Form 8-K Tonix Pharmaceuticals For: Sep 06

FREE Breaking News Alerts from StreetInsider.com!

StreetInsider.com Top Tickers, 8/21/2026

1. WMT
2. ROST
3. AAP
4. NVDA
5. SPY

6. AVGO
7. SPCX
8. OSIS
9. BJ
10. BABA

Top News Most Read Special Reports

September 6, 2016 7:06 AM EDT

E-mail

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (date of earliest event reported): September 6, 2016

TONIX PHARMACEUTICALS HOLDING CORP.

(Exact name of registrant as specified in its charter)

Nevada

001-36019

26-1434750

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

509 Madison Avenue, Suite 306, New York, New York 10022

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (212) 980-9155

Copy of correspondence to:

Marc J. Ross, Esq.

James M. Turner, Esq.

Sichenzia Ross Friedman Ference LLP

61 Broadway

New York, New York 10006

Tel: (212) 930-9700 Fax: (212) 930-9725

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01

Regulation FD Disclosure.

Tonix Pharmaceuticals Holding Corp. (the “Company”) intends to utilize an updated investor presentation to conduct meetings with investors, stockholders and analysts and at investor conferences, and which the Company intends to place on its website, which may contain non-public information. A copy of the presentation is filed as Exhibit 99.01.

The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.01, is furnished pursuant to, and shall not be deemed to be "filed" for the purposes of, Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information contained in Item 7.01 of this Current Report shall not be incorporated by reference into any registration statement or any other document filed pursuant to the Securities Act of 1933, as amended, except as otherwise expressly stated in such filing. By filing this Current Report on Form 8-K and furnishing the information contained in this Item 7.01, including Exhibit 99.01, the Company makes no admission as to the materiality of any such information that it is furnishing.

Item 8.01

Other Events.

On September 6, 2016, the Company issued a press release announcing preliminary topline results from its Phase 3 clinical study, AFFIRM, designed to evaluate the safety and efficacy of TNX-102 SL (cyclobenzaprine HCl sublingual tablets), 2.8 mg, in patients with fibromyalgia.

A copy of the press release that discusses this matter is filed as Exhibit 99.02 to, and incorporated by reference in, this report. The information in this Current Report is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section. The information in this Current Report shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, except as shall be expressly set forth by specific reference in any such filing.

Item 9.01

Financial Statements and Exhibits.

(d)

Exhibits.

99.01

Corporate Presentation by the Company for September 2016*

	99.02	Press release, dated September 6, 2016, issued by Tonix Pharmaceuticals Holding Corp.*

* Furnished herewith.

SIGNATURE

Pursuant to the requirement of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	TONIX PHARMACEUTICALS HOLDING CORP.

Date: September 6, 2016	By:	/s/ BRADLEY SAENGER
	Bradley Saenger
	Chief Financial Officer

Exhibit 99.01

Cautionary note on forward-looking statements Certainstatementsinthispresentationregardingstrategicplans,expectationsandobjectivesforfutureoperationsorresultsare“forward-lookingstatements”asdefinedbythePrivateSecuritiesLitigationReformActof1995.Thesestatementsmaybeidentifiedbytheuseofforward-lookingwordssuchas“anticipate,”“believe,”“forecast,”“estimate,”and“intend,”amongothers.Theseforward-lookingstatementsarebasedonTonix’scurrentexpectationsandactualresultscoulddiffermaterially.Thereareanumberoffactorsthatcouldcauseactualeventstodiffermateriallyfromthoseindicatedbysuchforward-lookingstatements.Thesefactorsinclude,butarenotlimitedto,substantialcompetition;ourneedforadditionalfinancing;uncertaintiesofpatentprotectionandlitigation;uncertaintiesofgovernmentorthirdpartypayorreimbursement;limitedresearchanddevelopmenteffortsanddependenceuponthirdparties;andrisksrelatedtofailuretoobtainU.SFoodandDrugAdministrationclearancesorapprovalsandnoncompliancewithitsregulations.Aswithanypharmaceuticalunderdevelopment,therearesignificantrisksinthedevelopment,regulatoryapprovalandcommercializationofnewproducts.Theforward-lookingstatementsinthispresentationaremadeasofthedateofthispresentation,evenifsubsequentlymadeavailablebytheCompanyonitswebsiteorotherwise.Tonixdoesnotundertakeanobligationtoupdateorreviseanyforward-lookingstatement,exceptasrequiredbylaw.InvestorsshouldreadtheriskfactorssetforthintheAnnualReportonForm10-KfortheyearendedDecember31,2015,asfiledwiththeSecuritiesandExchangeCommission(the“SEC”)onMarch3,2016,andfutureperiodicreportsfiledwiththeSEConorafterthedatehereof.AlloftheCompany'sforward-lookingstatementsareexpresslyqualifiedbyallsuchriskfactorsandothercautionarystatements. 2 © Copyright 2016 Tonix Pharmaceuticals

