Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Bio International 2020
23 slides from Tonix Pharmaceuticals's conference presentation, Jun 5, 2020
Slide 1: Bio International 2020 - Seth Lederman, CEO
© 2020 Tonix Pharmaceuticals Holding Corp. 1 Seth Lederman, CEO June 8 - 11, 2020 Version P0232 5 - 27 - 20 (Doc 0640) Bio International - 2020 NASDAQ:TNXP
Slide 2: Cautionary Note on Forward-Looking Statements
© 2020 Tonix Pharmaceuticals Holding Corp. 2 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 Litigat
Slide 3: Tonix Pharmaceuticals: Developing novel therapies for humanity
© 2020 Tonix Pharmaceuticals Holding Corp. 3 Tonix Pharmaceuticals © 2020 Tonix Pharmaceuticals Holding Corp. Developing novel therapies for humanity • A clinical - stage biopharmaceutical company committed to discovering and developing innovative and proprietary new therapeutics that address the ne
Slide 4: Our Pipeline
© 2020 Tonix Pharmaceuticals Holding Corp. 4 Our Pipeline CANDIDATES INDICATION STATUS CNS Portfolio TNX - 102 SL Fibromyalgia (FM) - Lead Program Phase 3 – ongoing PTSD Phase 3 – ongoing Agitation in Alzheimer’s Phase 2 ready Alcohol Use Disorder Pre - IND TNX - 1300 Cocaine Intoxication / Overdose
Slide 5: Overview of TNX-102 SL Protectic formulation
© 2020 Tonix Pharmaceuticals Holding Corp. 5 Overview of TNX - 102 SL Protectic ® proprietary formulation of cyclobenzaprine that supports sublingual administration Scientific Rationale for Protectic ® Formulation • Engenders unique pharmacokinetic and pharmacodynamic properties that emphasize sleep
Slide 6: TNX-102 SL: Differentiation from Oral Formulations
© 2020 Tonix Pharmaceuticals Holding Corp. 6 TNX - 102 SL: Differentiation from Oral Formulations FEATURE BENEFIT ADVANTAGE Cyclobenzaprine 40+ years as oral medication Established safety record Formulation: Protectic ® Allows submucosal absorption Not achievable with oral formulation Administration
Slide 7: TNX-102 SL: Results from Completed FM Trials
© 2020 Tonix Pharmaceuticals Holding Corp. 7 TNX - 102 SL: Results from Completed FM Trials Completed Trials in FM: • Phase 2 (F202 BESTFIT) – 205 patients randomized • Phase 3 (F301 AFFIRM) – 519 patients randomized Topline Efficacy Results: • Studies did not achieve statistical significance in the
Slide 8: Phase 2 F202 and Phase 3 F301 Efficacy Endpoints
© 2020 Tonix Pharmaceuticals Holding Corp. 8 p=0.005 p=0.038 P<0.001 P<0.001 P<0.001 Phase 3 F301 (AFFIRM) Dose: 2.8 mg Responder analysis 30% pain reduction (Logistic regression) • Imbalance in missing data and individuals with missing data treated as ‘non - responder’ • Current FDA statistical gui
Slide 9: Results from F301 (AFFIRM) Using Current FDA Statistical Guidance
© 2020 Tonix Pharmaceuticals Holding Corp. 9 Results from F301 (AFFIRM) Using Current FDA Statistical Guidance on Handling of Missing Data • A retrospective analysis conducted using Mean Pain Analysis, MMRM with MI † demonstrated a significant effect on pain, even though the dose was 2.8 mg -1.8 -1.
Slide 10: Where Are We on the Dose-Response Curve?
