Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 15, 2019 | Jun. 29, 2018 | |
Document and Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2018 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | BIO-PATH HOLDINGS INC | ||
Entity Central Index Key | 0001133818 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Public Float | $ 15,884,741 | ||
Trading Symbol | BPTH | ||
Entity Common Stock, Shares Outstanding | 2,507,239 | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | true |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets | ||
Cash | $ 1,004 | $ 5,965 |
Prepaid drug product for testing | 332 | 1,117 |
Other current assets | 593 | 353 |
Total current assets | 1,929 | 7,435 |
Fixed assets | ||
Furniture, fixtures & equipment | 998 | 984 |
Less accumulated depreciation | (592) | (330) |
Property, Plant and Equipment, Net | 406 | 654 |
Other assets | ||
Technology license | 0 | 2,500 |
Less accumulated amortization | 0 | (1,731) |
Intangible Assets, Net (Excluding Goodwill), Total | 0 | 769 |
Total Assets | 2,335 | 8,858 |
Current liabilities | ||
Accounts payable | 813 | 52 |
Accrued expenses | 304 | 739 |
Total current liabilities | 1,117 | 791 |
Total Liabilities | 1,117 | 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; 680 and 567 shares issued and outstanding, respectively | 1 | 1 |
Additional paid in capital | 48,957 | 47,223 |
Accumulated deficit | (47,740) | (39,157) |
Total shareholders' equity | 1,218 | 8,067 |
Total Liabilities & Shareholders' Equity | $ 2,335 | $ 8,858 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 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 | 680 | 567 |
Common Stock, shares outstanding | 680 | 567 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue | $ 0 | $ 37 |
Operating expenses | ||
Research and development | 4,603 | 5,480 |
General and administrative | 3,379 | 3,523 |
Impairment of technology license | 608 | 0 |
Total operating expenses | 8,590 | 9,003 |
Net operating loss | (8,590) | (8,966) |
Other income (loss) | ||
Change in fair value of warrant liability | 0 | 2,374 |
Loss on extinguishment of warrant liability | 0 | (440) |
Interest income | 7 | 9 |
Total other income | 7 | 1,943 |
Net loss | (8,583) | (7,023) |
Deemed dividend related to warrant conversion | 0 | (1,038) |
Net loss attributable to common stockholders | $ (8,583) | $ (8,061) |
Net loss per share, basic and diluted | $ (14.38) | $ (15.99) |
Basic and diluted weighted average number of common shares outstanding | 597 | 504 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flow from operating activities | ||
Net loss | $ (8,583) | $ (7,023) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Amortization | 161 | 160 |
Depreciation | 265 | 251 |
Stock-based compensation | 554 | 793 |
Impairment of technology license | 608 | 0 |
Change in fair value of warrant liability | 0 | (2,374) |
Loss on extinguishment of warrant liability | 0 | 440 |
(Increase) decrease in assets | ||
Prepaid drug product for testing | 785 | (741) |
Other current assets | (240) | 549 |
Increase (decrease) in liabilities | ||
Accounts payable and accrued expenses | 326 | (12) |
Net cash used in operating activities | (6,124) | (7,957) |
Cash flow from investing activities | ||
Purchases of furniture, fixtures & equipment | (17) | (538) |
Net cash used in investing activities | (17) | (538) |
Cash flow from financing activities | ||
Net proceeds from sale of common stock | 1,180 | 3,567 |
Net proceeds from exercise of warrants | 0 | 1,518 |
Net cash provided by financing activities | 1,180 | 5,085 |
Net decrease in cash | (4,961) | (3,410) |
Cash, beginning of period | 5,965 | 9,375 |
Cash, end of period | 1,004 | 5,965 |
Non-cash financing activities | ||
Warrants transferred to equity upon modification | 0 | 797 |
Conversion of warrant liability to equity | $ 0 | $ 175 |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Beginning Balance at Dec. 31, 2016 | $ 8,240 | $ 0 | $ 40,374 | $ (32,134) |
Beginning Balance (in shares) at Dec. 31, 2016 | 478 | |||
Issuance of common stock, net of fees | 3,567 | $ 1 | 3,566 | |
Issuance of common stock, net of fees (in shares) | 67 | |||
Exercise of warrants | 1,518 | $ 0 | 1,518 | |
Exercise of warrants (in shares) | 22 | |||
Warrants transferred to equity upon modification | 797 | 797 | ||
Conversion of warrant liability to equity | 175 | 175 | ||
Stock-based compensation | 793 | 793 | ||
Deemed dividend related to warrant modification | (1,038) | (1,038) | ||
Modification of warrant exercise price | 1,038 | 1,038 | ||
Net loss | (7,023) | (7,023) | ||
Ending Balance at Dec. 31, 2017 | 8,067 | $ 1 | 47,223 | (39,157) |
Ending Balance (in shares) at Dec. 31, 2017 | 567 | |||
Issuance of common stock, net of fees | 1,180 | $ 0 | 1,180 | |
Issuance of common stock, net of fees (in shares) | 113 | |||
Stock-based compensation | 554 | 554 | ||
Net loss | (8,583) | (8,583) | ||
Ending Balance at Dec. 31, 2018 | $ 1,218 | $ 1 | $ 48,957 | $ (47,740) |
Ending Balance (in shares) at Dec. 31, 2018 | 680 |
Organization and Business
Organization and Business | 12 Months Ended |
Dec. 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 nanoparticle drug development company utilizing a novel technology that achieves systemic delivery for target specific protein inhibition for any gene product that is over-expressed in disease. Our drug delivery and antisense technology, called DNAbilize®, is a platform that uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification that is intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a neutral charged lipid bilayer. We believe this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, Bio-Path Subsidiary was founded in May 2007 as a Utah corporation. In February 2008, Bio-Path Subsidiary completed a reverse merger with the Company, which at the time was traded over the counter and had no current operations. The prior name of Company was changed to Bio-Path Holdings, Inc. and the directors and officers of Bio-Path Subsidiary 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 million of its common stock from time to time, at Bio-Path’s discretion, through an investment banking firm, acting as sales agent. Sales of Bio-Path common stock under the ATM program will be made directly on or through The Nasdaq Capital Market, among other methods. The ATM program may be terminated by either the investment banking firm or the Company upon ten days’ notice. We are subject to certain restrictions on our ability to offer and sell shares of our common stock under the ATM program. To date, the Company has not offered or sold any shares of its common stock under the ATM program. In June 2016, the Company entered into a securities purchase agreement with certain healthcare focused institutional investors pursuant to which the Company agreed to sell an aggregate of 29,412 shares of the Company’s common stock and warrants (the “2016 Registered Warrants”) to purchase up to 14,706 shares of the Company’s common stock for gross proceeds of approximately $10.0 million (the “2016 Registered Direct Offering”). The 2016 Registered Direct Offering closed on July 5, 2016. The Company also issued warrants (the “2016 Placement Warrants,” and together with the 2016 Registered Warrants, the “2016 Warrants”) to purchase up to 1,250 shares of the Company’s common stock in a private placement to H.C. Wainwright & Co., LLC and its designees as compensation for its services as a placement agent in connection with the 2016 Registered Director Offering. In May 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 22,059 shares of our common stock. Pursuant to the Exercise Agreements, the Exercising Holders and the Company agreed that the Exercising Holders would exercise their Original Warrants with respect to 21,500 shares of our common stock underlying such Original Warrants for a reduced exercise price equal to $76.00 per share (the “Reduced Exercise Price”). The Exercising Holders also subsequently exercised their Original Warrants for the remaining 559 shares of our common stock underlying such Original Warrants for the Reduced Exercise Price. In connection with the execution of the Exercise Agreements, we issued to each Exercising Holder a new warrant (each, a “New Warrant”) to purchase shares of our common stock equal to the number of shares of our common stock received by such Exercising Holder upon exercise of such Exercising Holder’s Original Warrants. The terms of the New Warrants are substantially similar to the terms of the Original Warrants, except that the New Warrants (i) became exercisable immediately upon issuance for a period of five years from the closing date of the Exercise Agreements; (ii) have an exercise price equal to $120.00 per share and (iii) included revised language substantially similar to the language in the Warrant Amendments described below regarding fundamental transactions and net cash settlement. As noted below, this modified language results in the New Warrants qualifying for equity treatment on the Company’s Consolidated Balance Sheet. The net proceeds to the Company from the exercise of the New Warrants by the Exercising Holders, after deducting financial advisory fees and expenses and our offering expenses, were approximately $1.5 million. In June 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 6,398 shares of our common stock. The Warrant Amendments provide that (i) the Holders’ right to require the Company to purchase the outstanding warrants upon the occurrence of certain fundamental transactions will not apply if the fundamental transaction is a result of a transaction that has not been approved by the Board of Directors and (ii) in the event the Company does not have an effective registration statement registering the issuance of the underlying shares of our common stock to the Holders, there is no circumstance that would require the Company to net cash settle the outstanding warrants. As such, the changes made in the Warrant Amendments allow for equity treatment of the remaining 2016 Warrants. As a result of the Exercise Agreements and the Warrant Amendments, the Company’s Warrant Liability was extinguished, allowing the New Warrants and the remaining 2016 Warrants, as amended, to be treated as equity for all filings beginning with the quarter ended June 30, 2017. The Exercise Agreements for the 2014 Warrants resulted in the holders receiving $1.0 million in incremental value over the value of the warrants at the exchange date. This incremental value was recorded as a deemed dividend in additional paid-in capital due to the absence of retained earnings and increased the net loss available to common stockholders on the Consolidated Statements of Operations. The Exercise Agreements for the 2016 Warrants resulted in warrants with a fair value of $0.4 million being extinguished and resulted in the recognition of a loss on extinguishment of warrants of $0.4 million. Additionally, the Warrant Amendments resulted in the reclassification of the remaining 2016 Warrants with a fair value of $0.2 million from liability presentation to equity treatment on the Consolidated Balance Sheet. In November 2017, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell an aggregate of 66,667 shares of our common stock and warrants to purchase up to 33,334 shares of our common stock for gross proceeds of approximately $4.0 million under our effective shelf registration statement on Form S-3 (File No. 333-2152051 . We also issued warrants to purchase up to 800 shares of common stock in a private placement to Roth Capital Partners, LLC as compensation for its services as a placement agent in connection with the 2017 Registered Direct Offering. The 2017 Registered Direct Offering closed on November 6, 2017. The net proceeds to the Company from the 2017 Registered Direct Offering, after deducting the placement agent’s fees and expenses and our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offering, were approximately $3.6 million. On September 20, 2018, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell an aggregate of 98,454 shares of our common stock and pre-funded warrants to purchase up to 14,624 shares of our common stock for gross proceeds of approximately $1.5 113,077 shares of our common stock (the “2018 Private Placement”). Additionally, we issued warrants to purchase up to 6,785 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the 2018 Registered Direct Offering and the 2018 Private Placement. The 2018 Registered Direct Offering and the 2018 Private Placement closed on September 25, 2018. The net proceeds to the Company from the offerings, after deducting the placement agent’s fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $1.2 million. On January 14, 2019, we entered into an underwriting agreement with H.C. Wainwright & Co., LLC relating to an underwritten public offering of 429,616 shares of our common stock for gross proceeds of approximately $1.1 million under the 2017 Shelf Registration Statement (the “2019 Underwritten Offering”). The offering price to the public in the 2019 Underwritten Offering was $2.60 per share, and H.C. Wainwright & Co., LLC agreed to purchase the shares in the 2019 Underwritten Offering from the Company pursuant to the underwriting agreement at a price of $2.418 per share. Additionally, we issued warrants to purchase up to 25,777 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as underwriter in connection with the 2019 Underwritten Offering. The 2019 Underwritten Offering closed on January 17, 2019. The net proceeds to the Company from the 2019 Underwritten Offering, after deducting the underwriting discounts and commissions and expenses and the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the underwriter warrants, were approximately $0.9 million. On January 17, 2019, we effected a reverse stock split of our outstanding shares of common stock at a ratio of 1-for-20, and our common stock began trading on the split-adjusted basis on the Nasdaq Capital Market at the commencement of trading on January 18, 2019. All common stock share and per share amounts in our consolidated financial statements have been adjusted to give effect to the 1-for-20 reverse stock split. On January 18, 2019, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 648,233 shares of our common stock for gross proceeds of approximately $1.7 million under the 2017 Shelf Registration Statement (the “January 2019 Registered Direct Offering”). In a concurrent private placement, we also agreed pursuant to the securities purchase agreement to issue to such investors Series A warrants to purchase up to 324,117 shares of our common stock (the “January 2019 Private Placement”). Additionally, we issued warrants to purchase up to 38,894 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the 2019 Registered Direct Offering and the 2019 Private Placement. The 2019 Registered Direct Offering and the 2019 Private Placement closed on January 23, 2019. The net proceeds to the Company from the offerings, after deducting the placement agent’s fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $1.5 million. On March 12, 2019, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 712,910 shares of our common stock for gross proceeds of approximately $18.5 million under the 2017 Shelf Registration Statement (the “March 2019 Registered Direct Offering”). Additionally, we issued warrants to purchase up to 42,775 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the March 2019 Registered Direct Offering. The March 2019 Registered Direct Offering closed on March 14, 2019. The net proceeds to us from the offerings, after deducting the placement agent’s fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $17.0 million. 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Principles of Consolidation — The consolidated financial statements include the accounts of Bio-Path Holdings, Inc., and its wholly-owned subsidiary Bio-Path, Inc. All intercompany accounts and transactions have been eliminated in consolidation. Revenue Recognition — ® $ 50,000 50,000 Cash and Cash Equivalents — The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Concentration of Credit Risk — Financial instruments that potentially subject us to a significant concentration of credit risk consist of cash. The Company maintains its cash balances with one major commercial bank, JPMorgan Chase Bank. The balances are insured by the Federal Deposit Insurance Corporation (the “FDIC”) up to $250,000. As a result, as of December 31, 2018, approximately $0.8 million of our cash balances was not covered by the FDIC. As of December 31, 2017, we had approximately $6.0 million in cash on-hand, of which approximately $5.7 million was not covered by the FDIC. To date, the Company has not incurred any losses on its cash balances. Furniture, fixtures and equipment — Furniture, fixtures and equipment are stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets. Depreciation expense was $0.3 million for both the years ended December 31, 2018 and 2017, respectively. The estimated useful lives are as follows: Computers and equipment – 3 years Furniture and fixtures – 7 years Scientific equipment –7 years Leasehold improvements – Lesser of useful life or lease term Major additions and improvements are capitalized, while costs for minor replacements, maintenance, and repairs that do not increase the useful life of an asset are expensed as incurred. Long Lived Assets — Our long-lived assets consist of furniture, fixtures and equipment, leasehold improvements and a technology license. Long lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of the asset is measured by a comparison of the asset’s carrying amount to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated undiscounted future cash flows, an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. Intangible Assets/Impairment of Long-Lived Assets — Long-lived assets are reviewed for events of changes in circumstances which indicate that their carrying value may not be recoverable. The license agreement was mutually terminated on December 18, 2018, and the Company fully impaired the license as of December 31, 2018. The Company did not have any impairments in 2017. As of December 31, 2017, other assets totaled $0.8 million, comprised of $2.5 million in value acquiring our technology license and our intellectual property, less accumulated amortization of $1.7 million. Research and Development Costs — Costs and expenses that can be clearly identified as research and development are charged to expense. Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future research and 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. If the goods will not be delivered, or services will not be rendered, then the capitalized advance payment is charged to expense. The Company estimates its clinical trial expense accrual each period based on a cost per patient calculation which is derived from estimated start-up costs, clinical trial costs based on the number of patients and length of the study and clinical study report costs. These services are performed by the Company’s third-party clinical research organizations, laboratories and clinical investigative sites. The expense accrual is recorded in research and development expense each period. Amounts that have been prepaid in advance of work performed are recorded in other current assets. For the years ended December 31, 2018 and 2017, we had $4.6 million and $5.5 million of costs classified as research and development expense, respectively. Stock-Based Compensation — The Company has accounted for stock-based compensation under the provisions of generally accepted accounting principles (“GAAP”). The provisions require us to record an expense associated with the fair value of stock-based compensation. We currently use the Black-Scholes option valuation model to calculate stock-based compensation at the date of grant. Option pricing models require the input of highly subjective assumptions, including the expected price volatility. Changes in these assumptions can materially affect the fair value estimate. Net Loss Per Share — Basic net loss per common share is computed by dividing net loss attributable to common stockholders for the period by the weighted average number of common shares outstanding during the period. Although there were warrants and stock options outstanding during 2018 and 2017, no potential common shares shall be included in the computation of any diluted per-share amount when a loss exists, as it would be anti-dilutive. Consequently, diluted net loss per share as presented in the financial statements is equal to basic net loss per share for the years 2018 and 2017. The calculation of diluted earnings per share for 2018 did not include 15,286 shares and 183,714 shares issuable pursuant to the exercise of vested common stock options and outstanding warrants, respectively, as of December 31, 2018 as the effect would be anti-dilutive. The calculation of diluted earnings per share for 2017 did not include 28,102 shares and 63,889 shares issuable pursuant to the exercise of vested common stock options and outstanding warrants, respectively, as of December 31, 2017 as the effect would be anti-dilutive. Use of Estimates — The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States (“U.S.”) requires management to make estimates and assumptions that affect the amounts reported in the Company’s consolidated financial statements and accompanying notes. On an ongoing basis, the Company evaluates its estimates and judgments, which are based on historical and anticipated results and trends as well as on various other assumptions that the Company believes to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from the Company’s estimates. These estimates include accrued clinical trial costs, stock-based compensation expense, valuation of warrants and valuation of deferred tax assets. Income Taxes — Deferred income tax assets and liabilities are determined based upon differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Liquidity — Since its inception, the Company has devoted substantially all of its efforts to product development, raising capital and building infrastructure, and has not generated significant revenues from its planned principal operations. The Company does not anticipate generating significant revenues for the foreseeable future. The Company’s activities are subject to significant risks and uncertainties. The Company has experienced significant losses since its inception, including net losses of $8.6 million and $7.0 million for the years ended December 31, 2018 and 2017, respectively. As of December 31, 2018, the Company had an accumulated deficit of $47.7 million and $1.0 million in cash and cash equivalents. The Company has no debt commitments. Substantially all of the Company’s net losses have resulted from costs incurred in connection with its research and development activities and its general and administrative expenses to support operations. The Company’s net losses may fluctuate significantly from quarter to quarter and year to year. The Company expects to continue to incur net losses for the foreseeable future in connection with its ongoing activities, including conducting clinical trials, manufacturing development and seeking regulatory approval of its drug candidates, prexigebersen, BP1002 and BP1003. Accordingly, the Company will continue to require substantial additional capital to fund its projected operating requirements. Such additional capital may not be available when needed or on terms favorable to the Company. In addition, the Company may seek additional capital due to favorable market conditions or strategic considerations, even if it believes it has sufficient funds for our current and future operating plan. There can be no assurance that the Company will be able to continue to raise additional capital through the sale of securities in the future. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, financial condition and future prospects. Recent Accounting Pronouncements — that are adopted by the Company as of the specified effective date. If not discussed, management believes that the impact of recently issued standards, which are not yet effective, will not have a material impact on the Company’s consolidated financial statements upon adoption. In May 2014, 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 Lease-Targeted Improvements (Topic 842). In May 2017, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation: Scope of Modification Accounting . The new standard requires an entity to apply modification accounting provisions if the value, vesting conditions or classification of the award changes. The new guidance must be applied on a prospective basis and is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years, with early adoption permitted. The Company adopted the standard on January 1, 2018 on a prospective basis and determined that it did not have a significant impact on our consolidated financial statements In July 2017, the FASB issued ASU No. 2017-11 , Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. Part I of the new standard applies to entities that issue financial instruments such as warrants, convertible debt or convertible preferred stock that contain down round features. The ASU allows companies to exclude a down round feature when determining whether a financial instrument (or embedded conversion feature) is considered indexed to the entity’s own stock. As a result, financial instruments (or embedded conversion features) with down round features may no longer be required to be classified as liabilities. A company will recognize the value of a down round feature only when it is triggered and the strike price has been adjusted downward. Part II of the new standard replaces the indefinite deferrals for certain mandatorily redeemable noncontrolling interests and mandatorily redeemable financial instruments of nonpublic entities. ASU 2017-11 is effective for annual reporting periods beginning after December 15, 2018, including interim periods within those fiscal years, with early adoption permitted. Management early adopted the new standard during fiscal year 2017 and notes the adoption did not have a significant impact on the Company’s consolidated financial statements. In June 2018, the FASB issued ASU No. 2018-07, Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. The new standard simplifies the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees. Equity-classified share-based payments issued to nonemployees will be measured on the grant date instead of being remeasured through the performance completion date as required under the current guidance. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, with early adoption permitted. The Company early adopted this standard effective June 30, 2018 and notes the adoption did not have a significant impact on the Company’s consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement . The new standard eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. This standard is effective for fiscal years beginning after December 15, 2019, with early adoption permitted. Management is currently evaluating the impact of future adoption of the new standard on the Company’s consolidated financial statements. In August 2018, the SEC adopted the final rule under SEC Release No. 33-10532, Disclosure Update and Simplification , amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements on the analysis of stockholders' equity for interim financial statements. Under the amendments, an analysis of changes in each caption of stockholders' equity presented in the balance sheet must be provided in a note or separate statement. The analysis should present a reconciliation of the beginning balance to the ending balance of each period for which a statement of comprehensive income is required to be filed. The Company anticipates its first presentation of changes in shareholders' equity will be included in its Form 10-Q for the first quarter of fiscal year 2019. In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606. The new standard provides guidance on how to assess whether certain transactions between collaborative arrangement participants should be accounted for within the revenue recognition standard. The update also provides more comparability in the presentation of revenue for certain transactions between collaborative arrangement participants. The new standard is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years with early adoption permitted. The Company early adopted this standard effective December 31, 2018 and notes that it did not a significant impact on our consolidated financial statements as the Company currently does not have significant collaborative agreements in place. 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 | 12 Months Ended |
Dec. 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 totaling $1.1 million in late 2016 and all of 2017 pursuant to drug supply contracts for the manufacture and delivery of prexigebersen for testing in two Phase 2 clinical trials and Bcl-2 for testing in a Phase 1 clinical trial. This amount was carried on the Balance Sheet as of December 31, 2017 at cost as Prepaid Drug Product for Testing. The Company recognized certain expenses and incurred additional installment costs during 2018, with advanced payments totaling $0.3 million, which are carried on the Balance Sheet as of December 31, 2018 as Prepaid Drug Product for Testing (See Note 13). |
Other Current Assets
Other Current Assets | 12 Months Ended |
Dec. 31, 2018 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Other Current Assets | 4. Other Current Assets As of December 31, 2018, Other Current Assets included prepaid expenses of $0.6 $0.1 million and other prepaid expenses of $0.1 million. As of December 31, 2017, Other Current Assets included prepaid expenses of $0.4 million, comprised primarily of prepayments made to the Company’s clinical research organization for our clinical trial for prexigebersen in CML of $0.2 million, prepaid insurance of $0.1 million and other prepaid expenses of $0.1 million |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment Disclosure | 5. Property and Equipment The following table summarizes property and equipment as of December 31, 2018 and 2017: December 31, Estimated Useful Lives 2018 2017 (in years) (in thousands) Leasehold improvements 2 to 3 $ 432 $ 432 Computers and office equipment 3 60 63 Furniture and fixtures 7 46 46 Scientific equipment 7 460 443 Total 998 984 Less: Accumulated depreciation (592 ) (330 ) Net property and equipment $ 406 $ 654 |
Accounts Payable
Accounts Payable | 12 Months Ended |
Dec. 31, 2018 | |
Accounts Payable Disclosure [Abstract] | |
Accounts Payable | 6. Accounts Payable As of December 31, 2018, Current Liabilities included accounts payable of $0.8 million, comprised primarily of amounts owed to the Company’s clinical research organizations for our clinical trials for prexigebersen in AML and CML of $0.3 million, preclinical expenses of $0.2 million, an annual license maintenance fee of $0.1 million, manufacturing costs of $0.1 million and other payables of $0.1 million. As of December 31, 2017, Current Liabilities included accounts payable of $0.1 million. |
Accrued Expense
Accrued Expense | 12 Months Ended |
Dec. 31, 2018 | |
Accrued Liabilities [Abstract] | |
Accrued Expense | 7. Accrued Expense As of December 31, 2018, Current Liabilities included accrued expenses of $0.3 million, comprised primarily of accrued preclinical expenses of $0.1 million, employee vacation and bonus expenses of $0.1 million and legal and professional fees of $0.1 million. As of December 31, 2017, Current Liabilities included accrued expenses of $0.7 million, comprised primarily of accrued clinical and preclinical expenses of $0.4 million, employee vacation and bonus expenses of $0.1 million, an annual license maintenance fee of $0.1 million and other accrued expenses of $0.1 million. |
Warrant Liability
Warrant Liability | 12 Months Ended |
Dec. 31, 2018 | |
Derivative Liability [Abstract] | |
Warrant Liability | 8. Warrant Liability In connection with the 2016 Registered Direct Offering, the Company issued warrants to purchase up to 14,706 shares of the Company’s common stock at $460.00 per share to certain healthcare focused institutional investors, as well as warrants to purchase up to 1,250 shares of the Company’s common stock at $492.00 per share to H.C. Wainwright & Co., LLC and its designees as compensation for its services as the placement agent. When issued, the 2016 Warrants contained a provision for net cash settlement in the event of certain fundamental transactions involving the Company (defined in the 2016 Warrants to include, among other things, the Company’s approval and consummation of a merger with another entity, the Company’s approval and consummation of the sale of all or substantially all of the Company’s assets or the occurrence of certain other change of control transactions). Due to this provision and in accordance with ASC 480-10 (Distinguishing Liabilities from Equity), the 2016 Warrants were classified as a liability and recorded at fair value as calculated using the Binomial Lattice Model. As discussed in Note 1, certain of the 2016 Warrants were extinguished in 2017 as a result of the Exercise Agreements and resulted in recognition of a loss on extinguishment of warrants of $0.4 million. Additionally, warrants with a fair value of $0.2 million were reclassified to equity as a result of the Warrant Amendments. For the years ended December 31, 2018 and 2017, the net change in fair value of the 2016 Warrants of none and $2.4 million respectively, are shown as other income on the Company’s Consolidated Statements of Operations. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 9. Fair Value Measurements In accordance with ASC 820 (Fair Value Measurements and Disclosures), the Company uses various inputs to measure the 2016 Warrants on a recurring basis to determine the fair value of the liability. ASC 820 also establishes a hierarchy categorizing inputs into three levels used to measure and disclose fair value. The hierarchy gives the highest priority to quoted prices available in active markets and the lowest priority to unobservable inputs. An explanation of each level in the hierarchy is described below: Level 1 – Unadjusted quoted prices in active markets for identical instruments that are accessible by the Company on the measurement date Level 2 – Quoted prices in markets that are not active or inputs which are either directly or indirectly observable Level 3 – Unobservable inputs for the instrument requiring the development of assumptions by the Company The Company’s Warranty Liability was extinguished as of June 30, 2017 (See Note 1). The following table summarizes changes to the fair value of the Level 3 2016 Warrants for the year ended December 31, 2017: Fair Value of Warrant Liability (in thousands) Balance at December 31, 2016 $ 2,906 Change in fair value (2,374 ) Extinguished (357 ) Reclassified to equity (175 ) Balance at December 31, 2017 $ - The Company utilized the Binomial Lattice Model for estimating the fair value of the 2016 Warrants using the following assumptions on the reclassification dates of June 13, 2017 and May 21, 2017 and as of December 31, 2016: As of June 13, 2017 As of May 21, 2017 As of December 31, 2016 Risk-free interest rate 1.51 % 1.78 % 1.93 % Expected volatility 88 % 89 % 98 % Expected term in years 4.6 4.6 5.0 Dividend yield - % - % - % |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | 10. Stockholders’ Equity Issuances of Common Stock – On November 3, 2017, the Company entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell an aggregate of 66,667 shares of our common stock and warrants to purchase up to 33,334 shares of our common stock for gross proceeds of approximately $4.0 million under the 2017 Registration Statement. We also issued warrants to purchase up to 800 shares of common stock in a private placement to Roth Capital Partners, LLC as compensation for its services as a placement agent in connection with the 2017 Registered Direct Offering. The 2017 Registered Direct Offering closed on November 6, 2017. The net proceeds to the Company from the 2017 Registered Direct Offering, after deducting the placement agent’s fees and expenses and our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offering, were approximately $3.6 million. On September 20, 2018, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 98,454 shares of our common stock and pre-funded warrants to purchase up to 14,624 shares of our common stock for gross proceeds of approximately $1.5 million under the 2017 Shelf Registration Statement (the “2018 Registered Direct Offering”). In a concurrent private placement, we also agreed pursuant to the securities purchase agreement to issue to such investors Series A warrants to purchase up to 113,077 shares of our common stock (the “2018 Private Placement”). Additionally, we issued warrants to purchase up to 6,785 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the 2018 Registered Direct Offering and the 2018 Private Placement. The 2018 Registered Direct Offering and the 2018 Private Placement closed on September 25, 2018. The net proceeds to the Company from the offerings, after deducting the placement agent’s fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $1.2 million. Warrant Exercises – On May 21, 2017, the Company entered into the Exercise Agreements with the Exercising Holders of the Original Warrants to purchase up to 12,500 shares of common stock that we issued in January 2014. The Exercising Holders owned, in the aggregate, Original Warrants exercisable for 22,059 shares of our common stock. Pursuant to the Exercise Agreements, the Exercising Holders and the Company agreed that the Exercising Holders would exercise their Original Warrants with respect to 21,500 shares of our common stock underlying such Original Warrants for a reduced exercise price equal to $76.00 per share. The Exercising Holders also subsequently exercised their Original Warrants for the remaining 559 shares of our common stock underlying such Original Warrants for the Reduced Exercise Price. In connection with the execution of the Exercise Agreements, we issued to each Exercising Holder a New Warrant to purchase shares of our common stock equal to the number of shares of our common stock received by such Exercising Holder upon exercise of such Exercising Holder’s Original Warrants. The terms of the New Warrants are substantially similar to the terms of the Original Warrants, except that the New Warrants (i) became exercisable immediately upon issuance for a period of five years from the closing date of the Exercise Agreements; (ii) have an exercise price equal to $120.00 per share and (iii) included revised language substantially similar to the language in the Warrant Amendments described above regarding fundamental transactions and net cash settlement. The net proceeds to the Company from the exercise of the New Warrants by the Exercising Holders, after deducting financial advisory fees and expenses and our offering expenses, were approximately $1.5 million. Stockholders’ Equity totaled $0.7 million as of December 31, 2018 compared to $8.1 million as of December 31, 2017. There were 680,115 shares of common stock issued and outstanding as of December 31, 2018. There were no preferred shares outstanding as of December 31, 2018. |