Developinginnovative medicines for large and growing markets Targeting common central nervous system disordersOne clinical-stage proprietary candidate targeting posttraumatic stress disorder (PTSD) Differentiated product with potential for sustainable competitive advantages PTSD –Phase 2 trial reported May 2016TNX-102 SL15.6 mg was active in treating military-related PTSD Serious mental health problem2 Planning Phase 3 program in military-related PTSD Planning Phase 3 program in civilian PTSD All intellectual property owned by Tonix 1TNX-102 SL (cyclobenzaprine HClsublingual tablets) is an Investigational New Drug and is not approved for any indication. 2Schnurr, PP et al., Contemporary Clinical Trials 2015;41:75. 3 © Copyright 2016 Tonix Pharmaceuticals

Overview: PTSD program Results from multi-center, double-blind, randomized, placebo-controlled Phase 2 trial in military-related PTSD reported May 2016TNX-102 SL 5.6 mg was active in treating military-related PTSDReduction in symptoms and disease severity [(Clinician-Administered PTSD Scale) CAPS-5] Improvement in clinical global impression (CGI-I) Improvement in function (Sheehan Disability Scale domains for work/school and social/leisure) Systemic side effects include somnolence, dry mouth, headache and sedation Administrative site reactions were common (transient tongue numbness) Completion rate for TNX-102 SL 5.6 mg was 84% and for placebo was 73% Phase 3 program plannedU.S. Food and Drug Administration (FDA) acceptance of proposed Phase 3 program at August 2016 EOP2/Pre-Phase 3 meeting TNX-102 SL 5.6 mg is the appropriate dose for confirmatory study Confirmatory study design similar to Phase 2 AtEasestudy, except CAPS-5 enrollment threshold will be changed from ≥ 29 to ≥ 33 Potential for Breakthrough Designation Two confirmatory trials being planned Q1 2017: military-related PTSD Q2 2017: predominantly civilian PTSD 4 © Copyright 2016 Tonix Pharmaceuticals

Tonix is developing TNX-102 SL for PTSD Advanced sublingual tablet containing low-dose cyclobenzaprine (CBP) Designed for daily bedtime administration with no titration Efficient transmucosalabsorption Avoidance of first-pass metabolism reduces formation of long-lived metabolite TNX-102 SL’s pharmacologic action is believed to improve sleep qualityDisturbed sleep is a common clinical feature of PTSD TNX-102 SL targets receptors believed to play key roles in sleep physiology Phase 2 “AtEase” study was successfully completed in May 2016 5 © Copyright 2016 Tonix Pharmaceuticals

PTSD is a chronic stress disorder triggered by a traumatic event PTSD is characterized by: Considered a stress response, but prolonged and does not resolve with time20% of women and 8% of men in the U.S. who experience significant trauma develop PTSD1 Associated with significant life disruptionSocial isolation, inability to maintain employment, loss of independent living Unpredictable acts of violence, suicidal thoughts Re-experiencing the triggering event Negative alterations in mood/cognition Situation/stimulus avoidance Hyperarousal (anxiety, agitation & sleep disturbance) 1Kessler et al, Arch Gen Psychiatry 1995;52:1048. 6 © Copyright 2016 Tonix Pharmaceuticals

PTSD is a prevalent problem for both civilians and the military Affects 3.5% (8.5 M) U.S. Adults1 ~70% are considered to have moderate to severe symptoms Of those diagnosed, ~50% utilize professional healthcare (psychotherapy/pharmacotherapy)2 Higher prevalence in military population 20% of veterans from recent conflicts will have potential/provisional PTSD3 ~638,000 veterans with PTSD in the Veterans Affairs (VA) health system (2012)4 Majority are male Alcohol and substance abuse are common 1Kessler RC at al, Arch Gen Psychiatry 2005;62:617; U.S. Census Bureau, 2013 Projection. 2Wang et al, Arch Gen Psychiatry 2005;62:629. 3Report on VA Facility Specific Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans Diagnosed with Potential or Provisional PTSD. 4Bowe et al, J Dual Diagnosis 2015;11:22. 7 © Copyright 2016 Tonix Pharmaceuticals

