Mendus (IMMU) Q4 2024 earnings summary

Executive summary

• Vididencel advanced toward pivotal-stage readiness in AML, with updated survival data from the ADVANCE II trial and positive FDA/EMA feedback supporting a registration trial; large-scale manufacturing alliance with NorthX Biologics progressing as planned.

• Positive topline data from the ALISON Phase 1 trial in ovarian cancer confirmed immune response and strong safety profile for vididencel; long-term follow-up ongoing with two-year survival data expected in Q4 2025.

• Ilixadencel program in soft tissue sarcomas halted due to third-party funding withdrawal; now seeking partnership to advance this asset.

• Cash runway extended to early 2026, supported by share issues, warrant exercises, cost-saving measures, and grants.

Financial highlights

• Annual costs totaled SEK 136 million, with cash flow for the year at SEK 20 million, supported by warrant proceeds and grants.

• Q4 net loss was KSEK -31,515 (improved YoY); full-year net loss was KSEK -128,399, mainly due to increased R&D costs.

• Cash and cash equivalents at year-end were KSEK 101,905; equity ratio remained strong at 93%.

• Cash flow from operating activities for the year was KSEK -79,671, reflecting prior year prepayments for tech transfer.

• Cash runway projected to last until early 2026, including all pivotal trial preparations.

Outlook and guidance

• Preparations for phase III registration trial of vididencel in AML are ongoing, with pivotal-stage readiness expected in H2 2025.

• Next ALISON trial update based on two-year survival data expected in Q4 2025.

• Additional trials in AML and adjacent diseases are being prepared to broaden the addressable patient population.

• Additional capital or partnership will be needed for late-stage development beyond early 2026.