[Preliminary Information](index=1&type=section&id=Preliminary%20Information) [FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q%20Filing%20Information) This section details the filing as a Quarterly Report on Form 10-Q for Bio-Path Holdings, Inc., a non-accelerated and smaller reporting company, with 3,691,857 outstanding shares as of August 7, 2020 - This is a Quarterly Report on Form 10-Q for the period ended June 30, 2020[2](index=2&type=chunk) - Bio-Path Holdings, Inc. is a Delaware corporation with IRS Employer Identification No. 87-0652870[3](index=3&type=chunk) - The company is classified as a non-accelerated filer and a smaller reporting company[4](index=4&type=chunk) - As of August 7, 2020, there were **3,691,857 outstanding shares of common stock**[4](index=4&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=2&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section warns readers that the report contains forward-looking statements subject to inherent risks and uncertainties, which could cause actual results to differ materially - The report contains forward-looking statements based on current beliefs and expectations, subject to inherent risks and uncertainties[7](index=7&type=chunk) - Key risk factors include the impact of COVID-19, lack of significant revenue, need for substantial additional capital, and the highly competitive nature of the pharmaceutical industry[7](index=7&type=chunk) - Risks also encompass the success of clinical trials, regulatory approval, intellectual property protection, and market acceptance of drug candidates[7](index=7&type=chunk)[8](index=8&type=chunk) [Table of Contents](index=4&type=section&id=TABLE%20OF%20CONTENTS) This section provides an outline of the report's structure, dividing it into Part I (Financial Information) and Part II (Other Information) - The report is structured into two main parts: Part I - Financial Information and Part II - Other Information[13](index=13&type=chunk) - Part I includes Financial Statements, Management's Discussion and Analysis, Market Risk Disclosures, and Controls and Procedures[13](index=13&type=chunk) - Part II covers Legal Proceedings, Risk Factors, Sales of Equity Securities, Defaults, Mine Safety Disclosures, Other Information, and Exhibits[13](index=13&type=chunk) [PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [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 [Condensed Consolidated Balance Sheets (Unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(Unaudited)) **Condensed Consolidated Balance Sheets (in thousands):** | Metric | June 30, 2020 | December 31, 2019 | Change | | :----------------------------- | :------------ | :---------------- | :----- | | Cash | $14,411 | $20,426 | $(6,015) | | Total Current Assets | $16,924 | $21,990 | $(5,066) | | Total Assets | $17,520 | $22,660 | $(5,140) | | Total Current Liabilities | $1,225 | $1,244 | $(19) | | Total Liabilities | $1,509 | $1,574 | $(65) | | Total Shareholders' Equity | $16,011 | $21,086 | $(5,075) | [Condensed Consolidated Statements of Operations (Unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20(Unaudited)) **Condensed Consolidated Statements of Operations (in thousands):** **Three Months Ended June 30:** | Metric | 2020 | 2019 | Change | | :----------------------------- | :--- | :--- | :----- | | Research and development | $1,030 | $1,523 | $(493) | | General and administrative | $1,013 | $966 | $47 | | Total operating expenses | $2,043 | $2,489 | $(446) | | Net loss | $(2,040) | $(2,456) | $416 | | Net loss per share (basic & diluted) | $(0.55) | $(0.87) | $0.32 | **Six Months Ended June 30:** | Metric | 2020 | 2019 | Change | | :----------------------------- | :--- | :--- | :----- | | Research and development | $3,038 | $1,921 | $1,117 | | General and administrative | $2,349 | $2,088 | $261 | | Total operating expenses | $5,387 | $4,009 | $1,378 | | Net loss | $(5,364) | $(3,968) | $(1,396) | | Net loss per share (basic & diluted) | $(1.45) | $(1.75) | $0.30 | [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited)) **Condensed Consolidated Statements of Cash Flows (in thousands):** | Metric | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | Change | | :---------------------------------------- | :----------------------------- | :----------------------------- | :-------------------- | | Net cash used in operating activities | $(6,015) | $(4,223) | $(1,792) | | Net cash provided by financing activities | $0 | $20,325 | $(20,325) | | Net (decrease) increase in cash | $(6,015) | $16,102 | $(22,117) | | Cash, end of period | $14,411 | $17,106 | $(2,695) | [Condensed Consolidated Statements of Shareholders' Equity (Unaudited)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders'%20Equity%20(Unaudited)) **Condensed Consolidated Statements of Shareholders' Equity (in thousands):** | Metric | June 30, 2020 | December 31, 2019 | Change | | :----------------------------- | :------------ | :---------------- | :----- | | Common Stock | $4 | $4 | $0 | | Additional Paid in Capital | $77,710 | $77,421 | $289 | | Accumulated Deficit | $(61,703) | $(56,339) | $(5,364) | | Total Shareholders' Equity | $16,011 | $21,086 | $(5,075) | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [1. Organization and Business](index=9&type=section&id=1.