DALLAS, TX -- June 4th, 2025 -- Bio-Path Holdings, Inc. (OTCQB: BPTH): Stonegate Capital Partners Updates Coverage on Bio-Path Holdings, Inc. (OTCQB: BPTH) for Q1 2025. Bio-Path Holdings, Inc. (OTCQB: BPTH) is a clinical-stage biotechnology company based in Bellaire, Texas, pioneering RNA interference (RNAi) therapeutics through its proprietary DNAbilize® platform. This innovative technology employs neutral-charge, liposomal delivery of antisense oligonucleotides, enhancing drug stability and cellular uptake while minimizing toxicity. The Company's lead candidate, prexigebersen (BP1001), targets the Grb2 protein and is currently in Phase 2 trials for acute myeloid leukemia (AML). A modified version, BP1001-A, is undergoing Phase 1/1b trials for solid tumors and has shown promise in preclinical studies for obesity and type 2 diabetes. Another candidate, BP1002, targets the Bcl-2 protein and is being evaluated for blood cancers and solid tumors. Bio-Path is also preparing an Investigational New Drug (IND) application for BP1003, a STAT3 inhibitor aimed at treating pancreatic cancer.
Achievement of Third Pre-clinical Milestone for BP1001-A Confirms Potential for Treatment of Obesity in Type 2 Diabetes Patients
Ongoing Clinical Trials: The Company has various product candidates in different stages of development and continues to expect near-term results in key cohorts.
- Prexigebersen: Bio-Path has completed Phase 1 clinical trials for its lead candidate prexigebersen for acute myeloid leukemia (AML) and other blood cancers and is in the midst of a Phase 2 clinical trial for AML.
- BP1001-A: BP1001-A (prexigebersen with enhanced nanoparticle properties) has begun Phase 1 trials for the treatment of solid tumors and recently reported treating the first patient with a second, higher dose cohort in its Phase 1/1b clinical trial, continuing to demonstrate the drug’s favorable safety profile. The Company also recently reported encouraging results in preclinical studies of BP1001-A for obesity and related metabolic diseases in Type 2 diabetes patients.
- BP1002: Bio-Path is conducting one clinical trial for BP1002; patient enrollment has stopped for the lymphoma trial. A Phase 1 for patients with refractory/relapsed AML, including those who have relapsed from venetoclax-based treatment, is underway, and recently BPTH reported progressing to the fourth dose cohort of the dose escalation portion of the trial.
- BP1003: BP1003 is in pre-clinical development in a pancreatic patient-derived tumor model. In previous preclinical trials, it has been successful at penetrating pancreatic tumors.
Owning the Breakthrough Technology: Bio-Path has developed a proprietary antisense and liposome delivery technology for DNA drugs, DNAbilize®, potentially solving the challenges of delivering these molecules directly to target cells without side effects. DNAbilize® is Bio-Path’s novel and patented method for producing antisense DNA therapeutics for a broad spectrum of indications, including cancer. This technology overcomes certain drawbacks and challenges of the more traditional methods.
Strategic Relationships: The original technology platform was licensed from The MD Anderson Cancer Center; BPTH maintains a strong relationship with the Cancer Center as well numerous leading cancer centers across the US, with several hosting clinical trials.
Strong IP Position: Bio-path has a strong IP position with composition of matter and method patents for antisense targets and manufacturing, which helps ensure technology preservation and offers protection against competitors.
Cash Runway: The Company reported $122,000 as cash on hand as of 3/31/25; per the most recent filing, in addition to the April 2025 Promissory Notes, more funds will be required to meet operational requirements in 2025.
Valuation: Using comparable companies’ EV/R&D multiple - we gauge that Bio- Path is significantly undervalued next to its peers with numerous drug candidates in the pipeline and its lead drug candidate quickly approaching Phase 2 milestones that could indicate potential for approval. See page 13 for further details.
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