Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39811 Virios Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 85-431420 ...

PART I — FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Presents unaudited condensed financial statements for June 30, 2021, and December 31, 2020, covering balance sheets, operations, equity, cash flows, and detailed notes [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Presents the company's financial position, detailing assets, liabilities, and stockholders' equity as of June 30, 2021, and December 31, 2020 | Metric | June 30, 2021 | December 31, 2020 | | :-------------------------------- | :-------------- | :------------------ | | Cash | $21,835,092 | $29,795,366 | | Total current assets | $23,764,782 | $31,472,731 | | Total assets | $23,764,782 | $31,472,731 | | Total current liabilities | $906,257 | $1,531,842 | | Total liabilities | $906,257 | $1,531,842 | | Total stockholders' equity | $22,858,525 | $29,940,889 | | Accumulated deficit | $(35,304,100) | $(27,965,105) | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) Details the company's revenues, expenses, and net loss for the three and six months ended June 30, 2021, and June 30, 2020 | Metric | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $— | $— | $— | $— | | Research and development | $3,209,201 | $23,320 | $4,916,159 | $53,859 | | General and administrative expenses | $1,075,256 | $515,060 | $2,425,732 | $867,073 | | Total operating expenses | $4,284,457 | $538,380 | $7,341,891 | $920,932 | | Net loss | $(4,282,962) | $(654,585) | $(7,338,995) | $(1,121,138) | | Basic and diluted net loss per share | $(0.51) | $(0.14) | $(0.88) | $(0.23) | [Condensed Statements of Changes in Members' Deficit/Stockholders' Equity](index=5&type=section&id=Condensed%20Statements%20of%20Changes%20in%20Members'%20Deficit%2FStockholders'%20Equity) Outlines changes in total stockholders' equity, including share-based compensation, warrant exercises, and net loss, for specified periods | Metric | December 31, 2020 | March 31, 2021 | June 30, 2021 | | :-------------------------- | :---------------- | :------------- | :------------ | | Total Stockholders' Equity | $29,940,889 | $27,107,243 | $22,858,525 | | Share-based compensation expense | — | $24,825 | $34,244 | | Exercise of warrants | — | $197,562 | — | | Net loss | — | $(3,056,033) | $(4,282,962) | [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Summarizes cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2021, and June 30, 2020 | Metric | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--------------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(7,338,995) | $(1,121,138) | | Net cash used in operating activities | $(7,862,670) | $(1,049,944) | | Net cash (used in) provided by financing activities | $(97,604) | $1,789,052 | | Net (decrease) increase in cash | $(7,960,274) | $739,108 | | Cash, end of period | $21,835,092 | $1,048,492 | [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Provides detailed explanations of the company's accounting policies, organization, and specific financial statement line items [1. Organization and Nature of Business](index=7&type=section&id=1.%20Organization%20and%20Nature%20of%20Business) Virios Therapeutics, Inc., incorporated in December 2020, is a pre-revenue, clinical-stage biotech company developing IMC-1 for fibromyalgia - Company incorporated as Virios Therapeutics, Inc. on December 16, 2020, via corporate conversion from Virios Therapeutics, LLC[21](index=21&type=chunk)[23](index=23&type=chunk) - Operates as a pre-revenue, clinical-stage biotechnology company developing IMC-1 for fibromyalgia (FM)[22](index=22&type=chunk) - IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib, designed to inhibit HSV-1 activation and replication[22](index=22&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Unaudited interim financial statements are prepared per SEC rules, with the company electing extended transition for new accounting standards as an emerging growth company - Unaudited interim financial statements prepared per SEC rules, not full U.S. GAAP[28](index=28&type=chunk) - Company is an "emerging growth company" and uses the extended transition period for new accounting standards[34](index=34&type=chunk) - Management makes estimates and assumptions affecting reported amounts, including for contract manufacturers, equity valuation, and deferred taxes[29](index=29&type=chunk) [3. Prepaid Expenses and Other Current Assets](index=13&type=section&id=3.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) Prepaid expenses and other current assets increased to $1.93 million at June 30, 2021, from $1.68 million at December 31, 2020, primarily due to a significant increase in prepaid clinical research costs | Item | June 30, 2021 | December 31, 2020 | | :------------------------------ | :-------------- | :------------------ | | Prepaid insurance | $807,133 | $1,586,042 | | Prepaid clinical research costs | $1,084,942 | $85,270 | | Prepaid services | $36,858 | $5,729 | | Other miscellaneous current assets | $757 | $324 | | **Total** | **$1,929,690** | **$1,677,365** | [4. License Agreement](index=13&type=section&id=4.