%20Organization%20and%20Business) Bio-Path Holdings, Inc. is a clinical and preclinical stage oncology-focused RNAi nanoparticle drug development company utilizing its proprietary DNAbilize® technology - Bio-Path is an oncology-focused RNAi nanoparticle drug development company[26](index=26&type=chunk) - The company's proprietary DNAbilize® technology enables systemic delivery for target-specific protein inhibition[26](index=26&type=chunk) - Currently, four antisense drug candidates are in development to treat at least five different cancer disease indications[26](index=26&type=chunk) - Operations are subject to significant risks, including the need for additional funding and the outcome of clinical trials[27](index=27&type=chunk) [2. Significant Accounting Policies](index=9&type=section&id=2.%20Significant%20Accounting%20Policies) The financial statements are prepared in conformity with U.S. GAAP for interim financial information, with diluted net loss per share equaling basic net loss per share due to antidilutive effects - Interim financial statements are prepared in conformity with U.S. GAAP and SEC Form 10-Q instructions[25](index=25&type=chunk) - Diluted net loss per share equals basic net loss per share due to antidilutive effects of warrants and stock options[28](index=28&type=chunk) [3. Prepaid Drug Product for Testing](index=10&type=section&id=3.%20Prepaid%20Drug%20Product%20for%20Testing) Advance payments for drug products used in future clinical development are capitalized and expensed as goods are delivered or services performed - Prepaid drug product for testing increased to **$1.1 million** as of June 30, 2020, from **$0.8 million** at December 31, 2019[31](index=31&type=chunk) - These prepayments are for drug supply contracts for prexigebersen (Phase 2) and Bcl-2 (Phase 1) clinical trials[31](index=31&type=chunk) [4. Other Current Assets](index=10&type=section&id=4.%20Other%20Current%20Assets) Other current assets totaled $1.4 million as of June 30, 2020, primarily comprising prepayments for clinical trials, prepaid insurance, and BP1003 manufacturing activities - Other current assets increased to **$1.4 million** as of June 30, 2020, from **$0.8 million** at December 31, 2019[32](index=32&type=chunk) - Major components include prepayments for clinical trials (**$0.6M**), prepaid insurance (**$0.5M**), and BP1003 manufacturing (**$0.2M**)[32](index=32&type=chunk) [5. Accounts Payable](index=10&type=section&id=5.%20Accounts%20Payable) Accounts payable increased to $0.7 million as of June 30, 2020, mainly due to external research expenses related to manufacturing costs and clinical research organization fees - Accounts payable increased to **$0.7 million** as of June 30, 2020, from **$0.5 million** at December 31, 2019[33](index=33&type=chunk) - The increase is primarily due to manufacturing costs (**$0.3M**) and clinical research organization fees (**$0.2M**)[33](index=33&type=chunk) [6. Accrued Expense](index=10&type=section&id=6.%20Accrued%20Expense) Accrued expenses decreased to $0.4 million as of June 30, 2020, primarily due to lower accrued employee vacation and bonus expenses - Accrued expenses decreased to **$0.4 million** as of June 30, 2020, from **$0.7 million** at December 31, 2019[34](index=34&type=chunk) - The decrease is primarily due to lower accrued employee vacation and bonus expenses[34](index=34&type=chunk) [7. Stockholders' Equity](index=10&type=section&id=7.%20Stockholders'%20Equity) In 2019, the company raised substantial capital through several public and registered direct offerings of common stock and warrants, with no significant equity issuances in the first six months of 2020 - In 2019, the company completed multiple equity offerings (Underwritten, Registered Direct, Private Placement) raising significant capital[35](index=35&type=chunk)[36](index=36&type=chunk)[38](index=38&type=chunk)[39](index=39&type=chunk) - Net proceeds from 2019 offerings totaled approximately **$20.9 million**, plus **$1.1 million** from warrant exercises[35](index=35&type=chunk)[36](index=36&type=chunk)[38](index=38&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk) [8. Stock-Based Compensation Plan](index=12&type=section&id=8.%20Stock-Based%20Compensation%20Plan) The company's 2017 Stock Incentive Plan allows for various stock-based awards, with unamortized stock-based compensation expense of $1.1 million as of June 30, 2020 - Stock-based compensation expense for Q2 2020 was **$0.1 million**, a decrease from **$0.2 million** in Q2 2019[42](index=42&type=chunk) - Stock-based compensation expense for H1 2020 was **$0.3 million**, consistent with H1 2019[43](index=43&type=chunk) - As of June 30, 2020, unamortized stock-based compensation expense was **$1.1 million**, with a weighted average vesting period of **2.8 years**[46](index=46&type=chunk) **Stock Option Activity (Six Months Ended June 30, 2020):** | Metric | Options (in thousands) | Weighted-Average Exercise Price | | :----------------------------- | :--------------------- | :------------------------------ | | Outstanding at Dec 31, 2019 | 68 | $68.56 | | Granted | 204 | $5.01 | | Forfeited | (4) | $7.19 | | Expired | (1) | $28.54 | | Outstanding at June 30, 2020 | 267 | $20.98 | | Exercisable at June 30, 2020 | 45 | $88.48 | [9. Commitments and Contingencies](index=13&type=section&id=9.