Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 12, 2021 | Jun. 30, 2020 | |
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) | 101,903,979 | ||
Entity Public Float | $ 62.4 | ||
Entity Shell Company | false | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
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, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 18,515,595 | $ 14,177,349 |
Prepaid expenses, deposits and other current assets | 260,825 | 472,464 |
Total current assets | 18,776,420 | 14,649,813 |
Property and equipment, net | 149,198 | 252,366 |
Intangible asset | 8,639,000 | 8,639,000 |
Right of use asset | 149,162 | 247,043 |
Other assets | 15,771 | 322,301 |
Total assets | 27,729,551 | 24,110,523 |
Current liabilities: | ||
Accounts payable | 545,844 | 1,251,412 |
Accrued expenses and other current liabilities | 1,776,470 | 358,532 |
Current operating lease liability | 113,469 | 111,477 |
Total current liabilities | 2,435,783 | 1,721,421 |
Deferred income taxes | 443,893 | 2,119,274 |
Noncurrent operating lease liability | 35,693 | 135,566 |
Total liabilities | 2,915,369 | 3,976,261 |
Commitments and Contingencies (Note 6) | ||
Stockholders’ Equity: | ||
Common stock, $0.001 par value: 1,000,000,000 shares authorized; 64,015,441 and 33,480,365 shares issued and outstanding at December 31, 2020 and 2019, respectively | 64,016 | 33,481 |
Additional paid-in capital | 130,659,550 | 111,824,859 |
Accumulated deficit | (105,909,384) | (91,724,078) |
Total stockholders' equity | 24,814,182 | 20,134,262 |
Total liabilities and stockholders' equity | $ 27,729,551 | $ 24,110,523 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 1,000,000,000 | 1,000,000,000 |
Common stock, shares issued (in shares) | 64,015,441 | 33,480,365 |
Common stock, shares outstanding (in shares) | 64,015,441 | 33,480,365 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Operating expenses: | ||
Research and development | $ 9,427,667 | $ 6,619,597 |
General and administrative | 6,444,109 | 4,834,284 |
Depreciation | 103,168 | 97,915 |
Loss from operations | (15,974,944) | (11,551,796) |
Other income: | ||
Interest income | 114,257 | 85,302 |
Loss from operations before income taxes | (15,860,687) | (11,466,494) |
Income tax benefit (expense) | 1,675,381 | (332,885) |
Net loss | (14,185,306) | (11,799,379) |
Deemed dividend arising from warrant exchange | (1,950,378) | |
Net loss attributable to common stockholders | $ (16,135,684) | $ (11,799,379) |
Share information: | ||
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (0.30) | $ (1.76) |
Weighted average shares outstanding, basic and diluted (in dollars per share) | $ 53,831,973 | $ 6,706,509 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
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 |
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 | |
Issuance of common stock upon exercise of warrants (in shares) | 17,415,859 | |||
Issuance of common stock upon exercise of warrants | $ 17,416 | 3,871,009 | 3,888,425 | |
Stock-based compensation expense | 515,762 | 515,762 | ||
Net loss | (11,799,379) | (11,799,379) | ||
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 |
Issuance of common stock, pre-funded warrants and warrants, net of issuance costs (in shares) | 11,428,572 | |||
Issuance of common stock, pre-funded warrants and warrants, net of issuance costs | $ 11,429 | 10,330,202 | 10,341,631 | |
Issuance of common stock upon exercise of warrants (in shares) | 19,106,504 | |||
Issuance of common stock upon exercise of warrants | $ 19,106 | 7,768,370 | 7,787,476 | |
Stock-based compensation expense | 736,119 | 736,119 | ||
Net loss | (14,185,306) | (14,185,306) | ||
Balance (in shares) at Dec. 31, 2020 | 64,015,441 | |||
Balance at Dec. 31, 2020 | $ 64,016 | $ 130,659,550 | $ (105,909,384) | $ 24,814,182 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Operating activities: | ||
Net loss | $ (14,185,306) | $ (11,799,379) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 103,168 | 97,915 |
Stock-based compensation expense | 736,119 | 515,762 |
Change in deferred income taxes | (1,675,381) | 332,885 |
Changes in operating assets and liabilities: | ||
Prepaid expenses, deposits and other assets | 518,169 | 426,774 |
Accounts payable, accrued expenses and other liabilities | 950,602 | 567,668 |
Net cash used in operating activities | (13,552,629) | (9,858,375) |
Cash flows provided by financing activities: | ||
Proceeds from the sale of common stock | 10,827,100 | |
Proceeds from the sale of common stock, pre-funded warrants and warrants | 12,318,956 | |
Proceeds from the exercise of common stock warrants and pre-funded warrants | 8,046,103 | 3,888,425 |
