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, 2024

☐

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)

26 Main Street, Suite 101 Chatham, 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. ☐

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, 2024, based on the closing sales price

of the common stock as quoted on The NASDAQ Global Market was $6,857,126. For purposes of this computation, all officers and directors

are deemed to be affiliates. Such determination should not be deemed an admission that such directors, officers, or 5 percent

beneficial owners are, in fact, affiliates of the registrant.

As

of March 17, 2025, there were 6,434,881shares 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 65

Item 1B. Unresolved Staff Comments 98

Item 1C. Cybersecurity Disclosures 98

Item 2. Properties 99

Item 3. Legal Proceedings 99

Item 4. Mine Safety Disclosures 99

PART II

Item 7A. Quantitative and Qualitative Disclosures about Market Risk 114

Item 8. Financial Statements and Supplementary Data F-1 – F-35

Item 9A. Controls and Procedures 115

Item 9B. Other Information 116

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 116

PART III

Item 10. Directors, Executive Officers and Corporate Governance 117

Item 11. Executive Compensation 125

Item 14. Principal Accounting Fees and Services 137

PART IV

Item 15. Exhibits, Financial Statement Schedules 138

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. 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.

Forward-looking

statements include, but are not necessarily limited to, those relating to:

● Our ability to raise additional capital, if necessary;

3

Business

Overview

Tonix Pharmaceuticals (“Tonix” or the “Company”)

is a fully-integrated biopharmaceutical company developing and commercializing therapeutics to treat, and vaccines to prevent, disease

and alleviate suffering. Tonix’s primary focus is to obtain U.S. marketing authorization for TNX-102 SL (cyclobenzaprine HCl sublingual

tablet) 5.6 mg (2 x 2.8 mg tablets) for the management of fibromyalgia (“FM”) from the U.S. Food and Drug Administration (“FDA”).

The FDA assigned a prescription drug user fee act (“PDUFA”) goal date of August 15, 2025, for a decision on marketing authorization

for TNX-102 SL. In addition, we market two FDA-approved, prescription products for the treatment of acute migraine, and we are developing

a robust pipeline of potential new products.

Our pipeline has been generated from internal discovery, as well as licenses,

acquisitions and collaborations with academic institutions and non-profit organizations. Our development portfolio is focused on central

nervous system (“CNS”), disorders, but also consists of immunology, infectious disease and rare disease, product candidates.

The CNS portfolio includes small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions and includes

TNX-1300 which is in Phase 2 clinical development to treat cocaine intoxication partially funded by the U.S. National Institute on Drug

Abuse (NIDA). Our immunology portfolio includes TNX-1500 (anti-CD40L monoclonal antibody, or mAb), a biologic which has shown encouraging

results in Phase 1, which we plan to study to prevent organ transplant rejection and treat autoimmune diseases. Our infectious disease

portfolio includes TNX-801 (horsepox, live virus vaccine) a vaccine in development to prevent smallpox and mpox (formerly known as monkeypox)

and TNX-4200, which is a discovery program for broad spectrum antiviral drugs funded by a U.S Department of Defense contract for up to

$34 million over five years. TNX-4200 is being developed at our R&D facility located in Frederick, Maryland, (“RDC”),

which has biosafety level 2 (BSL-2) with BSL-3 components. Tonix’s product development candidates are investigational new drugs

or biologics and have not been approved for any indication.

Central

Nervous System (CNS) Pipeline

In October 2024, Tonix submitted a New

Drug Application (“NDA”) to the FDA for TNX-102 SL 5.6 mg for the management of FM, a proprietary sublingual tablet formulation

of cyclobenzaprine (“CBP”) designed for bedtime administration, and in December 2024, the FDA assigned a PDUFA goal date of

August 15, 2025, for a decision on marketing authorization for TNX-102 SL. FM is a chronic pain disorder characterized by widespread pain,

non-restorative sleep, fatigue and impaired cognition. TNX-102 SL is a centrally-acting, non-opioid analgesic designed for long-term bedtime

use and has been studied in three Phase 3 trials using TNX-102 SL 5.6 mg, two studies reported statistically significant results. The

FDA granted TNX-102 SL Fast Track designation in July 2024. We are preparing for a commercial launch of TNX-102 SL in the fourth quarter

of 2025, conditional on FDA approval.

