Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (August 2013)
24 slides from Tonix Pharmaceuticals's investor presentation, Aug 29, 2013
Slide 1: Investor Presentation August 2013
Investor Presentation August 2013 NASDAQ: TNXP
Slide 2: Safe Harbor Statement
TONIX PHARMACEUTICALS 2 CONFIDENTIAL TONIX PHARMACEUTICALS Safe Harbor Statement Certainstatementsinthispresentationregardingstrategicplans,expectationsandobjectives forfutureoperationsorresultsare“forward-lookingstatements”asdefinedbythePrivate SecuritiesLitigationReformActof1995.Thesestatementsmay
Slide 3: Investment Highlights
TONIX PHARMACEUTICALS 3 CONFIDENTIAL TONIX PHARMACEUTICALS Investment Highlights Developing novel medications for central pain disorders Addressing large and unmet needs in the central neuropathic pain market Fibromyalgia –lead indication Phase 2b/3 trial of TNX-102 SL to report in 2H 2014 Significa
Slide 4: Product Pipeline
TONIX PHARMACEUTICALS 4 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 5: Fibromyalgia (FM) – Lead Program
TONIX PHARMACEUTICALS 5 CONFIDENTIAL TONIX PHARMACEUTICALS Fibromyalgia (FM) –Lead Program Patients feel pain all over the body, but it originates in the brain Chronic, widespread pain with sleep, fatigue, mood, and memory problems Impairs daily function and productivity: poor quality of life Typica
Slide 6: Fibromyalgia Market Opportunity
TONIX PHARMACEUTICALS 6 CONFIDENTIAL TONIX PHARMACEUTICALS Fibromyalgia 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 only †Frost & Sull
Slide 7: Fibromyalgia: A Vicious Cycle of Pain and Poor Quality Sleep
TONIX PHARMACEUTICALS 77 Fibromyalgia: A Vicious Cycle of Pain and Poor Quality Sleep Patient chief complaint: “Hurt all over, can’t sleep” Pain exacerbates poor quality sleep; poor sleep exacerbates pain No benefit from opiates or prescription sleep drugs Tonixtreatment concept: improving sleep qua
Slide 8: TNX-102 SL: Nightly Bedtime Therapy as the Route to Improve FM Pain
TONIX PHARMACEUTICALS 8 CONFIDENTIAL TONIX PHARMACEUTICALS TNX-102 SL: Nightly Bedtime Therapy as the Route to Improve FM Pain Pain (0-10 scale) is FDA Accepted Endpoint TNX-102 SL 10 5 0 VICIOUS CYCLE cyclobenzaprine sublingual tablet
Slide 9: Phase 2a Study – Proof-of-Concept
TONIX PHARMACEUTICALS 9 CONFIDENTIAL TONIX PHARMACEUTICALS Phase 2a Study –Proof-of-Concept Results published in Journal of Rheumatology* Harvey Moldofsky, MD –lead investigator (University of Toronto) Double blind, randomized, placebo controlled study Conducted at two academic centers in Canada •un
Slide 10: Positive Results from Phase 2a VLD CBP in FM
TONIX PHARMACEUTICALS 10 CONFIDENTIAL TONIX PHARMACEUTICALS Positive Results from Phase 2a VLD CBP in FM -30 -20 -10 0 10 20 VLD CBP Placebo HAD = Hospital Anxiety and Depression Scale * p < 0.05, VLD CBP 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* HAD Depressio
Slide 11: TNX-102 SL Optimizes CBP for FM Therapy
TONIX PHARMACEUTICALS 11 CONFIDENTIAL TONIX PHARMACEUTICALS 11 TNX-102 SL Optimizes CBP for FM Therapy Dose Delivery current CBP products 5 10 oral GI absorption TNX-102 SL 2.8 sublingual transmucosal absorption fast s l o w •efficacy •tolerability/safety •chronic use •bedtime therapy •compliance •m
