Tonix Pharmaceuticals Completes the Acquisition of Two FDA Approved and Marketed Migraine Product

Strategic acquisition helps Tonix build its commercial capabilities and infrastructure ahead of potential launch of TNX 102 SL to manage Fibromyalgia

Tonix’s current intranasal clinical development program of TNX-1900, for migraine prevention, is complemented by the acquisition of Zembrace (r) SymTouch (r) and Tosymra (r) (sumatriptan spray).

CHATHAM, N.J., JULY 03, 2023 — Tonix Pharmaceuticals Holding Corp., a biopharmaceutical firm, and its wholly-owned subsidiary Tonix Medicines, Inc., (Tonix Medicines), announced today that they have completed the acquisition of the two currently-marketed products by Upsher-Smith Laboratories, LLC. Zembrace SymTouch (sumatriptan injectable) 3 mg, and Tosymra (sumatriptan) (ups) (Ups) (Ups) (Ups) (Ups) (Ups) (Ups) (Ups) (Ups As previously announced, the combined product sales for these products were approximately $23 millions in 2022.

Seth Lederman M.D. is the Chief Executive Officer at Tonix Pharmaceuticals. He said that the acquisition of these products represents a significant step in Tonix’s evolution into a fully-integrated biopharmaceutical firm and builds on Tonix’s expertise in central nervous system disorders. “In addition to the growth potential that these two products represent over time the acquisition helps Tonix build its commercial capabilities ahead of the possible launch of our TNX 102 SL product for the treatment fibromyalgia and aligns strongly Tonix’s TNX-1900 product candidate (intranasal-potentiated oxytocin), which is in clinical development.

“Migraine and breakthrough headaches are still a significant burden. We believe that both Zembrace SymTouch, and Tosymra, can be used to meet the unmet needs of those patients who use oral acute migraine medications currently, or have recently developed, especially for rapid-onset treatment,” stated James Hunter, Executive vice president of commercial operations at Tonix Pharmaceuticals, and President of Tonix Medicines.

It is the only sumatriptan-autoinjector brand actively promoted in the United States. Other sumatriptan-autoinjectors on the market include Imitrex (r) and generics of Imitrex (r). It is a low-dose product that has shown migraine pain relief as early as 10 minutes (17% of patients vs. only 5% of placebo patients). ² Zembrace SymTouch has also demonstrated migraine freedom for 46% (vs. 27% for the placebo group) at 2 hour in a double-blind, single-attack study (N=230). ³ Zembrace SymTouch has patent protection until 2036. Tosymra uses Intravail(r), a permeation enhancer, and is pharmacokinetically equal to 4 mg of subcutaneous sumatriptan.

About Migraine

Nearly 40,000,000 Americans suffer from migraine ⁷. It is the second leading cause for disability in the United States.

References:

1. IQVIA 2022 estimates Zembrace and Tosymra retail sales at $19.6M and $3.5M respectively.

2. Mathew NT, et al. Subcutaneous sumatriptan is effective and safe in doses ranging from 1 to 10 mg. US Sumatriptan Research Group. Arch Neurol. 1992;49(12):1271-1276.

3. Landy, S. et al. Efficacy of DFN-11 (3 mg sumatriptan) in adults with episodic headache: a multicenter, double-blind placebo-controlled, randomized study. J Headache Pain. 19, 69 (2018).

4. Brand-Schieber E, Munjal S, Kumar R, et al. Human factors validation of 3 mg sumatriptan injector for migraine patients. Med Devices (Auckl). 2016;9:131-137.

5. Tosymra [package leaflet]. Maple Grove, MN, Upsher-Smith Laboratories, LLC, Feb 2021.

6. Wendt J, et al. A randomized, controlled, double-blind trial evaluating the efficacy and safety of a subcutaneous dose of sumatriptan of 4 mg for the treatment acute migraine attacks among adults. Clinical Therapeutics. 2006;28(4):517-526.

