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Bio-Path Holdings Inc. (NASDAQ: BPTH) is a pioneering biotechnology company focused on developing innovative therapeutic products through its proprietary DNAbilize® technology. This technology enables the delivery of nucleic acid drugs throughout the human body via simple intravenous infusion. Bio-Path's primary focus is on oncology, aiming to provide effective treatments for various forms of cancer.
The company's lead product candidate, prexigebersen (BP1001), is currently in Phase II clinical trials for Acute Myeloid Leukemia (AML) in combination with low-dose cytarabine (LDAC) and decitabine. Additionally, Bio-Path is exploring prexigebersen's potential in combination with dasatinib for patients with blast-phase and accelerated-phase Chronic Myeloid Leukemia (CML).
Another key candidate, BP1002, targets the Bcl-2 protein, which plays a crucial role in cell survival for many cancers. BP1002 is being evaluated for its effectiveness against lymphoma and solid tumors, offering hope for venetoclax-resistant AML patients. The company's technological advantage lies in its DNAbilize® platform, a liposomal antisense DNA method that significantly improves oligonucleotide therapeutics' delivery and efficacy.
Bio-Path Holdings continues to expand its pipeline with additional candidates such as BP1003, a STAT3 antisense oligodeoxynucleotide, and BP1001-A, a modification designed for solid tumors. These developments emphasize the company's commitment to addressing unmet medical needs in oncology.
Recently, Bio-Path has made significant strides in its clinical programs, receiving positive feedback from the U.S. FDA and advancing its trials at renowned institutions including Weill Cornell Medical College and The University of Texas MD Anderson Cancer Center. The company maintains a robust intellectual property portfolio to protect its innovative DNAbilize® platform.
For investors and stakeholders, Bio-Path Holdings represents a forward-thinking entity with a strategic focus on developing novel RNAi nanoparticle drugs. The company's advancements in the clinical and preclinical stages underline its potential to make substantial contributions to cancer treatment paradigms.
Bio-Path Holdings (NASDAQ:BPTH) announced that CEO Peter Nielsen will give a pre-recorded presentation at the H.C. Wainwright 26th Annual Global Investment Conference on September 9, 2024, at 7:00 a.m. ET. The presentation will be available via audio webcast on the company's website for approximately 90 days.
Bio-Path is developing DNAbilize®, a novel RNAi nanoparticle drug delivery technology. Their pipeline includes:
- Prexigebersen (BP1001): In Phase 2 for blood cancers
- BP1001-A: In Phase 1/1b for solid tumors
- BP1002: Targeting Bcl-2 protein for blood cancers and solid tumors
- BP1003: STAT3 inhibitor with upcoming IND application
The company's technology allows for simple intravenous infusion of their targeted nucleic acid cancer drugs.
Bio-Path Holdings (NASDAQ:BPTH) reports positive outcomes from its ongoing clinical trials. In the Phase 1/1b trial of BP1001-A for solid tumors, the first patient treated with a higher dose (90 mg/m2) showed tumor regression and stable disease. This elderly female patient with gynecologic cancer experienced a 15% reduction in her primary tumor through six cycles of treatment, after failing multiple lines of chemotherapy and surgeries.
Additionally, two elderly patients in the Phase 2 triple combination study of prexigebersen for Acute Myeloid Leukemia (AML) demonstrated extended treatment durability. One patient has received 16 cycles over 21 months, while another has completed 12 cycles over 14 months, both remaining in complete remission.
These results support the potential of Bio-Path's DNAbilize® platform technology to treat vulnerable cancer patients with fewer side effects compared to standard therapies.
Bio-Path Holdings (NASDAQ:BPTH) reported its Q2 2024 financial results and corporate updates. Key highlights include:
Financial Results:
- Net loss of $1.9 million ($1.16 per share) vs $4.2 million ($10.64 per share) in Q2 2023
- R&D expenses decreased to $1.9 million from $3.1 million in Q2 2023
- G&A expenses remained stable at $1.2 million
- Cash position of $4.0 million as of June 30, 2024
Corporate Developments:
- Presented interim results from Phase 2 study of prexigebersen at ASCO and EHA
- Closed $4.0 million private placement in June
- Advancing clinical programs for blood cancers and solid tumors
Bio-Path Holdings (NASDAQ: BPTH) has announced it will host a live conference call and audio webcast on August 15, 2024 at 8:30 a.m. ET to report financial results for the second quarter ended June 30, 2024 and provide a business overview. The company is developing DNAbilize®, a novel RNAi nanoparticle drug technology administered via intravenous transfusion.
