1. Intellectual Property Estate Now Includes Valacyclovir-Celecoxib Combination

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases, announced today that the United States Patent and Trademark Office ("USPTO") has granted Virios Therapeutics patent exclusivity on its valacyclovir-celecoxib combination drug candidate to 2033. The Company's intellectual property portfolio now includes 21 issued patents, consisting of 13 issued U.S. patents and 8 issued foreign patents, with exclusivity into 2033. This portfolio of patents also covers the Company's lead development candidate IMC-1, a synergistic, fixed dose combination…

    Intellectual Property Estate Now Includes Valacyclovir-Celecoxib Combination

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases, announced today that the United States Patent and Trademark Office ("USPTO") has granted Virios Therapeutics patent exclusivity on its valacyclovir-celecoxib combination drug candidate to 2033. The Company's intellectual property portfolio now includes 21 issued patents, consisting of 13 issued U.S. patents and 8 issued foreign patents, with exclusivity into 2033. This portfolio of patents also covers the Company's lead development candidate IMC-1, a synergistic, fixed dose combination of famciclovir and celecoxib, which is in Phase 2b development for the treatment of fibromyalgia.

    "We are pleased to expand our substantial intellectual property portfolio with a new patent for an additional proprietary antiviral combination therapy," stated Greg Duncan, Chairman and Chief Executive Officer. "In the context of increasing recognition in the scientific community of the potential role of activated viruses in triggering a wide range of conditions, Virios is actively exploring new disease targets as a complement to our ongoing fibromyalgia Phase 2b program."

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel syndrome ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  2. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases, announced today that Greg Duncan, Chairman and Chief Executive Officer, will present a company overview at the H.C. Wainwright 23rd Annual Global Investment Conference which is taking place virtually September 13 – 15, 2021.

    The presentation will focus on the role of activated viruses triggering a wide range of conditions, including fibromyalgia, irritable bowel syndrome and fatigue-related disorders.

    The presentation will be available for on-demand access beginning Monday, September 13, 2021, at 7:00 AM ET, on Virios Therapeutics' website under the Investors section…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases, announced today that Greg Duncan, Chairman and Chief Executive Officer, will present a company overview at the H.C. Wainwright 23rd Annual Global Investment Conference which is taking place virtually September 13 – 15, 2021.

    The presentation will focus on the role of activated viruses triggering a wide range of conditions, including fibromyalgia, irritable bowel syndrome and fatigue-related disorders.

    The presentation will be available for on-demand access beginning Monday, September 13, 2021, at 7:00 AM ET, on Virios Therapeutics' website under the Investors section: Events and Presentations.

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  3. Data from Ongoing Phase 2b Fibromyalgia Trial Projected for Mid-2022

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, announced today the expansion of the company's social media platforms as well as social media disclosure.

    Virios has established a social presence on LinkedIn, Twitter and Facebook, where current and potential investors and other interested persons can connect with the company and receive future updates. The Company plans to use the newly established social media profiles in addition to the Company's existing Investor Relations website for the distribution of Company information. Accordingly, investors should…

    Data from Ongoing Phase 2b Fibromyalgia Trial Projected for Mid-2022

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, announced today the expansion of the company's social media platforms as well as social media disclosure.

    Virios has established a social presence on LinkedIn, Twitter and Facebook, where current and potential investors and other interested persons can connect with the company and receive future updates. The Company plans to use the newly established social media profiles in addition to the Company's existing Investor Relations website for the distribution of Company information. Accordingly, investors should connect with Virios to monitor these channels, along with following press releases, SEC filings and public conference calls and webcasts. The links can be found below to each of these platforms.

    Content will include company news and updates as well as educational, scientific-based posts regarding Herpes Simplex Virus-1 ("HSV-1"), fibromyalgia, irritable bowel syndrome ("IBS"), chronic fatigue syndrome ("CFS") and functional somatic syndrome, all of which are characterized by a waxing and waning manifestation of disease.

    "With the recent news that all 41 sites involved in our ongoing 460 patient Phase 2b fibromyalgia ("FM") trial are now fully activated and enrolling patients, now is the perfect time to expand our digital presence through social media," said Virios Therapeutics CEO Greg Duncan.

    Mr. Duncan continued, "The current trial builds on the encouraging results from our previously completed 2a FM clinical study that demonstrated our lead antiviral development candidate, orally administered IMC-1, met its primary endpoint of pain reduction and was statistically tolerated better than placebo. With the new trial underway we are excited to share new results and updates with investors and patients alike through these platforms."

    Virios Therapeutics LinkedIn: https://www.linkedin.com/company/ViriosBiotech/

    Virios Therapeutics Twitter: https://twitter.com/ViriosBiotech

    Virios Therapeutics Facebook: https://www.facebook.com/ViriosBiotech/

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable syndrome ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  4. Data from Ongoing Phase 2b Fibromyalgia Trial Projected for Mid-2022

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, announced today that Chairman and CEO, Greg Duncan, highlighted the Company's novel combination antiviral development approach, its ongoing Phase 2b trial Fibromyalgia trial and plans for expanded pipeline programs in irritable bowel syndrome (IBS) and fatigue related disorders during a video interview with Stock News Now, a microcap financial news portal that features news and insights from the microcap and emerging growth financial community.

    The archived replay of the interview may be accessed on the Virios…

    Data from Ongoing Phase 2b Fibromyalgia Trial Projected for Mid-2022

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, announced today that Chairman and CEO, Greg Duncan, highlighted the Company's novel combination antiviral development approach, its ongoing Phase 2b trial Fibromyalgia trial and plans for expanded pipeline programs in irritable bowel syndrome (IBS) and fatigue related disorders during a video interview with Stock News Now, a microcap financial news portal that features news and insights from the microcap and emerging growth financial community.

    The archived replay of the interview may be accessed on the Virios Therapeutics website under the Investors section: Events and Presentations.

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel syndrome ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  5. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, today reported financial results for the second quarter ended June 30, 2021 and provided a corporate update.

    "Our landmark Phase 2b fibromyalgia clinical trial, referred to as FORTRESS, has rapidly progressed and patients are being enrolled at more than 40 clinical trial sites, keeping us on track to announce top line results in mid-2022," stated Greg Duncan, Chairman and Chief Executive Officer. "There is increasing recognition in the scientific community of the potential role of activated viruses triggering a wide range of conditions, including fibromyalgia, irritable bowel…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, today reported financial results for the second quarter ended June 30, 2021 and provided a corporate update.

    "Our landmark Phase 2b fibromyalgia clinical trial, referred to as FORTRESS, has rapidly progressed and patients are being enrolled at more than 40 clinical trial sites, keeping us on track to announce top line results in mid-2022," stated Greg Duncan, Chairman and Chief Executive Officer. "There is increasing recognition in the scientific community of the potential role of activated viruses triggering a wide range of conditions, including fibromyalgia, irritable bowel syndrome and fatigue-related disorders. We are exploring the feasibility and timing of executing additional HSV-1 targeted research programs complementary to our fibromyalgia program and expect to provide an update on these plans later this year."

