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EX-10.02 - EXHIBIT 10.02 - Tonix Pharmaceuticals Holding Corp.v308499_ex10-02.htm
EX-10.01 - EXHIBIT 10.01 - Tonix Pharmaceuticals Holding Corp.v308499_ex10-01.htm
EX-99.02 - EXHIBIT 99.02 - Tonix Pharmaceuticals Holding Corp.v308499_ex99-02.htm
8-K - CURRENT REPORT - Tonix Pharmaceuticals Holding Corp.v308499_8k.htm

Corporate Presentation April 2012 Ticker: TNXP.OB

 
 

TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Disclosures Forward - looking Statements The statements and discussions contained in this presentation that are not historical facts constitute forward - looking statement s. These can be identified by the use of forward - looking words, such as “believes”, “expects”, “may”, “intends”, “anticipates”, “plans”, “es timates”, or any other analogous or similar expressions intended to identify forward - looking statements. These forward - looking statements and es timates as to future performance, estimates as to future valuations, and other statements contained herein regarding matters that are no t h istorical facts, are only predictions and actual events or results may differ materially. We cannot assure or guarantee that any futur e r esults described in this presentation will be achieved, and actual results could vary materially from those reflected in such forward - looking sta tements. Information contained in this presentation has been complied from sources believed to be credible and reliable. However, we ca nnot guarantee such credibility and reliability. The forecasts and projections of events contained herein are based upon subjecti ve valuations, analyses, and personal opinions. Information Regarding Disclosures The Common Stock and Warrants have not and will not be registered under the Securities Act of 1933, as amended (the “Act”), o r u nder any state securities laws, nor has the Securities and Exchange Commission (the “Commission”) or any state regulatory authority en dor sed the Offering. Any representation to the contrary is a criminal offense. In making an investment decision, investors must rely upon their own examination of the company and the terms of the Offering , i ncluding the merits and risks involved. The acquisition of the Stock, if offered, should be considered only by persons who can bear t he economic risk of their investment of ran indefinite period of time and can afford a total loss of their investment. Each prospective inves tor in the Offering should, prior to purchasing any Stock, consult his own attorney and business advisor as to the legal, business, tax, and rel ate d matters concerning its investment and is urged to ask questions of, and receive answers from, the Company concerning the terms and co ndi tions of the Offering and request any additional information they may consider Necessary in making an informed investment decision. This presentation does not constitute an offer to sell or a solicitation of an offer to purchase any securities of any nature wh atsoever, nor do the contents of the presentation constitute legal, tax, or business advice. This presentation and the offering of the Company's Stock shall be kept confidential. The recipient agrees not to disclose t o a ny third party any information contained herein, or any terms, conditions, or other facts with respect to he Offering, including, without li mit ation, that the Company is or may be contemplating the Offering. Information included herewith has been obtained from the Company and other sources believed to be reliable, but the accuracy or completeness of such information is not guaranteed by, and should not be construed as a representation by the Company. Any representations and warranties will be contained only in a definitive agreement signed by the investor and the Company. 2

 
 

TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS TONIX Pharmaceuticals Summary • Specialty pharmaceutical company developing innovative products for high - value CNS indications • Lead programs target fibromyalgia syndrome (FM) and post traumatic stress disorder (PTSD) - Reformulated cyclobenzaprine - Capital - efficient, low - risk development pathway - High ROI commercial strategy - Expect to follow successes of Lyrica® and Cymbalta® in FM • Fibromyalgia Phase 2(a) demonstrated statistically significant improvements in core symptoms • Pipeline of additional CNS product candidates 3

 
 

TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Experienced Leadership Management Team Seth Lederman, MD Founder, CEO, Chairman Co - founder, Vela, Targent, Validus, Fontus Benjamin Selzer Chief Operating Officer Aton, Reliant, investment banking (Lehman Brothers & Banc of America Securities) Leland Gershell, MD, PhD Chief Financial Officer Cowen, Apothecary Capital, Favus Institutional Research, Madison Williams Bruce Daugherty, PhD, MBA Senior Director, Drug Development Merck, Roche Institute 4

 
 

TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Accomplished Independent Board Board of Directors Seth Lederman, MD Founder, CEO, Chairman Stuart Davidson Former CEO of Alkermes & Combion Patrick Grace WR Grace, Chemed, Grace Institute Donald W. Landry, MD, PhD Columbia Chair of Medicine Ernest Mario, PhD Former CEO of Glaxo, Alza & Reliant Charles Mather Janney Montgomery Scott Securities, Cowen, Smith Barney John Rhodes Former Partner at Booz Allen Hamilton 5

 
 

TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS Fibromyalgia Market Opportunity • Approximately 5 million U.S. fibromyalgia (FM) patients* • U.S. FM drug market estimated at $1.2 billion** - 2007 - 2010 CAGR of 18.4 %** • Until 2007, there were no FDA approved FM drugs - Lyrica ® (Pfizer) was approved for FM in 2007 and is replacing off - label generic analgesics - Cymbalta® (Lilly) was approved for FM in 2008 and is replacing off - label generic anti - depressants • TNX - 102 is seeking FDA approval as a first - in - class drug for FM and to replace off - label generic muscle relaxants * National Institutes of Health, U.S. Department of Health and Human Services ** Source: Frost & Sullivan Fibromyalgia Market Study, December 2010 6

 
 

TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Fibromyalgia: Vicious Cycle 7 • Medications that target pain or depressed mood are approved for the maintenance of FM • TNX - 102 will be a first - in - class medication targeting disturbed or non - restorative sleep (NRS) in FM TNX - 102 Pain Lyrica Sleep Disturbance No approved medications Depressed Mood Cymbalta

 
 

TONIX PHARMACEUTICALS Comparison of Fibromyalgia Drugs Approved Treatments Pipeline Treatments • Antidepressant category • Suicidality warning • Taken 1 - 2 times a day • Interferes with sleep • Analgesic category • DEA scheduled • Taken 2 times a day • Interferes with sleep • Antidepressant category • Suicidality warning • Taken 1 - 2 times a day • Interferes with sleep • Probably in antidepressant category • FM is a follow - on indication after neurogenic orthostatic hypotension (Orphan indication) 8 • Physicians often switch drugs when patients are dissatisfied • TNX - 102 is a first - in - class bedtime treatment and is not expected to compete with approved treatments • Nonrestorative sleep category • 1 dose • Not restricted by DEA • Should be available at all pharmacies Northera ™ doxidopa

 
 

TONIX PHARMACEUTICALS Drugs Used to Treat Fibromyalgia 9 • Off - label drugs dominate the sleep quality market but are approved as “muscle relaxants” • TNX - 102 is proposed as first - in - class sleep quality treatment Sleep Disturbance Pain Depressed Mood “Muscle Spasm” FDA Approved • Lyrica ( pregabalin ) • Cymbalta (duloxetine) • Savella ( milnacipran ) In Development • TNX - 102 (VLD - cyclobenzaprine) • Northera ( droxidopa ) Development Abandoned • Rekinla (sodium oxybate ) Off L abel • Xyrem (sodium oxybate ) • Neurontin (gabapentin) • Opiates • (venlafaxine) • (bupropion) • (cyclobenzaprine) • ( tizanidine ) • (baclofen) • ( carisoprodol ) • ( metaxalone )

 
 

TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Cyclobenzaprine Has an Impressive Safety Record and is Widely Used • Merck developed and launched Flexeril ® in 1977 • O ver one billion tablets prescribed in 2010 • Extensive safety & efficacy studies conducted by Merck in 1990s • FDA approved controlled release products in 2007 (15 mg and 30 mg) • No DEA scheduling, no recognized addictive potential • Off - label Cyclobenzaprine is the third most widely prescribed medication for FM* 10 * Source: Frost & Sullivan Fibromyalgia Market Study, December 2010

 
 

TONIX PHARMACEUTICALS VLDC FM Pilot Study Results: Symptom Measures * Change from Baseline (week 8): tenderness measured by dolorimetry; HAD is the Hospital Anxiety and Depression Scale; HAD Depression is the HAD depression subscale -35% -30% -25% -20% -15% -10% -5% 0% 5% 10% 15% Pecrent Change from Baseline VLDC Placebo p=0.010 p=0.039 p=0.006 p=0.012 p=0.017 Fatigue HAD HAD Depression Pain Tenderness 0% 11 * Moldofsky et al., J. Rheum. December 2011: http://jrheum.org/content/early/2011/08/30/jrheum.110194.full.pdf+html • Study published in Journal of Rheumatology Dec. 2011 • Lead investigator Harvey Moldofsky thought leader in FM

 
 

TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS TNX - 102: VLDC New Formulation • Designed for the treatment of fibromyalgia - Muscle relaxant products aim for stable high blood levels over 24 hours - Aiming for faster and more reliable absorption for FM - Designed for high blood levels during the night and lower levels the next day to reduce next day somnolence • Differentiated from, but not competitive with other FM therapies - First - in - class sleep quality treatment for fibromyalgia - Bedtime versus daytime (Cymbalta, Lyrica, Savella) - Physicians switch patients between different classes when they are dissatisfied 12

 
 

TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS TNX - 102: Development Plan • Formulation and PK trials - PK Study on first version completed: 30 subjects; three week study - Follow - on PK Study expected to be completed in September 2012 • Following PK work, plan is to begin first pivotal trial - 2 - arm, 12 - week study with approximately 150 patients per arm - Study design and endpoints to mirror those used by Lyrica and Cymbalta • Pain and a composite endpoint of other FM symptoms - Results expected early 2014 13

