[PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section provides the unaudited condensed consolidated financial statements and management's discussion and analysis of Bio-Path Holdings, Inc's financial condition and results of operations [Item 1. Financial Statements](index=5&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 accounting policies, financial positions, and significant events for Bio-Path Holdings, Inc. for the periods ended June 30, 2025 and 2024 [Condensed Consolidated Balance Sheets (Unaudited and not reviewed)](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(Unaudited%20and%20not%20reviewed)) The balance sheets show a significant decrease in total assets and a shift to a shareholders' deficit by June 30, 2025, primarily due to a reduction in cash and an increase in current liabilities compared to December 31, 2024 Condensed Consolidated Balance Sheets (Unaudited) | Metric | As of June 30, 2025 (Unaudited) | As of December 31, 2024 | | :----------------------------- | :------------------------------ | :---------------------- | | Cash | $0 | $1,173 | | Total Assets | $746 | $3,883 | | Total Current Liabilities | $7,864 | $3,295 | | Total Shareholders' (Deficit) Equity | $(7,158) | $154 | [Condensed Consolidated Statements of Operations (Unaudited and not reviewed)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20(Unaudited%20and%20not%20reviewed)) The company reported increased net operating losses and net losses for both the three and six months ended June 30, 2025, compared to the same periods in 2024, primarily due to higher research and development expenses and a reduced gain from warrant liability fair value changes Condensed Consolidated Statements of Operations (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | | Research and development | $4,048 | $1,873 | | General and administrative | $514 | $1,165 | | Net operating loss | $(4,562) | $(3,038) | | Net loss | $(4,597) | $(1,869) | | Net loss per share, basic and diluted | $(0.55) | $(1.16) | Condensed Consolidated Statements of Operations (in thousands) | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :----------------------------- | :----------------------------- | | Research and development | $6,025 | $4,161 | | General and administrative | $1,778 | $2,572 | | Net operating loss | $(7,803) | $(6,733) | | Net loss | $(7,449) | $(5,026) | | Net loss per share, basic and diluted | $(0.97) | $(4.45) | [Condensed Consolidated Statements of Cash Flows (Unaudited and not reviewed)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited%20and%20not%20reviewed)) Cash used in operating activities decreased for the six months ended June 30, 2025, compared to 2024, while cash provided by financing activities significantly declined, leading to a net decrease in cash to zero by June 30, 2025 Condensed Consolidated Statements of Cash Flows (in thousands) | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(1,596) | $(4,266) | | Net cash provided by financing activities | $423 | $7,220 | | Net increase (decrease) in cash | $(1,173) | $2,954 | | Cash, end of period | $0 | $4,006 | [Condensed Consolidated Statements of Shareholders' (Deficit) Equity (Unaudited and not reviewed)](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders'%20(Deficit)%20Equity%20(Unaudited%20and%20not%20reviewed)) The company's shareholders' equity shifted from a positive balance to a significant deficit by June 30, 2025, primarily due to accumulated net losses, despite some capital increases from warrant exercises and stock-based compensation Condensed Consolidated Statements of Shareholders' (Deficit) Equity (in thousands) | Metric (in thousands) | As of June 30, 2025 | As of June 30, 2024 | | :-------------------------------- | :------------------ | :------------------ | | Common Stock (Shares) | 8,308 | 2,283 | | Common Stock (Amount) | $8 | $2 | | Additional Paid in Capital | $117,784 | $113,922 | | Accumulated Deficit | $(124,950) | $(112,633) | | Total Shareholders' (Deficit) Equity | $(7,158) | $1,291 | [Notes to the Unaudited and not Reviewed Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20the%20Unaudited%20and%20not%20Reviewed%20Condensed%20Consolidated%20Financial%20Statements) These notes provide essential context and detail for the condensed consolidated financial statements, covering the company's business, significant accounting policies, specific balance sheet and income statement items, equity changes, and subsequent events [Explanatory Note](index=11&type=section&id=Explanatory%20Note) The Quarterly Report on Form 10-Q for the period ended June 30, 2025, has not been reviewed by an independent registered public accounting firm and is considered deficient - The Quarterly Report on Form 10-Q for the period ended June 30, 2025, has not been reviewed by an independent registered public accounting firm and is considered **deficient**[19](index=19&type=chunk) - The Company plans to actively work with an independent registered public accounting firm to remedy the deficiency and will file an amendment to this Form 10-Q once the review is completed[20](index=20&type=chunk) [1. Organization and Business](index=11&type=section&id=1.