Company Overview
Bio-Path Holdings, Inc. (BPTH) is a clinical-stage biotechnology company at the forefront of developing a revolutionary DNA-based drug delivery technology, known as DNAbilize®, to address a wide range of diseases. Notably, the company has recently expanded its focus beyond oncology, initiating clinical development of its lead product candidate, BP1001-A, as a potential treatment for obesity and related metabolic disorders.
History and Incorporation
Bio-Path Holdings, Inc. was incorporated in May 2000 as a Utah corporation. In February 2008, Bio-Path's wholly-owned subsidiary, Bio-Path, Inc., completed a reverse merger with the company, which at the time was traded over the counter and had no current operations. The prior name of the company was changed to Bio-Path Holdings, Inc., and the directors and officers of Bio-Path, Inc. became the directors and officers of Bio-Path Holdings, Inc. Effective December 31, 2014, the company changed its state of incorporation from Utah to Delaware through a statutory conversion. On March 10, 2014, the company's common stock ceased trading on the OTCQX and commenced trading on the Nasdaq Capital Market under the ticker symbol BPTH.
Current Operations
The company's operations to date have been limited to organizing and staffing the company, acquiring, developing and securing its technology, and undertaking product development for a limited number of product candidates. As the company has not begun its planned principal operations of commercializing a product candidate, its activities have been subject to significant risks and uncertainties. Bio-Path has certain intellectual property as the basis for its current drug products in clinical development. It is developing RNAi antisense nanoparticle drug candidates based on its own patented technology to treat cancer and autoimmune disorders. As of the end of 2023, the company had an accumulated deficit of $107.6 million and had incurred significant operating losses, which is expected to continue as the company expands its drug development programs and commercialization efforts.
Drug Development Pipeline
Bio-Path's lead oncology drug candidate, prexigebersen (BP1001), is currently advancing through a Phase 2 clinical trial for the treatment of acute myeloid leukemia (AML). The Phase 2 trial is evaluating prexigebersen in combination with decitabine and venetoclax for newly diagnosed AML patients as well as relapsed/refractory AML patients. Preliminary data from the safety run-in portion of the trial showed high response rates compared to published data for the decitabine/venetoclax combination without prexigebersen.
In addition, the company is progressing a Phase 1/1b study of its Bcl-2-targeting drug, BP1002, in refractory/relapsed AML patients. BP1002 is also being evaluated in a Phase 1 clinical trial for the treatment of refractory/relapsed lymphoma and chronic lymphocytic leukemia (CLL).
The company is also conducting preclinical development of BP1003, which targets the STAT3 protein, for potential use in pancreatic cancer, non-small cell lung cancer, and AML. BP1003 is currently in IND-enabling studies.
Notably, in October 2024, Bio-Path unveiled its plans to expand the application of its DNAbilize® technology beyond oncology, initiating a clinical development program for BP1001-A as a potential treatment for obesity and related metabolic disorders. BP1001-A is a modified version of prexigebersen with a slightly different formulation. It has shown enhanced efficacy in preclinical solid tumor models, and a Phase 1b clinical trial has been initiated in patients with advanced or recurrent solid tumors, including ovarian, endometrial, pancreatic, and triple-negative breast cancer.
Financials and Liquidity
As of September 30, 2024, Bio-Path reported a cash balance of $0.562 million, which, combined with the $3.4 million in net proceeds received from the October 2024 private placement, will not be sufficient to fund the company's liquidity and capital expenditure requirements for the next 12 months. Consequently, Bio-Path will need to continue to access the capital markets to support its ongoing research and development activities.
In the third quarter of 2024, Bio-Path reported a net loss of $2.1 million, or $0.70 per share, compared to a net loss of $3.2 million, or $6.36 per share, in the same period of the previous year. Research and development expenses decreased to $1.3 million, down from $2.3 million in Q3 2023, primarily due to lower manufacturing costs and a reduction in expenses related to the company's AML clinical trial. General and administrative expenses, however, increased to $1.3 million, up from $1.0 million in the prior-year quarter, driven by higher legal fees and salaries.
For the nine months ended September 30, 2024, Bio-Path reported a net loss of $7.1 million, or $4.05 per share, compared to a net loss of $12.7 million, or $29.34 per share, in the same period of 2023. Research and development expenses decreased to $5.5 million from $9.3 million in the prior-year period, while general and administrative expenses increased to $3.9 million from $3.5 million.
For the full fiscal year 2023, Bio-Path reported a net loss of $16,078,000. The company's operating cash flow (OCF) and free cash flow (FCF) for 2023 were both negative $11,535,000.
As of September 30, 2024, Bio-Path's debt-to-equity ratio stood at 0.113, while its current ratio and quick ratio were both 0.859. The company currently has no lines of credit or other arranged access to debt financing.
Clinical Progress and Future Outlook
The company's ongoing clinical trials for prexigebersen, BP1002, and BP1001-A continue to advance, with several key milestones and data readouts anticipated in the coming quarters. Notably, the amended Stage 2 of the Phase 2 trial for prexigebersen in AML is currently paused for an interim analysis, amendment preparation, and FDA review, with enrollment expected to be completed in 2026.
Furthermore, Bio-Path has successfully completed the first two dosing cohorts in the Phase 1/1b study of BP1002 in refractory/relapsed AML patients, and the company has initiated enrollment for the third higher-dose cohort. Additionally, the company has identified a method for detecting BP1003 in trace quantities in plasma, which it expects will enable the completion of final safety studies required to submit an Investigational New Drug (IND) application for this STAT3-targeting candidate.
In October 2024, Bio-Path closed a $4.0 million private placement, providing additional capital to support the continued advancement of its pipeline. This follows a previous $4 million private placement in June 2024. The company's shares, however, have faced significant volatility, closing at $0.90 on November 14, 2024, down from $10.24 a year earlier.
Industry Trends and Market Position
Bio-Path operates in the oncology drug development industry, which has seen a compound annual growth rate (CAGR) of approximately 10-15% over the past 5 years. This growth has been driven by continued advancements in targeted cancer therapies and immunotherapies. As a clinical-stage company, Bio-Path is well-positioned to capitalize on these trends with its innovative DNAbilize® platform and diverse pipeline of drug candidates targeting various cancer indications.
The company currently only sells its products in the United States, focusing on developing its pipeline and advancing its clinical trials. As Bio-Path progresses its drug candidates through clinical development, it may explore opportunities for expansion into other geographic markets in the future.
Conclusion
Despite the ongoing challenges, Bio-Path remains committed to its mission of developing innovative DNA-powered medicines. The company's recent expansion into the obesity and metabolic disease space, coupled with its progress in advancing its oncology programs, underscores the versatility and potential of its DNAbilize® platform. As Bio-Path navigates the path forward, investors will closely monitor the company's ability to execute on its strategic initiatives, deliver meaningful clinical outcomes for patients in need, and secure the necessary funding to support its ongoing research and development efforts. The company's future success will largely depend on the clinical outcomes of its pipeline candidates and its ability to effectively commercialize its products in the competitive oncology drug market.