Bio-Path Holdings Reports Second Quarter 2021 Financial Results

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HOUSTON, Aug 13, 2021 (GLOBE NEWSWIRE) – Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal and antisense delivery technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced its financial results for the second quarter ended June 30, 2021 and provided an update on recent developments in the company.

“During the second quarter and over the past several weeks, we have made tremendous progress in advancing our entire DNAbilize portfolio. In June, we were delighted to announce a new patent related to our BP1003 program which further strengthens our intellectual property portfolio, ”said Peter Nielsen, President and CEO of Bio-Path Holdings. “Throughout the remainder of the year, we look forward to implementing our clinical development plans, including advancing our Phase 1 clinical trial evaluating BP1002 in patients with refractory acute myeloid leukemia. relapse. “

Recent Company Highlights

  • Key mechanism of action granted in the United States for patent BP1003. In June, Bio-Path announced that the United States Patent and Trademark Office had granted a new patent relating to the company’s BP1003 program, a novel oligodeoxynucleotide inhibitor incorporated into liposomes against signal transduction and transcription activator-3 (STAT3). The new patent builds on earlier granted patents that protect platform technology for DNAbilize, the company’s new RNAi nanoparticle drug platform.
  • Publication announced in Biomedicines. In April, Bio-Path announced the publication of a review highlighting the potential of prexigebersen (BP1001) in the antisense oligonucleotide drug delivery landscape in the peer-reviewed journal, Biomedicine.
  • Presentation of BP1002 data at the 2021 AACR annual meeting. In April, Bio-Path presented a poster highlighting preclinical data for BP1002 at the 2021 American Association for Cancer Research (AACR) annual meeting. BP1002 targets the Bcl-2 protein, which is responsible for cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with a poor prognosis for patients diagnosed with AML. The data presented in the AACR poster show that venetoclax-resistant cells are sensitive to the inhibitory effects of BP1002 in combination with decitabine, suggesting that this combination is a potential treatment for patients who have relapsed from first-line therapies to venetoclax base.
  • Triple Combination Safety Cohort Successfully Completed in Phase 2 2 Clinical trial in AML. In April, Bio-Path announced the successful completion of the safety run-in of Phase 2 of the Phase 2 clinical study of prexigebersen (BP1001), a Grb2 liposomal antisense, for the treatment of acute myeloid leukemia (AML ), in combination with first-line therapies, decitabine and venetoclax, in patients with acute myeloid leukemia (AML). The preliminary safety phase of step 2 of the phase 2 clinical trial included six evaluable patients who were treated with the triple combination of prexigebersen, decitabine and venetoclax.

Financial results for the second quarter ended June 30, 2021

  • The Company reported a net loss of $ 1.8 million, or $ 0.26 per share, for the quarter ended June 30, 2021, compared to a net loss of $ 2.0 million, or $ 0.55 per share, for the quarter ended June 30, 2020.
  • Research and development costs for the quarter ended June 30, 2021 decreased to $ 0.8 million from $ 1.0 million for the quarter ended June 30, 2020, primarily due to the timing of activities related to our clinical trials for BP1002 in lymphoma, prexigebersen in AML and prexigebersen-A in solid tumors.
  • General and administrative expenses for the quarter ended June 30, 2021 were $ 1.0 million, consistent with the comparable period of 2020.
  • As at June 30, 2021, the Company had cash of $ 28.1 million, compared to $ 13.8 million as at December 31, 2020. Net cash used in operating activities for the six-month period ended June 30 2021 was $ 4.2 million compared to $ 6.0 million for the comparable period in 2020. Free cash flow from financing activities for the six-month period ended June 30, 2021 was 18.6 millions of dollars.

Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these second quarter 2021 financial results and provide a general update on the Company. To access the conference call, please dial (844) 815-4963 (national) or (210) 229-8838 (international) and refer to Conference ID 4739446. A live audio webcast of the call and the archived webcast will be available in the Media Section of the Company’s website at www.biopathholdings.com.

About Bio-Path Holdings, Inc.

Bio-Path is a biotechnology company developing DNAbilize®, a new technology that has produced a pipeline of drugs based on RNAi nanoparticles that can be delivered through 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 prexigebersen-A, a drug modification of prexigebersen, is under review by the FDA to begin a Phase 1 study in solid tumors. It is followed by BP1002, targeting the Bcl-2 protein, where it is being evaluated in a phase 1 study in patients with advanced lymphoma and CLL. In addition, an IND should be filed for BP1003, a novel anti-sense STAT3 oligodeoxynucleotide incorporated into liposomes 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 in accordance with the safe harbor provisions of federal securities laws. These statements are based on management’s current expectations and are therefore subject to uncertainty and changes in circumstances. All express or implied statements contained in this press release that are not statements of historical fact can be considered as forward-looking statements. All statements that are not historical facts contained in this press release are forward-looking statements that involve risks and uncertainties, including the impact, risks and uncertainties relating to COVID-19 and actions taken by government authorities or others in this regard, the ability of Bio-Path to raise the necessary additional capital in a timely manner to enable it to continue its operations, to be successful in the clinical development of its technologies, the timing of recruitment and publication of data in these clinical studies, the accuracy of these data, the limited patient populations of early-stage clinical studies, and the possibility that the results of later-stage clinical trials with much larger patient populations may not be consistent with clinical trials at an earlier stage, the maintenance of intellectual property rights, as patents r existing or future patent applications are granted or that any granted patent will provide significant protection for our drug candidates, one of such other risks which are identified in Bio-Path’s most recent annual report on Form 10- K, in all 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 statement, whether as a result of new information, future events or otherwise.

Contact details:

Investors

Will o’connor
Stern Investor Relations, Inc.
212-362-1200
[email protected]

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


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