Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 10, 2023 | Jun. 30, 2022 | |
Document and Entity Information [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 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, $0.0001 Par Value per Share | ||
Trading Symbol | VIRI | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
Entity Shell Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Public Float | $ 31,229,227.08 | ||
Entity Common Stock, Shares Outstanding | 18,330,390 | ||
Entity Central Index Key | 0001818844 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Auditor Name | FORVIS, LLP (Formerly, Dixon Hughes Goodman LLP) | ||
Auditor Firm ID | 686 | ||
Auditor Location | Atlanta, Georgia |
BALANCE SHEETS
BALANCE SHEETS - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash | $ 7,030,992 | $ 14,008,184 |
Prepaid expenses and other current assets | 1,338,764 | 1,768,503 |
Total current assets | 8,369,756 | 15,776,687 |
Total assets | 8,369,756 | 15,776,687 |
Current liabilities: | ||
Accounts payable | 573,164 | 353,863 |
Accrued expenses | 470,098 | 921,760 |
Total current liabilities | 1,043,262 | 1,275,623 |
Total liabilities | 1,043,262 | 1,275,623 |
Commitments and contingencies (Note 8) | ||
Stockholders' equity: | ||
Common stock, $0.0001 par value; 43,000,000 shares authorized, 18,330,390 and 8,330,390 shares issued and outstanding at December 31, 2022 and 2021, respectively | 1,833 | 833 |
Preferred stock, $0.0001 par value; 2,000,000 shares authorized, no shares issued and outstanding at December 31, 2022 and 2021 | ||
Additional paid-in capital | 63,497,868 | 58,425,604 |
Accumulated deficit | (56,173,207) | (43,925,373) |
Total stockholders' equity | 7,326,494 | 14,501,064 |
Total liabilities and stockholders' equity | $ 8,369,756 | $ 15,776,687 |
BALANCE SHEETS (Parentheticals)
BALANCE SHEETS (Parentheticals) - $ / shares | Dec. 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) | 18,330,390 | 8,330,390 |
Common stock outstanding (in shares) | 18,330,390 | 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 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Condensed Statements of Operations | ||
Revenue | ||
Operating expenses: | ||
Research and development | 8,069,628 | 10,795,688 |
General and administrative expenses | 4,245,681 | 4,845,252 |
Total operating expenses | 12,315,309 | 15,640,940 |
Loss from operations | (12,315,309) | (15,640,940) |
Other income (expense): | ||
Interest income | 67,475 | 5,672 |
Other expense | (325,000) | |
Total other income (expense) | 67,475 | (319,328) |
Loss before income taxes | (12,247,834) | (15,960,268) |
Net loss | $ (12,247,834) | $ (15,960,268) |
Basic net loss per share | $ (1.11) | $ (1.92) |
Diluted net loss per share | $ (1.11) | $ (1.92) |
Weighted average number of shares outstanding - basic | 11,070,116 | 8,329,310 |
Weighted average number of shares outstanding - diluted | 11,070,116 | 8,329,310 |
STATEMENTS OF STOCKHOLDERS EQUI
STATEMENTS OF STOCKHOLDERS 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 | 322,881 | 322,881 | ||
Exercise of warrants | $ 3 | 197,559 | 197,562 | |
Exercise of warrants (in shares) | 25,315 | |||
Net loss | (15,960,268) | (15,960,268) | ||
Balances, Ending at Dec. 31, 2021 | $ 833 | 58,425,604 | (43,925,373) | 14,501,064 |
Balances, Ending (in shares) at Dec. 31, 2021 | 8,330,390 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Issuance of common shares in public offering, net of costs | $ 1,000 | 4,489,605 | 4,490,605 | |
Issuance of common shares in public offering, net of costs (shares) | 10,000,000 | |||
Share-based compensation expense | 582,659 | 582,659 | ||
Net loss | (12,247,834) | (12,247,834) | ||
Balances, Ending at Dec. 31, 2022 | $ 1,833 | $ 63,497,868 | $ (56,173,207) | $ 7,326,494 |
Balances, Ending (in shares) at Dec. 31, 2022 | 18,330,390 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (12,247,834) | $ (15,960,268) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based and equity compensation expense | 582,659 | 322,881 |
Changes in operating assets and liabilities: | ||
Decrease (increase) in prepaid expenses and other current assets | 429,739 | (91,138) |
Increase in accounts payable | 219,301 | 270,007 |
(Decrease) increase in accrued expenses | (451,662) | 147,773 |
Decrease in accrued salaries | (378,833) | |
Net cash used in operating activities | (11,467,797) | (15,689,578) |
Cash flows from financing activities | ||
Proceeds from initial public offering, net of costs | 4,490,605 | (295,166) |
Proceeds from the exercise of warrants | 197,562 | |
Net cash provided by (used in) financing activities | 4,490,605 | (97,604) |
Net decrease in cash | (6,977,192) | (15,787,182) |
Cash, beginning of period | 14,008,184 | 29,795,366 |
Cash, end of period | $ 7,030,992 | $ 14,008,184 |
Background and Organization
Background and Organization | 12 Months Ended |
Dec. 31, 2022 | |
Background and Organization | |
Background and Organization | 1. Background and Organization 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 combination 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 back 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. Public Offering On September 19, 2022, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with ThinkEquity LLC (the “Underwriter”) in connection with the issuance and sale by the Company in a public offering of 10,000,000 shares of its common stock at a public offering price of $0.50 per share (the “Offering”), pursuant to an effective shelf registration statement on Form S-3 (File No. 333-263700). The Offering closed on September 22, 2022 and the gross proceeds from the Offering were $5,000,000 . The net proceeds of the Offering were approximately $4,490,605 after deducting underwriting discounts, commissions and offering expenses payable by the Company. In conjunction with the Offering, the Company granted to the Underwriter 500,000 warrants to purchase shares of the Company’s common stock at an exercise price of $0.625 per share, which was 125% of the Offering price. Material Uncertainty Since its founding, the Company has been engaged in research and development activities as well as organizational activities, including raising capital. The Company has not generated any revenues to date. As such, the Company is subject to all of the risks associated with any development-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 has funded