Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (March 2019)
27 slides from Tonix Pharmaceuticals's investor presentation, Mar 18, 2019
Slide 1: Investor Presentation March 2019
Investor Presentation March 2019 Version P0165 3-18-19 (Doc 0449) © 2019 Tonix Pharmaceuticals Holding Corp.
Slide 2: Cautionary Note on Forward Looking Statements
Cautionary Note on Forward Looking Statements 2 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
Slide 3: Tonix Development Highlights
Tonix Development Highlights 3 Posttraumatic Stress Disorder (PTSD) – Lead program; new bedtime treatment - Tonmya ®1 • P302/RECOVERY Phase 3 clinical study initiated in March 2019 • Results from 2 efficacy studies improve the new Phase 3 study design New Phase Tablets • P302/RECOVERY study design f
Slide 4: Candidates in Development
5 Synthesized live horsepox virus Candidates in Development 4 Pipeline Product Indication Preclinical Phase 1 Phase 2 Phase 3 NDA 1 /BLA 2 Market Bedtime Treatment TNX-102 SL for PTSD – Tonmya® P302/ RECOVERY study initiated 1Q2019 Cyclobenzaprine HCl sublingual tablets Bedtime Treatment for Phase 2
Slide 5: Tonmya: a Potential Bedtime Treatment for PTSD
Tonmya: a Potential Bedtime Treatment for PTSD 5 First investigational new drug to show treatment effect in military-related PTSD in two potential pivotal efficacy studies • Phase 2 study (P201/AtEase) showed Tonmya 5.6 mg had a strong signal of treatment effect at Week 12 as measured by CAPS-5 1 •
Slide 6: Prevalence of PTSD Among Civilians and Veterans
Prevalence of PTSD Among Civilians and Veterans 6 4.7% 19-31% >19% Adult population 1 Vietnam veterans 2 Iraq/Afghanistan 3 12 million American adults annually 1 Women more likely to develop than men 1 1 Goldstein et al., 2016 (adjusted for 2019); 2 Norris, PTSD Res Quar . 2013; 3 Analysis of VA Hea
Slide 7: Unmet Need for Effective and Safe Therapies for Treatment of Military PTSD
Unmet Need for Effective and Safe Therapies for Treatment of Military PTSD 7 PTSD is signature wound of last 25 years of war • Affects servicemember health and performance, force readiness, retention • Believed to be the underlying cause of suicide in many cases No FDA-approved products for PTSD sin
Slide 8: TNX SL Intellectual Property
TNX 102 SL Intellectual Property – U.S. Protection until 2034 8 Composition of matter (eutectic) : Protection expected to 2034 • United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 9,636,408 in May 2017 U.S. Patent No. 9,956,188 in May 2018 and U.S. Patent No. 10,117,936 in Nove
Slide 9: Potential Therapeutic Advantages of Tonmya
Potential Therapeutic Advantages of Tonmya 9 Tonmya is believed to treat PTSD by improving sleep quality • The brain naturally processes memories during sleep • PTSD sufferers’ emotionally charged memories disturb sleep and disrupt the natural processing of memories during sleep • Tonmya is believed
Slide 10: Tonmya Phase 2 Dose Effect in Military Related PTSD
Tonmya Phase 2 Dose Effect in Military Related PTSD 1 10 PTSD Symptoms (CAPS-5 2 Score) 30% Remission at Weeks 8 & 12 25% * 21.10% 20% Placebo (N=77) Tonmya 2.8 mg (N=70) # Tonmya 5.6 mg (N=38) 15% 14.30% 10% 5.20% 5% 7.2 points Percent in Remission 0% Weeks 8 & 12 Remission = Loss of Diagnosis and
Slide 11: Primary Outcome (CAPS-5) in Phase 3 mITT and Time Since Trauma Subgroups
Primary Outcome (CAPS 5) in Phase 3 mITT) and 9 Years Time Since Trauma (TST) Subgroups 11 Phase 3 P301/HONOR Study 1 Modified intent to treat Time Since Trauma (mITT) population 9 yrs ~50% mITT Population * p=0.019, TNX-102 SL 5.6 mg group v. placebo, using ** p=0.004, * p=0.039, mixed model repeat
Slide 12: Retrospective Comparison of Time Since Trauma in P201/AtEase versus P301/HONOR
Retrospective Comparison of Time Since Trauma in P201/AtEase versus P301/HONOR (Tonmya 5.6 mg Groups) 12 P301 study was initiated approximately two years later than Phase 2 P201 • The median time since trauma in Phase 3 was 9.5 years compared to the median time since trauma in Phase 2 of 6.0 years f
Slide 13: Sustained Remission in Phase 2 and Phase 3 Studies
Sustained Remission in Phase 2 and Phase 3 Studies: Retrospective Analyses of P201 Entry CAPS 5 33 and P301 9 Years Since Trauma Subgroups 13 Remission is a clinical state that is essentially asymptomatic In order to confirm remission: • Determined rates of participants who met remission status at b
Slide 14: Adverse Events in P201/AtEase and P301/HONOR Studies
