Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 09, 2023 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-38634 | |
Entity Registrant Name | Reviva Pharmaceuticals Holdings, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 85-4306526 | |
Entity Address, Address Line One | 19925 Stevens Creek Blvd., Suite 100 | |
Entity Address, City or Town | Cupertino | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 95014 | |
City Area Code | 408 | |
Local Phone Number | 501-8881 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding (in shares) | 22,650,266 | |
Entity Central Index Key | 0001742927 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Common Stock [Member] | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | RVPH | |
Security Exchange Name | NASDAQ | |
Warrant [Member] | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Warrants | |
Trading Symbol | RVPHW | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Assets [Abstract] | ||
Cash and cash equivalents | $ 4,972,298 | $ 18,519,856 |
Prepaid expenses and other current assets | 414,743 | 403,819 |
Total Assets | 5,387,041 | 18,923,675 |
Liabilities [Abstract] | ||
Short-term debt | 222,500 | 0 |
Accounts payable | 5,278,375 | 3,520,271 |
Accrued expenses and other current liabilities | 7,532,187 | 2,519,569 |
Total current liabilities | 13,033,062 | 6,039,840 |
Warrant liabilities | 873,411 | 567,439 |
Total Liabilities | 13,906,473 | 6,607,279 |
Commitments and Contingencies | ||
Stockholders' Equity (Deficit) | ||
Common stock, par value of $0.0001; 115,000,000 shares authorized; 20,650,266 and 20,447,371 shares issued and outstanding as of September 30, 2023, and December 31, 2022, respectively | 2,265 | 2,045 |
Additional paid-in capital | 112,185,998 | 103,485,612 |
Accumulated deficit | (120,707,695) | (91,171,261) |
Total stockholders' equity (deficit) | (8,519,432) | 12,316,396 |
Total Liabilities and Stockholders' Equity (Deficit) | $ 5,387,041 | $ 18,923,675 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 115,000,000 | 115,000,000 |
Common Stock, Shares, Issued (in shares) | 20,650,266 | 20,447,371 |
Common Stock, Shares, Outstanding (in shares) | 20,650,266 | 20,447,371 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating expenses | ||||
Research and development | $ 8,717,273 | $ 2,305,981 | $ 22,943,522 | $ 12,650,388 |
General and administrative | 1,991,774 | 1,256,972 | 6,571,629 | 3,882,210 |
Total operating expenses | 10,709,047 | 3,562,953 | 29,515,151 | 16,532,598 |
Loss from operations | (10,709,047) | (3,562,953) | (29,515,151) | (16,532,598) |
Other income (expense) | ||||
Gain (loss) on remeasurement of warrant liabilities | 139,079 | 0 | (305,972) | 267,031 |
Interest expense | (5,901) | 0 | (20,414) | 0 |
Interest income | 91,763 | 53,150 | 341,854 | 68,710 |
Other income (expense), net | 5,194 | (3,641) | (15,220) | (11,749) |
Total other income (expense), net | 230,135 | 49,509 | 248 | 323,992 |
Loss before provision for income taxes | (10,478,912) | (3,513,444) | (29,514,903) | (16,208,606) |
Provision for income taxes | 12,117 | 1,864 | 21,531 | 12,414 |
Net loss | $ (10,491,029) | $ (3,515,308) | $ (29,536,434) | $ (16,221,020) |
Earnings Per Share [Abstract] | ||||
Basic and diluted (in dollars per share) | $ (0.44) | $ (0.18) | $ (1.30) | $ (0.87) |
Earnings Per Share, Basic, Other Disclosure [Abstract] | ||||
Basic and diluted (in shares) | 24,033,665 | 19,269,989 | 22,775,407 | 18,737,330 |
Condensed Consolidated Statem_2
Condensed Consolidated Statement of Stockholders' Equity (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance (in shares) at Dec. 31, 2021 | 14,433,286 | |||
Balance at Dec. 31, 2021 | $ 1,443 | $ 95,516,986 | $ (66,831,969) | $ 28,686,460 |
Stock-based compensation expense | 0 | 120,149 | 0 | 120,149 |
Net loss | $ 0 | 0 | (16,221,020) | (16,221,020) |
Common stock issued in connection with warrant exercises (in shares) | 4,033,300 | |||
Common stock issued in connection with warrant exercises | $ 403 | 0 | 0 | 403 |
Issuance of common stock and warrants in offering, net of transaction costs (in shares) | 1,976,285 | |||
Issuance of common stock and warrants in offering, net of transaction costs | $ 198 | 7,773,329 | 0 | 7,773,527 |
Balance (in shares) at Sep. 30, 2022 | 20,442,871 | |||
Balance at Sep. 30, 2022 | $ 2,044 | 103,410,464 | (83,052,989) | 20,359,519 |
Balance (in shares) at Dec. 31, 2021 | 14,433,286 | |||
Balance at Dec. 31, 2021 | $ 1,443 | 95,516,986 | (66,831,969) | 28,686,460 |
Balance (in shares) at Dec. 31, 2022 | 20,447,371 | |||
Balance at Dec. 31, 2022 | $ 2,045 | 103,485,612 | (91,171,261) | 12,316,396 |
Balance (in shares) at Jun. 30, 2022 | 15,133,286 | |||
Balance at Jun. 30, 2022 | $ 1,513 | 95,596,548 | (79,537,681) | 16,060,380 |
Stock-based compensation expense | 0 | 40,587 | 0 | 40,587 |
Net loss | $ 0 | 0 | (3,515,308) | (3,515,308) |
Common stock issued in connection with warrant exercises (in shares) | 3,333,300 | |||
Common stock issued in connection with warrant exercises | $ 333 | 0 | 0 | 333 |
Issuance of common stock and warrants in offering, net of transaction costs (in shares) | 1,976,285 | |||
Issuance of common stock and warrants in offering, net of transaction costs | $ 198 | 7,773,329 | 7,773,527 | |
Balance (in shares) at Sep. 30, 2022 | 20,442,871 | |||
Balance at Sep. 30, 2022 | $ 2,044 | 103,410,464 | (83,052,989) | 20,359,519 |
Balance (in shares) at Dec. 31, 2022 | 20,447,371 | |||
Balance at Dec. 31, 2022 | $ 2,045 | 103,485,612 | (91,171,261) | 12,316,396 |
Stock-based compensation expense | 0 | 3,022,756 | 0 | 3,022,756 |
Net loss | $ 0 | 0 | (29,536,434) | (29,536,434) |
Common stock issued in connection with warrant exercises (in shares) | 2,202,895 | |||
Common stock issued in connection with warrant exercises | $ 220 | 5,677,630 | 0 | 5,677,850 |
Balance (in shares) at Sep. 30, 2023 | 22,650,266 | |||
Balance at Sep. 30, 2023 | $ 2,265 | 112,185,998 | (120,707,695) | (8,519,432) |
Balance (in shares) at Jun. 30, 2023 | 22,650,266 | |||
Balance at Jun. 30, 2023 | $ 2,265 | 111,835,588 | (110,216,666) | 1,621,187 |
Stock-based compensation expense | 0 | 350,410 | 0 | 350,410 |
Net loss | $ 0 | 0 | (10,491,029) | (10,491,029) |
Balance (in shares) at Sep. 30, 2023 | 22,650,266 | |||
Balance at Sep. 30, 2023 | $ 2,265 | $ 112,185,998 | $ (120,707,695) | $ (8,519,432) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Net Cash Provided by (Used in) Operating Activities [Abstract] | |||||
Net loss | $ (10,491,029) | $ (3,515,308) | $ (29,536,434) | $ (16,221,020) | |
Adjustments to reconcile net loss to net cash used in operating activities | |||||
Change in fair value of warrant liabilities | 305,972 | (267,031) | |||
Stock-based compensation expense | 3,022,756 | 120,149 | |||
Changes in operating assets and liabilities: | |||||
Prepaid expenses and other current assets | (10,924) | 1,074,587 | |||
Accounts payable | 1,758,104 | 1,630,662 | |||
Accrued expenses and other current liabilities | 5,012,618 | (607,294) | |||
