Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (February 2020)
29 slides from Tonix Pharmaceuticals's investor presentation, Feb 10, 2020
Slide 1: Investor Presentation
Investor Presentation TONIX PHARMACEUTICALS Version P0221 2-8-20 (Doc 059!
Slide 2: Cautionary Note on Forward-Looking Statements
© 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 Litigation Reform ‘Act of 1995. These statements may
Slide 3: Tonix Pharmaceuticals: Lead Program
Tonix Pharmaceuticals: Lead Program a In Phase 3 clinical development of TNX-102 SL! for Fibromyal: + Chronic pain condition Fibromyalgia milestones (Phase 3 RELIEF study): 34 Quarter 2020 - Interim analysis results expected + 1 Half 2021 - Topline data expected ¥TNX-102 St (cyclobenzaprine HCI subl
Slide 4: CNS Candidates in Clinical Development
0) CNS Candidates in Clinical Development Pain, Psychiatry and Addiction TNX-102 SL and TNX-601 CR owned outright with no royalties due Pipeline Product Indication TNX102'SU* Bedtime treatment for Fibromyalgia mmzpane nei Beatin treatment for Agitation in Alzheimer's Zublngual tablets Protecoc® form
Slide 5: Preclinical Pipeline
© Preclinical Pipeline* Pipeline Product Indication(s) category Daytime treatment for PTSD Psychiatry Gea reopake ohio? ae Prevention and treatment of organ transplant rejection Trensplont ee oc, ‘Treatment of autoimmune conditions Autoimmunity a cw TNX-8015 Smallpox and monkeypox preventing vaccine
Slide 6: TNX-102 SL
© TNX-102 SL TNX-102 SL + Novel sublingual formulation of cyclobenzaprine HCI! designed for long-term daily use at bedtime + Rapid absorption + Transmucosal absorption bypasses first pass liver metabolism + Dynamic pharmacokinetic profile with increase in cyclobenzaprine concentration during sleep i
Slide 7: TNX-102 SL Intellectual Property
TNX-102 SL Intellectual Property - Patent Prote In expected until 2035 “7 Composition of matter (eutectic): protection expected to 2034/2035 10 patents issued worldwide; 35 patent applications pending Composition of matter (sublingual): protection expected to 2033 6 patents issued worldwide; 21 pate
Slide 8: Fibromyalgia
© Fibromyalgia Fibromyalgia is considered a neurobiological disorder characterized by*: chronic widespread pain, non-restorative sleep, fatigue, diminished cognition ng in central nervous system in the absence of Believed to result from inappropriate pain signal peripheral injury? ion adults in the
Slide 9: Large Need for New Fibromyalgia Therapies
Large Need for New Fibromyalgia Therapies that Provide Broad Symptom Improvement with Better Toleral y ~ Currently-approved medications may have side effects that limit long-term use? High rates of discontinuation, switching and augmentation + Attempts to treat multiple symptoms and/or avoid intoler
Slide 10: Potential Role of Sleep Quality in Fibromyalgia
Potential Role of Sleep Quality in Fibromyal: ~~ 10 Believed to result from inappropriate pain signaling in central nervous system + Absence of peripheral injury? Pain is a sensor system in the brain + When the system malfunctions, the pain alarm is turned on even through there has been no periphera
Slide 11: Phase 3 F301/AFFIRM Study Results of TNX-102 SL 2.8 mg in Fibromyalgia
Phase 3 F301/AFFIRM? Study Results of TNX-102 SL 2.8 mg in Fibromyalgia General study characteristics: Efficacy analyses: Randomized, double-blind, placebo-controlied trial in + Primary endpoint (30% responder analysis), p=0.095 fibromyalgia at 35 U.S. sites (N=519) + Key Secondary Endpoint: mean pa
Slide 12: Phase 3 AFFIRM (F301) Study Results: Mean Pain MMRM
1) Phase 3 AFFIRM (F301) Study Results: Mean Pain Analyzed by Mixed Model Repeated Measures (MMRM), with and without Multiple Imputation (MI) aa Pre-specified secondary analysis of AFFIRM: Retrospective analysis of AFFIRM: = Mean Pain Analysis, MMRM = Mean Pain Analysis, MMRM with MI? = TNX-102 SL N
Slide 13: TNX-102 SL for Fibromyalgia: New Phase 3 Study
TNX-102 SL for Fibromyalgi. lew Phase 3 Study: Higher (2x) Dose, New Primary Endpoint A 13 Clear guidance from FDA to advance fibromyalgia program using higher dose (5.6 mg) Long-term safety of 5.6 mg dose collected in PTSD studies expected to support fibromyalgia NDA Retrospective analysis of mean
Slide 14: TNX-102 SL 5.6 mg for Fibromyalgia: New Phase 3 RELIEF Study
TNX-102 SL 5.6 mg for Fibromyal New Phase 3 F304/RELIEF! Study Enroll General study characteristics: Primary endpoint (Week 14): + Randomized, double-bind,placebo-controlled study in _* Basine it he wah warape os eased bythe amuses ininy sea fibromyalgia in approximately 40 U.S. sites (N=470) (INRS)
Slide 15: Common Adverse Events Related to TNX-102 SL in prior PTSD Studies
Common Adverse Events (AEs) Related to TNX- 102 SL in prior Posttraumatic Stress order (PTSD) Studies “1s Systemic Adverse Events™ Product Taste Abnormal “nly adverse events (As are ted that are at a ate of = 58 many TOK-teated group ‘nadie sow far ether study means the AE nthe active groupe) in tha
