TNXP US Equity☆

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

WASHINGTON,

D.C. 20549

FORM

10-K

(Mark

One)

☒

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For

the Fiscal Year Ended December 31, 2025

☐

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission

File Number 001-36019

TONIX

PHARMACEUTICALS HOLDING CORP.

(Exact

name of registrant as specified in its charter)

200 Connell Drive, Suite 3100 Berkeley Heights, New Jersey 07928

(Address of principal executive office) (Zip Code)

(862) 799-8599 (Registrant’s telephone number, including area code)

Securities

registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol Name of each exchange on which registered

Common Stock, $0.001 par value TNXP The NASDAQ Stock Market LLC

Securities

registered pursuant to Section 12(g) of the Act: None

Indicate

by check mark if the registrant is a well-known seasoned issuer, as defined by Rule 405 of the Securities Act. Yes ☐ No

☒

Indicate

by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒

Indicate

by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange

Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),

and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate

by check mark whether the registrant has submitted electronically, if any, every Interactive Data File required to be submitted

pursuant to Rule 405 of Regulation S-T (§ 229.405 of this chapter) during the preceding 12 months (or for such shorter period

that the registrant was required to submit such files). Yes ☒ No ☐

Indicate

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting

company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,”

“smaller reporting company,” and an “emerging growth company” in Rule 12b-2 of the Exchange Act

Large accelerated filer ☐ Accelerated filer ☐

Non-accelerated filer ☒ Smaller reporting company ☒

Emerging growth company ☐

If

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for

complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate

by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness

of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered

public accounting firm that prepared or issued its audit report. ☐

If

securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the

registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

n

Indicate

by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation

received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).

☐

Indicate

by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The

aggregate market value of the voting common equity held by non-affiliates as of June 30, 2025, based on the closing sales price

of the common stock as quoted on The NASDAQ Stock Market was $271,370,839. For purposes of this computation, all officers and

directors are deemed to be affiliates.

As

of March 11, 2026, there were 13,405,401shares of registrant’s common stock outstanding.

DOCUMENTS

INCORPORATED BY REFERENCE

None.

TABLE

OF CONTENTS

PAGE

PART I

Item 1. Business 3

Item 1A. Risk Factors 59

Item 1B. Unresolved Staff Comments 84

Item 1C. Cybersecurity Disclosures 85

Item 2. Properties 85

Item 3. Legal Proceedings 86

Item 4. Mine Safety Disclosures 86

PART II

Item 6. Reserved 87

Item 7A. Quantitative and Qualitative Disclosures about Market Risk 93

Item 8. Financial Statements and Supplementary Data F-1 – F-29

Item 9A. Controls and Procedures 99

Item 9B. Other Information 100

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 100

PART III

Item 10. Directors, Executive Officers and Corporate Governance 101

Item 11. Executive Compensation 108

Item 14. Principal Accounting Fees and Services 119

PART IV

Item 15. Exhibits, Financial Statement Schedules 120

2

PART

I

ITEM

1 – BUSINESS

This

Annual Report on Form 10-K (including the section regarding Management’s Discussion and Analysis of Financial Condition and

Results of Operations) contains forward-looking statements regarding our business, financial condition, results of operations and

prospects. All statements contained in this Annual Report other than statements of historical fact, including, but not limited to,

statements regarding the launch and commercialization of TONMYA and our migraine products, our future results of operations and

financial position, business strategy, market size, potential growth opportunities, clinical and nonclinical development activities,

efficacy and safety profile of our marketed products and product candidates, potential therapeutic benefits and economic value of

TONMYATM, our migraine products and our product candidates, our ability to market and sell our products while maintaining full

compliance with applicable federal and state laws, rules and regulations, the timing and results of nonclinical studies and clinical

trials, the potential impact of global business or macroeconomic conditions, including as a result of inflation, changing interest

rates, cybersecurity incidents, significant political, trade or regulatory developments and global regional conflicts on our

operations, and the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates.

Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,”

“seeks,” “estimates” and similar expressions or variations of such words are intended to identify

forward-looking statements, but are not deemed to represent an all-inclusive means of identifying forward-looking statements as

denoted in this Annual Report on Form 10-K. Additionally, statements concerning future matters are forward-looking

statements.

Although

forward-looking statements in this Annual Report on Form 10-K reflect the good faith judgment of our management, such statements

can only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject

to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or

anticipated by the forward-looking statements. Factors that could cause or contribute to such differences in results and outcomes

include, without limitation, those specifically addressed under the heading “Risks Factors” below, as well as those

discussed elsewhere in this Annual Report on Form 10-K. Readers are urged not to place undue reliance on these forward-looking

statements, which speak only as of the date of this Annual Report on Form 10-K. We file reports with the Securities and Exchange

Commission (“SEC”). You can read and copy any materials we file or will file with the SEC, which, among other places,

can be found on the SEC’s website at http://www.sec.gov, as well as on our corporate website at www.tonixpharma.com).

We

undertake no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that

may arise after the date of this Annual Report on Form 10-K. Readers are urged to carefully review and consider the various disclosures

made throughout the entirety of this Annual Report, which attempt to advise interested parties of the risks and factors that may

affect our business, financial condition, results of operations and prospects.