    Key Highlights and Upcoming Milestones

    • Enrollment is ongoing in the FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1) Phase 2b trial;
    • 41 clinical trial sites are activated and enrolling patients for the FORTRESS trial;
    • Top line results of the FORTRESS Phase 2b clinical trial are expected in mid-2022;
    • Orally presented gastrointestinal (GI) biopsy study data highlighting the role of active HSV-1 as a potential root cause of chronic GI disorders at Digestive Disease Week 2021;
    • Poster presentation of safety data from the Phase 2a Fibromyalgia Trial at the International Association of the Study of Pain;
    • Poster presentation of the Phase 2a Fibromyalgia Trial data on efficacy analyses of key secondary endpoints at the EULAR European Congress of Rheumatology;
    • Presented at the Needham Healthcare Conference and the Benzinga Global Small Cap Conference;
    • Bloomberg News interview in July 2021 with our CEO, Greg Duncan;
    • Upcoming corporate presentations at two investor conferences: SNN Network Summer Virtual Event being held August 17-19, 2021, and H.C. Wainwright 23rd Annual Global Investment Conference being held September 13-15, 2021.

    Second Quarter 2021 Financial Results

    Research and development expenses for the second quarter ended June 30, 2021 were $3.2 million, compared to $0.02 million for the second quarter ended June 30, 2020. The $3.2 million increase was primarily attributable to increases in expenses for the FORTRESS clinical trial, the chronic toxicology program and drug development and manufacturing costs.

    General and administrative expenses for the second quarter ended June 30, 2021 were $1.1 million, compared to $0.5 million for the second quarter ended June 30, 2020. The $0.6 million increase was primarily attributable to costs associated with being a public company.

    Net loss for the second quarter ended June 30, 2021 was $4.3 million, or ($0.51) basic and diluted per share, compared to a net loss of $0.7 million, or ($0.14) basic and diluted per share, for the second quarter ended June 30, 2020.

    As of June 30, 2021, cash totaled $21.8 million. The Company believes it will have sufficient resources to fund its planned operations through the end of 2022.

    Conference Call & Webcast Details

    Virios Therapeutics management will host a webcast and conference call on August 12, 2021 at 8:30 a.m. ET to discuss the results and provide a corporate update. The live and archived webcast of the call may be accessed on the Virios Therapeutics website under the Investors section: Events and Presentations. The live call can also be accessed by dialing (844) 602-0380 (domestic) or (862) 298-0970 (international) and asking to be connected to the "Virios Therapeutics Conference Call".

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

    -Financial Tables Follow-

    VIRIOS THERAPEUTICS

    Selected Financial Data

    (unaudited)

    Condensed Statements of Operations Data

     

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

     

    2021

     

    2020

     

    2021

     

    2020

    Revenue

     

    $

     

     

    $

     

     

    $

     

     

    $

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    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

     

    Loss from operations

     

     

    (4,284,457

    )

     

     

    (538,380

    )

     

     

    (7,341,891

    )

     

     

    (920,932

    )

    Other income (expense)

     

     

    1,495

     

     

     

    (116,205

    )

     

     

    2,896

     

     

     

    (200,206

    )

    Net loss

     

    $

    (4,282,962

    )

     

    $

    (654,585

    )

     

    $

    (7,338,995

    )

     

    $

    (1,121,138

    )

    Net loss per share of common stock — basic and diluted

     

    $

    (0.51

    )

     

    $

    (0.14

    )

     

    $

    (0.88

    )

     

    $

    (0.23

    )

    Weighted average shares outstanding — basic and diluted

     

     

    8,330,390

     

     

     

    4,832,494

     

     

     

    8,328,212

     

     

     

    4,832,494

     

    Condensed Balance Sheet Data

    June 30,

     

    December 31,

     

    2021

     

    2020

     

     

     

     

     

     

     

     

    Cash

    $

    21,835,092

     

     

    $

    29,795,366

     

    Total assets

     

    23,764,782

     

     

     

    31,472,731

     

    Total liabilities

     

    906,257

     

     

     

    1,531,842

     

    Total stockholders' equity

     

    22,858,525

     

     

     

    29,940,889

     

     

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  6. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, announced today that Greg Duncan, Chairman and Chief Executive Officer, will present a company overview at the SNN Network Summer Virtual Conference on August 19, 2021 at 9:00 a.m. ET.

    The presentation will focus on the role of activated viruses triggering a wide range of conditions, including fibromyalgia ("FM"), irritable bowel syndrome and fatigue-related disorders, and progress in its currently enrolling Phase 2b FM clinical trial.

    Management will be available for one-on-one meetings to be held throughout the conference.

    The live and archived replay of the presentation…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, announced today that Greg Duncan, Chairman and Chief Executive Officer, will present a company overview at the SNN Network Summer Virtual Conference on August 19, 2021 at 9:00 a.m. ET.

    The presentation will focus on the role of activated viruses triggering a wide range of conditions, including fibromyalgia ("FM"), irritable bowel syndrome and fatigue-related disorders, and progress in its currently enrolling Phase 2b FM clinical trial.

    Management will be available for one-on-one meetings to be held throughout the conference.

    The live and archived replay of the presentation may be accessed on the Virios Therapeutics website under the Investors section: Events and Presentations.

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  7. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, announced today that an interview with Chairman and CEO, Greg Duncan, was aired on Bloomberg TV during The RedChip Money Report®, which delivers commentary on small-cap investing, interviews with Wall Street analysts, financial book reviews, as well as featured interviews with executives of public companies. The interview was focused on the Company's novel, combination antiviral research programs, with particular emphasis on its ongoing phase 2b fibromyalgia study.

    The archived replay of the interview may be accessed on the Virios Therapeutics website under the Investors section…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, announced today that an interview with Chairman and CEO, Greg Duncan, was aired on Bloomberg TV during The RedChip Money Report®, which delivers commentary on small-cap investing, interviews with Wall Street analysts, financial book reviews, as well as featured interviews with executives of public companies. The interview was focused on the Company's novel, combination antiviral research programs, with particular emphasis on its ongoing phase 2b fibromyalgia study.

    The archived replay of the interview may be accessed on the Virios Therapeutics website under the Investors section: Events and Presentations.

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  8. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, announced today that its second quarter 2021 financial results will be reported on Thursday, August 12, 2021 before the open of the financial markets. Management will also host a webcast and conference call on August 12, 2021 at 8:30 a.m. ET to discuss the results and provide a corporate update.