In

March 2024, Tonix announced it selected two contract manufacturing organizations (CMOs), one of which is Almac Pharma Services,

a member of the privately owned Almac Group, as dual supply sources for the potential launch and commercialization of TNX-102

SL in the U.S.

4

TNX-102

SL also is being developed also as a treatment for acute stress reaction (“ASR”) and to prevent acute stress disorder

(“ASD”) and posttraumatic stress disorder (“PTSD”) under a physician-initiated Investigational New Drug

Application (“IND”) in partnership with the University of North Carolina (“UNC”) 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 or AUD. Tonix is continuously evaluating further indications for which

TNX-102 SL could potentially provide benefit.

Another

CNS candidate in development is 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. In August of 2022, 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.

Finally, 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, and bone health in pediatric autism. TNX-1900 is in development through an investigator-initiated study at the University of

Washington for the treatment of social anxiety disorder.

Immunology

Pipeline

Our lead candidate in the immunology pipeline is TNX-1500, an Fc-modified humanized

monoclonal antibody (“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 was reported in the first

quarter of 2025.

5

TNX-1500 has also been studied in combination with other immunosuppressive

agents in allogeneic transplants in non-human primates at MGH. In experiments at MGH, TNX-1500 is being studied as monotherapy or in combination

with other immunosuppressive agents in heart and kidney allogeneic organ transplants in non-human primates. Results from experiments in

kidney and heart transplants indicate that TNX-1500 appears to have comparable efficacy to historical experiments using the chimeric mouse/human

IgG1 version (5c8H1) of the anti-CD40L mAb 5c8.

TNX-1500 also is being studied in combination with other immunosuppressive

agents in xenogeneic organ transplants in non-human primates at MGH. In some of these studies, genetically engineered (“GE”)

pigs in baboon transplants were treated with cold perfused ischemia minimization and a novel co-stimulation-based immunosuppressive regimen

including TNX-1500. The results of these preclinical studies were encouraging and demonstrated the potential of GE pig hearts in the context

of a clinically applicable regimen. The multi-GE pigs were provided by eGenesis and Revivicor. Revivicor is a subsidiary of United Therapeutics.

Some results from the collaboration with MGH and eGenesis were published in the peer-reviewed journal, Nature in 2023. In

March of 2024, MGH announced the first GE pig kidney transplant into a living recipient supported in part by the pre-clinical work with

TNX-1500. Subsequently, several other GE pig kidney transplants have been performed. TNX-1500 treatment has not been used in any human transplant

recipient.

Our

immunology pipeline also includes TNX-1700, a recombinant Trefoil Factor Family 2 (“hTFF2-HSA”) fusion protein that

was licensed from Columbia University in 2019. TNX-1700 consists of TFF2 fused to human serum albumin and is a biologic

being developed to treat gastric and colorectal cancers by an immune-oncology mechanism, in combination with PD1 blockers, and

is in the preclinical stage of development. We presented data that show a murine version of TNX-1700 consisting of a fusion protein

with murine serum albumin was able to evoke anti-tumor immunity in the MC38 mouse model of colorectal cancer as monotherapy and

that TNX-1700 augmented the efficacy of anti-PD1 therapy in both the MC38 model and the CT26.wt mouse models of colorectal cancer. We

plan to request an INTERACT meeting with the FDA in 2025 to seek early guidance on program development.

Infectious

Disease Pipeline

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. In 2022 the WHO determined that the upsurge of

mpox Clade IIb constituted a public health emergency of international concern (PHEIC). Mpox Clade IIB subsequently has become endemic

in the U.S. mostly in populations of men who have sex with men. In August 2024, the WHO determined that the upsurge of mpox clade Ib in

a growing number of countries in Africa constituted a PHEIC. The WHO reaffirmed the PHEIC status of mpox clade Ib in February of 2025.

