Moleculin Biotech, Inc. 8-K

What Happened Moleculin Biotech, Inc. filed a Form 8-K on March 23, 2026, disclosing that the 45th subject has been enrolled in its pivotal Phase 2B/3 MIRACLE trial evaluating Annamycin in combination with cytarabine (AnnAraC) for adult subjects with relapsed or refractory acute myeloid leukemia (R/R AML). The company said this milestone triggers final preparation for the trial’s planned interim unblinding of 45-subject data, which remains on track for mid-2026. A press release dated March 23, 2026 is attached as Exhibit 99.1.

Key Details

• Enrollment milestone: 45th subject enrolled in the Phase 2B/3 MIRACLE trial (AnnAraC).
• Drug/regimen: Annamycin in combination with cytarabine (AnnAraC).
• Indication: Adult relapsed or refractory acute myeloid leukemia (R/R AML).
• Timing: Interim unblinding of the 45-subject dataset is expected mid-2026.
• Filing: Disclosure made via Form 8-K (Exhibit 99.1 press release) filed March 23, 2026.

Why It Matters Reaching the 45-subject enrollment milestone moves the MIRACLE trial toward its first interim data readout, a potential near-term catalyst for the company. For investors, the mid-2026 interim unblinding could provide the earliest clinical efficacy/safety signals for Annamycin + cytarabine in R/R AML, which may materially affect Moleculin’s clinical outlook and risk profile.