Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (November 2013)
24 slides from Tonix Pharmaceuticals's investor presentation, Nov 14, 2013
Slide 1: Investor Presentation November 2013
Investor Presentation November 2013 NASDAQ: TNXP
Slide 2: Safe Harbor Statement
TONIX PHARMACEUTICALS 2 CONFIDENTIAL TONIX PHARMACEUTICALS Safe Harbor Statement Certainstatementsinthispresentationregardingstrategicplans,expectationsandobjectivesforfuture operationsorresultsare“forward-lookingstatements”asdefinedbythePrivateSecuritiesLitigationReform Actof1995.Thesestatementsmay
Slide 3: Tonix At-A-Glance
TONIX PHARMACEUTICALS 3 CONFIDENTIAL TONIX PHARMACEUTICALS TonixAt-A-Glance 3 Ticker TNXP Exchange NASDAQ Capital Market Close on 11/13/13 $4.18 60-dayrange* $3.55 –$4.40 Fiscal year end Dec. 31 Shares outstanding 4.87 M Market cap $20 M Year Founded 2007 Independent Directors 7 * September 14, 2013
Slide 4: Investment Thesis
TONIX PHARMACEUTICALS 4 CONFIDENTIAL TONIX PHARMACEUTICALS Investment Thesis Fibromyalgia (FM) –first anticipated pivotal trial enrolling $1.5B U.S. market; widely recognized; large unmet need Evidence of clinical benefit, well-tolerated in Phase 2 Top line results of Phase 2b/3 trial expected to be
Slide 5: Repurposing has created a league of successful, valuable products and companies
TONIX PHARMACEUTICALS 5 CONFIDENTIAL TONIX PHARMACEUTICALS Repurposing has created a league of successful, valuable products and companies Acquired by Allergan for $958M Revlimid® annual sales of $3.7B, as of year-end 2012 Out-licensed to Purdue Pharmafor up to $145M Medicis CelgeneCorporation Jazz
Slide 6: Advantages of "repurposed" vs. "new" drugs
TONIX PHARMACEUTICALS 6 CONFIDENTIAL TONIX PHARMACEUTICALS Advantages of “repurposed” vs. “new” drugs 6 Active Ingredient FDA Term Safety Risk to Develop Costto Develop Time to Develop New 505(b)1 Unknown Higher Higher Longer Repurposed 505(b)2 Known Lower Lower Shorter New Drugs Face high hurdles f
Slide 7: Product Pipeline
TONIX PHARMACEUTICALS 7 CONFIDENTIAL TONIX PHARMACEUTICALS Product Pipeline TNX-102 SL PTSD Fibromyalgia Preclinical Phase 1 Proof-of- Concept Pivotal NDA Market TNX-102 SL Candidate Indication TNX-201 Headache TNX-301 Alcoholism * * We expect to be able to enter human clinical studies directly base
Slide 8: Fibromyalgia – a significant market opportunity
TONIX PHARMACEUTICALS 8 CONFIDENTIAL TONIX PHARMACEUTICALS Fibromyalgia –a significant market opportunity *National Institutes of Health, U.S. Department of Health and Human Services **Robinson et al, Pain 2012; 13: 1366-76. *** Estimates based on information from publicly-available sources ‡ EU onl
Slide 9: Fibromyalgia: a large opportunity for an effective, well-tolerated, differentiated product
TONIX PHARMACEUTICALS 9 CONFIDENTIAL TONIX PHARMACEUTICALS Fibromyalgia: a large opportunity for an effective, well-tolerated, differentiated product Patients feel pain all over the body, but it originates in the brain Chronic, widespread pain with sleep, fatigue, mood, and memory problems Non-resto
Slide 10: Inter-relationship of pain and poor quality sleep in FM: target for drug therapy
TONIX PHARMACEUTICALS 10 CONFIDENTIAL TONIX PHARMACEUTICALS >90% of FM patients complain of poor sleep quality* Restorative sleep improves FM symptoms Poor sleep quality of FM patients can be objectively measured: Cyclic Alternating Pattern (CAP) A1 patterns indicate sleep stability A2, A3 patterns
Slide 11: Positive results from Phase 2a trial in FM
TONIX PHARMACEUTICALS 11 CONFIDENTIAL TONIX PHARMACEUTICALS -30 -25 -20 -15 -10 -5 0 TNX-102 capsules Placebo * p < 0.05 vs. placebo P e r c e n t C h a n g e f r o m B a s e l i n e a t W e e k 8 Pain* P e r c e n t o f S u b j e c t s † Sleep Quality* 0 10 20 30 40 50 60 70 80 Positive results fro
Slide 12: Normalized effect sizes of approved FM drugs on pain