3

Business

Overview

We (“Tonix” or the “Company”) are a fully-integrated

biopharmaceutical company commercializing and developing innovative therapies for central nervous system (“CNS”) disorders,

immunology, infectious diseases, and rare diseases. Our portfolio consists of commercial, development and discovery-stage programs. In

August 2025, we received approval from the U.S. Food and Drug Administration (“FDA”) for TONMYA for the treatment of fibromyalgia

in adults. TONMYA is our first internally developed product to receive FDA approval. We hold worldwide commercialization rights to TONMYA, a centrally acting, non-opioid analgesic designed for bedtime administration and long-term use.

We launched TONMYATM (cyclobenzaprine HCl sublingual tablets) for

the treatment of fibromyalgia in adults on November 17, 2025. TONMYA is the first new medicine for fibromyalgia in more than 15 years.

In addition to TONMYA, we market two FDA-approved prescription products for the treatment of acute migraine: Zembrace® SymTouch®

(sumatriptan injection) and Tosymra® (sumatriptan nasal spray). Our commercial platform includes sales, marketing, market access,

distribution, and patient support capabilities. We have generated a diversified pipeline of development candidates through internal discovery,

in-licensing, acquisitions, and collaborations with, commercial, academic and non-profit institutions. With commercial operations established

and a broad development portfolio, our strategy is to grow TONMYA into a leading therapy for fibromyalgia, advance pipeline programs,

and pursue strategic business development opportunities.

Our development pipeline includes multiple programs in clinical and preclinical development.

The proprietary cyclobenzaprine HCl sublingual tablet formulation contained

in TONMYA is referred to as “TNX-102 SL” outside of the fibromyalgia indication. We are exploring the utility of TNX-102

SL (cyclobenzaprine HCl sublingual tablets) in Phase 2 clinical trials for major depressive disorder (“MDD”) and acute stress

disorder (“ASD”) and acute stress reaction (“ASR”). TNX-102 SL is being developed to treat ASR and ASD under an

Investigator-Initiated investigational new drug application (“IND”) at the University of North Carolina (“UNC”)

in the ongoing OASIS study for which UNC received funding from the U.S. Department of Defense (“DoD”). A Phase 2 study of

TNX-102 SL for MDD is expected to commence mid-2026 under a Tonix IND that has been cleared by the FDA.

Our clinical stage programs

also include:

Our pre-clinical programs

include:

With

commercial operations established and a broad development portfolio advancing, our strategy is to grow TONMYA into a

leading therapy for fibromyalgia, advance pipeline programs, and pursue strategic business

development opportunities.

Our commercial portfolio

of FDA-approved medicines includes:

TONMYA

(cyclobenzaprine HCl sublingual tablets) – Fibromyalgia

TONMYA,

a proprietary sublingual formulation of cyclobenzaprine designed for bedtime dosing and long-term use, is approved in the United

States for the treatment of fibromyalgia in adults and was launched in November 2025. TONMYA was approved under the 505(b)(2)

pathway based on three Phase 3 studies, including two studies that demonstrated statistically significant improvement in pain

compared with placebo. Clinical studies showed rapid onset of benefit, sustained efficacy, and a safety profile consistent with

known cyclobenzaprine effects, with the most common adverse events being transient local oral reactions.

4

TONMYA

is designed to target the non-restorative sleep that we believe is central to fibromyalgia pathophysiology. TONMYA’s sublingual

formulation is designed for transmucosal delivery to bypass first-pass hepatic metabolism, which reduces formation of norcyclobenzaprine,

the persistent active metabolite that we believe interferes with the duration of any treatment effects from oral, swallowed cyclobenzaprine.

The sublingual, transmucosal formulation results in a distinct pharmacokinetic profile compared to oral cyclobenzaprine, with

greater relative bioavailability of the parent drug and reduced active metabolite exposure during sleep.

We commercialize TONMYA through

our sales organization, which includes an internal sales force, and a contracted salesforce, non-personal promotion, digital engagement,

market access programs, patient support services, and distribution through national wholesalers and specialty distributors. We are focused

on obtaining payer coverage, building physician awareness, and driving adoption primarily in practices that have a history of diagnosing

and treating fibromyalgia, which includes rheumatology, primary care, pain management and neurology practices.

We have contracted for two commercial supply sources of TONMYA, one of

which is Almac Pharma Services, a member of the privately owned Almac Group.

We are pursuing lifecycle management strategies for TONMYA, including potential

label expansion, real-world evidence generation, and geographic expansion.

Zembrace®

SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray) - Migraine Franchise

Zembrace

SymTouch (sumatriptan injection) 3 mg is a low-dose autoinjector designed for ease of use and rapid onset of action. Zembrace

is the only branded sumatriptan autoinjector actively promoted in the United States and has patent protection into 2036. Tosymra

(sumatriptan nasal spray) 10 mg is a rapid-acting intranasal formulation using Intravail® permeation enhancer technology

with patent protection into 2031. Effective January 1, 2026, Tosymra has preferred exclusive placement on a payer formulary representing

approximately 16 million covered lives.

