Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 15, 2023 | Jun. 30, 2022 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Transition Report | false | ||
Entity File Number | 000-24477 | ||
Entity Registrant Name | Diffusion Pharmaceuticals Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 30-0645032 | ||
Entity Address, Address Line One | 300 East Main Street, Suite 201 | ||
Entity Address, City or Town | Charlottesville | ||
Entity Address, State or Province | VA | ||
Entity Address, Postal Zip Code | 22902 | ||
City Area Code | 434 | ||
Local Phone Number | 220-0718 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | DFFN | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 13.6 | ||
Entity Common Stock, Shares Outstanding (in shares) | 2,039,878 | ||
Auditor Firm ID | 185 | ||
Auditor Name | KPMG LLP | ||
Auditor Location | McLean, Virginia | ||
Entity Central Index Key | 0001053691 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 10,113,706 | $ 37,313,558 |
Marketable securities | 12,408,940 | 0 |
Prepaid Expenses, Deposits, and Other Assets | 112,406 | 510,015 |
Total current assets | 22,635,052 | 37,823,573 |
Other assets | 0 | 15,578 |
Total assets | 22,635,052 | 37,839,151 |
Current liabilities: | ||
Accounts payable | 1,127,782 | 947,495 |
Accrued expenses and other current liabilities | 1,289,554 | 1,980,189 |
Total liabilities | 2,417,336 | 2,927,684 |
Stockholders’ Equity: | ||
Common stock, $0.001 par value: 1,000,000,000 shares authorized: 2,039,557 and 2,038,185 shares issued and outstanding at December 31, 2022 and 2021, respectively | 2,040 | 2,038 |
Additional paid-in capital | 165,847,590 | 164,914,540 |
Accumulated other comprehensive loss | (35,375) | 0 |
Accumulated deficit | (145,596,539) | (130,005,111) |
Total stockholders' equity | 20,217,716 | 34,911,467 |
Total liabilities and stockholders' equity | $ 22,635,052 | $ 37,839,151 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Common Stock, Par or Stated Value Per Share (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) | 2,039,557 | 2,038,185 |
Common stock, shares outstanding (in shares) | 2,039,557 | 2,038,185 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses: | ||
Research and development | $ 7,237,165 | $ 8,499,414 |
Intangible asset impairment charge | 0 | 8,639,000 |
General and administrative | 8,735,015 | 7,445,277 |
Depreciation | 0 | 93,416 |
Loss from operations | (15,972,180) | (24,677,107) |
Other income: | ||
Interest income | 380,752 | 137,487 |
Loss before income taxes | (15,591,428) | (24,539,620) |
Income tax benefit | 0 | 443,893 |
Net loss | $ (15,591,428) | $ (24,095,727) |
Share information: | ||
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (7.65) | $ (12.38) |
Weighted average shares outstanding, basic and diluted (in dollars per share) | $ 2,038,891 | $ 1,946,859 |
Comprehensive loss: | ||
Net loss | $ (15,591,428) | $ (24,095,727) |
Unrealized loss on marketable securities | (35,375) | 0 |
Comprehensive loss | $ (15,626,803) | $ (24,095,727) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Balance (in shares) at Dec. 31, 2020 | 1,280,207 | |||||
Balance at Dec. 31, 2020 | $ 1,280 | $ 130,722,286 | $ (105,909,384) | $ 24,814,182 | ||
Conversion of Series C preferred stock to common stock | 0 | |||||
Unrealized loss on marketable securities | 0 | |||||
Net loss | 0 | 0 | (24,095,727) | (24,095,727) | ||
Vesting of restricted stock units | $ 207 | 0 | 0 | 0 | ||
Sale of common stock (in shares) | 673,171 | |||||
Sale of common stock | $ 673 | 31,093,629 | 0 | 31,094,302 | ||
Issuance of common stock upon exercise of warrants (in shares) | 84,600 | |||||
Issuance of common stock upon exercise of warrants | $ 85 | 2,201,365 | 0 | 2,201,450 | ||
Stock-based compensation expense | $ 0 | 897,260 | 0 | 897,260 | ||
Balance (in shares) at Dec. 31, 2021 | 0 | 2,038,185 | ||||
Balance at Dec. 31, 2021 | $ 0 | $ 2,038 | 164,914,540 | (130,005,111) | $ 0 | 34,911,467 |
Sale of Series C preferred stock to related parties (in shares) | 10,000 | 0 | ||||
Sale of Series C preferred stock to related parties | $ 5,000 | $ 0 | 0 | 0 | 0 | 5,000 |
Conversion of Series C preferred stock to common stock (in shares) | (10,000) | (200) | ||||
Conversion of Series C preferred stock to common stock | $ (5,000) | (5,000) | ||||
Conversion of Series C preferred stock to common stock (in shares) | 10,000 | 200 | ||||
Stock-based compensation expense and vesting of restricted stock units (in shares) | 0 | 1,172 | ||||
Stock-based compensation expense and vesting of restricted stock units | $ 0 | $ 2 | 928,050 | 0 | 0 | 928,052 |
Unrealized loss on marketable securities | 0 | 0 | 0 | 0 | (35,375) | (35,375) |
Net loss | $ 0 | $ 0 | 0 | (15,591,428) | 0 | (15,591,428) |
Balance (in shares) at Dec. 31, 2022 | 0 | 2,039,557 | ||||
Balance at Dec. 31, 2022 | $ 0 | $ 2,040 | 165,847,590 | $ (145,596,539) | $ (35,375) | $ 20,217,716 |
Conversion of Series C preferred stock to common stock | $ 5,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (15,591,428) | $ (24,095,727) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 0 | 93,416 |
Loss on disposal of property and equipment | 0 | 51,782 |
Stock-based compensation expense | 928,052 | 897,260 |
Abandonment of in-process research and development intangible asset | 0 | 8,639,000 |
Change in deferred income taxes | 0 | (443,893) |
Amortization of premium and discount on marketable securities | 208,577 | 0 |
Changes in operating assets and liabilities: | ||
Prepaid expenses, deposits and other assets | 413,187 | (248,997) |
Accounts payable, accrued expenses and other current liabilities | (510,348) | 605,370 |
Net cash used in operating activities | (14,969,114) | (14,501,789) |
Cash flows from investing activities: | ||
Cash received from sale of property and equipment | 0 | 4,000 |
Purchases of marketable securities | (37,985,738) | 0 |
Maturities of marketable securities | 25,750,000 | 0 |
Net cash used in investing activities | (12,235,738) | 4,000 |
Cash flows from financing activities: | ||
Proceeds from the sale of common stock, net of issuance cost | 0 | 31,094,302 |
Proceeds from Warrant Exercises | 0 | 2,201,450 |