TONIX PHARMACEUTICALS 12 CONFIDENTIAL TONIX PHARMACEUTICALS 0.27 0.33 0.19 Lyrica Cymbalta Savella Normalized (“Cohen”) effect sizes of approved FM drugs on pain* 12 *Hauser et al., J. Pain. June 2010;CohenJ, "A power primer". Psychological Bulletin 112(1): 155–159. 0.2
Slide 13: TNX-102 SL optimized for use at bedtime
TONIX PHARMACEUTICALS 13 CONFIDENTIAL TONIX PHARMACEUTICALS 13 TNX-102 SL optimized for use at bedtime transmucosal absorption fast •efficacy •tolerability/safety •chronic use •bedtime therapy •compliance •metabolism 30 minutes 2 hours Optimized for: TNX-102 SL (sublingual) tablets Phase 2b/3
Slide 14: Drug reformulations have generated significant value
TONIX PHARMACEUTICALS 14 CONFIDENTIAL TONIX PHARMACEUTICALS Drug reformulations have generated significant value Acqui red by Allerg an for $958 M Revlimi d® annual sales of $3.7B, as of year- end 2012 Out- license d to Purdue Pharma for up to $145M Acquired by Allergan -$958 MM Acquired by Shire -$
Slide 15: TNX-102 SL – registration program in FM
TONIX PHARMACEUTICALS 15 CONFIDENTIAL TONIX PHARMACEUTICALS TNX-102 SL –registration program in FM 15 Held Pre-Phase 3 meeting with FDA in February 2013 Remaining clinical work to support New Drug Application: Two adequate and well-controlled safety and efficacy trials in FM patients Primary efficac
Slide 16: "BESTFIT" Phase 2b/3 trial in FM is enrolling
TONIX PHARMACEUTICALS 16 CONFIDENTIAL TONIX PHARMACEUTICALS “BESTFIT” Phase 2b/3 trial in FM is enrolling BESTFIT: BEdtimeSublingual TNX-102 SL as Fibromyalgia Intervention Therapy Randomized, double-blind, placebo-controlled; 12-15 sites, all in U.S. Primary efficacy endpoint = change in pain at we
Slide 17: TNX-102 SL: first-in-class fibromyalgia medicine
TONIX PHARMACEUTICALS 17 CONFIDENTIAL TONIX PHARMACEUTICALS TNX-102 SL: first-in-class fibromyalgia medicine Targets pain and poor sleep Unique mechanism of action among marketed FM products Sublingual tablet at bedtime Fast onset aligns exposure with sleeping period Designed to optimize ease-of-use
Slide 18: Post-Traumatic Stress Disorder
TONIX PHARMACEUTICALS 18 TONIX PHARMACEUTICALS Post-Traumatic Stress Disorder Overlap between PTSD and FM ~50% of FM orPTSD patients meet criteria for the otherdisorder Patients experience disturbed sleep and widespread pain Core defining feature is hyper-vigilance, that can disturb sleep Painkiller
Slide 19: Intellectual Property
TONIX PHARMACEUTICALS 19 CONFIDENTIAL TONIX PHARMACEUTICALS Intellectual Property 19 Pharmacokinetics (PK) Patents filed around unique PK profile Protection expected to 2033 Composition-of-matter Patent filed -“Eutectic” Protection expected to 2034 Method-of-use FM: patent issued, 3Q 2020 expiry PTS
Slide 20: Milestones – Recent and Upcoming
TONIX PHARMACEUTICALS 20 CONFIDENTIAL TONIX PHARMACEUTICALS Milestones –Recent and Upcoming □ 8/9/13 –TNXP stock uplistedto NASDAQ □ 8/14/13 –Gross proceeds of $11.4 million from underwritten offering □ 3Q 2013 –Began Phase 2b/3 trial of TNX-102 SL in FM □ 4Q 2013 –Begin open-label extension study o
Slide 21: Management Team
TONIX PHARMACEUTICALS 21 CONFIDENTIAL TONIX PHARMACEUTICALS Bruce Daugherty, PhD CSO Seth Lederman, MD CEO Management Team Leland Gershell, MD PhD CFO
Slide 22: Board of Directors
TONIX PHARMACEUTICALS 22 CONFIDENTIAL TONIX PHARMACEUTICALS Board of Directors 22 Samuel Saks, MDErnest Mario, PhD Stuart Davidson Alkermes Combion Charles Mather JanneyMontgomery Scott Cowen, Smith Barney Patrick Grace WR Grace Chemed John Rhodes Booz Allen Hamilton NYSERDA Donald Landry, MD PhD Ch
Slide 23: Why Invest in Tonix?
TONIX PHARMACEUTICALS 23 CONFIDENTIAL TONIX PHARMACEUTICALS Why Invest in Tonix? 23 • Late stage clinical program in large market indication • Strong evidence of clinical benefit in Phase 2a • Active ingredient has established safety profile at higher doses • FDA 505(b)(2) regulatory pathway offers
Slide 24: NASDAQ: TNXP
NASDAQ: TNXP
Tonix Pharmaceuticals Holding — Investor Presentation (November 2013) on 6ix