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. Tosymra is a novel intranasal sumatriptan product formulated with a permeation enhancer

that provides rapid and efficient absorption of sumatriptan. Tosymra was approved on the basis of bioequivalence to subcutaneous

(s.c.) sumatriptan. Tonix Medicines is the only manufacturer with both a branded injectable and nasal spray indicated for

the acute treatment of migraine with or without aura in adults.

Development

Pipeline

Central

Nervous System

In September 2025, we

announced the successful completion of a Type B Pre-IND meeting with the FDA regarding the development of TNX-102 SL for the treatment

of MDD. We received positive feedback from the FDA and plan to pursue a supplemental new drug application (“sNDA”) to expand

the therapeutic indication of TNX-102 SL to include MDD, based on exploratory findings suggesting that improving sleep quality may positively

impact depressive symptoms.

In November 2025, we announced

the FDA cleared the IND application to support clinical development of TNX-102 SL 5.6 mg for the treatment of MDD in adults. The unique

pharmacological profile of TNX-102 SL is designed to target the disturbed sleep which is often associated with depression. Prior studies

of TNX-102 SL in fibromyalgia and post-traumatic stress disorder (“PTSD”) showed promising signals for improvement of depressive

symptoms on the Beck Depression Inventory-II and the Montgomery-Åsberg Depression Rating Scale (“MADRS”), respectively.

The IND clearance enables Tonix to proceed with a potentially pivotal Phase

2 HORIZON study, a 6-week, randomized, double-blind, placebo-controlled study of TNX-102 SL as a first-line monotherapy in adults with

MDD. About 360 patients will be enrolled at approximately 30 U.S. sites. Eligible participants are 18 years or older and currently experiencing

a moderate to severe major depressive episode. The study will compare TNX-102 SL 5.6 mg, taken sublingually at bedtime, to placebo, with

the primary endpoint being the MADRS total score change from baseline at Week 6. Secondary endpoints include global impression scores,

anxiety ratings, and measures of sleep disturbance. We plan to initiate enrollment of the study in mid-year 2026.

5

TNX-102 SL also is being

developed as a treatment for ASR and ASD under an investigator-initiated IND with the University of North Carolina Institute for Trauma

Recovery.

In

addition, TNX-102 SL has active INDs for the treatment of PTSD, agitation in Alzheimer’s disease (“AAD”), alcohol

use disorder (“AUD”) and the management of multi-site pain associated with Long COVID (also known as Post-Acute SARS-CoV-2

or PASC). TNX-102 SL for AAD has been granted Fast Track designation by the FDA. We are currently not actively studying TNX-102

SL in PTSD, AAD, Long COVID or AUD, and are continuously evaluating further indications for which TNX-102 SL could potentially

provide benefit.

We are also developing TNX-1300 (double-mutant cocaine esterase), which

is in Phase 2 for the treatment of cocaine intoxication. TNX-1300 has been granted Breakthrough Therapy designation by the FDA. TNX-1300

was licensed from Columbia University in 2019 after a Phase 2 study showed that it rapidly and efficiently disintegrates cocaine in the

blood of volunteers who received intravenous (i.v.) cocaine. We received a Federal Grant from the U.S. National Institute on Drug

Abuse (“NIDA”), a part of the U.S. National Institutes of Health (“NIH”), to advance the development of TNX-1300

as a treatment for cocaine intoxication, and the funding period is now completed. Because of the challenges of recruiting eligible patients

into a Phase 2 study, we terminated that study and intend to meet with the FDA in 2026 to inform the clinical design of our next Phase

2 study.

We

are developing TNX-1900 (intranasal potentiated oxytocin) for several CNS disorders through investigator-initiated studies. TNX-1900

is in development through investigator-initiated studies at Massachusetts General Hospital (“MGH”) for the treatment of binge

eating disorder (“BED”), adolescent obesity, bone health in pediatric autism, and arginine-vasopressin deficiency.

Finally,

in December 2025, we in-licensed TNX-4900, formerly known as PW507, from Rutgers University. TNX-4900 is a highly selective

S1R antagonist with demonstrated analgesic activity in multiple models of neuropathic pain. TNX-4900 is in the pre-IND stages

of development.

Immunology

and Infectious Disease

Our lead candidate in the infectious disease pipeline is TNX-4800. Tonix

in-licensed worldwide rights to TNX-4800 (formerly known as mAb 2217LS), in September 2025. TNX-4800 is a long-acting fully human monoclonal

antibody that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the causative agent of Lyme disease in humans.

TNX-4800 is being developed for annual seasonal use and was invented and developed by researchers at UMass Chan Medical School, which

has licensed the technology to Tonix. There are currently no FDA-approved vaccines or prophylactics to protect against Lyme disease.

TNX-4800 has an engineered extended half-life and targets the outer-surface

protein A (OspA) on Lyme-causing Borrelia bacteria. By binding OspA when TNX-4800 containing blood is ingested by the tick, TNX-4800

kills and blocks the maturation of Borrelia burgdorferi in the mid-gut of infected deer ticks. Published work in non-human primates

showed that TNX-4800 was 95% effective in preventing infection after 6 days of exposure to ticks infected with Borrelia burgdorferi.

