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 ...

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 March 31, 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 (NASDAQ:BPTH) Q4 2018 Earnings Conference Call March 20, 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 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 the f ...