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”), today announced financial results
for the first quarter ended March 31, 2023.
Key Highlights
- The Company
proposed a Phase 3 program for its lead development candidate IMC-1
to the U.S. Food & Drug Administration (“FDA”) as a treatment
for FM 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 preceding pharmacokinetic/food effect
study.
- Based on data
from its recently completed FORTRESS Phase 2b trial, the Company
proposed a Phase 3 development program targeting community-based FM
patients, who have not participated in prior FM trials.
- Initial FDA
feedback was that the agency is amenable to the Company’s Phase 3
proposal, subject to review of the final results from its recently
completed chronic toxicology program. The Company submitted final
toxicology reports as per FDA’s request as part of their overall
review of the Phase 3 proposal in May 2023.
- 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.
- Top line
results from the exploratory Long-COVID study, featuring the
combination of valacyclovir and celecoxib to treat Long-COVID
sequelae, are expected in June 2023.
“Our initial discussions with the FDA regarding
our fibromyalgia program were constructive and we look forward to
further FDA feedback on our proposal to advance IMC-1 to Phase 3
development,” said Greg Duncan, Chairman and CEO of Virios
Therapeutics.
First Quarter 2023 Financial
Results
Research and development expenses for the first
quarter of 2023 were $0.5 million, compared to $2.8 million for the
first quarter of 2022. The quarter over quarter change was due to
decreases in expenses for clinical trials of $2.2 million,
toxicology studies of $0.1 million and salaries and related costs
of $0.1 million, offset by an increase in regulatory consulting
costs of $0.1 million.
General and administrative expenses for the
first quarter of 2023 were $1.1 million, compared to $1.2 million
for the first quarter of 2022. The quarter over quarter change was
primarily due to a decrease in salaries and related costs.
Net loss for the first quarter of 2023 was $1.5
million, or $0.08 basic and diluted net loss per share, compared to
a net loss of $4.0 million, or $0.48 basic and diluted net loss per
share, for the first quarter of 2022.
As of March 31, 2023, Virios Therapeutics’ cash
totaled $5.3 million. The Company believes it will have sufficient
resources to support general research and development and
administrative operations into the second quarter of 2024. Future
IMC-1 FM research or clinical trials will require additional
funding, licensing or partnership collaboration.
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 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/
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
-Financial Tables Follow- |
|
|
|
|
|
|
|
VIRIOS
THERAPEUTICSSelected Financial Data
(unaudited) |
|
|
|
Condensed Statements
of Operations Data |
|
|
|
|
Three Months EndedMarch 31, |
|
|
|
|
|
|
|
|
|
2023 |
|
|
2022 |
|
Revenue |
|
|
|
|
|
|
|
|
|
$ |
— |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
|
|
|
|
|
|
|
497,714 |
|
|
|
2,769,102 |
|
General and administrative |
|
|
|
|
|
|
|
|
|
|
1,059,573 |
|
|
|
1,192,112 |
|
Total operating expenses |
|
|
|
|
|
|
|
|
|
|
1,557,287 |
|
|
|
3,961,214 |
|
Loss
from operations |
|
|
|
|
|
|
|
|
|
|
(1,557,287 |
) |
|
|
(3,961,214 |
) |
Other
income |
|
|
|
|
|
|
|
|
|
|
40,423 |
|
|
|
906 |
|
Net
loss |
|
|
|
|
|
|
|
|
|
$ |
(1,516,864 |
) |
|
$ |
(3,960,308 |
) |
Net loss
per share of common stock — basic and diluted |
|
|
|
|
|
|
|
|
|
$ |
(0.08 |
) |
|
$ |
(0.48 |
) |
Weighted
average shares outstanding — basic and diluted |
|
|
|
|
|
|
|
|
|
|
18,330,390 |
|
|
|
8,330,390 |
|
Condensed Balance Sheet Data |
March 31, |
|
|
December 31, |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
|
Cash |
$ |
5,332,542 |
|
|
$ |
7,030,992 |
|
Total
assets |
|
6,520,617 |
|
|
|
8,369,756 |
|
Total
liabilities |
|
549,290 |
|
|
|
1,043,262 |
|
Total
stockholders’ equity |
|
5,971,327 |
|
|
|
7,326,494 |
|
Source: Virios Therapeutics, Inc.
Virios Therapeutics (NASDAQ:VIRI)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Virios Therapeutics (NASDAQ:VIRI)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024