Data suggest BP1001-A prevents fatty acid-induced insulin resistance in cellsHOUSTON, May 01, 2025 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (OTCQB: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 reported the achievement of a third milestone from recent preclinical studies of BP1001-A that provide additional support for its potential as a treatment for obesity. ...

Financial Results Announcement - Bio-Path Holdings, Inc. announced financial results for the year ended December 31, 2024, on March 28, 2025[5]. - The press release detailing the financial results is attached as Exhibit 99.1[5]. - The report does not include specific financial metrics or performance indicators in the provided content[4]. - The financial results announcement does not specify any new product developments or market expansions[5]. - There is no mention of user data or future guidance in the provided content[5]. Regulatory Compliance - The company is not classified as an emerging growth company under the Securities Act of 1933[3]. - The report is filed under the Securities Exchange Act of 1934, indicating compliance with regulatory requirements[4]. Company Information - The company’s principal executive offices are located at 4710 Bellaire Boulevard, Suite 210, Bellaire, Texas[2]. - The company’s trading symbol is BPTH, and it is registered under the Commission File Number 001-36333[2]. - The report was signed by Peter H. Nielsen, President and CEO, on the date of the announcement[10].

Core Insights - Bio-Path Holdings, Inc. reported financial results for the year ended December 31, 2024, highlighting advancements in its DNAbilize® platform for cancer and obesity treatments [1][5] - The company emphasized the potential of its proprietary technology to transform treatment paradigms in oncology and obesity, with ongoing clinical studies showing promising results [2] Recent Corporate Highlights - Bio-Path expanded its intellectual property portfolio, holding seven issued patents in the U.S. and 61 in foreign jurisdictions, with protections in 26 countries [4] - An update from the Phase 1/1b clinical trial of BP1002 for refractory/relapsed acute myeloid leukemia indicated meaningful patient responses, progressing to a higher dose cohort [4] Financial Results - The company reported a net loss of $9.9 million, or $4.12 per share, for the year ended December 31, 2024, a decrease from a net loss of $16.1 million, or $33.63 per share, in 2023 [7] - Research and development expenses decreased to $7.3 million from $11.6 million in 2023, while general and administrative expenses increased to $4.7 million from $4.2 million [7][11] - As of December 31, 2024, the company had cash of $1.2 million, up from $1.1 million in 2023, with net cash used in operating activities decreasing to $10.6 million from $11.5 million [11]

Drug Development - The company has four drug candidates in development targeting at least five different cancer indications, with the lead candidate BP1001 (prexigebersen) currently in a Phase 2 clinical trial for untreated AML patients[305]. - In the Phase 2 trial, 75% of newly diagnosed AML patients achieved complete remission or complete remission with incomplete blood count recovery (CR/CRi/CRh) after treatment with prexigebersen, decitabine, and venetoclax[309]. - The company plans to complete enrollment for the first two cohorts of the Phase 2 trial by 2026, with a total of approximately 98 evaluable patients in Cohort 1 and 54 in Cohort 2[309]. - The second drug candidate, BP1002, targeting the Bcl-2 protein, has discontinued enrollment in its Phase 1 trial due to challenges in recruiting patients in a competitive landscape[311]. - BP1003, targeting the STAT3 protein, is in IND enabling studies, with plans to file an IND application and initiate a Phase 1 study for pancreatic cancer and NSCLC[314]. - BP1001-A, a modified version of prexigebersen, is undergoing a Phase 1/1b trial, with the first dose cohort completed and no dose limiting toxicities reported[315]. - The company is exploring BP1001-A as a potential treatment for obesity and Type 2 diabetes, with preclinical studies showing it may enhance insulin sensitivity[316][317]. - The company is developing a molecular biomarker package to accompany prexigebersen treatment to identify patients more likely to respond to the investigational treatment[319]. - The company intends to apply its DNAbilize® technology to new disease-causing protein targets and develop new liposomal antisense drug candidates[318]. - The company holds intellectual property for its drug products in clinical development, including composition of matter and method of use patents for RNAi antisense nanoparticle drug products[320]. Financial Performance - As of December 31, 2024, the company had an accumulated deficit of $117.5 million and a net loss of $9.9 million, a decrease from $16.1 million in 2023[321]. - The company reported no revenue for the years ended December 31, 2024 and 2023, indicating a reliance on future drug candidate commercialization for revenue generation[322][329]. - Research and development expenses for 2024 were $7.3 million, down from $11.6 million in 2023, primarily due to decreased manufacturing expenses[330]. - General and administrative expenses increased to $4.7 million in 2024 from $4.2 million in 2023, attributed to higher salaries and expenses related to a special shareholder meeting[332]. - The net operating loss for 2024 was $12.0 million, a decrease of $3.8 million compared to 2023[332]. - The company had a cash balance of $1.2 million at December 31, 2024, which is insufficient to cover current liabilities and capital expenditures[336]. - Net cash used in operating activities for 2024 was $10.6 million, with the net loss contributing significantly to this figure[337]. - The net loss per share for 2024 was $4.12, a significant improvement from $33.63 per share in 2023[334]. - The company anticipates continued significant operating losses as it expands drug development and commercialization efforts[321]. Financing Activities - The company raised approximately $10.7 million through various financing activities in 2024, including registered direct offerings and private placements[339]. - The company entered into an At The Market Offering Agreement on April 4, 2024, allowing the sale of up to $2.0 million in common stock, resulting in the sale of 436,511 shares for gross proceeds of approximately $2.0 million and net proceeds of about $1.8 million after expenses[345]. - On April 19, 2024, the company increased the offering under the At The Market Offering Agreement by an additional $1.1 million, selling 334,929 shares for gross proceeds of approximately $1.1 million and net proceeds of about $1.0 million[346]. - The company completed a registered direct offering on April 19, 2024, selling 375,000 shares for gross proceeds of approximately $1.2 million, with net proceeds of around $0.9 million after fees[347]. - In June 2024, the company raised approximately $4.0 million through a private placement, selling 180,000 shares and various warrants, with net proceeds of about $3.3 million after expenses[350]. - The October 2024 private placement generated approximately $4.0 million in gross proceeds, with net proceeds of about $3.5 million after deducting fees, while canceling certain previously issued warrants[351]. - The company issued a promissory note for $161,000 on March 6, 2025, with a purchase price of $140,000 after a discount, requiring five payments totaling $161,000[352]. - The company expects to incur significant operating expenses for ongoing activities, including clinical trials and regulatory approvals, necessitating substantial additional capital[353]. - As of December 31, 2024, the company reported no material off-balance sheet arrangements[354].