 
 

TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS TNX - 102: Compelling Risk / Reward Profile 14 Risk Factor Commentary FDA Risk - Safety • Cyclobenzaprine is one of the more widely prescribed pharmaceuticals; 1 billion tablets per year in the U.S. • FDA approved and prescribed since the 1970’s • Widely studied in modern safety trials • 505(b)(2) registration; TONIX to benefit from existing safety data FDA Risk - Efficacy • Off - label Cyclobenzaprine is third most - widely - prescribed drug for FM • Phase 2a study demonstrated strong efficacy with very low dose cyclobenzaprine Commercial Risk • Off - label cyclobenzaprine already has market acceptance by physicians and patients despite never having been marketed for FM • TNX - 102 would be approved as a first - in - class treatment for FM and is expected to replace off - label use of muscle relaxants • Widely used off label for FM; 48.3 million tablets in 2010 (Frost & Sullivan) Reimbursement Risk • TNX - 102 is expected to be approved as a first - in - class treatment for FM • Currently no generic FM products Generic Competition • New, differentiated formulation relative to generic cyclobenzaprine • Lyrica and Cymbalta took market share from cheaper off - label generics once they obtained FDA approval for FM • Low risk – safety, efficacy and demand established

 
 

TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS TNX - 102: Compelling Risk / Reward Profile 15 • Short - term Monetization Focus - The first of two pivotal clinical trials to commence Q1 2013 - Initial “interim” data should be available by Q3 2013, with final study report available Q1 - Q2 2014 - Somewhere between those two milestones, TONIX plans to seek a major pharmaceutical partner or to monetize the company

 
 

TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS TNX - 105: VLDC for PTSD • 3.5% of U.S. adult population will have suffered from PTSD in past 12 months* - Any trauma can lead to PTSD • Unsatisfied market - Only Zoloft® and Paxil® have FDA approval • Widespread painkiller abuse and addiction • Leveraging formulation and clinical work from TNX - 102 to advance TNX - 105 16 * National Institutes of Mental Health & National Institutes of Health

 
 

TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS FM and PTSD - Related Conditions • PTSD, like FM is characterized by groups of symptoms - Some patients with FM meet PTSD criteria - Some patients with PTSD meet FM criteria - Some are believed to suffer from both conditions simultaneously • Overlap of PTSD and FM symptoms suggests VLDC may treat PTSD - PTSD is thought to be exacerbated by non - restorative sleep • PTSD has both combat and civilian forms - Zoloft and Paxil are approved for PTSD but market is unsatisfied - Brand prescriptions are now filled by generic sertraline and paroxetine - DOD has a strong interest in promoting research on therapeutics 17

 
 

TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS TONIX Pharmaceuticals Pipeline • TONIX has a comprehensive pipeline of CNS products 18 Product Indication Status TNX - 102 Fibromyalgia • Very low dose cyclobenzaprine in novel formulation • Phase 2a successfully completed • PK trial in new formulation completed YE 2011 • First of two pivotal trials expected to begin Q1 2013 TNX - 105 Post - Traumatic Stress Disorder • Low dose cyclobenzaprine in novel formulation • Will leverage data from TNX - 102 PK trial • Pivotal trials anticipated to start 2013 • Applied 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

 
 

TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Exclusivity & Patents • TNX - 102 - Issued Methods of Use patents for use of VLDC in treatment of fibromyalgia with expiration mid - 2020 - Two issued formulation patents with expiration in mid - 2021 - Further patents on pharmacokinetics expected to be filed in near term • TNX - 105 - Filed Methods of Use patent for use of VLDC in treatment of PTDS - Two issued formulation patents with expiration in mid - 2021 • Active patenting strategy to extend exclusivity - Plan to file patents around TONIX products’ unique PK profiles, which are difficult to circumvent • Hatch - Waxman exclusivity 3 years post launch for new indications 19

 
 

TONIX PHARMACEUTICALS TONIX PHARMACEUTICALS Upcoming Milestones 20 • Short and intermediate term value inflection milestones Timing Milestones Related to TNX - 102 April 2012 • Pharmacokinetic (PK) trial topline results Q2 2012 • PK study on second formulation Q3 2012 • PK/PD on “commercial” formulation and dose Q1 2013 • Commencement of initial pivotal trial Q3 2013 • Interim look at initial pivotal trial data Q1 - Q2 2014 • Completion of initial pivotal trial • Partnering or monetization event

 
 

TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Why Invest in TONIX? • Capital efficient drug development strategy focused on high - value, first - in - class products • FM and PTSD are significant unmet needs with large market opportunities • TNX - 102 is expected to be a first - in - class treatment for FM and differentiated from generic cyclobenzaprine • Low risk, low - cost development pathway • Short - term monetization • Experienced management and Board 21