Limitations of current FDA-approved pharmacotherapies for military-related PTSD No treatment response observed in U.S. military populationSertraline: negative large multi-center trial in U.S. military veterans1Placebo numerically superior on CAPS-2 Paroxetine: not studied in military population Inconsistent treatment response observed in males Sertraline: FDA-conducted post-hoc analysis concluded no effect for male civilian subgroup2 Paroxetine: no gender-related difference in treatment outcome3 Important tolerability considerations with SSRIs in this populationSexual dysfunction Insomnia SSRI: Selective Serotonin Reuptake Inhibitor. 1Friedman MJ et al. J ClinPsychiatry 2007;68:711-20. 2Zoloft® Package Insert, Pfizer, August 2014. 3Paxil® Package Insert, Glaxo, June 2014. 8 © Copyright 2016 Tonix Pharmaceuticals

Phase 2 AtEase study of TNX-102 SL in PTSD AtEase Study Randomized, double-blind, placebo-controlled trial DSM-5 diagnostic criteria for PTSD 231* participants studied 2:1:2 at 24 U.S. sites1 x TNX-102 SL 2.8 mg tablet: 2 x TNX-102 SL 2.8 mg tablets: placebo Evaluated the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) as primary endpointPre-specified primary analysis was 2.8 mg dose *Modified intent-to-treat (mITT) population 9 © Copyright 2016 Tonix Pharmaceuticals

Phase 2 AtEase trial of TNX-102 SL in PTSD Randomized, double-blind, placebo-controlled trial in military-related PTSD Analysis from 231 patients; 24 U.S. clinical sites Primary efficacy endpoint:Difference in CAPS score between TNX-102 SL 2.8 mg and placebo at week 12 TNX-102 SL was active at 5.6 mg dose TNX-102 SL at bedtime once-daily Placebo at bedtime once-daily 12 weeks N= 90 TNX-102 SL at bedtime once-daily N= 92 N= 49 2.8 mg 5.6 mg open-label extension Enrolled patients with baseline CAPS-5 ≥ 29 10 © Copyright 2016 Tonix Pharmaceuticals

AtEasestudy of TNX-102 SL in PTSD Key Demographics / Characteristics of AtEase 93% of the patients were male 98% had trauma during military service and were deployed on average 2.3 times Mean time since index trauma was 7 years Race and ethnicity generally consistent with U.S. military distribution Similar baseline CAPS-5 scores and MADRS1scores across treatment armsAverage CAPS-5 scores were greater than 39 for all groups ('severe' PTSD2) 1Montgomery–ÅsbergDepression Rating Scale 2personal communication –Frank Weathers PhD, National Center for PTSD 11 © Copyright 2016 Tonix Pharmaceuticals

AtEaseresults on key clinical endpoints Category Endpoint –week 121 pvalue PTSD Symptoms CAPS-5(MMRM with MI) 0.031 Global improvement CGI-I (Logistic Regression) 0.041 Arousal and reactivity CAPS-5 cluster (MMRM) 0.048 Sleep Quality CAPS-5 sleep (MMRM) 0.010 12 © Copyright 2016 Tonix Pharmaceuticals

AtEasestudy results:CAPS-5 total score mean change from baseline -25 -20 -15 -10 -5 0 Wk 0 Wk 2 Wk 4 Wk 6 Wk 8 Wk 10 Wk 12 Placebo TNX-102 SL 2.8 mg TNX-102 SL 5.6 mg * *p=0.031, comparing placebo and TNX-102 SL 5.6 mg,*p<0.05, comparing placebo and TNX-102 SL 2.8 mg, by MMRM with MI, mixed-effect model repeated measures with multiple imputation; CAPS-5, Clinician Administered PTSD Scale for DSM-5; LS Mean, least squares mean LS Mean Change * * 5.0 point difference in CAPS-5 change from baseline between placebo and TNX-102 SL 5.6 mg Effect Size = 0.36 (MMRM) 13 © Copyright 2016 Tonix Pharmaceuticals

AtEasestudy results: CAPS-5 sleep disturbance -1.6 -1.4 -1.2 -1 -0.8 -0.6 -0.4 -0.2 0 Wk 0 Wk 2 Wk 4 Wk 6 Wk 8 Wk 10 Wk 12 LS Mean Change from Baseline Placebo TNX-102 SL 2.8 mg TNX-102 SL 5.6 mg Change from baseline * * * * *p<0.05, 5.6 mg v. placebo, MMRM *p<0.05, 2.8 mg v. placebo, MMRM 14 © Copyright 2016 Tonix Pharmaceuticals