its losses primarily through issuance of members’ interests, convertible debt instruments and issuance of equity securities. For the years ended December 31, 2022 and 2021, the Company incurred net losses of $12,247,834 and $15,960,268, respectively, and had net cash flows used in operating activities of $11,467,797 and $15,689,578, respectively. As of December 31, 2022, the Company had an accumulated deficit of $56,173,207. As of the date these financial statements are issued, based on reasonable estimates, current cash is sufficient to fund operating expenses and obligations for at least 12 months. Currently, there are no planned research and development activities for 2023 other than minimal carryover costs associated with completing the final reports for the Company’s FORTRESS, (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1), study for the treatment of FM and the chronic toxicology program, regulatory consulting to prepare for the meeting with the FDA, the on-going grant to the Bateman Horne Center for the fully funded investigator-sponsored study in Long-COVID and the purchase of active pharmaceutical ingredients to support the start of a potential Phase 3 program for IMC-1. Our research and development expenses in 2022 primarily related to our FORTRESS study for IMC-1, the Company’s lead candidate, which was completed in August 2022 and two long-term animal toxicology studies; a 26-week study in rats, which was completed in the first quarter of 2022 and a 39-week study in dogs, which was completed in the second quarter of 2022. Overall, the study for IMC-1, did not achieve statistical significance on the prespecified primary efficacy endpoint of change from baseline to Week 14 in the weekly average of daily self-reported average pain severity scores comparing IMC-1 to placebo (p=0.302). However, management observed a differential response based on the timing of patient enrollment and believe it is highly unlikely due to chance or a random occurrence, thus further analysis of the data was warranted, particularly in the context of the previous IMC-1 Phase 2a study success. Based on the analysis of the data, management believes focusing the forward development of IMC-1 on new fibromyalgia patients remains a viable and manageable path forward. The Company is scheduled to meet with the FDA in March 2023 to discuss the most appropriate next steps in advancing IMC-1 development as a treatment for FM and hopefully agree on a Phase 3 program. If alignment can be reached, management will consider raising additional capital to fund future research and/or seek a partner to develop or co-develop IMC-1 as a treatment for FM. The Company will need to raise additional capital within the next 13 to 18 months to complete clinical development of and to commercially develop its product candidates. There is no assurance that such financing will be available when needed or on acceptable terms. The financial statements do not include any adjustments to reflect this uncertainty. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”). 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 Update (“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. Concentrations of Credit Risk Cash is potentially subject to concentrations of credit risk. The Company believes it is not exposed to significant credit risk due to the financial strength of the depository institutions in which the cash is held. Fair Value Measurements ASC Topic 820, Fair Value Measurement The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes: ● Level 1 — Quoted prices in active markets for identical assets or liabilities. ● Level 2 — Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace. ● Level 3 — Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. The carrying amount of the Company’s financial instruments, including cash, accounts payable and accrued expenses approximate their fair values. Cash Cash is maintained in bank deposit accounts, which exceed the federally insured limits of $250,000. The Company does not have any cash equivalents. Variable Interest Entities When determining whether a legal entity should be consolidated, the Company first determines whether it has a variable interest in the legal entity. If a variable interest exists, the Company determines whether the legal entity is a variable interest entity (“VIE”) due to either: 1) a lack of sufficient equity to finance its activities, 2) its equity holders lacking the characteristics of a controlling financial interest, or 3) the legal entity being structured with non-substantive voting rights. If the Company concludes that the legal entity is a VIE, the Company next determines whether it is the primary beneficiary due to it possessing both: 1) the power to direct the activities of a VIE that most significantly impact the VIE’s economic performance, and 2) the obligation to absorb losses of the VIE that potentially could be significant to the VIE or the right to receive benefits from the VIE which could be significant to the VIE. If the Company concludes that it is the primary beneficiary, it consolidates the entity. Equity Method Investment In 2017, the Company purchased a 25% ownership in Northriver Pharm, LLC (“NRP”) in the amount of $125,000 from existing investors of NRP. NRP is an entity with common ownership with the Company’s former Chief Executive Officer and Founder, who is also the Founder and sole voting member of NRP. The Company evaluated the ownership under VIE guidance and has determined that the Company does not have the power and economics to control the entity and are not the entity most closely associated with NRP. The Company previously accounted for the investment under the equity method of accounting. However, consistent with equity method accounting guidance, the Company has now discontinued applying the equity method accounting as the investment has been reduced to zero and the Company has not committed to provide further financial support and there is no expected return to profitable operations by NRP. Income Taxes The Company provides for income taxes using the asset and liability approach. Deferred tax assets and liabilities are recorded based on the differences between the financial statement and tax bases of assets and liabilities and the tax rates in effect when these differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company operated as an Alabama limited liability