Business Description

1. Nature of Business The terms “MBI” or “the Company”, “we”, “our” and “us” are used herein to refer to Moleculin Biotech, Inc. MBI is a clinical-stage pharmaceutical company, organized as a Delaware corporation in July 2015. MBI is a late-stage pharmaceutical development company currently conducting a pivotal Phase 2B/3 trial evaluating Annamycin, also known by its non-proprietary name "naxtarubicin", in combination with cytarabine for the treatment of subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML). The Company has two additional portfolios of technologies for hard-to-treat cancers and viruses with clinical and preclinical research funded primarily by investigators at academic institutions. Each of its three core technologies is based substantially on discoveries at, or in conjunction with and with rights originating from the University of Texas MD Anderson Cancer Center (MD Anderson) in Houston, Texas, and features one or more drugs that have successfully completed a Phase 1 clinical trial. Three of its drug candidates have shown human activity in clinical trials and are currently or have been in Phase 1B/2 or Phase 2 clinical trials. Since MBI’s inception, its drugs have completed, are in planning, are currently in, or have been permitted to proceed in, eighteen clinical trials. Annamycin, in a unique multilamellar lipid formulation, is the Company’s lead molecule, and in 2024 MBI has concluded treatment in several Phase 1B/2 clinical trials for treating AML and in March 2025 began treating subjects in its Phase 2B/3 clinical trial for the treatment of R/R AML. The latter is the main focus the Company’s management and resources. Annamycin was in two closed or concluded Phase 1B/2 clinical trials for treating Soft Tissue Sarcoma metastasized to the lungs (STS lung metastases, STS lung mets, or Advanced STS), with one physician-sponsored. The Company announced in 2025 a physician-sponsored trial for Annamycin for the treatment of pancreatic cancer intended to begin in the second half of 2026. Additionally, there is another phase 1B/2 clinical trial that is physician sponsored which is investigating using WP1066 in combination with radiation for the treatment of glioblastoma, a form of brain cancer, with another similar trial planned within the next year for pediatric brain tumors. The physician-sponsored trials utilize primarily external funds, such as grant funds, which are not presented in these financial statements. The Company does not have manufacturing facilities, and all manufacturing activities are contracted out to third parties. Additionally, the Company does not have a sales organization. The Company’s overall strategy is to seek potential out-licensing or outsourcing opportunities with development/commercialization strategic partners who are better suited for the marketing, sales and distribution of its drugs, if approved. In 2019, the Company sublicensed its technologies to Animal Life Sciences, Inc. (ALI), to enable research and commercialization for non-human use and share development data. As part of this agreement, ALI issued to the Company a 10% equity interest in ALI. On May 23, 2025, the Company received a letter from Nasdaq Stock Market LLC notifying the Company that it was not in compliance with Nasdaq Listing Rule 5550 (b)( 1 ) (the “Equity Rule”), which requires a minimum of $2.5 million in stockholders’ equity. The letter also noted that the Company did not meet the alternative compliance standards of market value of listed securities or net income from continuing operations under the Equity Rule. The notification had no immediate effect on the listing of the Company’s common stock on the Nasdaq Capital Market, and the Company was provided 45 calendar days to submit a plan to regain compliance. The Company’s compliance plan was subsequently accepted, and the Nasdaq staff granted an extension of up to 180 calendar days, through November 19, 2025, to demonstrate compliance. On June 27, 2025, the Company received an additional deficiency letter from the staff of Nasdaq indicating that, for the previous 30 consecutive business days, the closing bid price of the Company’s common stock had been below the minimum $1.00 per share requirement for continued listing on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550 (a)( 2 ) (the “Bid Price Rule”).…