Net cash used in operating activities | (19,447,908) | (14,269,947) | |||
Cash flows from financing activities | |||||
Proceeds from issuance of short-term debt | 667,500 | 0 | |||
Repayment of short-term debt | (445,000) | 0 | |||
Proceeds from issuance common stock and warrants in offering, net | 0 | 7,773,527 | |||
Proceeds from exercise of warrants | 5,677,850 | 403 | |||
Net cash provided by financing activities | 5,900,350 | 7,773,930 | |||
Net decrease in cash and cash equivalents | (13,547,558) | (6,496,017) | |||
Cash and cash equivalents, beginning of period | 18,519,856 | 29,687,944 | $ 29,687,944 | ||
Cash and cash equivalents, end of period | 4,972,298 | 23,191,927 | 4,972,298 | 23,191,927 | $ 18,519,856 |
Supplemental disclosures of cash flow information: | |||||
Cash paid for taxes | 18,674 | 4,981 | |||
Cash paid for interest | 20,414 | 0 | |||
Prepaid expenses included in accounts payable | $ 0 | $ 207,553 | $ 0 | $ 207,553 |
Note 1 - Organization and Natur
Note 1 - Organization and Nature of Operations | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] | 1. ORGANIZATION AND NATURE OF OPERATIONS On December 14, 2020, Reviva Pharmaceuticals Holdings, Inc. (the “Company”), a Delaware corporation and the successor by re-domiciliation to Tenzing Acquisition Corp. (“Tenzing”), a British Virgin Islands exempted company, Tenzing Merger Subsidiary Inc., a Delaware corporation and wholly-owned subsidiary of Tenzing (“Merger Sub”), and Reviva Pharmaceuticals, Inc., a Delaware corporation (together with its consolidated subsidiary), consummated a business combination (the “Business Combination”) through the merger of Merger Sub with and into Reviva Pharmaceuticals, Inc. (the "Merger"), in accordance with the Agreement and Plan of Merger, dated as of July 20, 2020 (the “Merger Agreement”), by and among Tenzing, Merger Sub, Reviva Pharmaceuticals, Inc., and the other parties thereto. Pursuant to the Merger Agreement, at the effective time of the Merger, Merger Sub merged with and into Reviva Pharmaceuticals, Inc., with Reviva Pharmaceuticals, Inc. as the surviving company in the Merger and, after giving effect to such Merger, Reviva Pharmaceuticals, Inc. becoming a wholly-owned subsidiary of Reviva Pharmaceuticals Holdings, Inc. In these notes to the unaudited condensed consolidated financial statements, unless otherwise specified or the context indicates otherwise, references to the “Company,” “Reviva,” “we,” “us” and “our” refer to Reviva Pharmaceuticals Holdings, Inc. and its consolidated subsidiaries. Reviva Pharmaceuticals, Inc. was originally incorporated in the state of Delaware and commenced operations on May 1, 2006 and its Indian subsidiary, Reviva Pharmaceuticals India Pvt. Ltd. was incorporated in 2014. The Company is a late-stage pharmaceutical company developing new therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases. |
Note 2 - Summary of Significant
Note 2 - Summary of Significant Accounting Policies and Basis of Presentation | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND BASIS OF PRESENTATION Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X. Certain footnotes and other financial information normally required by accounting principles generally accepted in the United States of America, or GAAP, have been condensed or omitted in accordance with such rules and regulations. In management’s opinion, these unaudited condensed consolidated financial statements have been prepared on the same basis as our annual consolidated financial statements and notes thereto and include all adjustments, consisting of normal recurring items, considered necessary for the fair presentation. The operating results for the three and nine months ended September 30, 2023, are not necessarily indicative of the results that may be expected for the full year ending December 31, 2023. The unaudited condensed consolidated balance sheet as of December 31, 2022, has been derived from our audited financial statements at that date but does not include all disclosures and financial information required by GAAP for complete financial statements. The information included in the quarterly report on Form 10-Q should be read in conjunction with our consolidated financial statements and notes thereto for the year ended December 31, 2022, which were included in our annual report on Form 10-K, as filed with the Securities and Exchange Commission on March 30, 2023. Liquidity and Going Concern The Company has incurred losses since inception and as of September 30, 2023, the Company had working capital deficit of approximately $7.6 million, an accumulated deficit of $120.7 million and cash and cash equivalents on hand of approximately $5.0 million. The Company’s net loss for the three months ended September 30, 2023 and 2022, was approximately $10.5 million and $3.5 million, respectively. The Company's net loss for the nine months ended September 30, 2023 and 2022, was approximately $29.5 million and $16.2 million, respectively. The Company expects to incur significant expenses and increased operating losses for the next several years. The Company expects its expenses to increase in connection with its ongoing activities to research, develop and commercialize its product candidates. The Company will need to generate significant revenues to achieve profitability, and it may never do so. The Company’s current cash on hand is not sufficient to satisfy its operating cash needs for the 12 months from the filing of this Quarterly Report on Form 10-Q. The Company believes that it has adequate cash on hand to cover anticipated outlays well into the fourth quarter of 2023, but will need additional fundraising activities and cash on hand during the fourth quarter of fiscal year 2023 for working capital requirements for fiscal year 2024. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued. Management’s plan to alleviate the conditions that raise substantial doubt include raising additional working capital through public or private equity or debt financings or other sources, which may include collaborations with third parties as well as disciplined cash spending. Adequate additional financing may not be available to the Company on acceptable terms, or at all. Should the Company be unable to raise sufficient additional capital, the Company may be required to undertake cost-cutting measures including delaying or discontinuing certain clinical activities. These factors among others create a substantial doubt about the Company’s ability to continue as a going concern. Use of estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of expenses during the reporting periods covered by the financial statements and accompanying notes. Significant areas requiring the use of management estimates include, but are not limited to, depreciation and amortization, useful lives, assumptions used to calculate the fair value of stock-based compensation, deferred taxes, and related valuation allowances. Actual results could differ materially from such estimates under different assumptions or circumstances. Concentration of credit risk and other risks and uncertainties Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. Currently, substantially all the Company’s cash and cash equivalents are held in demand deposit form at two financial institutions. Deposits in financial institutions may, from time to time, exceed federally insured limits. The Company has not experienced any losses on its deposits of cash. The Company is subject to all of the risks inherent in an early-stage company developing new pharmaceutical products. These risks include, but are not limited to, limited management resources, dependence upon medical acceptance of products in development, regulatory approvals, successful clinical trials, availability and willingness of patients to participate in human trials, and competition in the pharmaceutical industry. The Company’s operating results may be materially affected by the foregoing factors. |
