Dogwood Therapeutics (DWTX) 10-Q 14 Nov 22 2022 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2022	Nov. 11, 2022
Document and Entity Information [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 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		18,330,390
Entity Central Index Key	0001818844
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q3
Amendment Flag	false

Condensed Balance Sheets

Condensed Balance Sheets - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Current assets:
Cash	$ 9,788,397	$ 14,008,184
Prepaid expenses and other current assets	1,069,580	1,768,503
Total current assets	10,857,977	15,776,687
Total assets	10,857,977	15,776,687
Current liabilities:
Accounts payable	679,416	353,863
Accrued expenses	953,726	921,760
Total current liabilities	1,633,142	1,275,623
Total liabilities	1,633,142	1,275,623
Commitments and contingencies (Note 8)
Stockholders' equity:
Common stock, $0.0001 par value; 43,000,000 shares authorized, 18,330,390 shares issued and outstanding at September 30, 2022 and 8,330,390 shares issued and outstanding at December 31, 2021	1,833	833
Preferred stock, $0.0001 par value; 2,000,000 shares authorized, no shares issued and outstanding at September 30, 2022 and December 31, 2021
Additional paid-in capital	63,351,653	58,425,604
Accumulated deficit	(54,128,651)	(43,925,373)
Total stockholders' equity	9,224,835	14,501,064
Total liabilities and stockholders' equity	$ 10,857,977	$ 15,776,687

Condensed Balance Sheets (Paren

Condensed Balance Sheets (Parentheticals) - $ / shares	Sep. 30, 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

Condensed Statements of Operati

Condensed Statements of Operations - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Operating expenses:
Research and development	$ 1,622,374	$ 2,961,122	$ 6,797,914	$ 7,877,281
General and administrative expenses	969,946	1,150,369	3,427,679	3,576,101
Total operating expenses	2,592,320	4,111,491	10,225,593	11,453,382
Loss from operations	(2,592,320)	(4,111,491)	(10,225,593)	(11,453,382)
Other income:
Interest income	16,605	1,509	22,315	4,405
Total other income	16,605	1,509	22,315	4,405
Loss before income taxes	(2,575,715)	(4,109,982)	(10,203,278)	(11,448,977)
Net loss	$ (2,575,715)	$ (4,109,982)	$ (10,203,278)	$ (11,448,977)
Basic net loss per share	$ (0.28)	$ (0.49)	$ (1.18)	$ (1.37)
Diluted net loss per share	$ (0.28)	$ (0.49)	$ (1.18)	$ (1.37)
Weighted average number of shares outstanding - basic	9,199,955	8,330,390	8,623,430	8,328,946
Weighted average number of shares outstanding - diluted	9,199,955	8,330,390	8,623,430	8,328,946

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, 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]
Net loss				(11,448,977)
Balances, Ending at Sep. 30, 2021	$ 833	58,293,698	(39,414,082)	18,880,449
Balances, Ending (in shares) at Sep. 30, 2021	8,330,390
Balances, Beginning at Mar. 31, 2021	$ 833	58,127,548	(31,021,138)	27,107,243
Balances, Beginning (in shares) at Mar. 31, 2021	8,330,390
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Share-based compensation expense		34,244		34,244
Net loss			(4,282,962)	(4,282,962)
Balances, Ending at Jun. 30, 2021	$ 833	58,161,792	(35,304,100)	22,858,525
Balances, Ending (in shares) at Jun. 30, 2021	8,330,390
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Share-based compensation expense		131,906		131,906
Net loss			(4,109,982)	(4,109,982)
Balances, Ending at Sep. 30, 2021	$ 833	58,293,698	(39,414,082)	18,880,449
Balances, Ending (in shares) at Sep. 30, 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
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]
Net loss				(10,203,278)
Balances, Ending at Sep. 30, 2022	$ 1,833	63,351,653	(54,128,651)	9,224,835
Balances, Ending (in shares) at Sep. 30, 2022	18,330,390
Balances, Beginning at Mar. 31, 2022	$ 833	58,557,510	(47,885,681)	10,672,662
Balances, Beginning (in shares) at Mar. 31, 2022	8,330,390
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Share-based compensation expense		136,957		136,957
Net loss			(3,667,255)	(3,667,255)
Balances, Ending at Jun. 30, 2022	$ 833	58,694,467	(51,552,936)	7,142,364
Balances, Ending (in shares) at Jun. 30, 2022	8,330,390
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Issuance of common shares, net of costs	$ 1,000	4,492,920		4,493,920
Issuance of common shares, net of costs (shares)	10,000,000
Share-based compensation expense		164,266		164,266
Net loss			(2,575,715)	(2,575,715)
Balances, Ending at Sep. 30, 2022	$ 1,833	$ 63,351,653	$ (54,128,651)	$ 9,224,835
Balances, Ending (in shares) at Sep. 30, 2022	18,330,390

