Tonix Pharmaceuticals Holding Corp. (TNXP) Business

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 TONMYA™ (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.

11

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:

*Investigator
Initiated Studies

12

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
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.

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 active 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.

13

Global
NDA Requirements

We
are planning to develop TNX-102 SL for the treatment of FM in the UK, Europe and Japan. We plan to discuss the
development of TNX-102 SL for the treatment of FM with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA),
the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Cyclobenzaprine, the active ingredient of TNX-102 SL, has not been approved in the
UK, most countries in Europe, or in Japan. In February 2022, we held an End of Phase 2 Consultation with the Japanese PMDA, to
discuss the potential Japan development plan. PMDA has provided guidance on the overall nonclinical package to support a Japan NDA
filing for TNX-102 SL for the treatment of FM. We plan to have another Consultation with PMDA to provide program updates and discuss
the Japan development plan.

We
have also successfully completed a Phase 1 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.

A
Phase 1 PK study was initiated in March 2022 and the clinical phase was completed in May 2022. Since the similarity in PK profile
between people of Japanese and Chinese descent was confirmed, the PK data from the two ethnic groups were pooled as for Asian
data (n=20) and compared retrospectively with the Caucasian study data from Study TNX-CY-F110 (n=16). The Asian/Caucasian geometric
mean ratios of cyclobenzaprine Cmax, AUC0-T and AUC0-∞ were between 0.9 and 1.11 after both the 5.6
mg dose and the 2.8 mg dose. The 90% CI of Asian/Caucasian geometric mean ratios for Cmax, AUC0-T and AUC0-∞,
were all within the formal narrow equivalence limit of 0.8 to 1.25 after both the 5.6 mg dose and 2.8 mg dose, respectively. These
results support similarity in cyclobenzaprine PK between Asian (pooled Japanese and Chinese) and Caucasian samples.

TNX-102
SL (cyclobenzaprine HCl sublingual tablets) – Major Depressive Disorder (MDD) Program

We
are developing TNX-102 SL as a treatment for MDD. In September 2025, Tonix 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. The Company received positive feedback
from the FDA and plans 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, 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 disruptive 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 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. Tonix plans to initiate enrollment of the study in mid-year 2026.

TNX-102
SL – Acute Stress Disorder Program

TNX-102 SL is being developed as a bedtime treatment for ASR/ASD in collaboration
with the University of North Carolina under an investigator-initiated IND.

Phase
2 OASIS Study

This
investigator-initiated study is being conducted by the University of North Carolina Institute for Trauma Recovery. The University
of North Carolina has been awarded a $3 million grant from the DoD to investigate the potential of Tonix’s TNX-102 SL to
reduce the frequency and severity of adverse effects of acute trauma. The proposed Optimizing Acute Stress reaction Interventions
with TNX-102 SL (OASIS) trial will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric
sequelae among patients presenting to the emergency department (“ED”) after a motor vehicle collision. The investigator-initiated trial was commenced in May 2025 and is targeting to enroll approximately 180 individuals who acutely experienced trauma
at ED study sites across the U.S. and participants will be randomized in the ED to receive a two-week course of either TNX-102
SL or placebo. The OASIS trial will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric
sequelae among patients in the ED after a motor vehicle collision. A fourteen-day course of bedtime TNX-102 SL will be tested
in the immediate aftermath of motor vehicle collision trauma. The study will test the potential for TNX-102 SL to target trauma-related
sleep disturbance and its ability to facilitate recovery from ASR and to prevent PTSD. The results, if positive, may ultimately provide military
personnel with a new treatment option that, when administered in the early aftermath of a traumatic event to individuals with
ASR symptoms, improves warfighter function.

14

The
OASIS trial will build upon a foundation of knowledge and infrastructure developed through the University of North Carolina-led,
$40 million AURORA study. The AURORA study is a major national research initiative to improve the understanding, prevention,
and recovery of individuals who have experienced a traumatic event. AURORA is supported by funding from the NIH, leading brain
health nonprofit One Mind, private foundations, and partnerships with leading tech companies such as Mindstrong Health and Verily
Life Sciences, the health care arm of Google’s parent company Alphabet.

We presented clinical data
and rationale supporting the potential for TNX-102 SL to be studied for the treatment of ASR and prevention of PTSD. Prior studies showed
that treatment with TNX-102 SL showed effects on sleep and PTSD symptoms in PTSD patients at two and four weeks. This supportive data
on the effects of TNX-102 SL on reducing PTSD symptoms suggest early intervention immediately after trauma using TNX-102 SL has the potential
to reduce ASR and to be prophylactic for development of ASD and PTSD. Data from these trials support testing of TNX-102 SL within 24 hours
of index trauma for effects on ASR symptoms and the subsequent incidence of newly developed ASD within one month and PTSD after one month
from the index trauma.

TNX-4800
– Lyme Disease Prophylaxis

TNX-4800 (formerly known as
mAb 2217LS) is a humanized monoclonal antibody with an engineered extended half-life that 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 animals 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 pre-treated animals. TNX-4800 also sidesteps the multidose schedules required for OspA vaccines in development and
the 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.

TNX-4800
was studied in a randomized, double-blind, sequential dose-escalation phase 1 study (NCT04863287) that evaluated safety,
tolerability, pharmacokinetics (PK), and immunogenicity of TNX-4800 in healthy adults. Forty-four subjects were randomized and 41
completed the study. Subjects received a single subcutaneous (SC) administration of placebo or TNX-4800 at 0.5, 1.5, 5, or 10 mg/kg.
Safety was assessed via clinical and lab evaluations. Drug exposure increased by approximately 25-times for a 20-times increase in
dose. Serum TNX-4800 was measurable at the earliest sampling time of 24 hours, indicating rapid systemic absorption. TNX-4800
concentrations remained quantifiable for 200 days in 80% of volunteers at the lowest dose and for up to 350 days in the majority
of volunteers at higher doses (i.e., ≥ 1.5 mg/kg). Mean half-life ranged from 62–69 days across groups. Serum
concentrations remained quantifiable for up to 12 months in most subjects. Mean exposure for the 10 mg/kg cohort was less than 20%
of the highest exposures in a rat toxicology study. Anti-drug antibodies (ADA) were detected in 10% of treated subjects, with no
impact on PK. Most adverse events were mild or moderate. TNX-4800 was determined to be generally safe and well tolerated.

15

In
infected deer ticks, Borrelia’s OspA lipoprotein binds to tick-gut receptor TROSPA and helps it adhere to the
midgut lining. During a tick bite blood meal, Borrelia downregulates OspA, upregulates OspC, and activates motility
genes. Borrelia undergoes a metamorphic-like transformation, becoming highly flagellated and mobile, which facilitates
migration to the tick salivary glands and invasion of human host tissues. During a tick bite of an animal pre-treated with TNX-4800,
the tick ingests host blood containing TNX-4800, which kills and blocks the metamorphic-like transformation of Borrelia in
the tick’s midgut preventing transmission of the bacteria. Lyme-causing Borrelia-exposed or -infected individuals,
rarely make antibodies against OspA which allows for people to be reinfected despite having immunity to OspC. Consequently, we expect
that protection against Borrelia would require annual prophylaxis with TNX-4800.

TNX-1500
– Organ Transplant Rejection/Autoimmune Conditions

TNX-1500
is a humanized mAb directed against CD40-ligand, or CD40L (also known as CD154), engineered to modulate binding to Fc receptors.
TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease
(GvHD) after hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. The IND was cleared
for the prevention of kidney transplant. TNX-1500 incorporates the antigen binding fragment (Fab) region of hu5c8, which has been
extensively characterized including at the atomic level in complex with CD40-ligand.

CD40-ligand
is a protein expressed on the surface of activated T lymphocytes that mediates T cell helper function. CD40-ligand is also known
as CD154, the T cell-B cell activating molecule (T-BAM), TRAP and gp39. CD154 is a member of the Tumor Necrosis Factor (TNF) Super
Family. No mAb against CD154 has been approved for commercial use anywhere in the world. Other TNF Super Family members have been
successfully targeted by antagonist mAbs. Approved mAbs against TNFα include: infliximab (Remicade®), adalimumab (Humira®),
certolizumab pegol (Cimzia®), and golimumab (Simponi®) for the treatment of certain autoimmune conditions. Also, etanercept
(Enbrel®) is a TNFα antagonist receptor fusion protein. An approved mAb against RANKL (CD254) is denosumab (Prolia®
or Xgeva®) for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone.

The Fc-modified TNX-1500 has shown activity and has been well tolerated
in animals and in a single dose Phase 1 pharmacodynamic (PD) and pharmacokinetic (PK) study that supports monthly dosing. TNX-1500 was
engineered to modulate binding to Fc receptors with the goal of maintaining the activity of first-generation monoclonal antibodies (mAbs),
yet with reduced risk of thrombotic complications. TNX-1500 is being developed as a prophylaxis against organ transplant rejection as
well as to treat autoimmune conditions. A Phase 1 single ascending dose escalation study of TNX-1500 at 3 mg/kg, 10 mg/kg and 30 mg/kg
of TNX-1500 in healthy volunteers was initiated in the second quarter of 2023. The objectives of the Phase 1 trial were to assess the
safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous TNX-1500, as well as to support dosing in a planned Phase
2 trial in kidney transplant recipients. We reported positive topline data related to the Phase 1 in February of 2025. TNX-1500 showed
suppression of the primary and secondary antibody responses to KLH antigen challenges for the 10 and 30 mg/kg doses. Additionally, preliminary
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. Anti-CD40L has multiple potential indications in addition
to solid organ and bone marrow transplantation including autoimmune diseases.

In
pre-clinical experiments at MGH, TNX-1500 has been studied as monotherapy or in combination with immunosuppressive drugs in heart
and kidney organ transplants in animals. The data demonstrates that TNX-1500 showed activity in preventing organ rejection and
was well tolerated in animals. Blockade of CD40L with TNX-1500 monotherapy consistently prevented pathologic alloreactive in animal
models of cardiac and kidney allograft model without evidence of clinical thrombosis.

In
November 2025, we entered into a collaboration with MGH, a founding member of Mass General Brigham (MGB) to conduct an investigator-initiated Phase
2 clinical trial evaluating TNX-1500 in kidney transplant recipients. The 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 CD40 ligand (CD40L)
is also known as CD154. Study initiation is contingent on institutional review board (“IRB”) approval and FDA clearance
of an investigator-initiated IND. Pending IRB approval and IND clearance, the open-label, single-center study will enroll five
adult kidney transplant recipients at MGH. Patients will receive induction therapy with anti-thymocyte globulin, TNX-1500, tacrolimus,
and corticosteroids. The corticosteroids will be tapered and discontinued by Day 33 post-transplant. TNX-1500 will be continued
for 12 months (to the primary endpoint) with an option to continue treatment beyond 12 months. Tacrolimus at standard dose will
be continued for six months, at which point tacrolimus will be decreased to low dose with the expectation of discontinuing tacrolimus
after 12 months. The primary endpoint is the incidence of adverse and serious adverse events at 12 months. Secondary endpoints
include graft survival, renal function, biopsy-proven acute rejection, and incidence of donor-specific antibodies. The study is
expected to be initiated mid-2026.

16

Data
published in two peer reviewed articles in the American Journal of Transplantation demonstrate TNX-1500 prevents rejection, prolongs
survival and preserves graft function as a single agent or in combination with other drugs in animal renal and heart allografts

TNX-1300
– Cocaine Intoxication

TNX-1300
(T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) is being developed for the treatment of cocaine intoxication. TNX-1300
is a recombinant protein enzyme produced through rDNA technology in a non-disease-producing strain of E. coli bacteria. Cocaine Esterase
(“CocE”) was identified in bacteria (Rhodococcus) that use cocaine as the sole source of carbon and nitrogen and that
grow in soil surrounding coca plants. The gene encoding CocE was identified and the protein was extensively characterized. CocE catalyzes
the breakdown of cocaine into metabolite ecgonine methyl ester and benzoic acid. Wild-type CocE is unstable at body temperature, so targeted
mutations were introduced in the CocE gene and resulted in the T172R/G173Q double-mutant CocE, which is active for approximately 6 hours
at body temperature.

Currently
there is no specific pharmacotherapy indicated for cocaine intoxication, a state characterized by acute agitation, hyperthermia,
tachycardia, arrhythmias, and hypertension, with the potential life-threatening sequalae of myocardial infarction, cerebrovascular
accident, rhabdomyolysis, respiratory failure, and seizures. Patients are currently managed only by supportive care for the adverse
effects of cocaine overdose on the cardiovascular and central nervous systems. By targeting the cause of cocaine intoxication,
rather than the symptoms like other medicines in emergency usage, we believe TNX-1300 may offer significant advantages to the
current standard of care for cocaine overdose. TNX-1300 was developed by Columbia University, University of Kentucky and University
of Michigan, and in-licensed by Tonix from Columbia University in 2019.

In
a Phase 2 randomized, double-blind, placebo-controlled clinical study, TNX-1300 at 100 mg or 200 mg i.v. doses was well
tolerated and interrupted cocaine effects after cocaine 50 mg i.v. challenge.

In
August 2022, we announced that we received a Cooperative Agreement grant from NIDA, part of NIH, to support development of TNX-1300.
A positive Phase 2a study of volunteer cocaine users in a controlled laboratory setting has been previously completed. TNX-1300
has been granted Breakthrough Therapy designation by the FDA.

