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8-K2026-05-15· grok-4-1-fast-non-reasoning

MBRX · Moleculin Biotech, Inc.

0001437749-26-017226

SEC filing

Summary

Moleculin Biotech reported Q1 2026 financial results with $12.8M net loss, $10.3M cash position funding into Q3 2026, and positive blinded MIRACLE trial data showing 40% CRc rate at 45 subjects.

Key takeaways

Full analysis

Moleculin Biotech's Q1 2026 results reflect intensified clinical investment, with R&D expenses increasing $2.0 million year-over-year to $5.4 million, primarily driven by $1.4 million in MIRACLE trial costs in Europe and $0.3 million in additional nonclinical studies. G&A expenses remained stable at $2.5 million. The resulting GAAP net loss widened to $12.8 million or $(3.54) per share from $5.9 million or $(15.80) per share last year, impacted by warrant-related items including a $10.8 million gain on fair value change offset by $15.2 million loss on issuance and $1.8 million deemed dividend. Despite the loss, CEO Walter Klemp highlighted encouraging blinded efficacy trends in the pivotal MIRACLE Phase 2B/3 trial, maintaining a 40% composite complete remission rate across the first 45 difficult-to-treat relapsed/refractory AML subjects, supporting Annamycin's potential to improve outcomes without cardiotoxicity. Enrollment momentum positions the company for key unblindings: 45-subject data in Q2 2026 and 90 subjects in Q3 2026, advancing toward Part B in 2H 2026 and NDA submission in 2028. Balance sheet strengthened to $10.3 million cash from $8.9 million at year-end, bolstered by $8.3 million in Q1 financings, funding operations into Q3 2026 amid pipeline expansion including pancreatic cancer and pediatric AML studies.