Adverse Events (AEs) in P201/AtEase and P301/HONOR Studies 14 #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) in that study was at a rate of <5% No serious or unexpected AEs in P201 or P3
Slide 15: Response to Tonmya for Female Participants in P301/HONOR Study
Response to Tonmya for Female Participants in P301/HONOR Study 1 15 Females made up only 11% of the P301/HONOR study mITT population Difference in mean change from baseline in CAPS-5 in females between placebo (N=17) and Tonmya 5.6 mg (N=10) was: • At 4 weeks -11.5 points • At 12 weeks -9.1 points I
Slide 16: Response to Tonmya for Non Combat Traumas in P301/HONOR Study
Response to Tonmya for Non Combat Traumas in P301/HONOR Study in 9 Years Time Since Trauma Subgroup 1 16 Non-combat traumas studied are similar to traumas experienced in civilian populations with PTSD To determine the therapeutic effects of Tonmya 5.6 mg in a mixed civilian and military population,
Slide 17: New Phase 3 P302/RECOVERY Study – Initiated 1Q 2019
New Phase 3 P302/RECOVERY Study –Initiated 1Q 2019 17 General study characteristics: Primary endpoint: • Randomized, double-blind, placebo-controlled study with • CAPS-5 1 mean change from baseline at Week 4 (Tonmya 5.6 mg baseline CAPS-5 1 33 in approximately 30 U.S. sites vs. placebo) • Enrollment
Slide 18: Late Stage PTSD Drug Candidates
Late Stage PTSD Drug Candidates 18 Tonmya • Phase 3 development focused on military-related and civilian PTSD; showed activity in treatment of military-related PTSD in large multi-center trials MDMA-assisted psychotherapy • Breakthrough therapy that is Phase 3-ready; showed activity in a Phase 2 stu
Slide 19: TNX SL – Bedtime Treatment for Multiple Potential Indications
TNX 102 SL – Bedtime Treatment for Multiple Potential Indications 19 Management of Fibromyalgia (FM) – chronic pain condition • TNX-102 SL studied at low dose (2.8 mg) – half the dose being developed for PTSD – did not separate from placebo on primary endpoint, average pain improvement (responder an
Slide 20: TNX SL for Agitation in Alzheimer's – Regulatory Status and Registration Strategy
TNX 102 SL for Agitation in Alzheimer’s –Regulatory Status and Registration Strategy 20 FDA confirmed no additional study was needed prior to IND submission • Pre-IND meeting established open dialogue with the FDA on pivotal clinical study design and efficacy endpoints to support product registratio
Slide 21: TNX-601 (Tianeptine Oxalate): A Potential Clinical Candidate for PTSD
TNX 601 Tianeptine Oxalate): A Potential Clinical Candidate for PTSD 21 Targeted as a 1 st line monotherapy for PTSD: oral formulation for daytime dosing Leverages expertise in PTSD (clinical and regulatory experience, market analysis, etc.) Mechanism of Action (MOA) is different from TNX-102 SL Pre
Slide 22: TNX-801 (Synthesized Live Horsepox Virus): A Smallpox Preventing Vaccine Candidate
TNX 801 (Synthesized Live Horsepox Virus): A Smallpox Preventing Vaccine Candidate 22 Potential improvement over current biodefense tools against smallpox Leverages Tonix’s government affairs effort Collaboration with Professor David Evans and Dr. Ryan Noyce at University of Alberta Demonstrated pro
Slide 23: Financial Overview
Financial Overview 23 NASDAQ: TNXP Cash and cash equivalents, December 31, 2018 $25.0 million Common stock outstanding as of March 13, 2019 6.1 million © 2019 Tonix Pharmaceuticals Holding Corp.
Slide 24: Management Team
Management Team 24 Seth Lederman, MD President & CEO Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer Jessica Morris Chief Operating Officer © 2019 Tonix Pharmaceuticals Holding Corp.
Slide 25: Milestones – Recently Completed and Upcoming
Milestones – Recently Completed and Upcoming 25 July 2018 Completed P301/HONOR study interim analysis - result did not support study continuation but strengthened new Phase 3 study August 2018 Presentation of P301/HONOR study results at Military Health System Scientific Symposium October 2018 Met wi
Slide 26: Summary
Summary 26 Phase 3 development of new bedtime treatment for PTSD, including military-related PTSD • Major unmet need; ~12 million Americans annually • Benefited from FDA 505(b)(2) NDA approval requirement Complimentary day-time PTSD treatment in development • Leverages development expertise in PTSD,
Slide 27: Thank you!
NASDAQ: TNXP Thank you ! © 2019 Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals Holding — Investor Presentation (March 2019) on 6ix