BioNTech SE (BNTX) SEC Filings

BioNTech SE (BNTX) announced that its Supervisory Board has approved the appointment of KPMG AG Wirtschaftsprüfungsgesellschaft as the company’s independent auditor for the financial year ending December 31, 2027, subject to election by shareholders at the upcoming Annual General Meeting.

The decision follows a comprehensive and competitive audit tender process overseen by the Audit Committee, which unanimously recommended KPMG. BioNTech states that, although it is not subject to mandatory auditor rotation requirements, periodically reassessing external audit arrangements through such processes is viewed as consistent with good governance practices.

BioNTech SE (BNTX) Chief Executive Officer and ten percent owner Ugur Sahin reported open-market sales of BioNTech ordinary shares under a pre-arranged Rule 10b5-1 trading plan established on June 3, 2026. He sold 15,000 ordinary shares on September 16, 2026 at an average price of $96.0893 per share and 34,000 ordinary shares on September 15, 2026 at an average price of $96.4893 per share, for total reported sales of 49,000 shares.

Following these transactions, a reported 39,218,111 ordinary shares are held indirectly through Medine GmbH, of which Sahin is the sole shareholder. The filing notes that 106,721 of these shares are held in trust, where Medine GmbH has voting but not dispositive power, and that Sahin may be deemed to beneficially own the shares held by Medine GmbH.

BioNTech SE (BNTX) reported that Chief Executive Officer and major shareholder Ugur Sahin sold a total of 86,000 ordinary shares in mid-September 2026 under a pre-arranged trading plan. He sold 41,000 shares on September 14, 2026 at an average price of 99.4467 per share and 45,000 shares on September 11, 2026 at an average price of 96.9338 per share.

After these sales, an entity associated with him, Medine GmbH, held 39,218,111 ordinary shares indirectly, including 106,721 shares held in trust where Medine GmbH has voting power but not dispositive power. The sales were effected pursuant to a Rule 10b5-1 trading plan established on June 3, 2026.

BioNTech SE (BNTX) reported updated stage 1 data from the global Phase 3 PRESERVE-003 trial of gotistobart (BNT316/ONC-392) in patients with metastatic squamous non-small cell lung cancer whose disease progressed after prior immunotherapy and chemotherapy. In this randomized comparison versus docetaxel, gotistobart monotherapy showed a statistically significant, clinically meaningful improvement in median overall survival.

Among 87 randomized patients (45 gotistobart; 42 docetaxel) and a median follow-up of 25.4 months as of July 17, 2026, median overall survival was 18.5 months with gotistobart versus 10.0 months with docetaxel (hazard ratio 0.56, nominal p=0.0295). Grade ≥3 treatment-related adverse events occurred in 44.4% of patients on gotistobart and 48.8% on docetaxel, indicating a manageable safety profile. The pivotal stage 2 portion of PRESERVE-003 is ongoing at more than 160 sites globally, and gotistobart holds U.S. Fast Track and Orphan Drug Designations and a Breakthrough Therapy Designation in China for related NSCLC indications.

BioNTech SE (BNTX) reports that Chief Executive Officer and ten percent owner Ugur Sahin sold 20,500 Ordinary Shares on September 10, 2026 in an open-market or private transaction at $96.31 per share, under a Rule 10b5-1 trading plan established on June 3, 2026. Following this sale, he holds 688,209 Ordinary Shares directly and 39,218,111 Ordinary Shares indirectly through Medine GmbH, including 106,721 shares held in trust where Medine GmbH has voting but not dispositive power and Sahin may be deemed to beneficially own those shares.

BioNTech SE (BNTX) reported that Chief Executive Officer and ten percent owner Ugur Sahin sold ordinary shares in two open-market or private transactions under a pre-arranged Rule 10b5-1 trading plan established on June 3, 2026. On September 8 and 9, 2026 he sold an aggregate of 73,000 ordinary shares. An indirectly held position of 39,218,111 ordinary shares, mainly through Medine GmbH, is reported after these transactions.

BioNTech SE (BNTX) reported that Chief Executive Officer Ugur Sahin sold a total of 76,500 Ordinary Shares in open-market transactions pursuant to a Rule 10b5-1 trading plan established on June 3, 2026. The sales occurred on September 3 and September 4, 2026 at prices just above $102 and $103 per share.

BioNTech SE (BNTX) received a Rule 144 notice that Medine GmbH intends to sell up to 858,209 American Depositary Shares representing ordinary shares, to be sold through Berenberg Capital Markets LLC. The filing lists an aggregate market value of $89,090,676.29 for these securities and notes that BioNTech had 251,204,366 shares outstanding.

BioNTech SE (BNTX) has decided to terminate its Phase 2 colorectal cancer trial BNT122-01 (NCT04486378) of autogene cevumeran, an individualized mRNA cancer immunotherapy given as adjuvant monotherapy to ctDNA‑positive, surgically resected Stage II (high risk) and Stage III colorectal cancer patients. The decision, made in consultation with Genentech, follows a new recommendation from the independent Data Safety Monitoring Board, which identified a numerical imbalance in overall survival between treatment arms and concluded that further continuation was unlikely to change the efficacy outcome. No new safety signals were observed, and investigators and regulators have been informed. BioNTech plans a thorough data analysis to guide future mRNA oncology development, while the separate Phase 2 IMcode003 trial of autogene cevumeran in adjuvant pancreatic cancer in combination with checkpoint inhibition and chemotherapy continues as planned.