As
a biologic and new molecular entity, TNX-1300 is eligible for 12 years of U.S. market exclusivity upon approval by the FDA, in
addition to expected patent protection through 2029. Since in-licensing, Tonix has requalified existing inventory, developed a
lyophilized drug product to facilitate enhanced stability and handling conditions applicable for an ER treatment, updated the
process and analytical methods to current standards and manufactured Phase 2 drug product clinical supply.

We initiated a Phase 2 clinical trial, CATALYST, of TNX-1300 in the third
quarter of 2024. The Phase 2 trial was a single-blind, placebo-controlled, proof-of-concept study comparing the safety of a single 200
mg dose of TNX-1300 to standard of care alone in approximately 60 emergency department (ED) patients presenting with cocaine intoxication.
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.

TNX-1900
–Adolescent Obesity, Binge Eating Disorder, Bone Health in Pediatric Autism, and Arginine-Vasopressin Deficiency

TNX-1900 (intranasal potentiated oxytocin) is a proprietary formulation
of oxytocin primarily in development under investigator-initiated INDs for the treatment of adolescent obesity, binge eating disorder,
bone health in pediatric autism, , and arginine-vasopressin deficiency. In 2020, TNX-1900 was acquired from Trigemina, Inc. and licensed
from Stanford University. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin
into the nose.

Oxytocin
is a naturally occurring human hormone that acts as a neurotransmitter in the brain. Oxytocin has no recognized addiction potential.
It has been observed that low oxytocin levels in the body can lead to an increase in migraine headache frequency, and that increased
oxytocin levels can relieve migraine headaches. Certain other chronic pain conditions are also associated with decreased oxytocin
levels.

With
TNX-1900, the addition of magnesium to the oxytocin formula enhances oxytocin receptor binding as well as its effects on trigeminal
neurons and craniofacial analgesic effects in animal models. Intranasal oxytocin has been well tolerated in several clinical trials
in both adults and children.

There are four ongoing Phase 2 investigator-initiated studies enrolling
at MGH: the POWER study for the treatment of adolescent obesity, the STROBE study for the treatment of binge eating disorder, the BOX
study for the treatment of bone health in pediatric autism, and the FOCUS study for the treatment of arginine-vasopressin deficiency.

TNX-2900 – Prader-Willi
Syndrome (PWS)

TNX-2900 is based on our patented intranasal potentiated oxytocin formulation,
or TNX-1900, but being developed for PWS. We licensed technology using oxytocin-based therapeutics for the treatment of PWS and non-organic
failure to thrive disease from Inserm. The licensing agreement has been negotiated and signed by Inserm Transfert, the private subsidiary
of Inserm, on behalf of Inserm, Aix-Marseille Université and Centre Hospitalier Universitaire of Toulouse. 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.
There is currently no approved treatment for either the suckling deficit in infants or the obesity and hyperphagia in older children associated
with PWS. Since PWS is an orphan disease that occurs in approximately one in 10,000 to 1 in 30,000 births, TNX-2900 for PWS has been granted Orphan Drug
Designation and Rare Pediatric Disease Designation by the FDA. Tonix completed a pre-IND meeting with the FDA in November 2022 to discuss
the most efficient and appropriate investigational plan to establish the safety and effectiveness evidence to support the approval of
TNX-2900, and Tonix has received IND clearance.

17

The mechanisms involved in suckling
activity required for normal feeding and the role of oxytocin system in this process will be investigated. The results of this work are
expected to be useful in the clinical care of infants requiring support to achieve efficient suckling behavior. Intranasal oxytocin has
previously been shown to improve suckling in newborn animals and suppress feeding behaviors in adult animal models.

Research
suggests PWS is associated with a functional deficiency of oxytocin, a neuropeptide that regulates satiety and feeding behaviors through
the oxytocin receptor. Oxytocin treatment addresses several key features of PWS expressed in the MAGEL2 (MAGE-like 2) knock-out
mouse. Intranasal oxytocin therapy has shown benefits in infants with PWS.   Carbetocin has a different spectrum of activity
on oxytocin and vasopressin receptors than oxytocin. Oxytocin has dose-related inconsistencies in receptor activity that have been
described as “high-dose suppression” or an “inverted “U” dose response. TNX-2900 is formulated with
magnesium to further enhance oxytocin receptor binding and signaling, with the goal of providing more consistent and selective receptor
activation while minimizing off-target vasopressin effects. In vitro and in vivo in animals Mg++-
containing formulations reduce these inconsistencies.

In September 2025, we announced
plans to progress its TNX-2900 program for the treatment of PWS into a Phase 2 clinical trial. We plan to conduct 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.

TNX-1700
— Gastric and Colorectal Cancers

TNX-1700
is a recombinant Trefoil Factor Family 2 fused to human serum albumin (“hTFF2-HSA") licensed from The Trustees of Columbia
University in the City of New York in development for the treatment of gastric and colorectal cancers. The licensed patents are
directed to TFF2 compositions and methods of treatment, U.S. Patent No. 10,124,037 and U.S. Patent No. 11,167,010. The licensed
patents provide TNX-1700 with US market exclusivity until April 2033, subject to any patent term extensions. On August 27, 2020, we
filed International Patent Application No. PCT/IB2020/000699 entitled “Modified TFF2 Polypeptides.” The PCT application
is now nationalized in 12 countries.

In
preclinical studies, we have shown efficacy of TNX-1700 in combination with anti-PD-1 in tumor reduction, metastasis and increase
in survival in various models of gastric and colorectal cancer. The mechanism of action is to suppress immunosuppressive neutrophils
and activate anti-cancer CD8+ T cells, which is distinct from checkpoint inhibitors. There is potential synergy with anti-PD-1
or anti-PD-L1 mAbs.

TNX-801
–Smallpox and Mpox Vaccine

TNX-801
is a novel potential smallpox- and mpox-preventing vaccine based on a synthetic version of live horsepox virus, grown in cell
culture. Though it shares structural characteristics with vaccinia-based vaccines, TNX-801 has unique properties that we believe
indicate potential safety advantages over existing live replicating vaccinia virus vaccines, which have been associated with adverse
side effects such as myopericarditis in some individuals.  Emergent BioSolutions’ ACAM2000® is the only replicating
vaccinia virus vaccine currently approved by the FDA to protect against smallpox and mpox. We believe replicating virus vaccines
have potential efficacy advantages over non-replicating vaccines, relating to the stimulation of cell mediated immunity. Bavarian
Nordic’s Jynneos®, the only non-replicating virus vaccine, is currently approved by the FDA to protect against smallpox
and mpox. Jynneos® requires two-doses, with an efficacy of approximately 35% after one dose. During the most recent mpox outbreak
in the United States, dropout between doses was 24%. We believe TNX-801 has the potential to have improved tolerability relative
to replicating vaccinia vaccines and the potential to have improved efficacy relative to non-replicating vaccinia vaccines.

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. The Bipartisan Commission on Biodefense (2024) noted that “Smallpox and other orthopoxviruses
pose significant threats to the United States and the world due to their potential for weaponization, accidental release, and
vulnerability of populations who stopped routinely vaccinating against smallpox in the 1970s

We
are developing TNX-801 as a potential smallpox- and mpox-preventing vaccine for the U.S. strategic national stockpile and for
potential widespread immunization in the event of malicious reintroduction of variola, the virus that causes smallpox.

Mpox
has become endemic in the U.S. since it spread in the U.S. and other countries outside of Africa, mostly in populations of gay
men. In August 2024, the WHO determined that the upsurge of mpox in a growing number of countries in Africa constitutes a public
health emergency of international concern (“PHEIC”), the second such declaration in the past two years in response
to transmission of the virus. Mpox cases of the new clade Ib mpox have since also been detected in multiple countries outside
of Africa, including the U.S. Animals vaccinated with TNX-801 were protected from mpox in studies reported in the first quarter
of 2020. These data were published in the peer-reviewed journal Vaccines in 2023. Although PHEIC designation has been lifted
by WHO, mpox continues 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.

In
October 2025, at the World Vaccine Congress in Amsterdam, we presented data showing 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.

18

In
September 2024, at the DoD’s MHSRS conference and in October 2024 at the World Vaccine Congress in Barcelona, Spain, we
presented new data on 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 has the ability to block forward transmission. In September
2024, we also announced that the WHO’s preferred 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.

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. Similar data was also published in the peer-reviewed journal mSphere which presented data demonstrating that TNX-801
is less virulent than 20th Century vaccinia vaccines in immune-compromised mice.

In
August 2023 we received pre-IND meeting written responses from the FDA. Tonix believes the FDA feedback provides a path to agreement
on the design of a Phase 1/2 study and the overall clinical development plan. The Phase 1/2 clinical trial will assess the safety,
tolerability, and immunogenicity of TNX-801, following the submission and clearance of an IND. We are actively working to develop
a vaccine meeting cGMP quality to support a clinical study.

We
hold a U.S. Patent for TNX-801 smallpox and mpox vaccine and Recombinant Pox Virus (RPV) platform technology. This patent is expected
to provide Tonix with U.S. market exclusivity until 2037, excluding any possible patent term extensions or patent term adjustments.
In addition, we expect that TNX-801 will be eligible for 12 years of non-patent-based exclusivity under the Patient Protection
and Affordable Care Act, or PPACA.

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 Good Manufacturing
Practice (GMP)-capable advanced manufacturing facility in Dartmouth, MA was purpose-built to manufacture live virus vaccines, including
TNX-801. The GMP suites have been decommissioned and may be reactivated the earlier of 2027 or in case of a national or international
emergency.

TNX-4200
– Broad-Spectrum Antiviral

We are developing CD45-targeted therapeutics (TNX-4200). In July 2024
Tonix was awarded a contract with a potential for up to $34 million over five years by the U.S. Department of Defense, Defense Threat
Agency (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.

Our
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. We plan 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 hypothesis 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.

TNX-4900

TNX-4900
is a highly selective S1R antagonist with demonstrated analgesic activity in multiple animal models of neuropathic pain. TNX-4900
was created from a structure-based drug design program led by Dr. Youyi Peng and Dr. William Welsh at Rutgers University that
produced a series of potent and selective triazole-based S1R antagonists. The compound binds the human Sigma-1 receptor with
nanomolar affinity (Ki = 7.5 nM), demonstrates 100-fold selectivity over the Sigma-2 receptor, and exhibits
high blood-brain barrier penetration and favorable absorption, distribution, metabolism and elimination (ADME) properties, including
oral bioavailability of approximately 28%. TNX-4900 is in the pre-IND stages of development. In preclinical models of diabetic and
chemotherapy-induced neuropathic pain, TNX-4900 produced significant and durable reductions in pain behaviors after both acute and
chronic dosing without evidence of tolerance or motor impairment. Tonix plans to advance TNX-4900 through expanded pharmacokinetic,
formulation, and safety studies to support IND-enabling development.

19

Tonix’s
Facilities Overview

The
Research & Development Center (RDC)

We own the approximately 48,000 square foot RDC facility in Frederick,
Maryland. The RDC facility is operational and focuses on our development of vaccines and antiviral drugs against infectious diseases.
The RDC is the principal site for the research on TNX-4200, a broad-spectrum antiviral targeting CD45 funded by the DTRA contract. The
RDC also conducts research on CNS and immunology drugs. The RDC facility is biosafety level 2 (BSL-2) with BSL-3 components.

The
Advanced Development Center (ADC)

The
ADC located in the New Bedford business park in Dartmouth, Massachusetts is intended to accelerate development, clinical and commercial
scale manufacturing of live-virus vaccines and biologics. ADC includes single-use bioreactors and purification suites with equipment
for Good Manufacturing Practice (GMP) production of vaccines and biologics for clinical trials, including the capability of producing
sterile vaccines in glass vials.

The ADC is an approximately 45,000 square foot BSL-2 facility which can
employ up to 70 researchers, scientists, manufacturing, and technical support staff. This facility was decommissioned in May 2024, and
is ready to be reactivated on the earlier of 2027 or in the case of a national or international emergency.

Commercialization

Following FDA approval, we initiated the commercial launch of TONMYA in
2025, our first internally developed and commercialized product. We have established a focused commercial infrastructure and team designed
to support launch execution, drive prescriber awareness, and enable patient access, while maintaining compliance with applicable regulatory
and industry standards.

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 in the U.S., one of which is Almac Pharma Services, a member of the privately
owned Almac Group.

We
have managed the continued commercial operations for Zembrace Symtouch and Tosymra, following the acquisition of these products
in 2023.

Marketing,
Sales and Distribution

Marketing
activity for TONMYA, Zembrace Symtouch and Tosymra in the United States is conducted by our wholly-owned subsidiary, Tonix Medicines,
Inc. We focus our sales and marketing efforts on physicians in private practice and in public treatment systems. We employ standard
pharmaceutical marketing practices to promote our products, encompassing advertisements, professional symposia, sales initiatives,
and educational outreach aimed at physicians, nurses, social workers, counselors, and other stakeholders involved in treating
fibromyalgia and acute migraine in adults. We have established contracts with third-party vendors to handle logistics, offer customer
services, and manage other related aspects for our products. These services include managing product-specific websites, conducting
insurance research, processing orders, and handling delivery and fulfillment services. TONMYA, Zembrace Symtouch and Tosymra are
primarily sold to pharmaceutical wholesalers, pharmacies, and specialty distributors. We have implemented patient access programs
and expand distribution channels in our marketing efforts for our fibromyalgia and migraine drugs.

20

In
2024, Tonix engaged EVERSANA to support the launch strategy and commercial planning of TONMYA for the treatment of fibromyalgia.
Specifically, EVERSANA also worked with Tonix to assess the fibromyalgia landscape and help plan an efficient go-to-market strategy.

