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

DALLAS, TX -- September 30, 2022 --  Bio-Path Holdings, Inc. (Nasdaq:BPTH): The full report can be accessed by clicking on the following link: https://stonegateinc.com/reports/BPTH_Q2FY22.pdf

COMPANY DESCRIPTION

Bio-Path Holdings, Inc. (Bio-Path) is a clinical stage biotechnology company that focuses on developing nucleic acid cancer therapeutics using its proprietary nanoparticle RNAi antisense technology called DNAbilize®. This technology safely distributes nucleic acid based drugs systemically throughout the body via intravenous infusion. Bio-Path’s lead product candidate, prexigebersen (BP1001) is in Phase 2 clinical studies for the treatment of acute myeloid leukemia (AML), and the Company’s Investigational New Drug (IND) for a Phase 1 in solid tumors in was cleared in October 2021 (BP1001-A, Bio-Path’s fourth drug candidate). The Company’s second DNAbilize® drug candidate, Liposomal Bcl-2 (BP1002), for the treatment of lymphoma, chronic lymphocytic leukemia (CLL), colon, prostate and breast cancers, has had an IND application for a Phase 1 clinical trial cleared by the FDA in lymphoma and CLL patients, with dosing beginning in the Phase 1 in November 2020, and in August 2021 an additional IND filing was given clearance for refractory/relapsed AML patients. Bio-Path’s third drug candidate, BP1003, is currently in preclinical development in a pancreatic patient-derived tumor model with plans to pursue IND-enabling studies and file an IND 2022, and having a goal of entering first-in-human trials shortly thereafter.

SUMMARY

• Bio-Path’s pipeline continues to expand with new cancer indications, and once its DNAbilize® platform is proven successful for cancer, the core technology can easily be expanded to address new therapeutic areas, including autoimmune diseases. BPTH has five patents related to its DNAbilize® platform including its use in the treatment of cancers, autoimmune diseases and infectious diseases, and six pending patents.
• In contrast to other lipid delivery technologies that have dose-limiting toxicities, DNAbilize®, Bio-Path’s next generation oligonucleotide-based technology, enables the delivery of high doses of therapeutics to target cells, while demonstrating no evidence of toxicity. This lack of toxicity enables the development of therapies to address patients, particularly within the growing elderly population, who are unable to withstand aggressive regimens, and therefore, have limited options.
• Bio-Path has completed Phase 1 clinical trials for its lead candidate prexigebersen for AML and other blood cancers, and is in the midst of a Phase 2 clinical trial for AML. Importantly, in March 2019 the Company announced an update to interim data, reporting that prexigebersen plus LDAC continues to be well-tolerated and now has shown early anti-leukemic activity (revised upwards) in almost 65% of evaluable AML patients; notably, it was observed that 82% of the responding patients were secondary AML patients, historically a very difficult class to treat. Given the new data, BPTH developed a revised registration-directed clinical development plan (see page 4) and most recently reported successful completion of the safety cohort in Stage 2 of the Phase 2 trial testing the triple combination treatment of prexigebersen/decitabine/venetoclax.
• The clinical targets for BP1002 have initially been lymphoma and CLL, and potentially breast cancer, colon cancer, and prostate cancer. This novel, non-toxic, specific Bcl-2 inhibitor could be a significant advance in cancer therapeutics, with the potential to treat 40% to 60% of solid tumors, according to Bio-Path estimates. And given the most recent preclinical data, BPTH now believes that BP1002 likely could be used to treat CLL and AML patients who have relapsed following treatment with venetoclax. Venetoclax works against the anti-apoptotic protein Bcl-2 by neutralizing the protein’s BH3 domain, but some patients relapse due to BH3 domain mutation over time. However, BP1002’s activity is based on blocking the Bcl-2 messenger RNA and does not target the BH3 domain; hence, it would likely be able to treat these patients who have relapsed.
• Bio-Path is developing a third drug candidate, BP1003, for the treatment of pancreatic cancer; BP1003 targets the STAT3 protein and is currently in preclinical development in a pancreatic patient-derived tumor model, with previous preclinical models having shown BP1003 to successfully penetrate pancreatic tumors.
• The Company most recently reported that cash on hand as of 6/30/22 is sufficient to fund operations according to plan for at the next 12 months.
• With promising clinical data and several programs in the pipeline addressing sizable markets with unmet needs, BPTH remains undervalued relative to comparable companies at similar stages of development. See page 8 for further details.