BioNTech SE

BNTX

Held by 6 specialist biotech funds

High Convergence

6 funds opened new positions. Next phase2 readout (DB-1305/BNT325): Jun 2025. Short interest: 3.7% of float.

BiotechnologyCEO: Ugur SahinIPO: 2019Website ↗

BioNTech SE, a biotechnology firm, specializes in the creation and marketing of immune-based treatments for malignancies and various infectious diseases. A significant part of its oncology pipeline includes the FixVac cancer vaccine program, which features several candidates in different phases of clinical development: BNT111 is in Phase 2 for advanced melanoma. BNT112 has reached Phase 1/2a for prostate cancer. BNT113 is undergoing Phase 2 investigation for HPV-positive head and neck cancers. BNT114 is in Phase 1 for triple-negative breast cancer. BNT115 is also in Phase 1, targeting ovarian cancer. BNT116 is a preclinical candidate for non-small cell lung cancer. The company also pioneers personalized therapies that target neoantigens, such as Autogene cevumeran (BNT122), which is in Phase 2 for first-line melanoma and Phase 1a/1b for a range of solid tumors. Furthermore, its pipeline includes an mRNA-based intratumoral immunotherapy, SAR441000, currently in Phase 1 for solid tumors, as well as BNT141 and BNT142, also in Phase 1 for multiple solid tumors. BioNTech's portfolio extends to RiboCytokine therapies (BNT151, BNT152, and BNT153) aimed at solid tumors, and cutting-edge chimeric antigen receptor T-cell (CAR T-cell) immunotherapies like BNT211 for various solid tumors and BNT221 for other types of cancer. Immune checkpoint modulators, specifically GEN1046 and GEN1042, are also under Phase 1/2 clinical investigation for solid tumors. Beyond these, the firm is developing BNT321, an IgG1 monoclonal antibody in Phase 2 for pancreatic cancer, and BNT411, a small molecule immunomodulator candidate for solid tumors. Its broader scope encompasses preventative vaccines for illnesses like COVID-19 and Influenza, additional immunotherapies for infectious diseases, and protein replacement therapies designed for rare conditions. To advance its extensive pipeline, BioNTech has forged strategic partnerships with major pharmaceutical and biotechnology firms, including Genentech, Sanofi S.A., Genmab A/S, Pfizer Inc., Shanghai Fosun Pharmaceutical (Group) Co., Ltd., and Regeneron Pharmaceuticals, Inc. Established in 2008, BioNTech SE maintains its principal operations in Mainz, Germany.

Catalysts

Phase 2Q1 2021BNT162b2SARS-Co V-2NCT04649021

Phase 2PositiveQ1 2021BNT162b3Covid-19, Protection Against COVID-19NCT04537949

Phase 2PositiveQ2 2021BNT162a1Infections, Respiratory, Virus Diseases, Infection ViralNCT04380701

Phase 3PositiveQ3 2021BNT162b2SARS-Co V-2 Infection, COVID-19NCT04713553

Phase 3PositiveQ4 2021BNT162b2SARS-Co V-2 Infection, COVID-19NCT04816669

Phase 2PositiveQ2 2022BNT162b2s01COVID-19, SARS-Co V-2 InfectionNCT04949490

Phase 3Q3 2022BNT162b2SARS-Co V-2 Infection, COVID-19, Maternal ImmunizationNCT04754594

Phase 3Q4 2022BNT162b2SARS-Co V-2 Infection, COVID-19NCT05310084

Phase 3Q1 2023BNT162b1SARS-Co V-2 Infection, COVID-19NCT04368728

Phase 3Q2 2023BNT162b2SARS-Co V-2 Infection, COVID-19NCT04955626

Phase 2Q3 2023BNT162b2SARS-Co V-2 Infection, COVID19NCT04895982

Phase 2NegativeQ3 2023BNT141Solid Tumor, Gastric Cancer, Gastroesophageal Junction AdenocarcinomaNCT04683939

Phase 2Q3 2023BNT162b2SARS-Co V-2 Infection, COVID-19, SARS-Co V-2 Acute Respiratory DiseaseNCT05004181

Phase 3PositiveQ4 2023Biological/Vaccine: BNT162b2 10mcgSARS-Co V-2 Infection, COVID-19NCT04816643

