VIRI Virios Therapeutics Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
IMC-1 (FORTRESS)
Fibromyalgia
|
Phase 2b
Phase 2b
|
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Latest News
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Intellectual Property Estate Now Includes Valacyclovir-Celecoxib Combination
Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases, announced today that the United States Patent and Trademark Office ("USPTO") has granted Virios Therapeutics patent exclusivity on its valacyclovir-celecoxib combination drug candidate to 2033. The Company's intellectual property portfolio now includes 21 issued patents, consisting of 13 issued U.S. patents and 8 issued foreign patents, with exclusivity into 2033. This portfolio of patents also covers the Company's lead development candidate IMC-1, a synergistic, fixed dose combination of famciclovir and celecoxib, which is in Phase 2b development for the treatment of fibromyalgia.
"We are pleased to expand our substantial intellectual property portfolio with a new patent for an additional proprietary antiviral combination therapy," stated Greg Duncan, Chairman and Chief Executive Officer. "In the context of increasing recognition in the scientific community of the potential role of activated viruses in triggering a wide range of conditions, Virios is actively exploring new disease targets as a complement to our ongoing fibromyalgia Phase 2b program."
About Virios Therapeutics
Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, combination 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 syndrome ("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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210908005139/en/
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Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases, announced today that Greg Duncan, Chairman and Chief Executive Officer, will present a company overview at the H.C. Wainwright 23rd Annual Global Investment Conference which is taking place virtually September 13 – 15, 2021.
The presentation will focus on the role of activated viruses triggering a wide range of conditions, including fibromyalgia, irritable bowel syndrome and fatigue-related disorders.
The presentation will be available for on-demand access beginning Monday, September 13, 2021, at 7:00 AM ET, on Virios Therapeutics' website under the Investors section: Events and Presentations.
About Virios Therapeutics
Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, combination 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210902005063/en/
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Data from Ongoing Phase 2b Fibromyalgia Trial Projected for Mid-2022
Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, announced today the expansion of the company's social media platforms as well as social media disclosure.
Virios has established a social presence on LinkedIn, Twitter and Facebook, where current and potential investors and other interested persons can connect with the company and receive future updates. The Company plans to use the newly established social media profiles in addition to the Company's existing Investor Relations website for the distribution of Company information. Accordingly, investors should connect with Virios to monitor these channels, along with following press releases, SEC filings and public conference calls and webcasts. The links can be found below to each of these platforms.
Content will include company news and updates as well as educational, scientific-based posts regarding Herpes Simplex Virus-1 ("HSV-1"), fibromyalgia, irritable bowel syndrome ("IBS"), chronic fatigue syndrome ("CFS") and functional somatic syndrome, all of which are characterized by a waxing and waning manifestation of disease.
"With the recent news that all 41 sites involved in our ongoing 460 patient Phase 2b fibromyalgia ("FM") trial are now fully activated and enrolling patients, now is the perfect time to expand our digital presence through social media," said Virios Therapeutics CEO Greg Duncan.
Mr. Duncan continued, "The current trial builds on the encouraging results from our previously completed 2a FM clinical study that demonstrated our lead antiviral development candidate, orally administered IMC-1, met its primary endpoint of pain reduction and was statistically tolerated better than placebo. With the new trial underway we are excited to share new results and updates with investors and patients alike through these platforms."
Virios Therapeutics LinkedIn: https://www.linkedin.com/company/ViriosBiotech/
Virios Therapeutics Twitter: https://twitter.com/ViriosBiotech
Virios Therapeutics Facebook: https://www.facebook.com/ViriosBiotech/
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 syndrome ("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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210819005057/en/
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Data from Ongoing Phase 2b Fibromyalgia Trial Projected for Mid-2022
Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, announced today that Chairman and CEO, Greg Duncan, highlighted the Company's novel combination antiviral development approach, its ongoing Phase 2b trial Fibromyalgia trial and plans for expanded pipeline programs in irritable bowel syndrome (IBS) and fatigue related disorders during a video interview with Stock News Now, a microcap financial news portal that features news and insights from the microcap and emerging growth financial community.
The archived replay of the interview may be accessed on the Virios Therapeutics website under the Investors section: Events and Presentations.
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 syndrome ("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.
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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/