Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — IPO Roadshow (November 2019)
35 slides from Tonix Pharmaceuticals's IPO roadshow presentation, Nov 1, 2019
Slide 1: Investor Presentation
© 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute 1 November 1, 2019 Investor Presentation Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration No. 333 - 234263
Slide 2: Cautionary Note on Forward-Looking Statements
2 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute 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 statemen
Slide 3: Free Writing Prospectus Statement
3 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute Free Writing Prospectus Statement This presentation highlights basic information about us and the offering to which this communication relates. Because it is a summary, it does not contain all of the informa
Slide 4: Offering Summary
4 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute Offering Summary Issuer Tonix Pharmaceuticals Holding Corp. Exchange / Ticker NASDAQ / TNXP Offering Size Approximately $15 million (100% Primary) Over Allotment 15% (100% Primary) Use of Proceeds • To fund
Slide 5: Tonix Pharmaceuticals
5 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute Tonix Pharmaceuticals Who we are: • A clinical stage biopharmaceutical company dedicated to developing innovative treatments for patients and making meaningful contributions to society • Focusing on small mo
Slide 6: Management Team
6 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute Management Team Seth Lederman, MD President & CEO Jessica Morris Chief Operating Officer Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer
Slide 7: CNS Candidates in Clinical Development
7 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute CNS Candidates in Clinical Development Psychiatry, Pain and Addiction Phase 2 NDA 3 /BLA 4 Market Pipeline Product Indication Phase 3 TNX - 102 SL 1 Bedtime Treatment for PTSD – Tonmya ®2 Daytime Treatment f
Slide 8: Preclinical Pipeline
8 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute Preclinical Pipeline 1 1 (Experimental new medicines and biologics, not approved for any indication 2 (2S,4R,5R) - 5 - (((2 - aminobenzo[d]thiazol - 6 - yl)methyl)amino) - 2 - (bis(4 - fluorophenyl)methyl)te
Slide 9: SL Intellectual Property – U.S. Protection expected until 2035
9 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute TNX - 102 SL Intellectual Property – U.S. Protection expected until 2035 • United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 9636408 in May 2017, U.S. Patent No. 9956188 in May 2018, U
Slide 10: Prevalence of PTSD Among Civilians and Veterans
10 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute Prevalence of PTSD Among Civilians and Veterans 1 Goldstein et al., 2016 (adjusted for 2019) ; 2 Norris, PTSD Res Quar. 2013; 3 Analysis of VA Health Care Utilization among Operation Enduring Freedom, Opera
Slide 11: Unmet Need for Effective and Safe Therapies for Treatment of PTSD
11 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute Unmet Need for Effective and Safe Therapies for Treatment of PTSD No FDA - approved products for PTSD since Pfizer’s Zoloft ® (sertraline) in 1999 and GSK’s Paxil ® (paroxetine) in 2001 • Neither has shown
Slide 12: Potential Therapeutic Advantages of SL
12 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute Potential Therapeutic Advantages of TNX - 102 SL TNX - 102 SL is believed to treat PTSD by improving sleep quality • The brain naturally processes memories during sleep • PTSD sufferers’ emotionally charged
Slide 13: SL Phase 2 Dose-Effect in Military-Related PTSD
13 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute TNX - 102 SL Phase 2 Dose - Effect in Military - Related PTSD 1 1 Completed Phase 2 P201/AtEase study: Retrospective analysis of TNX - 102 SL 5.6 mg on CAPS - 5 ≥33 (high - moderate) subgroup. Primary analy
Slide 14: Primary Outcome (CAPS-5) in Phase 3 Study
© 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute 14 Primary Outcome (CAPS - 5) in Phase 3 Study: mITT and ≤9 Years Time Since Trauma Subgroup Modified intent to treat ( mITT ) population Phase 3 P301/HONOR Study 1 ** p=0.004, * p=0.039, # p=0.069, TNX - 102
Slide 15: Adverse Events in P201/AtEase and P301/HONOR Studies
15 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute Adverse Events (AEs) in P201/AtEase and P301/HONOR Studies No serious or unexpected AEs in P201 or P301 related to TNX - 102 SL • Systemic AEs comparable between studies and also consistent with those descr
Slide 16: SL for PTSD: Phase 3 P302/RECOVERY Study
16 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute TNX - 102 SL for PTSD: Phase 3 P302/RECOVERY Study Expecting Topline Data in 2Q 2020 Primary e ndpoint: • CAPS - 5 1 mean change from baseline at Week 4 (TNX - 102 SL 5.6 mg vs. placebo) Key Secondary e ndp
Slide 17: Opportunities for SL in Other Potential Indications
17 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute Opportunities for TNX - 102 SL in Other Potential Indications Psychiatric Disorders • Stress Disorders (PTSD) • Mood Disorders • Anxiety Disorders • Addiction (Alcohol Use Disorder) Chronic Pain States • Ch
Slide 18: Fibromyalgia as a Pain Signaling Disorder
18 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute Volkswagen Check Engine [Photograph]. (2011, October 14). Wikipedia • Pain is a sensor system in the brain, similar to a check engine light on a car’s dashboard • When the check engine light malfunctions, t
