Mendus (IMMU) Q1 2025 earnings summary

Executive summary

• Received supportive feedback from FDA and EMA for pivotal registration trial preparations with lead product vididencel in AML, including trial design and GMP production steps; first patient enrolled in AMLM22-CADENCE trial.

• Expanded clinical development with the AML-22 Cadence trial, managed by the Australasian Leukemia Lymphoma Group, and broadened pipeline to address AML, CML, and solid tumors.

• Advanced research collaborations, notably with University Medical Center Groningen on ovarian cancer and DCOne platform applications, with new data presented at major conferences.

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

• Established a large-scale manufacturing alliance with NorthX Biologics for GMP readiness in 2025H2.

Financial highlights

• Q1 2025 net loss was -30,482 KSEK, an improvement from -35,614 KSEK in Q1 2024.

• Cash position at quarter-end was 84,730 KSEK, with a cash runway projected until Q1 2026.

• Cash burn in Q1 was 16.0 MSEK, offset by a SEK 6 million grant from Oncode-PACT and prepaid tech transfer costs.

• No revenue reported for Q1 2025; other operating income was KSEK 1,340, mainly from research grants.

• Earnings per share for Q1 2025 was -0.61 SEK, compared to -0.83 SEK in Q1 2024.

Outlook and guidance

• Large-scale GMP manufacturing readiness for vididencel targeted for the second half of 2025, supporting late-stage clinical development.

• Registration trial preparations for vididencel in AML maintenance are on track, with global trial launch anticipated after 2025H2.

• Expansion of clinical development to additional AML and CML populations is planned.

• Cash position expected to fund operations until early 2026; additional capital may be needed thereafter.