Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Mar. 12, 2020 | Jun. 30, 2019 | |
Document Information [Line Items] | |||
Entity Registrant Name | Diffusion Pharmaceuticals Inc. | ||
Entity Central Index Key | 0001053691 | ||
Trading Symbol | dffn | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | true | ||
Entity Interactive Data Current | Yes | ||
Entity Common Stock, Shares Outstanding (in shares) | 34,604,436 | ||
Entity Public Float | $ 13.1 | ||
Entity Shell Company | false | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 14,177,349 | $ 7,991,172 |
Prepaid expenses, deposits and other current assets | 472,464 | 923,059 |
Total current assets | 14,649,813 | 8,914,231 |
Property and equipment, net | 252,366 | 350,281 |
Intangible asset | 8,639,000 | 8,639,000 |
Right of use asset | 247,043 | |
Other assets | 322,301 | 298,480 |
Total assets | 24,110,523 | 18,201,992 |
Current liabilities: | ||
Accounts payable | 1,251,412 | 198,818 |
Accrued expenses and other current liabilities | 358,532 | 605,226 |
Current operating lease liability | 111,477 | |
Total current liabilities | 1,721,421 | 804,044 |
Deferred income taxes | 2,119,274 | 1,786,389 |
Noncurrent operating lease liability | 135,566 | |
Total liabilities | 3,976,261 | 2,590,433 |
Commitments and Contingencies (Note 6) | ||
Stockholders’ Equity: | ||
Common stock, $0.001 par value: 1,000,000,000 shares authorized; 33,480,365 and 3,376,230 shares issued and outstanding at December 31, 2019 and 2018, respectively | 33,481 | 3,377 |
Additional paid-in capital | 111,824,859 | 95,532,881 |
Accumulated deficit | (91,724,078) | (79,924,699) |
Total stockholders' equity | 20,134,262 | 15,611,559 |
Total liabilities and stockholders' equity | $ 24,110,523 | $ 18,201,992 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized (in shares) | 1,000,000,000 | 1,000,000,000 |
Common stock, issued (in shares) | 33,480,365 | 3,376,230 |
Common stock, outstanding (in shares) | 33,480,365 | 3,376,230 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Operating expenses: | ||
Research and development | $ 6,619,597 | $ 5,751,940 |
General and administrative | 4,834,284 | 6,167,177 |
Goodwill impairment | 6,929,258 | |
Depreciation | 97,915 | 110,371 |
Loss from operations | 11,551,796 | 18,958,746 |
Other expense (income): | ||
Interest (income) expense, net | (85,302) | (151,647) |
Loss from operations before income taxes | (11,466,494) | (18,807,099) |
Income tax expense (benefit) | 332,885 | (437,289) |
Net loss | (11,799,379) | (18,369,810) |
Accretion of Series A cumulative preferred dividends | (85,993) | |
Deemed dividend related to the make-whole provision for the conversion of Series A convertible preferred stock into common stock | (8,167,895) | |
Net loss attributable to common stockholders | $ (11,799,379) | $ (26,623,698) |
Per share information: | ||
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (1.76) | $ (8.21) |
Weighted average shares outstanding, basic and diluted (in dollars per share) | $ 6,706,509 | $ 3,242,301 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Pre-funded Warrants [Member]Preferred Stock [Member]Series A Preferred Stock [Member] | Pre-funded Warrants [Member]Common Stock [Member] | Pre-funded Warrants [Member] | Preferred Stock [Member]Series A Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance (in shares) at Dec. 31, 2017 | 8,306,278 | 967,976 | ||||||
Balance at Dec. 31, 2017 | $ 968 | $ 82,783,865 | $ (61,554,889) | $ 21,229,944 | ||||
Conversion of Series A convertible preferred stock to common stock (in shares) | (8,306,278) | 553,752 | ||||||
Conversion of Series A convertible preferred stock to common stock | $ 554 | (554) | ||||||
Issuance of common stock to Series A convertible preferred stockholders under make-whole adjustment feature (in shares) | 777,895 | |||||||
Issuance of common stock to Series A convertible preferred stockholders under make-whole adjustment feature | $ 778 | (778) | ||||||
Issuance of common stock related to accrued dividends (in shares) | 68,815 | |||||||
Issuance of common stock related to accrued dividends | $ 69 | 1,148,238 | 1,148,307 | |||||
Series A cumulative preferred dividend | (85,993) | (85,993) | ||||||
Series A cumulative preferred dividend | (85,993) | (85,993) | ||||||
Issuance of common stock and warrants, net of issuance costs (in shares) | 1,000,000 | |||||||
Issuance of common stock and warrants, net of issuance costs | $ 1,000 | 10,416,520 | 10,417,520 | |||||
Common stock issued for advisory services (in shares) | 7,792 | |||||||
Common stock issued for advisory services | $ 8 | 49,992 | 50,000 | |||||
Stock-based compensation expense | 1,221,591 | 1,221,591 | ||||||
Net loss | (18,369,810) | (18,369,810) | ||||||
Balance (in shares) at Dec. 31, 2018 | 3,376,230 | |||||||
Balance at Dec. 31, 2018 | $ 3,377 | 95,532,881 | (79,924,699) | 15,611,559 | ||||
Stock-based compensation expense | 515,762 | 515,762 | ||||||
Net loss | (11,799,379) | (11,799,379) | ||||||
Issuance of common stock, pre-funded warrants and warrants, net of issuance costs (in shares) | 12,688,276 | |||||||
Issuance of common stock, pre-funded warrants and warrants, net of issuance costs | $ 12,688 | 11,905,207 | 11,917,895 | |||||
Proceeds from warrants (in shares) | 17,415,859 | |||||||
Proceeds from warrants | $ 17,416 | $ 3,888,425 | ||||||
Balance (in shares) at Dec. 31, 2019 | 33,480,365 | |||||||
Balance at Dec. 31, 2019 | $ 33,481 | $ 111,824,859 | $ (91,724,078) | $ 20,134,262 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flow - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Operating activities: | ||
Net loss | $ (11,799,379) | $ (18,369,810) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 97,915 | 110,371 |
Stock-based compensation expense | 515,762 | 1,221,591 |
Common stock issued for advisory services | 50,000 | |
Change in deferred income taxes | 332,885 | (437,289) |
Goodwill impairment | 6,929,258 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses, deposits and other assets | 426,774 | (1,102) |
Accounts payable, accrued expenses and other liabilities | 567,668 | (275,835) |
Net cash used in operating activities | (9,858,375) | (10,772,816) |
Cash flows provided by financing activities: | ||
Proceeds from sale of common stock, pre-funded warrants and warrants | 12,318,956 | 10,846,062 |
Proceeds from the exercise of common stock warrants and pre-funded warrants | 3,888,425 | |
Repayment of convertible debt | (550,000) | |
Payment of offering costs | (162,829) | (428,542) |
Net cash provided by financing activities | 16,044,552 | 9,867,520 |
Net increase (decrease) in cash and cash equivalents | 6,186,177 | (905,296) |
Cash and cash equivalents at beginning of year | 7,991,172 | 8,896,468 |
