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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) announced its second-quarter financial results as of June 30, 2020, highlighting progress in developing its COVID-19 vaccine candidate, TNX-1800. The company expects preclinical data for TNX-1800 in Q4 2020 and has completed the enrollment for the Phase 3 RELIEF trial of TNX-102 SL for fibromyalgia ahead of schedule. Financially, Tonix reported a net loss of $14.2 million ($0.23 per share) compared to $5.8 million ($9.42 per share) in Q2 2019. The company holds $55 million in cash and raised approximately $9.6 million through a recent stock offering.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced FDA clearance for its IND application to initiate a Phase 2 study of TNX-102 SL for treating alcohol use disorder (AUD). This milestone positions TNX-102 SL for potential FDA approval under the 505(b)(2) pathway. The company highlights the significance of improving sleep quality, which may enhance recovery rates for the estimated 36 million adults in the U.S. affected by AUD. Tonix continues to develop a robust pipeline of CNS and immunology products, including vaccines for infectious diseases and biologics targeting various conditions.
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced it has regained compliance with NASDAQ's minimum bid price requirement, following a letter received on August 3, 2020. The company’s shares closed above $1.00 for ten consecutive business days, satisfying NASDAQ Listing Rule 5450(a)(1). This is significant for the company as it ensures continued listing on the NASDAQ Global Market. Tonix focuses on developing small molecules and biologics for central nervous system and immunology indications, including COVID-19 vaccine candidates and treatments for fibromyalgia.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced preclinical results for TNX-1900, an intranasal oxytocin solution, to be presented at the American Academy of Neurology's Sports Concussion Conference on July 31 and August 1, 2020. The study, sponsored by Trigemina, reveals TNX-1900's potential to relieve pain and depressive behavior in a rodent model of mild traumatic brain injury. Tonix acquired Trigemina's assets in June, including valuable data for TNX-1900. The company is focused on developing solutions for CNS and immunology conditions, with several clinical-stage products in its pipeline.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has rescheduled its Special Meeting of Stockholders to August 28, 2020, moving it from June 26, 2020. The record date for stockholders eligible to vote is now July 15, 2020. The meeting will cover proposals previously mentioned in the proxy statement, with no new proposals introduced. Stockholders are encouraged to register online to attend the meeting. Tonix is developing vaccines and CNS therapies, including TNX-1800 for COVID-19, with data expected from animal studies in Q4 2020.
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) has successfully closed a registered direct offering, generating approximately $10.5 million before fees. The company issued 20,940,000 shares at $0.50 per share, raising its total outstanding shares to 125,743,906. A.G.P./Alliance Global Partners acted as the placement agent. This offering was made under an effective shelf registration statement with the SEC. Tonix focuses on developing therapies for CNS and immunology, with its lead candidates addressing COVID-19 and fibromyalgia.
Tonix Pharmaceuticals Holdings Corp. (NASDAQ: TNXP) has announced a securities purchase agreement with institutional investors for the sale of 20,940,000 shares at $0.50 per share, totaling approximately $10.5 million in gross proceeds. The registered direct offering is set to close on or about July 15, 2020. A.G.P./Alliance Global Partners is acting as the sole placement agent. Tonix is focused on developing treatments for CNS disorders and immunology, including vaccines for COVID-19 and smallpox, with upcoming data from various clinical trials expected in late 2020.
Tonix Pharmaceuticals (NASDAQ: TNXP) has entered a preclinical research agreement with Kansas State University to develop TNX-2300, a live replicating vaccine for COVID-19 based on bovine parainfluenza virus. This vaccine aims to stimulate T cell immunity through the CD40-ligand, promoting durable immunity and potentially preventing virus transmission. TNX-2300 is the second live viral vaccine platform for the company, complementing its lead candidate TNX-1800, which is based on horsepox virus. Both vaccines are in preclinical development stages.
Tonix Pharmaceuticals (Nasdaq: TNXP) achieved target enrollment of approximately 470 participants in its Phase 3 RELIEF trial for TNX-102 SL, a non-opioid treatment for fibromyalgia, ahead of schedule. An interim analysis of 50% of participants is expected in September 2020, with topline data anticipated in Q4 2020. The RELIEF study is designed to assess the efficacy and safety of TNX-102 SL, with results expected to provide insights into a new treatment option for the fibromyalgia community.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced plans to acquire a 40,000 sq. ft. facility in Massachusetts to establish an Advanced Development Center for R&D focused on immunology candidates, including vaccines for COVID-19. The new center will enhance Tonix's process and analytical development capabilities and is expected to be operational in 2022. Current collaborations with Southern Research and FUJIFILM Diosynth Biotechnologies for preclinical testing and manufacturing of TNX-801 and TNX-1800 vaccines will continue. Preclinical results for TNX-1800 are anticipated in Q4 2020.
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