Moleculin Biotech, INC. 8-K Filing
Ticker: MBRX · Form: 8-K · Filed: Dec 9, 2025 · CIK: 1659617
Sentiment: neutral
Filing Stats: 629 words · 3 min read · ~2 pages · Grade level 10.3 · Accepted 2025-12-09 08:16:41
Filing Documents
- mbrx20251208_8k.htm (8-K) — 26KB
- ex_897001.htm (EX-99.1) — 16KB
- m01.jpg (GRAPHIC) — 8KB
- 0001437749-25-037209.txt ( ) — 196KB
- mbrx-20251209.xsd (EX-101.SCH) — 3KB
- mbrx-20251209_def.xml (EX-101.DEF) — 11KB
- mbrx-20251209_lab.xml (EX-101.LAB) — 15KB
- mbrx-20251209_pre.xml (EX-101.PRE) — 11KB
- mbrx20251208_8k_htm.xml (XML) — 3KB
01
Item 7.01 Regulation FD Disclosure On December 9, 2025, Moleculin Biotech, Inc. (the "Company"), issued a press release which provided an update on enrollment from its November report with an increase to 78% of the target number of subjects for the first planned interim unblinding of data having consented to its pivotal Phase 2B/3 "MIRACLE" study of Annamycin in combination with cytarabine for the treatment of adult patients with acute myeloid leukemia (AML) who are refractory to or relapsed (R/R) after induction therapy (R/R AML). This is up from 60% in its report in November. The targeted number for the first unblinding of data is 45 subjects. Additional subjects beyond the 78% mark continue to be identified by site investigators. This update is as of December 3, 2025, as identification and recruitment are ongoing. The Company expects to complete treatment of the first 45 subjects in the first quarter of 2026. A copy of the press release is attached to this report as Exhibit 99.1 and is incorporated by reference herein. The information contained in Item 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, as amended ("Exchange Act"), nor shall it be incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended ("Securities Act"), unless specifically identified therein as being incorporated by reference.
Financial Statements and Exhibits
Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press Release dated December 9, 2025 104 Cover page Interactive Data File (formatted as Inline XBRL document) SIGNATURE Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. MOLECULIN BIOTECH, INC. Date: December 9, 2025 By: /s/ Jonathan P. Foster Jonathan P. Foster