Core Insights - Bio-Path Holdings, Inc. is a clinical-stage biotechnology company focused on RNA interference therapeutics using its DNAbilize® platform [1] - The lead candidate, prexigebersen (BP1001), is in Phase 2 trials for acute myeloid leukemia (AML) and shows potential for FDA approval [7] - Bio-Path is advancing its pipeline with multiple candidates targeting various cancers and metabolic diseases [1][7] Company Overview - Bio-Path Holdings, Inc. is based in Bellaire, Texas and specializes in RNAi therapeutics [1] - The company employs a proprietary liposomal delivery system to enhance drug stability and cellular uptake while reducing toxicity [1] Pipeline Development - Prexigebersen (BP1001) targets the Grb2 protein and is currently in Phase 2 trials for AML [1] - A modified version, BP1001-A, is in Phase 1/1b trials for solid tumors and has shown early efficacy [7] - Another candidate, BP1002, targets the Bcl-2 protein for blood cancers and solid tumors [1] - Bio-Path is preparing an IND application for BP1003, a STAT3 inhibitor for pancreatic cancer [1]

Bio-Path Holdings Conference Call Summary Company Overview - **Company**: Bio-Path Holdings (BPTH) - **Industry**: Biotechnology, focusing on DNA-powered medicine and therapeutics for oncology and obesity Key Points and Arguments 1. **Company Mission and Technology**: Bio-Path aims to usher in a new era of DNA-powered medicine, focusing on developing drug products from their platform technology and licensing them for commercialization [4][5] 2. **Investment Opportunity**: The company presents a strong investment opportunity due to the potential for high returns from licensing drug candidates, which can occur earlier than waiting for drug approvals [5] 3. **Pipeline Highlights**: - **Solid Tumor Treatment**: Potential for rapid clinical development [6] - **Relapsed AML Treatment**: Targeting patients with survival expectations of less than three months, with potential for Fast Track approval [6] - **Type 2 Diabetes and Obesity Treatment**: High return potential [6] 4. **DNAbilize Technology**: A patented method for producing antisense DNA therapeutics that overcomes traditional delivery challenges, allowing for high payload delivery without toxicity [7][8][9] 5. **Intellectual Property**: The company holds a robust patent portfolio with seven issued patents in the US and 61 in foreign jurisdictions, protecting their technology across 26 countries [10] 6. **Clinical Trials**: - **Prexigebersen**: Advancing in a Phase 2 trial for AML, with promising results from patients demonstrating treatment durability [11][12][13] - **BP1002**: Targeting Bcl-2 protein in refractory relapsed AML patients, with a focus on overcoming resistance mechanisms [14][15] - **BP1003**: Targeting STAT3 protein, with plans for an IND application to the FDA [19][20] - **BP1001 A**: A treatment for obesity and related metabolic diseases, with preclinical models showing promise in enhancing insulin sensitivity [21][22] 7. **Patient Outcomes**: Positive responses reported in clinical trials, including a patient with a 15% reduction in tumor size after treatment with BP1001 A [23][24] 8. **Market Resilience**: Despite recent market turbulence, the biotech sector remains innovative and presents growth opportunities [25] Additional Important Content - **Regulatory Pathway**: The company is preparing to file IND applications for BP1001 A in 2025 to initiate Phase 1 clinical trials [22] - **Patient Population**: The focus on vulnerable patient populations, particularly those with limited treatment options, highlights the company's commitment to addressing unmet medical needs [18][24] - **Future Outlook**: Bio-Path is well-positioned for continued success with a promising pipeline and expected meaningful news flow throughout the year [25]

HOUSTON, May 22, 2025 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (OTCQB:BPTH) a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer and obesity drugs, today announced that it will host a live conference call and audio webcast on Thursday, May 29, 2025 at 8:30 a.m. ET to provide a comprehensive business overview. To access the live conference call, please call (844) 481-3014 (domestic) or (412) 317-1879 (i ...

Table of Contents (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number: 001-36333 Bio-Path Holdings, Inc. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q | ...

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].