company until its Corporate Conversion. Therefore, the Company passed through all income and losses to its members until this point. As of December 31, 2022 and 2021, the Company had a full valuation allowance against deferred tax assets. The Company is subject to the provisions of ASC 740, Income Taxes Basic and Diluted Net Income (Loss) per Share Basic net loss per common share (“EPS”) is computed in accordance with U.S. GAAP. Basic 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 years ended December 31, 2022 and 2021, the Company had 1,924,397 and 1,041,647 options, respectively, and 672,500 and 172,500 warrants, respectively, to purchase common shares outstanding that were anti-dilutive. Research and Development Research and development costs are expensed as incurred. The Company arranges and contracts with third-party contract research organizations (“CROs”), contract development and manufacturing organizations (“CMOs”), contractor laboratories and independent consultants. As part of the process of preparing its financial statements, the Company may be required to estimate some of its expenses resulting from its obligations under these arrangements and contracts. The financial terms of these contracts are subject to negotiations which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided. The Company’s objective is to reflect the appropriate expenses in its financial statements by matching those expenses with the period in which services are rendered. The Company determines any accrual estimates based on account discussions with applicable personnel and outside service providers as to the progress or state of completion. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known at that time. The Company’s estimates are dependent upon the timely and accurate reporting of CROs, CMOs and other third-party vendors. At the end of each reporting period, the Company compares the payments made to each service provider to the estimated progress towards completion of the related project. Factors that the Company considers in preparing these estimates include the number of patients enrolled in studies, milestones achieved, and other criteria related to the efforts of its vendors. These estimates will be subject to change as additional information becomes available. Depending on the timing of payments to vendors and estimated services provided, the Company will record prepaid or accrued expenses related to these costs. Share-Based Compensation The Company recognizes compensation expense relating to share-based awards to employees and directors with a performance condition over the requisite service period if it is probable that the performance condition will be satisfied. For awards to non-employees, the Company recognizes compensation expense in the same manner as if the Company had paid cash for the goods or services. The Company estimates the fair value of options and warrants granted using an options pricing model, see Note 9. Expense is recognized within both research and development and general and administrative expenses and forfeitures are recognized as they are incurred. 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 is (i) no longer an emerging growth company or (ii) affirmatively and irrevocably opt 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 In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 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: December 31, December 31, 2022 2021 Prepaid insurance $ 1,165,634 $ 1,329,385 Prepaid clinical research costs 154,510 422,591 Prepaid services 11,329 15,664 Other miscellaneous current assets 7,291 863 $ 1,338,764 $ 1,768,503 |
License Agreement
License Agreement | 12 Months Ended |
Dec. 31, 2022 | |
License Agreement | |
License Agreement | 4. License Agreement 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 May 1, 2020 Second Amended and Restated Operating Agreement, the non-voting membership interest converted to a voting membership interest. Upon the Corporate Conversion, voting membership interest was 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 | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Expenses | |
Accrued Expenses | 5. Accrued Expenses Accrued expenses consist of the following: December 31, December 31, 2022 2021 Accrued compensation $ 159,704 $ 532,678 Accrued interest on preferred members’ interests 188,085 188,085 Accrued clinical research costs 78,349 138,522 Accrued director fees 31,000 31,000 Accrued professional fees 11,600 24,100 Other miscellaneous accrued expenses 1,360 7,375 $ 470,098 $ 921,760 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity | |
Stockholders' Equity | 6. Stockholders’ Equity The Company’s certificate of incorporation adopted on December 16, 2020, authorizes the issuance of two classes of stock to be designated, respectively, “Common Stock” and “Preferred Stock”. The total number of shares which the Company is authorized to issue is 45,000,000, each with a par value Common Stock Dividends Subject to the rights of holders of all classes of Company stock outstanding having rights that are senior to or equivalent to holders of the Common Stock are entitled to receive dividends when and as declared by the Board. Liquidation Subject to the rights of holders of all classes of stock outstanding having rights that are senior to or equivalent to the holders of Common Stock as to liquidation, upon liquidation, dissolution or winding up of the Company, the assets of the Company will be distributed to the holders of the Common Stock. Voting The holders of the Common Stock are entitled to one vote for each share of Common Stock held. There is no cumulative voting. Preferred Stock Preferred Stock may be issued from time to time by the Board in one or more series. |
Related Parties
Related Parties | 12 Months Ended |
Dec. 31, 2022 | |
Related Parties | |
Related Parties | 7 The Company uses Gendreau Consulting, LLC, a consulting firm (“Gendreau”), for drug development, clinical trial design, and planning, implementation and execution of contracted activities with CROs. 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 connect with the Company’s ongoing clinical development of product candidates. During the years ended December 31, 2022 and 2021, the Company paid Gendreau $356,088 and $326,416, respectively, and had accounts payable of $21,000 and $24,840 to Gendreau as of December 31, 2022 and 2021, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies | |
