Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2018 | May 07, 2018 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | BIO-PATH HOLDINGS INC | |
Entity Central Index Key | 1,133,818 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Trading Symbol | BPTH | |
Entity Common Stock, Shares Outstanding | 11,340,756 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Current assets | ||
Cash | $ 4,284 | $ 5,965 |
Prepaid drug product for testing | 1,256 | 1,117 |
Other current assets | 330 | 353 |
Total current assets | 5,870 | 7,435 |
Fixed assets | ||
Furniture, fixtures & equipment | 1,001 | 984 |
Less accumulated depreciation | (396) | (330) |
Property, Plant and Equipment, Net | 605 | 654 |
Other assets | ||
Technology licenses | 2,500 | 2,500 |
Less accumulated amortization | (1,771) | (1,731) |
Intangible Assets, Net (Excluding Goodwill), Total | 729 | 769 |
Total Assets | 7,204 | 8,858 |
Current liabilities | ||
Accounts payable | 136 | 52 |
Accrued expenses | 793 | 739 |
Total current liabilities | 929 | 791 |
Total Liabilities | 929 | 791 |
Shareholders' equity | ||
Preferred stock, $.001 par value; 10,000 shares authorized; no shares issued and outstanding | 0 | 0 |
Common stock, $.001 par value; 200,000 shares authorized; 11,341 and 11,339 shares issued and outstanding, respectively | 11 | 11 |
Additional paid in capital | 47,337 | 47,213 |
Accumulated deficit | (41,073) | (39,157) |
Total shareholders' equity | 6,275 | 8,067 |
Total Liabilities & Shareholders' Equity | $ 7,204 | $ 8,858 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares shares in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Preferred Stock, par value | $ 0.001 | $ 0.001 |
Preferred Stock, shares authorized | 10,000 | 10,000 |
Preferred Stock, shares issued | 0 | 0 |
Preferred Stock, shares outstanding | 0 | 0 |
Common Stock, par value | $ 0.001 | $ 0.001 |
Common Stock, shares authorized | 200,000 | 200,000 |
Common Stock, shares issued | 11,341 | 11,339 |
Common Stock, shares outstanding | 11,341 | 11,339 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Operating expenses | ||
Research and development | $ 932 | $ 1,026 |
General and administrative | 987 | 970 |
Total operating expenses | 1,919 | 1,996 |
Net operating loss | (1,919) | (1,996) |
Other income | ||
Change in fair value of warrant liability | 0 | 1,596 |
Interest income | 3 | 3 |
Total other income | 3 | 1,599 |
Net loss | $ (1,916) | $ (397) |
Loss per share | ||
Net loss per share, basic and diluted | $ (0.17) | $ (0.04) |
Basic and diluted weighted average number of common shares outstanding | 11,341 | 9,565 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Cash flow from operating activities | ||
Net loss | $ (1,916) | $ (397) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Amortization | 40 | 40 |
Depreciation | 66 | 33 |
Stock-based compensation | 124 | 249 |
Change in fair value of warrant liability | 0 | (1,596) |
(Increase) decrease in assets | ||
Prepaid drug product for testing | (139) | (1) |
Other current assets | 23 | 40 |
Increase (decrease) in liabilities | ||
Accounts payable and accrued expenses | 138 | (208) |
Net cash used in operating activities | (1,664) | (1,840) |
Cash flow from investing activities | ||
Purchases of furniture, fixtures & equipment | (17) | (424) |
Net cash used in investing activities | (17) | (424) |
Cash flow from financing activities | ||
Net decrease in cash | (1,681) | (2,264) |
Cash, beginning of period | 5,965 | 9,375 |
Cash, end of period | 4,284 | 7,111 |
Non-cash financing activities | ||
Capital expenditures included in accrued expenses | $ 0 | $ 114 |
Organization and Business
Organization and Business | 3 Months Ended |