Cash and cash equivalents at end of year | 14,177,349 | 7,991,172 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 40,142 | |
Supplemental disclosure of non-cash investing and financing activities: | ||
Offering costs in accounts payable and accrued expenses | 238,232 | |
Operating lease right of use asset and liability | 334,205 | |
Reclassification of accrued dividends related to the issuance of common stock to Series A convertible preferred stock holders | 1,148,307 | |
Series A cumulative preferred dividends | $ 85,993 |
Note 1 - Organization and Descr
Note 1 - Organization and Description of Business | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Nature of Operations [Text Block] | 1. Diffusion Pharmaceuticals Inc. (“Diffusion” or the “Company”), a Delaware corporation, is a clinical stage biotechnology company developing new treatments for life-threatening conditions by improving the body’s ability to bring oxygen to the areas where it is needed most. The Company is developing its lead product candidate, transcrocetinate sodium, also known as trans sodium crocetinate (“TSC”), for use in those life-threatening conditions in which cellular oxygen deprivation (“hypoxia”) is the basis for significant unmet medical needs. TSC is designed to safely and selectively target and re-oxygenate the micro-environment of hypoxic cells, and can potentially be used in many indications, including stroke, oncology and cardiovascular disease. In stroke, TSC helps promote the diffusion of oxygen into those brain cells in which oxygen-deprivation causes neuronal death resulting in patient mortality or morbidity. In cancer, TSC re-oxygenates treatment-resistant cancerous tissue, making the cancer cells up to three 529, may 529 PI3K/Akt/mTOR two 1 529 |
Note 2 - Liquidity
Note 2 - Liquidity | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Liquidity Disclosure [Text Block] | 2. The Company has not No The Company regularly explores alternative means of financing its operations and seeks funding through various sources, including public and private securities offerings, collaborative arrangements with third 2019, $16.0 three 7 The Company currently does not may third may not The Company has prepared its financial statements assuming that it will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred net losses since inception and it expects to generate losses from operations for the foreseeable future primarily due to research and development costs for its potential product candidates, which raises substantial doubt about the Company’s ability to continue as a going concern. The Company currently has no may not not Operations of the Company are subject to certain risks and uncertainties including various internal and external factors that will affect whether and when the Company’s product candidates become approved drugs and how significant their market share will be, some of which are outside of the Company’s control. The length of time and cost of developing and commercializing these product candidates and/or failure of them at any stage of the drug approval process will materially affect the Company’s financial condition and future operations. The Company believes its cash and cash equivalents as of December 31, 2019 January 2021. |
Note 3 - Basis of Presentation
Note 3 - Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | 3. Basis of Presentation The accompanying consolidated financial statements of the Company have been prepared in accordance with US GAAP. Any reference in these notes to applicable guidance is meant to refer to US GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). Use of Estimates The preparation of financial statements in conformity with US GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates using historical experience and other factors, including the current economic environment. Significant items subject to such estimates are assumptions used for purposes of determining stock-based compensation and accounting for research and development activities. Management believes its estimates to be reasonable under the circumstances. Actual results could differ significantly from those estimates. Fair Value of Financial Instruments Fair value is the price that could be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value determination in accordance with applicable accounting guidance requires that a number of significant judgments be made. Additionally, fair value is used on a nonrecurring basis to evaluate assets for impairment or as required for disclosure purposes by applicable accounting guidance on disclosures about fair value of financial instruments. Depending on the nature of the assets and liabilities, various valuation techniques and assumptions are used when estimating fair value. The carrying amounts of certain of the Company’s financial instruments, including cash equivalents and accounts payable are shown at cost, which approximates fair value due to the short-term nature of these instruments. The Company follows the provisions of FASB ASC Topic 820, Fair Value Measurement one three • Level 1: • Level 2: not • Level 3: no The following fair value hierarchy table presents information about the Company’s cash equivalents measured at fair value on a recurring basis: Fair value measurement at (in thousands) Quoted prices Significant Significant December 31, 2019: Assets: Cash equivalents $ 14,006,193 $ — $ — December 31, 2018: Assets: Cash equivalents $ 7,990,900 $ — $ — Concentration of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist principally of cash on deposit with multiple financial institutions, the balances of which frequently exceed federally insured limits. Cash and Cash Equivalents The Company considers any highly liquid investments, such as money market funds, with an original maturity of three Property and Equipment The Company records property and equipment at cost less accumulated depreciation and amortization. Costs of renewals and improvements that extend the useful lives of the assets are capitalized. Maintenance and repairs are expensed as incurred. Depreciation is recognized on a straight-line basis over the estimated useful lives of the assets, which generally range from 2 15 Long-Lived Assets Long-lived assets are reviewed for potential impairment whenever events indicate that the carrying amount of such assets may not not December 31, 2019 2018. Intangible Asset The Company has an indefinite-lived In-Process Research and Development Asset (IPR&D) called RES- 529, $8.6 December 31, 2019 December 31, 2018. 