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].

[PART I - FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section details the company's unaudited financial statements and management's analysis of its financial condition [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, cash flows, and shareholders' equity, along with detailed notes explaining significant accounting policies, financial instrument valuations, and recent financing activities [Condensed Consolidated Balance Sheets (Unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20%28Unaudited%29) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific dates | Metric (in thousands) | September 30, 2024 | December 31, 2023 | Change | % Change | | :-------------------- | :------------------ | :----------------- | :----- | :------- | | Cash | $562 | $1,052 | -$490 | -46.5% | | Total Current Assets | $2,899 | $3,042 | -$143 | -4.7% | | Total Assets | $2,965 | $3,220 | -$255 | -7.9% | | Total Current Liabilities | $3,375 | $1,906 | $1,469 | 77.1% | | Warrant Liability | $302 | $863 | -$561 | -65.0% | | Total Liabilities | $3,677 | $2,779 | $898 | 32.3% | | Total Shareholders' (Deficit) Equity | ($712) | $441 | -$1,153 | -261.4% | - The company's cash balance decreased by **46.5%** to **$562 thousand** as of September 30, 2024, from **$1,052 thousand** at December 31, 2023. Total shareholders' equity shifted from a positive **$441 thousand** to a deficit of **($712) thousand**, a decrease of **261.4%**[11](index=11&type=chunk) [Condensed Consolidated Statements of Operations (Unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20%28Unaudited%29) This section outlines the company's financial performance over specific periods, detailing revenues, expenses, and net loss Operating Expenses (in thousands) | Expense Category | Three Months Ended Sep 30, 2024 | Three Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | R&D | $1,317 | $2,292 | $5,478 | $9,332 | | G&A | $1,317 | $984 | $3,889 | $3,478 | | Total Operating Expenses | $2,634 | $3,276 | $9,367 | $12,810 | Net Loss and EPS (in thousands, except per share amounts) | Metric | Three Months Ended Sep 30, 2024 | Three Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Net Operating Loss | ($2,634) | ($3,276) | ($9,367) | ($12,810) | | Total Other Income | $519 | $77 | $2,226 | $104 | | Net Loss | ($2,115) | ($3,199) | ($7,141) | ($12,706) | | Net Loss per Share | ($0.70) | ($6.36) | ($4.05) | ($29.34) | - Net loss for the three months ended September 30, 2024, decreased by **$1.084 million (33.9%)** to **$2.115 million** compared to **$3.199 million** in the prior year period. For the nine months, net loss decreased by **$5.565 million (43.8%)** to **$7.141 million** from **$12.706 million**[15](index=15&type=chunk) - Research and development expenses decreased by **$0.975 million (42.5%)** for the three months and **$3.854 million (41.3%)** for the nine months ended September 30, 2024, primarily due to decreased manufacturing expenses[14](index=14&type=chunk) - General and administrative expenses increased by **$0.333 million (33.8%)** for the three months and **$0.411 million (11.8%)** for the nine months ended September 30, 2024, mainly due to increased legal fees and salaries[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20%28Unaudited%29) This section details the cash inflows and outflows from operating, investing, and financing activities over specific periods Cash Flow Activities (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :----------------- | :----------------------------- | :----------------------------- | | Operating Activities | ($7,694) | ($9,721) | | Financing Activities | $7,204 | $1,689 | | Net Increase (Decrease) in Cash | ($490) | ($8,032) | | Cash, End of Period | $562 | $2,352 | - Net cash used in operating activities decreased by **$2.027 million (20.8%)** to **$7.694 million** for the nine months ended September 30, 2024, compared to **$9.721 million** in the prior year[17](index=17&type=chunk) - Net cash provided by financing activities significantly increased to **$7.204 million** for the nine months ended September 30, 2024, from **$1.689 million** in the prior year, primarily due to proceeds from common stock sales[17](index=17&type=chunk) [Condensed Consolidated Statements of Shareholders' (Deficit) Equity (Unaudited)](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders%27%20%28Deficit%29%20Equity%20%28Unaudited%29) This