Sections include: Company Overview --- Focus on Fibromyalgia and Post-Traumatic Stress Disorder. Large Markets with Unmet Need --- Novel Formulation Technology Applied to Known Ingredients = Better Drugs --- Robust Product Pipeline with Nearterm Milestones, and more.
Collective Mining | Corporate Presentation - April 2024
TNXP Fact Sheet May 2012
1. TONIX Quick Facts
Trading Symbol: TNXP:OTCQB
Stock Price (4/30/12): $1.60
Shares Outstanding: 34.3 Million
Market Capitalization: $54.9 Million
Fiscal Year End: December 31
Stock Transfer Agent: vStock Transfer
SEC Counsel: Sichenzia Ross Friedman
FACT SHEET – May 1, 2012 Ference LLP
Auditors: EisnerAmper LLP
IR Contact: Benjamin Selzer
(212) 980‐9155 x106
Website: www.tonixpharma.com
Corporate Overview
TONIX Pharmaceuticals is developing new therapies for challenging disorders of the central nervous system (CNS). The
company targets conditions characterized by significant unmet medical need, inadequate existing treatment options,
and high dissatisfaction among both patients and physicians. TONIX reformulates and repurposes known pharmaceutical
agents to develop products with optimal safety, efficacy and predictability. TONIX also intends to commercialize generic
products through its wholly‐owned subsidiary, Krele LLC.
Focus on Fibromyalgia and Post‐Traumatic Stress Disorder – Large Markets with Unmet Need
TONIX is focusing its initial product development efforts on fibromyalgia syndrome (FM) and post‐traumatic stress
disorder (PTSD), two CNS conditions with related, often debilitating symptoms that can affect daily living. FM, which
affects about 5 million Americans, is characterized by chronic widespread pain and concurrent symptoms including sleep
disturbance, fatigue and decrease in physical and cognitive function. PTSD is a psychiatric disorder that can appear
following a traumatic experience, and has both combat and civilian forms. Approximately 3.5% of the U.S. adult
population will have suffered from PTSD within the past 12 months. Sleep disturbances including nightmares and
insomnia are core features of FM and PTSD. FM and PTSD share several common symptoms, and some patients are
believed to suffer from both.
Novel Formulation Technology Applied to Known Ingredients = Better Drugs
The company’s lead product candidates for these indications, TNX‐102 for FM and TNX‐105 for PTSD, are novel dosage
oral formulations of cyclobenzaprine, the active ingredient in two U.S. FDA‐ approved muscle relaxants. TONIX is
applying its patent‐protected formulation technology to improve absorption, drug clearance and peak blood levels
relative to currently marketed cyclobenzaprine products. In a Phase 2a study, very low dose cyclobenzaprine (VLDC)
administered at bedtime has been demonstrated to improve core FM symptoms, such as pain, tenderness, fatigue and
depression.
Strategy to Reduce Development Risk and Streamline Regulatory Path
A significant body of data on cyclobenzaprine, the active ingredient in the company’s drugs, is already in the public
domain and as the result of previously approved NDAs for marketed products. TONIX anticipate seeking approval of
TNX‐102 and TNX‐105 through the NDA process under Section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act
(FFDCA). This approach would allow TONIX to reference existing data for its NDA filings, and may enable its product
candidates to advance through development and the regulatory process on a less costly, shorter pathway than is typical
for pharmaceutical products based on novel active ingredients.
TONIX PHARMACEUTICALS, INC. 509 MADISON AVENUE, SUITE 306 NEW YORK, NY 10022
PHONE: (212) 980‐9155 FAX: (212) 923‐5700 www.tonixpharma.com
2. Robust Product Pipeline with Near‐term Milestones
Product Indication Status
TNX‐102 Fibromyalgia • Very low dose cyclobenzaprine in novel formulation
• Phase 2a successfully completed
• Completing formulation development
• First of two pivotal trials expected to begin Q1 2013
TNX‐105 Post‐Traumatic Stress • Low dose cyclobenzaprine in novel formulation
Disorder • Will leverage data from TNX‐102 PK trial
• Pivotal trials anticipated to start 2013
• Applying for Department of Defense funding
TNX‐201 Headache • NDA to be filed for existing DESI product
• Potentially shortened process for FDA approval
• DESI to NDA switch products enjoy mandated exclusivity
TNX‐301 Alcoholism • US patent allowed
• Potential for government funding
Experienced Leadership
Title Experience
Seth Lederman, MD CEO & Chairman • Co‐founder, Vela, Targent, Validus & Fontus
Benjamin A. Selzer COO • Aton, Reliant, investment banking
Leland J. Gershell, MD, PhD CFO • Cowen, Apothecary Capital, Favus Research, Madison
Williams
Bruce L. Daugherty, PhD, MBA Senior Director of • Merck, Roche Institute
Drug Development
Stuart Davidson Director • Managing Partner, Labrador Ventures
• Former CEO, Alkermes & Combion
Patrick P. Grace Director • Managing Partner, Apollo Philanthropy Partners, LLC
Donald W. Landry, MD, PhD Director • Columbia University, Chair of Medicine
Ernest Mario, PhD Director • Former CEO, Glaxo, Alza & Reliant
Charles Mather Director • Managing Director, Janney Capital Markets
John Rhodea Director • Former Partner, Booz Allen & Hamilton
Recent News Events
http://ir.stockpr.com/tonixpharma/press‐releases
TONIX PHARMACEUTICALS, INC. 509 MADISON AVENUE, SUITE 306 NEW YORK, NY 10022
PHONE: (212) 980‐9155 FAX: (212) 923‐5700 www.tonixpharma.com