BioNTech’s Clinical and Corporate Overhaul: Cancer Data Improves as COVID Era Ends
15.05.2026 - 07:33:34 | boerse-global.de
BioNTech is navigating a delicate balancing act. The German biotech posted a first-quarter net loss of €532 million on revenue of just €118 million, underscoring the rapid erosion of its COVID-vaccine franchise. In response, management has slashed 1,860 jobs worldwide and drawn up plans to close production sites in Idar-Oberstein, Marburg, Tübingen and Singapore by the end of 2027. The restructuring is meant to save €500 million a year from 2029 and free up cash for an aggressive pivot toward oncology.
The company’s cancer pipeline is starting to deliver tangible signs of progress. In April, BioNTech and partner DualityBio reported positive Phase 2 data for the antibody-drug conjugate BNT323/DB-1303 (trastuzumab pamirtecan) in advanced endometrial cancer. Among 73 previously treated patients with centrally confirmed HER2 expression, the objective response rate reached 49.3%. In the broader analysis of all centrally tested patients, the confirmed response rate stood at 47.9%, with a median progression-free survival of 8.1 months. The strongest signal emerged in the highest HER2 subgroup (IHC 3+), where the response rate exceeded 70%. For a disease with limited targeted options, the data look clinically meaningful.
BioNTech plans to file a marketing application with the U.S. FDA in 2026, depending on further discussions with the regulator. The drug was granted Fast Track and Breakthrough Therapy designations for endometrial cancer back in 2023, shortening the path to a potential approval. But the company’s oncology ambitions extend well beyond that single asset. It expects multiple late-stage readouts this year from immunomodulators, additional ADCs and mRNA-based programs. In the first quarter, five new registration-enabling studies for the bispecific Pumitamig were launched, covering breast, colorectal, gastric and lung cancers. Meanwhile, the CTLA-4 candidate Gotistobart showed a clinically relevant survival benefit in squamous lung cancer at the European lung cancer congress in March, with interim data from a registration trial due later in the year. BioNTech is also testing Pumitamig alongside an experimental DLL3/CD3 T-cell engager from Boehringer Ingelheim in advanced small-cell lung cancer.
Should investors sell immediately? Or is it worth buying BioNTech?
On the corporate side, the shake-up reaches the top. Founders Ugur Sahin and Özlem Türeci will give up their board seats at the end of 2026 to launch a new independent biotech focused on mRNA innovation. BioNTech will contribute technology and retain a minority stake in the spin-off. The current management team has also authorized a share buyback program of up to $1 billion through May 2027, aiming to support the stock while the restructuring takes hold.
Financially, the company retains a solid cushion with €16.8 billion in cash and securities as of end-March. Yet revenue guidance for 2026 remains modest at €2.0 billion to €2.3 billion, down from the €2.9 billion generated last year. The stock closed at €78.70 on Thursday, down 5.92% over the past month and roughly 10% below its 200-day moving average. The restructuring news triggered a further premarket slide of as much as 5.6%. Berenberg lowered its price target on May 12 but reiterated that the shares are “clearly undervalued,” citing the breadth of the pipeline and potential margin improvement as offsetting near-term headwinds from lower COVID expectations and the leadership transition.
Production of the COVID vaccine Comirnaty will be fully transferred to partner Pfizer by the end of 2026. Until then, BioNTech must demonstrate that its cancer pipeline can carry the growth story forward. Crucially, the company’s largest shareholder, ATHOS, which holds a 40% stake, remains committed. The coming months will test whether clinical signals can translate into regulatory milestones and whether the drastic cost cuts can buy the time needed to build a sustainable oncology franchise.
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