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]

Group 1 - Stonegate Capital Partners has updated its coverage on Bio-Path Holdings, Inc. (NASDAQ: BPTH) for Q3 2024 [2] - The announcement was made on December 13, 2024, indicating ongoing interest in Bio-Path Holdings [2] - The update is part of Stonegate's broader capital markets advisory services, which include investor relations and equity research [5]

Core Viewpoint - Bio-Path (BPTH) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive shift in earnings estimates which is a significant factor influencing stock prices [1][2]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the importance of changing earnings estimates, which are strongly correlated with near-term stock price movements [3][5]. - Institutional investors utilize earnings estimates to determine the fair value of stocks, leading to buying or selling actions that affect stock prices [3]. Company Performance Indicators - Bio-Path is projected to report earnings of -$3.17 per share for the fiscal year ending December 2024, reflecting a year-over-year change of 90.6% [7]. - Over the past three months, the Zacks Consensus Estimate for Bio-Path has increased by 48.9%, indicating a positive trend in earnings outlook [7]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks which have averaged a +25% annual return since 1988 [6]. - The upgrade to Zacks Rank 2 places Bio-Path in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Core Viewpoint - Bio-Path (BPTH) has shown a downtrend recently, losing 8.2% over the past week, but a hammer chart pattern suggests a potential trend reversal due to increased buying interest and support from bulls [1]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out, suggesting that selling pressure may be subsiding [1]. - This pattern forms when a stock opens lower, makes a new low, but then closes near its opening price, signaling a potential loss of control by bears [2]. Fundamental Analysis - There has been a significant upward trend in earnings estimate revisions for BPTH, with a 48.9% increase in the consensus EPS estimate over the last 30 days, indicating improved earnings expectations [3]. - BPTH holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [3]. - The Zacks Rank serves as a timing indicator, suggesting that BPTH's prospects are beginning to improve, further supporting the case for a trend reversal [3].

Financial Data and Key Metrics Changes - The company reported a net loss of $2.1 million, or $0.70 per share, for Q3 2024, compared to a net loss of $3.2 million, or $6.36 per share, for Q3 2023, indicating an improvement in financial performance [18] - Research and development expenses decreased to $1.3 million in Q3 2024 from $2.3 million in Q3 2023, primarily due to reduced manufacturing expenses and clinical trial costs [19] - General and administrative expenses increased to $1.3 million in Q3 2024 from $1.0 million in Q3 2023, mainly due to higher legal fees and salaries [20] - Cash reserves as of September 30, 2024, were $0.6 million, down from $1.1 million as of December 31, 2023 [20] - Net cash used in operating activities for the nine months ended September 30, 2024, was $7.7 million, compared to $9.7 million for the same period in 2023 [21] Business Line Data and Key Metrics Changes - The company is advancing its clinical development program for BP1001-A, targeting obesity and related metabolic diseases, marking a significant expansion of its DNAbilize platform beyond oncology [6][7] - Progress continues in the Phase 1/1b clinical trial of BP1001-A in patients with solid tumors, with a focus on safety evaluations [9] - The amended Stage 2 of the Phase 2 trial for prexigebersen in AML is ongoing, with a focus on achieving complete remission in patients [10] - The Phase 1/1b trial of BP1002 in refractory relapse AML patients is progressing, with initial dosing cohorts showing no dose-limiting toxicity [14] Market Data and Key Metrics Changes - The company is expanding its therapeutic focus to include obesity and metabolic diseases, which may open new market opportunities beyond its traditional oncology focus [6][8] - The ongoing trials for BP1001-A and BP1002 are being conducted at leading cancer centers, indicating a strong market presence and collaboration [9][14] Company Strategy and Development Direction - The company aims to deliver a new era of DNA-powered medicine, with a focus on expanding its DNAbilize platform into non-cancer applications [6] - There is a strategic emphasis on addressing unmet medical needs in both oncology and metabolic disease markets, which may enhance the company's growth potential [22] Management's Comments on Operating Environment and Future Outlook - Management expressed pride in the progress made and highlighted the potential of the DNAbilize platform to provide new treatment options for patients [6][22] - The company anticipates a strong finish to the year, driven by advancements across its pipeline and the introduction of new medicines [22] Other Important Information - The company has identified a method for oligo detection in trace quantities in plasma, which is expected to facilitate the submission of an investigational new drug application to the FDA for BP1003 [17] Q&A Session Summary - The Q&A session was brief, and no specific questions or answers were documented in the provided content [23]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Delaware 001-36333 87-0652870 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) Title of each class Trading Symbol Name of each exchange on which registered Common Stock, par value $0.001 per share BPTH The Nasdaq Capital Market FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of report (Date of earliest event reported): November 15, ...

Core Viewpoint - Bio-Path Holdings, Inc. is expanding its proprietary DNAbilize® technology beyond oncology into obesity treatment, indicating the broad therapeutic potential of its platform [1][2][3]. Recent Corporate Highlights - The company initiated the BP1001-A therapeutic program for obesity treatment, marking the first non-cancer application of DNAbilize® technology, which targets insulin resistance [3]. - Enrollment for the third dosing cohort of the Phase 1/1b clinical trial of BP1002 in venetoclax-resistant AML patients was completed ahead of schedule, highlighting the urgent need for new treatment options [4]. - An article was published in the peer-reviewed journal Biomedicines, showcasing the anti-tumor effects of BP1003 across various preclinical solid tumor models [5]. Clinical Trial Updates - The first patient in the second dose cohort of the Phase 1/1b advanced solid tumor clinical trial showed a positive response, with a 15% reduction in the primary tumor after six treatment cycles [6]. - The dose-finding portion of the Phase 1/1b trial for BP1001-A has successfully completed the initial prescribed dose and is now enrolling in a higher dose cohort [7]. Financial Results - For Q3 2024, the company reported a net loss of $2.1 million, or $0.70 per share, an improvement from a net loss of $3.2 million, or $6.36 per share, in Q3 2023 [9]. - Research and development expenses decreased to $1.3 million in Q3 2024 from $2.3 million in Q3 2023, primarily due to reduced manufacturing expenses [10]. - General and administrative expenses increased to $1.3 million in Q3 2024 from $1.0 million in Q3 2023, attributed to higher legal fees and salaries [11]. Cash Position - As of September 30, 2024, the company had cash of $0.6 million, down from $1.1 million as of December 31, 2023 [12]. - Net cash used in operating activities for the first nine months of 2024 was $7.7 million, compared to $9.7 million for the same period in 2023 [12]. Financing Activities - The company closed a private placement in October, raising approximately $4.0 million through the issuance of shares and warrants [8].

Table of Contents Delaware 87-0652870 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __ ...