On May 14, 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 first quarter ended March 31, 2025, and provided recent operational updates (Press release, ADC Therapeutics, MAY 14, 2025, View Source [SID1234653047]).
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"We are encouraged by the promising LOTIS-7 abstract data, which we believe demonstrate the potential for ZYNLONTA plus glofitamab to be a best-in-class combination in a dynamic market," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "Coupled with the progress of our LOTIS-5 confirmatory trial, we are confident in our path forward and the potential of ZYNLONTA as we pursue the substantially larger opportunity in earlier lines of DLBCL therapy."
First Quarter 2025 Operational Updates & Recent Highlights
•Abstract accepted for LOTIS-7 data presentations at EHA (Free EHA Whitepaper)2025 and ICML. As of the abstract cutoff date of January 17, 2025, 31 patients received ≥1 ZYNLONTA dose and were safety evaluable, with 22 patients evaluable for efficacy. ZYNLONTA plus glofitamab (COLUMVI) demonstrated an overall response rate (ORR) of 95.5% and complete response (CR) rate of 90.9%. Four of the efficacy evaluable patients (2 each at 120µg/kg and 150 µg/kg) converted to CR within 3 weeks after the data cutoff and are included as CRs. Twenty of 21 responders have remained in response and the median duration of response has not been reached. Manageable safety and tolerability were observed across all 31 safety evaluable patients. Updated data will be presented during a poster session on Saturday, June 14 at 12:30 p.m. ET at EHA (Free EHA Whitepaper)2025 taking place in Milan, Italy from June 12–15, 2025 and an oral presentation at ICML taking place in Lugano, Switzerland from June 17-21, 2025.
•Enrollment of 40 patients reached in LOTIS-7 dose expansion arm. Forty patients have been enrolled in the dose expansion arm of the Phase 1b clinical trial evaluating the safety and efficacy of ZYNLONTA in combination with the bispecific antibody glofitamab in patients with r/r DLBCL. The Company expects to provide an update on the LOTIS-7 trial in the second half of 2025.
•Abstract accepted for LOTIS-5 trial safety run-in data presentation at EHA (Free EHA Whitepaper)2025.
As of the abstract cutoff date of October 4, 2024, the safety run-in data included 20 patients, from LOTIS-5, a Phase 3, randomized trial of ZYNLONTA plus rituximab in patients with r/r DLBCL. Fixed treatment duration of this combination showed no new safety signals and demonstrated encouraging antitumor activity, with signs of durable responses in r/r DLBCL/HGBL patients >28 months after end of treatment. The data will be presented during a poster session on Saturday, June 14 at 12:30 p.m. ET at EHA (Free EHA Whitepaper)2025.
•LOTIS-5 remains on track to reach prespecified progression-free survival (PFS) events by end of 2025. After the prespecified number of PFS events is reached and data are available, the Company expects to provide topline data on the Phase 3 confirmatory trial evaluating ZYNLONTA in combination with rituximab in patients with 2L+ DLBCL.
•Abstract accepted for presentation of marginal zone lymphoma (MZL) data at ICML. A poster entitled, "Updated analysis of a phase 2 multicenter study of the loncastuximab in relapsed/refractory marginal zone lymphoma demonstrates high rate of complete responses" will be presented at ICML. This single-arm, open-label investigator-initiated study is being conducted at the Sylvester Comprehensive Cancer Center at University of Miami and City of Hope, and led by Izidore Lossos, MD, Professor, Director, Lymphoma Program at the Sylvester Comprehensive Cancer Center, University of Miami.
•Discontinuation of ADCT-602 trial. Based on the available clinical data, the Phase 1/2 ADCT-602 clinical trial, sponsored by The University of Texas MD Anderson Cancer Center, evaluating ADCT-602 in patients with r/r B-cell acute lymphoblastic leukemia will be discontinued.
•Preclinical programs highlighted at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025.Data from preclinical studies of our exatecan-based ADCs targeting Claudin-6 (CLDN6), prostate-specific membrane antigen (PSMA), and Alanine, Serine, Cysteine Transporter 2 (ASCT2) were featured.
First Quarter 2025 Financial Results
•Product Revenues: ZYNLONTA generated net product revenues of $17.4 million for the first quarter of 2025 as compared to $17.8 million for the first quarter of 2024.
•License Revenues and Royalties: License revenue and royalties were $5.6 million for the first quarter of 2025 as compared to $0.2 million for the first quarter of 2024. In March 2025, the Company recognized $5.0 million in license revenue in connection with a milestone payment due upon ZYNLONTA’s approval by Health Canada for the treatment of relapsed or refractory DLBCL after two or more lines of systemic therapy.
•Research and Development (R&D) Expense: R&D expense was $28.9 million for the first quarter of 2025 as compared to $25.7 million for the first quarter of 2024. The increase is primarily attributable to a net increase in spending on our next-generation investigational ADCs.
•Selling and Marketing (S&M) Expense: S&M expense was $10.6 million for the first quarter of 2025 as compared to $11.4 million for the first quarter of 2024. The quarter-over-quarter decrease in S&M expense was primarily due to lower marketing and advertising and travel-related costs, partially offset by higher share-based compensation expense.
•General & Administrative (G&A) Expense: G&A expense was $10.0 million for the first quarter of 2025 as compared to $12.0 million for the first quarter of 2024. The quarter-over-quarter decrease in G&A expense was primarily related to lower professional fees and VAT recoveries.
•Net Loss: Net loss for the quarter ended March 31, 2025 was $38.6 million, or a net loss of $0.36 per basic and diluted share, as compared to net loss of $46.6 million, or a net loss of $0.56 per basic and diluted share for the same period in 2024. The decrease in net loss during the quarter is primarily attributable to higher license revenues and royalties and lower other expense.
•Adjusted Net Loss: Adjusted net loss, which is a non-GAAP financial measure, was $24.0 million, or an adjusted net loss of $0.22 per basic and diluted share for the quarter ended March 31, 2025 as compared to adjusted net loss of $31.1 million, or $0.38 per basic and diluted share, for the same period in 2024. The decrease in adjusted net loss during the quarter is primarily attributable to higher license revenues and royalties and lower operating expenses, as adjusted for share-based compensation.
•Cash and cash equivalents: As of March 31, 2025, cash and cash equivalents were $194.7 million, compared to $250.9 million as of December 31, 2024, a change primarily driven by the timing of payments of the annual discarded drug rebate, annual bonuses and lower cash collections and partner reimbursements. The Company currently expects its cash runway to extend into the second half of 2026.
Conference Call Details
ADC Therapeutics management will host a conference call and live audio webcast to discuss first 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. 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.