Table of Contents 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 June 30, 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) | D ...

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]

Company Overview - Bio-Path Holdings, Inc. is a biotechnology company focused on developing targeted nucleic acid cancer and obesity drugs using its proprietary DNAbilize antisense RNAi nanoparticle technology [1][3] - The company has a pipeline of RNAi nanoparticle drugs that can be administered via intravenous infusion [3] Product Pipeline - The lead product candidate, prexigebersen (BP1001), is currently in a Phase 2 study for blood cancers [3] - BP1001-A, a modified version of prexigebersen, is in a Phase 1/1b study for solid tumors and is also being evaluated for obesity and related metabolic diseases in Type 2 diabetes patients [3] - The second product, BP1002, targets the Bcl-2 protein and is being evaluated for blood cancers and solid tumors, including acute myeloid leukemia [3] - An IND application for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide, is expected to be filed [3] Upcoming Events - The company will host a live conference call and audio webcast on May 29, 2025, at 8:30 a.m. ET to provide a comprehensive business overview [1]

[PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Unaudited Q1 2025 financials indicate a net loss, reduced cash, and a shareholders' deficit, raising going concern doubts [Condensed Consolidated Balance Sheets (Unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(Unaudited)) The March 31, 2025 balance sheet reflects decreased assets and cash, increased liabilities, and a shift to a shareholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $122 | $1,173 | | Total Current Assets | $2,120 | $3,776 | | **Total Assets** | **$2,195** | **$3,883** | | **Liabilities & Equity** | | | | Accounts Payable | $2,438 | $1,274 | | Notes Payable | $261 | $0 | | Total Current Liabilities | $4,744 | $3,295 | | Total Liabilities | $4,784 | $3,729 | | Total Shareholders' (Deficit) Equity | ($2,589) | $154 | | **Total Liabilities & Shareholders' (Deficit) Equity** | **$2,195** | **$3,883** | [Condensed Consolidated Statements of Operations (Unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20(Unaudited)) Q1 2025 operations show a reduced net loss of $2.9 million, driven by lower research and development and general and administrative expenses Condensed Consolidated Statements of Operations (in thousands, except per share amounts) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $1,977 | $2,288 | | General and administrative | $1,264 | $1,407 | | **Total operating expenses** | **$3,241** | **$3,695** | | Net operating loss | ($3,241) | ($3,695) | | Change in fair value of warrant liability | $394 | $538 | | **Net loss** | **($2,852)** | **($3,157)** | | Net loss per share, basic and diluted | ($0.40) | ($4.88) | [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited)) Q1 2025 cash flows reflect $1.3 million used in operations and a $1.1 million net decrease in cash, ending with $0.1 million Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($1,313) | ($1,038) | | Net cash provided by financing activities | $262 | $174 | | **Net decrease in cash** | **($1,051)** | **($864)** | | Cash, beginning of period | $1,173 | $1,052 | | **Cash, end of period** | **$122** | **$188** | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's business, accounting policies, and significant going concern doubt due to insufficient cash, alongside new debt financing - The company is a clinical and preclinical stage oncology and obesity-focused RNAi nanoparticle drug development company utilizing its proprietary DNAbilize® technology platform[20](index=20&type=chunk) - There is substantial doubt about the Company's ability to continue as a going concern, as **cash of $0.1 million** at March 31, 2025, plus April 2025 note proceeds, will not fund operations for the next 12 months[25](index=25&type=chunk) - In March 2025, the Company issued two promissory notes totaling **$261.55 thousand** principal, receiving **$227 thousand** net proceeds, with a **12%** one-time interest charge[33](index=33&type=chunk)[34](index=34&type=chunk) - The fair value of the warrant liability decreased from **$0.4 million** at year-end 2024 to **$40 thousand** at March 31, 2025, resulting in a non-cash gain of **$0.4 million**[40](index=40&type=chunk)[42](index=42&type=chunk) - Subsequent to quarter-end, in April 2025, the company issued another promissory note for a principal of **$161 thousand** at a purchase price of **$140 thousand**[60](index=60&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage pipeline, reduced Q1 2025 net loss, and critical liquidity issues raising going concern doubts [Overview](index=24&type=section&id=Overview) The company is a clinical-stage RNAi drug developer with a pipeline including oncology and obesity candidates, highlighting progress in AML trials - The lead drug candidate, prexigebersen, is in a Phase 2 clinical trial for AML, with interim data showing a **75% remission rate** in 20 evaluable newly diagnosed patients[63](index=63&type=chunk)[69](index=69&type=chunk) - The Phase 1 clinical trial for BP1002 in refractory/relapsed lymphoma and CLL was discontinued to focus on the obesity program due to enrollment challenges[70](index=70&type=chunk) - The company is exploring BP1001-A for obesity treatment, with preclinical data confirming increased insulin sensitivity and plans for an IND filing in 2025[76](index=76&type=chunk)[77](index=77&type=chunk) - On February 19, 2025, the company's stock was delisted from Nasdaq and began trading on the OTCQB Venture Market under the symbol 'BPTH'[85](index=85&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) Q1 2025 results show no revenue, with reduced R&D and G&A expenses leading to an improved net loss compared to Q1 2024 Comparison of Operating Results (in thousands) | Expense Category | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development expense | $1,977 | $2,288 | | General and administrative expense | $1,264 | $1,407 | | **Net Loss** | **$2,852** | **$3,157** | - The decrease in R&D expense was primarily due to decreased clinical trial expenses for BP1001 and BP1002 related to patient enrollment timing[95](index=95&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces critical liquidity issues with only **$0.1 million** cash, insufficient for 12 months, relying on equity and debt financing - The company had a cash balance of **$0.1 million** as of March 31, 2025, insufficient to meet obligations and fund liquidity for the next 12 months[100](index=100&type=chunk) - Net cash used in operating activities was **$1.3 million** for the three months ended March 31, 2025[101](index=101&type=chunk) - Net cash provided by financing activities was **$0.3 million** for Q1 2025, sourced from warrant exercises and March 2025 Promissory Notes[103](index=103&type=chunk) - The company has engaged in multiple financing activities, including registered direct offerings, private placements, ATM offerings, and promissory notes in March and April 2025 to raise capital[105](index=105&type=chunk)[108](index=108&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk)[116](index=116&type=chunk)[119](index=119&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not applicable to the company for the reporting period - Not applicable[125](index=125&type=chunk) [Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal controls - Management concluded that the company's disclosure controls and procedures were effective as of the end of the reporting period[127](index=127&type=chunk) - There were no material changes in internal control over financial reporting during the quarter[130](index=130&type=chunk) [PART II - OTHER INFORMATION](index=44&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no legal proceedings - None[132](index=132&type=chunk) [Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors were reported from the prior Annual Report on Form 10-K - There were no material changes from the risk factors previously disclosed in the Annual Report on Form 10-K for the fiscal year ended December 31, 2024[133](index=133&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=44&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities or use of proceeds for the period - None[134](index=134&type=chunk) [Other Information](index=44&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the last fiscal quarter - No directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the last fiscal quarter[137](index=137&type=chunk) [Exhibits](index=44&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including agreements, notes, lease amendments, and officer certifications