Slide 19: Large Need for New Fibromyalgia Therapies
19 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute 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 patient
Slide 20: SL 2.8 mg for Fibromyalgia: Completed Phase 3 Study F301
20 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute TNX - 102 SL 2.8 mg for Fibromyalgia: Summary of Completed Phase 3 Study F301 and Results General s tudy c haracteristics: • Randomized, 12 - week, double - blind, placebo - controlle d Phase 3 study of TNX
Slide 21: SL 2.8 mg for Fibromyalgia: F301 Results and Program Updates
21 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute TNX - 102 SL 2.8 mg for Fibromyalgia: F301 Study Results and Program Updates Safety results: • Good tolerability and low rates of systemic AEs. • The most common AEs were generally mild and transient events
Slide 22: SL 5.6 mg for Fibromyalgia: Planned Phase 3 F304 Study
22 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute TNX - 102 SL 5.6 mg for Fibromyalgia: Planned New Phase 3 F304 Study Primary e ndpoint (week 14) : • Daily diary pain severity score change (TNX - 102 SL 5.6 mg vs. placebo) from Baseline in the weekly aver
Slide 23: SL: Potential Treatment for Agitation in Alzheimer's Disease
23 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute TNX - 102 SL: Potential Treatment for Agitation in Alzheimer’s Disease (AAD) Agitation is one of the most distressing and debilitating of the behavioral complications of Alzheimer’s disease • Includes emoti
Slide 24: SL: Potential Treatment for Alcohol Use Disorder
24 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute TNX - 102 SL: Potential Treatment for Alcohol Use Disorder (AUD) AUD is a chronic relapsing brain disease • Characterized by compulsive alcohol use, loss of control over alcohol intake, and a negative emoti
Slide 25: TNX-1300 for the Treatment of Cocaine Intoxication
© 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute 25 TNX - 1300* for the Treatment of Cocaine Intoxication Recombinant protein that degrades cocaine in the bloodstream 1 • Double - mutant cocaine esterase ( CocE ) • CocE was identified in bacteria ( Rhodococc
Slide 26: Pharmacotherapies for Cocaine Intoxication Have Not Been Effective
26 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute Pharmacotherapies for Cocaine Intoxication Have Not Been Effective 1. Brim et al. Mol Pharmacol . 2011. 2. Melichar et al. Eur J Phamacol . 2003. 3. Narasimhan et al. Future Medicinal Chemistry. 2012. Opiat
Slide 27: TNX-1300 Is a Fast-acting Cocaine Antidote
27 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute TNX - 1300 (Cocaine Esterase or CocE ) Is a Fast - acting Cocaine Antidote CocE Rhodococcus bacteria living in the roots of the coca plant use CocE to metabolize cocaine 1 CocE cleaves chemical bonds in coc
Slide 28: Cocaine Intoxication Is a Growing Problem in the U.S.
28 Cocaine Intoxication Is a Growing Problem in the U.S. National Drug Overdose Deaths Involving Cocaine 0 5000 10000 15000 Cocaine is involved in more emergency department (ED) visits than any other illicit substance 1 Drug overdose deaths involving cocaine have increased dramatically in recent yea
Slide 29: Tianeptine Oxalate CR: Potential Daytime Treatment for PTSD
29 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute TNX - 601 * (Tianeptine Oxalate CR): A Potential Daytime Treatment for PTSD Pre - IND Candidate Targeted as a 1 st line monotherapy for PTSD: oral formulation for daytime dosing • Tianeptine sodium (amorpho
Slide 30: TNX-601 for PTSD
© 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute 30 TNX - 601* for PTSD Pharmacokinetic and safety study (ex - U.S.) of controlled release (CR) formulations underway • Targeting CR formulation for once - daily dosing Pre - IND meeting with FDA expected first
Slide 31: Milestones – Recently Completed and Upcoming
31 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute Milestones – Recently Completed and Upcoming □ March 2019 P302/RECOVERY study initiated □ April 2019 Received FDA formal minutes with clear guidance and support for new Phase 3 FM study using TNX - 102 SL 5
Slide 32: Capitalization Table
32 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute Capitalization Table* As of 10/31/2019 # of Shares WAEP $ Value % of Fully Diluted Common Shares Outstanding (D&O) 6,853 0.3% Common Shares Outstanding (Other) 1,564,888 71.9% Warrants 496,486 $42.14 $20.9M
Slide 33: Pipeline Summary – by Select Therapeutic Areas
33 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute Pipeline Summary – by Select Therapeutic Areas • Psychiatry/PTSD: • TNX - 102 SL – (sublingual cyclobenzaprine) for PTSD • Phase 3 • TNX - 601 – (tianeptine) for PTSD • Phase 1 formulation development • TNX
Slide 34: Pipeline Summary – by Phase of Development
34 © 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute Pipeline Summary – by Phase of Development Two Phase 3 Programs in indications affecting millions of Americans • TNX - 102 SL for PTSD: affects an estimated 12 million adults in U.S. • TNX - 102 SL for Fibr
Slide 35: Thank you!
© 2019 Tonix Pharmaceuticals Holding Corp. – Confidential – Do not duplicate or distribute 35 Thank you ! NASDAQ: TNXP
Tonix Pharmaceuticals Holding — IPO Roadshow (November 2019) on 6ix