%20Organization%20and%20Business) Bio-Path Holdings, Inc. is a clinical and preclinical stage oncology and obesity-focused RNAi nanoparticle drug development company, utilizing its proprietary DNAbilize® technology - The Company is a clinical and preclinical stage oncology and obesity-focused RNAi nanoparticle drug development company utilizing a novel technology called **DNAbilize®**[21](index=21&type=chunk) - The DNAbilize® platform allows for systemic delivery of antisense drug substances to reduce or eliminate target proteins in blood diseases and solid tumors, demonstrating an **excellent safety profile** in animal studies and clinical trials[21](index=21&type=chunk) - The Company currently has **four antisense drug candidates** in development to treat at least five different cancer disease indications and one indication in obesity[21](index=21&type=chunk) - Operations are subject to **significant risks and uncertainties**, including the potential requirement to secure additional funding, the outcome of clinical trials, and competition[23](index=23&type=chunk)[24](index=24&type=chunk) [2. Significant Accounting Policies](index=13&type=section&id=2.%20Significant%20Accounting%20Policies) Key accounting policies include basic net loss per share calculation, going concern uncertainty due to insufficient cash, single operating segment reporting, and warrant liability classification at fair value - Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding; **diluted net loss per share equals basic** due to antidilutive warrants and stock options[25](index=25&type=chunk) - **Substantial doubt exists** about the Company's ability to continue as a going concern due to **$0.0 million cash** at June 30, 2025, which is insufficient to fund liquidity and capital expenditure requirements for the next 12 months[26](index=26&type=chunk) - The Company views its operations as a **single operating segment**, a research and development drug development company[27](index=27&type=chunk) - Warrants are classified as a **liability and recorded at fair value** using Level 3 inputs, with changes in fair value recognized in the Condensed Consolidated Statement of Operations[28](index=28&type=chunk) [3. Prepaid Drug Product](index=13&type=section&id=3.%20Prepaid%20Drug%20Product) Prepaid drug product expenses decreased from $1.1 million at December 31, 2024, to $0.5 million at June 30, 2025, reflecting the recognition of these advance payments as expenses for clinical development activities Prepaid Drug Product | Metric | As of June 30, 2025 | As of December 31, 2024 | | :------------------ | :------------------ | :---------------------- | | Prepaid drug product | $474k | $1,074k | - Advance payments for contract drug manufacturing and raw material suppliers for prexigebersen for a Phase 2 clinical trial totaled **$1.1 million** as of December 31, 2024[30](index=30&type=chunk) - Advanced payments remaining to be expensed totaled **$0.5 million** as of June 30, 2025[31](index=31&type=chunk) [4. Other Current Assets](index=15&type=section&id=4.%20Other%20Current%20Assets) Other current assets significantly decreased from $1.5 million at December 31, 2024, to $0.2 million at June 30, 2025, primarily due to the expensing of prepayments for clinical trials for BP1001-A and BP1002 Other Current Assets | Metric | As of June 30, 2025 | As of December 31, 2024 | | :---------------- | :------------------ | :---------------------- | | Other current assets | $206k | $1,529k | - As of December 31, 2024, other current assets included **$1.2 million** in prepayments for clinical trials for BP1001-A and BP1002, and **$0.3 million** for prepaid insurance[32](index=32&type=chunk) [5. Accounts Payable](index=15&type=section&id=5.%20Accounts%20Payable) Accounts payable increased substantially from $1.3 million at December 31, 2024, to $3.5 million at June 30, 2025, mainly driven by higher clinical trial expenses, legal and patent fees, and drug manufacturing development costs Accounts Payable | Metric | As of June 30, 2025 | As of December 31, 2024 | | :--------------- | :------------------ | :---------------------- | | Accounts payable | $3,479k | $1,274k | - As of June 30, 2025, accounts payable primarily included **$2.0 million** for clinical trial expenses, **$0.6 million** for legal and patent fees, and **$0.4 million** for drug manufacturing development and testing services[33](index=33&type=chunk) [6. Notes Payable](index=15&type=section&id=6.