs”).

BioNTech and BMS are advancing a broad development plan for pumitamig in multiple cancer types, including lung cancer across disease stages, subgroups and lines of therapy. ROSETTA Lung-107 extends the program into the second-line NSCLC setting, and these data will inform the further development of pumitamig in this underserved patient population.

About ROSETTA Lung-107
The global, open-label, single-arm Phase 2 ROSETTA Lung-107 trial (NCT06841055) is evaluating pumitamig (BNT327/BMS986545) in combination with docetaxel in patients with stage IV squamous or non-squamous NSCLC whose disease progressed following first-line immunotherapy plus chemotherapy, with any level of PD-L1 expression. Patients with prior exposure to anti-VEGF monoclonal antibodies or PD-(L)1xVEGF bispecific antibodies were excluded. In Part 1 (safety run-in), patients received pumitamig 1400 mg or 2000 mg plus docetaxel 75 mg/m² every three weeks (Q3W). In Part 2 (dose expansion), patients received pumitamig 1400 mg plus docetaxel 75 mg/m² Q3W, the dose recommended by the internal review committee based on the totality of evidence from Part 1 and the broader pumitamig lung cancer program. The primary endpoints are dose-limiting toxicities (Part 1 only), safety, and objective response rate (“ORR”) per investigator’s assessment (RECIST 1.1). Secondary endpoints include disease control rate (“DCR”), duration of response (“DOR”), depth of response, time to response, progression-free survival (“PFS”), overall survival (“OS”), pharmacokinetics, and antidrug antibody prevalence. The trial enrolled 59 patients at sites in Australia, the Republic of Korea, Spain, Türkiye, the United Kingdom, and the United States.

About Pumitamig
Pumitamig is an investigational bispecific immunomodulator, jointly developed by BioNTech and BMS, designed to cooperatively bind to PD-L1 and VEGF-A. It is aimed at restoring the immune system’s ability to recognize and destroy tumor cells while simultaneously cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), preventing them from growing and proliferating. By anchoring to PD-L1 receptors on tumor cells, we believe pumitamig localizes VEGF-A blockade within the tumor microenvironment, potentially enhancing antitumor activity while minimizing systemic exposure.

More than 4,000 patients have been treated with pumitamig in clinical trials to date. Seven global Phase 3 trials with registrational potential are currently ongoing, evaluating pumitamig plus chemotherapy compared to standard of care treatments, in first-line small cell lung cancer (ROSETTA Lung-01, NCT06712355); first-line non-small cell lung cancer (ROSETTA Lung-02, NCT06712316); unresectable stage III non-small cell lung cancer (ROSETTA Lung-201, NCT07361497); first-line advanced PD-L1 ≥ 50% non-small cell lung cancer (ROSETTA Lung-202, NCT07361510); first-line triple-negative breast cancer (ROSETTA Breast-01, NCT07173751); first-line microsatellite stable colorectal cancer (ROSETTA CRC-203, NCT07221357); and first-line gastric cancer (ROSETTA Gastric-204, NCT07221149). Pumitamig is also being explored in 10+ novel-novel combination trials with ADCs and other novel modalities, with the aim of expanding its role across tumor types and identifying additional pivotal opportunities.

About NSCLC
Non-small cell lung cancer (NSCLC) covers all epithelial lung cancers other than small cell lung cancer and includes squamous cell carcinoma, large cell carcinoma, and adenocarcinoma of the lung. It is the most common type of lung cancer, accounting for approximately 85% of cases, and is the leading cause of cancer-related deaths worldwide.2 Scientific advances have transformed the treatment of NSCLC, improving outcomes for many patients. However, NSCLC remains an aggressive disease with a poor prognosis and a 5-year survival rate of 18 to 22% in advanced stages.3 Patients with low levels of PD-L1 expression typically do not respond well to checkpoint inhibitor-based regimens creating a significant unmet need for new treatment options that provide durable responses to a broad range of patients.

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.

BioNTech 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 collaboration with Bristol Myers Squibb (BMS); BioNTech and BMS’s ability to successfully co-develop and co-commercialize pumitamig (also known as BNT327 or BMS986545), if approved; the rate and degree of market acceptance of pumitamig, if approved; the initiation, timing, progress, and results of BioNTech’s research and development programs, including BioNTech’s current and future clinical trials, including statements regarding the expected timing of initiation, enrollment, and completion of trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations, including expectations regarding the potential indications in which pumitamig may be approved, if at all; the targeted timing and number of additional potentially registrational trials, and the registrational potential of any trial BioNTech may initiate; and discussions with regulatory agencies. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the impact of tariffs and escalations in trade policy; competition related to BioNTech’s product candidates; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s product 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; 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 press release in the event of new information, future developments or otherwise.

About Bristol Myers Squibb
At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram.

Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about Bristol Myers Squibb’s future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the expected benefits of, and opportunities related to the collaboration with BioNTech may not be realized by Bristol Myers Squibb or may take longer to realize than anticipated, that future study results may not be consistent with the results to date, that pumitamig (also known as BNT327 or BMS986545) alone or in combination with chemotherapy (such as docetaxel) may not achieve its primary study endpoint or receive regulatory approval for the indications described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether pumitamig alone or in combination with chemotherapy will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by Bristol Myers Squibb’s subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

CONTACTS

BioNTech
Media Relations
Jasmina Alatovic
[email protected]

Investor Relations
Douglas Maffei, PhD
[email protected]

Bristol Myers Squibb
Media Relations
[email protected]  

Investor Relations
[email protected]

1. Ahn MJ et al. J Clin Oncol. 2025;43(3):260–272.
2. Lin Z et al. Medicine (Baltimore). 2025 Jul 25;104(30):e43300.
3. Liu SV et al. Immunotherapy. 2025 Oct;17(14):1005-1013.

Late-breaking oral presentation will feature first data from the global ROSETTA Lung-107 Phase 2 clinical trial evaluating pumitamig, a PD-L1×VEGF-A bispecific immunomodulator, plus docetaxel in patients with metastatic non-small cell lung cancer following prior immunotherapy plus chemotherapy Global Phase 2 data for pumitamig plus elfetabart drozuntecan, a B7-H3-targeting antibody-drug conjugate, expand the body of evidence for this novel-novel combination in multiple advanced solid tumors Updates from across the pumitamig clinical development program underscore its pan-tumor potential, including in lung and breast cancer patients with brain metastases and patients with neuroendocrine neoplasms MAINZ, Germany, October 19, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present new clinical data from its late-stage oncology pipeline with 16 abstracts spanning the Company’s tumor focus areas, including lung and breast cancer, at the European Society for Medical Oncology (“ESMO”) 2026 Congress held in Madrid, Spain, from October 23–27, 2026.

Key oral presentations will focus on clinical data for pumitamig (BNT327/BMS986545), a PD-L1×VEGF-A bispecific immunomodulator being jointly developed with Bristol Myers Squibb (“BMS”), plus docetaxel in second-line metastatic non-small cell lung cancer (“NSCLC”) as well as pumitamig in combination with elfetabart drozuntecan (elfe-D or BNT324/DB-1311), a B7-H3-targeting antibody-drug conjugate (“ADC”) being jointly developed with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”), across several advanced solid tumors – complementing the data in lung cancer presented earlier this year. This new clinical data advances BioNTech’s differentiated novel-novel combination approach. Additional presentations for pumitamig and ADCs reflect BioNTech’s tumor-focused strategy aimed at addressing significant unmet medical needs across various stages of disease.