Note 3 - Loss Per Share
Note 3 - Loss Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | 3. LOSS PER SHARE Basic and diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding during the period. Diluted loss per share includes potentially dilutive securities such as stock options, warrants to purchase common stock, and other convertible instruments unless the result of inclusion would be anti-dilutive. These securities have been excluded from the calculation of diluted net loss per share for the three and nine months ended September 30, 2023 and 2022, because all such securities are anti-dilutive for all periods presented. In September 2022, the Company issued Private Pre-Funded Warrants to purchase up to an aggregate of 1,383,399 shares of common stock. The Private Pre-Funded Warrants were included in the basic and diluted net loss per share calculation during the three and nine months ended September 30, 2023 and 2022. The following table summarizes the Company’s potentially dilutive securities, in common share equivalents, which have been excluded from the calculation of dilutive loss per share as their effect would be anti-dilutive: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Shares issuable upon exercise of stock options 1,687,774 179,627 1,687,774 179,627 Shares issuable upon exercise of warrants to purchase common stock 15,030,209 17,237,604 15,030,209 17,237,604 Shares contingently issuable for earnout 1,000,000 1,000,000 1,000,000 1,000,000 17,717,983 18,417,231 17,717,983 18,417,231 The diluted loss per share computation equals basic loss per share for the three and nine months ended September 30, 2023 and 2022 because the Company had a net loss and the impact of the assumed exercise of stock options and warrants would have been anti-dilutive. |
Note 4 - Warrants
Note 4 - Warrants | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Warrants [Text Block] | 4. WARRANTS As of September 30, 2023, there were public warrants outstanding to purchase an aggregate of 6,325,000 shares of common stock, private warrants outstanding to purchase an aggregate of 1,939,712 shares of common stock, investor warrants outstanding to purchase an aggregate of 6,645,041 shares of common stock, private pre-funded warrants to purchase an aggregate of 1,383,399 shares of common stock, and assumed warrants outstanding to purchase an aggregate of 120,456 shares of common stock. 2020 Business Combination In connection with the closing of our Business Combination in 2020, our predecessor company, Tenzing, issued public warrants to purchase 6,325,000 shares and private placement warrants to purchase 556,313 shares. Further, there were assumed warrants to purchase an aggregate of 126,268 shares of common stock, of which 5,812 expired during fiscal year 2022. These warrants were classified as equity as of September 30, 2023 and September 30, 2022. The fair value of these warrants on the date of issuance was $1,279,182. Each public warrant entitles the holder thereof to purchase one We may call the public warrants for redemption, in whole and not in part, at a price of $0.01 per warrant; • if, and only if, the reported last sale price of the common stock equals or exceeds $21.00 per share (as adjusted for stock splits, stock dividends, reorganizations and recapitalizations), for any 20 trading days within a 30 trading day period ending on the third trading business day prior to the notice of redemption to holders of the public warrants, and • if, and only if, there is a current registration statement in effect with respect to the issuance of the shares of common stock underlying such Public Warrants at the time of redemption and for the entire 30-day trading period referred to above and continuing each day thereafter until the date of redemption • at any time while the public warrants are exercisable • upon not less than 30 days’ prior written notice of redemption to each warrant holder The private warrants are substantially similar to the public warrants except such private warrants; • are exercisable for cash or on a cashless basis, at the holder’s option • cannot be redeemed by us, so long as they are still held by the initial purchasers or their affiliates. • The redemption price is to be calculated as the 10-day average trading price ending one trading business day prior to the notice of redemption. In no event will the Company be required to net cash settle either the public or the private warrants. The exercise price and number of shares of common stock issuable on exercise of the warrants may be adjusted in certain circumstances including in the event of a share dividend, extraordinary dividend or a recapitalization, reorganization, merger or consolidation. The private warrants were classified as derivative liabilities pursuant to ASC 815 (see Note 8). 2021 Public Offering In connection with the Company's public offering of units completed on June 1, 2021, the Company issued pre-funded warrants ("2021 Pre-Funded Warrants") exercisable for 5,066,600 shares of common stock and warrants ("2021 Investor Warrants") exercisable for 6,900,000 shares of common stock. During fiscal year 2021, 1,033,300 of the 2021 Pre-Funded Warrants were exercised for $103 in proceeds, resulting in the issuance of 1,033,300 common shares. During fiscal year 2022, 4,033,300 of the 2021 Pre-Funded Warrants were exercised for $403 in proceeds, resulting in the issuance of 4,033,300 common shares. There were no During fiscal year 2022, 6,000 of the 2021 Investor Warrants were exercised for $18,563 in proceeds, resulting in the issuance of 4,500 shares of common stock. During the three months ended September 30, 2023, there were no 2021 Investor Warrants exercised. During the nine months ended September 30, 2023, 302,150 of the 2021 Investor Warrants were exercised for $934,766 in proceeds, resulting in the issuance of 226,610 shares of common stock. As of September 30, 2023, there are 2021 Investor Warrants outstanding to purchase an aggregate of 6,645,041 shares of common stock. 