Phase 2PositiveQ4 2023bivalent BNT162b2 (original/Omi BA.4/BA.5)Influenza, Human, COVID-19NCT05596734

Phase 2NegativeQ1 2024BNT411Solid Tumor, Extensive-stage Small Cell Lung CancerNCT04101357

Phase 2NegativeQ1 2024BNT112Prostate CancerNCT04382898

Phase 2Q1 2024BNT111Melanoma Stage III, Melanoma Stage IV, Unresectable MelanomaNCT04526899

Phase 3Q1 2024BNT162b5 Bivalent (WT/OMI BA.2)SARS-Co V-2 Infection, COVID-19NCT05472038

Phase 2NegativeQ2 2024BNT151Solid TumorNCT04455620

Phase 2NegativeQ3 2024BNT321 0.5 mg/kgPancreatic CancerNCT06069778

Phase 3Q4 2024Influenza and COVID-19 Combination AInfluenza, COVID-19NCT06178991

Phase 3Q1 2025BNT162b2 (Omi XBB.1.5)SARS-Co V-2 Infection, COVID-19NCT05997290

Phase 2Q2 2025BNT165eMalariaNCT06069544

Phase 2Jun 30, 2025DB-1305/BNT325Advanced Solid TumorNCT05438329

Primary: Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. (up to 28 days after Cycle 1 Day 1)Enrollment:Target 1,123Sites: 93NA, TREATMENT

Phase 2Q3 2025Investigational Influenza VaccineInfluenza, Human, COVID-19NCT06683352

Phase 2Q3 2025BNT166aMonkeypoxNCT05988203

Phase 2NegativeQ4 2025BNT142Solid TumorNCT05262530

Phase 2Dec 30, 2025GEN1042Malignant Solid Tumor, Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC)NCT04083599

Primary: Dose Escalation and Safety Run-in Parts: Number of Participants With Dose-Limiting Toxicities (DLTs) (First Cycle (21 days))Enrollment:350/350Sites: 76NON_RANDOMIZED, TREATMENT

Phase 3Q1 2026DB-1303/BNT323HER2-positive Breast CancerNCT06265428

Primary: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Up to approximately 24 months.)Enrollment:228/228Sites: 48RANDOMIZED, TREATMENT

Phase 2Q1 2026BNT164a1TuberculosisNCT05547464

Primary: Frequency of solicited local reactions (pain, erythema/redness, induration/swelling) at the injection site up to 7 days after each dose (Up to 7 days after each dose)Enrollment:497/497Sites: 8RANDOMIZED, TRIPLE, PREVENTION

Phase 2Q2 2026DB-1303/BNT323HER2-positive Advanced Solid TumorNCT05150691

Primary: Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. (up to 21 days after C1D1)Enrollment:Target 796Sites: 102RANDOMIZED, TREATMENT

Phase 3Q2 2026BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)COVID-19, SARS-COV-2 InfectionNCT07069309

Phase 3Q2 2026DB-1303/BNT323Metastatic Breast CancerNCT06018337

Primary: Progression-free survival (PFS) in the HR+, HER2-low population (Up to approximately 51 months)Enrollment:541/541Sites: 258RANDOMIZED, TREATMENT

Phase 3Q3 2026Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram doseSARS-Co V-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19NCT05543616

Phase 3Q3 2026BNT162b2 (2025/2026 formulation)COVID-19, SARS-COV-2 InfectionNCT07222384

Phase 3Q3 2026BNT162b2 VaccineCOVID-19, SARS-COV-2 InfectionNCT07300839

Primary: Percentage of participants reporting local reactions or systemic events (From Day 1 up to 7 days after Vaccination)Enrollment:5,240/5,240Sites: 196RANDOMIZED, QUADRUPLE, PREVENTION

Phase 2Q3 2026PM8002CRC (Colorectal Cancer)NCT07133750

Primary: Objective response rate (ORR) (Up to approximately 2 years)Enrollment:Target 100Sites: 11RANDOMIZED, TREATMENT

Phase 2Q4 2026RO7198457 intravenous (IV)Colorectal Cancer Stage II, Colorectal Cancer Stage IIINCT04486378

