Mendus (IMMU) Q3 2024 earnings summary

Executive summary

• Opened first clinical centers for the AMLM22-CADENCE trial in Australia, advancing pivotal-stage readiness for vididencel in AML maintenance therapy, with clinical network expanded via ALLG collaboration and a new subsidiary in Australia.

• Manufacturing alliance with NorthX Biologics progressing on schedule, supporting large-scale GMP production for late-stage clinical use by mid-2025.

• Collaboration with Institut Bergonié enables re-entry of ilixadencel into clinical trials for soft tissue sarcoma as part of the REGOMUNE trial, supported by Bayer and Merck.

• Multiple abstracts, including significant survival updates from the ADVANCE II phase 2 trial, to be presented at ASH and SITC 2024.

• Extended cash runway and implemented cost efficiencies to support operations through pivotal trial preparations, with Mendus Australia established to leverage clinical trial incentives.

Financial highlights

• Q3 net result: -SEK 23 million (KSEK -23,030); nine-month net result: -SEK 96 million (KSEK -96,884).

• Q3 cash flow from operations: SEK 20 million; nine-month cash flow: SEK 73.1 million.

• Cash and cash equivalents at September 30, 2024: SEK 109.3 million (KSEK 109,322), down from SEK 143.4 million year-over-year.

• No net sales reported for Q3 2024 or the nine-month period; other operating income for Q3 was KSEK 876, mainly from patent transfer and grants.

• Equity ratio at period end was 94% (93% prior year); shareholders’ equity was KSEK 675,691.

Outlook and guidance

• Pivotal-stage readiness for vididencel in AML targeted for mid-to-H2 2025, with phase 3 trial preparations ongoing and not dependent on the CADENCE trial.

• Cash runway extended to end of 2025 after efficiency improvements.

• Initial data from the CADENCE trial expected in the first half of 2026.

• Ovarian cancer program to report immune response data by year-end, with long-term survival data expected in 12+ months; topline safety and feasibility data from the ALISON Phase 1 trial expected in Q4 2024.

• Ilixadencel REGOMUNE trial in soft tissue sarcoma to start in H1 2025, with initial clinical data anticipated in H1 2026.