Core Insights - Bio-Path Holdings, Inc. reported promising preclinical results for BP1001-A, indicating its potential as a treatment for obesity and related metabolic diseases in Type 2 diabetes patients [1][3] - The company plans to conduct a final preclinical mouse model study in the first half of 2025 and aims to file an Investigational New Drug (IND) application by the end of 2025 to initiate a Phase 1 clinical trial [2][3] Company Overview - Bio-Path Holdings is a biotechnology company focused on developing its proprietary DNAbilize® technology, which has led to a pipeline of RNAi nanoparticle drugs [4] - The lead product candidate, prexigebersen (BP1001), is currently in a Phase 2 study for blood cancers, while BP1001-A is being evaluated for both solid tumors and obesity-related metabolic diseases [4] Preclinical Study Results - Recent studies demonstrated that BP1001-A can restore insulin sensitivity in muscle progenitor and skeletal muscle fiber cell models, which is crucial for treating obesity in Type 2 diabetes patients [3][7] - BP1001-A downregulates Grb2 expression, which is linked to increased insulin sensitivity and lower blood glucose levels in Type 2 diabetes patients [3][7] Future Plans - The company is preparing for the final stage of preclinical testing using a mouse model to assess BP1001-A's impact on weight, insulin sensitivity, and glucose tolerance [2][3] - If the upcoming studies are successful, Bio-Path anticipates filing an IND application in 2025 to begin human clinical trials [2][3]

Core Viewpoint - Bio-Path Holdings, Inc. reports significant progress in its clinical trials for BP1001-A in solid tumors and prexigebersen in Acute Myeloid Leukemia (AML), indicating potential for effective treatment options in challenging patient populations [1][2][3]. Group 1: Clinical Trial Updates - The first solid tumor patient treated with a higher dose of BP1001-A (90 mg/m) has shown tumor regression and stable disease after ten treatment cycles, marking a significant milestone for the company [2][5]. - The Phase 1/1b trial of BP1001-A has successfully completed the initial dose of 60 mg/m and is now enrolling patients in the higher dose cohort of 90 mg/m, with plans for further studies in combination with chemotherapy [6]. - In the Phase 2 study of prexigebersen for AML, two elderly patients have remained in complete remission after two years of treatment, demonstrating the drug's potential for long-term efficacy [3][8]. Group 2: Patient Outcomes - An elderly female patient with gynecologic cancer experienced a 15% reduction in her primary tumor after six cycles of BP1001-A treatment, contributing to improved quality of life and ability to engage in rigorous exercise [4]. - The first AML patient reported has received 20 cycles of treatment over 26 months and remains in complete remission, while another patient has received 16 cycles over 20 months, also maintaining complete remission [7][8]. Group 3: Company Overview - Bio-Path Holdings is focused on developing its proprietary DNAbilize technology, which has led to a pipeline of RNAi nanoparticle drugs, including prexigebersen and BP1001-A, targeting various cancers and obesity-related conditions [9].