Condensed Statements of Cash Fl

Condensed Statements of Cash Flows - USD ($)	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Cash flows from operating activities
Net loss	$ (10,203,278)	$ (11,448,977)
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation expense	433,129	190,975
Changes in operating assets and liabilities:
Decrease in prepaid expenses and other current assets	698,923	756,453
Increase in accounts payable	291,873	399,640
Decrease in accrued expenses	(17,034)	(30,696)
Decrease in accrued salaries		(378,833)
Net cash used in operating activities	(8,796,387)	(10,511,438)
Cash flows from financing activities
Proceeds from the exercise of warrants		197,562
Payment of offering costs for initial public offering		(295,166)
Proceeds from public offering of common stock, net of offering costs	4,576,600
Net cash provided by (used in) financing activities	4,576,600	(97,604)
Net decrease in cash	(4,219,787)	(10,609,042)
Cash, beginning of period	14,008,184	29,795,366
Cash, end of period	9,788,397	$ 19,186,324
Supplemental disclosure of non-cash financing transactions:
Public offering costs included in accounts payable and accrued expenses	$ 82,680

Organization and Nature of Busi

Organization and Nature of Business	9 Months Ended
	Sep. 30, 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 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 (the “Firm Shares”) 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). Pursuant to the Underwriting Agreement, the Company also granted to the Underwriter (1) a 45-day accrued and unpaid as of September 30, 2022. As of September 30, 2022, the Underwriter had not exercised the overallotment option. The overallotment option expired unexercised on November 3, 2022. Material Uncertainty 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 and nine months ended September 30, 2022 and 2021, the Company incurred net losses of $2,575,715 and $10,203,278, respectively, and $4,109,982 and $11,448,977, respectively, and had net cash outflows used in operating activities for the nine months ended September 30, 2022 and 2021 of $8,796,387 and $10,511,438, respectively. As of September 30, 2022, the Company had an accumulated deficit of $54,128,651 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. As of the date these financial statements are issued, based on reasonable estimates, current cash is sufficient to fund foreseeable operating expenses and obligations for at least 12 months. The Company will need to raise additional capital within the next 13

Summary of Significant Accounti

Summary of Significant Accounting Policies	9 Months Ended
	Sep. 30, 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 and nine months ended September 30, 2022 and 2021, the Company had options to purchase 1,304,147 and 1,041,647 shares of common stock, respectively and warrants to purchase 672,500 and 172,500 shares of common stock, respectively, outstanding that were anti-dilutive. In addition, for the three and nine months ended September 30, 2022, the Company’s Underwriter held an overallotment option to purchase up to 1,500,000 shares of common stock outstanding that was anti-dilutive. The overallotment option expired unexercised on November 3, 2022. 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. Subsequent Event On November 1, 2022, the Company received a letter from the Listing Qualifications Department of The Nasdaq Stock Market, LLC (“Nasdaq”) notifying the Company that, for the previous 30 consecutive business days, the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq. In accordance with Nasdaq Rules, the Company has until May 1, 2023 to regain compliance such that the closing bid price for the Company’s common stock is at least $1.00 for a minimum of 10 consecutive business days. The Company may be eligible for an additional 180 calendar day compliance period. At that time, the Company may appeal the Staff’s delisting determination to a Nasdaq Hearings Panel. The Company intends to monitor the closing bid price of its common stock and may, if appropriate, consider available options to regain compliance. 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	9 Months Ended
	Sep. 30, 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: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, ​ 2022 2021 Prepaid insurance ​ $ 318,901 ​ $ 1,329,385 Prepaid clinical research costs ​ ​ 717,482 ​ ​ 422,591 Prepaid services ​ ​ 19,520 ​ ​ 15,664 Other miscellaneous current assets ​ 13,677 ​ 863 ​ ​ $ 1,069,580 ​ $ 1,768,503 ​

