Moleculin Biotech, Inc. reported additional efficacy findings from the Company's ongoing Phase 1B/2 (MB-106) clinical trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of subjects with acute myeloid leukemia (AML). The preliminary data was presented at the European Hematology Association (EHA) 2024 Hybrid Congress. The Company also hosted a data presentation to leading AML experts as part of a KOL meeting held in conjunction with EHA 2024 Congress.

To date, a total of 22 subjects have been enrolled (the Intent-to-Treat population, ITT), 20 (Lines 1st-7th) of whom have completed efficacy evaluations with 9 subjects (45%) achieving a composite complete remission (CRc or CR/CRi), consisting of 8 (40%) subjects with complete remission (CR) and one subject with complete remission with an incomplete recovery of peripheral blood counts (CRi), following treatment with AnnAraC. Efficacy outcomes for 2 additional subjects (enrolled and treated) are pending. Of the 10 ITT subjects for whom AnnAraC was administered in the 2nd line setting, 5 achieved a CR (50%) and 6 achieved a CRc (60%).

Of the 13 subjects in the ITT evaluable population that were 1st or 2nd line treatment, 7 achieved a CR (54%) and 8 achieved a CRc (62%). The mDOR for the 9 subjects who achieved a CRc is approximately 6 months and climbing. Additionally, the median overall survival in the 2nd line subjects (n=10) is approximately 6 months and increasing.

Additionally, 89% of the subjects included in the CRc group (n=9) had cytogenetics and/or mutations generally considered to contribute to a poor prognosis. These include FLT3, IDH2, ASXL1, KMT2A and others. While not yet statistically relevant, the Company believes such cytogenetic and mutation data are informative to clinicians.

Currently, the median age of subjects in MB-106 is 69 years. Not including the two most recent subjects, a total of 17 subjects had relapsed/refractory AML and 3 subjects were first line treatment. Two subjects discontinued early due to allergic reactions.

All subjects who completed treatment had undergone post-therapy bone marrow assessment (Day 15 or later). No clinically significant signs of cardiotoxicity were noted during or after treatment in any of the subjects enrolled. The combination was well tolerated with myelosuppression and infections being the main adverse events (AEs).

All data from MB-106 is preliminary and subject to change.