2022 Registered Direct Offering and Private Placement On September 8, 2022, the Company completed a registered direct offering and concurrent private placement (the "September 2022 Offering"). In connection with this offering, the Company issued to investors warrants (the "2022 Private Placement Warrants") to purchase up to 3,359,684 shares of common stock. The 2022 Private Placement Warrants were immediately exercisable upon issuance. In a concurrent private placement, the Company issued pre-funded warrants (the "2022 Private Pre-Funded Warrants") to purchase up to an aggregate of 1,383,399 shares of common stock. The 2022 Private Pre-Funded Warrants were immediately exercisable. During the three months ended September 30, 2023, there were no 2022 Private Placement Warrants exercised. During the nine months ended September 30, 2023, an aggregate of 1,976,285 of the 2022 Private Placement Warrants were exercised for $4,743,084 in proceeds, resulting in the issuance of 1,976,285 shares of common stock. As of September 30, 2023, there are 1,383,399 of the 2022 Private Placement Warrants outstanding to purchase an aggregate of 1,383,399 shares of common stock. No 2022 Private Pre-Funded Warrants issued during the September 2022 Offering have been exercised as of September 30, 2023. The Company has determined that as the 2022 Private Pre-Funded Warrants and 2022 Private Placement Warrants were issued at fair value in an offering transaction in tandem with shares of equity with no debt funding included in the offering, the 2022 Private Pre-Funded Warrants and 2022 Private Placement Warrants should be classified as equity. The fair value of the 2022 Private Placement Warrants and 2022 Private Pre-Funded Warrants was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., Company share price of $2.20, exercise price of $2.40 for the 2022 Private Placement Warrants and $0.0001 for the 2022 Private Pre-Funded Warrants, term of 5 years, volatility of 111%, risk-free rate of 3.4%, and expected dividend rate of 0%) The Company evaluated the 2022 Private Placement Warrants and the 2022 Private Pre-Funded Warrants in accordance with the guidance at ASC 480, Distinguishing Liabilities from Equity Derivatives and Hedging |
Note 5 - Stock-based Compensati
Note 5 - Stock-based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | 5. STOCK-BASED COMPENSATION Stock-Based Compensation Expense On April 25, 2023, the Compensation Committee of the Company's Board of Directors (the "Compensation Committee") approved the grant of option awards to certain of the Company's officers and employees in accordance with the terms of the Company's 2020 Equity Incentive Plan ("2020 Plan"). The Compensation Committee's approval included options granted to purchase a total of 1,303,000 shares of common stock to the Company's executive officers and other employees of the Company. All of the options were granted pursuant to the 2020 Plan and have an exercise price of $6.74 per share, based on the closing price of the common stock on the grant date in accordance with the terms of the 2020 Plan. The options granted to the named executive officers and Vice President for Program & Portfolio Management were immediately vested as to 50% of the shares subject thereto on the grant date, and will vest as to an additional 1.389% of the shares subject thereto on the last day of each month thereafter and have a ten-year three four In August 2023, the Compensation Committee approved the grant of option awards to new employees in accordance with the terms of the Company's 2020 Plan. The Compensation Committee's approval included options granted to purchase a total of 260,000 shares of common stock to the new employees. All of the options were granted pursuant to the 2020 Plan and have an exercise price of $4.13 per share, based on the closing price of the common stock on the grant date in accordance with the terms of the 2020 Plan. The options will vest 25% upon the one-year anniversary of the Awardee's start date with the Company, and will vest as to an additional 2.0833% of the shares subject thereto on the last day of each month thereafter, provided that the Awardee remains employed by the Company on each such vesting date. The Company records stock-based compensation expense in connection with the amortization of the fair value of stock options granted to employees, non-employee consultants and non-employee directors. During the three months ended September 30, 2023 and 2022, the Company recorded stock-based compensation of $350,410 and $40,587 respectively. During the nine months ended September 30, 2023 and 2022, the Company recorded stock-based compensation of $3,022,756 and $120,149 respectively. As of September 30, 2023, the Company had unrecognized stock-based compensation expense of $4,204,281, which is expected to be recognized over a weighted-average period of 3.0 years. As of September 30, 2023, there are 0 and 1,037,063 shares of common stock available for issuance under the 2006 Equity Incentive Plan and the 2020 Plan, respectively. The 2006 Equity Incentive Plan is the Company’s prior equity incentive plan, under which no new grants of awards are permitted as of 2016. Determining Fair Value Valuation and Recognition – The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model. The Black-Scholes pricing model utilizes the following assumptions: Expected Term – Expected life of an option award is the average length of time over which the Company expects employees will exercise their options, which is based on historical experience with similar grants. Expected Volatility - Expected volatility is based on the Company’s historical stock volatility data over the expected term of the awards. Risk-Free Interest Rate - The Company bases the risk-free interest rate on the implied yield currently available on U.S. Treasury zero-coupon issues with an equivalent expected term. Dividend Yield – The Company has not paid a dividend and does not anticipate paying a dividend in the foreseeable future. The value of option grants is calculated using the Black-Scholes option pricing model with the following assumptions for options granted during the nine months ended September 30, 2023: September 30, 2023 Risk-free interest rate 3.43% Expected term (in years) 5.37 - 6.05 Expected volatility 86.45% - 88.56% Expected dividend yield 0% Activity under the stock plans for the nine months ended September 30, 2023, is as follows: Shares Available for Grant Number of Options Outstanding Weighted Average Exercise price per share Weighted Average Remaining Contractual Term in Years Aggregate Intrinsic Value Balance, December 31, 2022 2,600,063 244,774 $ 6.32 8.62 $ — Granted (1,563,000 ) 1,563,000 $ 6.30 Expired — (120,000 ) $ 4.80 Balance, September 30, 2023 1,037,063 1,687,774 $ 6.41 9.38 $ 314,468 Options exercisable at September 30, 2023 622,027 $ 6.92 9.10 $ 114,901 The options granted had a $4.60 weighted average grant date fair value during the nine months ended September 30, 2023. |