Core Insights - Bio-Path Holdings, Inc. has progressed its Phase 1/1b clinical trial for BP1002, targeting refractory/relapsed acute myeloid leukemia (AML), to the fourth higher dose cohort of 90 mg/m2, indicating promising patient responses [2][3] Company Overview - Bio-Path Holdings, Inc. is a biotechnology company focused on developing targeted nucleic acid cancer and obesity drugs using its proprietary DNAbilize® liposomal delivery and antisense technology [2][6] - The company’s lead product candidate, BP1001, is in a Phase 2 study for blood cancers, while BP1002 is being evaluated for blood cancers and solid tumors, including AML [6] Clinical Trial Progress - The ongoing Phase 1/1b clinical trial has shown a meaningful patient response, with one patient in the third cohort experiencing stable disease and a significant reduction in blast count after one treatment cycle [3] - The trial is being conducted at several leading cancer centers in the U.S., including Weill Medical College of Cornell University and MD Anderson Cancer Center [4][5] - The approved treatment cycle consists of two doses per week over four weeks, totaling eight doses administered over twenty-eight days [4] Treatment Context - The current standard of care for AML patients not eligible for intensive chemotherapy is venetoclax, which many patients become resistant to, leading to poor prognosis [3] - BP1002 aims to target Bcl-2 at the mRNA level, potentially overcoming resistance mechanisms associated with venetoclax treatment [3]

Core Viewpoint - Bio-Path Holdings, Inc. is advancing multiple clinical programs targeting significant unmet medical needs in oncology and obesity, with several milestones expected in 2025, including the development of new applications for existing drugs and the introduction of novel therapies [1]. Clinical Development Overview - The clinical development program includes one Phase 2 trial for acute myeloid leukemia (AML), two Phase 1 or 1/1b trials, and two preclinical programs [2]. - A molecular biomarker package has been developed for the Phase 2 AML trial to identify patients likely to respond to prexigebersen treatment, with plans to utilize this in 2025 [2]. Prexigebersen Phase 2 Clinical Trial - The Phase 2 trial consists of three patient cohorts, each targeting different AML patient groups, with the first two cohorts using a combination of prexigebersen, decitabine, and venetoclax [3]. - The trial aims to improve outcomes for older patients with a median survival of only 5 to 10 months who cannot receive intensive chemotherapy [3]. BP1001-A Phase 1/1b Clinical Trial - A Phase 1/1b trial for BP1001-A in advanced solid tumors is ongoing, showing promising results in a patient with gynecologic cancer, including a 15% reduction in tumor size after nine treatment cycles [4]. - The study is expected to progress to Phase 1b, assessing BP1001-A in combination with paclitaxel and gemcitabine for various cancers [5]. BP1002 Phase 1/1b Clinical Trial - The Phase 1/1b trial for BP1002 targets relapsed/refractory AML patients, including those resistant to venetoclax, with promising early results and no dose-limiting toxicities observed [6]. BP1001-A for Obesity in Type 2 Diabetes - BP1001-A is being explored as a treatment for obesity in Type 2 diabetes patients, with preclinical studies confirming its potential to lower blood glucose levels by downregulating Grb2 expression [7]. - An Investigational New Drug (IND) application for BP1001-A is expected to be filed later in 2025 [7]. Intellectual Property Protection - Bio-Path holds a robust patent portfolio, including composition of matter patents that protect its proprietary products and allow for the application of its technology to new protein targets [8][11].

Core Insights - Bio-Path Holdings, Inc. has reported promising preclinical results for BP1001-A, indicating its potential as a treatment for obesity and related metabolic diseases in Type 2 diabetes patients [1][3] - BP1001-A works by downregulating Grb2 expression, which enhances insulin sensitivity and lowers blood glucose levels [2][3] Group 1: Preclinical Study Results - BP1001-A has been shown to reduce Grb2 protein expression in myoblast cells [2] - The treatment increased levels of phosphorylated AKT and phosphorylated FOXO-1 in myoblast and hepatoma cells in the presence of insulin [2] - These findings confirm that BP1001-A enhances insulin-induced metabolic events through the insulin/PI3K/AKT pathway [2] Group 2: Company Development Plans - Bio-Path has initiated animal studies to further confirm the efficacy of BP1001-A for obesity and related metabolic diseases in Type 2 diabetes patients [3] - If animal studies are successful, the company plans to start a first-in-human Phase 1 clinical trial in 2025 to validate safety, measure pharmacokinetics, and establish dosing for potential pivotal trials [3] Group 3: Company Overview - Bio-Path Holdings, Inc. is focused on developing DNAbilize®, a novel technology that has led to a pipeline of RNAi nanoparticle drugs [4] - The company's lead product candidate, prexigebersen (BP1001), is currently in a Phase 2 study for blood cancers, while BP1001-A is in a Phase 1/1b study for solid tumors [4] - Bio-Path is also evaluating BP1002 for blood cancers and solid tumors, and plans to file an IND application for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide [4]

Stonegate Capital Partners Updates Coverage on Bio-Path Holdings, Inc. (BPTH) Q3 24December 13, 2024 4:44 PM EST | Source: Reportable, Inc.Dallas, Texas--(Newsfile Corp. - December 13, 2024) - Bio-Path Holdings, Inc. (NASDAQ: BPTH): Stonegate Capital Partners Updates Coverage on Bio-Path Holdings, Inc. (NASDAQ: BPTH) for Q3 2024. To view the full announcement, including downloadable images, bios, and more, click here. Click image above to view full announcement. About StonegateStonegate C ...