Mar. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Business | 1. Organization and Business The Company is a clinical and preclinical stage oncology focused RNAi nano particle drug development company utilizing a novel technology that achieves systemic delivery of antisense drug substances for target specific protein inhibition for any gene product that is over-expressed in disease. The Company’s drug delivery and antisense technology, called DNAbilize ® in vivo ® Using DNAbilize ® Our second drug candidate, Liposomal Bcl2 (“BP1002”), targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. We are currently preparing an Investigational New Drug (IND) application for BP1002 in addition to completing additional IND enabling studies. We intend to initiate a Phase 1 clinical trial of BP1002 in refractory or relapsed lymphoma patients once we receive approval from the FDA. Our third drug candidate, Liposomal Stat3 (“BP1003”), targets the Stat3 protein and is currently in preclinical development in a pancreatic patient-derived tumor model. Previous preclinical models have shown BP1003 to successfully penetrate pancreatic tumors and to significantly enhance the efficacy of standard frontline treatments. We intend to initiate IND enabling studies of BP1003 in 2018. Bio-Path Subsidiary was founded in May 2007 as a Utah corporation. In February 2008, Bio-Path Subsidiary completed a reverse merger with Ogden Golf Co. Corporation, a public company traded over the counter that had no current operations. The name of Ogden Golf was changed to Bio-Path Holdings, Inc. and the directors and officers of Bio-Path, Inc. became the directors and officers of Bio-Path Holdings, Inc. The Company’s operations to date have been limited to organizing and staffing the Company, acquiring, developing and securing its technology and undertaking product development for a limited number of product candidates. In June 2015, the Company established an “at the market” (“ATM”) program through which it may offer and sell up to $ 25.0 In June 2016, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain healthcare focused institutional investors pursuant to which the Company agreed to sell an aggregate of 588,235 294,118 10.0 25,000 9.3 0.3 On May 21, 2017, the Company entered into Warrant Exercise Agreements (the “Exercise Agreements”) with certain holders (the “Exercising Holders”) of the 2016 Warrants and warrants to purchase shares of common stock that we issued in January 2014 (the “2014 Warrants,” and together with the 2016 Warrants, the “Original Warrants”). The Exercising Holders owned, in the aggregate, Original Warrants exercisable for 441,176 430,000 3.80 11,176 6.00 1.5 On June 13, 2017, the Company entered into amendments (the “Warrant Amendments”) with holders (the “Holders”) of the remaining 2016 Warrants, which amended the terms of their 2016 Warrants exercisable for 127,941 The Exercise Agreements for the 2014 Warrants resulted in the holders receiving $ 1.0 0.4 0.4 0.2 On November 3, 2017, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell an aggregate of 1,333,333 666,667 4.0 16,000 3.6 On February 8, 2018, we effected a reverse stock split of our outstanding shares of common stock at a ratio of 1-for-10, and our common stock began trading on the split-adjusted basis on The Nasdaq Capital Market at the commencement of trading on February 9, 2018. All common stock share and per share amounts in this Quarterly Report on Form 10-Q have been adjusted to give effect to the 1-for-10 reverse stock split. As of March 31, 2018, the Company had $ 4.3 6.0 As the Company has not begun its planned principal operations of commercializing a product candidate, the Company’s activities are subject to significant risks and uncertainties, including the potential requirement to secure additional funding, the outcome of the Company’s clinical trials, and failing to operationalize the Company’s current drug candidates before another company develops similar products. |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 3 Months Ended |
Mar. 31, 2018 | |
New Accounting Pronouncements and Changes in Accounting Principles [Abstract] | |
Recent Accounting Pronouncements | 2. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers. In February 2016, the FASB issued ASU No. 2016-02, Leases In May 2017, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation: Scope of Modification Accounting Management has reviewed all other recently issued pronouncements and has determined they will have no material impact on the Company’s consolidated financial statements. |
Prepaid Drug Product for Testin
