Virios Therapeutics, Inc. (Nasdaq: VIRI), a
clinical-stage biotechnology company focused on advancing novel
antiviral therapies to treat debilitating chronic diseases, today
reported financial results for the second quarter ended June 30,
2021 and provided a corporate update.
“Our landmark Phase 2b fibromyalgia clinical trial, referred to
as FORTRESS, has rapidly progressed and patients are being enrolled
at more than 40 clinical trial sites, keeping us on track to
announce top line results in mid-2022,” stated Greg Duncan,
Chairman and Chief Executive Officer. “There is increasing
recognition in the scientific community of the potential role of
activated viruses triggering a wide range of conditions, including
fibromyalgia, irritable bowel syndrome and fatigue-related
disorders. We are exploring the feasibility and timing of executing
additional HSV-1 targeted research programs complementary to our
fibromyalgia program and expect to provide an update on these plans
later this year.”
Key Highlights and Upcoming Milestones
- Enrollment is ongoing in the FORTRESS (Fibromyalgia Outcome
Research Trial Evaluating Synergistic Suppression of HSV-1) Phase
2b trial;
- 41 clinical trial sites are activated and enrolling patients
for the FORTRESS trial;
- Top line results of the FORTRESS Phase 2b clinical trial are
expected in mid-2022;
- Orally presented gastrointestinal (GI) biopsy study data
highlighting the role of active HSV-1 as a potential root cause of
chronic GI disorders at Digestive Disease Week 2021;
- Poster presentation of safety data from the Phase 2a
Fibromyalgia Trial at the International Association of the Study of
Pain;
- Poster presentation of the Phase 2a Fibromyalgia Trial data on
efficacy analyses of key secondary endpoints at the EULAR European
Congress of Rheumatology;
- Presented at the Needham Healthcare Conference and the Benzinga
Global Small Cap Conference;
- Bloomberg News interview in July 2021 with our CEO, Greg
Duncan;
- Upcoming corporate presentations at two investor conferences:
SNN Network Summer Virtual Event being held August 17-19, 2021, and
H.C. Wainwright 23rd Annual Global Investment Conference being held
September 13-15, 2021.
Second Quarter 2021 Financial Results
Research and development expenses for the second quarter ended
June 30, 2021 were $3.2 million, compared to $0.02 million for the
second quarter ended June 30, 2020. The $3.2 million increase was
primarily attributable to increases in expenses for the FORTRESS
clinical trial, the chronic toxicology program and drug development
and manufacturing costs.
General and administrative expenses for the second quarter ended
June 30, 2021 were $1.1 million, compared to $0.5 million for the
second quarter ended June 30, 2020. The $0.6 million increase was
primarily attributable to costs associated with being a public
company.
Net loss for the second quarter ended June 30, 2021 was $4.3
million, or ($0.51) basic and diluted per share, compared to a net
loss of $0.7 million, or ($0.14) basic and diluted per share, for
the second quarter ended June 30, 2020.
As of June 30, 2021, cash totaled $21.8 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 August 12, 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 (844) 602-0380 (domestic)
or (862) 298-0970 (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 antiviral
therapies to treat debilitating chronic diseases, 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 2a 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, including risks related to the
completion and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange
Commission. Forward-looking statements contained in this
announcement are made as of this date, and Virios Therapeutics,
Inc. (VIRI) 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 June
30,
Six Months Ended June
30,
2021
2020
2021
2020
Revenue
$
—
$
—
$
—
$
—
Operating expenses:
Research and development
3,209,201
23,320
4,916,159
53,859
General and administrative
1,075,256
515,060
2,425,732
867,073
Total operating expenses
4,284,457
538,380
7,341,891
920,932
Loss from operations
(4,284,457
)
(538,380
)
(7,341,891
)
(920,932
)
Other income (expense)
1,495
(116,205
)
2,896
(200,206
)
Net loss
$
(4,282,962
)
$
(654,585
)
$
(7,338,995
)
$
(1,121,138
)
Net loss per share of common stock — basic
and diluted
$
(0.51
)
$
(0.14
)
$
(0.88
)
$
(0.23
)
Weighted average shares outstanding —
basic and diluted
8,330,390
4,832,494
8,328,212
4,832,494
Condensed Balance Sheet Data
June 30,
December 31,
2021
2020
Cash
$
21,835,092
$
29,795,366
Total assets
23,764,782
31,472,731
Total liabilities
906,257
1,531,842
Total stockholders’ equity
22,858,525
29,940,889
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210812005079/en/
Dave Gentry 1-800-733-2447 +1-407-491-4498 dave@redchip.com or
ir@virios.com
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