Common Stock
- Symbol
- MBRX
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 9.01 · 8-K
Moleculin Biotech, Inc.
MBRXNASDAQEQUITYCurrent
Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure On November 10, 2026, Moleculin Biotech, Inc. (the “Company”), issued a press release which announced new preclinical data showing that its lead drug candidate, Annamycin (naxtarubicin), combined with PD-1 immune checkpoint blockade, extended survival in pancreatic cancer models beyond that achieved with either agent alone.…
Company context
We are a late-stage pharmaceutical development company currently evaluating Annamycin, also known as L-Annamycin and by its generic name “naxtarubicin”, which we believe is a “next-generation” anthracycline and, with it, are conducting a pivotal Phase 2/3 trial in combination with cytarabine for the treatment of subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML). We call this the “MIRACLE” trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation). A blinded preliminary data readout has been released for the MIRACLE trial, we released an interim unblinding of data in June 2026, and we expect an additional unblinding at the end of 2026, thereby concluding Part A of the two-part trial. We believe such early visibility for a pivotal registration-enabling trial is unique in that stakeholders will receive preliminary safety and efficacy data long before the conclusion of the trial.
Current securities
Registered securities in this filing
MOLECULIN BIOTECH, INC. · 8-K · Filed 2026-11-10
Disclosure sections
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure
On November 10, 2026, Moleculin Biotech, Inc. (the “Company”), issued a press release which announced new preclinical data showing that its lead drug candidate, Annamycin (naxtarubicin), combined with PD-1 immune checkpoint blockade, extended survival in pancreatic cancer models beyond that achieved with either agent alone. The findings will be presented today by Waldemar Priebe, PhD, of The University of Texas MD Anderson Cancer Center, in an oral presentation at the 6th Annual Marie Skłodowska-Curie Symposium on Cancer Research and Care organized by Moffitt Cancer Center, being held November 8-11, 2026 in Tampa, Florida.
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.