TNX-4800 was derived from mAb 2217 by amino acid substitutions in its crystallizable fragment (Fc) domain which served to prolong the

serum half-life. A single administration in the Spring is designed to provide onset of immunity within two days and maintain protective

antibody titers for the entire tick season, providing pre-exposure prophylaxis against Lyme disease without relying on the recipient’s

immune system to generate antibodies. By delivering a well-characterized antibody directly, TNX-4800 has been shown to block transmission

of the major Borrelia genospecies from ticks to animals. TNX-4800 also sidesteps the elaborate immunization schedules required

for OspA vaccines in development and an FDA-approved vaccine that was withdrawn from the market. Tonix intends to advance TNX-4800 through

additional clinical trials with the goal of submitting a Biologics Licensing Application (BLA) to the FDA.

We

intend to meet with the FDA in 2026 to explore Phase 2/3 development options for TNX-4800, including a Phase 2 field study and a

Phase 2 human challenge study. The proposed field study would test TNX-4800 for prevention of Lyme in volunteers at risk for Lyme in

regions of the U.S. where Lyme is endemic. The proposed challenge study – also called a controlled human infection model

(“CHIM”) study – would test the ability of TNX-4800 to protect against Borrelia infection by exposing

treated or control volunteers to Borrelia-infected ticks that mimic natural infection. Pending clearances from FDA, we plan

to initiate the Phase 2 field study in 2027 and the Phase 2 human challenge study in 2028. Production of investigational product

under GMP is underway to enable initiation of the field early in 2027, pending FDA clearance. In animals, TNX-4800 provides

protection in approximately two days against the bacteria that causes Lyme disease after a single administration. The passive

immunity conferred by TNX-4800 is very different from the active immunity conferred by vaccines in development to protect against

Lyme disease in that TNX-4800 kills and blocks the metamorphic-like transformation of Borrelia in the tick’s

midgut, preventing transmission of the bacteria, whereas vaccines illicit an immune response in the body of a vaccinated person. Prophylaxis with TNX-4800 may also mitigate some of the limitations of vaccine products designed to actively immunize

against Lyme, including suboptimal immune responses due to age, immunocompetence, and other reasons.

6

Within immunology, we are developing TNX-1500, an Fc-modified humanized

mAb, directed against CD40-ligand (CD40L, also known as CD154). TNX-1500 was engineered to modulate binding to Fc receptors with the goal

of maintaining the activity of first-generation mAbs, yet with reduced risk of thrombotic complications. TNX-1500 is being developed to

prevent organ transplant rejection as well as to treat autoimmune conditions. Topline results from a Phase 1 single ascending dose escalation

study at 3 mg/kg, 10 mg/kg and 30 mg/kg of TNX-1500 in healthy volunteers were reported in the first quarter of 2025. Pharmacokinetic

results showed mean half-life (t1/2) for the 10 mg/kg and 30 mg/kg dose groups of 34-38 days, consistent with monthly dosing.

In healthy volunteers, TNX-1500 was generally well-tolerated with a favorable safety profile. Anti-CD40L has multiple potential indications

in addition to solid organ and bone marrow transplantation including autoimmune diseases. In November 2025, we announced an investigator-initiated

study with MGH, a founding member of Mass General Brigham (“MGB”), to conduct a Phase 2 clinical trial evaluating TNX-1500

in kidney transplant recipients. The investigator-initiated study will be led by Ayman Al Jurdi, M.D., at MGH and is designed to assess

the safety, tolerability and activity of Fc-modified anti-CD40L mAb TNX-1500 in preventing kidney transplant rejection while significantly

minimizing the dose of conventional immunosuppressive drugs, which are associated with infection, cancer, cardiovascular side effects

and various metabolic derangements. The study is expected to be initiated mid-year 2026 pending FDA clearance of the IND.

Our

immunology pipeline also includes TNX-1700, a recombinant Trefoil Factor Family 2 fused to human serum albumin (“hTFF2-HSA”)

that was licensed from Columbia University in 2019. TNX-1700 is an immunotherapy being developed to treat gastric and colorectal cancers,

in combination with PD-1 blockers, and is at the preclinical stage of development. Results of preclinical testing demonstrated that a

mouse version of TNX-1700 was able to evoke an increase in anti-tumor immunity in combination with anti-PD-1 in several mouse models

of gastric cancer by reducing immunosuppressive neutrophils and activating anti-tumoral CD8+ T cell responses. TNX-1700 as both monotherapy

and in combination with anti-PD-1 was also able to dramatically reduce metastasis and increase survival in these models. TNX-1700 also

exhibits efficacy in various mouse models of colorectal cancer in combination with anti-PD-1. An INTERACT (INitial Targeted Engagement

for Regulatory Advice on CBER/CDER ProducTs) meeting was held with the FDA in 2025 and received constructive early guidance on program

development.

Our infectious disease portfolio includes vaccines based on our live virus

vaccine or recombinant pox vaccine (“RPV”) platform. Live virus vaccines are believed to protect against poor clinical outcomes

of infectious diseases by eliciting T-cell responses in addition to antibody responses. TNX-801, a live minimally replicative vaccine

based on synthesized horsepox, is in the pre-IND stage of development to protect against smallpox and mpox. Preclinical data/studies demonstrate

that TNX-801, regardless of route of administration (i.e. intradermal, subcutaneous or intramuscular), provided 100% protection against

vaccinia virus and monkeypox virus challenge in terms of both mortality and clinical disease (lesions) in a highly sensitive rabbitpox

model.

