Tonix Pharmaceuticals Hld

Tonix Pharmaceuticals Holding Corp. is a clinical-stage biopharmaceutical company, which focuses on the discovery, acquisition, and development of small molecules and biologics to treat and prevent human disease and alleviate suffering. Its portfolio includes TNX-102 SL, TNX-601, TNX-801, and TNX-1800. The company was founded by Seth Lederman and Donald W. Landry on November 16, 2007 and is headquartered in Chatham, NJ.

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Enrollment Continues in Phase 3 RELIEF Study, with Interim Results of the First 50 Percent of Participants Expected in September 2020

Tonix Pharmaceuticals Achieves 50 Percent Enrollment in Phase 3 RELIEF Study of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) for Management of Fibromyalgia

NEW YORK, April  20, 2020  (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company) announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix, will be conducting a virtual presentation in conjunction with the Planet MicroCap Showcase Virtual Investor Conference on Wednesday, April 22, 2020, at 12:00 p.m. ET.

Tonix Pharmaceuticals to Deliver Virtual Presentation and Participate in Panel Discussion for Planet MicroCap Showcase Virtual Investor Conference 2020

NEW YORK, March  03, 2020  (GLOBE NEWSWIRE) -- TONIX PHARMACEUTICALS HOLDING CORP. (NASDAQ: TNXP) (“Tonix” or the “Company”), a clinical-stage biopharmaceutical company, today announced the closing of its previously announced registered direct offering, with gross proceeds of $16,005,000 before deducting fees and other estimated offering expenses.

Tonix Pharmaceuticals Holding Corp. Closes $16,005,000 Common Stock Registered Direct Offering

NEW YORK, Feb.  28, 2020  (GLOBE NEWSWIRE) -- TONIX PHARMACEUTICALS, INC. (NASDAQ: TNXP) (“Tonix” or the “Company”), a clinical-stage biopharmaceutical company, today announced it has entered into a securities purchase agreement with institutional investors for the purchase and sale of 14,550,000 shares of common stock, par value $0.001 per share at an offering price of $1.10 per share, pursuant to a registered direct offering, priced at-the-market under Nasdaq rules. The gross proceeds of the offering will be $16,005,000 before deducting fees and other estimated offering expenses. The closing of the registered direct offering is expected to take place on or about March 3, 2020, subject to the satisfaction of customary closing conditions.

Tonix Pharmaceuticals, Inc. Prices $16,005,000 Common Stock Offering Priced At-The-Market

NEW YORK, Feb.  11, 2020  (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today the closing of its previously announced underwritten public offering with total gross proceeds of approximately $7,500,000 before deducting underwriting discounts, commissions and other offering expenses payable by the Company.

Tonix Pharmaceuticals Announces Closing of $7.5 million Public Offering

NEW YORK, Feb.  07, 2020  (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today the pricing of an underwritten public offering with expected total gross proceeds of $7.5 million before deducting underwriting discounts, commissions and other offering expenses payable by the Company.

Tonix Pharmaceuticals Prices $7.5 million Public Offering

RECOVERY Study has Stopped Enrollment Due to Inadequate Separation from Placebo at Week-12 Based on Interim Analysis Results of the First 50% of Enrolled Participants

Tonix Pharmaceuticals Announces Outcome of Interim Analysis for Phase 3 RECOVERY Study  of Tonmya® (TNX-102 SL) in PTSD

Tonix Pharmaceuticals Moves Ahead, And Other News: The Good, Bad, And Ugly Of Biopharma

NEW YORK, Jan.  29, 2020  (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, presented preclinical results of TNX-801 (live virus vaccine for percutaneous administration) to potentially prevent smallpox and monkeypox in a poster at the 2020 ASM Biothreats Conference held January 28-30, 2020 in Arlington, Va. The poster, titled “Synthetic Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from Monkeypox” includes preclinical safety and efficacy analyses of TNX-801. The poster can be found on the Scientific Presentations page of Tonix’s website.

Tonix Pharmaceuticals Presented Results from a Preclinical Study of TNX-801, a Potential Vaccine to Prevent Smallpox and Monkeypox, in a Poster Presentation at the 2020 American Society for Microbiology (ASM) Biothreats Conference

   Tonix Expects the Data to Satisfy Pharmacokinetic Requirements for Potential New Drug Applications for TNX-102 SL for PTSD and Fibromyalgia

Tonix Pharmaceuticals Announces Successful Completion of a Fed-Fasting and Dose Proportionality Study of TNX-102 SL

TNX-601 CR Active Ingredient, Tianeptine, is Approved and Marketed as an Immediate Release Three-Times-a-Day Antidepressant in Europe, Asia, Russia and Latin America

Tonix Pharmaceuticals Announces Plan to Develop TNX-601 CR Tablets for Once-Daily Treatment of Major Depressive Disorder, in Addition to PTSD, After Successful Completion of Phase 1 Pharmacokinetic Study

NEW YORK, Dec.  11, 2019  (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the European Patent Office ("EPO") issued European Patent No. 2968992 to the Company on December 11, 2019. This patent, “Eutectic Formulations of Cyclobenzaprine Hydrochloride and Mannitol,” includes 14 claims directed to compositions comprising eutectics of cyclobenzaprine hydrochloride and mannitol and methods of making those compositions.  This patent is expected to provide Tonix with market exclusivity until 2034.