section presents changes in the company's equity, including common stock, additional paid-in capital, and accumulated deficit Shareholders' (Deficit) Equity Changes (in thousands) | Metric | Balance at Dec 31, 2023 | Balance at Sep 30, 2024 | | :--------------- | :---------------------- | :---------------------- | | Common Shares | 618 | 3,710 | | Stock Amount | $1 | $4 | | Additional Paid in Capital | $108,047 | $114,032 | | Accumulated Deficit | ($107,607) | ($114,748) | | Total Equity | $441 | ($712) | - Total shareholders' equity transitioned from a positive **$441 thousand** at December 31, 2023, to a deficit of **($712) thousand** at September 30, 2024, driven by net losses and common stock issuances[19](index=19&type=chunk) - Common shares outstanding increased significantly from **618 thousand** at December 31, 2023, to **3,710 thousand** at September 30, 2024, primarily due to various stock and warrant issuances[19](index=19&type=chunk) [Notes to the Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide essential context to the financial statements, detailing the company's business, significant accounting policies, and specific breakdowns of assets, liabilities, equity, and recent financing activities, including a going concern warning [1. Organization and Business](index=11&type=section&id=1.%20Organization%20and%20Business) This note describes the company's core business as a clinical and preclinical stage oncology-focused RNAi nanoparticle drug developer - Bio-Path Holdings, Inc. is a clinical and preclinical stage oncology-focused RNAi nanoparticle drug development company[21](index=21&type=chunk) - The company utilizes DNAbilize®, a novel drug delivery and antisense technology, for systemic delivery of target-specific protein inhibition in blood diseases and solid tumors[21](index=21&type=chunk) - Currently, Bio-Path has four antisense drug candidates in development for at least five different cancer indications, with operations limited to technology development and product candidates[21](index=21&type=chunk)[23](index=23&type=chunk) [2. Significant Accounting Policies](index=11&type=section&id=2.%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods applied in preparing the financial statements, including going concern considerations - The company's available cash of **$0.6 million** at September 30, 2024, along with October 2024 private placement proceeds, will not be sufficient to fund liquidity and capital expenditure requirements for the next 12 months, raising substantial doubt about its ability to continue as a going concern[26](index=26&type=chunk) - Warrants are classified as a liability and measured at fair value using Level 3 inputs (Black-Scholes model), with changes recorded in the Condensed Consolidated Statement of Operations[27](index=27&type=chunk) - Diluted net loss per share is equal to basic net loss per share as outstanding warrants and stock options would be antidilutive[24](index=24&type=chunk)[25](index=25&type=chunk) [3. Prepaid Drug Product](index=13&type=section&id=3.%20Prepaid%20Drug%20Product) This note details the company's advance payments for manufacturing and raw materials related to its drug candidates - Prepaid drug product decreased from **$0.6 million** at December 31, 2023, to **$0.5 million** at September 30, 2024, representing advance payments for manufacturing and raw materials for prexigebersen[29](index=29&type=chunk) [4. Other Current Assets](index=13&type=section&id=4.%20Other%20Current%20Assets) This note explains the composition and changes in other current assets, primarily related to clinical trial prepayments - Other current assets increased from **$1.4 million** at December 31, 2023, to **$1.8 million** at September 30, 2024, primarily due to increased prepayments for clinical trials (BP1001-A and BP1002) and prepaid insurance[30](index=30&type=chunk) [5. Accounts Payable](index=13&type=section&id=5.%20Accounts%20Payable) This note details the increase in accounts payable, mainly driven by higher clinical trial and professional fees - Accounts payable increased from **$0.5 million** at December 31, 2023, to **$1.0 million** at September 30, 2024, mainly due to higher clinical trial expenses, legal and patent fees, and financing activity expenses[31](index=31&type=chunk) [6. Accrued Expense](index=14&type=section&id=6.