Prepaid Drug Product for Testing | 3 Months Ended |
Mar. 31, 2018 | |
Prepaid Drug Product For Testing [Abstract] | |
Prepaid Drug Product for Testing | 3. Prepaid Drug Product for Testing Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future clinical development activities are deferred and capitalized. Such amounts will be recognized as an expense as the related goods are delivered or the related services are performed. The Company made payments to its contract drug manufacturing and raw material suppliers in late 2016 and through 2017 totaling $ 1.1 0.1 1.3 |
Other Current Assets
Other Current Assets | 3 Months Ended |
Mar. 31, 2018 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Other Current Assets | 4. Other Current Assets As of March 31, 2018, Other Current Assets included prepaid expenses of $ 0.3 0.3 0.4 |
Accounts Payable
Accounts Payable | 3 Months Ended |
Mar. 31, 2018 | |
Accounts Payable Disclosure [Abstract] | |
Accounts Payable | 5. Accounts Payable As of March 31, 2018, Current Liabilities included accounts payable of $ 0.1 0.1 |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2018 | |
Accrued Liabilities [Abstract] | |
Accrued Expenses | 6. Accrued Expenses As of March 31, 2018, Current Liabilities included accrued expenses of $ 0.8 0.4 0.2 0.1 0.1 0.7 0.4 0.1 0.1 0.1 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2018 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | 7. Stockholders’ Equity Stockholders’ Equity totaled $ 6.3 8.1 11,340,756 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | 8. Stock-Based Compensation The 2017 Plan On December 21, 2017, the Company’s stockholders approved the Bio-Path Holdings, Inc. 2017 Stock Incentive Plan (the “2017 Plan”), which replaced the First Amended 2007 Stock Incentive Plan, as amended (the “2007 Plan”). The 2007 Plan expired by its terms in January 2018, however, no awards were made under the 2007 Plan upon approval of the 2017 Plan. The 2017 Plan provides for the grant of Incentive Stock Options, Non-Qualified Stock Options, Restricted Shares, Restricted Share Units, Stock Appreciation Rights, Performance-Based Awards and other stock-based awards, or any combination of the foregoing to the Company’s employees, non-employee directors and consultants. As of December 31, 2017, the total number of shares reserved and available for grant and issuance pursuant to the 2017 Plan is 1,200,000 Stock-based compensation expense was $ 0.1 0.2 0.1 20,000 0.1 2018 2017 Risk-free interest rate 2.59 % 2.09 % Expected volatility 95 % 100 % Expected term in years 6.1 6.1 Dividend yield - % - % Weighted- Average Exercise Options Price (in thousands) Outstanding at December 31, 2017 642 $ 11.60 Granted 3 2.08 Cancelled (4) 11.88 Outstanding at March 31, 2018 641 11.58 Exercisable at March 31, 2018 573 $ 10.82 As of March 31, 2018, the aggregate intrinsic value of outstanding stock options was none. The aggregate intrinsic value represents the total pretax intrinsic value (the difference between the Company’s closing stock price on March 31, 2018 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on March 31, 2018. This amount changes based on the fair market value of the Company’s stock. As of March 31, 2018, unamortized stock-based compensation expense for all outstanding options was $ 0.8 2.1 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies Technology License The Company has negotiated exclusive licenses from MD Anderson to clinically develop liposomal antisense drug products. These licenses require, among other things, the Company to reimburse MD Anderson for ongoing patent expense and an annual license maintenance fee. The annual license maintenance fee attributable to the License Agreement totaling $ 0.1 Operating Lease 0.1 In April 2016, the Company entered into a three-year lease agreement for lab space located in Bellaire, Texas. The term of lease began on May 1, 2016 and terminates on April 30, 2019 and will require Bio-Path to pay $ 2,500 33,000 Drug Supplier Project Plan The amounts paid for manufacture of the Company’s Grb2 drug substance and prexigebersen that have not been expensed total $ 1.3 1.5 0.9 0.4 0.2 0.7 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | The Company utilized the Black-Scholes valuation model for estimating the fair value of the stock options granted, with the following weighted-average assumptions for options granted in the three months ended March 31, 2018 and 2017: 2018 2017 Risk-free interest rate 2.59 % 2.09 % Expected volatility 95 % 100 % Expected term in years 6.1 6.1 Dividend yield - % - % |