Payment of offering costs | (982,328) | (162,829) |
Net cash provided by financing activities | 17,890,875 | 16,044,552 |
Net increase in cash and cash equivalents | 4,338,247 | 6,186,177 |
Cash and cash equivalents at beginning of year | 14,177,349 | 7,991,172 |
Cash and cash equivalents at end of year | 18,515,595 | 14,177,349 |
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 |
Note 1 - Organization and Descr
Note 1 - Organization and Description of Business | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Nature of Operations [Text Block] | 1. Diffusion Pharmaceuticals Inc., a Delaware corporation, an innovative biopharmaceutical company developing novel therapies that enhance the body's ability to deliver oxygen to the areas where it is needed most. The Company's lead product candidate, TSC, is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine's most intractable and difficult-to-treat conditions. In addition to TSC, the Company's product candidate DFN- 529, PI3K/Akt/mTOR two 1 529 529 |
Note 2 - Liquidity
Note 2 - Liquidity | 12 Months Ended |
Dec. 31, 2020 | |
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 not may third may 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 expects that its existing cash and cash equivalents as of December 31, 2020, February 2021 first 2021 2 2023. |
Note 3 - Basis of Presentation
Note 3 - Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | 3. Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements of the Company have been prepared in accordance with GAAP. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification and Accounting Standards Updates of the Financial Accounting Standards Board. Use of Estimates The preparation of financial statements in conformity with 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 The carrying amounts of the Company's financial instruments, including cash equivalents and accounts payable approximate fair value due to the short-term nature of those instruments. 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, 2020 2019. Intangible Asset The Company has an indefinite-lived IPR&D asset, DFN- 529, $8.6 December 31, 2020 December 31, 2019. 529 PI3K/Akt/mTOR Intangible assets deemed to have indefinite lives are not October 1 no 529 December 31, 2020 2019. 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 consolidated 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 ASC 740 10 may not 50.0% 740 10, 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 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. For certain stock option grants, the expected term was estimated using the “simplified method” for employee options as the Company has limited historical information to develop reasonable expectations about future exercise patterns and post vesting employment termination behavior for its stock option grants. The simplified method is based on the average of the vesting tranches and the contractual life of each grant. During the year ended December 31, 2020, 10 For stock price volatility, the Company uses a combination of their own historical stock price and comparable public companies as a basis for its expected volatility to calculate the fair value of option grants. The Company assumes 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 debt, 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, 2020 2019 Common stock warrants 9,100,112 22,385,141 Stock options 2,240,204 309,276 11,340,316 22,694,417 Recently Issued But Not In December 2019, No. 2019 12, 740 Simplifying the Accounting for Income Taxes December 15, 2020 not No. 2019 12 Recently Adopted Accounting Pronouncements In August 2018, 2018 03, Disclosure Framework- Changes to the Disclosure Requirements for Fair Value Measurements, 820. 820's January 2020 not |
Note 4 - Property and Equipment
Note 4 - Property and Equipment | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | 4. Property and Equipment Property and equipment consists of the following: December 31, 2020 2019 Laboratory equipment $ 182,357 $ 182,357 Furniture and office equipment 151,442 151,442 Leasehold improvements 430,000 430,000 Total property and equipment 763,799 763,799 Less: accumulated depreciation and amortization (614,601 ) (511,433 ) Property and equipment, net $ 149,198 $ 252,366 Depreciation and amortization expense was approximately $0.1 December 31, 2020 2019. |
Note 5 - Accrued Expenses and O
