Virios Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Requirement
May 25 2023 - 4:05PM
Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a
clinical‐stage biopharmaceutical company, today announced that it
has regained compliance with the minimum bid price requirement for
continued listing on The Nasdaq Capital Market.
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.
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Forward-Looking Statements
Statements in this press release contain
“forward-looking statements,” within the meaning of the U.S.
Private Securities Litigation Reform Act of 1995, that are subject
to substantial risks and uncertainties. All statements, other than
statements of historical fact, contained in this press release are
forward-looking statements. Forward-looking statements contained in
this press release may be identified by the use of words such as
“anticipate,” “believe,” “contemplate,” “could,” “estimate,”
“expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,”
“predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,”
“would,” or the negative of these words or other similar
expressions, although not all forward-looking statements contain
these words. Forward-looking statements are based on Virios
Therapeutics’ current expectations and are subject to inherent
uncertainties, risks and assumptions that are difficult to predict,
including risks related to the completion, timing and results of
current and future clinical studies relating to Virios
Therapeutics’ product candidates. Further, certain forward-looking
statements are based on assumptions as to future events that may
not prove to be accurate. These and other risks and uncertainties
are described more fully in the section titled “Risk Factors” in
the Annual Report on Form 10-K for the year ended December 31,
2022, 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.
Contact:IR@Virios.com
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