Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | May 12, 2022 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-39811 | |
Entity Registrant Name | Virios Therapeutics, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 85-4314201 | |
Entity Address, Address Line One | 44 Milton Avenue | |
Entity Address, City or Town | Alpharetta | |
Entity Address State Or Province | GA | |
Entity Address, Postal Zip Code | 30009 | |
City Area Code | 866 | |
Local Phone Number | 620-8655 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | VIRI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 8,330,390 | |
Entity Central Index Key | 0001818844 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash | $ 11,352,167 | $ 14,008,184 |
Prepaid expenses and other current assets | 1,197,691 | 1,768,503 |
Total current assets | 12,549,858 | 15,776,687 |
Total assets | 12,549,858 | 15,776,687 |
Current liabilities: | ||
Accounts payable | 330,690 | 353,863 |
Accrued expenses | 1,546,506 | 921,760 |
Total current liabilities | 1,877,196 | 1,275,623 |
Total liabilities | 1,877,196 | 1,275,623 |
Commitments and contingencies (Note 8) | ||
Stockholders' equity: | ||
Common stock, $0.0001 par value; 43,000,000 shares authorized, 8,330,390 shares issued and outstanding at March 31, 2022 and December 31, 2021 | 833 | 833 |
Preferred stock, $0.0001 par value; 2,000,000 shares authorized, no shares issued and outstanding at March 31, 2022 and December 31, 2021 | ||
Additional paid-in capital | 58,557,510 | 58,425,604 |
Accumulated deficit | (47,885,681) | (43,925,373) |
Total stockholders' equity | 10,672,662 | 14,501,064 |
Total liabilities and stockholders' equity | $ 12,549,858 | $ 15,776,687 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parentheticals) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
Condensed Balance Sheets | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock authorized (in shares) | 43,000,000 | 43,000,000 |
Common stock issued (in shares) | 8,330,390 | 8,330,390 |
Common stock outstanding (in shares) | 8,330,390 | 8,330,390 |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock authorized (in shares) | 2,000,000 | 2,000,000 |
Preferred stock issued (in shares) | 0 | 0 |
Preferred stock outstanding (in shares) | 0 | 0 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Operating expenses: | ||
Research and development | $ 2,769,102 | $ 1,706,957 |
General and administrative expenses | 1,192,112 | 1,350,476 |
Total operating expenses | 3,961,214 | 3,057,433 |
Loss from operations | (3,961,214) | (3,057,433) |
Other income: | ||
Interest income | 906 | 1,400 |
Total other income | 906 | 1,400 |
Loss before income taxes | (3,960,308) | (3,056,033) |
Net loss | $ (3,960,308) | $ (3,056,033) |
Basic net loss per share | $ (0.48) | $ (0.37) |
Diluted net loss per share | $ (0.48) | $ (0.37) |
Weighted average number of shares outstanding - basic | 8,330,390 | 8,326,010 |
Weighted average number of shares outstanding - diluted | 8,330,390 | 8,326,010 |
Condensed Statements of Changes
Condensed Statements of Changes of Shareholders' Equity - USD ($) | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balances, Beginning at Dec. 31, 2020 | $ 830 | $ 57,905,164 | $ (27,965,105) | $ 29,940,889 |
Balances, Beginning (in shares) at Dec. 31, 2020 | 8,305,075 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Share-based compensation expense | 24,825 | 24,825 | ||
Exercise of warrants | $ 3 | 197,559 | 197,562 | |
Exercise of warrants (in shares) | 25,315 | |||
Net loss | (3,056,033) | (3,056,033) | ||
Balances, Ending at Mar. 31, 2021 | $ 833 | 58,127,548 | (31,021,138) | 27,107,243 |
Balances, Ending (in shares) at Mar. 31, 2021 | 8,330,390 | |||
Balances, Beginning at Dec. 31, 2021 | $ 833 | 58,425,604 | (43,925,373) | 14,501,064 |
Balances, Beginning (in shares) at Dec. 31, 2021 | 8,330,390 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Share-based compensation expense | 131,906 | 131,906 | ||
Net loss | (3,960,308) | (3,960,308) | ||
Balances, Ending at Mar. 31, 2022 | $ 833 | $ 58,557,510 | $ (47,885,681) | $ 10,672,662 |
Balances, Ending (in shares) at Mar. 31, 2022 | 8,330,390 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (3,960,308) | $ (3,056,033) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation expense | 131,906 | 24,825 |
Changes in operating assets and liabilities: | ||
Decrease (increase) in prepaid expenses and other current assets | 570,812 | (2,011,612) |
(Decrease) increase in accounts payable | (23,173) | 530,803 |
Increase (decrease) in accrued expenses | 624,746 | (221,352) |
Decrease in accrued salaries | (378,833) | |
Net cash used in operating activities | (2,656,017) | (5,112,202) |
Cash flows from financing activities | ||
Proceeds from the exercise of warrants | 197,562 | |
Payment of offering costs for initial public offering | (295,166) | |
Net cash used in financing activities | (97,604) | |
Net decrease in cash | (2,656,017) | (5,209,806) |
Cash, beginning of period | 14,008,184 | 29,795,366 |
Cash, end of period | $ 11,352,167 | $ 24,585,560 |
Organization and Nature of Busi
