Bio-Path Holdings, Inc. reported a net loss of $9.9 million for the fiscal year ending December 31, 2024, a decrease from a net loss of $16.1 million in the previous year. The company has not generated significant revenue to date, maintaining an accumulated deficit of $117.5 million. Research and development expenses decreased to $7.3 million from $11.6 million in 2023, primarily due to reduced manufacturing costs. General and administrative expenses increased to $4.7 million, attributed to higher salaries and costs associated with a special shareholder meeting.
The company is focused on developing its proprietary DNAbilize® technology, which enables systemic delivery of RNAi nanoparticle therapeutics. Bio-Path currently has four drug candidates in development, including BP1001 (prexigebersen), which is undergoing a Phase 2 clinical trial for acute myeloid leukemia (AML). Recent interim data from this trial indicated that 75% of newly diagnosed patients achieved complete remission or similar outcomes. The trial has been amended to replace the combination treatment of prexigebersen with low-dose cytarabine (LDAC) with a combination of prexigebersen and decitabine, reflecting changes in the AML treatment landscape.
In addition to BP1001, Bio-Path is advancing BP1002, targeting Bcl-2 for lymphoma and chronic lymphocytic leukemia, and BP1003, which targets STAT3 for pancreatic cancer and non-small cell lung cancer. BP1002's Phase 1 trial has been discontinued due to enrollment challenges, while BP1003 is in IND enabling studies. The company is also developing BP1001-A, a modified version of prexigebersen, for solid tumors and obesity-related metabolic diseases, with plans for a Phase 1 clinical trial in 2025.
As of December 31, 2024, Bio-Path had $1.2 million in cash, a slight increase from $1.1 million in the previous year. The company anticipates needing substantial additional capital to fund ongoing clinical trials and operational expenses. It has engaged in several financing activities, including a series of private placements and public offerings, to support its operations. However, the company faces significant risks, including reliance on third-party manufacturers for drug production and the competitive nature of the biotechnology industry, which could impact its ability to achieve profitability and sustain operations in the future.
About BIO-PATH HOLDINGS INC
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