Note 5 - Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Accounts Payable, Accrued Liabilities, and Other Liabilities Disclosure, Current [Text Block] | 5. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consist of the following: December 31, 2020 2019 Accrued payroll and payroll related expenses $ 653,899 $ 182,708 Accrued professional fees 31,809 48,338 Accrued clinical studies expenses 1,055,398 57,378 Other 35,364 70,108 Total $ 1,776,470 $ 358,532 |
Note 6 - Commitments and Contin
Note 6 - Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | 6. Commitments and Contingencies 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, 2020, 1.3 10.0%. second 2022 5 not December 31, 2020. Rent expense related to the Company's operating lease for both the years ended December 31, 2020 2019 $0.1 December 31, 2020 Rental Commitments 2021 $ 118,519 2022 39,735 Total 158,254 Less: imputed interest (9,092 ) $ 149,162 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 its 401 may 401 90.00% 4.0% 401 $56,000 $68,000 December 31, 2020 2019, Legal Proceedings On August 7, 2014, No. BC553996 December 30, 2014, April 1, 2015, April 14, 2015, January 8, 2016, November 19, 2018 not November 2020. August 2020, 19 August 16, 2021. may |
Note 7 - Stockholders' Equity a
Note 7 - Stockholders' Equity and Common Stock Warrants | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | 7. Stockholders' Equity and Common Stock Warrants 2020 In May 2020, May 2020 11,428,572 $1.05 $10.3 May 2020 571,429 May 2020 $1.3125 five Additionally, also in May 2020, 5,000,000 $0.35 $0.125 5,000,000 $0.5263 November 8, 2025. $2.0 December 31, 2020 In connection with the warrants exercised in May 2020, 250,000 $0.5938 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 Common Stock Warrants During its evaluation of equity classification for the Company's common stock warrants issued in 2020 2019, 815 40, Derivatives and Hedging, Contracts in an Entity s own Equity 815 40 not not 480, Distinguishing Liabilities from Equity not not 815, As of December 31, 2020, 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 January 2018 common stock offering 1,181,421 $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 497,140 $0.35 - $0.4375 May 2024 Common stock warrants issued related to the December 2019 Offering 313,339 $0.4335 - $0.6981 December 2024 and June 2025 Common stock warrants issued related to the May 2020 Offering 571,429 $1.31 March 2025 Common stock warrants issued related to the May 2020 Investor Warrant Exercise 4,250,000 $0.5263 - $0.5938 November 2025 9,100,112 During the year ended December 31, 2020, no 19,106,504 $8.0 December 31, 2019, 1,767 17,415,859 $3.9 |
Note 8 - Stock-based Compensati
Note 8 - Stock-based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Share-based Payment Arrangement [Text Block] | 8. Stock-Based Compensation 2015 The 2015 January 1 4.0% December 31, 2,560,618 January 1, 2021, may 2015 December 31, 2020, no 2015 270,000 December 31, 2020 2015 5635 4 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, 2020 2019 Research and development $ 164,791 $ 54,155 General and administrative 571,328 461,607 Total stock-based compensation expense $ 736,119 $ 515,762 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, 2019 203,736 $ 88.14 Granted 117,270 2.62 Forfeited (11,583 ) 83.81 Expired (147 ) 276.00 Balance at December 31, 2019 309,276 $ 55.78 6.98 — Granted 1,931,100 0.68 Expired (172 ) 142.50 Outstanding at December 31, 2020 2,240,204 $ 8.28 8.90 $ 289,067 Exercisable at December 31, 2020 1,129,733 $ 15.64 8.28 $ 219,010 Vested and expected to vest at December 31, 2020 2,240,204 $ 8.28 8.90 $ 289,067 The weighted average grant date fair value of stock option awards granted was $0.64 $2.16 December 31, 2020 2019, December 31, 2020 2019 $0.7 $0.6 No December 31, 2020, $0.8 2.2 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, 2020 2019: 2020 2019 Expected term (in years) 5.31 — 10.00 5.25 — 5.77 Risk-free interest rate 0.4% — 1.7% 1.9% — 2.5% Expected volatility 113.4% — 124.8% 112.4% — 114.4% Dividend yield — — — — — — Restricted Stock Unit Awards During the year ended December 31, 2020, 153,000 December 31, 2020 $0.65. 18 $18,000 December 31, 2020. December 31, 2020, $82,000 2.4 |
Note 9 - Income Taxes