License Agreement

License Agreement	9 Months Ended
	Sep. 30, 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	9 Months Ended
	Sep. 30, 2022
Accrued Expenses
Accrued Expenses	5 Accrued expenses consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, ​ 2022 2021 Accrued compensation ​ $ 261,347 ​ $ 532,678 Accrued interest on preferred members’ interests ​ 188,085 ​ 188,085 Accrued clinical research costs ​ ​ 379,721 ​ ​ 138,522 Accrued director fees ​ ​ 15,500 ​ ​ 31,000 Accrued professional fees ​ 103,575 ​ 24,100 Other miscellaneous accrued expenses ​ 5,498 ​ 7,375 ​ ​ $ 953,726 ​ $ 921,760 ​

Stockholders' Equity

Stockholders' Equity	9 Months Ended
	Sep. 30, 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 Overallotment Option Pursuant to the Underwriting Agreement and in connection with the Offering, the Company granted the Underwriter a 45-day shares at the public offer price. As of September 30, 2022, the overallotment option (the “Underwriters Option”) had not been exercised by the Underwriter. Company then considered the classification of the Underwriters Option as a liability or equity under ASC 480, Distinguishing Liability from Equity Derivatives and Hedging, and determined that the Underwriters Option is a derivative that meets all the criteria and qualifies for equity classification without recurring remeasurement to fair value. The Underwriters Option had an aggregate grant date fair value of $93,827 that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option pricing model include: (1) discount rate of 2.82% based on the daily yield curve rates for U.S. Treasury obligations, (2) expected life of 45 days The Underwriters Option expired unexercised on November 3, 2022.

Related Parties

Related Parties	9 Months Ended
	Sep. 30, 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 and nine months ended September 30, 2022 and 2021, the Company paid Gendreau $94,907 and $283,844, respectively, and $91,335 and $233,616, respectively, and had accounts payable of $27,052 and $24,840 to Gendreau as of September 30, 2022 and December 31, 2021, respectively.

Commitments and Contingencies

Commitments and Contingencies	9 Months Ended
	Sep. 30, 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.

Share-based compensation

Share-based compensation	9 Months Ended
	Sep. 30, 2022
Share-based compensation
Share-based compensation	9 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 September 30, 2022, 1,050,853 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 262,500 ​ 4.23 — Outstanding at September 30, 2022 1,011,647 ​ $ 7.79 8.71 Exercisable at September 30, 2022 650,681 ​ $ 9.35 8.31 ​ During the nine months ended September 30, 2022, the Company granted certain individuals options to purchase 262,500 shares of the Company’s common stock with an average exercise price of $4.23 per share, contractual terms of 10 years and vesting periods ranging from 100% after one year to 33.333% after one year and 66.667% in 24 monthly installments, thereafter. The options had an aggregate grant date fair value of $839,350 that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model included: (1) discount rates ranging from 3.145% to 3.15% based on the daily par 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 91.86% based on the average historical volatility of comparable companies’ stock, (4) no expected dividends and (5) fair market value of the Company’s stock of $4.23 per share. As of September 30, 2022 the aggregate intrinsic value of options outstanding was $0. The Company recognized share-based compensation expense related to stock options during the three and nine months ended September 30, 2022 and 2021, of $164,266 and $433,129, respectively, and $131,906 and $190,975, respectively. The unrecognized compensation expense for stock options at September 30, 2022 was $1,233,623. 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 8.22 years. As of September 30, 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 September 30, 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. 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 5.0 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 September 30, 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, 2021 172,500 ​ $ 12.50 3.96 Granted 500,000 ​ 0.63 — Outstanding at September 30, 2022 672,500 ​ $ 3.67 4.52 Exercisable at September 30, 2022 ​ 172,500 ​ $ 12.50 ​ 3.21 ​ As of September 30, 2022, the aggregate intrinsic value of the warrants outstanding was $0.

