Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (February 2016)
25 slides from Tonix Pharmaceuticals's investor presentation, Feb 16, 2016
Slide 1: Investor Presentation February 2016
© Copyright 2016 Tonix Pharmaceuticals - Confidential - Do not duplicate or distribute NASDAQ: TNXP Investor Presentation February 2016 © 2016 Tonix Pharmaceuticals Holding Corp. Version: P0006 - 02 - 16 - 16
Slide 2: Cautionary note on forward-looking statements
2 © Copyright 2016 Tonix Pharmaceuticals Cautionary note on forward - looking statements Certain statements in this presentation regarding strategic plans, expectations and objectives for future operations or results are “forward - looking statements” as defined by the Private Securities Litigation
Slide 3: Developing innovative medicines for large and growing markets
3 © Copyright 2016 Tonix Pharmaceuticals Developing innovative medicines for large and growing markets • Targeting a common pain condition and a serious psychiatric disorder ‒ One clinical - stage proprietary candidate targeting two indications ‒ Differentiated products with potential for sustainabl
Slide 4: Pipeline led by TNX-102 SL for fibromyalgia
4 © Copyright 2016 Tonix Pharmaceuticals Candidate Indication Near - term Catalyst TNX - 102 SL ( Tonmya ™ *) Fibromyalgia Top line data 3Q 2016 TNX - 102 SL Post - Traumatic Stress Disorder Top line data 2Q 2016 Pipeline led by TNX - 102 SL for fibromyalgia Preclinical Phase 1 Phase 2 Phase 3 NDA M
Slide 5: Fibromyalgia is a chronic, debilitating disorder imposing significant burden
5 © Copyright 2016 Tonix Pharmaceuticals Fibromyalgia is a chronic, debilitating disorder that imposes a significant societal and economic burden • Fibromyalgia is considered neurobiological disorder characterized by 1 : • Believed to result from amplified sensory and pain signaling in central nervo
Slide 6: Fibromyalgia is a prevalent disorder but remains underdiagnosed
6 © Copyright 2016 Tonix Pharmaceuticals Fibromyalgia is a prevalent disorder but remains underdiagnosed 1 Lawrence et al, Arthritis Rheum 2008;58:26; Vincent et al, Arthritis Care Res 2013;65:786; Jones et al, Arthritis Rheum 2015;67:568. 2 Robinson RL et al, Pain Med 2012;13:1366. 3 Product sales
Slide 7: Fewer than half of those treated receive sustained benefit from approved drugs
7 © Copyright 2016 Tonix Pharmaceuticals Fewer than half of those treated receive sustained benefit from the three FDA - approved drugs • The treatment objective is to restore functionality and quality of life by broadly improving symptoms while avoiding significant side effects • The majority fail
Slide 8: Large need for new fibromyalgia therapies with better tolerability
8 © Copyright 2016 Tonix Pharmaceuticals Large need for new fibromyalgia therapies that provide broad symptom improvement with better tolerability • Currently - approved medications may have side effects that limit long - term use 1 ‒ Many patients skip doses or discontinue altogether within months
Slide 9: Tonix is developing TNX-102 SL for fibromyalgia
9 © Copyright 2016 Tonix Pharmaceuticals Tonix is developing TNX - 102 SL for fibromyalgia • Advanced sublingual tablet containing low - dose cyclobenzaprine (CBP ) ‒ Designed for daily bedtime administration with no titration ‒ Efficient transmucosal absorption ‒ Avoidance of first - pass metabolis
Slide 10: Phase 2b BESTFIT study in fibromyalgia
10 © Copyright 2016 Tonix Pharmaceuticals Phase 2b “BESTFIT” study of TNX - 102 SL in fibromyalgia • BESTFIT = BE dtime S ublingual T NX - 102 SL as F ibromyalgia I ntervention T herapy ‒ Randomized , double - blind, placebo - controlled trial ‒ 2010 American College of Rheumatology diagnostic crite
Slide 11: BESTFIT results on key clinical endpoints
11 © Copyright 2016 Tonix Pharmaceuticals BESTFIT results on key clinical endpoints Category Endpoint – week 12 1 p value Pain Relief 30% responder analysis 2 0.033 Sleep Quality PROMIS Sleep Disturbance 0.005 Overal l response to therapy PGIC 0.025 Assessment of disease impact FIQ - R Total score 0
Slide 12: Safety and tolerability profile in the BESTFIT study
12 © Copyright 2016 Tonix Pharmaceuticals TNX - 102 SL safety and tolerability profile in the BESTFIT study • No serious adverse events (SAE) reported with TNX - 102 SL • Systemic adverse events reported by at least 3% of the total BESTFIT population • Most frequent local adverse events were adminis
Slide 13: Phase 3 AFFIRM study is underway
