Laryngeal Cleft

- New patent would extend coverage and expand potential value of Virios’ antiviral pipeline globally – - Active Long-COVID characterized by immune dysfunction leading to recurrent herpesviruses reactivation - - Published data indicates increased Epstein-Barr herpes virus in Long-COVID patients, highlighting potential for antiviral therapy to treat fatigue and other Long-COVID symptoms – ATLANTA, March 26, 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”), today announced that the World Intellectual Property Organization (WIPO) has published Virios’ global patent application titled “Valacyclovir and Celecoxib for the Treatment of Alzheimer’s and COVID-19”, which covers the use of IMC-2, a proprietary combination of valacyclovir and celecoxib. This milestone enables Virios to streamline the process for obtaining patent protection globally, representing a precursor to the national phase of patent examination by targeted countries across the globe. An open-label, exploratory LC study sponsored by Virios demonstrated that treatment with the combination of valacyclovir and celecoxib resulted in clinical and statistically significant reductions in LC associated fatigue, orthostatic intolerance, pain and anxiety. Combination treatment with valacyclovir and celecoxib is presently being assessed in a double blind, placebo-controlled study under the direction of Dr. Lucinda Bateman, MD, supported by an unrestricted, investigational grant provided by the Company to the Bateman Horne Center. Results from this important trial are expected this summer. The 2024 National Center for Health Statistics Household Pulse Survey estimates that 17.6% of the US population have experienced LC, representing upwards of 45 million potential adult patients, since the pandemic started in November of 2019. Previous estimates suggest that up to 10 million children in the US have also experienced LC. There are no treatments approved by the FDA to treat the symptoms associated with LC, further highlighting the need for new treatments. A multitude of studies suggest that while LC is a consequence of SARS-CoV-2 virus infection, the development of LC seems related to immune system dysfunction and complement activation. It has been postulated that an exhausted immune response to COVID-19 enables reactivation of previously dormant herpesviruses. Reactivated herpesviruses such as Epstein-Barr virus (EBV) may be associated with fatigue and cognitive dysfunction. Fatigue and cognitive dysfunction are predominant LC symptoms. About Virios Therapeutics Virios Therapeutics (Nasdaq: VIRI) 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”) 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 syndrome, LC, chronic fatigue syndrome and 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. Our lead development candidates are novel, proprietary, fixed dose combinations of an antiviral compound and celecoxib designed to synergistically suppress herpesvirus replication, with the end goal of reducing virally promoted disease symptoms. IMC-1 (fixed dosage combination of famciclovir and celecoxib) has been granted fast track designation by the FDA. For more information, please visit . Follow Virios Therapeutics Email Alerts: LinkedIn: Twitter: Facebook: Forward-Looking Statements Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Virios Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion, timing and results of current and future clinical studies relating to Virios Therapeutics’ product candidates. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission. In particular, there can be no assurance that any development partnership or other transaction involving Virios Therapeutics will be completed on favorable terms, or at all. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. undertakes no duty to update such information except as required under applicable law. Contact IR@Virios.com

ATLANTA, Feb. 29, 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”), today announced financial results for the fourth quarter and full year ended December 31, 2023. Key Highlights and Upcoming Milestones Virios received written communication from the Food and Drug Administration (“FDA”) on the development requirements and key endpoints associated with advancing IMC-2 into Phase 2 for treatment of LC symptoms. The FDA agreed that for its planned Phase 2 study, Virios can use fatigue as the primary endpoint and orthostatic intolerance as a key secondary endpoint to assess the effectiveness of IMC-2 in treating LC. New placebo-controlled 12-week clinical data assessing valacyclovir/celecoxib to treat Long-COVID, from an ongoing study conducted by the Bateman Horne Center via an unrestricted investigational grant provided by the Company, expected this summer. Initiation of a Phase 2 program in LC is targeted in the second half of 2024, contingent on securing funding for the program. Discussions are ongoing with