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 June 30, 2023 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) (State or other jurisdi ...

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 March 31, 2023 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) (State or other jurisd ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-39811 VIRIOS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 85-4314201 (State of Other Jurisdiction of incorporation or Organization) (I.R.S. ...

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, 2022 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 ...

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 June 30, 2022 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) (State or other jurisdi ...

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 March 31, 2022 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 85-4314201 (S ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-39811 VIRIOS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 85-4314201 (State of Other Jurisdiction of incorporation or Organization) (I.R.S. ...

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 ...

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 June 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) (State or other jurisdi ...

[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)