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 for 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 registration trial preparations.

• Positive topline data from the ALISON Phase 1 trial in ovarian cancer indicated immune responses and a strong safety profile for vididencel; majority of patients showed stable disease, with two-year follow-up data expected in Q4 2025.

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

• Large-scale manufacturing alliance with NorthX Biologics is on track for GMP readiness in H2 2025.

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

Financial highlights

• Full-year 2024 net loss was KSEK -130,655, slightly higher than -128,399 KSEK in 2023; Q4 net loss was KSEK -31,515, improved from -41,165 KSEK YoY.

• Cash and cash equivalents at year-end were KSEK 101,905, with a cash runway projected to last until early 2026.

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

• Shareholders’ equity stood at KSEK 645,149 at year-end.

• R&D expenses for the group were KSEK -101,075 for the year, accounting for 74% of group operating expenses.

Outlook and guidance

• Preparations for pivotal-stage registration trial of vididencel in AML are ongoing, with trial expected to begin after preparations complete in H2 2025.

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

• Focus remains on achieving pivotal-stage readiness, with potential for partnership or additional funding to support late-stage development.

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

• Ilixadencel program to seek partnering opportunities for further development.