0001437749-21-006236 | 10-K | XBRL Viewer | Diffusion Pharmaceuticals INC

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Document And Entity Information - USD ($) $ in Millions	12 Months Ended
Document And Entity Information - USD ($) $ in Millions	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 - 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 (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 Operations - USD ($)	12 Months Ended
Consolidated Statements of Operations - USD ($)	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 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

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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Amount of stockholders' equity (deficit), net of receivables from officers, directors, owners, and affiliates of the entity, attributable to both the parent and noncontrolling interests. Amount excludes temporary equity. Alternate caption for the concept is permanent equity.

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+ Details

Consolidated Statements of Cash Flows - USD ($)	12 Months Ended
Consolidated Statements of Cash Flows - USD ($)	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 Description of Business	12 Months Ended
Note 1 - Organization and Description of Business	Dec. 31, 2020
Notes to Financial Statements
Nature of Operations [Text Block]	1. Organization and Description of Business 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, a novel, allosteric PI3K/Akt/mTOR pathway inhibitor, is in early-stage development. The Company previously completed two Phase 1 clinical trials evaluating DFN- 529 in age-related macular degeneration. DFN- 529 was also previously in preclinical development in oncology, specifically GBM.

Note 2 - Liquidity	12 Months Ended
Note 2 - Liquidity	Dec. 31, 2020
Notes to Financial Statements
Liquidity Disclosure [Text Block]	2. Liquidity The Company has not generated any revenues from product sales and has funded operations primarily from the proceeds of public and private offerings of equity, convertible debt and convertible preferred stock. Substantial additional financing will be required by the Company to continue to fund its research and development activities. No assurance can be given that any such financing will be available when needed, or at all, or that the Company's research and development efforts will be successful. 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 parties and other strategic alliances and business transactions. The Company does not have any commitments to obtain additional funds and may be unable to obtain sufficient funding in the future on acceptable terms, if at all. If the Company cannot obtain the necessary funding, it will need to delay, scale back or eliminate some or all of its research and development programs or enter into collaborations with third parties to commercialize potential products or technologies that it might otherwise seek to develop or commercialize independently; consider other various strategic alternatives, including a merger or sale of the Company; or cease operations. If the Company engages in collaborations, it may receive lower consideration upon commercialization of such products than if it had not entered such arrangements or if it entered into such arrangements at later stages in the product development process. 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, combined with the proceeds received by the Company in connection with the completion of the February 2021 Offering and the exercise of certain warrants to purchase common stock during the first quarter of 2021 prior to the date of this Annual Report, will enable it to fund its operating expenses and capital expenditure requirements, including expected costs related to the planned TSC Oxygenation Trials and the Planned Phase 2 Hypoxia-related Indication Trial through 2023.

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]

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

months or less to be cash and cash equivalents.

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

years. The Company amortizes leasehold improvements over the shorter of the estimated useful life of the asset or the term of the related lease. Upon retirement or disposition of assets, the costs and related accumulated depreciation and amortization are removed from the accounts with the resulting gains or losses, if any, reflected in results of operations.

Long-Lived Assets

Long-lived assets are reviewed for potential impairment whenever events indicate that the carrying amount of such assets

may

not

be recoverable. The Company does this by comparing the carrying value of the long-lived assets with the estimated future undiscounted cash flows expected to result from the use of the assets, including cash flows from disposition. If it is determined an impairment exists, the asset is written down to its estimated fair value. The Company has

not

recognized any impairment of long-lived assets during the years ended

December 31, 2020

and

2019.

Intangible Asset

The Company has an indefinite-lived IPR&D asset, DFN-

529,

which has a balance of

$8.6

million at both

December 31, 2020

and

December 31, 2019.

DFN-

529

is a

PI3K/Akt/mTOR

pathway inhibitor in preclinical development for oncology.

Intangible assets deemed to have indefinite lives are

not

amortized but rather are assessed for impairment annually on

October 1

of the Company's fiscal year or more frequently if impairment indicators exist. There was

impairment to the Company's DFN-

529

intangible asset recognized during the years ended

December 31, 2020

and

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

-party service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the services provided, the Company

may

record net prepaid or accrued expenses relating to these costs.