%20Commitments%20and%20Contingencies) Total commitments for the company's drug supplier project plan were $1.1 million as of June 30, 2020, with $0.7 million expected to be incurred over the next 12 months - Total commitments for drug supplier project plan were **$1.1 million** as of June 30, 2020[47](index=47&type=chunk) - **$0.7 million** of these commitments are expected to be incurred in the next 12 months, mainly for manufacturing prexigebersen, BP1002, Grb2, Bcl-2, and STAT3 drug products/substances[47](index=47&type=chunk) [10. Subsequent Events](index=13&type=section&id=10.%20Subsequent%20Events) The company terminated its 'at the market' equity offering agreement with Cantor Fitzgerald and entered into a new agreement with H.C. Wainwright & Co., LLC for up to $7.0 million in common stock sales - Terminated 'at the market' equity offering agreement with Cantor Fitzgerald on July 2, 2020; no shares sold[48](index=48&type=chunk) - Entered into a new 'At-The-Market Offering Agreement' with H.C. Wainwright & Co., LLC on July 13, 2020, for up to **$7.0 million** in common stock sales[49](index=49&type=chunk) - Sales under the new agreement are subject to limitations if the public float remains less than **$75.0 million**[49](index=49&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) This section provides management's perspective on the company's financial condition and results of operations, highlighting drug development, operating expenses, net loss, and liquidity [Overview](index=15&type=section&id=Overview) Bio-Path is an oncology-focused RNAi nanoparticle drug development company with four drug candidates for at least five cancer indications, advancing multiple clinical and preclinical programs - Bio-Path is a clinical and preclinical stage oncology-focused RNAi nanoparticle drug development company utilizing DNAbilize® technology[53](index=53&type=chunk) - Four drug candidates are in development for at least five different cancer indications, demonstrating an excellent safety profile[54](index=54&type=chunk) - Preclinical studies for a triple combination of prexigebersen, decitabine, and venetoclax showed significant efficacy improvement in AML cell lines[55](index=55&type=chunk) - FDA cleared an amended Phase 2 AML trial protocol for triple combination treatment (decitabine, venetoclax, prexigebersen) and a two-drug combination (decitabine, prexigebersen) for venetoclax-resistant/intolerant patients[56](index=56&type=chunk)[57](index=57&type=chunk) - IND application filed for prexigebersen-A (modified prexigebersen) for Phase 1 clinical trial in solid tumors (ovarian, uterine, pancreatic, breast cancer)[59](index=59&type=chunk) - FDA cleared IND for BP1002 (Liposomal Bcl-2) for a Phase 1 clinical trial in refractory/relapsed lymphoma and chronic lymphocytic leukemia[60](index=60&type=chunk) - BP1003 (Liposomal STAT3) is in IND-enabling studies for pancreatic cancer, NSCLC, and AML, with an IND filing targeted for late 2020[61](index=61&type=chunk) - The company holds patents for its DNAbilize® technology, including its use in treating cancers, autoimmune, and infectious diseases[62](index=62&type=chunk)[63](index=63&type=chunk) [Company History and Available Information](index=18&type=section&id=Company%20History%20and%20Available%20Information) Bio-Path Holdings, Inc. was incorporated in 2000, underwent a reverse merger in 2008, began trading on Nasdaq in 2014, and effected reverse stock splits in 2018 and 2019 - Company incorporated in 2000, completed reverse merger in 2008, and listed on Nasdaq Capital Market in 2014[67](index=67&type=chunk) - Effected 1-for-10 reverse stock split in February 2018 and 1-for-20 reverse stock split in January 2019[68](index=68&type=chunk) [Recent Accounting Pronouncements](index=18&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 - No recent accounting pronouncements have a material impact on the financial statements[69](index=69&type=chunk) [Financial Operations Overview](index=18&type=section&id=Financial%20Operations%20Overview) This section outlines the company's financial operations, including its lack of significant revenue, the nature of its research and development expenses, and general and administrative costs [Revenue](index=18&type=section&id=Revenue) - No significant revenues generated to date; future revenue depends on successful drug development and commercialization[70](index=70&type=chunk)[72](index=72&type=chunk) - Potential future revenue sources include product sales, grants, service agreements, strategic alliances, and licensing[72](index=72&type=chunk) [Research and development expenses](index=19&type=section&id=Research%20and%20development%20expenses) - R&D expenses include personnel, external research (CROs, manufacturers), and material costs, expensed as incurred[73](index=73&type=chunk)[74](index=74&type=chunk) - R&D expenses are expected to be substantial and increase, subject to uncertainties in clinical trial outcomes, regulatory requirements, and external factors like COVID-19[75](index=75&type=chunk)[77](index=77&type=chunk) [General and administrative expenses](index=20&type=section&id=General%20and%20administrative%20expenses) - G&A