ADC Therapeutics (ADCT) H.C. Wainwright Home Series summary

Company strategy and product focus

• Focused on antibody-drug conjugates, with ZYNLONTA as the lead product approved for third-line plus DLBCL and ongoing studies to expand into earlier lines and indolent lymphomas.

• LOTIS-5 (phase III, ZYNLONTA + rituximab) and LOTIS-7 (ZYNLONTA + glofitamab) are key trials, with LOTIS-5 data expected in Q2 and LOTIS-7 by year-end.

• Sales of ZYNLONTA have been stable, averaging around $18 million per quarter, with variability due to rare disease dynamics and ordering patterns.

• Significant sales growth is anticipated post-2027, following potential LOTIS-5 approval and expansion into the second-line setting.

• Indolent lymphoma studies are ongoing, with data expected between late this year and mid-next year.

Market landscape and competitive positioning

• Second-line DLBCL treatment is split between complex therapies (CAR-T, bispecifics) and broadly accessible therapies (antibody-drug conjugates, monoclonal antibodies, chemotherapy).

• CAR-T and bispecifics are mainly available in academic centers, while community settings rely on more accessible therapies.

• Front-line advances (e.g., POLARIX) have set a high bar; most patients still require second-line therapies.

• CAR-T penetration remains at about 20% in second-line and third-line settings, with limited expected impact from new CAR-Ts or trispecifics before 2030.

• LOTIS-5 and LOTIS-7 regimens are positioned to address both complex and broadly accessible segments.

Clinical trial updates and expectations

• LOTIS-5 safety run-in showed an 80% overall response rate and 50% CR rate, with durable responses and manageable safety.

• The phase III LOTIS-5 trial is powered at 90% to detect a hazard ratio of 0.67 for PFS; interim futility analysis passed, and top-line data is expected in Q2.

• Regulatory filing for LOTIS-5 is planned 4-5 months after positive data, with potential approval by mid-2027.

• LOTIS-7 (ZYNLONTA + glofitamab) phase I-B showed a 90% ORR and 78% CR rate in 49 patients, including strong results in post-CAR-T patients.

• Both trials are expected to provide data that could support Compendia listings and regulatory submissions.