Note 9 - Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 9. Income Taxes 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, 2020 December 31, 2019 Net operating loss carryforwards $ 3,864,189 $ 1,504,496 Stock-based compensation 1,571,227 1,381,750 Orphan Drug credits 541,384 81,700 Lease liability 38,394 63,589 Capitalized start-up costs and other 10,709,631 9,187,898 Valuation allowance (14,906,646 ) (12,051,440 ) Deferred tax assets 1,818,179 167,993 Deferred tax liabilities Intangible assets (2,223,678 ) (2,223,678 ) Right of use asset (38,394 ) (63,589 ) Deferred tax liabilities (2,262,072 ) (2,287,267 ) Net deferred tax liability $ (443,893 ) $ (2,119,274 ) The Company does not December 31, 2020 December 31, 2019. The Company had NOL carryforwards for federal and state income tax purposes at December 31, 2020 2019 Combined NOL Carryforwards: December 31, 2020 December 31, 2019 Federal $ 15,013,388 $ 5,844,972 State 15,007,966 5,844,972 The pre- 2018 2020 November 2019, 382 December 31, 2020 A reconciliation of income tax benefit at the statutory federal income tax rate and income taxes as reflected in the consolidated financial statements is as follows: Rate reconciliation: December 31, 2020 December 31, 2019 Federal tax benefit at statutory rate (21.0 )% (21.0 )% State tax, net of Federal benefit (4.7 )% (2.5 )% Orphan drug credit (2.9 )% 25.3 % Change in valuation allowance 18.1 % (7.5 )% Stock compensation — % 8.6 % Other — % 0.1 % Total provision (10.5 )% 3.0 % The Company files income tax returns in the U.S. federal jurisdiction and various state jurisdictions. The Company's 2017 2019 |
Note 10 - Related Party Transac
Note 10 - Related Party Transactions | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Related Party Transactions Disclosure [Text Block] | 10. The Company's Director of Information Technologies is the son of the Chairman of the Board of Directors and he has held that position since December 2014. |
Note 11 - Subsequent Events
Note 11 - Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | 11. Subsequent Events 2021 From January 1, 2021 March 15, 2021, 4,230,000 $2.2 2021 In February 2021, February 2021 33,658,538 $1.025 30 February 2021 $31.2 February 2021 1,682,927 $1.28125 five |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
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 GAAP. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification and Accounting Standards Updates of the Financial Accounting Standards Board. |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements in conformity with 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 The carrying amounts of the Company's financial instruments, including cash equivalents and accounts payable approximate fair value due to the short-term nature of those instruments. |
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, 2020 2019. |
Goodwill and Intangible Assets, Policy [Policy Text Block] | Intangible Asset The Company has an indefinite-lived IPR&D asset, DFN- 529, $8.6 December 31, 2020 December 31, 2019. 529 PI3K/Akt/mTOR Intangible assets deemed to have indefinite lives are not October 1 no 529 December 31, 2020 2019. |
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 consolidated 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 ASC 740 10 may not 50.0% 740 10, |
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 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. For certain stock option grants, the expected term was estimated using the “simplified method” for employee options as the Company has limited historical information to develop reasonable expectations about future exercise patterns and post vesting employment termination behavior for its stock option grants. The simplified method is based on the average of the vesting tranches and the contractual life of each grant. During the year ended December 31, 2020, 10 For stock price volatility, the Company uses a combination of their own historical stock price and comparable public companies as a basis for its expected volatility to calculate the fair value of option grants. The Company assumes 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 debt, 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, 2020 2019 Common stock warrants 9,100,112 22,385,141 Stock options 2,240,204 309,276 11,340,316 22,694,417 |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Issued But Not In December 2019, No. 2019 12, 740 Simplifying the Accounting for Income Taxes December 15, 2020 not No. 2019 12 Recently Adopted Accounting Pronouncements In August 2018, 2018 03, Disclosure Framework- Changes to the Disclosure Requirements for Fair Value Measurements, 820. 820's January 2020 not |
Note 3 - Basis of Presentatio_2
Note 3 - Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | December 31, 2020 2019 Common stock warrants 9,100,112 22,385,141 Stock options 2,240,204 309,276 11,340,316 22,694,417 |
Note 4 - Property and Equipme_2
Note 4 - Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | December 31, 2020 2019 Laboratory equipment $ 182,357 $ 182,357 Furniture and office equipment 151,442 151,442 Leasehold improvements 430,000 430,000 Total property and equipment 763,799 763,799 Less: accumulated depreciation and amortization (614,601 ) (511,433 ) Property and equipment, net $ 149,198 $ 252,366 |