Our
commercialization strategy for TONMYA is centered on a cost-efficient, targeted sales and marketing approach focused on the top
prescribing healthcare providers who treat patients with fibromyalgia, including primary care physicians and relevant specialists.
Our field-based promotion is conducted through a combination of internal commercial personnel and contracted sales representatives.
As of December 31, 2025, our commercial organization included approximately 90 field sales representatives, inclusive of internal
and contracted resources, supported by sales leadership, training, and operations functions.

In addition to field-based promotion, we utilize non-personal promotion
and digital marketing initiatives to support disease awareness, product education, and appropriate utilization. These efforts are intended
to complement in-person engagement and expand reach within our target prescriber universe. We have 11 employees supporting sales administration
and marketing initiatives; customer service requests and top-tier headache specialists. We utilize third party vendors to
support trade, managed markets, marketing initiatives, and promotional compliance programs.

TONMYA is distributed in the United States through national pharmaceutical
wholesalers and specialty distributors pursuant to customary commercial arrangements. Tonix has contracted with its existing wholesalers
and specialty pharmacies for the distribution of TONMYA. We utilize third-party logistics providers to support product warehousing, order
fulfillment, and distribution activities. Our distribution and supply chain operations are structured to comply with applicable requirements,
including those under the Drug Supply Chain Security Act (DSCSA). Product returns are managed in accordance with industry-standard practices.

Market
Access and Patient Support

We
have implemented a market access strategy intended to support broad and appropriate patient access to TONMYA across key payer
segments, including commercial plans and government programs. Our market access efforts include engagement with payers and pharmacy
benefit managers, formulary review processes, and contracting activities customary for prescription pharmaceutical products.

We
also offer patient support services designed to assist with benefits verification, prior authorization support, and access to
available patient assistance programs. These services are administered through third-party vendors and are intended to facilitate
appropriate initiation and continuation of therapy, consistent with applicable laws and regulations.

Commercial
Compliance and Oversight

We
maintain policies, procedures, and controls designed to support compliant commercial operations, including a promotional review
committee (PRC) process for review and approval of promotional and non-promotional materials, field force compliance training,
and pharmacovigilance and adverse event reporting procedures. These activities are intended to support compliant engagement with
healthcare professionals, patients, and other stakeholders as we execute our commercial strategy.

Competition

Our
sector faces intense competition and experiences rapid, substantial technological advancements both domestically and internationally.
Our potential competitors encompass major pharmaceutical and biotechnology firms, specialty pharmaceutical and generic drug manufacturers,
academic institutions, government agencies, and research organizations. We consider efficacy, safety, tolerability, reliability,
pricing, and reimbursement levels as crucial competitive factors influencing the development and commercial success of our product
candidates. Numerous potential competitors, including some of the organizations listed below, possess considerably larger financial,
technical, and human resources, as well as extensive experience in discovering and developing product candidates, securing FDA
and other regulatory approvals, and commercializing those products, far surpassing our own capabilities. Hence, our competitors
might achieve greater success in securing FDA approval for drugs and gaining widespread market acceptance compared to us. The
drugs offered by our competitors may prove to be more effective or better marketed and sold than any product we bring to market,
potentially rendering our product candidates obsolete or non-competitive before we can recoup the expenses incurred in their development
and commercialization. We expect to encounter heightened competition as the market sees the introduction of new drugs and the
emergence of advanced technologies. Additionally, the evolution of novel treatment approaches for the conditions we are focusing
on may potentially diminish the competitiveness or relevance of our drugs. Below, we provide an overview of the competitive landscape
for the indications where Tonix has product candidates either in or nearing the clinical stages of development.

21

Fibromyalgia

As of 2026, the U.S. fibromyalgia therapeutic landscape consists of four
FDA-approved treatments.. The first three products - pregabalin (Lyrica ®), duloxetine (Cymbalta a®), and milnacipran (Savella
a®) - received FDA approval between 2007 and 2009 and have represented the standard of care for more than a decade. In August 2025,
FDA approved TONMYA, the first new fibromyalgia treatment in more than 15 years and the first approved therapy aimed at improving non-restorative
sleep, a core contributor to fibromyalgia pain and fatigue. The U.S. fibromyalgia market has historically been characterized by limited
innovation and treatment dissatisfaction, with many patients cycling through therapies or relying on off-label analgesics due to incomplete
symptom control. The approval of TONMYA introduces a differentiated mechanism targeting nonrestorative sleep.

We
actively monitor multiple companies advancing investigational therapies for fibromyalgia. In the U.S., Axsome Therapeutics, Inc.
initiated their Phase 3 trial of AXS-14 (esreboxetine) for the management of fibromyalgia in January 2026. Dogwood
Therapeutics, Inc. (formerly Virios Therapeutics, Inc.) continues the development of IMC-1, a fixed-dose combination
of famciclovir + celecoxib. Outside the U.S., Ono Pharmaceutical is advancing ONO-1110 as an oral medication designed for endocannabinoid
regulation. The drug is being developed in Japan for several indications, including fibromyalgia, postherpetic neuralgia, and
major depressive disorder. Tryptamine Therapeutics Ltd. reported positive Phase IIa data for TRP-8802 in fibromyalgia at the 2024
IASP meeting.

Migraine

Zembrace
SymTouch and Tosymra continue to serve the acute migraine market as branded formulations of sumatriptan, competing directly with
generic subcutaneous and intranasal products. Beyond generic pressure, both brands now operate within an increasingly competitive
landscape shaped by the growth of next-generation acute therapies, including oral CGRP antagonists such as Pfizer’s
Nurtec® ODT (rimegepant) and AbbVie’s Ubrelvy® (ubrogepant) and Qulipta® (atogepant), as well as intranasal
CGRP options like Pfizer’s Zavzpret™ (zavegepant).

The
competitive environment expanded further in 2025 with the FDA approval of Axsome Therapeutic Inc.’s Symbravo® (meloxicam
and rizatriptan). Satsuma Pharmaceuticals, Inc. received FDA approval for Atzumi, a nasal powder formulation of DHE (dihydroergotamine)
for acute treatment of migraine.

Meanwhile,
broader migraine development pipelines including but not limited to assets such as PUR-3100, an orally inhaled dry-powder
formulation of dihydroergotamine (DHE) developed by Pulmatrix, Inc., signal ongoing innovation and expected market expansion through
2026 as companies advance differentiated mechanisms and delivery formats.

Major
Depressive Disorder

Many
antidepressant medications are beyond their patent life and are generally produced by generic drug companies, including several
compounds in the tricyclic class (e.g., amitriptyline), the serotonin-selective reuptake inhibitor class (e.g., fluoxetine, paroxetine
and sertraline), the serotonin-norepinephrine reuptake inhibitor class (e.g., venlafaxine, duloxetine), as well as the norepinephrine-dopamine
reuptake inhibitor, bupropion. Tonix is aware of several companies developing novel prescription medicines for depression, including
companies with late-stage (Phase 3) clinical-stage programs, including but not limited to: Johnson & Johnson,
Inc., Luye Pharma Group, Ltd., Definium Therapeutics, Inc., and Vanda Pharmaceuticals, Inc.

Acute
Stress Reaction/Acute Stress Disorder (ASR/ASD)

There
are currently no approved drugs specifically for treating acute stress reaction (ASR) or for the prevention of acute stress disorder
(ASD). As of late 2025, BXCL501 (dexmedetomidine sublingual film) which is the FDA-approved drug marketed as IGALMI® remains
under investigation for stress-related indications but is not approved for ASR, ASD, or PTSD. BioXcel Therapeutics, with U.S.
Department of Defense support, expects to begin a Phase 2a trial of BXCL501 in patients experiencing ASD following motor vehicle
collisions.

22

Lyme
Disease

There
are no approved drugs for Lyme disease prevention. We are aware of several companies currently developing Lyme Disease vaccines. Pfizer,
in collaboration with Valneva, is developing VLA15, a multivalent recombinant protein subunit vaccine designed to prevent Lyme in the
U.S. and Europe. The program has completed its Phase 3 VALOR trial vaccinations, with a data readout expected in the first half of 2026.

Moderna
is advancing two mRNA-based vaccine candidates as part of its bacterial vaccine program (mRNA-1982 and mRNA-1975), which are in
Phase I/II clinical trials.

Transplantation
Rejection and Autoimmune Treatments with Anti-CD40-ligand Monoclonal Antibodies

We
are aware of multiple companies advancing the development of biologics targeting the CD40L molecule. Sanofi’s Frexalimab
(SAR441344) is in Phase III development for Multiple Sclerosis. Frexalimab is also being advanced in clinical trials for other
autoimmune diseases, including Systemic Lupus Erythematosus. Eledon Pharmaceuticals is advancing tegoprubart for organ
transplant rejection. The company completed its Phase II (BESTOW) trial in 2025 and plans to meet with the FDA to discuss Phase III
trial design and data requirements in 2026. Amgen Inc. is currently conducting a Phase III trial to test
dazodalibep for Sjogren’s Syndrome, with an estimated completion date for the second half of 2026. In November 2024,
UCB and Biogen announced the initiation of their potentially confirmatory Phase III trial to test dapirolizumab
Pegol for Systemic Lupus Erythematosus. Biogen expects topline data readouts in late 2027 or early 2028.

These
are a few key highlights that underscore the focus of major pharmaceutical companies in this area and we monitor the activity
of other companies in the process of developing antagonistic anti-CD40 mAbs, including Novartis, Boehringer Ingelheim GmbH, Kiniska
Pharmaceuticals, Boston Immune Therapies, and NapaJen Pharma Inc.

Prader
Willi Syndrome

Vykat® (Diazoxide Choline),
developed by Soleno Therapeutics, is approved for the treatment of Prader Willi Syndrome (PWS). Tonix is aware of several companies currently
developing treatments for PWS, including Harmony Biosciences and Aardvark Therapeutics. Harmony Biosciences is advancing pitolisant in
a Phase III clinical trial (TEMPO).

Gastric
and Colorectal Cancer

We
are aware of several companies that are focused on developing treatments for Gastric and Colorectal Cancer, including but not
limited to: Johnson & Johnson, AbbVie Inc., AstraZeneca PLC, Roche Holding AG, Novartis AG, Merck & Co. Inc., Pfizer Inc.,
GSL plc, Bristol Myers Squibb Company, BioNtech SE and Jazz Pharmaceuticals.

Smallpox
/ Mpox

There
are multiple approved vaccines globally for the prevention of smallpox and mpox including Jynneos®, developed by Bavarian
Nordic, ACAM2000®, developed by Emergent BioSolutions, and LC16m8®, developed by KM Biologics. We are aware of several
companies currently developing next-generation vaccines for smallpox and mpox, including but not limited to: Moderna, BioNTech SE, GeoVax
and NonoViricides.

Cocaine
Intoxication

There
are no approved antidotes for the treatment of cocaine intoxication. Patients generally receive supportive care. We are not aware of
any drugs in development for the treatment of cocaine intoxication.

Intellectual
Property

We believe that we have an extensive patent portfolio and substantial know-how
relating to TNX-102 SL, Zembrace®, Tosymra®, TNX-1300, TNX-1500, TNX-2900, TNX-1900, TNX-801, TNX-1800 and TNX-1700, and our
other product candidates. Our patent portfolio, described more fully below, includes claims directed to various compositions and methods
of use related to our product candidates. As of March 5, 2026, the patents we are either the owner of record of or own the contractual
right to include 45 issued U.S. patents and 46 issued non-U.S. patents. We are actively pursuing an additional 22 U.S. non-provisional
patent applications, 4 international patent applications (PCT), and 238 non-U.S./non-PCT patent applications.

23

We
strive to protect the proprietary technology that we believe is important to our business, including our proprietary technology
platform, our product candidates, and our processes. We seek patent protection in the U.S. and internationally for our products,
their methods of use and processes of manufacture, and any other technology to which we have rights, where available and when
appropriate. We also rely on trade secrets that may be important to the development of our business.

Our
success will depend on 1) the ability to obtain and maintain patent and other proprietary rights in commercially important technology,
inventions and know-how related to our business, 2) the validity and enforceability of our patents, 3) the continued confidentiality
of our trade secrets, and 4) our ability to operate without infringing the valid and enforceable patents and proprietary rights
of third parties. We also rely on continuing technological innovation and in-licensing opportunities to develop and maintain our
proprietary position.

We
cannot be certain that patents will be granted with respect to any of our pending patent applications or with respect to any patent
applications we may own or license in the future, nor can we be certain that any of our existing patents or any patents we may
own or license in the future will be useful in protecting our technology. For this and more comprehensive risks related to our
intellectual property, please see “Risk Factors — Risks Relating to Our Intellectual Property.”

The
term of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In most countries
in which we file, the patent term is 20 years from the date of filing the first non-provisional priority application. In the United
States, a patent’s term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays
by the PTO in granting a patent or may be shortened if a patent is terminally disclaimed over another patent.

The
term of a U.S. patent that covers a drug approved by the FDA or methods of making or using that drug may also be eligible for
patent term extension, which permits patent term restoration as compensation for the patent term lost during the FDA regulatory
review process. The Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act, is a federal law
that encourages new drug research by restoring patent term lost to regulatory delays by permitting a patent term extension of
up to five years beyond the statutory 20-year term of the patent for the approved product or its methods of manufacture or use
if the active ingredient has not been previously approved in the U.S. The length of the patent term extension is related to the
length of time the drug is under regulatory review. A patent term extension cannot extend the remaining term of a patent beyond
a total of 14 years from the date of product approval and only one patent applicable to an approved drug may be extended. Similar
provisions are available in Europe and some other foreign jurisdictions to extend the term of a patent that covers an approved
drug.

