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 expanded clinical network and ALLG collaboration.

• 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, with new multi-center trial preparations ongoing.

• Multiple presentations of vididencel data, including updated survival results from ADVANCE II, scheduled at ASH and SITC 2024.

• Cash runway extended to end of 2025 through cost efficiencies, grants, and optimized cash management.

Financial highlights

• Q3 2024 net loss was SEK 23 million (KSEK -23,030); nine-month net loss was SEK 96.9 million (KSEK -96,884).

• Cash flow from operating activities was SEK -20 million in Q3 and SEK -73.1 million for the first nine months.

• Cash position at end of Q3 was SEK 109.3 million (KSEK 109,322).

• No net sales reported; other operating income mainly from patent transfer and grants.

• Equity ratio at period end was 94% (prior year: 93%).

Outlook and guidance

• Pivotal-stage readiness for vididencel in AML targeted for H2 2025, with phase 3 trial preparations and regulatory alignment ongoing.

• Cash runway expected to fund operations through end-2025 after efficiency improvements.

• Initial data from the CADENCE trial expected in H1 2026; phase 3 trial preparations are not dependent on CADENCE timelines.

• Topline safety and feasibility data from the ALISON Phase 1 ovarian cancer trial expected in Q4 2024; long-term data expected in 12 months.

• Initial clinical data from the ilixadencel arm of the REGOMUNE trial anticipated in H1 2026.