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, today announced
financial results for the second quarter ended June 30, 2023 and
provided a corporate update.
Key Highlights and Upcoming
Milestones
- The Company
announced that the Food & Drug Administration (“FDA”)
communicated that, following their initial review of the Company’s
chronic toxicology program, the program’s studies appear adequate
to support the safety of IMC-1 at the dose proposed by the Company
for chronic use treating fibromyalgia.
- The Company
plans to initiate its proposed pharmacokinetic and food effect
study (“pK”) this year, while concurrently submitting a final Phase
3 program outline and associated Phase 3 study protocols for FDA
review.
- Following
completion of the pK study, the goal will be to begin enrollment in
the first fibromyalgia Phase 3 safety and efficacy study in
mid-2024.
- With the recent
completion of the IMC-2 (fixed combination of valacyclovir and
celecoxib) exploratory, open-label, Long-COVID proof of concept
study conducted by the Bateman Horne Center, we are planning to
sponsor a second investigator-initiated study with the Bateman
Horne Center this fall. This follow up study will be a
double-blinded placebo-controlled study otherwise very similar to
the initial proof of concept study.
- The Company
plans to meet with the FDA in the second half of 2023 to discuss a
proposal to advance its IMC-2 into Phase 2 development as a
potential treatment for the symptoms associated with Long-COVID
illness.
“We are encouraged about the potential to expand
our pipeline and progress IMC-1 into Phase 3 development as a
treatment for FM and IMC-2 into Phase 2 development as a treatment
for Long-COVID. Our team is working closely with the FDA to
determine next steps in advancing these promising programs,” said
Greg Duncan, Chairman and CEO of Virios Therapeutics.
Second Quarter 2023 Financial
Results
Research and development expenses for the second
quarter of 2023 were $0.6 million, compared to $2.4 million for the
second quarter of 2022. The decrease quarter over quarter was due
decreases in expenses related to human clinical trials of $1.7
million and animal toxicology studies of $0.2 million, offset by an
increase in drug development and manufacturing costs of $0.1
million.
General and administrative expenses for the
second quarter of 2023 were $0.9 million, compared to $1.3 million
for the second quarter of 2022. The decrease quarter over quarter
was due to decreases in expenses associated with being a public
company of $0.2 million, legal and accounting fees of $0.1 million
and salaries and related costs of $0.1 million.
Net loss for the second quarter of 2023 was $1.4
million, or $0.08 basic and diluted net loss per share, compared to
a net loss of $3.7 million, or $0.44 basic and diluted net loss per
share, for the second quarter of 2022.
As of June 30, 2023, Virios Therapeutics’ cash
totaled $4.6 million. As previously disclosed, in July 2023, the
Company entered into a Credit on DemandTM Sales Agreement (“Sales
Agreement”) with JonesTrading Institutional Services LLC. The
Company believes that the Company’s cash balance at June 30, 2023,
together with the additional $1.4 million raised using the Sales
Agreement subsequent to June 30, 2023, is sufficient to fund
operating expenses and capital requirements for at least the next
12 months.
Conference Call & Webcast
Details
Virios Therapeutics management will host a
webcast and conference call on August 10, 2023, at 8:30 a.m. ET to
discuss the Company’s financial results and provide a corporate
update. The live and archived webcast of the call may be accessed
on the Virios Therapeutics website under the Investors section:
Events and Presentations. The live call can be accessed by dialing
888-506-0062 (domestic) or 973-528-0011 (international) and asking
to be connected to the "Virios Therapeutics Conference Call" using
the access code: 133321.
About Virios Therapeutics
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. 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, Long-COVID, 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. The Company plans to engage the FDA in the latter half
of 2023 with the goal of filing an investigational new drug
application to formally assess IMC-2 (fixed combination of
valacyclovir and celecoxib) as a potential treatment for Long-COVID
sequelae.
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 EndedJune 30, |
|
|
Six Months EndedJune 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
557,843 |
|
|
|
2,406,438 |
|
|
|
1,055,557 |
|
|
|
5,175,540 |
|
General and administrative |
|
|
919,374 |
|
|
|
1,265,621 |
|
|
|
1,978,947 |
|
|
|
2,457,733 |
|
Total operating expenses |
|
|
1,477,217 |
|
|
|
3,672,059 |
|
|
|
3,034,504 |
|
|
|
7,633,273 |
|
Loss
from operations |
|
|
(1,477,217 |
) |
|
|
(3,672,059 |
) |
|
|
(3,034,504 |
) |
|
|
(7,633,273 |
) |
Other
income |
|
|
36,313 |
|
|
|
4,804 |
|
|
|
76,736 |
|
|
|
5,710 |
|
Net loss |
|
$ |
(1,440,904 |
) |
|
$ |
(3,667,255 |
) |
|
$ |
(2,957,768 |
) |
|
$ |
(7,627,563 |
) |
Net loss per share of common stock — basic and diluted |
|
$ |
(0.08 |
) |
|
$ |
(0. 44 |
) |
|
$ |
(0.16 |
) |
|
$ |
(0. 92 |
) |
Weighted average shares outstanding — basic and diluted |
|
|
18,411,399 |
|
|
|
8,330,390 |
|
|
|
18,371,118 |
|
|
|
8,330,390 |
|
Condensed Balance Sheet Data |
June 30, |
|
|
December 31, |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
|
Cash |
$ |
4,590,128 |
|
|
$ |
7,030,992 |
|
Total
assets |
|
5,212,119 |
|
|
|
8,369,756 |
|
Total
liabilities |
|
520,032 |
|
|
|
1,043,262 |
|
Total
stockholders’ equity |
|
4,692,087 |
|
|
|
7,326,494 |
|
|
|
|
|
|
|
|
|
Source: Virios Therapeutics, Inc.
Virios Therapeutics (NASDAQ:VIRI)
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Virios Therapeutics (NASDAQ:VIRI)
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