Tonix Pharmaceuticals Enters into Agreement to Acquire Two FDA-Approved, Marketed Migraine Products from Upsher-Smith Laboratories, LLC Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray) are

TONIX PHARMACEUTICALS HOLDING CORP. 8-K

Tonix Pharmaceuticals

Enters into Agreement to Acquire Two FDA-Approved,

Marketed Migraine Products from Upsher-Smith Laboratories, LLC

Zembrace SymTouch (sumatriptan injection)

and Tosymra (sumatriptan nasal spray) are Indicated for the Treatment of Acute Migraine in Adults

Strategic Acquisition Helps Build Tonix's

Commercial Capabilities and Infrastructure Ahead of Potential Launch of TNX-102 SL for the Treatment of Fibromyalgia

Acute Migraine Products Complement Tonix's

Current Intranasal Clinical Development Program of TNX-1900 for Migraine Prevention

Injection and Nasal Spray Products that Bypass

the Gastrointestinal Tract Have the Potential to Provide Treatment Options for Migraine Associated with Nausea

CHATHAM, N.J., June 26, 2023 - Tonix Pharmaceuticals

Holding Corp. (Nasdaq: TNXP) (Tonix Pharmaceuticals or Tonix) and its wholly-owned subsidiary Tonix Medicines, Inc. (Tonix Medicines),

a clinical-stage biopharmaceutical company, today announced that they have entered into an agreement to acquire two currently-marketed

products from Upsher-Smith Laboratories, LLC (Upsher-Smith): Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra

(sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are both indicated for the treatment of acute migraine with or without

aura in adults. Zembrace SymTouch is the only branded sumatriptan autoinjector professionally promoted in the United States and is designed

for ease of use and favorable tolerability with a low 3 mg dose.1,3 Tosymra is a novel intranasal sumatriptan product formulated

with a permeation enhancer that provides rapid and efficient absorption of sumatriptan.4,5 Collectively, these products generated

product sales of approximately $23 million for the full year 2022. 6 Zembrace SymTouch and Tosymra each may provide onset of

migraine pain relief in as few as 10 minutes for some patients and currently have patent protection to 2036 and 2031, respectively.1,4

the agreement with Upsher-Smith:

"Approximately 16% of Americans suffer from

migraines, which represents about 40 million patients in the U.S.7," said Seth Lederman, M.D., Chief Executive Officer

of Tonix Pharmaceuticals. "Sumatriptan remains the acute migraine gold standard' treatment for many patients and continues

to represent the largest segment of the market in terms of unit sales.8 With migraine pain relief possible in as few as ten

minutes for some patients and convenient administration, we believe both Zembrace SymTouch and Tosymra are well-suited to address the

unmet needs of patients using traditional or emerging oral acute migraine medications, particularly for rapid-onset treatment."

"Despite increasing options for prevention

and treatment of migraine, migraine headaches and breakthrough migraine headaches remain significant unmet needs, and can lead to emergency

room visits," said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. "For adults needing acute treatment

of migraine, Zembrace SymTouch and Tosymra have the potential to be first-line treatments or rescue' medications for breakthrough

migraines, due to their fast onset of action and high pain-relief rates. For certain patients who present to ERs, Zembrace SymTouch and

Tosymra also provide ER staff a straightforward acute treatment option. Additionally, because both of these products bypass the gastrointestinal

tract, they have the potential to provide a treatment option for migraines complicated by severe nausea and vomiting."

"These two products are a strategic fit for

our company, and we look forward to working with Upsher-Smith to ensure a smooth product transition. To that end, this transaction includes

established manufacturing and supplier relationships that allow for a seamless transition of manufacturing and supply chain responsibilities.

The franchise today is supported by managed care contracts covering approximately 200 million lives. During the transition, we expect

to secure our own contracts," said James Hunter, Executive Vice President of Commercial Operations at Tonix Pharmaceuticals and

President of Tonix Medicines.

Dr. Lederman concluded, "In addition to the

potential growth that these two on-market products represent over time, the acquisition helps build Tonix's commercial capabilities

ahead of the potential launch of our TNX-102 SL product candidate for the treatment of fibromyalgia. In addition, these products align

strongly with our TNX-1900 (intranasal potentiated oxytocin) product candidate, in clinical development for the prevention of chronic

migraine. This is an important step in the evolution of Tonix into a fully integrated pharmaceutical company."

Zembrace SymTouch (sumatriptan injection) 3 mg is

the only actively promoted brand of sumatriptan autoinjector in the United States (other sumatriptan autoinjector products on the market

are Imitrex and generics to Imitrex ). It has a unique low dose and has demonstrated onset of migraine pain relief in as few

as 10 minutes (17% of patients vs. 5% for placebo).9 Zembrace SymTouch also demonstrated migraine pain freedom for 46% of patients

(vs 27% for placebo) at 2 hours in a single-attack, double-blind study (N=230).2 Zembrace SymTouch currently has patent protection

to 2036. Tosymra (sumatriptan nasal spray) 10 mg employs Intravail permeation enhancer technology and is pharmacokinetically equivalent

to 4 mg subcutaneous sumatriptan.3,4 Tosymra delivers migraine pain relief in as little as 10 minutes with just

one spray for some patients (13% vs. 5% for placebo).4, 9,10 Tosymra currently has patent protection to 2031.

Nearly 40 million people in the United States suffer

from migraine6 and it has been recognized as the second leading cause of disability in the world.11 Migraine is

characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe

pain intensity often associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia).12

Zembrace SymTouch (sumatriptan

Injection): IMPORTANT SAFETY INFORMATION

Zembrace SymTouch (Zembrace) can cause serious side effects,

including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart

Zembrace is not for people with risk factors for heart disease

(high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace if you have:

Tell your provider about all of your medical conditions and medicines

you take, including vitamins and supplements.

Zembrace can cause dizziness, weakness, or drowsiness. If so,

do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace may cause serious side effects including:

The most common side effects of Zembrace include: pain

and redness at injection site; tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing);

discomfort or stiffness in your neck; feeling weak, drowsy, or tired.

Tell your provider if you

have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace. For more information,

This is the most important information to know about Zembrace

but is not comprehensive. For more information, talk to your provider and read the Patient Information

and Instructions for Use. You can also visit www.upsher-smith.com

or call 1-888-650-3789.

You are encouraged to report adverse effects of prescription

drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND USAGE

Zembrace is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with

Zembrace is not used to prevent

migraines. It is not known if it is safe and effective in children under 18 years of age.

Tosymra (sumatriptan nasal spray): IMPORTANT SAFETY INFORMATION

Tosymra can cause serious side effects, including heart attack

and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of heart attack:

Tosymra is not for people with risk factors for heart disease (high

blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done and shows no

Do not use Tosymra if you have:

Tell your provider about all of your medical conditions and medicines

you take, including vitamins and supplements.

Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive

a car, use machinery, or do anything where you need to be alert.

Tosymra may cause serious side effects including:

The most common side effects of Tosymra include: tingling, dizziness,

feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application

site (nasal) reactions, abnormal taste, and throat irritation.