529 PI3K/Akt/mTOR Intangible assets deemed to have indefinite lives are not October 1 no 529 December 31, 2019 2018. Leases In February 2016, 6 Research and Development Major components of research and development costs include internal research and development (such as salaries and related employee benefits, equity-based compensation, supplies and allocated facility costs) and contracted services (research and development activities performed on the Company’s behalf). Costs incurred for research and development are expensed as incurred. At the end of the reporting period, the Company compares payments made to third may Upfront payments made to third Patent Costs Patent costs, including related legal costs, are expensed as incurred and are recorded within general and administrative expenses in the statements of operations. Income Taxes As a corporation, the Company uses the asset and liability method of accounting for income taxes. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. A valuation allowance is provided when it is more likely than not not not Stock-based Compensation The Company measures stock-based awards at grant-date fair value and records compensation expense on a straight-line basis over the vesting period of the award. The Company uses the Black-Scholes option pricing model to value its stock option awards. Estimating the fair value of stock option awards requires management to apply judgment and make estimates, including the volatility of the Company’s common stock, the expected term of the Company’s stock options, the expected dividend yield and the fair value of the Company’s common stock on the measurement date. As a result, if factors change and management uses different assumptions, stock-based compensation expense could be materially different for future awards. The expected term of stock options was estimated using the “simplified method” for employee options as the Company has no no not not Net Loss Per Common Share Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during each period. Diluted net loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as convertible preferred stock, common stock warrants, stock options and unvested restricted stock that would result in the issuance of incremental shares of common stock. In computing the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remains the same for both calculations due to the fact that when a net loss exists, dilutive shares are not The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive: December 31, 2019 2018 Common stock warrants 22,385,141 2,087,012 Stock options 309,276 203,736 22,694,417 2,290,748 Recently Issued But Not In August 2018, 2018 03, Disclosure Framework- Changes to the Disclosure Requirements for Fair Value Measurements, 820. 820's December 15, 2019 not Recently Adopted Accounting Pronouncements In February 2016, 2016 02, Leases (Topic 842 842, The Company adopted ASC 842, January 1, 2019 not 842 $0.3 On January 1, 2019, 2018 07, Compensation—Stock Compensation (Topic 718 No. 2018 07” 505 50 Equity-based Payments to Non-employees 718 No. 2018 17 not |
Note 4 - Property and Equipment
Note 4 - Property and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | 4. Property and equipment consists of the following: December 31, 2019 2018 Laboratory equipment $ 182,357 $ 182,357 Furniture and office equipment 151,442 155,113 Leasehold improvements 430,000 430,000 Total property and equipment 763,799 767,470 Less: accumulated depreciation (511,433 ) (417,189 ) Property and equipment, net $ 252,366 $ 350,281 Depreciation expense was approximately $0.1 December 31, 2019 2018, |
Note 5 - Accrued Expenses and O
Note 5 - Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Accounts Payable, Accrued Liabilities, and Other Liabilities Disclosure, Current [Text Block] | 5. Accrued expenses and other current liabilities consist of the following: December 31, 2019 2018 Accrued payroll and payroll related expenses $ 182,708 $ 409,889 Accrued professional fees 48,338 69,231 Accrued clinical studies expenses 57,378 34,000 Other 70,108 92,106 Total $ 358,532 $ 605,226 |
Note 6 - Commitments and Contin
Note 6 - Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | 6. Office Space Lease Commitment The Company has a non-cancelable operating lease for office and laboratory space in Charlottesville, Virginia, which began in April 2017 December 31, 2019, 2.3 3, 842 first 2019 $0.1 $0.2 842 10%. second 2022 5 not December 31, 2019. Rent expense related to the Company's operating lease for both the years ended December 31, 2019 2018 $0.1 December 31, 2019 Rental Commitments 2020 $ 116,464 2021 118,519 2022 39,735 Total 274,718 Less: imputed interest (27,675 ) $ 247,043 Future minimum rental payments under the Company's non-cancelable operating lease was as follows as of December 31, 2018: Rental Commitments 2019 $ 114,409 2020 116,464 2021 118,519 2022 39,735 Total $ 389,127 Research and Development Arrangements In the course of normal business operations, the Company enters into agreements with universities and contract research organizations, or CROs, to assist in the performance of research and development activities and contract manufacturers to assist with chemistry, manufacturing, and controls related expenses. Expenditures to CROs represent a significant cost in clinical development for the Company. The Company could also enter into additional collaborative research, contract research, manufacturing, and supplier agreements in the future, which may Defined Contribution Retirement Plan The Company has established a 401 401 may 401 90% 4% 401 $68,000 December 31, 2019 2018. Legal Proceedings On August 7, 2014, Paul Feller v. RestorGenex Corporation, Pro Sports & Entertainment, Inc., ProElite, Inc. and Stratus Media Group, GmbH No. BC553996 December 30, 2014, April 1, 2015, April 14, 2015, January 8, 2016, November 19, 2018 not November 2020. may |
Note 7 - Stockholders' Equity a
Note 7 - Stockholders' Equity and Common Stock Warrants | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | 7. 2019 In December 2019, “December 2019 6,266,787 6,266,787 $0.5585 $3.0 December 2019 June 13, 2025 $0.4335 In addition, at the closing of the December 2019 313,339 $0.6981 five In November 2019, “November 2019 5,104,429 6,324,143 one 22,857,144 $0.35 $3.3 $0.35 11,428,572 18 11,428,572 5 December 31, 2019, 11,091,716 $3.9 In addition, at the closing of the November 2019 571,429 $0.4375 five In May 2019, “May 2019 1,317,060 1,317,060 $4.895 $5.6 November 29, 2024 $5.00. In addition, at the closing of the May 2019 65,853 $6.11875 5 2018 In January 2018, 1,000,000 1,000,000 $12.00 $10.8 150,000 150,000 131,375 $12.00 In addition, at the closing, the Company issued to designees of the underwriter warrants to purchase up to 50,000 $15.00 five As a result of the Company's common stock offering in January 2018, 1,400,462 553,752 68,815 777,895 $8.2 Common Stock Warrants During its evaluation of equity classification for the Company's common stock warrants issued in 2019 2018, 815 40, Derivatives and Hedging, Contracts in an Entity’s own Equity 815 40” 815 40 not not 480 Distinguishing Liabilities from Equity not not 815, As of December 31, 2019, Outstanding Range of exercise price per share Expiration dates Common stock warrants issued in 2017 related to Series A convertible preferred stock offering 903,870 $33.30 March 2022 Common stock warrants issued in 2018 related to the common stock offering 1,181,375 $12.00 - $15.00 January 2023 Common stock warrants issued related to the May 2019 Offering 1,382,913 $5.00 - $6.11875 May and December 2024 Common stock warrants issued related to the November 2019 Offering 12,336,857 $0.35 - $0.4375 May 2024 Common stock warrants issued related to the December 2019 Offering 6,580,126 $0.4335 - $0.6981 December 2024 and June 2025 22,385,141 During the years ended December 31, 2019 2018, 1,767 28,123 |