“Sixteen abstracts spanning ten tumor types – this is our significant data presence at this year’s ESMO. It demonstrates momentum for our late-stage oncology pipeline across strategic key assets and tumor areas such as lung and breast cancer,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “For our PD-L1xVEGF immunomodulator pumitamig, we will be sharing new data that highlights its pan-tumor potential, including in challenging treatment settings where patients still show limited benefit from current standard of care therapies. Our goal is to establish pumitamig as a potential backbone for future combination regimens across multiple tumor types, including novel-novel treatment combinations. At this year's conference, we will showcase the potential of this approach in two presentations featuring ADC combinations, aimed to further enhance outcomes for patients.”

Highlights from BioNTech’s presentations at ESMO 2026:

Pumitamig – an investigational PD-L1×VEGF-A bispecific immunomodulator:

NSCLC: First data from the global ROSETTA Lung-107 Phase 2 clinical trial (NCT06841055) evaluating pumitamig plus docetaxel in patients with metastatic NSCLC whose disease progressed after immunotherapy plus chemotherapy will be presented in a late-breaking oral presentation. This clinical trial extends evidence for pumitamig’s non-small cell lung cancer development program into the second-line setting where there remains high unmet medical need, representing the third global Phase 2 dataset in lung cancer.SCLC and TNBC with brain metastases: Results from a subgroup analysis of two Phase 2 clinical trials (NCT06449209; NCT06449222) evaluating pumitamig plus chemotherapy in patients with small cell lung cancer (“SCLC”) or triple-negative breast cancer (“TNBC”) showed systemic efficacy generally consistent in patients with and without brain metastases. These early data suggest intracranial efficacy and add to the clinical evidence for pumitamig plus chemotherapy in tumor types where brain metastases often occur and remain challenging to treat as many systemic therapies have limited ability to cross the blood-brain barrier.2L neuroendocrine neoplasms: First results from a Phase 2 clinical trial conducted in China (NCT05879055) evaluating pumitamig plus FOLFIRI (folinic acid, fluorouracil, and irinotecan) chemotherapy in patients with unresectable neuroendocrine neoplasms after first-line platinum-based chemotherapy showed encouraging preliminary antitumor activity and a manageable safety profile. These data broaden the clinical evidence for pumitamig across diverse tumor types. Novel-novel combination of pumitamig and elfetabart drozuntecan, an investigational B7-H3-targeted ADC:

Advanced solid tumors: First results from the global Phase 2 clinical trial (NCT06953089) evaluating pumitamig in combination with elfetabart drozuntecan in patients with advanced solid tumors showed encouraging preliminary antitumor activity across multiple tumor types and a manageable safety profile, with minimal overlapping toxicities observed. 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. BioNTech is advancing a diversified oncology pipeline spanning next-generation immunomodulators, ADCs, and mRNA cancer immunotherapies, both as monotherapies and novel-novel combination approaches. With 13 ongoing Phase 3 trials as well as multiple novel-novel combination trials, BioNTech is focused on developing innovative approaches to address the challenges of cancer treatment among the Company’s tumor focus areas from early- to late-stage conditions.

All abstracts are available through the ESMO website. Further information on BioNTech’s oncology pipeline can be accessed here.

Full presentation details:

CandidateAbstract TitleAbstract Number/Presentation DetailsPumitamig A global phase 2, open-label trial of pumitamig (PD-L1 × VEGF-A bsAb) + docetaxel post-chemoimmunotherapy in mNSCLC: First data from ROSETTA Lung-107Abstract #LBA76
Rapid Oral Presentation
NSCLC, Metastatic
Oct 25, 2026: 8:30 - 10:00am CETEfficacy of pumitamig (PD-L1 × VEGF-A bsAb) plus chemotherapy in patients with SCLC or TNBC with brain metastases: A subgroup analysis of two phase 2 trialsAbstract #1951RO
Rapid Oral Presentation
Investigational Immunotherapy
Oct 24, 2026: 8:30 - 10:00am CESTFirst results from a phase 2 trial of second-line pumitamig (PD-L1 × VEGF-A bsAb) plus chemotherapy in unresectable neuroendocrine neoplasmsAbstract #2393O
Proffered Paper Presentation
NETs and Endocrine Tumours
Oct 26, 2026: 10:15 - 11:45am CETROSETTA RCC-208: A phase 1/2, open-label, randomized study of pumitamig alone or in combination with ipilimumab or cabozantinib in advanced renal cell carcinoma (RCC)Abstract #3639TiP
Poster Presentation
Renal Cancer
Oct 23, 2026: 3:15 - 4:00pm CESTROSETTA Gastric-204: A randomized, phase 2/3 study of first-line (1L) pumitamig + chemotherapy versus nivolumab (NIVO) + chemotherapy in advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC), or esophageal adenocarcinoma (EAC)Abstract #3081eTiP
ePoster Presentation
Oesophagogastric Cancer
Oct 23 - 27, 2026A phase 1/2 trial of first-line pumitamig monotherapy or pumitamig plus ipilimumab in advanced or unresectable hepatocellular carcinoma (ROSETTA HCC-206)Abstract #1762eTiP
ePoster Presentation
Hepatocellular Carcinoma
Oct 23 - 27, 2026Pumitamig + elfetabart drozuntecanElfetabart drozuntecan (Elfe-D; DB-1311/BNT324 [B7H3 ADC]) + pumitamig (PD-L1 x VEGF-A bsAb) in patients with advanced solid tumors: First results from a global phase 2 trialAbstract #999O
Proffered Paper Presentation
Developmental Therapeutics
Oct 24, 2026: 2:45 - 4:15pm CESTPumitamig + trastuzumab pamirtecanPumitamig + trastuzumab pamirtecan (T-Pam) in patients (pts) with HR+, HER2-low advanced/metastatic breast cancer (a/mBC): Phase 1 results of a phase 1/2, open-label trial (BNT323-03)Abstract #1777P
Poster Presentation
HER2+ Breast Cancer
Oct 24, 2026: 12:00 - 12:45pm CESTElfetabart drozuntecanElfetabart drozuntecan (Elfe-D; DB-1311/BNT324 [B7H3 ADC]) in patients with platinum-resistant ovarian cancer (PROC): Efficacy and safety data from a Phase 2 dose optimization cohortAbstract #1255P
Poster Presentation
Gynaecological Cancers
Oct 26, 2026: 12:00 - 12:45pm CETBNT324-03: A phase 3, randomized, open-label trial comparing elfetabart drozuntecan, a B7H3 antibody-drug conjugate (ADC), with docetaxel as treatment of patients (pts) with taxane-naïve metastatic castration-resistant prostate cancer (mCRPC)Abstract #2300TiP
Poster Presentation
Metastatic Prostate Cancer
Oct 23, 2026: 3:15 - 4:00pm CESTGotistobartGotistobart plus pembrolizumab demonstrates durable antitumor activity in advanced melanoma refractory or resistant to both prior anti-CTLA-4 and anti-PD-(L)1 therapiesAbstract #2106P
Poster Presentation
Melanoma
Oct 24, 2026: 12:00 - 12:45 pm CESTBNT317BNT317: An anti–PD-1 × CD39 bispecific antibody demonstrating preclinical antitumor activityAbstract #420P
Poster Presentation
Basic Science
Oct 23, 2026: 3:15 - 4pm CESTBeruzatatug pelitecan (YL202/BNT326)Clinical outcomes of YL202/BNT326 (HER3 ADC) in advanced/metastatic HR+/HER2-null/low breast cancer (BC) in chemotherapy (chemo)-naïve and exposed patients (pts)Abstract #1881P
Poster Presentation
HR+ Breast Cancer
Oct 24, 2026: 12:00 - 12:45pm CESTBNT329A first-in-human phase 1/2 dose-escalation and expansion trial of BNT329 (an anti-carbohydrate antigen 19-9 antibody-drug conjugate [CA19-9 ADC]) in patients (pts) with advanced solid tumors that express CA19-9Abstract #1076TiP
Poster Presentation
Developmental Therapeutics
Oct 23, 2026: 3:15 - 4:00 pm CESTHealth Economics and Outcomes Research (HEOR)Real-world progression-free survival (rwPFS) from chemotherapy initiation in patients with HR+/HER2– metastatic breast cancer (mBC) in the USAbstract #1880P
Poster Presentation
HR+ Breast Cancer
Oct 24, 2026: 12:00 - 12:45pm CESTReal-world outcomes with first-line pembrolizumab-based chemoimmunotherapy in patients with advanced/metastatic non-small cell lung cancer in the USAAbstract #2705P
Poster Presentation
NSCLC, Metastatic
Oct 26, 2026: 12:00 - 12:45pm CET 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.

