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

Company strategy and product focus

• Focused on maximizing value of ZYNLONTA, an approved CD19-directed therapy for third-line plus DLBCL, with ongoing studies to expand into earlier lines and indolent lymphomas.

• LOTIS-5 (phase III, ZYNLONTA + rituximab) and LOTIS-7 (ZYNLONTA + glofitamab) are key studies, 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 promising early data in follicular and marginal zone lymphoma.

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 therapies are limited to about 20% of patients in second-line plus settings, mainly in academic centers.

• Bispecific-based therapies and new trispecifics are emerging, but broad adoption depends on efficacy, safety, and accessibility.

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

• Competitive threats from new CAR-Ts and bispecifics are expected to have limited impact on the core market opportunity.

Clinical trial updates and expectations

• LOTIS-5 phase III is powered to show a hazard ratio of 0.67 or less for PFS, with a positive interim futility analysis and no crossover in the trial.

• Safety run-in for LOTIS-5 showed 80% overall response and 50% complete response rates, with durable responses and manageable safety.

• LOTIS-7 (ZYNLONTA + glofitamab) showed a 90% overall response and 78% complete response rate in early data, with strong efficacy even in post-CAR-T patients.

• Both trials are expected to provide pivotal data in 2024, with regulatory filings and potential approvals targeted for 2027.

• Indolent lymphoma studies (follicular and marginal zone) have shown high response rates and are expected to support Compendia inclusion and possible regulatory filings.