Slide 16: Opportunities to Expand to Other Indications
© Opportunities to Expand to Other Indications Role of sleep disturbance more established in common psychiatric and neurological/pain disorders + Recognized as a core symptom of many of these disorders + Traditional sleep medications, which increase sleep quantity, may not provide benefit (benzodiaz
Slide 17: TNX-102 SL: Potential Treatment for Agitation in Alzheimer's Disease
TNX-102 SL: Potential Treatment for Agitation in Alzheimer’s Disease (AAD) a 17 Agitation is one of the most distressing and debilitating of the behavioral complications of Alzheimer’s disease + Includes emotional lability, restlessness, irritability and aggression’ Link between disturbed sleep and
Slide 18: TNX-102 SL: Potential Treatment for Alcohol Use Disorder
TNX-102 SL: Potential Treatment for Alcohol Use Disorder (AUD) 18 disease + Characterized by compulsive alcohol use, loss of control over alcohol intake, and a negative emotional state when not using Sleep disturbance is extremely common in alcohol recovery! + Significantly impacts daytime cognition
Slide 19: TNX-1300: Recombinant protein that degrades cocaine
19 Recombinant protein that degrades cocaine in the bloodstream* + Double-mutant cocaine esterase (CocE) + Cocé was identified in bacteria (Rhodococcus) that use cocaine as its sole source of carbon and nitrogen and that grow in soil surrounding coca plants? + CocE catalyzes the breakdown of cocaine
Slide 20: TNX-1300 Is a Fast-acting Cocaine Antidote
TNX-1300 (Cocaine Esterase or CocE) Is a Fast: acting Cocaine Antidote Pee — Coca plant Rhodococcus bacteria living in the roots of the coca plant use CocE to metabolize cocaine? CocE cleaves chemical bonds in cocaine and disintegrates it 800 times faster than the rate that naturally occurs in the h
Slide 21: Cocaine Intoxication Is a Growing Problem in the U.S.
© cocaine Intoxication Is a Growing Problem in the U.S. Drug overdose deaths involving cocaine have increased dramatically in recent years* p 15000, f 219 of all emergency £3 department (ED) visits g 2 .. involve cocaine se $3 2 28 5S 10000 2g oe 27 109] 3s ae a: ae 85 sooo] Hf a3 =8 =o o > A Ss s ~
Slide 22: TNX-601 CR (Tianeptine Oxalate Controlled Release) Tablets
TNX-601 CR* (Tianeptine Oxalate Controlled © Release) Tablets Proprietary new controlled release formulation for once-daily dosing + Suitability for once-daily dosing established in Phase 1 pharmacokinetic study, completed outside of the U.S. + Well tolerated in study and side effects were consisten
Slide 23: TNX-601 CR: A Potential Daytime Treatment for Depression and PTSD
TNX-601 CR: A Potential Daytime Treatment for © Depression and PTSD ng from depression do not have an adequate response to initial antidepressant therapy + Tianeptine sodium immediate release (IR) tablets for three times a day dosing is approved as an antidepressant in the EU, Russia, Asia and Latin
Slide 24: TNX-801: A Potential Smallpox and Monkeypox Preventing Vaccine
TNX-801 (Synthesized Live Horsepox Virus): ( A Potential Smallpox and Monkeypox Preventing Vaccine Potential improvement over current biodefense tools against smallpox ¥ Demonstrated protective vaccine activity in mice and macaques ¥ Collaboration with Professor David Evans and Dr. Ryan Noyce at Uni
Slide 25: No monkeypox lesions observed after challenge in vaccinated animals
25 No monkeypox lesions observed after monkeypox (MPXV) challenge in any of the eight animals vaccinated with TNX-801 A scsav 40x 10H 1b, soHexv 50x 18 PFU C. swsevan x otrry TNX-801 e TNX-801 ‘TNX-1200 ‘ays post MPXY change eye poet MPV change ays poo MPV cheng ‘ays post PAV change Laasnd: Cynomela
Slide 26: Pipeline Summary - by Select Therapeutic Areas
© Pipeline Summary - by Select Therapeutic Areas r 1 6 " » ¢g >) Pain Psychiatry Addiction Medicine Biodefense ) \ yp XN + TNX-102 SU - (sublingual + TWX-1200 - (cocaine esterase) = TNX-801 ~ (live horsepox Evclobenzoprine) for for cocaine intoxication voccine) - for preventing iremveisie phase? Smn
Slide 27: Milestones - Recently Completed and Upcoming
© Milestones - Recently Completed and Upcoming May 2019 October 2019 & October 2019 54% Quarter 2019 4% Quarter 2019 February 2020 2.1% Quarter 2020 23-4 Quarter 2020 2.2 Half 2020 2 1 Half 2021 In-licensed TNX-1300, in Phase 2 development for cocaine intoxication ‘Completed long-term exposure studi
Slide 28: Management Team
Management Team ~~ 2% Seth Lederman, MD , President & CEO TaggenT~ Efusiley vale. Gregory Sullivan, MD. Covumats Univansirr New York State. Fev ad or DmarmetofPocany chloe ieato Bradley Saenger, CPA a A - Chief Financ! Oftcer Ghire vibtix gif 2 Jessica Morris oer 0 Ofioer Deutsche Bank Pe Boper=
Slide 29: Tonix Pharmaceuticals
29 TONIX PHARMACEUTICALS NASDAQ: TNXP
Tonix Pharmaceuticals Holding — Investor Presentation (February 2020) on 6ix