VIRI Virios Therapeutics Inc

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 www.virios.com.

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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