AtEasestudy results: Sheehan Disability Scale 1.5 2 2.5 3 3.5 4 4.5 5 5.5 Wk 0 Wk 2 Wk 4 Wk 6 Wk 8 Wk 10 Wk 12 The symptoms have disrupted your work/school work Placebo TNX-102 SL 2.8 mg TNX-102 SL 5.6 mg 2.5 3 3.5 4 4.5 5 5.5 6 6.5 7 7.5 Wk 0 Wk 2 Wk 4 Wk 6 Wk 8 Wk 10 Wk 12 The symptoms have disrupted your social/leisure activities Placebo TNX-102 SL 2.8 mg TNX-102 SL 5.6 mg * * * * *p≤0.05, TNX-102 SL 5.6 mg v. Placebo, MMRM *p<0.05, TNX-102 SL 5.6 mg v. Placebo, MMRM Sheehan Disability Scale –Work/School & Social Leisure Domains LS Mean 15 © Copyright 2016 Tonix Pharmaceuticals

AtEasestudy results: Clinical Global Impression Clinical Global Impression –Improvement Scale Responders Patients (%) 44.6% 53.3% 63.3% 0% 10% 20% 30% 40% 50% 60% 70% Placebo TNX-102 SL 2.8 mg TNX-102 SL 5.6 mg *p=0.041, Logistic regression comparing placebo and TNX-102 SL 5.6 mg Responders are those rated as “much improved” or “very much improved” 16 © Copyright 2016 Tonix Pharmaceuticals

TNX-102 SL safety and tolerability profile in the AtEasestudy No serious adverse events reported with TNX-102 SL deemed related to treatment Systemic Adverse Events* Placebo(N=94) TNX-102 SL 2.8 mg(N=93) TNX-102 SL 5.6mg (N=50) Total TNX-102 SL(N=143) Somnolence 6.4% 11.8% 16.0% 13.3% DryMouth 10.6% 4.3% 16.0% 8.4% Headache 4.3% 5.4% 12.0% 7.7% Insomnia 8.5% 7.5% 6.0% 7.0% Sedation 1.1% 2.2% 12.0% 5.6% Administration Site Reactions* Hypoaesthesiaoral 2.1% 38.7% 36.0% 37.8% Paraesthesia 3.2% 16.1% 4.0% 11.9% Glossodynia 1.1% 3.2% 6.0% 4.2% 17 © Copyright 2016 Tonix Pharmaceuticals

Determining CAPS-5 severity criteria for entry in phase 3 trials CAPS-5hasnotbeenemployedpreviouslyinapharmacotherapytrial;entryseveritythresholdnotclear;≥29usedinthePhase2AtEasestudy PriorpharmacotherapytrialsinPTSDusingearlierversionsofCAPSwithdifferentscoringrangehavemostfrequentlyusedascoreof≥50forentry(similartoCAPS-5≥331) AnalysisofpatientswithCAPS-5≥33showedaneffectsizeof0.53onmeanchangefrombaselineatWeek12inTNX-102SL5.6mggroup(seefigureonnextslide) 1Sullivan, Gregory, et al. “The AtEaseStudy: Efficacy and Safety of a Low Dose, Bedtime, Sublingual Formulation of Cyclobenzaprine (TNX-102 SL) for the Treatment of Military-Related PTSD.” Poster session presented at: Military Health System Research Symposium (MHSRS) 2016 Annual Meeting; 2016 Aug 15-18; Kissimmee, FL. URL: http://bit.ly/2bFo4mx 18 © Copyright 2016 Tonix Pharmaceuticals

CAPS-5 mean change from baseline for entry CAPS ≥ 33 -30.0 -25.0 -20.0 -15.0 -10.0 -5.0 0.0 Wk 0 Wk 2 Wk 4 Wk 6 Wk 8 Wk 10 Wk 12 LS Mean (SE) Placebo TNX-102 SL 2.8 mg TNX-102 SL 5.6 mg 6.8 point difference in CAPS-5 change from baseline between placebo and TNX-102 SL 5.6 mg Effect Size = 0.53 * * * * * *p<0.025, comparing 5.6 mg group with placebo, MMRM *p=0.029, comparing 2.8 mg group with placebo, MMRM Retrospective subset analysisof patients with entry CAPS-5 ≥ 33 19 © Copyright 2016 Tonix Pharmaceuticals

