On November 10, 2025 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported financial results for the third quarter ended September 30, 2025, and provided operational updates.
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"The successful completion of our most recent PIPE financing strengthens our balance sheet and provides the resources to further invest in ZYNLONTA as we anticipate advancing into earlier lines of therapy for DLBCL and into indolent lymphomas," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We look forward to multiple upcoming clinical catalysts expected across LOTIS-7, LOTIS-5, and the ongoing Phase 2 IITs, starting with LOTIS-7 before the end of this year and continuing with data readouts throughout 2026."
Third Quarter 2025 Operational Updates & Recent Highlights
•Completed private investment in public equity (PIPE) financing. The Company entered into a securities purchase agreement for the sale of its equity securities to certain institutional investors in a $60 million PIPE financing, of which the net proceeds of approximately $57.6 million are anticipated to fund the commercial expansion of ZYNLONTA and strengthen the Company’s balance sheet.
•Updated data from LOTIS-7 expected by the end of the year. Beyond the initial results reported at European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress (EHA2025) and at the International Conference on Malignant Lymphoma (ICML) in June from the LOTIS-7 Phase 1b trial evaluating ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), the Company expects to share additional data from the LOTIS-7 trial through a corporate update by the end of the year. Once sufficient data with longer follow-up is available, the Company plans to engage with the U.S. Food and Drug Administration (FDA). In addition, the Company plans to pursue publication and compendia inclusion in the first half of 2027.
•LOTIS-5 topline results anticipated in 1H 2026. The Company expects to provide topline data in the first half of 2026 from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA in combination with rituximab in patients with 2L+ DLBCL once the pre-specified number of progression-free survival (PFS) events is reached and data are available. Assuming positive results, a supplemental Biologics License Application (sBLA) submission to regulatory authorities will follow, with potential confirmatory approval in 2L+ DLBCL as well as publication and compendia inclusion in the first half of 2027.
•Updated data from the Phase 2 investigator-initiated trial (IIT) of ZYNLONTA in r/r follicular lymphoma (FL) presented at the 22nd International Workshop on Non-Hodgkin Lymphoma (iwNHL). Juan Pablo Alderuccio, MD, Clinical Site Disease Group Leader, Lymphoma Section, at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, presented updated data at iwNHL in September from the Phase 2 IIT evaluating ZYNLONTA in combination with rituximab in r/r FL. Data from the 55 efficacy evaluable patients to date in this trial continue to demonstrate encouraging results with an overall response rate (ORR) of 98.2%, a complete response rate (CR) of 83.6%. After median follow-up of 28th months, median PFS was not reached, and the 12-month PFS was 93.9%. Safety was consistent with the known profile of ZYNLONTA. The trial has been expanded to enroll 100 patients, and the Company plans to assess regulatory and updated compendia pathways as soon as sufficient data are available.
•IND-enabling activities advancing for PSMA-targeting ADC. IND-enabling activities are ongoing for the Company’s exatecan-based, prostate-specific membrane antigen (PSMA)-targeting ADC with completion of these activities expected by the end of 2025.
Third Quarter and Year to Date 2025 Financial Results
•Product Revenues: Net product revenues were $15.8 million for the three months ended September 30, 2025, and $51.2 million for the nine months of 2025 as compared to $18.0 million and $52.9 million for the same periods in 2024. The period-over-period changes were primarily driven by lower sales volume, partially offset by higher sales price and favorability in gross-to-net sales adjustments.
•Research and Development (R&D) Expense: R&D expense was $26.8 million for the three months ended September 30, 2025, as compared to $32.5 million for the same period in 2024. The decrease in R&D costs for the three-month period was driven by a reduction in spending on discontinued programs and timing and enrollment of our ZYNLONTA clinical trials, partially offset by an increase in IND-enabling activities for our PSMA-targeting ADC. R&D expense was $85.8 million for the nine months ended September 30, 2025, as compared to $82.5 million for the same period in 2024. The increase in R&D costs for the nine-month period was driven by an increase in IND-enabling activities for our PSMA-targeting ADC and timing and enrollment of our ZYNLONTA clinical trials, partially offset by a reduction in spending on discontinued programs.
•Selling and Marketing (S&M) Expense: S&M expenses were relatively consistent at $10.7 million for the three months ended September 30, 2024, and 2025, respectively. S&M expense was $31.4 million for the nine months ended September 30, 2025, as compared to $32.8 million for the same period in 2024. The period-over-period decrease was primarily due to a reduction in marketing and advertising expenses.
•General & Administrative (G&A) Expense: G&A expense was $8.3 million and $27.1 million for the three and nine months ended September 30, 2025, respectively, compared to $10.0 million and $32.3 million for the same periods in 2024. The reductions in G&A expense were primarily due to lower external professional fees.
•Restructuring, impairment and other related costs: In connection with the strategic reprioritization and restructuring plan announced in June 2025, the Company incurred $0.4 million and $13.5 million in restructuring, impairment and other related costs for the three and nine months ended September 30, 2025, which consisted of $6.2 million in employee severance and related benefit costs, $6.4 million in non-cash impairment of assets and $0.8 million in retirement costs in connection with the close down of the UK facility.
•Net Loss: Net loss for the three months ended September 30, 2025, was $41.0 million, or a net loss of $0.30 per basic and diluted share, as compared to a net loss of $44.0 million, or a net loss of $0.42 per basic and diluted share, for the same period in 2024. The lower net loss for the three-month period was primarily due to lower R&D and G&A expenses. Net loss for
the nine months ended September 30, 2025, was $136.2 million, or a net loss of $1.14 per basic and diluted share, as compared to a net loss of $127.1 million, or a net loss of $1.35 per basic and diluted share, for the same period in 2024. The higher net loss for the nine-month period was primarily due to the increase in R&D expense, the restructuring, impairment and related costs incurred in connection with the strategic reprioritization and restructuring plan and lower interest income.
•Adjusted Net Loss: Adjusted net loss, which is a non-GAAP financial measure, was $25.5 million, or an adjusted net loss of $0.19 per basic and diluted share for the three months ended September 30, 2025, as compared to adjusted net loss of $29.4 million, or $0.28 per basic and diluted share, for the same period in 2024. Adjusted net loss for the nine months ended September 30, 2025, was $78.2 million, or an adjusted net loss of $0.66 per basic and diluted share, as compared to an adjusted net loss of $84.9 million, or $0.90 per basic and diluted share, for the same period in 2024. The decrease in adjusted net loss for the three-month and nine-month periods was due to lower operating expenses and a higher number of weighted average shares outstanding.
•Cash and cash equivalents: As of September 30, 2025, cash and cash equivalents were $234.7 million, compared to $250.9 million as of December 31, 2024. In October, the Company entered into securities purchase agreements for the sale of its equity securities to certain institutional investors in a $60.0 million PIPE financing. Giving effect to the estimated net proceeds from the PIPE financing of approximately $57.6 million (after deducting placement agent fees and estimated offering expenses), the Company would have had approximately $292.3 million of cash and cash equivalents as of that date.
Conference Call Details
ADC Therapeutics management will host a conference call and live audio webcast to discuss third quarter 2025 financial results and provide a company update today at 8:30 a.m. Eastern Time. 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, NOV 10, 2025, View Source [SID1234659699])