Upfront payments made to

third

parties who perform research and development services on the Company's behalf are expensed as services are rendered.

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

that some portion or all of a deferred tax asset will

not

be realized. The Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on its income tax return it files, if such a position is more likely than

not

to be sustained.

ASC

740

defines the criterion an individual tax position must meet for any part of the benefit of the tax position to be recognized in financial statements prepared in conformity with GAAP. The Company

may

recognize the tax benefit from an uncertain tax position only if it is more likely than

not

such tax position will be sustained on examination by the taxing authorities, based solely on the technical merits of the respective tax position. The tax benefits recognized in the financial statements from such a tax position should be measured based on the largest benefit having a greater than

50.0%

likelihood of being realized upon ultimate settlement with the tax authority. In accordance with the disclosure requirements of ASC

740

10,

the Company's policy on income statement classification of interest and penalties related to income tax obligations is to include such items as part of total interest expense and other expense, respectively.

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,

it became apparent that the expected term of the Company's stock options was commensurate with the contractual life (i.e.

years) of the stock option and therefore the Company began to use the contractual life as the expected term.

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

dividend yield because dividends are

not

expected to be paid in the near future, which is consistent with the Company's history of

not

paying dividends. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected life of the option. The Company accounts for forfeitures in the periods they occur.

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

included in the calculation as the impact is anti-dilutive.

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

Yet Adopted Accounting Pronouncements

December 2019,

the FASB issued ASU

No.

2019

12,

Income Taxes (Topic

740

Simplifying the Accounting for Income Taxes

. This guidance applies to all entities and aims to reduce the complexity of tax accounting standards while enhancing reporting disclosures. This guidance is effective for fiscal years beginning after

December 15, 2020

and interim periods therein. Early adoption is permitted for any annual periods for which financial statements have

not

been issued and interim periods therein. The Company is currently analyzing the impact of ASU

No.

2019

on the consolidated financial statements.

Recently Adopted Accounting Pronouncements

August 2018,

the FASB issued ASU

2018

03,

Disclosure Framework- Changes to the Disclosure Requirements for Fair Value Measurements,

which changes the fair value measurement disclosure requirements of ASC

820.

The goal of the ASU is to improve the effectiveness of ASC

820's

disclosure requirements. The Company adopted this standard in

January 2020

and the adoption did

not

have a material impact on its related disclosures.

Note 4 - Property and Equipment

12 Months Ended

Dec. 31, 2020

Notes to Financial Statements

Property, Plant and Equipment Disclosure [Text Block]

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

million for both the years ended

December 31, 2020

and

2019.

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]

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 Contingencies

12 Months Ended

Dec. 31, 2020

Notes to Financial Statements

Commitments and Contingencies Disclosure [Text Block]

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

and, as of

December 31, 2020,

has a remaining lease term of approximately

1.3

years. The discount rate used to account for the Company's operating lease is the Company's estimated incremental borrowing rate of

10.0%.

The original term of the lease ends in the

second

quarter of

2022

and the Company has an option to extend for another

years. This option to extend was

not

recognized as part of the Company's measurement of the right-of-use asset and operating lease liability as of

December 31, 2020.

Rent expense related to the Company's operating lease for both the years ended

December

31,

2020

and

2019

was approximately

$0.1

million. Future minimum rental payments under the Company's non-cancelable operating lease at

December

31,

2020

were as follows:

	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

require upfront payments and long-term commitments of cash.

Defined Contribution Retirement Plan

The Company has established its

401

(k) Plan, which covers all employees who qualify under the terms of the plan. Eligible employees

may

elect to contribute to the

401

(k) Plan up to

90.00%

of their compensation, limited by the IRS-imposed maximum. The Company provides a safe harbor match with a maximum amount of

4.0%

of the participant's compensation. The Company made matching contributions under the

401

(k) Plan of approximately

$56,000

and

$68,000

for the years ended

December

31,

2020

and

2019,

respectively.