    The live and archived webcast of the call may be accessed on the Virios Therapeutics website under the Investors section: Events and Presentations. The live call can also be accessed by dialing (844) 602-0380 (domestic) or (862) 298-0970 (international) and asking to be connected to…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, announced today that its second quarter 2021 financial results will be reported on Thursday, August 12, 2021 before the open of the financial markets. Management will also host a webcast and conference call on August 12, 2021 at 8:30 a.m. ET to discuss the results and provide a corporate update.

    The live and archived webcast of the call may be accessed on the Virios Therapeutics website under the Investors section: Events and Presentations. The live call can also be accessed by dialing (844) 602-0380 (domestic) or (862) 298-0970 (international) and asking to be connected to the "Virios Therapeutics Conference Call".

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  9. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat chronic pain and fatigue related diseases, announced today that all 41 sites involved in its ongoing 460 patient Phase 2b fibromyalgia (FM) trial are now fully activated and enrolling patients. This trial builds on the encouraging results from the Company's previously completed IMC-1 phase 2a FM clinical study. The 143-patient Phase 2a trial demonstrated that VIRI's lead antiviral development candidate, orally administered IMC-1, met its primary endpoint of pain reduction and was statistically better tolerated than placebo.

    IMC-1 is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat chronic pain and fatigue related diseases, announced today that all 41 sites involved in its ongoing 460 patient Phase 2b fibromyalgia (FM) trial are now fully activated and enrolling patients. This trial builds on the encouraging results from the Company's previously completed IMC-1 phase 2a FM clinical study. The 143-patient Phase 2a trial demonstrated that VIRI's lead antiviral development candidate, orally administered IMC-1, met its primary endpoint of pain reduction and was statistically better tolerated than placebo.

    IMC-1 is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress Herpes Simplex Virus-1 ("HSV-1") activation and replication. It is the Company's hypothesis that HSV-1 related immune responses can serve as a catalyst for symptoms commonly associated with FM, irritable bowel syndrome (IBS) and fatigue related disorders. This hypothesis is supported by both clinical and mechanistic data, the latter of which has suggested that HSV-1 is actively replicating in the tissue of patients diagnosed with FM and chronic GI disorders, such as IBS.

    "We are pleased that enrollment in our FORTRESS study is proceeding as planned and that all of our sites are now able to recruit patients," said Dr. R. Michael Gendreau, Virios' Chief Medical Officer.

    Dr. Gendreau continued, "Data from our prior clinical work has been presented in several recent medical meetings. These data demonstrate that in our Phase 2a FM trial, in addition to meeting the primary endpoint of significantly greater pain reduction compared with placebo, patients treated with IMC‑1 reported significantly greater improvement on the Revised Fibromyalgia Impact Questionnaire ("FIQ-R") total score showed significant improvement on all three of the FIQ‑R domains, and also showed statistical significance on the patient global impression of change (PGIC). In addition, treatment with IMC-1 was exceptionally well tolerated in this study. These secondary endpoint results, combined with excellent tolerability, suggest that IMC‑1 may represent a promising treatment option not only for alleviating pain, but also for improving other symptoms associated with FM, such as stiffness, sleep quality, depression, anxiety and fatigue."

    The Company anticipates reporting top line results from the currently enrolling FORTRESS Phase 2b FM trial in mid-2022.

    For more information, please visit www.virios.com.

    About IMC-1

    IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress HSV-1 activation and replication. IMC-1 combines two specific mechanisms of action purposely selected to inhibit HSV-1 activation and replication, thereby keeping HSV-1 in a latent (dormant) state or "down-regulating" HSV-1 from a lytic (active) state back to latency. The famciclovir component of IMC-1 inhibits viral DNA polymerase necessary for replication. The celecoxib component of IMC-1 inhibits both cyclooxegenase-2 ("COX-2") and COX-1 enzymes, used by HSV-1 to accelerate its own replication. Virios Therapeutics holds a U.S. "Composition of Matter" Synergistic Patent (US 10,251,853) for the synergistic combination for total daily dose of famciclovir and celecoxib.

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled 460 patient Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The Company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  10. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that data from the company's Phase 2a clinical trial PRID-201 demonstrated that IMC-1 was better tolerated than placebo in patients with fibromyalgia ("FM"). This result is highlighted in a poster presentation at the International Association for the Study of Pain (IASP) World Congress, being held virtually June 9 - 11, 2021 and June 16 - 18, 2021.

    IMC-1 is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that data from the company's Phase 2a clinical trial PRID-201 demonstrated that IMC-1 was better tolerated than placebo in patients with fibromyalgia ("FM"). This result is highlighted in a poster presentation at the International Association for the Study of Pain (IASP) World Congress, being held virtually June 9 - 11, 2021 and June 16 - 18, 2021.

    IMC-1 is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress Herpes Simplex Virus-1 ("HSV-1") activation and replication, with the end goal of reducing viral mediated disease burden.

    "There is a clear medical need for new, safe and effective treatments with the potential to improve care for the estimated 10 - 20 million FM patients in the U.S. and more than 200 million worldwide," commented R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Virios Therapeutics. "Our Phase 2a clinical trial data showed that IMC-1 treated patients had higher overall completion rates and lower rates of discontinuation due to adverse events, as compared with placebo-treated patients. This is an especially encouraging result when viewed in the background of current patient and provider dissatisfaction with the generally poor tolerability of existing approved FM treatments," concluded Dr. Gendreau.

    Title: The Safety of IMC‑1 in Patients with Fibromyalgia: Phase 2a Study Results

    Lead Author: William Pridgen, M.D., Tuscaloosa Surgical Associates

    Conclusions: IMC‑1 exhibited an encouraging safety profile, as AEs occurred at a lower rate and were less severe in the IMC‑1 treatment group compared with placebo. The discontinuation rate due to AEs was nearly 3‑fold higher in patients receiving placebo compared with patients receiving IMC‑1, suggesting that treatment with IMC‑1 was unusually well‑tolerated. In this study, IMC‑1 demonstrated significant reductions in pain, fatigue, and other important symptoms in patients with FM. These results suggest that IMC‑1 may offer a promising and well‑tolerated option to treat patients with FM.

    For more information, please visit www.virios.com.

    About IMC-1

    IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress HSV-1 activation and replication, with the end goal of reducing viral mediated disease burden. IMC-1 combines two specific mechanisms of action purposely selected to inhibit HSV-1 activation and replication, thereby keeping HSV-1 in a latent (dormant) state or "down-regulating" HSV-1 from a lytic (active) state back to latency. The famciclovir component of IMC-1 inhibits viral DNA polymerase necessary for replication. The celecoxib component of IMC-1 inhibits both cyclooxegenase-2 ("COX-2") and COX-1 enzymes, used by HSV-1 to accelerate its own replication. Virios Therapeutics holds a U.S. "Composition of Matter" Synergistic Patent (US 10,251,853) for the synergistic combination for total daily dose of famciclovir and celecoxib.