%20Notes%20Payable) The company incurred $0.4 million in notes payable by June 30, 2025, from March and April 2025 promissory notes, which include a 12% one-time interest charge and default provisions allowing for 150% repayment and conversion into common stock at a discounted price Notes Payable | Metric | As of June 30, 2025 | As of December 31, 2024 | | :----------- | :------------------ | :---------------------- | | Notes payable | $422k | $0 | - Current liabilities included **$0.4 million** in notes payable as of June 30, 2025, related to the March 2025 Promissory Notes and the April 2025 Promissory Note[34](index=34&type=chunk) - The promissory notes bear a **one-time interest charge of twelve percent** and include default provisions for immediate repayment at **150% of outstanding principal** plus interest, **22% default interest**, and a conversion right into common stock at **65% of the lowest closing bid price**[35](index=35&type=chunk)[36](index=36&type=chunk)[37](index=37&type=chunk)[38](index=38&type=chunk)[40](index=40&type=chunk) [7. Accrued Expense](index=17&type=section&id=7.%20Accrued%20Expense) Accrued expenses significantly increased from $1.9 million at December 31, 2024, to $3.9 million at June 30, 2025, primarily due to higher accrued clinical trial expenses Accrued Expenses | Metric | As of June 30, 2025 | As of December 31, 2024 | | :------------- | :------------------ | :---------------------- | | Accrued expenses | $3,906k | $1,938k | - As of June 30, 2025, accrued expenses primarily included **$3.5 million** for clinical trial expenses[41](index=41&type=chunk) [8. Warrant Liability](index=17&type=section&id=8.%20Warrant%20Liability) The fair value of warrant liability decreased from $0.4 million at December 31, 2024, to $40,000 at June 30, 2025, resulting in a non-cash income of $0.4 million, due to the revaluation of warrants classified as liabilities Warrant Liability | Metric | As of June 30, 2025 | As of December 31, 2024 | | :-------------- | :------------------ | :---------------------- | | Warrant liability | $40k | $434k | - The net change in fair value of warrant liability resulted in **$0.4 million of other income** on the Condensed Consolidated Statements of Operations[43](index=43&type=chunk) - Warrants are classified as a liability and recorded at fair value using the Black-Scholes valuation model due to a **fundamental transaction provision**[42](index=42&type=chunk)[43](index=43&type=chunk) [9. Fair Value Measurements](index=17&type=section&id=9.%20Fair%20Value%20Measurements) The company measures warrant liabilities at fair value using Level 3 unobservable inputs, with the fair value decreasing from $434,000 at December 31, 2024, to $40,000 at June 30, 2025, based on the Black-Scholes valuation model Warrant Liability (in thousands) | Metric (in thousands) | As of June 30, 2025 | As of December 31, 2024 | | :-------------------- | :------------------ | :---------------------- | | Warrant liability (Level 3) | $40 | $434 | - The fair value of warrants is estimated using the **Black-Scholes valuation model** with assumptions including a **risk-free interest rate of 3.92%**, expected volatility of **129%**, and an expected term of **3.9 years** as of June 30, 2025[45](index=45&type=chunk) [10. Stockholders' Equity](index=19&type=section&id=10.%20Stockholders'%20Equity) Stockholders' equity decreased to a deficit of $(7.2) million by June 30, 2025, from $0.2 million at December 31, 2024, despite some capital increases from pre-funded warrant exercises Stockholders' (Deficit) Equity | Metric | As of June 30, 2025 | As of December 31, 2024 | | :-------------------------------- | :------------------ | :---------------------- | | Stockholders' (Deficit) Equity | $(7.2) million | $0.2 million | | Common Stock Issued and Outstanding | 8,307,892 shares | 5,768,000 shares | - During the six months ended June 30, 2025, the Company issued **2.54 million shares of common stock** from the exercise of pre-funded warrants at a weighted average exercise price of approximately **$0.001 per share**[55](index=55&type=chunk) [11. Stock-Based Compensation Plan](index=23&type=section&id=11.%20Stock-Based%20Compensation%20Plan) Stock-based compensation expense decreased for both the three and six months ended June 30, 2025, compared to 2024, with no options granted in either period and $0.1 million unamortized expense remaining Stock-Based Compensation Expense (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | | Stock-based compensation expense | $28 | $100 | | G&A portion | $15 | $101 | | R&D portion | $13 | $40 | Stock-Based Compensation Expense (in thousands) | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :----------------------------- | :----------------------------- | | Stock-based compensation expense | $100 | $300 | | G&A portion | $100 | $200 | | R&D portion | $45 | $100 | - No stock options were granted in the six months ended June 30, 2025, or 2024[61](index=61&type=chunk) - As of June 30, 2025, unamortized stock-based compensation expense for all outstanding options was **$0.1 million**, expected to be recognized over a weighted average vesting period of **1.7 years**[62](index=62&type=chunk) [12. Commitments and Contingencies](index=23&type=section&id=12.