7. GBD 2016 Headache Collaborators. Global, regional, national, and local burden of migraine and tension type headache, 1990-2016 : a systematic study for the Global Burden of Disease Study 2016 Lancet Neurol 2018;17(11):954-976.

8. Headache Classification Committee (IHS) The International classification of headache disorders in its 3rd edition. Cephalalgia. 2018;38(1):1-211.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a biopharmaceutical firm that focuses on commercializing, developing and discovering therapeutics to treat, prevent and alleviate human disease. Tonix sells Zembrace(r), SymTouch (r) (sumatriptan injectable) 3 mg, and Tosymra (r) (sumatriptan spray) 10mg. Both are indicated for acute migraines with or without aura. Tonix’s product portfolio consists of candidates for the central nervous system, rare diseases, immunology and infections. Tonix’s CNS portfolio includes small molecules and biologics for treating pain, neurologic and psychiatric conditions, as well as addiction. Tonix’s leading CNS candidate (TNX-102 SL, cyclobenzaprine HCl Sublingual Tablet) is in Phase 3 development for the treatment of fibromyalgia. Topline data are expected in the first quarter 2024. TNX 102 SL is being developed for the treatment of Long COVID (a chronic post-acute COVID-19). The Phase 2 study enrollment is complete, and topline findings are expected to be available in the third quarter 2023. TNX-601 (tianeptine extended-release tablets), an oral once-daily formulation that is being developed to treat major depressive disorder, is also enrolling. Topline results are expected in the first half of 2024. TNX-4300 is a small molecule orally administered therapeutic that is in preclinical testing to treat MDD, Alzheimer’s disease and Parkinson’s disease. TNX-1900, intranasal-potentiated oxytocin, in development for chronic headaches, is currently enrolling. Topline data are expected in the fourthquarter of 2023. TNX-1300, a biologic that treats cocaine intoxication, has been designated as a Breakthrough Therapy by the FDA. A Phase 2 study for TNX-1300 should begin in the third quarter 2023. Tonix’s portfolio of rare disease development includes TNX-2900, an intranasal potentiated oxytocin for the treatment Prader-Willi Syndrome. TNX-2900 was granted Orphan Drug status by the FDA. Tonix’s Immunology Development Portfolio includes biologics that address organ transplantation rejection, autoimmunity, and cancer. TNX-1500 is a humanized, monoclonal, antibody targeting CD40L (CD154), which is being developed to prevent allograft reject and treat autoimmune diseases. A Phase 1 study for TNX-1500 should begin in the third quarter 2023. Tonix’s pipeline of infectious diseases includes TNX-801 – a vaccine being developed to prevent smallpox or mpox. TNX-801 can also be used as a platform for recombinant pox or live virus vaccines to treat other infectious diseases. The portfolio of infectious disease development also includes TNX-3900, TNX-4000 and classes of broad spectrum small molecule antivirals.

* Tonix’s product development candidates are investigational drugs or biologics that have not been approved by the FDA for any indication.

Tonix Medicines is the registered trademark owner of Zembrace SymTouch, Tosymra and Tosymra. Intravail, a registered trademark, is owned by Aegis Therapeutics, LLC, which is a wholly-owned subsidiary of Neurelis, Inc.

You can find this press release as well as additional information about Tonix at www.tonixpharma.com.

Forward-Looking Statements

Certain statements in this release are forward-looking, as defined by the Private Securities Litigation Reform Act of 1996. These statements can be identified by forward-looking words like “anticipate”, “believe”, “forecast”, “estimate”, “expect”, and “intend”. These forward-looking statement are based on Tonix’s current expectations, and actual results may differ materially. There are several factors that could cause the actual events to differ significantly from those stated in such forward-looking statement. These factors include but are not restricted to risks related the failure to obtain FDA approvals or clearances and non-compliance with FDA regulation; risks related the failure of our products to be successfully marketed; risks relating to the timing and the progress of clinical development for our product candidates; risks relating to our need for additional funding; uncertainties regarding patent protection and litigation, uncertainties regarding government or third party payer reimbursement; limited research efforts and dependence on third parties; and significant competition. As with any pharmaceutical product in development, there are risks associated with the development, approval by regulatory agencies, and commercialization of a new product. Tonix is not obligated to update or revise forward-looking statements. Investors are advised to read the risk factors in the Annual Report on the Form 10-K for year ending December 31, 2022 as filed with Securities and Exchange Commission (“SEC”) March 13, 2023 and periodic reports filed at or after that date. All forward-looking statements by Tonix are expressly qualified with all of these risk factors and cautionary statements. The information contained herein is only current as of the date it was published.