Mpox cases of the new clade Ib mpox have been detected in the United States and many other countries outside of Africa. Non-human primates

vaccinated with TNX-801 were protected from mpox clade Ia in studies reported in the first quarter of 2020 and published in the peer-reviewed

journal Vaccines in 2023.

In September 2024, at the DoD’s MHSRS conference and in October 2024 at the

World Vaccine Congress in Barcelona, Spain, Tonix presented new data on a potential mpox vaccine, TNX-801, demonstrating tolerability

and no evidence of spreading to blood or tissues, even at high doses, in immunocompromised animals. After a single-dose vaccination, TNX-801

prevented clinical disease and lesions, and also decreased shedding in the mouth and lungs of animals after a lethal challenge with clade

Ia monkeypox. These findings are consistent with TNX-801 inducing mucosal immunity and suggest TNX-801 may block forward transmission.

In September 2024, the Company also announced that the WHO’s preferred target product profile (“TPP”) aligns with the

characteristics of TNX-801. Key elements of the WHO draft TPP include single-dose, durable protection, administration without special

equipment, and stability at ambient temperature. Other potential beneficial characteristics include the ability to limit forward transmission,

use in case-contact vaccination strategies and suitability for use in immunocompromised individuals.

6

In October 2023, at the World Vaccine Congress - Europe, we reported that

the TNX-801 vaccine was shown to be greater than 10 to 1,000-fold more minimally replicative than older vaccinia-based smallpox vaccines

in both human primary cell lines and immunocompromised mice. In October 2024, at the World Vaccine Congress - Europe, we highlighted positive

preclinical efficacy data of TNX-801, demonstrating tolerability in immunocompromised animals and showed that TNX-801 is unable to spread

in blood or tissues in these animals, even at an approximately 100-fold higher dose than 20th century vaccinia vaccines in immune-comprised

mice. These data were published in the peer-reviewed journal mSphere in 2024.

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. The company’s

Good Manufacturing Practice (“GMP”)-capable advanced manufacturing facility in Dartmouth, MA was purpose-built to manufacture

TNX-801. The GMP suites are currently decommissioned but are ready to be reactivated in case of a national or international emergency.

TNX-1800 is a live virus vaccine on the RPV platform that expresses the

SARS-CoV-2 spike protein from the ancestral Wuhan strain, which has shown encouraging results in non-human primates. In June 2024, the

Company announced preclinical data, demonstrating immunity and tolerability, during an oral keynote talk at the Vaccine Congress 2024.

Like TNX-801, TNX-1800 is a live minimally replicative vaccine based on horsepox that is believed to provide immune protection with better

tolerability than modern vaccinia viruses. TNX-1800 was selected by the NIH’s Project NextGen for inclusion in clinical trials as

part of a select group of next generation COVID-19 vaccine candidates with the intent to identify promising vaccine platforms. If Tonix

is able to provide TNX-1800 to NIH, they would conduct a Phase 1 trial and cover the full cost. However, Tonix has not prioritized the

production of TNX-1800, so it is uncertain whether or how quickly this project will progress. The COVID-19 vaccines approved for use in

the U.S. have provided significant health benefits to the vaccinated population; however, they have shown limitations in the durability

of protection conferred, and in their ability to block forward transmission. Live virus vaccines that protect against other viral diseases

by eliciting T cell responses have shown durability of protection that lasts years to decades, and some live virus vaccines have significantly

inhibited forward transmission. With respect to TNX-1800 vaccination, we reported positive efficacy data from animal challenge studies

using live SARS-CoV-2 in the first quarter of 2021. These data were published in the peer-reviewed journal Vaccines in 2023. In

this study, TNX-1800 vaccinated, SARS-CoV-2 challenged animals had undetectable SARS-CoV-2 in the upper airways, which we believe relates

to potential inhibition of forward transmission of this respiratory pathogen.