© 2020 Tonix Pharmaceuticals Holding Corp. 10 Where Are We on the Dose - Response Curve? Basic Pharmacology • Dose can make the difference in the strength of the response Response Dosage Dose - Response Inconsistent response No clear response Consistent response Consistent but trade - offs (AEs) *Tr
Slide 11: Dose Response from Phase 2 PTSD Study
© 2020 Tonix Pharmaceuticals Holding Corp. 11 Dose Response from Phase 2 PTSD Study * Placebo 5.6 mg 2.8 mg * P < 0.05 Consistent Dose - response Across Primary and Key Secondary Endpoints at Week 12 • Clinician Administered PTSD Scale for DSM - 5 (CAP - 5) * Phase 2 study (AtEase), a randomized, pl
Slide 12: Dose Response from Phase 2 PTSD Study: SDS
© 2020 Tonix Pharmaceuticals Holding Corp. 12 Dose Response from Phase 2 PTSD Study Placebo 5.6 mg 2.8 mg * P < 0.05 Consistent Dose - response Across Primary and Key Secondary Endpoints at Week 12 • Sheehan Disability Score (SDS) -3 -2.5 -2 -1.5 -1 -0.5 0 SDS Work/School -4 -3.5 -3 -2.5 -2 -1.5 -1
Slide 13: Dose Response from Phase 2 PTSD Study: CGI-I and PGIC
© 2020 Tonix Pharmaceuticals Holding Corp. 13 Dose Response from Phase 2 PTSD Study 0% 10% 20% 30% 40% 50% 60% 70% Percent Responders CGI - I Responders 2.45 2.5 2.55 2.6 2.65 2.7 2.75 2.8 2.85 2.9 2.95 Mean Score PGIC Improvement Placebo 5.6 mg 2.8 mg * P < 0.05 * * Improvement Improvement • Consis
Slide 14: Effect of Dose on Adverse Events in PTSD Studies
© 2020 Tonix Pharmaceuticals Holding Corp. 14 Effect of Dose on Adverse Events (AEs) in the P201/ AtEase and P301/HONOR PTSD Studies # Only adverse events (AEs) are listed that are at a rate of ≥ 5% in any TNX - treated group *No values in a row for either study means the AE in the active group(s) i
Slide 15: TNX-102 SL: Ongoing Phase 3 Study in FM (RELIEF)
© 2020 Tonix Pharmaceuticals Holding Corp. 15 TNX - 102 SL: On - going Phase 3 Study in FM (F304/RELIEF) © 2020 Tonix Pharmaceuticals Holding Corp. • Key changes to protocol from previous Phase 3 trial in FM • Exclusive use of higher dose of 5.6 mg (2 x 2.8 mg) • Primary endpoint: mean pain improvem
Slide 16: TNX-1800, a SARS-CoV-2 Vaccine
© 2020 Tonix Pharmaceuticals Holding Corp. 16 TNX - 1800 1 , a SARS - CoV - 2 Vaccine Utilizes Tonix’s proprietary horsepox virus as a vector • Designed to express a protein from SARS - CoV - 2, the cause of COVID - 19 • Collaboration with Southern Research Status of Vaccines for COVID - 19 • No vac
Slide 17: Why Use a Horsepox Platform for a Vaccine?
© 2020 Tonix Pharmaceuticals Holding Corp. 17 Why Use a Horsepox Platform for a Vaccine? Horsepox can be engineered to express foreign genes • Lack of persistence or genomic integration in the host • Strong immunogenicity as a vaccine • Readily manufacture at scale • Live, replicating vaccine – dire
Slide 18: TNX-1800 is Based on a Horsepox Virus Vector
© 2020 Tonix Pharmaceuticals Holding Corp. 18 TNX - 1800 is Based on a Horsepox Virus (HPXV) Vector Designed to Express SARS - CoV - 2 S Protein *TNX - 1800 is at the pre - IND stage of development Horsepox sHPXV ~200,000 Bp TNX - 1800 * rHPXV/SARS - CoV - 2S ~200,000 Bp Homologous Recombination
Slide 19: TNX-1800 is Designed to Induce Robust TH1 Cellular Immunity
© 2020 Tonix Pharmaceuticals Holding Corp. 19 TNX - 1800 is Designed to Induce Robust T H 1 Cellular Immunity 1. Fulginiti VA, et al. Clin Infect Dis. 2003;37(2):241 - 250. 2. Liu L, et al. Nature Med. 2010;16(2):224 - 228. 3. Centers for Disease Control and Prevention. Accessed April 15, 2020. http
Slide 20: TNX-1800 Development Status
© 2020 Tonix Pharmaceuticals Holding Corp. 20 TNX - 1800 Development Status Southern Research will address two key questions: • Will vaccination of animals elicit an immune response to the S protein? • 4th Quarter 2020 – Small animal response expected 1 • Will immune response protect non - human pri
Slide 21: Tonix Pharmaceuticals: Lead Programs
© 2020 Tonix Pharmaceuticals Holding Corp. 21 Tonix Pharmaceuticals: Lead Programs 1 © 2020 Tonix Pharmaceuticals Holding Corp. • TNX - 102 SL for fibromyalgia (FM) • Phase 3 clinical development – RELIEF study enrolling • Sublingual cyclobenzaprine tablets at higher dose of 5.6 mg • Milestones: • S
Slide 22: Management Team
© 2020 Tonix Pharmaceuticals Holding Corp. 22 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 23: Thank You!
© 2020 Tonix Pharmaceuticals Holding Corp. 23 Thank You!
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