When
possible, depending upon the length of clinical trials and other factors involved in the filing of an NDA, we expect to apply
for patent term extensions for patents covering our product candidates and their methods of manufacture or use.

The patent portfolios for our proprietary technology platform and our most
advanced product candidates as of March 5, 2026 are summarized below.

TNX-102
SL — Central Nervous System Conditions

Our
patent portfolio for TNX-102 SL includes patents and patent applications directed to compositions of matter of CBP, formulations
containing CBP, and methods for treating CNS conditions, such as TNX-102 SL for PTSD, for pain, fatigue and sleep disturbances
in fibromyalgia, for treating or managing fibromyalgia (early onset response, favorable tolerability, or side effect profile),
for alcohol abuse, for disordered sleep, for sexual dysfunction, for depression in fibromyalgia, for fatigue and disordered sleep
(e.g., CAP rates), for post-acute sequelae of SARS-CoV-2 infection, for acute stress reaction/acute stress disorder, and for agitation
in neurodegenerative conditions, e.g., AD.

Certain
eutectic compositions were discovered by development partners and are termed the “Eutectic Technology.” The patent
portfolio for CBP compositions (e.g., TNX-102 SL) relating to the Eutectic Technology includes patents and patent applications
directed to eutectic compositions containing CBP, eutectic CBP formulations, methods for treating PTSD and other CNS conditions
utilizing eutectic CBP compositions and formulations, and methods of manufacturing eutectic CBP compositions. The Eutectic Technology
patent portfolio includes U.S. patents, such as U.S. Patent No. 9,636,408, U.S. Patent No. 9,956,188, U.S. Patent No. 10,117,936,
U.S. Patent No. 10,357,465, U.S. Patent No. 10,864,175, U.S. Patent No. 11,026,898, and U.S. Patent No. 11,839,594. These U.S.
patents and counterpart non-U.S. patents, and any U.S. and non-U.S. patents that issue in the future from this portfolio would
expire in 2034 or 2035, excluding any patent term adjustments or extensions.

The
unique pharmacokinetic profile of TNX-102 SL, or the PK Technology, was discovered by Tonix and its development partners. The
patent portfolio for TNX-102 SL relating to the PK Technology includes patent applications directed to compositions of matter
of CBP, formulations containing CBP, methods for treating PTSD, agitation in neurodegenerative conditions, and other CNS conditions
utilizing these compositions and formulations. The PK Technology patent portfolio includes U.S. Patent Application No. 19/409,704.
If U.S. and non-U.S. patents claiming priority from those applications issue, those patents would expire in 2033, excluding any
patent term adjustments or extensions.

24

On
May 2, 2017, U.S. Patent No. 9,636,408 entitled “Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline
Hydrochloride”, issued. The patent claims recite pharmaceutical compositions comprising the eutectic. The patent claims
also recite methods of manufacturing the eutectic.

On
September 13, 2017, European patent 2,501,234, entitled “Methods and Compositions for Treating Symptoms Associated with
PTSD Using Cyclobenzaprine”, issued. This patent recites the use of CBP for the treatment of PTSD. On January 11, 2024,
the European Patent Office Technical Board of Appeal reversed the October 2019 decision of the Opposition Division of the European
Patent Office maintaining the patent in unamended form and held the patent to be invalid. No appeal may be taken from that decision.

On
December 15, 2017, Japanese Patent No. 6259452, entitled “Compositions and Methods for Transmucosal Absorption,” issued.
These claims relate to the pharmacokinetic profile of TNX-102 SL.

On
August 3, 2022, European Patent No. 2861223, entitled “Compositions and Methods for Transmucosal Absorption,” issued.
These claims relate to the pharmacokinetic profile of TNX-102 SL.

On
March 20, 2018, U.S. Patent No. 9,918,948 entitled “Methods and Compositions for Treating Symptoms Associated with PTSD
Using Cyclobenzaprine,” issued. The claims recite a method of using TNX-102 SL’s active ingredient cyclobenzaprine
to treat PTSD and provides US market exclusivity until 2030, excluding any patent term extensions.

On
March 23, 2018, Japanese Patent No. 6310542 entitled “Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline
Hydrochloride”, issued. The claims recite pharmaceutical compositions comprising the eutectics and methods of manufacturing
these eutectic formulations.

On
May 1, 2018, U.S. Patent No. 9,956,188, entitled “Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline
Hydrochloride”, issued. The claims recite a eutectic of cyclobenzaprine hydrochloride and mannitol and methods of making
those eutectics.

On
November 6, 2018, U.S. Patent No. 10,117,936, entitled “Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline
Hydrochloride”, issued. The claims recite pharmaceutical compositions of eutectics of cyclobenzaprine hydrochloride and
mannitol and methods of making those compositions.

On
April 16, 2019, Chinese Patent No. ZL 201480024011.1 entitled “Eutectic Formulations of Cyclobenzaprine Hydrochloride and
Amitriptyline Hydrochloride”, issued. The claims recite pharmaceutical compositions comprising eutectics of cyclobenzaprine
hydrochloride and mannitol and methods of making those compositions.

On
August 4, 2023, Chinese Patent No. ZL201910263541.6, entitled “Eutectic Formulations of Cyclobenzaprine Hydrochloride and
Amitriptyline Hydrochloride,” issued. The claims recite a eutectics of cyclobenzaprine hydrochloride and beta-mannitol and
methods of making those eutectics.

On
July 23, 2019, U.S. Patent No. 10,357,465 entitled “Eutectic Formulations of Cyclobenzaprine Hydrochloride”, issued.
The claims recite a eutectic of cyclobenzaprine hydrochloride and mannitol and methods of making those eutectics.

On
December 11, 2019, European patent 2968992, entitled “Eutectic Formulations of Cyclobenzaprine Hydrochloride”, issued.
This patent recites pharmaceutical compositions comprising a eutectic of mannitol and Cyclobenzaprine HCl and methods of making
the same. In response to an opposition filed in September 2020 by Hexal AG, the European Patent Office’s Opposition Division
upheld the patent in unamended form after the January 2022 oral proceedings. Hexal AG did not appeal that decision.

On
December 25, 2019, European patent 2,683,245, entitled “Methods and Compositions for Treating Depression Using Cyclobenzaprine”,
issued. The claims recite the use of CBP for the treatment of depression in a FM patient. This patent provides TNX-102 SL with
European market exclusivity until March 2032 and may be extended based on the timing of the European marketing authorization of
TNX-102 SL for depression in a FM patient. In September 2020, Hexal AG filed an opposition against this patent. The European Patent
Office’s Opposition Division upheld the patent claims in unamended form after the February 2022 oral proceedings. Hexal
AG did not appeal that decision.

25

On
June 4, 2024, U.S. Patent No. 11,998,516, entitled “Methods and Compositions for Treating Depression Using Cyclobenzaprine,”
issued. The claims recite methods for treating major depressive disorder in a fibromyalgia patient using a composition comprising
cyclobenzaprine or its salts.

On
December 15, 2020, U.S. Patent No. 10,864,175 entitled “Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline
Hydrochloride”, issued. The claims recite a eutectic comprising cyclobenzaprine hydrochloride and beta-mannitol.

On
December 12, 2023, U.S. Patent No. 11,839,594 entitled “Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline
Hydrochloride”, issued. The claims recite a method of manufacturing a eutectic comprising cyclobenzaprine hydrochloride
and beta-mannitol comprising mixing or milling.

On
February 14, 2024, European Patent No. 3,650,081, entitled “Eutectic Formulations of Cyclobenzaprine Hydrochloride and Amitriptyline
Hydrochloride”, issued. The claims recite a eutectic of mannitol and cyclobenzaprine hydrochloride and methods of manufacturing
a eutectic.

On
April 8, 2021, U.S. non-provisional Patent Application No. 17/226,058 and International Patent Application No. PCT/US2021/026492,
entitled “Cyclobenzaprine Treatment for Sexual Dysfunction” were filed. The PCT application is now nationalized in
Australia, Canada, China, European Patent Office, Japan, and Hong Kong. On October 5, 2022, International Patent Application No.
PCT/US2022/045791, entitled “Cyclobenzaprine Treatment for Sexual Dysfunction,” was filed and is now nationalized
in European Patent Office and U.S. (U.S. Patent Application No. 18/698,483). The claims of these applications are directed to
methods using pharmaceutical compositions and combinations for treating sexual dysfunction with cyclobenzaprine or pharmaceutically
acceptable salts of cyclobenzaprine.

On
October 25, 2016 and July 28, 2020, U.S. Patent No. 9,474,728 and U.S. Patent No. 10,722,478, entitled “Methods and Compositions
for Treating Fatigue Associated with Disordered Sleep Using Very Low Dose Cyclobenzaprine”, issued, respectively. The claims
are directed to a method for monitoring the effectiveness of cyclobenzaprine treatment for disordered sleep and method for reducing
CAP rates A2 or A3 by treating a subject with a pharmaceutical composition comprising cyclobenzaprine.

On
December 11, 2018, International Patent Application No. PCT/IB2018/001509, entitled “Cyclobenzaprine Treatment for Agitation,
Psychosis and Cognitive Decline in Dementia and Neurodegenerative Conditions,” was filed. The PCT application is now nationalized
in 16 countries. The claims are directed to methods for treating or preventing agitation, cognitive decline, psychosis, and associated
symptoms thereof using pharmaceutical compositions and combinations with cyclobenzaprine or pharmaceutically acceptable salts
of cyclobenzaprine.

On
November 28, 2023, U.S. Patent No. 11,826,321, entitled “Cyclobenzaprine Treatment for Agitation, Psychosis and Cognitive
Decline in Dementia and Neurodegenerative Conditions,” issued. The claims are directed to a method for treating or preventing
one or more agitation associated symptoms comprising administering a eutectic of cyclobenzaprine HCl and mannitol.

On
August 20, 2019, International Patent Application No. PCT/IB2019/000940, entitled “Methods of Treating Acute Stress Disorder
and Posttraumatic Stress Disorder,” was filed. The PCT application is now nationalized in 18 countries. The claims are directed
to methods of treating acute stress disorder or post-traumatic stress disorder in a subject who has experienced a traumatic event
using pharmaceutical compositions with cyclobenzaprine, amitriptyline or pharmaceutically acceptable salts of cyclobenzaprine
or amitriptyline.

On
November 19, 2021, International Patent Application No. PCT/US2021/060011, entitled “Cyclobenzaprine Treatment for Alcohol
Use Disorder,” was filed. The PCT application is now nationalized in 13 countries. The claims are directed to methods for
treating alcohol use disorder and associated symptoms using pharmaceutical compositions with cyclobenzaprine or pharmaceutically
acceptable salts of cyclobenzaprine.

On
December 7, 2021, International Patent Application No. PCT/US2021/062244, entitled, “Cyclobenzaprine Treatment for Fibromyalgia,”
was filed. The PCT is now nationalized in 15 countries. The claims are directed to methods for treating fibromyalgia and its associated
symptoms of pain, sleep disturbance and/or fatigue by transmucosally administering a eutectic of cyclobenzaprine hydrochloride
and mannitol in dosage units with a basifying agent.

On
June 21, 2023, U.S. non-provisional Patent Application No. 18/212,500 and International Patent Application No. PCT/US2023/025895,
entitled “Cyclobenzaprine Treatment for Post-Acute Sequelae of (SARS)-CoV-2 Infection (PASC),” were filed. The PCT
is now nationalized in 9 countries. The claims are directed to methods of treating PASC or one or more associated symptoms comprising
administering cyclobenzaprine or a pharmaceutically acceptable salts of cyclobenzaprine.

26

On
December 19, 2024, U.S. non-provisional Patent Application No. 18/988,194 and International Patent Application No. PCT/US2024/061125,
entitled “Early Onset Response, Favorable Tolerability, and Side Effect Profile in the Treatment of Fibromyalgia,”
were filed. The claims are directed to methods for treating or managing fibromyalgia and its associated symptoms in subjects characterized
by an early onset of one or more of: (1) a reduction in widespread pain; (2) a reduction in sleep disturbance; (3) a reduction
in fatigue; or (4) an improved sleep quality. The claims are also directed to methods for preventing or avoiding clinically meaningful
changes in mean weight, in mean systolic blood pressure or mean diastolic blood pressure, or a decline in sexual functioning.

On
January 23, 2025, International Patent Application No. PCT/US2025/012803, entitled Cyclobenzaprine Treatment for Acute Stress
Reaction or Acute Stress Disorder,” was filed. The claims are directed to methods for treating or preventing acute stress
reaction (ASR) or acute stress disorder (ASD) and associated symptoms thereof using a composition with cyclobenzaprine or its
salts in.

TNX-1900
— Oxytocin-Based Treatments for the Treatment of Binge Eating Disorder, Adolescent Obesity, Bone Health in Pediatric Autism, and
Arginine-Vasopressin Deficiency

We
have acquired the migraine and pain treatment technologies of Trigemina, Inc., and have assumed its license rights to related
technologies from The Board of Trustees of the Leland Stanford Junior University. TNX-1900, an enhanced formulation of nasal oxytocin,
has demonstrated activity in several non-clinical studies in pain, including migraine.

