Virios Therapeutics Announces Fourth Quarter and Full Year 2023 Financial Results
- Alignment with FDA on IMC-2 Phase 2 development for LC
- Upcoming clinical data on valacyclovir/celecoxib for Long-COVID
- Initiation of Phase 2 program in LC targeted for second half of 2024
- Ongoing discussions with potential partners for IMC-1 Phase 3 development for FM
- Decrease in R&D expenses for Q4 and full year 2023 compared to 2022
- Net loss reduction for Q4 and full year 2023 compared to 2022
- Cash balance of $3.3 million as of December 31, 2023
- None.
Insights
The financial results of Virios Therapeutics reveal a significant reduction in net loss year-over-year, which is a positive signal for investors. The decrease in research and development expenses, particularly in clinical trials and toxicology studies, indicates a strategic shift or a completion of certain developmental phases, which may lead to reduced cash burn. However, the company's current cash position of $3.3 million, while sufficient to fund operations into Q4 2024, could raise concerns about future capital raising activities and potential dilution for current shareholders. Investors should monitor the company's ability to secure additional funding or partnerships, especially for the upcoming Phase 2 and Phase 3 trials.
Virios Therapeutics' alignment with the FDA on endpoints for the Phase 2 study of IMC-2 for Long-COVID is a critical milestone. The selection of fatigue as the primary endpoint is based on previous clinical evidence suggesting efficacy in this symptom. The focus on Long-COVID, a condition with no current FDA-approved treatments, could position Virios as a pioneer in this therapeutic area. However, the success of this program hinges on the clinical data expected this summer and the subsequent initiation of the Phase 2 program. The potential market for Long-COVID treatments is substantial, considering the global prevalence of the condition, but clinical and regulatory risks remain until the new data are available and analyzed.
The therapeutic area of fibromyalgia and Long-COVID, where Virios is focusing its efforts, is associated with a high unmet medical need. This presents a significant market opportunity for the company if its treatments prove to be effective and safe. Current discussions to fund Phase 3 development for the treatment of fibromyalgia indicate the company's proactive approach to partnership building. The outcomes of these discussions could greatly influence the company's valuation and market potential. Moreover, the company's strategic direction in addressing chronic viral diseases could set it apart within the biotech sector, provided that upcoming clinical milestones are met successfully.
ATLANTA, Feb. 29, 2024 (GLOBE NEWSWIRE) -- 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 (“LC”), today announced financial results for the fourth quarter and full year ended December 31, 2023.
Key Highlights and Upcoming Milestones
- Virios received written communication from the Food and Drug Administration (“FDA”) on the development requirements and key endpoints associated with advancing IMC-2 into Phase 2 for treatment of LC symptoms.
- The FDA agreed that for its planned Phase 2 study, Virios can use fatigue as the primary endpoint and orthostatic intolerance as a key secondary endpoint to assess the effectiveness of IMC-2 in treating LC.
- New placebo-controlled 12-week clinical data assessing valacyclovir/celecoxib to treat Long-COVID, from an ongoing study conducted by the Bateman Horne Center via an unrestricted investigational grant provided by the Company, expected this summer.
- Initiation of a Phase 2 program in LC is targeted in the second half of 2024, contingent on securing funding for the program.
- Discussions are ongoing with potential partners to fund the advancement of IMC-1 into Phase 3 development for the treatment of FM.
“We are pleased to have recently reached alignment with FDA on using fatigue response as the primary end point for evaluating IMC-2 as a treatment for Long-COVID symptoms,” said Greg Duncan, Chairman and CEO of Virios Therapeutics, Inc. “This is particularly encouraging given that our unique combination antiviral agents have demonstrated clinically and statistically significant improvement in patient fatigue in several studies, including for IMC-2 treated Long-COVID patients.”
Fourth Quarter 2023 Financial Results
Research and development expenses for the fourth quarter of 2023 were
General and administrative expenses for the fourth quarter of 2023 remained level with the fourth quarter of 2022 at
Net loss for the fourth quarter of 2023 was
Full Year 2023 Financial Results
Research and development expenses for the year ended December 31, 2023 were
General and administrative expenses for the year ended December 31, 2023 were
Net loss for the year ended December 31, 2023 was
As of December 31, 2023, Virios Therapeutics’ cash totaled
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 (“LC”). 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, LC, 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.
For more information, please visit www.virios.com.
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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, potential future partnerships or other material transactions, and the requirements of or feedback from Nasdaq regarding the continued listing of our common stock. 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.
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VIRIOS THERAPEUTICS
Selected Financial Data
(unaudited)
| Condensed Statements of Operations Data | Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue | $ | — | $ | — | $ | — | $ | — | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 298,320 | 1,271,714 | 1,728,078 | 8,069,628 | ||||||||||||
| General and administrative | 839,806 | 818,002 | 3,718,841 | 4,245,681 | ||||||||||||
| Total operating expenses | 1,138,126 | 2,089,716 | 5,446,919 | 12,315,309 | ||||||||||||
| Loss from operations | (1,138,126 | ) | (2,089,716 | ) | (5,446,919 | ) | (12,315,309 | ) | ||||||||
| Other income | 34,953 | 45,160 | 150,904 | 67,475 | ||||||||||||
| Net loss | $ | (1,103,173 | ) | $ | (2,044,556 | ) | $ | (5,296,015 | ) | $ | (12,247,834 | ) | ||||
| Net loss per share of common stock — basic and diluted | $ | (0.06 | ) | $ | (0.11 | ) | $ | (0.28 | ) | $ | (1. 11 | ) | ||||
| Weighted average shares outstanding — basic and diluted | 19,257,937 | 18,330,390 | 18,776,790 | 11,070,116 | ||||||||||||
| Condensed Balance Sheet Data | December 31, | December 31, | |||||
| 2023 | 2022 | ||||||
| Cash | $ | 3,316,946 | $ | 7,030,992 | |||
| Total assets | 4,165,442 | 8,369,756 | |||||
| Total liabilities | 358,548 | 1,043,262 | |||||
| Total stockholders’ equity | 3,806,894 | 7,326,494 | |||||
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