Proceeds from the sale of preferred stock | 5,000 | 0 |
Net cash provided by financing activities | 5,000 | 33,295,752 |
Net (decrease) increase in cash and cash equivalents | (27,199,852) | 18,797,963 |
Cash and cash equivalents at beginning of year | 37,313,558 | 18,515,595 |
Cash and cash equivalents at end of year | 10,113,706 | 37,313,558 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Conversion of Series C preferred stock to common stock | 5,000 | 0 |
Unrealized loss on marketable securities | 35,375 | 0 |
Vesting of restricted stock units | $ 1,361 | $ 207 |
Note 1 - Organization and Descr
Note 1 - Organization and Description of Business | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Nature of Operations [Text Block] | 1. Organization and Description of Business Diffusion Pharmaceuticals Inc., a Delaware corporation, is a biopharmaceutical company historically focused on developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most. The Company’s most advanced product candidate, TSC, has been investigated and 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, including GBM.. On April 18, 2022, the Company effected a 1-for-50 reverse split of its common stock. Any references in the consolidated financial statements and related notes to share or per share amounts give retroactive effect to this reverse stock split. |
Note 2 - Liquidity
Note 2 - Liquidity | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Liquidity Disclosure [Text Block] | 2. Liquidity The Company has not generated any revenues from product sales and has historically funded operations primarily from the proceeds of public and private offerings of equity, convertible debt, and convertible preferred stock. In July 2022, the Company entered into an at-the-market sales agreement (the "2022 Sales Agreement") with BTIG pursuant to which the Company may, from time to time and through BTIG as its agent, sell up to an aggregate of $20.0 million in shares of the Company’s common stock by any method permitted that is deemed an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act. To date, the Company has not On October 25, 2022, the Company announced that its Board authorized a thorough review and evaluation of a range of potential strategic opportunities in the interest of enhancing stockholder value, including transactional opportunities such as a merger, joint venture, licensing, sale, or divestiture of assets. As of the date of this Annual Report, the Board's review and evaluation remains ongoing and there is no assurance the Board’s review will result in any transaction being consummated. Depending on the outcome of the Board's strategic review process, the Company may in the future, among other things, (i) pursue a strategic transaction and, if consummated, dedicate its resources primarily to research and development activities related to the transactional counterparty's product candidates, (ii) dedicate its resources primarily to research and development activities related to the Company's existing product candidates, or (iii) elect to pursue a dissolution and liquidation of the Company. On February 16, 2023, in connection with the ongoing strategic review process and efforts to utilize and preserve assets in a manner that maximizes value for its stockholders, the Company committed to a reduction in force that is expected to impact six of the Company’s thirteen current employees. The reduction is a cash preservation measure and impacts employees primarily in the Company’s clinical operations function. In connection with the strategic review process and pending its conclusion, the Company has paused significant portions of its TSC development activities, including initiation of the Company’s previously announced Phase 2 study of TSC in newly diagnosed GBM patients. Substantial additional financing will be required by the Company to fund any research and development activities related to the Company's existing or future product candidates. 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. However, as of the date of this Annual Report, the Company does not have any commitments to obtain additional funds and no assurance can be given that any such financing will be available in the future — when needed, in sufficient amounts, on acceptable terms, or at all. If the Company cannot obtain the necessary funding, it may need to, among other things, delay, continue to scale back or eliminate research and development programs, modify its overall development strategy for one or more product candidates (or the Company as a whole) in a manner it would not if sufficient cash resources were available, or cease operations altogether. Operations of the Company are subject to certain additional risks and uncertainties as well, and any one or more of these factors could materially affect the Company’s financial condition, future operations and liquidity needs. Many of these risks and uncertainties are outside of the Company’s control, including the outcome of its ongoing strategic review process and various internal and external factors that may affect the success or failure of the Company's research and development efforts, the length of time and cost of developing and commercializing the Company's current or future product candidates, whether and when any such product candidates become approved drugs, and how significant a drug's market share will be, if approved, among others. Subject to the outcome and timing of its ongoing strategic review process, the Company currently expects that its existing cash, cash equivalents and marketable securities as of December 31, 2022 are sufficient to fund its current operations for at least 12 months following the issuance of these financial statements. |
Note 3 - Basis of Presentation
Note 3 - Basis of Presentation and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