CAPS-5 cluster scores Table shows the significance levels and effect sizes of the CAPS-5 cluster scores, comparing TNX-102 SL 5.6 mg and placebo, using a CAPS-5 baseline entry criterion of ≥ 33 and the per protocol threshold of ≥ 29 Entry criteria of CAPS-5 ≥ 33 Entry criteria of CAPS-5 ≥ 29 5.6 mg (N=38) vs Placebo (N=77) 5.6 mg (N=49) vs Placebo (N=92) CAPS-5 Cluster Effect Size P-value* Effect Size P-value* Cluster B (Intrusion) 0.46 0.026 0.26 0.161 Cluster C (Avoidance) 0.12 0.522 0.04 0.963 Cluster D (Mood/Cognitions) 0.39 0.065 0.35 0.062 Cluster E (Arousal & Reactivity) 0.52 0.012 0.35 0.048 20 © Copyright 2016 Tonix Pharmaceuticals

Rate of remission from PTSD in each treatment arm 14.3% 17.1% 28.9% 0% 5% 10% 15% 20% 25% 30% 35% Placebo(N=77) TNX-102 SL 2.8 mg(N=70) TNX-102 SL 5.6 mg(N=38) Percent of Remitters in Group #p=0.10 NS, comparing placebo and TNX-102 SL 5.6 mg, logistic regression # Remission is defined as CAPS-5 score <11 at week 12 Trend for greater rate in TNX-102 SL 5.6 mg versus placebo in entry CAPS-5 ≥ 33 sample Retrospective subset analysis of patients with entry CAPS-5 ≥ 33 21 © Copyright 2016 Tonix Pharmaceuticals

AtEasestudy conclusions This Phase 2 trial is the first large multi-center trial of an investigational new drug product that demonstrated efficacy in a population with military-related PTSDSymptom reduction (CAPS-5) Functional improvement (Sheehan Disability Scale domains) Global improvement (CGI-I) Early effects on sleep and hyperarousal are consistent with the mechanistic hypothesis of TNX-102 SL primary actions on sleep disturbance and autonomic balance Systemic side effects included include somnolence, dry mouth, headache and sedation; local reactions to sublingual TNX-102 SL administration were common (transient tongue numbness) A post-hoc analysis suggested that enrolling patients with a higher CAPS-5 score (≥ 33) would be similar to the entry criteria used in the registration studies supporting the approval of the marketed PTSD drug productsSame post-hoc analysis revealed a larger separation from placebo in the subset of patients with baseline CAPS-5 ≥ 33 at weeks 2, 4, 8 and 12 Phase 3 program will use CAPS-5 ≥ 33 as enrollment threshold 22 © Copyright 2016 Tonix Pharmaceuticals

Phase 3 program in PTSD being planned General Study Characteristics: Randomized, double-blind, placebo-controlled studies in PTSD N~400-500; approximately 35 U.S. clinical sites Primary Efficacy Endpoint: Mean change from baseline in total CAPS-5 at Week 12 compared between TNX-102 SL 5.6 mg and placebo Topline data for Phase 3 in Planning to confirm AtEasefinding in military-related PTSD and in predominantly civilian PTSD: •Larger studies •Targeting start in 2017 Placebo once-daily at bedtime 12 weeks TNX-102 SL once-daily at bedtime N ~ 200-250 N ~ 200-250 5.6 mg open-labelextension military-related PTSD study anticipated 1H 2018 23 © Copyright 2016 Tonix Pharmaceuticals

Intellectual property Composition-of-matter (eutectic)Patents filed Protection expected to 2034 Pharmacokinetics (PK)Patents filed Protection expected to 2033 Method-of-usePTSD: patents filed TNX-102 SL Wholly-owned by Tonixwith no obligations to others 24 © Copyright 2016 Tonix Pharmaceuticals

TNX-102 SL: active pharmaceutical ingredient

Cyclobenzaprine is a tricyclic molecule that binds to a number of central nervous system (CNS) receptor types

Highest affinity for three receptors believed to have a role in treating sleep disturbances5-HT2A receptor

