MBRX · Moleculin Biotech, Inc.

This disclosure represents a HIGH-material clinical milestone: the imminent unblinding of the first 45-subject interim analysis from Moleculin’s pivotal MIRACLE trial is a critical near-term inflection point for Annamycin’s development in R/R AML. The trial’s design — comparing two doses of Annamycin plus cytarabine against cytarabine plus placebo — enables a direct assessment of Annamycin’s additive benefit over current standard-of-care, which historically yields only 17–18% complete remission in this challenging population. With blinded CR data already approximating 30% and CRc exceeding 40%, the magnitude of potential improvement is clinically meaningful and could support accelerated regulatory pathways given the Fast Track and Orphan Drug designations. Recruitment progress (56/90 subjects enrolled as of May 1) confirms execution capability, and the absence of reported cardiotoxicity reinforces Annamycin’s differentiated safety profile relative to conventional anthracyclines. Importantly, the trial targets a high-unmet-need subgroup — over 30% of enrolled patients are R/R venetoclax failures — where treatment options are severely limited and outcomes remain poor. While the data remain blinded and unconfirmed, the timing (unblinding before June 30, 2026), rigor of design, and alignment with regulatory incentives position this event as a primary catalyst for valuation reassessment. Forward-looking statements in the release explicitly acknowledge financing dependency and regulatory uncertainty, underscoring that successful unblinding must be followed by robust confirmatory data and continued funding execution.