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  11. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today dosing of the first patient in its Phase 2b clinical trial, referred to as FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1), evaluating IMC-1 in patients with fibromyalgia.

    IMC-1 is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress Herpes Simplex Virus-1 ("HSV-1") activation and replication, with the end goal of reducing viral mediated disease burden.

    "There…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today dosing of the first patient in its Phase 2b clinical trial, referred to as FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1), evaluating IMC-1 in patients with fibromyalgia.

    IMC-1 is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress Herpes Simplex Virus-1 ("HSV-1") activation and replication, with the end goal of reducing viral mediated disease burden.

    "There is currently widespread dissatisfaction among fibromyalgia patients, healthcare providers and payers with the existing FDA approved medications for the management of fibromyalgia, most notably related to their generally poor tolerability," commented R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Virios Therapeutics. "We are excited about the FORTRESS trial as we are testing optimized doses of IMC-1, and we will be measuring patients' fibromyalgia related pain on a daily basis. Based on industry standard fibromyalgia patient recruitment rates, we expect to complete the trial and announce top line results in mid-2022."

    "The dosing of the first patient in this Phase 2b trial marks an important milestone for Virios, as we develop new, combination antiviral therapies to improve care standards for patients suffering from chronic diseases like fibromyalgia and irritable bowel syndrome," said Greg Duncan, Chairman and Chief Executive Officer of Virios Therapeutics. "Virios has a unique potential to create significant value in meeting the medical need for a new, safe and effective treatment to help the large market of 10-20 million fibromyalgia patients in the U.S. and more than 200 million worldwide."

    About IMC-1

    IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress HSV-1 activation and replication, with the end goal of reducing viral mediated disease burden. IMC-1 combines two specific mechanisms of action purposely selected to inhibit HSV-1 activation and replication, thereby keeping HSV-1 in a latent (dormant) state or "down-regulating" HSV-1 from a lytic (active) state back to latency. The famciclovir component of IMC-1 inhibits viral DNA polymerase necessary for replication. The celecoxib component of IMC-1 inhibits both cyclooxegenase-2 ("COX-2") and COX-1 enzymes, used by HSV-1 to accelerate its own replication. Virios Therapeutics holds a U.S. "Composition of Matter" Synergistic Patent (US 10,251,853) for the synergistic combination for total daily dose of famciclovir and celecoxib.

    About the IMC-1 Phase 2b Clinical Trial

    Virios Therapeutics is conducting FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1). This randomized, double-blind, multi-center, placebo-controlled Phase 2b trial is expected to enroll approximately 460 patients aged 18-65, all of whom having been diagnosed using the 2016 American College of Rheumatology diagnostic criteria for fibromyalgia. The primary endpoint for this trial will focus on reduction in pain over time, as measured daily by the Numerical Rating Scale ("NRS") 24-Hour Recall scale via an electronic diary that the patient will use at home for sixteen weeks. In addition to assessing patient's pain reduction, secondary endpoints will include change in fatigue, sleep disturbance, global health status, and patient function.

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  12. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that clinical data from its Phase 2a trial of IMC-1 in fibromyalgia ("FM") is featured in a poster presentation (poster POS0017) at the annual EULAR European Congress of Rheumatology, a renowned forum for interaction between medical doctors, scientists, people with arthritis/rheumatism, health professionals and representatives of the pharmaceutical industry worldwide, which is being held virtually June 2 - 5, 2021. The company's poster has been selected to be highlighted in a guided tour entitled "Epidemiology and treatment…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that clinical data from its Phase 2a trial of IMC-1 in fibromyalgia ("FM") is featured in a poster presentation (poster POS0017) at the annual EULAR European Congress of Rheumatology, a renowned forum for interaction between medical doctors, scientists, people with arthritis/rheumatism, health professionals and representatives of the pharmaceutical industry worldwide, which is being held virtually June 2 - 5, 2021. The company's poster has been selected to be highlighted in a guided tour entitled "Epidemiology and treatment of pain in Rheumatic and Musculoskeletal Disorders."

    IMC-1 is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress Herpes Simplex Virus-1 ("HSV-1") activation and replication, with the end goal of reducing viral mediated disease burden.

    "Given that FM is associated with a broad spectrum of symptoms beyond pain, it is important to understand the impact of IMC‑1 on other FM‑related symptoms," commented R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Virios Therapeutics. "In our Phase 2a FM trial, in addition to meeting the primary endpoints of greater tolerability and significantly greater pain reduction compared with placebo, patients treated with IMC‑1 reported significantly greater improvement compared with placebo on the Revised Fibromyalgia Impact Questionnaire ("FIQ-R") total score and on all three FIQ‑R domains. These secondary endpoint results suggest that IMC‑1 may represent a promising treatment option not only for alleviating pain, but also for improving other symptoms associated with FM, such as stiffness, sleep quality, depression, anxiety and fatigue," surmised Dr. Gendreau.

    Title: IMC‑1, a Fixed Dose Combination of Famciclovir and Celecoxib, Improves Common Symptoms Associated with Fibromyalgia in Addition to Pain: Post Hoc Analysis of a Phase 2a Trial

    Lead Author: William Pridgen, M.D., Tuscaloosa Surgical Associates

    Conclusions: In this post hoc analysis of a Phase 2a trial of IMC‑1 in patients with FM, patients treated with IMC‑1 reported significantly greater improvement compared with placebo on FIQ‑R total scores and on all FIQ‑R domains. Patients receiving IMC‑1 treatment reported significantly greater improvements versus placebo on the FIQ‑R symptom items for stiffness, sleep quality, depression, and anxiety. Improvements in patient global assessments and in fatigue assessments provide additional evidence for the beneficial effects of IMC‑1 on FM related symptoms. These results suggest that IMC‑1 may represent a promising treatment option not only for alleviating pain, but also for improving other symptoms associated with FM.

    For more information, please visit www.virios.com.

    About IMC-1

    IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress HSV-1 activation and replication, with the end goal of reducing viral mediated disease burden. IMC-1 combines two specific mechanisms of action purposely selected to inhibit HSV-1 activation and replication, thereby keeping HSV-1 in a latent (dormant) state or "down-regulating" HSV-1 from a lytic (active) state back to latency. The famciclovir component of IMC-1 inhibits viral DNA polymerase necessary for replication. The celecoxib component of IMC-1 inhibits both cyclooxegenase-2 ("COX-2") and COX-1 enzymes, used by HSV-1 to accelerate its own replication. Virios Therapeutics holds a U.S. "Composition of Matter" Synergistic Patent (US 10,251,853) for the synergistic combination for total daily dose of famciclovir and celecoxib.