α1 adrenergic receptor

H1 receptor

Receptor binding profile: Parent and primary metabolite 0 5 10 15 20 25 30 35 40 45 50 5-HT2c H1 5-HT2a α2c , NET 5-HT2b Undesirable Characteristics of Norcyclobenzaprine (nCBP) Half-life (t1/2) of 72 hours (will accumulate) At steady-state, projected similar exposure day and night Distinct receptor binding profile less selective for target receptors Potential undesirable off-target functional activities Bold Blue: Target receptors Black: Off-target receptors 0 5 10 15 20 25 30 35 40 45 50 Receptor Affinity (Ki (nM)) D1 α2b α2c SERT D3 NET 5-HT2c α1a M1 α1b H1 5-HT2a 5-HT2b Cyclobenzaprine Norcyclobenzaprine Lower Affinity Higher Affinity Receptor Binding Dot Plots for Human Receptors 26 © Copyright 2016 Tonix Pharmaceuticals

TNX-102 SL single-dose PK study TNX-102 SL 2.8 mg PK profile relative to 5 mg oral immediate release (IR) CBP: 0 500 1000 1500 2000 2500 3000 3500 4000 0 4 8 12 16 20 24 Concentration (ng/mL) TNX-102 SL 2.8 mg Oral IR CBP 5 mg xLower exposure of nCBP by 48% xHigher ratio of CBP relative to nCBP Ratio of CBP AUC 0-48 /nCBP AUC 0-48: •1.9 for TNX-102 SL 2.8 mg •1.2 for immediate release CBP 5 mg 0 200 400 600 800 1000 1200 1400 1600 0 4 8 12 16 20 24 Concentration (ng/mL) Oral IR CBP 5 mg TNX-102 SL 2.8 mg Hours Hours nCBP: xRapid absorption for bedtime dosing xPeak concentration (Cmax) reduced by 20% xMaintains tmaxat ~4 hours CBP: 27 © Copyright 2016 Tonix Pharmaceuticals

TNX-102 SL: Pharmacokinetic profile after sublingual route of administration Very rapid absorption after dosing (measurable in plasma within 3 minutes of administration)Reaching tmaxat ~4 hours after dosing Approximately 50% of exposure to cyclobenzaprine occurs during first 8 hours Avoids first-pass hepatic metabolism to long-lived major metabolite, norcyclobenzaprineLarge reduction in exposure to norcyclobenzaprine(↓48% AUC0-48) Decreased potential for adverse events 28 © Copyright 2016 Tonix Pharmaceuticals

Cyclobenzaprine is detected in plasma within minutes following sublingual TNX-102 SL Plasma Concentration Versus Time of TNX-102 SL Compared to Oral Cyclobenzaprine IR 0 0.5 1.0 1.5 Concentration (ng/L) 2500 1500 1000 500 2000 0 TNX-102 SL 2.8 mg (sublingual) Cyclobenzaprine IR 5 mg (oral) Time (h) Source: U.S. Patent applications 13/918,692 –Transmucosalabsorption. 29 © Copyright 2016 Tonix Pharmaceuticals

Management team Seth Lederman, MD President & CEO Jessica Edgar Morris EVP, Operations Bruce Daugherty, PhD, MBA Chief Scientific Officer Ronald Notvest, PhD EVP, Commercial Planning & Development Gregory Sullivan, MD Chief Medical Officer Bradley Saenger, CPA Chief Financial Officer 30 © Copyright 2016 Tonix Pharmaceuticals

Board of directors Seth Lederman, MD Chairman Ernest Mario, PhD ALZA, Glaxo, Reliant Pharma John Rhodes NYSERDA, NRDC, Booz Allen Hamilton Samuel Saks, MD Jazz Pharma, ALZA, Johnson & Johnson Charles Mather BTIG, Janney, Jefferies, Cowen, Smith Barney Stuart Davidson Labrador Ventures, Alkermes, Combion Patrick Grace Apollo Philanthropy, WR Grace, Chemed Donald Landry, MD, PhD Chair of Medicine, Columbia University 31 © Copyright 2016 Tonix Pharmaceuticals

Financial overview NASDAQ:TNXP Cash, cash equivalents, andmarketable securitiesreported at June 30, 2016 $ 31.2 million Net proceeds from overallotment in 3Q16 $1.4 million Sharesoutstanding(September 6, 2016) 25.9 million 32 © Copyright 2016 Tonix Pharmaceuticals

Milestones –recent and upcoming TNX-102 SL –Posttraumatic Stress Disorder December 2015Entered into Collaborative Research and Development Agreement (CRADA) with the United States Army Medical Materiel Development Activity (USAMMDA) May 2016Report results from AtEasestudy August 2016End of Phase 2 meeting with FDA

