DALLAS, TX / ACCESSWIRE / January 24, 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 first quarter 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 13 employees.
In clinical studies, Bio-Path's therapeutic platform has delivered a strong, effective therapeutic payload, with no evidence of toxicity; this novel target-based platform has the potential to transform the landscape of cancer treatment as well as other diseases with well-defined targets.
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 interim data, reporting that prexigebersen plus LDAC was well-tolerated and showed early anti-leukemic activity in almost 50% of evaluable AML patients; the antileukemia activity has recently been revised upward to 60%. Notably, in March 2018 data from the Phase 1/1b study relating to the treatment of hematological malignancies was published in The Lancet Haematology with expert commentary from Dr. Xavier Thomas included; additionally, the interim data for the AML Phase 2 was accepted for poster presentation at the American Society of Hematology (ASH) annual meeting 2018.
The clinical targets for BP1002 are 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.
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.
With Q318 results, management noted that cash on hand of ~$2.3M was sufficient to continue progress towards key milestones for 2019, 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 (share counts and per share amounts in this report adjusted accordingly).
With promising clinical data and several programs in the pipeline addressing sizable markets with unmet needs, our comparables analysis shows that BPTH appears undervalued at current levels. See the full report for further details.
About Stonegate Capital Partners
Stonegate Capital Partners is a Dallas-based corporate advisory firm dedicated to serving the specialized needs of small-cap public companies. Since our inception, our mission has been to find innovative, undervalued public companies for our network of leading institutional investors who seek high quality investment opportunities.
Laura Engel, (214) 987-4121
SOURCE: Stonegate Capital Partners