BioNTech 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: the initiation, timing, progress and results of BioNTech’s research and development programs in oncology, including the targeted timing and number of additional potentially registrational trials; BioNTech’s and its collaborators’ current and future preclinical and clinical trials in oncology, including the investigational bispecific immunomodulator pumitamig (BNT327/BMS986545), the investigational anti-CTLA-4 antibody gotistobart (BNT316/ONC-392), the investigational B7H3-targeting ADC elfetabart drozuntecan (BNT324/DB-1311) alone and in combination with pumitamig, the investigational HER2-targeting ADC trastuzumab pamirtecan (BNT323/DB-1303) in combination with pumitamig, the investigational anti-PD-1×CD39 antibody BNT317, the investigational HER3-targeting ADC Beruzatatug pelitecan (Beru-Pel/YL202/BNT326), and the investigational CA19-9-targeting ADC BNT329; the nature and characterization of and timing for release of clinical data across BioNTech’s platforms, which is subject to peer review, regulatory review and market interpretation; the planned next steps in BioNTech’s pipeline programs, including, but not limited to, statements regarding timing or plans for initiation or enrollment of clinical trials, or submission for and receipt of product approvals and potential commercialization with respect to BioNTech’s product candidates; and the potential safety and efficacy of BioNTech’s product candidates. 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; the ability to produce comparable clinical results in future clinical trials; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; discussions with regulatory agencies regarding timing and requirements for additional clinical trials; the impact of tariffs and escalations in trade policy; 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; 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 press release in the event of new information, future developments or otherwise.

CONTACTS

Media Relations
Jasmina Alatovic
[email protected]

Investor Relations
Douglas Maffei, Ph.D.
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Moderna isn't the only mRNA biotech stock that could deliver big gains for investors. BioNTech (BNTX -2.76%) has billions in cash on its books and a cancer treatment pipeline that could transform it from a COVID-19 vaccine maker into a major force in oncology.

With several promising therapies advancing through clinical trials, this biotech could already have the ingredients to fuel its next chapter of growth.

Image source: Getty Images.

The potential starts with its balance sheet.

BioNTech has plenty of cash to develop its candidates As of the end of the second quarter, the German biotech business had 16.6 billion euros in cash, cash equivalents, and securities on its balance sheet. That gives BioNTech significant financial flexibility to fund research, advance clinical trials, enter into partnerships, and develop new medicines for the market.

It also announced a share repurchase program of up to $1 billion. That's an encouraging sign that the company has strong operating cash flows that will allow it to fund that buyback while continuing to invest in its core business.

The bigger question, however, is what the company plans to do with the rest of the money.

Right now, its only commercialized product is Comirnaty, the COVID-19 vaccine that it developed and marketed in partnership with Pfizer. But BioNTech is working toward becoming a multiproduct company focused on oncology by 2030.

That shift could give investors exposure to a much broader business if its research pays off. Plus, unlike a cash-strapped biotech that must keep raising money to fund R&D, BioNTech can finance its development programs with resources already sitting on its balance sheet.

Indeed, what makes BioNTech interesting today is its combination of financial firepower and a pipeline moving beyond early-stage trials.

The cancer pipeline is becoming harder to ignore BioNTech's oncology strategy extends well beyond personalized mRNA cancer vaccines. The company is developing treatments across several categories, including immunomodulators, antibody-drug conjugates (ADCs), and cancer immunotherapies.

This diversification matters because cancer is not one disease with one solution. Different tumor types respond differently to treatment, and even patients with the same type of cancer may need different approaches. Building a broader portfolio gives BioNTech more potential avenues to drive future revenue growth.

For example, BioNTech reported 14 ongoing pivotal clinical trials and more than 10 novel combination approaches across major tumor types. These phase 2/3 and phase 3 trials are especially important because they can provide the evidence needed to support regulatory applications. Positive results could move candidate drugs closer to commercialization, while negative results would help the company narrow down which candidates it's focusing on.

One of BioNTech's most closely watched candidates is pumitamig, a potential cancer treatment developed in collaboration with Bristol Myers Squibb. The company reported encouraging results from a trial that combined the drug with chemotherapy as a treatment regimen for lung cancer.

On top of that, the commercial opportunity could extend well beyond lung cancer. BioNTech's ROSETTA development program includes seven pivotal trials evaluating pumitamig, covering multiple cancer types and treatment settings. It also initiated additional global trials in areas like breast cancer, colorectal cancer, and gastric cancer.

That growing pipeline is one of the strongest reasons to watch BioNTech closely, but valuation matters just as much.

Is BioNTech stock a buy at today's valuation? BNTX BioNTech Se$87.71-$2.49 (-2.76%)

NASDAQ · As of 4:00 PM ET 10/16/26

Wall Street is quite bullish on BioNTech. In fact, among the 20 analysts covering it, 13 rate the stock a strong buy, while the remainder rate it a hold. Their target prices imply potential upside of 5% to 64% over the next year, with an average implied gain of 39%.

On valuation, the stock trades at a price-to-sales ratio of 7, a level that could seem reasonable if the company successfully turns its pipeline into blockbuster drugs.

Of course, there are no guarantees in drug development. Clinical trials can fail, regulatory approvals can be delayed, and even if a company brings an effective treatment to market, competitors may develop treatments that outperform it.

At the same time, declining COVID-19 vaccine revenue and ongoing R&D spending could eat into BioNTech's cash reserves. These factors could weaken the bull case for the company.

Looking ahead, results from BioNTech's pivotal trials will provide fresh insights about whether its pipeline can deliver. If it does, BioNTech's massive cash reserves will give it plenty of dry powder to move beyond its COVID-19 business and fund its next phase of growth.

For long-term investors who are comfortable with the risks, a pipeline this deep and a cash cushion large enough to bring those candidates through the clinical trial process could make BioNTech worth considering.

BioNTech SE (BNTX -2.47%) is still widely viewed as a COVID-19 vaccine maker, but that picture is quickly changing. The company has quietly built a broad late-stage cancer pipeline spanning multiple promising treatments for different cancer types.

With the stock trading below $100, investors may be overlooking the significant upside the company can deliver by expanding its oncology portfolio.

Image source: Getty Images.

From COVID vaccine maker to multi-product cancer company BioNTech is a very different company following the COVID-19 pandemic, having expanded its oncology portfolio, which now spans multiple cancer types.

