NASDAQ: TNXP
HQ: Chatham, NJ
investor.relations@
tonixpharma.com
MANAGEMENT TEAM
Seth Lederman, MD
Co-Founder, CEO & Chairman
Gregory Sullivan, MD
Chief Medical Officer
Bradley Saenger, CPA
Chief Financial Officer
Jessica Morris
Chief Operating Officer
MAIN U.S. OFFICES
New Jersey Office
(Corporate & Tonix
Medicines Headquarters)
26 Main Street - Ste 101
What We Do
Tonix is a biopharmaceutical company that commercializes, develops, discovers and licenses therapeutics to treat and prevent human disease and alleviate suffering. Tonix is focused on filing the NDA for TNX-102
SL (sublingual cyclobenzaprine) with the FDA for the management of fibromyalgia in the 2nd half of 2024. The NDA is supported by two positive Phase 3 trials
Leveraging the expertise of the Company's leaders, Tonix's strategy includes:
- Progressing our curated portfolio of product candidates in development, including small molecule drugs and biologics, with a focus on central nervous system disorders
- Marketing FDA-approved products through our expanding in-housecapabilities and expertise in the migraine and pain space
- Partnering strategically with government institutions, other biotech companies and world-class academic organizations to reduce internal spend and bring innovative therapeutics to market faster
Key Clinical Candidates
TNX-102 SL is a non-opioid,non-addictive | |
TNX-102 SL | treatment in development for the |
management of fibromyalgia (FM) and other | |
Fibromyalgia | |
CNS indications such as FM-type Long | |
COVID and Acute Stress Disorder (ASD) |
Chatham, NJ 07928
Research and Development Center (RDC)
431 Aviation Way Frederick, MD 21701
Advanced Development Center (ADC)
259 Samuel Barnet Blvd
New Bedford Business Park
North Dartmouth, MA 02745
www.tonixpharma.com
@TonixPharma
TNX-1300
Cocaine
Intoxication
TNX-2900
Prader-Willi
Syndrome
TNX-1500
Transplant
Rejection
TNX-1300 is a recombinant protein which rapidly degrades cocaine in the bloodstream and has received FDA Breakthrough Therapy Designation as well as a Cooperative Agreement Grant from the National Institute on Drug Abuse (NIDA)
TNX-2900 is a novel formulation of intranasal oxytocin potentiated with magnesium in development for the treatment of Prader-Willi Syndrome, a rare genetic disorder, and has received FDA Orphan Drug Designation
TNX-1500 is a next generation anti-CD40L mAb designed to preserve efficacy without risk of thrombosis in development for the prevention of organ transplant rejection and autoimmune conditions
Version P0563 April 30, 2024 (Doc 1430)
Development Pipeline: Key Product Candidates
Using our integrated development engine, we advance innovative programs toward FDA approval
Molecule* | Indication | Phase 1 | Phase 2 | Phase 3 | NDA |
Submission | |||||
Fibromyalgia | Statistically Significant Phase 3 Topline Results | Expected 2H'24 | |||
Reported 4Q'23 | |||||
TNX-102 SL | Phase 2 Topline Results | ||
Long COVID | |||
Cyclobenzaprine HCl | Reported 3Q'23 | ||
Protectic® Sublingual Tablets | |||
Acute Stress Disorder | Phase 2 Study** Start | ||
Expected 2Q'24 | |||
TNX-1300 | |||
Cocaine Esterase | Cocaine Intoxication | Phase 2 Study Start | |
Expected 2Q'24 | |||
NIDA Funded & Breakthrough | |||
Therapy Designation | |||
TNX-2900 | |||
Intranasal Potentiated Oxytocin | Prader-Willi Syndrome | Phase 2 Ready | |
FDA Orphan Drug and Rare | |||
Pediatric Disease Designation | |||
TNX-1500 | Organ Transplant | Phase 1 | Clinical Stage Complete |
Anti-CD40L mAb | Rejection/ Autoimmune | Study | |
Conditions | Ongoing |
*All of Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. **Investigator-Initiated study
Filing NDA for the management of fibromyalgia supported by two positive Phase 3 trials expected 2H'24
Two CNS programs (Cocaine Intoxication and ASD) expected to begin enrolling in Phase 2 trials in 1H'24
TNX-1500 Phase 1 study clinical phase complete
Our Commercial Strategy
We market two FDA-approved products for the treatment of acute migraine
Zembrace® SymTouch® | Tosymra® | |
Indication | Acute migraine with or without aura in adults | Acute migraine with or without aura in adults |
Delivery | Sumatriptan injection, 3 mg | Sumatriptan nasal spray, 10 mg |
Only branded sumatriptan autoinjector promoted in the | Formulated with a permeation enhancer (Intravail® | |
technology) that provides rapid and efficient absorption | ||
Design | U.S. | |
of sumatriptan | ||
Designed for ease of use and favorable tolerability with | ||
Pharmacokinetically equivalent to 4 mg subcutaneous | ||
low 3 mg dose | ||
sumatriptan | ||
Patent | Patent protection until 2036 | Patent protection until 2031 |
Protection | ||
© 2024 Tonix Pharmaceuticals Holding Corp.
All rights reserved.
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Tonix Pharmaceuticals Holding Corp. published this content on 30 April 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 April 2024 18:59:42 UTC.