Commitments and Contingencies | 8 Litigation 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. On August 26, 2021, Torreya Capital LLC (“Torreya”) filed a demand for arbitration with the American Arbitration Association in New York, New York in connection with a claim by Torreya that it is entitled to a transaction fee of $1,035,000 in connection with the Company’s IPO, plus the costs of arbitration, based on services Torreya alleged it provided for the Company as a financial advisor to the Company prior to the IPO. On December 20, 2021, in order to avoid the risk, inconvenience and expense of a continued dispute, the Company entered into a release and settlement agreement with Torreya, whereby the Company agreed to pay Torreya Employment Agreement and Deferred Compensation Plan The Company has employment agreements with its CEO, SVP of Operations, and SVP of Finance (the “Executives”), as well as its CMO. Per the terms of the agreements, each Executive and the CMO are entitled to receive a cash bonus with a target amount of no less than 50% for the CEO, 35% for the CMO and 20% for the SVP of Operations and the SVP of Finance, of the then-current base salary. The bonuses are subject to achievement of annual bonus metrics set by the Board. The employment agreements will continue in effect until terminated by either party pursuant to its terms. Upon termination of the agreement by the Company for any reason other than for cause, death or disability or by one of the Executives or CMO for good reason, the Company shall pay to an Executive a “Severance Payment” equal to the aggregate of the Executive’s then-current annual base salary plus an amount equal to a prorated portion of the Executive’s cash bonus for the year in which the termination occurs. The Severance Payment to an Executive is payable in cash over a period of one year . The Company shall pay to the CMO a Severance Payment equal to 25% of the then-current annual base salary plus a prorated portion of the CMO’s cash bonus for the year in which the termination occurs over a period of three months and health benefits for a period of 12 months unless the CMO becomes eligible for health benefits under another employer. If the termination of the agreement is related to a change of control, the Company shall pay to the Executives and the CMO a “Change of Control Termination Payment” equal to the aggregate of 1.0 times the then-current annual base salary plus an amount equal to 1.0 times the Executives’ and CMO’s cash bonus for year in which the termination occurs. The Change of Control Termination Payments are payable in a single cash lump sum no later than 45 days after the triggering event. |
Share-based compensation
Share-based compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-based compensation | |
Share-based compensation | 9. Share-Based Compensation Equity Incentive Plan On June 16, 2022, the stockholders of the Company approved the Amended and Restated 2020 Equity Incentive Plan (the “Plan”) to increase the total number of shares of common stock reserved for issuance under the Plan by 1,250,000 shares to 2,062,500 total shares issuable under the Plan. As of December 31, 2022 and 2021, 430,603 and 63,353 shares, respectively, were available for future grants. The Plan provides for grants to employees, members of the Board, consultants and advisors to the Company, in the form of stock awards, options, and other equity-based awards. The amount and terms of grants are determined by the Board. Stock options have a maximum term of 10 years 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, 2020 519,163 $ 10.00 9.98 Granted 229,984 6.85 — Outstanding at December 31, 2021 749,147 $ 9.03 9.09 Granted 912,500 1.42 — Forfeited (29,750) 4.97 — Outstanding at December 31, 2022 1,631,897 $ 4.85 9.04 Exercisable at December 31, 2022 665,326 $ 9.30 8.06 As of December 31, 2022 and 2021, the aggregate intrinsic value of options outstanding and exercisable was $0. During the year ended December 31, 2022, the Company granted certain individuals options to purchase 912,500 shares of the Company’s common stock with an average exercise price of $1.42 per share, contractual terms of 10 years and vesting periods ranging from 100% vesting after one year to 33.333% vesting after one year with the remaining 66.667% vesting in 24 monthly installments, thereafter. The options had an aggregate grant date fair value of $980,075 as calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option pricing model include: (1) discount rates ranging from 3.145% to 3.765% based on the daily yield curve rates for U.S. Treasury obligations, (2) expected lives ranging from 5.5 years to 6.0 years based on the simplified method (vesting plus contractual term divided by two), (3) expected volatility ranging from 90.62% to 93.66% based on the average historical volatility of comparable companies' stock, (4) no expected dividends and (5) fair market value of the Company's stock ranging from $0.2789 to $4.23 per share. During the year ended December 31, 2021, the Company granted certain individuals options to purchase 229,984 shares of the Company’s common stock with an average exercise price of $6.85 per share, contractual terms of 10 years and vesting periods ranging from 8.33% monthly over one year to 33.333% vesting after one year with the remaining 66.667% vesting in 24 monthly installments, thereafter. The options had an aggregate grant date fair value of $1,150,284 as calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option pricing model include: (1) discount rates ranging from 0.505% to 1.075% based on the daily yield curve rates for U.S. Treasury obligations, (2) expected lives ranging from 5.27 years to 6.0 years based on the simplified method (vesting plus contractual term divided by two), (3) expected volatility ranging from 89.04% to 90.16% based on the average historical volatility of comparable companies' stock, (4) no expected dividends and (5) fair market value of the Company's stock ranging from $6.50 to $7.51 per share. For the years ended December 31, 2022 and 2021, the Company recognized share-based compensation expense related to stock options of $582,659 and $322,881, respectively. The unrecognized compensation expense for stock options at December 31, 2022 and 2021 was $1,114,073 and $827,402, respectively. Stock