Tonix Pharmaceuticals Announces New European Patent for the  Composition and Formulation of TNX-102 SL

Interim Analysis Results Expected Second Half 2020

Tonix Pharmaceuticals Enrolls First Patient in Phase 3 RELIEF Study of TNX-102 SL for the Management of Fibromyalgia

Minutes are Consistent with Guidance Received at FDA Meeting

Tonix Pharmaceuticals Announces Receipt of FDA Official Minutes from Breakthrough Therapy Type B Clinical Guidance Meeting for Tonmya® as a Potential New Treatment for PTSD

Shares of nano-cap biotech Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) were volatile Thursday morning following an announcement concerning its pre-investigational new drug application meeting with the U.S Food and Drug Administration.

Tonix Plans Regulatory Filing To Kick Off Study Of Alcohol Use Disorder Drug

First Patient Expected to be Dosed Before Year-End 2019 First Patient Expected to be Dosed Before Year-End 2019

Tonix Pharmaceuticals Announces Initiation of the Phase 3 RELIEF Study of TNX-102 SL for the Management of Fibromyalgia

FDA Official Meeting Minutes Support Tonix’s Plan to file an Investigational New Drug (IND) Application in the First Quarter of 2020 for a Phase 2 Proof-of-Concept Study FDA Official Meeting Minutes Support Tonix’s Plan to file an Investigational New Drug (IND) Application in the First Quarter of 2020 for a Phase 2 Proof-of-Concept Study

Tonix Pharmaceuticals Completes Pre-IND Meeting with FDA for TNX-102 SL as a Clinical Candidate for Alcohol Use Disorder

NEW YORK, Nov.  20, 2019  (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), clinical-stage biopharmaceutical company, announced today the closing of its previously announced underwritten public offering with total gross proceeds of approximately $9,000,000 before deducting underwriting discounts, commissions and other offering expenses payable by the Company.

Tonix Pharmaceuticals Announces Closing of $9.0 Million Public Offering

NEW YORK, Nov.  15, 2019  (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today the pricing of an underwritten public offering with expected total gross proceeds of $9.0 million before deducting underwriting discounts, commissions and other offering expenses payable by the Company.

Tonix Pharmaceuticals Prices $9.0 Million Public Offering

Primary Endpoint Will be Mean Change from Baseline in CAPS-5 at Week 12, Instead of Week 4

Tonix Pharmaceuticals Announces 12-Week Primary Endpoint and Addition of Adaptive Design Features in the Currently-Enrolling Phase 3 RECOVERY Study of Tonmya® for PTSD, Following FDA Meeting

NEW YORK, Oct.  31, 2019  (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that it will effect a 1-for-10 reverse stock split of its outstanding common stock. This will be effective for trading purposes as of the commencement of trading on November 1, 2019.

Tonix Pharmaceuticals Announces 1-for-10 Reverse Stock Split

NEW YORK, Oct.  23, 2019  (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the U.S. Patent and Trademark Office ("USPTO") issued U.S. Patent No. 10,449,203 to the Company on October 22, 2019. This patent, “Tianeptine Oxalate Salts and Polymorphs,” includes claims directed to crystalline tianeptine oxalate salts, and disclosures directed to methods of using those crystalline forms and their compositions. This patent, excluding possible patent term extensions, is expected to provide Tonix with U.S. market exclusivity until December 28, 2037.

Tonix Pharmaceuticals Announces Issuance of U.S. Patent for Crystalline Tianeptine Oxalate Salt, the Active Ingredient of TNX-601

NEW YORK, Oct.  15, 2019  (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that it has joined the Alliance for Biosecurity (the Alliance). The Alliance is a coalition of biopharmaceutical companies and laboratory/academic partners that promotes a strong public-private partnership to ensure medical countermeasures are available to protect public health and enhance national health security. The Alliance advocates for public policies and funding to support the rapid development, production, stockpiling, and distribution of critically needed medical countermeasures.

Tonix Pharmaceuticals Joins the Alliance for Biosecurity

First-in-Class Biologic for the Treatment of Gastric and Pancreatic Cancers First-in-Class Biologic for the Treatment of Gastric and Pancreatic Cancers

Tonix Pharmaceuticals Announces Licensing Agreement with Columbia University for the Development of Recombinant Trefoil Family Factor 2 (rTFF2), or TNX-1700, for the Treatment of Gastric and Pancreatic Cancers

NEW YORK, Sept.  16, 2019  (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the publication of a paper entitled “D-578, an orally active triple monoamine reuptake inhibitor, displays antidepressant and anti-PTSD effects in rats” in the European Journal of Pharmacology. The paper summarizes the behavioral pharmacological characterization of a novel triple reuptake inhibitor (TRI), TNX-1600, formerly known as D-578, which exhibits nanomolar potency at all three monoamine transporters (NET > SERT ≈ DAT) and exhibited little to no affinity for other off-target central nervous system (CNS) receptors. TNX-1600 was found to have greater efficacy in normalizing traumatic stress-induced extinction-retention learning in an animal model for posttraumatic stress disorder (PTSD) compared to paroxetine, a selective serotonin reuptake inhibitor (SSRI), which is approved by the U.S. Food and Drug Administration (FDA) to treat PTSD and other psychiatric conditions. These findings suggest TNX-1600 may reduce maladaptive retention of fearful memories via attenuation of the extinction learning and extinction retention deficits induced by traumatic stress, supporting further testing of this agent for the pharmacotherapy of PTSD. Additionally, TNX-1600 showed a robust effect in an animal model associated with antidepressant activity without affecting locomotor activity.

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