Schedule of Share-based Compensation, Stock Options, Activity | The following summary represents option activity under the Company’s stock-based compensation plan for the three months ended March 31, 2018: Weighted- Average Exercise Options Price (in thousands) Outstanding at December 31, 2017 642 $ 11.60 Granted 3 2.08 Cancelled (4) 11.88 Outstanding at March 31, 2018 641 11.58 Exercisable at March 31, 2018 573 $ 10.82 |
Organization and Business - Add
Organization and Business - Additional Information (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | Feb. 08, 2018 | Nov. 03, 2017 | May 21, 2017 | Jun. 30, 2016 | Jun. 30, 2015 | Mar. 31, 2018 | Dec. 31, 2017 | Jun. 13, 2017 | Mar. 31, 2017 | Dec. 31, 2016 |
Organization and Nature of Operations [Line Items] | ||||||||||
Cash | $ 4,284 | $ 5,965 | $ 7,111 | $ 9,375 | ||||||
Stock issued during period, shares, new issues | 588,235 | |||||||||
Proceeds from issuance initial public offering | $ 9,300 | |||||||||
Proceeds from Warrant Exercises | $ 1,500 | |||||||||
Class of Warrant or Right, Exercisable, Number | 441,176 | |||||||||
Class of Warrant or Right, Exercised, Number | 11,176 | |||||||||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Gain (Loss) Included in Earnings | 400 | |||||||||
Gain (Loss) on Extinguishment of Debt | 400 | |||||||||
Reclassified to equity | 200 | |||||||||
Adjustments to Additional Paid in Capital, Dividends in Excess of Retained Earnings | $ 1,000 | |||||||||
Stockholders' Equity, Reverse Stock Split | 1-for-10 | |||||||||
Reduced Exercise Price [Member] | ||||||||||
Organization and Nature of Operations [Line Items] | ||||||||||
Class of Warrant or Right, Exercised, Number | 430,000 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 3.80 | |||||||||
New Warrants [Member] | ||||||||||
Organization and Nature of Operations [Line Items] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 6 | |||||||||
Class of Warrant or Right, Terms | 5 years | |||||||||
Warrants 2016 [Member] | ||||||||||
Organization and Nature of Operations [Line Items] | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 127,941 | |||||||||
Warrant | ||||||||||
Organization and Nature of Operations [Line Items] | ||||||||||
Stock issued during period, shares, new issues | 294,118 | |||||||||
Stock issued during period, value, new issues | $ 10,000 | $ 25,000 | ||||||||
Proceeds from issuance initial public offering | $ 3,600 | |||||||||
2016 Registered Direct Offering | ||||||||||
Organization and Nature of Operations [Line Items] | ||||||||||
Debt Issuance Costs, Net | $ 300 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 25,000 | |||||||||
2017 Registered Direct Offering | ||||||||||
Organization and Nature of Operations [Line Items] | ||||||||||
Stock issued during period, shares, new issues | 1,333,333 | |||||||||
Stock issued during period, value, new issues | $ 4,000 | |||||||||
2017 Registered Direct Offering | Warrant | ||||||||||
Organization and Nature of Operations [Line Items] | ||||||||||
Stock issued during period, shares, new issues | 666,667 | |||||||||
Roth Capital Partners, Llc [Member] | 2017 Registered Direct Offering | Warrant | ||||||||||
Organization and Nature of Operations [Line Items] | ||||||||||
Stock issued during period, shares, new issues | 16,000 |
Prepaid Drug Product for Test17
Prepaid Drug Product for Testing - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Dec. 31, 2017 | |
Inventory Disclosure [Line Items] | ||
Prepaid drug product for testing | $ 1,100 | |
Payments to Suppliers | $ 100 | |
Prepaid Expense, Current | $ 1,256 | 1,117 |
Drug Supplier Project Plan [Member] | ||
Inventory Disclosure [Line Items] | ||
Prepaid Expense, Current | $ 1,300 |
