Mendus (IMMU) Q4 2024 earnings summary

Executive summary

• Updated survival data from the ADVANCE II Phase 2 trial in AML showed durable long-term survival with vididencel, with 58% estimated 5-year survival and 13 of 20 patients alive at median 41.8 months follow-up; positive regulatory feedback from FDA and EMA supports a registration trial, and large-scale manufacturing alliance with NorthX Biologics is progressing for GMP readiness in H2 2025.

• Positive topline data from the ALISON Phase 1 trial in ovarian cancer indicated immune responses, strong safety profile, and stable disease in most patients; 2-year follow-up data expected in Q4 2025.

• Ilixadencel program in soft tissue sarcomas halted due to third-party funding withdrawal; now seeking partners for further development.

• Expansion of clinical development includes the CADENCE trial (vididencel + oral azacitidine) and additional opportunities in AML and CML.

• Cash runway extended to early 2026, supported by warrants, grants, and share issues.

Financial highlights

• Annual costs were SEK 136 million; full-year net loss was SEK 130.655 million, with Q4 net loss at SEK 31.515 million, improved from prior year.

• Cash and cash equivalents at year-end were SEK 101.905 million, with a cash runway projected to early 2026.

• Q4 cash position changed by SEK 8 million, supported by grants and interest income.

• Shareholders’ equity at year-end was SEK 645.149 million; equity ratio remained strong at 93%.

• Cash flow from operating activities for the year was SEK -79.671 million, reflecting prior year prepayments for tech transfer.

Outlook and guidance

• Preparing for a pivotal-stage registration trial for vididencel in AML, with readiness expected in H2 2025 and ongoing regulatory engagement.

• ALISON Phase 1 ovarian cancer trial to deliver 2-year follow-up data in Q4 2025.

• CADENCE trial in combination with oral azacitidine is progressing, though site activation and patient enrollment are slower than expected.

• Ilixadencel program to seek partnering opportunities for further development.

• Additional funding or partnerships may be required for phase III trial execution.