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  13. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that clinical data was highlighted in an oral presentation at Digestive Disease Week® ("DDW") 2021, the premier global meeting for physicians, researchers and industry in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery, which was held virtually May 21 – 23, 2021.

    "The data presented by Dr. Duffy comprised a tissue biopsy study jointly conducted between the University of Alabama and Virios Therapeutics," commented R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Virios Therapeutics…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that clinical data was highlighted in an oral presentation at Digestive Disease Week® ("DDW") 2021, the premier global meeting for physicians, researchers and industry in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery, which was held virtually May 21 – 23, 2021.

    "The data presented by Dr. Duffy comprised a tissue biopsy study jointly conducted between the University of Alabama and Virios Therapeutics," commented R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Virios Therapeutics. "The study examined gastric mucosa biopsies from three cohorts: patients with functional gastrointestinal disorders ("FGID"), patients with both FGID and fibromyalgia (FM), and control patients. Biopsy specimens were analyzed for the presence of active herpesvirus infections. As is discussed in the presentation, there was a marked increase in the presence of actively replicating herpes simplex virus type 1 (HSV-1) in gastric mucosal tissue from FGID and FGID + FM patient groups as compared to control patients."

    "This finding highlights the potential role of activated HSV-1 as a potential root cause of chronic gastrointestinal disorders. Furthermore, this presentation provides further visibility to the medical community on the potential utility of combination antiviral drug therapies, such as IMC-1, for patients with chronic illnesses such as fibromyalgia ("FM") and irritable bowel syndrome ("IBS"), which are characterized by waxing and waning manifestation of disease," concluded Dr. Gendreau."

    Session: Clinical Science Late-Breaking Abstract Plenary

    Title: Active Herpes Simplex Virus Type 1 Infection of the Gastric Mucosa is Associated with Functional Gastrointestinal Disorders: A Pilot Case-Control Study (Abstract # 3581012)

    Presenter: Carol Duffy, Ph.D., University of Alabama

    Conclusions: Analysis of gastric mucosa biopsies revealed a significant positive association between actively replicating gastric HSV-1 and multiple functional gastrointestinal disorders, with and without concomitant FM. FGIDs including IBS, functional dysphagia, and functional dyspepsia may be related to active HSV-1 infection. Further investigation into the prevalence and possible causal nature of this association is warranted.

    For more information, please visit www.virios.com.

    About IMC-1

    IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress Herpes Simplex Virus-1 ("HSV-1") activation and replication, with the end goal of reducing viral mediated disease burden. IMC-1 combines two specific mechanisms of action purposely selected to inhibit HSV-1 activation and replication, thereby keeping HSV-1 in a latent (dormant) state or "down-regulating" HSV-1 from a lytic (active) state back to latency. The famciclovir component of IMC-1 inhibits viral DNA polymerase necessary for replication. The celecoxib component of IMC-1 inhibits both cyclooxegenase-2 ("COX-2") and COX-1 enzymes, used by HSV-1 to accelerate its own replication. Virios Therapeutics holds a U.S. "Composition of Matter" Synergistic Patent (US 10,251,853) for the synergistic combination for total daily dose of famciclovir and celecoxib.

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  14. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, today reported financial results for the first quarter ended March 31, 2021.

    "Our team has made significant operational progress to ensure the commencement of our landmark Phase 2b fibromyalgia clinical trial, referred to as FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1), with top line results projected in mid-2022," stated Greg Duncan, Chairman and Chief Executive Officer. "We are pleased to see the research community's growing excitement about IMC-1 as a potential treatment for fibromyalgia,

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, today reported financial results for the first quarter ended March 31, 2021.

    "Our team has made significant operational progress to ensure the commencement of our landmark Phase 2b fibromyalgia clinical trial, referred to as FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1), with top line results projected in mid-2022," stated Greg Duncan, Chairman and Chief Executive Officer. "We are pleased to see the research community's growing excitement about IMC-1 as a potential treatment for fibromyalgia, as evidenced by the rapid sign up of more than 40 clinical trial sites and the acceptance of new analyses from our Phase 2a study results to be presented in June at two major medical meetings, the European Congress of Rheumatology (EULAR), and the International Association for the Study of Pain (IASP) World Congress."

    Key Highlights

    • Prepared more than 40 research sites to commence recruitment of the FORTRESS Phase 2b study in Q2 2021;
    • Reported that the gastrointestinal (GI) biopsy study highlighting the role of active HSV-1 replication was accepted for oral presentation at the 2021 Digestive Disease Week medical conference, the largest GI focused meeting in the U.S.;
    • Commenced chronic toxicology program to support dosing of IMC-1 for intervals of 1 year or more;
    • Advanced collaboration with Dr. Michael Camilleri of the Mayo Clinic to explore the role of antiviral therapy in managing Irritable Bowel Syndrome (IBS); and
    • Presented at HC Wainwright Global Healthcare and BioConnect Conferences, BIO CEO & Investor Conference and Needham Healthcare Conference.

    First Quarter 2021 Financial Results

    Research and development expenses for the first quarter ended March 31, 2021 were $1.71 million, compared to $0.03 million for the first quarter ended March 31, 2020. The $1.68 million increase was primarily attributable to increases in expenses for the FORTRESS clinical trial and chronic toxicology program.

    General and administrative expenses for the first quarter ended March 31, 2021 were $1.35 million, compared to $0.35 million for the first quarter ended March 31, 2020. The $1.0 million increase was primarily attributable to legal and accounting fees and other costs associated with being a public company.

    Net loss for the first quarter ended March 31, 2021 was $3.1 million, or ($0.37) basic and diluted per share, compared to a net loss of $0.5 million, or ($0.10) basic and diluted per share, for the first quarter ended March 31, 2020.

    As of March 31, 2021, Virios Therapeutics cash totaled $24.6 million. The Company believes it will have sufficient resources to fund its planned operations through the end of 2022.

    Conference Call & Webcast Details

    Virios Therapeutics management will host a webcast and conference call on May 13, 2021 at 8:30 a.m. ET to discuss the results and provide a corporate update. The live and archived webcast of the call may be accessed on the Virios Therapeutics website under the Investors section: Events and Presentations. The live call can also be accessed by dialing (877) 407-8133 (domestic) or (201) 689-8040 (international) and asking to be connected to the "Virios Therapeutics Conference Call".

