Tonix Pharmaceuticals Appoints Irina Ishak as General Counsel

Rhea-AI Summary

Tonix Pharmaceuticals (Nasdaq: TNXP) appointed Irina Ishak as General Counsel, effective Dec 8, 2025. Ishak brings more than 25 years of corporate legal and life sciences experience and will lead legal, governance, and compliance functions. She previously served as Senior Counsel at Lowenstein Sandler since 2013 and advised Tonix since 2017 on financings, licensing, commercial agreements, and board matters.

The appointment coincides with Tonix commercializing FDA-approved TONMYA (first new fibromyalgia drug in >15 years) and advancing a diversified CNS, immunology, rare disease, and infectious disease pipeline.

Positive

• Effective date of appointment: Dec 8, 2025
• Ishak has 25+ years of life sciences legal experience
• Ishak advised Tonix since 2017 on financings and deals
• Tonix markets FDA-approved TONMYA, first fibromyalgia drug in >15 years

Negative

• None.

Key Figures

Legal experience More than 25 years Ms. Ishak’s corporate legal and strategic leadership experience

Fibromyalgia approval gap More than 15 years First FDA-approved fibromyalgia therapy in over 15 years

Fibromyalgia therapies First new therapy in >15 years TONMYA approval positioning in fibromyalgia market

Migraine treatments Two products Zembrace SymTouch and Tosymra for acute migraine in adults

TNX-1500 stage Phase 2-ready TNX-1500 Fc-modified humanized monoclonal antibody program

TNX-4800 stage Phase 2-ready Long-acting monoclonal antibody for Lyme disease prevention

DTRA contract value Up to $34 million Five-year U.S. DoD DTRA contract for TNX-4200

DTRA contract term Five years Duration of TNX-4200 DTRA contract

Market Reality Check

$19.60 Last Close

Volume Volume 475,700 is about 42% below the 20-day average of 825,724, suggesting limited trading interest around this governance news. low

Technical Shares at $19.89 are trading below the 200-day MA of $26.54, and remain well under the 52-week high of $130 but above the $6.76 low.

Peers on Argus

TNXP gained 1.27% while peers were mixed: NMRA -1.35%, ANNX +2.97%, CADL +0.55%, OMER +3.54%, VNDA +13.28%. No clear sector-wide direction, pointing to a stock-specific response.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 24	Clinical IND clearance	Positive	-11.3%	FDA IND clearance for potentially pivotal Phase 2 MDD study of TNX‑102 SL.
Nov 17	Product launch news	Positive	+5.7%	U.S. commercial availability announcement for TONMYA fibromyalgia treatment.
Nov 10	Earnings and update	Positive	+4.1%	Q3 2025 results with Tonmya approval, planned launch and cash runway into Q1 2027.
Nov 06	Conference participation	Positive	-3.9%	Announcement of presentation at Stifel 2025 Healthcare Conference and pipeline overview.
Nov 04	Clinical collaboration	Positive	-6.5%	Collaboration with MGH on Phase 2 TNX‑1500 trial to prevent kidney transplant rejection.

Pattern Detected

Recent positive clinical and commercial milestones have often seen mixed or even negative next-day price reactions, indicating a tendency toward divergence on good news.

Recent Company History

Over the last few months, Tonix reported several notable milestones. In November 2025, it secured FDA IND clearance for a potentially pivotal Phase 2 MDD study of TNX‑102 SL, launched TONMYA commercially in U.S. pharmacies, and posted Q3 results showing $3.3M product revenue and cash runway into Q1 2027. It also advanced a Phase 2 kidney transplant study for TNX‑1500. Today’s General Counsel appointment fits into this broader execution and commercialization phase.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-09-04

The company has an active S-3/A shelf registration dated 2025-09-04, expiring 2028-09-04, with at least one recent usage via a 424B5 on 2025-11-21. The shelf is not marked effective in this dataset, but its presence, alongside the updated at-the-market program, indicates pre-established capacity to issue additional equity if executed under effective registration.

