ADC Therapeutics reweighs ZYNLONTA path after FDA raises LOTIS-5 safety concerns

ADC Therapeutics SA reported second quarter 2026 results on August 13, 2026, with net product revenues of $18.6 million for the quarter and $38.7 million for the six months ended June 30, 2026, compared to $18.1 million and $35.5 million for the same periods in 2025.¹ Cash and cash equivalents stood at $219.1 million as of June 30, 2026, down from $261.3 million at year-end 2025, driven mainly by cash used in operations.¹ The company said its cash runway extends at least into 2028.¹

On regulatory matters, the company recently held a pre-sBLA meeting with the FDA, during which the agency noted substantial concerns regarding the benefit-risk or verification of clinical benefit observed in the LOTIS-5 trial, based on an imbalance in Grade 5 events assessed against a marginal treatment benefit.¹ Following that meeting, the company is assessing the best regulatory path forward and plans to update on strategy and timing soon, while ZYNLONTA remains available under accelerated approval as a monotherapy in third-line-plus DLBCL.¹

Separately, the LOTIS-7 Phase 1b trial evaluating ZYNLONTA combined with glofitamab (COLUMVI) in relapsed/refractory DLBCL completed enrollment of 100 patients at the selected 150 µg/kg starting dose.¹ The company is evaluating a regulatory pathway for this combination and plans to submit for Breakthrough Therapy designation this year.¹

The company also disclosed a restructuring: ADC Therapeutics implemented an approximately 17 percent global workforce reduction, expecting annualized cost savings of about $10 million.¹ R&D expense fell to $17.4 million for the quarter from $30.1 million a year earlier, and total operating expenses dropped to $44.7 million from $63.0 million, a 29% reduction.¹ Net loss was $16.6 million for the quarter, versus $56.6 million in the prior-year period.¹