Options for Unregistered Securities In addition to the stock options issued under the Plan, on December 16, 2020, the Company granted non-qualified stock options to purchase 292,500 shares of common stock as provided for in the employment agreement of the Company’s President at the time of and in conjunction with the Company’s IPO (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 7.96 years. As of December 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 December 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 have a five-year In conjunction with the Offering in September 2022, the Company granted the Underwriter warrants to purchase 500,000 shares of common stock at an exercise price of $0.625 per share. The warrants have a five-year contractual term and are not exercisable prior to March 18, 2023. The Company has accounted for the warrants as equity-based awards issued to a non-employee. The warrants had an aggregate grant date fair value of $178,462 that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option pricing model include: (1) discount rate of 3.69% based on the daily yield curve rates for U.S. Treasury obligations, (2) expected life of 5.0 years, (3) expected volatility of 96.46% based on the average historical volatility of comparable companies' stock, (4) no expected dividends and (5) fair market value (Offering price) of the Company's stock of $0.50 per share. There was no net impact recognized by the Company in the accompanying financial statements as the warrants were equity-based awards issued for services rendered by the Underwriter for the Offering that was offset by the Company recognizing the fair value of the warrants as a direct and incremental costs associated with the Offering by reducing paid-in capital for the same amount. There is no unrecognized compensation expense for these awards as of December 31, 2022. The table below sets forth the outstanding warrants to purchase common shares: Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (Years) Outstanding at December 31, 2020 172,500 $ 12.50 4.96 Granted — — — Outstanding at December 31, 2021 172,500 $ 12.50 3.96 Granted 500,000 0.63 — Outstanding at December 31, 2022 672,500 $ 3.67 4.27 Exercisable at December 31, 2022 172,500 $ 12.50 2.96 As of December 31, 2022, the aggregate intrinsic value of the warrants outstanding was $0. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes | |
Income Taxes | 10. Income Taxes As of December 31, 2022, the Company has U.S. federal and state net operating loss carryforwards of approximately $22,168,000, which have an indefinite carryforward. A reconciliation of the U.S. federal income tax rate to the Company’s effective tax rate is as follows: Year Ended December 31, 2022 2021 U.S. federal statutory income tax rate 21.00 % 21.00 % Permanent differences (0.57) % (0.33) % State taxes, net of federal benefit 4.83 % 4.47 % Deferred tax true-ups — % (1.82) % Other adjustments 0.06 % 0.15 % Change in valuation allowance (25.32) % (23.47) % Effective Income Tax rate — % — % Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes. The significant components of the Company’s deferred tax assets are comprised of the following: As of December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 5,692,533 $ 4,586,488 Capitalized research and development expenditures 1,873,211 — Stock compensation 1,411,624 1,338,234 Investment in partnership 30,771 30,593 Amortization 15,223 16,299 Gross deferred tax assets 9,023,362 5,971,614 Valuation allowance (8,682,497) (5,581,599) Net deferred tax assets 340,865 390,015 Deferred tax liabilities: Prepaid expenses (340,865) (390,015) Deferred tax liabilities (340,865) (390,015) Net deferred taxes $ — $ — For tax years beginning on or after January 1, 2022, the 2017 Tax Cuts and Jobs Act amended Section 174 of the code to eliminate current-year deductibility of research and development expenses and requires taxpayers to capitalize and amortize them over five years for research activities performed in the United States and fifteen years for research activities performed outside of the United States. For the 2022 tax year, the Company has capitalized $8,099,702 of research and development expenses. This has resulted in an increase in the deferred tax asset associated with capitalized research and development by As of December 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 year ended December 31, 2022. The Company does not have any material unrecognized tax benefits as of December 31, 2022. The Company experienced a net change in valuation allowance of $3,100,898 and $3,745,299 for the years ended December 31, 2022 and 2021, respectively. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”). 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 Update (“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. |
Concentrations of Credit Risk | Concentrations of Credit Risk Cash is potentially subject to concentrations of credit risk. The Company believes it is not exposed to significant credit risk due to the financial strength of the depository institutions in which the cash is held. |
Fair Value Measurements | Fair Value Measurements ASC Topic 820, Fair Value Measurement The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes: ● Level 1 — Quoted prices in active markets for identical assets or liabilities. ● Level 2 — Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace. ● Level 3 — Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. The carrying amount of the Company’s financial instruments, including cash, accounts payable and accrued expenses approximate their fair values. |
Cash | Cash Cash is maintained in bank deposit accounts, which exceed the federally insured limits of $250,000. The Company does not have any cash equivalents. |
Variable Interest Entities | Variable Interest Entities When determining whether a legal entity should be consolidated, the Company first determines whether it has a variable interest in the legal entity. If a variable interest exists, the Company determines whether the legal entity is a variable interest entity (“VIE”) due to either: 1) a lack of sufficient equity to finance its activities, 2) its equity holders lacking the characteristics of a controlling financial interest, or 3) the legal entity being structured with non-substantive voting rights. If the Company concludes that the legal entity is a VIE, the Company next determines whether it is the primary beneficiary due to it possessing both: 1) the power to direct the activities of a VIE that most significantly impact the VIE’s economic performance, and 2) the obligation to absorb losses of the VIE that potentially could be significant to the VIE or the right to receive benefits from the VIE which could be significant to the VIE. If the Company concludes that it is the primary beneficiary, it consolidates the entity. |