Bio-Path's pipeline includes prexigebersen (BP1001) in Phase 2 for blood cancers, BP1001-A in Phase 1/1b for solid tumors, and BP1002 targeting Bcl-2 protein for blood cancers and solid tumors. An IND is expected for BP1003, a STAT3 inhibitor.
Bio-Path Holdings (NASDAQ:BPTH), a biotechnology firm, has provided an update on its clinical programs and expansion plans. The company has made significant progress across multiple cancer studies and has completed the development of oncology molecular biomarkers. Additionally, Bio-Path is preparing preclinical studies for prexigebersen as a potential obesity treatment. The company's clinical development program includes one Phase 2 trial and three Phase 1/1b trials. Key updates include: advancing to the second dose level in a Phase 1/1b trial for BP1001-A, completing the second dose cohort in a Phase 1/1b trial for BP1002, and ongoing enrollment in a Phase 1 trial for BP1002 in refractory/relapsed lymphoma and CLL. Bio-Path has also announced preclinical work for BP1003 targeting STAT3 protein and the potential of prexigebersen for obesity-related cancers. The company’s DNAbilize® platform continues to show promise across multiple indications.
Bio-Path Holdings presented interim results from its Phase 2 study of prexigebersen (BP1001) in combination with decitabine and venetoclax for treating acute myeloid leukemia (AML) at the 2024 European Hematology Association Congress.
Dr. Jorge Cortes presented data showing the combination therapy was well-tolerated and demonstrated significant clinical improvements. In Cohort 1, 75% of evaluable newly diagnosed AML patients achieved complete remission (CR), CR with partial recovery (CRh), or CR with incomplete hematologic recovery (CRi). In Cohort 2, 55% of evaluable relapsed/refractory AML patients achieved CR/CRi/CRh. Adverse events included fatigue, anemia, and neutropenia, with severe events like febrile neutropenia and sepsis. Bio-Path plans to continue enrolling up to 98 and 54 patients for Cohorts 1 and 2 respectively.
Bio-Path Holdings (NASDAQ: BPTH) has completed a $4.0 million private placement.
This involved the issuance and sale of 1,809,955 shares of common stock and series A and B warrants to purchase an equal number of shares.
The purchase price was $2.21 per share, with the warrants exercisable immediately at $2.00 per share.
The series A warrants expire in five years, while the series B warrants are short-term and expire in 24 months.
H.C. Wainwright & Co. served as the exclusive placement agent. The net proceeds will be used for working capital and general corporate purposes.
Bio-Path Holdings (NASDAQ: BPTH) has received updated coverage from Stonegate Capital Partners for Q1 2024. Key highlights include the ongoing Phase 2 trial of Prexigebersen, a lead candidate in their pipeline. The company also boasts numerous other drug candidates undergoing development. Additionally, Bio-Path raised $3.5 million in 2024, ensuring they have sufficient liquidity to support their operations and ongoing trials.
Bio-Path Holdings (NASDAQ:BPTH) announced a private placement of $4.0 million, involving the sale of 1,809,955 shares of common stock and accompanying warrants priced at $2.21 per share. The series A warrants and series B warrants will be exercisable at $2.00 per share, with expiration periods of five years and 24 months, respectively. The closing is expected on June 5, 2024, pending customary conditions. H.C. Wainwright & Co. is the exclusive placement agent. The company plans to use the net proceeds for working capital and general corporate purposes. The securities are offered under Section 4(a)(2) and/or Regulation D and are not registered under the Securities Act.
Bio-Path Holdings (NASDAQ:BPTH) presented interim results from its Phase 2 study of prexigebersen (BP1001) at the ASCO Annual Meeting on June 1, 2024. The study involves treating acute myeloid leukemia (AML) patients with a combination of prexigebersen, decitabine, and venetoclax. Data from two cohorts were presented: 31 newly diagnosed patients and 38 relapsed/refractory patients.
In Cohort 1, 75% of evaluable newly diagnosed patients achieved complete or partial remission. In Cohort 2, 55% of evaluable relapsed/refractory patients achieved complete or partial remission. Adverse events were consistent with those typically associated with AML treatments, including fatigue, anemia, and neutropenia. Severe adverse events included febrile neutropenia (26%) and sepsis (5%).
Given these promising interim results, Bio-Path plans to continue patient enrollment to meet study targets. The company's DNAbilize® technology shows potential in developing RNAi nanoparticle drugs for various cancers.
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