Bio-Path expands into obesity treatment with new program

HOUSTON - Bio-Path Holdings, Inc. (NASDAQ:BPTH), a biotech firm known for its DNAbilize® antisense technology, announced the launch of a new therapeutic program aimed at treating obesity and related metabolic diseases. For the first time, the company is applying its cancer-targeting DNAbilize technology to a non-cancerous condition, signaling a significant shift in its development strategy.

Simultaneously, Bio-Path reported the completion of enrollment for the third dosing cohort in a Phase 1/1b trial of BP1002, designed for patients with refractory/relapsed acute myeloid leukemia (AML), including those resistant to venetoclax, a standard treatment. The swift enrollment pace is indicative of the urgent need for alternative treatments in this patient population.

Peter H. Nielsen, President and CEO of Bio-Path, expressed optimism about the new obesity program, citing the high probability of success due to the mechanism of action of BP1001-A, which is expected to tackle insulin resistance—a key factor in obesity, Type 2 diabetes, and other metabolic diseases. Preclinical studies for BP1001-A are slated to commence in the fourth quarter of 2024, with the aim of enhancing insulin sensitivity by downregulating Grb2 expression, a protein implicated in these conditions.

The completed enrollment for the AML clinical trial's third dosing cohort, which took place in a span of six weeks, reflects the company's commitment to addressing the needs of AML patients who have few options after relapse or resistance to existing therapies. BP1002 targets the mRNA of a protein involved in venetoclax treatment, potentially offering a new avenue for overcoming resistance mechanisms.

Bio-Path Holdings specializes in RNAi nanoparticle drugs administered via intravenous infusion. Its lead product candidate, prexigebersen (BP1001), is currently in a Phase 2 study for blood cancers, and its second product, BP1002, is under evaluation for both blood cancers and solid tumors.

The information presented is based on a press release statement from Bio-Path Holdings, Inc. The company has made forward-looking statements regarding its operations and clinical development timelines, which are subject to uncertainties and changes due to various factors, including but not limited to, capital requirements, clinical study outcomes, intellectual property rights, and the impact of global pandemics such as COVID-19.

In other recent news, Bio-Path Holdings, a pharmaceutical company, is facing a possible delisting from The Nasdaq Stock Market due to non-compliance with the minimum stockholders' equity requirement. The company has been given the opportunity to present a plan to regain compliance to the Nasdaq Hearings Panel. On the financial front, Bio-Path Holdings reported a net loss of $1.9 million for Q2 2024, balanced by a strengthened cash position due to recent financing.

Bio-Path Holdings is also making significant strides in their clinical trials. Promising interim results have been reported from their Phase II study for Acute Myeloid Leukemia (AML) treatment using their lead product candidate, prexigebersen. The company is moving forward with BP1001-A for solid tumors and BP1003, targeting the STAT3 protein, towards clinical trials.

Analyst firm Roth/MKM has maintained its Buy rating on Bio-Path Holdings, reflecting confidence in the company's ongoing research. The firm's rating comes after Bio-Path Holdings provided updates on its clinical trials, including extended therapy durations for two Phase 2 AML patients and potential antitumor properties of antisense DNA therapy. These developments provide a promising outlook for Bio-Path Holdings' future.

InvestingPro Insights

As Bio-Path Holdings, Inc. (NASDAQ:BPTH) ventures into the obesity treatment market and advances its cancer therapies, investors should consider some key financial metrics and insights from InvestingPro.

The company's market capitalization stands at a modest $2.17 million, reflecting its current developmental stage. This small size could indicate significant growth potential if its new obesity program and ongoing cancer trials prove successful. However, it also suggests a higher risk profile typical of early-stage biotech firms.

InvestingPro Tips highlight that Bio-Path holds more cash than debt on its balance sheet, which is crucial for a company in the resource-intensive process of drug development. This financial cushion may provide some runway for the company to advance its clinical programs without immediate funding concerns.

On the cautionary side, Bio-Path suffers from weak gross profit margins and is not profitable over the last twelve months, with a negative operating income of $13.04 million. This is not uncommon for biotech companies in the development phase, but it underscores the importance of successful clinical outcomes for the company's future.

The stock's recent performance has been challenging, with InvestingPro Data showing a significant price decline of 88.5% over the past year. The stock is currently trading near its 52-week low, which could present an opportunity for investors who believe in the company's long-term potential, particularly with its expansion into the lucrative obesity market.

Analysts do not anticipate the company to be profitable this year, which aligns with Bio-Path's focus on research and development rather than immediate commercialization. The next earnings date is set for November 14, 2024, which may provide more insights into the company's financial health and progress on its clinical programs.

For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for Bio-Path Holdings, providing a deeper understanding of the company's financial position and market performance.

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