Note 5 - Accrued Expenses and_2
Note 5 - Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Other Current Liabilities [Table Text Block] | December 31, 2020 2019 Accrued payroll and payroll related expenses $ 653,899 $ 182,708 Accrued professional fees 31,809 48,338 Accrued clinical studies expenses 1,055,398 57,378 Other 35,364 70,108 Total $ 1,776,470 $ 358,532 |
Note 6 - Commitments and Cont_2
Note 6 - Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | Rental Commitments 2021 $ 118,519 2022 39,735 Total 158,254 Less: imputed interest (9,092 ) $ 149,162 |
Note 7 - Stockholders' Equity_2
Note 7 - Stockholders' Equity and Common Stock Warrants (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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 January 2018 common stock offering 1,181,421 $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 497,140 $0.35 - $0.4375 May 2024 Common stock warrants issued related to the December 2019 Offering 313,339 $0.4335 - $0.6981 December 2024 and June 2025 Common stock warrants issued related to the May 2020 Offering 571,429 $1.31 March 2025 Common stock warrants issued related to the May 2020 Investor Warrant Exercise 4,250,000 $0.5263 - $0.5938 November 2025 9,100,112 |
Note 8 - Stock-based Compensa_2
Note 8 - Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Year ended December 31, 2020 2019 Research and development $ 164,791 $ 54,155 General and administrative 571,328 461,607 Total stock-based compensation expense $ 736,119 $ 515,762 |
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, 2019 203,736 $ 88.14 Granted 117,270 2.62 Forfeited (11,583 ) 83.81 Expired (147 ) 276.00 Balance at December 31, 2019 309,276 $ 55.78 6.98 — Granted 1,931,100 0.68 Expired (172 ) 142.50 Outstanding at December 31, 2020 2,240,204 $ 8.28 8.90 $ 289,067 Exercisable at December 31, 2020 1,129,733 $ 15.64 8.28 $ 219,010 Vested and expected to vest at December 31, 2020 2,240,204 $ 8.28 8.90 $ 289,067 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | 2020 2019 Expected term (in years) 5.31 — 10.00 5.25 — 5.77 Risk-free interest rate 0.4% — 1.7% 1.9% — 2.5% Expected volatility 113.4% — 124.8% 112.4% — 114.4% Dividend yield — — — — — — |
Note 9 - Income Taxes (Tables)
Note 9 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | Deferred tax assets December 31, 2020 December 31, 2019 Net operating loss carryforwards $ 3,864,189 $ 1,504,496 Stock-based compensation 1,571,227 1,381,750 Orphan Drug credits 541,384 81,700 Lease liability 38,394 63,589 Capitalized start-up costs and other 10,709,631 9,187,898 Valuation allowance (14,906,646 ) (12,051,440 ) Deferred tax assets 1,818,179 167,993 Deferred tax liabilities Intangible assets (2,223,678 ) (2,223,678 ) Right of use asset (38,394 ) (63,589 ) Deferred tax liabilities (2,262,072 ) (2,287,267 ) Net deferred tax liability $ (443,893 ) $ (2,119,274 ) |
Summary of Operating Loss Carryforwards [Table Text Block] | Combined NOL Carryforwards: December 31, 2020 December 31, 2019 Federal $ 15,013,388 $ 5,844,972 State 15,007,966 5,844,972 |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | Rate reconciliation: December 31, 2020 December 31, 2019 Federal tax benefit at statutory rate (21.0 )% (21.0 )% State tax, net of Federal benefit (4.7 )% (2.5 )% Orphan drug credit (2.9 )% 25.3 % Change in valuation allowance 18.1 % (7.5 )% Stock compensation — % 8.6 % Other — % 0.1 % Total provision (10.5 )% 3.0 % |
Note 2 - Liquidity (Details Tex
Note 2 - Liquidity (Details Textual) - USD ($) | 1 Months Ended | 2 Months Ended | 12 Months Ended | ||
Feb. 28, 2021 | Mar. 15, 2021 | Mar. 12, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Proceeds from Issuance of Common Stock | $ 10,827,100 | ||||
Proceeds from Warrant Exercises | $ 8,046,103 | $ 3,888,425 | |||
Subsequent Event [Member] | |||||
Proceeds from Issuance of Common Stock | $ 1,000,000 | ||||
Proceeds from Warrant Exercises | $ 2,200,000 | $ 2,000,000 |
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, 2020 | Dec. 31, 2019 | |
Indefinite-lived Intangible Assets (Excluding Goodwill), Ending Balance | $ 8,639,000 | $ 8,639,000 |
Share-based Payment Arrangement, Option [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term (Year) | 10 years | |
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 (Year) | 2 years | |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term (Year) | 5 years 113 days | 5 years 91 days |
Maximum [Member] | ||
Property, Plant and Equipment, Useful Life (Year) | 15 years | |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term (Year) | 10 years | 5 years 281 days |
