Announcement • Jun 29

Tonix Pharmaceuticals Holding Corp Announces First Patient Enrolled in Phase 2 Horizon Study of TNX-102 SL For Major Depressive Disorder

Tonix Pharmaceuticals Holding Corp. announced that the first participant was enrolled in HORIZON, a potentially pivotal Phase 2 study evaluating the Company's TNX-102 SL 5.6 mg product candidate as a first-line monotherapy in adults with major depressive disorder. HORIZON is a potentially pivotal, randomized, double-blind, placebo-controlled Phase 2 study evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg as a first-line monotherapy in adults with major depressive disorder. Primary endpoint is change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. TNX-102 SL was approved by the U.S. Food and Drug Administration in August 2025 and launched commercially as TONMYA for the treatment of fibromyalgia in adults. HORIZON is a 6-week, randomized, double-blind, placebo-controlled Phase 2 study evaluating TNX-102 SL 5.6 mg as a first-line monotherapy in adults with major depressive disorder. Approximately 360 patients are expected to enroll at approximately 30 sites across the United States. Eligible participants are 18 years of age or older and currently experiencing a moderate to severe major depressive episode. Participants will receive TNX-102 SL 5.6 mg taken sublingually at bedtime or matching placebo. The primary endpoint of the study is the change from baseline in MADRS total score at Week 6. Secondary endpoints include global impression scores, anxiety ratings, and measures of sleep quality and disturbance. TNX-102 SL is a novel sublingual tablet formulation of cyclobenzaprine hydrochloride that enables rapid transmucosal absorption and reduces production of the persistent active metabolite, norcyclobenzaprine, by bypassing first-pass hepatic metabolism. TNX-102 SL is a tertiary amine tricyclic and multifunctional agent with potent binding and antagonist activities at the 5-HT serotonergic, a-adrenergic, H1-histaminergic, and M1-muscarinic receptors. It is currently FDA approved in the U.S. as a once-daily bedtime treatment for fibromyalgia in adults under the brand name TONMYA (cyclobenzaprine HCl sublingual tablets). TNX-102 SL is also in development as a daily bedtime treatment for acute stress disorder/acute stress reaction under an investigator-initiated IND. In addition to major depressive disorder, Tonix also holds active INDs for the following indications for TNX-102 SL: Long COVID (post-acute sequelae of COVID-19), PTSD, alcohol use disorder, and agitation in Alzheimer's disease. The United States Patent and Trademark Office issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10357465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic protective eutectic and Angstro-Technology formulation claimed in the patents are important elements of Tonix's proprietary composition. These patents are expected to provide TNX-102 SL U.S. market exclusivity until 2034. Pending patent applications related to method of use could extend exclusivity until 2044. The potential use of TNX-102 SL in major depressive disorder, acute stress disorder/acute stress reaction, and other unapproved indications is currently under clinical development, and the safety and efficacy have not been evaluated by any regulatory authority. TONMYA is indicated for the treatment of fibromyalgia in adults. TONMYA is contraindicated: In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. With concomitant use of monoamine oxidase inhibitors or within 14 days after discontinuation of an MAO inhibitor. 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. 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. Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to tricyclic antidepressants. 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. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. 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. 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. Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. 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. Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (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 hepatic impairment (Child Pugh B) or severe hepatic impairment (Child Pugh C). Cyclobenzaprine exposure was increased in patients with mild hepatic impairment and moderate hepatic impairment 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., or the FDA.

Announcement • May 26

Tonix Pharmaceuticals Presents Real-World Claims Analysis And Launches TONMYA For Fibromyalgia Treatment

Tonix Pharmaceuticals commercially launched TONMYA in November 2025, the first new fibromyalgia drug for adults in the U.S. approved in over 15 years. Data presented at ISPOR 2026 represent a retrospective, multi-year, multi-cohort study using the Symphony Health closed claims database, encompassing administrative medical and pharmacy claims collected between April 2021 and April 2024. The study’s objective was to evaluate real-world characteristics, including demographics, comorbidities, and healthcare resource utilization among adults diagnosed with fibromyalgia (ICD-10-CM diagnosis code M79.7). The Year 3 cohort (April 2023 to March 2024) included 261,776 adult patients, with a median age of 53 years. Most patients were female (92.1%). Patients were White non-Hispanic (49.6%), Hispanic (22.4%), Other (19.6%), and Black (8.3%). Comorbidity burden was high, with 93.2% of patients having at least one fibromyalgia-related comorbidity, most commonly anxiety/depression (63.9%), dorsalgia/back pain (56.5%), hypertensive diseases (51.4%), and joint pain (48.4%). The medication use reflects reliance on multimodal pharmacologic strategies to manage fibromyalgia-related symptoms in routine clinical practice. TONMYA (cyclobenzaprine HCl sublingual tablets) is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, a1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TONMYA was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. TNX-102 SL is also being developed to treat acute stress disorder/acute stress reaction, and major depressive disorder. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic protective eutectic and Angstro-Technology formulation claimed in the patent are important elements of Tonix’s proprietary TONMYA composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034/2035. TONMYA is indicated for the treatment of fibromyalgia in adults. 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. 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 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. TONMYA monotherapy may cause central nervous system depression. Concomitant use of TONMYA with alcohol, barbiturates, or other central nervous system depressants may increase the risk of central nervous system 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. 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. 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. MAO inhibitors: Life-threatening interactions may occur. Other serotonergic drugs: Serotonin syndrome has been reported. Central nervous system depressants: Central nervous system depressant effects of alcohol, barbiturates, and other central nervous system depressants may be enhanced. Tramadol: Seizure risk may be enhanced.