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 Generally Accepted Accounting Principles. 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, cash equivalents, marketable securities, 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 equivalents. Marketable Securities The Company classifies its marketable securities as available-for-sale, which include commercial paper and U.S. government debt securities with original maturities of greater than three months from date of purchase. The Company considers its marketable securities as available for use in current operations, and therefore classifies these securities as current assets on the consolidated balance sheet. These securities are carried at fair value, with unrealized gains and losses reported in comprehensive loss and accumulated other comprehensive loss within stockholders’ equity. Gains or losses on marketable securities sold will be based on the specific identification method. Reverse Stock Split On April 18, 2022, the Company filed a Certificate of Amendment to its Certificate of Incorporation, as amended, with the Secretary of State of the State of Delaware to implement the Reverse Stock Split at a ratio of 1-to-50. No fractional shares were issued in connection with the Reverse Stock Split. Stockholders who otherwise would have been entitled to receive fractional shares of common stock became entitled to receive an amount in cash (without interest or deduction) equal to the fraction of one share to which such stockholder would otherwise be entitled multiplied by $12.93, representing the split-adjusted average closing price of the Company’s common stock on the Nasdaq Capital Market for the five consecutive trading days immediately preceding the effective date of the Reverse Stock Split. Proportional adjustments were made to the Company’s outstanding warrants, stock options, and other equity securities, as well as to the reserve of shares available for future issuance under the 2015 Equity Plan, to reflect the Reverse Stock Split, in each case, in accordance with the respective terms thereof. Intangible Asset In the third quarter of 2021, the Board of Directors made a determination to no longer dedicate financial resources to the Company's DFN-529 intangible asset and any future internal development efforts were abandoned. In connection with this decision, the Company concluded that DFN-529 was impaired in its entirety and as such, the Company recognized a non-cash impairment charge of $8.6 million in 2021. The abandonment also resulted in an income tax benefit of $0.4 million due to the tax effect of the reduction in the deferred tax liability associated with the asset. 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 and comprehensive loss. 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. FASB ASC Subtopic 740-10, Accounting for Uncertainty of Income Taxes 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, 2022, the Company uses the simplified method to estimate the expected term. For stock price volatility, the Company uses a combination of its 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 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 term 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 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 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, 2022 2021 Common stock warrants 111,891 129,989 Stock options 140,040 72,454 Unvested restricted stock units 3,652 5,509 255,583 207,952 Recently Issued But Not Yet Adopted Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses, Measurement of Credit Losses on Financial Instruments |
Note 4 - Cash, Cash Equivalents
Note 4 - Cash, Cash Equivalents and Marketable Securities | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Cash, Cash Equivalents, and Marketable Securities [Text Block] | 4. Cash, cash equivalents and marketable securities December 31, 2022 2021 Cash in banking institutions $ 1,586,920 $ 30,308,075 Money market funds 8,526,786 7,005,483 Total $ 10,113,706 $ 37,313,558 The following is a summary of the Company's marketable securities as of December 31, 2022: Amortized cost Unrealized gains Unrealized losses Fair Value Commercial paper $ 9,445,220 $ 263 $ (21,313 ) $ 9,424,170 U.S. treasury bonds 2,999,095 — (14,325 ) 2,984,770 Total $ 12,444,315 $ 263 $ (35,638 ) $ 12,408,940 The Company did not no no |
Note 5 - Fair Value of Financia
Note 5 - Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | 5. Fair Value of Financial Instruments Fair value is the price that could be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. Fair value determination in accordance with applicable accounting guidance requires that a number of significant judgments be made. Additionally, fair value is used on a nonrecurring basis to evaluate assets for impairment or as required for disclosure purposes by applicable accounting guidance on disclosures about fair value of financial instruments. Depending on the nature of the assets and liabilities, various valuation techniques and assumptions are used when estimating fair value. The carrying amounts of certain of the Company’s financial instruments, including prepaid expense and accounts payable are shown at cost, which approximates fair value due to the short-term nature of these instruments. The Company follows the provisions of FASB ASC Topic 820, Fair Value Measurement • Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. • Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liabilities. • Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). The following table presents the Company’s assets that are measured at fair value on a recurring basis: Fair value measurement at reporting date Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) December 31, 2022 Cash equivalents: Money market funds $ 8,526,786 $ — $ — Commercial paper — — — Total cash and cash equivalents $ 8,526,786 $ — $ — Marketable securities: Commercial paper $ — $ 9,424,170 $ — US treasury — 2,984,770 — Total marketable securities $ — $ 12,408,940 $ — Total financial assets $ 8,526,786 $ 12,408,940 $ — The fair values of the Company’s Level 2 marketable securities are estimated primarily based on benchmark yields, reported trades, market-based quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers, and reference data including market research publications, which represent a market approach. In general, a market approach is utilized if there is readily available and relevant market activity for an individual security. This valuation technique may change from period to period, based on the relevance and availability of market data. |