%20Commitments%20and%20Contingencies) Total commitments for the company's drug supplier project plan were $0.1 million as of June 30, 2025, primarily for testing services, with the full amount expected to be incurred within the next 12 months - Total commitments for the drug supplier project plan were **$0.1 million** as of June 30, 2025, primarily for testing services[63](index=63&type=chunk) - The Company expects to incur **$0.1 million** of these commitments over the next 12 months[63](index=63&type=chunk) [13. Subsequent Events](index=25&type=section&id=13.%20Subsequent%20Events) On August 13, 2025, the Board of Directors approved the dismissal of Ernst & Young LLP as the company's independent registered public accounting firm, and the company is actively seeking a new firm - On August 13, 2025, the Board of Directors approved the dismissal of **Ernst & Young LLP (EY)** as the Company's independent registered public accounting firm[64](index=64&type=chunk) - EY's reports for 2023 and 2024 included an explanatory paragraph regarding the Company's ability to continue as a **going concern**[65](index=65&type=chunk) - The Company is actively seeking a new independent registered public accounting firm[66](index=66&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section discusses Bio-Path Holdings, Inc.'s business, drug development programs, financial performance, and liquidity, emphasizing its oncology and obesity drug candidates, clinical trial updates, and financial challenges [Overview](index=26&type=section&id=Overview) Bio-Path is a clinical and preclinical stage oncology and obesity-focused RNAi nanoparticle drug development company using its DNAbilize® technology, with four drug candidates and recent operational pause to conserve capital - Bio-Path Holdings, Inc. is a clinical and preclinical stage oncology and obesity-focused RNAi nanoparticle drug development company utilizing its **DNAbilize® technology**[69](index=69&type=chunk) - The company has **four drug candidates** (BP1001/prexigebersen, BP1002, BP1003, BP1001-A) in development for at least five different cancer indications and one obesity indication[70](index=70&type=chunk) - The Phase 2 clinical trial for prexigebersen in AML was amended to include a **triple combination therapy** with decitabine and venetoclax, showing promising interim data with **75% CR/CRh/CRi** in newly diagnosed patients and **55%** in relapsed/refractory patients[70](index=70&type=chunk)[71](index=71&type=chunk)[72](index=72&type=chunk)[76](index=76&type=chunk) - The Phase 1 clinical trial for BP1002 in refractory/relapsed lymphoma and CLL was **discontinued** due to enrollment challenges, with increased focus on the obesity development program[77](index=77&type=chunk) - Preclinical studies for BP1001-A demonstrated its potential as a treatment for obesity by attenuating fatty acid-induced insulin resistance and **restoring insulin sensitivity**[83](index=83&type=chunk)[84](index=84&type=chunk) - On June 24, 2025, the Company instituted a **company-wide operational pause** and furloughed most employees to conserve capital while seeking financing[88](index=88&type=chunk) [Company History and Available Information](index=32&type=section&id=Company%20History%20and%20Available%20Information) Bio-Path Holdings, Inc. was incorporated in 2000, underwent a reverse merger in 2008, changed its state of incorporation to Delaware in 2014, and was delisted from Nasdaq in February 2025 - The Company was incorporated in May 2000 as a Utah corporation, completed a reverse merger in February 2008, and changed its state of incorporation to Delaware effective December 31, 2014[91](index=91&type=chunk) - On February 19, 2025, trading of the Company's common stock was **suspended on The Nasdaq Capital Market** and commenced on the OTCQB Venture Market under the ticker symbol 'BPTH'[93](index=93&type=chunk) - A **1-for-20 reverse stock split** of outstanding common stock was effected on February 22, 2024[92](index=92&type=chunk) [Recent Accounting Pronouncements](index=32&type=section&id=Recent%20Accounting%20Pronouncements) There are no recent accounting pronouncements that have a material impact on the company's condensed consolidated financial statements - There are no recent accounting pronouncements that have a material impact on the condensed consolidated financial statements[93](index=93&type=chunk) [Financial Operations Overview](index=34&type=section&id=Financial%20Operations%20Overview) This section outlines the company's revenue strategy, which currently lacks significant revenue and relies on future drug commercialization, and details the nature of research and development and general and administrative expenses [Revenue](index=34&type=section&id=Revenue) The company has not generated significant revenues to date and does not expect to for many years, if ever, as revenue generation is heavily dependent on successful drug development and commercialization - The Company has not generated significant revenues to date and does not expect to for many years, if ever[94](index=94&type=chunk) - Future revenue generation will depend heavily on the successful development and eventual commercialization of drug candidates, or from grants, service agreements, strategic alliances, and licensing