Bio-Path provides clinical update, expansion plans

Bio-Path Holdings provides an update on the Company’s clinical progress and plans for expansion. Clinical Program Overview: Bio-Path’s clinical development program consists of one Phase 2 clinical trial and three Phase 1 or 1/1b clinical trials. Bio-Path has developed a molecular biomarker package to accompany prexigebersen treatment and is currently expanding prexigebersen preclinical studies for the treatment of obesity. Prexigebersen Phase 2 Clinical Trial – The study is currently paused for an interim analysis, amendment preparation and U.S. Food and Drug Administration review. Bio-Path expects to complete enrollment in cohorts 1 and 2 of the study over the next eighteen months. Phase 1/1b Clinical Trial in BP1001-A in Advanced Solid Tumors – In recent months, Bio-Path advanced to dose level 2 and expects to complete enrollment in order to advance to dose level 3 by year-end. Phase 1/1b Clinical Trial in BP1002 in Relapsed/Refractory AML – Bio-Path recently completed the second dose cohort of 40 mg/m2 and is completing an analysis of PK/PD data to be submitted to the FDA in order to advance to the next dose level. Upon submission of data and approval from FDA, Bio-Path expects to advance to dose level 3 in the fourth quarter of 2024. Phase 1 Clinical Trial in BP1002 in Refractory/Relapsed Lymphoma and Chronic Lymphocytic Leukemia – Enrollment has continued for patients in the second BP1002 dose cohort of 40 mg/m2 and the Company expects to complete enrollment and to review these data by year-end. Preclinical Work for BP1003 – The Company continues to advance its drug candidate, BP1003, for the treatment of advanced solid tumors, including pancreatic cancer. BP1003 is an antisense RNAi nanoparticle targeting the STAT3 protein. Plans are to conduct a Phase 1 study of BP1003 in patients with refractory, metastatic solid tumors. Prexigebersen as Potential Treatment for Obesity and Obesity-related Cancers – The Company is preparing for preclinical development evaluating prexigebersen for the treatment of obesity and will continue thereafter to conduct additional Investigational New Drug-enabling studies with an aim to advance prexigebersen into first-in-human studies in this indication.