DALLAS, TX / ACCESSWIRE / December 6, 2019 / Bio-Path Holdings, Inc. (BPTH).
The full report can be accessed by clicking on the following link: http://stonegateinc.com/reports/BPTH%20DEC%202019.pdf
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 2020. 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's IND application for BP1002 has been cleared by the FDA in lymphoma and CLL patients, and first -in-human studies will begin 2020. 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 in 2020 and enter first-in-human trials the following year.
- 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 two issued patents related to its DNAbilize® platform including its use in the treatment of cancers, autoimmune diseases and infectious 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, 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 68% 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 recently reported successful completion of safety testing in Stage 2 of the Phase 2 clinical trial for AML.
- 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 CLL, and 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 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.
- At 9/30/19, BPTH reported cash balance of ~$15.4M, sufficient to achieve key milestones for its programs throughout the upcoming year; additionally, on 11/25/19, the Company completed a registered direct offering for gross proceeds of ~$8M.
- 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 page 8 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
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