Organization and Nature of Business | 3 Months Ended |
Mar. 31, 2022 | |
Organization and Nature of Business | |
Organization and Nature of Business | 1 Virios Therapeutics, Inc. (the “Company”) was incorporated under the laws of the State of Delaware on December 16, 2020 through a corporate conversion (the “Corporate Conversion”) just prior to the Company’s initial public offering (“IPO”). The Company was originally formed on February 28, 2012 as a limited liability company (“LLC”) under the laws of the State of Alabama as Innovative Med Concepts, LLC. On July 23, 2020, the Company changed its name from Innovative Med Concepts, LLC to Virios Therapeutics, LLC. The Company operates in one segment as a pre-revenue, development-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response. The Company is developing its initial product candidate, IMC-1, for people who are suffering from fibromyalgia (“FM”). Research has shown that the herpes virus could be a potential root cause of FM. IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib, both of which are drugs approved by the U.S. Food and Drug Administration (“FDA”) for other indications. IMC-1 combines these two specific mechanisms of action purposely designed to inhibit herpes virus activation and replication, thereby converting activated herpes virus from an active state to dormancy and/or by keeping the herpes virus in a latent or dormant state. The famciclovir component of IMC-1 inhibits viral DNA replication, thus inhibiting upregulation of the herpes virus. The celecoxib component of IMC-1 inhibits cyclooxegenase-2 (“COX-2”) enzymes used by the herpes virus to amplify or accelerate its own replication. IMC-1’s synergistic antiviral mechanism represents a first-in-class medicine designed specifically to inhibit both herpes virus activation and subsequent replication, with the goal of keeping tissue resident herpes virus in a latent state. Going Concern Since its founding, the Company has been engaged in organizational activities, including raising capital, and research and development activities. The Company has not generated any revenues to date. As such, the Company is subject to all of the risks associated with any clinical-stage biotechnology company that has substantial expenditures for research and development. Since inception, the Company has incurred losses and negative cash flows from operating activities. The Company does not expect to generate positive cash flows from operating activities in the near future. For the three months ended March 31, 2022 and 2021, the Company incurred net losses of $3,960,308 and $3,056,033, respectively, and had net cash outflows used in operating activities for the three months ended March 31, 2022 and 2021 of $2,656,017 and $5,112,202 , respectively. As of March 31, 2022, the Company had an accumulated deficit of $47,885,681 and is expected to incur losses in the future as it continues its development activities. Since its inception, the Company has funded its losses primarily through issuance of members’ interests, convertible debt instruments and issuance of equity securities. The Company intends on financing its future development activities and its working capital needs largely on the issuance and sale of equity securities. The Company’s cash on hand, together with any additional capital to be raised in 2022, is intended to fund continuing operations. The Company will need to raise additional capital within the next nine to remain a going concern and to further advance clinical development and to commercially develop its product candidates. Failure to secure the necessary financing in a timely manner and on favorable terms could have a material adverse effect on the Company’s strategy and value and could require the delay of product development and clinical trial plans. As a result, substantial doubt exists regarding the Company’s ability to continue as a going concern twelve months from the date the financial statements were available to be issued. The financial statements have been prepared on a going concern basis and do not include any adjustments to the amounts recognized or classifications of assets and liabilities should the Company be unable to continue as a going concern. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2022 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2 Basis of Presentation The accompanying condensed interim financial statements are unaudited. These unaudited financial statements have been prepared in accordance with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all the information and notes required by accounting principles generally accepted in the United States of America (“U.S. GAAP”) for complete financial statements. These unaudited condensed interim financial statements should be read in conjunction with the audited financial statements and accompanying notes as found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC. In the opinion of management, the unaudited condensed interim financial statements reflect all the adjustments (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position, results of operations and cash flows for the interim periods presented. The interim results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The December 31, 2021 balance sheet included herein was derived from the audited financial statements, but does not include all disclosures, including notes, required by U.S. GAAP for complete financial statements. Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). Use of Estimates The preparation of these financial statements and accompanying notes in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. The Company's significant estimates and assumptions include estimated work performed but not yet billed by contract manufacturers, engineers and research organizations, the valuation of equity and stock-based related instruments, and the valuation allowance related to deferred taxes. Some of these judgments can be subjective and complex, and, consequently, actual results could differ from those estimates. Although the Company believes that its estimates and assumptions are reasonable, they are based upon information available at the time the estimates and assumptions were made. Actual results could differ from those estimates. Basic and Diluted Net Loss per Share Basic net loss per common share (“EPS”) is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted EPS reflects potential dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period increased by the number of additional common shares that would have been outstanding if all potential common shares had been issued and were dilutive. However, potentially dilutive securities are excluded from the computation of diluted EPS to the extent that their effect is anti-dilutive. For the three months ended March 31, 2022 and 2021, the Company had options to purchase 1,041,647 and 874,397 shares of common stock, respectively, and warrants to purchase 172,500 shares of common stock outstanding that were anti-dilutive. Emerging Growth Company Status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it is (i) no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided by the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. Recent Accounting Pronouncements In December 2019, the FASB issued ASU 2019-12, Income Taxes (ASC 740): Simplifying the Accounting for Income Taxes |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 31, 2022 | |
Prepaid Expenses and Other Current Assets | |
Prepaid Expenses and Other Current Assets | 3 Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following: March 31, December 31, 2022 2021 Prepaid insurance $ 1,010,707 $ 1,329,385 Prepaid clinical research costs 124,915 422,591 Prepaid services 27,995 15,664 Other miscellaneous current assets 34,074 863 $ 1,197,691 $ 1,768,503 |
License Agreement
License Agreement | 3 Months Ended |
Mar. 31, 2022 | |
License Agreement | |
License Agreement | 4 The Company entered into a Know-How License Agreement (the “Agreement”) with the University of Alabama (“UA”) in 2012. In consideration for the Agreement, UA received a 10% non-voting membership interest in the Company. Upon the adoption of the Second Amended and Restated Operating Agreement the “Amended Operating Agreement”) on May 1, 2020, the non-voting membership interest converted to a voting membership interest. In conjunction with the Corporate Conversion, all of the Company’s outstanding membership interest converted into shares of common stock. The Agreement is in effect for 25 years and will terminate on June 1, 2037. |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2022 | |
Accrued Expenses | |
Accrued Expenses | 5 Accrued expenses consist of the following: March 31, December 31, 2022 2021 Accrued compensation $ 236,851 $ 532,678 Accrued interest on preferred members’ interests 188,085 188,085 Accrued clinical research costs 1,021,220 138,522 Accrued director fees 46,500 31,000 Accrued professional fees 41,350 24,100 Other miscellaneous accrued expenses 12,500 7,375 $ 1,546,506 $ 921,760 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2022 | |
Stockholders' Equity | |
Stockholders' Equity | 6 The Company’s certificate of incorporation, adopted on December 16, 2020, authorizes the issuance of two classes of stock: 43,000,000 shares of common stock and 2,000,000 shares of preferred stock, each with a par value of $0.0001 per share. |
Related Parties
Related Parties | 3 Months Ended |
Mar. 31, 2022 | |
Related Parties | |
Related Parties | 7 The Company uses Gendreau Consulting, LLC, a consulting firm (“Gendreau”), for drug development, clinical trial design, implementation and execution of contracted activities with the clinical research organization. Gendreau’s managing member became the Company’s Chief Medical Officer (“CMO”) effective January 1, 2021. The Company has and will continue to contract the services of the CMO’s spouse through the firm to perform certain activities in connection with the Company’s ongoing clinical trial in FM. During the three months ended March 31, 2022 and 2021, the Company paid Gendreau $85,548 and $64,446, respectively, and had accounts payable of $36,870 and $24,840 to Gendreau as of March 31, 2022 and December 31, 2021, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies | |
Commitments and Contingencies | 8 Litigation and Other The Company is subject, from time to time, to claims by third parties under various legal disputes. The defense of such claims, or any adverse outcome relating to any such claims, could have a material adverse effect on the Company’s liquidity, financial condition and cash flows. Employment Agreement On February 1, 2021, the Company entered into an employment agreement with its Director of Clinical Operations (the “Director”). Per the terms of the agreement, the Director is entitled to receive a cash bonus with a target amount of no less than 20% of the Director’s then-current base salary. The bonus is subject to achievement of annual bonus metrics set by the Board. The employment agreement will continue in effect until terminated by either party pursuant to its terms. If the termination of the agreement is related to a change of control, the Director is entitled to receive a change of control termination payment equal to 50% of the Director’s then-current base salary and 50% of the bonus for the year in which the termination occurs. |
Share-based compensation
Share-based compensation | 3 Months Ended |
Mar. 31, 2022 | |
Share-based compensation | |
Share-based compensation | 9 Equity Incentive Plan The Company’s 2020 Equity Incentive Plan (the “Plan”) became effective on December 21, 2020. As of March 31, 2022, 63,353 shares of common stock were available for future grants under the Plan. The table below sets forth the outstanding options to purchase common shares under the Plan: Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (Years) Outstanding at December 31, 2021 749,147 $ 9.03 9.09 Granted — — — Outstanding at March 31, 2022 749,147 $ 9.03 8.85 Exercisable at March 31, 2022 578,412 $ 9.67 8.76 There were no option issued during the three months ended March 31, 2022. As of March 31, 2022 the aggregate intrinsic value of options outstanding was $0. The Company recognized share-based compensation expense related to stock options of $131,906 and $24,825, during the three months ended March 31, 2022 and 2021, respectively. The unrecognized compensation expense for stock options at March 31, 2022 was $695,496. Stock Options for Unregistered Securities In addition to the stock options issued under the Plan, and in conjunction with the IPO, the Company granted non-qualified stock options to purchase 292,500 shares of common stock as provided for in the President’s employment agreement (the “President Options”). The President Options are exercisable within 10 years of the date of grant at $10.00 per share, were 100% vested at the grant date and have a remaining contractual term of 8.72 years. As of March 31, 2022, there was no unrecognized compensation expense related to these options as they were 100% vested upon issuance. The shares of common stock issuable upon exercise of the President Options will be unregistered, and the option agreement does not include any obligation on the part of the Company to register such shares of common stock. Consequently, the Company has not recognized a contingent liability associated with registering the securities for the arrangement. As of March 31, 2022, the aggregate intrinsic value of the President Options was $0. Underwriters Warrants In conjunction with the IPO, the Company granted the underwriters warrants to purchase 172,500 shares of common stock at an exercise price of $12.50 per share. The warrants became 100% exercisable on December 21, 2021. As of March 31, 2022, the warrants have a remaining contractual term of 3.72 and the aggregate intrinsic value of the warrants outstanding was $0. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2022 | |
Income Taxes | |
Income Taxes | 10 Prior to the Company’s Corporate Conversion, the Company operated as an Alabama limited liability company that passed through income and losses to its members. As a result, the Company was not subject to any U.S. federal or U.S. state income taxes as the related tax consequences are reported by the individual members. Upon the Corporate Conversion, the Company converted to a Delaware corporation and is now subject to filing U.S. federal and various U.S. state income tax returns. As the Company was incorporated in December 2020, all tax years of the Company remain open to examination by tax authorities. As of December 31, 2021, the Company had U.S. federal and state net operating loss carryforwards of approximately $17,956,000, which have an indefinite carryforward. As of March 31, 2022, the Company has not generated sufficient positive evidence for future earnings to support a position that it will be able to realize its net deferred tax asset. The Company has significant negative evidence to overcome in the form of cumulative pre-tax losses from continuing operations since its formation, as well as projected losses for the current year. Therefore, it will continue to maintain a full valuation allowance on its U.S. federal and state net deferred tax asset. The change in the valuation allowance offset the income tax benefit related to the pre-tax loss for the three months ended March 31, 2022. The Company does not have any material unrecognized tax benefits as of March 31, 2022. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying condensed interim financial statements are unaudited. These unaudited financial statements have been prepared in accordance with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all the information and notes required by accounting principles generally accepted in the United States of America (“U.S. GAAP”) for complete financial statements. These unaudited condensed interim financial statements should be read in conjunction with the audited financial statements and accompanying notes as found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC. In the opinion of management, the unaudited condensed interim financial statements reflect all the adjustments (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position, results of operations and cash flows for the interim periods presented. The interim results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The December 31, 2021 balance sheet included herein was derived from the audited financial statements, but does not include all disclosures, including notes, required by U.S. GAAP for complete financial statements. Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Use of Estimates | Use of Estimates The preparation of these financial statements and accompanying notes in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. The Company's significant estimates and assumptions include estimated work performed but not yet billed by contract manufacturers, engineers and research organizations, the valuation of equity and stock-based related instruments, and the valuation allowance related to deferred taxes. Some of these judgments can be subjective and complex, and, consequently, actual results could differ from those estimates. Although the Company believes that its estimates and assumptions are reasonable, they are based upon information available at the time the estimates and assumptions were made. Actual results could differ from those estimates. |
Basic and Diluted Net Loss per Share | Basic and Diluted Net Loss per Share Basic net loss per common share (“EPS”) is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted EPS reflects potential dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period increased by the number of additional common shares that would have been outstanding if all potential common shares had been issued and were dilutive. However, potentially dilutive securities are excluded from the computation of diluted EPS to the extent that their effect is anti-dilutive. For the three months ended March 31, 2022 and 2021, the Company had options to purchase 1,041,647 and 874,397 shares of common stock, respectively, and warrants to purchase 172,500 shares of common stock outstanding that were anti-dilutive. |
Emerging Growth Company Status | Emerging Growth Company Status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it is (i) no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended transition period provided by the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In December 2019, the FASB issued ASU 2019-12, Income Taxes (ASC 740): Simplifying the Accounting for Income Taxes |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Prepaid Expenses and Other Current Assets | |
Schedule of prepaid expenses and other current assets | March 31, December 31, 2022 2021 Prepaid insurance $ 1,010,707 $ 1,329,385 Prepaid clinical research costs 124,915 422,591 Prepaid services 27,995 15,664 Other miscellaneous current assets 34,074 863 $ 1,197,691 $ 1,768,503 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Accrued Expenses | |
Schedule of accrued expenses | March 31, December 31, 2022 2021 Accrued compensation $ 236,851 $ 532,678 Accrued interest on preferred members’ interests 188,085 188,085 Accrued clinical research costs 1,021,220 138,522 Accrued director fees 46,500 31,000 Accrued professional fees 41,350 24,100 Other miscellaneous accrued expenses 12,500 7,375 $ 1,546,506 $ 921,760 |
Share-based compensation (Table
Share-based compensation (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Share-based compensation | |
Schedule of stock options | Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (Years) Outstanding at December 31, 2021 749,147 $ 9.03 9.09 Granted — — — Outstanding at March 31, 2022 749,147 $ 9.03 8.85 Exercisable at March 31, 2022 578,412 $ 9.67 8.76 |
Organization and Nature of Bu_2
Organization and Nature of Business (Details) | 3 Months Ended | ||
Mar. 31, 2022USD ($)segment | Mar. 31, 2021USD ($) | Dec. 31, 2021USD ($) | |
Subsidiary, Sale of Stock [Line Items] | |||
Number of operating segments | segment | 1 | ||
Net loss | $ 3,960,308 | $ 3,056,033 | |
Net cash used in operating activities | 2,656,017 | $ 5,112,202 | |
Accumulated deficit | $ 47,885,681 | $ 43,925,373 | |
Minimum | |||
Subsidiary, Sale of Stock [Line Items] | |||