13 © Copyright 2016 Tonix Pharmaceuticals • Phase 3 AFFIRM Study is underway • Second Phase 3 Study (“REAFFIRM”) expected to begin in 2Q 2016 - E xpected to be similar to AFFIRM in design and size TNX - 102 SL in Phase 3 clinical development for fibromyalgia • Randomized, double - blind, placebo - c
Slide 14: TNX-102 SL in Phase 2 development for PTSD
14 © Copyright 2016 Tonix Pharmaceuticals Candidate Indication Near - term Catalyst TNX - 102 SL Post - Traumatic Stress Disorder Top line data 2Q 2016 TNX - 102 SL in Phase 2 development for post - traumatic stress disorder (PTSD) Preclinical Phase 1 Phase 2 Phase 3 NDA Market * Tonmya ™ has been c
Slide 15: PTSD is a chronic stress disorder triggered by a traumatic event
15 © Copyright 2016 Tonix Pharmaceuticals PTSD is a chronic stress disorder triggered by a traumatic event • PTSD is characterized by: • Considered a stress response, but prolonged and does not resolve with time ‒ 20% of women and 8 % of men who experience significant trauma develop PTSD 1 • Associa
Slide 16: PTSD is a prevalent problem for both civilians and the military
16 © Copyright 2016 Tonix Pharmaceuticals PTSD is a prevalent problem for both civilians and the military • ~70% are considered to have moderate to severe symptoms • Of those diagnosed, ~50% utilize professional healthcare (psycho/pharmacotherapy) 2 1 Kessler RC at al, Arch Gen Psychiatry 2013;62:61
Slide 17: Significant gap in current therapeutic landscape for PTSD
17 © Copyright 2016 Tonix Pharmaceuticals Significant gap in current therapeutic landscape for PTSD • M edicines approved for PTSD often provide inadequate and/or inconsistent benefit ‒ Limited to two SSRI antidepressants, both of which carry suicidality warnings ‒ U.S. Institute of Medicine (IOM) c
Slide 18: Potential as a treatment for PTSD supported by clinical evidence and pharmacology
18 © Copyright 2016 Tonix Pharmaceuticals TNX - 102 SL’s potential as a treatment for PTSD is supported by clinical evidence and pharmacology • TNX - 102 SL is active on receptor sites believed to have treatment potential for sleep problems in PTSD ‒ Targeted receptors include 5 - HT2a, alpha - 1 ad
Slide 19: Phase 2 AtEase trial in PTSD is fully enrolled
19 © Copyright 2016 Tonix Pharmaceuticals Phase 2 “ AtEase ” trial of TNX - 102 SL in PTSD is fully enrolled • Randomized, double - blind, placebo - controlled trial in military - related PTSD • N=240+; approximately 25 U.S. clinical sites • Primary efficacy endpoint: ‒ Difference in Clinician - Adm
Slide 20: Intellectual property
20 © Copyright 2016 Tonix Pharmaceuticals Intellectual property • Composition - of - matter (eutectic) ‒ Patents filed ‒ Protection expected to 2034 • Pharmacokinetics (PK) ‒ Patents filed ‒ Protection expected to 2033 • Method - of - use ‒ Fibromyalgia : patents issued, 2020 expiry ‒ PTSD: patents
Slide 21: Financial overview
21 © Copyright 2016 Tonix Pharmaceuticals Financial overview NASDAQ: TNXP Cash, cash equivalents, and marketable securities reported at September 30, 2015 $ 55.0 million Cash used in operations in 2015 through September 30 $ 30.6 million Shares outstanding (February 13, 2016) 18.8 million
Slide 22: Management team
22 © Copyright 2016 Tonix Pharmaceuticals Management team Seth Lederman, MD President & CEO Jessica Edgar Morris Acting CFO, Chief Administrative Officer Bruce Daugherty, PhD, MBA Chief Scientific Officer Ronald Notvest, PhD SVP, Commercial Planning & Development Gregory Sullivan, MD Chief Medical O
Slide 23: Board of directors
23 © Copyright 2016 Tonix Pharmaceuticals Board of directors Seth Lederman, MD Chairman Ernest Mario, PhD ALZA, Glaxo, Reliant Pharma John Rhodes NYSERDA, NRDC, Booz Allen Hamilton Samuel Saks, MD Jazz Pharma, ALZA, Johnson & Johnson Charles Mather BTIG, Janney, Jefferies, Cowen, Smith Barney Stuart
Slide 24: Milestones – recent and upcoming
24 © Copyright 2016 Tonix Pharmaceuticals Milestones – recent and upcoming TNX - 102 SL – Fibromyalgia □ May 2015 Began Phase 3 AFFIRM study □ November 2015 Presented additional data from Phase 2b BESTFIT study at ACR Meeting □ 3Q 2016 Report top - line results from AFFIRM study TNX - 102 SL – Post
Slide 25: - - Do not duplicate or distribute Madison Avenue New York, NY 10022 (212)
© Copyright 2016 Tonix Pharmaceuticals - Confidential - Do not duplicate or distribute NASDAQ: TNXP 509 Madison Avenue New York, NY 10022 (212) 980 - 9155 www.tonixpharma.com
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