%20License%20Agreement) The company holds a Know-How License Agreement with the University of Alabama, effective for 25 years until June 1, 2037, in exchange for a 10% membership interest - License Agreement with the University of Alabama (UA) since 2012[39](index=39&type=chunk) - UA received a **10% non-voting membership interest**, which converted to a voting interest in May 2020[39](index=39&type=chunk) - Agreement is in effect for **25 years**, terminating on June 1, 2037[39](index=39&type=chunk) [5. Accrued Expenses](index=13&type=section&id=5.%20Accrued%20Expenses) Accrued expenses decreased to $643,667 at June 30, 2021, from $784,104 at December 31, 2020, mainly due to a reduction in accrued compensation, partially offset by increases in professional fees and director fees | Item | June 30, 2021 | December 31, 2020 | | :-------------------------------- | :-------------- | :------------------ | | Accrued compensation | $345,312 | $573,479 | | Accrued interest on preferred members' interests | $188,085 | $188,085 | | Accrued professional fees | $64,220 | $8,992 | | Accrued director fees | $31,000 | $— | | Other | $15,050 | $13,548 | | **Total** | **$643,667** | **$784,104** | [6. Convertible Promissory Notes, Net](index=13&type=section&id=6.%20Convertible%20Promissory%20Notes%2C%20Net) All $6.7 million convertible promissory notes outstanding as of June 30, 2020, converted to equity by December 2020, eliminating related debt - Convertible promissory notes totaling **$6,706,633** were outstanding as of June 30, 2020[41](index=41&type=chunk) - All notes converted into membership interests prior to or during the Corporate Conversion[42](index=42&type=chunk) - No interest expense related to these notes was recognized for the three and six months ended June 30, 2021[43](index=43&type=chunk) [7. Members' Deficit](index=14&type=section&id=7.%20Members'%20Deficit) The company's membership structure changed on May 1, 2020, consolidating to one class of voting membership interests, which subsequently converted into common stock during the Corporate Conversion - Second Amended and Restated Operating Agreement adopted May 1, 2020, changing membership to one class of voting interests[44](index=44&type=chunk) - All outstanding membership interests converted into shares of common stock during the Corporate Conversion[45](index=45&type=chunk) [8. Stockholders' Equity](index=14&type=section&id=8.%20Stockholders'%20Equity) The company's certificate of incorporation, adopted December 16, 2020, authorizes 43 million shares of common stock and 2 million shares of preferred stock, each with a par value of $0.0001 - Authorized **43,000,000 shares of common stock** and **2,000,000 shares of preferred stock**[46](index=46&type=chunk) - Par value for both common and preferred stock is **$0.0001 per share**[46](index=46&type=chunk) [9. Related Parties](index=14&type=section&id=9.%20Related%20Parties) The company contracts Gendreau Consulting, LLC for drug development, with its managing member becoming CMO in January 2021 - Contracts Gendreau Consulting, LLC for drug development and clinical trials[47](index=47&type=chunk) - Managing member of Gendreau Consulting became the company's Chief Medical Officer (CMO) on January 1, 2021[47](index=47&type=chunk) | Period | Payments to Gendreau Consulting, LLC | | :-------------------------------- | :----------------------------------- | | Three months ended June 30, 2021 | $77,816 | | Six months ended June 30, 2021 | $142,282 | [10. Commitments and Contingencies](index=15&type=section&id=10.%20Commitments%20and%20Contingencies) No material legal actions were pending as of June 30, 2021, though an employment agreement includes potential bonuses and change of control payments - No pending material legal actions as of June 30, 2021[48](index=48&type=chunk) - Employment agreement with Director of Clinical Operations includes potential cash bonus (target **20% of base salary**) and change of control payment (**50% of base salary + 50% of bonus**)[49](index=49&type=chunk) [11. Share-based compensation](index=15&type=section&id=11.%20Share-based%20compensation) The 2020 Equity Incentive Plan, effective at IPO, had 230,603 shares available for grants; share-based compensation expense was $59,069 for the six months ended June 30, 2021 - 2020 Equity Incentive Plan effective December 21, 2020 (IPO closing)[50](index=50&type=chunk) - **230,603 shares** available for future grants as of June 30, 2021[50](index=50&type=chunk) | Metric | Six Months Ended June 30, 2021 | | :-------------------------------- | :----------------------------- | | Share-based compensation expense | $59,069 | | Unrecognized compensation expense | $1,091,215 | | Options granted | 299,984 | | Average exercise price of granted options | $6.85 | | Aggregate grant date fair value of options | $1,150,284 | [12. Income Taxes](index=16&type=section&id=12.