-Proposed Phase 3 and NDA plan accepted -Breakthrough Therapy Designation Request can be submitted for review Q1 2017 Target commencement of Phase 3 study in military-related PTSD Q2 2017 Target commencement of Phase 3 study in predominantly civilian PTSD 33 © Copyright 2016 Tonix Pharmaceuticals

Exhibit 99.02

Tonix Pharmaceuticals Reports Topline Results from Phase 3 AFFIRM Study of TNX-102 SL in Fibromyalgia and Provides Corporate Update

Following Completion of AFFIRM, Tonix to Prioritize Resources for Advancing Posttraumatic Stress Disorder (PTSD) Program into Phase 3

TNX-102 SL Generally Well Tolerated; No New Safety Signals Observed

NEW YORK, Sept. 6, 2016 – Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix) announced preliminary topline results from its Phase 3 clinical study, AFFIRM, designed to evaluate the safety and efficacy of TNX-102 SL (cyclobenzaprine HCl sublingual tablets), 2.8 mg, in patients with fibromyalgia. AFFIRM was a 12-week randomized, double-blind, placebo-controlled trial of TNX-102 SL taken daily at bedtime, in which 519 participants were enrolled at 35 centers in the U.S. Fibromyalgia is a multi-symptom disorder that originates in the central nervous system and is characterized by widespread pain, non-restorative sleep, fatigue, and disability.

The AFFIRM data did not achieve statistical significance in the primary efficacy endpoint: the proportion of patients who reported a 30 percent or greater reduction in pain from baseline to the end of the 12-week treatment period based on the pre-specified primary analysis (p=0.095, Table 1). However, TNX-102 SL did show statistically significant effects on pain when analyzed by other standard statistical approaches (Table 1). TNX-102 SL activity in fibromyalgia was cross-validated by two additional endpoints, Patient Global Impression of Change (PGIC) and Fibromyalgia Impact Questionnaire-Revised (FIQ-R) (Table 2). These endpoints assess global improvement and a range of fibromyalgia symptoms and function. TNX-102 SL showed strong effects on improving sleep quality by the daily diary and the PROMIS sleep disturbance scale (Table 2). The internal consistency of these results provides clear evidence of beneficial effect of TNX-102 SL for the treatment of fibromyalgia.

Seth Lederman, M.D., president and chief executive officer of Tonix, commented, "TNX-102 SL showed broad beneficial effects across key fibromyalgia symptoms and was well-tolerated in the AFFIRM study. Despite achieving clinically meaningful results from AFFIRM, we have greater clarity on the regulatory path forward in our PTSD program. We will therefore discontinue the fibromyalgia program in order to fully focus Tonix’s resources on advancing our potential breakthrough PTSD program to Phase 3. We owe it to our investors, and to patients who are waiting for meaningful clinical innovation, to steward our resources effectively.” Dr. Lederman continued, “We thank those who contributed to the AFFIRM trial, from the clinical teams to the patients and their families. They helped us evaluate this potential new therapy and their involvement provided valuable clinical and scientific information.”

An unexpected imbalance in patient discontinuations for reasons unrelated to efficacy or tolerability (for example, a patient relocating away from the clinical site) (Table 3), created a negative bias in the primary responder analysis because any patient who left the study, for any reason prior to completion, was labeled a non-responder despite their results up to that point. Another standard statistical method for assessing the 30 percent responder analysis that considers the reason for discontinuation showed statistical significance in the primary pain data (Table 1, P=0.012).

Overall, TNX-102 SL was well-tolerated in the AFFIRM study and the adverse events reported were similar to those seen in other TNX-102 SL clinical studies (Table 4). There were seven serious adverse events (SAEs) reported during the study: four in the placebo group and three in the active group. No new safety signals were observed; multiple causal factors were involved in each SAE, and all were resolved quickly and without sequelae.

Table 1. Primary and Other Standard Analyses of Pain

Analysis Method	Imputation	Result
30% Responder Analysis Pre-specified	BOCF all discontinuations	P=0.095
30% Responder Analysis	BOCF for LOE and AE; LOCF for others	P=0.012
ANCOVA; MCFB	Multiple imputation; LOE, AE and ID considered MNAR	P=0.009
ANCOVA; MCFB	Multiple imputation; all MNAR except LTF	P=0.042
MMRM of MCFB	None	P<0.001
50% Responder Analysis	BOCF all discontinuations	P=0.035

