Bio-Path(BPTH) - 2020 Q2 - Quarterly Report

Preliminary Information FORM 10-Q Filing Information 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] - Bio-Path Holdings, Inc. is a Delaware corporation with IRS Employer Identification No. 87-0652870[3] - The company is classified as a non-accelerated filer and a smaller reporting company[4] - As of August 7, 2020, there were 3,691,857 outstanding shares of common stock[4] Cautionary Note Regarding Forward-Looking Statements 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] - 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] - Risks also encompass the success of clinical trials, regulatory approval, intellectual property protection, and market acceptance of drug candidates[7][8] Table of Contents 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] - Part I includes Financial Statements, Management's Discussion and Analysis, Market Risk Disclosures, and Controls and Procedures[13] - Part II covers Legal Proceedings, Risk Factors, Sales of Equity Securities, Defaults, Mine Safety Disclosures, Other Information, and Exhibits[13] PART I - FINANCIAL INFORMATION ITEM 1. Financial Statements 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) 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) 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) 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) 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 1. Organization and Business 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] - The company's proprietary DNAbilize® technology enables systemic delivery for target-specific protein inhibition[26] - Currently, four antisense drug candidates are in development to treat at least five different cancer disease indications[26] - Operations are subject to significant risks, including the need for additional funding and the outcome of clinical trials[27] 2. Significant Accounting Policies 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] - Diluted net loss per share equals basic net loss per share due to antidilutive effects of warrants and stock options[28] 3. Prepaid Drug Product for Testing 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] - These prepayments are for drug supply contracts for prexigebersen (Phase 2) and Bcl-2 (Phase 1) clinical trials[31] 4. Other Current Assets 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] - Major components include prepayments for clinical trials ($0.6M), prepaid insurance ($0.5M), and BP1003 manufacturing ($0.2M)[32] 5. Accounts Payable 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] - The increase is primarily due to manufacturing costs ($0.3M) and clinical research organization fees ($0.2M)[33] 6. Accrued Expense 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] - The decrease is primarily due to lower accrued employee vacation and bonus expenses[34] 7. Stockholders' Equity 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][36][38][39] - Net proceeds from 2019 offerings totaled approximately $20.9 million, plus $1.1 million from warrant exercises[35][36][38][39][40] 8. Stock-Based Compensation Plan 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] - Stock-based compensation expense for H1 2020 was $0.3 million, consistent with H1 2019[43] - 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] 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 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] - $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] 10. Subsequent Events 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] - 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] - Sales under the new agreement are subject to limitations if the public float remains less than $75.0 million[49] ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 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 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] - Four drug candidates are in development for at least five different cancer indications, demonstrating an excellent safety profile[54] - Preclinical studies for a triple combination of prexigebersen, decitabine, and venetoclax showed significant efficacy improvement in AML cell lines[55] - 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][57] - IND application filed for prexigebersen-A (modified prexigebersen) for Phase 1 clinical trial in solid tumors (ovarian, uterine, pancreatic, breast cancer)[59] - FDA cleared IND for BP1002 (Liposomal Bcl-2) for a Phase 1 clinical trial in refractory/relapsed lymphoma and chronic lymphocytic leukemia[60] - BP1003 (Liposomal STAT3) is in IND-enabling studies for pancreatic cancer, NSCLC, and AML, with an IND filing targeted for late 2020[61] - The company holds patents for its DNAbilize® technology, including its use in treating cancers, autoimmune, and infectious diseases[62][63] Company History and Available Information 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] - Effected 1-for-10 reverse stock split in February 2018 and 1-for-20 reverse stock split in January 2019[68] Recent Accounting Pronouncements 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] Financial Operations Overview 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 - No significant revenues generated to date; future revenue depends on successful drug development and commercialization[70][72] - Potential future revenue sources include product sales, grants, service agreements, strategic alliances, and licensing[72] Research and development expenses - R&D expenses include personnel, external research (CROs, manufacturers), and material costs, expensed as incurred[73][74] - 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][77] General and administrative expenses - G&A expenses primarily consist of salaries, benefits, professional fees (legal, accounting), travel, and facility costs[78] Results of Operations 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 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 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 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 - Operations are funded primarily through public and private equity offerings[86] - Cash balance as of June 30, 2020, was $14.4 million, a decrease of $6.0 million from December 31, 2019[87] - 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][98] - The company currently has no lines of credit or other arranged access to debt financing[86] Cash Flows - Net cash used in operating activities for H1 2020 was $6.0 million, compared to $4.2 million in H1 2019[88] - 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] 2019 Shelf Registration Statement - A 2019 Shelf Registration Statement allows for offering up to $125.0 million in securities[91] - 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] 2019 Underwritten Offering - January 2019 Underwritten Offering generated $1.1 million gross proceeds and $0.9 million net proceeds from 429,616 common stock shares[92] January 2019 Registered Direct Offering and January 2019 Private Placement - January 2019 Registered Direct Offering and Private Placement generated $1.7 million gross proceeds and $1.5 million net proceeds[93] March 2019 Registered Direct Offering - March 2019 Registered Direct Offering generated $18.5 million gross proceeds and $17.0 million net proceeds from 712,910 common stock shares[95] November 2019 Registered Direct Offering - 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] At-The-Market Offering Agreement - New At-The-Market Offering Agreement entered on July 13, 2020, allows for sales of up to $7.0 million in common stock[97] - Sales are subject to public float limitations and a 3% commission to the sales agent[97] - No shares have been sold under this agreement as of the report date[97] Future Capital Requirements - Significant operating expenses are expected for clinical trials, manufacturing, and regulatory approvals of drug candidates[98] - Substantial additional capital will be required, with no assurance of availability or favorable terms[98] Off-Balance Sheet Arrangements - No material off-balance sheet arrangements as of June 30, 2020[100] Critical Accounting Policies - No significant changes to critical accounting policies since December 31, 2019[101] ITEM 3. Quantitative and Qualitative Disclosures About Market Risk 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] ITEM 4. Controls and Procedures 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 - Management determined disclosure controls and procedures were effective as of June 30, 2020[104] Changes in Internal Control over Financial Reporting - No material changes in internal control over financial reporting during the quarter[105] PART II - OTHER INFORMATION ITEM 1. Legal Proceedings This section states that there are no legal proceedings to report for the period - No legal proceedings to report[108] ITEM 1A. Risk Factors 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] - COVID-19 could adversely impact clinical trials (site initiation, recruitment, dosing, monitoring, data analysis) and regulatory review[111] - Current COVID-19 impact is limited to travel restrictions and site access, with anticipated effects on patient recruiting[112] - Operational issues related to COVID-19 are expected to be managed through remote monitoring capabilities[112] ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 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] ITEM 3. Defaults Upon Senior Securities This section states that there are no defaults upon senior securities to report for the period - No defaults upon senior securities to report[115] ITEM 4. Mine Safety Disclosures This section states that there are no mine safety disclosures to report for the period - No mine safety disclosures to report[119] ITEM 5. Other Information This section states that there is no other information to report for the period - No other information to report[120] ITEM 6. Exhibits 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] - XBRL instance and taxonomy documents are also filed[118] SIGNATURE 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]