%20Income%20Taxes) Subject to federal and state income taxes since December 2020, the company maintains a full valuation allowance on its net deferred tax asset due to cumulative losses - Subject to U.S. federal and state income taxes since Corporate Conversion in December 2020[55](index=55&type=chunk) - Maintains a full valuation allowance on its U.S. federal and state net deferred tax asset due to cumulative pre-tax losses and projected losses[56](index=56&type=chunk) - Had U.S. federal and state NOL carryforwards of approximately **$2,316,000** as of December 31, 2020, with an indefinite carryforward[55](index=55&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and results, noting increased operating expenses from R&D for IMC-1, liquidity, capital resources, and emerging growth company status [Cautionary Note Regarding Forward-Looking Statements](index=17&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section warns that the report contains forward-looking statements subject to risks and uncertainties, where actual results may differ materially - This report contains forward-looking statements subject to substantial risks and uncertainties, and actual results may differ materially[59](index=59&type=chunk) - Statements are based on a combination of facts and factors currently known and expectations of the future, about which the company cannot be certain[59](index=59&type=chunk) - Forward-looking statements include business strategies, regulatory approval, clinical trial timing/costs, reliance on third parties, competitive position, market assumptions, intellectual property, financial condition, liquidity, and financing plans[60](index=60&type=chunk) [Overview](index=19&type=section&id=Overview) Virios Therapeutics is a development-stage biotech company focused on advancing IMC-1, a novel antiviral therapy for fibromyalgia, currently in Phase 2b clinical trials - Virios Therapeutics is 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)[62](index=62&type=chunk) - The lead product, IMC-1, is a novel, proprietary, fixed dose combination of famciclovir and celecoxib, designed to synergistically suppress HSV-1 activation and replication[62](index=62&type=chunk)[63](index=63&type=chunk) - IMC-1 has been designated for **fast-track review status** by the FDA for FM and granted a synergy patent[63](index=63&type=chunk) - The company announced the dosing of its first patient in its Phase 2b clinical trial (FORTRESS study) in FM in June 2021, with top-line results projected for mid-2022[64](index=64&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) Operating expenses significantly increased for the three and six months ended June 30, 2021, driven by higher R&D costs for clinical trials and increased general and administrative expenses | Operating Expenses | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $3,209,201 | $23,320 | $4,916,159 | $53,859 | | General and administrative | $1,075,256 | $515,060 | $2,425,732 | $867,073 | | **Total operating expenses** | **$4,284,457** | **$538,380** | **$7,341,891** | **$920,932** | [Research and Development Expenses](index=21&type=section&id=Research%20and%20Development%20Expenses) Details the significant increase in R&D expenses for the three and six months ended June 30, 2021, primarily due to clinical trials and toxicology studies - Research and development expenses increased by **$3.2 million** for the three months ended June 30, 2021, and **$4.9 million** for the six months ended June 30, 2021, compared to prior year periods[67](index=67&type=chunk) - Increases were primarily due to expenses for clinical trials (**$1.8M** for 3 months, **$2.6M** for 6 months), toxicology studies (**$0.8M** for 3 months, **$1.2M** for 6 months), salaries and related costs, and drug development and manufacturing costs[67](index=67&type=chunk) [General and Administrative Expenses](index=21&type=section&id=General%20and%20Administrative%20Expenses) Explains the increase in general and administrative expenses for the three and six months ended June 30, 2021, due to public company costs - General and administrative expenses increased by **$0.6 million** for the three months ended June 30, 2021, and **$1.6 million** for the six months ended June 30, 2021, compared to prior year periods[68](index=68&type=chunk) - The increase was due to costs associated with being a public company, including legal and accounting fees (**$0.3M** for 6 months) and salaries, benefits, and compensation costs (**$0.1M** for 6 months)[68](index=68&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) Operations are funded by equity and debt, with no product revenues; $21.8 million cash as of June 30, 2021, is expected to fund operations through 2022, but additional capital is needed - Since inception, operations have been financed through public offerings of common stock and private placements of membership interests and convertible promissory notes, with no revenues from product sales to date[69](index=69&type=chunk) - Principal source of liquidity as of June 30, 2021, was cash totaling **$21.8 million**[69](index=69&type=chunk) - Current cash is estimated to be sufficient to fund operations