Equity Method Investment | Equity Method Investment In 2017, the Company purchased a 25% ownership in Northriver Pharm, LLC (“NRP”) in the amount of $125,000 from existing investors of NRP. NRP is an entity with common ownership with the Company’s former Chief Executive Officer and Founder, who is also the Founder and sole voting member of NRP. The Company evaluated the ownership under VIE guidance and has determined that the Company does not have the power and economics to control the entity and are not the entity most closely associated with NRP. The Company previously accounted for the investment under the equity method of accounting. However, consistent with equity method accounting guidance, the Company has now discontinued applying the equity method accounting as the investment has been reduced to zero and the Company has not committed to provide further financial support and there is no expected return to profitable operations by NRP. |
Income Taxes | The Company provides for income taxes using the asset and liability approach. Deferred tax assets and liabilities are recorded based on the differences between the financial statement and tax bases of assets and liabilities and the tax rates in effect when these differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company operated as an Alabama limited liability company until its Corporate Conversion. Therefore, the Company passed through all income and losses to its members until this point. As of December 31, 2022 and 2021, the Company had a full valuation allowance against deferred tax assets. The Company is subject to the provisions of ASC 740, Income Taxes |
Basic and Diluted Net Income (Loss) per Share | Basic and Diluted Net Income (Loss) per Share Basic net loss per common share (“EPS”) is computed in accordance with U.S. GAAP. Basic 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 years ended December 31, 2022 and 2021, the Company had 1,924,397 and 1,041,647 options, respectively, and 672,500 and 172,500 warrants, respectively, to purchase common shares outstanding that were anti-dilutive. |
Research and Development | Research and Development Research and development costs are expensed as incurred. The Company arranges and contracts with third-party contract research organizations (“CROs”), contract development and manufacturing organizations (“CMOs”), contractor laboratories and independent consultants. As part of the process of preparing its financial statements, the Company may be required to estimate some of its expenses resulting from its obligations under these arrangements and contracts. The financial terms of these contracts are subject to negotiations which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided. The Company’s objective is to reflect the appropriate expenses in its financial statements by matching those expenses with the period in which services are rendered. The Company determines any accrual estimates based on account discussions with applicable personnel and outside service providers as to the progress or state of completion. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known at that time. The Company’s estimates are dependent upon the timely and accurate reporting of CROs, CMOs and other third-party vendors. At the end of each reporting period, the Company compares the payments made to each service provider to the estimated progress towards completion of the related project. Factors that the Company considers in preparing these estimates include the number of patients enrolled in studies, milestones achieved, and other criteria related to the efforts of its vendors. These estimates will be subject to change as additional information becomes available. Depending on the timing of payments to vendors and estimated services provided, the Company will record prepaid or accrued expenses related to these costs. |
Share-Based Compensation | Share-Based Compensation The Company recognizes compensation expense relating to share-based awards to employees and directors with a performance condition over the requisite service period if it is probable that the performance condition will be satisfied. For awards to non-employees, the Company recognizes compensation expense in the same manner as if the Company had paid cash for the goods or services. The Company estimates the fair value of options and warrants granted using an options pricing model, see Note 9. Expense is recognized within both research and development and general and administrative expenses and forfeitures are recognized as they are incurred. |
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 is (i) no longer an emerging growth company or (ii) affirmatively and irrevocably opt 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 In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Prepaid Expenses and Other Current Assets | |
Schedule of prepaid expenses and other current assets | December 31, December 31, 2022 2021 Prepaid insurance $ 1,165,634 $ 1,329,385 Prepaid clinical research costs 154,510 422,591 Prepaid services 11,329 15,664 Other miscellaneous current assets 7,291 863 $ 1,338,764 $ 1,768,503 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Expenses | |
Schedule of accrued expenses | December 31, December 31, 2022 2021 Accrued compensation $ 159,704 $ 532,678 Accrued interest on preferred members’ interests 188,085 188,085 Accrued clinical research costs 78,349 138,522 Accrued director fees 31,000 31,000 Accrued professional fees 11,600 24,100 Other miscellaneous accrued expenses 1,360 7,375 $ 470,098 $ 921,760 |
Share-based compensation (Table
Share-based compensation (Tables) | 12 Months Ended |
Dec. 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, 2020 519,163 $ 10.00 9.98 Granted 229,984 6.85 — Outstanding at December 31, 2021 749,147 $ 9.03 9.09 Granted 912,500 1.42 — Forfeited (29,750) 4.97 — Outstanding at December 31, 2022 1,631,897 $ 4.85 9.04 Exercisable at December 31, 2022 665,326 $ 9.30 8.06 |
