Mendus (IMMU) Q1 2025 earnings summary

Executive summary

• Received supportive feedback from FDA and EMA for Phase 3 registration trial preparations with lead product Vididencel in AML, including trial design and GMP production steps.

• Expanded clinical development with the AML-22 Cadence trial, managed by the Australasian Leukemia Lymphoma Group, with first patient recruited in Q1 2025.

• Advanced research collaborations, notably with University Medical Center Groningen on ovarian cancer and DCOne platform applications, with data supporting TIL expansion.

• Appointed Tariq Mughal as Chief Medical Officer to strengthen late-stage clinical development.

• Net loss for Q1 2025 was KSEK -30,482, an improvement from KSEK -35,614 year-over-year.

Financial highlights

• Operating loss of SEK 30 million for Q1 2025, with no revenue reported; other operating income was KSEK 1,340, mainly from research grants.

• Cash position at end of Q1 was SEK 84.7 million (KSEK 84,730), down from SEK 101.9 million at year-end 2024.

• Cash burn during Q1 was approximately SEK 16 million, offset by a SEK 6 million grant from Oncode-PACT and prepaid tech transfer costs.

• Operating expenses decreased to KSEK -31,562 from KSEK -38,101 year-over-year, mainly due to lower R&D costs.

• Earnings per share improved to SEK -0.61 from SEK -0.83 year-over-year.

Outlook and guidance

• GMP readiness for large-scale Vididencel production targeted for the second half of 2025, supporting late-stage clinical development.

• Pivotal-stage readiness for Vididencel in AML expected in 2025H2, with ongoing regulatory and manufacturing preparations.

• Cash reserves expected to last beyond year-end 2025 and into Q1 2026; additional capital may be needed thereafter.

• Ongoing expansion of clinical development in AML and adjacent diseases, with preparations for broader patient populations.

• Phase three trial preparations underway, including protocol finalization and hospital network setup.