Note 6 - Accrued Expenses and O
Note 6 - Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Accounts Payable, Accrued Liabilities, and Other Liabilities Disclosure, Current [Text Block] | 6. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consist of the following: December 31, 2022 2021 Accrued payroll and payroll related expenses $ 131,777 $ 879,971 Accrued professional fees 552,785 247,704 Accrued clinical studies expenses 475,141 786,579 Other 129,851 65,935 Total $ 1,289,554 $ 1,980,189 |
Note 7 - Stockholders' Equity a
Note 7 - Stockholders' Equity and Common Stock Warrants | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | 7. Stockholders' Equity and Common Stock Warrants Common Stock Warrants As of December 31, 2022, 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 2018 related to the January 2018 Offering 23,639 $599.71 - $749.76 January 2023 Common stock warrants issued related to the May 2019 Offering 27,648 $250.09 - $306.04 May and December 2024 Common stock warrants issued related to the November 2019 Offering 4,269 $17.51 November 2024 Common stock warrants issued related to the December 2019 Offering 6,264 $21.68 - $34.92 December 2024 and June 2025 Common stock warrants issued related to the May 2020 Offering 11,424 $65.65 March 2025 Common stock warrants issued related to the May 2020 Investor Warrant Exercise 4,998 $29.70 November 2025 Common stock warrants issued related to the February 2021 Offering 33,649 $64.08 February 2026 111,891 During the years ended December 31, 2022 and 2021, 18,077 and 1,071 warrants expired, respectively. |
Note 8- Stock-based Compensatio
Note 8- Stock-based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | 8. 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, 81,582 shares were added to the reserve as of January 1, 2023, 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, 2022, there were 24,953 shares available for future issuance under the 2015 Equity Plan. The Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of operations and comprehensive loss for the periods indicated: December 31, 2022 2021 Research and development $ 215,904 $ 154,041 General and administrative 712,148 743,219 Total stock-based compensation expense $ 928,052 $ 897,260 The following table summarizes the activity related to all stock options: Number of Options Weighted average exercise price per share Weighted average remaining contractual term (in years) Aggregate Intrinsic Value Balance at January 1, 2021 44,738 $ 407.60 Granted 36,310 44.66 Expired (8,594 ) 68.48 Balance at December 31, 2021 72,454 265.91 Granted 77,088 9.87 Forfeited (8,892 ) 147.28 Expired (610 ) 1,562.92 Outstanding at December 31, 2022 140,040 126.75 8.5 — Exercisable at December 31, 2022 74,086 $ 226.95 7.9 — Vested and expected to vest at December 31, 2022 140,040 $ 126.75 8.5 — The weighted average grant date fair value of stock option awards granted was $9.87 and $44.66 during the years ended December 31, 2022 and 2021, respectively. The total fair value of options vested during the years ended December 31, 2022 and 2021 were $0.8 million and $0.8 million, respectively. No options were exercised during any of the periods presented. At December 31, 2022, there was $0.9 million of unrecognized compensation cost related to unvested options that will be recognized as expense over a weighted-average period of 1.5 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, 2022 and 2021: 2022 2021 Expected term (in years) 5.5 — 5.7 10 Risk-free interest rate 1.7% — 3.9% 1.3% — 1.7% Expected volatility 121.4% — 137.1% 122.6% — 125.8% Dividend yield — — — — — — Restricted Stock Unit Awards The Company issues restricted stock ("RSU") to newly elected, non-executive members of the board of directors that vest in six, tri-monthly installments beginning 18 months after the respective grant date. The fair value of an RSU is equal to the fair market value price of the Company’s common stock on the date of grant. RSU expense is recorded on a straight-line basis over the service period. The following table summarizes activity related to RSU stock-based payment awards: Number of Units Weighted average grant date fair value Balance at January 1, 2022 5,509 $ 34.78 Vested (1) (1,857 ) 31.41 Outstanding at December 31, 2022 3,652 36.49 (1) The RSUs vested during the year ended December 31, 2022 were settled on a hybrid basis. The Company withheld 685 shares of common stock and, in lieu of delivering such shares, paid the RSU holder an amount in cash equal to the fair market value of such shares on the vesting date, representing the holder's approximate tax liability associated with the vesting. The Company recognized approximately $65,000 and $54,000 in expense related to these units during the years ended December 31, 2022 and 2021, respectively. At December 31, 2022, there was approximately $0.1 million of unrecognized compensation cost that will be recognized over a weighted average period of 1.3 years. |
Note 9 - Commitments and Contin
Note 9 - Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | 9. Commitments and Contingencies Office Space Lease Commitment As of December 31, 2022, the Company had short-term agreements to utilize membership-based co-working space in both Charlottesville, Virginia and Philadelphia, Pennsylvania. Rent expense related to the Company's short-term agreements for the years ended December 31, 2022 and 2021 was approximately $18,000 and $5,000, respectively. 