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
- Form 8-K - Current report • Edgar (US Regulatory) • 11/04/2024 12:30:21 PM
- Tonix Pharmaceuticals Announces Research Agreement with Kenya Medical Research Institute (KEMRI) to Design, Plan and Seek Regulatory Approval for a Phase I Clinical Study of TNX-801 for Mpox in Kenya • GlobeNewswire Inc. • 11/04/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/01/2024 11:05:20 AM
- Tonix Pharmaceuticals Presented Data on Potential Mpox Vaccine TNX-801 at World Vaccine Congress-Europe 2024 • GlobeNewswire Inc. • 11/01/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2024 08:30:37 PM
- Tonix Pharmaceuticals to Present at BIO-Europe® 2024 • GlobeNewswire Inc. • 10/29/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/28/2024 09:16:22 PM
- Tonix Pharmaceuticals to Present at the 2024 ThinkEquity Conference • GlobeNewswire Inc. • 10/25/2024 12:00:00 PM
- Tonix Pharmaceuticals Announces Oral Presentation at the World Vaccine Congress Europe 2024 • GlobeNewswire Inc. • 10/24/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/17/2024 12:05:14 PM
- Tonix Pharmaceuticals Receives First Contract Payment from U.S. Department of Defense for Accelerated Development of Broad-Spectrum Antivirals with the Defense Threat Reduction Agency (DTRA) • GlobeNewswire Inc. • 10/17/2024 12:00:00 PM
- Form SC 13G/A - Statement of Beneficial Ownership by Certain Investors: [Amend] • Edgar (US Regulatory) • 10/16/2024 01:01:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/16/2024 12:05:35 PM
- Tonix Pharmaceuticals Announces Submission of the TNX-102 SL New Drug Application (NDA) for Fibromyalgia to the U.S. Food and Drug Administration (FDA) • GlobeNewswire Inc. • 10/16/2024 12:00:00 PM
- Tonix Pharmaceuticals Announces AI Collaboration with X-Chem to Develop Broad-Spectrum Antivirals • GlobeNewswire Inc. • 10/08/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/08/2024 11:05:22 AM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 10/01/2024 04:15:07 AM
- Tonix Pharmaceuticals Announces Participation in Endpoints Panel at the Long COVID Workshop and RECOVER TLC Workshop Convened by the Foundation for the National Institutes of Health (FNIH) and the National Institute of Allergy and Infectious Diseases (NIAI • GlobeNewswire Inc. • 09/30/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/27/2024 11:05:27 AM
- Tonix Pharmaceuticals Announces Issuance of U.S. Patent Covering the Subcutaneous Delivery of FDA-Approved Zembrace® SymTouch® to Treat Migraines • GlobeNewswire Inc. • 09/27/2024 11:00:00 AM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 09/23/2024 09:09:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/23/2024 11:08:50 AM
- Tonix Pharmaceuticals Announces Data Presentations on TNX-102 SL for Fibromyalgia at the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems (PDDS 2024) • GlobeNewswire Inc. • 09/23/2024 11:00:00 AM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 09/20/2024 09:03:56 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/19/2024 11:05:26 AM
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