That pipeline has moved much further along than many investors realize. BioNTech said it has more than 25 phase 2 and phase 3 oncology trials underway and is targeting 15 phase 3 trials by the end of 2026. It's now approaching the point where several of these programs could potentially become commercial products.

And that brings us to the most important piece of BioNTech's pipeline: pumitamig. The opportunity is broad because the company isn't developing this exciting new drug for just one cancer. Specifically, it's being tested across multiple types of solid tumors, including lung, breast, gastric, and kidney cancers, to name a few.

The company is also combining pumitamig with other therapies rather than treating it as a stand-alone product. Should the trials be successful, the drug could become an overall game changer in cancer therapy.

The late-stage pipeline keeps expanding across tumor types One interesting aspect of BioNTech's pipeline is its novel-novel combination strategy. The company is testing pumitamig alongside other kinds of cancer therapies. Essentially, the goal is to build combinations that attack tumors in different ways.

That matters because BioNTech isn't trying to win with one blockbuster drug alone. Instead, it's positioning itself around a portfolio of cancer medicines that can potentially be combined.

In a recent publication, BioNTech identified at least 17 late-stage data readouts through 2030 and beyond, spanning lung, breast, gastrointestinal, and other cancers. The company sees these programs as building blocks for becoming a multi-product oncology company.

Notably, BioNTech is still developing its nRNA oncology platform. BNT113 is in phase 3 development for HPV16-positive head and neck cancer, while autogene cevumeran is being developed as a personalized cancer vaccine for colorectal, pancreatic, and other cancers.

That means investors don't need every program to succeed, since a diversified pipeline can create significant value if several drugs prove effective as they move toward commercialization. The upside could be even greater if some of those drugs are used for multiple tumor types or in combination with one another.

Partnerships add another layer of support. BioNTech has collaborated with companies such as Bristol Myers Squibb, Duality Biologics, and Genentech, enabling it to share development capabilities across its portfolio.

BioNTech's pivot away from COVID hasn't been painless. Revenue fell by about 60% year over year in its latest quarter, and losses widened as the company poured more money into oncology research, even as it named incoming CEO Guido Oelkers to help steer that transition.

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But the good news is that BioNTech's balance sheet gives the company plenty of room to move ahead. The company ended the quarter with more than 16 billion euros in cash and securities, providing a cushion to fund its pipeline while it waits on catalysts, including roughly 600 million euros in Bristol Myers Squibb collaboration revenue expected later this year.

What matters now is what the company's oncology portfolio could become. Investors today are gaining exposure to a deep late-stage oncology pipeline, with multiple cancer drugs that offer real diversification. If pumitamig and other late-stage candidates continue to deliver positive data, BioNTech could be closer to becoming a major oncology player than the market realizes.

And with the stock trading below $100, now could be a compelling entry point for investors willing to look past the COVID-era narrative.

German COVID‑19 vaccine maker BioNTech (22UAy.DE) said on Monday it would close ​sites in Germany and Singapore because ‌it failed to find buyers after pivoting away from pandemic-era manufacturing.

"Despite the best efforts of ​all those involved and a wide-ranging ​sales process, it has unfortunately not ⁠been possible to finalise a sale," said ​a spokesperson.

The spokesperson added that the biotech ​firm had agreed with the works council on socially responsible solutions and supplementary redundancy terms for ​affected staff.

BioNTech said in May it would ​seek buyers for its German sites in Idar-Oberstein, ‌Marburg ⁠and Tuebingen, as well as in Singapore, or otherwise wind them down.

The restructuring, affecting up to 1,860 jobs, was part ​of a ​production transfer ⁠of its COVID-19 vaccine to partner Pfizer (PFE.N).

BioNTech, the initial inventor ​of the Western world's most commonly ​used ⁠immunisation shot during the pandemic, said in March that its two co-founders would leave by ⁠the ​end of this year ​to start a new venture.

($1 = 0.8554 euros)

BMO (BMO +1.55%) Capital Markets has been quite bullish about BioNTech SE (BNTX +2.02%) this year. However, that's no longer the case.

On Sept. 8, 2026, BioNTech's shares dipped after BMO downgraded the biotech stock from an "outperform" rating to a "market perform" rating. BMO also lowered its 12-month price target for BioNTech from $128 to $105.

There's a simple explanation for BMO's new take on BioNTech. But is Wall Street underestimating the company's cancer pipeline?

Image source: Getty Images.

What the downgrade got right -- and wrong It isn't all that surprising that BMO Capital Markets is now significantly less optimistic about BioNTech's near-term prospects than it once was. The global demand for BioNTech's COVID-19 vaccines continues to wane.

BMO's downgrade also followed a key setback in BioNTech's pipeline. On Aug. 28, 2026, the company announced that it was canceling a Phase 2 clinical trial evaluating the personalized mRNA cancer vaccine BNT122-01 for the treatment of colorectal cancer. There weren't any safety concerns, but the experimental therapy didn't demonstrate statistically significant efficacy. As a result of the bad news, the company lowered its full-year revenue guidance to €1.6 billion to €1.9 billion from its previous forecast of €2 billion to €2.3 billion.

Investors were excited about BioNTech after Moderna (MRNA +12.27%) and Merck (MRK +1.79%) reported positive results from a late-stage study of Moderna's personalized mRNA cancer vaccine intismeran autogene, in combination with Merck's blockbuster immunotherapy Keytruda. However, the momentum has now nearly evaporated.

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But the rest of BioNTech's oncology pipeline shouldn't be ignored. The company has over 25 Phase 2 and Phase 3 clinical studies evaluating experimental cancer therapies underway. It recently announced encouraging results from one of them, with gotistobart nearly doubling median overall survival compared with standard-of-care chemotherapy in previously treated patients with squamous non-small cell lung cancer (NSCLC).

BioNTech expects to report data from 11 other late-stage clinical studies by the end of 2029. These trials focus on multiple types of tumors, including breast cancer, gastrointestinal cancer, and lung cancer. Data from three studies will be announced before the end of this year.

A biotech stock that's still worth buying Meanwhile, BioNTech's market cap hovers around $24 billion. As of June 30, 2026, the company's cash, cash equivalents, and security investments totaled roughly €16.6 billion (around $19 billion). This arguably puts BioNTech in value stock territory.

Yes, BioNTech has experienced a big clinical setback and cut its full-year guidance. On the surface, the stock might seem to deserve a downgrade. However, investing in BioNTech right now amounts to getting a robust pipeline essentially for free. This biotech stock is still worth buying, in my view.

BioNTech's (BNTX +2.95%) shares were flying high in the aftermath of Moderna's (MRNA +8.55%) and Merck's (MRK +1.55%) announcement of impressive late-stage results for personalized messenger RNA (mRNA) cancer vaccine intismeran autogene in combination with Keytruda. The surge made sense, considering that BioNTech is developing its own mRNA cancer vaccines.

However, BioNTech's momentum came to a screeching halt with the company's update on Aug. 28, 2026, from a Phase 2 study of mRNA vaccine autogene cevumeran in treating colorectal cancer. BioNTech and its partner, Roche's (OTC: RHHBY) Genentech unit, decided to cancel the clinical trial due to a lack of efficacy. Should this move to throw in the towel worry investors?

Image source: Getty Images.

What is the real impact of BioNTech's setback? BioNTech's pipeline setback shouldn't have completely surprised investors. The independent Data Safety Monitoring Board (DSMB) for the Phase 2 study of autogene cevumeran concluded in October 2025 that the data were not yet mature enough to support reliable conclusions about efficacy. BioNTech and Genentech decided then to go ahead with the clinical trial.