Market Pulse Summary

This announcement highlights Tonix’s effort to reinforce its legal and governance infrastructure as it commercializes TONMYA and advances a broad CNS, immunology, rare disease, and infectious disease pipeline. The hire follows recent milestones such as FDA approval and launch of TONMYA and a DTRA contract of up to $34 million. Investors may focus on execution of commercialization, clinical progress for Phase 2‑ready assets, and future capital-raising activity under existing registration frameworks.

Key Terms

investigator-initiated ind regulatory

"TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University..."

An investigator-initiated IND is a regulatory filing where a clinical researcher, rather than a drug company, takes the lead to test an experimental medicine in humans. For investors, it matters because this setup can accelerate independent clinical testing or generate new data without the sponsor bearing full cost or control, but it may also create uncertainty about who owns the data, who funds further development, and how quickly results can be turned into a commercial opportunity — think of it like a researcher renovating a house with their own plans rather than the builder driving the project.

monoclonal antibody medical

"TNX-1500, which is a Phase 2- ready Fc-modified humanized monoclonal antibody targeting CD40-ligand..."

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

cd40-ligand medical

"TNX-1500, which is a Phase 2- ready Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154)..."

CD40 ligand is a protein displayed on certain immune cells and platelets that acts like a switch, turning on other immune cells and helping the body make antibodies and inflame tissues. Investors care because drugs that block or mimic this molecule can alter immune responses—potentially treating autoimmune disease, transplant rejection, or cancer—but such therapies can also affect blood clotting and inflammation, creating both opportunity and safety risk.

prader-willi syndrome medical

"TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome..."

A rare genetic disorder caused by missing or altered instructions on a specific chromosome that leads to constant hunger, low muscle tone, learning challenges, and hormonal problems; think of it as a faulty instruction manual that affects growth, appetite control, and development. Investors care because the condition creates a defined patient population, special regulatory incentives, and long-term medical needs that shape demand for therapies, diagnostics, and care services, influencing market size and risk for drug developers.

mpox medical

"TNX-801, a vaccine in development for mpox and smallpox..."

Mpox is an infectious viral disease that causes fever, rash and swollen lymph nodes and spreads through close contact; think of it like a less common cousin of seasonal illnesses that can lead to local outbreaks. It matters to investors because outbreaks can change demand for medical supplies, affect healthcare and insurance costs, disrupt travel and workforce availability, and trigger regulatory or public health responses that influence company revenues and risk profiles.

AI-generated analysis. Not financial advice.

Ms. Ishak brings more than 25 years of corporate legal and strategic leadership experience in the life sciences industry

CHATHAM, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated commercial-stage biotechnology company today announced the appointment of Irina Ishak as General Counsel, effective December 8, 2025. Ms. Ishak will lead Tonix’s legal, corporate governance, and compliance functions.

“Irina is a highly accomplished corporate and commercial attorney whose experience spans public and private life sciences companies, as well as advising life sciences investors,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “Her deep background in complex transactions, public company matters, and governance will be a significant asset as we commercialize our marketed products, advance our pipeline, manage our partnerships, and continue to execute on Tonix’s long-term strategy.”

Ms. Ishak joins Tonix from Lowenstein Sandler LLP, where she served since 2013 as Senior Counsel, and has advised Tonix since 2017 in structuring and negotiating financings, licensing and other strategic transactions, key commercial agreements, and employment-related contracts, and advising senior management and the Board of Directors on corporate strategy, governance, risk, and securities offerings and filings. In addition to Tonix, Ms. Ishak acted as outside general counsel, corporate secretary, and advisor to certain other public and private life sciences companies, as well as to investors. Previously, she was Senior Director, Legal and Assistant Corporate Secretary at Savient Pharmaceuticals, Inc., which developed, won US Food and Drug Administration (FDA) approval for, and launched KRYSTEXXA^® (pegloticase), a biologic treatment for chronic gout in adults. Earlier in her career Ms. Ishak was a corporate associate at Fried, Frank, Harris, Shriver & Jacobson LLP. She received her J.D. from New York University School of Law and her B.A., with highest honors, from Rutgers College in New Brunswick, N.J.

