Stonegate Capital Partners Updates Coverage on Bio-Path Holdings, Inc. (OTCQB:BPTH) Q4 24

DALLAS, TX -- April 16th, 2025 --  Bio-Path Holdings, Inc. (OTCQB:BPTH): Stonegate Capital Partners Updates Coverage on Bio-Path Holdings, Inc. (OTCQB:BPTH) for Q4 2024.  Bio-Path Holdings, Inc. (OTCQB: BPTH) is a clinical-stage biotechnology company leveraging its proprietary DNAbilize® platform to develop RNAi nanoparticle therapeutics for cancer and metabolic diseases. Its lead candidate, prexigebersen (BP1001), targeting Grb2, is in a Phase 2 trial for AML, with interim data showing strong response rates in newly diagnosed and relapsed/refractory patients. A modified version, BP1001-A, is in a Phase 1/1b trial for advanced solid tumors, with early signs of efficacy, and is also in preclinical development for obesity and type 2 diabetes. BP1002, which inhibits the Bcl-2 protein, is in a Phase 1/1b study for AML, showing notable responses in venetoclax-resistant patients. BP1003, a liposomal STAT3 inhibitor, is advancing toward an IND for pancreatic cancer. Across its pipeline, Bio-Path is pursuing targeted therapies to address significant unmet needs, combining molecular precision with its novel delivery technology to improve outcomes in hematologic malignancies, solid tumors, and chronic metabolic conditions.

DNAbilize® Platform Demonstrates Potential to Change the Paradigm in Both Obesity and Oncology with Recently Reported Therapeutic Effects.

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 $1.2M as cash on hand as of 12/31/24; per the most recent filing, additional 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.