%20Accrued%20Expense) This note explains the increase in accrued expenses, primarily due to higher clinical trial costs and employee-related accruals - Accrued expenses increased from **$1.3 million** at December 31, 2023, to **$2.3 million** at September 30, 2024, primarily driven by higher accrued clinical trial expenses (**$1.6 million**), employee vacation/bonus expenses, and professional fees[32](index=32&type=chunk) [7. Warrant Liability](index=15&type=section&id=7.%20Warrant%20Liability) This note details the fair value changes of the company's warrant liability, resulting in non-cash income - The fair value of the total warrant liability decreased from **$0.9 million** at December 31, 2023, to **$0.3 million** at September 30, 2024[34](index=34&type=chunk) - The net change in fair value of warrant liability resulted in non-cash income of **$0.5 million** for the three months and **$2.2 million** for the nine months ended September 30, 2024[34](index=34&type=chunk) [8. Fair Value Measurements](index=15&type=section&id=8.%20Fair%20Value%20Measurements) This note describes the valuation methodology and key assumptions used for measuring the fair value of warrant liabilities Warrant Liability Fair Value (in thousands) | Metric | September 30, 2024 | December 31, 2023 | | :----- | :----------------- | :---------------- | | Level 3 Warrant Liability | $302 | $863 | Changes in Level 3 Warrant Liability (in thousands) for Nine Months Ended Sep 30, 2024 | Activity | Amount | | :------- | :----- | | Balance at Dec 31, 2023 | $863 | | Issuance | $1,655 | | Change in fair value | ($2,216) | | Balance at Sep 30, 2024 | $302 | - The company uses the Black-Scholes valuation model for warrants, with key assumptions as of September 30, 2024: risk-free interest rate of **3.58%**, expected volatility of **109%**, and expected term of **4.4 years**[39](index=39&type=chunk) [9. Stockholders' Equity](index=16&type=section&id=9.%20Stockholders%27%20Equity) This note details the changes in stockholders' equity, including common stock issuances and the impact of net losses - Total Stockholders' (Deficit) Equity was **($0.7) million** as of September 30, 2024, a decrease from **$0.4 million** as of December 31, 2023[47](index=47&type=chunk) - The company issued common stock and warrants through several offerings in 2023 and 2024, including the 2023 Public Offering (**$1.7 million** net proceeds), March 2024 Registered Direct Offering (**$0.2 million** net proceeds), At The Market Offering (**$1.8 million** and **$1.0 million** net proceeds from two tranches), April 2024 Registered Direct Offering (**$0.9 million** net proceeds), and June 2024 PIPE (**$3.3 million** net proceeds)[40](index=40&type=chunk)[42](index=42&type=chunk)[43](index=43&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk)[46](index=46&type=chunk) - As of September 30, 2024, there were **3,710,190 shares** of common stock issued and outstanding[47](index=47&type=chunk) [10. Stock-Based Compensation Plan](index=19&type=section&id=10.%20Stock-Based%20Compensation%20Plan) This note outlines the stock-based compensation expenses and activity related to stock options Stock-Based Compensation Expense (in thousands) | Period | R&D Expense | G&A Expense | Total Expense | | :----- | :---------- | :---------- | :------------ | | 3 Months Ended Sep 30, 2024 | $34 | $94 | $128 | | 3 Months Ended Sep 30, 2023 | $45 | $133 | $178 | | 9 Months Ended Sep 30, 2024 | $114 | $325 | $439 | | 9 Months Ended Sep 30, 2023 | $137 | $417 | $554 | Stock Option Activity (in thousands) | Activity | Options | Weighted-Average Exercise Price | | :------- | :------ | :------------------------------ | | Outstanding at Dec 31, 2023 | 43 | $161.20 | | Granted | 53 | $1.55 | | Outstanding at Sep 30, 2024 | 96 | $71.40 | | Exercisable at Sep 30, 2024 | 34 | $184.17 | - As of September 30, 2024, unamortized stock-based compensation expense was **$0.5 million**, expected to be recognized over a weighted average vesting period of **1.6 years**[53](index=53&type=chunk) [11. Commitments and Contingencies](index=22&type=section&id=11.%20Commitments%20and%20Contingencies) This note details the company's contractual obligations, primarily related to drug supplier project plans - Total commitments for the drug supplier project plan were **$0.8 million** as of September 30, 2024, with **$0.7 million** expected to be incurred over the next 12 months[54](index=54&type=chunk) - Commitments include **$0.5 million** for prexigebersen and BP1001-A drug products, **$0.2 million** for Grb2 drug substance, and **$0.1 million** for testing services[54](index=54&type=chunk) [12. Subsequent Events](index=22&type=section&id=12.