What is the real impact of the termination of the Phase 2 study of the mRNA vaccine in treating colorectal cancer? It's certainly not as bad as the situation would have been if autogene cevumeran had safety issues. Serious safety concerns would have forced BioNTech to completely abandon the experimental vaccine.

But that isn't the case. BioNTech and Genentech continue to evaluate autogene cevumeran in another Phase 2 study targeting pancreatic cancer.

Both colorectal and pancreatic cancer are "cold" tumors that don't trigger strong immune responses. Moderna's mRNA vaccine achieved successful results in melanoma, a "hot" tumor for which the body's immune system mounts a significant natural response. BioNTech's failure in colorectal cancer, therefore, raises questions about whether or not the vaccine will work in treating pancreatic cancer.

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A cause for concern -- but not panic It's too early to write off BioNTech's prospects in pancreatic cancer, though. Any speculation that the company might reduce emphasis on its mRNA cancer vaccine focus is also premature. BioNTech co-founder and Chief Medical Officer Özlem Türeci stated, "We remain committed to mRNA as a key pillar in our oncology strategy, and our novel combination approaches."

BioNTech continues to advance other experimental mRNA cancer vaccines targeting head and neck cancer and non-small cell lung cancer. Its pipeline also features multiple other types of cancer therapies. The company recently announced that one of them, gotistibart, nearly doubled the median overall survival compared with chemotherapy in previously treated patients with squamous non-small cell lung cancer.

The bottom line is that BioNTech's termination of its Phase 2 study of autogene cevumeran in colorectal cancer is a legitimate cause of concern for investors. However, it isn't a reason to panic about the biotech stock.

Keith Speights has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends BioNTech Se, Merck, and Moderna. The Motley Fool recommends Roche Holding AG. The Motley Fool has a disclosure policy.

BioNTech SE (22UAy.DE) said it will end a mid-stage study of ‌its experimental mRNA cancer vaccine after an independent committee found the treatment was unlikely to help colorectal cancer patients live longer, sending the company's U.S.-listed shares 7.5% lower on Friday.

The trial was testing whether the immunotherapy, autogene cevumeran, prevented a recurrence in patients with high-risk, mid-stage colorectal cancer who ​had already undergone surgery but still had traces of cancer DNA in their blood.

BioNTech's trial failure comes ​days after Merck (MRK.N) and Moderna (MRNA.O) said their mRNA-based vaccine helped prevent the return and spread of melanoma in ⁠a trial of more than 1,000 patients whose tumors were removed surgically but who had a high risk of ​recurrence.

That success had raised hopes for similar mRNA-based vaccines, lifting shares of BioNTech 20% on the day.

The committee responsible for overseeing ​the safety and integrity of BioNTech's trial identified a "numerical imbalance" in overall survival between the patient groups in the study. It said continuing the trial was unlikely to show the vaccine was effective.

Analysts said the "numerical imbalance" likely meant more deaths occurred in the vaccine group than ​the control group.

BioNTech did not respond to a request for comment.

"Today's update is more concerning than a conventional futility stop ​given the numerical (overall survival) imbalance, although the magnitude remains unclear," BMO Capital Markets analyst Evan Seigerman said in a note.

The trial evaluated ‌whether ⁠the vaccine alone, given after surgery and three months of chemotherapy, could prevent recurrence in high-risk patients compared to standard watchful waiting.

CHALLENGES FOR MRNA VACCINES IN SOME TUMORS
BioNTech, a German vaccine maker, which is partnering with Roche's (ROPC.S) Genentech for the mRNA-based cancer vaccine, said that its decision to drop the study would not affect its other trial involving pancreatic cancer patients. ​Data from this study is ​expected in 2031.

Analysts said the ⁠failure is a negative signal for mRNA vaccines in "cold" tumors historically resistant to immunotherapy, like colorectal and pancreatic cancers, unlike "hot" tumors such as melanoma where Moderna succeeded.

This could also dim ​prospects for BioNTech's remaining pancreatic trial, despite its use of combination therapy with Roche's ​Tecentriq, analysts said.

BioNTech's vaccine, ⁠autogene cevumeran, is personalized to deliver instructions that teach the immune system to recognize each patient's specific tumor cells. The Merck-Moderna vaccine is similarly designed to target mutations unique to an individual patient's tumor.

The setback will likely accelerate BioNTech's strategic shift ⁠toward its ​non-mRNA pipeline, particularly its antibody-drug conjugates (ADCs) and bispecific cancer therapies, such as ​the experimental drug pumitamig.

BioNTech is also developing other mRNA-based cancer therapies, including BNT113 for head and neck cancer. Interim data from this study is expected ​later this year.

Pumitamig plus B7H3-targeting elfetabart drozuntecan delivers the first data in lung cancer for any PD-(L)1xVEGF bispecific immunomodulator combined with an antibody-drug conjugate, underscoring BioNTech’s leadership in novel-novel combination treatment strategiesUpdated overall survival data for gotistobart from the PRESERVE-003 Phase 3 clinical trial will add to the growing body of evidence for this chemotherapy-free treatment approach in the second- and later-line treatment of advanced squamous non-small cell lung cancer following prior immunotherapyBioNTech is advancing a diversified development program in lung cancer treatment spanning more than 16 ongoing clinical trials across subtypes, biomarkers and treatment settings, including five ongoing Phase 3 clinical trials and two novel-novel combination trials  MAINZ, Germany, August 20, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present new clinical data from its diversified development program in lung cancer treatment at the IASLC 2026 World Conference on Lung Cancer (“WCLC”) in Seoul, Republic of Korea, from September 12-15, 2026.

The breadth of data highlights the latest progress across key strategic assets, pumitamig (BNT327/BMS986545) and gotistobart (BNT316/ONC-392), as well as BioNTech’s mRNA-based immunotherapy approaches, highlighting the strength of BioNTech’s lung cancer treatment pipeline. Additionally, a late breaking oral presentation will detail data from the novel-novel combination trial of pumitamig with the investigational B7H3-targeted antibody-drug conjugate (“ADC”) elfetabart drozuntecan (elfe-D or BNT324/DB-1311), representing the first combination data for any PD-(L)1xVEGF bispecific immunomodulator and an ADC in lung cancer.

“Progress in lung cancer care means both improving treatment outcomes for patients and, importantly, finding better options for more patients who still do not sufficiently benefit from current standard therapies,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “The data we are presenting at this year’s WCLC provide further clinical evidence for our late-stage assets, gotistobart and pumitamig, and help to define the role of next-generation immunomodulators in addressing unmet medical needs in lung cancer. We are also presenting the first clinical evidence from a novel-novel treatment combination in lung cancer as part of our evaluation of pumitamig as a potential backbone for combination strategies of complementary mechanisms. Taken together, these data will inform the next steps in our clinical development programs and our broader efforts to expand treatment options for patients.”