Note 8 - Stock-based Compensati
Note 8 - Stock-based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Share-based Payment Arrangement [Text Block] | 8. 2015 The Diffusion Pharmaceuticals Inc. 2015 "2015 January 1 4.0% December 31, 1,339,215 January 1, 2020, may 2015 December 31, 2019, 19,740 2015 ten 10 three 3 The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations for the periods indicated: Year ended December 31, 2019 2018 Research and development $ 54,155 $ 62,161 General and administrative 461,607 1,159,430 Total stock-based compensation expense $ 515,762 $ 1,221,591 The following table summarizes the activity related to all stock option: Number of Options Weighted average exercise price per share Weighted average remaining contractual life (in years) Aggregate Intrinsic Value Balance at January 1, 2018 170,461 $ 109.74 Granted 44,005 15.37 Forfeited (10,583 ) 131.25 Expired (147 ) 256.50 Balance at January 1, 2019 203,736 $ 88.14 6.70 $ 143 Granted 117,270 2.62 Forfeited (11,583 ) 83.81 Expired (147 ) 276.00 Outstanding at December 31, 2019 309,276 $ 55.78 6.98 $ — Exercisable at December 31, 2019 235,415 $ 71.75 6.34 $ — Vested and expected to vest at December 31, 2019 309,276 $ 55.78 6.98 $ — The weighted average grant date fair value of stock option awards granted was $2.16 $12.63 December 31, 2019 2018, December 31, 2019 2018 $0.6 $1.2 No December 31, 2019, $0.3 1.06 The grant date fair value of employee stock options is determined using the Black-Scholes model. The following assumptions were used during the years ended December 31, 2019 2018: 2019 2018 Expected term (in years) 5.25 — 5.77 5.27 — 5.66 Risk-free interest rate 1.9 % — 2.5 % 2.3 % — 2.8 % Expected volatility 112.4 % — 114.4 % 113.6 % — 115.0 % Dividend yield — — — — — — |
Note 9 - Income Taxes
Note 9 - Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 9. Since inception, the Company has incurred net losses, and until 2018, not 2018, 2017 2017 2019, 382, 2018 2019 Deferred tax assets and liabilities are determined based on the differences between the financial statement carrying amounts and tax bases of assets and liabilities using enacted tax rates in effect for years in which differences are expected to reverse. Significant components of the Company's deferred tax assets for federal income taxes consisted of the following: Deferred tax assets December 31, 2019 December 31, 2018 Net operating loss carryforwards $ 1,504,496 $ 5,875,074 Stock option compensation 1,381,750 2,456,410 Orphan Drug credits 81,700 2,847,803 Lease liability 63,589 Capitalized start-up costs and other 9,187,898 7,349,092 Valuation allowance (12,051,440 ) (18,091,090 ) Deferred tax assets 167,993 437,289 Deferred tax liabilities Intangible assets (2,223,678 ) (2,223,678 ) Right of use asset (63,589 ) — Deferred tax liabilities (2,287,267 ) (2,223,678 ) Net deferred tax liability $ (2,119,274 ) $ (1,786,389 ) The Company does not December 31, 2019 December 31, 2018. The Company had net operating loss carryforwards (“NOL”) for federal and state income tax purposes at December 31, 2019 2018 Combined NOL Carryforwards: December 31, 2019 December 31, 2018 Federal $ 5,844,972 $ 22,819,972 State 5,844,972 22,845,568 The pre- 2018 2020 November 2019, 382 December 31, 2019 A reconciliation of income tax benefit at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows: Rate reconciliation: December 31, 2019 December 31, 2018 Federal tax benefit at statutory rate (21.0 )% (21.0 )% State tax, net of Federal benefit (2.5 )% (2.9 )% Goodwill impairment — % 7.7 % Orphan drug credit 25.3 % (1.3 )% Change in valuation allowance (7.5 )% 15.2 % Stock compensation 8.6 % — % Other 0.1 % — % Total provision 3.0 % (2.3 )% The Company files income tax returns in the U.S. federal jurisdiction and various state jurisdictions. The Company’s 2016 2018 |
Note 10 - Related Party Transac
Note 10 - Related Party Transactions | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Related Party Transactions Disclosure [Text Block] | 10. The Company’s Director of Information Technologies is the son of the Chief Executive Officer and he has held that position since December 2014. |
Note 11 - Subsequent Event
Note 11 - Subsequent Event | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | 11. Through March 17, 2020, 1,124,071 $0.35 $0.4 |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation The accompanying consolidated financial statements of the Company have been prepared in accordance with US GAAP. Any reference in these notes to applicable guidance is meant to refer to US GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements in conformity with US GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates using historical experience and other factors, including the current economic environment. Significant items subject to such estimates are assumptions used for purposes of determining stock-based compensation and accounting for research and development activities. Management believes its estimates to be reasonable under the circumstances. Actual results could differ significantly from those estimates. |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Fair Value of Financial Instruments Fair value is the price that could be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value determination in accordance with applicable accounting guidance requires that a number of significant judgments be made. Additionally, fair value is used on a nonrecurring basis to evaluate assets for impairment or as required for disclosure purposes by applicable accounting guidance on disclosures about fair value of financial instruments. Depending on the nature of the assets and liabilities, various valuation techniques and assumptions are used when estimating fair