Core Insights - Bio-Path Holdings, Inc. has reported promising preclinical results for BP1001-A, indicating its potential to prevent insulin resistance in cells, particularly in the context of obesity and Type 2 diabetes [1][3][5] Group 1: BP1001-A Development - BP1001-A has shown the ability to rescue the decrease in AKT activity in liver cells, which is associated with palmitic acid treatment, suggesting its effectiveness in preventing insulin resistance [1][3] - The drug downregulates Grb2 expression, which is linked to improved insulin signaling in both muscle and liver cell models [3][5] - Bio-Path plans to conduct further preclinical testing using a mouse model to evaluate BP1001-A's impact on weight, insulin sensitivity, and glucose tolerance [4] Group 2: Mechanism of Action - BP1001-A targets the Grb2 protein to enhance insulin sensitivity and lower blood glucose levels in Type 2 diabetes patients [5] - The drug has demonstrated the ability to restore insulin signaling in C2C12 myoblasts, myotubes, and HepG2 liver cells treated with palmitic acid [3][5] Group 3: Future Plans - If preclinical testing is successful, Bio-Path anticipates filing an Investigational New Drug (IND) application in 2025 to initiate a Phase 1 clinical trial [4] - The company is also advancing other product candidates, including BP1002 and BP1003, targeting different proteins for various cancers and metabolic diseases [6]

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]