and capital requirements through the end of **2022**, including the completion of the Phase 2b clinical trial for IMC-1 and planning for Phase 3[74](index=74&type=chunk) [Equity Financings](index=21&type=section&id=Equity%20Financings) Details the company's Initial Public Offering (IPO) on December 21, 2020, which raised $34.5 million in gross proceeds - Closed Initial Public Offering (IPO) on December 21, 2020[71](index=71&type=chunk) - Raised gross proceeds of **$34.5 million** and net proceeds of approximately **$31.1 million** after deducting underwriting discounts, commissions, and offering expenses[71](index=71&type=chunk) [Debt Financings](index=23&type=section&id=Debt%20Financings) Describes the $2.0 million convertible promissory notes issued in 2020, which converted to common interests, leaving no outstanding debt - Issued an aggregate of **$2.0 million** principal amount of convertible promissory notes in 2020[73](index=73&type=chunk) - These notes converted to common interests at the Corporate Conversion, resulting in no debt outstanding for the year ended December 31, 2020[73](index=73&type=chunk) [Future Capital Requirements](index=23&type=section&id=Future%20Capital%20Requirements) Outlines the need for additional capital beyond current cash to complete clinical development and commercialize product candidates, with no committed external funding - Current cash of **$21.8 million** at June 30, 2021, is estimated to fund operations and capital requirements through the end of 2022[74](index=74&type=chunk) - Additional capital will be needed to complete clinical development and commercially develop product candidates[75](index=75&type=chunk) - There are no committed external sources of funds, and additional financing may not be available on acceptable terms[75](index=75&type=chunk) [Summary of Cash Flows](index=23&type=section&id=Summary%20of%20Cash%20Flows) Summarizes cash flow activities, noting a net decrease in cash for the six months ended June 30, 2021, primarily from operating activities | Cash Flow Activity | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Operating activities | $(7,862,670) | $(1,049,944) | | Financing activities | $(97,604) | $1,789,052 | | **Net (decrease) increase in cash** | **$(7,960,274)** | **$739,108** | - Net cash used in operating activities for the six months ended June 30, 2021, was **$7.9 million**, primarily due to the net loss of **$7.3 million** and changes in operating assets and liabilities[77](index=77&type=chunk) - Net cash used by financing activities for the six months ended June 30, 2021, was **$0.1 million**, attributable to proceeds from warrant exercises (**$0.2M**) offset by IPO offering costs (**$0.3M**)[79](index=79&type=chunk) [Off-Balance Sheet Arrangements](index=25&type=section&id=Off-Balance%20Sheet%20Arrangements) Confirms the absence of any off-balance sheet arrangements or relationships with unconsolidated entities as of June 30, 2021 - As of June 30, 2021, the company did not have any off-balance sheet arrangements or relationships with unconsolidated entities or financial partnerships[81](index=81&type=chunk) [JOBS Act](index=25&type=section&id=JOBS%20Act) The company, as an "emerging growth company," utilizes the extended transition period for new accounting standards and is exempt from certain reporting requirements - The company is an "emerging growth company" as defined in the Jumpstart Our Business Startups Act of 2012 (JOBS Act)[82](index=82&type=chunk) - The company has elected to use the extended transition period for complying with new or revised accounting standards[82](index=82&type=chunk) - As an emerging growth company, the company is exempt from certain reporting requirements, including providing an auditor's attestation report on internal controls over financial reporting (Section 404)[83](index=83&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This item is not required for smaller reporting companies, and therefore, no disclosures regarding quantitative and qualitative market risk are provided - This item is not required for smaller reporting companies[84](index=84&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective as of June 30, 2021, due to a material weakness in internal control over financial reporting, with remediation efforts ongoing - Management concluded that disclosure controls and procedures were not effective at a reasonable assurance level as of June 30, 2021[87](index=87&type=chunk) - A material weakness in internal control over financial reporting exists due to ineffective segregation of duties, financial statement reporting, and general technology controls, primarily due to the size of the organization[88](index=88&type=chunk) - Remediation steps include contracting third-party controller assistance, adding mitigating controls for cash disbursements, and adopting a Delegation of Authority Policy to improve segregation of duties[89](index=89&type=chunk) PART II — OTHER INFORMATION [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material pending litigation as of June 30, 2021, though it may