Schedule of underwriters warrants to purchase common shares | Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (Years) Outstanding at December 31, 2020 172,500 $ 12.50 4.96 Granted — — — Outstanding at December 31, 2021 172,500 $ 12.50 3.96 Granted 500,000 0.63 — Outstanding at December 31, 2022 672,500 $ 3.67 4.27 Exercisable at December 31, 2022 172,500 $ 12.50 2.96 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes | |
Schedule of reconciliation of federal income tax rate to effective tax rate | Year Ended December 31, 2022 2021 U.S. federal statutory income tax rate 21.00 % 21.00 % Permanent differences (0.57) % (0.33) % State taxes, net of federal benefit 4.83 % 4.47 % Deferred tax true-ups — % (1.82) % Other adjustments 0.06 % 0.15 % Change in valuation allowance (25.32) % (23.47) % Effective Income Tax rate — % — % |
Schedule of net deferred tax assets | As of December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 5,692,533 $ 4,586,488 Capitalized research and development expenditures 1,873,211 — Stock compensation 1,411,624 1,338,234 Investment in partnership 30,771 30,593 Amortization 15,223 16,299 Gross deferred tax assets 9,023,362 5,971,614 Valuation allowance (8,682,497) (5,581,599) Net deferred tax assets 340,865 390,015 Deferred tax liabilities: Prepaid expenses (340,865) (390,015) Deferred tax liabilities (340,865) (390,015) Net deferred taxes $ — $ — |
Background and Organization (De
Background and Organization (Details) - USD ($) | 12 Months Ended | |||
Sep. 19, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 21, 2021 | |
Subsidiary, Sale of Stock [Line Items] | ||||
Share price | $ 0.50 | |||
Gross proceeds | $ 5,000,000 | |||
Net proceeds | $ 4,490,605 | |||
Warrants exercise price percentage of IPO Price | 125% | |||
Warrants to purchase shares | 500,000 | 172,500 | ||
Warrants exercise price | $ 0.625 | $ 12.50 | ||
Net loss | $ 12,247,834 | $ 15,960,268 | ||
Net cash used in operating activities | 11,467,797 | 15,689,578 | ||
Accumulated deficit | $ 56,173,207 | $ 43,925,373 | ||
Minimum | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Period in which the company has to raise additional capital to complete clinical development | 13 months | |||
Maximum | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Period in which the company has to raise additional capital to complete clinical development | 18 months | |||
IPO | Maximum | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Shares issued | 10,000,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Cash (Details) | Dec. 31, 2022 USD ($) |
Summary of Significant Accounting Policies | |
Federally insured limit | $ 250,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Equity Method Investment (Details) - NRP | Dec. 31, 2017 USD ($) |
Accounting Policies [Line Items] | |
Ownership percentage | 25% |
Equity method investment | $ 125,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Basic and Diluted Net Loss Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 1,924,397 | 1,041,647 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 672,500 | 172,500 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid Expenses and Other Current Assets | ||
Prepaid insurance | $ 1,165,634 | $ 1,329,385 |
Prepaid clinical research costs | 154,510 | 422,591 |
Prepaid services | 11,329 | 15,664 |
Other miscellaneous current assets | 7,291 | 863 |
Total prepaid expenses and other current assets | $ 1,338,764 | $ 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% |
License agreement expiration period | 25 years |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued Expenses | ||
Accrued compensation | $ 159,704 | $ 532,678 |
Accrued interest on preferred members' interests | 188,085 | 188,085 |
Accrued clinical research costs | 78,349 | 138,522 |
Accrued director fees | 31,000 | 31,000 |
Accrued professional fees | 11,600 | 24,100 |
Other miscellaneous accrued expenses | 1,360 | 7,375 |
Accrued expenses | $ 470,098 | $ 921,760 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | 12 Months Ended | ||
Dec. 31, 2022 item $ / shares shares | Dec. 31, 2021 $ / shares shares | Dec. 16, 2020 $ / shares shares | |
Stockholders' Equity | |||
Common and preferred stock authorized (in shares) | 45,000,000 | ||
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) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Number of votes per common stock | item | 1 |
Related Parties (Details)
Related Parties (Details) - Gendreau Consulting, LLC - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Related Party Transaction [Line Items] | ||
Amount paid to the firm | $ 356,088 | $ 326,416 |
Accounts payable | $ 21,000 | $ 24,840 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | 12 Months Ended | |||
Dec. 20, 2021 | Aug. 26, 2021 | Sep. 10, 2020 | Dec. 31, 2022 | |
Commitments and Contingencies | ||||
Severance payment period | 1 year | |||
Period of termination due to change of control. | 45 days | |||
CEO | ||||
Commitments and Contingencies | ||||
Percentage of cash bonus on salary | 50% | |||
VP of Operations and Finance | ||||
Commitments and Contingencies | ||||
Percentage of cash bonus on salary | 20% | |||
CMO | ||||
Commitments and Contingencies | ||||
Percentage of then current annual base salary. | 25% | |||
Threshold termination period | 3 months | |||
Employment agreement, health benefit offered period on termination | 12 months | |||
Ratio of current annual base salary | 1 | |||
Ratio of cash bonus | 1 | |||
Minimum | CMO | ||||
Commitments and Contingencies | ||||
Percentage of cash bonus on salary | 35% | |||
Torreya Capital LLC | ||||
Commitments and Contingencies | ||||
Transaction fee | $ 1,035,000 | |||
Other (expense) income | $ 325,000 |
Share-based compensation - Equi
Share-based compensation - Equity Incentive Plan (Details) - Plan - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Number of Shares | |||
Outstanding at the beginning of the period | 749,147 | 519,163 | |
Granted | 912,500 | 229,984 | |
Forfeited | (29,750) | ||
Outstanding at the end of the period | 1,631,897 | 749,147 | 519,163 |
Exercisable at December 31, 2022 | 665,326 | ||
Weighted Average Exercise Price | |||
Outstanding the beginning of the period | $ 9.03 | $ 10 | |
Granted | 1.42 | 6.85 | |
Forfeited | 4.97 | ||
Outstanding at the end of the period | 4.85 | $ 9.03 | $ 10 |
Exercisable at December 31, 2022 | $ 9.30 | ||
