On March 27, 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 fourth quarter and full year ended December 31, 2024, and provided recent operational updates (Press release, ADC Therapeutics, MAR 27, 2025, View Source [SID1234651516]).
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"We achieved several key milestones in 2024, advancing our expansion trials with ZYNLONTA in combinations and in earlier lines of DLBCL therapy, progressing our early research solid tumor program to the IND-enabling stage and reducing operational spend while at the same time strengthening the balance sheet," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We closed the year by fully enrolling our confirmatory LOTIS-5 DLBCL study, reported encouraging initial data from our LOTIS-7 DLBCL study and were pleased to see promising Phase 2 IIT data reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting evaluating ZYNLONTA in indolent lymphomas. We are confident in our path forward and believe we are well positioned for success as we progress toward additional pivotal milestones in 2025."
Fourth Quarter 2024 Operational Updates and Upcoming Milestones
•Full enrollment achieved in LOTIS-5. Enrollment for the Phase 3 confirmatory trial evaluating ZYNLONTA in combination with rituximab in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) was completed in December 2024. The Company expects to provide updated data before the end of 2025, once the pre-specified number of progression-free survival (PFS) events is reached.
•Encouraging initial data from LOTIS-7. The Company reported positive initial data in December 2024 from the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in patients with r/r non-Hodgkin Lymphoma (NHL). The best overall response rate (ORR) among the 18 r/r DLBCL efficacy evaluable patients was 94%, and the complete response rate (CRR) was 72%. These encouraging efficacy data were observed across patients with different numbers of lines and types of prior treatments. Initial safety data on all 29 r/r NHL patients suggest the combination is generally well tolerated with no dose-limiting toxicities across all dose levels. Enrollment of 40 patients in the dose expansion is expected to be completed in the second quarter of 2025. We expect to share data on a subset of patients in the second quarter of 2025 with a fuller, more mature data update anticipated during the second half of 2025.
•Promising data from the Phase 2 investigator-initiated trials evaluating ZYNLONTA in indolent lymphomas. Updated data from the investigator-initiated trials (IITs) of ZYNLONTA were presented at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2024. Both the Phase 2 clinical trial evaluating ZYNLONTA in combination with rituximab in patients with r/r follicular lymphoma (FL) and the Phase 2 clinical trial evaluating ZYNLONTA for the treatment of r/r marginal zone lymphoma (MZL) are ongoing and being conducted at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine. Results from both trials as presented at ASH (Free ASH Whitepaper) and the FL trial simultaneously published in Lancet Haematology can be found here. Additional data are expected to be shared at a medical conference and/or in publication with plans to engage regulatory agencies and evaluate compendia strategies.
•Abstracts to be presented in oral and poster presentations in April at AACR (Free AACR Whitepaper) 2025. An abstract on the Company’s Claudin-6 targeting ADC was accepted for oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025. Abstracts on the Company’s PSMA and ASCT2-targeting ADCs were also accepted for poster presentations at the meeting.
Fourth Quarter and Full Year 2024 Financial Results
•Product Revenues: ZYNLONTA reached commercial brand profitability in 2024, generating net product revenues of $16.4 million for the fourth quarter ended December 31, 2024, and $69.3 million for the full year of 2024 as compared to $16.6 million and $69.1 million for the same periods in 2023. The quarter-over-quarter decrease is driven by lower sales volume, partially offset by a higher selling price. The year-to-date increase is primarily attributable to a higher selling price and favorability in prior period GTN sales adjustments, partially offset by lower sales volume.
•Research and Development (R&D) Expense: R&D expense was $27.1 million and $109.6 million for the fourth quarter and full year ended December 31, 2024, respectively. This compares to R&D expense of $30.3 million and $127.1 million for the same periods in 2023. The decrease during both periods is due primarily to the implementation of productivity initiatives and focused investment in prioritized development programs.
•Selling and Marketing (S&M) Expense: S&M expense was $11.3 million and $44.0 million for the fourth quarter and full year ended December 31, 2024, respectively. This compares to S&M expense of $13.9 million and $57.5 million for the same periods in 2023. The quarter-over-quarter decrease in S&M expense was primarily due to lower marketing and advertising costs, partially offset by higher share-based compensation expense. The year-to-date decrease was primarily due to lower marketing and advertising costs as well as lower wages and benefits.
•General & Administrative (G&A) Expense: G&A expense was $9.6 million and $41.9 million for the fourth quarter and full year ended December 31, 2024, respectively. This compares to G&A expense of $11.3 million and $48.4 million for the same periods in 2023. The quarter-over-quarter decrease in G&A expense was primarily related to lower professional fees. The year-to-date decrease was primarily related to lower share-based compensation expense, professional fees and insurance premiums.
•Net Loss: Net loss for the quarter ended December 31, 2024, was $30.7 million, or a net loss of $0.29 per basic and diluted share, as compared to net loss of $85.0 million, or a net loss of $1.03 per basic and diluted share for the same period in 2023. Net loss for the full year ended December 31, 2024, was $157.8 million, or a net loss of $1.62 per basic and diluted share, as compared to net loss of $240.1 million, or a net loss of $2.94 per basic and diluted share for the full year ended December 31, 2023. The decrease in net loss during both periods is primarily attributable to lower income tax expense and lower operating expenses.
•Adjusted Net Loss: Adjusted net loss, which is a non-GAAP financial measure, was $26.5 million, or an adjusted net loss of $0.25 per basic and diluted share for the quarter ended December 31, 2024, as compared to an adjusted net loss of $79.5 million, or $0.97 per basic and diluted share, for the same period in 2023. Adjusted net loss for the full year ended December 31, 2024, was $111.4 million, or an adjusted net loss of $1.15 per basic and diluted share, as compared to net loss of $185.7 million, or an adjusted net loss of $2.27 per basic and diluted share for the full year ended December 31, 2023. The decrease in adjusted net loss during both periods is primarily attributable to lower income tax expense and lower operating expenses.
•Cash and cash equivalents: As of December 31, 2024, cash and cash equivalents were $250.9 million, compared to $278.6 million as of December 31, 2023. In May 2024 the Company completed an underwritten offering resulting in net proceeds of approximately $97.4 million, extending the expected cash runway into the second half of 2026.
Conference Call Details
ADC Therapeutics management will host a conference call and live audio webcast to discuss fourth quarter and full year 2024 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the conference call, please register here. The participant toll-free dial-in number is 1-800-836-8184 for North America and Canada. 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.
About ZYNLONTA
ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.
ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.