Slide 12: Sublingual vs. Oral Delivery of CBP
TONIX PHARMACEUTICALS 12 CONFIDENTIAL TONIX PHARMACEUTICALS Sublingual vs. Oral Delivery of CBP 12
Slide 13: CBP Effects on Nerve Cell Signaling
TONIX PHARMACEUTICALS 13 CBP Effects on Nerve Cell Signaling Untreated Effects of TNX-102 SL CBP is a multi-functional drug - inhibits Serotonin and Norepinephrine reuptake - blocks Serotonin 5HT 2a and Norepinephrine a 1 receptors SNARI = Serotonin and Norepinephrine receptor Antagonist and Reuptak
Slide 14: FM Treatments: Central Pain Inhibitors
TONIX PHARMACEUTICALS 14 CONFIDENTIAL TONIX PHARMACEUTICALS FM Treatments: Central Pain Inhibitors SNRI Cymbalta (duloxetine) Savella(milnacipran) Membrane Stabilizer Lyrica (pregabalin) SNRI – Serotonin & Norepinephrine Reuptake Inhibitor SNARI – Serotonin & Norepinephrine receptor Antagonist and R
Slide 15: TNX-102 SL: BESTFIT Phase 2b/3 trial in FM
TONIX PHARMACEUTICALS 15 CONFIDENTIAL TONIX PHARMACEUTICALS TNX-102 SL: “BESTFIT” Phase 2b/3 trial in FM 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 wee
Slide 16: TNX-102 SL: First-in-Class Fibromyalgia Medicine
TONIX PHARMACEUTICALS 16 CONFIDENTIAL TONIX PHARMACEUTICALS TNX-102 SL: First-in-Class Fibromyalgia Medicine Targets pain and poor sleep SNARI –unique mechanism of action among marketed FM products Sublingual tablet at bedtime Fast onset aligns exposure with sleeping period Designed to optimize ease
Slide 17: TNX-102 SL: Post-Traumatic Stress Disorder
TONIX PHARMACEUTICALS 17 TONIX PHARMACEUTICALS TNX-102 SL: 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 night terrors, a form of sleep disturb
Slide 18: Drugs Used Off-Label in PTSD
TONIX PHARMACEUTICALS 18 Drugs Used Off-Label in PTSD TNX-102 SL Trazodone Trazodone(disordered sleep), Prazosin(night terrors) - Trazodoneinhibits serotonin 5HT 2a receptors and serotonin reuptake (SARI) - Prazosinblocks norepinephrine a 1 receptors Prazosin SARI –Serotonin Receptor Antagonist & Re
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 –Begin Phase 2b/3 trial of TNX-102 SL in FM □ 4Q 2013 –File IND for TNX-102 SL in PTSD □
Slide 21: Management Team
TONIX PHARMACEUTICALS 21 CONFIDENTIAL TONIX PHARMACEUTICALS Management Team Selected Previous Corporate Affiliations Selected Previous ProductAffiliations Seth Lederman, MD CEO & Chairman • Vela • Targent • Validus • Fontus Leland Gershell, MD, PhD CFO • Cowen • Apothecary Capital • MadisonWilliams
Slide 22: Board of Directors
TONIX PHARMACEUTICALS 22 CONFIDENTIAL TONIX PHARMACEUTICALS Board of Directors Selected Current & PreviousAffiliations Selected Previous ProductAffiliations Seth Lederman, MD Chairman • Vela • Targent • Validus/Fontus Stuart Davidson • Alkermes • Combion Patrick Grace • WR Grace • Chemed • Grace Ins
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 desired treatment effect in Phase 2a •Active ingredient has established safety profile at higher doses •Team distinguished by track record of
Slide 24: Pharmaceuticals
PHARMACEUTICALS NASDAQ: TNXP
Tonix Pharmaceuticals Holding — Investor Presentation (August 2013) on 6ix