arrangements[94](index=94&type=chunk)[95](index=95&type=chunk) [Research and development expenses](index=34&type=section&id=Research%20and%20development%20expenses) R&D expenses are charged as incurred, with advance payments capitalized, and are expected to be substantial and increase, with significant uncertainty regarding the timing and costs of drug candidate development - Research and development expenses are charged to expense as incurred, with advance payments for future activities deferred and capitalized[96](index=96&type=chunk) - R&D expenses are expected to be **substantial and increase over time**, with the successful development of drug candidates being highly uncertain[97](index=97&type=chunk) - Uncertainties include the rate of progress, results, and costs of clinical trials, regulatory approvals, competing developments, and performance of third-party manufacturers[97](index=97&type=chunk)[98](index=98&type=chunk)[100](index=100&type=chunk) [General and administrative expenses](index=36&type=section&id=General%20and%20administrative%20expenses) G&A expenses primarily cover management and administrative personnel salaries and benefits, professional fees (legal, accounting), travel, and facility costs - General and administrative expenses primarily consist of salaries and benefits for management and administrative personnel, professional fees (legal, accounting), travel costs, and facility-related costs[101](index=101&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) This section details the financial performance for the three and six months ended June 30, 2025, compared to the same periods in 2024, highlighting changes in operating expenses, net operating loss, and net loss per share [Comparisons of the Three Months Ended June 30, 2025 to the Three Months Ended June 30, 2024](index=36&type=section&id=Comparisons%20of%20the%20Three%20Months%20Ended%20June%2030,%202025%20to%20the%20Three%20Months%20Ended%20June%2030,%202024) For Q2 2025, the company reported no revenue, a significant increase in R&D expenses due to clinical trial pauses, a decrease in G&A expenses, and a higher net loss compared to Q2 2024 - No revenue was generated for the three months ended June 30, 2025 and 2024[102](index=102&type=chunk) Financial Performance (in thousands) | Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change | | :-------------------- | :--------------------------- | :--------------------------- | :----- | | Research and Development | $4,048 | $1,873 | +$2,175 | | General and Administrative | $514 | $1,165 | -$651 | | Net Operating Loss | $(4,562) | $(3,038) | -$(1,524) | | Net Loss | $(4,597) | $(1,869) | -$(2,728) | | Net Loss per Share | $(0.55) | $(1.16) | +$0.61 | - The increase in R&D expense was primarily due to expenses related to **pausing clinical trials** for BP1001 and BP1001-A, partially offset by decreased manufacturing expenses[103](index=103&type=chunk) - The decrease in G&A expense was primarily due to decreased salaries and benefits expense, as well as decreased professional and consulting fees[103](index=103&type=chunk) [Comparisons of the Six Months Ended June 30, 2025 to the Six Months Ended June 30, 2024](index=36&type=section&id=Comparisons%20of%20the%20Six%20Months%20Ended%20June%2030,%202025%20to%20the%20Six%20Months%20Ended%20June%2030,%202024) For H1 2025, the company reported no revenue, increased R&D expenses due to clinical trial pauses and manufacturing, decreased G&A expenses, and a higher net loss compared to H1 2024 - No revenue was generated for the six months ended June 30, 2025 and 2024[106](index=106&type=chunk) Financial Performance (in thousands) | Metric (in thousands) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change | | :-------------------- | :--------------------------- | :--------------------------- | :----- | | Research and Development | $6,025 | $4,161 | +$1,864 | | General and Administrative | $1,778 | $2,572 | -$794 | | Net Operating Loss | $(7,803) | $(6,733) | -$(1,070) | | Net Loss | $(7,449) | $(5,026) | -$(2,423) | | Net Loss per Share | $(0.97) | $(4.45) | +$3.48 | - The increase in R&D expense was primarily due to expenses related to **pausing clinical trials** for BP1001 and BP1001-A, as well as increased manufacturing expenses related to drug product releases in 2025[107](index=107&type=chunk) - The decrease in G&A expense was primarily due to decreased salaries and benefits expense, professional and consulting fees, and shareholder meeting expenses related to a special shareholder meeting in Q1 2024[107](index=107&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's financial position, highlighting its reliance on external financing due to a lack of significant revenue and the ongoing need for substantial additional capital, which raises substantial doubt about its ability to continue as a going concern [Overview](index=37&type=section&id=Overview) The company has not generated significant revenue and relies on equity/debt financings, with **$0 cash** at June 30, 2025, raising substantial doubt about