Income Taxes

Income Taxes	9 Months Ended
	Sep. 30, 2022
Income Taxes
Income Taxes	10 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 $18,266,000, which have an indefinite carryforward. As of September 30, 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 net operating loss for the three and nine months ended September 30, 2022 and 2021. The Company does not have any material unrecognized tax benefits as of September 30, 2022.

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 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 and nine months ended September 30, 2022 and 2021, the Company had options to purchase 1,304,147 and 1,041,647 shares of common stock, respectively and warrants to purchase 672,500 and 172,500 shares of common stock, respectively, outstanding that were anti-dilutive. In addition, for the three and nine months ended September 30, 2022, the Company’s Underwriter held an overallotment option to purchase up to 1,500,000 shares of common stock outstanding that was anti-dilutive. The overallotment option expired unexercised on November 3, 2022.
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.
Subsequent Event	Subsequent Event On November 1, 2022, the Company received a letter from the Listing Qualifications Department of The Nasdaq Stock Market, LLC (“Nasdaq”) notifying the Company that, for the previous 30 consecutive business days, the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq. In accordance with Nasdaq Rules, the Company has until May 1, 2023 to regain compliance such that the closing bid price for the Company’s common stock is at least $1.00 for a minimum of 10 consecutive business days. The Company may be eligible for an additional 180 calendar day compliance period. At that time, the Company may appeal the Staff’s delisting determination to a Nasdaq Hearings Panel. The Company intends to monitor the closing bid price of its common stock and may, if appropriate, consider available options to regain compliance.
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)	9 Months Ended
	Sep. 30, 2022
Prepaid Expenses and Other Current Assets
Schedule of prepaid expenses and other current assets	​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, ​ 2022 2021 Prepaid insurance ​ $ 318,901 ​ $ 1,329,385 Prepaid clinical research costs ​ ​ 717,482 ​ ​ 422,591 Prepaid services ​ ​ 19,520 ​ ​ 15,664 Other miscellaneous current assets ​ 13,677 ​ 863 ​ ​ $ 1,069,580 ​ $ 1,768,503

Accrued Expenses (Tables)

Accrued Expenses (Tables)	9 Months Ended
	Sep. 30, 2022
Accrued Expenses
Schedule of accrued expenses	​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, ​ 2022 2021 Accrued compensation ​ $ 261,347 ​ $ 532,678 Accrued interest on preferred members’ interests ​ 188,085 ​ 188,085 Accrued clinical research costs ​ ​ 379,721 ​ ​ 138,522 Accrued director fees ​ ​ 15,500 ​ ​ 31,000 Accrued professional fees ​ 103,575 ​ 24,100 Other miscellaneous accrued expenses ​ 5,498 ​ 7,375 ​ ​ $ 953,726 ​ $ 921,760

Share-based compensation (Table

Share-based compensation (Tables)	9 Months Ended
	Sep. 30, 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 262,500 ​ 4.23 — Outstanding at September 30, 2022 1,011,647 ​ $ 7.79 8.71 Exercisable at September 30, 2022 650,681 ​ $ 9.35 8.31
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, 2021 172,500 ​ $ 12.50 3.96 Granted 500,000 ​ 0.63 — Outstanding at September 30, 2022 672,500 ​ $ 3.67 4.52 Exercisable at September 30, 2022 ​ 172,500 ​ $ 12.50 ​ 3.21