TNX-801 also serves as the live virus vaccine platform for other infectious

diseases, for which subsequent products will be designed by expressing other viral antigens in the horsepox vector. Our GMP-capable advanced

manufacturing facility in Dartmouth, Massachusetts was purpose-built to manufacture TNX-801. The GMP suites are currently decommissioned

and may be reactivated on the earlier of 2027 or in the case of a national or international emergency.

We are developing a potential broad-spectrum antiviral CD45-targeted therapeutic

(TNX-4200). The DoD announced in December 2022 a plan to move beyond a “one bug, one drug” approach and is seeking

broad-spectrum drugs as it may be hard to predict which or how many viruses may be deployed on the battlefield.

In

July 2024, we were awarded a contract with a potential for up to $34 million over five years by DTRA. The objective of the contract is to develop small molecule broad-spectrum

antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological

threat environments. The program focuses on optimization and development of TNX-4200 to develop an orally available CD45 antagonist

with broad-spectrum efficacy against a range of viral families through preclinical evaluation. The program is expected to establish

physicochemical properties, pharmacokinetics, and safety attributes to support an IND submission and to fund a first-in-human

Phase 1 clinical study. Tonix plans to leverage previous research on phosphatase inhibitors, specifically compounds that target

CD45, to optimize lead compounds for therapeutic intervention of biothreat agents and provide the government with a complete and

cost-effective solution for a broad-spectrum medical countermeasure. We believe that partial inhibition of CD45

will provide optimal antiviral protection while requiring lower plasma drug concentrations, a lower dose, and a better safety

profile.

We will utilize our state-of-the-art

research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and Animal Biosafety Level 3 (ABSL-3) facility, in Frederick,

Maryland (“RDC”), as well as experienced in-house personnel, to develop vaccines and antiviral therapies for mpox, smallpox

and other infectious diseases. We intend to collaborate with academic partners to test the efficacy of CD45 inhibitor compounds against

multiple viral select agents using BSL-4 facilities.

7

Rare

Disease Pipeline

Our rare disease portfolio consists of TNX-2900 (intranasal potentiated oxytocin) for Prader-Willi syndrome (“PWS”),

a rare genetic disorder and the leading cause of life-threatening childhood obesity, affecting about 1 in 10,000 to 1 in 30,000

births. Infants often present with poor muscle tone and feeding difficulties, while children and adolescents develop hyperphagia,

behavioral challenges, and severe obesity and metabolic disease. Current interventions are difficult to sustain and often inadequate.

The formulation technology for TNX-2900 was acquired from Trigemina, Inc. and licensed from Stanford University in 2020. The potentiated

formulation includes magnesium, which has been shown in animal studies to potentiate binding of oxytocin to the oxytocin receptor.

The therapeutic technology was licensed from Inserm, the French National Institute of Health and Medical Research. TNX-2900 was

granted Orphan-Drug Designation by the FDA in the second half of 2023, and the IND was cleared by the FDA in the fourth quarter

of 2023, and received Rare Pediatric Disease Designation in March 2024, which would make us eligible for a transferable Priority

Review Voucher upon approval.

We

plan to progress our TNX-2900 program for the treatment of PWS into a Phase 2, randomized, double-blind, placebo-controlled,

parallel-design study to evaluate the safety, tolerability, and efficacy of TNX-2900 in male and female participants with PWS,

ages 8 to 17.5 years. Eligible participants will be randomized to receive 12-weeks of treatment with TNX-2900 at one of three

dose levels, or placebo, in a 1:1:1:1 ratio. The primary efficacy endpoint will be the change from baseline in the validated Hyperphagia

Questionnaire for Clinical Trials (HQ-CT), a widely used measure of hyperphagia severity in PWS. Secondary objectives will include

assessments of behavior, caregiver burden, and quality of life measures, as well as safety and tolerability outcomes. We intend

to initiate enrollment in this study in the first quarter of 2027.

Facilities

Relating to our development programs, we own and operate the RDC in Frederick,

Maryland consisting of one building totaling approximately 48,000 square feet. The RDC conducts research on CNS, immunology, and infectious

disease candidates. The RDC facility is mostly biosafety level 2 (BSL-2), with some components designated BSL-3. We also own an Advanced

Development Center (“ADC”) located in the New Bedford business park in Dartmouth, Massachusetts. This approximately 45,000

square foot BSL-2 facility is intended to accelerate development, clinical and commercial scale manufacturing of live-virus vaccines and

biologics to support clinical trials. This facility was decommissioned in 2024, and may be reactivated on the earlier of 2027 or in the

case of a national or international emergency.

We

are led by a management team with significant industry experience in commercialization and drug development. We complement our

management team with a network of scientific, clinical, and regulatory advisors that includes recognized experts in their respective

fields.