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 a 401(k) defined contribution plan that 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% of their compensation, limited by the IRS-imposed maximum. The Company provides a safe harbor match with a maximum amount of 4% of the participant’s compensation. The Company made matching contributions under the 401(k) Plan of approximately $97,000 and $75,000 for the years ended December 31, 2022 and 2021, respectively. Legal Proceedings On 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 related hearing 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, originally for November 2020 but later postponed due to the COVID-19 pandemic and related restrictions on gatherings in the State of California. In addition, following the November 2018 hearing, an automatic stay was placed on the arbitration in connection with the plaintiff filing for personal bankruptcy protection. On October 22, 2021, following a determination by the bankruptcy trustee not to pursue the claims and release them back to the plaintiff, the parties entered into a stipulation to abandon arbitration and return the matter to state court. A case management conference was held on February 23, 2022 at which an initial trial date of May 24, 2023 was set, and the parties have agreed to stipulate to mediation in advance of the trial. On October 20, 2022, the parties filed a joint stipulation to continue the trial and certain deadlines related to the mediation in order to allow plaintiff's counsel to continue to seek treatment for an ongoing medical issue. On November 1, 2022, based on the parties joint stipulation, the court entered an order continuing the trial date to October 25, 2023. The Company believes the claims in this matter are without merit and is defending itself vigorously. However, at this stage, the Company is unable to predict the outcome and 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 consolidated financial position, results of operations and cash flows. |
Note 10 - Income Taxes
Note 10 - Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 10. Income Taxes Income tax expense is summarized as follows: December 31, 2022 December 31, 2021 Federal $ — $ (362,150 ) State — (81,743 ) Total — (443,893 ) 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, 2022 December 31, 2021 Net operating loss carryforwards $ 8,650,404 $ 6,033,726 Stock option compensation 1,754,906 1,641,354 Orphan Drug credits 1,306,682 647,937 Capitalized start-up costs and other 12,788,834 12,403,925 Valuation allowance (24,471,392 ) (20,726,942 ) Deferred tax assets $ — $ — The Company does not The Company had NOL carryforwards for federal and state income tax purposes at December 31, 2022 and 2021 of approximately: Combined NOL Carryforwards: December 31, 2022 December 31, 2021 Federal $ 34,116,553 $ 23,442,045 State 30,727,733 23,436,624 The pre-2018 net operating loss carryforwards have begun to expire for both federal and state income tax purposes. Net operating loss carryforwards post Tax Cuts and Jobs Act of 2017 have an indefinite life. In November 2019, the Company increased the number of shares outstanding resulting in a change of ownership, under the provisions of Internal Revenue Code Section 382 and similar state provisions. These provisions limit the Company’s ability to utilize these net operating loss carryforwards to offset future income. The amounts above reflect the amount of NOLs that the Company expects to be able to utilize as a result of the limitation. The Company recorded a 100% valuation allowance of the deferred tax assets as of December 31, 2022 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, 2022 December 31, 2021 Federal tax benefit at statutory rate (21.0 )% (21.0 )% State tax, net of Federal benefit (3.9 )% (4.7 )% Orphan drug credit (4.5 )% (0.4 )% Change in valuation allowance 29.0 % 24.3 % Stock compensation 0.4 % — % Other — % — % Total provision — % (1.8 )% The Company files income tax returns in the U.S. federal jurisdiction and various state jurisdictions. The Company’s 2018 |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
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 |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of Credit Risk |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents |
Marketable Securities, Policy [Policy Text Block] | Marketable Securities |
Stockholders' Equity, Policy [Policy Text Block] | Reverse Stock Split |
Goodwill and Intangible Assets, Policy [Policy Text Block] | Intangible Asset |
Research and Development Expense, Policy [Policy Text Block] | Research and Development |
Legal Costs, Policy [Policy Text Block] | Patent Costs |
Income Tax, Policy [Policy Text Block] | Income Taxes Accounting for Uncertainty of Income Taxes |
Share-Based Payment Arrangement [Policy Text Block] | Stock-based Compensation |
Earnings Per Share, Policy [Policy Text Block] | Net Loss Per Common Share December 31, 2022 2021 Common stock warrants 111,891 129,989 Stock options 140,040 72,454 Unvested restricted stock units 3,652 5,509 255,583 207,952 |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Issued But Not Yet Adopted Accounting Pronouncements Financial Instruments—Credit Losses, Measurement of Credit Losses on Financial Instruments |
Note 3 - Basis of Presentatio_2
Note 3 - Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | December 31, 2022 2021 Common stock warrants 111,891 129,989 Stock options 140,040 72,454 Unvested restricted stock units 3,652 5,509 255,583 207,952 |
Note 4 - Cash, Cash Equivalen_2
Note 4 - Cash, Cash Equivalents and Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Cash and Cash Equivalents [Table Text Block] | December 31, 2022 2021 Cash in banking institutions $ 1,586,920 $ 30,308,075 Money market funds 8,526,786 7,005,483 Total $ 10,113,706 $ 37,313,558 |
Debt Securities, Available-for-Sale [Table Text Block] | Amortized cost Unrealized gains Unrealized losses Fair Value Commercial paper $ 9,445,220 $ 263 $ (21,313 ) $ 9,424,170 U.S. treasury bonds 2,999,095 — (14,325 ) 2,984,770 Total $ 12,444,315 $ 263 $ (35,638 ) $ 12,408,940 |
Note 5 - Fair Value of Financ_2
Note 5 - Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | Fair value measurement at reporting date Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) December 31, 2022 Cash equivalents: Money market funds $ 8,526,786 $ — $ — Commercial paper — — — Total cash and cash equivalents $ 8,526,786 $ — $ — Marketable securities: Commercial paper $ — $ 9,424,170 $ — US treasury — 2,984,770 — Total marketable securities $ — $ 12,408,940 $ — Total financial assets $ 8,526,786 $ 12,408,940 $ — |
Note 6 - Accrued Expenses and_2