Investor Contact

Jessica Morris

Tonix Pharmaceuticals

[email protected]

(862) 904-8182

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ICR Westwicke

[email protected]

(443) 213-0505

Media Contact

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Zembrace(r) SymTouch(r) (sumatriptan Injection): IMPORTANT SAFETY INFORMATION

Zembrace SymTouch can cause serious side-effects, including heart attacks and other heart problems that may lead to death. If you experience any symptoms of a heart attacks, stop using the product and seek emergency medical attention.

• Discomfort in the middle of your chest that lasts more than a few moments or comes and goes

• Severe tightness, pain, or pressure in your chest, neck, jaw, or throat

• You may experience pain in your arms, back or neck, jaw, or stomach

• Shortness of breath without chest discomfort

• Breaking out in cold sweat

• nausea or vomiting

• Feeling lightheaded
  

Zembrace should not be used by people with heart disease risk factors (high blood pressure, high cholesterol, smoking or being overweight, diabetes, a family history of heart problems, etc.) unless an examination of the heart shows that there is no problem.

Zembrace should not be used if you:

• Heart problems in the past

• Narrowing of blood vessels in your legs, arms or stomach (peripheral arterial disease)

• Uncontrolled high blood pressure

• Hemiplegic migraines or basilar headaches. Ask your provider if you are unsure if you suffer from these migraines.

• Have you had a stroke or TIA?

• severe liver problems

• Taken any of the following medications in the past 24 hours: ergotamines (dihydroergotamine), eletriptan.

• If you are taking monoamine oxidase-A (MAO-A) inhibitors, or if it has been less than 2 weeks since you stopped taking MAO-A inhibiters. If you are unsure, ask your doctor for a list.

• Zembrace is not recommended for people who have an allergy to sumatriptan, or any of its components.
  

Tell your provider all your medical conditions, medications and vitamins and supplements you take.

Zembrace may cause dizziness or weakness. If you feel drowsy, do not drive, operate machinery, or perform any other activity that requires alertness.

Zembrace can cause serious side effects, including:

• Changes in color or sensation of your fingers and toes

• Weight loss, nausea, vomiting, constipation, diarrhea, or bloody diarrhea

• If you experience any of the following symptoms, please consult your doctor.

• Increased blood pressure, including a sudden and severe increase even if there is no history of high pressure

• Medication overuse headaches are caused by taking migraine medication for more than 10 days per month. If your headaches get worse, call your provider.

• Serotonin Syndrome is a rare, but serious, problem that can occur in people who use Zembrace. This is especially true when combined with antidepressant drugs called SSRIs and SNRIs. Call your doctor immediately if you experience mental changes, such as seeing things not there (hallucinations), agitation or coma, a fast heartbeat, changes in blood pressure or high body temperature.

• Hives (itchy bumps); swelling in your mouth, throat, or tongue

• Even people who have never experienced seizures can experience seizures

The most commonly reported side effects of Zembrace are: Pain and redness around the injection site, tingling in your fingers or toes, dizziness, a warm, hot or burning sensation on your face (flushing), discomfort or stiffness in the neck, feeling weak, drowsy or tired.

Inform your provider if any side effects bother you or do not go away. These are not the only possible side effects that can occur with Zembrace. Ask your provider for more information.