potential partners to fund the advancement of IMC-1 into Phase 3 development for the treatment of FM. “We are pleased to have recently reached alignment with FDA on using fatigue response as the primary end point for evaluating IMC-2 as a treatment for Long-COVID symptoms,” said Greg Duncan, Chairman and CEO of Virios Therapeutics, Inc. “This is particularly encouraging given that our unique combination antiviral agents have demonstrated clinically and statistically significant improvement in patient fatigue in several studies, including for IMC-2 treated Long-COVID patients.” Fourth Quarter 2023 Financial Results Research and development expenses for the fourth quarter of 2023 were $0.3 million, compared to $1.3 million for the fourth quarter of 2022. The decrease quarter over quarter was due to decreases in expenses for clinical trials of $0.6 million, toxicology studies of $0.3 million and salaries and related personnel costs of $0.1 million. General and administrative expenses for the fourth quarter of 2023 remained level with the fourth quarter of 2022 at $0.8 million. Net loss for the fourth quarter of 2023 was $1.1 million, or $0.06 basic and diluted net loss per share, compared to a net loss of $2.0 million, or $0.11 basic and diluted net loss per share, for the fourth quarter of 2022. Full Year 2023 Financial Results Research and development expenses for the year ended December 31, 2023 were $1.7 million, compared to $8.1 million for the year ended December 31, 2022. The $6.4 million decrease was primarily due to decreases in expenses for clinical trials of $5.5 million, toxicology studies of $0.6 million, drug development and manufacturing costs of $0.1 million, and salaries and related personnel costs of $0.3 million partially offset by an increase in regulatory consulting of $0.1 million. General and administrative expenses for the year ended December 31, 2023 were $3.7 million, compared to $4.2 million for the year ended December 31, 2022. The $0.5 million decrease was primarily due to a decrease in costs associated with being a public company. Net loss for the year ended December 31, 2023 was $5.3 million, or $0.28 basic and diluted net loss per share, compared to a net loss of $12.2 million, or $1.11 basic and diluted net loss per share, for the year ended December 31, 2022. As of December 31, 2023, Virios Therapeutics’ cash totaled $3.3 million. The Company believes it has sufficient resources to fund operations into the fourth quarter of 2024. About Virios Therapeutics Virios Therapeutics (Nasdaq: VIRI) 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”) 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 syndrome, LC, chronic fatigue syndrome and 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. Our lead development candidates are novel, proprietary, fixed dose combinations of an antiviral compound and celecoxib designed to synergistically suppress herpesvirus replication, with the end goal of reducing virally promoted disease symptoms. IMC-1 (fixed dose combination of famciclovir and celecoxib) has been granted fast track designation by the FDA. For more information, please visit . Follow Virios Therapeutics Email Alerts: LinkedIn: Twitter: Facebook: Forward-Looking Statements Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Virios Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion, timing and results of current and future clinical studies relating to Virios Therapeutics’ product candidates, potential future partnerships or other material transactions, and the requirements of or feedback from Nasdaq regarding the continued listing of our common stock. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission. Forward looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. undertakes no duty to update such information except as required under applicable law. Contact: IR@Virios.com VIRIOS THERAPEUTICS Selected Financial Data (unaudited) Condensed Statements of Operations Data Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 Revenue $ — $ — $ — $ — Operating expenses: Research and development 298,320 1,271,714 1,728,078 8,069,628 General and administrative 839,806 818,002 3,718,841 4,245,681 Total operating expenses 1,138,126 2,089,716 5,446,919 12,315,309 Loss from operations (1,138,126 ) (2,089,716 ) (5,446,919 ) (12,315,309 ) Other income 34,953 45,160 150,904 67,475 Net loss $ (1,103,173 ) $ (2,044,556 ) $ (5,296,015 ) $ (12,247,834 ) Net loss per share of common stock — basic and diluted $ (0.06 ) $ (0.11 ) $ (0.28 ) $ (1. 11 ) Weighted average shares outstanding — basic and diluted 19,257,937 18,330,390 18,776,790 11,070,116 Condensed Balance Sheet Data December 31, December 31, 2023 2022 Cash $ 3,316,946 $ 7,030,992 Total assets 4,165,442 8,369,756 Total liabilities 358,548 1,043,262 Total stockholders’ equity 3,806,894 7,326,494

