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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Disclaimer

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.