Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (August 2014)
27 slides from Tonix Pharmaceuticals's investor presentation, Aug 12, 2014
Slide 1: Tonix Pharmaceuticals Investor Presentation
TONIX PHARMACEUTICALS Investor Presentation ‘Aanueaie NASDAQ: TNXP
Slide 2: Safe harbor statement
Safe harbor statement 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 Reform Act of 1995, These statements may be identified by the use of
Slide 3: Tonix: first-in-class CNS medicines
Tive I First-in-class medicines for common disorders of the central nervous system (CNS) New treatmentparadigms Late stage candidates Large unmet medical needs Fibromyalgia (FM) — Top line results from potential pivotal trial in 4Q 2014 Post-traumatic Stress Disorder (PTSD) — Phase 2 trial to begin
Slide 4: Development programs
_ Development programs. Proof-of- Concept | Pivotal Candidate Indication Preclinical | Phase1 / Phase 2a /Phase 2b/3 NDA Market. Te ESE | Fibromyalgia Top line results 4Q14 TNx-102 St [fag FOE tcadache => TNX “Te conduct comparative pharmacokinetic and safety study in 10 2018 TNX-102 St (gtobenzapri
Slide 5: New approaches to treating CNS disorders
New approaches to treating CNS disorders Targeting sleep quality in FM and PTSD TINX-102 SLis designed as a chronic therapy for bedtime use Non-restorative sleep linked to pain, fatigue, hyper- vigilance, and arousals Restorative sleep improves FM and PTSD symptoms Novel molecular targetin tension h
Slide 6: Fibromyalgia market opportunity
Fibromyalgia market opportunity 5 million U.S. patients* 2.6 million diagnosed; 2.4 million receiving treatment”™ Three FDA approved prescription medications Membrane Stabitzer [ie Prizer 2007 $475 million cymbalta® ——EliLily 2008 $600 million Savella® Forest 2009 $100 million TNKAO2 SL__—‘Tonix 201
Slide 7: Fibromyalgia: many dissatisfied patients
Fibromyalgia: many dissatisfied patients Chronic, widespread pain with sleep, fatigue, mood, and memory problems Typical patient has onset at 30-40 years of age with persistence for rest of life Impairs daily function and productivity; poor quality of life Predominantly female Patients remain unsati
Slide 8: Fibromyalgia has a high economic impact
Fibromyalgia has a high economic impact Resource utilization over preceding 12 months Outpatient visits 82.9% Any emergency room visit 40.2% Mean number of emergency room visits’ 24 Productivity measures over preceding 12 months Missed any work due to FM 474% Mean days of work missed* 58.4 Received
Slide 9: Sleep quality is a new target for FM therapy
Sleep quality is a new target for FM therapy >90% of FM patients complain of poorsleep quality* Restorative sleep improves pain and other FM symptoms Sleep quality of FM patients can be objectively measured: Cyclic Alternating Patter (CAP) Al patterns indicate sleep stability A2, A3 patterns indicat
Slide 10: Phase 2a trial of TNX-102 capsules in FM
Phase 2a trial of TNX-102 capsules in FM Double-blind, randomized, placebo-controlled Conducted at two academic centers in Canada Enrolled 36 subjects with fibromyalgia; 18 per arm TNX-102 capsules or placebo taken between dinner and bedtime daily Eight-week, dose-escalating study Daily dosing range
Slide 11: Positive efficacy results from Phase 2a trial
Positive efficacy results from Phase 2a trial of TNX-102 capsules in FM Pain Sleep Quality TNX-102 Placebo TNX-102 Placebo: wo +O 80 cs F 70 2 5 2 a 60 § 0 % 2 B50 B -15 Bao Fa 3 — 20 $ 20 2s * 20 7 = 10 5 2 = az & 26% reduction in pain Improvement in objectivesleep vs. placebo quality measures vs.