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

    -Financial Tables Follow-

    VIRIOS THERAPEUTICS

    Selected Financial Data

    (unaudited)

    Condensed Statements of

    Operations Data

     

    Three Months Ended

    March 31,

     

     

     

     

    2021

     

     

    2020

     

     

    Revenue

     

    $

     

     

    $

     

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

    Research and development

     

     

    1,706,957

     

     

     

    30,539

     

     

    General and administrative

     

     

    1,350,476

     

     

     

    352,014

     

     

    Total operating expenses

     

     

    3,057,433

     

     

     

    382,553

     

     

    Loss from operations

     

     

    (3,057,433

    )

     

     

    (382,553

    )

     

    Other income (expense)

     

     

    1,400

     

     

     

    (84,000

    )

     

    Net loss

     

    $

    (3,056,033

    )

     

    $

    (466,553

    )

     

    Net loss per share of common stock —

    basic and diluted

     

    $

    (0.37

    )

     

    $

    (0.10

    )

     

    Weighted average shares outstanding —

    basic and diluted

     

     

    8,326,010

     

     

     

    4,832,494

     

     

    Condensed Balance Sheet Data

    March 31,

     

     

    December 31,

     

     

    2021

     

     

    2020

     

     

     

     

     

     

     

     

     

    Cash

    $

    24,585,560

     

     

    $

    29,795,366

     

    Total assets

     

    28,274,537

     

     

     

    31,472,731

     

    Total liabilities

     

    1,167,294

     

     

     

    1,531,842

     

    Total stockholders' equity

     

    27,107,243

     

     

     

    29,940,889

     

     

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  15. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that Greg Duncan, Chairman and Chief Executive Officer, will present a company overview at the Benzinga Global Small Cap Conference on May 14, 2021 at 11:55 a.m. ET.

    The presentation will focus on the need for new approaches to treat fibromyalgia ("FM"), the novel antiviral approach being pursued by Virios Therapeutics, and the potential of IMC-1 as an FM treatment, based on positive results from a Phase 2 proof of concept clinical trial.

    A link to the live and archived webcast of the presentation may be accessed on…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that Greg Duncan, Chairman and Chief Executive Officer, will present a company overview at the Benzinga Global Small Cap Conference on May 14, 2021 at 11:55 a.m. ET.

    The presentation will focus on the need for new approaches to treat fibromyalgia ("FM"), the novel antiviral approach being pursued by Virios Therapeutics, and the potential of IMC-1 as an FM treatment, based on positive results from a Phase 2 proof of concept clinical trial.

    A link to the live and archived webcast of the presentation may be accessed on Virios Therapeutics' website under the Investors section: Events and Presentations.

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2 clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2B trial designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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. 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, 2020 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.

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  16. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that its first quarter 2021 financial results will be reported on Thursday, May 13, 2021 before the open of the financial markets. Management will also host a webcast and conference call on May 13, 2021 at 8:30 a.m. ET to discuss the results and provide a corporate update.

    The live and archived webcast of the call may be accessed on the Virios Therapeutics website under the Investors section: Events and Presentations. The live call can also be accessed by dialing (877) 407-8133 (domestic) or (201) 689-8040 (international…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that its first quarter 2021 financial results will be reported on Thursday, May 13, 2021 before the open of the financial markets. Management will also host a webcast and conference call on May 13, 2021 at 8:30 a.m. ET to discuss the results and provide a corporate update.

    The live and archived webcast of the call may be accessed on the Virios Therapeutics website under the Investors section: Events and Presentations. The live call can also be accessed by dialing (877) 407-8133 (domestic) or (201) 689-8040 (international) and asking to be connected to the "Virios Therapeutics Conference Call".

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  17. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, today announced an interview with Chairman and CEO, Greg Duncan, will air on The RedChip Money Report on the Bloomberg Network in the U.S. on Saturday, April 17, 2021 at 7 p.m. Eastern Time across the United States. The RedChip Money Report airs on Bloomberg Television U.S. on Saturdays at 7 p.m. Eastern Time in 73 million homes.

    To view the interview segment, please visit: https://youtu.be/9M0B8RPahYs

    "The RedChip Money Report" delivers insightful commentary on small-cap investing, interviews with Wall Street analysts, financial…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, today announced an interview with Chairman and CEO, Greg Duncan, will air on The RedChip Money Report on the Bloomberg Network in the U.S. on Saturday, April 17, 2021 at 7 p.m. Eastern Time across the United States. The RedChip Money Report airs on Bloomberg Television U.S. on Saturdays at 7 p.m. Eastern Time in 73 million homes.

    To view the interview segment, please visit: https://youtu.be/9M0B8RPahYs

    "The RedChip Money Report" delivers insightful commentary on small-cap investing, interviews with Wall Street analysts, financial book reviews, as well as featured interviews with executives of public companies.

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2 clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2B trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  18. Virios Therapeutics, Inc. (NASDAQ:VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that Greg Duncan, Chairman and Chief Executive Officer, and R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer, will present a company overview at the Needham Virtual Healthcare Conference on April 14, 2021 at 4:30 p.m. ET.

    The presentation will focus on the need for new approaches to treat fibromyalgia ("FM"), the novel antiviral approach being pursued by Virios, and the potential of IMC-1 as an FM treatment, based on positive results from a Phase 2 proof of concept clinical trial. Management will be available…

    Virios Therapeutics, Inc. (NASDAQ:VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that Greg Duncan, Chairman and Chief Executive Officer, and R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer, will present a company overview at the Needham Virtual Healthcare Conference on April 14, 2021 at 4:30 p.m. ET.

    The presentation will focus on the need for new approaches to treat fibromyalgia ("FM"), the novel antiviral approach being pursued by Virios, and the potential of IMC-1 as an FM treatment, based on positive results from a Phase 2 proof of concept clinical trial. Management will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

    A link to the live and archived webcast of the presentation may be accessed on Virios Therapeutics' website under the Investors section: Events and Presentations.

    About Virios Therapeutics

    Virios Therapeutics (NASDAQ:VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2 clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2B trial designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com/.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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. 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, 2020 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.

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  19. Virios Therapeutics, Inc. (NASDAQ:VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, today reported financial results for the fourth quarter and year ended December 31, 2020 and provided a corporate update.

    "Since our initial public offering in December 2020, the Virios Therapeutics team has made significant operational progress to ensure the commencement in May of this year of our landmark Phase 2b fibromyalgia clinical trial, referred to as FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1), with top line results projected in the second quarter of 2022," stated Greg Duncan…

    Virios Therapeutics, Inc. (NASDAQ:VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, today reported financial results for the fourth quarter and year ended December 31, 2020 and provided a corporate update.

    "Since our initial public offering in December 2020, the Virios Therapeutics team has made significant operational progress to ensure the commencement in May of this year of our landmark Phase 2b fibromyalgia clinical trial, referred to as FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1), with top line results projected in the second quarter of 2022," stated Greg Duncan, Chairman and Chief Executive Officer. "In addition, we recently announced a collaboration with Dr. Michael Camilleri of the Mayo Clinic to explore the role of antiviral inhibitor therapy in treating irritable bowel syndrome. We are pleased to reiterate our cash position supports operations through the end of 2022."