Highlights from BioNTech’s presentations at WCLC 2026:

Novel-novel combination trial of pumitamig, developed in collaboration with Bristol Myers Squibb Company (“BMS”), and elfetabart drozuntecan, developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”):

Advanced/metastatic SCLC and NSCLC: First data from the global Phase 1/2 trial (NCT06892548) evaluating pumitamig in combination with the B7H3-targeting ADC elfetabart drozuntecan in patients with advanced or metastatic small cell lung cancer (“SCLC”) and NSCLC will be presented for this novel-novel treatment combination approach, underlining BioNTech’s leadership in novel-novel combination treatment strategies. Gotistobart – a tumor microenvironment-selective regulatory T cell depletion candidate targeting CTLA-4, developed in collaboration with OncoC4, Inc. (“OncoC4”):

2L+ squamous NSCLC: Updated overall survival data from stage 1 of the PRESERVE-003 Phase 3 clinical trial (NCT05671510) of gotistobart in patients with squamous non-small cell lung cancer (“NSCLC”) who progressed on prior PD-(L)1 inhibitor treatment will be presented. The results further contribute to the growing body of evidence for this chemotherapy-free treatment approach. The pivotal stage 2 part of the trial is ongoing. All abstracts are available through the WCLC website. Further information on BioNTech’s lung cancer pipeline can be accessed here.

Full presentation details:

CandidateAbstract TitleAbstract Number/Presentation DetailsPumitamig + elfetabart drozuntecanPumitamig (PD-L1 x VEGF-A bsAb) + Elfetabart Drozuntecan (Elfe-D, B7H3 ADC) in Patients with Advanced/Metastatic Lung Cancer (NSCLC or SCLC)Abstract # OA14.01
Oral Presentation
The Breakthrough Immunotherapy for Advanced NSCLC
Sep 15, 2026: 12:30 - 01:45pm KSTPumitamigFirst-line Pumitamig (PD-L1 × VEGF-A bsAb) Plus Chemotherapy in Unresectable Malignant Mesothelioma: Long-term PFS and OSAbstract #MO04.09
Mini Oral
Novel Therapeutics and Molecular Insights in Thymic Malignancies and Pleural Mesothelioma
Sep 13, 2026: 4:45 - 6:00pm KSTROSETTA Lung‑201: A Phase 3 Trial of Pumitamig Monotherapy vs Durvalumab in Unresectable Stage III NSCLC Post-ChemoradiationAbstract #P2.330
Poster
Clinical Trials in Progress
Sep 14, 2026: 10:30am - 12:00pm KSTROSETTA Lung-202: A Phase 3 trial of first-line pumitamig monotherapy vs pembrolizumab in locally advanced/metastatic NSCLCAbstract #P2.355
Poster
Clinical Trials in Progress
Sep 14, 2026: 10:30am - 12:00pm KSTGotistobartGotistobart vs Docetaxel in Metastatic Squamous NSCLC After PD-(L)1 Progression: Updated Overall Survival of the stage 1 of PRESERVE-003Abstract #MO07.04
Mini Oral
Novel Immunotherapeutic Strategies in mNSCLC
Sep 14, 2026: 5:00 - 6:15pm KSTBNT116Neoadjuvant BNT116 + Cemiplimab + Carboplatin + Paclitaxel in Resectable NSCLC: Preliminary Results From a Phase I TrialAbstract #MO06.03
Mini Oral
Emerging Precision Approaches in Perioperative Therapy for Resectable NSCLC Integrating Targeted Therapy, Immunotherapy, Biomarkers, and Multimodal Strategies
Sep 14, 2026: 3:30 - 4:45pm KST
About BioNTech in Lung Cancer Treatment
Lung cancer is one of BioNTech’s key focus areas. Through a diversified portfolio of investigational next-generation immunomodulators, ADCs and mRNA-based cancer immunotherapies, the Company is pursuing multiple approaches designed to address significant unmet needs for patients across lung cancer subtypes, histologies and treatment settings. BioNTech’s clinical pipeline encompasses both monotherapies and combinations with standard of care treatments, as well as novel-novel combination regimens aimed at delivering differentiated therapeutic profiles for the treatment of patients with lung cancer. With 16 ongoing lung cancer trials, including five pivotal Phase 3 and two novel-novel combination trials, BioNTech is advancing a comprehensive development strategy with the aim of improving outcomes for patients across the continuum of lung cancer.

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.

BioNTech 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: the initiation, timing, progress and results of BioNTech’s research and development programs in oncology, including the targeted timing and number of additional potentially registrational trials; BioNTech’s and its collaborators’ current and future preclinical and clinical trials in oncology, including the investigational bispecific immunomodulator pumitamig (BNT327/BMS986545) in unresectable malignant mesothelioma, the investigational anti-CTLA-4 antibody gotistobart (BNT316/ONC-392) in metastatic squamous NSCLC, the investigational B7H3-targeted ADC elfetabart drozuntecan (BNT324/DB-1311) in combination with pumitamig in (N)SCLC, and the investigational mRNA cancer immunotherapy candidate BNT116 in resectable NSCLC; the nature and characterization of and timing for release of clinical data across BioNTech’s platforms, which is subject to peer review, regulatory review and market interpretation; the planned next steps in BioNTech’s pipeline programs, including, but not limited to, statements regarding timing or plans for initiation or enrollment of clinical trials, or submission for and receipt of product approvals and potential commercialization with respect to BioNTech’s product candidates; and the potential safety and efficacy of BioNTech’s product candidates. 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; the ability to produce comparable clinical results in future clinical trials; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; discussions with regulatory agencies regarding timing and requirements for additional clinical trials; the impact of tariffs and escalations in trade policy; 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; 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 press release in the event of new information, future developments or otherwise.

CONTACTS

Media Relations
Jasmina Alatovic
[email protected]

Investor Relations
Douglas Maffei, PhD
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4 Reasons Pfizer Could Be a Value Play You Can't MissBioNTech NASDAQ: BNTX reported second-quarter 2026 revenue of €106 million, down from €261 million a year earlier, as lower U.S. demand for its COVID-19 vaccine weighed on results. The prior-year quarter also benefited from a one-time compensation payment from Pfizer related to its decision to opt out of a shingles vaccine development program.

The company lowered its full-year revenue outlook to €1.6 billion to €1.9 billion, citing softer-than-expected global COVID-19 vaccine demand, Germany’s planned use of previously manufactured vaccine inventory for the upcoming season, and the delayed timing of an out-licensed research-and-development milestone. BioNTech expects most of its 2026 revenue in the second half, including a €613 million collaboration payment from Bristol Myers Squibb expected in the third quarter.

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CEO Transition and Oncology Strategy Moderna Dips on Q2 Earnings But Can It Rip on a Short Squeeze?BioNTech announced that Guido Oelkers will become chief executive officer by Feb. 1 at the latest. Helmut Jeggle, chairman of the supervisory board, said Oelkers was selected for his strategic leadership, experience scaling global biopharmaceutical businesses and record of developing innovation-driven organizations.

Oelkers most recently served as CEO of Sobi, where Jeggle said he more than quadrupled revenue over nine years. Current CEO and co-founder Ugur Sahin said he will remain actively involved in preparing for Oelkers’ onboarding and characterized the transition as part of BioNTech’s evolution from a research-focused organization into a multi-product biopharmaceutical company.

Novavax Plunges on Earnings Miss: Falling Knife or Buying Opp?Sahin said BioNTech is advancing a tumor-focused oncology strategy spanning next-generation immunomodulators, antibody-drug conjugates, or ADCs, and mRNA cancer immunotherapies. The company is targeting more than 17 late-stage and pivotal-trial readouts through 2030 and beyond.

Lung Cancer Programs Advance Chief Medical Officer and co-founder Özlem Türeci highlighted progress for pumitamig, BioNTech’s investigational bispecific immunomodulator targeting PD-L1 and VEGF-A that is being developed with Bristol Myers Squibb. The company is running four registrational lung-cancer programs for the candidate, including trials in small cell lung cancer, first-line non-small cell lung cancer, PD-L1-high non-small cell lung cancer and unresectable stage 3 non-small cell lung cancer.