Organization and Nature of Bu_2

Organization and Nature of Business (Details)		3 Months Ended						9 Months Ended
	Sep. 19, 2022 USD ($) $ / shares shares	Sep. 30, 2022 USD ($)	Jun. 30, 2022 USD ($)	Mar. 31, 2022 USD ($)	Sep. 30, 2021 USD ($)	Jun. 30, 2021 USD ($)	Mar. 31, 2021 USD ($)	Sep. 30, 2022 USD ($) segment	Sep. 30, 2021 USD ($)	Dec. 31, 2021 USD ($) $ / shares
Subsidiary, Sale of Stock [Line Items]
Number of operating segments | segment								1
Share price | $ / shares	$ 0.50
Gross proceeds	$ 5,000,000							$ 4,576,600
Net proceeds	$ 4,500,000
Warrants exercise price percentage of IPO Price	125%
Warrants exercise price | $ / shares	$ 0.625									$ 12.50
Offering costs								82,680
Net loss		$ 2,575,715	$ 3,667,255	$ 3,960,308	$ 4,109,982	$ 4,282,962	$ 3,056,033	10,203,278	$ 11,448,977
Net cash used in operating activities								8,796,387	$ 10,511,438
Accumulated deficit		$ 54,128,651						$ 54,128,651		$ 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								15 months
IPO | Maximum
Subsidiary, Sale of Stock [Line Items]
Shares issued | shares	10,000,000
Underwriter option
Subsidiary, Sale of Stock [Line Items]
Days to purchase additional shares granted to underwriters	45
Warrants exercise price | $ / shares	$ 0.625
Number of warrants, as percentage of shares sold	5%
Underwriter option | Maximum
Subsidiary, Sale of Stock [Line Items]
Shares issued | shares	1,500,000

Summary of Significant Accoun_3

Summary of Significant Accounting Policies - Basic and Diluted Net Loss Per Share (Details)		3 Months Ended		9 Months Ended
	Nov. 01, 2022 D $ / shares	Sep. 30, 2022 shares	Sep. 30, 2021 shares	Sep. 30, 2022 shares	Sep. 30, 2021 shares
Subsequent Events.
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Consecutive business days | D	30
Bid price per share | $ / shares	$ 1
Threshold business days | D	10
Additional compliance period	180 days
Stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive securities		1,304,147	1,041,647	1,304,147	1,041,647
Warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive securities		672,500	172,500	672,500	172,500
Common Stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive securities		1,500,000		1,500,000

Prepaid Expenses and Other Cu_3

Prepaid Expenses and Other Current Assets (Details) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Prepaid Expenses and Other Current Assets
Prepaid insurance	$ 318,901	$ 1,329,385
Prepaid clinical research costs	717,482	422,591
Prepaid services	19,520	15,664
Other miscellaneous current assets	13,677	863
Total prepaid expenses and other assets	$ 1,069,580	$ 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 ($)	Sep. 30, 2022	Dec. 31, 2021
Accrued Expenses
Accrued compensation	$ 261,347	$ 532,678
Accrued interest on preferred members' interests	188,085	188,085
Accrued clinical research costs	379,721	138,522
Accrued director fees	15,500	31,000
Accrued professional fees	103,575	24,100
Other miscellaneous accrued expenses	5,498	7,375
Accrued expenses	$ 953,726	$ 921,760

Stockholders' Equity (Details)

Stockholders' Equity (Details) - $ / shares	Sep. 30, 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

Stockholders' Equity - Overallo

Stockholders' Equity - Overallotment Option (Details) - Underwriter option	Sep. 19, 2022 USD ($) shares
Subsidiary, Sale of Stock [Line Items]
Days to purchase additional shares granted to underwriters	45
Maximum number of shares issuable | shares	1,500,000
Equity Contract [Member]
Subsidiary, Sale of Stock [Line Items]
Fair value of equity-classified financial instrument | $	$ 93,827
Equity Contract [Member] | Measurement Input, Discount Rate [Member]
Subsidiary, Sale of Stock [Line Items]
Warrants and rights outstanding, measurement input	0.0282
Equity Contract [Member] | Measurement Input, Expected Term [Member]
Subsidiary, Sale of Stock [Line Items]
Warrants and rights outstanding, measurement input	45
Equity Contract [Member] | Measurement Input, Option Volatility [Member]
Subsidiary, Sale of Stock [Line Items]
Warrants and rights outstanding, measurement input	0.886
Equity Contract [Member] | Measurement Input, Expected Dividend Rate [Member]
Subsidiary, Sale of Stock [Line Items]
Warrants and rights outstanding, measurement input	0
Equity Contract [Member] | Measurement Input, Share Price [Member]
Subsidiary, Sale of Stock [Line Items]
Warrants and rights outstanding, measurement input	0.50

