Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (March 2019)
27 slides from Tonix Pharmaceuticals's investor presentation, Mar 5, 2019
Slide 1: Investor Presentation, March 2019
© 2019 Tonix Pharmaceuticals Holding Corp. March 2019 Version P0159 3 - 5 - 19 (Doc 0437) Investor Presentation
Slide 2: Cautionary Note on Forward-Looking Statements
© 2019 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 Development Highlights
© 2019 Tonix Pharmaceuticals Holding Corp. 3 Posttraumatic Stress Disorder (PTSD) – Lead program; new bedtime treatment - Tonmya ®1 • P302/RECOVERY Phase 3 clinical study with Week 4 primary endpoint to initiate in 1Q2019 • Results from 2 efficacy studies improve the new Phase 3 study design New Pha
Slide 4: Candidates in Development
© 2019 Tonix Pharmaceuticals Holding Corp. 4 Candidates in Development Preclinical Phase 2 NDA 1 /BLA 2 Market Pipeline Product Indication Phase 3 TNX - 102 SL Bedtime Treatment for PTSD – Tonmya ® Daytime Treatment for PTSD TNX - 601 Novel polymorph and salt discovered and characterized; Preliminar
Slide 5: Tonmya: a Potential Bedtime Treatment for PTSD
© 2019 Tonix Pharmaceuticals Holding Corp. 5 Tonmya : a Potential Bedtime Treatment for PTSD 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 treatm
Slide 6: Prevalence of PTSD Among Civilians and Veterans
© 2019 Tonix Pharmaceuticals Holding Corp. 6 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, Operation Iraqi Freedom, and Operation New Dawn Veter
Slide 7: Unmet Need for Effective and Safe Therapies for Military PTSD
© 2019 Tonix Pharmaceuticals Holding Corp. 7 Unmet Need for Effective and Safe Therapies for Treatment of Military PTSD 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
Slide 8: TNX-102 SL Intellectual Property – U.S. Protection until 2034
© 2019 Tonix Pharmaceuticals Holding Corp. 8 TNX - 102 SL Intellectual Property – U.S. Protection until 2034 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 M
Slide 9: Potential Therapeutic Advantages of Tonmya
© 2019 Tonix Pharmaceuticals Holding Corp. 9 Potential Therapeutic Advantages of Tonmya 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
Slide 10: Tonmya Phase 2 Dose-Effect in Military-Related PTSD
© 2019 Tonix Pharmaceuticals Holding Corp. 10 Tonmya Phase 2 Dose - Effect in Military - Related PTSD 1 1 Completed Phase 2 P201/AtEase study: Retrospective analysis of Tonmya 5.6 mg on CAPS - 5 ≥33 (high - moderate) subgroup. Primary analysis of P 201/AtEase was on Tonmya 2.8 mg in participants wit
Slide 11: Primary Outcome (CAPS-5) in Phase 3 mITT and ≤9 Years Subgroups
© 2019 Tonix Pharmaceuticals Holding Corp. Primary Outcome (CAPS - 5) in Phase 3 ( mITT ) and ≤9 Years Time Since Trauma (TST) Subgroups Modified intent to treat ( mITT ) population Phase 3 P301/HONOR Study 1 ** p=0.004, * p=0.039, # p=0.069, TNX - 102 SL 5.6 mg group v. placebo, using MMRM with MI
Slide 12: Retrospective Comparison of Time Since Trauma in P201 versus P301
© 2019 Tonix Pharmaceuticals Holding Corp. 12 Retrospective Comparison of Time Since Trauma in P201/AtEase versus P301/HONOR (Tonmya 5.6 mg Groups) 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
Slide 13: Sustained Remission in Phase 2 and Phase 3 Studies
© 2019 Tonix Pharmaceuticals Holding Corp. 13 Sustained Remission in Phase 2 and Phase 3 Studies: Retrospective Analyses of P201 Entry CAPS - 5 ≥33 and P301 ≤9 Years Since Trauma Subgroups Remission is a clinical state that is essentially asymptomatic In order to confirm remission: • Determined rate
Slide 14: Adverse Events in P201/AtEase and P301/HONOR Studies