expenses primarily consist of salaries, benefits, professional fees (legal, accounting), travel, and facility costs[78](index=78&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) This section details the company's financial performance for the three and six months ended June 30, 2020, compared to the same periods in 2019 [Comparisons of the Three Months Ended June 30, 2020 to the Three Months Ended June 30, 2019](index=20&type=section&id=Comparisons%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202020%20to%20the%20Three%20Months%20Ended%20June%2030%2C%202019) **Financial Performance (Three Months Ended June 30, in thousands):** | Metric | Q2 2020 | Q2 2019 | Change | | :----------------------------- | :------ | :------ | :----- | | Research and Development Expense | $1,030 | $1,523 | $(493) | | General and Administrative Expense | $1,013 | $966 | $47 | | Net Operating Loss | $(2,043) | $(2,489) | $446 | | Net Loss | $(2,040) | $(2,456) | $416 | | Net Loss per Share | $(0.55) | $(0.87) | $0.32 | [Comparisons of the Six Months Ended June 30, 2020 to the Six Months Ended June 30, 2019](index=21&type=section&id=Comparisons%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202020%20to%20the%20Six%20Months%20Ended%20June%2030%2C%202019) **Financial Performance (Six Months Ended June 30, in thousands):** | Metric | H1 2020 | H1 2019 | Change | | :----------------------------- | :------ | :------ | :----- | | Research and Development Expense | $3,038 | $1,921 | $1,117 | | General and Administrative Expense | $2,349 | $2,088 | $261 | | Net Operating Loss | $(5,387) | $(4,009) | $(1,378) | | Net Loss | $(5,364) | $(3,968) | $(1,396) | | Net Loss per Share | $(1.45) | $(1.75) | $0.30 | [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's financial liquidity, capital resources, and funding strategies, highlighting reliance on equity offerings and the need for additional capital [Overview](index=21&type=section&id=Overview) - Operations are funded primarily through public and private equity offerings[86](index=86&type=chunk) - Cash balance as of June 30, 2020, was **$14.4 million**, a decrease of **$6.0 million** from December 31, 2019[87](index=87&type=chunk) - Current cash is expected to be sufficient for at least the next 12 months, but substantial additional capital will be required for future drug development and commercialization[87](index=87&type=chunk)[98](index=98&type=chunk) - The company currently has no lines of credit or other arranged access to debt financing[86](index=86&type=chunk) [Cash Flows](index=21&type=section&id=Cash%20Flows) - Net cash used in operating activities for H1 2020 was **$6.0 million**, compared to **$4.2 million** in H1 2019[88](index=88&type=chunk) - No cash was provided by financing activities in H1 2020, a significant change from **$20.3 million** provided in H1 2019 from equity offerings and warrant exercises[90](index=90&type=chunk) [2019 Shelf Registration Statement](index=23&type=section&id=2019%20Shelf%20Registration%20Statement) - A 2019 Shelf Registration Statement allows for offering up to **$125.0 million** in securities[91](index=91&type=chunk) - Sales are limited to one-third of the public float over any 12 consecutive months due to the public float being less than **$75 million**[91](index=91&type=chunk) [2019 Underwritten Offering](index=23&type=section&id=2019%20Underwritten%20Offering) - January 2019 Underwritten Offering generated **$1.1 million** gross proceeds and **$0.9 million** net proceeds from **429,616 common stock shares**[92](index=92&type=chunk) [January 2019 Registered Direct Offering and January 2019 Private Placement](index=23&type=section&id=January%202019%20Registered%20Direct%20Offering%20and%20January%202019%20Private%20Placement) - January 2019 Registered Direct Offering and Private Placement generated **$1.7 million** gross proceeds and **$1.5 million** net proceeds[93](index=93&type=chunk) [March 2019 Registered Direct Offering](index=24&type=section&id=March%202019%20Registered%20Direct%20Offering) - March 2019 Registered Direct Offering generated **$18.5 million** gross proceeds and **$17.0 million** net proceeds from **712,910 common stock shares**[95](index=95&type=chunk) [November 2019 Registered Direct Offering](index=24&type=section&id=November%202019%20Registered%20Direct%20Offering) - November 2019 Registered Direct Offering generated **$8.0 million** gross proceeds and **$7.3 million** net proceeds from **808,080 common stock shares** and warrants[96](index=96&type=chunk) [At-The-Market Offering Agreement](index=24&type=section&id=At-The-Market%20Offering%20Agreement) - New At-The-Market Offering Agreement entered on July 13, 2020, allows for sales of up to **$7.0 million** in common stock[97](index=97&type=chunk) - Sales are subject to public float limitations and a **3% commission** to the sales agent[97](index=97&type=chunk) - No shares have been sold under this agreement as of the report date[97](index=97&type=chunk) [Future Capital Requirements](index=24&type=section&id=Future%20Capital%20Requirements) - Significant operating expenses are expected for clinical trials, manufacturing, and regulatory approvals of drug candidates[98](index=98&type=chunk) - Substantial