face claims in the ordinary course of business - No material pending litigation to which the company is a party or its property is subject as of June 30, 2021[93](index=93&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) This item is not required for smaller reporting companies, and therefore, no specific risk factors are disclosed in this section - This item is not required for smaller reporting companies[94](index=94&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - None to report for unregistered sales of equity securities and use of proceeds[95](index=95&type=chunk) [Item 3. Defaults Upon Senior Securities](index=28&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report for the period - None to report for defaults upon senior securities[96](index=96&type=chunk) [Item 4. Mine Safety Disclosures](index=28&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable to the company[97](index=97&type=chunk) [Item 5. Other Information](index=28&type=section&id=Item%205.%20Other%20Information) There is no other information to report for the period - None to report for other information[98](index=98&type=chunk) [Item 6. Exhibits](index=28&type=section&id=Item%206.%20Exhibits) Lists exhibits filed with Form 10-Q, including corporate documents, certifications (302 and 906), and XBRL documents - Includes Certificate of Incorporation, Bylaws, and Specimen Certificate evidencing shares of common stock[102](index=102&type=chunk) - Includes Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 302 and Section 906 of the Sarbanes-Oxley Act of 2002[102](index=102&type=chunk) - Includes XBRL Instance Document, Taxonomy Extension Schema, Calculation Linkbase, Definition Linkbase, Label Linkbase, Presentation Linkbase Documents, and Cover Page Interactive Data File[102](index=102&type=chunk) [Signatures](index=30&type=section&id=Signatures) The report is signed by Greg Duncan, Chairman and CEO, and Angela Walsh, SVP of Finance, on August 13, 2021 - Report signed by Greg Duncan (Chairman of the Board of Directors and Chief Executive Officer) and Angela Walsh (SVP of Finance, Corporate Secretary and Treasurer)[105](index=105&type=chunk) - Date of signature: August 13, 2021[105](index=105&type=chunk)

[Part I: Financial Information](index=3&type=section&id=Part%20I%20Financial%20Information) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company presents its unaudited interim balance sheets, operations, equity, and cash flow statements [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to $28.3 million, primarily driven by a reduction in cash from the prior year-end Condensed Balance Sheet Highlights (Unaudited) | Balance Sheet Item | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Cash | $24,585,560 | $29,795,366 | | Total Current Assets | $28,274,537 | $31,472,731 | | Total Liabilities | $1,167,294 | $1,531,842 | | Total Stockholders' Equity | $27,107,243 | $29,940,889 | | **Total Liabilities and Stockholders' Equity** | **$28,274,537** | **$31,472,731** | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) The company reported no revenue and a net loss of $3.1 million, a significant increase from the prior year Statement of Operations Summary (Unaudited) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Revenue | $0 | $0 | | Research and development | $1,706,957 | $30,539 | | General and administrative expenses | $1,350,476 | $352,014 | | Loss from operations | ($3,057,433) | ($382,553) | | **Net loss** | **($3,056,033)** | **($466,553)** | | **Basic and diluted net loss per share** | **($0.37)** | **($0.10)** | [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operations was $5.1 million, leading to a period-end cash balance of $24.6 million Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($5,112,202) | ($277,379) | | Net cash (used in) provided by financing activities | ($97,604) | $1,162,500 | | **Net (decrease) increase in cash** | **($5,209,806)** | **$885,121** | | **Cash, end of period** | **$24,585,560** | **$1,194,505** | [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes detail the company's focus on IMC-1, its recent IPO, and management's view on its cash runway - The company is a pre-revenue, clinical-stage biotechnology company developing IMC-1, a novel fixed-dose combination of famciclovir and celecoxib, to treat fibromyalgia by suppressing the Herpes Simplex Virus-1 (HSV-1)[23](index=23&type=chunk) - In December 2020, the company completed its IPO, selling 3,450,000 shares at $10.00 per share, generating **gross proceeds of $34.5 million** and **net proceeds of approximately $31.1 million**[25](index=25&type=chunk) - Despite a history of net losses and an **accumulated deficit of approximately $31.0 million** as of March 31, 2021, management believes that cash from the recent IPO is sufficient to fund operations for at least the next 12 months[27](index=27&type=chunk)[28](index=28&type=chunk) - During Q1 2021, the company granted 62,734 stock options to employees and recognized **share-based compensation expense of $24,825**[52](index=52&type=chunk)[53](index=53&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its