ADC Therapeutics (NYSE:ADCT) reported second-quarter 2026 net product revenue of $18.6 million for ZYNLONTA, up from $18.1 million in the prior-year period, while executives said the treatment’s commercial performance remained broadly consistent with recent quarters.
The company also said it is reassessing the regulatory path for its LOTIS-5 confirmatory study after receiving FDA feedback that raised “substantial concerns” about the benefit-risk profile and verification of the treatment benefit observed in the trial.
“The discussions with the FDA were related only to the trial,” Mallik said during the company’s earnings call. “There was no feedback at all about the single agent.”
FDA Raises Concerns on LOTIS-5
LOTIS-5 is a Phase III confirmatory trial evaluating ZYNLONTA in combination with rituximab against R-GemOx in patients with second-line DLBCL. The company said the study met its primary endpoint of progression-free survival and announced top-line results in June.
However, following an early-August pre-supplemental biologics license application meeting, Chief Medical Officer Mohamed Zaki said the FDA expressed substantial concerns regarding the benefit-risk assessment and verification of the benefit observed in the study.
ADC Therapeutics said it is assessing whether additional data, risk-management measures, or potential label modifications could address the agency’s concerns. The company did not provide a timeline for an updated regulatory strategy.
In response to analyst questions regarding serious infections in LOTIS-5, Mallik said the primary type of infections involved bacterial infections. He noted that LOTIS-7, a separate study of ZYNLONTA in combination with glofitamab, includes recommendations for prophylaxis and vaccinations covering viral, fungal and bacterial infections, including Pneumocystis jirovecii pneumonia and herpes virus. Those measures were not included in the LOTIS-5 protocol.
ADC Therapeutics submitted full LOTIS-5 data for presentation at the American Society of Hematology meeting and is pursuing publication. The company also expects to seek potential compendia inclusion beginning in 2027.
LOTIS-7 Enrollment Completed; Breakthrough Request Planned
The company completed enrollment of 100 patients at the selected ZYNLONTA dose level in LOTIS-7, a Phase Ib study evaluating ZYNLONTA plus glofitamab in second-line-plus DLBCL. ADC Therapeutics submitted an abstract containing data from most of the enrolled population to ASH.
Mallik said the company believes the submitted data show compelling efficacy and safety, while Zaki said the combination has the potential to be a best-in-class regimen. The company did not disclose the updated data during the call.
ADC Therapeutics plans to submit a request for breakthrough therapy designation for the ZYNLONTA-glofitamab combination this year and is evaluating a potential Phase III study. Mallik said the company is still gathering feedback from the medical community and would need to work with the FDA on a final trial design, making it too early to discuss timing or cost.
Management said it does not expect the safety findings from LOTIS-5 to have implications for LOTIS-7 or for potential compendia inclusion of the latter regimen, citing differences in the study regimens and preventive-infection protocols. Mallik referenced the company’s prior December disclosure, which showed approximately 4% grade-five events among 49 patients in the earlier LOTIS-7 dataset.
Beyond DLBCL, the company said updated investigator-initiated trial data in marginal zone lymphoma were submitted to ASH. Updated follicular lymphoma data are anticipated in the second quarter of 2027. ADC Therapeutics also plans to assess regulatory paths in indolent lymphomas and expects to seek breakthrough designation in marginal zone lymphoma.
Costs Decline as Reorganization Takes Effect
ADC Therapeutics reported total operating expenses of $44.7 million for the second quarter. On a non-GAAP basis, adjusted operating expenses were $37.2 million, a 22% decline from the prior-year quarter, primarily due to lower research and development expenses.
The company recorded a GAAP net loss of $16.6 million, compared with a net loss of $56.6 million a year earlier. Its non-GAAP adjusted net loss was $16.3 million, compared with $28.7 million in the second quarter of 2025.
In June, ADC Therapeutics announced a strategic reorganization that included a workforce reduction of approximately 17% and additional operational efficiencies. The company expects the actions to generate about $10 million in annualized cost savings while maintaining its commercial footprint for ZYNLONTA in third-line-plus DLBCL.
Cash and cash equivalents totaled $219.1 million at June 30, down from $231 million at March 31, primarily because of cash used in operations. The company said its cash runway is expected to extend at least into 2028.
Since receiving accelerated approval in 2021, ZYNLONTA monotherapy has been used to treat approximately 5,000 patients in the United States, according to Mallik. Management said it expects the therapy’s current commercial performance to remain stable and sees potential growth beginning in 2027 through expansion into earlier DLBCL treatment lines and indolent lymphomas.
About ADC Therapeutics (NYSE:ADCT)
ADC Therapeutics SA is a clinical-stage biopharmaceutical company focused on the discovery and development of highly targeted antibody-drug conjugates (ADCs) designed to treat hematological malignancies such as non-Hodgkin lymphoma and acute myeloid leukemia. By marrying the specificity of monoclonal antibodies with potent cytotoxic payloads, the company aims to maximize tumor cell eradication while limiting off-target toxicity.
At the core of ADC Therapeutics’ portfolio is loncastuximab tesirine-lpyl, a CD19-directed ADC that received accelerated approval from the U.S.