additional capital will be required, with no assurance of availability or favorable terms[98](index=98&type=chunk) [Off-Balance Sheet Arrangements](index=25&type=section&id=Off-Balance%20Sheet%20Arrangements) - No material off-balance sheet arrangements as of June 30, 2020[100](index=100&type=chunk) [Critical Accounting Policies](index=25&type=section&id=Critical%20Accounting%20Policies) - No significant changes to critical accounting policies since December 31, 2019[101](index=101&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) This section states that the company has no material quantitative or qualitative disclosures about market risk to report - The company states that this item is 'Not applicable'[102](index=102&type=chunk) [ITEM 4. Controls and Procedures](index=25&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) This section details management's evaluation of the company's disclosure controls and procedures, confirming their effectiveness and no material changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=25&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Management determined disclosure controls and procedures were effective as of June 30, 2020[104](index=104&type=chunk) [Changes in Internal Control over Financial Reporting](index=25&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) - No material changes in internal control over financial reporting during the quarter[105](index=105&type=chunk) [PART II - OTHER INFORMATION](index=26&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [ITEM 1. Legal Proceedings](index=26&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) This section states that there are no legal proceedings to report for the period - No legal proceedings to report[108](index=108&type=chunk) [ITEM 1A. Risk Factors](index=26&type=section&id=ITEM%201A.%20RISK%20FACTORS) This section indicates no material changes to previously disclosed risk factors, except for additional disclosure regarding the potential adverse impact of the COVID-19 pandemic - No material changes to risk factors, except for additional disclosure on COVID-19 impact[109](index=109&type=chunk) - COVID-19 could adversely impact clinical trials (site initiation, recruitment, dosing, monitoring, data analysis) and regulatory review[111](index=111&type=chunk) - Current COVID-19 impact is limited to travel restrictions and site access, with anticipated effects on patient recruiting[112](index=112&type=chunk) - Operational issues related to COVID-19 are expected to be managed through remote monitoring capabilities[112](index=112&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=26&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) This section states that there are no unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities or use of proceeds to report[114](index=114&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=26&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) This section states that there are no defaults upon senior securities to report for the period - No defaults upon senior securities to report[115](index=115&type=chunk) [ITEM 4. Mine Safety Disclosures](index=27&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This section states that there are no mine safety disclosures to report for the period - No mine safety disclosures to report[119](index=119&type=chunk) [ITEM 5. Other Information](index=27&type=section&id=ITEM%205.%20OTHER%20INFORMATION) This section states that there is no other information to report for the period - No other information to report[120](index=120&type=chunk) [ITEM 6. Exhibits](index=27&type=section&id=ITEM%206.%20EXHIBITS) This section lists the exhibits filed with the Form 10-Q, including various agreements, certificates, and XBRL documents, which provide supporting information for the report - The report includes various exhibits such as merger agreements, certificates of incorporation, bylaws, stock incentive plans, and an At-the-Market Offering Agreement[118](index=118&type=chunk) - XBRL instance and taxonomy documents are also filed[118](index=118&type=chunk) [SIGNATURE](index=28&type=section&id=SIGNATURE) [Signature](index=28&type=section&id=SIGNATURE) This section contains the signature of Peter H. Nielsen, President, Chief Executive Officer, and Chief Financial Officer of Bio-Path Holdings, Inc., certifying the report on August 13, 2020 - The report was signed by Peter H. Nielsen, President, CEO, and CFO, on August 13, 2020[126](index=126&type=chunk)

Bio-Path Holdings, Inc. (NASDAQ:BPTH) Q1 2020 Results Earnings Conference Call May 15, 2020 8:30 AM ET Company Participants Will O'Connor - Investor Relations, Stern Investor Relations Peter Nielsen - President, Chief Executive Officer and Chief Financial Officer Anthony Price - Senior Vice President of Finance, Accounting and Administration Conference Call Participants Yi Chen - H.C. Wainwright & Co. Operator Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings First Quarter 2020 Earnings C ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Delaware 87-0652870 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) 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 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 Or ¨ TRANSITIO ...

