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 new subsidiary in Australia.

• Manufacturing alliance with NorthX Biologics progressing as planned, with large-scale GMP production for late-stage clinical use expected by mid-2025.

• Collaboration with Institut Bergonié enables re-entry of ilixadencel into clinical trials for soft tissue sarcoma, with REGOMUNE trial preparations ongoing.

• Multiple presentations of vididencel data, including survival updates from ADVANCE II, scheduled at major conferences such as ASH and SITC 2024.

• Cash runway extended to end of 2025 due to cost efficiencies, grants, and financing activities.

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).

• Q3 cash flow from operations: SEK -20.1 million; nine-month cash flow: SEK -73.1 million.

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

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

• Other operating income for Q3 was KSEK 876, mainly from patent transfer and grants.

Outlook and guidance

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

• Cash runway expected to fund operations through end of 2025.

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

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

• Ongoing expansion of clinical development for vididencel in combination with oral azacitidine.