value. The carrying amounts of certain of the Company’s financial instruments, including cash equivalents and accounts payable are shown at cost, which approximates fair value due to the short-term nature of these instruments. The Company follows the provisions of FASB ASC Topic 820, Fair Value Measurement one three • Level 1: • Level 2: not • Level 3: no The following fair value hierarchy table presents information about the Company’s cash equivalents measured at fair value on a recurring basis: Fair value measurement at (in thousands) Quoted prices Significant Significant December 31, 2019: Assets: Cash equivalents $ 14,006,193 $ — $ — December 31, 2018: Assets: Cash equivalents $ 7,990,900 $ — $ — |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist principally of cash on deposit with multiple financial institutions, the balances of which frequently exceed federally insured limits. |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents The Company considers any highly liquid investments, such as money market funds, with an original maturity of three |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment The Company records property and equipment at cost less accumulated depreciation and amortization. Costs of renewals and improvements that extend the useful lives of the assets are capitalized. Maintenance and repairs are expensed as incurred. Depreciation is recognized on a straight-line basis over the estimated useful lives of the assets, which generally range from 2 15 |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Long-Lived Assets Long-lived assets are reviewed for potential impairment whenever events indicate that the carrying amount of such assets may not not December 31, 2019 2018. |
Goodwill and Intangible Assets, Policy [Policy Text Block] | Intangible Asset The Company has an indefinite-lived In-Process Research and Development Asset (IPR&D) called RES- 529, $8.6 December 31, 2019 December 31, 2018. 529 PI3K/Akt/mTOR Intangible assets deemed to have indefinite lives are not October 1 no 529 December 31, 2019 2018. |
Lessee, Leases [Policy Text Block] | Leases In February 2016, 6 |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Major components of research and development costs include internal research and development (such as salaries and related employee benefits, equity-based compensation, supplies and allocated facility costs) and contracted services (research and development activities performed on the Company’s behalf). Costs incurred for research and development are expensed as incurred. At the end of the reporting period, the Company compares payments made to third may Upfront payments made to third |
Legal Costs, Policy [Policy Text Block] | Patent Costs Patent costs, including related legal costs, are expensed as incurred and are recorded within general and administrative expenses in the statements of operations. |
Income Tax, Policy [Policy Text Block] | Income Taxes As a corporation, the Company uses the asset and liability method of accounting for income taxes. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. A valuation allowance is provided when it is more likely than not not not |
Share-based Payment Arrangement [Policy Text Block] | Stock-based Compensation The Company measures stock-based awards at grant-date fair value and records compensation expense on a straight-line basis over the vesting period of the award. The Company uses the Black-Scholes option pricing model to value its stock option awards. Estimating the fair value of stock option awards requires management to apply judgment and make estimates, including the volatility of the Company’s common stock, the expected term of the Company’s stock options, the expected dividend yield and the fair value of the Company’s common stock on the measurement date. As a result, if factors change and management uses different assumptions, stock-based compensation expense could be materially different for future awards. The expected term of stock options was estimated using the “simplified method” for employee options as the Company has no no not not |
Earnings Per Share, Policy [Policy Text Block] | Net Loss Per Common Share Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during each period. Diluted net loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as convertible preferred stock, common stock warrants, stock options and unvested restricted stock that would result in the issuance of incremental shares of common stock. In computing the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remains the same for both calculations due to the fact that when a net loss exists, dilutive shares are not The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive: December 31, 2019 2018 Common stock warrants 22,385,141 2,087,012 Stock options 309,276 203,736 22,694,417 2,290,748 |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Issued But Not In August 2018, 2018 03, Disclosure Framework- Changes to the Disclosure Requirements for Fair Value Measurements, 820. 820's December 15, 2019 not Recently Adopted Accounting Pronouncements In February 2016, 2016 02, Leases (Topic 842 842, The Company adopted ASC 842, January 1, 2019 not 842 $0.3 On January 1, 2019, 2018 07, Compensation—Stock Compensation (Topic 718 No. 2018 07” 505 50 Equity-based Payments to Non-employees 718 No. 2018 17 not |
Note 3 - Basis of Presentatio_2
Note 3 - Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Notes Tables | |
Fair Value Measurements, Recurring and Nonrecurring [Table Text Block] | Fair value measurement at (in thousands) Quoted prices Significant Significant December 31, 2019: Assets: Cash equivalents $ 14,006,193 $ — $ — December 31, 2018: Assets: Cash equivalents $ 7,990,900 $ — $ — |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | December 31, 2019 2018 Common stock warrants 22,385,141 2,087,012 Stock options 309,276 203,736 22,694,417 2,290,748 |
Note 4 - Property and Equipme_2
Note 4 - Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | December 31, 2019 2018 Laboratory equipment $ 182,357 $ 182,357 Furniture and office equipment 151,442 155,113 Leasehold improvements 430,000 430,000 Total property and equipment 763,799 767,470 Less: accumulated depreciation (511,433 ) (417,189 ) Property and equipment, net $ 252,366 $ 350,281 |
Note 5 - Accrued Expenses and_2
Note 5 - Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Notes Tables | |
Other Current Liabilities [Table Text Block] | December 31, 2019 2018 Accrued payroll and payroll related expenses $ 182,708 $ 409,889 Accrued professional fees 48,338 69,231 Accrued clinical studies expenses 57,378 34,000 Other 70,108 92,106 Total $ 358,532 $ 605,226 |
Note 6 - Commitments and Cont_2
