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Bio-Path Holdings, Inc. (BPTH)

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Previous Close6.27
Open6.28
Bid0.00 x 1800
Ask0.00 x 900
Day's Range6.25 - 6.72
52 Week Range3.12 - 24.34
Volume307,346
Avg. Volume2,544,198
Market Cap46.273M
Beta (5Y Monthly)2.05
PE Ratio (TTM)N/A
EPS (TTM)-2.83
Earnings DateMar 10, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est12.50
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  • Bio-Path Holdings Presents BP1002 Data at 2021 American Association for Cancer Research Annual Meeting
    GlobeNewswire

    Bio-Path Holdings Presents BP1002 Data at 2021 American Association for Cancer Research Annual Meeting

    Preclinical Data Support BP1002 Combination Therapy in Venetoclax-resistant AML PatientsHOUSTON, April 12, 2021 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announces the presentation of a poster highlighting preclinical BP1002 data at the 2021 American Association for Cancer Research (AACR) Annual Meeting. The poster, titled “The combination of liposomal Bcl-2 antisense oligonucleotide (BP1002) with decitabine is efficacious in venetoclax-resistant cells,” was presented virtually by Dr. Maria Gagliardi, Research Scientist at Bio-Path Holdings. "We are particularly pleased to have these preclinical results of the BP1002 plus decitabine combination against venetoclax-resistant cells highlighted in a poster before an audience of the world’s leading cancer researchers at this important scientific meeting," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. “We look forward to filing a second Investigational New Drug (IND) application for BP1002 and to initiating a clinical study in combination with decitabine in acute myeloid leukemia (AML) patients who have relapsed from venetoclax-based treatments.” Venetoclax, an FDA-approved Bcl-2 inhibitor, is indicated for hematologic malignancies. However, venetoclax resistance among these AML patients is a growing problem. A recent study found that AML patients who had relapsed from frontline venetoclax-based treatment were also resistant to salvage therapy and had a median survival of less than 3 months1. Thus, novel treatment approaches for these most vulnerable patients are urgently needed. BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with poor prognosis for patients diagnosed with AML. Prior preclinical studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target, and the Company believes that its benign safety profile should enable BP1002 combination therapy with approved agents. The data presented in the AACR poster show that venetoclax-resistant cells are sensitive to the inhibitory effects of BP1002 combined with decitabine, suggesting that this combination is a potential treatment for patients who have relapsed from frontline venetoclax-based therapies. 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 transfusion. Bio-Path’s lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for the treatment of blood cancers and prexigebersen-A, a drug product modification of prexigebersen, is under consideration by the FDA to commence Phase 1 studies in solid tumors. This is followed by BP1002, targeting the Bcl-2 protein, where it is being evaluated in a Phase 1 study in advanced lymphoma and chronic lymphocytic leukemia patients. For more information, please visit the Company's website at http://www.biopathholdings.com. 1) Maiti et al. Haematologica, 2021, 106(3):894-898. 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 the impact, risks and uncertainties related to COVID-19 and actions taken by governmental authorities or others in connection therewith, Bio-Path’s ability to raise needed additional capital on a timely basis in order for it to continue its operations, Bio-Path's ability to have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies and 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 for future patent applications will be issued or that any issued patents will provide meaningful protection of our drug candidates, risks relating to maintaining Bio-Path's listing on the Nasdaq Capital Market 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’ConnorStern Investor Relations 212-362-1200will@sternir.com Doug Morris Investor Relations Bio-Path Holdings, Inc. 832-742-1369

  • Bio-Path Stock Is Trading Higher As Prexigebersen Triplet Combo Shows Favorable Safety Profile In Acute Myeloid Leukemia Study
    Benzinga

    Bio-Path Stock Is Trading Higher As Prexigebersen Triplet Combo Shows Favorable Safety Profile In Acute Myeloid Leukemia Study

    Bio-Path Holdings Inc (NASDAQ: BPTH) has completed the safety run-in of Stage 2 of the Phase 2 study evaluating prexigebersen to treat acute myeloid leukemia (AML) in combination with frontline therapies, decitabine and venetoclax. The safety run-in comprised six evaluable patients. In the preliminary safety data review, five patients responded to treatment, including four achieving complete response (CR) and one complete response with incomplete hematologic recovery (CRi). CR rates to combination treatment with decitabine and venetoclax for relapsed/refractory AML patients is 42-52% and 0-39% for relapsed/refractory secondary AML patients. Response rates to frontline treatment decitabine and venetoclax for newly diagnosed AML patients are 62-71%. Interim data showed the treatment was well-tolerated, and no dose-limiting toxicities were observed. Three patients remained on treatment for more than one cycle. The Phase 2 clinical trial continues with 21 patients currently enrolled across all three cohorts. Price Action: BPTH shares are up 19.5% at $8.4 in the premarket trading on the last check Monday. See more from BenzingaClick here for options trades from BenzingaAbbVie's Upadacitinib US Application Review In Atopic Dermatitis PostponedAcadia Stock Drops After FDA CRL For Pimavanserin Application In Hallucinations and Dementia-Related Psychosis© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