At the American Society of Clinical Oncology meeting in June, BioNTech presented global phase II data from ROSETTA-Lung 02, which is evaluating pumitamig plus chemotherapy in previously untreated advanced non-small cell lung cancer. Among 40 evaluable patients, the combination generated unconfirmed and confirmed overall response rates of 72.5% and 62.5%, respectively, according to Türeci.

In patients with PD-L1 tumor proportion scores below 1%, the confirmed objective response rate was 47.6%. It was 77.8% among patients with scores between 1% and 49%, while all six patients with scores of at least 50% responded. Türeci said the safety profile was manageable, with no new safety signals, and that the results support the ongoing global phase III program.

BioNTech also expects a first interim analysis for gotistobart in late 2026 in pivotal-stage testing for metastatic squamous non-small cell lung cancer. Gotistobart is a selective regulatory T-cell-depleting CTLA-4 antibody being developed with OncoC4. In the non-pivotal first stage of the PRESERVE-003 study, Türeci said gotistobart reduced the risk of death by 54% versus docetaxel, with a hazard ratio of 0.46. Median overall survival had not been reached in the gotistobart arm, compared with about 10 months for docetaxel.

ADC and mRNA Programs The company dosed the first patient in a phase III study of elfetabart drozuntecan, formerly known as BNT324, in taxane-naive metastatic castration-resistant prostate cancer. The B7-H3-targeting ADC is being developed with DualityBio and is being tested against docetaxel in patients whose disease progressed after second-generation androgen receptor pathway inhibitors.

Sahin said more than 1,000 patients have received the ADC across more than 10 tumor types, including 400 treated in combination with pumitamig. He said the company has seen durable disease control and a tolerable safety profile, including no significant interstitial lung disease events observed so far among patients treated for more than a year.

BioNTech expects to present data later in 2026 from a phase I/II trial of pumitamig plus BNT324 in advanced non-small cell and small cell lung cancers. Türeci described the dataset as the first clinical data for a PD-L1/VEGF-A bispecific antibody combined with an ADC in lung cancer.

In mRNA cancer immunotherapy, enrollment has been completed in a randomized phase II trial of autogene cevumeran in high-risk stage 2 or stage 3 colorectal cancer. An independent data safety monitoring board reviewed an interim analysis in June and recommended continuing the trial without modification. BioNTech expects the final, event-driven analysis in 2027.

The company also expects a phase III progression-free-survival interim analysis later this year for BNT113, its HPV16-targeting mRNA immunotherapy being tested with pembrolizumab in first-line, PD-L1-positive HPV16-positive head and neck cancer.

Guidance, Expenses and Capital Allocation BioNTech reported adjusted research-and-development expense of €477 million in the second quarter, down from €509 million a year earlier, reflecting portfolio prioritization and favorable partner cost-sharing effects. Adjusted selling, general and administrative expense rose to €198 million from €137 million, driven by investments in operational systems, prelaunch activities and the inclusion of CureVac operations following the merger.

For 2026, the company now expects adjusted R&D expense of €2 billion to €2.3 billion, while maintaining adjusted SG&A guidance of €700 million to €800 million. BioNTech ended the quarter with €16.6 billion in cash equivalents and security investments.

CFO Ramon Zapata said the company has repurchased $152 million of shares under its up-to-$1 billion repurchase authorization. He said BioNTech’s capital-allocation priorities remain funding its priority pipeline and commercial capabilities, maintaining flexibility for external opportunities, and returning capital to shareholders.

About BioNTech (NASDAQ:BNTX)BioNTech SE NASDAQ: BNTX is a Germany-based biotechnology company that develops next-generation immunotherapies and vaccines, with a primary focus on messenger RNA (mRNA) technology. Founded in 2008 and headquartered in Mainz, BioNTech advances a platform approach to design and manufacture therapeutics across oncology, infectious diseases and other high unmet-need areas. The company is publicly traded on the NASDAQ exchange and became widely known for its rapid development and global deployment of an mRNA-based COVID-19 vaccine in collaboration with Pfizer.

BioNTech's core activities include discovery research, clinical development and manufacturing of mRNA-based medicines, personalized cancer immunotherapies, engineered cell therapies, and antibody- and protein-based therapeutics.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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Data indicate that the 2026-2027 COVID-19 vaccine formula, targeting the XFG variant, induces a strong immune response against contemporary circulating and emerging lineages More than five billion doses of the Pfizer-BioNTech COVID-19 vaccines distributed globallyVaccine demonstrates a favorable safety and efficacy profile Shipping will begin soon to ensure rapid access of this season’s vaccine   NEW YORK and MAINZ, GERMANY, July 29, 2026 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the European Commission (EC) has granted marketing authorization for the companies’ 2026-2027 COVID-19 vaccine formula, targeting the XFG variant, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the Emergency Task Force (ETF) of the European Medicines Agency (EMA) to update COVID-19 vaccines to target the XFG variant of the JN.1 lineage for the 2026-2027 season. The ETF stated that “the evidence suggests that targeting XFG would provide the best protection against COVID-19.”1

The marketing authorization is valid in all 27 European Union (“EU”) Member States, as well as Iceland, Liechtenstein and Norway. Pfizer and BioNTech have already initiated manufacturing of the monovalent XFG-adapted COVID-19 vaccine at risk to ensure supply readiness in anticipation of the respiratory disease season, when the demand for COVID-19 vaccination is expected to increase. EU Member States as well as Norway, will be supplied either via the EC contract or according to individual country government policies.

The EC approval follows the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommendation from July 23, 2026 based on the cumulative body of evidence previously submitted by Pfizer and BioNTech that includes clinical, non-clinical and real-world data supporting the safety and efficacy of the Pfizer and BioNTech COVID-19 vaccine as well as manufacturing/quality and non-clinical data showing that the monovalent XFG-adapted COVID-19 vaccine generated strong immune responses against currently circulating SARS-CoV-2 lineages, including XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1 and other contemporary lineages.2

The companies have also submitted data for the updated COVID-19 vaccine to regulatory authorities around the world. The companies are continuing to monitor the evolving epidemiology of COVID-19 in preparation to meet global public health needs.

The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for the Pfizer-BioNTech COVID-19 vaccine and its adapted vaccines in the United States, the EU, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in other countries. 

EU SUMMARY OF PRODUCT CHARACTERISTICS 

Please see here for the full Summary of Product Characteristics for the Pfizer-BioNTech COVID-19 vaccine. 