Slide 12: Safety results from Phase 2a trial
Safety results from Phase 2a trial of TNX-102 capsules in FM TINX-102, % Placebo, % No serious adverse events Adverse Event (N=18) 3) event 3 No discontinuations due to Headache 39 v adverse events in treatment arm Diy; mouth: 8 5 Somnolence 2 u Constipation wv 6 Dizziness uv 6 Nausea a 2 Flusyndrom
Slide 13: TNX-102 SL is a sublingual tablet formulation
TNX-102 SL is a sublingual tablet formulation optimized for chronic use at bedtime Phase 2a Phase 2b/3 TNX-102 TNX-102 SL capsules (sublingual) tablets = transmucosal absorption absorption « bedtime therapy 10x faster absorption* * Absorption lag time tq) based on clinical pharmacokinetic data + com
Slide 14: Registration program for TNX-102 SL in FM
Registration program for TNX-102 SL in FM Two adequateand well-controlled efficacy and safety trials in FM patients Primary efficacy endpoint = pain © First trial has completed enrollment — “BESTFIT* QO Top line BESTAIT data expected in Q4 2014 Long-term exposure data to support chronic use label 10
Slide 15: PTSD market opportunity
PTSD market opportunity 8.4 million U.S. patients* 4.2 million receiving medical treatment™ Two FDA approved prescription medications Paxil? Glaxo 2001 RI Zoloft? Prizer 1999 TNKA02 SL Toni 2019E Phase 2 efficacy study of TNX-102 SL to begin in 4Q 2014 Leverage fibromyalgia formulation, clinical exp
Slide 16: PTSD is an important public health problem
PTSD is an important public health problem Post-traumatic stress disorder (PTSD) is a chronic debilitating condition Patients desperate despite two FDA approved drugs; no new treatmentin > 10 years Associated with suicide and unpredictable, violent behaviors 3.5% of U.S. adult population has suffere
Slide 17: Sleep quality is a new target for PTSD therapy
Sleep quality is a new target for PTSD therapy PTSD patients complain of poor sleep quality asa core symptom Distressing dreams (nightmares) are part of “re-experiencing” Restless sleep is part of “hyper-arousal” Poor sleep quality after traumais linked to onset of PTSD Poor sleep correlates with de
Slide 18: AtEase Phase 2 trial of TNX-102 SL in PTSD
“AtEase” Phase 2 trial of TNX-102 SL in PTSD Arm. TNX-102 SL 2.8 mg, at bedtime nightly (n=88) Arm. TNX-102 SL 5.6 mg, at bedtime nightly (n=44) Arm Placebo, at bedtime nightly (n=88) R a N D ° ™ T Zz A T 1 ° N k 12 weeks >| Randomized, double-blind, placebo-controlled: to begin enrollment in 4Q14 N
Slide 19: TNX-201 - Episodic tension-type headache
TNX-201 - Episodic tension-type headache (ETTH) 92 million adults in the U.S. experience tension-type headaches* Constant band of pressure on the back/sides of head; "squeezed in a vice" feeling Projected that 34 million experience frequent episodes™, 12 million seek a medical consult*** Three FDA a
Slide 20: TNX-201 to enter clinical development in 2015
TNX-201 to enter clinical development in 2015 Novel molecular mechanism Based on proprietary discoveries by Tonix Non-barbiturate, non-opioid Mechanism of action distinct from acetaminophen and barbiturates Comparative pharmacokinetic and safety study to be conducted in 1Q 2015 Pre-IND meeting with
Slide 21: Intellectual property
Intellectual property AILIP wholly-owned by Tonix - no royalties / future obligations TNX-102 SL Fibromyalgia, PTSD TNX-201 Headache ‘Composition-of-matter Patents filed Protection expected to 2034 Pharmacokinetics (PK) Patents filed Protection expected to 2033 Method-of-use FM: patents issued, 3Q 2
Slide 22: Milestones - recent and upcoming
Milestones - recent and upcoming Corporate & July 2014-$7.2 million in net proceeds from common stock offering TNX-102 SL - Fibromyalgia & May 2014-Completed enrollment in BESTFIT trial 4Q2014-Reporttop line results from BESTFIT TNX-102 SL - PTSD @ June 2014- Received IND clearance Q 4Q2014- Start P
Slide 23: Management team
_ Management team Seth Lederman, MD TARGENT~ i * —_ — eland Gershell, MD, PhD COWEN ATON™ z CFO uo Bruce Daugherty, ¢@ MER <fioche> re ty, PhD CK @ sePRAcoR 24
Slide 24: Board of directors
_ Board of directors Seth Lederman, MD (Chair) Ernest Mario, PhD Targent Pharmaceuticals Glaxo, ALZA Vela Pharmaceuticals Reliant Pharm: ticals Stuart Davidson Charles Mather Alkermes Janney Montgomery Scott ‘Combion ‘Cowen, Smith Barney Patrick Grace John Rhodes WR Grace NYSERDA, NRDC Chemed Booz A
Slide 25: Cash reported at June 30, 2014 $43.9 million
NASDAQ: TNXP Cash reported at June 30, 2014 $43.9 million Net cash used in operations in 2Q14 $ 5.7 million Shares outstanding’ 10.6 million + As of August 7 2008 26
Slide 26: Why invest in Tonix now?
Why invest in Tonix now? TNX-102 SL: late-stage clinical program in large market in + Strong evidence of clinical benefitin Phase 2a + Current FM treatment options leave many patients unsatisfied + Fibromyalgia is a current focus of the FDA + Multiple opportunities (fibromyalgia, PTSD, headache) + T
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Tonix Pharmaceuticals Holding — Investor Presentation (August 2014) on 6ix