Note 6 - Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Other Current Liabilities [Table Text Block] | December 31, 2022 2021 Accrued payroll and payroll related expenses $ 131,777 $ 879,971 Accrued professional fees 552,785 247,704 Accrued clinical studies expenses 475,141 786,579 Other 129,851 65,935 Total $ 1,289,554 $ 1,980,189 |
Note 7 - Stockholders' Equity_2
Note 7 - Stockholders' Equity and Common Stock Warrants (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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 2018 related to the January 2018 Offering 23,639 $599.71 - $749.76 January 2023 Common stock warrants issued related to the May 2019 Offering 27,648 $250.09 - $306.04 May and December 2024 Common stock warrants issued related to the November 2019 Offering 4,269 $17.51 November 2024 Common stock warrants issued related to the December 2019 Offering 6,264 $21.68 - $34.92 December 2024 and June 2025 Common stock warrants issued related to the May 2020 Offering 11,424 $65.65 March 2025 Common stock warrants issued related to the May 2020 Investor Warrant Exercise 4,998 $29.70 November 2025 Common stock warrants issued related to the February 2021 Offering 33,649 $64.08 February 2026 111,891 |
Note 8- Stock-based Compensat_2
Note 8- Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | December 31, 2022 2021 Research and development $ 215,904 $ 154,041 General and administrative 712,148 743,219 Total stock-based compensation expense $ 928,052 $ 897,260 |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Number of Options Weighted average exercise price per share Weighted average remaining contractual term (in years) Aggregate Intrinsic Value Balance at January 1, 2021 44,738 $ 407.60 Granted 36,310 44.66 Expired (8,594 ) 68.48 Balance at December 31, 2021 72,454 265.91 Granted 77,088 9.87 Forfeited (8,892 ) 147.28 Expired (610 ) 1,562.92 Outstanding at December 31, 2022 140,040 126.75 8.5 — Exercisable at December 31, 2022 74,086 $ 226.95 7.9 — Vested and expected to vest at December 31, 2022 140,040 $ 126.75 8.5 — |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | 2022 2021 Expected term (in years) 5.5 — 5.7 10 Risk-free interest rate 1.7% — 3.9% 1.3% — 1.7% Expected volatility 121.4% — 137.1% 122.6% — 125.8% Dividend yield — — — — — — |
Share-Based Payment Arrangement, Restricted Stock Unit, Activity [Table Text Block] | Number of Units Weighted average grant date fair value Balance at January 1, 2022 5,509 $ 34.78 Vested (1) (1,857 ) 31.41 Outstanding at December 31, 2022 3,652 36.49 |
Note 10 - Income Taxes (Tables)
Note 10 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Components of Income Tax Expense (Benefit) [Table Text Block] | December 31, 2022 December 31, 2021 Federal $ — $ (362,150 ) State — (81,743 ) Total — (443,893 ) |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | Deferred tax assets December 31, 2022 December 31, 2021 Net operating loss carryforwards $ 8,650,404 $ 6,033,726 Stock option compensation 1,754,906 1,641,354 Orphan Drug credits 1,306,682 647,937 Capitalized start-up costs and other 12,788,834 12,403,925 Valuation allowance (24,471,392 ) (20,726,942 ) Deferred tax assets $ — $ — |
Summary of Operating Loss Carryforwards [Table Text Block] | Combined NOL Carryforwards: December 31, 2022 December 31, 2021 Federal $ 34,116,553 $ 23,442,045 State 30,727,733 23,436,624 |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | Rate reconciliation: December 31, 2022 December 31, 2021 Federal tax benefit at statutory rate (21.0 )% (21.0 )% State tax, net of Federal benefit (3.9 )% (4.7 )% Orphan drug credit (4.5 )% (0.4 )% Change in valuation allowance 29.0 % 24.3 % Stock compensation 0.4 % — % Other — % — % Total provision — % (1.8 )% |
Note 1 - Organization and Des_2
Note 1 - Organization and Description of Business (Details Textual) | Apr. 18, 2022 |
Reverse Stock Split [Member ] | |
Stockholders' Equity Note, Stock Split, Conversion Ratio | 50 |
Note 2 - Liquidity (Details Tex
Note 2 - Liquidity (Details Textual) - BTIG, LLC [Member] shares in Thousands, $ in Millions | 12 Months Ended |
Dec. 31, 2022 USD ($) shares | |
Common Stock, Value, Subscriptions | $ | $ 20 |
Stock Issued During Period, Shares, New Issues (in shares) | shares | 0 |
Note 3 - Basis of Presentatio_3
Note 3 - Basis of Presentation and Summary of Significant Accounting Policies (Details Textual) - USD ($) | 12 Months Ended | ||
Apr. 18, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Reverse Stock Split, Fractional Shares, Cash, Multiple | $ 12.93 | ||
Impairment of Intangible Assets, Indefinite-Lived (Excluding Goodwill) | $ 0 | $ 8,639,000 | |
Income Tax Expense (Benefit), Total | $ 0 | $ (443,893) |
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, 2022 | Dec. 31, 2021 | |
Anti-dilutive securities (in shares) | 255,583 | 207,952 |
Warrant [Member] | ||
Anti-dilutive securities (in shares) | 111,891 | 129,989 |
Share-Based Payment Arrangement, Option [Member] | ||
Anti-dilutive securities (in shares) | 140,040 | 72,454 |
Unvested Restricted Stock Units [Member] | ||
Anti-dilutive securities (in shares) | 3,652 | 5,509 |
Note 4 - Cash, Cash Equivalen_3
Note 4 - Cash, Cash Equivalents and Marketable Securities (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Debt Securities, Available-for-Sale, Total | $ 12,408,940 | $ 0 |
Marketable Securities, Unrealized Gain (Loss), Excluding Other-than-temporary Impairment Loss | (35,638) | |
Marketable Securities, Other-than-temporary Impairment Loss | 0 | |
Marketable Securities, Realized Gain (Loss), Excluding Other-than-temporary Impairment Loss | $ 0 | |
Minimum [Member] | ||
Marketable Securities Contractual Maturity (Month) | 3 months | |
Maximum [Member] | ||
Marketable Securities Contractual Maturity (Month) | 12 months |
Note 4 - Cash, Cash Equivalen_4
Note 4 - Cash, Cash Equivalents and Marketable Securities - Cash and Cah Equivalents (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Cash and cash equivalents | $ 10,113,706 | $ 37,313,558 |
Bank Time Deposits [Member] | ||
Cash and cash equivalents | 1,586,920 | 30,308,075 |
Money Market Funds [Member] | ||
Cash and cash equivalents | $ 8,526,786 | $ 7,005,483 |
Note 4 - Cash, Cash Equivalen_5