Bio-Path Holdings, Inc. (NASDAQ:BPTH) Q4 2019 Earnings Conference Call March 6, 2020 8:30 AM ET Company Participants Will O'Connor - Stern IR Peter Nielsen - President & CEO Anthony Price - VP, Finance & Accounting Conference Call Participants Yi Chen - H.C. Wainwright Laura Engle - Stonegate Capital Partners Operator Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings Year End 2019 Earnings Conference Call. At this time, all participants are in listen-only mode. Following the formal remark ...

Part I [Business](index=6&type=section&id=Item%201.%20Business) Bio-Path Holdings is an oncology company developing RNAi nanoparticle drugs using its DNAbilize® platform, with three candidates in clinical and preclinical stages - The company's core technology is **DNAbilize®**, a novel RNAi nanoparticle drug delivery platform designed for systemic, target-specific protein inhibition with a strong safety profile[16](index=16&type=chunk) Drug Development Pipeline | Drug Candidate | Target Protein | Key Indications | Development Stage | | :--- | :--- | :--- | :--- | | **Prexigebersen** | Grb2 | Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myeloid Leukemia (CML), Solid Tumors | Phase 2 (AML/MDS), Phase 2a planned (CML), Phase 1 planned (Solid Tumors) | | **BP1002** | Bcl-2 | Lymphoma, Chronic Lymphocytic Leukemia (CLL) | Phase 1 (IND cleared) | | **BP1003** | Stat3 | Pancreatic Cancer, Non-Small Cell Lung Cancer (NSCLC), AML | IND-enabling studies | - The company's strategy focuses on developing its lead candidates for multiple indications, expanding the DNAbilize® platform beyond cancer, and establishing partnerships for co-development and licensing[44](index=44&type=chunk)[49](index=49&type=chunk)[50](index=50&type=chunk) - Bio-Path relies entirely on third-party manufacturers for its clinical drug supplies and currently has no internal manufacturing, sales, or marketing capabilities[125](index=125&type=chunk)[126](index=126&type=chunk) - The company has strengthened its intellectual property portfolio with two issued U.S. patents for its **DNAbilize®** technology, covering its use in treating cancers, autoimmune diseases, and infectious diseases[129](index=129&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including operating losses, capital needs, intense competition, uncertain drug development, reliance on third parties, and stock price volatility - The company is a clinical-stage entity with no significant revenue, a history of operating losses (**$56.3 million accumulated deficit as of Dec 31, 2019**), and expects to incur future losses; profitability is not guaranteed[182](index=182&type=chunk)[183](index=183&type=chunk) - Substantial additional capital is required for future operations; failure to raise funds may force the company to delay, reduce, or eliminate drug development programs[186](index=186&type=chunk)[189](index=189&type=chunk) - The success of the business hinges on completing extensive and costly clinical trials to demonstrate the safety and efficacy of its drug candidates, a process with a high risk of failure[233](index=233&type=chunk)[234](index=234&type=chunk) - The company relies on third-party manufacturers for its clinical drug supplies, which poses risks related to regulatory compliance, quality assurance, and potential supply disruptions[267](index=267&type=chunk)[268](index=268&type=chunk) - The company's common stock is thinly traded and has been highly volatile, with a price range from **$1.61 to $270.00 (split-adjusted) between Jan 2017 and Dec 2019**; failure to maintain a minimum stock price of **$1.00** could lead to delisting from The Nasdaq Capital Market[320](index=320&type=chunk)[322](index=322&type=chunk)[332](index=332&type=chunk) [Unresolved Staff Comments](index=57&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) There are no unresolved staff comments reported by the company - There are no unresolved staff comments[334](index=334&type=chunk) [Properties](index=57&type=section&id=Item%202.%20Properties) The company leases office and lab space in Bellaire, Texas, with leases extending to October 2024 and April 2022, respectively - The company leases office space in Bellaire, Texas, with the lease term extended to **October 31, 2024**[335](index=335&type=chunk) - The company also leases lab space in Bellaire, Texas, for research and development, with the lease term extended to **April 30, 2022**[336](index=336&type=chunk) [Legal Proceedings](index=57&type=section&id=Item%203.