Our

Strategy

Our

strategy is to use our integrated development and marketing capabilities to advance innovative programs across multiple therapeutic

areas through the drug development process, with the ultimate objectives of FDA approval and commercialization. The principal

components of our strategy are to:

8

Disease

and Market Overview

Our

product candidates address disorders that are not well served by currently available therapies or have no approved treatment which

represent large potential commercial market opportunities. Background information on the disorders and related commercial markets

that may be addressed by our product candidates in or nearing the clinical stage of development is set forth below.

Central

Nervous System

Fibromyalgia

(FM)

Fibromyalgia

is a common chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous

system, called central sensitization. Brain imaging studies have localized the functional disorder to the brain’s insular

and anterior cingulate cortex. Fibromyalgia afflicts more than 10 million adults in the U.S., the majority of whom are women.

Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction).

Other associated symptoms include mood disturbances, including depression, anxiety, headaches, and abdominal pain or cramps. Individuals

suffering from fibromyalgia often struggle with their daily activities, have impaired quality of life, and frequently are disabled.

Physicians and patients report common dissatisfaction with currently marketed products. Fibromyalgia is now recognized as the

prototypic nociplastic syndrome. Nociplastic pain is the third primary type of pain in addition to nociceptive pain and neuropathic

pain. Many patients present with pain syndromes that are combinations of the three primary types of pain. Nociplastic syndromes

can involve components of both central and peripheral sensitization. Fibromyalgia can occur without any identifiable precipitating

event. However, many fibromyalgia cases follow one or more precipitating event(s) including: chronic nociceptive or neuropathic

pain states; recovery from an infectious illness; a cancer diagnosis or cancer treatment; a metabolic or endocrine stress; or

a traumatic event. In the case of recovery from an infectious illness, fibromyalgia is considered an Infection-Associated Chronic

Condition. In addition to fibromyalgia cases associated with other conditions or stressors, the U.S. National Academies of Sciences,

Engineering, and Medicine, has concluded that fibromyalgia is a diagnosable condition that occurs after recovery from COVID

in the context of Long COVID. Fibromyalgia is also recognized as a Chronic Overlapping Pain Condition, due to shared symptoms

with chronic fatigue syndrome/myalgic encephalomyelitis, irritable bowel syndrome, endometriosis, low back pain, post-concussive

syndrome (also known as mild traumatic brain injury), chronic Lyme disease, chronic diabetic neuropathy and chronic post-herpetic

neuralgia.

9

We

believe that diagnosing fibromyalgia in Long COVID patients will increase the potential market for TNX-102 SL as compared to market

estimates from before the COVID-19 pandemic. Tonix has previously presented its analysis of real-world evidence from the TriNetX

claims database suggesting that over 40% of Long COVID patients present with a constellation of symptoms that overlap with fibromyalgia.

Based

on market research which we commissioned, despite the availability of approved medications, the majority of patients fail therapy due to either

insufficient efficacy, poor tolerability, or both. Prescription pain and sleep medications, including opioids, are frequently

prescribed off-label for symptomatic relief, despite the lack of evidence that such medications provide a meaningful or durable

therapeutic benefit, and many of these medications carry significant safety risks and risk of dependence. For example, based on U.S.

claims data, approximately 50% of patients diagnosed with FM are prescribed opioids within 18 months of diagnosis, despite the lack

of evidence for their effectiveness and the risk of addiction and toxicity, including overdose.

Major

Depressive Disorder

MDD is a prevalent and serious psychiatric illness that affects adults of all ages, races, and backgrounds.

It is characterized by persistent feelings of sadness or loss of interest, along with symptoms such as sleep and appetite disturbances,

fatigue, difficulty concentrating, and thoughts of worthlessness or suicide. These symptoms must last at least two weeks and significantly

impair daily functioning. In the United States, more than 21 million adults experience a major depressive episode each year. While

several antidepressant medications are available, many individuals do not achieve adequate relief or discontinue treatment due

to side effects like weight gain, sleep disruption, and sexual dysfunction. MDD is associated with increased risk of suicide and

substantial impairment in quality of life, underscoring the urgent need for new, first-line therapies that are both effective

and well-tolerated.

Acute

Stress Disorder and Acute Stress Reaction

ASD

is a mental health condition that can occur within the first month of experiencing a traumatic event. The symptoms are similar

to those of PTSD and can affect both civilian and military populations. ASR is a transient, often severe, emotional and physical response

occurring minutes to days after a traumatic event, such as assault, disaster, or accident. Symptoms include anxiety, flashbacks, numbness,

and insomnia, typically resolving within a few days or up to one month. According to the National Center for PTSD, in the U.S.

about 60% of men and 50% of women experience at least one trauma in their lives. In the U.S. alone, one-third of emergency department

visits (40-50 million patients per year) involve evaluation after trauma exposures, and in a 2014 study involving U.S. veterans,

87% reported exposure to at least one potentially traumatic event during their service. No medications are currently available

at or near the point of care to treat patients suffering from acute traumatic events and to support long-term health.