IMPORTANT SAFETY INFORMATION

You or your child should NOT get COMIRNATY® (COVID-19 Vaccine, mRNA) if you or your child had a severe allergic reaction after a previous dose of COMIRNATY or any Pfizer-BioNTech COVID-19 vaccine or to any ingredient in these vaccinesThere is a remote chance that COMIRNATY could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. For this reason, the vaccination provider may ask you or your child to stay at the place where you or your child received the vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include: Difficulty breathingSwelling of the face and throatA fast heartbeatA bad rash all over the bodyDizziness and weakness Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines, including COMIRNATY and Pfizer-BioNTech COVID-19 vaccines. Myocarditis and pericarditis following administration of mRNA COVID-19 vaccines have occurred most commonly in males 12 years through 24 years of age. In most of these people, symptoms began within a week following vaccination. You should seek medical attention right away if you or your child have any of the following symptoms after receiving the COMIRNATY, particularly during the 2 weeks after receiving a dose of the vaccine: Chest painShortness of breathFeelings of having a fast-beating, fluttering, or pounding heartAdditional symptoms, particularly in children, may include: FaintingUnusual and persistent fatigue or lack of energyPersistent vomitingPersistent pain in the abdomenUnusual and persistent cool, pale skin Fainting can happen after getting injectable vaccines including COMIRNATY. Your vaccination provider may ask you to sit or lie downPeople with weakened immune systems may have a reduced immune response to COMIRNATYVaccination with COMIRNATY may not protect all people who receive the vaccine Before getting COMIRNATY, tell your vaccination provider about all of your or your child’s medical conditions, including if you or your child:

have any allergieshad a severe allergic reaction after receiving a previous dose of any COVID-19 vaccinehave had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)have a feverhave a bleeding disorder or are on a blood thinnerare immunocompromised or are on a medicine that affects your immune systemare pregnant, plan to become pregnant, or are breastfeedinghave received another COVID-19 vaccinehave ever fainted in association with an injection Additional side effects that have been reported with COMIRNATY or Pfizer-BioNTech COVID-19 vaccines include:

Non-severe allergic reactions such as rash, itching, hives, or swelling of the faceInjection site reactions: pain, swelling, redness, arm painGeneral side effects: tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell, swollen lymph nodes (lymphadenopathy), decreased appetite, diarrhea, vomiting, dizziness These may not be all the possible side effects of COMIRNATY. Ask your or your child’s healthcare provider about any side effects that concern you.

In addition, you can report side effects to Pfizer Inc. at 1-800-438-1985 or www.pfizersafetyreporting.com.

Please click here for full Prescribing Information and Patient Information for COMIRNATY.

About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. 

Pfizer Disclosure Notice
The information contained in this release is as of July 29, 2026. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about the Pfizer-BioNTech COVID-19 vaccine, including its potential benefits, manufacturing and supply, expectations regarding demand for COVID-19 vaccination and an approval by the European Commission to update the marketing authorization for the Pfizer-BioNTech COVID-19 vaccine to target the XFG variant of the JN.1 lineage for the 2026-2027 season, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of the Pfizer-BioNTech COVID-19 vaccine; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when applications may be filed with regulatory authorities in particular jurisdictions for the Pfizer-BioNTech COVID-19 vaccine for any potential indication, including for the 2026-2027 COVID-19 vaccine formula; whether and when any such applications that may be pending or filed for the Pfizer-BioNTech COVID-19 vaccine may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether the Pfizer-BioNTech COVID-19 vaccine will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of the Pfizer-BioNTech COVID-19 vaccine; risks and uncertainties related to changes to vaccine or other healthcare policy in the EU, the U.S. or other jurisdictions; the risk that demand for any products may be reduced or no longer exist or not meet expectations which may lead to reduced revenues or excess inventory on-hand and/or in the channel or other unanticipated charges; uncertainties related to recommendations and coverage for, and the public’s adherence to vaccines, boosters, treatments or combinations; risks related to our ability to accurately predict or achieve our revenue forecasts for the Pfizer-BioNTech COVID-19 vaccine or any potential future COVID-19 vaccines; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

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.

BioNTech 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 efforts to combat COVID-19; the collaboration between BioNTech and Pfizer; regulatory submissions and regulatory approvals or authorizations, including an approval by the European Commission to update the marketing authorization for the Pfizer-BioNTech COVID-19 vaccine to target the XFG variant of the JN.1 lineage for the 2026-2027 season; expectations regarding manufacturing, distribution and supply; qualitative assessments of available data and expectations of potential benefits, including the adapted vaccine’s response against multiple SARS-CoV-2 lineages, including the XFG variant of the JN.1 lineage and other circulating sublineages; 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. 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 from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with 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; 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; the availability of raw materials to manufacture a vaccine; our vaccine’s formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery; competition from other COVID-19 vaccines or related to BioNTech’s other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for BioNTech’s 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; the impact of COVID-19 on BioNTech’s development programs, supply chain, collaborators and financial performance; unforeseen safety issues and potential claims that are alleged to arise from the use of BioNTech’s COVID-19 vaccine and other products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market BioNTech’s COVID-19 vaccine and, if approved, its product candidates; BioNTech’s ability to manage its development and related expenses; regulatory developments in the United States and other countries; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time.

You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech's Report on Form 6-K for the period ended March 31, 2026, and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at https://www.sec.gov/. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.

CONTACTS

Pfizer:
Media Relations
+1 (212) 733-1226
[email protected]

Investor Relations
+1 (212) 733-4848
[email protected]

BioNTech:
Media Relations
Jasmina Alatovic
[email protected]

Investor Relations
Douglas Maffei, Ph.D.
[email protected]

1 ETF. ETF recommends updating COVID-19 vaccines to target XFG variant. Updated May 29, 2026. Accessed June 25, 2026. https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-xfg-variant
2 Vaccines and Related Biological Products Advisory Committee. Meeting Presentation - 2026-2027 COVID-19 Vaccine Formula: Pfizer/BioNTech Supportive Data. May 28, 2026. Accessed June 25, 2026. https://www.fda.gov/media/192765/download

On July 7, Cathie Wood's Ark Genomic Revolution ETF (ARKG +0.39%) sold over 44,000 shares of BioNTech (BNTX 0.32%), a German immunotherapy maker. The next day, it sold over 78,000 shares, a transaction valued at around $7.4 million.

As of July 10, that left her asset management company with just 307 shares, valued at a little more than $28,000. Because Ark Invest holds positions worth millions of dollars and BioNTech is now the smallest holding in this entire exchange-traded fund (ETF), it may be fair to assume that Wood has moved on from BioNTech.

Image source: Getty Images.

What may have caused BioNTech to get the boot One thing to know about ARKG is that it's an actively managed ETF, so it's common for the fund to move in and out of stocks frequently.

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Because Wood's ETF has now sold most of its BioNTech shares, it appears to be moving on, freeing up capital for Ark Invest. BioNTech stock has underperformed this year; as of this writing, its price is down nearly 4% year to date and has dipped more than 17% over the last 12 months. But there are challenges ahead that could continue to send shares lower.

One is that revenue is expected to land somewhere between 2 billion euros ($2.2 billion) and 2.3 billion euros ($2.6 billion) in 2026, a significant decrease from the 2.9 billion euros ($3.3 billion) reported for 2025. That's largely due to an expected drop in revenue from its COVID-19 vaccine, developed in partnership with Pfizer.

Another financial issue is that BioNTech reported back-to-back net losses in 2024 and 2025, after a net profit of 900 million euros ($1 billion) in 2023. That trend of net losses will likely continue, as BioNTech already showed a net loss in its 2026 first-quarter earnings report.

There are also issues on the leadership front. BioNTech's co-founders, Uğur Şahin and Özlem Türeci, are leaving the company by the end of 2026. Şahin is the CEO, and Türeci is the chief medical officer, so those are significant roles to fill. What makes that leadership transition even more challenging is that BioNTech has been shifting its focus from vaccines to oncology treatments.

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Is it time to sell BioNTech? The move from Ark Invest is notable. While investors shouldn't automatically follow its lead in selling the stock, BioNTech is trying to overcome several challenges at once. The company has a promising clinical pipeline of more than 25 phase 2 or phase 3 trials in oncology, but it only has one commercial product -- that COVID vaccine with slumping sales. All of this is complicated by the need to find new leadership.

If you haven't invested yet, you may want to consider holding off on starting a position -- at least until new management is found and the drugs in the pipeline show more progress.