%20Subsequent%20Events) This note describes significant events occurring after the reporting period, including a private placement and lease amendment - On October 8, 2024, the company closed a private placement for approximately **$4.0 million** in gross proceeds (**$3.4 million** net), involving pre-funded warrants and Series A/B warrants, and canceled prior warrants from the June 2024 PIPE[55](index=55&type=chunk) - In October 2024, the company amended its administrative office lease agreement to extend the term for one year, from November 1, 2024, to October 31, 2025[56](index=56&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of the company's clinical-stage oncology drug development, detailing progress on its DNAbilize® platform and drug candidates. It also analyzes financial performance, including revenue, operating expenses, net loss, and liquidity, highlighting the need for additional capital [Overview](index=23&type=section&id=Overview) This section introduces the company's drug development focus, proprietary technology, and progress on its lead drug candidates - Bio-Path is an oncology-focused RNAi nanoparticle drug development company utilizing its proprietary DNAbilize® technology for systemic delivery of antisense drugs to treat blood diseases and solid tumors[59](index=59&type=chunk) - Prexigebersen (BP1001), the lead drug candidate targeting Grb2, is in an amended Phase 2 clinical trial for AML, now including a triple combination treatment with decitabine and venetoclax. Interim data showed **86% CR/CRi** in newly diagnosed AML patients and **57% CR/CRi** in relapsed/refractory AML patients, significantly higher than published rates for two-drug combinations[60](index=60&type=chunk)[61](index=61&type=chunk)[65](index=65&type=chunk) - BP1002 (Liposomal Bcl-2) is in Phase 1 clinical trials for refractory/relapsed lymphoma/CLL and AML (including venetoclax-resistant patients). The first two dose cohorts for AML were successfully completed, and enrollment for the third cohort is complete, with plans to advance to a higher dose in Q4 2024[68](index=68&type=chunk)[69](index=69&type=chunk) - BP1003 (Liposomal STAT3) is in IND-enabling studies for pancreatic cancer, NSCLC, and AML, showing broad antitumor effects in preclinical models. The company aims to file an IND application and initiate a Phase 1 study after completing one additional IND-enabling study[70](index=70&type=chunk) - BP1001-A, a modified prexigebersen formulation, is in a Phase 1/1b clinical trial for advanced or recurrent solid tumors. The first dose cohort was completed, and enrollment for the second dose cohort is open, with plans to explore its potential for obesity and related metabolic diseases[71](index=71&type=chunk)[72](index=72&type=chunk)[73](index=73&type=chunk) [Company History and Available Information](index=31&type=section&id=Company%20History%20and%20Available%20Information) This section provides historical context, including a recent reverse stock split, and information on company filings - The company completed a **1-for-20 reverse stock split** on February 22, 2024, with common stock trading on a split-adjusted basis on Nasdaq from February 23, 2024[79](index=79&type=chunk) [Recent Accounting Pronouncements](index=31&type=section&id=Recent%20Accounting%20Pronouncements) This section confirms that no recent accounting pronouncements have a material impact on the company's financial statements - There are no recent accounting pronouncements that have a material impact on the company's condensed consolidated financial statements[80](index=80&type=chunk) [Financial Operations Overview](index=31&type=section&id=Financial%20Operations%20Overview) This section outlines the company's revenue expectations, and the nature of its research and development and general and administrative expenses - The company has not generated significant revenues to date and expects revenue generation to be heavily dependent on successful development and commercialization of drug candidates, which is not anticipated for many years[81](index=81&type=chunk) - Research and development expenses are expected to be substantial and increase over time, driven by clinical trials, manufacturing, and regulatory