Virios Therapeutics, Inc. (Nasdaq: VIRI), a development-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases including fibromyalgia, today announced financial results for the second quarter ended June 30, 2022.
Key Highlights and Upcoming Milestones
- Completed patient dosing in Phase 2b FORTRESS fibromyalgia study
- Top line FORTRESS results 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, Chairman and CEO of Virios Therapeutics. “Furthermore, evidence of the potential of our lead development candidate, oral IMC-1, to improve treatment outcomes for FM patients had been established in a previously completed Phase 2a clinical study. If our forthcoming Phase 2b study results 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 over 100 million FM patients worldwide.”
“I could not be prouder of the highly commendable efforts of the Virios Therapeutics research team in completing the Phase 2b FORTRESS study on time, despite the extraordinary circumstances associated with conducting a clinical study during the COVID-19 pandemic,” said Michael Gendreau, MD, PhD, Chief Medical Officer of Virios Therapeutics. “If the FORTRESS results are positive, we will immediately approach FDA for a guidance meeting to determine Phase 3 requirements, with the goal of moving IMC-1 forward into late-stage development as soon as possible.”
Second Quarter 2022 Financial Results
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 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 due primarily to increases in 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 $0.44 basic and diluted net loss per share, compared to a net loss of $4.3 million, or $0.51 basic and diluted net loss per share, for the second quarter ended 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 it will have sufficient resources to fund its planned operations through the end of 2022.
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 potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease, 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 herpes virus replication, with the end goal of reducing virally promoted disease symptoms. 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 trial (“FORTRESS”), designed to potentially serve as a supportive registrational study. Evidence of IMC-1’s efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial.
The Company is pursuing a second antiviral development combination, IMC-2 (valacyclovir and celecoxib), as a potential treatment for managing the various symptoms associated with Long COVID, otherwise known as Post-Acute Sequelae of COVID-19 (PASC). The Company has provided Bateman Horne Center (“BHC”) with an unrestricted investigational grant to conduct this study. BHC is a non-profit, interdisciplinary Center of Excellence advancing the diagnosis and treatment of chronic fatigue disorders, FM, post-viral syndromes, and related comorbidities.
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