Legal Proceedings

August 7, 2014,

a complaint was filed in the Superior Court of Los Angeles County, California by Paul Feller, the former Chief Executive Officer of the Company's legal predecessor under the caption Paul Feller v. RestorGenex Corporation, Pro Sports & Entertainment, Inc., ProElite, Inc. and Stratus Media Group, GmbH (Case

No.

BC553996

). The complaint asserts various causes of action, including, among other things, promissory fraud, negligent misrepresentation, breach of contract, breach of employment agreement, breach of the covenant of good faith and fair dealing, violations of the California Labor Code and common counts. The plaintiff is seeking, among other things, compensatory damages in an undetermined amount, punitive damages, accrued interest and an award of attorneys' fees and costs. On

December 30, 2014,

the Company filed a petition to compel arbitration and a motion to stay the action. On

April 1, 2015,

the plaintiff filed a petition in opposition to the Company's petition to compel arbitration and a motion to stay the action. After a hearing for the petition and motion on

April 14, 2015,

the Court granted the Company's petition to compel arbitration and a motion to stay the action. On

January 8, 2016,

the plaintiff filed an arbitration demand with the American Arbitration Association. On

November 19, 2018

at an Order to Show Cause Re Dismissal Hearing, the Court found sufficient grounds

not

to dismiss the case, and an arbitration hearing was scheduled for

November 2020.

August 2020,

due to the ongoing COVID-

pandemic and related restrictions on gatherings in the State of California, the arbitration hearing was postponed to

August 16, 2021.

The Company believes this matter is without merit and intends to defend the arbitration vigorously. However, at this stage, the Company is unable to predict its outcome and the possible loss or range of loss, if any, associated with its resolution or any potential effect the matter

may

have on the Company's financial position. Depending on the outcome or resolution of this matter, it could have a material effect on the Company's financial position.

Note 7 - Stockholders' Equity and Common Stock Warrants

12 Months Ended

Dec. 31, 2020

Notes to Financial Statements

Stockholders' Equity Note Disclosure [Text Block]

Stockholders' Equity and Common Stock Warrants

2020

Common Stock Offering

May 2020,

the Company completed the

May 2020

Offering, a public offering of

11,428,572

shares of common stock for a purchase price of

$1.05

per share for net proceeds of

$10.3

million after deducting commissions, discounts, and other offering costs. In addition, at the closing of the

May 2020

Offering, the Company issued warrants to purchase up to

571,429

shares of common stock to designees of the placement agent for the

May 2020

Offering. The placement agent's warrants have an exercise price of

$1.3125

per share and a term of

five

years from the date of issuance.

Additionally, also in

May 2020,

the Company entered into a warrant exercise agreement with an investor who held a previously outstanding warrant to purchase up to an aggregate of

5,000,000

shares of our common stock at an exercise price of

$0.35

per share(the Prior Warrant). In consideration for the exercise of the Prior Warrant for cash and an additional

$0.125

per each share of common stock resulting from the exercise, the exercising investor received new unregistered warrants to purchase up to an aggregate of

5,000,000

shares of common stock in a private placement. The warrants are exercisable immediately at an exercise price of

$0.5263

per share and exercisable until

November 8, 2025.

The Company recognized a deemed dividend of

$2.0

million to reflect the consideration given as an inducement for the investor to exercise the warrants. This deemed dividend is recorded in the Company's consolidated statement of operations during the year ended

December 31, 2020

as an increase to the net loss attributable to common stockholders for purposes of computing net loss per share, basic and diluted.

In connection with the warrants exercised in

May 2020,

the Company issued warrants to purchase up to

250,000

shares of common stock to the placement agent with an exercise price of

$0.5938

per share and otherwise have identical terms to the warrants issued to the investor.

2019

Common Stock Offerings

December 2019,

Company completed the

December 2019

Offering, an offering of

6,266,787

shares of its common stock and warrants to purchase

6,266,787

shares of common stock. The shares of common stock and warrants were sold for a combined purchase price of

$0.5585

per share for net proceeds of

$3.0

million. The

December 2019

Offering warrants are exercisable beginning on the date of their issuance until

June 13, 2025

at an initial exercise price equal to

$0.4335

per share.

