Virios Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Virios Therapeutics, Inc. has filed its 2023 annual report (10-K), detailing its financial performance and corporate activities for the fiscal year ending December 31, 2023.</b>

AI Summary

Virios Therapeutics, Inc. (DWTX) filed a Annual Report (10-K) with the SEC on March 1, 2024. Virios Therapeutics, Inc. filed its 2023 annual report on Form 10-K on March 1, 2024. The company's fiscal year ends on December 31st. The filing covers the period from January 1, 2023, to December 31, 2023. The company was formerly known as Virios Therapeutics, LLC, with a name change effective July 21, 2020. The filing includes details on equity incentive plans, including the Equity Incentive Plan 2020.

Why It Matters

For investors and stakeholders tracking Virios Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Virios Therapeutics' financial health, operational status, and strategic direction for the past fiscal year, which is crucial for investors to assess the company's progress and future prospects. The inclusion of details on equity incentive plans and stock options is important for understanding executive compensation and potential dilution effects for shareholders.

Risk Assessment

Risk Level: medium — Virios Therapeutics, Inc. shows moderate risk based on this filing. The company is in the pharmaceutical preparations industry, which is subject to significant regulatory hurdles, clinical trial risks, and market competition, as indicated by its SIC code and the nature of its business.

Analyst Insight

Investors should review the detailed financial statements and risk factors within the 10-K to understand the company's current financial position and potential challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (The end date of the reporting period.)
• 2024-03-01 — Filing Date (The date the 10-K was filed.)
• 2020-07-21 — Name Change Date (Date Virios Therapeutics, LLC became Virios Therapeutics, Inc.)

Key Players & Entities

• Virios Therapeutics, Inc. (company) — Filer name
• 2023 (date) — Reporting period
• March 1, 2024 (date) — Filing date
• December 31, 2023 (date) — Fiscal year end
• Virios Therapeutics, LLC (company) — Former company name
• July 21, 2020 (date) — Date of name change
• Equity Incentive Plan 2020 (company) — Specific plan mentioned

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The pharmaceutical industry is subject to extensive regulation by government agencies, which can impact product development, approval, and marketing.
• Market Competition [medium — market]: The company faces competition from other pharmaceutical companies, which could affect its market share and profitability.
• Clinical Trial Risks [high — operational]: The success of pharmaceutical products depends on the outcome of clinical trials, which can be lengthy, expensive, and may not yield successful results.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-03-01: 10-K Filing Date — The date the annual report was officially submitted to the SEC.

Glossary

10-K

An annual report required by the U.S. Securities and Exchange Commission (SEC), which gives a comprehensive summary of a company's financial performance. (This filing provides the official annual financial and business overview of Virios Therapeutics, Inc.)

Key Financial Figures

• $0.0001 — ) On Which Registered Common Stock, $0.0001 Par Value per Share VIRI Nasdaq Cap

Filing Documents

• tmb-20231231x10k.htm (10-K) — 1324KB
• tmb-20231231xex23d1.htm (EX-23.1) — 3KB
• tmb-20231231xex31d1.htm (EX-31.1) — 15KB
• tmb-20231231xex31d2.htm (EX-31.2) — 14KB
• tmb-20231231xex32.htm (EX-32) — 10KB
• tmb-20231231xex97.htm (EX-97) — 40KB
• tmb-20231231x10k001.jpg (GRAPHIC) — 87KB
• tmb-20231231x10k002.jpg (GRAPHIC) — 34KB
• tmb-20231231x10k003.jpg (GRAPHIC) — 11KB
• tmb-20231231x10k004.jpg (GRAPHIC) — 27KB
• 0001558370-24-002239.txt (&nbsp;) — 5331KB
• tmb-20231231.xsd (EX-101.SCH) — 34KB
• tmb-20231231_cal.xml (EX-101.CAL) — 32KB
• tmb-20231231_def.xml (EX-101.DEF) — 137KB
• tmb-20231231_lab.xml (EX-101.LAB) — 328KB
• tmb-20231231_pre.xml (EX-101.PRE) — 253KB
• tmb-20231231x10k_htm.xml (XML) — 542KB

Business

Item 1. Business 6

Risk Factors

Item 1A. Risk Factors 29

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 69

Cybersecurity

Item 1C. Cybersecurity 69

Properties

Item 2. Properties 70

Legal Proceedings

Item 3. Legal Proceedings 70

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 70 PART II

Market for Registrant ' s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 5. Market for Registrant ' s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 70

Selected Financial Data

Item 6. Selected Financial Data 72

Management ' s Discussion and Analysis of Financial Condition and Results of Operations

Item 7. Management ' s Discussion and Analysis of Financial Condition and Results of Operations 73

Quantitative and Qualitative Disclosures About Market Risk

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 81

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data 82

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 99

Controls and Procedures

Item 9A. Controls and Procedures 99

Other Information

Item 9B. Other Information 100 PART III

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 100

Executive Compensation

Item 11. Executive Compensation 100

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 100

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence 100

Principal Accounting Fees and Services

Item 14. Principal Accounting Fees and Services 100 PART IV

Exhibits and Financial Statement Schedules

Item 15. Exhibits and Financial Statement Schedules 100

Form 10 K Summary

Item 16. Form 10 K Summary 102 2 CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K, including "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Item 7, contains forward-looking statements. All statements other than statements of historical facts contained in this Annual Report on Form 10-K, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated products, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this Annual Report on Form 10-K are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Annual Report on Form 10-K and are subject to a number of risks, uncertainties and assumptions described under the sections in this Annual Report on Form 10-K titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in

Business

Item 1. Business Our Company We were incorporated under the laws of the State of Delaware on December 16, 2020 through a 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 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. We are a development-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response such as fibromyalgia ("FM") and Long-COVID ("LC"). Overactive immune response related to activation of tissue resident herpesvirus has been postulated to be a potential root cause of chronic illnesses such as FM, irritable bowel disease ("IBS"), LC, chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by a waxing and waning manifestation of disease, often triggered by events which compromise the immune system. While not completely understood, there is general agreement in the medical community that activation of the herpesvirus is triggered by some form of environmental and/or health stressor. Our lead product candidates, IMC-1 and IMC-2, are novel, proprietary, fixed dose combinations of anti-herpes antivirals and celecoxib. IMC-1 is a novel combination of famciclovir and celecoxib intended to synergistically suppress herpesvirus activation and replication, with the end goal of reducing viral mediated disease burden. IMC-2 is a combination of valacyclovir and celecoxib that, like IMC-1, is intended to synergistically suppress herpesvirus activation and replication with a more specific activity against the Epstein-Barr virus (herpesvirus HHV-4). IMC-1 and IMC-2 combine two specific mechanisms of action purposely designed to inhibit herpesvirus activation and replication, thereby keeping t

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