its ability to continue as a going concern - The Company has not generated significant revenues and funds operations primarily through public and private offerings of capital stock and other securities[110](index=110&type=chunk) - As of June 30, 2025, the Company had a cash balance of **$0.0 million**, a decrease of **$1.2 million** compared to December 31, 2024[111](index=111&type=chunk) - **Substantial doubt exists** about the Company's ability to continue as a going concern for the next 12 months due to insufficient cash to meet obligations and fund capital expenditure requirements[111](index=111&type=chunk)[112](index=112&type=chunk) - The Company will continue to require substantial additional capital and may seek collaborations and license arrangements for drug candidates[110](index=110&type=chunk) [Cash Flows](index=38&type=section&id=Cash%20Flows) Net cash used in operating activities decreased in H1 2025 compared to H1 2024, while net cash provided by financing activities significantly declined, leading to a net decrease in cash to zero Cash Flow Activity (in thousands) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(1,596) | $(4,266) | | Net cash provided by financing activities | $423 | $7,220 | - Net cash used in operating activities for H1 2025 primarily consisted of a net loss of **$7.4 million**, offset by an increase in accounts payable and accrued expenses of **$4.1 million**, and decreases in other current assets and prepaid drug product[113](index=113&type=chunk) - Net cash provided by financing activities for H1 2025 was **$0.4 million** from warrant exercises and promissory notes, a significant decrease from **$7.2 million** in H1 2024 from various equity offerings[114](index=114&type=chunk) [2022 Shelf Registration Statement](index=38&type=section&id=2022%20Shelf%20Registration%20Statement) The company's 2022 Shelf Registration Statement, effective June 2022, allowed for the offering of up to $110.0 million in securities, but the company is no longer eligible to utilize this statement - The 2022 Shelf Registration Statement, effective June 14, 2022, registered the offering, issuance, and sale of up to **$110.0 million** of common stock, preferred stock, warrants, or combinations thereof[115](index=115&type=chunk) - As of the date of this report, the Company is **not eligible** to utilize the 2022 Shelf Registration Statement[115](index=115&type=chunk) [March 2024 Registered Direct Offering and March 2024 Private Placement](index=38&type=section&id=March%202024%20Registered%20Direct%20Offering%20and%20March%202024%20Private%20Placement) In March 2024, the company raised approximately $0.2 million net proceeds from a registered direct offering of common stock and a concurrent private placement of warrants - In March 2024, the Company sold **75,000 shares of common stock** in a registered direct offering and issued warrants to purchase up to **75,000 shares** in a concurrent private placement[116](index=116&type=chunk) - Net proceeds from these offerings were approximately **$0.2 million**[116](index=116&type=chunk) [At the Market Offering](index=40&type=section&id=At%20the%20Market%20Offering) In April 2024, the company sold 436,511 shares for $2.0 million gross proceeds under an ATM agreement, then increased the offering by $1.1 million, selling 334,929 shares for $1.1 million gross proceeds by June 30, 2025 - In April 2024, the Company sold **436,511 shares of common stock** for gross proceeds of approximately **$2.0 million** under an At The Market Offering Agreement, with net proceeds of approximately **$1.8 million**[117](index=117&type=chunk) - Subsequently, the Company increased the ATM offering by **$1.1 million**, selling **334,929 shares** for gross proceeds of approximately **$1.1 million** and net proceeds of approximately **$1.0 million** by June 30, 2025[118](index=118&type=chunk) [April 2024 Registered Direct Offering and April 2024 Private Placement](index=40&type=section&id=April%202024%20Registered%20Direct%20Offering%20and%20April%202024%20Private%20Placement) In April 2024, the company raised approximately $0.9 million net proceeds from a registered direct offering of common stock and a concurrent private placement of warrants - In April 2024, the Company sold **375,000 shares of common stock** in a registered direct offering and issued warrants to purchase up to **375,000 shares** in a concurrent private placement[119](index=119&type=chunk) - Net proceeds from these offerings were approximately **$0.9 million**[119](index=119&type=chunk) [June 2024 PIPE](index=40&type=section&id=June%202024%20PIPE) In June 2024, the company completed a private placement (PIPE) raising approximately $3.3 million net proceeds by selling common stock, pre-funded warrants, and Series A and B warrants - In June 2024, the Company completed a private placement (PIPE) for gross proceeds of approximately **$4.0 million**[120](index=120&type=chunk) - The PIPE involved the sale of common stock, pre-funded warrants, and Series A and B warrants[120](index=120&type=chunk) - Net