Bio-Path Holdings, Inc. provided a clinical development and operational update. Important Near-Term Clinical Milestones: BP1001-A Phase 1/1b Clinical Trial in Solid Tumors: Important trial with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer with initial cohort completion and data readout expected before mid-year. BP1002 Phase 1/1b Clinical Trial in Relapsed/Refractory AML: Focus on patients who relapsed on venetoclax treatment with initial cohort completion and readout expected in the second quarter of 2023.

Prexigebersen (BP1001) Phase 2 Clinical Trial in AML: Two of the three cohorts in the clinical trial already exceed the minimum efficacy required for enrollment expansion. Assess safety and efficacy of each cohort treatment combination therapy with potential to qualify for expedited program status after cohort's initial interim analysis, which are expected to commence by cohort in the second quarter of 2023. 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.

There is one additional drug candidate that is in preclinical development, which may be submitted to the FDA later in the year in an Investigational New Drug (IND) application. Phase 2 Clinical Trial – Bio-Path's Phase 2 clinical trial is treating Acute Myeloid Leukemia (AML) patients. This trial is comprised of three separate cohorts of patients and treatments, each separately approvable by the FDA as a new drug treatment.

The first two cohorts are treating patients with the triple combination of prexigebersen (Bio-Path's drug candidate BP1001), decitabine and venetoclax. The first cohort includes untreated AML patients, and the second cohort includes relapsed/refractory AML patients. Finally, the third cohort is treating relapsed/refractory AML patients, who are venetoclax-resistant or -intolerant, with the two-drug combination of prexigebersen and decitabine.

The interim analysis of each cohort to assess the safety and efficacy of treatment combination therapy is expected to commence by cohort in the second quarter of 2023, with the potential to qualify for expedited regulatory status. Phase 1/1b Clinical Trial in BP1001-A in Advanced Solid Tumors – Phase 1/1b clinical trial of BP1001-A in patients with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer. BP1001-A is a modified product candidate that incorporates the same drug substance as prexigebersen but has a slightly modified formulation designed to enhance nanoparticle properties.

Completion of the first dose escalation cohort is expected in the coming months. Phase 1/1b Clinical Trial in BP1002 in Relapsed/Refractory AML. Phase 1/1b clinical trial for BP1002 to treat relapsed/refractory AML patients, including venetoclax-resistant patients.

BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. AML patients that fail frontline venetoclax-based therapy have very poor prognosis with median overall survival of less than three months. Completion of the first dose escalation cohort is expected in the coming months.

Phase 1 Clinical Trial in BP1002 in Refractory/Relapsed Lymphoma and Chronic Lymphocytic Leukemia (CLL). Phase 1 clinical trial for refractory/relapsed lymphoma and CLL. The Phase 1 clinical trial is being conducted at several leading cancer centers, including the Georgia Cancer Center, The University of Texas Southwest and New York Medical College.

Completion of the current patient cohort is expected in 2023. 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 (pancreatic, non-small cell lung cancer). Manufacturing Supply: The COVID-19 pandemic created manufacturing interruptions over the last several years.

The Company experienced manufacturing shutdowns in supply chain manufacturing plants and an increase in lost manufactured product batches that created supply disruptions. In addition, the onset of messenger RNA vaccine development for COVID-19 created increased backlog time at oligonucleotide suppliers. These conditions created drug candidate supply shortfalls that caused enrollment challenges for Bio-Path's clinical trials.

The result of these factors led Bio-Path to double the Company's supply chain, increase capacity, quality and improve scheduling flexibility. These goals were achieved in 2022 and have resulted in increased drug candidate supply, quality and patient enrollment.