Tonix

is developing potential broad-spectrum antiviral drugs in three programs: CD45-targeted therapeutics (TNX-4200), cathepsin inhibitors

(TNX-3900) and viral glycan-targeted engineered biologics (TNX-4000). The DoD announced in December 2022 a plan to move beyond

a ‘one bug, one drug’ approach and are seeking broad-spectrum drugs since it may be hard to predict which or how many

viruses may be deployed on the battlefield.

In July 2024 Tonix was awarded a contract with a potential for up to $34

million over five years by the Defense Threat Reduction Agency (DTRA), an agency within the DoD. 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. Tonix’s program will focus on optimization and development of its TNX-4200 program,

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. Tonix’s premise is that partial inhibition of

CD45 will provide optimal antiviral protection while requiring lower plasma drug concentrations, a lower dose, and a better safety profile.

Tonix will utilize its state-of-the-art research laboratory capabilities,

including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility at the RDC, as well as experienced personnel

in-house.

7

Rare

Disease Pipeline

Our rare disease portfolio consists of TNX-2900 (intranasal potentiated

oxytocin) for Prader-Willi syndrome (“PWS”), a genetic disorder characterized by complex symptoms. 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

on March 21, 2024. PWS, an orphan condition, is a rare genetic disorder of failure to thrive in infancy, associated with uncontrolled

appetite beginning in childhood with complications of obesity and diabetes. We have sponsored a research program at Inserm to study oxytocin

on suckling behavior in mice that have been engineered to express one of the PWS gene mutations.

Marketed

Medicines

Our

commercial portfolio consists of two FDA-approved prescription products for the treatment of migraine: Zembrace SymTouch (sumatriptan

injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are both indicated for the treatment

of acute migraine with or without aura in adults. Zembrace SymTouch is the only branded sumatriptan autoinjector professionally

promoted in the United States and is designed for ease of use and favorable tolerability with a low 3 mg dose. 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.

In

September 2024, Tonix announced that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 12,097,183 to

the Company, claiming use of a pre-filled autoinjector comprising a composition of Zembrace® SymTouch® for treating migraines

via subcutaneous administration. This patent, excluding possible patent term extensions, is expected to fortify protection and

market exclusivity into 2036. Additionally, Tonix announced that the USPTO issued U.S. Patent No. 12,090,139 to the Company, claiming

a pharmaceutical composition, a method of treating migraine via intranasal administration, and an intranasal delivery system for

Tosymra®. This patent is expected to fortify protection and market exclusivity into 2030.

In

June 2024, the Company presented data at the 66th Annual Scientific Meeting of the American Headache Society (AHS) comparing real-world

data with real-world usage of non-oral migraine products with the most recent AHS consensus statement. This data stressed the

need for customizing treatment of migraine headaches to the needs of patients. Thus far, real world data show that conformity

with the guidelines and the consensus statement have yet to be achieved but has the potential to be increased. The data show the

use of non-oral drugs for treating an acute migraine attack was only 7% in 2012 and has decreased to below 4% in 2023, when the

potential need for such drugs is anticipated to be a more substantial percentage of migraineurs based on epidemiological data.

In 2024, Tonix Medicines launched a national educational campaign focusing on the link between migraine, gastroparesis, and the

need for non-oral acute migraine therapies.

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 but Tonix has the ability to reactivate it should we choose to do so.

8

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:

9

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 cases 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-19

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.

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.

According to reports by Frost

and Sullivan and Eversana that 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 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.

10

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.

Acute

Stress Disorder (ASD)

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. 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.

11

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 triggers an immune reaction that leads to rejection. Overcoming this difficulty is paramount to a patient’s

survival as organ donations are in limited supply.

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

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. The WHO reaffirmed the PHEIC status of mpox clade Ib in February of 2025.