Cocaine

Intoxication

Cocaine

is an illegal recreational drug taken for its pleasurable effects and associated euphoria. Pharmacologically, cocaine blocks the

reuptake of the neurotransmitter dopamine from central nervous system synapses, resulting in the accumulation of dopamine within

the synapse and an amplification of dopamine signaling that is related to its role in creating positive feeling. With the continued

use of cocaine, however, intense cocaine cravings occur resulting in a high potential for abuse and addiction, or dependence,

as well as the risk of cocaine intoxication. Cocaine intoxication refers to the deleterious effects on other parts of the body,

especially those involving the cardiovascular system. Common symptoms of cocaine intoxication include tachyarrhythmias and elevated

blood pressure, either of which can be life-threatening. As a result, individuals with known or suspected cocaine intoxication

are sent immediately to the emergency department, preferably by ambulance in case cardiac arrest occurs during transit. There

are approximately 505,000 emergency room visits for cocaine abuse each year in the U.S., of which 61,000 require detoxification

services. According to the National Institute on Drug Abuse, cocaine-involved deaths rose nearly 54% from 2019 to 2021, resulting

in over 24,486 deaths total.

Immunology

Organ

Transplant Rejection

Organ

transplant rejection occurs when the immune system of the organ recipient attacks the new organ as if it was an infection or tumor.

Often transplantation is the last resort for most end-stage organ failure patients, affecting either kidneys, liver, heart, lungs,

and/or pancreas. Genetic disparity between organ donor and recipient is often at the root of the rejection. Mismatched or not

closely matched organs trigger an immune reaction that leads to rejection. Overcoming this difficulty is paramount to a patient’s

survival as organ donations are in limited supply.

10

Gastric

and Colorectal Cancers

Gastric

or stomach cancer is a disease in which malignant cancer cells line the inner lumen of the stomach. Development of this form of

cancer is often influenced by age, diet and other stomach diseases. This type of cancer begins to form in the mucosa, the surface

of the lumen that is in direct contact with the contents of the stomach, and spreads through the outer layers of the stomach as

the tumor grows.

Currently,

per the National Cancer Institute, the 5-year relative survival for stomach cancer is 36.4%. According to 2018-2021 data, approximately

0.8 percent of men and women will be diagnosed with stomach cancer during their lifetime. In 2021, there were an estimated 130,263

people living with stomach cancer in the U.S. As of 2024, there were approximately 26,890 new cases with 10,880 deaths.

Colorectal

cancer includes cancers in the colon and the rectum, organs that are crucial to absorption of water by the body and the elimination

of food-waste. Most colorectal cancers start as a growth or polyp on the inner lining of the colon or rectum. Some types of polyps

can change into cancer over time (usually many years), but not all polyps become cancer. Adenomatous polyps are the ones that

turn malignant with time. Similar to gastric cancer, malignancy begins in the mucosal layer and spreads outwards.

The

5-year relative survival rate with colorectal cancer is 65.0%, per the National Cancer Institute. Based on 2018-2021 data, approximately

4.0 percent of men and women will be diagnosed with colorectal cancer during their lifetime. In 2021, there were an estimated

1,392,445 people living with colorectal cancer in the United States. As of 2024, there were approximately 152,810 new cases with

53,010 deaths. It is the 3rd leading cause of cancer death in women, and 2nd in men.

Infectious

Diseases

Lyme

Disease

Lyme

disease is caused by the bacterium Borrelia burgdorferi. Lyme disease remains the most common vector-borne infection in the United

States and its incidence is climbing each year. It occurs most commonly in the Northeast, mid-Atlantic, and upper-Midwest regions. Lyme

disease bacteria are transmitted through the bite of infected Ixodes ticks. Typical symptoms include fever, headache, fatigue, and a

characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, the heart, and the nervous system.

Laboratory testing is helpful if used correctly and performed with FDA-cleared tests.

Smallpox

and Mpox

Smallpox

is an acute contagious disease caused by the variola virus, or VARV, which is a member of the orthopoxvirus family. Smallpox was

declared eradicated in 1980 following a global immunization campaign. Smallpox is transmitted from person to person by infective

droplets during close contact with infected symptomatic people. Mpox is an acute contagious disease caused by the monkeypox virus

or MPXV, which is also a member of the orthopoxvirus family. Mpox symptoms are similar to those of smallpox, although less severe.

Mpox is emerging as an important zoonotic infection in humans in Central and West Africa. Until 2022, only a few cases of mpox

had been reported outside of Africa in patients who had been infected while in Africa. Starting in May of 2022, mpox clade II

cases spread rapidly in the U.S. and other countries. The Clade II mpox affects mostly men who have sex with men in the U.S.,

where it has become endemic. In August 2024, the World Health Organization (“WHO”) declared mpox Clade Ib to be a

public health emergency of international concern (“PHEIC”) due to an outbreak in the Democratic Republic of the Congo

that spread globally, including to the United States. Clade Ib affects children as well as adults. Although PHEIC designation

has been lifted by WHO, mpox continues to spread in Africa and mutations of the virus are considered by public health experts

to be an ongoing threat to be monitored for new epidemic spread.

Smallpox

was eradicated by a World Health Organization program that vaccinated individuals with live replicating vaccinia vaccines wherever

smallpox appeared. In the 1970s, vaccination of civilians to protect against smallpox was discontinued in the U.S.; however, smallpox

remains a material threat to national security and a proportion of military personnel, including members of the Global Response

Force continue to be vaccinated. Vaccines for smallpox and mpox are stockpiled by the U.S. government in the strategic national

stockpile and for potential widespread immunization in the event of malicious reintroduction of VARV. The U.S. National Academy

of Sciences has recently issued a consensus report raising concerns about the state of new mpox vaccines in development.