focus on the IMC-1 clinical trial, rising expenses, and its liquidity position [Overview](index=21&type=section&id=Overview) The company is advancing its lead candidate IMC-1 for fibromyalgia following its recent IPO - The lead product, IMC-1, is a novel combination of famciclovir and celecoxib designed to suppress Herpes Simplex Virus-1 (HSV-1) activation and replication, a potential cause of FM[65](index=65&type=chunk)[66](index=66&type=chunk) - The company is preparing to execute its Phase 2b clinical trial in FM, named the **FORTRESS study**, which is planned to enroll approximately 460 patients[67](index=67&type=chunk)[68](index=68&type=chunk) - A collaboration has been initiated with Dr. Michael Camilleri at the Mayo Clinic to explore the potential of antiviral therapy in managing Irritable Bowel Syndrome (IBS)[69](index=69&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Operating expenses rose sharply to $3.1 million, driven by increased R&D and G&A costs Operating Expenses Comparison (Unaudited) | Expense Category | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Research and development | $1,706,957 | $30,539 | | General and administrative | $1,350,476 | $352,014 | | **Total operating expenses** | **$3,057,433** | **$382,553** | - The **$1.68 million increase in R&D expenses** was primarily due to costs for clinical trials ($0.83M), toxicology studies ($0.34M), salaries ($0.27M), and drug development ($0.24M)[74](index=74&type=chunk) - The **$1.0 million increase in G&A expenses** was driven by higher salaries and compensation ($0.2M), legal and accounting fees ($0.3M), and other public company costs ($0.6M)[75](index=75&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $24.6 million in cash, which is deemed sufficient to fund operations through 2022 - The principal source of liquidity is cash, which totaled **$24.6 million** as of March 31, 2021[76](index=76&type=chunk) - The company's IPO in December 2020 raised **net proceeds of approximately $31.1 million**[79](index=79&type=chunk) - Current cash is estimated to be **sufficient to fund operations through the end of 2022**, which includes completing the Phase 2b clinical trial for IMC-1 and planning for a Phase 3 study[81](index=81&type=chunk) Cash Flow Summary | Cash Flow Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,112,202) | $(277,379) | | Net cash (used in) provided by financing activities | $(97,604) | $1,162,500 | | **(Decrease) increase in cash** | **$(5,209,806)** | **$885,121** | [Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company is exempt from this disclosure as a smaller reporting company - As a smaller reporting company, Virios Therapeutics is not required to provide this disclosure[92](index=92&type=chunk) [Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls were deemed ineffective due to a material weakness in internal financial reporting controls - Management concluded that **disclosure controls and procedures were not effective** as of the end of the reporting period[94](index=94&type=chunk) - A **material weakness in internal control over financial reporting exists** due to a lack of effective segregation of duties, financial statement reporting, and general technology controls[95](index=95&type=chunk) - Remediation efforts initiated in April 2021 include contracting with a third party for controller assistance and implementing a Delegation of Authority Policy to improve segregation of duties[96](index=96&type=chunk) [Part II: Other Information](index=29&type=section&id=Part%20II%20Other%20Information) [Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company does not currently have any pending litigation that it believes to be material[100](index=100&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company is exempt from this disclosure as a smaller reporting company - As a smaller reporting company, Virios Therapeutics is not required to provide this disclosure[101](index=101&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=29&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the period - None reported for the period[102](index=102&type=chunk) [Defaults Upon Senior Securities](index=29&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - None reported[103](index=103&type=chunk) [Mine Safety Disclosures](index=29&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This disclosure is not applicable to the company's operations - Not applicable[104](index=104&type=chunk) [Other Information](index=29&type=section&id=Item%205.%20Other%20Information) No other material information was required to be disclosed for the period - None reported[105](index=105&type=chunk) [Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the report, including certifications and XBRL data - The Exhibit Index lists documents filed with the report, including the Certificate of Incorporation, Bylaws, CEO/CFO certifications (302 and 906), and XBRL data files[109](index=109&type=chunk)

