MECHELEN, Belgium, August 10, 2026
Lakefront Biotherapeutics NV reported its half-year 2026 financial results and provided a business update highlighting the completed acquisition of Ouro Medicines with Gilead Sciences and the continued development of gamgertamig, a potential first-in-class and best-in-class BCMAxCD3 T-cell engager being developed for autoimmune diseases. The transaction, completed in June 2026, is expected to expand Lakefront’s immunology portfolio and accelerate development of gamgertamig across multiple autoimmune indications. The investigational therapy has received Fast Track and Orphan Drug Designation from the U.S. FDA for autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP), with registrational studies expected to begin in 2027. Lakefront also plans to initiate additional proof-of-concept basket studies in other autoimmune diseases next year, while ongoing Phase 1b trials continue enrolling patients in the United States, Australia and other international markets.
Lakefront Advances Gamgertamig Across Autoimmune Diseases
Lakefront Biotherapeutics said ongoing clinical studies of gamgertamig are actively enrolling patients with autoimmune cytopenias and seropositive autoimmune diseases. The Phase 1b study NCT07083960 is evaluating gamgertamig in autoimmune cytopenias, including ITP and AIHA, while NCT07229144 is assessing the therapy in diseases including idiopathic inflammatory myositis, Sjögren’s disease, pemphigus vulgaris and pemphigus foliaceus. Lakefront expects to expand the clinical development program in 2027 with additional proof-of-concept basket studies designed to evaluate the potential of gamgertamig across multiple autoimmune conditions. Keymed is also conducting company-sponsored studies in Greater China covering malignant and autoimmune indications. At the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress, Lakefront presented clinical findings involving gamgertamig in a patient with active antiphospholipid antibody syndrome and concurrent autoimmune thrombocytopenia. The company said emerging clinical data continue to demonstrate durability and consistent responses in recently evaluated cohorts, although larger and later-stage studies will be required to establish efficacy and safety.
Ouro Acquisition Strengthens Lakefront’s Immunology Portfolio
The completed Ouro Medicines acquisition has expanded Lakefront’s pipeline beyond gamgertamig. The company in-licensed a preclinical portfolio comprising three autoimmune and inflammatory disease programs originally developed by Ouro, with Gilead holding an option for a 50/50 profit split following clinical proof-of-concept for $75 million per program. Lakefront also provided an update on GLPG3667, noting that the Phase 2 GALARISSO study in dermatomyositis completed its 24-week open-label extension with sustained efficacy and consistent safety. The Phase 2 GALACELA study in systemic lupus erythematosus completed with favorable safety at 48 weeks but did not meet its Week 32 primary endpoint or comparable Week 48 secondary endpoint. The company is evaluating strategic options for the GLPG3667 program. Meanwhile, Lakefront’s previously announced wind-down of its oncology CAR-T cell therapy activities remains on schedule and is expected to be substantially completed by the end of Q3 2026, while the HESPERIA follow-up study continues monitoring previously treated patients.
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Lakefront Maintains Approximately €2 Billion Cash Guidance
For the first half of 2026, Lakefront reported total net revenues of €18.6 million, compared with €140.3 million during the same period in 2025, while research and development expenses declined sharply to €56.5 million from €278.0 million. The company reported an operating loss of €107.2 million, compared with €215.7 million in the prior-year period, while net financial income reached €123.2 million. Lakefront reported net profit of €16.6 million, reversing a net loss of €259.1 million in the first half of 2025. Financial investments, cash and cash equivalents totaled €2.24 billion at June 30, 2026. Despite the €733.5 million cash outflow associated with the Ouro acquisition and a newly announced €50 million share repurchase program, the company maintained its year-end 2026 cash and financial investments guidance at approximately €1.975 billion to €2.05 billion. Lakefront expects at least €1.6 billion of cash to remain available for additional strategic transactions and other capital allocation priorities after funding its portfolio through the first potential gamgertamig approval. The Ouro transaction, expanding gamgertamig clinical development and substantial financial resources position Lakefront Biotherapeutics for continued investment in autoimmune drug development.
Source:Lakefront Biotherapeutics press release