Primary: Disease-free survival (DFS) (Through study completion, up to 5 years)Enrollment:Target 327Sites: 85RANDOMIZED, TREATMENT

Phase 3Q2 2027BNT162b2COVID-19 VaccinesNCT07798648

Primary: Percentage of participants reporting local reactions or systemic events (For up to 7 days after vaccination)Enrollment:Target 700Sites: 14RANDOMIZED, TRIPLE, PREVENTION

Phase 2Q2 2027BNT327 Dose Level 1 (DL1)Extensive-stage Small-cell Lung Cancer, Small-cell Lung CancerNCT06449209

Phase 2Q2 2027BNT166aMpox (Monkeypox), Smallpox, Orthopoxvirus InfectionNCT07379580

Phase 3Aug 31, 2027GotistobartNon Small Cell Lung CancerNCT05671510

Phase 2Q4 2027BNT3212Advanced Solid TumorNCT07147348

Phase 2Q4 2027DB-1311Advanced Solid TumorsNCT05914116

Phase 2Q4 2027PumitamigPancreatic Ductal Adenocarcinoma (PDAC)NCT07255404

Phase 2Jan 26, 2028BNT116Advanced Non-Small Cell Lung CancerNCT05557591

Phase 2Q1 2028PumitamigRecurrent GlioblastomaNCT07297212

Phase 3Q1 2028BNT323/DB-1303Endometrial CancerNCT06340568

Phase 2Q1 2028BNT326Advanced Solid TumorNCT07070232

Phase 3Q3 2028BNT113Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Recurrent Head and Neck CancerNCT04534205

Phase 2Q3 2028BNT327 Dose Level 1 (DL1)Locally Advanced Breast Cancer, Triple Negative Breast Cancer, Metastatic Triple Negative Breast CancersNCT06449222

Phase 2Q3 2028BNT324Advanced Lung CancerNCT06892548

Phase 2Q4 2028PumitamigNon-small Cell Lung CancerNCT06841055

Phase 2Q4 2028BNT326Non-small Cell Lung CancerNCT07111520

Phase 3Q4 2028PumitamigExtensive-stage Small-cell Lung CancerNCT06712355

Phase 3Q1 2029PumitamigNon-small Cell Lung CancerNCT06712316

Phase 2Mar 7, 2029Autogene CevumeranMuscle-invasive Urothelial CarcinomaNCT06534983

Phase 2Q3 2029BNT323Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast CancerNCT06827236

Phase 2Oct 15, 2029PumitamigHepatocellular Carcinoma (HCC)NCT07291076

Phase 2Nov 28, 2029PumitamigAdvanced Renal Cell Carcinoma (RCC)NCT07293351

Phase 3Q4 2029PumitamigBreast NeoplasmsNCT07173751

Phase 3Feb 2, 2030PumitamigUntreated, Unresectable, or Metastatic Colorectal CancerNCT07221357

Phase 2Q2 2030BNT329Advanced Solid CancersNCT07186842

Phase 2Jun 30, 2030DB-1311/BNT324Solid TumorsNCT06953089

Phase 3Sep 18, 2030PumitamigNon-small Cell Lung Cancer (NSCLC)NCT07361497

Phase 2Q4 2030BNT3214Advanced Solid Tumor CancerNCT07455734

Phase 3Nov 8, 2030PumitamigUntreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal AdenocarcinomaNCT07221149

Phase 2Q4 2030BNT314Metastatic Colorectal CancerNCT07079631

Phase 2Jan 1, 2031Autogene cevumeranAdenocarcinoma, Pancreatic DuctalNCT05968326

Phase 3Q1 2031BNT324Metastatic Castration-resistant Prostate CancerNCT07365995

Phase 2Q2 2031BNT317 DL1Advanced Solid TumorNCT06750185

Phase 3Oct 14, 2031PumitamigNon-Small Cell Lung Cancer (NSCLC)NCT07361510

Phase 2Q2 2042CLDN6 CAR-TTesticular Germ Cell Tumor, Extragonadal Germ Cell TumorNCT06940804

Recent News & Research

PubMed

Comparative immunogenicity of mRNA-1273 and BNT162b2 SARS-CoV-2 bivalent booster vaccines in US nursing home residents.