Note 3 - Basis of Presentatio_4
Note 3 - Basis of Presentation and Summary of Significant Accounting Policies - Outstanding Dilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Anti-dilutive securities (in shares) | 11,340,316 | 22,694,417 |
Warrant [Member] | ||
Anti-dilutive securities (in shares) | 9,100,112 | 22,385,141 |
Share-based Payment Arrangement, Option [Member] | ||
Anti-dilutive securities (in shares) | 2,240,204 | 309,276 |
Note 4 - Property and Equipme_3
Note 4 - Property and Equipment (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Depreciation, Total | $ 103,168 | $ 97,915 |
Note 4 - Property and Equipme_4
Note 4 - Property and Equipment - Property and Equipment (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Property and equipment, gross | $ 763,799 | $ 763,799 |
Less: accumulated depreciation and amortization | (614,601) | (511,433) |
Property and equipment, net | 149,198 | 252,366 |
Laboratory Equipment [Member] | ||
Property and equipment, gross | 182,357 | 182,357 |
Furniture and Fixtures [Member] | ||
Property and equipment, gross | 151,442 | 151,442 |
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, 2020 | Dec. 31, 2019 |
Accrued payroll and payroll related expenses | $ 653,899 | $ 182,708 |
Accrued professional fees | 31,809 | 48,338 |
Accrued clinical studies expenses | 1,055,398 | 57,378 |
Other | 35,364 | 70,108 |
Total | $ 1,776,470 | $ 358,532 |
Note 6 - Commitments and Cont_3
Note 6 - Commitments and Contingencies (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Lessee, Operating Lease, Remaining Lease Term (Year) | 1 year 109 days | |
Lessee, Operating Lease, Discount Rate | 10.00% | |
Lessee, Operating Lease, Renewal Term (Year) | 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 | $ 56,000 | $ 68,000 |
Note 6 - Commitments and Cont_4
Note 6 - Commitments and Contingencies - Future Minimum Rental Payments (Details) | Dec. 31, 2020USD ($) |
2021 | $ 118,519 |
2022 | 39,735 |
Total | 158,254 |
Less: imputed interest | (9,092) |
Operating Lease, Liability, Total | $ 149,162 |
Note 7 - Stockholders' Equity_3
Note 7 - Stockholders' Equity and Common Stock Warrants (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
May 31, 2020 | Dec. 31, 2019 | Nov. 30, 2019 | May 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | |
Proceeds from Issuance of Common Stock | $ 10,827,100 | |||||
Deemed Dividend From Warrant Exchange | $ 2,000,000 | $ 1,950,378 | ||||
Class of Warrant or Right, Exercised During Period (in shares) | 19,106,504 | 17,415,859 | ||||
Proceeds from Warrant Exercises | $ 8,046,103 | $ 3,888,425 | ||||
Class of Warrant or Rights, Expired (in shares) | 0 | 1,767 | ||||
The May 2020 Offering Warrants [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 571,429 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 1.3125 | $ 1.31 | ||||
Warrants and Rights Outstanding, Term (Year) | 5 years | |||||
Prior Warrant [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 5,000,000 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.35 | |||||
Class of Warrant or Right, Exchange, Additional Consideration Per Share (in dollars per share) | $ 0.125 | |||||
New Warrants Issued May 8, 2020 [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 5,000,000 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.5263 | |||||
The May 2020 PA Warrants [Member] | H.C Wainwright & Co., LLC [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 250,000 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.5938 | |||||
Warrants Issued in Connection with the December 2019 Offering [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 6,266,787 | 6,266,787 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.4335 | $ 0.4335 | ||||
Placement Agent Warrant [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 313,339 | 571,429 | 65,853 | 313,339 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.6981 | $ 0.4375 | $ 6.11875 | $ 0.6981 | ||
Warrants and Rights Outstanding, Term (Year) | 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 (in dollars per share) | $ 0.35 | |||||
Class of Warrant or Right, Issued During Period (in shares) | 6,324,143 | |||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right (in shares) | 1 | |||||
Warrants with 18 Months Term Issued in Connection with the November 2019 Offering [Member] | ||||||
Warrants and Rights Outstanding, Term (Year) | 1 year 180 days | |||||
Class of Warrant or Right, Issued During Period (in shares) | 11,428,572 | |||||
Warrants with 5 Years Term Issued in Connection with the November 2019 Offering [Member] | ||||||
Warrants and Rights Outstanding, Term (Year) | 5 years | |||||