Note 6 - Short-term Debt
Note 6 - Short-term Debt | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Short-Term Debt [Text Block] | 6. SHORT-TERM DEBT Insurance Funding The Company obtained financing for certain Director & Officer liability insurance policy premiums. The governing agreement assigns the Lender a first priority lien on and security interest in the financed policies and any additional premium required in the financed policies. The total premiums, taxes and fees financed is $667,500 with an annual interest rate of 8.735%. In consideration of the premium payment by the Lender to the insurance companies or the agent or broker, the Company unconditionally promises to pay the Lender the amount financed plus interest and other charges permitted under the governing agreement. As of September 30, 2023, the Company has repaid $445,000 towards the short-term debt and has recorded at such date the remaining insurance financing debt payable balance of $222,500, as short-term debt, on its unaudited condensed consolidated balance sheet. The Company has paid the remaining insurance financing through the last quarterly installment payment on October 3, 2023 (see note 9). |
Note 7 - Commitments and Contin
Note 7 - Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | 7. COMMITMENTS AND CONTINGENCIES Clinical trials Since 2010, the Company has entered into multiple clinical trial agreements with medical institutions in the United States, Europe and Asia for the purpose of enrolling patients into various clinical trials. The agreements are substantially similar by trial and include a detailed listing of the clinical trial services for which the Company will pay, the amount to be paid for each service, a set-up charge (if any), Investigational Review Board fees, contractual term, and other provisions. The clinical trial services provided by each site generally include the screening of prospective patients and, for those patients to be enrolled in the study, administration of the Company’s investigation drug according to the trial protocol, any required hospitalization, ancillary medical supplies, and 2-week patient follow-up. Further, each agreement requires the Company to indemnify each respective clinical site against any and all liability, loss, or damage it may suffer as a result of third-party claims; the Company maintains product liability insurance of not less than $10 million in conjunction with this indemnification. The agreements may be terminated upon 30 days’ written notice, subject to conditions of paying all liabilities incurred through the date of termination. Additionally, with each screened patient, the Company incurs expense with other entities engaged to provide independent review of patient medical records. As part of the Company's agreement with one of its clinical research organizations, the Company is required to maintain a 7% upfront float for fees related to expenses incurred in clinical studies. When the float has depleted to 15% (i.e. 85% of the float has been used) the Company will receive an invoice to replenish the float up to 7% of the remaining estimated budget for the studies. During the three months ended September 30, 2023, the Company did not make any additional payments to replenish the float and expensed approximately $0.7 million. During the nine months ended September 30, 2023, the Company paid approximately $0.9 million to replenish the float and expensed approximately $1.0 million. As of September 30, 2023, the Company has no Indemnification From time to time, in its normal course of business, the Company may indemnify other parties, with whom it enters into contractual relationships, including lessors and parties to other transactions with the Company. The Company may agree to hold other parties harmless against specific losses, such as those that could arise from a breach of representation, covenant or third-party infringement claims. It may not be possible to determine the maximum potential amount of liability under such indemnification obligations due to the unique facts and circumstances that are likely to be involved in each particular claim and indemnification provision. Historically, there have been no such indemnification claims. The Company has also indemnified its directors and executive officers, to the extent legally permissible, against all liabilities reasonably incurred in connection with any action in which such individual may be involved by reason of such individual being or having been a director or executive officer. |
Note 8 - Fair Value Measurement
Note 8 - Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | 8. FAIR VALUE MEASUREMENTS Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value: • Level 1 — Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. • Level 2 — Directly or indirectly observable inputs as of the reporting date through correlation with market data, including quoted prices for similar assets and liabilities in active markets and quoted prices in markets that are not active. Level 2 also includes assets and liabilities that are valued using models or other pricing methodologies that do not require significant judgment since the input assumptions used in the models, such as interest rates and volatility factors, are corroborated by readily observable data from actively quoted markets for substantially the full term of the financial instrument. • Level 3 — Unobservable inputs that are supported by little or no market activity and reflect the use of significant management judgment. These values are generally determined using pricing models for which the assumptions utilize management’s estimates of market participant assumptions. The determination of where assets and liabilities fall within this hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The following is a listing of the Company’s warrant liabilities required to be measured at fair value on a recurring basis and where they are classified within the fair value hierarchy as of September 30, 2023 and December 31, 2022: September 30, 2023 Level 1 Level 2 Level 3 Total (unaudited) Liabilities: Warrant liability — — $ 873,411 $ 873,411 Total $ — $ — $ 873,411 $ 873,411 December 31, 2022 Level 1 Level 2 Level 3 Total Liabilities: Warrant liability $ — $ — $ 567,439 $ 567,439 Total $ — $ — $ 567,439 $ 567,439 The following table summarizes the changes in the fair value of the warrant liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (unaudited) (unaudited) Balance, beginning of period $ 1,012,490 105,699 567,439 $ 372,730 Change in fair value of warrant liability (139,079 ) — 305,972 (267,031 ) Balance, end of period $ 873,411 $ 105,699 $ 873,411 $ 105,699 The Company classified the private warrants pursuant to ASC 815 as derivative liabilities, as the warrants have terms which are modified upon any future transfer of ownership, with subsequent changes in their fair values to be recognized in the consolidated financial statements at each reporting date. The Company calculated the fair value of the private warrants as of September 30, 2023 as $873,411 using a Black-Scholes model. The key inputs used in the Black-Scholes calculation were the risk-free interest rate, expected volatility, expected life, exercise price and stock price. The risk-free interest rate was estimated to be 4.98%, the expected volatility was estimated to be 91.80%, and the expected life was estimated to be 2.21 years. The exercise price was $11.50, and the stock price $4.88. The Company recorded a gain on remeasurement of warrant liabilities of $139,079 for the three months ended September 30, 2023. There was no gain or loss on remeasurement of warrant liabilities for the three months ended September 30, 2022. The Company recorded a loss on remeasurement of warrant liabilities of $305,972 and a gain of $267,031 for the nine months ended September 30, 2023 and 2022, respectively. |