%20Legal%20Proceedings) The company reports no legal proceedings - There are no legal proceedings to report[338](index=338&type=chunk) [Mine Safety Disclosures](index=57&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[339](index=339&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=58&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under "BPTH," with **3.69 million** shares outstanding as of February 2020, and no cash dividends have been paid or are anticipated - The company's common stock trades on The Nasdaq Capital Market under the symbol **"BPTH"**[342](index=342&type=chunk) - As of **February 27, 2020**, there were **3,691,857 shares** of common stock outstanding[342](index=342&type=chunk) - The company has never paid cash dividends and does not plan to in the foreseeable future[343](index=343&type=chunk) [Selected Consolidated Financial Data](index=58&type=section&id=Item%206.%20Selected%20Consolidated%20Financial%20Data) This item is not applicable to the company - Not applicable[346](index=346&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operation](index=58&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operation) In FY2019, the company reported no revenue, a net loss of **$8.6 million**, stable R&D, increased G&A, and a significant cash increase to **$20.4 million** from financing activities Results of Operations (in thousands) | Metric | FY 2019 | FY 2018 | Change | | :--- | :--- | :--- | :--- | | **Revenue** | $0 | $0 | - | | **Research & Development Expense** | $4,585 | $4,603 | ($18) | | **General & Administrative Expense** | $4,108 | $3,379 | $729 | | **Net Operating Loss** | ($8,693) | ($8,590) | ($103) | | **Net Loss** | ($8,599) | ($8,583) | ($16) | | **Net Loss Per Share** | ($3.24) | ($14.38) | $11.14 | - The company's cash balance increased significantly from **$1.0 million** at the end of 2018 to **$20.4 million** at the end of 2019[368](index=368&type=chunk) - Net cash provided by financing activities was **$27.8 million** in 2019, primarily from multiple registered direct offerings, an underwritten offering, and warrant exercises[371](index=371&type=chunk) - Management believes that the available cash of **$20.4 million** as of **December 31, 2019**, is sufficient to fund operations and capital requirements for at least the next **12 months**[368](index=368&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=66&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not applicable to the company - Not applicable[398](index=398&type=chunk) [Financial Statements and Supplementary Data](index=67&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section refers to the consolidated financial statements and the independent auditor's report, located starting on page F-1 - The company's consolidated financial statements and the independent auditor's report are included beginning on page **F-1**[400](index=400&type=chunk) [Changes and Disagreements with Accountants on Accounting and Financial Disclosure](index=67&type=section&id=Item%209.%20Changes%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes or disagreements with accountants on accounting and financial disclosure - There were no disagreements with accountants on accounting and financial disclosure[400](index=400&type=chunk) [Controls and Procedures](index=67&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls and internal control over financial reporting were effective as of December 31, 2019, having remediated a prior material weakness - Management concluded that the company's disclosure controls and procedures were effective as of **December 31, 2019**[402](index=402&type=chunk) - A material weakness in internal control over financial reporting, identified in the prior year related to clinical trial expense accrual, was remediated through improved processes and communication between clinical and finance personnel[406](index=406&type=chunk) - Based on its evaluation, management believes that the company's internal control over financial reporting was effective as of **December 31, 2019**[407](index=407&type=chunk) [Other Information](index=68&type=section&id=Item%209B.%20Other%20Information) The company reports no other information - None[409](index=409&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=68&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The company's Board of Directors has five members, including CEO Peter H. Nielsen, with three independent directors and standing committees composed of independent members - The Board of Directors is comprised of **five members**, with **Peter H. Nielsen** serving as Chairman, CEO, President, and CFO[411](index=411&type=chunk)[413](index=413&type=chunk) - **Three** of the **five directors** are independent: **Heath W. Cleaver, Paul D. Aubert, and Martina Molsbergen**[419](index=419&type=chunk) - The Board has **three** standing committees: Audit, Compensation, and Nominating/Corporate Governance, each composed of independent directors[421](index=421&type=chunk) [Executive Compensation](index=73&type=section&id=Item%2011.