Weighted Average Remaining Contractual Term (years) | |||
Weighted average remaining contractual term (years) | 9 years 14 days | 9 years 1 month 2 days | 9 years 11 months 23 days |
Exercisable at December 31, 2022 | 8 years 21 days |
Share-based compensation - Narr
Share-based compensation - Narrative (Details) - USD ($) | 12 Months Ended | |||
Sep. 19, 2022 | Jun. 16, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Aggregate grant date fair value | $ 178,462 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||||
Discount rates | 3.69% | |||
Expected life | 5 years | |||
Expected volatility | 96.46% | |||
Expected dividends | $ 0 | |||
Share price | $ 0.50 | |||
Unrecognized compensation expense | $ 0 | |||
Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of additional shares authorized | 1,250,000 | |||
Shares authorized | 2,062,500 | |||
Shares available for future grant | 430,603 | 63,353 | ||
Options term | 10 years | |||
Vesting period | 10 years | 10 years | ||
Aggregate grant date fair value | $ 980,075 | $ 1,150,284 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||||
Expected dividends | 0 | 0 | ||
Intrinsic value of options outstanding | $ 0 | $ 0 | ||
Plan | Employee Director | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Maximum aggregate number of shares | 500,000 | |||
Plan | Non-Employee Director | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Maximum aggregate number of shares | 200,000 | |||
Plan | Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||||
Discount rates | 3.145% | 0.505% | ||
Expected life | 5 years 6 months | 5 years 3 months 7 days | ||
Expected volatility | 90.62% | 89.04% | ||
Fair market value | $ 0.2789 | $ 6.50 | ||
Plan | Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||||
Discount rates | 3.765% | 1.075% | ||
Expected life | 6 years | 6 years | ||
Expected volatility | 93.66% | 90.16% | ||
Fair market value | $ 4.23 | $ 7.51 | ||
Plan | Vesting over one year | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting percentage | 100% | 8.33% | ||
Plan | Vesting after one year | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting percentage | 33.333% | 33.333% | ||
Plan | Vesting in 24 monthly installments thereafter | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting percentage | 66.667% | 66.667% | ||
Plan | Stock options | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||||
Share-based compensation expense | $ 582,659 | $ 322,881 | ||
Unrecognized compensation expense | $ 1,114,073 | $ 827,402 |
Share-based compensation - Unre
Share-based compensation - Unregistered Securities (Details) - USD ($) | 12 Months Ended | ||||
Sep. 19, 2022 | Jun. 16, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation expense | $ 0 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | |||||
Discount rates | 3.69% | ||||
Expected life | 5 years | ||||
Expected volatility | 96.46% | ||||
Share price | $ 0.50 | ||||
Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Granted | 912,500 | 229,984 | |||
Options term | 10 years | ||||
Exercise price | $ 1.42 | $ 6.85 | |||
Remaining contractual term | 9 years 14 days | 9 years 1 month 2 days | 9 years 11 months 23 days | ||
Intrinsic value of options outstanding | $ 0 | $ 0 | |||
Plan | Non-qualified stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Granted | 292,500 | ||||
Exercise price | $ 10 | ||||
Vesting percentage | 100% | ||||
Remaining contractual term | 7 years 11 months 15 days | ||||
Unrecognized compensation expense | $ 0 | ||||
Term | 10 years | ||||
Intrinsic value of options outstanding | $ 0 |
Share-based compensation - Unde
Share-based compensation - Underwriters Warrants (Details) - USD ($) | 12 Months Ended | ||||
Sep. 19, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 21, 2021 | |
Share-based compensation | |||||
Warrants to purchase shares | 500,000 | 172,500 | |||
Warrants exercise price | $ 0.625 | $ 12.50 | |||
Remaining contractual term | 5 years | 5 years | |||
Aggregate grant date fair value | $ 178,462 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | |||||
Discount rates | 3.69% | ||||
Expected life | 5 years | ||||
Expected volatility | 96.46% | ||||
Expected dividends | $ 0 | ||||
Share price | $ 0.50 | ||||
Unrecognized compensation expense | $ 0 | ||||
Number of Shares | |||||
Warrants outstanding at the beginning of the period | 172,500 | 172,500 | |||
Warrants granted | 500,000 | ||||
Warrants outstanding at the end of the period | 672,500 | 172,500 | 172,500 | ||
Exercisable at December 31, 2022 | 172,500 | ||||
Weighted Average Exercise Price | |||||
Outstanding at the beginning of the period | $ 12.50 | $ 12.50 | |||
Granted | 0.63 | ||||
Outstanding at the end of the period | 3.67 | $ 12.50 | $ 12.50 | ||
Exercisable at December 31, 2022 | $ 12.50 | ||||
Remaining term | 4 years 3 months 7 days | 3 years 11 months 15 days | 4 years 11 months 15 days | ||
Exercisable contractual term | 2 years 11 months 15 days | ||||
Intrinsic value of warrants outstanding | $ 0 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes | ||
Net operating loss carryforwards | $ 22,168,000 | |
Net change in valuation allowance | 3,100,898 | $ 3,745,299 |
Deferred Tax Assets, Capitalized Research and Development Expenses | 1,873,211 | |
Capitalized research and development expenses | $ 8,099,702 |
Income Taxes - Reconciliation (
Income Taxes - Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Reconciliation of federal income tax rate to effective tax rate | ||
U.S. federal statutory income tax rate | 21% | 21% |
Permanent differences | (0.57%) | (0.33%) |
State taxes, net of federal benefit | 4.83% | 4.47% |
Deferred tax true-ups | (1.82%) | |
Other adjustments | 0.06% | 0.15% |
Change in valuation allowance | (25.32%) | (23.47%) |
Effective Income Tax rate | 0% | 0% |
Income Taxes - Net deferred tax
Income Taxes - Net deferred tax assets (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 5,692,533 | $ 4,586,488 |
Capitalized research and development expenditures | 1,873,211 | |
Stock compensation | 1,411,624 | 1,338,234 |
Investment in partnership | 30,771 | 30,593 |
Amortization | 15,223 | 16,299 |
Gross deferred tax assets | 9,023,362 | 5,971,614 |
Valuation allowance | (8,682,497) | (5,581,599) |
Net deferred tax assets | 340,865 | 390,015 |
Deferred tax liabilities: | ||
Prepaid expenses | 340,865 | 390,015 |
Deferred tax liabilities | 340,865 | 390,015 |
Net deferred taxes | $ 0 | $ 0 |