AE- Adverse Event; ANCOVA- Analysis of Covariance; BOCF- Baseline Observation Carried Forward; ID- Investigator Decision; LOCF- Last Observation Carried Forward; LOE- Lack of Efficacy; LTF- Lost to Follow-up; MCFB- Mean Change from Baseline; MMRM- Mixed Models Repeated Measures; MNAR- Missing Not at Random

Table 2. Key Secondary Efficacy Data

Measure	Analysis Method	Imputation	Result
PGIC	Responder Analysis	BOCF	0.038
FIQ-R Total Score	MMRM of MCFB	None	<0.001
FIQ-R Symptom Domain	MMRM of MCFB	None	<0.001
FIQ-R Function Domain	MMRM of MCFB	None	<0.001
Clinic 7-day pain recall	MMRM of MCFB	None	0.003
FIQ-R Pain Item	MMRM of MCFB	None	<0.001
PROMIS Fatigue	MMRM of MCFB	None	<0.001
Daily Sleep Quality Diary	MMRM of MCFB	None	<0.001
PROMIS Sleep Disturbance	MMRM of MCFB	None	<0.001
FIQ-R Sleep Quality Item	MMRM of MCFB	None	<0.001

Table 3. Reasons for Patient Dropouts/Discontinuations

Reason	TNX-102 SL	Placebo
Occurrence of an Adverse Event	20 (7.6%)	11 (4.3%)
Withdrawal of Consent	15 (5.7%)	3 (1.2%)
Investigator Decision	6 (2.3%)	0 (0%)
Lack of Efficacy	6 (2.3%)	5 (1.9%)
Lost to Follow-up	11 (4.2%)	15 (5.8%)
Other	1 (0.4%)	1 (0.4%)
Total	59 (22.5%)	35 (13.6%)

Among subjects randomized to the TNX-102 SL and control arms, 77.5 percent and 86.4 percent, respectively, completed the 12-week dosing period. As observed in other TNX-102 SL clinical studies, the rate of tongue numbness was higher in the active treatment group (40.2 percent vs. 0.8 percent). Transient tongue numbness, the most frequent adverse reaction, is a local effect related to TNX-102 SL sublingual administration and it did not appear to bias efficacy results. The most common systemic adverse reactions occurring in greater than or equal to 3 percent of patients in TNX-102 SL group and greater than placebo, are listed in Table 4.

Table 4. Most Common Systemic Adverse Reactions Occurring in > 3% of Patients in the TNX-102 SL Group and Greater than Placebo

Preferred term	TNX-102 SL (N = 261)*	Placebo (N=257)*
Fatigue	15 (5.7%)	6 (2.3%)
Somnolence	8 (3.1%)	4 (1.6%)

*Safety Population = 518 patients

About PTSD

PTSD affects approximately 8.5 million Americans and is a chronic and debilitating condition, in which patients experience nightmares and disturbed sleep, and which is associated with depression and suicide. Individuals who suffer from PTSD experience impaired social functioning, occupational disability, intense anxiety and avoidance, emotional numbness, intense guilt or worry, agitation and an overall poor quality of life. PTSD is sometimes associated with substance abuse and unpredictable or violent behaviors, additional reasons that make it a critical public health concern. PTSD can develop from witnessing or experiencing a traumatic event in which there was the threat or actual occurrence of grave physical harm.

About TNX-102 SL

TNX-102 SL is an Investigational New Drug and has not been approved for any indication. TNX-102 SL is designed to deliver cyclobenzaprine to the bloodstream rapidly via sublingual (under the tongue) absorption and to bypass first-pass hepatic metabolism. As a multifunctional agent with antagonist activities at the serotonin-2A, alpha-1 adrenergic, and histamine H1 receptors, TNX-102 SL is under clinical development for the treatment of PTSD and is intended to provide broad spectrum improvement by targeting sleep quality and the stress response. Tonix is developing TNX-102 SL, 5.6 mg, for daily bedtime administration for the treatment of PTSD.

About Tonix Pharmaceuticals Holding Corp.

Tonix is developing next-generation medicines for common disorders of the central nervous system, with its lead program focusing on PTSD. This disorder is characterized by chronic disability, inadequate treatment options, high utilization of healthcare services, and significant economic burden. This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission (the “SEC”) on March 3, 2016, and future periodic reports filed with the SEC on or after the date hereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.

Contacts

Bradley J. Saenger, CPA

Chief Financial Officer

[email protected]

(212) 980-9155 x107

Jessica Smiley

Investor Relations

[email protected]

(212) 980-9155 x185

Edison Advisors (investors)

Tirth Patel

[email protected]