Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage
biotechnology company focused on advancing novel antiviral
therapies to treat diseases associated with virally triggered or
maintained immune responses, today reported financial results for
the fourth quarter and year ended December 31, 2020 and provided a
corporate update.
“Since our initial public offering in December 2020, the Virios
Therapeutics team has made significant operational progress to
ensure the commencement in May of this year of our landmark Phase
2b fibromyalgia clinical trial, referred to as FORTRESS
(Fibromyalgia Outcome Research Trial Evaluating Synergistic
Suppression of HSV-1), with top line results projected in the
second quarter of 2022,” stated Greg Duncan, Chairman and Chief
Executive Officer. “In addition, we recently announced a
collaboration with Dr. Michael Camilleri of the Mayo Clinic to
explore the role of antiviral inhibitor therapy in treating
irritable bowel syndrome. We are pleased to reiterate our cash
position supports operations through the end of 2022.”
Key Highlights
- Identified and began establishing agreements with target
clinical trial sites to enable initiation of the FORTRESS clinical
trial in May 2021;
- Announced collaboration with Dr. Michael Camilleri of the Mayo
Clinic to explore the role of antiviral therapy in managing
Irritable Bowel Syndrome (IBS);
- Completed initial public offering (IPO) in December 2020,
generating gross proceeds of $34.5 million;
- Presented at HC Wainwright Global Healthcare and BioConnect
Conferences and BIO CEO & Investor Conference; and
- Scheduled to present at Needham 2021 Virtual Healthcare
Conference on April 13, 2021.
Fourth Quarter 2020 Financial Results
Research and development expenses for the fourth quarter of 2020
were $0.03 million, compared to $0.26 million for the fourth
quarter of 2019. The $0.23 million decrease was primarily
attributable to decreases in expenses for the Human
Pharmacokinetics Study conducted in 2019.
General and administrative expenses for the fourth quarter of
2020 were $6.4 million, compared to $0.3 million for the fourth
quarter of 2019. The $6.1 million increase was primarily
attributable to non-cash expenses related to share-based
compensation expense of $5.4 million, issued pursuant to executive
employment agreements upon the IPO, and $0.7 million in additional
salary, legal and accounting fees and other costs associated with
being a public company, offset by lower business development
costs.
Net loss for the fourth quarter of 2020 was $6.5 million, or
($1.25) basic and diluted per share, compared to a net loss of $0.6
million, or ($0.13) basic and diluted per share, for the fourth
quarter of 2019.
Full Year 2020 Financial Results
Research and development expenses for the year ended December
31, 2020 were $0.2 million, compared to $0.8 million for the year
ended December 31, 2019. The $0.6 million decrease was primarily
attributable to decreases in expenses for the Human Pharmacokinetic
Study conducted in 2019.
General and administrative expenses for the year ended December
31, 2020 were $9.8 million, compared to $1.4 million for the year
ended December 31, 2019. The $8.4 million increase was primarily
the result of non-cash expenses related to equity and share-based
compensation expense of $7.4 million, issued pursuant to executive
employment agreements, and $1.0 million in additional salary, legal
and accounting fees and other costs associated with being a public
company, offset by lower business development costs.
Net loss for the year ended December 31, 2020 was $10.3 million,
or ($2.10) basic and diluted per share, compared to a net loss of
$2.5 million, or ($0.51) basic and diluted per share, for the year
ended December 31, 2019.
As of December 31, 2020, Virios Therapeutics cash totaled $29.8
million. The Company believes it will have sufficient resources to
fund its planned operations through the end of 2022.
Conference Call & Webcast Details
Virios Therapeutics management will host a webcast and
conference call on March 18, 2021 at 8:30 a.m. ET to discuss the
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 also be accessed by dialing (877) 407-8133 (domestic)
or (201) 689-8040 (international) and asking to be connected to the
“Virios Therapeutics Conference Call”.
About Virios Therapeutics
Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage
biotechnology company focused on advancing novel, dual mechanism
antiviral therapies to treat conditions associated with virally
triggered or maintained immune responses, such as fibromyalgia
(“FM”). Immune responses related to the activation of tissue
resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a
potential root cause triggering and/or sustaining chronic illnesses
such as FM, irritable bowel disease (“IBS”), 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 HSV-1 replication, with the
end goal of reducing virally promoted disease symptoms.
Evidence of IMC-1’s efficacy on a broad spectrum of FM outcome
measures was previously demonstrated in a Phase 2 clinical trial.
These trial results are suggestive that IMC-1 may represent a new
and novel treatment for fibromyalgia. IMC-1 has been granted fast
track designation by the FDA and is currently being tested in a
multi-center, randomized, double-blind, placebo-controlled Phase 2B
trial (“FORTRESS”) designed to set the stage for registrational
studies. The company is led by an executive team highly experienced
in the successful development and commercialization of novel
therapies. For more information, please visit www.virios.com.
Forward-Looking Statements
Statements in this press release contain “forward-looking
statements” 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,”
“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. 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 final prospectus related to our initial public offering filed
with the Securities and Exchange Commission on December 18, 2020.
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.
-Financial Tables Follow-
VIRIOS THERAPEUTICS Selected Financial Data
(unaudited)
Condensed Statements of Operations
Data
Three Months Ended December
31,
Twelve Months Ended December
31,
2020
2019
2020
2019
Revenue
$
—
$
—
$
—
$
—
Operating expenses:
Research and development
32,070
259,548
194,013
800,620
General and administrative
6,389,582
306,183
9,811,381
1,377,879
Total operating expenses
6,421,652
565,731
10,005,394
2,178,499
Loss from operations
(6,421,652
)
(565,731
)
(10,005,394
)
(2,178,499
)
Other expense
(79,576
)
(72,858
)
(341,001
)
(295,128
)
Net loss
$
(6,501,228
)
$
(638,589
)
$
(10,346,395
)
$
(2,473,627
)
Net loss per share of common stock — basic
and diluted
$
(1.25
)
$
(0.13
)
$
(2.10
)
$
(0.51
)
Weighted average shares outstanding —
basic and diluted
5,212,534
4,832,494
4,926,985
4,832,494
Condensed Balance Sheet Data
December 31,
December 31,
2020
2019
Cash
$
29,795,366
$
309,384
Total assets
31,472,731
315,900
Convertible promissory notes, net
—
3,637,543
Total liabilities
1,531,842
5,258,409
Preferred members’ interests,
non-voting
—
75,000
Total members’/stockholders’ equity
(deficit)
29,940,889
(5,017,509
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210318005178/en/
Jenny Kobin IR@Virios.com
Virios Therapeutics (NASDAQ:VIRI)
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