Note 4 - Cash, Cash Equivalents and Marketable Securities - Marketable Securities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Amortized cost | $ 12,444,315 | |
Unrealized gains | 263 | |
Unrealized losses | (35,638) | |
Fair Value | 12,408,940 | $ 0 |
Commercial Paper, Not Included with Cash and Cash Equivalents [Member] | ||
Amortized cost | 9,445,220 | |
Unrealized gains | 263 | |
Unrealized losses | (21,313) | |
Fair Value | 9,424,170 | |
US Treasury Securities [Member] | ||
Amortized cost | 2,999,095 | |
Unrealized gains | 0 | |
Unrealized losses | (14,325) | |
Fair Value | $ 2,984,770 |
Note 5 - Fair Value of Financ_3
Note 5 - Fair Value of Financial Instruments - Assets Measured at Fair Value on Recurring Basis (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value | $ 12,408,940 | $ 0 |
Commercial Paper, Not Included with Cash and Cash Equivalents [Member] | ||
Fair Value | 9,424,170 | |
US Treasury Securities [Member] | ||
Fair Value | 2,984,770 | |
Fair Value, Inputs, Level 1 [Member] | Fair Value, Recurring [Member] | ||
Cash and cash equivalents | 8,526,786 | |
Fair Value | 0 | |
Total financial assets | 8,526,786 | |
Fair Value, Inputs, Level 1 [Member] | Fair Value, Recurring [Member] | Commercial Paper, Not Included with Cash and Cash Equivalents [Member] | ||
Fair Value | 0 | |
Fair Value, Inputs, Level 1 [Member] | Fair Value, Recurring [Member] | US Treasury Securities [Member] | ||
Fair Value | 0 | |
Fair Value, Inputs, Level 2 [Member] | Fair Value, Recurring [Member] | ||
Cash and cash equivalents | 0 | |
Fair Value | 12,408,940 | |
Total financial assets | 12,408,940 | |
Fair Value, Inputs, Level 2 [Member] | Fair Value, Recurring [Member] | Commercial Paper, Not Included with Cash and Cash Equivalents [Member] | ||
Fair Value | 9,424,170 | |
Fair Value, Inputs, Level 2 [Member] | Fair Value, Recurring [Member] | US Treasury Securities [Member] | ||
Fair Value | 2,984,770 | |
Fair Value, Inputs, Level 3 [Member] | Fair Value, Recurring [Member] | ||
Cash and cash equivalents | 0 | |
Fair Value | 0 | |
Total financial assets | 0 | |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | Fair Value, Recurring [Member] | ||
Cash and cash equivalents | 8,526,786 | |
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | Fair Value, Recurring [Member] | ||
Cash and cash equivalents | 0 | |
Commercial Paper [Member] | Fair Value, Inputs, Level 1 [Member] | Fair Value, Recurring [Member] | ||
Cash and cash equivalents | 0 | |
Commercial Paper [Member] | Fair Value, Inputs, Level 2 [Member] | Fair Value, Recurring [Member] | ||
Cash and cash equivalents | $ 0 |
Note 6 - Accrued Expenses and_3
Note 6 - Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued payroll and payroll related expenses | $ 131,777 | $ 879,971 |
Accrued professional fees | 552,785 | 247,704 |
Accrued clinical studies expenses | 475,141 | 786,579 |
Other | 129,851 | 65,935 |
Total | $ 1,289,554 | $ 1,980,189 |
Note 7 - Stockholders' Equity_3
Note 7 - Stockholders' Equity and Common Stock Warrants (Details Textual) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Class of Warrant or Rights, Expired | 18,077 | 1,071 |
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, 2022 | Dec. 31, 2021 |
Common stock warrants, outstanding (in shares) | 111,891 | |
Warrants Issued in Connection with the January 2018 Offering [Member] | ||
Common stock warrants, outstanding (in shares) | 23,639 | |
Warrants Issued in Connection with the January 2018 Offering [Member] | Minimum [Member] | ||
Range of exercise price (in dollars per share) | $ 599.71 | |
Warrants Issued in Connection with the January 2018 Offering [Member] | Maximum [Member] | ||
Range of exercise price (in dollars per share) | 749.76 | |
Warrants Issued in Connection with May 2019 Public Offering [Member] | ||
Common stock warrants, outstanding (in shares) | 27,648 | |
Warrants Issued in Connection with May 2019 Public Offering [Member] | Minimum [Member] | ||
Range of exercise price (in dollars per share) | 250.09 | |
Warrants Issued in Connection with May 2019 Public Offering [Member] | Maximum [Member] | ||
Range of exercise price (in dollars per share) | 306.04 | |
Warrants Issued in Connection with the November 2019 Offering [Member] | ||
Common stock warrants, outstanding (in shares) | 4,269 | |
Range of exercise price (in dollars per share) | $ 17.51 | |
Warrants Issued in Connection with the December 2019 Offering [Member] | ||
Common stock warrants, outstanding (in shares) | 6,264 | |
Warrants Issued in Connection with the December 2019 Offering [Member] | Minimum [Member] | ||
Range of exercise price (in dollars per share) | $ 21.68 | |
Warrants Issued in Connection with the December 2019 Offering [Member] | Maximum [Member] | ||
Range of exercise price (in dollars per share) | $ 34.92 | |
The May 2020 Offering Warrants [Member] | ||
Common stock warrants, outstanding (in shares) | 11,424 | |
Range of exercise price (in dollars per share) | $ 65.65 | |
The May 2020 Investor Warrant Exercise [Member] | ||
Common stock warrants, outstanding (in shares) | 4,998 | |
Range of exercise price (in dollars per share) | $ 29.70 | |
Underwriter Warrants in Connection with the February 2021 Common Stock Offering [Member] | ||
Common stock warrants, outstanding (in shares) | 33,649 | |
Range of exercise price (in dollars per share) | $ 64.08 |
Note 8- Stock-based Compensat_3
Note 8- Stock-based Compensation (Details Textual) - USD ($) | 12 Months Ended | ||
Jan. 01, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 9.87 | $ 44.66 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested in Period, Fair Value | $ 800,000 | $ 800,000 | |
Share-Based Payment Arrangement, Shares Withheld for Tax Withholding Obligation | 685 | ||
Share-Based Payment Arrangement, Expense | $ 928,052 | 897,260 | |
Share-Based Payment Arrangement, Option [Member] | |||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ 900,000 | ||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 1 year 6 months | ||
Restricted Stock Units (RSUs) [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period | 18 months | ||