In addition, at the closing of the

December 2019

Offering, the Company issued warrants to purchase up to

313,339

shares of common stock to designees of the placement agent. The placement agent's warrants have an exercise price of

$0.6981

per share and a term of

five

years from the date of issuance.

November 2019,

the Company completed the

November 2019

Offering, a registered direct public offering of

5,104,429

shares of its common stock, and

6,324,143

pre-funded warrants each to purchase

one

share of common stock, together with warrants to purchase up to

22,857,144

shares of common stock at a combined public offering price of

$0.35

per share and associated warrants for total net proceeds of

$3.3

million. The warrants were issued with an exercise price of

$0.35

per warrant and are exercisable beginning on their date of issuance. Of the warrants issued,

11,428,572

have a term of

months and

11,428,572

have a term of

years. During the year ended

December 31, 2019,

11,091,716

of those warrants were exercised for additional proceeds of

$3.9

million.

In addition, at the closing of the

November 2019

Offering, the Company issued warrants to purchase up to

571,429

shares of common stock to designees of the placement agent. The placement agent's warrants have an exercise price of

$0.4375

per share and a term of

five

years from the date of issuance.

May 2019,

the Company completed the

May 2019

Offering, a registered direct public offering of

1,317,060

shares of common stock and a private placement of warrants to purchase

1,317,060

shares of common stock. The shares of common stock and warrants were sold for a combined purchase price of

$4.895

for total net proceeds of

$5.6

million. The warrants are exercisable beginning on the date of their issuance until

November 29, 2024

at an initial exercise price equal to

$5.00.

In addition, at the closing of the

May 2019

Offering, the Company issued warrants to purchase up to

65,853

shares of common stock to designees of the placement agent. The placement agent's warrants have an exercise price of

$6.11875

per share, a term of

years from the date of issuance and otherwise substantially similar terms to the form of the investor warrant.

Common Stock Warrants

During its evaluation of equity classification for the Company's common stock warrants issued in

2020

and

2019,

the Company considered the conditions as prescribed within ASC

815

40,

Derivatives and Hedging, Contracts in an Entity

s own Equity

. The conditions within ASC

815

are

not

subject to a probability assessment. The warrants do

not

fall under the liability criteria within ASC

480,

Distinguishing Liabilities from Equity

as they are

not

puttable and do

not

represent an instrument that has a redeemable underlying security. The warrants do meet the definition of a derivative instrument under ASC

815,

but are eligible for the scope exception as they are indexed to the Company's own stock and would be classified in permanent equity if freestanding.

As of

December

31,

2020,

the Company had the following warrants outstanding to acquire shares of its common stock:

	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,

warrants expired and

19,106,504

warrants were exercised for gross proceeds of

$8.0

million. During the year ended

December 31, 2019,

1,767

warrants expired and

17,415,859

warrants were exercised for net proceeds of

$3.9

million.

Note 8 - Stock-based Compensation

12 Months Ended

Dec. 31, 2020

Notes to Financial Statements

Share-based Payment Arrangement [Text Block]

Stock-Based Compensation

2015

Equity Plan

The

2015

Equity Plan provides for increases to the number of shares reserved for issuance thereunder each

January 1

equal to

4.0%

of the total shares of the Company's common stock outstanding as of the immediately preceding

December 31,

unless a lesser amount is stipulated by the Compensation Committee of the Company's board of directors. Accordingly,

2,560,618

shares were added to the reserve as of

January 1, 2021,

which shares

may

be issued in connection with the grant of stock-based awards, including stock options, restricted stock, restricted stock units, stock appreciation rights and other types of awards as deemed appropriate, in each case, in accordance with the terms of the

2015

Equity Plan. As of

December

31,

2020,

there were

shares of common stock available for future issuance under the

2015

Equity Plan. Further, the Company granted options to purchase

270,000

shares of common stock to employees during the year ended

December

31,

2020

that were granted outside of the

2015

Equity Plan as an inducement material to the employee's acceptance of employment with the Company in accordance with Nasdaq Listing Rule

5635

(c)(

). Generally, the options have a

ten

(

) year contractual term and vest in equal monthly installments over

three

(

) years.