Class of Warrant or Right, Issued During Period (in shares) | 11,428,572 | |||||
Class of Warrant or Right, Exercised During Period (in shares) | 11,091,716 | |||||
Proceeds from Warrant Exercises | $ 3,900,000 | |||||
The May 2020 Offering [Member] | ||||||
Stock Issued During Period, Shares, New Issues (in shares) | 11,428,572 | |||||
Shares Issued, Price Per Share (in dollars per share) | $ 1.05 | |||||
Proceeds from Issuance of Common Stock | $ 10,300,000 | |||||
December 2019 Public Offering [Member] | ||||||
Stock Issued During Period, Shares, New Issues (in shares) | 6,266,787 | |||||
Shares Issued, Price Per Share (in dollars 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 (in shares) | 5,104,429 | |||||
Shares Issued, Price Per Share (in dollars 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 (in shares) | 22,857,144 | |||||
May 2019 Public Offering [Member] | ||||||
Stock Issued During Period, Shares, New Issues (in shares) | 1,317,060 | |||||
Shares Issued, Price Per Share (in dollars 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 (in shares) | 1,317,060 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 5 |
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, 2020 | May 31, 2020 | Dec. 31, 2019 | Nov. 30, 2019 |
Common stock warrants, outstanding (in shares) | 9,100,112 | |||
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) | 1,181,421 | |||
Range of exercise price (in dollars per share) | ||||
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) | 497,140 | |||
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) | 313,339 | |||
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 | |||
The May 2020 Offering Warrants [Member] | ||||
Common stock warrants, outstanding (in shares) | 571,429 | |||
Range of exercise price (in dollars per share) | $ 1.31 | $ 1.3125 | ||
The May 2020 Investor Warrant Exercise [Member] | ||||
Common stock warrants, outstanding (in shares) | 4,250,000 | |||
The May 2020 Investor Warrant Exercise [Member] | Minimum [Member] | ||||
Range of exercise price (in dollars per share) | $ 0.5263 | |||
The May 2020 Investor Warrant Exercise [Member] | Maximum [Member] | ||||
Range of exercise price (in dollars per share) | $ 0.5938 |
Note 8 - Stock-based Compensa_3
Note 8 - Stock-based Compensation (Details Textual) - USD ($) | Jan. 01, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross (in shares) | 1,931,100 | 117,270 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 0.64 | $ 2.16 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $ 700,000 | $ 600,000 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period (in shares) | 0 | 0 | |
Share-based Payment Arrangement, Expense | $ 736,119 | $ 515,762 | |
Share-based Payment Arrangement, Option [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period (Year) | 10 years | ||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period (Year) | 3 years | ||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ 800,000 | ||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 2 years 73 days | ||
Restricted Stock Units (RSUs) [Member] | Director [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period (Year) | 1 year 180 days | ||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ 82,000 | ||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 2 years 146 days | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period (in shares) | 153,000 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 0.65 | ||
Share-based Payment Arrangement, Expense | $ 18,000 | ||
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 (in shares) | 0 | ||
Equity Incentive Plan 2015 [Member] | Subsequent Event [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares) | 2,560,618 | ||
Outside of the 2015 Equity Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross (in shares) | 270,000 |
Note 8 - Stock-based Compensa_4
Note 8 - Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Stock-based compensation expense | $ 736,119 | $ 515,762 |
Research and Development Expense [Member] | ||
Stock-based compensation expense | 164,791 | 54,155 |
General and Administrative Expense [Member] | ||
Stock-based compensation expense | $ 571,328 | $ 461,607 |
Note 8 - Stock-based Compensa_5
Note 8 - Stock-based Compensation - Stock Option Activity (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Options outstanding, number (in shares) | 309,276 | 203,736 |
Options outstanding, weighted-average exercise price (in dollars per share) | $ 55.78 | $ 88.14 |
Granted (in shares) | 1,931,100 | 117,270 |
Granted, weighted-average exercise price (in dollars per share) | $ 0.68 | $ 2.62 |
Forfeited (in shares) | (11,583) | |
