Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a
development-stage biotechnology company focused on advancing novel
antiviral therapies to treat debilitating chronic diseases,
including fibromyalgia (“FM”) and Long-COVID (“LC”), today issued a
Shareholder Letter highlighting the Company’s progress and key
milestones in 2024.
Dear Virios (VIRI)
Shareholders,
On behalf of the Virios directors and the
executive team, we would like to provide a corporate progress
report on several key topics as we proceed through the first
quarter of 2024.
Special Shareholder Meeting: On
March 1, 2024, we will hold a special shareholder meeting, whereby
we are requesting your approval to execute a reverse stock split
some time over the course of the next 12 months. In our outreach to
shareholders in connection with the meeting, we heard concerns
about whether and when the reverse stock split would be
implemented, if approved, and we want to address those concerns
here. Approval of this proposal does not commit the Company to the
execution of a reverse stock split. It does provide maximum
strategic optionality moving forward, including the ability to
execute strategic transactions and to enable future fund
raising.
Indeed, the Board’s unanimous view is that the
implementation of the reverse stock split should be deferred until
after the Company has clarity on the results of the current
Long-COVID (“LC”) study being independently run via an unrestricted
grant to the Bateman Horne Center. Results from this study are
currently projected to be reported in the second half of 2024.
Director Fee and Management Team 10%
Salary Cut: We work diligently to minimize operational
expenses and deploy our cash to fund value creating research as
evidenced by the fact that we operate VIRI as a public company with
four full-time employees. In order to underscore the management
team’s alignment as fellow shareholders and to emphasize our
commitment to long-term success and value creation, all of Virios’
employees have agreed to a 10% salary compensation reduction in
exchange for future vesting stock options. In addition, our
directors have also agreed to a 10% reduction in cash director
fees.
IMC-2 Long-COVID Development
Program: We have clarity from the Food and Drug
Administration (“FDA”) on the development requirements for
advancing IMC-2 (combination of valacyclovir and celecoxib) into
Phase 2 development as a treatment for LC symptoms. As noted above,
we expect to receive top line results from the ongoing Bateman
Horne Center independent investigator supported study in the second
half of 2024. There continues to remain a high unmet medical need
for treating LC symptoms. Recently, a USA Today Health article
reported that federal estimates suggest at least 16 million
Americans have LC and as many as 4 million of them are
disabled by it. There are currently no FDA approved LC treatments.
We are excited that IMC-2 has the potential to be one of the first
approved treatments for LC and are exploring various means by which
to fund execution of the important Phase 2b IMC-2 trial.
IMC-1 Fibromyalgia Development
Program: We reached alignment with the FDA on the IMC-1
(combination of famciclovir and celecoxib) Phase 3 development
program for treatment of fibromyalgia. We continue to be engaged
with potential external entities who have an interest in partnering
for this important program.
The Virios team remains committed to delivering
on the promise of combination antiviral therapy to address a
multitude of serious health issues and illnesses. We appreciate
your support.
Sincerely,
Greg DuncanChairman & Chief Executive OfficerVirios
Therapeutics, Inc.
About Virios Therapeutics, Inc.
Virios Therapeutics (Nasdaq: VIRI) 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”) and
Long-COVID (“LC”). Overactive immune response related to activation
of tissue resident herpesvirus has been postulated to be a
potential root cause of chronic illnesses such as FM, irritable
bowel syndrome, LC, chronic fatigue syndrome and functional somatic
syndromes, all of which are characterized by a waxing and waning
manifestation of disease, often triggered by events which
compromise the immune system. Our lead development candidates are
novel, proprietary, fixed dose combinations of an antiviral
compound and celecoxib designed to synergistically suppress
herpesvirus replication, with the end goal of reducing virally
promoted disease symptoms. IMC-1 (fixed dose combination of
famciclovir and celecoxib) has been granted fast track designation
by the FDA.
For more information, please visit
www.virios.com.
Follow Virios Therapeutics
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Forward-Looking Statements
Statements in this announcement 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, potential future partnerships or
other material transactions, and the requirements of or feedback
from Nasdaq regarding the continued listing of our common stock.
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
Virios Therapeutics (NASDAQ:VIRI)
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