Stonegate Capital Partners Updates Coverage on Bio-Path Holdings, Inc. (Nasdaq:BPTH) Q4 '22

DALLAS, TX -- April 10th, 2023 --  Bio-Path Holdings, Inc. (Nasdaq:BPTH): The full report can be accessed by clicking on the following link: https://stonegateinc.com/reports/BPTH_Q422.pdf

Additional Progress in Q422 – Strong Pipeline

• 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 strong relationship with the Cancer Center as well as 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.
• Ongoing Clinical Trials: The Company has various product candidates in different stages of development.
• 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.
• BP1002 – Bio-Path is conducting two clinical trials for BP1002. A Phase 1 clinical trial of BP1002 in patients with advanced lymphoid malignancies is ongoing. Also, a Phase 1 is underway for patients with refractory/relapsed AML, including those who have relapsed from venetoclax-based treatment.
• 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.
• First Patients Recently Dosed: In October 2022, BPTH announced that the first patient had been enrolled and dosed in the Phase 1/1b clinical trial of BP1002 in refractory/relapsed AML patients; in December 2022, the first patient was also dosed in the Phase 1/1b trial of BP1001-A for treatment of solid tumors.
• Cash Runway: The Company reported $10.4M as cash on hand as of 12/31/22, and management has stated that additional funds will be needed to continue operations according to plan for the upcoming 12 months.
• 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 is quickly approaching milestone indication that could indicate potential for approval. See page 12 for further details.