ADDED
false --12-31 FY 2025 true true true false One of the key responsibilities of our board of directors is informed oversight of our risk management process, including risks from cybersecurity threats.
Our board of directors is responsible for monitoring and assessing strategic risk exposure, and our executive officers are responsible for the day-to-day management of the material risks we face.
Our board of directors administers its cybersecurity risk oversight function through the audit committee, which provides oversight of our cybersecurity program as part of its periodic review of overall risk management program.
One of the key responsibilities of our board of directors is informed oversight of our risk management process, including risks from cybersecurity threats.
Our board of directors is responsible for monitoring and assessing strategic risk exposure, and our executive officers are responsible for the day-to-day management of the material risks we face.
Our board of directors administers its cybersecurity risk oversight function through the audit committee, which provides oversight of our cybersecurity program as part of its periodic review of overall risk management program.
Management's Discussion and Analysis of Financial Condition and Results of Operations 54 Item 7A.
BUSINESS BUSINESS Business Summary 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 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, and we expect to have an interim unblinding of data in mid-2026 and an additional unblinding in the second half of 2026, thereby concluding Part A of the two-part trial.
REMOVED
Management's Discussion and Analysis of Financial Condition and Results of Operations 47 Item 7A.
BUSINESS BUSINESS Business Summary We are a late-stage pharmaceutical development company currently conducting a pivotal Phase 3 trial evaluating Annamycin, a non-cardiotoxic anthracycline, in combination with Cytarabine for the treatment of subjects with relapsed/refractory acute myeloid leukemia (AML).
This Phase 3 trial should have an interim unblinding of data by the end of 2025, less than a year from its commencement, and an additional unblinding in the first half of 2026.
We believe such early visibility for a pivotal registration-enabling trial is highly unique in that stakeholders will receive preliminary safety and efficacy data in the MIRACLE trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) within one year of dosing the first subject.
Each of our three core technologies is based substantially on discoveries made at and licensed 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 our six 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 our inception, our drug candidates have completed, are currently in, or have been permitted to proceed in, fourteen clinical trials.
Annamycin is in a class of drugs referred to as Anthracyclines, which are an inhibitor of topoisomerase II, enabling them to cause DNA damage in rapidly replicating tumor cells.
Annamycin, in a unique multilamellar lipid formulation, is our lead molecule and we have recently concluded one Phase 1B/2 clinical trial for treating AML and are embarking on a Phase 3 clinical trial for the treatment of AML, which we believe will be pivotal.
Annamycin was also in two Phase 1B/2 clinical trials for treating Soft Tissue Sarcoma metastasized to the lungs (STS lung metastases, STS lung mets, or Advanced STS).