%20Executive%20Compensation) In FY2019, CEO Peter H. Nielsen received **$734,734** in total compensation, while non-employee directors receive cash retainers, meeting fees, and stock option grants NEO Compensation (Peter H. Nielsen) | Year | Salary | Option Awards | Total Compensation | | :--- | :--- | :--- | :--- | | **2019** | $490,000 | $244,570 | $734,734 | | **2018** | $490,000 | $181,711 | $671,927 | - Non-employee director compensation includes annual cash retainers, fees for board and committee meeting attendance, and an annual stock option grant for **1,000 shares** of common stock[459](index=459&type=chunk)[464](index=464&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=76&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of February 27, 2020, CEO Peter H. Nielsen beneficially owned **1.17%** of common stock, with all executive officers and directors as a group owning less than **1%** - As of **February 27, 2020**, CEO **Peter H. Nielsen** beneficially owned **43,401 shares**, representing **1.17%** of the class[466](index=466&type=chunk) - All executive officers and directors as a group beneficially owned less than **1%** of the company's common stock[466](index=466&type=chunk) [Certain Relationships and Related Party Transactions, and Director Independence](index=77&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Party%20Transactions%2C%20and%20Director%20Independence) The Audit Committee reviews related party transactions, with no material transactions reported beyond standard compensation, and three directors are deemed independent - The Audit Committee reviews and pre-approves all related party transactions; no material related party transactions were disclosed for the last two fiscal years, aside from compensation and indemnification agreements[474](index=474&type=chunk)[476](index=476&type=chunk)[477](index=477&type=chunk) - The Board has identified **Heath W. Cleaver, Paul D. Aubert, and Martina Molsbergen** as independent directors[479](index=479&type=chunk) [Principal Accounting Fees and Services](index=78&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) In FY2019, the company paid **$225,000** in audit fees to BDO USA, LLP, a decrease from **$230,000** in FY2018 Accounting Fees (in thousands) | Fee Type | FY 2019 | FY 2018 | | :--- | :--- | :--- | | **Audit Fees** | $225 | $230 | | **Audit-Related Fees** | $0 | $0 | | **Tax Fees** | $0 | $0 | | **All Other Fees** | $0 | $0 | | **Total** | **$225** | **$230** | Part IV [Exhibits and Financial Statement Schedules](index=78&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section confirms the inclusion of financial statements and the omission of schedules, along with a list of filed exhibits - The required financial statements are included in the report, starting on page **F-1**[486](index=486&type=chunk) - All financial statement schedules are omitted because they are not applicable or the required information is already included elsewhere[487](index=487&type=chunk) [Form 10-K Summary](index=82&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports no Form 10-K summary - None[519](index=519&type=chunk)

Bio-Path Holdings, Inc (NASDAQ:BPTH) Q3 2019 Earnings Conference Call November 15, 2019 8:30 AM ET Company Participants Kerry Conlin - Stern Investor Relations Peter Nielsen - President and Chief Executive Officer Anthony Price - Vice President, Finance and Accounting Conference Call Participants Laura Engle - Stonegate Capital Partners Yi Chen - H.C. Wainwright Operator Good morning ladies and gentlemen. Welcome to the Bio-Path Holdings Third Quarter 2019 Earnings Conference Call. At this time, all partici ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 Or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __ to __ Commission file number: 001-36333 Bio-Path Holdings, Inc. (Exact name of registrant as specified in its charter) | --- | --- | |----------------- ...

Bio-Path Holdings, Inc. (NASDAQ:BPTH) Q2 2019 Earnings Conference Call August 15, 2019 8:30 AM ET Company Participants Peter Nielsen - President, Chief Executive Officer Anthony Price - Vice President, Finance and Accounting Will O’Connor - Stern Investor Relations Conference Call Participants Laura Engle - Stonegate Capital Partners Yi Chen - H.C. Wainwright & Co, LLC * Operator Good morning ladies and gentlemen. Welcome to the Bio-Path Holdings Second Quarter 2019 Earnings Conference Call. At this time, a ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 Or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number: 001-36333 Bio-Path Holdings, Inc. (Exact name of registrant as specified in its charter) | --- | --- | |------ ...

Bio-Path Holdings, Inc. (BPTH) Q1 2019 Earnings Conference Call May 16, 2019 8:30 AM ET Company Participants Peter Nielsen - President, Chief Executive Officer Anthony Price - Vice President, Finance and Accounting Will O’Connor - Stern Investor Relations Conference Call Participants Laura Engle - Stonegate Capital Partners Operator Good morning ladies and gentlemen. Welcome to the Bio-Path Holdings full year 2018 earnings conference call. At this time, all participants are in a listen-only mode. Following ...