Note 9 - Subsequent Events
Note 9 - Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | 9. SUBSEQUENT EVENTS In connection with the financing obtained for certain Director & Officer liability insurance policy premiums, the Company has recorded a debt payable balance of $222,500, as short-term debt as of September 30, 2023. The remaining balance was paid on October 3, 2023. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X. Certain footnotes and other financial information normally required by accounting principles generally accepted in the United States of America, or GAAP, have been condensed or omitted in accordance with such rules and regulations. In management’s opinion, these unaudited condensed consolidated financial statements have been prepared on the same basis as our annual consolidated financial statements and notes thereto and include all adjustments, consisting of normal recurring items, considered necessary for the fair presentation. The operating results for the three and nine months ended September 30, 2023, are not necessarily indicative of the results that may be expected for the full year ending December 31, 2023. The unaudited condensed consolidated balance sheet as of December 31, 2022, has been derived from our audited financial statements at that date but does not include all disclosures and financial information required by GAAP for complete financial statements. The information included in the quarterly report on Form 10-Q should be read in conjunction with our consolidated financial statements and notes thereto for the year ended December 31, 2022, which were included in our annual report on Form 10-K, as filed with the Securities and Exchange Commission on March 30, 2023. |
Going Concern [Policy Text Block] | Liquidity and Going Concern The Company has incurred losses since inception and as of September 30, 2023, the Company had working capital deficit of approximately $7.6 million, an accumulated deficit of $120.7 million and cash and cash equivalents on hand of approximately $5.0 million. The Company’s net loss for the three months ended September 30, 2023 and 2022, was approximately $10.5 million and $3.5 million, respectively. The Company's net loss for the nine months ended September 30, 2023 and 2022, was approximately $29.5 million and $16.2 million, respectively. The Company expects to incur significant expenses and increased operating losses for the next several years. The Company expects its expenses to increase in connection with its ongoing activities to research, develop and commercialize its product candidates. The Company will need to generate significant revenues to achieve profitability, and it may never do so. The Company’s current cash on hand is not sufficient to satisfy its operating cash needs for the 12 months from the filing of this Quarterly Report on Form 10-Q. The Company believes that it has adequate cash on hand to cover anticipated outlays well into the fourth quarter of 2023, but will need additional fundraising activities and cash on hand during the fourth quarter of fiscal year 2023 for working capital requirements for fiscal year 2024. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued. Management’s plan to alleviate the conditions that raise substantial doubt include raising additional working capital through public or private equity or debt financings or other sources, which may include collaborations with third parties as well as disciplined cash spending. Adequate additional financing may not be available to the Company on acceptable terms, or at all. Should the Company be unable to raise sufficient additional capital, the Company may be required to undertake cost-cutting measures including delaying or discontinuing certain clinical activities. These factors among others create a substantial doubt about the Company’s ability to continue as a going concern. |
Use of Estimates, Policy [Policy Text Block] | Use of estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of expenses during the reporting periods covered by the financial statements and accompanying notes. Significant areas requiring the use of management estimates include, but are not limited to, depreciation and amortization, useful lives, assumptions used to calculate the fair value of stock-based compensation, deferred taxes, and related valuation allowances. Actual results could differ materially from such estimates under different assumptions or circumstances. |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of credit risk and other risks and uncertainties Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. Currently, substantially all the Company’s cash and cash equivalents are held in demand deposit form at two financial institutions. Deposits in financial institutions may, from time to time, exceed federally insured limits. The Company has not experienced any losses on its deposits of cash. The Company is subject to all of the risks inherent in an early-stage company developing new pharmaceutical products. These risks include, but are not limited to, limited management resources, dependence upon medical acceptance of products in development, regulatory approvals, successful clinical trials, availability and willingness of patients to participate in human trials, and competition in the pharmaceutical industry. The Company’s operating results may be materially affected by the foregoing factors. |
Note 3 - Loss Per Share (Tables
Note 3 - Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Shares issuable upon exercise of stock options 1,687,774 179,627 1,687,774 179,627 Shares issuable upon exercise of warrants to purchase common stock 15,030,209 17,237,604 15,030,209 17,237,604 Shares contingently issuable for earnout 1,000,000 1,000,000 1,000,000 1,000,000 17,717,983 18,417,231 17,717,983 18,417,231 |
Note 5 - Stock-based Compensa_2