As
part of our acquisition, we acquired International Patent Application No. PCT/US2016/012512, filed on January 7, 2016, entitled
“Magnesium-Containing Oxytocin Formulations and Methods of Use” (nationalized in 13 countries). We also acquired U.S.
Patent Nos. 9,629,894 and 11,389,473, entitled “Magnesium-Containing Oxytocin Formulations and Methods of Use”, which
will expire in January 2036, excluding any patent term extensions. On July 1, 2022, Chinese Patent No. ZL201680013809.5, entitled
“Magnesium-Containing Oxytocin Formulations and Methods of Use,” issued. On October 4, 2023, European Patent No. 3242676,
entitled “Magnesium-Containing Oxytocin Formulations and Methods of Use,” issued.

We
also acquired International Patent Application No. PCT/US2017/027265, filed April 12, 2017, entitled “Magnesium-Containing
Oxytocin Formulations and Methods of Use” (nationalized in 9 countries). On December 3, 2024, U.S. Patent No. 12,156,897,
entitled “Magnesium-Containing Oxytocin Formulations and Methods of Use,” issued. The patent, which claims methods
for treating autism spectrum disorder, social anxiety disorder, or a social communication disorder, will expire in April 2037,
excluding any patent term extensions. On January 1, 2023, Chinese Patent No. ZL201780036185.3, entitled “Magnesium-Containing
Oxytocin Formulations and Methods of Use,” issued. On November 13, 2025 Japan Patent No. 7093559, entitled “Magnesium-Containing
Oxytocin Formulations and Methods of Use,” issued.

We
also have rights to International Patent Application No. PCT/US2019/020419, filed on April 12, 2017, entitled “Labeled Oxytocin
and Method of Manufacture and Use” (nationalized in the U.S., European Patent Office and Japan). On April 30, 2024, U.S.
Patent No. 11,970,554, entitled “Labeled Oxytocin and Method of Manufacture and Use,” issued. On November 11, 2025,
U.S. Patent No. 12,466,855, entitled “Labeled Oxytocin and Method of Manufacture and Use,” issued.

We
have entered into an exclusive license to the University of Geneva’s technology for using oxytocin to treat insulin resistance
and related syndromes, including obesity. This license expands our intranasal potentiated oxytocin development program, TNX-1900,
into cardiometabolic syndromes. Under the license, we have rights to European Patent No. EP2571511B1, entitled “New Uses
of Oxytocin-like Molecules and Related Methods.” We also have rights to U.S. Patent No. 9,101,569, entitled “Methods
for the Treatment of Insulin Resistance.” The U.S. and non-U.S. patents expire in May 2031, excluding any patent term adjustments
or extensions.

We
are developing oxytocin peptide analogs for headache disorders. On March 18, 2025, we filed International Patent Application No.
PCT/US2025/020483, entitled “Oxytocin Peptide Analogs.”

TNX-2900
— Oxytocin-Based Therapeutics Treatments for Prader-Willi Syndrome (PWS)

We
have licensed technology using oxytocin-based therapeutics for the treatment of PWS and non-organic failure to thrive disease
from the French National Institute of Health and Medical Research (INSERM). The co-exclusive license relates to TNX-2900, an intranasal
potentiated oxytocin, for the treatment of Prader-Willi syndrome and other feeding disorders. Under the license, we have rights
to European Patent No. EP2575853B1, entitled “Methods and Pharmaceutical Composition for the Treatment of a Feeding Disorder
with Early-Onset in a Patient”; U.S. Patent No. 8,853,158, entitled “Methods for the Treatment of a Feeding Disorder
with Onset During Neonate Development Using an Agonist of the Oxytocin Receptor”; and U.S. Patent No. 9,125,862, entitled
“Methods for the Treatment of Prader-Willi-like Syndrome or Non-Organic Failure to Thrive (NOFITT) Feeding Disorder Using
an Agonist of the Oxytocin Receptor.” The U.S. and non-U.S. patents expire in May 2031, excluding any patent term extensions.

27

TNX-1300
— Cocaine Intoxication Treatment

We
have licensed rights from The Trustees of Columbia University in the City of New York, The Regents of the University of Michigan,
and University of Kentucky Research Foundation to develop a potential product, TNX-1300, for the treatment of cocaine intoxication.
The licensed patents are directed to mutant cocaine esterase polypeptides and methods of using these polypeptides as anti-cocaine
therapeutics. They include U.S. Patent Nos. 8,318,156 and 9,200,265, entitled “Anti-Cocaine Compositions and Treatment”
and various counterpart patents outside of the U.S (e.g., European Patent 2046368). These patents provide TNX-1300 with US market
exclusivity until February 2029, and market exclusivity outside of the U.S. until July 10, 2027, subject to any patent term extensions.

TNX-1500
— anti-CD40L Therapeutics

We
are developing TNX-1500, a humanized mAb that targets CD40L for the prevention and treatment of organ transplant rejection. In
this regard, we filed International Application No. PCT/EP2020/068589, entitled “Anti-CD154 antibodies and uses thereof”
on July 1, 2020 (nationalized in 15 countries). We also filed International Patent Application No. PCT/US2020/028002 on April
13, 2020, entitled “Inhibitors of CD40-CD154 Binding” (nationalized in U.S., Canada, China, European Patent Office
and Japan). We also filed International Patent Application No. PCT/US2022/011404, entitled “Methods of Inducing Immune Tolerance
with Modified Anti-CD154 Antibodies” on January 6, 2022 (nationalized in 14 countries). We also filed International Patent
Application No. PCT/EP2025/065085, entitled “Treatment Methods Comprising Administration of Modified CD154 Antibodies”
on May 30, 2025.

On
August 28, 2024, European Patent No. 3993876, entitled “Anti-CD154 Antibodies and Uses Thereof,” issued (validated
in 37 countries). The claims recite an isolated antibody that binds CD154, compositions comprising the antibody, and use of the
compositions for treating or preventing a transplant rejection.

On
April 22, 2025, Chinese Patent No. ZL202080059891.1, entitled “Anti-CD154 antibodies and uses thereof,” issued. The
claims recite an isolated antibody that binds CD154, compositions comprising the antibody, and uses of the antibody for inhibiting
an immune response, treating or preventing a transplant rejection, or inhibiting xenotransplant rejection.

On
November 14, 2025, Japanese Patent No. 7775080, entitled “Anti-CD154 antibodies and uses thereof,” issued. The claims
recite an antibody or isolated antibody that binds CD154 and compositions comprising the antibody for use in treating or preventing
a transplant rejection, inducing hematopoietic chimerism in a transplant recipient, inducing central tolerance in a transplant
recipient, or inhibiting xenotransplant rejection.

TNX-801
— Live Horsepox Vaccine for Prevention of Smallpox and Mpox

We
own the rights to develop a potential biodefense technology, TNX-801, a live horsepox that is being developed as a new smallpox
and mpox preventing vaccine, we have filed patent applications directed to synthetic chimeric poxviruses and methods of using
these poxviruses to protect individuals against smallpox. These applications include U.S. non-provisional Patent Application No.
15/802,189 and International Patent Application No. PCT/US2017/059782 (nationalized in 15 countries and filed in 4 non-PCT countries).
We also own the rights to develop other vaccine candidates against smallpox. With respect to these vaccine candidates, we own
International Patent Application No. PCT/US2019/030486 and the non-convention and national phase applications related thereto
(nationalized in 17 countries and filed in 2 non-PCT countries). The smallpox vaccine technologies relate to proprietary forms
of live horsepox and vaccinia vaccines which may be safer than ACAM2000, the only currently available replication competent, live
vaccinia vaccine to protect against smallpox disease. We believe that this technology, after further development, may be of interest
to biodefense agencies in the U.S. and other countries.

On
May 31, 2022, U.S. Patent No. 11,345,896 was issued. The claims recite a synthetic chimeric orthopoxvirus (scOPV), a synthetic
chimeric horsepox virus (scHPXV), methods of generating the scOPV and scHPXV, and compositions comprising the scOPV or scHPXV.

On
July 22, 2025, U.S. Patent No. 12,365,879, entitled “Synthetic Chimeric Poxviruses,” issued. The claims recite methods
of producing a synthetic chimeric orthopoxvirus (scOPV) and a synthetic chimeric horsepox virus (scHPXV) and methods of treating
infections using the scOPV or scHPXV.

On
April 2, 2024, Chinese Patent No. ZL201780078546.0, entitled “Synthetic Chimeric Poxviruses,” issued. The claims recite
a synthetic chimeric orthopoxvirus (scOPV), methods of producing an scOPV, compositions comprising the scOPV, and uses of the
scOPV.

TNX-1800
and TNX-1850 — Live Modified Horsepox Vaccine for Prevention of COVID

We
are developing TNX-1800 and TNX-1850, live minimally replicative modified HPXVs, as a COVID preventing vaccine against different
strains of SARS-CoV-2. On February 26, 2021, we filed International Patent Application No. PCT/US2021/020119, entitled “Recombinant
Poxvirus Based Vaccine Against SARS-CoV-2.” On the same date, we also filed applications in Argentina and Taiwan and we
filed U.S. Application No. 17/187,678. The PCT application is now nationalized in 19 countries. These applications are directed
to synthetic poxviruses comprising a SARS-CoV-2 virus protein, poxvirus delivery vectors for SARS-CoV-2 virus proteins and methods
of using these modified poxviruses to protect individuals against COVID.

28

TNX-1700
— Recombinant Trefoil Family Factor 2 (rTFF2) to Treat Gastric and Colorectal Cancers

We
have licensed rights from The Trustees of Columbia University in the City of New York to develop a potential product, TNX-1700, for the
treatment of gastric and colorectal cancers. The licensed patents are directed to rTFF2 compositions and methods of treatment. The licensed
patents, U.S. Patent No. 10,124,037 and U.S. Patent No. 11,167,010, provide TNX-1700 with US market exclusivity until April 2033, subject
to any patent term extensions. On August 27, 2020, we filed International Patent Application No. PCT/IB2020/000699 entitled “Modified
TFF2 Polypeptides.” The PCT application is now nationalized in 12 countries.

Zembrace
and Tosymra — Sumatriptan

We
have acquired the intellectual property rights of Zembrace SymTouch and Tosymra and their uses in treating migraine from Upsher-Smith
Laboratories, LLC. These rights include U.S. Patent No. 9,211, 282, U.S. Patent No. 9,610,280, U.S. Patent No. 9,974,770, U.S.
Patent No. 10,603,305, U.S. Patent No. 11,337,962, U.S. Patent No. 10,537,554, and U.S. Patent No. 11,364, 224. These rights also
include International Patent Application No. PCT/US2016/015961, entitled “Pharmaceutical Composition Comprising Sumatriptan
for Treating Migraine,” (nationalized in 7 countries, excluding rights in Brazil and China) and International Patent Application
No. PCT/IB2010/001708, entitled “Formulations Comprising Triptan Compounds,” (nationalized in 11 countries, excluding
rights in Brazil, Russia, India, and China).

Trade
Secrets

In
addition to patents, we rely on trade secrets and know-how to develop and maintain our competitive position. For example, significant
aspects of our proprietary technology platform are based on unpatented trade secrets and know-how. Trade secrets and know-how
can be difficult to protect. We seek to protect our proprietary technology and processes, in part, by confidentiality agreements
and invention assignment agreements with our employees, consultants, scientific advisors, contractors, and commercial partners.
These agreements are designed to protect our proprietary information and, in the case of the invention assignment agreements,
to grant us ownership of technologies that are developed through a relationship with a third party. We also seek to preserve the
integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and
electronic security of our information technology systems. While we have confidence in these individuals, organizations and systems,
agreements or security measures may be breached, and we may not have adequate remedies for any breach. In addition, our trade
secrets may otherwise become known or be independently discovered by competitors. To the extent that our contractors use intellectual
property owned by others in their work for us, disputes may arise as to rights in related or resulting inventions and know-how.

29

Issued
Patents

Our
current patents owned or licensed include:

Anti-Cocaine
Therapeutics

Sublingual
CBP/Amitriptyline

30

CBP
– Depression

CBP
– PTSD

CBP
Fatigue

31

CBP
– Agitation in Neurodegenerative Condition

CBP/Amitriptyline
Eutectic Formulations

32

33

Analogs
of CBP

34

Oxytocin
therapeutics

35

36

Nociceptin/Orphanin
FQ therapeutics

Tianeptine
– Neurocognitive Dysfunction

TFF2
therapeutics

37

Synthetic
Chimeric Poxviruses

Synthetic
Vaccinia Virus

Poxvirus
vaccine against COVID-19

Triptan
Compound – Formulations

38

Triptan
Compound – Migraine

CD40
and anti-CD154 Therapeutics

CBP
- ASD and PTSD

CBP
– Sexual dysfunction

39

Pending
Patent Applications

Our
current pending patent applications are as follows:

CD40
and anti-CD154 Therapeutics

40

CBP/Amitriptyline
Eutectic Formulations

Sublingual
CBP/Amitriptyline

CBP
– Agitation in Neurodegenerative Condition

41

Analogs
of CBP

CBP
– ASD and PTSD

CBP
– Fibromyalgia

42

CBP
– Fibromyalgia (Early Onset Response, Favorable Tolerability, and Side Effect Profile)

CBP
– Acute Stress Reaction or Acute Stress Disorder

CBP
– Alcohol Use Disorder

CBP
– Sexual dysfunction

43

CBP
– Post-Acute Sequelae of SARS-CoV-2 (PASC)

Oxytocin
therapeutics

44

Nociceptin/Orphanin
FQ therapeutics

Synthetic
Chimeric Poxviruses

Synthetic
Vaccinia Virus

45

Poxvirus
vaccine against COVID-19

TFF2
therapeutics

Triptan
Compound – Formulations

Triptan
Compound – Migraine

46

Tianeptine
– Conditions Associated with Peroxisome Proliferator-Activated Receptor

Trademarks
and Service Marks

Tonix
Pharmaceuticals, Inc.

