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

DALLAS, TX -- April 16th, 2025 --  Bio-Path Holdings, Inc. (Nasdaq:BPTH): Stonegate Capital Partners Updates Coverage on Bio-Path Holdings, Inc. (Nasdaq:BPTH) for Q4 2024.  

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.

About Stonegate
Stonegate Capital Partners is a leading capital markets advisory firm providing investor relations, equity research, and institutional investor outreach services for public companies. Our affiliate, Stonegate Capital Markets (member FINRA) provides a full spectrum of investment banking services for public and private companies.

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