On November 7, 2024 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, 2024, and provided recent operational updates (Press release, ADC Therapeutics, NOV 7, 2024, View Source [SID1234647915]).

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"We are excited about the advancements in our ZYNLONTA trials in earlier lines of diffuse large B-cell lymphoma therapy and look forward to reporting more on the combination with glofitamab in our LOTIS-7 trial, as well as reaching the expected full enrollment in LOTIS-5 before year-end," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We are discontinuing ADCT-601 targeting AXL and will prioritize our exatecan-based platform for solid tumors moving forward. With our expected cash runway into mid-2026, we believe we are well positioned to execute our strategy and advance multiple value-generating catalysts going forward."

Third Quarter 2024 Operational Updates & Recent Highlights

•Full enrollment expected by year-end in LOTIS-5.Enrollment for the Phase 3 confirmatory trial evaluating ZYNLONTA in combination with rituximab in patients with 2L+ diffuse large B-cell lymphoma (DLBCL) is expected to be completed by year-end 2024 with a data update expected in late 2025 once the pre-specified number of events is reached.

•LOTIS-7 enrollment continues with expected interim data update in December 2024.Enrollment continued in the Part 2 dose expansion of LOTIS-7, a Phase 1b open-label clinical trial evaluating ZYNLONTA in combination with the bispecific antibody glofitamab in patients with relapsed or refractory DLBCL. An interim update on safety and efficacy in a subset of patients is expected in December with additional data anticipated in the first half of 2025.

•Abstracts accepted for presentation at the 66th annual American Society of Hematology (ASH) (Free ASH Whitepaper) 2024 Annual Meeting. Updated data from the investigator-initiated Phase 2 clinical trial, conducted at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, evaluating ZYNLONTA in combination with rituximab in patients with relapsed or refractory follicular lymphoma will be shared during an oral presentation titled, "Loncastuximab tesirine with rituximab induces robust and durable complete metabolic responses in high-risk relapsed/refractory follicular lymphoma" (Abstract #337) on December 7, 2024 at 4 p.m. PT.

Updated data from the investigator-initiated Phase 2 clinical trial, conducted at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, evaluating ZYNLONTA for the treatment of relapsed or refractory marginal zone lymphoma (MZL) will be presented during a poster presentation titled, "Limited duration loncastuximab tesirine induces a high rate of complete responses in patients in relapsed/refractory marginal zone lymphoma – report of first planned interim futility analysis of a multicenter Phase II study" (Abstract #3032) on December 8, 2024 from 6 – 8 p.m. PT.

•Discontinuation of ADCT-601 program targeting AXL. Based on the available clinical data and capital requirements for continued development, the Company will discontinue the Phase 1b ADCT-601 program targeting AXL as a single agent and/or in combination for patients with sarcoma, pancreatic cancer and non-small cell lung cancer. Although early signs of antitumor activity were observed during the dose escalation phase, we were unable to demonstrate a favorable benefit-risk profile during the dose optimization/expansion phase.

•ADCT-602 targeting CD22 dose escalation progressing. The Phase 1/2 clinical trial, sponsored by The University of Texas MD Anderson Cancer Center, evaluating ADCT-602 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia continues to progress and dose escalation continues at 60 µg/kg dose.

•IND-enabling studies ongoing in early-stage pipeline. Progress continues in the Investigational New Drug (IND) enabling studies for the Company’s exatecan-based programs for ADCs targeting Claudin-6, PSMA and NaPi2b, while our ASCT2 targeting ADC is in the drug candidate selection stage. The Company has selected one target to move toward IND which is expected to be disclosed in 2025.

Third Quarter and Year-to-Date 2024 Financial Results

•Product Revenues: ZYNLONTA generated net product revenues of $18.0 million for the third quarter ended September 30, 2024 and $52.9 million for the first nine months of 2024 as compared to $14.3 million and $52.4 million for the same periods in 2023. The quarter-over-quarter increase is driven by higher sales volume, a higher selling price and lower gross-to-net deductions. The year-to-date increase is primarily attributable to a higher price, partially offset by lower sales volume.

•Research and Development (R&D) Expense: R&D expense was $32.5 million and $82.5 million for the three and nine months ended September 30, 2024, respectively. This compares to R&D expense of $27.1 million and $96.8 million for the same periods in 2023. The increase during the three months ended September 30, 2024 is due primarily to focused investment in prioritized development programs, including ADCT-601 and ZYNLONTA. The decrease during the nine months ended September 30, 2024 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 $10.7 million and $32.8 million for the three and nine months ended September 30, 2024, respectively. This compares to S&M expense of $13.7 million and $43.5 million for the same periods in 2023. The decreases in S&M expense were primarily due to lower marketing and advertising costs and personnel related expenses.

•General & Administrative (G&A) Expense: G&A expense was $10.0 million and $32.3 million for the three and nine months ended September 30, 2024, respectively. This compares to G&A expense of $9.6 million and $37.1 million for the same periods in 2023. The quarter-over-quarter increase in G&A expense was primarily related to higher personnel related expenses, partially offset by lower insurance costs while the year-to-date decrease was primarily related to lower personnel related expenses as well as lower insurance and IT expenses.

•Net Loss: Net loss for the quarter ended September 30, 2024 was $44.0 million, or a net loss of $0.42 per basic and diluted share, as compared to net loss of $46.7 million, or a net loss of $0.57 per basic and diluted share for the same period in 2023. Net loss for the nine months ended September 30, 2024 was $127.1 million, or a net loss of $1.35 per basic and diluted share, as compared to net loss of $155.0 million, or a net loss of $1.90 per basic and diluted share for the nine months ended September 30, 2023. The decrease for the three months ended September 30, 2024 is primarily related to higher revenues and a lower equity in net loss of our joint venture partially offset by higher operating expenses. The decrease for the nine months ended September 30, 2024 is primarily due to lower operating expenses.

•Adjusted Net Loss: Adjusted net loss, which is a non-GAAP financial measure, was $29.4 million, or an adjusted net loss of $0.28 per basic and diluted share for the quarter ended September 30, 2024 as compared to adjusted net loss of $32.4 million, or $0.39 per basic and diluted share, for the same period in 2023. Adjusted net loss for the nine months ended September 30, 2024 was $84.9 million, or an adjusted net loss of $0.90 per basic and diluted share, as compared to net loss of $106.3 million, or an adjusted net loss of $1.30 per basic and diluted share for the nine months ended September 30, 2023. The decrease in adjusted net loss for the three months ended September 30, 2024 is primarily related to higher revenues and a lower equity in net loss of our joint venture partially offset by higher operating expenses. The decrease in adjusted net loss for the nine months ended September 30, 2024 is primarily attributable to lower operating expenses.

•Cash and cash equivalents: As of September 30, 2024, cash and cash equivalents were $274.3 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 mid-2026.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss third quarter 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.