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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COVID-19

SARS-CoV-2 is a contagious virus causing the disease COVID-19 that became

a global pandemic in 2019 and has resulted in more than three million deaths. While the infection and mortality rates have slowed in regions

of the world with high vaccination rates, the struggle with the pathogen is ongoing and evolving since SARS-CoV-2 is mutating into new

variants. COVID-19 is characterized by fever, sore throat, acute shortness of breath, cough, and oxygen desaturation in the blood. New

variants continue to sweep across the world in successive waves. With new variants of the virus emerging, therapeutic research is addressing

the challenge of keeping up with this rapidly mutating virus. The early vaccines have been effective in limiting the severity of disease

in vaccinated individuals. Vaccines that elicit strong T cell responses are believed to have the potential to provide long-term or durable

protection.

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. The hallmarks of PWS are lack of suckling in infants and, in children and adults, severe

hyperphagia, an overriding physiological drive to eat, leading to severe obesity and other complications associated with significant

morbidity and mortality. PWS is an orphan disease that occurs in approximately one in 15,000 births. There is currently no approved

treatment for obesity and hyperphagia in adults and older children associated with PWS.

Tonix’s

Marketed Migraine Products

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.

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Lead

Product Candidates

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 Acute Stress Reaction Phase 2 ready* – investigator-initiated IND

TNX-1300 Cocaine Intoxication Mid-Phase 2

TNX-1500 Kidney Transplant Rejection Phase 1 topline reported 1Q’25

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

TNX-1800 COVID-19 vaccine Preclinical, pre-IND

TNX-2900 Prader-Willi Syndrome Phase 2 ready

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

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

*Investigator

Initiated Studies

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. We have active IND’s

for TNX-102 SL as a bedtime treatment for fibromyalgia, PTSD, of multi-site pain associated with Long COVID, AAD and AUD. The University of North Carolina

has an investigator-initiated IND for ASD that references our INDs. 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 characterized by burdensome symptoms and sensitivity to medications.

The

active ingredient in TNX-102 SL is CBP, a multi-functional drug that blocks the serotonin-2A, alpha-1 adrenergic, muscarinic M1

and histaminergic H1 receptors.

CBP

is a tertiary amine tricyclic, that is the listed active ingredient of two products that are approved in the U.S. for the treatment

of muscle spasm: Flexeril® (5 mg and 10 mg oral immediate-release, or IR, tablet) and Amrix® (15 mg and 30

mg oral extended-release capsule or ER capsule). The Flexeril brand of CBP IR tablet has been discontinued since May 2013. There

are numerous generic versions of CBP IR tablets on the market. CBP-containing products are approved for short term use (two to

three weeks) only as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal

conditions. CBP IR tablets are recommended for three times per day dosing, which results in relatively stable blood levels of

CBP after several days of treatment. Extended-release (ER) CBP capsules taken once a day mimic, and flatten, the pharmacokinetic

profile of three times per day CBP IR tablets.

14

Both the IR and ER tablet formulations of CBP result in accumulation

of the persistent metabolite norcyclobenzaprine (“norCBP”) to blood levels that exceed the levels of CBP. NorCBP is a secondary

amine tricyclic with a relatively stronger inhibitory activity of the norepinephrine transporter (NET) than the parent CBP. We believe

that the accumulation of norCBP is undesirable in a medicine to be taken chronically at bedtime because norCBP accumulates over weeks,

potentially interfering with the dynamic receptor effects of CBP and also may interrupt sleep quality by inhibiting the NET.

We

designed TNX-102 SL to be administered once-daily at bedtime and with the intention for long-term use. We believe the selected

dose of TNX-102 SL and its unique pharmacokinetic profile will enable it to achieve a desirable balance of efficacy, safety, and

tolerability. Our Phase 1 pharmacokinetic comparative trials showed that, on a dose-adjusted basis, TNX-102 SL results in faster

systemic absorption and significantly higher plasma levels of CBP in the first hour following sublingual administration relative

to oral IR CBP tablets. It also showed that the sublingual route of administration, which bypasses the “first pass”

hepatic metabolism that swallowed medications undergo, results in a higher plasma level of CBP relative to norcyclobenzaprine

during sleeping hours when taken at bedtime. We believe the dynamic changes in CBP after TNX-102 SL administration at steady state

during chronic use contribute to its activity in treating fibromyalgia. We believe this is the first drug designed to

increase the activity of the tertiary amine tricyclic parent and decrease the activity of the secondary amine tricyclic metabolite.