Other Current Assets- Additiona
Other Current Assets- Additional Information (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Other Assets Current | $ 330 | $ 353 |
Acute Myeloid Leukemia | ||
Other Assets Current | 300 | |
Prepaid Expenses | ||
Other Assets Current | $ 300 | $ 400 |
Accounts Payable - Additional I
Accounts Payable - Additional Information (Detail) - USD ($) $ in Millions | Mar. 31, 2018 | Dec. 31, 2017 |
Accounts Payable [Line Items] | ||
Accounts payable | $ 0.1 | $ 0.1 |
Accrued Expenses - Additional I
Accrued Expenses - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Accounts Payable and Accrued Liabilities [Line Items] | ||
Accrued expenses | $ 793 | $ 739 |
Accrued Vacation And Bonus | 200 | 100 |
Accrued Clinical And Preclinical | 400 | 400 |
Accrued License Maintenance Fee | 100 | 100 |
Other Accrued Liabilities | $ 100 | $ 100 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) shares in Thousands, $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Shareholders Equity [Line Items] | ||
Common Stock, shares issued | 11,341 | 11,339 |
Common Stock, shares outstanding | 11,341 | 11,339 |
Stockholders Equity | $ 6,275 | $ 8,067 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | ||
Mar. 31, 2018 | Mar. 31, 2017 | Dec. 31, 2017 | |
Stock Based Compensation Plans [Line Items] | |||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 800 | ||
Stock-based compensation expense | $ 100 | $ 200 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 2 years 1 month 6 days | ||
Research and Development Expense | |||
Stock Based Compensation Plans [Line Items] | |||
Stock-based compensation expense | $ 20,000 | 100 | |
General and Administrative Expense | |||
Stock Based Compensation Plans [Line Items] | |||
Stock-based compensation expense | $ 100 | $ 100 | |
2007 Stock Incentive Plan | |||
Stock Based Compensation Plans [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 1,200,000 |
Weighted Average Assumptions (D
Weighted Average Assumptions (Detail) | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Share Based Compensation Plans [Line Items] | ||
Risk-free interest rate | 2.59% | 2.09% |
Expected volatility | 95.00% | 100.00% |
Expected term in years | 6 years 1 month 6 days | 6 years 1 month 6 days |
Dividend yield | 0.00% | 0.00% |
Option Activity Under Plan (Det
Option Activity Under Plan (Detail) shares in Thousands | 3 Months Ended |
Mar. 31, 2018$ / sharesshares | |
Share Based Compensation Plans [Line Items] | |
Options, Outstanding | shares | 642 |
Options, Granted | shares | 3 |
Options, Cancelled | shares | (4) |
Options, Outstanding | shares | 641 |
Options, Exercisable | shares | 573 |
Weighted - Average Exercise Price, Outstanding | $ / shares | $ 11.6 |
Weighted - Average Exercise Price, Granted | $ / shares | 2.08 |
Weighted - Average Exercise Price, Cancelled | $ / shares | 11.88 |
Weighted - Average Exercise Price, Outstanding | $ / shares | 11.58 |
Weighted - Average Exercise Price, Exercisable | $ / shares | $ 10.82 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | ||
Apr. 30, 2016 | Mar. 31, 2018 | Dec. 31, 2017 | |
Product Liability Contingency [Line Items] | |||
Accounts payable and accrued liabilities | $ 100 | $ 100 | |
Operating Leases, Future Minimum Payments Due | 33,000 | ||
Prepaid Expense, Current | 1,256 | $ 1,117 | |
Other Commitment, Due in Next Twelve Months | 700 | ||
Drug Supplier Project Plan [Member] | |||
Product Liability Contingency [Line Items] | |||
Prepaid Expense, Current | 1,300 | ||
Other Commitment | 1,500 | ||
Manufacturer of Prexigebersen [Member] | |||
Product Liability Contingency [Line Items] | |||
Other Commitment | 900 | ||
Manufacture of Drug Substance [Member] | |||
Product Liability Contingency [Line Items] | |||
Other Commitment | 400 | ||
Manufacturing Development [Member] | |||
Product Liability Contingency [Line Items] | |||
Other Commitment | 200 | ||
Office Space | |||
Product Liability Contingency [Line Items] | |||
Operating Leases, Future Minimum Payments Due | $ 100 | ||
Lab Space | |||
Product Liability Contingency [Line Items] | |||
Operating Lease Monthly Rental Payments | $ 2,500 |