ADC Therapeutics SA

Good morning, ladies and gentlemen, and welcome to the ADC Therapeutics Third Quarter 2024 Earnings Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star followed by zero for the operator. This call is being recorded on Thursday, November 7, I will now turn the call over to Marcy Graham, Investor Relations Officer for ADCT. Marcy, please go ahead.

Thank you, Operator. This morning, we issued a press release announcing our third quarter 2024 financial results and business update. This release and the slides we will use in today's presentation are available on the Investor section of the ADC Therapeutics website. I'm joined on today's call by our Chief Executive Officer, Amit Malik, who will discuss our operational performance and recent business highlights, followed by our Chief Financial Officer, Pepe Carmona, who will review our third quarter 2024 financial results. We will then open the call to questions. Before we begin, I would like to remind listeners that some of the statements made during this conference call will contain forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain known and unknown risks and uncertainties, and actual results, performance, and achievements could differ materially. They are identified and described in the accompanying slide presentation and in the company's filings with the SEC, including Form 10-K, 10-Q, and 8-K. ADC Therapeutics is providing this information as of today's date and does not undertake any obligation to update any forward-looking statements contained in this conference call as a result of new information, future events, circumstances except as required by law. The company cautions investors not to place undue reliance on these forward-looking statements. Today's presentation also includes non-GAAP financial reporting. These non-GAAP measures should be considered in addition to and not in isolation or as a substitute for the information prepared in accordance with GAAP. You should refer to the company's third quarter earnings release for information and reconciliation of historical non-GAAP measures to the comparable GAAP measures. I will now turn the call over to our CEO, Amit Malek. Amit?

Thanks, Marcy, and good morning, everyone. Thank you for joining us on today's call. The third quarter of 2024 represented a solid period of continued performance for our company. Throughout the quarter, we continued to focus on execution and delivering on our commercial strategy. Even in a highly competitive market, we have been able to secure our place as a treatment option for third-line plus patients with DLVCL. Our third quarter net product revenues increased to $18 million during the quarter, bringing year-to-date Zynlanta revenues to $52.9 million. We are confident in Zynlanta's profile with rapid, deep, and durable efficacy, a manageable safety profile, and ease of administration. Beyond our current indication, we believe in the potential to expand the use of Zynlanta into earlier lines of therapy in DLBCL and in the lymphomas through combinations significantly growing the commercial opportunity. Enrollment in Lotus 5, our phase three confirmatory study of Zinlanta, in combination with rituximab in patients with second-line plus DLBCL, is nearing completion with full enrollment expected by the end of this year. Data are expected by the end of 2025, once the pre-specified number of events is reached. Interim data, including safety and efficacy in a subset of patients, from our Lotus 7 Part 2 dose expansion of the Zynlanta plus clofidamab combination arm in second-line plus DLBCL are expected in December with additional data anticipated in the first half of 2025. In addition, we are excited that two key investigator-initiated trials conducted at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine studying Zynlanta and indolent lymphomas will be presented at the American Society of Hematology meeting in December. This includes an oral presentation with updated data from the Phase II IIT evaluating Zynlanta in combination with rituximab in patients with high-risk, relapsed, or refractory follicular lymphoma, as well as a poster presentation with updated data from the Phase II IIT evaluating Zynlanta for the treatment of relapsed or refractory marginal zone lymphoma. We look forward to the updates from these two studies evaluating the potential of Zinlanta in these lymphomas. The Phase I-II clinical trial sponsored by the University of Texas MD Anderson Cancer Center evaluating ADCT602 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia continues to progress and dose escalation continues at the 60 microgram per kilogram dose. Within our solid tumor programs, we have made the decision to discontinue the Phase 1b ADCT601 program targeting Axel as a single agent and or in combination with patients with sarcoma, pancreatic cancer, and non-small cell lung cancer. Although early signs of anti-tumor activity were observed during the dose escalation phase, we were unable to demonstrate a favorable benefit-risk profile during the dose optimization and expansion phase. Moving forward, we will prioritize our exotecan-based platform in solid tumors, where progress continues in the IND enabling studies for the company's exotecan-based programs for ADCs targeting CLAUDIN6, 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. At the same time, we continue to explore potential partnership opportunities. Looking specifically at DLBCL, when you move beyond the front line, cure rates are extremely low. Here, physicians make treatment decisions based on efficacy, safety, and accessibility in the context of individual patient considerations. Zinlata delivers on all three, which we believe positions it well for use in combination in Second Line Plus DLBCL. The market has evolved to essentially four modalities, cellular therapies, bispecifics, ADCs, and monoclonal antibodies, as well as chemotherapy, and is moving toward combinations that offer rapid, deep, durable responses with manageable toxicities, which can be administered in the outpatient setting. Given the improvement expected in the clinical profile with bispecifics and ADC-based combinations, we believe these regimens have the potential to grow at the expense of cell therapy and chemotherapy use. Here we see the promise of our LOTUS 5 and LOTUS 7 combination studies. With LOTUS 5, we are combining Xenlanta with rituximab, a therapy that community physicians are comfortable using and is a backbone of DLBCL therapy. We feel this combination offers competitive second-line plus efficacy with favorable safety and a convenient dosing schedule, well suited for use across care settings. In addition, this is a non-systemic chemo regimen that avoids the irreversible toxicities associated with chemotherapy, a class that is still widely used in second-line plus DLD-CL. With Lotus 7, we are combining Zimanta and anti-CD19 ADC and Glufidamab and anti-CD20, CD3 T-cell-engaging bispecific antibody, and have completed dose escalation where the combination demonstrated no dose-limiting toxicities and early signs of anti-tumor activity. Our hypothesis with this study is that combining these two powerful approved single-agent drugs is expected to have additive or synergistic efficacy, along with a manageable safety profile given no overlapping non-hematologic toxicities. In addition, we believe Zinlata used prior to glufidamab may debulk the tumors and reduce peripheral B-cells, leading to lower CRS rates and severity. This would open up the use of this combination in earlier lines of therapy across care settings. We saw encouraging data in the Phase 1B dose escalation and are currently enrolling patients in Part 2 dose expansion with Enlanta at two dose levels in combination with Bofidamab in second line plus DLBCL. We anticipate sharing safety and efficacy data on 15 to 20 patients in December. This includes all DLBCL patients from Part 1 and Part 2 dosed with gofetamab plus Enlanta at the 120 and 150 microgram per kilogram doses where scans are available. We expect to share data on additional patients with longer follow-up in the first half of 2025. Beyond DLBCL, we also see the potential to expand into the second-line plus settings of indolent lymphomas. based on data from investigator-initiated trials at the University of Miami exploring Xenlanta plus rituximab in high-risk relapsed or refractory follicular lymphoma and Xenlanta monotherapy in relapsed or refractory marginal zone lymphoma. Early data from these studies demonstrate the potential for rapid, deep, and durable efficacy with a fixed duration of therapy and a manageable side effect profile. Based on the high complete metabolic response rates seen thus far in these studies, we believe there is the potential to provide marginal zone and follicular lymphoma patients with years of remission. We are looking forward to the lead investigator sharing more on these studies at the ASH meeting in December. As there remains significant unmet need across these lymphomas, with sufficient data, we plan to discuss the path forward with regulatory authorities as well as seek inclusion in Compendia. With that, I would like to turn the call over to Pepe.