8-K - Moleculin Biotech, Inc. | StockGist

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Moleculin Biotech, Inc. announced enrollment of the 45th subject in its pivotal Phase 2B/3 MIRACLE trial evaluating AnnAraC for relapsed or refractory acute myeloid leukemia, triggering final preparations for interim data unblinding on track for mid-2026. This milestone represents a potentially defining inflection point for the Company.

Key Takeaways

145th subject enrolled in MIRACLE trial on March 23, 2026

2Interim unblinding of first 45 subjects (approx. 30 on AnnAraC, 15 control) expected mid-2026

3Preliminary blinded 40% composite complete remission rate (30% CR, 10% CRh) in first 30 patients

435% of subjects previously failed venetoclax-based therapies

5Enrollment accelerating toward 90 subjects by Q3 2026

6Over 100 patients treated with Annamycin without cardiotoxicity

Current Report Details

Event Type

Regulation Fd

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be “filed” for the purpose of the Securities Exchange Act of 1934,

Regulation Fd

9.01

Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press Release dated March 23, 2026 104 Cover page Interactive Data File (formatted

Exhibits Only

Source Document

Exhibits (2)

8-K

FORM 8-K

99.1

EXHIBIT 99.1