Moleculin Biotech, Inc. announced recent activity, new positive data and expected near term milestones across its clinical development pipeline. Ongoing Clinical Trial Updates: Next Generation Anthracycline – Annamycin: Annamycin is the Company's next-generation anthracycline that has been designed to be non-cardiotoxic (unlike currently prescribed anthracyclines) and has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin (a commonly prescribed anthracycline), as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. An independent expert has reported no signs of cardiotoxicity in the first 42 patients in the Company's three clinical trials, which total includes 32 patients treated over the lifetime maximum anthracycline dose set by the U.S. Food and Drug Administration (FDA).

Annamycin is currently in development for the treatment of STS lung metastases (STS lung mets) and relapsed or refractory acute myeloid leukemia (AML) and the Company believes the drug may have the potential to treat additional indications. STS Lung Mets: The Company is currently in the Phase 2 portion of its ongoing U.S. Phase 1b/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (MB107).  Upcoming Milestones Expectations: STS (U.S.): Report Phase 2 interim data. STS (EU): Report Phase 1b/2 interim data.

AML: Present CSR for MB-105 Phase 1 results at an upcoming conference. Flagship Immune/Transcription Modulator – WP1066: Moleculin is in ongoing discussions with multiple academic institutions in separate programs evaluating WP1066 for the treatment of brain tumors. The Company expects investigator-sponsored clinical trials or programs for the treatment of adult and pediatric brain tumors to commence in the first half of 2023.

Expected Upcoming Milestones: Report topline results from investigator-initiated Phase 1 study in pediatric brain tumors. Seek to capitalize on external funding with opportunities for an investigator-initiated clinical trial in adult and pediatric cancer patients in 2023. Metabolism/Glycosylation Inhibitor – WP1122 Portfolio: WP1122 was developed as a prodrug of 2 deoxy-D-Glucose (2-DG) to provide a more favorable pharmacological profile and was found to have greater potency than 2-DG alone in preclinical models where tumor cells require higher glycolytic activity than normal cells.

WP1122 has also been shown to have a greater antiviral effect than 2-DG against SARS-CoV-2 in MRC-5 cells in culture. The improved pharmacokinetic and pharmacodynamic (PK/PD) profile of WP1122 compared to 2-DG was noted in mice following oral dosing at equimolar (i.e., equivalent levels of 2-DG) doses. The WP1122 Portfolio includes numerous analogs, including WP1096, which has demonstrated the potential for broad antiviral capabilities in a wide range of in vitro models including multiple arenaviruses, Zika virus, and HIV.

The Company looks forward to the potential externally funded clinical trials to confirm such activity. Expected Upcoming Milestones: Report preliminary findings of National Institutes of Health (NIH) funded animal testing of WP1096 in the Tacaribe Arenavirus. Identify investigators interested in initiating a clinical trial to study the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.

General Information on the Company's Core Technologies: Annamycin currently has Fast Track Status (FTS) and Orphan Drug Designation (ODD) from the FDA for the treatment of soft tissue sarcoma, in addition to ODD for the treatment of acute myeloid leukemia. WP1066 has ODD for the treatment of GBM and has four treatments designated for the FDA Rare Pediatric Disease Priority Review Voucher (PRV) Program. WP1122 has ODD for GBM, as well, and FTS for GBM.