approvals, with significant uncertainties regarding timing and costs[86](index=86&type=chunk) - General and administrative expenses primarily consist of salaries, benefits, professional fees (legal, accounting), travel, and facility-related costs[88](index=88&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) The company reported no revenue for both periods. Research and development expenses decreased significantly, while general and administrative expenses increased. Net loss decreased for both the three and nine-month periods, partly due to non-cash income from warrant liability fair value changes [Comparisons of the Three Months Ended September 30, 2024 to the Three Months Ended September 30, 2023](index=33&type=section&id=Comparisons%20of%20the%20Three%20Months%20Ended%20September%2030%2C%202024%20to%20the%20Three%20Months%20Ended%20September%2030%2C%202023) This section compares the company's financial performance for the three-month periods, highlighting changes in expenses and net loss - Revenue: **$0** for both periods[89](index=89&type=chunk) Research and Development Expense (in thousands) | Category | Sep 30, 2024 | Sep 30, 2023 | Change | % Change | | :------- | :----------- | :----------- | :----- | :------- | | R&D Expense | $1,283 | $2,247 | -$964 | -42.9% | | Non-cash Stock-based Comp. | $34 | $45 | -$11 | -24.4% | | Total R&D Expense | $1,317 | $2,292 | -$975 | -42.5% | General and Administrative Expense (in thousands) | Category | Sep 30, 2024 | Sep 30, 2023 | Change | % Change | | :------- | :----------- | :----------- | :----- | :------- | | G&A Expense | $1,223 | $851 | $372 | 43.7% | | Non-cash Stock-based Comp. | $94 | $133 | -$39 | -29.3% | | Total G&A Expense | $1,317 | $984 | $333 | 33.8% | - Net Operating Loss: Decreased by **$0.6 million** to **$2.6 million** (Sep 30, 2024) from **$3.2 million** (Sep 30, 2023)[92](index=92&type=chunk) - Change in Fair Value of Warrant Liability: Non-cash income of **$0.5 million** (Sep 30, 2024)[93](index=93&type=chunk) - Net Loss: Decreased by **$1.1 million** to **$2.1 million** (Sep 30, 2024) from **$3.2 million** (Sep 30, 2023)[93](index=93&type=chunk) - Net Loss per Share: Decreased to **$0.70** (Sep 30, 2024) from **$6.36** (Sep 30, 2023)[94](index=94&type=chunk) [Comparisons of the Nine Months Ended September 30, 2024 to the Nine Months Ended September 30, 2023](index=34&type=section&id=Comparisons%20of%20the%20Nine%20Months%20Ended%20September%2030%2C%202024%20to%20the%20Nine%20Months%20Ended%20September%2030%2C%202023) This section compares the company's financial performance for the nine-month periods, detailing changes in expenses and net loss - Revenue: **$0** for both periods[96](index=96&type=chunk) Research and Development Expense (in thousands) | Category | Sep 30, 2024 | Sep 30, 2023 | Change | % Change | | :------- | :----------- | :----------- | :----- | :------- | | R&D Expense | $5,364 | $9,195 | -$3,831 | -41.7% | | Non-cash Stock-based Comp. | $114 | $137 | -$23 | -16.8% | | Total R&D Expense | $5,478 | $9,332 | -$3,854 | -41.3% | General and Administrative Expense (in thousands) | Category | Sep 30, 2024 | Sep 30, 2023 | Change | % Change | | :------- | :----------- | :----------- | :----- | :------- | | G&A Expense | $3,564 | $3,061 | $503 | 16.4% | | Non-cash Stock-based Comp. | $325 | $417 | -$92 | -22.1% | | Total G&A Expense | $3,889 | $3,478 | $411 | 11.8% | - Net Operating Loss: Decreased by **$3.4 million** to **$9.4 million** (Sep 30, 2024) from **$12.8 million** (Sep 30, 2023)[99](index=99&type=chunk) - Change in Fair Value of Warrant Liability: Non-cash income of **$2.2 million** (Sep 30, 2024)[100](index=100&type=chunk) - Net Loss: Decreased by **$5.6 million** to **$7.1 million** (Sep 30, 2024) from **$12.7 million** (Sep 30, 2023)[100](index=100&type=chunk) - Net Loss per Share: Decreased to **$4.05** (Sep 30, 2024) from **$29.34** (Sep 30, 2023)[101](index=101&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its short-term obligations and fund operations, highlighting its reliance on external financing - The company's cash balance was **$0.6 million** as of September 30, 2024, a decrease of **$0.5 million** from December 31, 2023[103](index=103&type=chunk) - The company does not believe its current cash, even with recent private placement proceeds, will be sufficient to meet obligations for the next 12 months, indicating substantial doubt about its ability to continue