Forfeited, weighted-average exercise price (in dollars per share) | $ 83.81 | |
Expired (in shares) | (172) | (147) |
Expired, weighted-average exercise price (in dollars per share) | $ 142.50 | $ 276 |
Options outstanding, weighted-average remaining contractual life (Year) | 8 years 328 days | 6 years 357 days |
Options outstanding, aggregate intrinsic value | $ 289,067 | |
Options outstanding, number (in shares) | 2,240,204 | 309,276 |
Options outstanding, weighted-average exercise price (in dollars per share) | $ 8.28 | $ 55.78 |
Options outstanding, weighted-average remaining contractual life (Year) | 8 years 328 days | 6 years 357 days |
Exercisable (in shares) | 1,129,733 | |
Exercisable, weighted-average exercise price (in dollars per share) | $ 15.64 | |
Exercisable, weighted-average remaining contractual life (Year) | 8 years 102 days | |
Exercisable, aggregate intrinsic value | $ 219,010 | |
Vested and expected to vest (in shares) | 2,240,204 | |
Vested and expected to vest, weighted-average exercise price (in dollars per share) | $ 8.28 | |
Vested and expected to vest, weighted-average remaining contractual life (Year) | 8 years 328 days | |
Vested and expected to vest, aggregate intrinsic value | $ 289,067 |
Note 8 - Stock-based Compensa_6
Note 8 - Stock-based Compensation - Fair Value Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Minimum [Member] | ||
Expected term (Year) | 5 years 113 days | 5 years 91 days |
Risk-free interest rate | 0.40% | 1.90% |
Expected volatility | 113.40% | 112.40% |
Dividend yield | ||
Maximum [Member] | ||
Expected term (Year) | 10 years | 5 years 281 days |
Risk-free interest rate | 1.70% | 2.50% |
Expected volatility | 124.80% | 114.40% |
Dividend yield |
Note 9 - Income Taxes (Details
Note 9 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Unrecognized Tax Benefits, Ending Balance | $ 0 | $ 0 |
Open Tax Year | 2017 2018 2019 |
Note 9 - Income Taxes - Deferre
Note 9 - Income Taxes - Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Net operating loss carryforwards | $ 3,864,189 | $ 1,504,496 |
Stock-based compensation | 1,571,227 | 1,381,750 |
Orphan Drug credits | 541,384 | 81,700 |
Lease liability | 38,394 | 63,589 |
Capitalized start-up costs and other | 10,709,631 | 9,187,898 |
Valuation allowance | (14,906,646) | (12,051,440) |
Deferred tax assets | 1,818,179 | 167,993 |
Intangible assets | (2,223,678) | (2,223,678) |
Right of use asset | (38,394) | (63,589) |
Deferred tax liabilities | (2,262,072) | (2,287,267) |
Net deferred tax liability | $ (443,893) | $ (2,119,274) |
Note 9 - Income Taxes - Operati
Note 9 - Income Taxes - Operating Loss Carryforwards (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Domestic Tax Authority [Member] | ||
Operating loss carryforwards | $ 15,013,388 | $ 5,844,972 |
State and Local Jurisdiction [Member] | ||
Operating loss carryforwards | $ 15,007,966 | $ 5,844,972 |
Note 9 - Income Taxes - Reconci
Note 9 - Income Taxes - Reconciliation of Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Federal tax benefit at statutory rate | (21.00%) | (21.00%) |
State tax, net of Federal benefit | (4.70%) | (2.50%) |
Orphan drug credit | (2.90%) | 25.30% |
Change in valuation allowance | 18.10% | (7.50%) |
Stock compensation | 8.60% | |
Other | 0.10% | |
Total provision | (10.50%) | 3.00% |
Note 11 - Subsequent Events (De
Note 11 - Subsequent Events (Details Textual) - USD ($) | 1 Months Ended | 2 Months Ended | 12 Months Ended | ||
Feb. 28, 2021 | Mar. 15, 2021 | Mar. 12, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Class of Warrant or Right, Exercised During Period (in shares) | 19,106,504 | 17,415,859 | |||
Proceeds from Warrant Exercises | $ 8,046,103 | $ 3,888,425 | |||
Proceeds from Issuance of Common Stock | $ 10,827,100 | ||||
Subsequent Event [Member] | |||||
Class of Warrant or Right, Exercised During Period (in shares) | 4,230,000 | ||||
Proceeds from Warrant Exercises | $ 2,200,000 | $ 2,000,000 | |||
Proceeds from Issuance of Common Stock | $ 1,000,000 | ||||
Subsequent Event [Member] | Underwriter Warrants in Connection with the February 2021 Common Stock Offering [Member] | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 1,682,927 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 1.28125 | ||||
Warrants and Rights Outstanding, Term (Year) | 5 years | ||||
Subsequent Event [Member] | Public Offering, Inclusive of Underwriter Shares [Member] | |||||
Stock Issued During Period, Shares, New Issues (in shares) | 33,658,538 | ||||
Shares Issued, Price Per Share (in dollars per share) | $ 1.025 | ||||
Underwriter Option to Purchase Additional Shares, Term (Day) | 30 days | ||||
Proceeds from Issuance of Common Stock | $ 31,200,000 |