proceeds from the June 2024 PIPE were approximately **$3.3 million**[120](index=120&type=chunk) [October 2024 Private Placement](index=40&type=section&id=October%202024%20Private%20Placement) In October 2024, the company raised approximately $3.5 million net proceeds from a private placement of pre-funded warrants and Series A and B warrants, which also involved the cancellation of previously issued warrants - In October 2024, the Company completed a private placement for gross proceeds of approximately **$4.0 million**[123](index=123&type=chunk) - The offering included pre-funded warrants, Series A warrants, and Series B warrants[121](index=121&type=chunk)[123](index=123&type=chunk) - Net proceeds from the October 2024 Private Placement were approximately **$3.5 million**[123](index=123&type=chunk) [Pre-Funded Warrant Exercises](index=42&type=section&id=Pre-Funded%20Warrant%20Exercises) In February 2025, investors exercised remaining pre-funded warrants, resulting in the issuance of 2.54 million common shares at a weighted average exercise price of approximately $0.001 per share - In February 2025, investors exercised remaining outstanding pre-funded warrants to purchase **2.54 million shares of common stock**[124](index=124&type=chunk) - The weighted average exercise price for these warrants was approximately **$0.001 per share**[124](index=124&type=chunk) [March 2025 Promissory Notes](index=42&type=section&id=March%202025%20Promissory%20Notes) In March 2025, the company entered into two promissory notes totaling $261,050 in principal, with a 12% one-time interest charge and default terms including a 150% repayment penalty and conversion rights - On March 6, 2025, the Company entered into a promissory note for **$161,000 principal amount**, and on March 28, 2025, another for **$100,050 principal amount**[125](index=125&type=chunk)[126](index=126&type=chunk) - Both March 2025 Promissory Notes bear a **one-time interest charge of twelve percent**[125](index=125&type=chunk)[126](index=126&type=chunk) - Upon an Event of Default, the notes become immediately due and payable at **150% of the outstanding principal** plus accrued interest, with a **22% default interest rate**, and include a conversion right into common stock at **65% of the lowest closing bid price**[127](index=127&type=chunk) [April 2025 Promissory Note](index=42&type=section&id=April%202025%20Promissory%20Note) In April 2025, the company entered into a promissory note for $161,000 principal, with a 12% one-time interest charge and default terms mirroring the March 2025 notes, including a 150% repayment penalty and conversion rights - On April 28, 2025, the Company entered into a promissory note for **$161,000 principal amount**[128](index=128&type=chunk) - The April 2025 Promissory Note bears a **one-time interest charge of twelve percent**[128](index=128&type=chunk) - Upon an Event of Default, the note becomes immediately due and payable at **150% of the outstanding principal** plus accrued interest, with a **22% default interest rate**, and includes a conversion right into common stock at **65% of the lowest closing bid price**[129](index=129&type=chunk) [Future Capital Requirements](index=44&type=section&id=Future%20Capital%20Requirements) The company expects to continue incurring significant operating expenses for drug development and will require substantial additional capital, which may not be available on favorable terms or at all - The Company expects to continue incurring significant operating expenses for drug development, including clinical trials, manufacturing, and regulatory approval[130](index=130&type=chunk) - **Substantial additional capital will be required** to fund projected operating requirements, and there is no assurance that such capital will be available when needed or on favorable terms[130](index=130&type=chunk) [Off-Balance Sheet Arrangements](index=44&type=section&id=Off-Balance%20Sheet%20Arrangements) As of June 30, 2025, the company did not have any material off-balance sheet arrangements - As of June 30, 2025, the Company did not have any material off-balance sheet arrangements[131](index=131&type=chunk) [Critical Accounting Policies](index=44&type=section&id=Critical%20Accounting%20Policies) 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, 2024 - There have been no significant changes to the Company's critical accounting policies from those disclosed in its Annual Report on Form 10-K as of the year ended December 31, 2024[132](index=132&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that quantitative and qualitative disclosures about market risk are not applicable to the company - This item is not applicable[133](index=133&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the management's evaluation of the company's disclosure controls and procedures, confirming their effectiveness as of June 30, 2025, and reporting no material changes in internal control over financial reporting during the period [Evaluation of Disclosure Controls and