as a going concern[103](index=103&type=chunk) - Net cash provided by financing activities for the nine months ended September 30, 2024, was **$7.2 million**, significantly higher than **$1.7 million** in the prior year, primarily from various common stock and warrant offerings[105](index=105&type=chunk) - Financing activities in 2024 included the March 2024 Registered Direct Offering (**$0.2 million** net), At The Market Offering (**$1.8 million** and **$1.0 million** net), April 2024 Registered Direct Offering (**$0.9 million** net), June 2024 PIPE (**$3.3 million** net), and October 2024 Private Placement (**$3.4 million** net)[108](index=108&type=chunk)[109](index=109&type=chunk)[110](index=110&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk)[114](index=114&type=chunk) [Future Capital Requirements](index=40&type=section&id=Future%20Capital%20Requirements) This section discusses the company's anticipated need for additional capital to fund ongoing operations and drug development - The company expects to continue incurring significant operating expenses for clinical trials, manufacturing, and regulatory approval, requiring substantial additional capital[115](index=115&type=chunk) - There is no assurance that additional capital will be available when needed or on favorable terms, and the company currently has no lines of credit or other arranged debt financing[115](index=115&type=chunk) [Off-Balance Sheet Arrangements](index=40&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the absence of any material off-balance sheet arrangements as of the reporting date - As of September 30, 2024, the company did not have any material off-balance sheet arrangements[116](index=116&type=chunk) [Critical Accounting Policies](index=40&type=section&id=Critical%20Accounting%20Policies) This section states that there have been no significant changes to the company's critical accounting policies - There have been no significant changes to the company's critical accounting policies from those disclosed in its Annual Report on Form 10-K for the year ended December 31, 2023[116](index=116&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that there are no quantitative and qualitative disclosures about market risk applicable to the company - This item is not applicable to the company[117](index=117&type=chunk) [Item 4. Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details management's evaluation of the company's disclosure controls and procedures, concluding their effectiveness, and confirms no material changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=40&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section confirms management's assessment of the effectiveness of the company's disclosure controls and procedures - Management, including the CEO/CFO, evaluated the effectiveness of disclosure controls and procedures as of September 30, 2024[119](index=119&type=chunk) - It was determined that the disclosure controls and procedures were effective to ensure information required by the Exchange Act is recorded, processed, summarized, and reported timely[120](index=120&type=chunk) [Changes in Internal Control over Financial Reporting](index=42&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section confirms no material changes in internal control over financial reporting during the reporting period - There were no changes in internal control over financial reporting during the period that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[121](index=121&type=chunk) [PART II - OTHER INFORMATION](index=43&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section provides additional information not covered in the financial statements, including legal, risk, and equity matters [Item 1. Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) This section states that there are no legal proceedings to report - None[123](index=123&type=chunk) [Item 1A. Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) This section highlights the significant risk of potential delisting from The Nasdaq Capital Market due to non-compliance with the minimum stockholders' equity requirement, and the ongoing appeal process - The company received a delisting determination letter from Nasdaq on September 12, 2024, for not meeting the Stockholders' Equity Requirement[125](index=125&type=chunk) - A hearing request was submitted to the Nasdaq Hearings Panel on September 19, 2024, staying the suspension of securities pending the Panel's decision, with the hearing scheduled for November 5, 2024[125](index=125&type=chunk) - Delisting could negatively impact stock price, liquidity, access to capital markets, and lead to loss of confidence from stakeholders[126](index=126&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=43&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section indicates that there were no unregistered sales of equity securities or use of proceeds to report - None[127](index=127&type=chunk) [Item 3. Defaults Upon Senior Securities](index=43&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there were no defaults upon senior securities to report - None[127](index=127&type=chunk) [Item 4. Mine Safety Disclosures](index=43&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that there are no mine safety disclosures applicable to the company - None[127](index=127&type=chunk) [Item 5. Other Information](index=44&type=section&id=Item%205.%20Other%20Information) This section confirms that no directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the last fiscal quarter - None of the company's directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the last fiscal quarter[129](index=129&type=chunk) [Item 6. Exhibits](index=44&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Quarterly Report on Form 10-Q, including agreements, certificates, and certifications - The report includes various exhibits such as merger agreements, certificates of incorporation, bylaws, forms of warrants, securities purchase agreements, registration rights agreements, and certifications[130](index=130&type=chunk) [Signature](index=46&type=section&id=Signature) This section provides the official signature and title of the company's authorized officer for the report - The report was signed on November 14, 2024, by Peter H. Nielsen, President, Chief Executive Officer, and Chief Financial Officer of Bio-Path Holdings, Inc.[131](index=131&type=chunk)

HOUSTON, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ: BPTH) a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced that it will host a live conference call and audio webcast on Friday, November 15, 2024 at 8:30 a.m. ET to report financial results for the third quarter ended September 30, 2024 and to provide a business overview. To access the live conference call, ...

. Stonegate Capital Partners Updates Coverage on Bio-Path Holdings, Inc. (BPTH) Q2 24 September 04, 2024 5:48 PM EDT | Source: Reportable, Inc. Dallas, Texas--(Newsfile Corp. - September 4, 2024) - Bio-Path Holdings, Inc. (NASDAQ: BPTH): Stonegate Capital Partners Updates Coverage on Bio-Path Holdings, Inc. (NASDAQ: BPTH) for Q2 2024. To view the full announcement, including downloadable images, bios, and more, click here. Click image above to view full announcement. About Stonegate Stonegate Capital Partne ...

Bio-Path Holdings, Inc. (NASDAQ:BPTH) Q2 2024 Earnings Conference Call August 15, 2024 8:30 AM ET Company Participants Will O'Connor - IR, Stern Investor Relations Peter Nielsen - CEO and CFO Anthony Price - SVP of Finance, Accounting and Administration Operator Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings Second Quarter 2024 Earnings Conference Call. At this time all participants are in a listen-only mode. [Operator Instructions] At this time, I'd like to turn the floor over to Will ...

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): August 15, 2 ...

HOUSTON, Aug. 15, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced its financial results for the second quarter ended June 30, 2024 and provided an update on recent corporate developments. "The first half of 2024 was marked by considerable corporate and clinical progress across the organization. We were encouraged b ...

Table of Contents Delaware 87-0652870 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 4710 Bellaire Boulevard, Suite 210, Bellaire, Texas 77401 (Address of principal executive offices) (Zip Code) 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, 2024 Or ☐ TRANSITION REPORT PURSUANT TO S ...

HOUSTON, July 08, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today provides an update on the Company's clinical progress and plans for expansion. Clinical Program Overview Bio-Path's clinical development program consists of one Phase 2 clinical trial and three Phase 1 or 1/1b clinical trials. Bio-Path has developed a mol ...