BioNTech SE

BNTX

Held by 6 specialist biotech funds

High Convergence

6 funds opened new positions. Next phase3 readout (BNT162b2): Oct 2022. Short interest: 3.8% of float.

BiotechnologyCEO: Ugur SahinIPO: 2019Website ↗

BioNTech SE, a biotechnology company, develops and commercializes immunotherapies for cancer and other infectious diseases. The company is developing FixVac product candidates, including BNT111, which is in Phase II clinical trial for advance melanoma; BNT112 that is in Phase I/IIa clinical trial for prostate cancer; BNT113, which is in Phase II clinical trial to treat HPV+ head and neck cancers; BNT114 that is in Phase I clinical trial for triple negative breast cancer; BNT115, which is in Phase I clinical trial in ovarian cancer; and BNT116, a preclinical stage product for non-small cell lung cancer. It also develops neoantigen specific immunotherapies, such as Autogene cevumeran (BNT122), which is in Phase II clinical trial for first-line melanoma, as well as in Phase 1a/1b clinical trial to treat multiple solid tumors; mRNA intratumoral immunotherapy comprising SAR441000 that is in Phase I clinical trial for solid tumors; and BNT141 and BNT142 that are in Phase I clinical trial to treat multiple solid tumors. In addition, the company develops RiboCytokines, which include BNT151, BNT152, and BNT153 to treat solid tumors; chimeric antigen receptor T cell immunotherapies, such as BNT211 to treat multiple solid tumors, and BNT221 for other cancers; and checkpoint immunomodulators consisting of GEN1046 and GEN1042, which are in Phase I/II clinical trial to treat solid tumors. Further, it develops BNT321, an IgG1 monoclonal antibody in Phase II clinical trial for pancreatic cancer; BNT411, a small molecule immunomodulator product candidate for solid tumors; prophylactic vaccine for COVID-19 and Influenza; and infectious disease immunotherapies and rare disease protein replacement therapies. The company has collaborations with Genentech, Inc.; Sanofi S.A.; Genmab A/S; Pfizer Inc.; Shanghai Fosun Pharmaceutical (Group) Co., Ltd.; and Regeneron Pharmaceuticals, Inc. BioNTech SE was incorporated in 2008 and is headquartered in Mainz, Germany.

Catalysts

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

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

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

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

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

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

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

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 2Q2 2025BNT165eMalariaNCT06069544

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

Phase 2NegativeQ4 2025BNT142Solid TumorNCT05262530

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

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

Phase 2Q1 2026BNT164a1TuberculosisNCT05547464

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

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

Phase 3Q2 2026DB-1303/BNT323Metastatic Breast CancerNCT06018337

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 VaccineCOVID-19, SARS-COV-2 InfectionNCT07300839

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

Phase 2Q3 2026PM8002CRC (Colorectal Cancer)NCT07133750

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

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 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 3Q2 2029BNT113Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Recurrent Head and Neck CancerNCT04534205

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 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

BNT162b2 mRNA Vaccination Activates Spike-Reactive Regulatory T Cells in Humans.

# Investment Summary: BNTX Spike-Reactive Treg Activation **Clinical Finding:** The study demonstrates that BNT162b2 vaccination induces regulatory T cells (Tregs) specific to the spike protein, suggesting a mechanism for immune tolerance alongside protective immunity. **Investor Implications:** This finding could support BNTX's pipeline development for next-generation vaccines or therapeutic applications, as Treg activation may explain favorable safety profiles and durability patterns. However, the commercial relevance depends on whether this mechanism differentiates BNT162b2 from competitors or enables new indications—clarification would be needed on whether Treg induction is desirable or potentially limits efficacy against emerging variants.

Aug 24, 2026

PubMed

Role of plasmacytoid dendritic cells in humoural and CD8(+) T-cell memory responses following BNT162b2 mRNA vaccination: a preclinical mouse study.

# Investment Summary: BioNTech pDC Research This preclinical study demonstrates that plasmacytoid dendritic cells (pDCs) play a functional role in generating both antibody and CD8+ T-cell memory responses to BNT162b2, identifying a specific immune mechanism underlying the vaccine's efficacy. Understanding pDC activation could inform optimization of BioNTech's mRNA vaccine platform for improved durability or breadth of immune response in future formulations. For investors, this mechanistic insight supports potential competitive advantages in next-generation mRNA vaccine development, though clinical translation and commercial value remain contingent on demonstrating superiority over existing vaccines in phase trials.

Aug 21, 2026

PubMed

2024-2025 BNT162b2 KP.2 COVID-19 full season vaccine effectiveness from vaccine registries linked to administrative claims in two states: A cohort study in non-immunocompromised adults.

# BioNTech COVID-19 Vaccine Effectiveness Study Summary This study demonstrates real-world effectiveness of BioNTech's KP.2-targeted COVID-19 vaccine during the 2024-2025 season in non-immunocompromised adults using linked administrative data, providing evidence supporting continued vaccination recommendations and potential market demand. The full-season effectiveness data strengthens the clinical rationale for annual COVID boosters, which could support sustained revenue from the endemic COVID market, though the magnitude of protection and comparison to prior variants will determine commercial significance. Published effectiveness evidence may influence formulary decisions and public health guidance, directly impacting vaccination rates and market penetration in the U.S. market. **Investor relevance:** Real-world effectiveness data validates BioNTech's vaccine strategy for evolving variants and supports predictability of recurring annual revenue, though absolute efficacy levels and competitive positioning against other manufacturers remain critical to assess

Aug 13, 2026

PubMed

SARS-CoV-2 mRNA Vaccination Induces Neutralizing Antibodies and Type I IFN Changes in People Living With HIV.

# BioNTech Investment Summary **Clinical Finding:** The study demonstrates that BioNTech's mRNA COVID-19 vaccine generates neutralizing antibodies and Type I interferon responses in immunocompromised HIV-positive patients, validating safety and immunogenicity in a vulnerable population previously considered high-risk for vaccination. **Investment Implication:** This data supports BioNTech's mRNA platform applicability across immunocompromised populations and strengthens the commercial case for expanded vaccine access in underserved markets, while potentially reducing liability concerns around vaccine safety in HIV+ populations—a meaningful consideration for emerging market penetration and public health partnerships.

Aug 1, 2026

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