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

and

$2.16

during the years ended

December

31,

2020

and

2019,

respectively. The total fair value of options vested during the years ended

December

31,

2020

and

2019

were

$0.7

million and

$0.6

million, respectively.

options were exercised during any of the periods presented. At

December

31,

2020,

there was

$0.8

million of unrecognized compensation cost related to unvested options that will be recognized as expense over a weighted-average period of

2.2

years.

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

and

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,

the Company granted

153,000

restricted stock units to members of the board of directors of the Company. The weighted average grant date fair value of the restricted stock units granted during the year ended

December

31,

2020

was

$0.65.

The shares begin to vest

months after the grant date. The Company recognized approximately

$18,000

in expense related to these units during the year ended

December

31,

2020.

December

31,

2020,

there was approximately

$82,000

of unrecognized compensation cost that will be recognized over a weighted average period of

2.4

years.

Note 9 - Income Taxes

12 Months Ended

Dec. 31, 2020

Notes to Financial Statements

Income Tax Disclosure [Text Block]

Income Taxes

Since inception, the Company has incurred net losses, and until

2018,

had

not

recorded any U.S. federal or state income tax benefits for the losses. In

2018,

as a result of the change in net operating loss carryforward period associated with the

2017

Tax Act, the Company recognized an income tax benefit to reflect the adjustment allowed by the

2017

Tax Act to utilize indefinite deferred tax liabilities as a source of income against indefinite lived portions of the Company's deferred tax assets. In

2019,

as a result of a change in ownership under the provisions of Internal Revenue Code Section

382,

the cumulative benefit of net operating losses was remeasured which resulted in tax expense to reverse the

2018

benefit recorded and record a benefit relative to losses incurred in

2019

after the date of the change in ownership.

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

have unrecognized tax benefits as of

December

31,

2020

December 31, 2019.

The Company recognizes interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.

The Company had NOL carryforwards for federal and state income tax purposes at

December

31,

2020

and

2019

of approximately:

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

net operating loss carryforwards begin expiring in

2020

for both federal and state income tax purposes. In

November 2019,

as a result of a change of ownership, under the provisions of Internal Revenue Code Section

382

and similar state provisions, the Company's ability to utilize their net operating loss carryforwards to offset future income was limited. The Company recorded a valuation allowance against a portion of their deferred tax assets as of

December 31, 2020

because of the uncertainty of their realization.

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

tax years remain open and subject to examination.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References + Details

Note 10 - Related Party Transactions	12 Months Ended
Note 10 - Related Party Transactions	Dec. 31, 2020
Notes to Financial Statements
Related Party Transactions Disclosure [Text Block]	10. Related Party Transactions 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	12 Months Ended
Note 11 - Subsequent Events	Dec. 31, 2020
Notes to Financial Statements
Subsequent Events [Text Block]	11. Subsequent Events 2021 Warrant Exercises From January 1, 2021 through March 15, 2021, warrants were exercised by multiple holders to purchase a total of 4,230,000 shares of the Company's common stock for aggregate gross proceeds of approximately $2.2 million. 2021 Common Stock Offering In February 2021, the Company completed the February 2021 Offering in which it offered and sold 33,658,538 shares of its common stock in an underwritten, public offering for a purchase price to the public of $1.025 per share, inclusive of shares offered and sold pursuant to the exercise-in-full by the underwriter of its 30 -day option to purchase additional shares. The February 2021 Offering resulted in aggregate net proceeds to the Company of $31.2 million, after deducting underwriting commissions, discounts, and expenses but prior to deducting other offering costs. In addition, at the closings of the February 2021 Offering, the Company issued to designees of the underwriter of the transaction warrants to purchase up to an aggregate of 1,682,927 shares of common stock to designees. The underwriter warrants have an exercise price of $1.28125 per share and a term of five years from the date of issuance.

Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2020

Accounting Policies [Abstract]

Basis of Accounting, Policy [Policy Text Block]

Basis of Presentation

Use of Estimates, Policy [Policy Text Block]

Use of 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

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

months or less to be cash and cash equivalents.

Property, Plant and Equipment, Policy [Policy Text Block]

Property and Equipment

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

recognized any impairment of long-lived assets during the years ended

December 31, 2020

and

2019.

Goodwill and Intangible Assets, Policy [Policy Text Block]

Intangible Asset

The Company has an indefinite-lived IPR&D asset, DFN-

529,

which has a balance of

$8.6

million at both

December 31, 2020

and

December 31, 2019.

DFN-

529

is a

PI3K/Akt/mTOR

pathway inhibitor in preclinical development for oncology.

Intangible assets deemed to have indefinite lives are

not

amortized but rather are assessed for impairment annually on

October 1

of the Company's fiscal year or more frequently if impairment indicators exist. There was

impairment to the Company's DFN-

529

intangible asset recognized during the years ended

December 31, 2020

and

2019.

Research and Development Expense, Policy [Policy Text Block]

Research and Development

At the end of the reporting period, the Company compares payments made to

third

may

record net prepaid or accrued expenses relating to these costs.

Upfront payments made to

third

parties who perform research and development services on the Company's behalf are expensed as services are rendered.

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

not

that some portion or all of a deferred tax asset will

not

be realized. The Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on its income tax return it files, if such a position is more likely than

not

to be sustained.

ASC

740

defines the criterion an individual tax position must meet for any part of the benefit of the tax position to be recognized in financial statements prepared in conformity with GAAP. The Company

may

recognize the tax benefit from an uncertain tax position only if it is more likely than

not

50.0%

likelihood of being realized upon ultimate settlement with the tax authority. In accordance with the disclosure requirements of ASC

740

10,

Share-based Payment Arrangement [Policy Text Block]

Stock-based Compensation

December 31, 2020,

it became apparent that the expected term of the Company's stock options was commensurate with the contractual life (i.e.

years) of the stock option and therefore the Company began to use the contractual life as the expected term.

dividend yield because dividends are

not

expected to be paid in the near future, which is consistent with the Company's history of

not

Earnings Per Share, Policy [Policy Text Block]

Net Loss Per Common Share

not

included in the calculation as the impact is anti-dilutive.

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

Yet Adopted Accounting Pronouncements

December 2019,

the FASB issued ASU

No.

2019

12,

Income Taxes (Topic

740

Simplifying the Accounting for Income Taxes

December 15, 2020

and interim periods therein. Early adoption is permitted for any annual periods for which financial statements have

not

been issued and interim periods therein. The Company is currently analyzing the impact of ASU

No.

2019

on the consolidated financial statements.

Recently Adopted Accounting Pronouncements

August 2018,

the FASB issued ASU

2018

03,

Disclosure Framework- Changes to the Disclosure Requirements for Fair Value Measurements,

which changes the fair value measurement disclosure requirements of ASC

820.

The goal of the ASU is to improve the effectiveness of ASC

820's

disclosure requirements. The Company adopted this standard in

January 2020

and the adoption did

not

have a material impact on its related disclosures.

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 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 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 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 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 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)

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 Textual) - USD ($)	1 Months Ended	2 Months Ended		12 Months Ended
Note 2 - Liquidity (Details Textual) - USD ($)	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 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 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 Equipment (Details Textual) - USD ($)	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Depreciation, Total	$ 103,168	$ 97,915

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 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 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 Contingencies - Future Minimum Rental Payments (Details)	Dec. 31, 2020 USD ($)
2021	$ 118,519
2022	39,735
Total	158,254
Less: imputed interest	(9,092)
Operating Lease, Liability, Total	$ 149,162

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 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 Compensation (Details Textual) - USD ($)		12 Months Ended
	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 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 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 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 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 - 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 - 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 - 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 (Details Textual) - USD ($)	1 Months Ended	2 Months Ended		12 Months Ended
Note 11 - Subsequent Events (Details Textual) - USD ($)	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