Stock-Based Compensation Plan
Stock-Based Compensation Plan | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation Plans | 11. Stock-Based Compensation Plan 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,” and together with the 2017 Plan, the “Plans”). 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, 2018, the total number of shares reserved and available for grant and issuance pursuant to the 2017 Plan is 60,000 shares, subject to the terms of the 2017 Plan. Under the 2017 Plan, the exercise price of awards is determined by the Board of Directors or the compensation committee of the Board of Directors, and for options intended to qualify as qualified Incentive Stock Options, may not be less than the fair market value as determined by the closing stock price at the date of the grant. Each option and award under the 2017 Plan shall vest and expire as determined by the Board of Directors or the compensation committee. Options expire no later than ten years from the date of grant. All grants provide for accelerated vesting if there is a change of control, as defined in the 2017 Plan. Stock option awards granted for the years 2018 and 2017 were estimated to have a weighted average fair value per share of $26.55 and $120.00, respectively. The fair value calculation is based on stock options granted during the year using the Black-Scholes option-pricing model on the date of grant. In addition, for all stock options granted, exercise price was determined based on the fair market value as determined by the closing stock price at the date of the grant. For stock options granted during 2018 and 2017 the following weighted average assumptions were used in determining fair value: 2018 2017 Risk-free interest rate 2.70 % 2.06 % Expected volatility 90 % 99 % Expected term in years 6.1 6.1 Dividend yield - % - % The Company determines the expected term of its stock option awards using the simplified method based on the weighted average of the length of the vesting period and the term of the exercise period. Expected volatility is determined by the volatility of the Company’s historical stock price over the expected term of the grant. The risk-free interest rate for the expected term of each option granted is based on the U.S. Treasury yield curve in effect at the time of grant. Option activity under the Plans for the year ended December 31, 2018, was as follows (in thousands, except as noted): Weighted Weighted- Average Average Remaining Aggregate Exercise Contractual Intrinsic Options Price Term Value (per share) (in years) Year Ended December 31, 2018 Outstanding at December 31, 2017 32 $ 232.00 4.0 $ - Granted 20 34.60 9.3 Forfeited - - Expired (15 ) 267.20 Outstanding at December 31, 2018 37 $ 112.60 7.5 $ - Vested and expected to vest December 31, 2018 31 $ 124.60 7.2 $ - Exercisable at December 31, 2018 15 $ 181.00 5.1 $ - The aggregate intrinsic value represents the total pretax intrinsic value (the difference between the Company’s closing stock price on December 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 December 31, 2018. This amount changes based on the fair market value of the Company’s stock. Option activity under the Plans for the year ended December 31, 2017, was as follows (in thousands, except as noted): Weighted Weighted- Average Average Remaining Aggregate Exercise Contractual Intrinsic Options Price Term Value (per share) (in years) Year Ended December 31, 2017 Outstanding at December 31, 2016 35 $ 266.00 5.2 $ 2,241 Granted 3 150.00 9.3 Forfeited (4 ) 330.00 Expired (2 ) 426.00 Outstanding at December 31, 2017 32 $ 232.00 4.0 $ - Vested and expected to vest December 31, 2017 31 $ 230.00 3.8 $ - Exercisable at December 31, 2017 28 $ 214.00 3.3 $ - The aggregate intrinsic value represents the total pretax intrinsic value (the difference between the Company’s closing stock price on December 31, 2017 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 December 31, 2017. This amount changes based on the fair market value of the Company’s stock. Stock-Based Compensation Expense – Total stock-based compensation expense for the year ended 2018 was $0.6 million which consisted of research and development expense of $0.1 million and general and administrative expense of $0.5 million. As of December 31, 2018, future stock-based compensation expense for all outstanding unvested options was $0.8 million, which is expected to be recognized over a weighted-average vesting period of 2.0 years. Total stock-based compensation expense for the year ended 2017 was $0.8 million which consisted of research and development expense of $0.3 million and general and administrative expense of $0.5 million. |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2018 | |
Derivative Financial Instruments Indexed to, and Potentially Settled in, Entity's Own Stock [Abstract] | |
Warrants | 12. Warrants A summary of warrants outstanding and exercisable as of December 31, 2018 (in thousands, except as noted): Warrants Outstanding Warrants Exercisable Weighted Average Weighted Weighted Remaining Average Average Number Contractual Exercise Number Exercise Year Issued Outstanding Life Price Exercisable Price (in years) (per share) (per share) 2014 1 0.1 $ 948.00 1 $ 948.00 2016 6 3.0 466.26 6 466.26 2017 (Note 10) 56 3.7 55.63 56 55.63 2018 (Note 10) 120 5.2 19.20 - - 183 4.6 $ 52.24 63 $ 114.28 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 13. Commitments and Contingencies Operating Lease – In April 2014, the Company entered into a five-year lease agreement for administrative office space located in Bellaire, Texas. The term of the lease began on August 1, 2014 and terminates on July 31, 2019. The remaining lease payments due under this lease as of December 31, 2018 are $0.1 million. 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 requires Bio-Path to pay $2,500 per month over the term of the lease. In December 2018, we entered into an amendment to the agreement with the term of the extension beginning on May 1, 2019 and terminating on April 30, 2022 and will require Bio-Path to pay $2,575 per month over the term. The remaining lease payments due under the original lease and the lease extension as of December 31, 2018 are $0.1 million. A summary of future payments under operating leases as of December 31, 2018: For the Year Ending December 31, (in thousands) 2019 $ 82 2020 31 2021 31 2022 10 Total $ 154 Drug Supplier Project Plan – The amounts paid for manufacture of the Company’s Grb2 drug substance, prexigebersen, Bcl-2 drug substance and BP1002 drug product that have not been expensed total $0.3 million and are carried on the balance sheet as of December 31, 2018 as Prepaid Drug Product for Testing (See Note 3). Total commitments for the Company’s drug supplier project plan are $1.6 million as of December 31, 2018, comprised of $1.0 million to the manufacturer of prexigebersen and BP1002, $0.5 million for manufacture of our Grb2 and Bcl-2 drug substance and $0.1 million for manufacturing development. We expect to incur $1.0 million of these commitments over the next 12 months. |
Benefit Plan
Benefit Plan | 12 Months Ended |
Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |
Compensation and Employee Benefit Plans | 14. Benefit Plan The Company initiated a contribution savings plan under Section 401(k) of the Internal Revenue Code in 2016. Under the plan, all eligible employees may contribute up to the statutory allowable amount governed by the Internal Revenue Service for any calendar year. We make matching contributions equal to 100% of the first 3% and 50% of the next 2% of each employee’s base salary up to the allowable amount which is fully vested on the date the matching contributions are made. For the years ended December 31, 2018 and 2017, matching contributions totaled $35,000 and $47,000, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 15. Income Taxes At December 31, 2018, the Company had a net operating loss carryforward for federal income tax purposes of $43.8 million, $35.8 million of which begins to expire in varying amounts in tax year 2026. $8.0 million of net operating losses, incurred after December 31, 2017, carryforward indefinitely. During the years ended December 31, 2018 and 2017, the Company raised additional equity capital. IRC Section 382 imposes certain limitations on the use of a net operating losses to offset future taxable income when an ownership change has occurred. The Company has yet to determine whether an ownership change occurred in 2018 or 2017. If an ownership change is determined to have occurred, additional limitations on the Company’s net operating losses incurred prior to the ownership change may apply. The Company has a research and development tax credit carryforward of $1.8 million for federal income tax purposes that begins to expire in varying amounts in tax year 2028. In assessing the ability to realize its deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers evidence such as the reversal of deferred tax liabilities, projected future results of operations, and tax planning strategies in making this assessment. Based upon the level of historical taxable income, significant book losses during the current and prior periods, and projections for future results of operations over the periods in which the deferred tax assets are deductible, among other factors, management continues to conclude that the Company does not meet the “more likely than not” requirement of ASC 740 in order to recognize deferred tax assets. As such, a valuation allowance has been recorded to offset the Company’s net deferred tax assets at December 31, 2018. The Company recorded an increase in the valuation allowance of $1.8 million for the year ended December 31, 2018. On December 22, 2017, the U.S. enacted the Tax Cuts and Jobs Act (the “2017 Tax Act”). The 2017 Tax Act significantly changes corporate income tax laws in the U.S. including reducing the corporate income tax rate from a maximum of 35% to a flat rate of 21%, effective January 1, 2018. As a result of the reduction in the corporate income tax rate under the 2017 Tax Act, an adjustment was recorded in 2017 to the deferred tax asset of $4.9 million. Due to the uncertainty surrounding the realization of the benefits of its deferred assets, including NOL carryforwards, the Company has provided a 100% valuation allowance on its deferred tax assets at December 31, 2018 and 2017. $11.4 million and $9.5 The components of the Company’s deferred tax asset are as follows: December 31, 2018 2017 (in thousands) Deferred tax assets – non-current Accrued bonuses $ 12 $ - Accrued vacation 15 17 Net operating loss (NOL) carryover 9,191 7,516 Technology license amortization - 36 Research & development tax credits 1,780 1,542 Share based expense 310 387 Other 5 5 Fixed asset depreciation 50 15 Total deferred tax asset 11,363 9,518 Less: valuation allowance (11,363 ) (9,518 ) Net deferred tax asset - - Deferred tax liability- non-current - - Net deferred tax asset $ - $ - Reconciliation between income taxes at the statutory tax rate (21% to 34%) and the actual income tax provision for continuing operations follows: December 31, 2018 2017 2016 (in thousands) Loss before income taxes $ (8,583 ) $ (7,023 ) $ (6,750 ) Tax (benefit) at statutory tax rate (1,802 ) (2,388 ) (2,295 ) Effects of: Exclusion of incentive stock option expense 47 86 117 R&D tax credits (238 ) (283 ) (252 ) Increase (decrease) in valuation allowance 1,845 (1,447 ) 3,001 FMV of warrants - (658 ) (582 ) Prior year adjustments - 5 6 Carryforward adjustment 2 (252 ) 5 Stock option forfeitures 146 - - Rate change on net deferred tax asset - 4,937 - Provision for income taxes $ - $ - $ - As of December 31, 2018, the Company had no unrecognized income tax benefits. The Company’s policy for classifying interest and penalties associated with unrecognized income tax benefits is to include such items as tax expense. No interest or penalties have been recorded as of the year ended December 31, 2018, and no interest or penalties have been accrued as of December 31, 2018 and 2017. The Company’s open years for Internal Revenue Service (IRS) examination purposes due to normal statute of limitation are 2015, 2016 and 2017. However, since the Company has operating loss carryforwards, the IRS has the ability to make adjustments to items that originate in a year otherwise barred by the statute of limitations under Section 6501 of the Internal Revenue Code of 1986, as amended (the “code”), in order to redetermine tax for an open year to which those items are carried. Therefore, in a year in which a net operating loss deduction was claimed, the IRS may examine the year in which the net operating loss was generated and adjust it accordingly for purposes of assessing additional tax in the year the net operating loss was claimed. The Company is not currently under examination by the IRS or any other taxing authorities. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | 16. Subsequent Events On January 14, 2019, the Company entered into an underwriting agreement with H.C. Wainwright & Co., LLC relating to an underwritten public offering of 429,616 shares of our common stock for gross proceeds of approximately $1.1 million under the 2017 Shelf Registration Statement. The offering price to the public in the 2019 Underwritten Offering was $2.60 per share, and H.C. Wainwright & Co., LLC agreed to purchase the shares in the 2019 Underwritten Offering from the Company pursuant to the underwriting agreement at a price of $2.418 per share. Additionally, we issued warrants to purchase up to 25,777 shares of our common stock in a private placement to the H.C. Wainwright & Co., LLC as compensation for its services as underwriter in connection with the 2019 Underwritten Offering. The 2019 Underwritten Offering closed on January 17, 2019. The net proceeds to the Company from the 2019 Underwritten Offering, after deducting the underwriting discounts and commissions and expenses and the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the underwriter warrants, were approximately $0.9 million. On January 17, 2019, the Company effected a reverse stock split of our outstanding shares of common stock at a ratio of 1-for-20, and our common stock began trading on the split-adjusted basis on The Nasdaq Capital Market at the commencement of trading on January 18, 2019 (See Note 1). On January 18, 2019, the Company entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 648,233 shares of our common stock for gross proceeds of approximately $1.7 million under the 2017 Shelf Registration Statement. In a concurrent private placement, we also agreed pursuant to the securities purchase agreement to issue to such investors Series A warrants to purchase up to 324,117 shares of our common stock. Additionally, we issued warrants to purchase up to 38,894 $1.5 million. On March 12, 2019, we entered into a securities purchase agreement with certain investors pursuant to which we agreed to sell, in a registered direct offering, an aggregate of 712,910 shares of our common stock for gross proceeds of approximately $18.5 million under our effective shelf registration statement on Form S-3 (File No. 333-215205), which became effective on January 9, 2017. Additionally, we issued warrants to purchase up to 42,775 shares of our common stock in a private placement to H.C. Wainwright & Co., LLC as compensation for its services as a placement agent in connection with the March 2019 Registered Direct Offering. The March 2019 Registered Direct Offering closed on March 14, 2019. The net proceeds to us from the offerings, after deducting the placement agent’s fees and expenses, our offering expenses, and excluding the proceeds, if any, from the exercise of the warrants issued in the offerings, were approximately $17.0 million. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation — The consolidated financial statements include the accounts of Bio-Path Holdings, Inc., and its wholly-owned subsidiary Bio-Path, Inc. All intercompany accounts and transactions have been eliminated in consolidation. |
Revenue Recognition | Revenue Recognition — ® $ 50,000 50,000 |
Cash and Cash Equivalents | Cash and Cash Equivalents — The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. |
Concentration of Credit Risk | Concentration of Credit Risk — Financial instruments that potentially subject us to a significant concentration of credit risk consist of cash. The Company maintains its cash balances with one major commercial bank, JPMorgan Chase Bank. The balances are insured by the Federal Deposit Insurance Corporation (the “FDIC”) up to $250,000. As a result, as of December 31, 2018, approximately $0.8 million of our cash balances was not covered by the FDIC. As of December 31, 2017, we had approximately $6.0 million in cash on-hand, of which approximately $5.7 million was not covered by the FDIC. To date, the Company has not incurred any losses on its cash balances. |
Furniture, fixtures and equipment | Furniture, fixtures and equipment — Furniture, fixtures and equipment are stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets. Depreciation expense was $0.3 million for both the years ended December 31, 2018 and 2017, respectively. The estimated useful lives are as follows: Computers and equipment – 3 years Furniture and fixtures – 7 years Scientific equipment –7 years Leasehold improvements – Lesser of useful life or lease term Major additions and improvements are capitalized, while costs for minor replacements, maintenance, and repairs that do not increase the useful life of an asset are expensed as incurred. |
Long-Lived Assets | Long Lived Assets — Our long-lived assets consist of furniture, fixtures and equipment, leasehold improvements and a technology license. Long lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of the asset is measured by a comparison of the asset’s carrying amount to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated undiscounted future cash flows, an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. |
Intangible Assets | Intangible Assets/Impairment of Long-Lived Assets — Long-lived assets are reviewed for events of changes in circumstances which indicate that their carrying value may not be recoverable. The license agreement was mutually terminated on December 18, 2018, and the Company fully impaired the license as of December 31, 2018. The Company did not have any impairments in 2017. As of December 31, 2017, other assets totaled $0.8 million, comprised of $2.5 million in value acquiring our technology license and our intellectual property, less accumulated amortization of $1.7 million. |
Research and Development Costs | Research and Development Costs — Costs and expenses that can be clearly identified as research and development are charged to expense. Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future research and 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. If the goods will not be delivered, or services will not be rendered, then the capitalized advance payment is charged to expense. The Company estimates its clinical trial expense accrual each period based on a cost per patient calculation which is derived from estimated start-up costs, clinical trial costs based on the number of patients and length of the study and clinical study report costs. These services are performed by the Company’s third-party clinical research organizations, laboratories and clinical investigative sites. The expense accrual is recorded in research and development expense each period. Amounts that have been prepaid in advance of work performed are recorded in other current assets. For the years ended December 31, 2018 and 2017, we had $4.6 million and $5.5 million of costs classified as research and development expense, respectively. |
Stock-Based Compensation | Stock-Based Compensation — The Company has accounted for stock-based compensation under the provisions of generally accepted accounting principles (“GAAP”). The provisions require us to record an expense associated with the fair value of stock-based compensation. We currently use the Black-Scholes option valuation model to calculate stock-based compensation at the date of grant. Option pricing models require the input of highly subjective assumptions, including the expected price volatility. Changes in these assumptions can materially affect the fair value estimate. |
Net Loss Per Share | Net Loss Per Share — Basic net loss per common share is computed by dividing net loss attributable to common stockholders for the period by the weighted average number of common shares outstanding during the period. Although there were warrants and stock options outstanding during 2018 and 2017, no potential common shares shall be included in the computation of any diluted per-share amount when a loss exists, as it would be anti-dilutive. Consequently, diluted net loss per share as presented in the financial statements is equal to basic net loss per share for the years 2018 and 2017. The calculation of diluted earnings per share for 2018 did not include 15,286 shares and 183,714 shares issuable pursuant to the exercise of vested common stock options and outstanding warrants, respectively, as of December 31, 2018 as the effect would be anti-dilutive. The calculation of diluted earnings per share for 2017 did not include 28,102 shares and 63,889 shares issuable pursuant to the exercise of vested common stock options and outstanding warrants, respectively, as of December 31, 2017 as the effect would be anti-dilutive. |
Use of Estimates | Use of Estimates — The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States (“U.S.”) requires management to make estimates and assumptions that affect the amounts reported in the Company’s consolidated financial statements and accompanying notes. On an ongoing basis, the Company evaluates its estimates and judgments, which are based on historical and anticipated results and trends as well as on various other assumptions that the Company believes to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from the Company’s estimates. These estimates include accrued clinical trial costs, stock-based compensation expense, valuation of warrants and valuation of deferred tax assets. |
Income Tax | Income Taxes — Deferred income tax assets and liabilities are determined based upon differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. |
Liquidity | Liquidity — Since its inception, the Company has devoted substantially all of its efforts to product development, raising capital and building infrastructure, and has not generated significant revenues from its planned principal operations. The Company does not anticipate generating significant revenues for the foreseeable future. The Company’s activities are subject to significant risks and uncertainties. The Company has experienced significant losses since its inception, including net losses of $8.6 million and $7.0 million for the years ended December 31, 2018 and 2017, respectively. As of December 31, 2018, the Company had an accumulated deficit of $47.7 million and $1.0 million in cash and cash equivalents. The Company has no debt commitments. Substantially all of the Company’s net losses have resulted from costs incurred in connection with its research and development activities and its general and administrative expenses to support operations. The Company’s net losses may fluctuate significantly from quarter to quarter and year to year. The Company expects to continue to incur net losses for the foreseeable future in connection with its ongoing activities, including conducting clinical trials, manufacturing development and seeking regulatory approval of its drug candidates, prexigebersen, BP1002 and BP1003. Accordingly, the Company will continue to require substantial additional capital to fund its projected operating requirements. Such additional capital may not be available when needed or on terms favorable to the Company. In addition, the Company may seek additional capital due to favorable market conditions or strategic considerations, even if it believes it has sufficient funds for our current and future operating plan. There can be no assurance that the Company will be able to continue to raise additional capital through the sale of securities in the future. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, financial condition and future prospects. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements — that are adopted by the Company as of the specified effective date. If not discussed, management believes that the impact of recently issued standards, which are not yet effective, will not have a material impact on the Company’s consolidated financial statements upon adoption. In May 2014, 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 Lease-Targeted Improvements (Topic 842). In May 2017, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation: Scope of Modification Accounting . The new standard requires an entity to apply modification accounting provisions if the value, vesting conditions or classification of the award changes. The new guidance must be applied on a prospective basis and is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years, with early adoption permitted. The Company adopted the standard on January 1, 2018 on a prospective basis and determined that it did not have a significant impact on our consolidated financial statements In July 2017, the FASB issued ASU No. 2017-11 , Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. Part I of the new standard applies to entities that issue financial instruments such as warrants, convertible debt or convertible preferred stock that contain down round features. The ASU allows companies to exclude a down round feature when determining whether a financial instrument (or embedded conversion feature) is considered indexed to the entity’s own stock. As a result, financial instruments (or embedded conversion features) with down round features may no longer be required to be classified as liabilities. A company will recognize the value of a down round feature only when it is triggered and the strike price has been adjusted downward. Part II of the new standard replaces the indefinite deferrals for certain mandatorily redeemable noncontrolling interests and mandatorily redeemable financial instruments of nonpublic entities. ASU 2017-11 is effective for annual reporting periods beginning after December 15, 2018, including interim periods within those fiscal years, with early adoption permitted. Management early adopted the new standard during fiscal year 2017 and notes the adoption did not have a significant impact on the Company’s consolidated financial statements. In June 2018, the FASB issued ASU No. 2018-07, Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. The new standard simplifies the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees. Equity-classified share-based payments issued to nonemployees will be measured on the grant date instead of being remeasured through the performance completion date as required under the current guidance. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, with early adoption permitted. The Company early adopted this standard effective June 30, 2018 and notes the adoption did not have a significant impact on the Company’s consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement . The new standard eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. This standard is effective for fiscal years beginning after December 15, 2019, with early adoption permitted. Management is currently evaluating the impact of future adoption of the new standard on the Company’s consolidated financial statements. In August 2018, the SEC adopted the final rule under SEC Release No. 33-10532, Disclosure Update and Simplification , amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements on the analysis of stockholders' equity for interim financial statements. Under the amendments, an analysis of changes in each caption of stockholders' equity presented in the balance sheet must be provided in a note or separate statement. The analysis should present a reconciliation of the beginning balance to the ending balance of each period for which a statement of comprehensive income is required to be filed. The Company anticipates its first presentation of changes in shareholders' equity will be included in its Form 10-Q for the first quarter of fiscal year 2019. In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606. The new standard provides guidance on how to assess whether certain transactions between collaborative arrangement participants should be accounted for within the revenue recognition standard. The update also provides more comparability in the presentation of revenue for certain transactions between collaborative arrangement participants. The new standard is effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years with early adoption permitted. The Company early adopted this standard effective December 31, 2018 and notes that it did not a significant impact on our consolidated financial statements as the Company currently does not have significant collaborative agreements in place. Management has reviewed all other recently issued pronouncements and has determined they will have no material impact on the Company’s consolidated financial statements. |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | The following table summarizes property and equipment as of December 31, 2018 and 2017: December 31, Estimated Useful Lives 2018 2017 (in years) (in thousands) Leasehold improvements 2 to 3 $ 432 $ 432 Computers and office equipment 3 60 63 Furniture and fixtures 7 46 46 Scientific equipment 7 460 443 Total 998 984 Less: Accumulated depreciation (592 ) (330 ) Net property and equipment $ 406 $ 654 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value, Instruments Classified in Shareholders' Equity Measured on Recurring Basis, Unobservable Input Reconciliation | The following table summarizes changes to the fair value of the Level 3 2016 Warrants for the year ended December 31, 2017: Fair Value of Warrant Liability (in thousands) Balance at December 31, 2016 $ 2,906 Change in fair value (2,374 ) Extinguished (357 ) Reclassified to equity (175 ) Balance at December 31, 2017 $ - |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques | The Company utilized the Binomial Lattice Model for estimating the fair value of the 2016 Warrants using the following assumptions on the reclassification dates of June 13, 2017 and May 21, 2017 and as of December 31, 2016: As of June 13, 2017 As of May 21, 2017 As of December 31, 2016 Risk-free interest rate 1.51 % 1.78 % 1.93 % Expected volatility 88 % 89 % 98 % Expected term in years 4.6 4.6 5.0 Dividend yield - % - % - % |
Stock-Based Compensation Plan (
Stock-Based Compensation Plan (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | Option activity under the Plans for the year ended December 31, 2018, was as follows (in thousands, except as noted): Weighted Weighted- Average Average Remaining Aggregate Exercise Contractual Intrinsic Options Price Term Value (per share) (in years) Year Ended December 31, 2018 Outstanding at December 31, 2017 32 $ 232.00 4.0 $ - Granted 20 34.60 9.3 Forfeited - - Expired (15 ) 267.20 Outstanding at December 31, 2018 37 $ 112.60 7.5 $ - Vested and expected to vest December 31, 2018 31 $ 124.60 7.2 $ - Exercisable at December 31, 2018 15 $ 181.00 5.1 $ - Option activity under the Plans for the year ended December 31, 2017, was as follows (in thousands, except as noted): Weighted Weighted- Average Average Remaining Aggregate Exercise Contractual Intrinsic Options Price Term Value (per share) (in years) Year Ended December 31, 2017 Outstanding at December 31, 2016 35 $ 266.00 5.2 $ 2,241 Granted 3 150.00 9.3 Forfeited (4 ) 330.00 Expired (2 ) 426.00 Outstanding at December 31, 2017 32 $ 232.00 4.0 $ - Vested and expected to vest December 31, 2017 31 $ 230.00 3.8 $ - Exercisable at December 31, 2017 28 $ 214.00 3.3 $ - |
Warrant [Member] | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | For stock options granted during 2018 and 2017 the following weighted average assumptions were used in determining fair value: 2018 2017 Risk-free interest rate 2.70 % 2.06 % Expected volatility 90 % 99 % Expected term in years 6.1 6.1 Dividend yield - % - % |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Derivative Financial Instruments Indexed to, and Potentially Settled in, Entity's Own Stock [Abstract] | |
Schedule of Stockholders' Equity Note, Warrants or Rights | A summary of warrants outstanding and exercisable as of December 31, 2018 (in thousands, except as noted): Warrants Outstanding Warrants Exercisable Weighted Average Weighted Weighted Remaining Average Average Number Contractual Exercise Number Exercise Year Issued Outstanding Life Price Exercisable Price (in years) (per share) (per share) 2014 1 0.1 $ 948.00 1 $ 948.00 2016 6 3.0 466.26 6 466.26 2017 (Note 10) 56 3.7 55.63 56 55.63 2018 (Note 10) 120 5.2 19.20 - - 183 4.6 $ 52.24 63 $ 114.28 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Remaining Lease Payments Due Under Lease | A summary of future payments under operating leases as of December 31, 2018: For the Year Ending December 31, (in thousands) 2019 $ 82 2020 31 2021 31 2022 10 Total $ 154 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Tax Assets and Liabilities | The components of the Company’s deferred tax asset are as follows: December 31, 2018 2017 (in thousands) Deferred tax assets – non-current Accrued bonuses $ 12 $ - Accrued vacation 15 17 Net operating loss (NOL) carryover 9,191 7,516 Technology license amortization - 36 Research & development tax credits 1,780 1,542 Share based expense 310 387 Other 5 5 Fixed asset depreciation 50 15 Total deferred tax asset 11,363 9,518 Less: valuation allowance (11,363 ) (9,518 ) Net deferred tax asset - - Deferred tax liability- non-current - - Net deferred tax asset $ - $ - |
Schedule of Effective Income Tax Rate Reconciliation | Reconciliation between income taxes at the statutory tax rate (21% to 34%) and the actual income tax provision for continuing operations follows: December 31, 2018 2017 2016 (in thousands) Loss before income taxes $ (8,583 ) $ (7,023 ) $ (6,750 ) Tax (benefit) at statutory tax rate (1,802 ) (2,388 ) (2,295 ) Effects of: Exclusion of incentive stock option expense 47 86 117 R&D tax credits (238 ) (283 ) (252 ) Increase (decrease) in valuation allowance 1,845 (1,447 ) 3,001 FMV of warrants - (658 ) (582 ) Prior year adjustments - 5 6 Carryforward adjustment 2 (252 ) 5 Stock option forfeitures 146 - - Rate change on net deferred tax asset - 4,937 - Provision for income taxes $ - $ - $ - |
Organization and Business - Add
Organization and Business - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Mar. 12, 2019 | Jan. 14, 2019 | Nov. 03, 2017 | Jan. 31, 2019 | Jan. 18, 2019 | Jan. 17, 2019 | Sep. 20, 2018 | Nov. 30, 2017 | May 31, 2017 | May 21, 2017 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2018 | Dec. 31, 2017 | Jun. 30, 2017 |
Organization and Nature of Operations [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 29,412 | ||||||||||||||
Stock issued during period, value, new issues | $ 1,180 | $ 3,567 | |||||||||||||
Proceeds from Issuance of Common Stock | $ 17,000 | $ 1,180 | 3,567 | ||||||||||||
Class Of Warrant Or Right Exercisable Number | 22,059 | 22,059 | |||||||||||||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Settlements | $ (175) | ||||||||||||||
Class Of Warrant Or Right Exercised Number | 559 | 559 | |||||||||||||
Common Stock, Shares, Issued | 680 | 567 | |||||||||||||
Subsequent Event [Member] | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 648,233 | ||||||||||||||
Stock issued during period, value, new issues | $ 1,700 | ||||||||||||||
Proceeds from Issuance of Common Stock | $ 17,000 | $ 900 | $ 900 | $ 1,500 | |||||||||||
Stockholders' Equity, Reverse Stock Split | 1-for-20 | common stock at a ratio of 1-for-20, and our common stock began trading on the split-adjusted basis on the Nasdaq Capital Market at the commencement of trading on January 18, 2019. All common stock share and per share amounts in our consolidated financial statements have been adjusted to give effect to the 1-for-20 reverse stock split. | |||||||||||||
New Warrants [Member] | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Proceeds from Issuance of Common Stock | $ 1,500 | ||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 120 | $ 120 | |||||||||||||
Class Of Warrant Or Right Terms | 5 years | ||||||||||||||
Warrants 2016 [Member] | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Proceeds from Issuance of Common Stock | $ 1,200 | ||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 6,398 | ||||||||||||||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Settlements | $ 200 | ||||||||||||||
Extinguishment of Debt, Amount | 400 | ||||||||||||||
Warrants2014 [Member] | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Adjustments to Additional Paid in Capital, Dividends in Excess of Retained Earnings | $ 1,000 | ||||||||||||||
Reduced Exercise Price [Member] | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 76 | $ 76 | |||||||||||||
Class Of Warrant Or Right Exercised Number | 21,500 | 21,500 | |||||||||||||
Warrant | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 14,706 | ||||||||||||||
Stock issued during period, value, new issues | $ 10,000 | $ 25,000 | |||||||||||||
Proceeds from Issuance of Common Stock | $ 1,200 | ||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 12,500 | ||||||||||||||
Warrant | Subsequent Event [Member] | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 712,910 | ||||||||||||||
Stock issued during period, value, new issues | $ 18,500 | ||||||||||||||
Warrants issued | 42,775 | ||||||||||||||
Series A Warrants [Member] | Subsequent Event [Member] | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 324,117 | ||||||||||||||
HC Wainwright LLC [Member] | Subsequent Event [Member] | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Shares Issued, Price Per Share | $ 2.418 | ||||||||||||||
Common Stock [Member] | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 113,000 | 67,000 | |||||||||||||
Stock issued during period, value, new issues | $ 0 | $ 1 | |||||||||||||
Common Stock [Member] | Subsequent Event [Member] | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 38,894 | ||||||||||||||
2016 Registered Direct Offering | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,250 | ||||||||||||||
Registered Direct Offering 2017 [Member] | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 66,667 | 66,667 | |||||||||||||
Stock issued during period, value, new issues | $ 4,000 | $ 4,000 | |||||||||||||
Proceeds from Issuance of Common Stock | $ 3,600 | ||||||||||||||
Registered Direct Offering 2017 [Member] | Warrant | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 33,334 | 33,334 | |||||||||||||
2018 Registered Direct Offering | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 98,454 | ||||||||||||||
Stock issued during period, value, new issues | $ 1,500 | ||||||||||||||
2018 Registered Direct Offering | Warrant | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 14,624 | ||||||||||||||
Private Placement [Member] | Subsequent Event [Member] | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Common Stock, Shares, Issued | 25,777 | ||||||||||||||
Private Placement [Member] | Series A Warrants [Member] | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 113,077 | ||||||||||||||
IPO [Member] | Subsequent Event [Member] | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 712,910 | 429,616 | |||||||||||||
Stock issued during period, value, new issues | $ 18,500 | ||||||||||||||
Proceeds from Issuance of Common Stock | $ 1,100 | ||||||||||||||
Shares Issued, Price Per Share | $ 2.60 | ||||||||||||||
Roth Capital Partners, Llc [Member] | Registered Direct Offering 2017 [Member] | Warrant | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 800 | 800 | |||||||||||||
HC Wainwright Co [Member] | 2018 Registered Direct Offering | |||||||||||||||
Organization and Nature of Operations [Line Items] | |||||||||||||||
Stock issued during period, shares, new issues | 6,785 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Addtional Information (Detail) - USD ($) | Mar. 12, 2019 | Jan. 14, 2019 | Mar. 31, 2019 | Jan. 31, 2019 | Jan. 18, 2019 | Sep. 20, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Significant Accounting Policies [Line Items] | |||||||||
Other Intangible Assets, Net | $ 800,000 | ||||||||
Other Finite-Lived Intangible Assets, Gross | 2,500,000 | ||||||||
Cash | $ 1,004,000 | 5,965,000 | $ 9,375,000 | ||||||
Depreciation | 265,000 | 251,000 | |||||||
Research and Development Costs Expenses | $ 4,600,000 | $ 5,500,000 | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 15,286 | 28,102 | |||||||
Development Project Service Evaluation Exchange Cost | $ 50,000 | ||||||||
Net Income (Loss) Attributable to Parent | (8,583,000) | $ (7,023,000) | |||||||
Retained Earnings (Accumulated Deficit) | (47,740,000) | (39,157,000) | |||||||
Proceeds from Issuance of Common Stock | $ 17,000,000 | $ 1,180,000 | 3,567,000 | ||||||
Technology Service [Member] | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 50,000 | ||||||||
Warrant | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 183,714 | 63,889 | |||||||
Proceeds from Issuance of Common Stock | $ 1,200,000 | ||||||||
Subsequent Event [Member] | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Proceeds from Issuance of Private Placement | $ 17,000,000 | $ 1,500,000 | |||||||
Proceeds from Issuance of Common Stock | $ 17,000,000 | $ 900,000 | $ 900,000 | $ 1,500,000 | |||||
Furniture and fixtures | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Property, Plant and Equipment, Useful Life | 7 years | ||||||||
Computers and equipment | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Property, Plant and Equipment, Useful Life | 3 years | ||||||||
Scientific equipment | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Property, Plant and Equipment, Useful Life | 7 years | ||||||||
Jp Morgan Chase Bank | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Cash, FDIC Insured Amount | $ 800,000 | $ 5,700,000 | |||||||
Federal Deposit Insurance | $ 250,000 | ||||||||
Cash | 6,000,000 | ||||||||
Md Anderson | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Amortization of Intangible Assets | $ 1,700,000 |
Prepaid Drug Product for Test_2
Prepaid Drug Product for Testing - Additional Information (Detail) - USD ($) $ in Millions | Dec. 31, 2018 | Dec. 31, 2017 |
Prepaid Drug Product For Testing [Line Items] | ||
Prepaid drug product for testing | $ 0.3 | $ 1.1 |
Other Current Assets- Additiona
Other Current Assets- Additional Information (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Other Assets, Current | $ 593 | $ 353 |
Prepaid Insurance | 100 | 100 |
Chronic Myelogenous Lleukemia [Member] | ||
Other Assets, Current | 400 | 200 |
Prepaid Expenses [Member] | ||
Other Assets, Current | 600 | 400 |
Other Prepaid Expenses [Member] | ||
Other Assets, Current | $ 100 | $ 100 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Property, Plant and Equipment, Gross | $ 998 | $ 984 |
Less accumulated depreciation | (592) | (330) |
Net property and equipment | 406 | 654 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment, Gross | $ 432 | 432 |
Leasehold Improvements [Member] | Maximum [Member] | ||
Property, Plant and Equipment, Useful Life | 3 years | |
Leasehold Improvements [Member] | Minimum [Member] | ||
Property, Plant and Equipment, Useful Life | 2 years | |
Computer And Office Equipment [Member] | ||
Property, Plant and Equipment, Useful Life | 3 years | |
Property, Plant and Equipment, Gross | $ 60 | 63 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment, Useful Life | 7 years | |
Property, Plant and Equipment, Gross | $ 46 | 46 |
Scientific Equipment [Member] | ||
Property, Plant and Equipment, Useful Life | 7 years | |
Property, Plant and Equipment, Gross | $ 460 | $ 443 |
Accounts Payable - Additional I
Accounts Payable - Additional Information (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Accounts Payable [Line Items] | ||
Accounts Payable, Current | $ 813 | $ 52 |
Other Payables [Member] | ||
Accounts Payable [Line Items] | ||
Accounts Payable, Current | 100 | |
Preclinical Expenses [Member] | ||
Accounts Payable [Line Items] | ||
Accounts Payable, Current | 200 | |
License Maintenance Fee [Member] | ||
Accounts Payable [Line Items] | ||
Accounts Payable, Current | 100 | |
Manufacturing Costs [Member] | ||
Accounts Payable [Line Items] | ||
Accounts Payable, Current | 100 | |
Clinical Research Organizations [Member] | ||
Accounts Payable [Line Items] | ||
Accounts Payable, Current | $ 300 |
Accrued Expense - Additional In
Accrued Expense - Additional Information (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Accounts Payable and Accrued Liabilities [Line Items] | ||
Accrued expense | $ 304 | $ 739 |
Accrued Vacation And Bonus | 100 | 100 |
Accrued Clinical And Preclinical Expenses | 100 | 400 |
Accrued License Maintenance Fee | 100 | |
Other Accrued Liabilities | $ 100 | |
Accrued Legal And Professional Fee | $ 100 |
Warrant Liability - Additional
Warrant Liability - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Jun. 30, 2017 | Dec. 31, 2016 | |
Warrant Liability [Line Items] | ||||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Settlements | $ (175) | |||
Warrants 2016 [Member] | ||||
Warrant Liability [Line Items] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 6,398 | |||
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Settlements | $ 200 | |||
Extinguishment of Debt, Amount | 400 | |||
Increase (Decrease) in Derivative Liabilities | $ 0 | $ 2,400 | ||
Health care Institutional Investors | ||||
Warrant Liability [Line Items] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 14,706 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 460 | |||
Hc Wainwright Co Llc | ||||
Warrant Liability [Line Items] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,250 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 492 |
Fair Value Of Warrant Liability
Fair Value Of Warrant Liability (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2017USD ($) | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Balance | $ 2,906 |
Change in fair value | (2,374) |
Extinguished | (357) |
Reclassified to equity | (175) |
Balance | $ 0 |
Fair Value Assumptions and Meth
Fair Value Assumptions and Methodology for Assets and Liabilities (Detail) | Jun. 13, 2017 | May 21, 2017 | Dec. 31, 2016 |
Measurement Input, Risk Free Interest Rate [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Debt Instrument, Measurement Input | 1.51 | 1.78 | 1.93 |
Measurement Input, Price Volatility [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Debt Instrument, Measurement Input | 88 | 89 | 98 |
Measurement Input, Expected Term [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Debt Instrument, Measurement Input | 4.6 | 4.6 | 5 |
Measurement Input, Expected Dividend Rate [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Debt Instrument, Measurement Input | 0 | 0 | 0 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Mar. 12, 2019 | Nov. 03, 2017 | Sep. 20, 2018 | Nov. 30, 2017 | May 31, 2017 | May 21, 2017 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Shareholders Equity [Line Items] | |||||||||||
Common Stock, shares issued | 680 | 567 | |||||||||
Stock Issued During Period, Shares, New Issues | 29,412 | ||||||||||
Stock Issued During Period, Value, New Issues | $ 1,180 | $ 3,567 | |||||||||
Stockholders' Equity Attributable to Parent | 1,218 | 8,067 | $ 8,240 | ||||||||
Proceeds from Issuance of Common Stock | $ 17,000 | $ 1,180 | $ 3,567 | ||||||||
Class Of Warrant Or Right Exercisable Number | 22,059 | 22,059 | |||||||||
Class Of Warrant Or Right Exercised Number | 559 | 559 | |||||||||
New Warrants [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 120 | $ 120 | |||||||||
Proceeds from Issuance of Common Stock | $ 1,500 | ||||||||||
Proceeds from Warrant Exercises | $ 1,500 | ||||||||||
Reduced Exercise Price [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 76 | $ 76 | |||||||||
Class Of Warrant Or Right Exercised Number | 21,500 | 21,500 | |||||||||
Registered Direct Offering 2017 [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Stock Issued During Period, Shares, New Issues | 66,667 | 66,667 | |||||||||
Stock Issued During Period, Value, New Issues | $ 4,000 | $ 4,000 | |||||||||
Proceeds from Issuance of Common Stock | $ 3,600 | ||||||||||
2018 Registered Direct Offering | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Stock Issued During Period, Shares, New Issues | 98,454 | ||||||||||
Stock Issued During Period, Value, New Issues | $ 1,500 | ||||||||||
Warrant | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Stock Issued During Period, Shares, New Issues | 14,706 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 12,500 | ||||||||||
Stock Issued During Period, Value, New Issues | $ 10,000 | $ 25,000 | |||||||||
Proceeds from Issuance of Common Stock | $ 1,200 | ||||||||||
Warrant | Registered Direct Offering 2017 [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Stock Issued During Period, Shares, New Issues | 33,334 | 33,334 | |||||||||
Warrant | 2018 Registered Direct Offering | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Stock Issued During Period, Shares, New Issues | 14,624 | ||||||||||
Series A Warrants [Member] | Private Placement [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Stock Issued During Period, Shares, New Issues | 113,077 | ||||||||||
Roth Capital Partners, Llc [Member] | Warrant | Registered Direct Offering 2017 [Member] | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Stock Issued During Period, Shares, New Issues | 800 | 800 | |||||||||
