Exhibit 99.01
The AtEase Study: An Evaluation
of the Efficacy of a Low Dose, Bedtime, Sublingual Formulation of Cyclobenzaprine (TNX-102 SL) for the Treatment of Military-Related
PTSD Gregory M. Sullivan1, Judy F. Gendreau1, R. Michael Gendreau2, Amy Schaberg3, Bruce L. Daugherty1, Heather Jividen1, Ashild
Peters1, Perry Peters1, Seth Lederman1 1Tonix Pharmaceuticals, Inc., New York, NY 10022; 2Gendreau Consulting, Poway, CA 92064;
3Schaberg Consulting, Cary, NC 27513 INTRODUCTION . There is an urgent unmet need for efficacious pharmacotherapy interventions
for military-related posttraumatic stress disorder (PTSD) . TNX-102 SL# is a proprietary formulation of low dose cyclobenzaprine
(CBP) HCl, a tricyclic molecule, administered by sublingual (SL) route nightly at bedtime . Efficacy of tricyclic class in PTSD
is supported by clinical data1 . In a Phase 2b trial in fibromyalgia, TNX-102 SL demonstrated significant improvement on sleep
disturbance (p=.005), and anxiety (p=.015) and sensory sensitivity (p=.017) item scores, relevant to PTSD; while being well tolerated
over 12 weeks of treatment2 * . TNX-102 SL is intended to target sleep disturbance and hyperarousal in order to improve global
symptoms of PTSD . The eAtEase Studyf (TNX-CY-P201) is evaluating the potential clinical benefit of TNX-102 SL in the treatment
of militaryrelated PTSD METHODS . Randomized, double blind, placebo-controlled 12-week trial testing 3 groups in 2:2:1 ratio:
(1) placebo, (2) TNX-102 SL 2.8 mg, and (3) TNX-102 SL 5.6 mg . Total N=220 . 25 private trial clinics within the continental
United States (US) . Male and female US military personnel and veterans age 18-65 with PTSD DSM-5 Criterion A trauma(s) that occurred
during military service in last 14 years INVESTIGATIONAL PRODUCT . TNX-102 SL: a proprietary formulation of low dose cyclobenzaprine
2.8 mg tablets for sublingual administration . more rapid absorption into the circulation (Fig 1) . Bypasses gfirst passh metabolism
to norcyclobenzaprine (nCBP), a long half-life (72 hr) active metabolite, by liver (Fig 2); AUC0-48 for CBP/nCBP of 1.9 vs. 1.2
for oral IR form2 . CBP is a multifunctional agent with potent 5-HT2A, ¿1- adrenergic, and H1-receptor blocking properties
(Fig 3 & 4) CURRENT STUDY STATUS . Currently enrolling; over 50% enrolled to date . Recruitment information found at AtEaseStudy.com
CONCLUSIONS . Prior clinical studies of TNX-102 SL in fibromyalgia suggest evidence of broad activity relevant to PTSD treatment
in concert with good systemic tolerability . The AtEase Study, a registration quality clinical trial of TNX-102 SL for the treatment
of military-related PTSD, is currently enrolling across the US . Primary Outcome Measure: The Clinician Administered PTSD Scale
for DSM-5 (CAPS-5), which is a standardized structured clinical interview that is the gold standard in research for measuring
PTSD symptom severity . Inclusion criteria include: . PTSD diagnosed by CAPS-5; severity . 29 . No antidepressant treatment within
2 months . Willing and able to discontinue medications including opioids, ¿-adrenergic agents, mood stabilizers, antipsychotics,
stimulants, benzodiazepines, nonbenzodiazepine hypnotics for period of the study . No trauma-focused psychotherapy during study
.. Exclusion criteria include: . Greatly increased suicidal risk (based on C-SSRS & MINI 7.0 criteria, and/or history of attempt
within prior 12 months) . Moderate or severe traumatic brain injury (TBI) . Severe depression based on MADRS score of . 30 . Unstable
medical conditions; BMI > 40 . Lifetime diagnosis bipolar disorder, psychotic disorder, OCD, or antisocial personality disorder
by MINI 7.0 . Alcohol or substance use disorder in remission <6 months . Efficacy Assessments . Primary outcome: change in
PTSD severity on the CAPS-5 . Secondary efficacy assessments include PTSD Checklist-5 (PCL-5), CGI-I, PGIC, PROMIS Sleep Disturbance,
Pain Questionnaire, Sheehan Disability Scale (SDS) Figure 1 . Plasma concentration vs. time for TNX-102 SL & CBP IR Figure
2 . Hepatic metabolism of CBP to active metabolite Figure 3 . Schematic of inhibitory activities of CBP & nCBP Figure 4 .
Functional antagonism (IC50) of CBP and nCBP 1Davidson J. J Psychopharm 29(3):264-9, 2015; 2Lederman et al., European Congress
of ClinicalTrials.gov Identifier: NCT02277704 Rheumatology, Rome, June 2015 1220 Increasing Potency #TNX-102 SL is an Investigational
New Drug and has not been approved for any indication *Most common adverse event: oral hypoaesthesia, 42% in TNX-102 SL vs. 1%
in placebo