DALLAS, TX / ACCESSWIRE / October 23, 2017 / Bio-Path Holdings, Inc. (BPTH):
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 preclinical studies for solid tumors. The Company's second DNAbilize® drug candidate, Liposomal Bcl2 (BP1002), for the treatment of lymphoma, leukemia, colon, prostate and breast cancers, has completed preclinical studies for non-Hodgkin's lymphoma. Bio-Path is planning a broad Phase 1 clinical trial in lymphoma in the beginning of 2018. Bio-Path is headquartered in Bellaire, Texas, and currently employs 11 full-time.
Despite ongoing advancements in the development of nucleic acid drugs, pharmaceutical developers are still facing the challenge of delivering therapeutics to targeted cells without causing severe side effects in the patient. 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 therapeutic landscape of cancer treatment and also address other diseases that have 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 therapeutic regimens, and therefore, have limited available treatment 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 1b/2 clinical trial for CML. Importantly, the Company expects to complete an interim analysis in 2H 2017 of the first 19 patients enrolled in the Phase 2 efficacy trial for AML, with the possibility of switching to a registration trial for accelerated approval.
- The clinical targets for BP1002 are lymphoma, and potentially breast cancer, colon cancer, and prostate cancer. This novel, non-toxic, specific Bcl2 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 is collaborating with respected academic and clinical institutions, including M.D. Anderson, Thomas Jefferson University and UT Southwestern, to expand indications inside and outside of cancer, which we view as a validation of Bio-Path's DNAbilize® technology. Going forward, we believe the versatility of the DNAbilize® platform could represent significant drug development and licensing opportunities for Bio-Path.
- Recent results include a net loss attributable to common stockholders of ($3.0M) for the quarter ended 6/30/17 vs. ($1.9M) for the comparable quarter of prior year. Operating expenses for Q217 were similar Y-O-Y, with a slight increase in R&D. The Company recognized a ($1.0M) for a deemed dividend related to warrant conversion in the most recent quarter. Management states that cash on hand of approximately $6.2M is sufficient to fund operations for the next 12 months.
With promising clinical data and several programs in the pipeline addressing sizable markets with unmet needs, our valuation analysis for the BP1001 for AML and CML programs alone results in an estimated range of $3.71-$4.55/share, with a mid-point of approximately $4.09. See the full report for further details.
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SOURCE: Stonegate Capital Partners