    Key Highlights

    • Identified and began establishing agreements with target clinical trial sites to enable initiation of the FORTRESS clinical trial in May 2021;
    • Announced collaboration with Dr. Michael Camilleri of the Mayo Clinic to explore the role of antiviral therapy in managing Irritable Bowel Syndrome (IBS);
    • Completed initial public offering (IPO) in December 2020, generating gross proceeds of $34.5 million;
    • Presented at HC Wainwright Global Healthcare and BioConnect Conferences and BIO CEO & Investor Conference; and
    • Scheduled to present at Needham 2021 Virtual Healthcare Conference on April 13, 2021.

    Fourth Quarter 2020 Financial Results

    Research and development expenses for the fourth quarter of 2020 were $0.03 million, compared to $0.26 million for the fourth quarter of 2019. The $0.23 million decrease was primarily attributable to decreases in expenses for the Human Pharmacokinetics Study conducted in 2019.

    General and administrative expenses for the fourth quarter of 2020 were $6.4 million, compared to $0.3 million for the fourth quarter of 2019. The $6.1 million increase was primarily attributable to non-cash expenses related to share-based compensation expense of $5.4 million, issued pursuant to executive employment agreements upon the IPO, and $0.7 million in additional salary, legal and accounting fees and other costs associated with being a public company, offset by lower business development costs.

    Net loss for the fourth quarter of 2020 was $6.5 million, or ($1.25) basic and diluted per share, compared to a net loss of $0.6 million, or ($0.13) basic and diluted per share, for the fourth quarter of 2019.

    Full Year 2020 Financial Results

    Research and development expenses for the year ended December 31, 2020 were $0.2 million, compared to $0.8 million for the year ended December 31, 2019. The $0.6 million decrease was primarily attributable to decreases in expenses for the Human Pharmacokinetic Study conducted in 2019.

    General and administrative expenses for the year ended December 31, 2020 were $9.8 million, compared to $1.4 million for the year ended December 31, 2019. The $8.4 million increase was primarily the result of non-cash expenses related to equity and share-based compensation expense of $7.4 million, issued pursuant to executive employment agreements, and $1.0 million in additional salary, legal and accounting fees and other costs associated with being a public company, offset by lower business development costs.

    Net loss for the year ended December 31, 2020 was $10.3 million, or ($2.10) basic and diluted per share, compared to a net loss of $2.5 million, or ($0.51) basic and diluted per share, for the year ended December 31, 2019.

    As of December 31, 2020, Virios Therapeutics cash totaled $29.8 million. The Company believes it will have sufficient resources to fund its planned operations through the end of 2022.

    Conference Call & Webcast Details

    Virios Therapeutics management will host a webcast and conference call on March 18, 2021 at 8:30 a.m. ET to discuss the results and provide a corporate update. The live and archived webcast of the call may be accessed on the Virios Therapeutics website under the Investors section: Events and Presentations. The live call can also be accessed by dialing (877) 407-8133 (domestic) or (201) 689-8040 (international) and asking to be connected to the "Virios Therapeutics Conference Call".

    About Virios Therapeutics

    Virios Therapeutics (NASDAQ:VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2 clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2B trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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. 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 final prospectus related to our initial public offering filed with the Securities and Exchange Commission on December 18, 2020. 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.

    -Financial Tables Follow-

    VIRIOS THERAPEUTICS

    Selected Financial Data

    (unaudited)

     

    Condensed Statements of

    Operations Data

     

    Three Months Ended

    December 31,

     

     

    Twelve Months Ended

    December 31,

     

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Revenue

     

    $

     

     

    $

     

     

    $

     

     

    $

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

     

    32,070

     

     

     

    259,548

     

     

     

    194,013

     

     

     

    800,620

     

    General and administrative

     

     

    6,389,582

     

     

     

    306,183

     

     

     

    9,811,381

     

     

     

    1,377,879

     

    Total operating expenses

     

     

    6,421,652

     

     

     

    565,731

     

     

     

    10,005,394

     

     

     

    2,178,499

     

    Loss from operations

     

     

    (6,421,652

    )

     

     

    (565,731

    )

     

     

    (10,005,394

    )

     

     

    (2,178,499

    )

    Other expense

     

     

    (79,576

    )

     

     

    (72,858

    )

     

     

    (341,001

    )

     

     

    (295,128

    )

    Net loss

     

    $

    (6,501,228

    )

     

    $

    (638,589

    )

     

    $

    (10,346,395

    )

     

    $

    (2,473,627

    )

    Net loss per share of common stock — basic and diluted

     

    $

    (1.25

    )

     

    $

    (0.13

    )

     

    $

    (2.10

    )

     

    $

    (0.51

    )

    Weighted average shares outstanding — basic and diluted

     

     

    5,212,534

     

     

     

    4,832,494

     

     

     

    4,926,985

     

     

     

    4,832,494

     

     
     

    Condensed Balance Sheet Data

    December 31,

     

     

    December 31,

     

     

    2020

     

     

    2019

     

     

     

     

     

     

     

     

     

    Cash

    $

    29,795,366

     

     

    $

    309,384

     

    Total assets

     

    31,472,731

     

     

     

    315,900

     

    Convertible promissory notes, net

     

     

     

     

    3,637,543

     

    Total liabilities

     

    1,531,842

     

     

     

    5,258,409

     

    Preferred members' interests, non-voting

     

     

     

     

    75,000

     

    Total members'/stockholders' equity (deficit)

     

    29,940,889

     

     

     

    (5,017,509

    )

     

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  20. Virios Therapeutics, Inc. (NASDAQ:VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that its fourth quarter and full year 2020 financial results will be reported on Thursday, March 18, 2021 before the open of the financial markets. Management will also host a webcast and conference call on March 18, 2021 at 8:30 a.m. ET to discuss the results and provide a corporate update.

    The live and archived webcast of the call may be accessed on the Virios Therapeutics website under the Investors section: Events and Presentations. The live call can also be accessed by dialing (877) 407-8133 (domestic) or (201…

    Virios Therapeutics, Inc. (NASDAQ:VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that its fourth quarter and full year 2020 financial results will be reported on Thursday, March 18, 2021 before the open of the financial markets. Management will also host a webcast and conference call on March 18, 2021 at 8:30 a.m. ET to discuss the results and provide a corporate update.

    The live and archived webcast of the call may be accessed on the Virios Therapeutics website under the Investors section: Events and Presentations. The live call can also be accessed by dialing (877) 407-8133 (domestic) or (201) 689-8040 (international) and asking to be connected to the "Virios Therapeutics Conference Call".

    About Virios Therapeutics

    Virios Therapeutics (NASDAQ:VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2 clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2B trial designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com/.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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. 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 final prospectus related to our initial public offering filed with the Securities and Exchange Commission on December 18, 2020. 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.

    View Full Article Hide Full Article
  21. Virios Therapeutics, Inc. (NASDAQ:VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that Greg Duncan, Chairman and Chief Executive Officer, will present a company overview at the H.C. Wainwright Global Life Sciences Conference, which is taking place March 9 - 10, 2021.

