Moleculin Biotech, Inc. 8-K

What Happened
Moleculin Biotech (MBRX) filed an 8-K (Regulation FD disclosure) on Feb 18, 2026, reporting that 35 subjects have been treated to date in its pivotal Phase 2B/3 “MIRACLE” study of Annamycin combined with cytarabine for adults with relapsed or refractory acute myeloid leukemia (R/R AML). An additional 11 subjects are in screening or have been identified. The company said it is targeting the first unblinding of data after 45 subjects and believes it is on track to treat the 45th subject in Q1 2026. This update reflects status as of Feb 10, 2026. A press release announcing the update is attached as Exhibit 99.1.

Key Details

• 35 subjects treated to date in the MIRACLE Phase 2B/3 trial (update as of Feb 10, 2026).
• 11 additional subjects are in screening or identified.
• Target for first unblinding: after 45 subjects are treated; company expects to reach 45th subject in Q1 2026.
• Disclosure made via a press release filed as Exhibit 99.1 to the Form 8-K.

Why It Matters
This filing provides a concrete enrollment update on Moleculin’s pivotal trial, a near-term operational milestone for the Annamycin program. Reaching and unblinding data after 45 subjects is a key timeline event that investors will watch for progress signals and potential future regulatory or clinical decisions. The disclosure is informational — it reports trial enrollment status and timing expectations but contains no new efficacy or safety results.