HOUSTON - Bio-Path Holdings, Inc. (NASDAQ:BPTH), a biotechnology firm specializing in nucleic acid cancer drugs, provided an update on its clinical development and operational advancements for 2024 today.
The company is progressing with a Phase 2 clinical trial for its lead candidate, prexigebersen, and several Phase 1 and 1b trials for other drug candidates. Bio-Path is also exploring the potential of prexigebersen as a treatment for obesity.
The Phase 2 trial targets Acute Myeloid Leukemia (AML) patients and is structured in three separate cohorts, each with the potential for FDA approval as a new drug indication. Positive interim data has prompted the company to seek FDA Fast Track designation for prexigebersen for fragile AML patients who cannot endure intensive chemotherapy.
In addition to the AML focus, Bio-Path is conducting a Phase 1/1b clinical trial of BP1001-A in advanced solid tumors, including ovarian, uterine, pancreatic, and breast cancer.
BP1002, another drug candidate targeting the Bcl-2 protein associated with cell survival in many cancers, is also undergoing a Phase 1/1b trial for relapsed/refractory AML and a Phase 1 trial for refractory/relapsed lymphoma and chronic lymphocytic leukemia (CLL).
The company is finalizing preclinical development of BP1003, a STAT3 protein inhibitor, for advanced solid tumors with a planned IND submission to the FDA later this year. Bio-Path is also developing a molecular biomarker package to enhance the efficacy of its treatments by identifying patients most likely to respond.
Bio-Path's proprietary DNAbilize® technology forms the backbone of its drug development platform, allowing for the creation of RNAi nanoparticle drugs administered through intravenous transfusion. The company's patent portfolio includes five issued patents in the U.S. and 53 in foreign jurisdictions, covering 21 countries.
The update on clinical trials and operational activities is based on a press release statement from Bio-Path Holdings. The company continues to explore new applications for its technologies while advancing its existing drug candidates through clinical development.
InvestingPro Insights
Bio-Path Holdings, Inc. (NASDAQ:BPTH) has shown a significant return over the last week, with a 14.43% increase, according to recent data. This uptick in price may reflect investor optimism surrounding the company's clinical developments and operational advancements.
Nevertheless, the company's financial health shows some concerns, particularly with a negative EBITDA growth at -14.1% in the last twelve months as of Q4 2023 and a high Price / Book ratio of 8.19, which could indicate that the stock is currently overvalued relative to its book value.
Investors should note that Bio-Path's market capitalization stands at a modest 3.47 million USD. While the company holds more cash than debt on its balance sheet, which is a positive sign for financial stability, analysts are not expecting Bio-Path to be profitable this year. The lack of profitability is further underscored by a negative Price/Earnings (P/E) ratio of -0.22, reflecting the company's current earnings challenges.
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