ADC Therapeutics SA Q1 FY2025 earnings call

Key Points

• Total first quarter revenues stood at $23 million, with net product revenues of $17.4 million and $5.6 million from milestones and royalties.
• LOTIS-7 data was accepted for presentation at EHA and ICML in June, showing an overall response rate of 95.5% and a complete response rate of 90.9% in 22 efficacy-evaluable patients. 40 patients have been enrolled in the LOTIS-7 dose expansion arm, and plans to expand enrollment to 100 patients are underway.
• LOTIS-5 is on track to reach the pre-specified number of progression-free survival events by the end of 2025, with top-line data from the Phase 3 confirmatory trial expected afterward.
• Data from the Phase 2 IIT in marginal zone lymphoma will be presented at ICML. The ADCT602 trial was discontinued based on clinical data.
• Preclinical exatecan-based ADCs targeting Claudin-6, PSMA, and ASCT2 were featured at the American Association for Cancer Research annual meeting.

Total first quarter revenues were $23 million, including net product revenues of $17.4 million and an additional $5.6 million in milestone and royalty payments. ZYNLONTA contributed net product revenues of $17.4 million, representing a significant portion of the total revenue.

Forward-Looking Statements

• LOTIS-7 data will be presented at EHA and ICML in June, with updated data on the 40 patients in the dose expansion arm to be shared in the second half of 2025.
• LOTIS-5 is expected to provide top-line data on the Phase 3 confirmatory trial evaluating ZYNLONTA in combination with rituximab once the pre-specified number of progression-free survival events is reached.
• The company has a cash runway into the second half of 2026, positioning it to advance its catalysts and drive value creation.

Risks

• Forward-looking statements are subject to known and unknown risks and uncertainties, with actual results potentially differing materially.
• Clinical trial outcomes, including those for LOTIS-7 and LOTIS-5, are uncertain and could impact future growth.
• Regulatory approvals and compendia strategies are dependent on successful trial data and may face challenges.

Q: Could you please provide some color on the follow-up time for the patients from the update today and also for the 18 patients who achieved a complete response last year? Any color on CR conversion time to durability?

A: The patients are followed up based on Lugano criteria, with assessments at 6 and 12 weeks and monthly. The high complete response rates are encouraging but it's too early to speak on durability; more data will be presented at EHA.

Q: On the compendia strategy, you mentioned that you plan to engage with regulatory authorities. Is it when you have data from 40 patients that are already enrolled or would you wait for 100 patients?

A: We believe we'll need a publication including approximately 100 patients with about a year of follow-up, similar to recent bispecific accommodation examples.

Q: In regards to LOTIS 5, with the guidance of reaching PFS events by the end of 2025, do you still expect that top-line data to be a 2025 event, or is that going to be pushed to like an early 2026 data readout?

A: We still expect the PFS events to happen in 2025, but the data readout could occur end of 2025 or early 2026 as it's PFS-driven and takes time to cleanse and assess data.

Q: The 602 program was discontinued. Does that free up capital to bring one of the exatecan-based ADCs to the IND filing and even maybe initiating a Phase 1 with the one that emerges?

A: The cost implications of discontinuing the 602 program are minimal. Progress on research BD efforts is ongoing, with updates expected in the near term.