Note 6 - Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Notes Tables | |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | Rental Commitments 2020 $ 116,464 2021 118,519 2022 39,735 Total 274,718 Less: imputed interest (27,675 ) $ 247,043 Rental Commitments 2019 $ 114,409 2020 116,464 2021 118,519 2022 39,735 Total $ 389,127 |
Note 7 - Stockholders' Equity_2
Note 7 - Stockholders' Equity and Common Stock Warrants (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Notes Tables | |
Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block] | Outstanding Range of exercise price per share Expiration dates Common stock warrants issued in 2017 related to Series A convertible preferred stock offering 903,870 $33.30 March 2022 Common stock warrants issued in 2018 related to the common stock offering 1,181,375 $12.00 - $15.00 January 2023 Common stock warrants issued related to the May 2019 Offering 1,382,913 $5.00 - $6.11875 May and December 2024 Common stock warrants issued related to the November 2019 Offering 12,336,857 $0.35 - $0.4375 May 2024 Common stock warrants issued related to the December 2019 Offering 6,580,126 $0.4335 - $0.6981 December 2024 and June 2025 22,385,141 |
Note 8 - Stock-based Compensa_2
Note 8 - Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Notes Tables | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Year ended December 31, 2019 2018 Research and development $ 54,155 $ 62,161 General and administrative 461,607 1,159,430 Total stock-based compensation expense $ 515,762 $ 1,221,591 |
Share-based Payment Arrangement, Option, Activity [Table Text Block] | Number of Options Weighted average exercise price per share Weighted average remaining contractual life (in years) Aggregate Intrinsic Value Balance at January 1, 2018 170,461 $ 109.74 Granted 44,005 15.37 Forfeited (10,583 ) 131.25 Expired (147 ) 256.50 Balance at January 1, 2019 203,736 $ 88.14 6.70 $ 143 Granted 117,270 2.62 Forfeited (11,583 ) 83.81 Expired (147 ) 276.00 Outstanding at December 31, 2019 309,276 $ 55.78 6.98 $ — Exercisable at December 31, 2019 235,415 $ 71.75 6.34 $ — Vested and expected to vest at December 31, 2019 309,276 $ 55.78 6.98 $ — |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | 2019 2018 Expected term (in years) 5.25 — 5.77 5.27 — 5.66 Risk-free interest rate 1.9 % — 2.5 % 2.3 % — 2.8 % Expected volatility 112.4 % — 114.4 % 113.6 % — 115.0 % Dividend yield — — — — — — |
Note 9 - Income Taxes (Tables)
Note 9 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Notes Tables | |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | Deferred tax assets December 31, 2019 December 31, 2018 Net operating loss carryforwards $ 1,504,496 $ 5,875,074 Stock option compensation 1,381,750 2,456,410 Orphan Drug credits 81,700 2,847,803 Lease liability 63,589 Capitalized start-up costs and other 9,187,898 7,349,092 Valuation allowance (12,051,440 ) (18,091,090 ) Deferred tax assets 167,993 437,289 Deferred tax liabilities Intangible assets (2,223,678 ) (2,223,678 ) Right of use asset (63,589 ) — Deferred tax liabilities (2,287,267 ) (2,223,678 ) Net deferred tax liability $ (2,119,274 ) $ (1,786,389 ) |
Summary of Operating Loss Carryforwards [Table Text Block] | Combined NOL Carryforwards: December 31, 2019 December 31, 2018 Federal $ 5,844,972 $ 22,819,972 State 5,844,972 22,845,568 |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | Rate reconciliation: December 31, 2019 December 31, 2018 Federal tax benefit at statutory rate (21.0 )% (21.0 )% State tax, net of Federal benefit (2.5 )% (2.9 )% Goodwill impairment — % 7.7 % Orphan drug credit 25.3 % (1.3 )% Change in valuation allowance (7.5 )% 15.2 % Stock compensation 8.6 % — % Other 0.1 % — % Total provision 3.0 % (2.3 )% |
Note 2 - Liquidity (Details Tex
Note 2 - Liquidity (Details Textual) $ in Millions | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Proceeds from Issuance or Sale of Equity, Total | $ 16 |
Note 3 - Basis of Presentatio_3
Note 3 - Basis of Presentation and Summary of Significant Accounting Policies (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Jan. 01, 2019 | |
Indefinite-lived Intangible Assets (Excluding Goodwill), Ending Balance | $ 8,639,000 | $ 8,639,000 | |
Operating Lease, Right-of-Use Asset | 247,043 | ||
Operating Lease, Liability, Total | 247,043 | ||
Accounting Standards Update 2016-02 [Member] | |||
Operating Lease, Right-of-Use Asset | $ 300,000 | ||
Operating Lease, Liability, Total | $ 300,000 | ||
In-Process Research and Development Asset [Member] | |||
Indefinite-lived Intangible Assets (Excluding Goodwill), Ending Balance | 8,600,000 | 8,600,000 | |
Impairment of Intangible Assets, Indefinite-lived (Excluding Goodwill) | $ 0 | $ 0 | |
Minimum [Member] | |||
Property, Plant and Equipment, Useful Life | 2 years | ||
Maximum [Member] | |||
Property, Plant and Equipment, Useful Life | 15 years |
Note 3 - Basis of Presentatio_4
Note 3 - Basis of Presentation and Summary of Significant Accounting Policies - Fair Value on Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Fair Value, Inputs, Level 1 [Member] | ||
Cash equivalents | $ 14,006,193 | $ 7,990,900 |
Fair Value, Inputs, Level 2 [Member] | ||
Cash equivalents | ||
Fair Value, Inputs, Level 3 [Member] | ||
Cash equivalents |
Note 3 - Basis of Presentatio_5
Note 3 - Basis of Presentation and Summary of Significant Accounting Policies - Outstanding Dilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Anti-dilutive securities (in shares) | 22,694,417 | 2,290,748 |
Warrant [Member] | ||
Anti-dilutive securities (in shares) | 22,385,141 | 2,087,012 |
Share-based Payment Arrangement, Option [Member] | ||
Anti-dilutive securities (in shares) | 309,276 | 203,736 |
Note 4 - Property and Equipme_3
Note 4 - Property and Equipment (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Depreciation, Total | $ 97,915 | $ 110,371 |
Note 4 - Property and Equipme_4
Note 4 - Property and Equipment - Property and Equipment (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Property and equipment, gross | $ 763,799 | $ 767,470 |
Less: accumulated depreciation | (511,433) | (417,189) |
Property and equipment, net | 252,366 | 350,281 |
Laboratory Equipment [Member] | ||
Property and equipment, gross | 182,357 | 182,357 |
Furniture and Fixtures [Member] | ||
Property and equipment, gross | 151,442 | 155,113 |
Leasehold Improvements [Member] | ||
Property and equipment, gross | $ 430,000 | $ 430,000 |
Note 5 - Accrued Expenses and_3
Note 5 - Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Accrued payroll and payroll related expenses | $ 182,708 | $ 409,889 |
Accrued professional fees | 48,338 | 69,231 |
Accrued clinical studies expenses | 57,378 | 34,000 |
Other | 70,108 | 92,106 |
Total | $ 358,532 | $ 605,226 |