© 2019 Tonix Pharmaceuticals Holding Corp. 14 Adverse Events (AEs) in P201/AtEase and P301/HONOR Studies No serious or unexpected AEs in P201 or P301 related to Tonmya • Systemic AEs comparable between studies and also consistent with those described in approved oral cyclobenzaprine product labeling
Slide 15: Response to Tonmya for Female Participants in P301/HONOR Study
© 2019 Tonix Pharmaceuticals Holding Corp. 15 Response to Tonmya for Female Participants in P301/HONOR Study 1 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 w
Slide 16: Non-combat traumas similar to traumas in civilian PTSD populations
© 2019 Tonix Pharmaceuticals Holding Corp. 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, difference in MCFB in CAPS - 5 was assessed in non - comb
Slide 17: New Phase 3 P302/RECOVERY Study – Expected to Start 1Q 2019
© 2019 Tonix Pharmaceuticals Holding Corp. 17 New Phase 3 P302/RECOVERY Study – Expected to Start 1Q 2019 Primary e ndpoint: • CAPS - 5 1 mean change from baseline at Week 4 ( Tonmya 5.6 mg vs. placebo) Key Secondary e ndpoint s include: • CAPS - 5 m ean change from baseline at W eek 12 (Tonmya 5.6
Slide 18: Late-Stage PTSD Drug Candidates
© 2019 Tonix Pharmaceuticals Holding Corp. 18 Late - Stage PTSD Drug Candidates 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 th
Slide 19: TNX-102 SL – Bedtime Treatment for Multiple Potential Indications
© 2019 Tonix Pharmaceuticals Holding Corp. 19 TNX - 102 SL – Bedtime Treatment for Multiple Potential Indications Ma nagement 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
Slide 20: TNX-102 SL for Agitation in Alzheimer's – Regulatory Status and Registration Strategy
© 2019 Tonix Pharmaceuticals Holding Corp. 20 TNX - 102 SL for Agitation in Alzheimer’s – Regulatory Status and Registration Strategy 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 e
Slide 21: TNX-601 (Tianeptine Oxalate): A Potential Clinical Candidate for PTSD
© 2019 Tonix Pharmaceuticals Holding Corp. 21 TNX - 601 ( Tianeptine Oxalate): A Potential Clinical Candidate for PTSD Pre - IND Candidate Targeted as a 1 st line monotherapy for PTSD: oral formulation for daytime dosing x Leverages expertise in PTSD (clinical and regulatory experience, market analy
Slide 22: TNX-801 (Synthesized Live Horsepox Virus): A Smallpox-Preventing Vaccine Candidate
© 2019 Tonix Pharmaceuticals Holding Corp. 22 TNX - 801 (Synthesized Live Horsepox Virus): A Smallpox - Preventing Vaccine Candidate Pre - IND Stage Potential improvement over current biodefense tools against smallpox ✓ Leverages Tonix’s government affairs effort ✓ Collaboration with Professor David
Slide 23: Financial Overview
© 2019 Tonix Pharmaceuticals Holding Corp. 23 Financial Overview NASDAQ: TNXP Cash and cash equivalents, September 30, 2018 $14.8 million Net proceeds from equity offerings in 4Q2018 $17.3 million Common Stock outstanding post December 2018 underwritten equity offering ( a s of March 1, 2019) 4.7 mi
Slide 24: Management Team
© 2019 Tonix Pharmaceuticals Holding Corp. 24 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 25: Milestones – Recently Completed and Upcoming
© 2019 Tonix Pharmaceuticals Holding Corp. 25 Milestones – Recently Completed and Upcoming □ July 201 8 Completed P301/HONOR study interim analysis - result did not support study continuation but strengthened new Phase 3 study □ August 201 8 Presentation of P301/HONOR study results at Military Healt
Slide 26: Summary
© 2019 Tonix Pharmaceuticals Holding Corp. 26 Summary 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 develop
Slide 27: Thank you!
© 2019 Tonix Pharmaceuticals Holding Corp. Thank you ! NASDAQ: TNXP
Tonix Pharmaceuticals Holding — Investor Presentation (March 2019) on 6ix