Fatigue Syndrome, Chronic

LONDON, March 15, 2024 /PRNewswire/ -- Virax Biolabs Group Limited (NASDAQ: VRAX) ("Virax" or the "Company"), an innovative biotechnology company focused on the detection of immune responses and diagnosis of viral diseases, announced that it received a notice from The Nasdaq Stock Market LLC ("Nasdaq") dated March 13, 2024, notifying the Company that it is not in compliance with the minimum bid price requirement as set forth under NASDAQ Listing Rule 5550(a)(2)(the "Minimum Bid Price Rule") for continued listing on the NASDAQ. NASDAQ Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has a compliance period of one hundred eighty (180) calendar days, or until September 9, 2024 (the "Compliance Period"), to regain compliance with Nasdaq's minimum bid price requirement. If at any time during the Compliance Period, the closing bid price per share of the Company's ordinary shares is at least $1.00 for a minimum of ten (10) consecutive business days, Nasdaq will provide the Company a written confirmation of compliance and the matter will be closed. In the event the Company does not regain compliance by September 9, 2024, the Company may be eligible for an additional 180 calendar day grace period. The Nasdaq notification letter does not result in the immediate delisting of the Company's ordinary shares, and the shares will continue to trade uninterrupted under the symbol "VRAX." About Virax Biolabs Group Limited. Virax Biolabs Group Limited is an innovative biotechnology company focused on the detection of immune responses to and diagnosis of viral diseases. In addition to distributing an array of in-vitro diagnostic test kits, Virax Biolabs Group Limited is currently developing T cell based test technologies with the intention of providing an immunology profiling platform. T cell testing can be particularly effective in the diagnosis and therapeutics of Long COVid as well as chronic inflammation and other post viral syndromes including myalgic encephalomyelitis, Hepaitis B, Malaria, Herpes and Human Papillomavirus. For more information, please visit . Caution Concerning Forward Looking Statements: This press release contains forward-looking statements. In addition, from time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as "may," "should," "expects," "anticipates," "contemplates," "estimates," "believes," "plans," "projected," "predicts," "potential," or "hopes" or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of the Company; our ability to keep pace with new technology and changing market needs; and the competitive environment of our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties, and assumptions about us. These forward-looking statements are based on information currently available to Virax and its current plans or expectations and are subject to a number of known and unknown uncertainties, risks and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the "Risk Factors" section of Virax's Annual Report on Form 20-F for the year ended March 31, 2023. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. We are not obligated to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions, the forward-looking events discussed in this press release and other statements made from time to time by us or our representatives might not occur. SOURCE Virax Biolabs

In an innovative step towards combating chronic pain, Bestqool, a leader in therapeutic devices, unveils a new range of red light therapy products designed to provide relief from back, waist, neck, and shoulder pain. This breakthrough approach harnesses the power of red and near-infrared light wavelengths, offering a drug-free alternative to traditional pain management techniques. Back pain affects about 80% of adults at some point in their lives. This widespread problem may have a big influence on our everyday lives and health. Bestqool's latest offering is inspired by centuries of phototherapy research, from the ancient Egyptians' use of sunlight to the latest scientific findings on the benefits of red light therapy (RLT). Light’s therapeutic potential has been studied for centuries, starting with the ancient Egyptians, who used sunlight to treat a variety of ailments and continuing into modern scientific research. In phototherapy, red light therapy is an emerging miraculous therapy. It works by penetrating the skin and accelerating cellular processes with particular red and near-infrared light wavelengths. According to studies, this therapy can help relieve pain in the back, waist, neck, and shoulders by reducing inflammation, promoting tissue healing and not requiring the use of drugs. How Red Light Therapy Works Red light therapy operates by delivering specific