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Friday, June 23, 2023 11:00:39 AM
Below are some recent key developments in the business, including the Company regaining compliance with the minimum bid price requirement.
Key Highlights
On May 24th, 2023, the Company received a letter from The Nasdaq Stock Market LLC (“Nasdaq”) stating that because Virios Therapeutic’s (“VIRI”) shares had a closing bid price at or above $1.00 per share for 10 consecutive business days, VIRI stock had regained compliance with the minimum bid price requirement of $1.00 per share for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(a)(2), and the matter is now closed.
The Company proposed a Phase 3 program for lead development candidate IMC-1 to the U.S. Food & Drug Administration (“FDA”) as treatment for fibromyalgia consisting of four primary components: two adequate and well-controlled clinical studies, one of which would be a full factorial design with each of the individual components of IMC-1 (famciclovir and celecoxib) as separate comparator arms, a long-term safety trial, and a pharmacokinetic/food effect study.
The Company submitted final toxicology reports as per FDA’s request as part of their overall review of the Phase 3 proposal.
An updated IMC-1 Phase 3 program proposal, responsive to FDA guidance, will also be provided once FDA completes its review of the chronic toxicology reports.
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.
The Company is pursuing a second development candidate, a combination of valacyclovir and celecoxib, as a potential treatment for managing the fatigue, sleep, attention, pain, autonomic function, and anxiety associated with Long-COVID, otherwise known as Post-Acute Sequelae of COVID-19 (PASC). The Company has provided the Bateman Horne Center (“BHC”) with an unrestricted investigational grant to conduct this open-label 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.
For more information, please visit www.virios.com.
Follow Virios Therapeutics
Email Alerts: https://ir.virios.com/resources/email-alerts
LinkedIn: https://www.linkedin.com/company/viriosbiotech/
Twitter: https://twitter.com/ViriosBiotech
Facebook: https://www.facebook.com/ViriosBiotech/
Recent VIRI News
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 10/07/2024 12:06:54 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/07/2024 12:02:34 PM
- Virios Therapeutics, Inc. and Wex Pharmaceuticals, Inc. Announce Business Combination to Form Dogwood Therapeutics, Inc. (Nasdaq: “DWTX”) • GlobeNewswire Inc. • 10/07/2024 11:05:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2024 02:15:38 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/08/2024 01:30:13 PM
- Virios Therapeutics Announces Second Quarter 2024 Financial Results • GlobeNewswire Inc. • 08/08/2024 01:15:00 PM
- Virios Therapeutics to Report Second Quarter 2024 Financial Results on Thursday, August 8, 2024 • GlobeNewswire Inc. • 08/01/2024 01:41:56 PM
- Virios Therapeutics Announces Completion of Enrollment in IMC-2 Phase 2 Long-COVID Study Being Conducted by Bateman Horne Center • GlobeNewswire Inc. • 07/23/2024 01:15:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/20/2024 01:15:13 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/12/2024 01:15:20 PM
- Virios Therapeutics Announces Closing of $1.7 Million Public Offering of Common Stock to Commence Preparations for Planned IMC-2 Long-COVID Phase 2b Study • GlobeNewswire Inc. • 05/22/2024 05:30:00 PM
- Form 424B4 - Prospectus [Rule 424(b)(4)] • Edgar (US Regulatory) • 05/20/2024 08:05:49 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/20/2024 01:28:00 PM
- Virios Therapeutics Announces Pricing of $1.7 Million Public Offering of Common Stock to Commence Preparations for Planned IMC-2 Long-COVID Phase 2b Study • GlobeNewswire Inc. • 05/20/2024 12:53:09 AM
- Virios Therapeutics Announces Proposed Public Offering of Common Stock to Commence Preparations for Planned IMC-2 Long-COVID Phase 2b Study • GlobeNewswire Inc. • 05/17/2024 08:10:00 PM
- Form 424B4 - Prospectus [Rule 424(b)(4)] • Edgar (US Regulatory) • 05/17/2024 08:01:45 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 02:30:38 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 12:01:31 PM
- Virios Therapeutics Announces First Quarter 2024 Financial Results and Provides Corporate Update • GlobeNewswire Inc. • 05/09/2024 11:45:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/07/2024 09:25:53 PM
- Virios Therapeutics to Report First Quarter 2024 Financial Results on Thursday, May 9, 2024 • GlobeNewswire Inc. • 05/02/2024 01:15:00 PM
- Virios Therapeutics Announces Publication of International Patent for IMC-2 Covering Antiviral Treatment of Long-COVID • GlobeNewswire Inc. • 03/26/2024 01:15:00 PM
- Form 10-K/A - Annual report [Section 13 and 15(d), not S-K Item 405]: [Amend] • Edgar (US Regulatory) • 03/08/2024 10:00:32 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 09:30:13 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/01/2024 02:10:56 PM
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