Financial Performance - The company reported a net loss of $10,346,395 for the year ended December 31, 2020, compared to a net loss of $2,473,627 for the year ended December 31, 2019, representing an increase in loss of approximately 318%[445]. - Total operating expenses for 2020 were $10,005,394, significantly higher than $2,178,499 in 2019, indicating a year-over-year increase of approximately 359%[445]. - The company had net cash used in operating activities of $3,895,195 for the year ended December 31, 2020, compared to $2,092,150 for the year ended December 31, 2019, indicating a 86% increase in cash outflows[463]. - As of December 31, 2020, the company had an accumulated deficit of approximately $28.0 million[463]. - The company has not generated any revenues to date and expects to incur losses in the future as it continues its development activities[462]. Expenses Breakdown - Research and development expenses decreased to $194,013 in 2020 from $800,620 in 2019, a reduction of about 76%[445]. - General and administrative expenses surged to $9,811,381 in 2020, up from $1,377,879 in 2019, reflecting an increase of approximately 613%[445]. - The Company recognized interest expense related to the amortization of issuance costs for convertible promissory notes amounting to $53,983 for the year ended December 31, 2020, compared to $26,325 in 2019[478]. - The total accrued expenses amounted to $784,104, an increase from $525,445 in 2019[495]. - Interest expense related to the Fourth Offering was $231,364 for 2020 and $163,123 for 2019, while the Fifth Offering incurred $98,634 in interest expense for 2020[500]. Assets and Liabilities - The company had total current assets of $31,472,731 as of December 31, 2020, compared to $315,900 as of December 31, 2019, marking a substantial increase of approximately 9,895%[443]. - Total liabilities decreased to $1,531,842 in 2020 from $5,258,409 in 2019, a reduction of about 71%[443]. - The company had cash reserves of $29,795,366 as of December 31, 2020, compared to $309,384 at the end of 2019, indicating an increase of approximately 9,523%[443]. - The total prepaid expenses and other current assets as of December 31, 2020, were $1,677,365, significantly higher than $6,516 in 2019[493]. Capital and Funding - The company raised approximately $31.1 million in net proceeds from its initial public offering (IPO) on December 16, 2020, after deducting underwriting discounts and offering expenses[461]. - The IPO involved the sale of 3,450,000 shares of common stock at an initial offering price of $10.00 per share, generating gross proceeds of $34.5 million[461]. - The Company completed its Fourth Offering in 2019, raising a total of $2,430,000 across three rounds: $925,000 in the first round, $925,000 in the second round, and $580,000 in the third round[499]. - The Company raised $1,320,000 in its Third Offering from January to August 2018, with a total issuance cost of $69,532[515]. - The Company will need to raise additional capital to complete clinical development and commercially develop its product candidates[464]. Corporate Structure and Governance - The Company converted from a limited liability company to a corporation on December 16, 2020, prior to its IPO[459]. - The Company is classified as an emerging growth company, allowing it to delay adopting new accounting standards until they apply to private companies[487]. - The Company converted to a Delaware corporation and is now subject to U.S. federal and state income taxes, with no income tax expense or benefit reported for the years ended December 31, 2020 and 2019 due to losses[552]. Stock and Equity Compensation - The weighted average number of shares outstanding increased to 4,926,985 in 2020 from 4,832,494 in 2019, reflecting a growth of about 2%[445]. - As of December 31, 2020, the Company had authorized the issuance of 45,000,000 shares, including 43,000,000 Common Stock and 2,000,000 Preferred Stock[521]. - The Company recognized share-based compensation expense of $3,441,687 during 2020 related to stock options, with no unrecognized compensation expense as the options were 100% vested upon issuance[542]. - The Company granted 172,500 warrants to underwriters at an exercise price of $12.50 per share, which is 125% of the IPO price, with a five-year term[543]. - The Company issued non-qualified stock options to the President equal to 6.0% of outstanding shares prior to the IPO, with a strike price of $10.00 per share and an aggregate grant date fair value of $1,987,831[548]. Future Outlook and Risks - The company anticipates the need for additional capital to fund operations, which may lead to dilution for existing shareholders[9]. - The company is heavily dependent on the success of its drug candidate IMC-1, and failure to obtain regulatory approval could significantly harm its business[9]. - The Company has determined that it does not have any material unrecognized tax benefits or obligations as of December 31, 2020[481]. - The Company recorded a net operating loss carryforward of $2,315,510 for both Federal and Georgia income tax purposes as of December 31, 2020, which can be carried forward indefinitely[554].