ATLANTA–(BUSINESS THREAD)–Virios Therapeutics, Inc. (Nasdaq: VIRI), a development-stage biotechnology company focused on advancing novel combination antiviral therapies to treat debilitating chronic diseases such as fibromyalgiatoday announced financial results for the second quarter ended June 30, 2022.
Key aspects and upcoming milestones
Patient dosing in the Phase 2b FORTRESS fibromyalgia study has been completed. First-line FORTRESS results are expected in September 2022
“Data published earlier this year provide evidence of a mechanistic correlation between activated herpes viruses and patients suffering from fibromyalgia (FM) and comorbid functional gastrointestinal disorders,” said Greg Duncan, president and CEO of Virios Therapeutics. “Furthermore, evidence had been established for the potential of our lead development candidate, oral IMC-1, to improve treatment outcomes for patients with FM in a previously completed Phase 2a clinical study. If our upcoming results from Phase 2b study are consistent with our previously successful Phase 2a study, we believe our combination antiviral development candidate, IMC-1, has the potential to raise the standard of care for more than 100 millions of FM patients worldwide.”
“I could not be more proud of the very commendable efforts of the research team at Virios Therapeutics to complete the Phase 2b FORTRESS study on time, despite the extraordinary circumstances associated with conducting a clinical study during the pandemic of COVID-19,” said Michael Gendreau, MD. , PhD, Chief Medical Officer of Virios Therapeutics. “If the FORTRESS results are positive, we will immediately approach the FDA for an orientation meeting to determine Phase 3 requirements, with the goal of advancing IMC-1 to late-stage development as soon as possible.” as possible.”
Financial results for the second quarter of 2022
Research and development expenses for the second quarter ended June 30, 2022 were $2.4 million, compared to $3.2 million for the second quarter ended June 30, 2021. The decrease was was primarily due to a decrease in expenses related to our toxicology studies.
General and administrative expenses for the second quarter ended June 30, 2022 were $1.3 million, compared to $1.1 million for the second quarter ended June 30, 2021. The increase was primarily due to increased expenses for legal and accounting fees of $0.1 million and an increase in salaries and related costs of $0.1 million.
Net loss for the second quarter ended June 30, 2022 was $3.7 million, or a basic and diluted net loss of $0.44 per share, compared to a net loss of $4.3 million dollars, or a basic and diluted net loss of $0.51 per share, for the second quarter ended in June. 30, 2021. The lower net loss was primarily due to a decrease in research and development costs.
As of June 30, 2022, Virios Therapeutics’ cash totaled $7.7 million. The company believes that it will have sufficient resources to finance its planned operations until the end of 2022.
Details of the teleconference and webcast
Virios Therapeutics management will host a webcast and conference call on August 11, 2022 at 8:30 am ET to discuss the company’s financial results and provide a corporate update. A live and archived webcast of the call can be accessed on the Virios Therapeutics website under the Investors section: Events and Presentations. The live call may also be accessed by dialing 888-506-0062 (domestic) or 973-528-0011 (international) and asking to be connected to the “Virios Therapeutics Conference Call” using access code: 179784.
About Virios Therapeutics
Virios Therapeutics (Nasdaq: VIRI) is a development-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 have been postulated as a possible root cause that triggers and/or maintains chronic diseases such as FM, irritable bowel disease, chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by hair removal and waxing. diminishing symptoms without obvious etiology. Our lead development candidate (“IMC-1”) is a novel, proprietary, fixed-dose combination of famciclovir and celecoxib designed to synergistically suppress herpes virus replication, with the ultimate goal of reducing herpes symptoms virally promoted disease. IMC-1 has received fast-track designation from the FDA and is currently being tested in a multicenter, randomized, double-blind, placebo-controlled trial (“FORTRESS”), designed to potentially serve as a supporting registration study. Evidence for the efficacy of IMC-1 across a broad spectrum of FM outcome measures was previously demonstrated in a phase 2a clinical trial.
The company is pursuing a second antiviral combination in development, IMC-2 (valaciclovir and celecoxib), as a potential treatment to manage the various symptoms associated with COVID-19, also known as post-acute sequelae of COVID-19 (PASC ). The Company has provided the Bateman Horne Center (“BHC”) with an unrestricted research grant to conduct this study. BHC is a not-for-profit interdisciplinary center of excellence advancing the diagnosis and treatment of chronic fatigue disorders, FM, postviral syndromes and related comorbidities.
For more information, visit www.virios.com.
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Forward-looking statements
The statements in this press release contain “forward-looking statements,” within the meaning of the US Private Securities Litigation Reform Act of 1995, which are subject to substantial risks and uncertainties. All statements, other than those of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release can be identified by the use of words such as “anticipate,” “believe,” “anticipate,” “could,” “estimate,” “expect,” “attempt,” “seek , ” “may”, “could”, “plan”, “potential”, “predict”, “project”, “suggest”, “goal”, “goal”, “should”, “should” or the negative of such words or other similar expressions, although not all forward-looking statements contain such 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 success, cost and timing of Virios Therapeutics’ preclinical studies and clinical trials; its ability to obtain regulatory approval for IMC-1, IMC-2 and any future product candidates; the need for the additional financing company; and Virios Therapeutics’ ability to develop and, if approved, commercialize its product candidates Statements are based on assumptions about future events that may not be accurate. These and other risks and uncertainties are described in more detail in the section entitled “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission and Values. The forward-looking statements contained in this announcement are made as of the date hereof, and Virios Therapeutics, Inc. (VIRI) assumes no duty to update this information, except as required by applicable law.
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