ADC Therapeutics SA (ADCT) News & EventsADCTNews & EventsADC Therapeutics SA

ZYNLONTA Q2 Revenue at $18.6M, Below Consensus

Reports Q2 revenue $18.6M, consensus $18.9M. "We are pleased by our Q2 performance, which reflects continued commercial momentum and strong operational discipline through ongoing cost reduction efforts. Over the course of this year, we have released LOTIS-5 data and completed the LOTIS-7 trial. With these data now in hand, we believe that ZYNLONTA plus glofitamab offers an opportunity to take a leading second-line plus position, in the context of the evolving competitive landscape, solidifying ZYNLONTA as a foundational therapy in DLBCL," said CEO Ameet Mallik. "Additionally, following the FDA pre-sBLA meeting for the LOTIS-5 trial, we are assessing regulatory approaches to determine the best path forward." "As we work to advance ZYNLONTA into earlier lines of DLBCL, we remain confident that ZYNLONTA will continue to play a meaningful role for patients with B-cell malignancies, in the 3L+ DLBCL setting, and through potential compendia inclusion starting in 2027," said Mohamed Zaki, Chief Medical Officer. "We look forward to the presentation of the LOTIS-5, LOTIS-7 and MZL investigator-initiated trial data later this year and expect submission for publication. In addition, we expect to submit LOTIS-7 and MZL data to the FDA for Breakthrough Designation."

ADC Therapeutics Completes Enrollment in LOTIS-7 Clinical Trial

ADC Therapeutics announced the completion of enrollment in the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of Zynlonta in combination with the bispecific antibody glofitamab in patients with relapsed or refractory diffuse large B-cell lymphoma, or r/r DLBCL. LOTIS-7 trial enrollment is now complete with 100 r/r DLBCL patients dosed at the selected 150 microgram/kg dose of ZYNLONTA plus glofitamab. Primary endpoints of the study include safety and tolerability. Secondary endpoints include overall response rate, duration of response, complete response, relapse free survival, progression-free survival, and overall survival, as well as pharmacokinetics and immunogenicity. The company plans to share full data from LOTIS-7 at a medical meeting and submit the results for publication by the end of 2026.

ADC Therapeutics Reduces Workforce by 17% to Support ZYNLONTA

ADC Therapeutics announced a strategic reorganization to focus resources behind key value-driving initiatives in support of the ZYNLONTA, or loncastuximab tesirine-lpyl, franchise. As part of the reorganization, ADC Therapeutics plans to reduce its workforce globally by approximately 17%. The reduction is driven by the expected completion of the LOTIS-5 and LOTIS-7 trials this year, as well as operational efficiencies. With these changes, the Company is resourced to deliver on its key clinical, regulatory and manufacturing activities while maintaining the full externally facing medical affairs and commercial footprint to support ZYNLONTA. The Company is preparing for a scheduled pre-sBLA meeting with the FDA in August 2026 to discuss the potential regulatory path forward for ZYNLONTA in combination with rituximab to treat relapsed or refractory diffuse large B-cell lymphoma following the recent topline data results from the Phase 3 LOTIS-5 trial. ADC Therapeutics expects to submit an sBLA in the fourth quarter of 2026. In addition, the Company continues to advance the ZYNLONTA franchise through the ongoing Phase 1b LOTIS-7 trial evaluating ZYNLONTA in combination with glofitamab in 2L+ DLBCL. ADC Therapeutics expects the reorganization to generate annualized estimated cost savings of approximately $10M. ADC Therapeutics estimates that it will incur one-time pre-tax charges of approximately $3M for employee severance, benefits and related termination costs, the majority of which will be recognized in the Q2. The Company has an expected cash runway at least into 2028.