Note 6 - Commitments and Cont_3
Note 6 - Commitments and Contingencies (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2019 | |
Operating Lease, Remaining Lease Term | 2 years 109 days | ||
Operating Lease, Liability, Current | $ 111,477 | $ 100,000 | |
Operating Lease, Liability, Noncurrent | 135,566 | $ 200,000 | |
Lessee, Operating Lease, Discount Rate | 10.00% | ||
Lessee, Operating Lease, Renewal Term | 5 years | ||
Operating Lease, Expense | $ 100,000 | 100,000 | |
Defined Contribution Plan, Maximum Annual Contributions Per Employee, Percent | 90.00% | ||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 4.00% | ||
Defined Contribution Plan, Employer Discretionary Contribution Amount | $ 68,000 | $ 68,000 |
Note 6 - Commitments and Cont_4
Note 6 - Commitments and Contingencies - Future Minimum Rental Payments (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
2020 | $ 116,464 | $ 114,409 |
2021 | 118,519 | 116,464 |
2022 | 39,735 | 118,519 |
Total | 274,718 | 389,127 |
Less: imputed interest | (27,675) | |
$ 247,043 | ||
2022 | $ 39,735 |
Note 7 - Stockholders' Equity_3
Note 7 - Stockholders' Equity and Common Stock Warrants (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Dec. 31, 2019 | Nov. 30, 2019 | May 31, 2019 | Jan. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | |
Proceeds from Issuance or Sale of Equity, Total | $ 16,000,000 | |||||
Proceeds from Warrant Exercises | 3,888,425 | |||||
Conversion of Stock, Shares Issued | 1,400,462 | |||||
Stock Issued During Period, Shares, Conversion of Convertible Securities | 553,752 | |||||
Common Stock Dividends, Shares | 68,815 | |||||
Stock Issued During Period, Shares, Make-whole Adjustment | 777,895 | |||||
Dividends, Make-whole Adjustment | $ 8,200,000 | $ 8,167,895 | ||||
Class of Warrant or Rights, Expired | 1,767 | 28,123 | ||||
Warrants Issued in Connection with the December 2019 Offering [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 6,266,787 | 6,266,787 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.4335 | $ 0.4335 | ||||
Warrants Issued in Connection with the December 2019 Offering [Member] | Maximum [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.6981 | $ 0.6981 | ||||
Placement Agent Warrant [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 313,339 | 571,429 | 65,853 | 313,339 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.6981 | $ 0.4375 | $ 6.11875 | $ 0.6981 | ||
Warrants and Rights Outstanding, Term | 5 years | 5 years | 5 years | 5 years | ||
Warrants Issued in Connection with the November 2019 Offering [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.35 | |||||
Class of Warrant or Right, Issued During Period | 6,324,143 | |||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 1 | |||||
Class of Warrant or Right, Exercised During Period | 11,091,716 | |||||
Proceeds from Warrant Exercises | $ 3,900,000 | |||||
Warrants Issued in Connection with the November 2019 Offering [Member] | Maximum [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.4375 | $ 0.4375 | ||||
Warrants with 18 Months Term Issued in Connection with the November 2019 Offering [Member] | ||||||
Warrants and Rights Outstanding, Term | 1 year 180 days | |||||
Class of Warrant or Right, Issued During Period | 11,428,572 | |||||
Warrants with 5 Years Term Issued in Connection with the November 2019 Offering [Member] | ||||||
Warrants and Rights Outstanding, Term | 5 years | |||||
Class of Warrant or Right, Issued During Period | 11,428,572 | |||||
Warrants Issued in Connection with the January 2018 Offering [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,000,000 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 12 | |||||
Warrants Issued in Connection with the January 2018 Offering [Member] | Maximum [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 15 | 15 | ||||
Option Warrants [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 150,000 | |||||
Additional Warrants [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 12 | |||||
Class of Warrant or Right, Granted | 131,375 | |||||
Underwriter Warrants [Member] | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 15 | |||||
Class of Warrant or Right, Term | 5 years | |||||
Underwriter Warrants [Member] | Maximum [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 50,000 | |||||
December 2019 Public Offering [Member] | ||||||
Stock Issued During Period, Shares, New Issues | 6,266,787 | |||||
Shares Issued, Price Per Share | $ 0.5585 | $ 0.5585 | ||||
Proceeds from Issuance or Sale of Equity, Total | $ 3,000,000 | |||||
November 2019 Public Offering [Member] | ||||||
Stock Issued During Period, Shares, New Issues | 5,104,429 | |||||
Shares Issued, Price Per Share | $ 0.35 | |||||
Proceeds from Issuance or Sale of Equity, Total | $ 3,300,000 | |||||
Stock and Warrants Issued During Period, Number of Securities Called by Stock and Warrants | 22,857,144 | |||||
May 2019 Public Offering [Member] | ||||||
Stock Issued During Period, Shares, New Issues | 1,317,060 | |||||
Shares Issued, Price Per Share | $ 4.895 | |||||
Proceeds from Issuance or Sale of Equity, Total | $ 5,600,000 | |||||
Warrants Issued in Connection with May 2019 Public Offering [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,317,060 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 5 | |||||
January 2018 Offering [Member] | ||||||
Stock Issued During Period, Shares, New Issues | 1,000,000 | |||||
Proceeds from Issuance or Sale of Equity, Total | $ 10,800,000 | |||||
Stock Issued During Period, Shares, Issued for Services | 150,000 |
Note 7 - Stockholders' Equity_4
Note 7 - Stockholders' Equity and Common Stock Warrants - Warrants Outstanding to Acquire Shares of Its Common Stock (Details) - $ / shares | Dec. 31, 2019 | Nov. 30, 2019 | Jan. 31, 2018 |
Common stock warrants, outstanding (in shares) | 22,385,141 | ||
Warrants Attached to Series A Convertible Preferred Stock [Member] | |||
Common stock warrants, outstanding (in shares) | 903,870 | ||
Range of exercise price (in dollars per share) | $ 33.30 | ||
Warrants Issued in Connection with the January 2018 Offering [Member] | |||
Common stock warrants, outstanding (in shares) | 1,181,375 | ||
Range of exercise price (in dollars per share) | $ 12 | ||
Warrants Issued in Connection with the January 2018 Offering [Member] | Minimum [Member] | |||
Range of exercise price (in dollars per share) | $ 12 | ||
Warrants Issued in Connection with the January 2018 Offering [Member] | Maximum [Member] | |||
Range of exercise price (in dollars per share) | $ 15 | ||
Warrants Issued in Connection with May 2019 Public Offering [Member] | |||
Common stock warrants, outstanding (in shares) | 1,382,913 | ||
Warrants Issued in Connection with May 2019 Public Offering [Member] | Minimum [Member] | |||
