Tonix Pharmaceuticals Announces Enrollment Initiated in the MGH Phase 2 STROBE' Study of TNX-1900 (Intranasal Potentiated Oxytocin) for the Treatment of Binge-Eating Disorder Preliminary Data Show that Oxytocin Decreases

Tonix Pharmaceuticals Holding Corp. 8-K

Tonix Pharmaceuticals Announces

Enrollment Initiated in the MGH Phase 2 STROBE' Study of TNX-1900 (Intranasal Potentiated Oxytocin) for the Treatment of

Binge-Eating Disorder

Preliminary Data Show that Oxytocin Decreases Impulsivity

and Reduces Food Intake

TNX-1900 (Intranasal Potentiated Oxytocin) May Serve

as a Novel Neuroendocrine Treatment for Binge-Eating Disorder

CHATHAM, N.J., July 31, 2023

- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced

that the first participant was enrolled in the investigator-initiated Phase 2 Study of The Results of Oxytocin in Binge Eating STROBE'

study of TNX-1900 (intranasal potentiated oxytocin) for the treatment of binge-eating disorder at the Massachusetts General Hospital (MGH).

The aim of the study is to investigate the efficacy and safety of TNX-1900 as a novel therapeutic agent to reduce binge eating frequency

in adults with binge-eating disorder. Tonix is supporting the STROBE study through a clinical trial agreement with MGH. MGH is the sponsor

of the trial, which is being conducted under an investigator-initiated investigational new drug (IND) application.

The 8-week double-blind,

placebo-controlled trial has a target enrollment of at least 60 participants 18-45 years old with binge-eating disorder.

"Binge-eating disorder

is identified as a reduced ability to control behavioral impulses and formed habits, disrupting the regulation of food intake and energy

balance,"1-4 said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "While existing treatment

options may produce remission from binge eating in some cases, up to 50% of patients continue to engage in binge eating."5-7

Elizabeth A. Lawson, M.D., M.M.Sc., Director, Interdisciplinary

Oxytocin Research Program in the Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and principal investigator

of the study added, "Individuals with binge-eating disorder experience loss of control over eating that is thought to be driven

by increased hedonic drive to eat as well as impulsivity.8-10 The oxytocin system has been linked to likelihood of lifetime

binge eating in women11, and our preliminary studies of intranasal oxytocin at the dose used in this trial show that oxytocin

modulates areas of the brain responsible for hedonic eating and impulse control12, improves impulsivity13, and reduces

caloric intake.14 The goal of the STROBE study is to assess whether 8 weeks intranasal administration of oxytocin will decrease

binge eating frequency by lowering the drive to eat and improving impulse control."

About the Phase 2 STROBE Study

The Phase 2 STROBE study is a randomized, double blind,

placebo-controlled study to evaluate the efficacy and safety of TNX-1900 for the treatment of binge-eating disorder in adults. The 8-week

trial has a target enrollment of at least 60 participants 18-45 years old with binge-eating disorder. Subjects will be randomized to receive

TNX-1900 or placebo and will be studied at Massachusetts General Hospital. Subjects will self-administer TNX-1900 or placebo as two sprays

total (one spray in each nostril) up to four times per day for 8 weeks. The primary endpoint is 8-week change from baseline in binge frequency.

For more information, see ClinicalTrials.gov Identifier:

About Binge Eating Disorder

Binge-eating disorder (BED) is a psychiatric

illness characterized by frequent episodes of uncontrollable consumption of large amounts of food. It is the most common eating disorder

and often leads to obesity-associated complications and later psychopathology15. BED is characterized by increased homeostatic

appetite and sensitivity to reward (including food reward)16, which may lead to initiation of binge episodes, and a reduced

ability to control behavioral impulses and formed habits, creating an imbalance in the sensitive interplay between these bottom-up and

top-down processes governing the adaptive regulation of food intake and energy balance1-4.

TNX-1900 (intranasal potentiated oxytocin) is a proprietary

formulation of oxytocin in development as a candidate for prevention of chronic migraine and other conditions. In 2020, TNX-1900 was acquired

from Trigemina, Inc. who had licensed the technology underlying the composition and method from Stanford University. TNX-1900 is a drug-device

combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Oxytocin is a naturally occurring

human peptide hormone that also acts as a neurotransmitter in the brain. Oxytocin has no recognized addiction potential. It has been observed

that low oxytocin levels in the body are associated with increases in migraine headache frequency, and that increased oxytocin levels

are associated with fewer migraine headaches. Certain other chronic pain conditions are also associated with decreased oxytocin levels.

Migraine attacks are caused, in part, by the activity of pain-sensing trigeminal neurons which, when activated, release of calcitonin

gene-related peptide (CGRP) which binds to receptors on other nerve cells and starts a cascade of events that is believed to result in

headache. Oxytocin when delivered via the nasal route, concentrates in the trigeminal system17 resulting in binding of oxytocin

to receptors on neurons in the trigeminal system, inhibiting the release of CGRP and transmission of pain signals returning from the site

of CGRP release.18 Blocking CGRP release is a distinct mechanism compared with CGRP antagonist and anti-CGRP antibody drugs,

which block the binding of CGRP to its receptor. With TNX-1900, the addition of magnesium to the oxytocin formulation enhances oxytocin

receptor binding19 as well as its inhibitory effects on trigeminal neurons and resultant craniofacial analgesic effects, as

demonstrated in animal models20. Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both

adults and children21. Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target

effects, which could potentially occur with systemic CGRP antagonists such as anti-CGRP antibodies22. For example, CGRP has

roles in dilating blood vessels in response to ischemia, including in the heart. The Company believes nasally targeted delivery of oxytocin

could translate into selective blockade of CGRP release from neurons in the trigeminal ganglion and not throughout the body, which could

be a potential safety advantage over systemic CGRP inhibition. In addition, daily dosing is more rapidly reversible, in contrast to monthly

or quarterly dosing, as is the case with anti-CGRP antibodies, giving physicians and their patients greater control. In addition to chronic

migraine, TNX-1900 will be developed for treatment of episodic migraine, binge eating disorder, craniofacial pain conditions, and insulin

resistance. Tonix also has a license with the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related

TNX-2900 is another intranasal potentiated oxytocin-based

therapeutic candidate, being developed for the treatment of Prader-Willi syndrome, or PWS. The technology for TNX-2900 was licensed from

the French National Institute of Health and Medical Research. PWS, an orphan condition, is a rare genetic disorder of failure to thrive

in infancy, associated with uncontrolled appetite later in childhood.

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Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on commercializing,

developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix markets Zembrace