LAKEFRONT BIOTHERAPEUTICS NV

Lakefront Biotherapeutics said it plans to begin registrational studies next year for its lead T-cell engager, gamgertamig, in immune thrombocytopenia and autoimmune hemolytic anemia, with two additional autoimmune basket studies expected early that year. Speaking at Morgan Stanley's Global Healthcare Conference, Chief Executive Officer Henry Gosebruch said the company, previously known as Galapagos, has shifted focus from its legacy ex vivo CAR-T programs to a portfolio of four T-cell engager candidates following its acquisition of assets from Ouro Medicines in March. Gamgertamig is a BCMA-directed therapy that Gilead Sciences is expected to commercialize, with Lakefront receiving a royalty; Gilead contributed half of the Ouro deal consideration and about $5 billion to the company under a strategic alliance established in 2019 that has roughly three years remaining. Chief Financial Officer Aaron Cox said Lakefront expects to end the year with about €2 billion in cash, supported by Gilead funding, legacy royalties of approximately €15 million to €20 million annually related to Jyseleca, and tax-credit receipts of approximately €20 million to €35 million annually over the next several years. The company has largely completed the wind-down of its legacy cell-therapy operations, which had more than 650 employees and approximately $300 million in annual spending, and announced a €50 million share buyback in June that it expects to complete by year-end. The FDA has granted Orphan Drug Designation for gamgertamig in ITP, AIHA and pemphigus.

Lakefront Biotherapeutics NV announced it repurchased 117,471 of its own shares between August 17 and August 21, 2026, under the repurchase program announced on June 9, 2026. The buybacks were executed via a discretionary mandate to an independent financial intermediary across Euronext Amsterdam, CBOE Europe, Turquoise, and Aquis venues, at an average price of €24.40 per share for a total consideration of €2,866,035.10. As of market close on August 21, 2026, Lakefront holds 1,033,528 of its own ordinary shares.

Lakefront Biotherapeutics announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to gamgertamig for the treatment of pemphigus. Gamgertamig was previously granted both Fast Track and Orphan Drug Designation by the U.S. FDA for the treatment of autoimmune hemolytic anemia and immune thrombocytopenia. The drug is being developed by Lakefront in collaboration with Gilead Sciences, with ongoing clinical trials in autoimmune diseases actively enrolling and expansion of the clinical trials program anticipated in 2027. Gamgertamig is an investigational BCMAxCD3 bispecific T cell engager currently in Phase 2 studies and is expected to enter registrational studies in 2027.

Lakefront Biotherapeutics reported a net profit of €16.6 million for the first half of 2026, compared to a net loss of €259.1 million a year earlier, and maintained its year-end 2026 cash and financial investments guidance of approximately €2 billion, which now includes a €50 million share repurchase program. The company completed its acquisition of Ouro Medicines with Gilead Sciences in June, advancing gamgertamig, a potential first-in-class and best-in-class T-cell engager for autoimmune diseases. Lakefront forecasts at least €1.6 billion of cash remaining after funding the portfolio to first gamgertamig approval. Total net revenues fell 87% to €18.6 million, while R&D expenses dropped 80% to €56.5 million, reflecting the prior year's strategic reorganization costs. The company's cash and financial investments stood at €2.24 billion as of June 30, 2026.

Lakefront Biotherapeutics repurchased 83,530 of its own shares between 22 June and 26 June 2026 as part of the repurchase program announced on 9 June 2026. The shares were bought on Euronext Amsterdam at an average price of €25.24, for a total consideration of €2,108,045.52. Following these transactions, the company holds 199,734 of its own ordinary shares.

Lakefront Biotherapeutics received a transparency notification from Madison Avenue Partners indicating that the investment firm crossed above the 5% voting rights threshold on an aggregated basis on June 15, 2026. Following the acquisition of voting rights, Madison Avenue Partners, jointly with its affiliates, held 3,498,892 voting rights as of June 24, 2026, representing 5.31% of Lakefront's currently outstanding 65,897,071 shares. The notification was made pursuant to Belgian transparency legislation.

Lakefront Biotherapeutics NV has repurchased 77,667 of its own shares between June 15 and June 19, 2026, as part of the share repurchase program announced on June 9, 2026. The shares were bought on the Euronext market at an average price of €24.6586, for a total consideration of €1,915,162.13. Following these transactions, Lakefront holds 116,204 of its own ordinary shares as of market close on June 19, 2026.