Moleculin Biotech (MBRX) Q4 2025 earnings summary

Executive summary

• Reported full year 2025 financial results and highlighted progress in the pivotal MIRACLE trial for relapsed/refractory AML, with interim data unblinding for 45 patients on track for mid-2026.

• Preliminary blinded CRc rate of 40% in the first 30 patients in the MIRACLE trial suggests promising efficacy, especially in a heavily pretreated population.

• Advanced multiple clinical programs, including new collaborations and positive early-stage results in brain and pancreatic cancers.

Financial highlights

• Research and development expense was $15.9 million for 2025, down from $17.7 million in 2024, mainly due to reduced sponsored research activities.

• General and administrative expenses were $9.2 million in 2025, up from $8.9 million in 2024, driven by higher regulatory, legal, and consulting costs.

• Net loss for 2025 was $33.7 million, compared to $26.0 million in 2024.

• Cash and cash equivalents stood at $8.9 million as of December 31, 2025, with $8.3 million in additional gross proceeds received in Q1 2026.

Outlook and guidance

• MIRACLE trial interim unblinding for 45 subjects expected mid-2026, with further milestones including 90 subjects treated and Part B initiation in 2H 2026.

• Management expects current cash resources plus recent financing to fund operations into Q3 2026; significant additional financing will be required for future milestones.

• New clinical trials in pancreatic and pediatric AML planned for 2026–2027, with primary efficacy data and NDA submission targeted for 2028.