Quarterly report pursuant to Section 13 or 15(d)

Organization and Nature of Business

v3.22.2.2
Organization and Nature of Business
9 Months Ended
Sep. 30, 2022
Organization and Nature of Business  
Organization and Nature of Business

1Organization and Nature of Business

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 overallotment option to purchase up to 1,500,000 shares (the “Option Shares”) at the public offer price and (2) warrants to purchase up to 5% of the Firm Shares and Option Shares purchased in the Offering at an exercise price of $0.625 per share, which is 125% of the public offering price. The public offering closed on September 22, 2022 and the gross proceeds from the public offering were $5.0 million. The net proceeds of the public offering were approximately $4.5 million after deducting underwriting discounts, commissions and offering expenses payable by the Company, including offering costs of $82,680 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 to 15 months to further advance clinical development 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.