We
seek trademark and service mark protection in the United States and outside of the United States where available and when appropriate.
We are the owner of the following U.S. federally registered mark: TONIX PHARMACEUTICALS (Reg. No. 4656463, issued December 16,
2014).

We
are the owner of the following marks for which applications for U.S. federal registration are currently pending: FYMRALIN (Serial
No. 98/327953, filed December 22, 2023), MODALTIN (Serial No. 99/562722, filed December 23, 2025), RAPONTIS (Serial No. 90/562733,
filed December 23, 2025), PROTECTIC (Serial No. 99/562746, filed December 23, 2025), TONIX PHARMACEUTICALS (Serial No. 98/577945,
filed May 31, 2024), ANGSTRO-TECHNOLOGY (Serial No. 98/006538, filed May 22, 2023) ).

Tonix
Medicines, Inc.

We
are the owner of the following U.S. federally registered marks: NOTIME4MIGRAINES (Reg. No. 5392512, issued January 30, 2018);
SYMTOUCH (Reg. No. 5186988, issued April 18, 2017); TOSYMRA (Reg. No. 5981221, issued February 11, 2020); TOSYMRA & DROPLET
Design (Reg. No. 6124333, issued August 11, 2020); ZEMBRACE (Reg. No. 5186989, issued April 18, 2017); ZEMBRACE SYMTOUCH (Reg.
No.5478282, issued May 29, 2018); DROPLET Design (Reg. No. 6117797, issued August 4, 2020); TONIX ONE LOGO Design (Serial No.
99/057051, filed February 26, 2025). We are the owner of the following International Registrations under the Madrid Protocol:
TOSYMRA (Reg. No. 1501060, issued October 16, 2019 – Extensions of Protection to: Canada, European Union, Japan, Republic
of Korea); ZEMBRACE (Reg. No. 1683288, issued August 17, 2022 – Extensions of Protection to: Canada, China, European Union,
Israel, Mexico, United Kingdom); DROPLET Design (Reg. No. 1545038, issued June 29, 2020 – Extensions of Protection to: Canada,
European Union, Israel, Japan, Norway, Republic of Korea, Switzerland, Turkey, United Kingdom); European Union: TONIX ONE LOGO
Design (Registration No. 019151272, issued July 9, 2025); United Kingdom: TOSYMRA, Reg. No. UK00801501060.

47

Tonix
Pharma Limited

We
are the owner of the mark TONMYA for which U.S. Application Serial Number: 97/185424, filed December 22, 2021, is currently pending.

Research
and Development

We
have approximately 70 employees dedicated to research and development. Our research and development operations are located in
Berkeley Heights, NJ, Frederick, Maryland, Dublin, Ireland and Montreal, Canada. We have used, and expect to continue to use, third parties
to conduct our nonclinical and clinical studies.

Manufacturing

We
have contracted with third-party cGMP-compliant contract manufacturer organizations(“CMOs”), for the manufacture of
TNX-102 SL drug substance and drug products for clinical and commercial supply. Our manufacturing operations are managed and controlled
out of our Dublin, Ireland offices.

All
of our small molecules drug candidates are synthesized using industry standard processes, and our drug products are formulated
using commercially available pharmaceutical grade excipients.

We own a 45,000 square foot facility in Massachusetts, to house our new
Advanced Development Center for accelerated development and manufacturing of vaccines and biologics. This facility is currently decommissioned.
It was designed for the manufacture of nonclinical and clinical investigational products for our Infectious Disease portfolio. The current
focus of which is TNX-801 a Smallpox and Mpox Preventing Vaccine. This facility was decommissioned in 2024 but may be reactivated the
earlier of 2027 or in the case of a national or international emergency.

Our
other marketed products, Zembrace and Tosymra, are manufactured at cGMP compliant, FDA audited, U.S. based CMOs with expertise
in pre-filled syringe and inhalation expertise.

Government
Regulations

Government
authorities in the United States, at the federal, state and local level, and other countries extensively regulate, among other things,
the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion,
advertising, distribution, post-approval monitoring and reporting, marketing and export and import of products such as those we are developing.

U.S.
Government Regulation

In
the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and its implementing regulations,
and biologics under the FDCA and the Public Health Service Act, or PHSA, and its implementing regulations. FDA approval is required before
any new unapproved drug or dosage form, including a new use of a previously approved drug, can be marketed in the United States. Drugs
and biologics are also subject to other federal, state and local statutes and regulations. If we fail to comply with applicable FDA or
other requirements at any time during the drug development process, clinical testing, the approval process or after approval, we may
become subject to administrative or judicial sanctions. These sanctions could include the FDA’s refusal to approve pending applications,
license suspension or revocation, withdrawal of an approval, warning letters, product recalls, product seizures, placement on Import
Alerts, debarment of personnel, employees or officers, total or partial suspension of production or distribution, injunctions, fines,
civil penalties or criminal prosecution.

The
process required by the FDA before product candidates may be marketed in the United States generally involves the following:

48

An
IND is a request for authorization from the FDA to administer an investigational new drug product to humans. The central focus of an
IND submission is on the general investigational plan and the protocol(s) for human studies. The IND also includes results of animal
and in vitro studies assessing the toxicology, pharmacokinetics, pharmacology and pharmacodynamic characteristics of the product; chemistry,
manufacturing and controls information; and any available human data or literature to support the use of the investigational new drug.
An IND must become effective before human clinical studies may begin. An IND will automatically become effective 30 days after receipt
by the FDA, unless before that time the FDA raises concerns or questions related to the proposed clinical studies. In such a case, the
IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before clinical
studies can begin. Accordingly, submission of an IND may or may not result in the FDA allowing clinical studies to commence.

Clinical
Studies

Clinical
studies involve the administration of the investigational new drug to human subjects under the supervision of qualified investigators
in accordance with GCPs, which include the requirement that all research subjects provide their informed consent for their participation
in any clinical study. Clinical studies are conducted under protocols detailing, among other things, the objectives of the study, and
the parameters to be used in monitoring safety and the efficacy criteria to be evaluated. A protocol for each clinical study and any
subsequent protocol amendments must be submitted to the FDA as part of the IND. Additionally, approval must also be obtained from each
clinical study site’s IRB before the studies may be initiated, and the IRB must monitor the study until completed. There are also
requirements governing the reporting of ongoing clinical studies and clinical study results to public registries, such as ClinicalTrials.gov.

The
clinical investigation of a drug or biologic is generally divided into three or four phases. Although the phases are usually conducted
sequentially, they may overlap or be combined.

A
confirmatory or pivotal study is a clinical study that adequately meets regulatory agency requirements for the evaluation of a drug candidate’s
efficacy and safety such that it can be used to justify the approval of the product. Generally, pivotal studies are Phase 3 studies,
but the FDA may accept results from Phase 2 studies if the study design provides a well-controlled and reliable assessment of clinical
benefit, particularly in situations where there is an unmet medical need and the results are sufficiently robust. In such cases, FDA
may require post-market studies for safety and efficacy to be conducted for the drug candidate. The FDA may withdraw the approval if
the results indicate that the approved drug is not safe or effective.

The
FDA, the IRB or the clinical study sponsor may suspend or terminate a clinical study at any time on various grounds, including a finding
that the research subjects are being exposed to an unacceptable health risk. Additionally, some clinical studies are overseen by an independent
group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board or committee. This group
provides authorization for whether or not a study may move forward at designated check points based on access to certain data from the
study. We may also suspend or terminate a clinical study based on evolving business objectives and/or competitive climate.

49

Chemistry,
Manufacturing and Control Information

Companies
seeking FDA approval of drugs must also develop data and information about the physical characteristics of the components of a product
as well as finalize processes for manufacturing the components in commercial quantities in accordance with GMP requirements.  The
manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the
sponsor must develop methods for testing the identity, strength, quality, potency and purity of the final product. Additionally, appropriate
packaging must be selected and tested, and stability studies must be conducted to demonstrate that the components of a product candidate
do not undergo unacceptable deterioration over their shelf life.

Submission
of an NDA or BLA to the FDA

Assuming
successful completion of all required testing in accordance with all applicable regulatory requirements, detailed investigational new
drug product information is submitted to the FDA in the form of an NDA or BLA requesting approval to market the product for one or more
indications. Under federal law, the submission of most NDAs and BLAs is subject to a substantial application user fee. Applications for
orphan drug products are exempted from the NDA and BLA application user fees.

An
NDA or BLA must include all relevant data available from pertinent preclinical and clinical studies, including negative or ambiguous
results as well as positive findings, together with detailed information relating to the product’s chemistry, manufacturing, controls
and proposed labeling, among other things. Data can come from company-sponsored clinical studies intended to test the safety and effectiveness
of a use of a product, or from a number of alternative sources, including studies initiated by investigators. To support marketing approval,
the data submitted must be sufficient in quality and quantity to establish the safety and effectiveness of the investigational product
to the satisfaction of the FDA.

Once
an NDA or BLA has been submitted, the FDA’s goal is to review the application within ten months after it accepts the application
for filing, or, if the application relates to an unmet medical need in a serious or life-threatening indication, six months after the
FDA accepts the application for filing. The review process is often significantly extended by FDA requests for additional information
or clarification.

Before
approving an NDA or BLA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not
approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements
and adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA or
BLA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP.

The
FDA is required to refer an application for an investigational drug or biologic to an advisory committee or explain why such referral
was not made. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews,
evaluates and provides a recommendation as to whether the investigational product application should be approved and under what conditions.
The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions
and typically follows such recommendations.

The
FDA’s Decision on an NDA or BLA

After
the FDA evaluates the NDA or BLA and conducts inspections of manufacturing facilities, it may issue an approval letter or a Complete
Response Letter. An approval letter authorizes commercial marketing of the drug or biologic with specific prescribing information for
specific indications. A Complete Response Letter indicates that the review cycle of the application is complete, and the application
is not ready for approval. A Complete Response Letter may require additional clinical data and/or an additional pivotal Phase 3 clinical
study(ies), and/or other significant, expensive and time-consuming requirements related to clinical studies, preclinical studies or manufacturing.
Even if such additional information is submitted, the FDA may ultimately decide that the NDA or BLA does not satisfy the criteria for
approval. The FDA could also approve the NDA or BLA with a REMS to mitigate risks, which could include medication guides, physician communication
plans or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.
The FDA also may condition approval on, among other things, changes to proposed labeling, development of adequate controls and specifications
or a commitment to conduct one or more post-market studies or clinical studies. Such post-market testing may include Phase 4 clinical
studies and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization. The FDA
may have the authority to withdraw its approval if post-market testing fails to verify the approved drug’s clinical benefit, if
the applicant does not perform the required testing with due diligence, or if the any other evidence demonstrates the approved drug is
not safe or effective, among other reasons. Also, new government requirements, including those resulting from new legislation, may be
established, or the FDA’s policies may change, which could delay or prevent regulatory approval of our products under development.

50

Expedited
Review and Accelerated Approval Programs

The
FDA has various programs, including fast track designation, breakthrough therapy designation, accelerated approval, regenerative medicine
advanced therapy and priority review, that are intended to expedite the development and approval of new drugs and biologics that address
unmet medical needs in the treatment of serious or life-threatening diseases and conditions. To be eligible for a fast-track designation,
the FDA must determine, based on the request of a sponsor, that a product is intended to treat a serious or life-threatening disease
or condition and demonstrates the potential to address an unmet medical need. The FDA may review sections of the NDA for a fast-track
product on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the
sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays
any required user fees upon submission of the first section of the NDA.

The
FDA may give a priority review designation to drugs that offer major advances in treatment or provide a treatment where no adequate therapy
exists. A priority review means that the goal for the FDA to review an application is six months, rather than the standard review of
ten months under current. These six and ten-month review periods are measured from the “filing” date rather than the receipt
date for NDAs for new molecular entities, which typically adds approximately two months to the timeline for review and decision from
the date of submission. Most products that are eligible for fast-track designation are also likely to be considered appropriate to receive
a priority review.

In
addition, products studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful
therapeutic benefit over existing treatments may be eligible for accelerated approval and may be approved on the basis of adequate and
well-controlled clinical studies establishing that the product has an effect on a surrogate endpoint that is reasonably likely to predict
clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably
likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity
or prevalence of the condition and the availability or lack of alternative treatments. As a condition of approval, the FDA may require
a sponsor of a drug receiving accelerated approval to perform post-marketing studies to verify and describe the predicted effect on irreversible
morbidity or mortality or other clinical endpoint, and the drug may be subject to accelerated withdrawal procedures.

Moreover,
under the provisions of the FDA Safety and Innovation Act passed in July 2012, a sponsor can request designation of a drug candidate
as a “breakthrough therapy.” A breakthrough therapy is defined as a drug or biologic that is intended, alone or in combination
with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence
indicates that the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints,
such as substantial treatment effects observed early in clinical development. Drugs designated as breakthrough therapies are also eligible
for the other expedited review and approval programs, including accelerated approval, priority review, regenerative medicine advanced
therapy, and fast-track designation. The FDA must take certain actions, such as holding timely meetings and providing advice, intended
to expedite the development and review of an application for approval of a breakthrough therapy.