period in which the company has to raise additional capital to complete clinical development | 9 months | ||
Maximum | |||
Subsidiary, Sale of Stock [Line Items] | |||
period in which the company has to raise additional capital to complete clinical development | 12 months |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Basic and Diluted Net Loss Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 1,041,647 | 874,397 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 172,500 | 172,500 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Prepaid Expenses and Other Current Assets | ||
Prepaid insurance | $ 1,010,707 | $ 1,329,385 |
Prepaid clinical research costs | 124,915 | 422,591 |
Prepaid services | 27,995 | 15,664 |
Other miscellaneous current assets | 34,074 | 863 |
Total prepaid expenses and other assets | $ 1,197,691 | $ 1,768,503 |
License Agreement (Details)
License Agreement (Details) - Agreement | 12 Months Ended |
Dec. 31, 2012 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Percentage of non-voting membership interest | 10.00% |
License agreement expiration period | 25 years |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Accrued Expenses | ||
Accrued compensation | $ 236,851 | $ 532,678 |
Accrued interest on preferred members' interests | 188,085 | 188,085 |
Accrued clinical research costs | 1,021,220 | 138,522 |
Accrued director fees | 46,500 | 31,000 |
Accrued professional fees | 41,350 | 24,100 |
Other miscellaneous accrued expenses | 12,500 | 7,375 |
Accrued expenses | $ 1,546,506 | $ 921,760 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 | Dec. 16, 2020 |
Stockholders' Equity | |||
Common stock authorized (in shares) | 43,000,000 | 43,000,000 | 43,000,000 |
Preferred stock authorized (in shares) | 2,000,000 | 2,000,000 | 2,000,000 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Related Parties (Details)
Related Parties (Details) - Gendreau Consulting, LLC - USD ($) | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Related Party Transaction [Line Items] | |||
Amount paid to the firm | $ 85,548 | $ 64,446 | |
Accounts payable | $ 36,870 | $ 24,840 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - Director | Feb. 01, 2021 |
Commitments and Contingencies | |
Percentage of cash bonus on salary | 20.00% |
Percentage of current base annual salary | 50.00% |
Percentage of cash bonus on termination | 50.00% |
Share-based compensation - Equi
Share-based compensation - Equity Incentive Plan (Details) - Plan - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Number of Shares | ||
Outstanding at the beginning of the period | 749,147 | |
Granted | 0 | |
Outstanding at the end of the period | 749,147 | 749,147 |
Exercisable at December 31, 2021 | 578,412 | |
Weighted Average Exercise Price | ||
Outstanding the beginning of the period | $ 9.03 | |
Outstanding at the end of the period | 9.03 | $ 9.03 |
Exercisable at December 31, 2021 | $ 9.67 | |
Weighted Average Remaining Contractual Term (years) | ||
Weighted average remaining contractual term (years) | 8 years 10 months 6 days | 9 years 1 month 2 days |
Exercisable at December 31, 2021 | 8 years 9 months 3 days | |
Intrinsic value of options outstanding | $ 0 |
Share-based compensation - Narr
Share-based compensation - Narrative (Details) - Plan - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares available for future grant | 63,353 | |
Granted | 0 | |
Stock options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expense | $ 695,496 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Abstract] | ||
Share-based compensation expense | $ 131,906 | $ 24,825 |
Share-based compensation - Unre
Share-based compensation - Unregistered Securities (Details) - Plan - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Granted | 0 | |
Remaining contractual term | 8 years 10 months 6 days | 9 years 1 month 2 days |
Intrinsic value of options outstanding | $ 0 | |
Non-qualified stock options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Granted | 292,500 | |
Term | 10 years | |
Exercise price | $ 10 | |
Vesting percentage | 100.00% | |
Remaining contractual term | 8 years 8 months 19 days | |
Unrecognized compensation expense | $ 0 | |
Intrinsic value of options exercisable | $ 0 |
Share-based compensation - Unde
Share-based compensation - Underwriters Warrants (Details) | 3 Months Ended |
Mar. 31, 2022USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Warrants to purchase shares | shares | 172,500 |
Warrants exercise price | $ / shares | $ 12.50 |
Aggregate intrinsic value of the warrants outstanding | $ | $ 0 |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | |
Percentage of warrants exercisable | 100.00% |
Warrants | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Remaining contractual term | 3 years 8 months 19 days |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | |
Remaining contractual term | 3 years 8 months 19 days |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | Mar. 31, 2022 | Dec. 31, 2021 |
Income Taxes | ||
Net operating loss carryforwards | $ 17,956,000 | |
Unrecognized tax benefits | $ 0 |