On August 13, 2026 ADC Therapeutics SA (NYSE: ADCT) reported financial results for the second quarter ended June 30, 2026, and provided recent operational updates.
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ZYNLONTA commercial performance as a monotherapy in 3L+ diffuse large B-cell lymphoma (DLBCL) in the second quarter of 2026 continued to be broadly in line with recent quarters. Abstracts for LOTIS-5, LOTIS-7 and MZL IIT data have all been submitted to the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition and will be submitted for publication as well as potential compendia inclusion. The Company anticipates growth starting in 2027.
Recently, the Company held a pre-supplemental Biologics License Application (sBLA) meeting with the U.S. Food and Drug Administration (FDA), during which the LOTIS-5 data was discussed. Following FDA meeting feedback regarding the benefit-risk observed in the LOTIS-5 trial, the Company is assessing the best regulatory path forward. Beyond this, enrollment in LOTIS-7 is now complete, and these data support the Company’s belief that ZYNLONTA plus glofitamab demonstrates the most compelling combination data generated to date in 2L+ DLBCL with a safety profile generally consistent with prior LOTIS-7 disclosures. Based on this potentially practice-changing LOTIS-7 data, the Company is assessing a Phase 3 trial for the combination of ZYNLONTA plus glofitamab. As the Company continues to commercialize ZYNLONTA in the 3L+ DLBCL setting, we will work closely with the FDA to determine how to best obtain full approval and to advance ZYNLONTA combinations into earlier lines of therapy in DLBCL.
"We are pleased by our second quarter 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 Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "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, M.D., Ph.D., Chief Medical Officer of ADC Therapeutics. "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."
Second Quarter 2026 Operational Updates and Upcoming Milestones
LOTIS-5 pre-sBLA meeting held; Company evaluating regulatory path forward. In June 2026, the Company announced topline results from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA in combination with rituximab, which met the trial’s primary endpoint of progression-free survival (PFS). The Company submitted full data to ASH (Free ASH Whitepaper).
The Company recently held a pre-sBLA meeting with the FDA. During this meeting, the FDA noted substantial concerns regarding the benefit-risk or verification of clinical benefit observed in this trial based on the imbalance in Grade 5 events, when assessed in the context of a marginal treatment benefit. Following this meeting, the Company is assessing the best regulatory path forward and plans to provide an update on regulatory strategy and timing in the near future. ZYNLONTA remains available under accelerated approval as a monotherapy in 3L+ DLBCL and the Company plans to continue to commercialize in this setting.
LOTIS-7 trial completed enrollment. The LOTIS-7 Phase 1b trial evaluating ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in patients with r/r DLBCL completed enrollment of 100 patients at the selected 150 µg/kg starting dose of ZYNLONTA. Of note, consistent with other glofitamab trials, the protocol for LOTIS-7 recommends prophylaxis (including vaccinations) for viral, fungal, and bacterial infections (including PJP and herpesvirus), which was not a part of the LOTIS-5 protocol.
The Company submitted LOTIS-7 data to ASH (Free ASH Whitepaper), which continues to demonstrate potential best-in-class bispecific combination data with a safety profile generally consistent with prior LOTIS-7 disclosures. The Company is preparing to submit the complete trial results for publication, which will then be submitted to compendia. The Company is also evaluating a regulatory pathway for this combination and plans to submit for Breakthrough Therapy designation (BTD) this year.
Announced strategic reorganization to support ZYNLONTA growth opportunities and regulatory priorities. ADC Therapeutics implemented an approximately 17 percent workforce reduction globally and estimates that the reorganization will generate annualized estimated cost savings of approximately $10 million. 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 its full externally facing medical affairs and commercial footprint to support ZYNLONTA.
Investigator-Initiated trials (IITs) evaluating ZYNLONTA in additional B-cell malignancies continue to advance. The University of Miami Sylvester Comprehensive Cancer Center-led multi-center Phase 2 trials of ZYNLONTA in combination with rituximab to treat r/r follicular lymphoma (FL) and ZYNLONTA as a monotherapy to treat marginal zone lymphoma (MZL) are ongoing. Updated MZL data were submitted to ASH (Free ASH Whitepaper) and the Company anticipates presentation of this data before the end of the year, with publication and compendia submission to follow. The Company also anticipates presentation of updated FL data in Q2 2027. The Company intends to assess potential regulatory pathways and plans to submit for BTD for MZL.
Second Quarter 2026 Financial Results
Product Revenues: Net product revenues were $18.6 million and $38.7 million for the second quarter and six months ended June 30, 2026, as compared to $18.1 million and $35.5 million for the same periods in 2025. The quarter-over-quarter increase was driven by higher price. The increase for the six-month period was primarily driven by volume increase, which reflects the normal variability in customer ordering patterns, as well as higher price.