The information below is important but not exhaustive. Talk to your doctor and read the Patient Information & Instructions for use. You can also call 1-888 650-3789 or visit www.upshersmith.com.

Reporting adverse effects of prescription medications to the FDA is encouraged. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATIONS AND USAGE

Zembrace, a prescription medication, is used to treat migraine headaches in adults with or without aura.

Zembrace does not prevent migraines. It is unknown if Zembrace is safe and effective for children under the age of 18.

Tosymra(r) (sumatriptan nasal spray): IMPORTANT SAFETY INFORMATION

Tosymra may cause serious side effects including heart attacks and other heart problems that can lead to death. If you experience any signs of a heart attack, stop taking Tosymra immediately and seek emergency medical attention.

• Discomfort in the middle of your chest that lasts more than a few moments or comes and goes

• Severe tightness, pain, or pressure in your chest, neck, jaw, or throat

• You may experience pain in your arms, neck, jaw or stomach.

• Shortness of breath without chest discomfort

• Breaking out in cold sweat

• nausea or vomiting

• Feeling lightheaded
  

Tosymra should not be used by people with heart disease risk factors (high blood pressure, high cholesterol, smoking, obesity, diabetes, family history, etc.) unless an exam of the heart shows that there is no problem.

Use Tosymra only if you do not have:

• Heart problems in the past

• Narrowing of blood vessels in your legs, arms or stomach (peripheral arterial disease)

• Uncontrolled high blood pressure

• severe liver problems

• Hemiplegic migraines or basilar headaches. Ask your healthcare provider if you are unsure if you suffer from these migraines.

• Have you had a stroke or TIA?

• If you have taken any of these medicines within the last 24 hours, please let your provider know. If you are unsure if your medication is listed, ask your provider.

• If you are taking monoamine oxidase-A (MAO-A) inhibitors, or if it has been less than 2 weeks since you stopped taking MAO-A inhibiters. If you are unsure, ask your doctor for a list.

• Tosymra or any of its ingredients can cause an allergic reaction to sumatriptan
  

Tell your provider all your medical conditions, medications and vitamins and supplements you take.

Tosymra can cause dizziness, weakness, or drowsiness. If you feel this way, avoid driving a car or using machinery.

Tosymra can cause serious side effects, including:

• Changes in color or sensation of your fingers and toes

• Weight loss, nausea, vomiting, constipation, diarrhea, or bloody diarrhea

• If you experience pain or cramping in your legs and hips, you may also experience a feeling of heaviness in the muscles. You may also experience burning or aching in your toes or feet while at rest, or numbness.

• Increased blood pressure, including a sudden and severe increase, even if there is no history of high pressure

• Overuse headaches are caused by taking migraine medication for more than 10 days per month. If your headaches get worse, call your provider.

• Serotonin Syndrome is a rare, but serious, problem that can occur in people who use Tosymra. This occurs more often when combined with antidepressant drugs called SSRIs and SNRIs. Contact your doctor immediately if you experience any of the following: mental changes, such as seeing things not there (hallucinations), agitation or coma.

• Hives (itchy bumps); swelling in your mouth, throat, or tongue

• Even people who have never experienced seizures can experience seizures

Tosymra’s most common side effects include: tingling or dizziness; feeling hot or warm; feeling of heaviness and pressure. Other symptoms include flushing, tightness, numbness.

Inform your provider if any side effects bother you or do not go away. Tosymra can cause other side effects. Ask your provider for more information.

Tosymra is not covered in this list. Talk to your doctor and read the Patient Information & Instructions for use. You can also call 1-888-650-378 or visit www.upshersmith.com.

Reporting side effects of prescription medications to the FDA is encouraged. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATIONS AND USAGE

Tosymra, a prescription medication, is used to treat adults with acute migraine headaches that may or may not have an aura.

Tosymra cannot be used to treat other types headaches, such as hemiplegic migraines, basilar migraines, or cluster headaches.

Tosymra does not prevent migraines. Tosymra may be safe and effective for children under the age of 18.