“I am honored to join Tonix as General Counsel at such a pivotal moment in the Company’s evolution,” said Ms. Ishak. “Tonix has just launched the first therapy approved by the FDA for treating fibromyalgia in more than 15 years. Now the company is maximizing that science to expand into other conditions. It’s an exciting time at Tonix and there is immense opportunity to make a valuable contribution. I look forward to working closely with Seth, the leadership team, and the Board to support the Company’s next phase of growth.”

Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix markets FDA-approved TONMYA™, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. TONMYA is the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. Tonix also markets two treatments for acute migraine in adults: Zembrace^® SymTouch^® (sumatriptan injection) and Tosymra^® (sumatriptan nasal spray). Tonix’s development portfolio* is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a Phase 2- ready Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a potential pivotal Phase 2 study in 2026. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a Phase 2- ready long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease. Finally, TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.

* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication under development.

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, risks related to the failure to successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; 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 substantial competition. 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, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. 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 thereof.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals 
investor.relations@tonixpharma.com 
(862) 799-8599 

Brian Korb 
astr partners 
(917) 653-5122 
brian.korb@astrpartners.com 

Media Contacts
Mary Ann Ondish
Tonix Pharmaceuticals
maryann.ondish@tonixpharma.com

Ray Jordan 
Putnam Insights 
ray@putnaminsights.com 

INDICATION
TONMYA is indicated for the treatment of fibromyalgia in adults.

CONTRAINDICATIONS
TONMYA is contraindicated:

In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.

With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.

During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.

In patients with hyperthyroidism.

WARNINGS AND PRECAUTIONS
Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.

Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.

Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.

Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.

CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.

Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

DRUG INTERACTIONS

MAO inhibitors: Life-threatening interactions may occur.

Other serotonergic drugs: Serotonin syndrome has been reported.

CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.

Tramadol: Seizure risk may be enhanced.

Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.

USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).

Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.

Pediatric use: The safety and effectiveness of TONMYA have not been established.

Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.

Please see additional safety information in the full Prescribing Information.

To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indication and Usage
Zembrace^® SymTouch^® (sumatriptan succinate) injection (Zembrace) and Tosymra^® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.

Important Safety Information

Zembrace and Tosymra 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 attack:

• discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
• severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
• pain or discomfort in your arms, back, neck, jaw or stomach
• shortness of breath with or without chest discomfort
• breaking out in a cold sweat
• nausea or vomiting
• feeling lightheaded
  

Zembrace and Tosymra are 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 or Tosymra if you have:

• history of heart problems
• narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
• uncontrolled high blood pressure
• hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
• had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
• severe liver problems
• taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
• are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
• an allergy to sumatriptan or any of the components of Zembrace or Tosymra
  

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace and 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.

Zembrace and Tosymra may cause serious side effects including:

• changes in color or sensation in your fingers and toes
• sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
• cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
• increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
• medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
• serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
• hives (itchy bumps); swelling of your tongue, mouth, or throat
• seizures even in people who have never had seizures before

The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); 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; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).

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 and Tosymra. For more information, ask your provider.

This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

FAQ

When did Tonix appoint Irina Ishak as General Counsel (TNXP)?

Irina Ishak was appointed General Counsel effective Dec 8, 2025.

What experience does Irina Ishak bring to Tonix (TNXP)?

She brings more than 25 years of corporate legal and strategic life sciences experience, including Senior Counsel at Lowenstein Sandler.

What functions will the new General Counsel lead at Tonix (TNXP)?

She will lead Tonix’s legal, corporate governance, and compliance functions.

Had Irina Ishak worked with Tonix before her appointment (TNXP)?

Yes. She advised Tonix since 2017 on financings, licensing, commercial agreements, and board matters.

How does this appointment relate to Tonix’s commercial stage (TNXP)?

The hire aligns with commercialization of FDA-approved TONMYA and advancement of Tonix’s CNS, immunology, rare disease, and infectious disease pipeline.