- Bateman Horne Center completed enrollment in its groundbreaking investigator-initiated Long-COVID phase 2a study featuring valacyclovir and celecoxib (IMC-2) - - Top-line results from the Bateman Horne Center's Long-COVID phase 2a study expected in October 2024, will provide key insights into final design of planned Phase 2b study - ATLANTA, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the "Company"), a development-stage biotechnology company focused on advancing novel antiv ...

ATLANTA, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the "Company"), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia ("FM") and Long-COVID ("LC"), announced today that it will report second quarter 2024 financial results on Thursday, August 8, 2024 before the open of the financial markets. About Virios Therapeutics Virios Therapeutics (Nasdaq: VIRI) is a development-stage b ...

ATLANTA, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the "Company"), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia ("FM") and Long-COVID ("LC"), announced today that it will report second quarter 2024 financial results on Thursday, August 8, 2024 before the open of the financial markets. About Virios Therapeutics Virios Therapeutics (Nasdaq: VIRI) is a development-stage b ...

Core Insights - Virios Therapeutics is advancing a combination therapy of valacyclovir and celecoxib (IMC-2) for treating Long-COVID (LC) symptoms, following a positive proof of concept study that showed improvements in fatigue, pain, and overall health compared to untreated controls [2][4][9] - The company has completed enrollment for its investigator-initiated LC study, with top line results expected in October 2024 [4] - The National Center for Health Statistics estimates that 17.6% of the U.S. population, or nearly 45 million adults, have experienced Long-COVID since the pandemic began, highlighting a significant unmet medical need [5] Company Overview - Virios Therapeutics focuses on developing novel antiviral therapies for chronic diseases linked to viral infections, including fibromyalgia and Long-COVID [10] - The company’s lead candidates are fixed-dose combinations of antiviral compounds and celecoxib aimed at reducing symptoms associated with herpesvirus activation [10] - IMC-1, a combination of famciclovir and celecoxib, has received fast track designation from the FDA, indicating its potential significance in treating these conditions [10]

Core Insights - The article highlights the potential of antiviral therapy targeting Epstein-Barr virus in treating Long-COVID symptoms, particularly fatigue [1][6] - Virios Therapeutics is focused on developing novel antiviral therapies for chronic diseases linked to viral-triggered immune responses, including Long-COVID and fibromyalgia [2][5] Company Overview - Virios Therapeutics (Nasdaq: VIRI) is a development-stage biotechnology company aiming to advance antiviral therapies for diseases like fibromyalgia and Long-COVID [2] - The company’s lead candidates are fixed-dose combinations of antiviral compounds and celecoxib, designed to suppress herpesvirus replication [2] Clinical Studies - The Bateman Horne Center has completed enrollment for a proof of concept study evaluating the combination of valacyclovir and celecoxib (IMC-2) for Long-COVID symptoms, with top-line results expected in October 2024 [3][4] - Previous studies indicated that the valacyclovir/celecoxib combination improved various symptoms associated with Long-COVID compared to untreated controls [4] Market Need - An estimated 17.6% of the U.S. population, nearly 45 million adults, have experienced Long-COVID since the pandemic began, highlighting a significant unmet medical need for effective treatments [5] - Currently, there are no FDA-approved treatments for Long-COVID symptoms, emphasizing the urgency for new therapeutic options [5]

Financial Performance - The company reported net losses of $1,291,335 for the three months ended March 31, 2024, compared to $1,516,864 for the same period in 2023, indicating a decrease in losses of approximately 15%[73]. - Total operating expenses for the three months ended March 31, 2024, were $1,314,101, down from $1,557,287 in the same period of 2023, reflecting a reduction of about 15.6%[79]. - For the three months ended March 31, 2024, net cash used in operations was $0.9 million, compared to $1.7 million for the same period in 2023, indicating a reduction of approximately 47%[89][90]. - The net loss for the three months ended March 31, 2024, was $1.3 million, slightly higher than the net loss of $1.5 million reported for the same period in 2023[89][90]. - The company has incurred an accumulated deficit of $62,760,557 as of March 31, 2024[73]. Operating Expenses - Research and development expenses decreased to $343,717 for the three months ended March 31, 2024, from $497,714 in the same period of 2023, a decline of approximately 30.9%[80]. - General and administrative expenses also decreased to $970,384 for the three months ended March 31, 2024, from $1,059,573 in the same period of 2023, a reduction of about 8.4%[81]. Cash Position and Funding Needs - As of March 31, 2024, the company's cash totaled $2.4 million, which is insufficient to fund operations for the next 12 months, necessitating additional capital raising within the next three to five months[82][86]. - As of March 31, 2024, there were no off-balance sheet arrangements or relationships with unconsolidated entities[91]. Revenue Generation - The company has not generated any revenue since inception and does not anticipate generating revenue in the foreseeable future[82]. Research and Development Initiatives - The company plans to submit an investigational new drug application for IMC-2 to treat symptoms associated with Long-COVID, with ongoing studies expected to yield results in the second half of 2024[66][69]. - The company received FDA feedback on advancing IMC-1 into Phase 3 development for the treatment of fibromyalgia (FM)[65]. Strategic Partnerships - The company is actively exploring strategic partnerships and collaborations to enhance shareholder value and advance its product candidates[72]. Accounting and Reporting - There were no significant changes to critical accounting policies during the three months ended March 31, 2024, compared to the previous year[92]. - The company is utilizing the extended transition period provided by the JOBS Act, which reduces certain reporting requirements for emerging growth companies[93][94].

Financial Performance - Net loss for Q1 2024 was $1.3 million, or $0.07 per share, compared to a net loss of $1.5 million, or $0.08 per share, in Q1 2023[6] - Total operating expenses for Q1 2024 were $1.3 million, down from $1.6 million in Q1 2023[14] - General and administrative expenses for Q1 2024 were $1.0 million, down from $1.1 million in Q1 2023, primarily due to reduced insurance costs[6] - Research and development expenses for Q1 2024 were $0.3 million, a decrease of 40% from $0.5 million in Q1 2023[5] - Total stockholders' equity as of March 31, 2024, was $2.7 million, a decrease from $3.8 million at the end of 2023[14] Cash Position - As of March 31, 2024, cash totaled $2.4 million, with sufficient resources expected to fund operations into Q4 2024[7] Clinical Development - The ongoing BHC-202 study has surpassed 50% enrollment, with top-line results expected in the second half of 2024[3] - Preliminary safety analysis of the BHC-202 study shows no serious adverse events reported, indicating good tolerance for the IMC-2 combination[3] - Discussions are ongoing to find a partner for advancing IMC-1 into Phase 3 development for fibromyalgia treatment[3] - The global patent for IMC-2 has been published, facilitating the process for obtaining patent protection worldwide[3]

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, 2023 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. ...

Exhibit 99.1 Virios Therapeutics Announces Fourth Quarter and Full Year 2023 Financial Results ATLANTA, Ga., February 29, 2024 -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the "Company"), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia ("FM") and Long-COVID ("LC"), today announced financial results for the fourth quarter and full year ended December 31, 2023. Key Highlights and Upcoming Milestones "We are ...

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, 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 ju ...