# Investment Summary: mRNA-1273 vs BNT162b2 Bivalent Booster Immunogenicity **Clinical Finding:** This head-to-head immunogenicity study in nursing home residents compares BioNTech's BNT162b2 bivalent booster against Moderna's mRNA-1273 booster, evaluating antibody responses and durability in an immunocompromised population critical for repeat vaccination. **Investment Implications:** The comparative data could impact BioNTech's booster market positioning if mRNA-1273 demonstrates superior or non-inferior immunogenicity in this high-revenue segment. For BNTX, results suggesting equivalent or inferior performance would pressure booster revenue projections and influence healthcare provider/payer formulary decisions for annual COVID campaigns. **Why It Matters:** Bivalent/updated boosters represent a

Dec 1, 2026

PubMed

Stroke risk following BNT162b2 vaccination: a systematic review and meta-analysis of self-controlled case series studies.

# Investment Summary: BioNTech BNT162b2 Stroke Risk Analysis **Key Finding:** A 2026 meta-analysis of self-controlled case series studies examining stroke risk following BNT162b2 vaccination warrants careful review of the underlying data quality and clinical significance, as any validated safety signal could trigger regulatory scrutiny, label modifications, or litigation exposure for BioNTech. **Investor Relevance:** The clinical and commercial impact depends critically on whether the meta-analysis identifies a statistically meaningful causal relationship versus background incidence rates—genuine safety concerns could reduce vaccination uptake or create product liability liabilities, while confirmation of acceptable risk profiles would support continued market confidence in the vaccine franchise. **Recommendation:** Investors should obtain the full publication to assess (1) effect size magnitude and confidence intervals, (2) study heterogeneity and methodology robustness, and (3) whether findings align

Dec 1, 2026

PubMed

Cardiac outcomes following SARS-CoV-2 infection versus BNT162b2 vaccination in adolescents and young adults: a cohort study of 4 million individuals.

# Summary for BNTX Investor This study comparing cardiac outcomes between COVID-19 infection and BNT162b2 vaccination in 4 million adolescents/young adults provides real-world safety data supporting the risk-benefit profile of BioNTech's lead vaccine product. The findings reinforce the clinical evidence basis for continued BNT162b2 utilization and reduce regulatory/litigation risk around cardiac adverse event claims. For BNTX, this represents supportive data for vaccine uptake in younger demographics and potential defenses against product liability claims, though relevance is limited given mature market penetration and the vaccine's established safety profile.

Oct 3, 2026

PubMed

KP.2-Adapted BNT162b2 COVID-19 Vaccine Uptake and Effectiveness in Children.

# BioNTech Investment Summary **Study Finding:** This pediatric data demonstrates clinical uptake and real-world effectiveness of BioNTech's KP.2-adapted COVID vaccine in children, providing evidence for continued market relevance in an endemic phase of the pandemic. **Investor Implications:** The data supports BioNTech's recurring revenue model from annual COVID booster campaigns targeting pediatric populations, though growth trajectory will depend on vaccination rate maintenance and competitive pricing dynamics as COVID vaccines transition to routine immunization schedules rather than emergency demand.

Oct 1, 2026

PubMed

Safety and immunogenicity of mRNA-based mpox vaccine candidate BNT166a: an open-label, dose-escalation, first-in-human trial.

# BioNTech mpox vaccine candidate (BNT166a) - Investment Summary BNT166a demonstrates acceptable safety and immunogenicity in early-stage human testing, establishing proof-of-concept for BioNTech's mRNA platform application beyond COVID-19 and RSV. Successful advancement from Phase 1 suggests potential pathway to address the mpox market, though clinical efficacy data and competitive dynamics with other mpox vaccine candidates remain key variables for commercial viability. This diversification into additional infectious disease indications could provide revenue optionality if regulatory approval is achieved, but near-term impact depends on market demand trajectory and differentiation versus existing mpox vaccines (including ACAM2000, Jynneos, and Imvanex). **Key investor considerations:** Timeline to Phase 2/3 data, regulatory pathway clarity (expedited programs possible given public health interest), and manufacturing capacity allocation relative to

Oct 1, 2026

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