License Revenues and Royalties: License revenue and royalties were $0.6 million for the second quarter and $1.4 million for the six months ended June 30, 2026, as compared to $0.8 million and $6.4 million for the same periods in 2025. The decrease for the six-month period was primarily driven by a prior-year milestone received from our partner.
Cost of Product Sales: Cost of product sales was $2.3 million and $6.0 million for the second quarter and six months ended June 30, 2026, as compared to $0.8 million and $2.9 million for the same periods in 2025. The increase in cost of product sales was primarily attributable to a $1.1 million increase for the second quarter and a $2.5 million increase for the six-month period in certain personnel costs. This reflects a change in focus of these personnel from research and development clinical supply activities to commercial manufacturing activities.
Research and Development (R&D) Expense: R&D expense was $17.4 million and $37.2 million for the second quarter and six months ended June 30, 2026, as compared to $30.1 million and $59.0 million for the same periods in 2025. The decrease in R&D costs was primarily driven by a reduction in spending on discontinued programs and completion of the IND-enabling activities for our PSMA-targeting ADC. The decrease was also driven by a shift of certain personnel costs totaling $1.7 million for the quarter and $3.8 million for the six-month period to cost of product sales ($1.1 million QoQ/$2.3 million YoY), inventory capitalization, and selling and marketing expense, reflecting a change in focus of these personnel from research and development activities toward commercial manufacturing and fulfillment activities.
Selling and Marketing (S&M) Expense: S&M expense was $12.6 million and $25.3 million for the second quarter and six months ended June 30, 2026, as compared to $10.1 million and $20.7 million for the same periods in 2025. The increase period-over-period was primarily due to higher marketing and advertising expenses and higher wages and benefits.
General & Administrative (G&A) Expense: G&A expense was $9.7 million and $19.6 million for the second quarter and six months ended June 30, 2026, as compared to $8.8 million and $18.8 million for the same periods in 2025. The increase period-over-period was primarily due to increased professional and IT expenses, partially offset by lower wages and benefits.
Restructuring, impairment and other related costs: In connection with the strategic reorganization and workforce reduction announced in June 2026, we incurred employee severance and related benefit costs of $2.7 million for the second quarter and six months ended June 30, 2026. In connection with the strategic reprioritization and restructuring plan announced in June 2025, we incurred $13.1 million in restructuring and impairment costs for the second quarter and six months ended June 30, 2025, which consisted of $6.7 million in employee severance and related benefit costs, and $6.4 million in non-cash impairment of assets in connection with the close down of the UK facility.
Total Operating Expenses and Adjusted Total Operating Expenses: Total operating expenses were $44.7 million and $90.8 million for the second quarter and six months ended June 30, 2026, as compared to $63.0 million and $114.5 million for the same periods in 2025, a reduction of 29% and 21%, respectively. On a non-GAAP basis, total adjusted operating expenses were $37.2 million and $80.1 million for the second quarter and six months ended June 30, 2026, as compared to $47.8 million and $96.9 million for the same periods in 2025, a reduction of 22% and 17.3%, respectively. The reduction in total adjusted operating expenses was primarily driven by lower R&D expenses.
Net Loss and Adjusted Net Loss: Net loss for the second quarter and six months ended June 30, 2026, was $16.6 million or $49.5 million, or a net loss of $0.11 and $0.32 per basic and diluted share, as compared to a net loss of $56.6 million and $95.2 million, or a net loss of $0.50 and $0.86 per basic and diluted share, for the same periods in 2025. On a non-GAAP basis, adjusted net loss for the second quarter and six months ended June 30, 2026, was $16.3 million or $36.0 million, or a net loss of $0.11 and $0.23 per basic and diluted share, as compared to a net loss of $28.7 million and $52.6 million, or a net loss of $0.25 and $0.48 per basic and diluted share, for the same periods in 2025. The lower net loss and adjusted net loss were primarily due to lower operating expenses, and on a per basic and diluted share basis, by a higher number of weighted average shares outstanding. Net loss was also favorably impacted by the change in fair value of warrants and the cumulative catch-up adjustment of the Company’s deferred royalty obligation.
Cash and Cash Equivalents: As of June 30, 2026, cash and cash equivalents were $219.1 million, compared to $261.3 million as of December 31, 2025, a change primarily driven by cash used in operations. The Company has an expected cash runway at least into 2028.
Conference Call Details
ADC Therapeutics management will host a conference call and live audio webcast to discuss first quarter 2026 financial results and provide a company update today at 8:30 a.m. EDT. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events & Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.
(Press release, ADC Therapeutics, AUG 13, 2026, View Source [SID1234670086])