Range of exercise price (in dollars per share) | $ 5 | ||
Warrants Issued in Connection with May 2019 Public Offering [Member] | Maximum [Member] | |||
Range of exercise price (in dollars per share) | $ 6.11875 | ||
Warrants Issued in Connection with the November 2019 Offering [Member] | |||
Common stock warrants, outstanding (in shares) | 12,336,857 | ||
Range of exercise price (in dollars per share) | $ 0.35 | ||
Warrants Issued in Connection with the November 2019 Offering [Member] | Minimum [Member] | |||
Range of exercise price (in dollars per share) | $ 0.35 | ||
Warrants Issued in Connection with the November 2019 Offering [Member] | Maximum [Member] | |||
Range of exercise price (in dollars per share) | $ 0.4375 | ||
Warrants Issued in Connection with the December 2019 Offering [Member] | |||
Common stock warrants, outstanding (in shares) | 6,580,126 | ||
Range of exercise price (in dollars per share) | $ 0.4335 | ||
Warrants Issued in Connection with the December 2019 Offering [Member] | Minimum [Member] | |||
Range of exercise price (in dollars per share) | 0.4335 | ||
Warrants Issued in Connection with the December 2019 Offering [Member] | Maximum [Member] | |||
Range of exercise price (in dollars per share) | $ 0.6981 |
Note 8 - Stock-based Compensa_3
Note 8 - Stock-based Compensation (Details Textual) - USD ($) $ / shares in Units, $ in Millions | Jan. 01, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 2.16 | $ 12.63 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $ 0.6 | $ 1.2 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 0 | 0 | |
Share-based Payment Arrangement, Option [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 3 years | ||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ 0.3 | ||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 1 year 21 days | ||
Equity Incentive Plan 2015 [Member] | |||
Percentage of Total Shares Eligible for Plan Reserve, On an Annual Basis | 4.00% | ||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 19,740 | ||
Equity Incentive Plan 2015 [Member] | Subsequent Event [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 1,339,215 |
Note 8 - Stock-based Compensa_4
Note 8 - Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Stock-based compensation expense | $ 515,762 | $ 1,221,591 |
Research and Development Expense [Member] | ||
Stock-based compensation expense | 54,155 | 62,161 |
General and Administrative Expense [Member] | ||
Stock-based compensation expense | $ 461,607 | $ 1,159,430 |
Note 8 - Stock-based Compensa_5
Note 8 - Stock-based Compensation - Stock Option Activity (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Options outstanding, number (in shares) | 203,736 | 170,461 |
Options outstanding, weighted-average exercise price (in dollars per share) | $ 88.14 | $ 109.74 |
Granted (in shares) | 117,270 | 44,005 |
Granted, weighted-average exercise price (in dollars per share) | $ 2.62 | $ 15.37 |
Forfeited (in shares) | (11,583) | (10,583) |
Forfeited, weighted-average exercise price (in dollars per share) | $ 83.81 | $ 131.25 |
Expired (in shares) | (147) | (147) |
Expired, weighted-average exercise price (in dollars per share) | $ 276 | $ 256.50 |
Options outstanding, weighted-average remaining contractual life (Year) | 6 years 357 days | 6 years 255 days |
Options outstanding, aggregate intrinsic value | $ 143 | |
Options outstanding, number (in shares) | 309,276 | 203,736 |
Options outstanding, weighted-average exercise price (in dollars per share) | $ 55.78 | $ 88.14 |
Options outstanding, weighted-average remaining contractual life (Year) | 6 years 357 days | 6 years 255 days |
Exercisable (in shares) | 235,415 | |
Exercisable, weighted-average exercise price (in dollars per share) | $ 71.75 | |
Exercisable, weighted-average remaining contractual life (Year) | 6 years 124 days | |
Exercisable, aggregate intrinsic value | ||
Vested and expected to vest (in shares) | 309,276 | |
Vested and expected to vest, weighted-average exercise price (in dollars per share) | $ 55.78 | |
Vested and expected to vest, weighted-average remaining contractual life (Year) | 6 years 357 days | |
Vested and expected to vest, aggregate intrinsic value |
Note 8 - Stock-based Compensa_6
Note 8 - Stock-based Compensation - Fair Value Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Minimum [Member] | ||
Expected term (Year) | 5 years 91 days | 5 years 98 days |
Risk-free interest rate | 1.90% | 2.30% |
Expected volatility | 112.40% | 113.60% |
Dividend yield | ||
Maximum [Member] | ||
Expected term (Year) | 5 years 281 days | 5 years 240 days |
Risk-free interest rate | 2.50% | 2.80% |
Expected volatility | 114.40% | 115.00% |
Dividend yield |
Note 9 - Income Taxes (Details
Note 9 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Unrecognized Tax Benefits, Ending Balance | $ 0 | $ 0 |
Open Tax Year | 2016 2017 2018 |
Note 9 - Income Taxes - Deferre
Note 9 - Income Taxes - Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Net operating loss carryforwards | $ 1,504,496 | $ 5,875,074 |
Stock option compensation | 1,381,750 | 2,456,410 |
Orphan Drug credits | 81,700 | 2,847,803 |
Lease liability | 63,589 | |
Capitalized start-up costs and other | 9,187,898 | 7,349,092 |
Valuation allowance | (12,051,440) | (18,091,090) |
Deferred tax assets | 167,993 | 437,289 |
Intangible assets | (2,223,678) | (2,223,678) |
Right of use asset | (63,589) | |
Deferred tax liabilities | (2,287,267) | (2,223,678) |
Net deferred tax liability | $ (2,119,274) | $ (1,786,389) |
Note 9 - Income Taxes - Operati
Note 9 - Income Taxes - Operating Loss Carryforwards (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Domestic Tax Authority [Member] | ||
Operating loss carryforwards | $ 5,844,972 | $ 22,819,972 |
State and Local Jurisdiction [Member] | ||
Operating loss carryforwards | $ 5,844,972 | $ 22,845,568 |
Note 9 - Income Taxes - Reconci
Note 9 - Income Taxes - Reconciliation of Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Federal tax benefit at statutory rate | (21.00%) | (21.00%) |
State tax, net of Federal benefit | (2.50%) | (2.90%) |
Goodwill impairment | 7.70% | |
Orphan drug credit | 25.30% | (1.30%) |
Change in valuation allowance | (7.50%) | 15.20% |
Stock compensation | 8.60% | |
Other | 0.10% | |
Total provision | 3.00% | (2.30%) |
Note 11 - Subsequent Event (Det
Note 11 - Subsequent Event (Details Textual) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 17, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Proceeds from Warrant Exercises | $ 3,888,425 | ||
Subsequent Event [Member] | |||
Class of Warrant or Right, Exercised | 1,124,071 | ||
Class of Warrant or Right, Exercised During Period, Exercise Price | $ 0.35 | ||
Proceeds from Warrant Exercises | $ 400,000 |