In
addition, the 21st Century Cures Act in 2016 made the Regenerative Medicine Advanced Therapy, or RMAT, designation available for investigational
drugs that are intended to treat, modify, reverse, or cure a serious condition, with preliminary clinical evidence indicating that the
drug has the potential for addressing unmet medical needs for such condition. The RMAT designation is available for cell therapy, therapeutic
tissue engineering products, human cell and tissue products, and combination products that use such therapies or products. The advantages
of RMAT designation include those of breakthrough and fast track designations, such as early interactions with FDA and rolling review
of applications, and the drug candidate with the RMAT designation may be eligible for accelerated approval. Requests for RMAT designations
should be made with the IND application (if preliminary clinical evidence is available), but no later than the end-of-phase-2 meeting.

Even
if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for
qualification or decide that the time period for FDA review or approval will not be shortened.

Post-Approval
Requirements

Drugs
and biologics marketed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other
things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and
reporting of adverse experiences with the product. After approval, most changes to the approved product, such as adding new indications
or other labeling claims are subject to prior FDA review and approval. There also are continuing, annual user fee requirements.

51

Manufacturers
are subject to periodic unannounced inspections by the FDA and state agencies for compliance with cGMP requirements. Changes to the manufacturing
process are strictly regulated and, depending on the significance of the change, may require prior FDA approval before being implemented.
FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements
upon us and any third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue to expend time, money and
effort in the area of production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance.

Discovery
of previously unknown problems with a product or the failure to comply with applicable requirements may result in restrictions on a product,
manufacturer or holder of an approved NDA or BLA, including withdrawal or recall of the product from the market or other voluntary, FDA-initiated
or judicial action that could delay or prohibit further marketing. Also, new government requirements, including those resulting from
new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory approval of our
products under development.

The
FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product
reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity
or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved
labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks; or imposition
of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things.

The
FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Drugs may be promoted
only for the approved indications and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce
the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label
uses may be subject to significant liability.

Pediatric
Exclusivity

Pediatric
exclusivity is another type of non-patent marketing exclusivity in the United States and, if granted, provides for the attachment of
an additional six months to the term of any existing patent or regulatory exclusivity for drug products. This six-month exclusivity may
be granted if an NDA sponsor submits pediatric data that fairly respond to a written request from the FDA for such data. The data do
not need to show the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly respond
to the FDA’s request, the additional protection is granted. If reports of requested pediatric studies are submitted to and accepted
by the FDA within the statutory time limits, whatever statutory or regulatory periods of exclusivity or patent protection cover the product
are extended by six months. This is not a patent term extension, but effectively extends the regulatory period during which the FDA cannot
approve another application. With regard to patents, the six-month pediatric exclusivity period will not attach to any patents for which
a generic (ANDA or 505(b)(2) NDA) sponsor submitted a Paragraph IV certification, unless the NDA sponsor or patent owner first obtains
a court determination that the patent is valid and infringed by a proposed generic product.

Orphan
Designation and Exclusivity

Under
the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, defined
as a disease or condition with a patient population of fewer than 200,000 individuals in the United States, or a patient population greater
than 200,000 individuals in the United States and when there is no reasonable expectation that the cost of developing and making available
the drug or biologic in the United States will be recovered from sales in the United States for that drug or biologic. Orphan drug designation
must be requested before submitting a BLA or NDA. After the FDA grants orphan drug designation, the generic identity of the therapeutic
agent and its potential orphan use are disclosed publicly by the FDA.

52

If
a product that has orphan drug designation subsequently receives the first FDA approval for a particular active ingredient for the disease
for which it has such designation, the product is entitled to orphan product marketing exclusivity, which means that the FDA may not
approve any other applications, including a full BLA, to market the same biologic for the same use or indication for seven years, except
in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity or if FDA finds that
the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug
to meet the needs of patients with the disease or condition for which the drug was designated. Orphan drug exclusivity does not prevent
the FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic for a different disease
or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the BLA or NDA
application user fee.

A
designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which
it received orphan designation. In addition, orphan drug exclusive marketing rights in the United States may be lost if the FDA later
determines that the request for designation was materially defective or, as noted above, if the second applicant demonstrates that its
product is clinically superior to the approved product with orphan exclusivity or the manufacturer of the approved product is unable
to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.

Biosimilars
and Exclusivity

The
Affordable Care Act, signed into law in 2010, includes a subtitle called the Biologics Price Competition and Innovation Act of 2009,
or BPCIA, which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed
reference biological product. To date, only a handful of biosimilars have been licensed under the BPCIA, although numerous biosimilars
have been approved in Europe. The FDA has issued several guidance documents outlining an approach to review and approval of biosimilars.

Biosimilarity,
which requires that there be no clinically meaningful differences between the biological product and the reference product in terms of
safety, purity and potency, can be shown through analytical studies, human PK and PD studies, clinical immunogenicity assessments, animal
studies and a clinical study or studies. Interchangeability requires that a product is biosimilar to the reference product and the product
must demonstrate that it can be expected to produce the same clinical results as the reference product in any given patient and, for
products that are administered multiple times to an individual, the biologic and the reference biologic may be alternated or switched
after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use
of the reference biologic. However, complexities associated with the larger, and often more complex, structures of biological products,
as well as the processes by which such products are manufactured, pose significant hurdles to implementation of the abbreviated approval
pathway that are still being worked out by the FDA.

Under
the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference
product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12
years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may
still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing that applicant’s
own preclinical data and data from adequate and well-controlled clinical studies to demonstrate the safety, purity and potency of its
product. The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products. At this juncture, it
is unclear whether products deemed “interchangeable” by the FDA will, in fact, be readily substituted by pharmacies, which
are governed by state pharmacy law.

A
biological product can also obtain pediatric market exclusivity in the United States. Pediatric exclusivity, if granted, adds six months
to existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection
or patent term, may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued “Written
Request” for such a study.

The
BPCIA is complex and continues to be interpreted and implemented by the FDA. In addition, recent government proposals have sought to
reduce the 12-year reference product exclusivity period. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions,
have also been the subject of recent litigation. As a result, the ultimate impact, implementation, and impact of the BPCIA is subject
to significant uncertainty.

Hatch-Waxman
Amendments, 505(b)(2) NDAs and Exclusivity

Section
505 of the FDCA describes three types of marketing applications that may be submitted to the FDA to request marketing authorization for
a new drug. A Section 505(b)(1) NDA is an application that contains full reports of investigations of safety and efficacy. A 505(b)(2)
NDA is an application that contains full reports of investigations of safety and efficacy but where at least some of the information
required for approval comes from investigations that were not conducted by or for the applicant and for which the applicant has not obtained
a right of reference or use from the person by or for whom the investigations were conducted. This regulatory pathway enables the applicant
to rely, in part, on the FDA’s prior findings of safety and efficacy for an existing product, or published literature, in support
of its application. Section 505(j) establishes an abbreviated approval process for a generic version of approved drug products through
the submission of an ANDA. An ANDA provides for marketing of a generic drug product that has the same active ingredients, dosage form,
strength, route of administration, labeling, performance characteristics and intended use, among other things, to a previously approved
product. ANDAs are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical
(human) data to establish safety and efficacy. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent
to, or performs in the same manner as, the innovator drug through in vitro, in vivo or other testing. The generic version must deliver
the same amount of active ingredients into a subject’s bloodstream in the same amount of time as the innovator drug and can often
be substituted by pharmacists under prescriptions written for the reference listed drug. In seeking approval for a drug through an NDA,
applicants are required to list with the FDA each patent with claims that cover the applicant’s drug or a method of using the drug.
Upon approval of a drug, each of the patents listed in the application for the drug is then published in the Orange Book. Drugs listed
in the Orange Book can, in turn, be cited by potential competitors in support of approval of an ANDA or 505(b)(2) NDA.

53

Upon
submission of an ANDA or a 505(b)(2) NDA, an applicant must certify to the FDA that (1) no patent information on the drug product that
is the subject of the application has been submitted to the FDA; (2) such patent has expired; (3) the date on which such patent expires;
or (4) such patent is invalid or will not be infringed upon by the manufacture, use or sale of the drug product for which the application
is submitted. Generally, the ANDA or 505(b)(2) NDA cannot be approved until all listed patents have expired, except where the ANDA or
505(b)(2) NDA applicant challenges a listed patent through the last type of certification, also known as a paragraph IV certification.
If the applicant does not challenge the listed patents or indicates that it is not seeking approval of a patented method of use, the
ANDA or 505(b)(2) NDA application will not be approved until all of the listed patents claiming the referenced product have expired.

If
the ANDA or 505(b)(2) NDA applicant has provided a Paragraph IV certification to the FDA, the applicant must send notice of the Paragraph
IV certification to the NDA and patent holders once the application has been accepted for filing by the FDA. The NDA and patent holders
may then initiate a patent infringement lawsuit in response to the notice of the paragraph IV certification. If the paragraph IV certification
is challenged by an NDA holder or the patent owner(s) asserts a patent challenge to the paragraph IV certification, the FDA may not approve
that application until the earlier of 30 months from the receipt of the notice of the paragraph IV certification, the expiration of the
patent, when the infringement case concerning each such patent was favorably decided in the applicant’s favor or settled, or such
shorter or longer period as may be ordered by a court. This prohibition is generally referred to as the 30-month stay. In instances where
an ANDA or 505(b)(2) NDA applicant files a paragraph IV certification, the NDA holder or patent owner(s) regularly take action to trigger
the 30-month stay, recognizing that the related patent litigation may take many months or years to resolve.

The
FDA also cannot approve an ANDA or 505(b)(2) application until all applicable non-patent exclusivities listed in the Orange Book for
the branded reference drug have expired. For example, a pharmaceutical manufacturer may obtain five years of non-patent exclusivity upon
NDA approval of a new chemical entity, or NCE, which is a drug containing an active moiety that has not been approved by FDA in any other
NDA. An “active moiety” is defined as the molecule responsible for the drug substance’s physiological or pharmacologic
action. During that five-year exclusivity period, the FDA cannot accept for filing (and therefore cannot approve) any ANDA seeking approval
of a generic version of that drug or any 505(b)(2) NDA that relies on the FDA’s approval of the drug, provided that that the FDA
may accept an ANDA four years into the NCE exclusivity period if the ANDA applicant also files a Paragraph IV certification.

A
drug, including one approved under Section 505(b)(2), may obtain a three-year period of exclusivity for a particular condition of approval,
or change to a marketed product, such as a new formulation for a previously approved product, if one or more new clinical studies (other
than bioavailability or bioequivalence studies) was essential to the approval of the application and was conducted/sponsored by the applicant.
Should this occur, the FDA would be precluded from approving any ANDA or 505(b)(2) application for the protected modification until after
that three-year exclusivity period has run. However, unlike NCE exclusivity, the FDA can accept an application and begin the review process
during the exclusivity period.

A
Section 505(b)(2) NDA may be submitted for a drug for which one or more of the investigations relied upon by the applicant was not conducted
by or for the applicant and for which the applicant has no right of reference from the person by or for whom the investigations were
conducted. A Section 505(b)(2) NDA may be submitted based in whole or in part on published literature or on the FDA’s finding of
safety and efficacy of one or more previously approved drugs, which are known as reference drugs. Thus, the filing of a Section 505(b)(2)
NDA may result in approval of a drug based on fewer clinical or nonclinical studies than would be required under a full NDA. The number
and size of studies that need to be conducted by the sponsor depends on the amount and quality of data pertaining to the reference drug
that are publicly available, and on the similarity of and differences between the applicant’s drug and the reference drug. In some
cases, extensive, time-consuming, and costly clinical and nonclinical studies may still be required for approval of a Section 505(b)(2)
NDA.

54

Our
drug approval strategy for our new formulations of approved chemical entities is to submit Section 505(b)(2) NDAs to the FDA. TONMYA
was approved as a Section 505(b)(2) NDA and we plan to submit an 505(b)(2)for TNX-2900 for Prader Willi Syndrome. The FDA may not agree
that our product candidates are approvable as Section 505(b)(2) NDAs. If the FDA determines that a Section 505(b)(2) NDA is not appropriate
and that a full NDA is required, the time and financial resources required to obtain FDA approval could substantially and materially
increase and be less likely to be approved. If the FDA requires a full NDA or requires more extensive testing and development for some
other reason, our ability to compete with alternative products that arrive on the market more quickly than our product candidates would
be adversely impacted. If reference listed products are withdrawn from the market by the FDA for a safety reason, we may not be able
to reference such products to support our anticipated 505(b)(2) NDAs, and we may be required to follow the requirements of Section 505(b)(1).

Patent
Term Restoration and Extension

A
patent claiming a new drug product, its method of use or its method of manufacture may be eligible for a limited patent term extension
under the Hatch-Waxman Act, which permits a patent restoration of up to five years for patent term lost during product development and
the FDA regulatory review. The restoration period granted on a patent covering a product is typically one-half the time between the effective
date of when a clinical trial involving human beings has begun and the submission date of an application for approval, plus the time
between the submission date of an application and the ultimate approval date. Patent term restoration cannot be used to extend the remaining
patent term past a total of 14 years from the product’s approval date. Only one patent applicable to an approved product is eligible
for the extension, and the application for the extension must be submitted prior to the expiration of the patent in question. A patent
that covers multiple products for which approval is sought can only be extended in connection with one of the approvals. The USPTO reviews
and approves the application for any patent term extension or restoration in consultation with the FDA.