Snowflake Score
Valuation	5/6
Future Growth	2/6
Past Performance	0/6
Financial Health	5/6
Dividends	0/6

Historical stock prices
Current Share Price	US$11.87
52 Week High	US$31.28
52 Week Low	US$9.40
Beta	1.75
1 Month Change	-0.84%
3 Month Change	4.58%
1 Year Change	-58.51%
3 Year Change	-99.60%
5 Year Change	-99.90%
Change since IPO	-99.90%

	TNXP	US Biotechs	US Market
7D	-9.7%	-5.3%	-1.0%
1Y	-58.5%	37.0%	14.1%

TNXP volatility
TNXP Average Weekly Movement	9.3%
Biotechs Industry Average Movement	9.6%
Market Average Movement	6.9%
10% most volatile stocks in US Market	15.3%
10% least volatile stocks in US Market	2.9%

TNXP fundamental statistics
Market cap	US$210.61m
Earnings (TTM)	-US$159.67m
Revenue (TTM)	US$29.10m

Key profitability statistics from the latest earnings report (TTM)
TNXP income statement (TTM)
Revenue	US$29.10m
Cost of Revenue	US$4.71m
Gross Profit	US$24.40m
Other Expenses	US$184.06m
Earnings	-US$159.67m

Earnings per share (EPS)	-9.31
Gross Margin	83.83%
Net Profit Margin	-548.64%
Debt/Equity Ratio	0%

Data	Last Updated (UTC time)
Company Analysis	2026/09/11 18:28
End of Day Share Price	2026/09/11 00:00
Earnings	2026/06/30
Annual Earnings	2025/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Tonix Pharmaceuticals Holding (TNXP) Stock Overview

Rewards

Risk Analysis

Analyst Price Targets

Fibromyalgia Leadership And Lyme Prevention Pipeline Will Drive Compelling Long Term Upside

Fibromyalgia Launch And Lyme Program Will Redefine Long Term Prospects

Fibromyalgia And Lyme Setbacks Will Pressure Margins Yet Long-Term Pipeline Potential Remains

Top Analyst Narratives

Fibromyalgia Leadership And Lyme Prevention Pipeline Will Drive Compelling Long Term Upside

Fibromyalgia Launch And Lyme Program Will Redefine Long Term Prospects

Fibromyalgia And Lyme Setbacks Will Pressure Margins Yet Long-Term Pipeline Potential Remains

Tonix Pharmaceuticals Holding Corp. Competitors

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Price History & Performance

Recent News & Updates

Tonix Pharmaceuticals Holding Corp. Announces Appointment of Thomas Englese to Chief Commercial Officer, Effective September 8, 2026

Fibromyalgia Launch And Lyme Program Will Redefine Long Term Prospects

Fibromyalgia Leadership And Lyme Prevention Pipeline Will Drive Compelling Long Term Upside

Tonix Pharmaceuticals Holding Corp. Announces Appointment of Seth Lederman as Interim Chief Medical Officer

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) Reported Earnings Last Week And Analysts Are Already Upgrading Their Estimates

Second quarter 2026 earnings: EPS and revenues exceed analyst expectations

Recent updates

Tonix Pharmaceuticals Holding Corp. Announces Appointment of Thomas Englese to Chief Commercial Officer, Effective September 8, 2026

Fibromyalgia Launch And Lyme Program Will Redefine Long Term Prospects

Fibromyalgia Leadership And Lyme Prevention Pipeline Will Drive Compelling Long Term Upside

Tonix Pharmaceuticals Holding Corp. Announces Appointment of Seth Lederman as Interim Chief Medical Officer

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) Reported Earnings Last Week And Analysts Are Already Upgrading Their Estimates

Second quarter 2026 earnings: EPS and revenues exceed analyst expectations

Tonix Delivers A Beat, But The Real Test Starts Now

Fibromyalgia And Lyme Setbacks Will Pressure Margins Yet Long-Term Pipeline Potential Remains

Tonix Pharmaceuticals Announces Positive Minutes From Type C FDA Meeting To Discuss Adaptive Phase 2 Field Study Of TNX-4800, A Human, Anti-OspA Monoclonal Antibody, To Prevent Lyme Disease In The US

Tonix Pharmaceuticals Holding Corp. to Report Q2, 2026 Results on Aug 10, 2026

New minor risk - Share price stability

Tonix Pharmaceuticals Holding Corp. Announces Retirement of Gregory M. Sullivan as Chief Medical Officer, Effective August 20, 2026