wavelengths of light (660 - 850 nm) deep into the skin, stimulating cellular processes that facilitate pain relief. The therapy enhances mitochondrial function, thereby increasing the production of adenosine triphosphate (ATP), which is crucial for healing and reducing inflammation. Furthermore, it accelerates tissue repair and regeneration, making it an effective treatment for musculoskeletal pain. Increased Cellular Energy Production (ATP) Increasing the production of cellular energy (ATP) is one of red light therapy’s primary mechanisms of action. The “powerhouse” of the cell, the mitochondria, are activated to bring about this effect. These mitochondria boost the synthesis of ATP, the main energy source for different biological processes. Higher levels of ATP promote better cellular function, which lessens pain and promotes tissue healing. Reduction of Inflammation Red light therapy also works by reducing inflammation which is a major contributor to pain. Studies suggest that it can promote the activity of immune cells and other factors involved in the inflammatory response. By reducing this inflammatory response, red light therapy contributes to pain relief and accelerates tissue healing. Stimulation of tissue repair and regeneration Various studies indicate that red light therapy also stimulates tissue repair and regeneration. It promotes collagen production, an important protein for building and supporting tissues. Also, it enhances the activity of growth factors involved in tissue repair. This stimulation of repair mechanisms leads to faster healing and pain reduction in affected areas. Scientific Research Supporting RLT for Pain Relief More than 4000 scientific studies on pubmed.gov concluded that red light therapy has a positive effect on acute and chronic musculoskeletal pain. A notable review in the MOJ Orthopedics & Rheumatology journal highlighted its benefits for musculoskeletal discomfort, emphasizing its safety, cost-effectiveness, and role in enhancing the quality of life without the need for medication. st-effective therapy for pain could elevate quality of life while reducing financial strains. Red Light Therapy for Back and Waist Pain A study published in the European Journal of Scientific Research suggested that if infrared therapy is applied on the affected area (back or waist) with appropriate dose, exposure time and wavelength, it helps in relieving pain without any side effects. In 2020, another study on light-emitting diode photobiomodulation therapy for non-specific low back pain in working nurses was published in the journal “Medicine”. Patients received 6 LED red light therapy sessions (with wavelengths of both 630 nm and 850 nm) in two weeks. This study examined that LED therapy could be an effective alternative treatment for reducing non-specific back pain. Red Light Therapy for Shoulder Pain In a study published in 2022, ten adults with shoulder pain received LED red light therapy (wavelength 780 nm) for 3 minutes on the affected shoulder. After therapy, the symptoms of the neck with shoulder pain were improved. These symptoms improved further after 15 minutes of irradiation. It found that RLT is safe and effective for the treatment of shoulder pain. A systematic review and meta-analysis on the efficacy of low-level laser therapy for shoulder tendinopathy published in the journal Physiotherapy Research International in 2014 shows that optimal RLT can offer pain relief and induce a more rapid improvement, whether it is used alone or in combination with physiotherapy treatments. Red Light Therapy for Neck Pain A 2016 study published in the Journal “Functional Neurology, Rehabilitation, and Ergonomics found that red laser therapy is safe and effective for temporary pain relief and improving the range of motion for patients with chronic pain in the neck and shoulder caused by osteoarthritis, muscle spasms and cervical and thoracic spine strain. It also suggested that when RLT is used in conjunction with physical therapy and chiropractic care, it may help patients live normal, active and healthy lives without the need for analgesics. A systematic review in the Journal of Lasers in Surgery and Medicine analyzed various randomized controlled trials and suggested that infrared laser therapy helps in the treatment of acute and chronic neck pain. Another research in the Open Orthopedics Journal showed that red light therapy can moderately reduce chronic neck pain. Red Light Therapy Parameters For red light therapy to be effective, the irradiation parameters (wavelength, power, power density, pulse parameters, energy density, total energy and time) must fall within specific ranges. The optimum penetrating wavelengths fall between 660–850nm, and at 