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Tonix Pharmaceuticals Holding Corp. (symbol: TNXP) is a pioneering biopharmaceutical company dedicated to developing, licensing, and commercializing innovative therapeutics to treat and prevent human diseases. With a focus on central nervous system (CNS) disorders, Tonix is at the forefront of addressing major public health challenges.
One of Tonix's key projects is Tonmya, aimed at treating PTSD, which is currently in advanced stages of development. Additionally, the company is working on TNX-601 (tianeptine oxalate), a daytime treatment for PTSD, and TNX-801, a synthetic version of the horsepox virus, intended as a potential smallpox vaccine, both at the pre-IND (Investigational New Drug) application stage.
The company’s immunology development portfolio includes TNX-1500, a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154), being developed to prevent allograft rejection and treat autoimmune diseases. This portfolio demonstrates Tonix's commitment to addressing both organ transplant rejection and autoimmunity, as well as cancer.
Tonix’s mission to alleviate suffering extends beyond CNS disorders and immunology, as it is also exploring therapeutic solutions for rare and infectious diseases. Their dedication to research and innovation has established partnerships with reputable institutions, such as Massachusetts General Hospital, ensuring that their projects are backed by cutting-edge science and expertise.
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Tonix Pharmaceuticals (Nasdaq: TNXP) has expanded its collaboration with Columbia University to study immune responses to COVID-19. This research targets healthy volunteers with previous infections or those asymptomatic, focusing on T cell and antibody responses. Principal investigators Dr. Ilya Trakht and Dr. Sergei Rudchenko aim to identify biomarkers for protective immunity, potentially leading to tailored vaccines and monoclonal antibody therapeutics. Tonix's lead vaccine candidate, TNX-1800, is advancing toward a Phase 1 study, expected to begin in early 2022.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that its President and CEO, Seth Lederman, will present at the 2021 Cantor Virtual Global Healthcare Conference on September 28, 2021, at 2:00 p.m. ET. Investors can arrange virtual meetings with the management. A webcast of the presentation will be accessible on the Tonix website under the Investors section, with a replay available for 90 days. Tonix focuses on developing treatments for various conditions, including COVID-19, utilizing a platform of innovative product candidates.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced progress on its live virus vaccine TNX-1800, designed to provide long-lasting T cell immunity against COVID-19. Following a pre-IND meeting with the FDA, the company received guidance on the Phase 1 study, expected to commence in H1 2022. TNX-1800 demonstrated efficacy in animal studies, effectively protecting upper and lower airways from SARS-CoV-2. The vaccine, based on horsepox, may offer advantages like scalability and reduced cold chain requirements compared to existing mRNA vaccines.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that its President and CEO, Seth Lederman, will present at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. Interested investors may arrange virtual meetings with management. A webcast of the presentation will be available on-demand starting September 13, 2021, at 7:00 a.m. on the Tonix website, with a replay accessible for 90 days. Tonix focuses on developing therapies in CNS and immunology, including lead candidates for fibromyalgia and COVID-19 vaccines.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced plans to submit an Investigational New Drug (IND) application in Q4 2021 for TNX-102 SL as a treatment for Long COVID, focusing on patients with symptoms overlapping fibromyalgia. The FDA has provided guidance on the Phase 2 study design following a Type B pre-IND meeting. Long COVID affects over 30% of COVID-19 patients and can lead to persistent symptoms such as fatigue and pain. The company aims to leverage insights from its mid-Phase 3 fibromyalgia trials to inform this new treatment approach.
Tonix Pharmaceuticals (Nasdaq: TNXP) reported its Q2 2021 financial results, highlighting ongoing clinical trials for TNX-1300 and TNX-1900, and a Phase 3 study for TNX-102 SL. The company aims to enhance R&D and manufacturing capabilities with new facilities and expects a cash balance of approximately $166 million as of June 30, 2021. Research and development expenses rose to $18.1 million, while the net loss was $23.6 million, or $0.07 per share. The company’s focus includes advancing COVID-19 product candidates and expanding its CNS pipeline.
Tonix Pharmaceuticals announced a groundbreaking ceremony for its new Advanced Development Center (ADC) in New Bedford, MA, scheduled for August 3, 2021. The 45,000 sq. ft. facility will enhance the company's capacity for vaccine development, focusing on infectious diseases, including COVID-19. It aims to be operational in the first half of 2022 and will employ up to 70 staff. The ADC will support clinical manufacturing under Good Manufacturing Practices (GMP) and is a significant step toward addressing public health challenges.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced the acquisition of a 48,000 square foot R&D facility in Frederick, MD, from Southern Research. This facility will expand Tonix's capabilities in developing vaccines and antiviral drugs, specifically against COVID-19 and other infectious diseases. The acquisition aims to enhance the production and efficiency of Tonix’s vaccine candidates, including TNX-1800 and TNX-801. Expected to close by Q4 2021, this strategic move addresses challenges revealed by the COVID-19 pandemic and positions Tonix within Maryland’s biotech corridor.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced it will stop enrolling new participants in the Phase 3 RALLY study of TNX-102 SL (5.6 mg) for fibromyalgia management. This decision follows an interim analysis by the Independent Data Monitoring Committee (IDMC), indicating that the treatment is unlikely to show statistically significant improvements compared to placebo. The study initially enrolled 514 participants across 40 sites. Tonix plans to continue studying currently enrolled participants and expects to report topline results in Q4 2021.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the appointment of Carolyn E. Taylor to its Board of Directors, effective July 16, 2021. Taylor brings over 35 years of corporate law experience, including 15 years as a partner at Covington & Burling LLP. CEO Seth Lederman expressed optimism about Taylor's broad transactional expertise contributing to the company's growth. Tonix focuses on developing treatments for CNS and immunology conditions, with key candidates including TNX-102 SL for fibromyalgia and TNX-1800 for COVID-19.
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