Procedures](index=44&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management, including the Interim CEO/CFO, evaluated the effectiveness of disclosure controls and procedures as of June 30, 2025, and determined them to be effective - Management, including the Interim Chief Executive Officer (who is also the Interim Chief Financial Officer), reviewed and evaluated the effectiveness of disclosure controls and procedures as of June 30, 2025[135](index=135&type=chunk) - It was determined that as of June 30, 2025, the disclosure controls and procedures were **effective**[135](index=135&type=chunk) [Changes in Internal Control over Financial Reporting](index=46&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) There were no changes in internal control over financial reporting during the period that materially affected or are reasonably likely to materially affect these controls - There were no changes in internal control over financial reporting that occurred during the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, internal control over financial reporting[136](index=136&type=chunk) [PART II - OTHER INFORMATION](index=47&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section provides additional information including legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits [Item 1. Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - The Company reported no legal proceedings[139](index=139&type=chunk) [Item 1A. Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) The company highlights that its operational pause and employee furloughs, implemented to conserve capital, may not achieve intended outcomes and could lead to negative consequences - The operational pause and furlough of most employees, implemented on June 24, 2025, to conserve capital, may not achieve intended outcomes[140](index=140&type=chunk) - Potential negative consequences include **loss of institutional knowledge and expertise**, attrition beyond intended numbers, decreased morale, and difficulty pursuing new opportunities or initiatives[140](index=140&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=47&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the period - The Company reported no unregistered sales of equity securities and use of proceeds[141](index=141&type=chunk) [Item 3. Defaults Upon Senior Securities](index=47&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - The Company reported no defaults upon senior securities[142](index=142&type=chunk) [Item 4. Mine Safety Disclosures](index=47&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reported no mine safety disclosures during the period - The Company reported no mine safety disclosures[143](index=143&type=chunk) [Item 5. Other Information](index=47&type=section&id=Item%205.%20Other%20Information) This section covers insider trading arrangements and the recent appointment of an Interim Chief Executive Officer and Interim Chief Financial Officer [Insider Adoption or Termination of Trading Arrangements](index=47&type=section&id=Insider%20Adoption%20or%20Termination%20of%20Trading%20Arrangements) 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[144](index=144&type=chunk) [Appointment of Interim Chief Executive Officer and Interim Chief Financial Officer](index=47&type=section&id=Appointment%20of%20Interim%20Chief%20Executive%20Officer%20and%20Interim%20Chief%20Financial%20Officer) On August 14, 2025, Douglas P. Morris was appointed Interim CEO and Interim CFO, a co-founder and director, and is currently the only officer of the company - On August 14, 2025, Douglas P. Morris was appointed as interim Chief Executive Officer and interim Chief Financial Officer[145](index=145&type=chunk) - Mr. Morris is a co-founder of Bio-Path, has served as a director since 2007, and previously served as an officer from 2007 to June 2014[145](index=145&type=chunk) - At this time, Mr. Morris is the only officer of the Company[145](index=145&type=chunk) [Item 6. Exhibits](index=49&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including various agreements, certificates, and certifications - The section lists various agreements, certificates, and certifications filed as exhibits to the Form 10-Q[147](index=147&type=chunk)

For more information, please visit the Company's website at http://www.biopathholdings.com. Forward-Looking Statements HOUSTON, June 09, 2025 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (OTC: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 announced Peter Nielsen, Chief Executive Officer, will present a corporate overview at the Life Sciences Virtual Investor Forum ...

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]

Highlights Promise of DNAbilize® Platform to Produce New Drug Candidates and Potential Licensing Opportunities HOUSTON, June 03, 2025 (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 and obesity drugs, today announced highlights from the recent clinical development and operational update conference call and webcast held May 26, 2025. An ar ...

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]