8-K - Moleculin Biotech, Inc. | StockGist

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Moleculin Biotech, Inc. disclosed preliminary blinded data from its Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine in R/R AML, reporting a 40% CRc rate (30% CR, 10% CRh) in the first 30 subjects, with 35 subjects treated as of February 10, 2026, and on track for first unblinding after treating 45 subjects in Q1 2026. The Company highlighted a 67% improvement over historical cytarabine CR rates and absence of cardiotoxicity.

Key Takeaways

135 subjects treated in MIRACLE trial as of February 10, 2026, with 11 more in screening or identified

2Preliminary blinded CRc rate of 40% (30% CR + 10% CRh) in first 30 subjects

367% improvement over historical cytarabine CR rate of 17-18%

4Roughly 35% of subjects are R/R from venetoclax regimens

5On track to treat 45th subject in Q1 2026 with unblinding thereafter

6Continued absence of cardiotoxicity observed

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 February 18, 2026 104 Cover page Interactive Data File (format

Exhibits Only

Source Document

Exhibits (2)

8-K

FORM 8-K

99.1

EXHIBIT 99.1