Note 5 - Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | September 30, 2023 Risk-free interest rate 3.43% Expected term (in years) 5.37 - 6.05 Expected volatility 86.45% - 88.56% Expected dividend yield 0% |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Shares Available for Grant Number of Options Outstanding Weighted Average Exercise price per share Weighted Average Remaining Contractual Term in Years Aggregate Intrinsic Value Balance, December 31, 2022 2,600,063 244,774 $ 6.32 8.62 $ — Granted (1,563,000 ) 1,563,000 $ 6.30 Expired — (120,000 ) $ 4.80 Balance, September 30, 2023 1,037,063 1,687,774 $ 6.41 9.38 $ 314,468 Options exercisable at September 30, 2023 622,027 $ 6.92 9.10 $ 114,901 |
Note 8 - Fair Value Measureme_2
Note 8 - Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Notes Tables | |
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | September 30, 2023 Level 1 Level 2 Level 3 Total (unaudited) Liabilities: Warrant liability — — $ 873,411 $ 873,411 Total $ — $ — $ 873,411 $ 873,411 December 31, 2022 Level 1 Level 2 Level 3 Total Liabilities: Warrant liability $ — $ — $ 567,439 $ 567,439 Total $ — $ — $ 567,439 $ 567,439 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (unaudited) (unaudited) Balance, beginning of period $ 1,012,490 105,699 567,439 $ 372,730 Change in fair value of warrant liability (139,079 ) — 305,972 (267,031 ) Balance, end of period $ 873,411 $ 105,699 $ 873,411 $ 105,699 |
Note 2 - Summary of Significa_2
Note 2 - Summary of Significant Accounting Policies and Basis of Presentation (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Working Capital | $ (7,600,000) | $ (7,600,000) | |||
Retained Earnings (Accumulated Deficit), Total | 120,707,695 | 120,707,695 | $ 91,171,261 | ||
Cash | 5,000,000 | 5,000,000 | |||
Net Income (Loss) Attributable to Parent, Total | (10,491,029) | $ (3,515,308) | (29,536,434) | $ (16,221,020) | |
Net Income (Loss) Attributable to Parent | $ 10,491,029 | $ 3,515,308 | $ 29,536,434 | $ 16,221,020 |
Note 3 - Loss Per Share - Antid
Note 3 - Loss Per Share - Antidilutive Securities (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive securities (in shares) | 17,717,983 | 18,417,231 | 17,717,983 | 18,417,231 |
Share-Based Payment Arrangement, Option [Member] | ||||
Antidilutive securities (in shares) | 1,687,774 | 179,627 | 1,687,774 | 179,627 |
Warrant [Member] | ||||
Antidilutive securities (in shares) | 15,030,209 | 17,237,604 | 15,030,209 | 17,237,604 |
Earn-out Shares [Member] | ||||
Antidilutive securities (in shares) | 1,000,000 | 1,000,000 | 1,000,000 | 1,000,000 |
Note 4 - Warrants (Details Text
Note 4 - Warrants (Details Textual) | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) shares | Dec. 31, 2021 USD ($) shares | Sep. 08, 2022 USD ($) $ / shares shares | Jun. 01, 2021 shares | Dec. 31, 2020 USD ($) shares | |
Proceeds from Warrant Exercises | $ | $ 5,677,850 | $ 403 | |||||
Share Price | $ / shares | $ 2.20 | ||||||
Public Warrants [Member] | |||||||
Class of Warrant or Right, Outstanding | 6,325,000 | ||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 1 | 6,325,000 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 11.50 | ||||||
Class of Warrant or Right, Redemption Price Per Share | $ / shares | 0.01 | ||||||
Threshold Closing Price for Specified Number of Trading Days | $ / shares | $ 21 | ||||||
Threshold Trading Days for Sale of Shares (Day) | 20 days | ||||||
Threshold Consecutive Trading Days for Sale of Shares (Day) | 30 days | ||||||
Private Warrants [Member] | |||||||
Class of Warrant or Right, Outstanding | 1,939,712 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 11.50 | ||||||
Share Price | $ / shares | $ 4.88 | ||||||
Private Warrants [Member] | Measurement Input, Price Volatility [Member] | |||||||
Warrants and Rights Outstanding, Measurement Input | 0.9180 | ||||||
Private Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||||
Warrants and Rights Outstanding, Measurement Input | 0.0498 | ||||||
Investor Warrant [Member] | |||||||
Class of Warrant or Right, Outstanding | 6,645,041 | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 6,900,000 | ||||||
Class of Warrant or Right, Exercised During Period (in shares) | 302,150 | 6,000 | |||||
Proceeds from Warrant Exercises | $ | $ 934,766 | $ 18,563 | |||||
Stock Issued During Period, Shares, Warrants Exercised (in shares) | 226,610 | 4,500 | |||||
Private Pre-funded Warrant [Member] | |||||||
Class of Warrant or Right, Outstanding | 1,383,399 | ||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 1,383,399 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.0001 | ||||||
Assumed Warrants [Member] | |||||||
Class of Warrant or Right, Outstanding | 120,456 | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 126,268 | ||||||
Class of Warrant or Right, Expired During Period | 5,812 | ||||||
Warrants and Rights Outstanding | $ | $ 1,279,182 | ||||||
Private Placement Warrants [Member] | |||||||
Class of Warrant or Right, Outstanding | 1,383,399 | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,383,399 | 3,359,684 | 556,313 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 2.40 | ||||||
Class of Warrant or Right, Exercised During Period (in shares) | 1,976,285 | ||||||
Proceeds from Warrant Exercises | $ | $ 4,743,084 | ||||||
Stock Issued During Period, Shares, Warrants Exercised (in shares) | 1,976,285 | ||||||
Pre-Funded Warrant [Member] | |||||||
Class of Warrant or Right, Outstanding | 0 | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 5,066,600 | ||||||
Class of Warrant or Right, Exercised During Period (in shares) | 4,033,300 | 1,033,300 | |||||
Proceeds from Warrant Exercises | $ | $ 403 | $ 103 | |||||
Stock Issued During Period, Shares, Warrants Exercised (in shares) | 4,033,300 | 1,033,300 | |||||
Private Placement Warrants and Private Pre-funded Warrants [Member] | |||||||
Warrants and Rights Outstanding | $ | $ 5,712,592 | ||||||
Warrants and Rights Outstanding, Term | 5 years | ||||||
Private Placement Warrants and Private Pre-funded Warrants [Member] | Measurement Input, Price Volatility [Member] | |||||||
Warrants and Rights Outstanding, Measurement Input | 1.11 | ||||||
Private Placement Warrants and Private Pre-funded Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||||
Warrants and Rights Outstanding, Measurement Input | 0.034 | ||||||
Private Placement Warrants and Private Pre-funded Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] | |||||||
Warrants and Rights Outstanding, Measurement Input | 0 |
Note 5 - Stock-based Compensa_3
Note 5 - Stock-based Compensation (Details Textual) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Apr. 25, 2023 | Aug. 31, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross | 1,303,000 | 260,000 | ||||
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 6.74 | $ 4.13 | ||||
Share-Based Payment Arrangement, Expense | $ 350,410 | $ 40,587 | $ 3,022,756 | $ 120,149 | ||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 4,204,281 | $ 4,204,281 | ||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 3 years | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 4.60 | |||||