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Rare

Disease

Prader-Willi

Syndrome

PWS

is recognized as the most common genetic cause of life-threatening childhood obesity and affects males and females with equal

frequency and all races and ethnicities. PWS results from the absence of expression of a group of genes, specifically related to the

MAGE (melanoma antigen) gene family on the Prader–Willi critical region (15q11–q13) on the paternally acquired

chromosome. The hallmarks of PWS are lack of suckling in newborns and, in children and adolescents, severe hyperphagia – an

overriding physiological drive to eat, leading to severe obesity and other complications associated with significant mortality. A

systematic review of the morbidity and mortality as a consequence of hyperphagia in PWS found that the average age of death in PWS

was 22.1 years. Given the serious or life-threatening manifestations of these conditions, there is a critical need for effective

treatments to decrease morbidity and mortality, improve quality of life, and increase life expectancy in people with PWS. Oxytocin

has potent effects in correcting behavioral characteristics of the MAGEL2 knock-out mouse model for PWS and autism. Six clinical

trials have investigated intranasal oxytocin as a treatment in pediatric patients with PWS. Four clinical studies showed evidence

for improvement in PWS-related behaviors/symptoms. Three of these clinical studies reported evidence for improvement in hyperphagia

and one showed an improvement in sucking in infants.

Tonix’s

Marketed Products

TONMYA

– Treatment of Fibromyalgia

In

August 2025, we received approval from the FDA for TONMYA (cyclobenzaprine HCl sublingual tablets) for the treatment

of fibromyalgia. TONMYA in adults, Tonix’s first internally developed product, was commercially launched by the Company in the United

States on November 17, 2025. TONMYA is the first new treatment for fibromyalgia in more than 15 years and is a centrally acting,

differentiated non-opioid analgesic designed for bedtime administration and long-term use, addressing core symptoms of fibromyalgia

including pain, disturbed sleep and fatigue. The approval and launch of TONMYA marked a major milestone in our evolution

as an organization with growing revenues and an expanding customer footprint. We hold worldwide commercialization rights to TONMYA.

Zembrace

SymTouch and Tosymra – Acute Migraine in Adults

In

June 2023, we acquired two FDA-approved, marketed products from 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 actively promoted brand of sumatriptan autoinjector in the United States. 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). 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). Zembrace SymTouch currently has patent protection to 2036. Tosymra employs Intravail® permeation enhancer technology

and is pharmacokinetically equivalent to 4 mg subcutaneous sumatriptan. Tosymra delivers migraine pain relief in as little as

10 minutes with just one spray for some patients (13% vs. 5% for placebo). Tosymra currently has patent protection to 2031.

Together,

these products form the foundation of our commercial platform, including sales, marketing, market access, distribution,

and patient support capabilities.

Product

Candidates in Development

We

believe that our product candidates offer innovative therapeutic approaches and may provide significant advantages relative to

available therapies. We have worldwide commercialization rights to all of our product candidates listed below. The following table

summarizes our later stage product candidates that are in or nearing the clinic:

Product Candidate Indication Stage of Development

TNX-102 SL Major Depressive Disorder Phase 2 expected to commence mid-2026

TNX-102 SL Acute Stress Reaction/Acute Stress Disorder Phase 2 enrolling*

TNX-1500 Kidney Transplant Rejection Phase 2 study planned for mid 2026*

TNX-1300 Cocaine Intoxication Mid-Phase 2

TNX-2900 Prader-Willi Syndrome Phase 2 expected to commence first quarter 2027

TNX-801 Smallpox and Mpox vaccine Preclinical, pre-IND

TNX-4200 Treatment or Prevention of Viral Disease Preclinical, pre-IND

TNX-4900 Neuropathic pain Preclinical, pre-IND

TNX-1700 Gastric and colorectal Cancer Preclinical, pre-IND

*Investigator

Initiated Studies

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TNX-102

SL

Overview

TNX-102

SL is a proprietary sublingual tablet formulation of cyclobenzaprine (“CBP”) that efficiently delivers CBP across the

oral mucosal membrane into the systemic circulation. TNX-102 SL is approved under the brand name TONMYA, for the treatment of

fibromyalgia in the U.S. We have active IND’s for TNX-102 SL as a treatment for MDD, ASD/ASR, PTSD, or multi-site pain

associated with Long COVID, AAD and AUD however, we are not currently studying TNX-102 SL in PTSD, AAD, Long Covid or AUD. We own all rights to TNX-102 SL in all geographies, and we bear no obligations to third

parties for any future development or commercialization. Excipients used in TNX-102 SL are approved for pharmaceutical use. Some of

the excipients were specially selected to promote a local oral environment that facilitates transmucosal absorption of

CBP.

The

current TNX-102 SL sublingual tablets each contain 2.8 mg of CBP. We selected this dose with the goal of providing a balance of

efficacy, safety, and tolerability that would be acceptable as a first-line therapy and for long-term use, and in-patient populations