Monday, March 15, 2021 5:32:41 PM
Today 4:45 PM ET (Dow Jones)Print
2021-03-15 20:45:00 GMT Press Release: Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Operational Highlights
Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Operational Highlights
Announced Positive Phase 3 RELIEF Study Results for TNX-102 SL 5.6 mg in Fibromyalgia
Interim Analysis Results from Second Confirmatory Phase 3 Study, RALLY, Expected in Third Quarter 2021: Interim Cohort Enrolled
Efficacy Data from Animal Studies of COVID-19 Vaccine Candidate, TNX-1800, Expected in First Quarter 2021
Phase 1 Safety Study in Humans of TNX-1800 Expected to Start in Second Half 2021
At December 31, 2020, Cash and Cash Equivalents Totaled $77.1 Million; Approximately $110 Million in Gross Proceeds Raised Subsequent to Year-End
CHATHAM, N.J., March 15, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and full year ended December 31, 2020, and provided an overview of recent operational highlights.
"We continue to make progress across our development programs and are steadily advancing our diverse pipeline of CNS and immunology product candidates," said Seth Lederman, M.D., President and Chief Executive Officer. "In 2021, we expect to deliver on several important milestones. Following on the success of our first pivotal Phase 3 fibromyalgia study, RELIEF, we look forward to reporting interim and topline data from a second potentially pivotal Phase 3 fibromyalgia study, RALLY, this year. We recently reported that we achieved enrollment of the first 50 percent of participants in RALLY, which we expect will be the interim analysis cohort. We also expect to report preclinical efficacy data from our COVID-19 vaccine candidate this quarter and start a Phase 1 study in humans in the second half of this year. Finally, we expect to initiate new clinical trials this year for several other programs including a Phase 2 cocaine intoxication trial, Phase 2 migraine trial, and a proof-of-concept study for the skin test for COVID-19 exposure to measure T cell immunity."
Recent TNXP News
- Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights • GlobeNewswire Inc. • 04/01/2024 08:15:00 PM
- Tonix Pharmaceuticals Announces Pricing of $4.4 Million Registered Direct Offering • GlobeNewswire Inc. • 03/28/2024 01:32:56 PM
- Tonix Pharmaceuticals Receives Rare Pediatric Disease Designation from the FDA for TNX-2900 for the Treatment of Prader-Willi Syndrome • GlobeNewswire Inc. • 03/25/2024 12:00:00 PM
- Tonix Pharmaceuticals Announces Poster Presentation Describing Discovery of Novel Next-Generation Oxytocin Analogues at the American Chemistry Society (ACS) Spring 2024 Meeting • GlobeNewswire Inc. • 03/21/2024 12:00:00 PM
- Tonix Pharmaceuticals Announces Selection of Two Contract Manufacturing Organizations for the Launch and Commercial Manufacture of Tonmya™ for the Management of Fibromyalgia • GlobeNewswire Inc. • 03/20/2024 12:00:00 PM
- Tonix Pharmaceuticals Announces Transition to Fully Integrated Biopharmaceutical Company Expected on April 1, 2024 • GlobeNewswire Inc. • 03/19/2024 12:00:00 PM
- Tonix Pharmaceuticals Announces Presentation at BIO-Europe Spring • GlobeNewswire Inc. • 03/12/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/11/2024 12:05:22 PM
- Tonix Pharmaceuticals Reports Improvement in “Brain Fog,” in Fibromyalgia Patients Treated with Tonmya™ in RESILIENT, an NDA-Enabling Phase 3 Clinical Trial, at the 6th International Congress on Controversies in Fibromyalgia • GlobeNewswire Inc. • 03/11/2024 12:00:00 PM
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- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 01:06:09 PM
- Tonix Pharmaceuticals Announces Publication in Psychiatry Research Showing Activity of Bedtime TNX-102 SL on PTSD Symptoms and Sleep Quality in Military-Related PTSD at Four Weeks of Therapy • GlobeNewswire Inc. • 03/07/2024 01:00:00 PM
- Form 4/A - Statement of changes in beneficial ownership of securities: [Amend] • Edgar (US Regulatory) • 03/06/2024 10:01:16 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 01:05:29 PM
- Tonix Pharmaceuticals Selects EVERSANA® to Support Launch Strategy and Commercialization Planning of Tonmya™ for the Management of Fibromyalgia • GlobeNewswire Inc. • 03/06/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/05/2024 01:05:37 PM
- Tonix Pharmaceuticals Announces Translation of Preclinical Pharmacokinetic Parameters of TNX-1500 (Fc-modified humanized anti-CD40L mAb) Supports Monthly i.v. Dosing in Humans • GlobeNewswire Inc. • 03/05/2024 01:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 10:08:09 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 10:07:19 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 10:06:23 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/29/2024 10:05:49 PM
- Tonix Pharmaceuticals Announces Presentation at The 6th International Congress on Controversies in Fibromyalgia • GlobeNewswire Inc. • 02/29/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/28/2024 01:06:21 PM
- Tonix Pharmaceuticals Completes Clinical Stage of Phase 1 Trial for TNX-1500 (Fc-modified humanized anti-CD40L mAb) in Healthy Volunteers • GlobeNewswire Inc. • 02/28/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/27/2024 01:07:07 PM
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