Material
Threat Medical Countermeasures

In
2016, the 21st Century Cures Act, or Act, was signed into law to support ongoing biomedical innovation. One part of the Act,
Section 3086, is aimed at “Encouraging Treatments for Agents that Present a National Security Threat.” The Act created a
new priority review voucher program for approved “material threat medical countermeasure applications.” The Act defines such
countermeasures as drug or biological products, including vaccines intended to treat biological, chemical, radiological, or nuclear agents
that present a national security threat or to treat harm from a condition that may be caused by administering a drug or biological product
against such an agent. The Department of Homeland Security has identified 13 such threats, including anthrax, smallpox, Ebola/Marburg,
tularemia, botulinum toxin, and pandemic influenza, which includes SARS-CoV-2.

Other
Healthcare Laws and Compliance Requirements

Pharmaceutical
companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states
and foreign jurisdictions in which they conduct their business. Such laws include, without limitation, state and federal anti-kickback,
fraud and abuse, false claims, privacy and security and physician sunshine laws and regulations. If their operations are found to be
in violation of any of such laws or any other governmental regulations that apply, they may be subject to penalties, including, without
limitation, civil and criminal penalties, damages, fines, the curtailment or restructuring of operations, exclusion from participation
in federal and state healthcare programs and individual imprisonment.

Coverage
and Reimbursement

Sales
of any product depend, in part, on the extent to which such product will be covered by third-party payors, such as federal, state and
foreign government healthcare programs, commercial insurance and managed healthcare organizations and the level of reimbursement for
such product by third-party payors. Decisions regarding the extent of coverage and amount of reimbursement to be provided are made on
a plan-by-plan basis. These third-party payors are increasingly reducing reimbursements for medical products, drugs and services. In
addition, the U.S. government, state legislatures and foreign governments have continued implementing cost-containment programs, including
price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. Adoption of price controls
and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could
further limit sales of any product. Decreases in third-party reimbursement for any product or a decision by a third-party payor not to
cover a product could reduce physician usage and patient demand for the product and also have a material adverse effect on sales. Even
after FDA approves a product, failure to have the product covered by third-party payors may have material adverse effect on sales. Federal
and state governments continue to promulgate new policies and regulations; such policies and regulations may have material adverse effect
on sales. These laws and regulations may restrict, prohibit, or preventing us from implementing a wide range of pricing, discounting,
marketing, promotion, sales commission, incentive programs, and other business activities. No uniform policy of coverage and reimbursement
among third-party payors exists in the United States. Such payors often rely upon Medicare coverage policy establishing their coverage
and reimbursement policies. However, each payor makes independent and separate decisions regarding the extent of coverage and amount
of reimbursement to be provided.

55

Legislative
and Regulatory Changes, Including Health Care Reform

The
laws and regulation that affect our business are subject to change from time to time, and entirely new laws and regulations are sometimes
adopted.  In particular, healthcare reforms that have been adopted, and that may be adopted in the future, could result in further
reductions in coverage and levels of reimbursement for pharmaceutical products, increases in rebates payable under U.S. government rebate
programs and additional downward pressure on pharmaceutical product prices. Individual states in the United States have also become
increasingly active in implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement
constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in
some cases, proposing to encourage importation from other countries and bulk purchasing. It is unclear to what extent these and
other statutory, regulatory, and administrative initiatives will be enacted and implemented.

Foreign
Corrupt Practices Act

Our
business activities may be subject to the Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery or anti-corruption laws, regulations
or rules of other countries in which we operate. The FCPA generally prohibits offering, promising, giving, or authorizing others to give
anything of value, either directly or indirectly, to a non-U.S. government official in order to influence official action, or otherwise
obtain or retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect
the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. Our business is heavily
regulated and therefore involves significant interaction with public officials, including officials of non-U.S. governments. Additionally,
in many other countries, the health care providers who prescribe pharmaceuticals are employed by their government, and the purchasers
of pharmaceuticals are government entities; therefore, our dealings with these prescribers and purchasers are subject to regulation under
the FCPA. There is no certainty that all of our employees, agents, suppliers, manufacturers, contractors, or collaborators, or those
of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws.
Violations of these laws and regulations could result in fines, criminal sanctions against us, our officers, or our employees, the closing
down of facilities, including those of our suppliers and manufacturers, requirements to obtain export licenses, cessation of business
activities in sanctioned countries, implementation of compliance programs, and prohibitions on the conduct of our business. Any such
violations could include prohibitions on our ability to offer our products in one or more countries as well as difficulties in manufacturing
or continuing to develop our products, and could materially damage our reputation, our brand, our international expansion efforts, our
ability to attract and retain employees, and our business, prospects, operating results, and financial condition.

European
Union Drug Development

In
the European Union, our product candidates may also be subject to extensive regulatory requirements. As in the United States, medicinal
products can only be marketed if a marketing authorization from the competent regulatory agencies has been obtained.

Similar
to the United States, the various phases of preclinical and clinical research in the European Union are subject to significant regulatory
controls. Clinical trials of medicinal products in the European Union must be conducted in accordance with European Union, national regulations
and international standards for good clinical practice, or GCP.

Clinical
trials are currently governed by EU Clinical Trials Directive 2001/20/EC that set out common rules for the control and authorization
of clinical trials in the European Union.

To
improve the current system, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use was adopted in 2014. The
Regulation aims at harmonizing and streamlining the clinical trials authorization process, simplifying adverse event reporting procedures,
improving the supervision of clinical trials, and increasing their transparency, notably via a clinical trial information system set
up by the EMA. The new Regulation expressly provides that it will not be applied before six months after the publication of a notice
delivered by the European Commission on the European Union clinical trial portal and database. As such notice requires a successful (partial)
audit of the database and as that database is still under development, there is no scheduled application date yet. Pursuant to the transitory
provisions of the new regulation, the Clinical Trials Directive 2001/20/EC will still apply for three years after the implementation
of the European Union clinical trial portal and database. Thus, the sponsor has the possibility to choose between the requirements of
the directive and the regulation for a period of three years from the entry into force of the regulation.

56

European
Union Drug Review and Approval

In
the EEA (which is comprised of the 28 Member States of the European Union plus Norway, Iceland and Liechtenstein), medicinal products
can only be commercialized after obtaining a Marketing Authorization, or MA. MAs may be granted either centrally (Community MA) or nationally
(National MA).

The
Community MA is issued centrally by the European Commission through the Centralized Procedure, based on the opinion of the CHMP of the
EMA and is valid throughout the entire territory of the EEA. The Centralized Procedure is mandatory for certain types of products such
as orphan medicinal products and medicinal products containing a new active substance indicated for the treatment of neurodegenerative
disorders. The Centralized Procedure is optional for products containing a new active substance not yet authorized in the EEA, or for
products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health
in the European Union.

National
MAs are issued nationally by the competent authorities of the Member States of the EEA and only cover their respective territory. National
MAs are available for products not falling within the mandatory scope of the Centralized Procedure. We do not foresee that any of our
current product candidates will be suitable for a National MA as they fall within the mandatory criteria for the Centralized Procedure.
Therefore, our product candidates will be approved through Community MAs.

Under
the above-described procedures, before granting the MA, the EMA or the competent authorities of the Member States of the EEA make an
assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.

The
pediatric use marketing authorization, or PUMA, is a dedicated marketing authorization for medicinal products indicated exclusively for
use in the pediatric population, with, if necessary, an age-appropriate formulation. Pursuant to Regulation (EC) No. 1901/2006 (The “Pediatric
Regulation”), all PUMA applications for marketing authorization for new medicines must include to be valid, in addition to
the particulars and documents referred to in Directive 2001/83/EC, the results of all studies performed and details of all information
collected in compliance with a pediatric investigation plan agreed between regulatory authorities and the applicant, unless the medicine
is exempt because of a deferral or waiver of the EMA.

Before
the EMA is able to begin its assessment of a Community MA application, it will validate that the applicant has complied with the agreed
pediatric investigation plan. The applicant and the EMA may, where such a step is adequately justified, agree to modify a pediatric investigation
plan to assist validation. Modifications are not always possible; may take longer to agree than the period of validation permits; and
may still require the applicant to withdraw its marketing authorization application and to conduct additional non-clinical and clinical
studies. Products that are granted a MA on the basis of the pediatric clinical trials conducted in accordance with the Pediatric Investigation
Plan, or PIP, are eligible for a six-month extension of the protection under a supplementary protection certificate (if any is in effect
at the time of approval) or, in the case of orphan medicinal products, a two-year extension of the orphan market exclusivity. This pediatric
reward is subject to specific conditions and is not automatically available when data in compliance with the PIP are developed and submitted.

Orphan
Drugs

In
the European Union, Regulation (EC) No 141/2000 of the European Parliament and of the Council of December 16, 1999 on orphan medicinal
products, as amended, states that a drug shall be designated as an orphan drug if its sponsor can establish that the three following
cumulative conditions are met:

Pursuant
to Regulation (EC) No. 847/2000 of April 27, 2000 laying down the provisions for implementation of the criteria for designation of a
medicinal product as an orphan medicinal product and definitions of the concepts “similar medicinal product” and “clinical
superiority”, an application for the designation of a drug as an orphan drug must be submitted at any stage of development of the
drug before filing of a MA application.

57

The
European Union offers incentives to encourage the development of designated orphan medicines (protocol assistance, fee reductions, etc.)
and provides opportunities for market exclusivity. Pursuant to abovementioned Regulation (EC) No. 141/2000, products receiving orphan
designation in the European Union can obtain market exclusivity for a certain number of years in the European Union following the marketing
approval.

If
a Community MA in respect of an orphan drug is granted, regulatory authorities will not, for a period of usually ten years, accept another
application for a MA, or grant a MA or accept an application to extend an existing MA, for the same therapeutic indication, in respect
of a similar drug. This period may however be reduced to six years if, at the end of the fifth year, it is established, in respect of
the drug concerned, that the above-mentioned criteria for orphan drug designation are no longer met, in other words, when it is shown
on the basis of available evidence that the product is sufficiently profitable not to justify maintenance of market exclusivity.

Pursuant
to Regulation No. 1901/2006, for orphan medicinal products, instead of an extension of the supplementary protection certificate, the
ten-year period of orphan market exclusivity should be extended to 12 years if the requirement for data on use in the pediatric population
is fully met (i.e. when the request contains the results of all studies carried out under the approved PIP and when the declaration attesting
the conformity of the request to this PIP is included in the MA).

Notwithstanding
the foregoing, a MA may be granted, for the same therapeutic indication, to a similar drug if:

The
abovementioned Regulation (EC) No. 141/2000 provides for other incentives regarding orphan medicinal products.

Post-Approval
Controls

The
holder of a MA must comply with EU requirements applicable to manufacturing, marketing, promotion and sale of medicinal products. In
particular, the holder of the MA must establish and maintain a pharmacovigilance system and appoint an individual qualified person for
pharmacovigilance, or QPPV, who is responsible for oversight of that system and who will reside and operate in the EU. Key obligations
include safety expedited reporting of suspected serious adverse reactions and submission of periodic safety update reports, or PSURs.

All
new MAs must include a risk management plan, or RMP, to submit to the EMA, describing the risk management system that the company will
put in place and documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also
impose specific obligations as a condition of the MA. Such risk-minimization measures or post-authorization obligations may include additional
safety monitoring, more frequent submission of PSURs, or the conduct of additional clinical trials or post-authorization safety studies.
RMPs and PSURs are routinely available to third parties requesting access, subject to limited redactions. All advertising and promotional
activities for the product must be consistent with the approved summary of product characteristics, and therefore all off-label promotion
is prohibited. Direct-to-consumer advertising of prescription medicines is also prohibited in the European Union. Although general requirements
for advertising and promotion of medicinal products are established under EU directives, the details are governed by regulations in each
EU Member State and can differ from one country to another.

Reimbursement

The
European Union provides options for its Member States to restrict the range of medicinal products for which their national health insurance
systems provide reimbursement and to control the prices of medicinal products for human use. A Member State may approve a specific price
for the medicinal product, or it may instead adopt a system of direct or indirect controls on the profitability of the company placing
the medicinal product on the market. For example, in France, effective market access will be supported by agreements with hospitals and
products may be reimbursed by the Social Security Fund. The price of medicines covered by national health insurance is negotiated with
the Economic Committee for Health Products, or CEPS. There can be no assurance that any country that has price controls or reimbursement
limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our product candidates.
Historically, products launched in the European Union do not follow price structures of the United States and generally prices tend to
be significantly lower.

58

Human
Capital Resources

As of March 12, 2026, we had 142 full-time employees, of whom 29 hold M.D.
or Ph.D. degrees. We have 70 employees dedicated to research and development. We have 10 employees supporting sales administration and
marketing initiatives; customer service requests and top-tier headache specialists. None of our employees are represented by a collective
bargaining agreement. We believe that the skills, experience and industry knowledge of our key employees significantly benefit our operations
and performance. Our research and development operations are located in Berkeley Heights, New Jersey, Dartmouth, Massachusetts, Frederick,
Maryland, Dublin, Ireland and Montreal, Canada. We have used, and expect to continue to use, third parties to conduct our nonclinical
and clinical studies as well as part-time employees.

Employee
health and safety in the workplace is one of our core values.

Employee
levels are managed to align with the pace of business and management believes it has sufficient human capital to operate its business
successfully.

Corporate
Information

We
lease the space for our principal executive offices, which are located at 200 Connell Drive, Suite 3100, Berkeley Heights, New
Jersey 07922, and our telephone number is (862) 799 8599. Our website address is www.tonixpharma.com. We do not incorporate the
information on our websites into this Annual Report, and you should not consider such information part of this Annual Report.

We
were incorporated on November 16, 2007, under the laws of the State of Nevada as Tamandare Explorations Inc. On October 11, 2011,
we changed our name to Tonix Pharmaceuticals Holding Corp.