In clinical studies, TNX-102 SL 2.8 mg and TNX-102 SL 5.6 mg were generally well-tolerated, with no drug-related serious and unexpected

adverse reactions reported in these studies. The most common adverse event was transient numbness in the mouth after TNX-102 SL

administration.

In

September 2024, at the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems (PDDS 2024), the Company announced

data highlighting the proprietary formulation technology and pharmacokinetic properties of TNX-102 SL, including composition and

methods patents based on the proprietary eutectic formulation of TNX-102 SL that are expected to provide market exclusivity until

at least 2034 in the U.S., EU, Japan, China and other jurisdictions. The eutectic protects cyclobenzaprine HCl from interacting

with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. The formulation

of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target

disturbed sleep, improve pain and other fibromyalgia symptoms, while reducing the risk of daytime somnolence.

We have successfully completed the pivotal exposure bridging study

with TNX-102 SL compared to Amrix. Results from this study support the approval of TNX-102 SL under Section 505(b)(2) of the Federal

Food, Drug and Cosmetic Act (“FDCA”) with Amrix as the listed drug. We believe that TNX-102 SL has the potential to provide clinical

benefit in fibromyalgia and PTSD and possibly other CNS indications that are underserved by currently marketed

products or have no approved treatment.

We

have also successfully completed a bridging pharmacokinetic study in ethnic Japanese and Chinese volunteers that shows similar

characteristics to our historical data in Caucasian volunteers. We believe this will satisfy one of the criteria for approval

in Japan and China and will allow us to reference the U.S. efficacy data to support marketing applications in those countries.

TNX-102 SL (cyclobenzaprine HCl sublingual tablets) – FM program

We

are developing TNX-102 SL as a bedtime treatment for FM.

Clinical

Development Plan

NDA

Acceptance and PDUFA Goal Date

In October 2024, Tonix submitted its NDA to the FDA for TNX-102 SL 5.6

mg for the management of fibromyalgia and in December 2024, the FDA assigned a PDUFA goal date of August 15, 2025, for a decision on marketing

authorization for TNX-102 SL. We are preparing for a commercial launch of TNX-102 SL in the fourth quarter of 2025, conditional on FDA

approval.

15

Pre-NDA

Meetings and Fast Track Designation

In July 2024, Tonix was granted Fast Track designation by the FDA for TNX-102

SL for FM. The designation validates that FM is a serious condition and that TNX-102 SL has the potential to address this unmet medical

need. Tonix previously announced alignment with the FDA regarding the content of its proposed NDA submission, following completion of

the Company’s pre-NDA meetings.

During the second quarter of 2024, Tonix successfully completed two positive

pre-NDA meetings with the FDA for TNX-102 SL for the management of fibromyalgia. The first, with minutes announced in June 2024, was a

Type B Chemistry, Manufacturing, and Controls (CMC) meeting to seek alignment and agreement with the FDA on key CMC topics to support

the planned NDA submission for TNX-102 SL. Based on formal meeting minutes, the Company believes it is aligned with the FDA on proposed

drug substance and drug product commercial specifications, shelf life assignment, manufacturing and commercial drug packaging. At the

second pre-NDA meeting announced in July 2024, the Company and the FDA aligned on nonclinical, clinical pharmacology and clinical matters

and agreed that the proposed data package is sufficient to support the NDA submission.

Completed

Phase 3 RESILIENT Study (F307) with Statistically Significant Improvement in Primary Endpoint of Pain Reduction

The

first patient was enrolled in the pivotal Phase 3 RESILIENT study in April 2022. The RESILIENT study was a double-blind, randomized,

placebo-controlled adaptive design trial designed to evaluate the efficacy and safety of TNX-102 SL in FM. The two-arm trial enrolled