Restricted Stock Units (RSUs) [Member] | Director [Member] | |||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ 100,000 | ||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 1 year 3 months 18 days | ||
Share-Based Payment Arrangement, Expense | $ 65,000 | $ 54,000 | |
Equity Incentive Plan 2015 [Member] | |||
Percentage of Total Shares Eligible for Plan Reserve, On an Annual Basis | 4% | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant | 24,953 | ||
Equity Incentive Plan 2015 [Member] | Subsequent Event [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Additional Shares Authorized | 81,582 |
Note 8 - Stock-based Compensati
Note 8 - Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Research and development | $ 928,052 | $ 897,260 |
Research and Development Expense [Member] | ||
Research and development | 215,904 | 154,041 |
General and Administrative Expense [Member] | ||
Research and development | $ 712,148 | $ 743,219 |
Note 8 - Stock-based Compensa_2
Note 8 - Stock-based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Balance (in shares) | 72,454 | 44,738 |
Balance, weighted-average exercise price (in dollars per share) | $ 265.91 | $ 407.60 |
Granted, number (in shares) | 77,088 | 36,310 |
Granted, weighted-average exercise price (in dollars per share) | $ 9.87 | $ 44.66 |
Expired, number (in shares) | (610) | (8,594) |
Expired, weighted-average exercise price (in dollars per share) | $ 1,562.92 | $ 68.48 |
Forfeited, number (in shares) | (8,892) | |
Forfeited, weighted-average exercise price (in dollars per share) | $ 147.28 | |
Balance (in shares) | 140,040 | 72,454 |
Balance, weighted-average exercise price (in dollars per share) | $ 126.75 | $ 265.91 |
Options outstanding, weighted-average remaining contractual life (Year) | 8 years 6 months | |
Options outstanding, aggregate intrinsic value | $ 0 | |
Exercisable, number (in shares) | 74,086 | |
Exercisable, weighted-average exercise price (in dollars per share) | $ 226.95 | |
Exercisable, weighted-average remaining contractual life (Year) | 7 years 10 months 24 days | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Intrinsic Value | $ 0 | |
Vested and expected to vest, shares (in shares) | 140,040 | |
Vested and expected to vest, weighted-average exercise price (in dollars per share) | $ 126.75 | |
Vested and expected to vest, weighted-average remaining contractual life (Year) | 8 years 6 months | |
Vested and expected to vest, aggregate intrinsic value | $ 0 |
Note 8 - Stock-based Compensa_3
Note 8 - Stock-based Compensation - Fair Value Assumptions (Details) - Share-Based Payment Arrangement, Option [Member] | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Expected term (in years) (Year) | 10 years | |
Minimum [Member] | ||
Expected term (in years) (Year) | 5 years 6 months | |
Risk-free interest rate | 1.70% | 1.30% |
Expected volatility | 121.40% | 122.60% |
Dividend yield | 0% | 0% |
Maximum [Member] | ||
Expected term (in years) (Year) | 5 years 8 months 12 days | |
Risk-free interest rate | 3.90% | 1.70% |
Expected volatility | 137.10% | 125.80% |
Dividend yield | 0% | 0% |
Note 8 - Stock-based Compensa_4
Note 8 - Stock-based Compensation - RSU Stock-based Payment Awards (Details) - Restricted Stock Units (RSUs) [Member] | 12 Months Ended | |
Dec. 31, 2021 $ / shares shares | ||
Balance at January 1, 2022 (in shares) | shares | 5,509 | |
Balance at January 1, 2022 (in dollars per share) | $ / shares | $ 34.78 | |
Vested(1) (in shares) | shares | (1,857) | [1] |
Vested(1) (in dollars per share) | $ / shares | $ 31.41 | [1] |
Outstanding at December 31, 2022 (in shares) | shares | 3,652 | |
Outstanding at December 31, 2022 (in dollars per share) | $ / shares | $ 36.49 | |
[1]The RSUs vested during the year ended December 31, 2022 were settled on a hybrid basis. The Company withheld 685 shares of common stock and, in lieu of delivering such shares, paid the RSU holder an amount in cash equal to the fair market value of such shares on the vesting date, representing the holder's approximate tax liability associated with the vesting. |
Note 9 - Commitments and Cont_2
Note 9 - Commitments and Contingencies (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Lease, Expense | $ 18,000 | $ 5,000 |
Defined Contribution Plan, Maximum Annual Contributions Per Employee, Percent | 90% | |
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 4% | |
Defined Contribution Plan, Employer Discretionary Contribution Amount | $ 97,000 | $ 75,000 |
Note 10 - Income Taxes (Details
Note 10 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Unrecognized Tax Benefits, Ending Balance | $ 0 | $ 0 |
Deferred Tax Assets, Valuation Allowance, Percentage | 100% | |
Open Tax Year | 2018 2019 2020 2021 2022 |
Note 10 - Income Taxes - Income
Note 10 - Income Taxes - Income Tax Expense (benefit) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income tax expense (benefit) | $ 0 | $ (443,893) |
Domestic Tax Authority [Member] | ||
Income tax expense (benefit) | 0 | (362,150) |
State and Local Jurisdiction [Member] | ||
Income tax expense (benefit) | $ 0 | $ (81,743) |
Note 10 - Income Taxes - Deferr
Note 10 - Income Taxes - Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Net operating loss carryforwards | $ 8,650,404 | $ 6,033,726 |
Stock option compensation | 1,754,906 | 1,641,354 |
Orphan Drug credits | 1,306,682 | 647,937 |
Capitalized start-up costs and other | 12,788,834 | 12,403,925 |
Valuation allowance | (24,471,392) | (20,726,942) |
Deferred tax assets | $ 0 | $ 0 |
Note 10 - Income Taxes - Operat
Note 10 - Income Taxes - Operating Loss Carryforwards (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Domestic Tax Authority [Member] | ||
Operating loss carryforwards | $ 34,116,553 | $ 23,442,045 |
State and Local Jurisdiction [Member] | ||
Operating loss carryforwards | $ 30,727,733 | $ 23,436,624 |
Note 10 - Income Taxes - Reconc
Note 10 - Income Taxes - Reconciliation of Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Federal tax benefit at statutory rate | (21.00%) | (21.00%) |
State tax, net of Federal benefit | (3.90%) | (4.70%) |
Orphan drug credit | (4.50%) | (0.40%) |
Change in valuation allowance | 29% | 24.30% |
Stock compensation | 0.40% | 0% |
Other | 0% | 0% |
Total provision | 0% | (1.80%) |