Tonix Pharmaceuticals Advances Tnx-801 Live Attenuated Minimally Replicative Investigational Vaccine Candidate Based on Horsepox Virus to Protect Against Mpox Disease

Tonix Pharmaceuticals Holding Corp. Announces Major Managed Medicare Agreement for Tonmya and Expands Pharmacy Coverage

Tonix Pharmaceuticals Enrolls First Patient in Phase 2 Study for Major Depressive Disorder

Tonix Pharmaceuticals Holding Corp Announces First Patient Enrolled in Phase 2 Horizon Study of TNX-102 SL For Major Depressive Disorder

Co-Founder recently bought US$59k worth of stock

Tonix Pharmaceuticals Holding Corp. Announces Publication Of Phase 1 Clinical Data Of TNX-1500 Fc-Modified Anti-CD40L Monoclonal Antibody

Tonix Pharmaceuticals Presents Real-World Claims Analysis And Launches TONMYA For Fibromyalgia Treatment

Consensus revenue estimates decrease by 58%

New minor risk - Share price stability

New minor risk - Profitability

Forecast to breakeven in 2028

Consensus revenue estimates increase by 21%

New minor risk - Profitability

Tonix Pharmaceuticals Holding Corp. Announces Presentation of Phase 1 Data and Plans for an Adaptive Phase 2 Field Study of Tnx-4800

Co-Founder recently bought US$63k worth of stock

New minor risk - Share price stability

Tonix Pharmaceuticals Holding Corp Presents Phase 1 Data And Outlines Planned Adaptive Phase 2 Field Study Of TNX-4800 For Prevention Of Lyme Disease

Tonix Pharmaceuticals Holding Corp Announces First Participant Dosed in Phase 1 Investigator-Initiated Pharmacodynamic Study of TNX-1900

Forecast to breakeven in 2028

Tonix Pharmaceuticals Holding Corp., Annual General Meeting, May 07, 2026

Co-Founder recently bought US$223k worth of stock

Price target decreased by 20% to US$54.33

Full year 2025 earnings: Revenues exceed analysts expectations while EPS lags behind

New major risk - Revenue and earnings growth

Tonix Pharmaceuticals Presents Post Hoc Analyses of Phase 3 Data on TONMYATM at the 8th International Congress on Controversies in Fibromyalgia

Tonix Pharmaceuticals Holding Corp Announces Publication of Clinical Pharmacokinetic Studies of TONMYA and Prototype Formulations in the Journal Clinical Pharmacology in Drug Development

New minor risk - Share price stability

Tonix Pharmaceuticals Holding Corp. Presents Phase 3 RESILIENT Data on TONMYA™ (Cyclobenzaprine HCl Sublingual Tablets) At the 2026 Non-Opioid Pain Therapeutics Summit

Tonix Pharmaceuticals Holding Corp. Announces Program Updates on Tnx-4800 Product Candidate for Protection Against Lyme Disease

Tonix Pharmaceuticals Holding Corp. has filed a Follow-on Equity Offering in the amount of $19.999998 million.

Tonix Pharmaceuticals Holding Corp. Appoints Irina Ishak as General Counsel, Effective December 8, 2025

Consensus EPS estimates upgraded to US$13.03 loss

Will Tonix Pharmaceuticals Holding (NASDAQ:TNXP) Spend Its Cash Wisely?

Tonix Pharmaceuticals Holding Corp. Announces FDA IND Clearance for Phase 2 Study of TNX-102 SL for the Treatment of Major Depressive Disorder

Tonix Pharmaceuticals Announces U.S. Commercial Availability of TONMYA (Cybobenzaprine HCl Sublingual Tablets) as A First-In-Class Fibromyalgia Treatment

Third quarter 2025 earnings: EPS in line with analyst expectations despite revenue beat

Tonix Pharmaceuticals Holding Corp. Presents Data on Tonmya at the 2025 American College of Rheumatology Convergence

Tonix Pharmaceuticals Holding Corp. Announces First Patient Dosed in the Investigator-Initiated FOCUS Study of Tonix’s Intranasal Potentiated Oxytocin in AVP-D Conducted by Massachusetts General Hospital

Tonix Pharmaceuticals Holding Corp. Presents Data on TNX-801 Mpox Vaccine at World Vaccine Congress-Europe 2025

Tonix Pharmaceuticals Holding Corp. Appoints Ganesh Kamath as Head of Market Access, Effective September 29, 2025

Tonix Pharmaceuticals Holding Corp. Plans to Initiate Prader-Willi Syndrome Phase 2 Trial of Tnx-2900 (Intranasal Potentiated Oxytocin) in 2026

Tonix Pharmaceuticals Holding Corp. Announces Positive Pre-IND Meeting with FDA for TNX-102 SL for the Treatment of Major Depressive Disorder

Tonix Pharmaceuticals Holding Corp. Presents Clinical Data on Tonmya for the Treatment of Fibromyalgia at PAINWEEK 2025