Related Parties (Details)

Related Parties (Details) - Gendreau Consulting, LLC - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Related Party Transaction [Line Items]
Amount paid to the firm	$ 94,907	$ 91,335	$ 283,844	$ 233,616
Accounts payable	$ 27,052		$ 27,052		$ 24,840

Share-based compensation - Equi

Share-based compensation - Equity Incentive Plan (Details) - Plan - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2021
Number of Shares
Outstanding at the beginning of the period	749,147
Granted	262,500
Outstanding at the end of the period	1,011,647	749,147
Exercisable at June 30, 2022	650,681
Weighted Average Exercise Price
Outstanding the beginning of the period	$ 9.03
Granted	4.23
Outstanding at the end of the period	7.79	$ 9.03
Exercisable at June 30, 2022	$ 9.35
Weighted Average Remaining Contractual Term (years)
Weighted average remaining contractual term (years)	8 years 8 months 15 days	9 years 1 month 2 days
Exercisable at June 30, 2022	8 years 3 months 21 days

Share-based compensation - Narr

Share-based compensation - Narrative (Details) - USD ($)			3 Months Ended		9 Months Ended
	Sep. 19, 2022	Jun. 16, 2022	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Jun. 30, 2022
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
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							1,050,853
Options term					10 years
Aggregate grant date fair value					$ 839,350
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract]
Expected dividends					$ 0
Share price			$ 4.23		$ 4.23
Intrinsic value of options outstanding			$ 0		$ 0
Plan | Minimum
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract]
Discount rates					3.145%
Expected life					5 years 6 months
Expected volatility					90.62%
Plan | Maximum
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract]
Discount rates					3.15%
Expected life					6 years
Expected volatility					91.86%
Plan | Vesting over one year
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting percentage					100%
Plan | Vesting after one year
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting percentage					33.333%
Plan | Vesting in 24 monthly installments thereafter
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Vesting percentage					66.667%
Plan | Stock options
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract]
Share-based compensation expense			164,266	$ 131,906	$ 433,129	$ 190,975
Unrecognized compensation expense			$ 1,233,623		$ 1,233,623

Share-based compensation - Unre

Share-based compensation - Unregistered Securities (Details) - USD ($)		9 Months Ended	12 Months Ended
	Sep. 19, 2022	Sep. 30, 2022	Dec. 31, 2021
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		262,500
Options term		10 years
Exercise price		$ 4.23
Remaining contractual term		8 years 8 months 15 days	9 years 1 month 2 days
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract]
Share price		$ 4.23
Plan | Non-qualified stock options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Granted		292,500
Options term		10 years
Exercise price		$ 10
Vesting percentage		100%
Remaining contractual term		8 years 2 months 19 days
Unrecognized compensation expense		$ 0
Intrinsic value of options exercisable		$ 0

Share-based compensation - Unde

Share-based compensation - Underwriters Warrants (Details) - USD ($)		9 Months Ended	12 Months Ended
	Sep. 19, 2022	Sep. 30, 2022	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Warrants to purchase shares	500,000		172,500
Warrants exercise price	$ 0.625		$ 12.50
Percentage of warrants exercisable			100%
Remaining contractual term	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
Number of Shares
Warrants outstanding at the beginning of the period		172,500
Warrants granted		500,000
Warrants outstanding at the end of the period		672,500	172,500
Exercisable at December 31, 2021		172,500
Weighted Average Exercise Price
Outstanding at the beginning of the period		$ 12.50
Granted		0.63
Outstanding at the end of the period		3.67	$ 12.50
Exercisable at December 31, 2021		$ 12.50
Remaining term		4 years 6 months 6 days	3 years 11 months 12 days
Exercisable contractual term		3 years 2 months 17 days
Intrinsic value of warrants outstanding		$ 0
Warrants
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract]
Unrecognized compensation expense		$ 0

Income Taxes - Narrative (Detai

Income Taxes - Narrative (Details)	Dec. 31, 2021 USD ($)
Income Taxes
Net operating loss carryforwards	$ 18,266,000