5 cm depth, they can reach a light density of 5 mW/cm2 when the surface density is 5 mW/cm2, and the beam power is 1 watt. RLT has four clinical objectives: To promote healing, remodeling and reduce inflammation in the injured/affected area Lymph nodes to lessen inflammation and edema Nerves to induce numbness Trigger points to ease tenderness and relaxation of contracted muscles Treatment times per point range between 30 to 60 seconds on average. For simple cases, one point may be treated; however, for complex dysfunctions like lumbar radiculopathy or chronic pain, ten to fifteen points may be treated. Choosing the Best Red Light therapy If you are suffering from any chronic fatigue and pain, red light therapy devices like the ones offered by Bestqool can be a game-changer. It offers you a range of high-quality red light devices and portable devices to manage your pain with the benefit of lowering your reliance on pharmaceutical drugs. Whether you aim to get rid of chronic pain or to improve overall health, you can adjust treatment goals as per your needs. All Bestqool red light therapy devices are FDA class II cleared, and usage cannot directly cause any harm to the human body. Remember, red light therapy devices are not a substitute for professional medical treatment to cure diseases. Still, they can help people who are medically powerless and relieve their physical and mental discomfort. References Roche, G. C., Murphy, D. J., Berry, T. S., & Shanks, S. (2016). Low-level laser therapy for the treatment of chronic neck and shoulder pain. Functional Neurology, Rehabilitation, and Ergonomics, 6(2), 97. Cotler, H. B., Chow, R. T., Hamblin, M. R., & Carroll, J. (2015). The Use of Low Level Laser Therapy (LLLT) For Musculoskeletal Pain. MOJ orthopedics & rheumatology, 2(5), 00068. Haslerud, S., Magnussen, L. H., Joensen, J., Lopes‐Martins, R. A. B., & Bjordal, J. M. (2015). The efficacy of Low‐Level laser therapy for shoulder tendinopathy: a systematic review and Meta‐Analysis of randomized controlled trials. Physiotherapy Research International, 20(2), 108-125. Lin, Y. P., Su, Y. H., Chin, S. F., Chou, Y. C., & Chia, W. T. (2020). Light-emitting diode photobiomodulation therapy for non-specific low back pain in working nurses: A single-center, double-blind, prospective, randomized controlled trial. Medicine, 99(32), e21611. Chow, R. T., & Barnsley, L. (2005). Systematic review of the literature of low‐level laser therapy (LLLT) in the management of neck pain. Lasers in Surgery and Medicine: The Official Journal of the American Society for Laser Medicine and Surgery, 37(1), 46-52.

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 $0.3 million, compared to $1.3 million for the fourth quarter of 2022. The decrease quarter over quarter was due to decreases in expenses for clinical trials of $0.6 million, toxicology studies of $0.3 million and salaries and related personnel costs of $0.1 million. General and administrative expenses for the fourth quarter of 2023 remained level with the fourth quarter of 2022 at $0.8 million. Net loss for the fourth quarter of 2023 was $1.1 million, or $0.06 basic and diluted net loss per share, compared to a net loss of $2.0 million, or $0.11 basic and diluted net loss per share, for the fourth quarter of 2022. Full Year 2023 Financial Results Research and development expenses for the year ended December 31, 2023 were $1.7 million, compared to $8.1 million for the year ended December 31, 2022. The $6.4 million decrease was primarily due to decreases in expenses for clinical trials of $5.5 million, toxicology studies of $0.6 million, drug development and manufacturing costs of $0.1 million, and salaries and related personnel costs of $0.3 million partially offset by an increase in regulatory consulting of $0.1 million. General and administrative expenses for the year ended December 31, 2023 were $3.7 million, compared to $4.2 million for the year ended December 31, 2022. The $0.5 million decrease was primarily due to a decrease in costs associated with being a public company. Net loss for the year ended December 31, 2023 was $5.3 million, or $0.28 basic and diluted net loss per share, compared to a net loss of $12.2 million, or $1.11 basic and diluted net loss per share, for the year ended December 31, 2022. As of December 31, 2023, Virios Therapeutics’ cash totaled $3.3 million. The Company believes it has sufficient resources to fund operations into the fourth quarter of 2024. 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 . Follow Virios Therapeutics Email Alerts: LinkedIn: Twitter: Facebook: 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. Contact: IR@Virios.com 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