HC Wainwright Co [Member] | 2018 Registered Direct Offering | |||||||||||
Shareholders Equity [Line Items] | |||||||||||
Stock Issued During Period, Shares, New Issues | 6,785 |
Weighted Average Assumptions (D
Weighted Average Assumptions (Detail) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Plans [Line Items] | ||
Risk-free interest rate | 2.70% | 2.06% |
Expected volatility | 90.00% | 99.00% |
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) - USD ($) $ / shares in Units, shares in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share Based Compensation Plans [Line Items] | |||
Outstanding | 32 | 35 | |
Granted | 20 | 3 | |
Forfeited | 0 | (4) | |
Expired | (15) | (2) | |
Outstanding | 37 | 32 | 35 |
Vested and expected to vest | 31 | 31 | |
Exercisable | 15 | 28 | |
Weighted - Average Exercise Price, Outstanding | $ 232 | $ 266 | |
Weighted - Average Exercise Price, Granted | 34.60 | 150 | |
Weighted - Average Exercise Price, Forfeited | 0 | 330 | |
Weighted - Average Exercise Price,Expired | 267.20 | 426 | |
Weighted - Average Exercise Price, Outstanding | 112.60 | 232 | $ 266 |
Weighted - Average Exercise Price, Vested and expected to vest | 124.60 | 230 | |
Weighted - Average Exercise Price, Exercisable | $ 181 | $ 214 | |
Weighted Average Remaining Contractual Term (In years), Outstanding | 7 years 6 months | 4 years | 5 years 2 months 12 days |
Weighted Average Remaining Contractual Term (In years), Granted | 9 years 3 months 18 days | 9 years 3 months 18 days | |
Weighted Average Remaining Contractual Term (In years), Vested and expected to vest | 7 years 2 months 12 days | 3 years 9 months 18 days | |
Weighted Average Remaining Contractual Term (In years), Exercisable | 5 years 1 month 6 days | 3 years 3 months 18 days | |
Aggregate Intrinsic Value, Outstanding | $ 0 | $ 2,241 | |
Aggregate Intrinsic Value, Outstanding | 0 | 0 | $ 2,241 |
Aggregate Intrinsic Value, Vested and expected to vest | 0 | 0 | |
Aggregate Intrinsic Value, Exercisable | $ 0 | $ 0 |
Stock-Based Compensation Plan -
Stock-Based Compensation Plan - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Stock Based Compensation Plans [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 60,000 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 26.55 | $ 120 | |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 0.8 | ||
Stock-based compensation expense | $ 0.6 | $ 0.8 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 7 years 6 months | 4 years | 5 years 2 months 12 days |
Research and Development Expense | |||
Stock Based Compensation Plans [Line Items] | |||
Stock-based compensation expense | $ 0.1 | $ 0.3 | |
General and Administrative Expense | |||
Stock Based Compensation Plans [Line Items] | |||
Stock-based compensation expense | $ 0.5 | $ 0.5 |
Warrants Outstanding and Exerci
Warrants Outstanding and Exercisable (Detail) shares in Thousands | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Class of Warrant or Right [Line Items] | |
Warrants Outstanding, Number Outstanding | shares | 183 |
Warrants Outstanding, Weighted Average Remaining Contractual Life (Years) | 4 years 7 months 6 days |
Warrants Outstanding, Weighted Average Exercise Price (per share) | $ / shares | $ 52.24 |
Warrants Exercisable, Number Exercisable | shares | 63 |
Warrants Exercisable, Weighted Average Exercise Price (per share) | $ / shares | $ 114.28 |
Warrants 2014 [Member] | |
Class of Warrant or Right [Line Items] | |
Warrants Outstanding, Number Outstanding | shares | 1 |
Warrants Outstanding, Weighted Average Remaining Contractual Life (Years) | 1 month 6 days |
Warrants Outstanding, Weighted Average Exercise Price (per share) | $ / shares | $ 948 |
Warrants Exercisable, Number Exercisable | shares | 1 |
Warrants Exercisable, Weighted Average Exercise Price (per share) | $ / shares | $ 948 |
Warrants 2016 [Member] | |
Class of Warrant or Right [Line Items] | |
Warrants Outstanding, Number Outstanding | shares | 6 |
Warrants Outstanding, Weighted Average Remaining Contractual Life (Years) | 3 years |
Warrants Outstanding, Weighted Average Exercise Price (per share) | $ / shares | $ 466.26 |
Warrants Exercisable, Number Exercisable | shares | 6 |
Warrants Exercisable, Weighted Average Exercise Price (per share) | $ / shares | $ 466.26 |
Warrants 2017 [Member] | |
Class of Warrant or Right [Line Items] | |
Warrants Outstanding, Number Outstanding | shares | 56 |
Warrants Outstanding, Weighted Average Remaining Contractual Life (Years) | 3 years 8 months 12 days |
Warrants Outstanding, Weighted Average Exercise Price (per share) | $ / shares | $ 55.63 |
Warrants Exercisable, Number Exercisable | shares | 56 |
Warrants Exercisable, Weighted Average Exercise Price (per share) | $ / shares | $ 55.63 |
Warrants 2018 [Member] | |
Class of Warrant or Right [Line Items] | |
Warrants Outstanding, Number Outstanding | shares | 120 |
Warrants Outstanding, Weighted Average Remaining Contractual Life (Years) | 5 years 2 months 12 days |
Warrants Outstanding, Weighted Average Exercise Price (per share) | $ / shares | $ 19.20 |
Warrants Exercisable, Number Exercisable | shares | 0 |
Warrants Exercisable, Weighted Average Exercise Price (per share) | $ / shares | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | |
Apr. 30, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | |
Product Liability Contingency [Line Items] | |||
Operating Leases, Future Minimum Payments Due | $ 154,000 | ||
Other Prepaid Expense, Current | 300,000 | $ 1,100,000 | |
Other Commitment, Due in Next Twelve Months | 1,000,000 | ||
Lessee, Operating Lease, Liability, Payments, Due | 100,000 | ||
Drug Supplier Project Plan [Member] | |||
Product Liability Contingency [Line Items] | |||
Other Commitment | 1,600,000 | ||
Manufacturer Of Prexigebersen [Member] | |||
Product Liability Contingency [Line Items] | |||
Other Commitment | 1,000,000 | ||
Manufacture Of Drug Substance [Member] | |||
Product Liability Contingency [Line Items] | |||
Other Commitment | 500,000 | ||
Manufacturing Development [Member] | |||
Product Liability Contingency [Line Items] | |||
Other Commitment | 100,000 | ||
Lab Space [Member] | |||
Product Liability Contingency [Line Items] | |||
Operating Lease Monthly Rental Payments | $ 2,500 | ||
Extended Lab Space [Member] | |||
Product Liability Contingency [Line Items] | |||
Operating Leases, Future Minimum Payments Due | 100,000 | ||
Operating Lease Monthly Rental Payments | $ 2,575 |
Schedule of future payments und
Schedule of future payments under operating leases (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Operating Leased Assets [Line Items] | |
2019 | $ 82 |
2020 | 31 |
2021 | 31 |
2022 | 10 |
Total | $ 154 |
Benefit Plan - Additional Infor
Benefit Plan - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Defined Benefit Plan Disclosure [Line Items] | ||
Defined Benefit Plan, Accumulated Benefit Obligation | $ 35,000 | $ 47,000 |
Retirement Benefits, Description | We make matching contributions equal to 100% of the first 3% and 50% of the next 2% of each employee’s base salary up to the allowable amount which is fully vested on the date the matching contributions are made. |
Income Taxes - Addtional Inform
Income Taxes - Addtional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax [Line Items] | |||
Operating Loss Carryforwards | $ 43,800 | ||
Deferred Tax Assets, Tax Credit Carryforwards, Research | 1,780 | $ 1,542 | |
Effective Income Tax Rate Reconciliation, Change in Deferred Tax Assets Valuation Allowance, Amount | $ 1,845 | $ (1,447) | $ 3,001 |
Research And Development Tax Credit Carryforward, Expiration Period | 2028 years | ||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 35.00% | ||
Effective Income Tax Rate Reconciliation, Change in Enacted Tax Rate, Amount | $ 4,900 | ||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | $ 11,400 | $ 9,500 | |
Deferred Tax Assets, Operating Loss Carryforwards, Subject to Expiration | 35,800 | ||
Deferred Tax Assets, Operating Loss Carryforwards, Not Subject to Expiration | $ 8,000 | ||
Scenario, Plan [Member] | |||
Income Tax [Line Items] | |||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | ||
Research and Development Expense [Member] | |||
Income Tax [Line Items] | |||
Deferred Tax Assets, Tax Credit Carryforwards, Research | $ 1,800 | ||
Minimum [Member] | |||
Income Tax [Line Items] | |||
Operating Loss Carry forwards Expiration Period | 2026 |
Components Of Companys Deferred
Components Of Companys Deferred Tax Asset (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets-non current | ||
Accrued bonuses | $ 12 | $ 0 |
Accrued vacation | 15 | 17 |
Net operating loss (NOL) carryover | 9,191 | 7,516 |
Technology licenses amortization | 0 | 36 |
Research & development tax credits | 1,780 | 1,542 |
Share based expense | 310 | 387 |
Other | 5 | 5 |
Fixed asset depreciation | 50 | 15 |
Total deferred tax asset | 11,363 | 9,518 |
Less: valuation allowance | (11,363) | (9,518) |
Net deferred tax asset | 0 | 0 |
Deferred tax liability- non current | 0 | 0 |
Net deferred tax asset | $ 0 | $ 0 |
Reconciliation Between Income T
Reconciliation Between Income Taxes at Statutory Tax Rate (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Schedule Of Effective Income Tax Rate Reconciliation [Line Items] | |||
Loss before income taxes | $ (8,583) | $ (7,023) | $ (6,750) |
Tax (benefit) at statutory tax rate | (1,802) | (2,388) | (2,295) |
Effects of: | |||
Exclusion of incentive stock option expense | 47 | 86 | 117 |
R&D tax credits | (238) | (283) | (252) |
Increase (decrease) in valuation allowance | 1,845 | (1,447) | 3,001 |
FMV of warrants | 0 | (658) | (582) |
Prior year adjustments | 0 | 5 | 6 |
Carryforward adjustment | 2 | (252) | 5 |
Stock option forfeitures | 146 | 0 | 0 |
Rate change on net deferred tax asset | 0 | 4,937 | 0 |
Provision for income taxes | $ 0 | $ 0 | $ 0 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Mar. 12, 2019 | Jan. 14, 2019 | Jan. 31, 2019 | Jan. 18, 2019 | Jan. 17, 2019 | Sep. 20, 2018 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2018 | Dec. 31, 2017 |
Subsequent Event [Line Items] | ||||||||||
Stock Issued During Period, Shares, New Issues | 29,412 | |||||||||
Stock Issued During Period, Value, New Issues | $ 1,180 | $ 3,567 | ||||||||
Proceeds from Issuance of Common Stock | $ 17,000 | $ 1,180 | $ 3,567 | |||||||
Warrant [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Stock Issued During Period, Shares, New Issues | 14,706 | |||||||||
Stock Issued During Period, Value, New Issues | $ 10,000 | $ 25,000 | ||||||||
Proceeds from Issuance of Common Stock | $ 1,200 | |||||||||
Subsequent Event [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Stockholders' Equity, Reverse Stock Split | 1-for-20 | common stock at a ratio of 1-for-20, and our common stock began trading on the split-adjusted basis on the Nasdaq Capital Market at the commencement of trading on January 18, 2019. All common stock share and per share amounts in our consolidated financial statements have been adjusted to give effect to the 1-for-20 reverse stock split. | ||||||||
Stock Issued During Period, Shares, New Issues | 648,233 | |||||||||
Stock Issued During Period, Value, New Issues | $ 1,700 | |||||||||
Proceeds from Issuance of Common Stock | $ 17,000 | $ 900 | $ 900 | $ 1,500 | ||||||
Subsequent Event [Member] | Two Thousand Nineteen Underwritten Offering [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Stock Issued During Period, Shares, New Issues | 429,616 | |||||||||
Stock Issued During Period, Value, New Issues | $ 1,100 | |||||||||
Proceeds from Issuance Initial Public Offering | $ 900 | |||||||||
Revised Share Offering Price | $ 2.418 | |||||||||
Stock Issued During Period, Shares, Issued for Services | 25,777 | |||||||||
Share Offering Price | $ 2.60 | |||||||||
Subsequent Event [Member] | Two Thousand Nineteen Registered Direct Offering [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Stock Issued During Period, Shares, New Issues | 648,233 | |||||||||
Stock Issued During Period, Value, New Issues | $ 1,700 | |||||||||
Proceeds from Issuance Initial Public Offering | $ 1,500 | |||||||||
Subsequent Event [Member] | Two Thousand Nineteen Registered Direct Offering [Member] | HC Wainwright Co [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Stock Issued During Period, Shares, New Issues | 38,894 | |||||||||
Subsequent Event [Member] | Series A Warrant [Member] | Private Placement [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Stock Issued During Period, Shares, New Issues | 324,117 | |||||||||
Subsequent Event [Member] | Warrant [Member] | ||||||||||
Subsequent Event [Line Items] | ||||||||||
Stock Issued During Period, Shares, New Issues | 712,910 | |||||||||
Stock Issued During Period, Value, New Issues | $ 18,500 | |||||||||
Warrants issued | 42,775 |