Virios Therapeutics Announces Third Quarter 2021 Financial Results and Provides Corporate Update
- Over 200 patients Enrolled in Fibromyalgia Phase 2b Trial
- Filed Investigational New Drug Application with FDA to Assess IMC-1 Potential to Treat Irritable Bowel Syndrome
- Cash Position Supports Operations into Q1 2023
-
Management to Host Webcast and Conference Call at
8:30 a.m. EST November 11, 2021
“We are pleased to have enrolled over 200 patients into our landmark Phase 2b fibromyalgia clinical trial, referred to as FORTRESS, with the goal to announce top line results in Q3 2022,” stated
Recent Key Highlights and Upcoming Milestones
- Over 200 of the target 460 patients enrolled in ongoing fibromyalgia Phase 2b Trial;
- Filed IND with FDA to explore the utility of IMC-1 in treating patients diagnosed with IBS;
-
The United States Patent and Trademark Office granted
Virios Therapeutics patent exclusivity on its valacyclovir-celecoxib combination drug candidate (“IMC-2”) to 2033, bringing the Company’s intellectual property portfolio to 21 issued patents; and -
Virios Therapeutics CEO featured in Red Chip Money Report interview on Bloomberg TV onOctober 30, 2021 .
Third Quarter 2021 Financial Results
Research and development expenses were
General and administrative expenses were
Net loss for the third quarter ended
As of
Conference Call & Webcast Details
About
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”, within the meaning of the
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Selected Financial Data |
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(unaudited) |
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Condensed Statements of Operations Data |
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Three Months Ended
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Nine Months Ended
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|
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2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
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Revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
2,961,122 |
|
|
|
108,086 |
|
|
|
7,877,281 |
|
|
|
161,944 |
|
General and administrative |
|
|
1,150,369 |
|
|
|
2,554,724 |
|
|
|
3,576,101 |
|
|
|
3,421,798 |
|
Total operating expenses |
|
|
4,111,491 |
|
|
|
2,662,810 |
|
|
|
11,453,382 |
|
|
|
3,583,742 |
|
Loss from operations |
|
|
(4,111,491 |
) |
|
|
(2,662,810 |
) |
|
|
(11,453,382 |
) |
|
|
(3,583,742 |
) |
Other income (expense) |
|
|
1,509 |
|
|
|
(61,219 |
) |
|
|
4,405 |
|
|
|
(261,425 |
) |
Net loss |
|
$ |
(4,109,982 |
) |
|
$ |
(2,724,029 |
) |
|
$ |
(11,448,977 |
) |
|
$ |
(3,845,167 |
) |
Net loss per share of common stock — basic and diluted |
|
$ |
(0.49 |
) |
|
$ |
(0.56 |
) |
|
$ |
(1.37 |
) |
|
$ |
(0.80 |
) |
Weighted average shares outstanding — basic and diluted |
|
|
8,330,390 |
|
|
|
4,832,494 |
|
|
|
8,328,946 |
|
|
|
4,832,494 |
|
Condensed Balance Sheet Data |
|
|
|
|
|
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|
2021 |
|
|
2020 |
|
||
|
|
|
|
|
|
|
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Cash |
$ |
19,186,324 |
|
|
$ |
29,795,366 |
|
Total assets |
|
20,107,236 |
|
|
|
31,472,731 |
|
Total liabilities |
|
1,226,787 |
|
|
|
1,531,842 |
|
Total stockholders’ equity |
|
18,880,449 |
|
|
|
29,940,889 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20211111005226/en/
1-800-733-2447
+1-407-491-4498
dave@redchip.com
or
ir@virios.com
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