  • Bio-Path Holdings Announces Successful Completion of Safety Cohort of Triple Combination of Prexigebersen, Decitabine and Venetoclax in Stage 2 of Phase 2 Clinical Trial in Acute Myeloid Leukemia
    GlobeNewswire

    Bio-Path Holdings Announces Successful Completion of Safety Cohort of Triple Combination of Prexigebersen, Decitabine and Venetoclax in Stage 2 of Phase 2 Clinical Trial in Acute Myeloid Leukemia

    HOUSTON, April 05, 2021 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced the successful completion of the safety run-in of the Stage 2 of the Phase 2 clinical study of prexigebersen (BP1001), a liposomal Grb2 antisense, for the treatment of acute myeloid leukemia (AML), in combination with frontline therapies, decitabine and venetoclax, in acute myeloid leukemia (AML) patients. The safety run-in of Stage 2 of the Phase 2 clinical trial was comprised of six evaluable patients who were treated with the triple combination of prexigebersen, decitabine and venetoclax. “We are particularly pleased with the clean side effect profile and lack of toxicity shown in this segment of the study, as our Phase 2 efficacy segment will include de novo fragile AML patients for whom drug side effect profiles are particularly important. We are also very encouraged by the efficacy signals shown in this dataset, with five of six evaluable relapsed, refractory and newly diagnosed AML patients demonstrating clinical activity. These positive signals give us further confidence in the potential for this program in these late-stage and compromised patients,” stated Peter H. Nielsen, Chief Executive Officer of Bio-Path Holdings. “We look forward to advancing this Phase 2 study, as we believe its unique design provides us with several definable registration pathways. We believe that prexigebersen, with its promising efficacy and safety profile, has the potential to be an ideal combination candidate with frontline therapies,” concluded Mr. Nielsen. In the safety run-in, six evaluable patients were treated with the combination of prexigebersen, decitabine and venetoclax. These patients included four relapsed/refractory AML patients, and two newly diagnosed AML patients. In the preliminary safety data review, five of the patients (83%) responded to treatment, including four (67%) achieving complete response (CR) and one (17%) complete response with incomplete hematologic recovery (CRi). CR rates to combination treatment with decitabine and venetoclax for relapsed/refractory AML patients is 42-52%1,2 and 0-39%1,2 for relapsed/refractory secondary AML patients. Response rates to frontline treatment decitabine and venetoclax for newly diagnosed AML patients is 62-71%3,4. These preliminary data showed the treatment was well-tolerated and there were no dose limiting toxicities attributed to prexigebersen. Three patients remained on treatment for more than one cycle. Stage 2 of the Phase 2 clinical trial has three treatment cohorts, which the Company believes provides for several potential regulatory pathways. The first two cohorts will treat patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort includes newly diagnosed AML patients and the second cohort includes relapsed/refractory AML patients. Finally, the third cohort treats relapsed/refractory AML patients who are venetoclax resistant or intolerant with the two-drug combination of prexigebersen and decitabine. The Phase 2 clinical trial continues with 21 patients currently enrolled across all three cohorts. Enrollment of 19 patients in each cohort should enable a data review to determine if there is a comparative increase in efficacy versus the decitabine and venetoclax combination therapy sufficient to support petitioning the FDA for approval to switch to breakthrough therapy for accelerated approval. The Phase 2 trial will be conducted at up to ten clinical sites in the U.S. For more information on the Phase 2 study, visit www.clinicaltrials.gov. 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 transfusion. 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 product modification of prexigebersen, is under consideration by the FDA to commence Phase 1 studies in solid tumors. This is followed by BP1002, targeting the Bcl-2 protein, where it will be evaluated in lymphoma and solid tumors clinical studies. For more information, please visit the Company's website at http://www.biopathholdings.com. 1) DiNardo et al. Lancet Haematology, 2020, Oct;7(10):e724-e736.2) Aldoss et al. Haematol, 2018, 103:e404-e407.3) DiNardo et al. Blood, 2019, 133(1): 1-7.4) Venclexta Package Insert. 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 the impact, risks and uncertainties related to COVID-19 and actions taken by governmental authorities or others in connection therewith, Bio-Path’s ability to raise needed additional capital on a timely basis in order for it to continue its operations, Bio-Path's ability to have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies and 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 for future patent applications will be issued or that any issued patents will provide meaningful protection of our drug candidates, risks relating to maintaining Bio-Path's listing on the Nasdaq Capital Market 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’ConnorStern Investor Relations, Inc.212-362-1200will@sternir.com Doug Morris Investor Relations Bio-Path Holdings, Inc. 832-742-1369