Equity Incentive Plan 2006 [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized | 0 | 0 | ||||
Equity Incentive Plan 2020 [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized | 1,037,063 | 1,037,063 | ||||
Vest at the End of Each Month [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights, Percentage | 2.0833% | |||||
Vesting at the One Year Anniversary [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights, Percentage | 25% | |||||
Share-Based Payment Arrangement, Option [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross | 1,563,000 | |||||
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ 6.30 | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period | 10 years | |||||
Share-Based Payment Arrangement, Option [Member] | Minimum [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period | 3 years | |||||
Share-Based Payment Arrangement, Option [Member] | Maximum [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period | 4 years | |||||
Share-Based Payment Arrangement, Option [Member] | Vesting Immediately [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights, Percentage | 50% | |||||
Share-Based Payment Arrangement, Option [Member] | Vest at the End of Each Month [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights, Percentage | 1.389% |
Note 5 - Stock-based Compensa_4
Note 5 - Stock-based Compensation - Schedule of Valuation Assumptions (Details) | 9 Months Ended |
Sep. 30, 2023 | |
Risk-free interest rate | 3.43% |
Expected dividend yield | 0% |
Minimum [Member] | |
Expected term (in years) (Year) | 5 years 4 months 13 days |
Expected volatility | 86.45% |
Maximum [Member] | |
Expected term (in years) (Year) | 6 years 18 days |
Expected volatility | 88.56% |
Note 5 - Stock-based Compensa_5
Note 5 - Stock-based Compensation - Stock Option Activity (Details) - USD ($) | 1 Months Ended | 9 Months Ended | 12 Months Ended | |
Apr. 25, 2023 | Aug. 31, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | |
Granted, number of options outstanding (in shares) | 1,303,000 | 260,000 | ||
Granted, weighted average exercise price (in dollars per share) | $ 6.74 | $ 4.13 | ||
Expired, options (in shares) | (120,000) | |||
Expired, weighted average exercise price (in dollars per share) | $ 4.80 | |||
Share-Based Payment Arrangement, Option [Member] | ||||
Balance, shares available for grant (in shares) | 2,600,063 | |||
Balance, option outstanding (in shares) | 244,774 | |||
Balance, weighted average exercise price (in dollars per share) | $ 6.32 | |||
Balance, weighted average remaining contractual term (Year) | 9 years 4 months 17 days | 8 years 7 months 13 days | ||
Balance, aggregate intrinsic value | $ 314,468 | $ 0 | ||
Granted (in shares) | (1,563,000) | |||
Granted, number of options outstanding (in shares) | 1,563,000 | |||
Granted, weighted average exercise price (in dollars per share) | $ 6.30 | |||
Balance, shares available for grant (in shares) | 1,037,063 | |||
Balance, option outstanding (in shares) | 1,687,774 | |||
Balance, weighted average exercise price (in dollars per share) | $ 6.41 | |||
Options exercisable (in shares) | 622,027 | |||
Options exercisable, weighted average exercise price (in dollars per share) | $ 6.92 | |||
Options exercisable, weighted average remaining contractual term (Year) | 9 years 1 month 6 days | |||
Options exercisable, aggregate intrinsic value | $ 114,901 |
Note 6 - Short-term Debt (Detai
Note 6 - Short-term Debt (Details Textual) - USD ($) | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Repayments of Short-Term Debt | $ 445,000 | $ 0 | |
Short-Term Debt | 222,500 | $ 0 | |
Financing for Liability Insurance Policy Premiums [Member] | |||
Debt Instrument, Face Amount | $ 667,500 | ||
Debt Instrument, Interest Rate, Stated Percentage | 8.735% | ||
Repayments of Short-Term Debt | $ 445,000 | ||
Short-Term Debt | $ 222,500 |
Note 7 - Commitments and Cont_2
Note 7 - Commitments and Contingencies (Details Textual) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 USD ($) | Sep. 30, 2023 USD ($) | |
Agreement With One of Clinical Research Organizations [Member] | ||
Agreement, Required Upfront Float for Fees, Percentage | 7% | 7% |
Agreement, Upfront Float, Percentage Left to Receive Invoice to Replenish | 15% | 15% |
Agreement, Upfront Float, Percentage Used to Receive Invoice to Replenish | 85% | 85% |
Prepaid Float Expense | $ 700 | $ 1,000 |
Payments for Upfront Float | 900 | |
Prepaid Float | 0 | 0 |
Minimum [Member] | ||
General Product Liability Insurance | $ 10,000 | $ 10,000 |
Note 8 - Fair Value Measureme_3
Note 8 - Fair Value Measurements (Details Textual) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 USD ($) $ / shares | Sep. 30, 2023 USD ($) $ / shares | Sep. 30, 2022 USD ($) | Sep. 08, 2022 $ / shares | |
Share Price | $ / shares | $ 2.20 | |||
Change in fair value of warrant liabilities | $ 305,972 | $ (267,031) | ||
Fair Value Adjustment of Warrants | (305,972) | 267,031 | ||
Fair Value Adjustment of Warrants | 305,972 | (267,031) | ||
Private Warrants [Member] | ||||
Warrants and Rights Outstanding, Fair Value | $ 873,411 | $ 873,411 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 11.50 | $ 11.50 | ||
Share Price | $ / shares | $ 4.88 | $ 4.88 | ||
Change in fair value of warrant liabilities | $ 139,079 | $ (305,972) | 267,031 | |
Fair Value Adjustment of Warrants | (139,079) | 305,972 | (267,031) | |
Fair Value Adjustment of Warrants | $ 139,079 | $ (305,972) | $ 267,031 | |
Private Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||||
Warrants and Rights Outstanding, Measurement Input | 0.0498 | 0.0498 | ||
Private Warrants [Member] | Measurement Input, Price Volatility [Member] | ||||
Warrants and Rights Outstanding, Measurement Input | 0.9180 | 0.9180 | ||
Private Warrants [Member] | Measurement Input, Expected Term [Member] | ||||
Warrants and Rights Outstanding, Measurement Input | 2.21 | 2.21 |
Note 8 - Fair Value Measureme_4
Note 8 - Fair Value Measurements - Fair Value on Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Warrant liability | $ 873,411 | $ 567,439 |
Total | 873,411 | 567,439 |
Fair Value, Inputs, Level 1 [Member] | ||
Warrant liability | 0 | |
Total | 0 | |
Fair Value, Inputs, Level 2 [Member] | ||
Warrant liability | 0 | |
Total | 0 | |
Fair Value, Inputs, Level 3 [Member] | ||
Warrant liability | 873,411 | 567,439 |
Total | $ 873,411 | $ 567,439 |
Note 8 - Fair Value Measureme_5
Note 8 - Fair Value Measurements - Fair Value on Recurring Basis Unobservable Input Reconciliation (Details) - Fair Value, Recurring [Member] - Fair Value, Inputs, Level 3 [Member] - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Balance, beginning of period | $ 1,012,490 | $ 105,699 | $ 567,439 | $ 372,730 |
Change in fair value of warrant liability | 139,079 | 0 | (305,972) | 267,031 |
Balance, end of period | $ 873,411 | $ 105,699 | $ 873,411 | $ 105,699 |
Note 9 - Subsequent Events (Det
Note 9 - Subsequent Events (Details Textual) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Short-Term Debt | $ 222,500 | $ 0 |