    The presentation will focus on the need for new approaches to treat fibromyalgia ("FM"), the novel antiviral approach being pursued by Virios, and the potential of IMC-1 as an FM treatment, based on positive results from a Phase 2 proof of concept clinical trial. Management will be available to participate in one-on-one meetings with…

    Virios Therapeutics, Inc. (NASDAQ:VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that Greg Duncan, Chairman and Chief Executive Officer, will present a company overview at the H.C. Wainwright Global Life Sciences Conference, which is taking place March 9 - 10, 2021.

    The presentation will focus on the need for new approaches to treat fibromyalgia ("FM"), the novel antiviral approach being pursued by Virios, and the potential of IMC-1 as an FM treatment, based on positive results from a Phase 2 proof of concept clinical trial. Management will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

    A link to the presentation will be available for on-demand access beginning Tuesday, March 9, 2021, on Virios Therapeutics' website under the Investors section: Events and Presentations.

    About Virios Therapeutics

    Virios Therapeutics (NASDAQ:VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2 clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2B trial designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com/.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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. 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 final prospectus related to the public offering 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.

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  22. Virios Therapeutics, Inc. (NASDAQ:VIRI), a biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response, announced today that it is entering a collaboration with Dr. Michael Camilleri of the Mayo Clinic to explore the role of antiviral therapy in managing Irritable Bowel Syndrome (IBS). The first step in the collaboration is focused on designing a phase 2 proof of concept study to treat the pain associated with IBS, with the longer-term goal of conducting the phase 2 study.

    Greg Duncan, CEO stated, "We are very excited to be working with Dr. Camilleri, a world-renowned expert in gastrointestinal disorders. This proof-of-concept study is intended to evaluate…

    Virios Therapeutics, Inc. (NASDAQ:VIRI), a biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response, announced today that it is entering a collaboration with Dr. Michael Camilleri of the Mayo Clinic to explore the role of antiviral therapy in managing Irritable Bowel Syndrome (IBS). The first step in the collaboration is focused on designing a phase 2 proof of concept study to treat the pain associated with IBS, with the longer-term goal of conducting the phase 2 study.

    Greg Duncan, CEO stated, "We are very excited to be working with Dr. Camilleri, a world-renowned expert in gastrointestinal disorders. This proof-of-concept study is intended to evaluate if IMC-1, our proprietary fixed dose antiviral combination of famciclovir and celecoxib, can play a role in addressing the pain associated with IBS."

    About Virios Therapeutics

    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"). Overactive immune response related to activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") has been postulated to be a potential root cause of chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and functional somatic syndrome, all of which are characterized by a waxing and waning manifestation of disease. While not completely understood, there is general agreement in the medical community that activation of HSV-1 is triggered by some form of environmental and/or health stressor. Our lead development candidate ("IMC-1"), is a novel, proprietary, fixed dose combination of famciclovir and celecoxib. IMC-1 represents a novel combination antiviral therapy designed to synergistically suppress HSV-1 activation and replication, with the end goal of reducing viral mediated disease burden.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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. 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 final prospectus related to the public offering 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.

    View Full Article Hide Full Article
  23. Virios Therapeutics, Inc. (NASDAQ:VIRI), a biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response, announced today that Greg Duncan, Chairman and Chief Executive Officer, will present a company overview at the virtual 2021 BIO CEO & Investor Conference to be held from February 16-18, 2021.

    The presentation will focus on the need for new approaches to treat fibromyalgia ("FM"), the novel antiviral approach being pursued by Virios, and the potential of IMC-1 as an FM treatment, based on positive results from a Phase 2 proof of concept clinical trial. Management will be available to participate in one-on-one meetings with qualified members of the investor…

    Virios Therapeutics, Inc. (NASDAQ:VIRI), a biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response, announced today that Greg Duncan, Chairman and Chief Executive Officer, will present a company overview at the virtual 2021 BIO CEO & Investor Conference to be held from February 16-18, 2021.

    The presentation will focus on the need for new approaches to treat fibromyalgia ("FM"), the novel antiviral approach being pursued by Virios, and the potential of IMC-1 as an FM treatment, based on positive results from a Phase 2 proof of concept clinical trial. Management will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

    A link to the presentation will be available for on-demand access beginning Tuesday, February 16, 2021, on Virios Therapeutics' website under the Investors section: Events and Presentations.

    About Virios Therapeutics

    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"). Overactive immune response related to activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") has been postulated to be a potential root cause of chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and functional somatic syndrome, all of which are characterized by a waxing and waning manifestation of disease. While not completely understood, there is general agreement in the medical community that activation of HSV-1 is triggered by some form of environmental and/or health stressor. Our lead development candidate ("IMC-1"), is a novel, proprietary, fixed dose combination of famciclovir and celecoxib. IMC-1 represents a novel combination antiviral therapy designed to synergistically suppress HSV-1 activation and replication, with the end goal of reducing viral mediated disease burden.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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. 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 final prospectus related to the public offering 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.

    View Full Article Hide Full Article
  24. Virios Therapeutics, Inc. (NASDAQ:VIRI), a biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response, announced today that Greg Duncan, Chairman and Chief Executive Officer, and R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer, will present a company overview at the H.C. Wainwright Virtual BioConnect Conference, which is taking place January 11 - 14, 2021.

    The presentation will be available for on-demand access beginning Monday, January 11, 2021, at 6:00 AM ET, on Virios Therapeutics' website under the Investors section: Events and Presentations.

    About Virios Therapeutics

    Virios Therapeutics is a development-stage biotechnology company focused…

    Virios Therapeutics, Inc. (NASDAQ:VIRI), a biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response, announced today that Greg Duncan, Chairman and Chief Executive Officer, and R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer, will present a company overview at the H.C. Wainwright Virtual BioConnect Conference, which is taking place January 11 - 14, 2021.

    The presentation will be available for on-demand access beginning Monday, January 11, 2021, at 6:00 AM ET, on Virios Therapeutics' website under the Investors section: Events and Presentations.

    About Virios Therapeutics

    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"). Overactive immune response related to activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") has been postulated to be a potential root cause of chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and functional somatic syndrome, all of which are characterized by a waxing and waning manifestation of disease. While not completely understood, there is general agreement in the medical community that activation of HSV-1 is triggered by some form of environmental and/or health stressor. Our lead development candidate ("IMC-1"), is a novel, proprietary, fixed dose combination of famciclovir and celecoxib. IMC-1 represents a novel combination antiviral therapy designed to synergistically suppress HSV-1 activation and replication, with the end goal of reducing viral mediated disease burden.

    Forward Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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. 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 final prospectus related to the public offering 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.

    View Full Article Hide Full Article