Bio-Path Holdings, Inc.

What they do

Bio-Path uses its DNAbilize platform, a P-ethoxy modified antisense DNA delivered in a neutral lipid bilayer, to develop drug candidates for cancer and obesity. The lead candidate, prexigebersen (BP1001), targets Grb2 and is in a Phase 2 trial for acute myeloid leukemia (AML). The company has four drug candidates in development for at least five cancer indications and one obesity indication.

Revenue drivers

• No approved products — The company has no commercial sales; revenue has been $0 or minimal ($13,000 in 2016, $37,000 in 2017) and came from grant or licensing income, not product sales.

Recent performance

For fiscal 2024, Bio-Path reported a net loss of $9.9 million, diluted EPS of -$4.12, and operating cash flow of -$10.6 million. As of March 31, 2026, the company had only $12,000 in cash and equivalents, total assets of $677,000, and total liabilities of $9.2 million, resulting in negative shareholders' equity of -$8.5 million. The company has incurred recurring operating losses since inception and expects to continue losing money.

Strategy

Management is focused on advancing prexigebersen in a Phase 2 clinical trial for AML, with three cohorts: newly diagnosed, relapsed/refractory, and venetoclax-resistant patients. The strategy includes combining prexigebersen with decitabine and venetoclax based on preclinical efficacy. The company also plans to leverage its DNAbilize platform for other cancer and obesity targets. Given the cash position, the company will need to raise additional capital to fund ongoing operations and development.

Risks

• Cash runway risk — With $12,000 in cash as of March 31, 2026, the company lacks sufficient capital to continue operations without immediate additional funding.
• Clinical trial risk — The Phase 2 AML trial may fail to demonstrate safety or efficacy, or may be delayed, which could impair the company's ability to obtain regulatory approval.
• Going concern risk — Negative shareholders' equity of -$8.5 million and recurring operating losses raise substantial doubt about the company's ability to continue as a going concern.
• Dependence on third parties — The company relies on third parties for clinical trials and manufacturing, and any failure or delay by these parties could harm development.

Outlook

Management expects to continue incurring losses and requires substantial additional capital to fund the Phase 2 trial and other development activities. The company intends to pursue the triple combination of prexigebersen, decitabine, and venetoclax as a potential frontline AML therapy. The outcome of the interim analyses and overall trial results will be pivotal for the company's future.