Bio-Path Holdings Expands Global Patent Portfolio

Rhea-AI Summary

Bio-Path Holdings (NASDAQ:BPTH) has expanded its global patent portfolio with new patents in the United States and New Zealand. The company received Notice of Allowance for U.S. Patent No. 17/339,366 for STAT3 inhibition and New Zealand Patent No. 741793 for liposomal formulation, both related to their DNAbilize® platform technology.

The company's current intellectual property portfolio includes seven issued patents in the U.S. and 61 issued patents in foreign jurisdictions, providing protection in 26 countries. Bio-Path has three pending patent applications in the U.S. and five additional allowed patent applications in foreign jurisdictions.

Bio-Path is developing RNAi nanoparticle drugs, with their lead candidate prexigebersen in Phase 2 for blood cancers, BP1001-A in Phase 1/1b for solid tumors, and BP1002 being evaluated for blood cancers and solid tumors. The company is also preparing an IND application for BP1003, a STAT3 inhibitor.

Positive

• Expansion of patent protection in US and New Zealand strengthens intellectual property portfolio
• Broad global patent coverage with 68 issued patents across 26 countries
• Multiple drug candidates in clinical development phases
• Additional pending patent applications in US and foreign jurisdictions

Negative

• None.

Insights

Intellectual Property Analyst

The expansion of Bio-Path's patent portfolio represents a significant strengthening of their competitive moat, particularly in the important RNAi therapeutics space. The new US patent covering STAT3 inhibition is especially valuable, as STAT3 is a well-validated target in oncology, particularly for non-small cell lung cancer - a market projected to reach $25 billion by 2027.

The strategic timing of these patent grants is crucial, as they provide:

• Extended market exclusivity for the DNAbilize® platform technology, potentially through the late 2030s
• Territorial protection across 26 countries, creating significant barriers to entry for competitors
• Multiple layers of IP protection through both composition and method patents

For a micro-cap biotech with a market cap of just $4.4 million, this robust IP portfolio provides disproportionate strategic value. It not only protects their current pipeline but also creates opportunities for licensing deals or strategic partnerships. The breadth of protection across major markets enhances the company's negotiating position for potential collaborations or M&A activities.

However, investors should note that while strong IP protection is necessary, it's not sufficient for commercial success. The company still needs to demonstrate clinical efficacy and secure regulatory approvals. The pending patent applications, if granted, could provide additional layers of protection as the clinical programs advance.

Builds on Global Intellectual Property Portfolio to Protect DNAbilize® Platform

HOUSTON, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize^® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer and obesity drugs, today announced the receipt of newly issued patents in the United States and New Zealand, and updated investors on the extent of its global intellectual property portfolio.

Bio-Path received Notice of Allowance from the United States Patent and Trademark Office for U.S. Patent No. 17/339,366 titled, "P-ethoxy nucleic acids for STAT3 inhibition." The New Zealand Intellectual Property Office has granted Patent No. 741793 titled, “P-ethoxy nucleic acids for liposomal formulation.” These new patents build on earlier patents granted that protect the platform technology for DNAbilize^®, the Company’s novel RNAi nanoparticle drugs.

“We are proud of our growing global intellectual property portfolio as it safeguards our technology, serves as a deterrent to would-be competitors and creates value around our core competencies,” said Peter Nielsen, Chief Executive Officer of Bio-Path. “These efforts are designed to protect our investments and advance our clinical programs to bring new medicines to patients suffering with obesity and cancer. Importantly, our newly issued U.S. patent provides additional intellectual property protection around our STAT3 program, where we intend to advance into non-small cell lung cancer.”

Bio-Path continues to expand its intellectual property portfolio by filing patent applications that are applicable to its technology and business strategy. Bio-Path’s patent portfolio currently includes seven issued patents in the U.S. and 61 issued patents in foreign jurisdictions, providing protection in 26 countries. The Company has three additional pending patent applications in the U.S. and five additional allowed patent applications in foreign jurisdictions.

About Bio-Path Holdings, Inc.

Bio-Path is a biotechnology company developing DNAbilize^®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous infusion. Bio-Path’s lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for blood cancers, and BP1001-A, a drug product modification of prexigebersen, is in a Phase 1/1b study for solid tumors. The Company’s second product, BP1002, which targets the Bcl-2 protein, is being evaluated for the treatment of blood cancers and solid tumors, including acute myeloid leukemia. In addition, an IND application is expected to be filed for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide developed by Bio-Path as a specific inhibitor of STAT3.

For more information, please visit the Company's website at http://www.biopathholdings.com.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws. These statements are based on management's current expectations and accordingly are subject to uncertainty and changes in circumstances. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Bio-Path’s ability to raise needed additional capital on a timely basis in order for it to continue its operations, have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies, the accuracy of such data, limited patient populations of early stage clinical studies and the possibility that results from later stage clinical trials with much larger patient populations may not be consistent with earlier stage clinical trials, the maintenance of intellectual property rights, that patents relating to existing or future patent applications will be issued or that any issued patents will provide meaningful protection of our drug candidates, the impact, risks and uncertainties related to global pandemics, including the COVID-19 pandemic, and actions taken by governmental authorities or others in connection therewith, and such other risks which are identified in Bio-Path's most recent Annual Report on Form 10-K, in any subsequent quarterly reports on Form 10-Q and in other reports that Bio-Path files with the Securities and Exchange Commission from time to time. These documents are available on request from Bio-Path Holdings or at www.sec.gov. Bio-Path disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact Information:

Investors

Will O’Connor
Stern Investor Relations, Inc.
212-362-1200
will@sternir.com   

Doug Morris
Investor Relations
Bio-Path Holdings, Inc.
832-742-1369

FAQ

What new patents did Bio-Path Holdings (BPTH) receive in 2025?

In February 2025, Bio-Path Holdings received U.S. Patent No. 17/339,366 for STAT3 inhibition and New Zealand Patent No. 741793 for liposomal formulation, both protecting their DNAbilize® technology.

How many patents does Bio-Path Holdings (BPTH) currently hold globally?

Bio-Path Holdings currently holds 7 issued patents in the United States and 61 issued patents in foreign jurisdictions, covering 26 countries.

What clinical trials is Bio-Path Holdings (BPTH) currently conducting?

Bio-Path is conducting a Phase 2 study of prexigebersen for blood cancers, a Phase 1/1b study of BP1001-A for solid tumors, and evaluating BP1002 for blood cancers and solid tumors.

What is the status of Bio-Path Holdings' (BPTH) STAT3 inhibitor program?

Bio-Path is preparing to file an IND application for BP1003, their STAT3 inhibitor, and has received a new U.S. patent providing additional protection for the STAT3 program.