ATLANTA, Ga., Feb. 28, 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”), today issued a Shareholder Letter highlighting the Company’s progress and key milestones in 2024. Dear Virios (VIRI) Shareholders, On behalf of the Virios directors and the executive team, we would like to provide a corporate progress report on several key topics as we proceed through the first quarter of 2024. Special Shareholder Meeting: On March 1, 2024, we will hold a special shareholder meeting, whereby we are requesting your approval to execute a reverse stock split some time over the course of the next 12 months. In our outreach to shareholders in connection with the meeting, we heard concerns about whether and when the reverse stock split would be implemented, if approved, and we want to address those concerns here. Approval of this proposal does not commit the Company to the execution of a reverse stock split. It does provide maximum strategic optionality moving forward, including the ability to execute strategic transactions and to enable future fund raising. Indeed, the Board’s unanimous view is that the implementation of the reverse stock split should be deferred until after the Company has clarity on the results of the current Long-COVID (“LC”) study being independently run via an unrestricted grant to the Bateman Horne Center. Results from this study are currently projected to be reported in the second half of 2024. Director Fee and Management Team 10% Salary Cut: We work diligently to minimize operational expenses and deploy our cash to fund value creating research as evidenced by the fact that we operate VIRI as a public company with four full-time employees. In order to underscore the management team’s alignment as fellow shareholders and to emphasize our commitment to long-term success and value creation, all of Virios’ employees have agreed to a 10% salary compensation reduction in exchange for future vesting stock options. In addition, our directors have also agreed to a 10% reduction in cash director fees. IMC-2 Long-COVID Development Program: We have clarity from the Food and Drug Administration (“FDA”) on the development requirements for advancing IMC-2 (combination of valacyclovir and celecoxib) into Phase 2 development as a treatment for LC symptoms. As noted above, we expect to receive top line results from the ongoing Bateman Horne Center independent investigator supported study in the second half of 2024. There continues to remain a high unmet medical need for treating LC symptoms. Recently, a USA Today Health article reported that federal estimates suggest at least 16 million Americans have LC and as many as 4 million of them are disabled by it. There are currently no FDA approved LC treatments. We are excited that IMC-2 has the potential to be one of the first approved treatments for LC and are exploring various means by which to fund execution of the important Phase 2b IMC-2 trial. IMC-1 Fibromyalgia Development Program: We reached alignment with the FDA on the IMC-1 (combination of famciclovir and celecoxib) Phase 3 development program for treatment of fibromyalgia. We continue to be engaged with potential external entities who have an interest in partnering for this important program. The Virios team remains committed to delivering on the promise of combination antiviral therapy to address a multitude of serious health issues and illnesses. We appreciate your support. Sincerely, Greg DuncanChairman & Chief Executive OfficerVirios Therapeutics, Inc. About Virios Therapeutics, Inc. Virios Therapeutics (Nasdaq: VIRI) 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”) 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 syndrome, LC, chronic fatigue syndrome and 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. Our lead development candidates are novel, proprietary, fixed dose combinations of an antiviral compound and celecoxib designed to synergistically suppress herpesvirus replication, with the end goal of reducing virally promoted disease symptoms. IMC-1 (fixed dose combination of famciclovir and celecoxib) has been granted fast track designation by the FDA. For more information, please visit www.virios.com. Follow Virios Therapeutics Email Alerts: https://ir.virios.com/resources/email-alerts LinkedIn: https://www.linkedin.com/company/viriosbiotech/ Twitter: https://twitter.com/ViriosBiotech Facebook: https://www.facebook.com/ViriosBiotech/ Forward-Looking Statements Statements in this announcement contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Virios Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion, timing and results of current and future clinical studies relating to Virios Therapeutics’ product candidates, potential future partnerships or other material transactions, and the requirements of or feedback from Nasdaq regarding the continued listing of our common stock. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. undertakes no duty to update such information except as required under applicable law. Contact IR@Virios.com