BELLAIRE, TX / ACCESSWIRE / April 29, 2019 / Bio-Path Holdings, Inc. (BPTH).
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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 and chronic myeloid leukemia (AML and CML), and the Company has plans to enroll a Phase 1 in solid tumors in 2019. The Company's second DNAbilize® drug candidate, Liposomal Bcl-2 (BP1002), for the treatment of lymphoma, leukemia, colon, prostate and breast cancers, has completed initial preclinical studies for non-Hodgkin's lymphoma and completed one additional safety study per FDA request. Bio-Path is targeting a broad Phase 1 clinical trial in lymphoma and CLL, with plans to submit an IND application, anticipated by early 2019. Bio-Path's third drug candidate, BP1003, is currently in preclinical development in a pancreatic patient-derived tumor model with plans to initiate IND enabling studies in 2019. BPTH is headquartered in Bellaire, Texas, and has 8 employees.
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.
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, CML and other blood cancers, and is in the midst of a Phase 2 clinical trial for AML and a Phase 2a clinical trial for CML. Importantly, the Company recently 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 68% of the responding patients were secondary AML patients, historically a very difficult class to treat. Given the new data, BPTH has a developed a revised registration-directed clinical development plan detailed on page 4 of this report.
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 clinical data, BPTH now believes that BP1002 likely could be used to treat AML and CLL 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 on Venetoclax.
Bio-Path has announced its 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.
For Q418/FY18 results, management reported cash on hand of ~$1.0M, and subsequent to quarter-end, BPTH raised an additional $2.8M in January 2019 and effected a 1-for-20 reverse stock split as of 1/17/19. Additionally, an $18.5M registered direct offering closed 3/14/19; thus, cash on hand is sufficient to achieve key milestones for the Company's programs throughout the upcoming year and beyond.
With promising clinical data and several programs in the pipeline addressing sizable markets with unmet needs, our comparables analysis shows that BPTH remains undervalued at current levels. See the report for further details.
About Stonegate Capital Partners
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Laura Engel, (214) 987-4121
SOURCE: Stonegate Capital Partners
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